The-Ave.US

This article from Dr. Humphreys hit home. I have seen the same story before. The problem is not the company’s fault, the problem is a huge crack in how the free market works together with the scientific method to hurt the interests of science and of patients.

Let me offer another example. Everyone knows about the miracle of the cholesterol lowering drugs, the “statins.” Based on what we know of the mechanism of these drugs, all statins should have the same effect on atherosclerosis. Because we now have generic statins this should be good news for patients. Sadly, the system does not work that way. Science itself requires proof, proof that generic statin is better than the on-patent, labelled versions that have undergone billions of dollars in clinical tests.

In my experience, the drug companies are very honest about their data, however, their decsions on which bets to make, which drugs to back is a financial decision. They will only ask questions about drugs that may work AND will make money.

Read more from Dr. Keith Humphrey:

A medical school colleague laid out a moral dilemma yesterday that illustrates the lack of a simple answer to the question of whether involvement of industry in clinical research is good or bad. We are having a civil war in the medical research community, stimulated in part by Senator Grassley’s investigations, over whether we can or should be free of all industry contact. In some researchers’ eyes, contact with the for-profit sector is a conflict of interest that will inevitably corrupt the scientific and clinical enterprise. Others see industry involvement as a non-issue because they believe that scientists will report the facts objectively rather than skew them based on any money they might receive.

Here is my colleague’s not-as-simple-as-all-that dilemma. He has pilot data showing that a cheap, generic drug has a potentially life saving medical application. He now has a grant from the NIH (i.e., not industry) to study it in a major trial. A for-profit company has a copycat version of the generic drug that is virtually the same but is still on patent and is thus highly expensive. The question is whether he should study the generic version or the proprietary one.

If the experiment proves that the generic version of the drug is effective, he will get a very nice paper in a medical journal. And that will be the end of it. We have a million studies showing that clinical practice is minimally influenced by journal articles alone. In contrast, if he studies the proprietary drug, a profit making company will send out their armies of marketers to physicians and get many of them to use it, making a great deal of money for themselves in the process…but this will also save lives, because aggressive marketing and promotion such as the industry does has been proven to affect clinical practice dramatically.

What would you do and what would be your reasoning? I will post back here later what my colleague decided.

UPDATE — Provision of more information per comments so far: Studying both drugs is impossible, that would require a third study arm and a 50% budget increase, so a choice is ineluctable. If successful, the study would be a new use of both the generic and the proprietary version. The grant includes zero money for the scientists to disseminate the results.

SECOND UPDATE 21 JAN 2011 — My colleague decided to study the cheap drug with the expired patent.