Marketing disguised as research

[kugel]

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when paranoia becomes truth...

Marketing, Disguised as Research
Seeding studies are trials that are funded entirely by drug manufacturers for the primary purpose of exposing physicians to new drugs.

"Seeding trials" are clinical studies that appear to answer a scientific question but whose main purpose is marketing of a drug. Researchers, who were paid to be consultants for plaintiffs, reviewed confidential documents that were made public as a result of litigation against Merck. The specific case involved a study in which rofecoxib (Vioxx) was compared with naproxen for the stated purpose of evaluating gastrointestinal tolerability; study results were published in a peer-reviewed journal (Ann Intern Med 2003; 139:539).

Merck internal communications revealed that their marketing division had conceived the clinical trial, with the goal of encouraging physicians to gain experience with rofecoxib prior to and during its critical launch phase. The trial was designed to target "customers" (primary care physicians) to become investigators and to demonstrate the value of the drug to these physicians. Employees of Merck’s marketing division collected, analyzed, and disseminated the data (i.e., wrote the paper). They also tracked rates of rofecoxib prescribing by study physicians. But, physician-investigators, study participants, the U.S. FDA, and institutional review boards were not informed of marketing objectives; they all were told that the purpose was to evaluate gastrointestinal safety of rofecoxib. A marketing employee wrote in an e-mail, "It may be a seeding study, but let’s not call it that in our internal documents." A Merck research director wrote in an e-mail, "[This and other] marketing studies . . are intellectually redundant."

Comment: Editorialists note that "deception [regarding intent] is the key to a successful seeding trial," and that "shining a bright light on their existence may have already sown the seeds of their destruction." Clearly, physicians must be aware that seeding trials exist and must be alert to spot them. The findings of this investigation are remarkable — in fact, shocking — and they speak for themselves.

— Richard Saitz, MD, MPH, FACP, FASAM

Published in Journal Watch General Medicine October 9, 2008

Citation(s):
Hill KP et al. The ADVANTAGE seeding trial: A review of internal documents. Ann Intern Med 2008 Aug 19; 149:251.

Sox HC and Rennie D. Seeding trials: Just say "no". Ann Intern Med 2008 Aug 19; 149:279.

 

[Anasazi23]

Good to know this is out there. But why is it entirely evil again?

 

[kugel]

Merck internal communications revealed that their marketing division had conceived the clinical trial....
Merck’s marketing division collected, analyzed, and disseminated the data (i.e., wrote the paper).
The "investigator" physicians were duped into becoming advertisers for a product. Patients were lied to when they were recruited as subjects.
With the crackdown on drug detailing and drug rep. gifts, it would not be surprising to find that Pharma is increasing the publication of trials written by marketing staff.
At the very least, it is enlightening to learn we must read everything, even studies in prestigious journals, with an eye toward whether the marketing dept. collected, reported, analyzed the data - making every data point somewhat suspicious.

Evil? No. We have to assume the marketing dept of drug companies will do anything to convince us of the a product's usefulness and safety. That's what they're paid to do. IF the FDA and journal editors are unable to discern what's a "seeding trial" and what isn't, then it's up to all of us to find ways to discern the difference.

 

[Anasazi23]

But this was still done as an exploratory trial, right? And the marketing team is involved in the design and implementation of the trial? How can subjects be lied to? Did they not meet criteria for the study somehow?

Is this just the amalgamation of marketing with clinical trial design? If so, I agree it muddies the waters to an unethical degree. How are readers supposed to spot these then?

 

[kugel]

"deception is the key to a successful seeding trial."
Both physicians and subjects were told that this "study" would answer questions about GI tolerability - a question already answered. The study was designed to introduce physicians to the drug, not to answer any clinical question. Since the data were collected, analyzed, and the paper written by marketing staff, we have no way of knowing whether any of the reported data is true.

How can we pick these up? There's no really perfect answer. Journal editors need to be wary. Readers need to look for studies that don't seem to add anything to the clinical knowledge base; "Well, duh" studies. Clinic physicians could alert the AMA when they are approached to to become "investigators" in a study that has them sending the data to the company rather than an academic PI.

Be very wary of articles provided by drug reps that have not yet been published. Reps will sometimes hand out items that look like professional journal reprints, but are actually just data collected by marketing studies.

 

[gman33]

No real news here if you have ever worked in Pharma.
Phase 4 trials are commonly referred to as marketing or post-marketing studies. You are basically just collecting data from a larger sample size.
They do provide some value, as you are getting safety data from a larger pool.

Why would you assume the data collected had any less validity just because the marketing department was involved? At a for profit company, basically everyone is the marketing dept. They wouldn't be in business if they weren't trying to push their products.