I wasn’t long into medical practice when I realized that the system which brings drugs to the American market is fatally flawed. Early on, I filed a couple of Adverse Event Reports—these document ill effects that occur while patients are using a given medication—that simply disappeared into some bureaucratic void. I suspected those reports hadn’t completely escaped attention, though; the number of visits I received from representatives of the involved companies seemed to rise exponentially. I was peppered with marketing tools that extolled the virtues of the drugs in question.

What troubled me, though, was that all of their slick, weighty handouts were reprints of studies that had been funded by the very drug companies who stood to profit from favorable research results.

I’m not a statistician, nor am I a qualified researcher. But I do have the capability to add and subtract, and even four years of medical school and three years of residency couldn’t totally obliterate my ability to think. It is na?ve to assume that any industry, given the latitude that pharmaceutical companies enjoy, would remain objective and honest in reporting negative data.

Unfortunately, we’re not talking about a pair of jeans that will shrink more than is promised on the label; we’re not worrying over a set of tires that will wear out 10,000 miles before the warranty implies. We’re talking about putting substances into our bodies that can possibly injure or kill us; we deserve to have all the information known to the manufacturers of these products before they hit the market.

Jerry Avorn, MD, is professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. I defer to his expertise. In the November 23, 2006, issue of the New England Journal of Medicine, Dr. Avorn discusses the activities of two drug companies whose shenanigans cast a well-deserved shadow over the entire pharmaceutical industry.

On September 30, 2004, Merck announced that its golden drug, Vioxx, doubled the risk of heart attack and stroke, and subsequently removed it from the market. This occurred after five years of heavy promotion and use in some 20 million patients. During Vioxx’s time in the sun, Merck repeatedly denied that the drug presented any increased risks of myocardial infarction, but it commissioned two studies to evaluate a potential relationship. Dr. Avorn and his colleagues performed one of those studies, which confirmed an increased risk. Interestingly, Merck dismissed their findings and questioned the validity of research methods that it had previously accepted. The second study also confirmed a tie between Vioxx and heart attack risk, but the results of that study were withheld from public view until after the drug was withdrawn from the market.

On September 30, 2006, the New York Times carried a front page article reporting that the Food and Drug Administration had issued a warning regarding aprotinin, a drug used to reduce bleeding in patients undergoing heart surgery. The drug was found to increase the risks of kidney failure, congestive heart failure, stroke, and death. This is a drug that had concerned some experts since its release in 1993, and a recent study supported that concern. However, on September 21st of this year—following publication of the study—the FDA concluded that there was no need for additional warnings on the drug’s labeling. Nine days later it was revealed that Bayer (the drug’s manufacturer) had conducted its own independent analysis of the drug’s risks, that the analysis had confirmed those risks, and that the results were withheld from the FDA—even though the information was available before the September 21st advisory meeting.

Bayer has since admitted that suppression of this information was a “mistake,” but this company behaved similarly during investigations surrounding its cholesterol-lowering drug, Baycol, before it, too, w

I’m not a statistician, nor am I a qualified researcher. But I do have the capability to add and subtract, and even four years of medical school and three years of residency couldn’t totally obliterate my ability to think. It is na?ve to assume that any industry, given the latitude that pharmaceutical companies enjoy, would remain objective and honest in reporting negative data.

Unfortunately, we’re not talking about a pair of jeans that will shrink more than is promised on the label; we’re not worrying over a set of tires that will wear out 10,000 miles before the warranty implies. We’re talking about putting substances into our bodies that can possibly injure or kill us; we deserve to have all the information known to the manufacturers of these products before they hit the market.

Jerry Avorn, MD, is professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. I defer to his expertise. In the November 23, 2006, issue of the New England Journal of Medicine, Dr. Avorn discusses the activities of two drug companies whose shenanigans cast a well-deserved shadow over the entire pharmaceutical industry.

On September 30, 2004, Merck announced that its golden drug, Vioxx, doubled the risk of heart attack and stroke, and subsequently removed it from the market. This occurred after five years of heavy promotion and use in some 20 million patients. During Vioxx’s time in the sun, Merck repeatedly denied that the drug presented any increased risks of myocardial infarction, but it commissioned two studies to evaluate a potential relationship. Dr. Avorn and his colleagues performed one of those studies, which confirmed an increased risk. Interestingly, Merck dismissed their findings and questioned the validity of research methods that it had previously accepted. The second study also confirmed a tie between Vioxx and heart attack risk, but the results of that study were withheld from public view until after the drug was withdrawn from the market.

