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

MMdallas_2808435b

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.

Categories

More like this

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.

By Eric Lund (not verified) on 28 Oct 2014 #permalink

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.

By machintelligence (not verified) on 28 Oct 2014 #permalink

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.

By Helianthus (not verified) on 28 Oct 2014 #permalink

"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.

By Eric Lund (not verified) on 28 Oct 2014 #permalink

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.

By JustaTech (not verified) on 28 Oct 2014 #permalink

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

I'm in total agreement.

By Denice Walter (not verified) on 28 Oct 2014 #permalink

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.)

By Xplodyncow (not verified) on 28 Oct 2014 #permalink

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.

By Rich Woods (not verified) on 28 Oct 2014 #permalink

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.

"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.

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.

By Krebiozen (not verified) on 29 Oct 2014 #permalink

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.

By Krebiozen (not verified) on 29 Oct 2014 #permalink

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

By palindrom (not verified) on 29 Oct 2014 #permalink

@

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.

By The Grouchybeast (not verified) on 29 Oct 2014 #permalink

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.

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.
-----
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.

By Tsu Dho Nimh (not verified) on 29 Oct 2014 #permalink

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.

By Krebiozen (not verified) on 29 Oct 2014 #permalink

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.

By Denice Walter (not verified) on 29 Oct 2014 #permalink

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.

By Krebiozen (not verified) on 30 Oct 2014 #permalink

Philip Aries wrote a book about it:

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

By Krebiozen (not verified) on 30 Oct 2014 #permalink

@ 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.

By Denice Walter (not verified) on 30 Oct 2014 #permalink

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.

By squirrelelite (not verified) on 30 Oct 2014 #permalink

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.

By Krebiozen (not verified) on 30 Oct 2014 #permalink

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.

By Denice Walter (not verified) on 30 Oct 2014 #permalink

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?

@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.

By squirrelelite (not verified) on 30 Oct 2014 #permalink

@ 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?

By Denice Walter (not verified) on 30 Oct 2014 #permalink

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.

By Mephistopheles… (not verified) on 11 Nov 2014 #permalink

government - biggest scape goat second to "jewish"