Lessons from Vioxx
MERCK PHARMACEUTICAL company took the pain reliever Vioxx off the market more than a year ago, after a clinical study found that it caused heart attacks. And now instead of helping people with chronic pain, it is the subject of thousands of lawsuits contending that it helped to kill them. The drug might be doing some good in limited use today, if only the Food and Drug Administration had slowed the approval process enough for the data about danger to catch up with the marketing hype, which included an article in the New England Journal of Medicine.
Six and a half years ago, Merck was riding high as the FDA allowed Vioxx to go on sale. It would compete with Pfizer's Celebrex as a prescription medicine to relieve the pain of people with arthritis and other chronic pain conditions. Its great advantage over aspirin and other traditional pain relievers was that it wouldn't cause stomach bleeding in people who used it regularly.
Several of Merck's blockbuster drugs were losing their patent protection, but, aided by a marketing campaign spearheaded by the figure skater Dorothy Hamill, who glided pain-free across the ice in television commercials, Merck was confident of making billions of dollars from the new medicine. ''Vioxx has indeed been the biggest, fastest, and best launch ever in Merck history," said David W. Anstice, president of Merck Human Health, North America, late in 1999.
Earlier in 1999 researchers at the University of Pennsylvania had found that these kinds of pain relievers, called COX-2 inhibitors, might erode the body's protection against blood clots, which can cause heart attacks and strokes. The risk seemed small in the limited studies, but the finding argued for a cautious rollout and constant monitoring of patients to determine risk, not the Big Bang of marketing efforts.
But the industry and Congress want these drugs made available quickly, and the drug manufacturers pay the cost of the FDA approval process to hurry them along. This represents a change in attitude from a generation ago, when the FDA was proud of its deliberate pace. A quicker policy is justified in treatments for such life-threatening diseases as AIDS, but Vioxx and Celebrex, for all their pain-relieving potential, do not present the same case for urgency.
RELATED STORY: Scientists plan huge painkiller risk study
In 2000, physicians associated with Merck submitted an article to the New England Journal of Medicine that found that Vioxx did indeed minimize stomach problems compared with a different kind of pain medicine. Buried within the piece was the hint that there was other data somewhere about heart troubles, but any differences there were ascribed to beneficial side effects of the control drug, not the harmful impact of Vioxx.
In hindsight, the New England Journal's staff should have been especially vigilant about the Vioxx article. Journal editors did vet it with outside experts, as is customary, but greater scrutiny is needed when the article deals with a drug with great profit-making capabilities. In September, the Journal and other prestigious medical publications decided to insist that all the data from clinical trials mentioned in articles be available for verification. That's an important improvement if journal editors make sure companies clearly disclose any problems with the drugs.
The real problem, however, is the FDA and the entrepreneurial atmosphere that surrounds the introduction of many new drugs. Prescription medicine, aided by massive marketing and the absence of price controls in the United States, is considered a major growth industry by Wall Street. With billions of dollars at stake, corners may be cut.
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The Journal said its investigation benefited from information obtained by subpoena in one of the 6,400 lawsuits filed by aggrieved Vioxx users or their families. It shouldn't take court proceedings to reveal damaging information about prescription drugs, but that's going to happen again unless the FDA toughens its approval process.
Senator Charles Grassley, the Iowa Republican who heads the Finance Committee, and Senator Christopher Dodd have bills to do just that, but they have languished since February in the Senate Health, Education, and Labor Committee. This is headed by Mike Enzi of Wyoming; the ranking Democrat is Edward Kennedy.
Grassley's proposal would mandate that information from clinical trials be put in publicly available data bases. This would compel the drug companies to provide the data that the journal editors are seeking.
Grassley also wants to establish a separate drug safety office within the FDA. This ought to provide an institutional check on FDA inclination to approve drugs too quickly. Both of Grassley's proposals seem to be sensible improvements in the status quo, but perhaps Enzi and Kennedy can come up with some that are better. A plan to improve the approval process needs to get out of committee and win congressional approval next year.
RELATED STORY: Scientists plan huge painkiller risk study
Other proposals range from limiting television advertising to reverting back to the system in which the government, not the drug companies, defrayed the cost of approving a drug. It's hard to envision Congress giving up a source of revenue when the federal budget is many billions of dollars in the red. But Congress ought to ban consumer advertising, which the FDA did not allow until 1997. Prescription drugs should not be the object of a consumer marketing frenzy.
