The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.
The issue here is slightly different. As the law works, there is absolutely a lot wrong with lying, cheating, stealing and killing if you are poor or black.
White billionare? Nope. You can literally rape your toddler daughter and go free because the judge feels you would "not fare well in prison." (DuPont heir).
Large corporation? Lol. The attorney general will argue on your behalf instead of bringing a case against you. (JP Morgan).
Maybe as a condition of hire, the appicliant, if hired by the FDA, couldn't seek future employment in any aspect of the Pharmacutical industry?
I belonged to a union that flat out told apprentices that they were forbidden from going through the program and opening up a non-union shop. I've always wondered about the
legality of putting conditions on a job? I know the formentioned union still has the clause in it's bylaws, and it's a union in a huge city.
It all comes down to the incentives. I doubt the FDA is beating away applicants as it is. If the FDA enacts your proposed policy, what do we do if they can't find qualified applicants?
The US pharmaceutical industry is too wealthy for that to be workable. The game is to make friends while working at the FDA, and then to cash in. In order to serve the public interest, drug discovery and testing ought to occur in academia. The pharmaceutical industry should play no role in that, and should merely manufacture approved drugs.
Edit: Please see The Truth About Drug Companies, by Marcia Angell, M.D., formerly an editor of the New England Journal of Medicine.
Academia already does much of the fundamental research.
It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma industry. Some of this could be addressed by making clinical trials cheaper to operate and initialize, but it's always going to be quite expensive.
I agree that most fundamental (chemistry, biology) research is done in academia. But fundamental research doesn't deliver new drugs, it only supports discovery.
About 24% of new drugs are discovered in academia.[1] The remainder come from industry. I think offloading all discovery to academia, plus the "D" part of R&D would be something academia would struggle with.
Sure, a lot of discovery is done in industry too (and, as you note, is supported by academic outputs). But that's not the expensive part which is what I was trying to say -- obviously not clearly enough.
Reforming the current system would be difficult, no doubt. And perhaps it's unworkable. Big pharma also owns academia. Much of the peer-reviewed literature for many drugs has been ghostwritten by industry-funded consultants. Sometimes the authors don't even read their manuscripts, and in some cases haven't been informed of them. Some journals have been addressing this, but it's pervasive.
In any case, the current system isn't working. Incentives for fraud far outweigh those for improving public health. And there is virtually no accountability.
It's a sensible solution to the issue, from a distance. Then there are realities like this:
"Today, medical-journal editors estimate that 95 percent of the academic-medicine specialists who assess patented treatments have financial relationships with pharmaceutical companies, and even the prestigious NEJM [New England Journal of Medicine] gave up its search for objective reviewers in June 1992, announcing that it could find no reviewers that did not accept industry funds.
> given that industry insiders go back and forth between jobs in Industry
Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.
Very true, and there is very little done to reveal "Conflicts of Interests".
Sure there is. If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances.
The tough part is that you can't stop folks from moving between industry and the FDA. Both organizations are looking for the best folks. It reminds me of doctors being paid for clinical trials. Of course it's always the top doctors getting paid because if you're a company, do you want the crappy doctors running your trial?
> If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances.
I don't care if you work for the pharma, but please don't keep posting demonstrably false comments shilling for the industry:
"Since the lion's share [of FDA user fees] can only go to expedite approvals, that area of the agency has grown while staffing and resources in other parts of the FDA have been relatively starved. As drugs enter the market faster, it becomes increasingly difficult for the FDA to perform its other functions -- including monitoring drug safety, ensuring manufacturing standards, and regulating marketing. [...]
Furthermore, the FDA is subject to industry pressures through its eighteen standing advisory committes, which consist of outside experts in various specialties, are charged with reviewing new drug applications and making recommendations to the agency about approval. The FDA almost always takes their advice. Many members of these committees have financial connections to interested companies. Although there are conflict of interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable. USA Today examined FDA hearing records in 2000 and found that 'at 92 percent of the meetings at least one member had a financial conflict of interest,' and 'at 55 percent of meetings, half or more of the FDA advisers had conflicts of interest.'
Members of FDA advisory committees are said to command unusually high consulting fees from drug companies. They are certainly in a position to do so. They probably don't even have to say, 'Pay me if you want your drugs approved.' According to the Washington Times reporter August Gribbin, 'One drug company executive who asked not to be identified referred to the advisory committee members' approaches for obtaining [consulting] work as 'shakedowns' because a company that refused to yield to such requests could doom products that cost tens of millions of dollars to develop.'" Source: The Truth About Drug Companies, p. 209
Once again, "conflict of interest" is not a binary thing. People can have weak conflicts of interest (owning pharma stock in their 401k) and strong conflicts of interest (sitting on the board of a pharma company). The FDA needs to balance that with getting the best folks they can on their advisory committees.
So yes, some folks who have conflicts of interest remain on the committees. I don't think it's something that can be avoided. The point is that the FDA is trying to address the issue and many folks who have strong conflicts of interest usually recuse themselves from those discussions.
This doesn't really reflect my understanding of the matter. In fact, the onerous restrictions required to work for the FDA (or any discretionary government agency, really) are one of the biggest reasons that people move to private industry...
