legislation

The problem with mandatory breast density reporting laws

oracknows — Mon, 15 Jun 2015 01:00:20 +0000

The problem with mandatory breast density reporting laws

Over the years, I've written a lot about the intersection between the law and science in medicine. Sometimes, I support a particular bill, such as SB 277. Sometimes I oppose a bill, such as right-to-try or laws licensing naturopaths. The case I will discuss here is unusual in that it is a case of the law getting ahead of what the science says in a manner that will likely do little, if any, good for patients, cause a lot of confusion until the science is worked out better, and end up costing patients money for little or no benefit. I am referring to laws mandating the reporting of high-breast-density to women with dense breasts undergoing mammography. These laws are sweeping the country (albeit not as rapidly as "right-to-try" laws), with a total of 22 states having passed them as of today since Connecticut became the first to do so in 2009. The most recent of these laws went into effect in my own state of Michigan exactly two weeks ago:

Women with dense breast tissue — the sort that can hide potentially deadly tumors from routine mammograms — must be notified in writing and encouraged to consider additional tests under a new state law that is effective Monday.

While mammograms remain the gold standard for detecting breast tumors, they're less reliable in almost half of women with dense breast tissue. Dense or fibrous tissue shows up as splotches of white on a mammogram — so do tumors.

That will likely surprise many of the millions of women who rely on mammography for catching the earliest signs of cancer, said Nancy Cappello. The Connecticut woman was shocked in 2004, when her gynecologist found a lump — advanced cancer that had already spread to her lymph nodes — just months after a mammogram deemed her cancer-free.

Yes, mammography is imperfect, and I have not shied away from discussing its imperfections and problems, such as overdiagnosis leading to overtreatment. All these issues aside, a review by the World Health Organization (WHO) International Agency for Research on Cancer (IARC) of mammographic screening hot off the presses last week in the New England Journal of Medicine nonetheless concluded that, for women between the ages of 50 and 74 at least, there is sufficient evidence to conclude that mammographic screening results in a significant reduction in the risk of dying of breast cancer, although the same report affirmed doubts about the adequacy of evidence for women between the ages of 40 and 49 that the USPSTF originally used in 2009 to base its recommendation that mammographic screening not begin until age 50 for most women. In other words, mammography, as imperfect as it is, does reduce the risk of death from breast cancer in women over 50.

Breast density, mammography, and cancer risk

It has long been known that mammography tends to be less effective in women with dense breasts. What is causes "density" on mammographic imaging is the high level of fibrous and glandular tissue relative to fatty tissue compared to breasts that are not considered dense. The reasons why mammographic screening of dense breasts might be less effective are fairly simple to understand. Mammography is basically an X-ray of the breast taken in a specified, highly standardized manner. As such, the image rendered shows up as areas of white and dark, with the white representing denser tissue and the dark less dense tissue, usually fat, which lets X-rays pass through easily. Lesions suspicious for breast cancer manifest themselves as a density that stands out among the darker, less dense tissue, of which there are two kinds: a tissue density or calcifications. I could ramble on and on and on about what characteristics make a tissue density or an area of calcifications suspicious and another area of tissue density or calcifications benign-appearing (or at least much less suspicious). The details aren't important for purposes of this post. What is important for purposes of understanding the effect of mammographic density on the ability to detect cancer is that it depends on the contrast between the denser lesions that are suspicious for cancer and the surrounding breast and fatty tissue. The less contrast there is, the harder it is for the radiologist, even with computer-aided detection, to differentiate between suspicious lesions and normal breast tissue. That's why mammography works really well in breasts that are largely replaced by fatty tissue, as is the case in many postmenopausal women, in whom dense breast tissue is less common than in premenopausal women. Basically, as estrogen and progesterone levels plummet, over time the glandular tissue in postmenopausal breasts becomes replaced with fatty tissue.

Just to give you an idea, here are images of breasts of low, intermediate, and high density on mammography:

And here is an example of what microcalcifications look like:

And of how many breast cancers appear on mammography:

You can see how it would be more difficult to see these lesions in dense breasts, especially when they are more subtle and not as obvious. Indeed, the National Cancer Institute (NCI) points out on its website that the "main cause of false-negative results is high breast density." In any case, the reason why mammography is more problematic in women aged 40 to 49 boils down to the fact that most premenopausal women have denser breasts due to higher levels of hormones and the incidence of breast cancer is lower, such that a positive finding is much more likely to be a false positive than a true positive than it is in older women. As I've explained before, for a screening program to be effective, the disease being screened for has to be sufficiently common for this not to happen. There's a reason why even the most zealous supporters of mammography don't recommend that routine screening begin before age 40; breast cancer incidence is just too low in this age group.

So far, so clear (I hope). However, recent science has thrown a new wrinkle into the equation. That science is the consensus that has emerged over the last couple of decades, based on numerous studies, that breast density is an independent risk factor for the development of breast cancer. In other words, women who have dense breasts, all other clinical characteristics being equal, have a higher risk of developing breast cancer. According to a recent review article, women with the highest breast density have a risk that is 2 to 6 times higher than women with the lowest breast density, and that as many as 30% of postmenopausal women still have dense breasts. Breast density correlates with a number of factors, including age (negative correlation), serum and tissue hormone levels (positive correlation), genetics, and body mass index (negative). Paradoxically, although high BMI is correlated with decreased breast density, obesity is correlated with an increased risk of breast cancer in postmenopausal women.

Because breast density is an independent predictor of breast cancer risk, naturally, the question has been asked what the biology is behind this and whether it is a modifiable risk factor. (Indeed, in the interests of full disclosure, I have been involved in a study that asks that very question and uses a new ultrasound technology to quantify breast density.) It is known, for instance, that Tamoxifen can decrease breast density, and it is also known that Tamoxifen can decrease the risk of breast cancer significantly in women at high risk. Are the two related? Does Tamoxifen's ability to decrease breast cancer risk have to do with its ability to decrease breast density? We don't yet know. Does the decrease in breast density due to Tamoxifen cause the decrease in risk or is the decreased breast density an epiphenomenon associated with the decreased risk? We don't yet know. Does reduction in breast density over time correlate with decreased breast cancer risk? Yes, to some extent. A recent case control study, for instance, found that women who did not develop breast cancer showed a decrease in mammographic density between first and second prediagnostic mammogram compared to women who did develop breast cancer, who did not.

In other words, it's complicated, and the science is far from settled. We know that breast density is associated with an increased risk of breast cancer, but the biology is not well understood, we don't yet know if it's a modifiable risk factor, and we don't know the molecular basis. All we know are factors that are associated with increased breast density and that increased breast density is an independent risk factor for breast cancer. Research is ongoing and likely will be ongoing for quite some time before answers start to become clear.

Mandatory breast density reporting

It's impossible to discuss mandatory breast density reporting laws without discussing the woman who started the movement, Nancy Cappello, PhD, and her organization Are You Dense? Advocacy, whose mission is described as:

To ensure that women with dense breast tissue have access to an early breast cancer diagnosis. To that end, women need to be informed of their breast density, the limitations of mammography to find cancer in dense breast tissue and the increased risk factor of dense breast tissue.

As described in the story I first cited above, Cappello's gynecologist found a lump months after she had had a "negative" mammogram in 2004, and she was diagnosed with stage IIIC breast cancer. As she herself relates in a recent article, "Decade of 'Normal' Mammography Reports–The Happygram":

I ate healthy, exercised daily, examined my breasts regularly, and underwent yearly mammography. I had no family history of breast cancer. In 2003, my annual screening mammogram was reported as normal, just as the decade of reports before 2003. I was faithful to my health care regimen; my routine annual gynecologic examination was 6 weeks later. As my physician was examining my breasts, she felt a ridge in my right breast and ordered diagnostic mammography and ultrasound. The diagnostic mammogram revealed nothing, but the ultrasound examination revealed a 2.5-cm mass. A breast biopsy confirmed invasive cancer, which was later verified as stage IIIC breast cancer. At the time of diagnosis, my tumor was more than 1 inch in size, and it had metastasized to 13 lymph nodes. The American Cancer Society reports the 5-year survival rate for stage IIIC breast cancer as 49%, compared with stage I at 88% [1]. I expected, in the event of a cancer diagnosis, an early stage because of my faithful program of annual screening mammography. I questioned my doctors as to what had happened. This was the first time that I was told that I had extremely dense tissue and that, as breast density increases, the sensitivity of mammography decreases.

I was stunned that my doctors knew about dense breast tissue and its impact on the effectiveness of mammography but had never informed me. I also discovered that my physician received reports generated by radiologists that included more details about my mammographic results and, as in most reports, my breast tissue composition. This information is usually not reported in the patient's "happygram" report. My decade of radiologists' reports, unknown to me, read, "Patient has extremely dense breasts…no change from prior exam." My radiologist knew that I had dense breasts. My doctor knew that I had dense breasts. The only person who did not know was me: the woman with the dense breasts.

Regular readers who have been paying attention to my posts on mammography and screening know that there is a huge misconception in this story, namely the belief that catching a cancer earlier results in a better chance of survival. It's a common misunderstanding, even among physicians. Clearly, Cappello doesn't understand the concept of lead time bias, but she's in good company. Neither do a lot of physicians. Basically, earlier detection can make survival after diagnosis seem longer even if the treatments used have no effect at all. It seems an opportune time to explain why this is by resurrecting one of my favorite explanations for lead time bias, by Aaron Carroll:

Let's say there's a new cancer of the thumb killing people. From the time the first cancer cell appears, you have nine years to live, with chemo. From the time you can feel a lump, you have four years to live, with chemo. Let's say we have no way to detect the disease until you feel a lump. The five year survival rate for this cancer is about 0, because within five years of detection, everyone dies, even on therapy.

Now I invent a new scanner that can detect thumb cancer when only one cell is there. Because it's the United States, we invest heavily in those scanners. Early detection is everything, right? We have protests and lawsuits and now everyone is getting scanned like crazy. Not only that, but people are getting chemo earlier and earlier for the cancer. Sure, the side effects are terrible, but we want to live.

We made no improvements to the treatment. Everyone is still dying four years after they feel the lump. But since we are making the diagnosis five years earlier, our five year survival rate is now approaching 100%! Everyone is living nine years with the disease. Meanwhile, in England, they say that the scanner doesn't extend life and won't pay for it. Rationing! That's why their five year survival rate is still 0%.

As I've said before, I don't think screening for breast cancer is useless. Neither does the WHO. It's just that the relationship between screening, finding cancer earlier, and increasing cancer survival is not simple. Would finding Cappello's cancer earlier have increased her chance of survival? There's no way of knowing because she was one of the lucky ones who survived stage IIIC cancer. In fairness, her treatment probably would have been less brutal, but it's impossible to know in any single case whether early detection would have made a difference.

So Cappello became an advocate, and a successful one. Over the last several years, she and her collaborators have successfully gotten notification bills passed in 22 states. The new law in Michigan is typical. In the case of a finding of increased breast density, it mandates that the patient receive a letter that states:

Your mammogram shows that your breast tissue is dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer through a mammogram. Also, dense breast tissue may increase your risk for breast cancer. This information about the result of your mammogram is given to you to raise your awareness. Use this information to discuss with your health care provider whether other supplemental tests in addition to your mammogram may be appropriate for you, based on your individual risk. A report of your results was sent to your ordering physician. If you are self-referred, a report of your results was sent to you in addition to this summary.

So what's wrong with this? More information is always a better thing, right? Even if it's vague and just tells the patient to discuss the matter with her health care provider? There's more wrong than you might think.

The problem with mandatory breast density reporting laws

There are a number of problems that these laws produce. The most difficult to navigate problems include what to recommend for these patients and how to reassure them. The reasons are simple. First, there is as yet no standardization for determining breast density, and, indeed, measuring density is still a fairly subjective process that radiologists do, with rather high interobserver variability. It is true that there are now automated systems designed to estimate breast density using image analysis, such as Volpara (there are other competing software systems), but most breast centers don't yet have them and still use the American College of Radiology BI-RADS lexicon. My breast center does (it's an NCI-designated Comprehensive Cancer Center, after all), but most mammography centers do not. Over time, no doubt the whole process will become much more standardized, but until then there will remain a lot of subjectivity in breast density assessments.

More importantly, indeed, most importantly of all, there is no consensus as to what to do next. As described in an editorial by Marcia Javitt, Section Editor for Women's Imaging Director of Medical Imaging, Rambam Healthcare Campus in Israel, no large randomized clinical trials have shown that breast cancer mortality is reduced by alternative screening and "although the use of alternative imaging techniques, such as breast ultrasound, breast MRI, digital breast tomosynthesis, and molecular breast imaging (MBI) may enable the detection of mammographically occult cancers in patients with increased breast density, refinement and validation are required for successful large-scale supplemental screening." The American Cancer Society guidelines call for MRI screening in addition to mammography for women at high lifetime risk (20-25%) to develop breast cancer, but states there is "insufficient evidence to recommend for or against MRI screening" in women whose mammographs indicate extremely dense or heterogeneous breast tissue. Javitt also notes that the potential number of women who would need to be considered for additional imaging after being informed of having heterogeneously or extremely dense breast tissue could be huge, adding that "if all of these women opt for adjunct screening procedures, a staggeringly high number of alternative screening studies in the United States could overwhelm the available resources."

One of the most commonly suggested alternative additional modalities to use, whole breast ultrasound, is highly operator-dependent and has never been shown to decrease breast cancer mortality, although it can increase the detection rate in dense breasts, but at a cost. For example, the American College of Radiology Imaging Network (ACRIN) 6666 trial showed that using breast ultrasound to supplement mammography in women with dense breast tissue and increased risk for breast cancer resulted in improved cancer detection (an additional 4.3 cancers per thousand women screened) at the cost of an increased recall rate, a large increase in the false positive rate, and reduced positive biopsy rate. Also, there was no control group, and the study only evaluated women at increased risk of breast cancer, not women of average risk. (Once again, in the interests of full disclosure, my cancer center has developed a 3D ultrasound imaging technology that we have high hopes for.)

And I forgot to mention: The vast majority of these laws do not mandate that insurance companies pay for additional screening, which is a big problem, since most insurers don't cover additional imaging for women with "clean" mammograms. The Affordable Care Act doesn't require it, and, with the exception of Connecticut, Illinois, New Jersey, and Indiana, states with these mandatory reporting laws don't require it. So, in most states that have passed these laws, women who get these notices are faced with the choice of just living with it or paying out of pocket for additional testing that has not been validated as being able to decrease their risk of dying of breast cancer. For some tests, MRI for instance, that expense could be quite high.

Finally, not all dense breasts are created equal, if you'll excuse the cliché. Some are truly high risk, and some are not. At a website set up by radiologists to try to navigate the vagaries of these laws, BreastDensity.info, there is a flow sheet that informs us that:

If the report states her density is heterogeneously dense, this is associated with minimal risk above average (RR=1.2 compared to average breast density).
If her density is extremely dense (also sometimes called simply dense), this factor doubles her risk of breast cancer compared to average density, similar to the risk associated with a family history of breast cancer in a mother, sister, or daughter. For example, having extremely dense tissue on its own raises the 10-year risk of breast cancer in the average 50 year old woman from 1 in 42 to 1 in 21.

It also goes on to point out that, in the absence of other risk factors associated with breast cancer, elevated breast density alone does not put a woman at high risk for breast cancer. For instance, a recent prospective cohort study with over 365,000 women found that, in the absence of other risk factors for breast cancer, high breast density alone has a rather modest effect on breast cancer risk, leading the authors to warn:

Breast density should not be the sole criterion for deciding whether supplemental imaging is justified because not all women with dense breasts have high interval cancer rates. BCSC 5-year risk combined with BI-RADS breast density can identify women at high risk for interval cancer to inform patient–provider discussions about alternative screening strategies.

The study also found that about half of all women with heterogeneously or extremely dense breasts did not meet the threshold for high rates of interval breast cancer and that the threshold of screening all women with heterogeneously dense breasts required 1,124 supplemental tests per additional cancer case detected. In other words, an emphasis on breast density alone is probably ill-advised based on what we know now.

I can understand why women like Nancy Cappello become activists. I really can. They think they've been wronged by the medical system and that they've discovered something that doctors either aren't aware of or didn't think important enough to tell them. Unfortunately, in the case of breast density that something is information that is both unreliable and does not as yet have a consensus about it over what to do. As a result, what they've done is advocate for laws that are ahead of where the science is, but not in a good way.

oracknows Sun, 06/14/2015 - 21:00

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Ebola, "right-to-try," and placebo legislation

oracknows — Tue, 28 Oct 2014 09:00:39 +0000

Ebola, "right-to-try," and placebo legislation

One of the biggest medical conspiracy theories for a long time has been that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement. who posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA called off, free market innovation would flourish and all these cures, so long suppressed by an overweening regulatory apparatus, the floodgates would open and these cures, long held back by the dam of the FDA, would flow to the people.(Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.

Unfortunately, a week and a half ago, the cruel sham that was the Michigan right-to-try bill was passed into law and signed by Governor Rick Snyder. It’s rather interesting how this came about. Senator John Pappageorge introduced Senate Bill 991 in the Michigan Senate over the summer. There was very little news coverage, which I considered odd, given the heavy news coverage of right-to-try bills in other states. In fact, I only happened to hear that the Michigan right-to-try bill had even been introduced into the Senate when a colleague who happens to deal with the legislature as part of his job let me know about it. I also learned that in addition to home grown patient advocates supporting the bill, there was a flack from the Goldwater Institute flown in to testify and that no one from Michigan universities or academic medical centers was particularly eager to testify against the bill due to the expected backlash.

I can totally understand the patient impetus for these laws, given that I have had family members with terminal illnesses. Unfortunately, however, forces like the Goldwater Institute are taking advantage of the very human desire not to die and not to be forced to watch one’s loved ones die, all in order to push bad legislation. Indeed, the Goldwater Institute uses terminally ill patients desperate for their lives in much the same way Stanislaw Burzynski uses them: As shields and weapons in their battle against the FDA and state medical boards. That’s why, as I’ve morbidly joked before, being against right-to-try in the eye of the public is not unlike being against Mom, apple pie, the American flag, and puppies, hence the reluctance of even doctors doing clinical trials to publicly voice opposition. The most predictable attack against anyone who dares to publicly oppose these bills has been to portray opponents as not just callous, but as practically twirling their mustaches with delight and cackling evilly while watching terminally ill patients die without hope. (I exaggerate—but only slightly.) Few are the physicians and scientists (and even fewer still the medical centers and universities) who want to risk being portrayed that way, and one who did testify against it reported enduring withering looks from patient advocates, who, like Burzynski patients and families, really do view opponents of right-to-try as enemies actively seeking to prevent them from saving their lives or the lives of family members.

