Publicizing Positive Research Data While Hiding Negative Data is Currently Legal for U.S. Corporations
Are negative studies about drugs or medical devices therefore far less likely to be published in medical journals than positive studies?
And if there were, for example, 20 negative studies and three positive studies on a particular drug or device, but due to drug or device company decisions only the three positive studies were submitted for publication and subsequently published, how would doctors and patients gain adequate information on whether to use the drug or device?
Only with a subpoena, as Dr. John Abramson, author of Overdosed America has pointed out. Only if a case against a company goes to trial and the company is subpoenaed and forced to reveal its original data can a traditional medical journal normally have any proof that the data it is given are complete and accurate.
Shouldn’t there be a law?
Well, there should be a law but frankly, laws are only useful insofar as they are complied with. I think more than a law is called for here. A change in the structure and design of medical journals is needed. As someone who has written for and edited both popular journals and medical journals (I edited a student journal at the Harvard School of Public Health), I have been astonished that when it comes to medical journals, there is a very strange lack of skepticism in some spheres. Editors know that someone has been paid to write an article, paid for their opinion, yet they rely upon their objectivity. Popular journalism is not at all that trusting; it’s much more skeptical. Popular journalism relies upon advertising, but medical journals rely on advertising from one industry. There are major structural and cultural problems in the way that traditional medical journals are organized.
Along these lines, could you please discuss “seeding trials” and “switching trials,” and how those are structured by the corporations that fund them?
These are perfect examples of marketing posing as “research” that often dupes journals. The point of both seeding and switching trials is not to generate objective information about a malady; the point is to sell a product. Seeding trials are those in which a large number of physicians are induced to use a particular medication. The idea is that they are all going to use that medication and then they will report how their patients respond. On the surface, this would help to evaluate the medication.
But in reality, because of the nebulous, even sloppy way seeding trials often are structured, with an alarming lack of rigor and oversight, you get very little medically useful feedback from the doctors, but you get large numbers of doctors using this medication for their patients, which is the point. The companies then cherry-pick the positive responses and use them when their detail men, drug reps and “thought leaders” sell the virtues of the product to physicians. They use the positive information and ignore, marginalize or snarkily explain away the negative information. Meanwhile, the corporations have the added benefit that there are huge numbers of doctors using their medication who would not normally be using it. That’s a seeding trial.
A switching trial is one where you’ve got physicians who have been using a particular medication, say for epilepsy, and they are induced by a pharmaceutical company representative to switch to a different medication that is under patent and is being sold by the rep’s company.
Is the inducement financial? Are they paid to switch?
There is a variety of material rewards, some subtle and some more overt. For example, the drugs reps can provide the physician with lots of free medication samples. The physician appreciates this because he or she wants to be able to provide these to poor or elderly patients who can’t afford the meds. But the doctor knows that to keep these samples coming, he’s occasionally got to do something for this drug rep. Quid pro quo, that’s the nature of the relationship, a reciprocity between physicians and drug reps. I do something for you, and you do something for me.
Sometimes the inducement is less altruistic: The doctor wants to keep the overpaid speaking engagements, lavish dinners, support for university appointments, and funding for “educational” jaunts to the Caribbean coming. And drug companies will not continue to lavish such prizes or physicians who do not contribute to and cooperate with their marketing efforts.
Then there’s also the situation where physicians become, in effect, medical investigators. They’re told, “We want you to join this study.” This can be prestigious; it looks good on one’s resume and bolsters academic advancement. Some of the inducements are more subtle than others. The point is that many physicians are convinced to do this by the drug reps. When they switch to the new drug, they inform the company of the results they see, after which the drug company will selectively use the information that will best help them to sell the drug. Switching trials do not have any scientific rigor to them but they’re very useful for selling lots of drugs.