Friday, November 19, 2004
Vioxx
I have too much time on my hands. Being currently unemployed I spend way too much time following the news. The more I follow the news, the more curmudgeonly I become, and the less employable. I'll keep struggling with that.
Case in point; yesterday I watched the Senate Finance Committee hearings on Vioxx on CSPAN (really I did, it was riveting). The drug's maker, Merck, recently pulled the drug off of the market siting evidence of an increased risk for heart attacks. The portion of the hearings that I watched covered the testimony of three doctors who struggled first to obtain scientific studies on Vioxx and then to warn the public about its dangers. It turns out that studies completed 4 years ago showed Vioxx to significantly increase the risk of heart attacks. One researcher from Stanford University, Dr. Gurkipal Singh, testified that a senior executive of Merck & Co. Inc., contacted his superiors and suggested that Singh would have career problems if he continued to raise concerns.
The response of the FDA to early studies showing greatly increased heart attack risks, due to its own rules, was to work with the drug maker to fashion a warning that was mutually acceptable to the drug company and the FDA! You read that right - current rules require that the drug company accept the language of FDA mandated warnings.
Dr. Singh's testimony was very powerful. He testified that the agreed upon label change was not even put in the warning section of the label but instead appeared under the title of Precautions. The precaution was something to the effect of: Vioxx unlike Aspirin has not been found to be a prophylactic against cardiac arrest. (Transcripts are not yet available from the hearing so I am unable to quote the exact wording Dr. Singh used.) Dr. Singh was extremely angry about this feeble and ridiculous labeling change given the nature of the dire public health dangers of this drug. He said, first of all that Vioxx was a pain killer prescribed to millions for arthritis and for other chronic pain sufferers. No one had ever claimed that it was for heart attack prevention. He said that the precaution might as well have stated that Vioxx did not prevent unwanted pregnancy. Nothing in this labeling change told physicians that patients using Vioxx doubled their risk of heart attacks or strokes.
When the testimony again returned to Dr. Graham it was time for Senator Orrin Hatch to question him. From his expression I could tell that this guy was about to get the treatment for standing up to protect the public. Hatch said, and again I am paraphrasing, Isn't it true Dr. Graham that one of the co-authors of your study is a paid consultant from rival drug maker Pfizer and aren't you concerned that this fact undermines your credibility?
I almost fell out of my chair when I heard this ridiculous slam. Dr. Graham responded that first of all he did not know of this at the time of his study, and secondly that 7 other researchers were involved as well and finally that the results of the study indicating the pronounced increase in heart attack risk have not been challenged only the number of actual heart attacks has been.
I strongly felt that this doctor was a good man, not a political guy, but someone who has devoted his life to public health. In over 20 years with the FDA he has recommended 12 drugs be removed from the market and of the 12 only 2 still remain approved for sale. This guy was trying to warn the Senate oversight committee that drugs were increasingly being approved whose risk-return ratio was way out of whack and that there are quite possibly 55,000 dead Americans as a result. So what does Hatch do, he attempts to slam the whistle blower making it less likely that we'll increase our knowledge of drug safety in the future.
The fact that Dr. Graham is not political made him unlikely to respond to Hatch's obvious smear attempt by saying what I would have said, "Senator Hatch, aren't you concerned that the fact that you have accepted $459,124 over the last Senatorial election cycle from the pharmaceutical industry, the very industry that you are charged with overseeing, may lead some to question your credibility and do you think maybe, just maybe, that could be part of the problem?"
One of the biggest stories today is that Dr. Graham named 5 drugs that, in his opinion, posed great enough public health risks that their continued sale should be reviewed. He did not voluntarily name these drugs and expressed concern that naming them publicly would cause him to be attacked for effecting their makers' stock prices. It was Hatch who bullied him into naming names and now Dr. Graham gets attacked for doing so.
Today I read the slanted coverage in the NY Times about yesterday's testimony and I can't help wondering if advertising dollars from the pharmaceutical industry has effected their credibility as well. As usual if you read the whole article the Times does present both sides of the argument, but not before it slants its coverage against the whistle blowers in the first page. Here is my favorite part, observe the magic that clever language can do:
"The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial partners and those who see the drug makers as antagonists needing to be curbed."
Let's analyze this powerful paragraph to try to get at the opinion of the writer (or more likely, his editor). Doctors Graham and Singh on one side and Bush appointed FDA officials on the other. Let's see if I understand this correctly. The doctors believe - Drug makers produce high-priced products many with risky side effects and they are antagonists that need to be curbed. Top FDA appointees (and senator Hatch) believe: Drug makers focus on the potential of drugs to cure the sick and dying and they are beneficial partners for public health. Who sounds shrill here? The doctors sound cynical and against all progress, their superiors who ignored warnings from scientists allowing thousands of folks to suffer heart attacks and die are optimisitic, can-do folks intent on saving lives.
This description comes no where close to representing the doctors that I watched on CSPAN yesterday. These guys were not in any way, shape, or form against the development of effective pharmaceuticals, in fact they have committed their lives to it. They just happen to put their obligation to protect public health ahead of private profit. That's their job and I am damn grateful for them.
There is a lesson here that transcends this one issue. The watchdog has been put to sleep. Be worried but not defeated. Consider giving Orrin Hatch a call and tell him he is a jerk (202) 224-5251 or write him at:
104 HART SENATE OFFICE BUILDING WASHINGTON DC 20510.
I have too much time on my hands. Being currently unemployed I spend way too much time following the news. The more I follow the news, the more curmudgeonly I become, and the less employable. I'll keep struggling with that.