Before I knew it, Senate Bill 991 had passed overwhelmingly. So, seeing what was coming next, I wrote my House Representative to urge that he oppose the bill, House Bill 5651. He was receptive and a little surprised that anyone would be against the bill, but he admitted that my arguments made him think. Even so, I was under no illusion that he was likely ever to vote against it. He didn’t. On October 1, House Bill 5651 passed the House unanimously and was signed by Governor Rick Snyder on October 17. Interestingly, despite my having tried to pay close attention to news reports and House activity, I only learned of this last week, when news stories noted that Snyder had already signed the bill! The fix appeared to have been in, as this bill passed with about as close to zero news coverage as I’ve seen for a bill this major in every other state where it’s appeared.

Not surprisingly, libertarians are declaring this a big “win” for patient’s rights. It’s nothing of the sort. The flavor of the arguments can best be seen in two articles from Reason.com’s Nick Gillespie, who is clearly clueless about clinical trials. Basically, he took to Reason.com to gloat, referencing an article from over two weeks ago that he entitled The Upside of Ebola (Yes, There May Actually Be One). It’s about as blatant a move to take advantage of the Ebola outbreak to promote bad right-to-try legislation as I’ve ever seen. The subtitle exults:

A rising death toll, mass panic, scary mortality rate—what could possibly be good about the out-of-control epidemic? It may accelerate the adoption of laws giving patients more power.

Yeah, sure. Thousands of people are dying of a horrible disease in Africa while people in the U.S. are freaking out about the possibility of the virus causing outbreaks right here at home, and Gillespie sees these events, apparently more than anything else, as an opportunity to push his libertarian agenda with respect to medicine:

Ebola’s arrival and seeming spread in America is causing mass panic, tasteless Internet jokes, and incredibly poorly timed magazine covers. Can anything good come out of the disease, which has no known cure and a terrifying mortality rate of 50 percent?

Yes. To the extent it forces a conversation about the regulations surrounding the development of new drugs and the right of terminal patients to experiment with their own bodies, Ebola in the United States may well accelerate adoption of so-called right-to-try laws. These radical laws allow terminally ill patients access to drugs, devices, and treatments that haven’t yet been fully approved by the Federal Drug Administration and other medical authorities. The patients and their estates agree not to bring legal action against caregivers, pharmaceutical companies, and insurers.

You don’t have to be a doctrinaire libertarian—though it helps—to see the value in letting people with nothing left to lose experiment on themselves. They may get a new lease on life. The rest of us get meaningful information that may speed up the development of the next great medical intervention.

Actually, you do rather have to be a doctrinaire libertarian to have a reality distortion field as powerful as Nick Gillespie’s that leads him to write drivel like this. Ebola and right-to-try laws. Hmmmm. How is one thing not like the other (or not related to the other)? First of all, Gillespie’s rationale is a complete non sequitur, clearly designed to take advantage of the Ebola panic to persuade people that right-to-try laws are a good idea, even though such laws would not have had one whit of an effect on the odd patient in the US who might be infected with Ebola. After all, Ebola, as deadly as it is, is not a terminal illness. Second, I can’t help but note that existing FDA mechanisms got ZMapp to American Ebola patients rather rapidly, no need for right-to-try laws necessary. But excuse me. What Gillespie says is that Ebola and ZMapp are “forcing a conversation.” I suppose that’s true, but it’s the wrong conversation, a profoundly deceptive conversation, in which an advocate of right-to-try laws shamelessly takes plays on people’s fears of Ebola to promote these bad laws. Claiming that there is “no good argument against right-to-try” (wrong, wrong, wrong), Gillespie also shamelessly attacks straw men, representing the primary argument against right-to-try as giving patients “false hope.” There are lots of other reasons why these are bad laws.

But Gillespie is just getting warmed up:

But what’s already cruel is the FDA’s drug-testing process. It’s massively expensive and overly long, costing between $800 million and $1 billion to bring a drug to market and taking a decade or more to complete the approval process. There’s every reason to believe that the FDA approval process is killing as many or more people than it saves, especially as the FDA doesn’t allow approvals from Europe and elsewhere to stand in for trials here.

Uh, no. There is not “every reason to believe” anything of the sort. See? Once again, there’s the myth that there are all these fantastic cures out there that the FDA, through its bureaucratic inertia, is keeping from you. I am rather grateful, though, that Gillespie, through his link, makes his intent very clear. The article to which he linkes is entitled Kill The FDA (Before It Kills Again), in which, referencing the movie Dallas Buyers Club—which I finally saw on cable and was surprised to find that, leaving aside its historical inaccuracies about the AIDS epidemic in the 1980s, taken just as a movie it was at best just OK (I was seriously disappointed)—Gillespie proclaims that the FDA “continues to choke down the supply of life-saving and life-enhancing drugs that will everyone agrees will play a massive role not just in reducing future health care costs but in improving the quality of all our lives.” And what is his rationale? Wrap your mind around this:

As my Reason colleague Ronald Bailey has written, this means the FDA’s caution “may be killing more people than it saves.” How’s that? “If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”

Completely missing from Bailey’s and Gillespie’s equation is the number of drugs that the FDA doesn’t approve because they don’t show efficacy and safety that could allow even more than those 20,000 people a year to die or even actively kill some of them. As conceded by even Bailey, it was the FDA that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world. Bailey's argument is, at best, tenuous, at worse misleading. Gillespie notes:

A 2006 Government Accountability Office (GAO) study found that the number of new drug applications submitted to the FDA between 1993 and 2004 increased by just 38 percent despite an increase in research and development of 147 percent. The mismatch, said GAO, was the result of many factors, ranging from basic issues with translating discoveries into usable drugs, patent law, and dubious business decisions by drug makers. But the problems also included “uncertainty regarding regulatory standards for determining whether a drug should be approved as safe and effective,” a reality that almost certainly made pharmaceutical companies more likely to tweak old drugs rather than go all in on new medicines.

Notice how this is another non sequitur applied to right-to-try laws, given that the answer to this problem would be regulatory clarity, not state-by-state right-to-try laws. Think of it this way: What’s more uncertain? The FDA or having different laws in different states regarding “right to try”? Gillespie’s citing his previous article claiming that the FDA is killing you in an article promoting right-to-try is a very good indication what these laws are really about. They are not about helping patients. That’s how they are sold to desperately ill patients, but in reality libertarians like Gillespie and Bailey are using desperately ill patients in the same way that Stanislaw Burzynski is: As a powerful tool to sway public opinion against the FDA and towards their viewpoint.

There’s a reason that certain aspects of these laws are not as widely emphasized in the PR offensive in favor of right to try. It’s because they are pure “health freedom” and libertarian wingnuttery. For example, if you look at the Goldwater Institute template for right to try laws, which, unfortunately, has been the basis of every right to try law passed and under consideration, you’ll notice a number of highly problematic clauses. As I’ve discussed multiple times, there is the requirement that the drug or device has only passed phase 1 trials, which, given how few drugs that have passed phase 1 actually make it through to approval, is a really low bar, especially since most phase 1 trials involve fewer than around 25 patients.

More disturbing are the financial aspects. The Goldwater Institute legislative language template (to which the Michigan legislation is virtually identical) allows drug companies to charge patients, with no provision to help patients pay for exercising right-to-try. Indeed, it specifically states that the bill “does not require any governmental agency to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device” and that insurance companies do not have to pay for costs associated with the use of such therapies. You know what this means? Insurance companies could refuse to pay for care related to complications that might occur because of experimental treatments. You use an experimental drug and suffer a complication? Too bad! Your insurance company can cut you off! Now, it’s unlikely that government entities like Medicare or Medicaid would do that, but insurance companies certainly will.

Basically, what this law says is: If you can afford it yourself, no help, you can have it. If not, you’re SOL. As I’ve pointed out, if there’s one thing worse than dying of a terminal illness, it’s suffering unnecessary complications from a drug that is incredibly unlikely to save or significantly prolong your life and bankrupting yourself and family in the process. Right-to-try encourages just that. What’s more compassionate? Attacking the FDA and degrading the approval process that requires drug safety and efficacy while dangling false hope in front of patients or standing up and protecting patients from the harm such a policy could cause. Let’s just put it this way: I predict that Stanislaw Burzynski will soon be sending antineoplastons to patients in right-to-try states if, as he keeps bragging, the FDA has allowed him to reopen his clinical trials. After all, his antineoplastons would qualify just fine under right-to-try laws if they’re back under clinical trial. Indeed, if there's one thing the decades-long battle between the FDA and Burzynski tells us, it's that the FDA actually bends over way too far backwards to allow manufacturers of dubious drugs to prove themselves.

Finally, the anti-FDA rhetoric, such as linked to by Gillespie, is a very good indication that the true purpose of right-to-try legislation is to neuter the FDA's power to control drug approval, thus greatly loosening or even eliminating hurdles to the drug approval process. It is no coincidence that the strongest, richest, and most vocal proponents of these laws are the Goldwater Institute and libertarians like Nick Gillespie and Ronald Bailey, who, not coincidentally, think that the FDA is “killing us.” Those articles are a definite tell. It's also clearly a strategy to get right-to-try passed in as many states as possible and get referendums passed by wide margins to pressure the federal government to weaken the FDA.

In the end, though, right-to-try laws are what I like to call “placebo” laws in that they make people who pass them and support them feel good but don’t actually address the problem that they are supposedly intended to address. Drug approval regulatory authority lies with the FDA; it could completely ignore state right-to-try laws. The FDA also has a compassionate use program and rarely turns down such requests. Admittedly, the application process is long and probably too onerous, but the answer to that problem is not state right-to-try laws. It’s to address the issue at the federal level. I’ve also said in an interview that, now that my state government has foolishly passed a right-to-try law, one of two things is likely to happen: Either nothing, because federal authority trumps state authority, or disaster for patients, doctors, and, yes, biotech and drug companies. Everybody, myself included, wants to help terminally ill patients. After all, I’ve seen too many of them. Right to try and similar misguided efforts, however, are not the way.

oracknows Tue, 10/28/2014 - 05:00

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False hope is, generally speaking, more cruel than no hope. That's what makes Burzynski so odious (as well as so successful, because his marks^H^H^H^H^Hpatients don't realize he's only offering false hope). The same can be said for these "right-to-try" laws, which practically invite hucksters like Burzynski to sell their alleged treatments to people who have or can raise the money to pay for them.

Sadly rather inevitable that some people would use the fast tracking of Ebola treatments (which might be needed for diseases like Ebola), as an excuse to peddle false hope to the vulnerable.
On an unrelated note, Google has one of those picture things to celebrate the 100th Birthday of Jonas Salk. It should be interesting to see how the anti-vaccine crowd react...

What we really need is a better national conversation on death and dying. We have to stop looking at death as the enemy, and stop treating hospice as "giving up," when it's anything but.

I see no point in pushing experimental drugs on people in the vain hope "it might help" prolong your life by a few days at the cost of miserable side effects like nausea, vomiting, diarrhea or increased pain.

First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly.

If passing Phase 1 clinical trials actually was proof that a drug although not necessarily effective was safe, we'd never see drugs like Vioxx, Zelnorm, Baycol, Trasylol, Meridia, Permax, etc....all of which flew thorugh Phase 1 and wnet on through Phase 2 and 3 and received FDA approval--being discontinued/pulled from the market, would we?

It’s also clearly a strategy to get right-to-try passed in as many states as possible and get referendums passed by wide margins to pressure the federal government to weaken the FDA.

I think you hit the nail on the head, and this is what I've been thinking about these laws, as well. They are a wedge strategy. They know that they can't get things changed so dramatically at the Federal level right away, so go about, state by state, until you have a sufficient number to point to and say, "See? The people want this. Why aren't you Washington bureaucrats listening to them?"

This seems to be a further example of the *new = better* trope.
Oddly enough, it is something liberals and conservatives agree on.

The rest of us get meaningful information

I would disagree with Mr Gillespie on this. Most of the information may well be meaningless.
In the rushed-up process of a right-to-try, it seems unlikely that there will be proper controls (placebo or previous standard of care). Actually, the very objective of a right-to-try would preclude the possibility of giving a placebo - as it is framed, I don't see desperate people asking to try an untested wonder drug settling for a 50% chance of getting it.
That would make comparison with other treatments difficult to do.

the movie Dallas Buyers Club

Isn't the story behind the movie actually a good example of how right-to-try initiatives could be easily misguided? I understood that the Dallas Buyers Club people rejected then-newly drug AZT as too toxic and went for smuggling other untested drugs.
While these other drugs may had merits, AZT has become a very famous first-line treatment, once the dosage was reduced. It would have been a pity to abandon it altogether.
It's easy to play with "if", but It sounds as much dangerous to rush the rejection of a drug as to rush its acceptation. As cold as it sounds, time is needed the properly assess the merit of a drug.

"You do have to be a doctrinaire libertarian to have a reality distortion field as powerful as Nick Gillespie’s."

Yeah, baby! The world definitely needs more Nick Gillespie smack. Crapping on the concept of reason since 1968, the fuddy-duddy rag Reason got hip and went for the Web crowd when Gillespie signed on in 1993. No more would 'Hitler wasn't so bad' essays join Pearl Harbor conspiracy theories in painting WWII as the first Vietnam, amidst ads trumpeting "The most daring investment book EVER written: YOU CAN PROFIT FROM THE COMING MIDEAST WAR" (2/76).

The always leather-jacket clad Slick Nick managed to bring Reason hipster cache and mainstream respectability at the same time. So effective a tool for dereglatory dogma disguised daring counter-culturalism (yuppie version) did Gillespie make Reason become, that he secured the backing of, who else, Charles and David Koch.

Methinks Orac has been hit with the Pharma Shill label so often, and not wanting to come off as pandering to his critics, he is indeed too kind to biotech and drug companies in imagining they would suffer should the dreamed deregulation come to pass.They would make out like bandits... wait, they already do that... they would make out like sultans or maybe even a Koch brother. Once the free market fix is in with "right to try," all the fantastical benefits of phase 1 pharms with flow to those with the cash, the cash with flow to the drug companies, and they'll re-invest the profits in buying enough Congressmen to repeal the patent limiits, retroactively, and bye-bye generics since Disney knows real freedom means getting to hold onto your intellectual property forever and ever. Shame on the nanny state for robbing them of the financial incentive to innovate!

Confronted with the real, actual thing, beleagured and maligned Orac can't quite bring himself to call a spud a spud: there are Shills for Big Pharma, they are pond scum of the lowest sort, and Nick Gillespie is the genuine article.
............

How reasonable is Reason? The magazine's "Heroes of Freedom" include:
John Ashcroft, Jeff Bezos, William Burroughs, Larry Flynt, Milton Friedman, Barry Goldwater, F.A. Hayek, Robert A. Heinlein, Madonna, Willie Nelson, Richard Nixon, Les Paul, Ron Paul, Ayn Rand, Dennis Rodman, Margaret Thatcher, and Clarence Thomas.

That's right, Dennis Rodman.

Now that would be one wild party. Freidman would drooling watching Rand trying to get into Rodman's pants as Rodman hit up Burroughs for drugs, as Burroughs was looking for an apple to put on Maggie's head. As the two liberals who snuck into the room Madonna and Nixon would be comparing notes on achieving total world domination.

Flynt would be giving Ashcroft joy-rides in his hot-rodded wheel-chair. Bezos would lure Hayak and Ron Paul into a game of high stakes Texas Hold 'Em and take all their money. Les Paul and Willie would sneak out to the nearest bar with an open mic and do some Bob Wills songs, Heinlein would be edging away as Thomas tried to engage him in a discussion of how much he loved Farnham's Freehold, leaving Goldwater alone to talk to Clint Eastwood's stool.

The problem is that the argument makes superficial sense: Why would you refuse medical intervention to a terminally ill patient that might save their life?

But the pitfall is inherent in the naming of the state laws vs. the FDA's program: "right to try" vs. "compassionate use." Right-to-try laws are all about "give the patient the right to try 'experimental' therapies." On the patient's judgement and at the patient's expense. That's a recipe for the creation of the stereotypical snake oil salesmen, in an environment where direct-to-consumer sales and marketing takes overwhelming precedence over any sort of medical judgement, and reduces all medicine to the "oogie-boogie" level of homeopathy. "Compassionate use," on the other hand, implies that some sort of medical judgement is applied to evaluate risk vs. reward in applying medical treatment.
While "compassionate use" has its own problems (not insignificant the incompatibility of government bureaucracy with "compassion"), "right to try" is based on the fallacy that, because everyone's entitled to an opinion, everyone's opinion is therefore equal, and expertise can be excluded from specialized fields. And while I'm all for people taking responsibility for being knowledgeable about their own health medical treatments, I'm not deluded into thinking that a half-hour on the internet is an effective substitute for a a decade of medical training.

The magazine’s “Heroes of Freedom” include:
John Ashcroft, Jeff Bezos, William Burroughs, Larry Flynt, Milton Friedman, Barry Goldwater, F.A. Hayek, Robert A. Heinlein, Madonna, Willie Nelson, Richard Nixon, Les Paul, Ron Paul, Ayn Rand, Dennis Rodman, Margaret Thatcher, and Clarence Thomas.

I'll grant them Flynt and maybe Nelson. I don't know enough about Les Paul to offer an opinion. The rest range from dubious to WTF. That would be the John Ashcroft who, as US Attorney General, ordered the statue of Justice covered up so the public would not be corrupted by her bare breast; the Richard Nixon who, as President, maintained an enemies list; the Clarence Thomas who, as Supreme Court Justice, routinely opposes civil liberties for individuals; etc. I could see why somebody who only knew Heinlein from his fiction might think him a supporter of freedom, but his politics (particularly from the late 1950s onward; he had been more liberal before he married Virginia Gerstenfeld) are an entirely different matter. Don't get me started on economists like Friedman and Hayek. Or authors like Ayn Rand.

I love how these "right to try" people act like the only reason new drugs/treatments don't get FDA approval is some kind of malice.

How many treatments get through Phase II only to have the analysis show that they aren't affective? Lots of stuff doesn't get approved because it *doesn't work*. But no, it's got to be a conspiracy.

At least when it comes to medicine and health (especially public health), I find libertarianism to be shockingly naive.

Eric Lund said:
" Don't get me started on economists like Friedman and Hayek. Or authors like Ayn Rand"

I'm in total agreement.

so, where's the money? you hinted at it with the Burzynski hypothesis. Who else stands to gain, that were being 'stymied' by FDA from preying on the desperate?

There are two directions rule-wise the FDA might save itself. Ideally, the first is to become less burdensome and develop enlightened policies, recognizable to the public, that better remove the chaff and deliver more of the wheat sooner with less price burden effects. Second is to try to defuse the situation with better selective exemptions rather than the states' attempts.

One problem is the monopolistc nature of this FDA system, nominally based on a rather plutocratic version of EBM rather than science per se. Orac clearly rejects the "...life, liberty and pursuit of happiness"-everybody version to protect the unwashed masses from charlatans. A big question is who does have a right to try, or has even earned a right to try?

So, for treatments outside of the standards based MD-DO using FDA approved drugs, what groups of nonmedical citizens are sufficiently qualified to fully exercise and self determine their own risk acceptance? STEM degrees, HYPS graduates, IQ 140+, or just MIT-CIT-UCB PhDs. Who?

