AngryToxicologist is a scientist in the public health sector, knows plenty about toxicology, and is occasionally angry about it all. Drop me a line at 
A couple of weeks ago, as I'm sure you heard, the FDA held an advisory committee meeting that concluded that there should be no use of cough/cold products for children under 6. There is a good amount of evidence that the drugs (including antitussive, expectorant, nasal decongestant, antihistamine and combination products) were not effective and are harmful in some cases. Now what happens?
A couple of signs: Most manufacturers took all under 2 cough/cold medicines off the shelf. Many, like Wyeth who makes Dimetapp and Robitussin have recalled Children's Dimetapp and some Robitussin to replace the dosing cups with those that have half-teaspoon marks (the recommened dose for kids 2-6). A bit of a digression here: The Children's products came with a dispenser that only had marks for the adult amounts? That's rediculous! No wonder there are accidents with dosing (one of the main concerns of the panel). I should note that Dimetapp has only had a dosing cup for a couple months; Robitussin has had one since the early 90s.
You'll note that medicines for 2-6 weren't taken off the shelf voluntarily. The FDA has hinted in the press that changing the regs to disallow under 6 use (or even under 2 use) would take years. Years? Unacceptable, I say! I'm not the only one; Sen Dodd sent a letter to the FDA Commissioner saying, basically: Unacceptable! Get your ass in gear! Of course, he said it in much nicer language. He also said:
In response to the strong votes by the FDA's advisory committees, officials at the FDA are quoted in press reports as merely urging parents to continue following directions on these products. I find FDA's comments deeply troubling as it is these very directions that have been identified as misleading to parents.
It's sad that someone has to point this out. And because he says it so well, I'll include this left jab that lands nicely:
As you will recall, I, along with Senator Jack Reed, have written you and your predecessors at the FDA for more than 10 years in an effort to push the FDA to issue a final monograph on sunscreen products that would inform consumers about sunscreen protection from both UVA and UVB rays. All in all, it took the FDA nearly 30 years to issue the final sunscreen monograph for UVA and UVB protection. I am deeply troubled by reports that the FDA may consider a similar regulatory process before informing parents about the risks and benefits of using OTC cough and cold products. Children and their families should not be forced to wait on a lengthy, bureaucratic process, when action can and should be taken quickly to protect our nation's children from possible harm.
Yeah, that's right. 30 years. Something's rotten at the FDA and it smells like bureaucracy. Here's my take on why bureaucracy is so bad at the federal government: because it is so dang fair and has to justify every little thing it does was the best possible decision. I know that doesn't sound so bad but hear me out. The government can't make decisions that it thinks is right; it has to prove beyond all reasonable doubt that it is right. It also has to make sure that it is completely consistant all the time so as not to give advantage to one party over the other. These constraints would kill any business. In a business, you make the best decision with the information you have at hand. With public institutions, however, there needs to be a balance between responsibility to the public in terms of fairness and accountability with efficiency and public service. Unfotunately, they are not completely compatible. Both are necessary but can't be fully served. It seems to me that when agencies are routinely saying they "get back to you in a coulple of years" with things that they know are problems now, we've swung way too far into the legalistic fairness and assuredness territory (see FDA and food and OTC drugs; CDC and formaldehyde trailers; EPA and phthalates; DoD and armor...ETC).
We need to have some more flexible agencies paired with some strong IG offices so that fairness is given a more critical eye. In that vein, Sens. Waxman, Kennedy and Allen have introduced a bill that would allow the FDA to quickly ban the marketing of the drugs while the rulemaking takes place and put the authority for OTC ads under FDA's jurisdiction (it's currently under the FTC; go figure). It's a good thing, but it would be nice if it didn't take an act of Congress to make any decision in DC.
Of course, right now we have political interference that makes things unfair/unsound and more burecratic hurdles. Isn't it ironic, that the people that complain about big government the most are the same ones who throw the most barriers in the way of governence, creating a larger burecratic morass?
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Comments
If the only fault of the FDA approval process was the long delays attributable to efforts to prove "beyond all reasonable doubt" that their decisisons are correct, I might chalk that up to zealous pursuit of the truth -- not a bad thing among scientists. But I find the role of politics in FDA decision-making much more worrisome. Consider Plan B....
Posted by: bob koepp | November 7, 2007 9:34 AM
No government agency can be purely driven by science. If the FDA was purely driven by science, drugs would list possible benefits and side effects. But that is not how it works. The FDA must weigh the science, the politics, and the morality. A risk that is acceptable for an adult may not be acceptable for a child. This is not a science based decision, but rather a political and moral based decision. And to me, that is reasonable.
Posted by: Mike | November 7, 2007 5:02 PM
I see the point of taking these things off the shelf. But, from a parent who had kids who were very sick with respiratory ailments when they were little, what's a parent to do? Breathing steam just doesn't cut it.