Vioxx is held in such low regard that a jury deadlocked on a verdict last week even though the patient, a man with a heart condition who later died, had only taken the drug for a month. Vioxx probably didn't cause all the heart attacks for which it will be blamed in court, but because Merck portrayed it as a safe drug for so long, many jurors are loath to give the company the benefit of the doubt.
No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth.
Six and a half years ago, Merck was riding high as the FDA allowed Vioxx to go on sale. It would compete with Pfizer's Celebrex as a prescription medicine to relieve the pain of people with arthritis and other chronic pain conditions. Its great advantage over aspirin and other traditional pain relievers was that it wouldn't cause stomach bleeding in people who used it regularly.
Several of Merck's blockbuster drugs were losing their patent protection, but, aided by a marketing campaign spearheaded by the figure skater Dorothy Hamill, who glided pain-free across the ice in television commercials, Merck was confident of making billions of dollars from the new medicine. ''Vioxx has indeed been the biggest, fastest, and best launch ever in Merck history," said David W. Anstice, president of Merck Human Health, North America, late in 1999.
Earlier in 1999 researchers at the University of Pennsylvania had found that these kinds of pain relievers, called COX-2 inhibitors, might erode the body's protection against blood clots, which can cause heart attacks and strokes. The risk seemed small in the limited studies, but the finding argued for a cautious rollout and constant monitoring of patients to determine risk, not the Big Bang of marketing efforts.
But the industry and Congress want these drugs made available quickly, and the drug manufacturers pay the cost of the FDA approval process to hurry them along. This represents a change in attitude from a generation ago, when the FDA was proud of its deliberate pace. A quicker policy is justified in treatments for such life-threatening diseases as AIDS, but Vioxx and Celebrex, for all their pain-relieving potential, do not present the same case for urgency.
RELATED STORY: Scientists plan huge painkiller risk study
In 2000, physicians associated with Merck submitted an article to the New England Journal of Medicine that found that Vioxx did indeed minimize stomach problems compared with a different kind of pain medicine. Buried within the piece was the hint that there was other data somewhere about heart troubles, but any differences there were ascribed to beneficial side effects of the control drug, not the harmful impact of Vioxx.
In hindsight, the New England Journal's staff should have been especially vigilant about the Vioxx article. Journal editors did vet it with outside experts, as is customary, but greater scrutiny is needed when the article deals with a drug with great profit-making capabilities. In September, the Journal and other prestigious medical publications decided to insist that all the data from clinical trials mentioned in articles be available for verification. That's an important improvement if journal editors make sure companies clearly disclose any problems with the drugs.
The real problem, however, is the FDA and the entrepreneurial atmosphere that surrounds the introduction of many new drugs. Prescription medicine, aided by massive marketing and the absence of price controls in the United States, is considered a major growth industry by Wall Street. With billions of dollars at stake, corners may be cut.
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The Journal said its investigation benefited from information obtained by subpoena in one of the 6,400 lawsuits filed by aggrieved Vioxx users or their families. It shouldn't take court proceedings to reveal damaging information about prescription drugs, but that's going to happen again unless the FDA toughens its approval process.
Senator Charles Grassley, the Iowa Republican who heads the Finance Committee, and Senator Christopher Dodd have bills to do just that, but they have languished since February in the Senate Health, Education, and Labor Committee. This is headed by Mike Enzi of Wyoming; the ranking Democrat is Edward Kennedy.
Grassley's proposal would mandate that information from clinical trials be put in publicly available data bases. This would compel the drug companies to provide the data that the journal editors are seeking.
Grassley also wants to establish a separate drug safety office within the FDA. This ought to provide an institutional check on FDA inclination to approve drugs too quickly. Both of Grassley's proposals seem to be sensible improvements in the status quo, but perhaps Enzi and Kennedy can come up with some that are better. A plan to improve the approval process needs to get out of committee and win congressional approval next year.
RELATED STORY: Scientists plan huge painkiller risk study
Other proposals range from limiting television advertising to reverting back to the system in which the government, not the drug companies, defrayed the cost of approving a drug. It's hard to envision Congress giving up a source of revenue when the federal budget is many billions of dollars in the red. But Congress ought to ban consumer advertising, which the FDA did not allow until 1997. Prescription drugs should not be the object of a consumer marketing frenzy.
Vioxx is held in such low regard that a jury deadlocked on a verdict last week even though the patient, a man with a heart condition who later died, had only taken the drug for a month. Vioxx probably didn't cause all the heart attacks for which it will be blamed in court, but because Merck portrayed it as a safe drug for so long, many jurors are loath to give the company the benefit of the doubt.
No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth.
posted by Chris Placitella at 8:17 AM
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