@Nick J: I'm guessing you're referring to sadmar, because I think I made it quite clear that I don't think money or profits for pharma is the main motivation of libertarians promoting right-to-try. In fact, people in pharma I've spoken to are overwhelmingly against these laws for reasons I've explained in previous posts. One key reason is that making experimental drugs is expensive; most companies generally make only enough pharmaceutical-grade material to do the necessary clinical trials to win approval. If they don't have any left over to give right-to-try patients, and making more is expensive. Startup biotech companies, in particular, dependent as they are on venture capital would be hard-pressed to honor right-to-try requests. Their investors wouldn't like the additional expense, and from a PR standpoint they would be hard-pressed to charge patients the astronomical amounts of money it would take to recoup the cost of making more drug. Right-to-try would drive up costs.

No, right-to-try is far more about ideology than anything else. Libertarians believe that the jackbooted thugs of the FDA stifle innovation and, worst of all, prevent an economic transaction between two parties that want to have an economic transaction, which, as you know, must be a horrific affront to FREEDOM, just as the thought of the government telling them they can't put something into their bodies is also an affront to FREEDOM. (Just peruse some of the comments under Gillespie's "FDA is going to kill you" article.) They harken back to a magical, mystical time that never existed when the free market would determine which drugs succeed and fail based on how well they work. It's about the idea that the federal government has no business requiring that drugs be both safe and effective before allowing them to be marketed. Indeed, one argument the Goldwater Institute trots out is that, before thalidomide, the FDA's charge was only to make sure that drugs were not dangerous, not that they were effective. Yeah, that worked out real well.

In any case, in one of the most monumental bits of irony ever, if you scope out libertarian arguments on this issue, they really believe that drug safety should be primarily ruled by the tort system, with patients using the courts against companies that produce unsafe and ineffective drugs. Then, libertarians also do everything they can to make it more difficult for consumers to sue corporations for defective products. Convenient, no? An alternative (or complementary) argument is that private, free-enterprise, third party associations, like Underwriters Laboratories, would spring up and certify the safety and efficacy of drugs rather than the FDA. Of course, one could easily imagine in such a system the incentive for such laboratories to become rubber stamps in order to win the most business or for some pharma companies just to start selling drugs that made it through phase 1.

Ideally, the first is to become less burdensome and develop enlightened policies, recognizable to the public, that better remove the chaff and deliver more of the wheat sooner with less price burden effects.

So exactly what policy changes do you believe the FDA could adopt which would likely result in the delivery of "more of the wheat sooner" and at lowered cost but without compromising drug safety and efficacy, prn?

Phase 3 studies are ridiculously expensive, but what financial incentive would biotech or pharma companies have to sell drugs to individuals after phase 1 trials? One patient's financial resources are no match for those of the insurance companies and Medicare/Medicaid, which are more likely to cover approved drugs than an experimental therapy. I think the amount of money raked in for charging each person for a hypothetical post-phase-1 drug, Cancer-B-Gone, would be significantly less than the amount raked in by charging the government and insurance companies for the same compound in FDA-approved form, STUPIDXBRANDQNAME (trixareforkidzimab).

So even if the right-to-try-ers get some laws passed, who's gonna sell these magical, potentially life-saving compounds to desperate patients? (Rhetorical question. Totally.)

I googled a little, and found that a bill in Delaware has been introduced in Delaware, a Rep. in Hawaii is (or will be) introducing the bill, and some references to bills in NJ and Minnesota.

yes!: Ballotpedia quotes Dr. Gorski under opposition to the AZ. referendum.

@machineintelligence #6:

This seems to be a further example of the *new = better* trope. Oddly enough, it is something liberals and conservatives agree on.

New = better? Speak for yourself! To me, new or old doesn't matter: greater efficacy matters. I'd embrace 200-year-old homeopathy over this year's chemotherapy if it were proven to provide better objective outcome.

Now tell me whether I'm a liberal or a conservative.

The most predictable attack against anyone who dares to publicly oppose these bills has been to portray opponents as not just callous, but as practically twirling their mustaches with delight and cackling evilly while watching terminally ill patients die without hope. (I exaggerate—but only slightly.)

Considering some of the comments Orac received for criticizing Burzynski, no, I don't think he's exaggerating at all.

Panacea @ #3:

Just out of curiosity, are there any cultures that are more accepting of death and dying than we are? That is, they don't fear death and they don't see dying as "giving up"? Maybe we can learn a little from them.

One patient’s financial resources are no match for those of the insurance companies and Medicare/Medicaid, which are more likely to cover approved drugs than an experimental therapy.

You talk like a person who makes sense, or an Obama-loving nanny-state socialist, whichever you prefer. We're not talking about one patient, maybe 100. 100 very VERY rich patients.

The Fordist economy in which average workers could afford to buy the goods they produced is receding out of sight in the rear view mirror. No more mass production for mass consumption. "If you can afford it yourself, you can have it. If not, you’re SOL" is the economic model of a lot of profitable businesses these days. Is it sustainable? No. Do Wall Street ideologues realize that and act with common sense? Absolutely not!

Did you miss this part of the OP:

Insurance companies could refuse to pay for care related to complications that might occur because of experimental treatments. You use an experimental drug and suffer a complication? Too bad! Your insurance company can cut you off! Now, it’s unlikely that government entities like Medicare or Medicaid would do that, but insurance companies certainly will.

Have you forgotten that Shrub was intent on privatizing Medicare? Do you think any R who makes it through the 2016 primaries won't be bundling that in the fabulous free-market solution to replace that awful Obamacare?

I'm guessing the pharma folk Orac talks to are more research-oriented and given not to thinking outside-the-box in terms of economic models. The execs and the fund managers they answer to may take a different point of view.

Making experimental drugs is expensive because companies make only enough pharmaceutical-grade material to do the necessary clinical trials to win approval, leaving nothing left over they might give hypothetical right-to-try patients. Now. But if the State legislation dominoes keep falling, as mho indicates they will, that changes. Once there's a market, supply will follow and costs will come down to the price range of the 1%, and that's all Pfizer or Lily will need to open up a boutique division to cash-in.

As a current and former resident of the land just north of Silicon Valley, I'm gonna hafta pull geography on our Michigander host about the economics of start-ups and venture capital. Venture capitalists will pour plenty of cash into startup biotech companies designed to honor right-to-try requests. These guys are all making bank on side bets at a roulette wheel. Most start-ups fail miserably, and everybody still makes money. The VCs are all taking long odds trying to hit the big score. It's baby sea turtle economics - they lay lots of cash eggs knowing most of the cute little critters will be gobbled up by predators, but if one makes it to the IPOcean, they've got the next Twitter.

Do you know where the biggest concentration of startups per capita in the U. S. is? Fairfield, Iowa. Do you know why that's a hot spot? Because is the home of The Maharishi University of Management, which of course is into Integrative Medicine big-time, with the endorsement not only of Orac's pal Tom Harkin, but Gov. Terry Branstad and every significant Republican pol in the state. They do love them some free-market entrepreneurial spirit!

And who established the entrepreneurial culture of Fairfield back in the early 1980s? Ed Beckly, "The Father of the Infomercial" whose ads for his "Millionaire Maker" program to get rich quick by buying real estate with no money down were ubiquitous on late-night TV nationwide back in the day. He had moved to Fairfield to be near Maharishi U as he was very into TM. He brought his self-help sales empire with him. The Beckley Group was selling 25,000-40,000 "courses" a week at $295 each. It had 700 employees, mostly telemarketers handling calls coming in from the infomercials, and trying to 're-sell' dissatisfied customers asking for the 30 day money-back-guarantee. Alas, they kept asking, and Ed didn't send out refunds until those Evil freedom-crushing regulators of the FTC and the State AG came knocking. At which point poor Ed had to cough up $3 million, so he declared bankruptcy, and folded the Beckley Group putting 10% of the town out of work. Undaunted, Ed started another smaller self-help-course business in Fairfield, which lasted until he was convicted of wire fraud in 1993 and sent off to the federal pokey. He has apparently been unable to levitate over the barbed-wire.

In short, start-ups can be seen as sophisticated, legitimized Ponzi schemes. It's easy for a Big Pharma Corporation to set up a subdivision to go for a piece of that action that has enough de jure distance from their mainstream biz to not threaten that rep or bottom line. And when the lucky VC gets his eager-beaver techies to develop a new thingie that passes Phase One, the Big Dogs will come sniffing, trying to get in on the ground floor, over-bid, then the winner will promote the living daylights out of the prize acquisition and they'll still make money in the long run, selling Rolls Royce experimental treatments to The Achievers.

I speculate, of course, which is part of the fun of being a social critic. It doesn't cost anything. But if you were going to bet money in one of those prediction markets, I wouldn't bet against it.

It looks like right-to-try may soon be the law of the land. We'll see what happens. I'll eat my plate of mangy virtual crow if right-to-try remains no more than an ideological triumph, and fails to affect the marketplace. I probably hope I'll lose. Time will tell.

they don’t fear death

I used to worship a Cult like that ... https://www.youtube.com/watch?v=ClQcUyhoxTg

"In short, start-ups can be seen as sophisticated, legitimized Ponzi schemes."

It seems start-ups are another topic on which sadmar ignorantly pontificates.

I started at a start-up sixteen years ago. I was the 25th employee. Thirteen years later we had 2500 employees -- that's 2500 people who had pretty good salaries to support their families with -- when we were finally gobbled up by a bigger firm. An awful lot of people made money off our company including a whole lot of employees. We didn't cheat anybody. We didn't lie to anybody about our monetary situation. We just got in there and worked night and day to make the very best product we could, and it is a good product that a lot of people's livelihoods still depend on.

And sadmar in its infinite wisdom announces that we were just running a Ponzi scheme.

This seems to be a further example of the *new = better* trope. Oddly enough, it is something liberals and conservatives agree on.

You can have my Springfield musket when you pry it out of my cold, dead Yankee hands.

You've got me beat, Shay. I admit I like the oldies, but I don't care for smoke poles.

I do have a coupla 03 Springfields (adopted by the Army in 1903), including a Mark 1, an M-1 with a 6 digit serial number (the first digit is a 1, meaning it's prior to WWII), my carry gun (on the rare occasion I feel the need) is a .38 Spl (a cartridge that was developed in 1898), except when a new James Bond movie comes out, when I put my Walther PPK (designed in 1924) in my pocket, because, hey, James Bond.

I also have a pair of Ruger Vaqueros that look like old Colt SAAs, but are, of course, modern design. Also, all of my 1911 clones are, well, clones, but look like the pistol adopted in 1911.

But black powder is just a little too old school for me.

I used to worship a Cult like that

A drug by the name of World Without End!

LW: "And sadmar in its infinite wisdom announces that we were just running a Ponzi scheme."

Am I the only one that ignores sadmar's TL/DR screeds? Seriously, does this guy have anything other to offer than tone trolling and nonsense?

LW: “And sadmar in its infinite wisdom announces that we were just running a Ponzi scheme.”

Chris, I tried to ignore sadmar's posts, but (s)he manages to post comments which are downright insulting. The posts about Andrew Wakefield and the murdering mothers of autistic children were vile.

All that stuff about Fairfield Iowa were ripped off from the Wikipedia entry or from an Oprah show which featured the small town, and (s)he knows nothing about venture capital, equity capital and start up companies.

http://www.sba.gov/content/venture-capital

Well ya'll could loosen up on they hydroxyzine. Think of it as a *loss leader*...

In short, start-ups can be seen as sophisticated, legitimized Ponzi schemes.

Absolutely true,according to a reality show I came across called South Park.

In short, start-ups can be seen as sophisticated, legitimized Ponzi schemes.

Actually it's pretty funny that sadmar, who is so much smarter and wiser and more skilled at communication than the rest of us ignorant rabble, doesn't know that, if you start a sentence with "in short", the rest of the sentence should have some connection to the prior discussion. Wise compassionate all-knowing sadmar failed to present any evidence that start-ups are Ponzi schemes; in fact quite the opposite since sadmar compared VCs to gamblers, which is not actually a completely fair comparison since VCs do due dilligence to try to weed out the real losers and are not relying solely on luck. Nevertheless, gamblers are not running Ponzi schemes. VCs who lose money on one investment but make money on another are not running Ponzi schemes.

Perhaps before next gracing us with condescending bloviation, sadmar might try looking up the meanings of words.

In other news honorary doctor of oriental medicine* Mark Sircus claims he can cure Ebola with magnesium, iodine, baking soda, selenium and vitamin C in what he amusingly calls 'Natural Allopathic Medicine'. Sircus is known for his measured and rational response to the CDC's evil support of vaccination ('String the Bastards Up').

* His honorary doctorate was awarded by a Mexican hospital in thanks for his work there - can he legally use the title 'doctor' like this? It's clearly designed to deceive people into thinking he has some clue about medicine.

I ignore sadmar's posts, not because of their content, but because of their extraordinary length. I've got work to do.

I think the amount of money raked in for charging each person for a hypothetical post-phase-1 drug, Cancer-B-Gone, would be significantly less than the amount raked in by charging the government and insurance companies for the same compound in FDA-approved form, STUPIDXBRANDQNAME (trixareforkidzimab).

Only if you assume an honest company and a drug that actually works. The profit lies in the overwhelming majority of new drugs that never make it from trials to sales. Push any old rubbish with a vaguely plausible hypothesis through Phase One trials, and then sit back and reap a steady flow of profits from the desperate and dying while pretending to do further trials. Heck, I bet there's plenty of failed drug IP for sale, so you might not even need to do the Phase One trial yourself.

Johnny, my pappy was a black-powder shooter so I had to join the Marines before I got to fire something manufactured after 1863.

My current arsenal includes the .38 that Grandpa Frank carried when he was a cavalryman, chasing Pancho Villa around the border back in 1911. Lovely weapon. Practically a work of art.

His honorary doctorate was awarded by a Mexican hospital in thanks for his work there – can he legally use the title ‘doctor’ like this?

From Brazil? I don't know who's going to stop him.

I'd still like to know about cultures who have a better grasp on death and dying than the US does, cultures who don't worry about death as much as we do and don't see dying as simply "giving up". I'm not an anthropologist, so I don't know anything about this.

I’d still like to know about cultures who have a better grasp on death and dying than the US does, cultures who don’t worry about death as much as we do and don’t see dying as simply “giving up”.

Try anyplace where Mahayana Buddhism is a dominant force.

^ E.g., Vietnam.

sadmar's x-acto knife: be cautious in attributing intent to phrases that may be typing/editing mistakes, or grammatical ambiguities.

And Hanlon's razor, too.

"Start-ups can be seen as Ponzi schemes." is ambiguous (as opposed to "Start-ups are Ponzi schemes.") because "can be seen" leaves open whether the subject is 'all startups' or 'some startups'.

i was specifically referring to the TM-related startups in Fairfield and their ilk elsewhere, and yes I presented evidence of conning in the form of the legacy of Ed Beckley. I did not mean "all startups".

Regardless, "Ponzi scheme" was the wrong term, even loosely applied. I retract the entire sentence.

To elaborate, LW, while a few startups may be con-games in themselves, overall my impression is that most startups are created by very hard-working people who neither cheat nor lie. However, if your company brought a successful product to market, surely you know you are the exception, not the rule.

To that extent, it strikes me as odd you offer individual anecdotal experience as evidence, apparently imagining that I have no personal knowledge of startups that turned out differently. I live in the Bay Area. I know guys who were in the Homebrew Computer Club with Woz at Stanford PARC before the beginning, and who've been involved in dozens of startups since then.

My earlier post was meant to question Orac's hypothesis that right-to-try is merely ideological and will have no effect in the market. I was trying to frame an alternative scenario that could happen, based on the larger economic processes at work in pharmaceutical companies and investment capital.

In this, the Fairfield example was meant as "this is how this can go while still being legitimated by politicians and the market" not "this is what happens all the time."

I did not mean to disparage the sort of firm where LW worked, nor any of the many failed firms my acquaintances have been involved in. I was obviously not clear in that, and I apologize.
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As usual here, the central points of my argument are either ignored or simply not-comprehended, and the comments go ape-poop picking at some minor point to which someone takes personal offense. The inference lenses are staggeringly selective, distorting, presumptive and negative. As it happens, I know about Fairfield because I lived a half-hour down the road from there between '84-'88 and had a number of interactions with folks from Maharishi U. (Cue attack on "arrogance" of previous factual statement in 3-2-1...)

That was supposed to read: "this is how _far_ this can go while still being legitimated..."

My brain to finger connection skips words all the time, and my eye to brain connection misses seeing the errors. Sorry about that. It is what it is, though.

In Arizona, the "right to try" is going as an initiative ... no legislature involved.

Lucario,

I’d still like to know about cultures who have a better grasp on death and dying than the US does, cultures who don’t worry about death as much as we do and don’t see dying as simply “giving up”.

From what I remember of studying social anthropology some years ago, I think most pre-industrial societies have a less problematic relationship with death than we do, if only because they are more familiar with it. I certainly remember Margaret Mead describing Samoan children playing around dead bodies, which she suggested made adults more comfortable with death (Mead's accounts of Samoan culture have been challenged, but this rings true with me). That said, the funerals I have run into in India and Egypt seemed to have plenty of grief-stricken people in attendance.

Also, societies that truly believe in a life after death may see death as a good thing - we see something similar in Islamic suicide bombers, for example, though the 72 virgins may be a mistranslation and should be 'chilled raisins' (there may be some very disappointed young Muslims in a garden of paradise somewhere). I remember having a heated argument with a fellow student who could not accept that a person might celebrate the death of a parent in a culture that had these beliefs (I forget which culture it was). My position was, and still is, that the meaning of death (and everything else, pretty much) is learned culturally, and may be very different depending on one's upbringing.

Poor misunderstood sadmar starts up with,

As a current and former resident of the land just north of Silicon Valley, I’m gonna hafta pull geography on our Michigander host about the economics of start-ups and venture capital.

To a reasonable person, this implies that sadmar is going to educate us children about all start-ups, not just the one start-up that sadmar happens to be thinking about. sadmar pours out over five hundred words vilifying start-ups, saying "start-ups can be seen as Ponzi schemes" (which is asinine), never once indicating that this vilification was only supposed to apply to some start-ups, and then whines that,

the comments go ape-p__p picking at some minor point to which someone takes personal offense

Communication tip to the communication expert: if you start talking about all members of a group, but decide to vilify only some of the group, indicate at some point the switch from all to some. Otherwise, people will use an existence proof: here is a case that proves you are spouting ignorant nonsense.

Communication tip to the communication expert: when you babble on for over five hundred words on a topic in a comment, people may assume that that is not a minor point.

Reading Kreb's comment above ( pre-literate cultures' relationship with death) inspired me to read a little ( via Wikip-)
about El Dia de los Muertos, All Saints'/Souls' and Samhain- which are all nearly upon us.

