This article on the Guardian’s website, on the failure of the Food and Drug Administration to be sufficiently pro-consumer, pro-safety in its drug approval process, does a nice job of summing up the issues (and poking holes in the FDA’s lame defenses). One particularly fine observation:
Let’s not forget that a provision in the FDA reform bill calling for a two-year moratorium on DTC [direct to consumer] ads on some new drugs was rejected because it limited commercial freedom of speech. In 21st century America, the right to misinform consumers is protected, but consumers’ right to information is denied because they might misinform themselves.
There is complete and utter schizophrenia on the question of consumer information and choice in the medical arena. One popular school of thought holds that consumers need to exercise greater control over their medical decisions, out of the the view that medicine is just another market, consumers can think for themselves, and given the realities of stretched medical budgets, they can make the best determination as to how to spend their limited medical dollars.
Nice theory, and if you tease that logic out, you’d give every consumer his own prescription pad and let him order his own medical tests too (at least in our paternalistic state of New York, that’s a no no). I can see it now: Botox parties where people get together to shoot each other’s foreheads up….
More seriously, Maggie Mahar, in her excellent book Money-Driven Medicine, depicts the American health care problem as a market failure created by information assymetry. As Tyler Cowen explained in his comment on the book:
….the American health care cost spiral comes from suppliers and their entrepreneurial abilities to market expensive and highly specialized services of dubious medical efficacy. Medical care starts off as ambiguous in value and hard to measure in quality. Customers are cowed by doctors and other family members into accepting or even demanding what is offered to them. Third-party payments make the problem worse, and government intervention has stoked rather than checked the basic dynamic. You end up with massive expenses, lots of stupidity, and – because of its expense — radically incomplete coverage. Every now and then the extra services do pay off, but not frequently enough to boost American stats on health care quality.
Back to the immediate FDA issue. One way to alleviate this imbalance, and it’s admittedly a modest step, is to let consumers have more information, particularly about drug efficacy and trial results. Yet the FDA is resisting that move, saying that letting consumers have all that information will confuse them.
Again, that argument doesn’t hold water. Consumers can already get tons of information about drug studies (haven’t they heard of PubMed?). It would be better for the research-minded to have access to the full data set rather than be limited to a selection that is arbitrary (due to what is available on line) and pro big Pharam (by the studies pointing to little or no efficacy and side effects being withheld).
From the Guardian:
“Sunlight is said to be the best of disinfectants,” Supreme Court Justice Louis Brandeis famously wrote. Alas, if mother nature submitted sunlight as a new drug to the food and drug administration, she would get turned down flat.
In the wake of the latest study showing heart attack risk in Avandia, an FDA-approved diabetes drug – a study that was only enabled by the company’s public release of dozens of clinical trials on its own website – there have been increased calls for greater transparency of clinical trial results. The FDA reform bill passed by the Senate two weeks ago had a limited disclosure requirement, which was backed by the Pharmaceutical Research and Manufacturers Association, the drug industry’s powerful lobbying arm.
There was nothing in the bill requiring that companies and independent investigators post all trial results, including those conducted after drugs hit the market. Companies often run dozens of these trials to promote new drugs among the practicing physicians paid to enlist their patients in the trials.
What does the FDA think about public release of data? Barry Meier in Wednesday’s New York Times elicited this quote from Steve Galson, director of the drug evaluation and research division of the FDA: “I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” he said.
Meier then noted the recommendations in last year’s Institute of Medicine report, which called on the FDA to release summaries of all clinical trial data it collects on new drugs, both pre- and post-approval. The FDA sees the recommendation as overly burdensome. “It is not that we are philosophically opposed to it, but the work would be enormous,” Galson said.
I spoke Tuesday with Steve Nissen of the Cleveland Clinic, who conducted the analysis of Avandia, GlaxoSmithKline’s diabetes drug that probably carries an increased risk of heart attack compared to cheaper alternatives. “This whole situation shows how important transparency is,” he said. “There are independent players out there without axes to grind who need access to this data.”
Nissen’s statistician (he himself is not an expert in manipulating statistics) pooled the results of 42 clinical trials to come up with the analysis. Would individual consumers, if given access to the data, get confused or misled if they looked up an individual trial and drew an incorrect conclusion?
It’s a risk, of course. But would they be any more confused than they now are from the information they get from direct-to-consumer (DTC) advertising? Let’s not forget that a provision in the FDA reform bill calling for a two-year moratorium on DTC ads on some new drugs was rejected because it limited commercial freedom of speech. In 21st century America, the right to misinform consumers is protected, but consumers’ right to information is denied because they might misinform themselves.
“To have a drug on the market for eight years and still not have the outcomes data is too long,” Nissen said.
What does the top official at the FDA think about greater and earlier disclosure? In a response printed alongside a USA Today editorial that pointed out that the company gave the FDA much of the latest data about Avandia last August, FDA commissioner Andrew von Eschenbach noted the warning issued Monday by the agency. “Our policy, which we followed with Avandia, is to inform the public about potential risks at the earliest appropriate time, even if our investigation is not complete,” he wrote.
The timing of this warning undermines the credibility of von Eschenbach’s claim. The warning was issued a few hours after the release of Nissen’s study.
Art Levin of the Center for Medical Consumers, who serves as the consumer rep on the drug safety advisory committee at the FDA, yesterday outlined what he thought ought to be in the House version of the FDA reform bill:
* Complete transparency of data derived from all studies and trials; and FDA access to insurance industry (including Medicare) databases so the agency can determine how drugs are being used and what outcomes they are generating. “The public health can only benefit from having lots of good minds analyzing complete data and reaching their own conclusions,” he said.
* Prescribers and the public should always be immediately alerted to any signals of serious toxicity – the duty to warn should take precedence over any other considerations; and
* An independent safety office, one whose culture is all about public protection and whose triumphs are uncovering safety problems and resolving them appropriately.
The IOM report noted problems in the internal culture at the FDA. Since passage of industry user fees in 1992, the mindset at the agency has gone from protecting the public from unsafe or ineffective drugs to one of helping industry get more and faster new drug approvals. Galson’s comments are a perfect reflection of that mindset.