Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases.
To contact Derek email him directly: derekb.lowe@gmail.com
Twitter: Dereklowe
When, if ever, are the laws going to be rewritten so that "the public" will realize that pharmaceuticals are tested to the best of everyone's ability, but *are not perfect* and they need to balance that fact with this litigatious atmosphere. In other words, when are all the disclaimers and warnings going to actually be enough so that people will suck up the consequences and not be able to sue for everything?
2. Steve Eisenberg on December 18, 2004 8:45 PM writes...
Drew asks above: "When, if ever, are the laws going to be rewritten so that ‘the public’ will realize that pharmaceuticals are tested to the best of everyone's ability . . . ."
As a member of the public, it seems to me that it would be suicidal for a drug company to test to the best of its ability. More testing is always better, so testing would never get done. This is especially true with preventive, maintenance, and psychiatric drugs, where docs are likely to prescribe them for many years on end. If you didn't run the tests in the way most likely to get early government approval, instead truly testing the way doctors are most likely to use the drug, you would be doing a disservice to your stockholders.
As for lawsuits, I hate 'em. However, if you are going to advertise to patients that the newest drug in its class is a first line treatment, rather than a last resort when time-tested remedies fail, well, of course people are going to feel misled over the hype, and some will sue.
My personal preference is to go back to the system we had ca. 1950 that gave us synthroid, prednisone, benydrl, ibuprofen, classic chemotherapy, multi-drug TB treatment, synthetic quinine for malaria and lupus, first blood pressure pills, etc., etc. Just accept the reality that it takes decades for physicians to work out the best uses for new drugs. If we were to drop Phase III testing, marketing, and promises, then there would be more reasons than my irrational distaste to get mad at those who sue the drug companies.
I think the real problem is utopian laws based on the idea that good drugs can be proven safe and effective with a few years' study using experimental subjects. Big pharma is neither evil nor good – it just has to try to do the best it can with whatever damn fool system is handed to it.
I read Marcia Angell’s book and liked her description of the problem – that’s what drew me to check out this site.
I haven't paid attention to the gnarly details, but I hope both Pfizer and Merck did proper testing around the effect of people who use aspirin as "heart attack prevention" medication. (The Cox-1 enzyme is associated with blood clotting and gastro-wall protection. Cox-2 is associated with some types of pain.) If people are taking a Cox-2 for pain/arthritis, they probably take less aspirin. As a result, the likelihood that they may have heart attacks could increase. Or more accurately, they would be back to "normal" in heart attack chances.
1. Drew on December 17, 2004 6:50 PM writes...
When, if ever, are the laws going to be rewritten so that "the public" will realize that pharmaceuticals are tested to the best of everyone's ability, but *are not perfect* and they need to balance that fact with this litigatious atmosphere. In other words, when are all the disclaimers and warnings going to actually be enough so that people will suck up the consequences and not be able to sue for everything?
Permalink to Comment2. Steve Eisenberg on December 18, 2004 8:45 PM writes...
Drew asks above: "When, if ever, are the laws going to be rewritten so that ‘the public’ will realize that pharmaceuticals are tested to the best of everyone's ability . . . ."
As a member of the public, it seems to me that it would be suicidal for a drug company to test to the best of its ability. More testing is always better, so testing would never get done. This is especially true with preventive, maintenance, and psychiatric drugs, where docs are likely to prescribe them for many years on end. If you didn't run the tests in the way most likely to get early government approval, instead truly testing the way doctors are most likely to use the drug, you would be doing a disservice to your stockholders.
As for lawsuits, I hate 'em. However, if you are going to advertise to patients that the newest drug in its class is a first line treatment, rather than a last resort when time-tested remedies fail, well, of course people are going to feel misled over the hype, and some will sue.
My personal preference is to go back to the system we had ca. 1950 that gave us synthroid, prednisone, benydrl, ibuprofen, classic chemotherapy, multi-drug TB treatment, synthetic quinine for malaria and lupus, first blood pressure pills, etc., etc. Just accept the reality that it takes decades for physicians to work out the best uses for new drugs. If we were to drop Phase III testing, marketing, and promises, then there would be more reasons than my irrational distaste to get mad at those who sue the drug companies.
I think the real problem is utopian laws based on the idea that good drugs can be proven safe and effective with a few years' study using experimental subjects. Big pharma is neither evil nor good – it just has to try to do the best it can with whatever damn fool system is handed to it.
I read Marcia Angell’s book and liked her description of the problem – that’s what drew me to check out this site.
Permalink to Comment3. Jack Vinson on December 20, 2004 12:30 AM writes...
I haven't paid attention to the gnarly details, but I hope both Pfizer and Merck did proper testing around the effect of people who use aspirin as "heart attack prevention" medication. (The Cox-1 enzyme is associated with blood clotting and gastro-wall protection. Cox-2 is associated with some types of pain.) If people are taking a Cox-2 for pain/arthritis, they probably take less aspirin. As a result, the likelihood that they may have heart attacks could increase. Or more accurately, they would be back to "normal" in heart attack chances.
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