J’accuse – academic medicine

This thought provoking article highlights the danger of going to bed with the pharmaceutical industry. Academic institutions, looking for more research money, often belly up to the pharmaceutical trough. However, this trough can have poison mixed with the food.

Contracts Keep Drug Research Out of Reach

In recent months, the outrage over the withheld antidepressant data has led calls for change and promises of some. Drug companies, faced with widespread criticism about their handling of test information, have promised to release more of it. Legislation has been introduced in Congress that would require all makers of drugs and medical devices to list clinical trials and their results in a public database.

Critics say, however, that academic institutions and their researchers need to examine their own practices because they share part of the blame.

The problem starts with the terms of the contracts that some universities sign for clinical trials, but of equal importance is how researchers choose to describe study results and even whether they pursue publication.

“People who are blaming this all on industry are missing the point,” said Dr. Robert M. Califf, associate vice chancellor for clinical research at Duke University Medical Center. “I think that academia is part of the problem right now and not part of the solution.”

Virtually all the pediatric antidepressant studies were run in part at medical schools, and in many cases the tests were led by academic scientists. But while one study of the drug Paxil, which showed positive results in depressed children, was published, another study showing that it was ineffective was not submitted to a medical journal. In addition, studies involving other antidepressants, like the drugs Remeron and Serzone, were also not published.

Makers of drugs and medical devices frequently turn to medical schools and academic teaching hospitals to run clinical trials and recruit patients for them. The industry pays many academic institutions millions of dollars annually to run such trials; the involvement of a leading academic researcher in an industry-sponsored test gives it both prestige and credibility. Medical researchers who attract studies reap the benefits of such rainmaking with bigger research budgets and career advancement.

Drug companies say that because they pay for a trial they own the data it generates. They say that contract clauses – including ones for confidentiality – are not intended to suppress possibly negative trial findings but to make sure that data is properly analyzed before it is released.

A major problem discussed above is the problem of publication bias. Journals publish positive studies more easily than negative studies.

One of those researchers, Dr. Neal Ryan, a professor of psychiatry at the University of Pittsburgh, said there has typically been little publishing interest in studies with inconclusive findings or those that failed to work because of study design, a type sometimes referred to as a negative study.

“No one gets famous from publishing negative studies,” Dr. Ryan said.

Academic medicine must rid ourselves of complicity with poor research. The journals must publish negative studies so that we can get a balanced view of research.

We fool ourselves if we believe that drug company sponsored research is easy money. Robert Heinlein coined the term TANSTAAFL (borrowed from a quote by Milton Friedman). In fact, there are no free lunches. Our system of relying on the pharmaceutical industry to design their own studies remains fraught with hazard. I would prefer an independent agency which receives moneys from the industry to test a new product. The company can specify the indication and have all the data. The researchers and the public domain would also have all the data.