Olivieri and Clinical Trials 

Olivieri and Clinical Trials

Dr. Nancy Olivieri is back in the news--in a fairly modest way. Dr. Miriam Shuchman has published a book--one she has been working on for years, about the famous Olivieri case. Olivieri was one of the main physicians carrying out clinical trials with a drug to treat patients with thalassemia, a rare blood disorder. As more results came in, Olivieri change from one of the biggest boosters of the drug, to a critic who was worried that the drug was doing more harm than good, and no one should take it.

The pharmaceutical company Apotex, mostly famous for producing cut-rate generic drugs, acted in the most ham-handed way possible, stopping the trial and refusing Olivieri permission to publish the reasons for her misgivings--indeed threatening to sue if she went public at all. Shuchman apparently makes it clear, however, that she is also somewhat sceptical of Dr. Olivieri. At an earlier stage in her career, she applied for major dollars for clinical trials on this drug--and did not mention warnings of its toxicity that had already circulated in the research world. She is apparently one of these people who thinks whatever tune she has chosen at the moment, everyone must dance to it. Schuchman thinks there is now significant evidence that the drug that was tested, if it is used properly, can help quite a few people--and thalassemia sufferers in other countries are getting more benefit from it that patients in Canada, partly because of the publicity about Olivieri.

There will always be a debate about Olivieri herself, and whether she was right to oppose the drug so completely when she did. The larger question, however, is more interesting. Are clinical trials, in general, ethical?

There was a piece in the news quite recently about what was called the first clinical trial on humans that actually worked. In the last few decades, hospitals were giving large amounts of oxygen to premature newborns who struggled to breathe. There was an assumption that there was no such thing as too much oxygen, and when the babies showed signs of being unable to be weaned off the O2, the experts were baffled. One doctor proposed a classic study--one group of babies with the usual dose of O2, another group with a small dose. Lo and behold, the latter group did as well or better throughout the test, and were able to be weaned off once they were bigger with no difficulty.

Are clinical trials ethical? If your state of knowledge is such that you just don't know who is more likely to be harmed, the control group or the experimental group? If your knowledge is such that you're pretty sure the drug you're testing is toxic, as in Olivieri's case?

In one episode of House, the good doctor said matter of factly that the new benefactor wanted to give a hundred million dollars to the hospital, and take over the board, simply to carry out clinical trials--"and that is unethical; [I'm paraphrasing] it involves treating patients in a way that is different from: do no harm, find the most promising for this patient, here and now."

There have been several cop shows about how the drug companies will try to control the news about a product on which they hold the patent--letting the good news out in the most effective way possible, suppressing the bad news.

The Ontario government is directly supporting clinical trials involving cancer therapies.

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