Perhaps these festivities originated in a time when the land of the dead seemed less alien than it does to moderns:
on those days the veil between the world of the living and that the dead grew thinner, we're told, and the living communed with the shades.

Go to the source, Denice; The Roman Catholic Church

http://www.catholiceducation.org/en/culture/catholic-contributions/all-…

There are some interesting articles under "Science"....including same sex parenting.

Denice,

Perhaps these festivities originated in a time when the land of the dead seemed less alien than it does to moderns:
on those days the veil between the world of the living and that the dead grew thinner, we’re told, and the living communed with the shades.

The timeliness of the topic hadn't occurred to me. I wonder if that kind of cultural festivity is a symptom of a fear of death, rather than familiarity, a bit like the Victorian attitude to death (memento mori such as skulls on gravestones and taking photos of a dead child were popular, for example), or at least of an ambiguous relationship.

Another thought - in societies in which life is/was nasty, brutish and short, the land of the dead may seem more attractive than the land of the living. I suppose it depends how the land of the dead is portrayed: the Roman underworld sounds like a pretty miserable place compared with the Islamic Garden of Delights. Someone somewhere has probably written a PhD thesis on the subject.

Philip Aries wrote a book about it:
http://www.amazon.com/The-Hour-Our-Death-Attitudes/dp/0394751566

Philip Aries wrote a book about it:

Added to my enormous pile of stuff to read, thanks.

@ Krebiozen:

Sure, the stories of paradises and the sugar-coated skulls mask the fear.

Also, as someone who has studied memory I often wonder how much tales of the beyond and spirits are merely emotionally fuelled instances of recall of the dead person alive and mobile afterwards.
-btw- I had to read through Frazer's seasonal stuff last night.

@ lilady:
Well, I obviously can't go THERE.
Although these days, at least the guy in charge welcomes atheists.

Without trying to research deeply into the origins, I get the impression from living here in the southwest that Dia de los Muertos http://education.nationalgeographic.com/education/media/dia-de-los-muer…
is mainly about remembering and honoring the dead.
It integrates native American traditions tracing back to the Aztecs with Catholicism.
What we did in the Protestant churches I have attended over the years on All Saints Day is similar in spirit but with a lot less celebration.

Denice and squirrelite,
I find it hard to understand how skeletons and skulls help to either mask the fear or honor the dead. I prefer to remember my deceased loved ones as they were, not as I imagine them after decomposition*, though they were mostly cremated**. That may just be my cultural biases, of course.

* The reappearance of my beloved dead cat, dug up by foxes as you may remember, was not at all reassuring.
** To be clear, the ones that were cremated were entirely cremated, some others were buried.

I was recently at a film festival ( not the crappy one where AJW won a docu prize) where a guy was discussing a new film/ TV show ( ?) he just sold about....
zombified animals.. "They're MUCH harder to kill than the human kind".
I swear, I'm not making this up: I'm creative but not THAT creative.

I noted "ideally", as an enlightened policy is supposed to be their job, not really my expectation. I'm not asking for the impossible, just too many scandals and symptoms of failure show that the FDA has not performed well at implemented enlightened policy.

Pragmatically, I expect a crisis driven exception/exemption/waiver model to allow political pressure to relieve political disasters in the making in many cases. Just not always.

As I’ve pointed out, if there’s one thing worse than dying of a terminal illness, it’s suffering unnecessary complications from a drug that is incredibly unlikely to save or significantly prolong your life and bankrupting yourself and family in the process.
IRL, completely the opposite situation for us. Drugs and materials not US FDA approved have greatly prolonged our lives, improved quality of life and avoided bankrupting medical bills.

The real problem is that the average American doesn't have support from knowledgeable doctors who can deliver safer, more effective treatments, way off label.

I’m not asking for the impossible, just too many scandals and symptoms of failure show that the FDA has not performed well at implemented enlightened policy

The only FDA decisions I can think of that would qualify as 'scandalous' are their failure to block Burzynski from continuing to dispense antineoplastin therapy, and their political decision to override their scientific advisory board and withold approval of over the counter sales of "Plan B" contraception to women 16 years of age or older. What examples are you thinking of?

Drugs and materials not US FDA approved have greatly prolonged our lives, improved quality of life and avoided bankrupting medical bills.

Which drugs and materials are these, and have they been approved by regualtory boards other than the FDA in other nations? If not, how have they been shown to be both safe and effective (i.e., to greatly prolong and/or improve the quality of anyone's life) for specific indications?

The real problem is that the average American doesn’t have support from knowledgeable doctors who can deliver safer, more effective treatments, way off label.

How do those knowledgable doctors determine that a drug is apporpriate--i.e., both safe and effective--for treatment of off-label illnesses prior to offering it to patients in their care?

Philip Aries wrote a book about it

In the juvenalia department, so did Bradbury.

@Krebiozen,

I'd probably be upset if I dug up the skeleton of my pet dog that's buried in the back yard too.

Unlike some ancient cultures, the current practices are more symbolic in nature.

@ prn:

Here's what I don't get:

how do you know which of these doctors are the knowledgeable ones and which are the quacks?
-If you don't have peer reviewed research
-if you don't follow governmental bodies' or professional associations' advice?

How can you tell which are worthwhile?
Do you go by their word?

Drugs and materials not US FDA approved have greatly prolonged our lives, improved quality of life and avoided bankrupting medical bills.

Which ones? I'd settle for what you consider the Top Ten.

The FDA is often credited with approving drugs with recognized toxcities that later were black boxed or removed from market, just as predicted by some. The Vioxx incident alone that also involved FDA favoritism or foot dragging, is credited with tens of thousands of excess deaths more than DrB could possibly have.

...have they been approved by regualtory boards other than the FDA in other nations?
Some were approved in apparently unreliable countries like Germany, Japan and UK. Some are financial orphans and some are great controversies with dramatic benefits when used properly.

How do those knowledgable doctors determine that a drug is appropriate
read their own literature and monitor their patients' results

The Vioxx incident alone that also involved FDA favoritism or foot dragging, is credited with tens of thousands of excess deaths more than DrB could possibly have.

The canonical figure is, what, 30,000? 50,000? Is it corrected for the toxicity of other Cox inhibitors? Is there any good reason for rofecoxib not to be on the market? It's still approved, you know.

how do you know which of these doctors are the knowledgeable ones and which are the quacks?

Honestly Denice, I think most doctors are a little quacky or ill informed. So I focus on their strengths based on talent, skills, experience and results. I treat each interview as a learning and testing opportunity. I ask questions based on literature that I read and previous interviews then compare their answers for new or testable information. Then I try to observe or measure results.

-If you don’t have peer reviewed research
I usually do have peer reviewed literature. Going with the flow, doctors often don't read their own literature in their own field concerning meritorious orphans.

-if you don’t follow governmental bodies’ or professional associations’ advice?
Read, not blindly follow. I prefer direct results and my own review of experiment based literature. Bodies and ass'n - too much generalization and obsolesence with too many agendas to be optimal or maximal.

How can you tell which are worthwhile? Do you go by their word?

By extended comparison and analysis of many papers' details and results, a lot ambiguity, conflict and errors resolve and self interested crap falls away. Also I feel more confidence if there are some anomalous effects or results that one can replicate or predict, as quick acid tests. Long term, high quality, high density data helps too.

Shay re "Top 10" - a little personal and more spew back overload than I want to handle at a time.

Narad: Is there any good reason for rofecoxib not to be on the market? It’s still approved, you know.

Lawsuit magnetism? Celecoxib may only have half the risk and may have other benefits. I wouldn't favor the return of Vioxx until the mfr could identify patients at risk and a remedial technique e.g. some particular inhibitor or blood thinning technique.

Lawsuit magnetism? Celecoxib may only have half the risk and may have other benefits. I wouldn’t favor the return of Vioxx until the mfr could identify patients at risk and a remedial technique e.g. some particular inhibitor or blood thinning technique.

"I prefer direct results and my own review of experiment based literature."

Well? It would look awfully silly if you had just ripped a page from the Playbook of Kneejerk Big pHARMa "Talking" Points.

Why don't we do the placebo pill for now since it has been proven that it makes the symtemps for illnesses 2 times less powerful?

@dylan - gonna need a source for that.

government - biggest scape goat second to "jewish"

The cruel sham of "right to try" comes to Michigan

oracknows — Thu, 14 Aug 2014 02:00:28 +0000

The cruel sham of "right to try" comes to Michigan

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy over at SBM and I have both written about them before. With the passage of the first such bill into law in Colorado in May, followed by Missouri and Louisiana, and its heading to the voters of Arizona as a referendum in November, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit at least since the news out of Colorado in May, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) introduced into the legislature in Michigan by Senator John Pappageorge. It was unanimously passed, almost without comment, by the Michigan Senate Health Policy Committee, and certainly there was minimal news coverage. Moreover, I just learned that it was being taken up by the Senate yesterday. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.

I joke (somewhat grimly) about seeming to be opposing mom, apple pie, and the American flag (not to mention apparently also about wanting to disembowel puppies) when I discuss right-to-try bills, but there’s a reason for that. These bills tend to have not just broad bipartisan support in the legislature, because opposing such laws seems on the surface to be the equivalent of denying dying patients a last ditch chance at life, but broad support among the public because of the seemingly reasonable question, “What’s the harm?” Unfortunately, disaster can result when normal human compassion for fellow suffering humans is yoked to misinformation and misunderstanding of science (in this case how clinical trials work), who really controls drug development and regulation in the US, and the real harm that using such drugs prematurely can cause. For right-to-try, the result is perniciously popular legislation that provides lots of false hope and virtually no benefit to terminally ill patients. In the face of this, even politicians with a reasonable understanding of the science, why such laws represent nothing but false hope, and why, even if they go into effect without objection by the FDA, would be far more likely to harm patients than help them, hesitate.

Right-to-try in Colorado

Before I get to my own state, let’s look at Colorado’s right-to-try law, since it was the first to pass. One thing that I feel obligated to point out again is that virtually all the recent “right-to-try” bills introduced into state legislature have been based on model legislation designed by the Goldwater Institute, a libertarian think tank whose specious and misleading arguments for such legislation I’ve discussed before . In her previous post on right-to-try bills, Jann Bellamy mentioned that there is “nothing like a touching anecdote to spur a politician into action,” and she’s right. That’s why the Goldwater Institute’s web page on its right-to-try initiatives is populated with intentionally emotionally manipulative heart-wrenching testimonials of (mostly) cancer patients arguing that, if only they had had access to experimental drugs, they might survive or of dead patients whose family or friends tearfully argue that “if only”—if only—right to try had been passed before their loved one died that loved one might still be alive. In the wake of the passage of Colorado’s right-to-try law in May, anecdotes ruled, heart-wrenching anecdotes such as this one about Nick Auden, a Colorado man with stage IV melanoma who died six months before the legislation passed:

Who isn’t moved by the struggles of a father who wants to survive for his children? Who wouldn’t want to help this man? What kind of monster am I to oppose a law that would provide brave suffering patients like Nick Auden another shot at life, no matter how slim the chance? Such is the level of discourse directed at those who have the temerity to point out that right-to-try laws are a sham, false hope, and far more likely to harm terminally ill patients than help them; that is, if they have any effect whatsoever, which is unlikely. They are what I like to call placebo laws in that they make the body politic feel better but have no real effect on the underlying problem that they are meant to address. Indeed, as Jann Bellamy pointed out, a much less emotion-driven analysis of these so-called “right-to-try” bills currently before several state legislatures reveals disturbing truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

This can be seen by a simple comparison of the text of the Goldwater Institute model legislation and the final text of the Colorado right-to-try law as enacted. The Colorado law, in fact, bears a very close similarity to the Goldwater Institute model legislation. Some differences between the Goldwater Institute template and the actual Colorado law that leapt out at me included that the Colorado law:

Adds a mention that the drug approval process in the US “protects future patients from premature, ineffective, and unsafe medications and treatments over the long run, but the process” (not in the Goldwater template text) and “often takes many years” (in the Goldwater text)
Alters eligibility to include patients who have “been unable to participate in a clinical trial for the terminal illness within one hundred miles of the patient's home address for the terminal illness, or not been accepted to the clinical trial within one week of completion of the clinical trial application process”
States that “an insurer may deny coverage to an eligible patient from the time the eligible patient begins use of the investigational drug, biologic product, or device through a period not to exceed six months from the time the investigational drug, biologic product, or device is no longer used by the eligible patient; except that coverage may not be denied for a preexisting condition and for coverage for benefits which commenced prior to the time the eligible patient begins use of such drug, biologic product or device”

There are other differences, of course, but they’re mostly wording and Colorado-specific language about state statutes effected. I tend to interpret #1 as having been added to make it sound less as though the FDA approval process is useless, as the Goldwater text does. My guess about #2 is that it was undoubtedly added in order to exclude patients who just want experimental drugs but aren’t interested in enrolling in a clinical trial. Finally, I’m not completely sure how to interpret #3 and would welcome a lawyer’s input (particularly if it’s a health lawyer), but it sounds rather ominous in that it allows insurers to deny new coverage to a patient for a six month period from the time the patient starts use of an investigational drug, but can’t deny coverage for a preexisting condition (i.e., the condition that led the patient to be terminally ill, and any other preexisting conditions) or any benefits that commenced prior to the time the patient starts using an experimental drug or device. On the other hand, to me the language implies that insurance companies can deny coverage for any complications that arise from the use of experimental therapy under right-to-try, whether caused by that therapy or not. So if the patient develops a complication from the treatment, he’s out of luck. If he happens to be hit by a car, he might be out of luck. Thus, a bill that sounds compassionate appears to have a cruel, punishing twist embedded in it.

That is not in the least bit surprising. This law is very “libertarian” in that it says that patients can try an experimental therapy that’s passed phase I trials to phase II or beyond, but anything that happens after that is all on the patient. (Indeed, my interpretation of right-to-try is that it would allow access to a drug that's only passed phase I, even if the phase II trial hasn't accrued a single patient yet, as long as there's a phase II trial open.) The doctor recommending the treatment is off the hook, no matter how bad his decision to recommend the experimental therapy was. The drug company is off the hook, no matter how many problems the drug might have. The insurance companies appear to be off the hook, complete with a potential loophole to let them refuse to cover various treatments in terminally ill patients. Basically, if you’re rich, you can bypass clinical trials (if the company is willing) and buy up experimental drug for yourself. If you’re poor, or even just not rich (remember, these drugs will cost big time), you’re, as they say, SOL. You can have the hope dangled in front of you and just die. No wonder the Goldwater Institute flew a flack to Lansing last month to testify about the bill, as it appears to be doing for every state considering right-to-try legislation.

At this point, I think it’s a good idea for me to remind my readers once again that that these right-to-try laws cover any drug, treatment, or experimental device that has passed phase I clinical trials. Indeed, in the video above, the reporter made a highly misleading statement when she stated that the Colorado “right-to-try” law “only applies to drugs that have been deemed safe by the FDA.” That statement is so wrong it’s not even wrong, as skeptics sometimes like to say. Just because a drug has passed phase I clinical trials does not—I repeat, does not—mean that the drug has been “deemed safe by the FDA.” Phase I trials, also known as “first in human” trials, don’t enroll very many patients. Sometimes it’s as few as 20 patients, sometimes even less. That is not enough to adequately determine safety, nor is it intended to. That’s because phase I trials are designed primarily to identify major side effects and to use a process known as dose escalation to determine what is commonly referred to as the “maximum tolerated dose” (MTD). It is utterly impossible for such a small clinical trial to adequately assess the safety of a drug. All it can do is to make sure there are no unexpected major adverse events, that the expected side effects are tolerable, and that the drug has a side effect profile that isn’t grossly more unsafe than the disease itself. Phase II and phase III trials are needed to confirm safety. That’s why the premature diffusion of unapproved drugs has the potential to increase morbidity from adverse events and even hasten death. One example is amonifide for treating breast cancer. The drug made it through phase I trials, but serious life-threatening hematologic toxicity emerged during phase II trials.

Think of phase I trials as a screening test looking for the most obvious toxicities, with phase II and III studies confirming them. Indeed, even phase III trials can’t always adequately demonstrate that a drug is safe; it’s not uncommon for less common adverse effects not to show up until post-marketing surveillance, when much larger numbers of patients receive the drug. Moreover, only 5% of all cancer drugs that enter clinical testing are ultimately approved for patient use. Among drugs tested in phase II trials, only 30% go on to phase III. So, to equate having passed phase I clinical trials with having been “deemed safe by the FDA” betrays a profound misunderstanding at the heart of the bill of what a phase I trial is and what passing it means. The potential for disaster is there.

The false hope of right-to-try metastasizes to Michigan

I’ll discuss more of what’s wrong with right-to-try laws and how misguided they are, but first I want to take look at the right-to try bills currently under consideration in the Michigan legislature. Oddly enough, I was completely unaware that a right-to-try bill had been introduced into the Michigan legislature until last month, when I got a message from a concerned person. It had basically already passed committee. Before that contact, as hard as it is to believe right now, I had heard absolutely nothing about these bills, but I’m a fast learner. I didn’t have much help, though, because there was very little media notice taken of the Senate hearing about this bill other than a Detroit Free Press article that I found days after the hearing and self-serving articles on John Pappageorge’s website touting mistakenly how this bill would allow “access to potentially life-saving treatments.” Either that, or I missed it because I was out of town at TAM in the days leading up to the hearing. Now, I hear that the bill is being debated in the Senate, but yesterday I couldn’t find a single news article about it. It was sneaked in, apparently, and I only heard about it because an interested activist let me know.

Now, going back to look over the coverage, I found that the Freep article bought in the same compassionate but incorrect framing as was the case in the other states considering such laws:

Arlene Kalley has lived with terminal cancer for years — and with each new drug she uses to keep the disease at bay, her options dwindle.

Earlier today, the Michigan Senate’s health policy committee approved a bill that would offer Kalley and other terminally ill patients in Michigan better access to experimental medication.

It doesn’t require manufacturers to provide the drug nor does it require insurers to cover the costs. But it gives patients a “right to try,” said Sen. John Pappageorge, R-Troy, whose first wife died of cancer in 1993.

He introduced the bill earlier this year after speaking with Terry Kalley, a partner with Global Logistics Strategies in Bloomfield Hills.

And this is how the idea for introducing bill came about:

His wife, Arlene, was taking Avastin in 2011 to keep metastatic breast cancer at bay when the U.S. Food and Drug Administration yanked its approval of the drug, questioning its safety and efficacy.

Ultimately, Arlene Kalley was able to keep taking Avastin because it still was being used to treat other cancers, but the experience got the Kalleys thinking about what could happen if Arlene Kalley’s current treatment is no longer effective one day.

