Wednesday, August 20, 2008

Drug Trials - Buyer (and Physician) Beware

Pharmaceutical companies often perform drug trials to prove the effectiveness of their drug by paying physicians to participate in a clinical trial and use the drug on their patients, using the trial protocols. The Annals of Internal Medicine wisely asks the question this month:

"Why would pharmaceutical companies go to the expense and bother of conducting numerous trials with private physicians and a few of their patients, rather than conduct large trials at medical centers to accomplish the same scientific results with greater efficiency?"

Dr. Harold Sox (editor and brilliant thinker) answers it: "The true purpose is to get physicians in the habit of prescribing a new drug." A secondary purpose is to get physicians to be "opinion leaders" and advocate with their colleagues about the new drug. They get paid to do so and become de facto marketers for the drug, without really being aware of it.

These drug studies are called "seeding trials" and they are exceedingly common. But those days are coming to an end as greater awareness of how drug company sponsored trials, and the physicians who consult on them are made public.

As Sox says:

"Physicians have a fiduciary obligation to ask questions on behalf of their patients, as do institutional review boards and researchers, which have the skill set and personnel to judge whether a trial is asking an already-answered question. They could look for other clues, such as a study with an open-label design, no control group, a very large projected enrollment relative to the importance of the question, a short-term study of a chronic disease, a study of an already approved drug, and so forth. None of these clues is highly specific, but institutional review boards should start asking questions when a study has several of them. "

Private practice physicians have no "institutional review board" and will need to rely on their own ethical and professional barometer. As Dr. Sox says "Just Say No to Seeding Trials". This practice is marketing in the guise of science.


Anonymous said...

I had a friend who wanted to get into a clinical trial for ovarian cancer when the 17 months of chemo. stopped working plus the four or five chemos she tried after didn't help. She did all the tests to get in and then wasn't accepted because of one criteria that was previously known before the tests they made her go through.
She died a few months later.

I could see how some of these "Seeding Trials" could play on the emotional last chance of a cancer patient and their family and pressures their doctor has following their own ethics of knowledge he or she has about the trial which the patient doesn't know about the trial not being ethical. The doctor might be trying to do what is best for the patient and use good ethics at the same time. It could be a tough,and complex situation.

Thanks for bringing this informative info. up.

Toni Brayer MD said...

KM: The cancer trials are not usually seeding trials because they are usually run by academic consortiums with very strict guidelines and criteria for patient entry.

Seeding trials are often done in individual physician offices for common chronic diseases (arthritis, headache, hypertension, depression) and with small numbers of patients. Physicians are paid to enroll the patient and are also on consulting panels to speak on the disease.

Anonymous said...

Thank you for your explaination.

Gramz said...

My daughter's 9 month old baby girl has only gained 1 once and 1/4" in length since her 6 month well-baby check up. She weighed 7 lbs. 15 oz. at birth (12/7/07) and had been thriving well. Her hemoglobin was 11.5 so that's good. Her development is good - she crawls, stands up and walks around furniture - and has taken four steps unassisted. Pediatrician is recommending 4 oz. formula three x.s daily from sippy cup to supplement breastfeeding and solids. She says a few words with meaning. My daughter is trying high calorie foods, avocado, ground meats which the baby likes as well as cooked vegetables - My daughter doesn't want her breast milk supply to decrease because of the formula.
Any suggestions? Sorry to have interjected this on this blog, but didn't know how to reach you.
Can you email me at in case I can't get back to this blog page.
Thank you!

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