Why are pharmaceutical companies allowed to do their own trials?
A recent New York Times article clearly addressed the problem with big pharma being in charge of its own trials. In this case it was Pfizer doing a trial for Celebrex, but I previously wrote about Merck doing corrupt trials for Vioxx (see How Big Pharma Cooks Data: The Case of Vioxx and Heart Disease). In the article, it has the following damning evidence that this practice is ludicrous:
- Research Director Dr. Samuel Zwillich, in an email after a medical conference discussing Celebrex, stated: “They swallowed our story, hook, line and sinker.”
- Executives considered attacking the trial’s design before they even knew the results. “Worse case: we have to attack the trial design if we do not see the results we want,” a memo read. It went on: “If other endpoints do not deliver, we will also need to strategize on how we provide the data.” This simply can’t happen. There should be an outside third-party firm in charge of trial design, and there needs to be sign-off on the design in advance so no monkey business like this takes place.
- Executives disregarded the advice of an employee and an outside consultant who had argued the companies should disclose the fact that they were using incomplete data – they were using only half. This kind of statistical dishonesty is the easiest way to get numbers you want.
- In another email, associate medical director Dr. Emilio Arbe from Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better.” Mind you, this statement was made in September 2000, so in other words the side effects of Celebrex have been known for over a decade.
- Medical Director Dr. Mona Wahba described it as “cherry-picking” the data. In May 2001.
Why is this happening? It’s all about money:
It is one of the company’s best-selling drugs, racking up more than $2.5 billion in sales, and was prescribed to 2.4 million patients in the United States last year alone.
How much are you in doubt that the people in charge are being pressured not to be honest? Dr. Samuel Zwillich claims the hook, line and sinker statement was probably about something else. The cherry-picking Dr. Mona Wahba now can’t remember what she meant.
This is bullshit, people. Statistics is getting a bad name, and people are suffering and dying from bad medicine, not to mention paying way too much for fancy meds that don’t actually help them more than aspirin.
What we need here is some basic integrity. And it’s not just a few bad eggs either – stay tuned for a post on Prof. David Madigan’s recent research on the robustness of medical trials and research in general.
mathbabe 
Designing independent trials ought to be a kind of pro bono social science contribution.
LikeLike
I’m not surprised. Big Pharma “capture” of medical research works much the same way as the Big Finance regulatory capture. With the amount of public money in medical research you’d think we’d have better ways to reduce this influence. Keeping the regulators unsullied by Pharma money and having them provide meaningful checks on study design and analysis would be a start. The money is there. Ideally, they could balance the perspectives of industry/university “researchers” and practitioners who’ve nibbled at Pharma’s fruits.
Perhaps there’d be less nibbling if researchers were required to publish their industry ties and those of the practitioners involved in the studies. There’s a strong case that all payments from Big Pharma to practitioners and researchers should be publicly disclosed. Transparency might help researchers and practitioners understand the integrity issue before grabbing the fruit. Look forward to your post on Madigan’s research.
LikeLike
There’s not much one can do about powerful institutions influencing science, especially when a research target is a product. A main problem is that medical doctors just follow along, while others fall quickly for the propaganda.
The basic science and inherent properties of things such as cholesterol, saturated fat, and some inflammatory proteins reveal stupidity in general and in believing in the necessity of these drugs.
While a “top-down” fix would be faster, it could simply not happen, as those who benefit from status quo provide too much resistance. Self-education and an eventual bottom-up movement is probably necessary. Unfortunately, even minor paradigm changes seem to take about a decade to gain *any* notoriety and/or acceptance; most people are comfortable with taking orders from an authoritative MD or nutritionist/dietician.
LikeLike
Right you are, the government should pay for all
clinical trials. That would expedite innovative
drugs into the marketplace.
LikeLike
I can’t tell if this is sarcasm. If not, I will defer any tax increases to you as the cost of this solution will be astronomical.
LikeLike
Roy Poses raises the same issue in this post on Health Care Renewal:
http://hcrenewal.blogspot.com/2012/06/more-marketing-than-science-anonymous.html
Also, see this editorial by Jerry Hoffman and Richelle Cooper in Archives of Internal Medicine (subscription required):
http://archinte.jamanetwork.com/article.aspx?articleid=1203523
They state:
“First, we strongly support the recommendation of Prasad et al4 to change the funding of clinical trials. As long as someone is selling a test or a treatment the use of which increases in proportion to the number of disease cases diagnosed, we will be prodded to overdiagnose and then to overtreat.”
.
LikeLike
If the government paid for clinical trials we would never have a product to market. What do you think the NIH is for?
LikeLike
Excellent article, and let me state the obvious: trial integrity costs money. Who’s gonna pay? The government? Please. The FDA gets its funding cut each year, and it has to beg to be allowed to collect fees from the heavily lobbying pharma industry. Self-regulation is the solution of choice for this conservative, governmentally averse nation. But self-regulation is no less corruptible than government regulation; arguably more.
The solution is to apply a pillar of science- reproduction of results by peers. Yes, it would add time and cost, and diminish profit margins. But if the correct incentives were there (e.g. patent extensions), it would produce the best result- validated drugs that do some good with minimal risk.
Besides, Pfizer has never cared a tenth for patients as much as they do for profit. J&J- same boat. It’s hard to find integrity, elected of a corporation’s own volition, in this ruthlessly profit driven industry.
Pharma Insider
LikeLike
Contrary to what Pharma Insider said, FDA appropriations gets increased each year. In addition, the part of FDA responsible for drug approval (so-called CDER) is financed mainly by industry money, through the fees industry pays when they submit drug applications. This logically leads to CDER being very responsive to big pharma interests. In practical terms, CDER wants to approve any drug they can possibly approve, including those with marginal safety and efficacy records. While doing that, FDA CDER also extracts a pound of flesh in the form of often unnecessary and onerous requirements – after all it has to justify its existence. This is also serves the interests of big pharma because smaller and more innovative outfits have problems navigating FDA bureaucratic maze and are forced to contract with the biggies to do so.
FDA Insider
LikeLike