While I can understand why this case might have led the Kalleys to wonder about right to try, I must point out here that Avastin was a very different case than situations envisioned in right-to-try legislation. Specifically, Avastin had undergone randomized clinical trials (RCTs) beyond phase I and had already been approved for other cancers before being approved by the “fast track” approval process for advanced breast cancer. Its approval for advanced breast cancer was based on two RCTs that showed a modest increase in progression-free survival (PFS) when Avastin was added to chemotherapy, but no effect on overall survival (OS). In 2008, based on a program to “fast track” promising drugs that was developed in 1990s, the FDA gave provisional approval to Genentech to market Avastin for metastatic breast cancer with the condition that Genentech had to perform additional studies to verify the results upon which the original approval had been based. At the time, there was a great deal of argument over whether this was a wise decision, particularly given how expensive Avastin is and the lack of evidence that it improved quality of life or overall survival. Unfortunately, the results of those additional clinical trials were very disappointing to all of us who take care of breast cancer patients. The AVADO trial only found an increase in PFS of less than a month when Avastin was added to docetaxel with no increase in OS, while the RIBBON-1 trial found an improvement in PFS of 2.9 months when added to capecitabine, and 1.2 months when added to anthracycline-based chemotherapy. That’s why in July 2010 the FDA advisory committee revoked the fast track approval.

In other words, although I realize that Arlene Kalley was simply worried about what her options would be if her current treatment regimen ceases to keep her cancer in check, in a manner of speaking she is inadvertently comparing apples and oranges in a way that could lead those unfamiliar with the Avastin saga to believe that Avastin and right-to-try are related by anything other than the fact that she has done well on Avastin thus far. I bring this up because the saga of Avastin for breast cancer is relevant to right-to-try bills, but not in the manner implied. Contrary to the arguments made in favor of right-to-try laws that a single phase I trial is enough for a treatment to be deemed "safe," even though Avastin was FDA-approved for other cancers and provisionally approved for breast cancer, in the subsequent clinical trials for advanced breast cancer there was evidence of harm due to Avastin. That harm likely accounted for why the increase in PFS did not translate into an improvement in OS. Specifically, the drug’s toxicity likely “took back” those gains in PFS. As Fran Visco of the National Breast Cancer Coalition put it, “The FDA should never have approved Avastin for breast cancer to begin with. We don’t see evidence of benefit, but we do see evidence of harm.” And that was just Avastin, not a drug with much less extensive testing, such as the experimental therapies right-to-try bills propose releasing “into the wild,” so to speak.

So what do the Michigan bills SB 991 (Senate) and HB 5651 (House) propose? It’s basically very similar to the Colorado law and the Goldwater Institute boilerplate, with a couple of notable exceptions. For example, SB 991 requires:

A statement in the “written informed consent” for using the experimental drug that informs the patient that “the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment and that care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements.”
A statement in the “written informed consent” for using the experimental drug that attests that the “patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.”

The first of these is odd and unnecessary in that hospices tell patients up front that if they undertake curative treatment again they are no longer eligible to be in hospice while undergoing the treatment. Including such a provision in SB 991 strikes me as redundant, a duplication of law and policy that already exists for hospices. The second of these is to me quite objectionable. Not only does it put the patient on the hook for any expenses or debt that he incurs using experimental treatments, but it seems custom-made for drug companies, to make sure that they get their money for experimental therapies administered under “right-to-try,” no matter what, even letting them go after a deceased patient’s estate, something that will frequently be necessary because patients eligible for "right-to-try" by definition have a terminal illness. The vast majority of even the most promising drugs will likely only prolong their life at best, not save it. Either way, both of these Michigan provisions make a bad bill even worse.

In fairness, though, there is also a provision that explicitly states that a patient’s heirs are not liable for outstanding debt related to the treatment or lack of insurance and specifies that this act “does not affect any mandatory health care coverage for participation in clinical trials under the insurance code of 1956, 1956 PA 218, MCL 500.100 to 500.8302,” which, unlike the truly vile language in Colorado’s law, means that insurance companies must continue to cover all treatments not related to the experimental treatment. Also in fairness, SB 991 does add a provision to the usual Goldwater Institute boilerplate that states that “an official, employee, or agent of this state shall not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device” by adding that “counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section.” As faculty at a state institution, I would have been very worried about the part about not blocking access as a provision that might get me in trouble if I were simply to voice my medical opinion.

There was also a curious substitution resulting in a “substituted bill” for SB 991 that stops referring to “terminal illnesses” and instead refers to such illnesses as “advanced illnesses”:

(a) "Advanced illness" means a disease or medical or surgical condition with significant functional impairment that is not reversible even with administration of current federal drug administration approved and available treatments that is expected to result in death or a state of unconsciousness from which recovery is not expected. For purposes of this act only, advanced illness has the same general meaning as terminal illness has in the medical community.

For the life of me, I can’t figure out why this change was made, when the substituted bill states that for the purposes of this bill “advanced illness has the same general meaning as terminal illness has in the medical field.” I can’t help but get a sneaking suspicion, which could be wrong, that perhaps the bill’s sponsors are already thinking ahead to eventually expand eligibility for right-to-try to patients who are not terminally ill by laying the groundwork to have “advanced illness” associated with right-to-try rather than just terminal illness. That would fit in with the general anti-FDA tenor of the Goldwater Institute and much of the movement pushing these bills. Remember, the Goldwater Institute wants to turn back the clock at least 50 years, stripping the FDA of its powers gained after the thalidomide tragedy. I could be wrong, of course, but I don’t think so. Alternatively maybe there’s some regulatory or political reason for the substitution. Either way, the Michigan right-to-try bills are in some ways worse and in some ways not as bad as the Colorado right-to-try law. That doesn’t change how much these laws are flawed in their very conception.

The problem with right to try

I can understand the desperation of families, at least, facing the loss of a loved one to a terminal disease, be it cancer or something just as bad or even worse, such as amyotropic lateral sclerosis (ALS), more commonly known to the public as Lou Gehrig’s disease. After all, it was only five years ago that my wife and I faced the death of her mother from metastatic triple negative breast cancer, including brain metastases. Knowing, as all cancer doctors do, that it could happen to me (particularly now that I’m on the wrong side of 50), I can’t even guarantee that I wouldn’t be tempted by the siren call of right-to-try were one of these bills, or some variant thereof, to be passed into law in Michigan and I later was diagnosed with a terminal illness.

Even so, when people ask, “What’s the harm? and “How can it get worse?” I know that there is harm and it can get worse. If there’s anything worse than dying prematurely of a terminal illness, it’s accelerating your demise, suffering unnecessarily during the little time you have left, and/or emptying your bank account while doing either or both of these things. Compassion impels us to want to help terminally ill people in any way we can, but a less emotional analysis of right-to-try bills, coupled with a knowledge of the science and conduct of clinical trials reveals that these laws, as currently constituted, are almost universally a bad idea. Indeed, with such a low bar for a drug or device to qualify for right-to-try (a single phase I trial), it’s almost guaranteed that such laws are highly unlikely to help, at the cost of a not-insignificant risk of causing harm. These laws would be less odious if the bar had been raised a bit, for instance requiring that at least a phase II trial before a drug is eligible, but that's not what any of these bills propose, including Michigan’s.

Right-to-try laws also provide false hope. For one thing, these laws rest on a faulty assumption that there are all sorts of “miracle drugs” out there that can save the lives of terminally ill patients if only the FDA would get out of the way and let the patients have them. This assumption becomes rapidly apparent perusing the Goldwater Institute’s pages on right to try, which is packed with loaded language about the FDA and terminally ill patients, with every experimental drug apparently “potentially life-saving” and patients dying because they can’t get these drugs. Besides the greater likelihood of resulting in patient harm than help, contrary to what their advocates promise, right-to-try laws won’t deliver increased access to experimental drugs. The reason, as Jann and I have both explained at more length before, is because the federal government, through the FDA, controls drug approval, and federal law trumps state law. State right-to-try laws have no power over the FDA, and nothing states can do can compel the FDA to abide by their right-to-try laws. Moreover, drug companies are understandably reluctant to allow just anyone the use of investigational drugs still in clinical trials, because if something bad happens it could very well affect their application for approval:

However, companies and regulators alike have expressed some hesitancies about the program. For companies, expanded access means letting products out of tightly controlled and heavily monitored environments, potentially subjecting the product to incorrect use and previously-unknown adverse events, which would still need to be reported to FDA. Such incidents could potentially raise questions for regulators, thereby harming the chance of a product getting to market. Further, some companies have expressed their fears about expanded access programs robbing their clinical trials of some patients, which could reduce the statistical validity of a trial and potentially harm other patients by delaying a drug's path to market.

Another issue is a practical one. Manufacturing a new drug for the first time is expensive, which is why, quite often, only enough is manufactured to supply approved clinical trials to be used to support an application for FDA approval. “On-demand” manufacturing would not be easy to implement, particularly if enough patients asked for the drug under right-to-try. This could be a particular problem for small biotechnology companies, which often can barely scrape together the capital to do the necessary clinical trials to support FDA approval. Given that these small biotech companies are often the most innovative and least likely to be seeking approval for “me-too” drugs, the effect of right-to-try on the pharmaceutical industry’s already weak innovation could be significant.

It’s also important to note that right-to-try laws are more about ideology than science. Proponents and supporters of right-to-try tend to use arguments very similar to those used by the “health freedom movement” that rely on questions like, “Who owns you?” and appeals to the belief that the government shouldn’t tell people how they should manage their health. For instance, the Alliance for Natural Health USA, a key “health freedom” organization that advocates relaxing laws regulating the practice of medicine, the better to let quackery (particularly “natural treatments” flourish, is very much in favor of a federal version of “right-to-try,” which is every bit as much a bad idea as the state right-to-try laws, given that it would actually do something. As I alluded to above but did not explain, the Goldwater Institute, in an article promoting right-to-try, gives itself away by bemoaning the expansion of FDA authority in the 1960s by the Kefauver-Harris Amendments that required that the FDA not just require demonstration of safety but of efficacy as well before approving new drugs. This expansion of FDA power was in reaction to the thalidomide debacle, leading the Goldwater Institute to make the bizarre argument that because the issue with thalidomide was a safety problem, not an efficacy problem and because thalidomide was never approved in the US (mainly due to the FDA, let’s not forget), the expansion of FDA power in response to the thalidomide debacle was “unwarranted.”

Unfortunately, right-to-try bills and laws are nothing but feel-good measures that provide the illusion of actually doing something without actually doing anything substantive to help desperately ill patients, particularly given that the FDA already has an expanded access program to allow patients to use drugs outside of clinical trials. There are estimated to be 1,000 requests per year now, and it is uncommon for the FDA to deny a request for expanded access. Indeed, in FY2013, only three such requests were denied; in 2012, four; in 2011, one; and in 2010, sixteen. If, as proponents of these bills believe, expanded access programs aren’t easy enough to access, the answer is not to pass state right-to-try laws. It’s to reform the FDA’s expanded use program, something that’s occurred before and is ongoing, just as the FDA has developed a “fast-track” approval program, the same one under which Avastin was approved.

As David Kroll pointed out, true compassionate use reform will require that we as a society come to an agreement about the balance between access and scientific rigor, realizing that unapproved drugs, particularly the biologicals, such as monoclonal antibodies (which are very tricky to manufacture), are often in short supply. It doesn’t help terminally ill patients if patients demanding right-to-try put companies in a dilemma in which they either surrender some of their precious stock of investigational drug for “right-to-try” requests, thus endangering the company’s ability to conduct proper clinical trials, nor does it help patients to spend their life’s savings on investigational drugs that are unlikely to help them and could hurt them. Although their supporters are well-meaning and sincerely think they are helping the most desperate of their fellow human beings, right-to-try laws are a cruel sham perpetrated on terminally ill patients and should be opposed wherever they metastasize.

oracknows Wed, 08/13/2014 - 22:00

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Technology

Maurice Saatchi (see http://en.wikipedia.org/wiki/Maurice_Saatchi,_Baron_Saatchi), A former advertising executive, given a seat in the UK House of Lords in recognition of his support for the Conservative party, has submitted a bill along these lines in the UK. The bill has been promoted with the full weight of an advertising company behind it - including an editorial article written by the promoters of the bill (but without declaring the COI, so it would appear they were written by an independent journalist).

Fortunately, there has been a considerable reaction on twitter as well as in the medical press (e.g. http://www.bmj.com/content/348/bmj.g3464) and the mainstream media (e.g. http://www.theguardian.com/science/brain-flapping/2014/may/21/saatchi-m…).

Yeah, the last time I discussed right to try, I included a section on the Saatchi bill, which is clearly cut from the same cloth as American right to try bills:

http://scienceblogs.com/insolence/2014/03/06/right-to-try-laws-are-meta…

The main difference in the US is that right to try is clearly intended as a step towards neutering the FDA and bringing us back to a libertarian paradise in which the FDA has minimal power over drugs and drug companies will, through the power of the market, magically make sure their drugs are safe and effective, because, you know, the market. They also say that the tort system will keep drug companies in line, which is hilarious, because the Goldwater Institute also does its best to neuter consumer protection laws that would let people harmed by drugs sue the manufacturer. I also note that the Goldwater Institute template for right to try laws explicitly eliminates liability for drug companies and doctors for almost anything associated with the use of experimental therapeutics.

One point I'm missing....would the drug companies be required to provide the drugs...even if they are still unapproved and in short supply? Couldn't companies just say they are not available? I'm not sure I'm seeing how this bill would transfer the drugs from clinical trials to "me to" patients.

Other than that point, I'm so glad you are addressing these "feel-good" bills. Thanks.

Regarding item 2 in the Colorado law, the 100 mile radius provision isn't facially absurd, because people who are seriously ill often can't travel long distances. Except that the people who live in those places are overwhelmingly likely to be poor, so the "caveat emptor" wording of item 3 is a major problem. I'm assuming that trial sites would tend to be hospitals or clinics in big cities and/or affiliated with major universities, which in Colorado basically means the Front Range region (Pueblo to Fort Collins, including metro Denver)--most of the money in the state is either there or in the mountain resort towns, and the latter have a high concentration of second homes. As for enrolling within one week, that depends on how long it typically takes to enroll a patient (on which point I have no knowledge), but if the paperwork normally takes more than a few days, yes, that's a problem.

As for these John Galt wannabes who think we should do an end run around the FDA: The FDA exists for a reason, and the reason has to do with the outcomes of the last time we had the sort of regulatory regime they advocate.

I have familiarity with some research protocols. I'm not sure I get the one week thing.

Usually they know right away if you meet the eligibility criteria or not and consent you right away (although depending on the trial it may take more than a week from consent to your first study visit as it depends on the schedule of the doctors/clinics involved as they usually see regular patients as well so only have so many study visits per week). Although sometimes you do get what is called a deferred status if you are waiting for medical records from a facility or a visit with one of your other doctors before they can know if you are eligible or not.

Most of the time patients aren't spontaneously registering for your trial on a website or mailing in an application then waiting for weeks or months to find out if they are in or out. Most of the time it is the study staff spending a lot of time tracking down individuals who are on lists of possibly eligible people (like a cancer registry list or a list given to the study by a doctor or clinic), as well as hanging out in the clinic in case someone eligible comes in that day.

Like I said sometimes there is a delay between when you say yes you want to be in it and they have all the medical test results needed to confirm you are eligible. One study I was a guinea pig for took awhile because one medical test they wanted the results for was done at an outside clinic and not the main hospital and especially in the paper record days it took awhile for them to get the record sent as it wasn't needed immediately and the people with stat requests always go first when copying/ faxing/mailing

Thanks, KayMarie. It sounds like a one week delay in enrolling in a study would be commonplace, depending on details, so allowing a patient to skip the process on those grounds is unreasonable.

Can you blame people for being somewhat skeptical of the FDA, when stuff like the MelaFind debacle happens?

I don't think the FDA should relinquish any role in determining safety, although I think they should take a looser role in determining efficacy.

Are there not Federal laws (FDA) that would nullify or take precedent over these state measures? Certainly a company in New Jersey has no obligation to offer an investigational new drug to a Colorado citizen. These laws if they can be applied will only affect companies within the state borders but again I would think they would be superseded by federal law.

"State right-to-try laws have no power over the FDA, and nothing states can do can compel the FDA to abide by their right-to-try laws." Never mind. Should have read more carefully.

A Right to Try bill has been introduced into both the Senate and Assembly in NJ in June and referred to their respective Health, Human and Senior Services Committees.

http://www.njleg.state.nj.us/2014/Bills/A3500/3474_I1.PDF
http://www.njleg.state.nj.us/2014/Bills/S2500/2186_I1.PDF
(Identical Bills)

I plan on writing some strongly worded letters. Future schedules for each committee have not been posted yet but in the case of the senate both sponsors are on the committee, one of whom is the chair, so I don't have high hopes.

It is fine line between encouraging innovation & letting dangerous products on to the market....

I'm sorry, but I'm not seeing a 'debacle' documented at the site you linked to. The device was narrowly approved, due to real concerns--principally the high rate of false positives which would result in unnecesary biopsies and the fact that it's not designed to detect large melanomas, colorless melanomas, and other types of skin cancer (such as basal and squamous cell carcinomas) all of which are detecatble by standard dermatoscope examination.

I think a very good lesson in Right To Try comes from the experience with AZT. It's a great case study in the difficulties faced by FDA to do their due diligence to ensure that a product is safe enough to release to the public while moving fast enough to keep good products from being unduly delayed.

The short story is this: word got out about a possible AIDS drug that was being studied, but had not yet completed clinical trials. AIDS patient advocacy groups became very vocal, pressuring FDA to allow this drug to be used immediately. The FDA ended up caving to pressure and approved AZT before trials were completed and adequate safety and dosing information was in. Lots of AIDS patients began taking the drug, and lots suffered very serious side effects. Over the following years, as more data came in, the dosing was adjusted down to the point that it was finally tolerable and still effective. The advocacy groups admitted that they were wrong to pressure for AZT's immediate approval and acknowledged that the FDA (surprise, surprise) was actually useful and not simply being obstructionist.

The switch from "terminal" to "advanced" is curious. The two are not only not interchangeable, but they don't mean the same thing at all. My husband is terminal, but not advanced - I.e. there is no cure for his cancer, and it will eventually kill him (unless one of the new drugs coming down the pike does the trick - he's in a phase 2 trial right now), but he's not advanced - he has a single known metastasis, which currently has little-to-no effect on his daily life or ability to function. Push comes to shove, his brother is sicker than he is - except for the fact that his brother can expect to live for about 30 more years, while his life expectancy is about 3-5 years.

Brett, I agree with JGC, that is kind of a non-story. Plus it was about detection, and there is an issue with misleading diagnostic tests.

Plus it has nothing to do with "right to try." What they want the "right to try" are experimental pharmaceuticals may not help, and could cause further harm... plus hamper real research into actual effective treatments. As noted by Todd W. and AZT.

More like "Right to Die" as opposed to "Right to Try"

Rob says "One point I’m missing….would the drug companies be required to provide the drugs…even if they are still unapproved and in short supply? Couldn’t companies just say they are not available? I’m not sure I’m seeing how this bill would transfer the drugs from clinical trials to “me to” patients."