Posted by: SciLibby | November 8, 2007 11:41 AM
It's simple. The top decision makers at the FDA are in bed with the pharmaceutical barons, each receiving a million for every approval. That's why they can't make decisions: they are beholden to their real employers. It's a puppet show. We need an honorable investigative team to delve into the financial lives of the top agency echelon, though they be well laundered. With that kind of kick-backs, ethics succumb to greed. The Donald Rumsfeld 'encouragement' for Vioxx passage while on the company's board is a perfect example. The FDA is just eye candy for the malleable Everyman unwilling to consider impure motives in the hearts of their protectors. But, there is deceit and blatant disregard for the health of every American, precious little children included, at the federal level. And we are, at least right now, powerless to defeat this behemoth that rules us from a very selfishly dark place.
Posted by: jan gibson | November 9, 2007 12:39 PM
Delays and denials are not cost free. I've seen more than one analysis that concludes that the FDA is likely to have cost more lives through the time it takes to approve a good medicine than it has saved from disaprroving bad ones.
As an engineer in the pharmaceutical industry, working freelance mostly with small companies who are tryign to develop new products, I can tell you that we spend most of our time worrying about the FDA, and doing everything we can (often expensively and well beyond what is actually needed for product safety) to make sure they can't raise any eyebrows about our products. If the FDA was in the pockets of the industry, this wouldn't be such an issue.
It *is* important that there be solid evidence before pulling a product off the market, and even then it should often be in the form of more information to the doctors and consumers rather than a complete ban. Vioxx and its relatives, for example, did an awful lot of good for an awful lot of people, and there are many who would love to have it back, even knowing the risks they now know.
Arbitrary recalls based on incomplete information (a) costs the good the drug can do for the right people, (b) costs livelihoods for people who work at the companies, and (c) makes it harder to raise money for developing better alternatives.
PhilB
Posted by: Phil Boncer | November 9, 2007 8:03 PM
that would allow the FDA to quickly ban the marketing of the drugs while the rulemaking takes place and put the authority for OTC ads under FDA's jurisdiction (it's currently under the FTC; go figure). It's a good thing, but it would be nice if it didn't take an act of Congress to make any decision in DC.
Right! It would be nice, but as you pointed out, the government is a very complicated thing. It's nice they could move quickly on this!
Dave Briggs :~)
Posted by: Dave Briggs | December 12, 2007 4:53 PM
Actually, one of the biggest problems this country has is the number of "departments" and bureaucracies that *don't* need an act of Congress to make a decision. Our government was designed to be limited and deliberative, so as not to be dumping ill-considered legislation around willy-nilly. The original concept was that ANY law or regulation the federal government put forth would *literally* require an act of Congress.
Instead, we now have dozens of regulatory bodies creating regulations that effectively have the force of law, along with a Congress that too often doesn't even bother to read in detail what they are passing.
So I differ. I think it would be nice if it DID take an act of Congress to make any decision in DC.
PhilB
Posted by: Phil Boncer | December 13, 2007 1:31 AM
Upping the ante, let's look at the real realities of drug sales, which show unacceptable levels of preventable risk for the entire population - perhaps fifty percent? This is an excerpt from my blog- I hope the links are clickable:
Robert Pear informed us that drug sales run approximately $180 billion annually, (Growth of National Health Spending Slows Along With Drug Sales, NYT,1/10/06). Yet researchers Ernst and Grizzle informed us that the adverse effects of drugs exceeds $177 billion in annual spending (Drug Related Morbidity and Mortality, Updating the Cost of Illness Model), (J Am Pharm Assoc, 41 (2), 2001.
How much suffering and expense could be prevented by a simple blood test? In a December, 2003 interview, GlaxoSmithKlein vice president, Dr. Alan Roses noted that half the population is unable to benefit from pharmaceuticals due to genetic biodiversity,(Independent.co.uk article, Glaxo chief: Our Drugs do Not Work on Most Patients by S. Connor).
Posted by: Barbara Rubin | December 23, 2007 5:19 AM
It is true that the effects of most drugs vary widely from person to person, based on genetics, behavior, and environment. A "simple blood test", though, is not currently the feasible answer, because it is rarely known which of these factors interact with what drugs in what ways. Clinical trials to find this out for each drug would be far too large and expensive to be possible, even if we knew how to sort out the data and find the answers; we already have a problem with drug approval being too expensive to warrant the investment for a cure for many diseases and conditions that are less than very common.
As we decode the genome, and begin serious work on the proteome, we are on the way to having a good enough understanding of biology to figure this stuff out. I expect that within 50 years or so, we'll know enough to be able to prescribe medications based on a fairly reliable ability to predict the effects (desired and side) of any given drug on any given patient. But we're nowhere near that now.
The practice of medicine is still a lot about trial-and-error, educated guesses, probabilities, and so on. We do the best we can, and it does a lot of people a lot of good. Western medicine, even as currently practiced, is still a huge net benefit to humanity.
PhilB
Posted by: Phil Boncer | December 26, 2007 4:34 PM
another sloppy work of the FDA.
Posted by: Gene | December 28, 2007 6:16 AM