It’s marketing, not science
No pharmaceutical company would admit to conducting seeding trials, but they’ve become a common part of the marketing of new drugs.
Seeding trials are technically clinical trials, but ones in which the goal is not to test the efficacy of a drug but rather to suggest new uses to doctors so they can have scientific data to support their off-label usage. These trials are marketing ploys, for lack of a more technical phrase.
In one of the first articles that illuminated the practice, Drs. Harold Sox and Drummond Rennie explained that pharmaceutical companies often recruit physicians to lead these trials through flattery and then pay them significant consulting fees to advise the company on the drug’s use and help enroll patients. When the physicians become invested in the drug’s success, they become more likely to see the results they desire. Once their name is added as an author to the study, it’s in their best interests to promote the work. But really what they’re doing is simply helping to market the drug. Sox and Rennie say this is the goal of the seeding trial:
“It is to change the prescribing habits of large numbers of physicians. A secondary purpose is to transform physicians into advocates for the sponsor’s drug.”
In a normal pharmaceutical trial, researchers test the hypothesis that a drug works a certain way by monitoring its use in a large group of patients and then comparing their outcomes to a control group who didn’t take the drug. Seeding trials, on the other hand, often use small groups of patients, can be unblinded, and even lack control groups because the goal is not to collect valuable scientific information.
Sometimes a seeding trial involves nothing more than giving doctors free access to drugs to test on their patients in the hopes that some will see new results that the drug can then be marketed to produce. Because the drugs used in seeding trials are already FDA-approved, doctors can simply prescribe them for off-label uses.
The truth is that since a trial designed solely for marketing purposes would be so unethical, we don’t have clear proof that they are occurring (at least not in every case that we suspect) because companies and physicians deny that they engage in this type of behavior. We can’t know for sure what their intentions are unless they admit them or a whistleblower steps forward. Either way, it wouldn’t be illegal, just unethical.
Of course, there are cases where some good has come of these trials and new uses have been discovered. But does that justify the cost, the risk, and the willful disregard of appropriate protocol?
Resources:
When Clinical Trials Are Marketing Ploys, Not Science (Forbes, 2018) disclaimer: I wrote this article
Are Clinical Drug Trials More Marketing Than Science? (BMC Blogs, 2016)
A Yale Clinician Ponders the Ethics Of A Seeding Trial Masquerading As Research (Yale Medicine Magazine, 2012)
The True Purpose Of A Drug Trial Is Not Always Obvious (The Guardian op-ed, 2011)
Useless Studies, Real Harm (New York Times op-ed, 2011)
How Pharmaceutical Companies Might Sow the Seeds For Their Drugs’ Growth (The Pharmaceutical Journal, 2008)