“This practice—a seeding trial—is marketing in the guise of science,” write Harold Sox and Drummond Rennie, in an editorial in Annals of Internal Medicine. “The apparent purpose is to test a hypothesis. The true purpose is to get physicians in the habit of prescribing a new drug.”
In that journal researchers - led by Kevin Hill, of McLean Hospital, Belmont - use documents obtained through litigation to analyse the ADVANTAGE trial of drug Vioxx and to show that it was "designed and executed" by Merck's marketing division. These documents have previously been the source of other damaging allegations against Merck (see this Nature story).
A seeding trial or marketing trial is a form of marketing, conducted in supposedly the name of research, designed to target product sampling towards selected victims of the industrial pharmaceutical complex. The primary objective of these trials is to introduce the concept of a particular medical intervention--such as a pharmaceutical drug or medical device--to physicians, rather than to test a scientific hypothesis.
In the seeding trial, the marketing department of a pharmaceutical firm recruits physicians to participate in clinical research. The drug company pays the physicians for their participation, designs the study, collects and analyzes the data. The physician has only to prescribe the drug to his or her patients. The typical seeding trial, however, is unlike a proper clinical trial in that it is not blinded, has no controls, subjects don't give informed consent, and placebos are not used.
In such trials, many, many physicians are signed up as investigators, so that each only has to sign up a few patients, and the drug company pays them for each patient and provides all the support necessary for monitoring and paperwork. Meanwhile the reward for physicians participating is the prestige of being an investigator for a clinical trial, coupled with in essence no penalty because the drug company more than reimburses for the time spent, which isn't all that much given that each physician only has to sign up a few patients. In reality, however, the design of the trial is very inefficient. For a real scientific question being tested in a clinical trial, it would be far more efficient to concentrate the patient accrual in a few large academic centers that could find patients much more quickly and already have the infrastructure to do clinical trials. But for seeding trials the scientific question is almost besides the point, an afterthought. The real, unstated purpose of such trials is to expose as many doctors as possible to using the drug and thereby make them comfortable using it. The real purpose of seeding studies is to make these physicians advocates for the new drug. The real purpose of seeding trials is marketing, not science. (Respectful Insolence)
"Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners—each recruiting a few patients—when a study based at a few large medical centers could accomplish the same scientific purposes much more efficiently? The main point of the seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians," as stated in the editiorial by Sox and Ronnie.
According to an article published in the June 27th issue of the Archives of Internal Medicine a clinical trial of gabapentin, that was supposed to be for studying dosages of the drug, could actually be nothing more than a seeding trial designed to expose more docs to the drug and ultimately to dupe them into writing more prescriptions for the stuff.
Sadly, the questionable gabapentin trial, called “Study of Neurontin: Titrate to Effect, Profile of Safety [STEPS],” resulted in not just one but two articles being published in major medical journals. Yet when independent consultants reviewed the documentation from the trial all kinds of alarm bells went off.
To start with the study was shoddily designed. It was both uncontrolled and unblinded making the quality of the data coming out of it dubious at best. But even worse documents from the study shockingly suggest that Pfizer’s marketing team could have been involved in data collection!
In fact, the documents appear to suggest that the marketers saw the trial itself…not just the end results…as an excellent promotional vehicle for their cash cow gabapentin.
A 1994 article in The New England Journal of Medicine by former FDA commissioner David Kessler et al. states:
Some company-sponsored trials of approved drugs appear to serve little or no scientific purpose. Because they are, in fact, thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company, they are often referred to as "seeding trials." Features that distinguish such trials from scientifically rigorous studies include the use of a design that does not support the stated research goals, the recruitment of investigators not because they are experts or leading researchers but because they are frequent prescribers of competing products in the same therapeutic class, disproportionately high payments given to "investigators" for their work (although the only work may be to write prescriptions for the drug), sponsorship of the studies by the company's sales and marketing division rather than its research department, minimal requirements for data, and the collection of data that are of little or no value to the company. Typically, these trials involve introducing a new drug in a crowded therapeutic class. The success of such a new product may depend on undoing physicians' comfortable habits of prescribing a competing, more established product (Kessler et al., 1994).
A bureaucratic solution, such as relying on institutional review boards, could help to rid us of seeding trials, but simply shining a bright light on their existence may have already sown the seeds of their destruction. The next step would be a societal consensus that it is wrong to deceive institutional review boards and participants about the true purpose of a trial.
Another solution is just to get rid of Big Pharma all together!