So... is it a good drug or a bad one?

Posted on Dec 3rd, 2006 by

Relative to my last blog, Good Drugs, Bad Drugs...Pfizer announced today that it is stopping the trials for the cholesterol-lowering medication, Torceptrapib due to higher than expected deaths in the control group. Imagine if the folks that died on Torceptrapib could have been identified as having a higher risk profile before taking the drug and therefore not eligible for the trial. It is conceivable that the drug trials would be continuing and perhaps even progress to the market. Particular patients who would benefit from this treatment would be able to take it, those who are at risk for side effects, would be identified and avoid it. A dramatic example of good drug, bad drug, is that of Thalidomide. Prescribed as a treatment for morning sickness in the late 50' and early 60's, it caused horrific birth defects and was eventually withdrawn from the market. The drug caused a great deal of suffering for over 10,000 families. Forty years later the drug is back on the market with a strict risk management plan to avoid it being given to any pregnant woman. The drug is now approved for treatment of multiple myeloma, leprosy and certain cancers. In these cases, the drug is a good drug. For pregnant women, it is very bad. When we hear of drugs that are withdrawn from the market for safety reasons, we think about how lucky we all are that the bad drug has finally been discovered for what it is. But what about those who had relied on the treatment with little ill effects (whose numbers dwarf the ones with the crippling side effects). Many of these folks take the meds because others don't work. We need better methods to assess the individual impact of therapies that will allow patients to have ultimately more options for treatment. The drug companies will, in the end, make less money, because treatments will be more diversified. Fewer 'blockbusters' for sure. But more choice for patients is a worthy goal and one that will move us away from one-size-fits-all and ultimately away from the associated clinical trial disappointments like Pfizer's has experienced today.

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Tagged with: drugs, medicine, integral health, integral medicine, personalized medicine

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2 months later

dr travis said

I agree with you about the need for metabolic profiling in relation to drug prescriptions. I've heard that a major roadblock to doing this successfully, however, is the patenting of the genetic sequence that relates to the drug's action.

I can't remember the specific drug (it was a discussion on NPR's science friday), but the manufacturer patented the genetic sequence that could be tested to determine whether or not the drug would work on each patient. But instead of putting it to use so the the drug could be selectively prescribed (thereby limiting the profits), the company is sitting on the patent. No access to the sequence by researchers means no test to determine whether the drug will actually work. Therefore, it's business as usual.

Have you heard of this practice?

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10 months later

spiral5 said

Hi Dr Travis,

I apologize for the extended time between your comment and my response, but I missed the comment when you first posted. Sorry.

I have not heard of the practice you describe but it does not surprise me. I know a test can be patented but was not aware the attempt to sequence the gene for this purpose. I remember when an academic group tried to patent the COX-2 gene and thereby invalidate Pfizer’s Celebrex patent. Utlimately that class had other issues as the press enthusiastically reported, but the patenting of genes has been a sticky issue for a while. I think one problem was that early on, many patent applications got through the system basically under the radar. The commercial aspects were not really considered. With the completion of the human genome sequencing, it became apparent that there would be an awful lot of gene patents and a very complicated situation for drug companies, academics, diagnistics companies etc. The patenting of genes became much more difficult, requiring utilty be proved not just the existance of the gene.

With regard to your comment about hurdles to implementing genetic testing to profile for drug-fit, I think you are right about companies being reluctant to employ these tests. In fact there seem to be several hurdles to personlizing medication that are summed up nicely in the latest Harvard Business Review ( Oct 07).

Thanks for your comment–what kind of Dr are you?