Imagine you're an ethical pharmaCEO. A member of the public petitions you for access to an investigational drug per this type of law. Your company says 'no'. Good luck pleading restricted supply, safety concerns or anything else when the s*** hits the public relations fan. You may have no politically-digestible means to avoid releasing the drug for these cases. That is, while still a bad idea it becomes the lesser evil.

And the way the law is written, if said drug causes the person to die, there is no recourse for the family to sue.....

Good luck pleading restricted supply, safety concerns or anything else when the s*** hits the public relations fan.

In this scenario, you have a public relations firm available to fight fire with fire. Have them ask among your clinical patient trials for a few cases who would be willing to go public (privacy laws require this step). Point out that these patients, who unlike the petitioner were willing and able to play by FDA's rules, need the drug too, and because they are playing by the rules, they get priority. Everybody else can join the queue.

No, this is not going to persuade narcissistic libertarian kooks (pardon the redundancy). But normal people (who we hope are most of the population) will understand that limited resources must be distributed according to some rules, and as long as those rules are clear and fair, most people will accept the results.

Sounds like we are already seeing how that issue with supply plays out with the potential Ebola drugs. Sure we can let the companies give it out (and it isn't like we really can let them infect people with Ebola for clinical trials and who knows when the next outbreak will hit).

For a lot of these more unique compounds they are made by small start up type companies that don't have the resources to make huge vats of the stuff.

Of course the Ebola companies are damned if they do damned if they don't. If the give them only to Africans then we are just being colonial and using them for our own ends. If we give them to Americans we don't care about anyone but our own.

I can't agree with you on this one. Your primary argument is that the likelihood that an as-yet-unapproved drug will help a patient is small, and thus giving them access to those drugs is a "false hope". It seems to me that the patients would very likely know this, however, and are willing to gamble. You say that degrading the time they have left and emptying their bank accounts is a worse outcome -- but that's strictly a matter of opinion. And frankly, it smacks of paternalism. As long as all parties are going into this with their eyes open, they should be allowed to.

Your point about the FDA being federally run and thus not beholden to state law is certainly valid. But all that does is make me think that we need a federal right-to-try law.

Ebola:
(1) it seems from what I've read that giving the zMapp product to four people has exhausted the world supply of it; and
(2) the FDA didn't seem to have any problem with allowing it to be used.

But, more generally, it's one thing for physicians to prescribe approved drugs "off-label" for a condition for which they are not approved - the Kalley situation, as Orac notes - it's both legal and I understand widely accepted under appropriate circumstances; but it's quite another to take anything that's been through Phase 1 and remove all state-level restrictions on its prescription. It's an invitation to the Burzynskis of the world, and we surely don't need more of them.

Daniel @21
The patients consent means little; these patients won't have their eyes wide open because the risks are UNKNOWN.
As far as the financial liability, many of these patients will also not likely realize the impact of what they are agreeing to. They are desperate and under tremendous emotional stress, and they rarely [probably never] take an attorney along with them to a clinic. These situations are not the same as applying for an adjustible rate mortgage.
In circumventing hospital review boards, this law removes the advocate for the patient. Not only are patients under great stress, they absolutely cannot do their due diligence because they have no data. The laboratory studies are proprietary.
It isn't paternalistic to require that a drug have an adequate safety profile, its responsible government.

Orac, except for the substitution of "advanced illness," the Michigan bill wording is the same as the final Colorado bill--you may have been looking at a version of the Co. bill before it was amended.

Perhaps Jann is the person to ask--is there any one who would have standing to challenge these laws and get them thrown out?

Orac wrote:
" it seems custom-made for drug companies, to make sure that they get their money for experimental therapies administered under “right-to-try,” no matter what, even letting them go after a deceased patient’s estate."

IMHO, the political-economy argument in Orac's post is right on the, er, money. At the beginning of the article I was thinking, 'yeah, this is bad science, but not that harmful, so maybe not a priority.' But then, as Orac unpacked the Libertarian Kool-Aid behind all this, I changed my mind. What we have here is pseudo-science performing it's typical economic function: letting greedhead scum fill their pockets with profits by sucking dry people facing pain and death. Except this is WORSE in an way than the lies of the NAM-scammers because it writes some very scary things into law, establishing precedent that can be more widely applied, and so on.

The recurring theme of my posts here is that the fight against pseudo-science will not be won by applying the methods of science. It's a political problem, a persuasion problem, and thus rhetorical strategy is key to the outcome. From the standpoint of rhetorical analysis, the question is not whether a given claim is true in any absolute sense, but how well it works in terms of the audience in question. The whole "SBMers are just shills for Big Pharma," schtick has a lot of purchase, for reasons that 'make sense' I shan't detail here. So when Orac makes statements like the one quoted above, the rhetorical value is immense, as they provide effective ammunition to counter an effective discursive tool used by the bad-guys. This ammo is all the more useful as the issue of profiteering is especially a concern to people who are more-or-less on-the-fence on some of these questions, and politics typically swing on whether and where the 'uncommited' may fall.

In short: Bravo, Orac! Good stuff.

Good luck pleading restricted supply, safety concerns or anything else when the s*** hits the public relations fan.

In this scenario, you have a public relations firm available to fight fire with fire.

This notion didn't exactly pan out for Chimerix.

For what it's worth, my Michigan House representative is on the Committee on Health Policy and was not one of the cosponsors of the legislation. I actually passed your writeup on the problems with right-to-try legislation along to one of his staffers, so if' we're lucky that might slow things down a bit.

Thanks. I'm under no illusions about our ability to stop this awful bill. As I morbidly joked in the post, to most people opposing this law is akin to advocating a law mandating puppy disembowelment. You're viewed as the killjoy, the cruel, insensitive guy so uncaring about real patients that he doesn't care that he's "taking hope away from dying patients," rather than as the person trying to protect dying patients from abuse. I spoke with one of the only people who testified against this bill when it went before the Senate health committee. He said the looks he got from supporters of the law were vicious.

That the bill will pass the Senate is already pretty much a foregone conclusion, particularly the way they're sneaking it through without any fanfare. (I still haven't seen any new news accounts since last month.) If it's going to be stopped, the House is where the stand will have to be made. My representative gave me a respectful hearing. He is a cosponsor of the House version, but it is clear to me from his comments that he really didn't know what he was signing on to, which is probably true of most of the cosponsors.

While there are surely issues with the bills, I personally disagree with the extreme opposition argued here. Clean data is good but too many people don't have an option to wait for clean data.

Most such patients would realize it's a 'hail Mary' situation but that's all they have. They don't have time to see scientific verification proceed at its necessarily measured pace.

People are entitled to take their own risks, especially when it's their life on the line. "I'm sorry, we are not ready to be sure this drug is safe enough for you" doesn't cut it. Waiting patiently for scientific rigor is not an option.

@Jay - and when these "untested" treatments start killing people - because we don't know proper dosing or all of the potential side-effects, what will you say then?

How about a potentially life-saving treatment that is rushed through (via this bill) and kills a bunch of people, but it turns out that if testing had been done, those effects could have been avoided (but now the drug is blacklisted in the public's mind, because of the first series of incidents).

Just because people can make an emotional appeal does not mean the government needs to be party to what may be, in effect, assisted-suicide.

I am the wife/caregiver of a terminally ill patient. My husband has stage IV lung cancer. For the most part, I disagree with your argument.

Assigning a big picture secret libertarian motive to the bill is no worse than CAM people insisting that 'Big Pharma doesn't want to find the cure so they can continue to make money on chemo." The intent of the bill is not a libertarian takeover, but rather a means to provide terminally ill patients access to medication that could help them extend their lives.

Your false hope argument is offensive for a couple of reasons. First of all terminally ill people aren't stupid. They are acutely aware of their limited time to be alive. Even though my husband had a complete response to chemo, we understand the cancer is lurking and will come back and kill him. False hope is for the rest of you who don't have to face your mortality. Have you made a will, bought cemetery plots, checked into your life insurance, bought a suit to be buried in, asked a friend to sing "Amazing Grace" at your funeral? Probably not. There's no denial or false hope here. That being said, we can't live our lives in death mode all the time. It's all about quality of life--and good news and hope improve quality of life. When you are terminally ill, the idea that something can extend your life is comforting. Thank God there's always someone like you ready and eager to pull that pillow out from under dying patients' heads. God forbid they may actually think there's hope.

The approval process takes too long. For example, Nivolumab, an immunotherapy drug, still isn't approved for use. Phase 3 trials are done and the results demonstrate that it works in a certain percentage of patients. It's still not available. I think it's finally been approved in Japan, but not here. The rumor mill predicts Nivolumab will be approved in late 2015. That's 160K LC deaths from now.

You argued allowing terminally ill patients access to meds isn't equitable due to wealth and other factors. I agree. But please remember that these same inequities already apply in the trial process. Although the medications are free, the trial process is only available to those who either live near a trial or can afford to travel to one. Also, certain hospitals participate in more trials and it's usually hospitals that accept a variety of insurances. If you're at an HMO that isn't at a comprehensive cancer center or University, chances are your doctor may not have access or knowledge of all available trials. People in most poor countries don't have access at all. Does that mean we should stop doing trials? Of course not. We shouldn't fight to exclude the wealthy, we should fight to include the poor.

Finally, people with certain preexisting conditions are precluded from participating in trials. Drug companies want their drugs to succeed (rightly) so they set very specific guidelines for whom can participate. If you have an autoimmune disease, you probably aren't going to be accepted into a trial. Loosening the noose around these restrictions would give access to potentially life extending drugs to those who were excluded from trials due to somewhat arbitrary guidelines. And unlike chemo, many of the new drugs have fewer side effects and therefore improve quality of life.

I don't disagree with you entirely. We need restrictions and guidelines. Perhaps Phase 1 is too early. Maybe we could up it to stage 2 and insist the decision to try a medication be made with the approval of a doctor.

@jay

The likelihood that this bill will allow someone to get access to a lifesaving drug is vanishingly small. The vast majority of drugs that go into clinical testing will never come to market, and of the ones that do only a tiny, tiny minority will be drugs capable of providing a cure to a terminally ill person. The majority of people who get access to a drug through this kind of legislation will end up wasting their time and money on drugs that, at best, do nothing and at worst make them sicker or even kill them sooner. This is why Orac calls it a cruel sham. The law should protect people from harm, not encourage it.

For example, Nivolumab, an immunotherapy drug, still isn’t approved for use. Phase 3 trials are done and the results demonstrate that it works in a certain percentage of patients. It’s still not available.

The reason why it's not been approved? Bristol Meyers hasn't yet submitted it to the FDA for approval. BM expects to do so later this quarter, which will still be months ahead of the predicted timeline. Hard to see how you can blame the regulatory process for a decision made by the company developing the drug.

I'll also note that Merck's pembrolizumab, a competing anti PD-1 antibody, is about 8 months ahead of Nivolumab in teh approval process, so it's not like Nivolumab is the only game in town.

Does this mean I can dust off the drugs we've thrown in the trash the last 20 years, open phase II's on them that I secretly plan to recruit 1 patient per year (at most) for, and start pushing them on patients at astronomical prices and without any risk to myself. Will it make a garden where a thousand Burzynskis can bloom?

How about if my friends open the phase II more than 100 miles away - I forgot about that part.

Assigning a big picture secret libertarian motive to the bill is no worse than CAM people insisting that ‘Big Pharma doesn’t want to find the cure so they can continue to make money on chemo.” The intent of the bill is not a libertarian takeover, but rather a means to provide terminally ill patients access to medication that could help them extend their lives.

I’m terribly sorry for you and your husband. Lest you think I don’t have any personal experience with this sort of situation, my wife quit her job just under six years ago to take care of her mother, who was dying with stage IV breast cancer, complete with liver, lung, bone, skin, and brain metastases. She observed first hand on a daily basis what happened, and I observed less frequently (but as frequently as I could) because my wife actually moved in with her mother for a few months to do this. It was not an easy time for either of us. So I am not entirely unfamiliar with the personal issues you bring up, although fortunately not (yet) personally or with my wife.

That being said, it is not a “conspiracy theory.” As someone who is knowledgeable about the “health freedom” movement, I recognize in the Goldwater Institute a lot of the same code words that are more about neutering the FDA and allowing the free market to determine what drugs are sold, particularly the part where they discuss having the FDA only assure safety and not efficacy (the Kefauver-Harris Amendments). The arguments made by the Goldwater Institute are also riddled with misrepresentations of the clinical trial process, the law, and the likelihood that patients will be helped by drugs administered off of clinical trial. Note that all of the current right-to-try laws and all of the right-to-try bills being considered by legislatures (such as in Michigan and New Jersey) were written, sometimes word-for-word, from a template produced by the Goldwater Institute. Certainly, the Michigan and Colorado laws are, with only slight variations. Also, if the Goldwater Institute isn’t such a driving force, why is it that it’s flying its representatives to every state legislature considering such bills to testify in their favor. That’s what happened in Michigan.

My analysis of the situation, taken in context with my long time study of “health freedom” advocates, leads me to conclude that the Goldwater Institute and “health freedom” advocates are using terminally ill patients to further their antigovernment agenda, holding out the false hope of “right to try” laws out to attract terminally ill patients to endorse it and to portray opponents who point out that there’s nothing in such bills that is likely to help terminally ill patients as cruel, cold, uncaring monsters who want to deny hope to the terminally ill. Certainly, I’ve been portrayed that way on Twitter by a Missouri right-to-try advocate and by Christine Sandefur of the Goldwater Institute herself. Nothing could be further from the truth. It is because I don’t want to see such patients taken advantage of that I do what I do, even as I know I’m likely to be attacked, perhaps viciously, in social media and elsewhere, for bringing a science-based, rather than Goldwater Institute misinformation-based view to the issue. A particularly good example of Goldwater Institute misinformation is its claim that only drugs “deemed safe” by the FDA would be eligible. Sorry, Ms. Sandefur. Phase I is not an adequate standard for “safety,” even for terminally ill patients, for the reasons I explained in the post.

Your false hope argument is offensive for a couple of reasons. First of all terminally ill people aren’t stupid. They are acutely aware of their limited time to be alive. Even though my husband had a complete response to chemo, we understand the cancer is lurking and will come back and kill him. False hope is for the rest of you who don’t have to face your mortality.

No one said that terminally ill people are stupid, least of all me.

Have you made a will, bought cemetery plots, checked into your life insurance, bought a suit to be buried in, asked a friend to sing “Amazing Grace” at your funeral? Probably not. There’s no denial or false hope here. That being said, we can’t live our lives in death mode all the time. It’s all about quality of life–and good news and hope improve quality of life. When you are terminally ill, the idea that something can extend your life is comforting. Thank God there’s always someone like you ready and eager to pull that pillow out from under dying patients’ heads. God forbid they may actually think there’s hope.

Whether you realize it or not, you have just very eloquently described why even the most rational and intelligent person who is terminally ill can still be very much prone to pitches that provide false hope, like right-to-try. As I said in this very post, I can’t even 100% guarantee that I wouldn’t be tempted by such a hope if I were to be diagnosed with a terminal illness. I would hope, however, that someone with a more objective perspective would try to stop me, if it were ever to come to that.

You argued allowing terminally ill patients access to meds isn’t equitable due to wealth and other factors. I agree. But please remember that these same inequities already apply in the trial process. Although the medications are free, the trial process is only available to those who either live near a trial or can afford to travel to one. Also, certain hospitals participate in more trials and it’s usually hospitals that accept a variety of insurances. If you’re at an HMO that isn’t at a comprehensive cancer center or University, chances are your doctor may not have access or knowledge of all available trials. People in most poor countries don’t have access at all. Does that mean we should stop doing trials? Of course not. We shouldn’t fight to exclude the wealthy, we should fight to include the poor.

I’m aware of the issues with clinical trials, working, as I have, in two different NCI-designated comprehensive cancer centers for my entire post-training career. Several years ago, when I worked in NJ, it was a big deal that the state came to an agreement with insurers that they would pay for clinical trial care. I would also agree that access to clinical trials should be expanded. Here’s the difference. Given our limited resources, where should we as a society spend our money? On expanding access to clinical trials that are likely to produce generalizable knowledge validating new treatments? Or on using untested, potentially dangerous drugs in a far less controlled manner, in a way that is likely to be very expensive and even less likely to help patients than the most longshot clinical trial? Expand access to clinical trials, yes. Right-to-try is the wrong way to go about it, particularly given the hidden agenda to weaken the FDA that is clearly part of the reason for these right-to-try bills and the observation that such programs are far more likely to harm patients than to help.

Finally, there already is an expanded access program. We can discuss whether it’s too difficult (and, yes, the paperwork load is onerous for a doctor who wants to put a patient on an investigational drug through expanded access), although it is rare for an expanded access request to be turned down by the FDA if the company is willing. If there is to be reform, that is where it should be, not in state right-to-try laws, which will only serve to make such issues even more difficult to resolve than they are. It also needs to be understood that clinical trials are always an uneasy tug of war between scientific rigor and ethics. We want to include as many patients as possible, but being too liberal often decreases the odds that a meaningful result will come out of the trial. It’s a question clinical trialists wrestle with every time they design a clinical trial. There’s a reason why I called right-to-try laws “placebo” laws. They don’t actually do much of anything (other than confuse things) but make legislators feel good that they think they’ve done something to help the terminally ill.

Does this mean I can dust off the drugs we’ve thrown in the trash the last 20 years, open phase II’s on them that I secretly plan to recruit 1 patient per year (at most) for, and start pushing them on patients at astronomical prices and without any risk to myself. Will it make a garden where a thousand Burzynskis can bloom?

The answer is yes, as far as I've been able to ascertain. Right-to-try basically legalizes that. Its only requirements are that the drug has to have passed phase I and still be in clinical trials. However, you might run afoul of the FDA. That shouldn't be a major concern, though, as we all know from the history of the FDA's dealings with Burzynski. You could certainly get away with it for a decade at least before the FDA makes even a half-hearted attempt to shut you down. And you could go after the estates of your victims patients to collect. The Michigan bill explicitly allows that. You and any doctor helping you couldn't be sued, either.

Its basically a license to print money on the backs of terminally-ill patients....

The reason why it’s not been approved? Bristol Meyers hasn’t yet submitted it to the FDA for approval. BM expects to do so later this quarter, which will still be months ahead of the predicted timeline. Hard to see how you can blame the regulatory process for a decision made by the company developing the drug.

I’ll also note that Merck’s pembrolizumab, a competing anti PD-1 antibody, is about 8 months ahead of Nivolumab in teh approval process, so it’s not like Nivolumab is the only game in town.

There's no game in town right now. They aren't available. That's the big point and the unfortunate truth. Why hasn't BM submitted their data for approval? I don't want to believe it's for financial reasons. I don't buy the 'big pharma' crap for a second, but something is keeping it from being released. What is it? And whether or not it's Merck or BM, doesn't matter. There are drugs that can extend the life of certain lung cancer patients (160K dead a year) but for whatever reason, be it bureaucratic red tape or corporate sludginess, they aren't available. Lung cancer, the deadliest cancer, is one of the least funded due to stigma. Lung cancer patients rely on gains made for more "deserving" cancer. Sad but true.