Case in point; yesterday I watched the Senate Finance Committee hearings on Vioxx on CSPAN (really I did, it was riveting). The drug's maker, Merck, recently pulled the drug off of the market siting evidence of an increased risk for heart attacks. The portion of the hearings that I watched covered the testimony of three doctors who struggled first to obtain scientific studies on Vioxx and then to warn the public about its dangers. It turns out that studies completed 4 years ago showed Vioxx to significantly increase the risk of heart attacks. One researcher from Stanford University, Dr. Gurkipal Singh, testified that a senior executive of Merck & Co. Inc., contacted his superiors and suggested that Singh would have career problems if he continued to raise concerns.
"I was warned that if I persisted in this fashion, there would be serious consequences for me," Singh said.
Dr. David Graham, an FDA scientists, testified that the information gained from the 2000 study indicated that the drug could cause over 100,000 patients to suffer heart attacks, with as many as 55,000 being fatal. Merck has sold $2.5 billion of Vioxx pills in the US. I myself used it briefly for back spasms and it worked great without causing fatique or nausea.The response of the FDA to early studies showing greatly increased heart attack risks, due to its own rules, was to work with the drug maker to fashion a warning that was mutually acceptable to the drug company and the FDA! You read that right - current rules require that the drug company accept the language of FDA mandated warnings.
Dr. Singh's testimony was very powerful. He testified that the agreed upon label change was not even put in the warning section of the label but instead appeared under the title of Precautions. The precaution was something to the effect of: Vioxx unlike Aspirin has not been found to be a prophylactic against cardiac arrest. (Transcripts are not yet available from the hearing so I am unable to quote the exact wording Dr. Singh used.) Dr. Singh was extremely angry about this feeble and ridiculous labeling change given the nature of the dire public health dangers of this drug. He said, first of all that Vioxx was a pain killer prescribed to millions for arthritis and for other chronic pain sufferers. No one had ever claimed that it was for heart attack prevention. He said that the precaution might as well have stated that Vioxx did not prevent unwanted pregnancy. Nothing in this labeling change told physicians that patients using Vioxx doubled their risk of heart attacks or strokes.
When the testimony again returned to Dr. Graham it was time for Senator Orrin Hatch to question him. From his expression I could tell that this guy was about to get the treatment for standing up to protect the public. Hatch said, and again I am paraphrasing, Isn't it true Dr. Graham that one of the co-authors of your study is a paid consultant from rival drug maker Pfizer and aren't you concerned that this fact undermines your credibility?
I almost fell out of my chair when I heard this ridiculous slam. Dr. Graham responded that first of all he did not know of this at the time of his study, and secondly that 7 other researchers were involved as well and finally that the results of the study indicating the pronounced increase in heart attack risk have not been challenged only the number of actual heart attacks has been.
I strongly felt that this doctor was a good man, not a political guy, but someone who has devoted his life to public health. In over 20 years with the FDA he has recommended 12 drugs be removed from the market and of the 12 only 2 still remain approved for sale. This guy was trying to warn the Senate oversight committee that drugs were increasingly being approved whose risk-return ratio was way out of whack and that there are quite possibly 55,000 dead Americans as a result. So what does Hatch do, he attempts to slam the whistle blower making it less likely that we'll increase our knowledge of drug safety in the future.
The fact that Dr. Graham is not political made him unlikely to respond to Hatch's obvious smear attempt by saying what I would have said, "Senator Hatch, aren't you concerned that the fact that you have accepted $459,124 over the last Senatorial election cycle from the pharmaceutical industry, the very industry that you are charged with overseeing, may lead some to question your credibility and do you think maybe, just maybe, that could be part of the problem?"
One of the biggest stories today is that Dr. Graham named 5 drugs that, in his opinion, posed great enough public health risks that their continued sale should be reviewed. He did not voluntarily name these drugs and expressed concern that naming them publicly would cause him to be attacked for effecting their makers' stock prices. It was Hatch who bullied him into naming names and now Dr. Graham gets attacked for doing so.
Today I read the slanted coverage in the NY Times about yesterday's testimony and I can't help wondering if advertising dollars from the pharmaceutical industry has effected their credibility as well. As usual if you read the whole article the Times does present both sides of the argument, but not before it slants its coverage against the whistle blowers in the first page. Here is my favorite part, observe the magic that clever language can do:
"The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial partners and those who see the drug makers as antagonists needing to be curbed."
Let's analyze this powerful paragraph to try to get at the opinion of the writer (or more likely, his editor). Doctors Graham and Singh on one side and Bush appointed FDA officials on the other. Let's see if I understand this correctly. The doctors believe - Drug makers produce high-priced products many with risky side effects and they are antagonists that need to be curbed. Top FDA appointees (and senator Hatch) believe: Drug makers focus on the potential of drugs to cure the sick and dying and they are beneficial partners for public health. Who sounds shrill here? The doctors sound cynical and against all progress, their superiors who ignored warnings from scientists allowing thousands of folks to suffer heart attacks and die are optimisitic, can-do folks intent on saving lives.
This description comes no where close to representing the doctors that I watched on CSPAN yesterday. These guys were not in any way, shape, or form against the development of effective pharmaceuticals, in fact they have committed their lives to it. They just happen to put their obligation to protect public health ahead of private profit. That's their job and I am damn grateful for them.
There is a lesson here that transcends this one issue. The watchdog has been put to sleep. Be worried but not defeated. Consider giving Orrin Hatch a call and tell him he is a jerk (202) 224-5251 or write him at:
104 HART SENATE OFFICE BUILDING WASHINGTON DC 20510.
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