On September 30, 2006, the New York Times carried a front page article reporting that the Food and Drug Administration had issued a warning regarding aprotinin, a drug used to reduce bleeding in patients undergoing heart surgery. The drug was found to increase the risks of kidney failure, congestive heart failure, stroke, and death. This is a drug that had concerned some experts since its release in 1993, and a recent study supported that concern. However, on September 21st of this year—following publication of the study—the FDA concluded that there was no need for additional warnings on the drug’s labeling. Nine days later it was revealed that Bayer (the drug’s manufacturer) had conducted its own independent analysis of the drug’s risks, that the analysis had confirmed those risks, and that the results were withheld from the FDA—even though the information was available before the September 21st advisory meeting.

Bayer has since admitted that suppression of this information was a “mistake,” but this company behaved similarly during investigations surrounding its cholesterol-lowering drug, Baycol, before it, too,

Jerry Avorn, MD, is professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. I defer to his expertise. In the November 23, 2006, issue of the New England Journal of Medicine, Dr. Avorn discusses the activities of two drug companies whose shenanigans cast a well-deserved shadow over the entire pharmaceutical industry.

On September 30, 2004, Merck announced that its golden drug, Vioxx, doubled the risk of heart attack and stroke, and subsequently removed it from the market. This occurred after five years of heavy promotion and use in some 20 million patients. During Vioxx’s time in the sun, Merck repeatedly denied that the drug presented any increased risks of myocardial infarction, but it commissioned two studies to evaluate a potential relationship. Dr. Avorn and his colleagues performed one of those studies, which confirmed an increased risk. Interestingly, Merck dismissed their findings and questioned the validity of research methods that it had previously accepted. The second study also confirmed a tie between Vioxx and heart attack risk, but the results of that study were withheld from public view until after the drug was withdrawn from the market.

On September 30, 2006, the New York Times carried a front page article reporting that the Food and Drug Administration had issued a warning regarding aprotinin, a drug used to reduce bleeding in patients undergoing heart surgery. The drug was found to increase the risks of kidney failure, congestive heart failure, stroke, and death. This is a drug that had concerned some experts since its release in 1993, and a recent study supported that concern. However, on September 21st of this year—following publication of the study—the FDA concluded that there was no need for additional warnings on the drug’s labeling. Nine days later it was revealed that Bayer (the drug’s manufacturer) had conducted its own independent analysis of the drug’s risks, that the analysis had confirmed those risks, and that the results were withheld from the FDA—even though the information was available before the September 21st advisory meeting.

Bayer has since admitted that suppression of this information was a “mistake,” but this company behaved similarly during investigations surrounding its cholesterol-lowering drug, Baycol, before it, too,

On September 30, 2006, the New York Times carried a front page article reporting that the Food and Drug Administration had issued a warning regarding aprotinin, a drug used to reduce bleeding in patients undergoing heart surgery. The drug was found to increase the risks of kidney failure, congestive heart failure, stroke, and death. This is a drug that had concerned some experts since its release in 1993, and a recent study supported that concern. However, on September 21st of this year—following publication of the study—the FDA concluded that there was no need for additional warnings on the drug’s labeling. Nine days later it was revealed that Bayer (the drug’s manufacturer) had conducted its own independent analysis of the drug’s risks, that the analysis had confirmed those risks, and that the results were withheld from the FDA—even though the information was available before the September 21st advisory meeting.

Bayer has since admitted that suppression of this information was a “mistake,” but this company behaved similarly during investigations surrounding its cholesterol-lowering drug, Baycol, before it, too,

Bayer has since admitted that suppression of this information was a “mistake,” but this company behaved similarly during investigations surrounding its cholesterol-lowering drug, Baycol, before it, too, was removed from the market.

According to Dr. Avorn: “A few years ago, it was discovered that some companies had funded multiple clinical trials of their selective serotonin-reuptake inhibitor antidepressants (drugs like Prozac, Paxil, Zoloft, Celexa, or Lexapro) but reported the results of only the favorable trials—distorting the evidence base physicians use in choosing drugs.” (Parenthetical text is mine).

Clearly, obfuscation is an industry-wide problem. Apparently, the FDA either doesn’t have the clout or doesn’t possess the desire to reign in an industry that is marketing drugs that could sicken or kill thousands. Sadly, physicians are using incomplete or inaccurate information to determine standards of medical care in America.

It is time we designed a system that removes control of critical data from companies that use such information for their own purposes. Instead, we must provide public support for research regarding drugs’ risks and benefits so that we, as patients, know exactly what we’re doing when we take that next pill or capsule.

Big Pharma is not our friend.

I’ve been saying it for twenty years… ain’t I been sayin’ it?