I apologize if my comments came across as a slight to the FDA. That wasn't the intention. My intention was to highlight how there are effective drugs that aren't available to people.

Polly

There’s no game in town right now. They aren’t available.

You're missing my points, perhaps deliberately.

First, as Bristol meyers has not yet applied to the FDA for approval of Nivolumab, I don't see how one can reasonably argue its failure to have reached the market is a function of a failed approval process.

Second, Nivolumab is is not the only anti PD-1 antibody in development and on track toward approval. At least one other that I'm aware of is also in development and is actually several months ahead in the approval process.

Nivolumab is also not unique in targeting the PI 3 Kinase
T-cell activation pathway: FDA approved Yervoy (Ipilimumab), an anti CTLA-4 antibody, targets the same pathway.

While I agree it would be great if the Nivolumab had demonstrated safety and efficacy and was aready approved, I don't see how the approval process is to balme for its failure to already be approved.

You say that the approval process takes too long: how exactly would you change it to reduce the time required< while still ensuring tht potential new drugs demonstrated sufficiently that they were both safe and efficacious?

The approval process always takes time - whether it be one week or several months....time is time.

If the drug is approved on Tuesday, then people will have died on Monday waiting for it - you're never going to satisfy everyone.

I got your point. Did you read my response? My point is this: It doesn't matter why it takes so long, whether it's due to "bureaucratic red tape or corporate sludginess". I'm not looking to blame anyone or anything only to inspire change. The point is that life-saving or life-extending drugs exist but are not available. There's a lengthy space of time after a medication is proven effective until it actually hits the market. In the case of Nivolumab, we're talking a couple of years. Considering the median survival for lung cancer with treatment is 8 months, that's too long, whatever the reason. There should be a way to make the meds available in that space between. (actually there is, but it's very limited)
As for Yervoy, last I read it was in clinical trials for NSCLC and not fda approved for anything other than melanoma.
Believe it or not, these drugs, at this point most likely won't help my situation. My dh is a chemo-responder and I've spent most of the summer enjoying the hell out of his company. :) Chemo responders are LESS likely to respond to immunotherapy. I'm hoping future research shows why.

And finally, I am not asking for false hope, but actual real hope. Immunotherapy drugs have evidence behind them. They aren't Gerson or homeopathy or chiropractors, which are sadly (ironically?) easily available and not restricted by law.

"That being said, it is not a “conspiracy theory.” As someone who is knowledgeable about the “health freedom” movement, I recognize in the Goldwater Institute a lot of the same code words that are more about neutering the FDA and allowing the free market to determine what drugs are sold, particularly the part where they discuss having the FDA only assure safety and not efficacy (the Kefauver-Harris Amendments)."

I have to give you this point. I don't know enough about it. For my demographic, it's not about politics. It's about access.

When Joe was first diagnosed with cancer I was repeatedly given two bits of really bad medical advice. The first was to banish all sugar from his diet. The second was to consider not "poisoning" Joe's body with chemo. I researched both issues and discovered the sugar advice was unfounded but basically harmless. For the chemo issue I found this article: http://scienceblogs.com/insolence/2009/05/20/chemotherapy-versus-death-… And from then on, your blog became one of the voices I counted on with " a more objective perspective". I totally appreciate your blog for this reason. Anytime I hear about a new treatment, I look it up on your blog.

However, I believe that making access easier to SOME drugs could extend the lives of many nsclc stage iv patients. (and probably other patients I don't know anything about). It's not false hope if they actually work. If the bill is bad, can it be rewritten so it makes sense?

<blockquote. I’m not looking to blame anyone or anything only to inspire change.

Inspire what type of change, however--what changes do you believe could be enacted that would accelerate drug approval without compromising safety and ensuring efficacy with respect to identified indications?

There’s a lengthy space of time after a medication is proven effective until it actually hits the market.

I’d argue that until the developer has submitted all required documents to the FDA, detailing all results from all pre-clinical and Phase I, II and III clinical trials, and the FDA has the time to not only perform an independent audit and review of the evidence but also to respond the developer and request additional information or direct additional studies be completed, and they finally actually approve the drug for sale, it hasn’t been proven safe and effective.

Considering the median survival for lung cancer with treatment is 8 months, that’s too long, whatever the reason.

If the basis for concluding that it’s too long is that people who might be saved if it were available now will not survive, surely any regulatory process that goes beyond a simple rubber-stamp procedure must be considered ‘too long’.

I cannot at this point think of changes to the regulatory system that would have shortened the approval process with respect to Novimulab. Bristol Meyers cannot submit the drug for approval until they’ve prepared and validated their documents (a long, detailed and highly technical undertaking) and the study was completed quite recently (results were announced in June 2014). The FDA certainly can’t act until they receive the completed submission package. It seems to me both BM and the FDA are moving with all appropriate haste (and, it’s important to recall, are actually months ahead of schedule.)

As for Yervoy, last I read it was in clinical trials for NSCLC and not fda approved for anything other than melanoma.

The Phase III clinical trial showing Novimulab to be effective was also with respect to melanoma, and if approved at this time it also would be approved only for melanoma.

However, I believe that making access easier to SOME drugs could extend the lives of many nsclc stage iv patients. (and probably other patients I don’t know anything about). It’s not false hope if they actually work. If the bill is bad, can it be rewritten so it makes sense?

There probably are some who may be helped by the few drugs that are well into phase III so we may have enough data to know if there is more hope than false hope.

Unfortunately that isn't the way the people pushing for these bills want and sadly in today's political climate I don't think we can get a common sense bill.

It is either going to be all or none, and all is really bad, especially when we don't yet know with much certainty what kind of dosing regime may be effective and safe enough you don't cause way too much damage to the person. While we try to make drugs specific to tumors, you usually kill some healthy cells along the way and not knowing at all what kind of dose may be effective (just what didn't kill a dozen or so healthy people) it is really scary.

Especially with way too many doctors promising cures with inappropriately dosed drugs along with the woo they peddle. Give them access to a much bigger range of drugs, it may hurt a lot more people than it helps.

A few drugs, under pretty tightly controlled conditions may be OK, but the free for all the bills being written are...and the people supporting those bills are not likely to support something reasonable. The reason the bill isn't reasonable now is they don't want something scientifically rational and reasonable and will fight against that tooth and nail, IMO.

JGC,

Maybe I should clarify. The fda approval process is only too long for people with terminal diseases. We don't need to alter the fda approval process. It's important that data is reviewed and scrutinized. However, we need to find exceptions for terminally ill patients to access drugs that aren't yet on the market but have been proven effective. That's the change that needs to be made. I understand there needs to be very, very specific guidelines. We have something in place now called compassionate use but it is so limited.

As to the "can't win, don't try argument'. That's a terrible argument. The goal in medicine should be to heal. Obviously, you can't save everyone (or anyone for that matter), but the goal is to heal as many as possible. The fact that some people die waiting for medication is an outcome we can change. Procedural improvements are made all the time to improve outcome. That's the whole point of medical science, isn't it? Could you imagine if a doctor said, "Well, no matter how successful bypass surgery is, people will still continue to die from clogged arteries. Therefore we shouldn't do bypass surgery." It sounds ridiculous. Do want to have a doctor who says, "Wear gloves? Why? No matter what I do, I can't stop every infection so why should I wear gloves?" There are a million ways procedural changes have improved outcomes in medicine.

Right now (expecially now with this the immunotherapy ball is really rolling) we can make a change that will improve the outcome for stage iv lung cancer patients. I believe we should find a way to make that change. I agree with Orec that this bill oversteps. While it might improve some people's lives, it could potentially cause great harm to others. However, let's not throw out the baby with the bathwater. If the crazy libertarians have a bill, counter it with something better.

Why can't there be a two-step approval process? Step 1 patients wait for the drug. Step 2 patients can receive a drug that has finished phase 3 trials (or phase 2 if the results are phenomenal) and is expected to be approved. Approval would be subject to dx and other conditions. (2 failed lines of chemo, supervision of board certified oncologist, release of responsiblity, etc... whatever it needs to be.) All this would do is make compassionate use more universal and it would allow drug companies to get paid for the drug prior to it's general release.

Polly

Well, there is no correct way to address this legislation that would be applicable to any / all circumstances. But, for one company that is backing this bill is Neuralstem, and if you had Lou Gehrig's disease, what choice would you have ?

Neuralstems answer is repair unhealthy or dying cells, with healthy cells, similar to what most anyone would do if they needed an organ transplant. The body understands cells, more so than it would understand most drugs. If they have passed Phase One for safety, are showing efficacy in PHASE TWO, then why should an ALS terminally ill patient wait ?

Neuralstem, as many companies emerging in the Regenerative Medicine sector are the tip of the arrow as the science progresses. Advanced Cell Technology, and their CSO Robert Lanza are sandbagging years worth of data, that will absolutely astound the medical community. With their Hemangioblast Derived Mesenchymal Cells, they have eliminated Multiple Sclerosis in animal models in six days, with just one injection. ACTC has stated these MSC's are applicable to over 100 different Auto-Immune disorders.

So, based on what vantage point you choose to see on the horizon, at least for ALS, THE Right To Try bill is Right On.

FAMILY Act would reduce pressure on workers to choose between their jobs and their families’ health

lborkowski — Thu, 12 Dec 2013 12:34:29 +0000

FAMILY Act would reduce pressure on workers to choose between their jobs and their families’ health

Today, Senator Kirsten Gillibrand (D-NY) and Representative Rosa DeLauro (D-CT) introduced the Family and Medical Leave Insurance Act, or FAMILY Act, federal legislation to create a "social insurance" system for paid medical and family leave. A new office within the Social Security Administration would administer the system, which would be funded by a payroll tax (two-tenths of one percent of workers' wages, or $1.50 per week for the average worker). Eligible employees could receive 66% of their monthly wages, up to a capped amount, for up to 12 weeks while dealing with their own serious health conditions, bonding with a new birth or adopted child, or caring for a family member (including a domestic partner) with a serious health condition.

Right now, many workers with serious health conditions, or a child or parent who's seriously ill, must face the difficult choice between going to work in order to keep their pay coming in, or staying home to recover or provide needed care to a family member. In a country that values work and values families, this shouldn't be the case. The FAMILY Act would allow workers to take time off for their families' health without losing their entire income for that time period.

On the 20th anniversary of the Family and Medical Leave Act (FMLA) back in February, health advocates noted that the law, while an important step, falls far short of providing the kind of support the US workforce needs. The FMLA allows eligible workers to take up to 12 weeks of unpaid leave to deal with their own serious health condition or that of a loved one, or to care for a new child, without being fired for doing so. Because the leave is unpaid, though, many workers can’t afford to take it. It only applies employers with 50 or more employees, and to workers have been with their employers for at least a year and worked at least 1,250 hours for that employer over the past 12 months, which means new hires and many part-time workers are excluded. As a result, around 40% of US workers are ineligible for FMLA leave.

The FAMILY Act would address major gaps left by the FMLA. Family and medical leave would be paid, and it would be available to workers regardless of whether they work full-time or part-time, how long they’ve worked for their current employer, and how large their employer is. Anyone who pays into Social Security and is eligible for Social Security Disability Insurance benefits would be able to receive partial salary replacement under the FAMILY Act.

Workers would be able to use leave to address their own serious health condition (as defined by the Department of Labor for FMLA purposes) or to care for a child, parent, spouse, or domestic partner with a serious health condition. The Act would also allow workers to take leave to care for an injured military family member or deal with exigencies arising from a servicemember’s deployment.

Today, the US is the only industrialized country that doesn’t guarantee workers any paid maternity leave. (Many, but not all, of these industrialized countries also offer paid leave to new fathers, and to parents of either sex who have adopted a child.) Studies have found associations between paid maternity leave and higher rates of well-baby visits, decreased infant mortality, longer periods of breastfeeding, and improved mental health of new mothers – all of which contribute to children's health and development. Children recover from illnesses more quickly with a parent’s care. Medicare patients with family caregivers tend to have shorter hospital stays, and the availability of family caregivers can delay or prevent entry into nursing homes.

In short, paid medical and family leave is good for public health. That’s why the American Public Health Association has endorsed laws that expand access to paid medical and family leave, as well as the FAMILY Act specifically.

Paid family and medical leave are also good for the economy. Liz Ben-Ishai writes about the FAMILY Act at MomsRising.org:

This kind of program would make a huge difference in workers’ lives. Only 11 percent of private sector workers currently have paid family leave, and fewer than forty percent have access to disability insurance for personal medical leave. Under the FAMILY Act, a majority of workers could breathe a sigh of relief knowing that caring for a sick parent or child or welcoming a newborn wouldn’t push them into economic insecurity. Moreover, the program would boost the economy; when workers are secure in their jobs and able to handle life’s inevitable obstacles without fear of income or job loss, they’re more likely to put money back into the economy. That’s money they’ll spend in their communities to help sustain local and national businesses.

Conscientious employers care about their employees, but also have to mind the bottom line. The FAMILY Act makes business sense because employers’ financial contributions to the program are minimal, while the potential benefits for productivity and employee loyalty are great. Cynthia DiBartolo, CEO of Tigress Financial Partners, explains: “Companies can measurably improve their bottom line by transforming a company’s corporate culture into one of a truly caring organization—which basically means, putting the interests of their employees first!” According to DiBartolo, the FAMILY Act “will help businesses to do what’s good for employees and good for the bottom line.” That’s probably why, as polling from Small Business Majority shows, a plurality of small business owners from across the country support a family and medical leave insurance program like the one proposed under FAMILY.

The FAMILY Act builds on the success of state-level family leave insurance programs, like those in California and New Jersey. Rhode Island recently passed a family leave insurance law, as well, and will soon implement the program. The experiences of California and New Jersey further demonstrate the benefits of paid leave for workers, business owners, and the economy. In California, nine out of ten employers report either positive effects or no effect of paid family leave insurance on business operations. And 91 percent of workers in low-wage jobs who used paid leave say it helped them to better care for a new child.

The FAMILY Act can reduce inequality, improve public health, and bolster the US economy. It seems like something all the family-friendly members of Congress should be able to support.

lborkowski Thu, 12/12/2013 - 07:34

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How to frame this:

"I call on every member of Congress who has ever uttered the words _family values_, to put money where mouths are and vote for this Act."

Hold their feet to the fire on this.

And for those who don't vote for it, bird-dog them with the phrase "family values" until they howl at the Moon.

At DC City Council hearing, support for policies that help working families

lborkowski — Tue, 29 Oct 2013 17:02:57 +0000

At DC City Council hearing, support for policies that help working families

I spent much of yesterday at a hearing held by the District of Columbia City Council’s Committee on Business, Consumer, and Regulatory Affairs – but I didn’t manage to stay for the entire 11 hours. Nearly 150 witnesses signed up to testify about the two main issues under consideration: raising the city’s minimum wage, and improving its paid-sick-leave law, which denies many workers access to paid sick days. The presence of so many witnesses, and the many hours they and Committee Chair Vincent Orange spent in the hearing room, demonstrate the importance of these issues that affect so many working families. (By one estimate, approximately 100 witnesses got to testify; many had to leave before the hearing wrapped up at 9pm.)

I was at the hearing primarily to testify in support of improvements to DC’s paid sick leave law. When the Council passed the law in 2008, it was only the second city in the nation to do so. (San Francisco was the first, in 2006, and it’s still the only one to require that all employers let employees earn paid sick time.) The law also includes “safe” leave, time that victims of domestic violence and sexual abuse can use to obtain medical, social, or legal services. DC’s law has some serious shortcomings, though. It excludes tipped restaurant workers (which is terrible for public health) and workers in their first year of employment, and it doesn’t include penalties to effectively discourage employers from denying workers the paid sick time they’ve earned.

The Earned Sick and Safe Leave Amendment Act of 2013 (PDF), introduced to the City Council earlier this month, would expand the law to include tipped restaurant workers, allow employees to access paid leave after 90 days working for their employer, and includes financial penalties for employers who violate the paid-leave law. Many of the Council members who spoke at the hearing voiced support for improving DC’s paid sick leave law – and, thanks in large part to the work of the Paid Sick Days for All coalition, 11 of the Council’s 13 members either co-introduced or co-sponsored the bill.

Combining the issues of paid sick leave and the minimum wage into a single hearing – and, potentially, into a single bill that can be voted on in December – makes sense because the current laws on both issues disadvantage low-income families. With turnover especially high in low-wage jobs, many workers aren’t with the same employer long enough to pass the one-year waiting period to access paid sick days. Low-income workers are the least likely to be able to miss a day’s pay in order to stay home to recover from illness or care for a sick family member. Minimum-wage workers have been without a raise for years, even as the cost of living has risen quickly.

DC’s minimum wage is $8.25 per hour; by law, it’s one dollar higher than the federal minimum. The multiple bill that have been introduced propose increases to amounts ranging from $10.50 to $12.50 per hour, with increases to be phased in over multiple years. Several councilmembers said they’d prefer that the federal government raise the minimum wage, but think DC should act on its own because Congress seems unlikely to make progress on this issue. Councilmembers and witnesses alike alluded to DC’s recent economic boom, and said that this prosperity should be shared across the city’s population. Council Chair Orange also noted that DC is in discussions with two neighboring counties – Maryland’s Montgomery and Prince George’s Counties – about acting to raise their minimum wages at the same time.

The prospects for DC legislation that both increases the minimum wage and improve the paid-sick-leave law looks good. “This train has left the station, it’s not going to stop,” Orange said about raising the minimum wage, suggesting that it wasn’t a question of whether the city’s minimum wage would increase, but by how much and how quickly. Because higher incomes are associated with better health outcomes, combining a minimum-wage increase with expanded access to paid sick days would be an excellent way to improve public health in Washington, DC.

lborkowski Tue, 10/29/2013 - 13:02

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Occupational Health News Roundup

lborkowski — Mon, 13 May 2013 13:46:17 +0000

Occupational Health News Roundup

While the official death toll from the collapse of the Rana Plaza factory building in Bangladesh was still rising (it has now passed 1,100), a fire at another garment factory in Dhaka killed eight people. (If you haven't yet seen Elizabeth Grossman's post from Friday, she explores the reaction from the Asian Network for the Rigths of Occupational and Environmental Victims (ANROEV).) In the Los Angeles Times, Mark Magnier notes that although this latest disaster has spurred additional calls for reform, change will be a challenge:

The Bangladesh garment industry, a national golden goose, is politically well-connected. Clothing accounts for a whopping 80% of the country’s $24 billion in annual exports and employs 4 million people, with dozens of lawmakers closely linked to factory owners.

And though many Western apparel companies adopt codes of conduct, they’re keen to drive production costs down and maximize profit atop an industry of constantly changing subcontractors. Feeding all this are Western consumers looking for cheap deals.

The average wage for garment workers in Bangladesh is 10 to 30 cents an hour, labor activists say, and many of the factories lack fire escapes, windows or emergency exits.

Garment factory fires have been a recurrent problem in Bangladesh, killing about 700 people since 2006, according to the Clean Clothes Campaign. Last year, at least 110 people were killed in a fire at the Tazreen Fashions factory, with another eight killed in January.

Magnier reports that Bangladesh has announced temporary closures of 18 factories deemed to be dangerous and plans to hire 200 more building inspectors within six months.

For the Associated Press, Jonathan Fahey and Anne D'Innocenzio explain that it will be difficult for major brands to pull out of Bangladesh, because the country has enough workers and manufacturing capacity to reliably produce clothing at high volume and low prices. They also note that retailers rarely know where all of the pieces of a particular garment are produced, because contractors will subcontract out to many small factories.

Several major clothing retailers, including H&M, have just signed on to a legally binding plan under which retailers will help finance fire safety and building improvements in the Bangladesh factories that make their products. The New York Times' Steven Greenhouse reports:

Consumer and labor groups hailed the move by Sweden-based H&M – which is the largest purchaser of garments from Bangladesh – as an important step toward improving factory safety in Bangladesh, saying it would increase pressure on other Western retailers and apparel brands to do likewise.

Within hours of H&M's Monday statement, C&A of the Netherlands and two British retailers, Primark and Tesco, also joined in.

The factory safety agreement calls for independent, rigorous factory safety inspections with public reports and mandatory repairs and renovations underwritten by Western retailers. A legally enforceable contract, it also calls for retailers to stop doing business with any factory that refuses to make necessary safety improvements, and for workers and their unions to have a substantial voice in factory safety.

In other news:

MSNBC: Over 100 workers from roughly 30 different St. Louis fast-food restaurants walked off the job, as part of a campaign to raise the state's minimum wage and win the chance to unionize without intimidation. (For more background, see Josh Eidelson's Salon piece on St. Louis fast-food workers.)

Washington Post: Retired NFL players often require extensive, costly medical care years after their football careers end and the league stops providing their health insurance. The NFL disability board denies nearly 60% of disability claims.

Huffington Post: In an op-ed, US Representative Gwen Moore and AFL-CIO Executive Vice President Arlene Holt Baker warn that House Republicans' "Working Families Flexibility Act" gives employers flexibility not to pay overtime. "In reality, this bill would provide more work and less pay," they write.

Los Angeles Times: Cal/OSHA has fined Bumble Bee Foods almost $74,000 for violations related to the death of Jose Melena, 62, who was burned to death inside an industrial pressure cooker.

NIOSH Science Blog: For Women's Health Week, researchers take a look at women in the workplace and summarize findings: "Women generally have more work-related cases of carpal tunnel syndrome, tendonitis, respiratory diseases, infectious diseases, and anxiety and stress disorders," and health hazards related to reproductive health and pregnancy are also a concern.

lborkowski Mon, 05/13/2013 - 09:46

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Confined Space @ TPH

Occup Health News Roundup

Occupational Health & Safety

Governor Brown vetoes bills to protect California domestic and field workers

lborkowski — Mon, 01 Oct 2012 15:33:14 +0000

Governor Brown vetoes bills to protect California domestic and field workers

California Governor Jerry Brown has vetoed two bills that worker advocates promoted. The Humane Treatment for Farm Workers Act, AB 2676, required that farmworkers' supervisors ensure the workers have continuous access to shade and enough cool water to drink one quart per hour during each shift; failing to provide water or shade under high heat conditions would be a misdemeanor punishable by fines or jail time.

The governor stated that instead of a new crime applying to one group of employers, the state should "continue to enforce our stringent standards for the benefit of all workers." But Peter Dreier notes in the Huffington Post that California regulations issued in 2005 have not prevented heat deaths among farmworkers. He cites the 2008 death of 17-year-old Maria Isabel Jimenez, who collapsed after pruning in a vineyard for nine hours straight without water or shade, and the July death of Maximo Lopez Barajas who collapsed in 100+-degree heat while pruning in a pomegranate orchard.

Brown also vetoed the Domestic Worker Bill of Rights (AB 889), which would have extended rights to overtime pay and rest and meal breaks to domestic employees. (I wrote about the bill here.) Hannah Dreier of the Associated Press reports that Brown, while stating that domestic workers deserve fair pay and safe working conditions, cited unanswered questions in explaining his veto:

Brown outlined his own list of eight questions in a veto message.

They include the effect of increased costs he said could burden the disabled and elderly and their families. He also suggested the additional cost could mean fewer jobs for domestic workers and strain state regulators trying to enforce the requirements. Moreover, he said, a drafting error would have cost the state more than $200 million annually because the bill would have applied to In-Home Supportive Service workers.

"In the face of consequences both unknown and unintended, I find it more prudent to do the studies before considering an untested legal regime for those that work in our homes," Brown wrote.

I don't know about all the particular circumstances Brown was referring to, but this isn't a completely uncharted territory. The California bill was based on 2010 New York legislation, which has resulted in 80 investigations and $250,000 in recovered wages.

A subset of domestic workers, home care workers, still has a chance to receive the wage and hour protections that non-exempt employees in other industries enjoy under the federal Fair Labor Standards Act. In December 2011, the Department of Labor published a proposed rule to amend FLSA regulations so that the "companions for the elderly" exemption could no longer be used to deny minimum-wage and overtime protections to home care workers who help clients with bathing, dressing, eating, wound care, and other essential activities (read more about the proposal and its projected impacts here). Given the current pace of regulatory activity, though, home care workers will likely need to wait until 2013 to learn the outcome of this proposal.

lborkowski Mon, 10/01/2012 - 11:33

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Occupational Health & Safety

Getting closer to sane transportation legislation

lborkowski — Thu, 15 Mar 2012 17:45:43 +0000

Getting closer to sane transportation legislation

Yesterday, the Senate passed a two-year transportation bill by a vote of 74 to 22, putting us close to getting a reasonably good piece of legislation signed by March 31, when the current stopgap extension will expire. Last month, the House Natural Resources Committee approved a terrible bill that would have eliminated the current dedicated funding for public transportation, but House Speaker John Boehner (R-Ohio) has so far not brought it to the floor for a vote. The American Public Health Association and 15 other public-health groups wrote to Representatives urging a "no" vote on the House bill not only because it would strip out public transit funding but because it would eliminate dedicated money for the Safe Routes to School and Transportation Enhancements programs, which help communities support walking and bicycling.

Stephen Lee Davis of Transportation for America compares the two chambers' bills point by point. He explains that the Senate bill preserves the dedication of 20% of federal gas tax revenue to public transportation, and allows some flexibility for spending the money on operations rather than new equipment. (Many transit systems have struggled to keep buses running as gas prices have risen and laid-off commuters have stayed home, so this flexibility will be welcome.) He also reports that the Senate bill consolidates programs for safer walking and biking and gives metro areas greater control in deciding which projects these funds should support. Ben Goldman of Streetsblog points out that greater local control might mean that some areas decline to fund bike or pedestrian improvements at all, though.

Thanks to an amendment from Senator Charles Schumer (D-NY), MAP-21 also restores parity between pre-tax employee benefits for transit and parking. At the end of 2011, the maximum amount employees could set aside tax-free for public transportation dropped from $230 per month to $125, while the maximum for parking rose from $230 to $240. (I wrote here about what this kind of savings can mean for commuters.)

That's the fairly good news. Then there's bad news.

Brad Plumer at Wonkblog explains that the Senate bill patches together money for the next two years, but doesn't do anything to address the overarching difficulty of transportation money -- not just for buses and trains, but for highways and bridges:

But what happens after those two years are up? It looks like the federal government will simply run out of money to fund the country's transportation needs. The Highway Trust Fund, which is paid for by the federal gas tax, is rapidly dwindling. Americans are buying more fuel-efficient cars and driving less. And the 18.4-cents-per-gallon gas tax isn't indexed to inflation. That means that, right now, there isn't enough money to maintain transportation spending at current levels. The Senate bill, which passed on a 74-22 vote on Tuesday, had to resort to a bunch of side-measures to make up the shortfall. But the Senate could only stretch things out so far. When 2014 rolls around, the trust fund will be broke.

Here's how the $109 billion Senate transportation bill will be paid for. The gas tax is set to raise $72 billion over the next two years, according to the Congressional Budget Office. That's the biggest chunk of it. The bill would then also use future revenue over the next 10 years to fund current spending. That's another big part of it. But there was a cost to all this gimmickry. According to the CBO, the Highway Trust Fund will be totally bankrupt by 2014.

And even then, there was still a $10 billion shortfall in the Senate bill. So they had to scrounge around for the rest. Some of the money, about $3.7 billion, came out of a separate trust fund intended to clean up leaking underground fuel tanks (which was originally paid for by part of the gas tax). Another $2.8 billion came from ending the tax deduction for "black liquor," a byproduct of paper manufacturing. Another $743 million came from revoking passports for people who owe $50,000 in back taxes. The IRS was given more power to collect delinquent Medicare taxes and transfer some tariffs into the Highway Trust Fund.

It'll be even harder to come up with this kind of additional revenue in 2014, but Plumer points out that there's a straightforward solution: raise the gas tax, or at least index it to inflation. (Plumer notes that Senator Mike Enzi, R-WY, offered an amendment to index the tax to inflation, but it didn't succeed.)

While now isn't a great time for a tax increase, it's the most sensible way to maintain our transportation infrastructure and systems, which are essential to all our lives. A predictable and gradual increase could also give people time to arrange their lives to require less gas consumption -- setting up a carpool with co-workers, buying more fuel-efficient vehicles, figuring out how to use the local bus system, advocating for bike lanes in their neighborhoods, etc. More tax revenue for transit, bike, and pedestrian improvements can also make it easier for people to rely less heavily on their cars, which will make them less vulnerable to spikes in gas prices. As I've said before, I'm not saying everyone needs to give up their cars -- I'm advocating for more transportation options, so those who'd rather not drive in every situation don't have to. Fewer cars on the road means cleaner air and less congestion for all, and walking and biking are good ways to get exercise. We need transportation legislation that moves us toward a less driving-centric future; for now, the Senate bill at least avoids taking us backwards.

lborkowski Thu, 03/15/2012 - 13:45

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New Avenues to Knowledge

milhayser — Mon, 12 Mar 2012 09:18:50 +0000

New Avenues to Knowledge

Science publishing is at a crossroads. On We Beasties, Kevin Bonham says that early scientists "communicated amongst themselves in person or in letters or in books. They shared discoveries freely and it was possible for an individual human to be aware of almost the entire sum of human knowledge." As the pace of discovery accelerated, scientific journals became instrumental in recording and disseminating knowledge. But today, while earnest researchers must "publish or perish," and millions of students stand to benefit from open access, publishers themselves are focused on turning a profit. Bonham debunks the antiquated advantages of classical journals, and envisions a future where "distribution of scientific knowledge returns to the model of the 19th century - free and openly distributed - but now also instantly and globally distributed at the same time." Meanwhile, on Confessions of a Science Librarian, John DuPuis joins the boycott against publisher Elsevier in response to their "excessive commercial avarice" and encourages other librarians to take a stand. And on Aarvarchaeology, Martin Rundkvist outlines his involvement with progressive publishing—and invites us to download his new book, free of charge.

The Future of Science Publishing on We Beasties
Elsevier boycott: Time for librarians to rise up! on Confessions of a Science Librarian
My Recent Mead-halls Book Available On Open Access on Aardvarchaeology

UPDATE:

Elsevier Blinks, Will No Longer Support Research Works Act on Denialism Blog

Posted to the homepage on February 23, 2012.

milhayser Mon, 03/12/2012 - 05:18

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archaeology

legislation

Publishing

Weather Explains Politics

drorzel — Wed, 03 Feb 2010 08:55:19 +0000

Weather Explains Politics

In the wake of recent political developments, there has been a lot of hand-wringing about why Democrats in Congress are so spineless, and have been unable to pass meaningful legislation despite huge majorities. After thinking about my travel plans last night, I think I have the key to the Grand Unified Theory of American politics.

The problem is not that Democratic politicians are uniquely craven, or venal, or anything like that. The problem is Washington, DC.

No, this is not a prelude to some right-wing rant about how the Real America can be found only in states with more livestock than people. The problem is that Democratic politicians have spent far too much time in Washington, DC, and as a result have internalized the city's characteristic approach to its environment, which is pants-wetting terror.

We're talking about a city that shuts down its schools when there is snow forecast. Not falling, not piling up on the ground, forecast. If the long-range forecast calls for snow on Friday, the stores sell out of bread, milk, and toilet paper on Tuesday, Wednesday at the latest.

Spend enough time in that environment, and it starts to get to you. I spent six years living in DC when I was a grad student, and by the end of that time, I was starting to fall into the DC mode. A light dusting of snow, the sort of thing I wouldn't think twice about going out drinking in when I was in the Northeast, started to keep me home. I said it was because I didn't want to deal with the idiot locals, but that's just the first step down the slippery slope toward, well, becoming a Democratic congressman.

Democratic politicians are so spineless because they've spent so much time living surrounded by people whose reaction to the slightest bit of weather-related adversity is to crawl back into bed and cry for their mommies. Given that environment, you can't really expect them to stand up for themselves in the face of, well, anything. A strong headwind makes their knees go wobbly-- it's no wonder they cave in the face of Republican parliamentary tactics.

"Ah," you say, "that might explain Democrats, but how do you explain the Republicans? They're not turned into craven cowards by living in DC."

Au contraire, I reply, because I took French in high school. You forget that there are two failure modes for humans gripped by paralyzing fear. Some retreat and cower, while others lash out. They try to compensate for their own crippling inadequacy by bullying those smaller and weaker than themselves.

If you know where to look, you can see clear indicators of this element of Republican psychology. Yeah, they're great at dominating Democrats and kicking kittens, but look at their response to terror. The mere suggestion that we might possibly consider transferring suspected terrorists from Guantanamo to maximum security prisons on American soil gives them the vapors. From their reaction, you would think that the wimpiest terror suspect being held in Cuba was Galactus, Eater of Worlds, rather than an unsuccessful Afghan poppy farmer sold out by his neighbors.

Clearly, both political parties have been infected by the corrupting influence of Washington DC. It's not the money, it's not the power, it's not the corrupting influence of mephistopholean lobbyists. It's the weather. Specifically, the negative influence of living in a community that goes into vapor lock when it gets a little cloudy.

"All right, smart guy," you say. "You've got your Unified Theory of Politics that explains the behavior of the political parties. How do we fix this?"

The solution is clear, and obvious. We need to go back to basics, and look to the Founding Fathers for guidance. Specifically, George Washington, our first president, whose capital was... New York City.

Washington had it right. New York is the right place for the capital. It's not just that it's the city with the most money and power, it's the city with the most attitude. New Yorkers are tough, and not cowed by mass murder within the borough of Manhattan, let alone a little bit of weather. People in New York don't cower in bed when it snows, they shake it off and go on with their day.

That's the kind of fortitude that is sorely lacking in our modern politicians, of both parties. When New York politicians suffer a setback due to parliamentary maneuver, they don't cringe away and offer timid compromises. They either lock the other party out of the legislative chambers-- literally. If they get locked out, they don't whine to the press, they steal a key and a spare gavel, and break in.

(Yeah, OK, they're also wildly corrupt. But who would notice the difference?)

We need more of that backbone. The problems facing us are too serious and too urgent to be dealt with by cowards and bullies. We need legislators who will stand up and fight in the face of adversity, and you just can't do that in a city that wets its collective pants when the weather gets a little rough.

And that's why we need to abandon Washington DC, and bring the government back where it belongs: New York City.

drorzel Wed, 02/03/2010 - 03:55

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I think you're on to something. Perhaps this is what Colbert can ask in his interviews with congresspersons: what, specifically, makes you cower in pants-wetting fear?

Full disclosure: It snowed last night and I'm taking the day off, not from fear, but because the government is letting me. I didn't want to dig out my car at 5 AM; I wanted to sleep instead.

Following a bit further why stop at New York City, Buffalo if you want to stay has worse weather and lives with it, or perhaps Bismark ND, or Glendive MT, or Fairbanks, AK. All places where a little snow does not shut the place down.

How is fortitude a matter of concern ?
I just read that the Credit Default Swaps went from
140 billion up to 65 trillion in 10 years. CDSs are
supposed to be insurance against some company going
bankrupt. How well do any of these congress critters
understand this stuff? It seems to indicate that companies
are 500 times more worried about bankrupcy than 10 years
ago. Talbott says that the immediate cause of the market
meltdown was inability to make margin calls on this stuff.
Paulson was going to have a reverse auction but discovered
that all these things are convoluted contracts - it did not
work. So - it looks like things are so complicated that
nobody can figure it out - that, rather than fortitude,
seems to be a huge problem. Another is that nobody knows
the risks a company has because these derivatives are not
public knowledge.

I'm with Lyle, let's let the government be near the center of the country. Fargo, ND floods too often, so that's out. I'll vote for the Twin Cities here. We get a snow day in my school district once every two or three years. We don't even cancel parades unless it's worse than 30 below.

Plus, I could get hired for a cushy paper-pusher job for triple what I'm paid in education. That'd be neat!

I hate to undermine your grand theory...

Every suburban school district in the DC area is closed today due to three inches of snow. DC Public Schools opened on time.

Every suburban school district in the DC area is closed today due to three inches of snow. DC Public Schools opened on time.

That doesn't really undermine Chad's theory. Do Congresscritters who have school-age children send them to DC public schools? I don't actually know for sure, but some common options would be (1) back home, wherever that is; (2) if they have a house in the DC suburbs (Rick Santorum, when he was a Senator, maintained a house in northern Virginia), perhaps the public schools there; (3) a private school such as Sidwell Friends. Also, people in the District can actually get places on the Metro, whereas those who live in the suburbs are much more likely to be totally car-dependent.

If you want a geographically centered capital, the ideal spot is near Castle Rock, South Dakota. To fit it in with existing transport infrastructure, you would probably want to put it in Rapid City, which is about 60 miles south. (Note: This is the geographical center if Alaska and Hawaii are included. Simply googling "us geographical center" leads you to Lebanon, Kansas, which is the closest town to the geographical center of the 48 conterminous states.) Blizzards are a fact of winter life in South Dakota, so they don't shut down for a little bit of snow--but you do need to watch out for snow drifts.

Basically our only hope for rational government is to relocate congress to a biosphere.

Sure, I can go along with that.

Weather silliness aside, the characterization of politicians of both parties as excessively fear-driven seems dead on to me. But maybe it's a fair reflection of their constituents.

I agree, although you forgot the effects of our gawd-awful heat and humidity in the summer. Wearing a suit when it is 90 degrees with 95% humdity does bad things to your brain.

If your theory holds, you'd expect freshmen Democrats from Northern states to be the least pusillanimous, while Southern Republicans, coming from states even less able to handle winter weather. I think Al Franken and Jim DeMint are pretty solid evidence for you.

Of course, you missed the whole contretemps last winter when Obama mocked his kids' school for closing due to snow, and D.C. responded by pointing out he works from home.