reinforcing findings of other trials" as two... FDA advisory committees on Wednesday plan to begin
meetings on the medications, the AP/Long Island Newsday reports. The study involved the records of 7,232 patients ages 40 and older who
took Vioxx, Celebrex or Bextra for at least 18 months and the records of 629,245 individuals of similar ages who did not take the medications. The study,
which WellPoint began after Merck in late September 2004 voluntarily withdrew Vioxx from the
market over safety concerns, included patient records from January 2001 through June 20, 2004. The study found that participants who took Vioxx and
Celebrex had a 20% increased risk for heart attack and stroke and that those who took Bextra had a 50% increased risk. Merck and Pfizer, which manufactures Celebrex and Bextra, have said that such studies -- which retrospectively examine patient
records -- are not as accurate as blind, placebo-controlled clinical trials. However, Sam Nussbaum, WellPoint executive vice president and chief medical
officer, said, "This is how drugs are used in the real world. It is an important and sound analysis." Nussbaum added that although the study provides
additional evidence of an "increasingly compelling trend," WellPoint will not revise a policy that requires physicians to obtain prior authorization before they
prescribe Celebrex and Bextra. However, the policy "could change depending on the outcome of the FDA hearing" on COX-2 inhibitors, the AP/
Newsday reports. Nussbaum said he had shared the study results with FDA and Pfizer. Pfizer spokesperson Mariann Caprino said that the
company has not examined the results of the study or methodology used. In addition, a Pfizer review of internal trials had found Celebrex and Bextra did
not increase cardiovascular risk. Eric Matteson, a professor of medicine in the division of rheumatology at the Mayo Clinic, called the WellPoint study
significant, adding, "All the signals are pointing in the same direction. ... Clearly there is a degree of risk in these drugs and doctors need to be more
careful about prescribing them." Matteson added that he does not expect FDA to remove Celebrex or Bextra from the market (Agovino, AP/Long Island
Newsday, 2/14).
FDA Advisory Committee Meetings
"Much rides" on the "critical" FDA advisory committee meetings
this week: consumer "confidence in painkillers, prescribing habits for doctors, and the credibility of the FDA itself, under constant fire for bungling its drug
safety oversight mission," the Boston Globe reports (Henderson, Boston Globe, 2/15). Members of the FDA arthritis and drug safety and risk
management advisory committees on Wednesday will begin meetings to determine whether to remove COX-2 inhibitors from the market over safety
concerns. The members of the advisory committees will review hundreds of documents from FDA scientists and the manufacturers of COX-2 inhibitors
and hear testimony from scientists, physicians and patients. A committee of the European Medicines
Agency this week also plans to hold meetings on COX-2 inhibitors (Kaiser Daily Health Policy Report, 2/14). Some witnesses at the FDA advisory committee meetings
likely will testify that COX-2 inhibitors should remain on the market with increased warnings and more restrictions on who should take the medications (
Boston Globe, 2/15). According to the Philadelphia
Inquirer, the FDA advisory committees likely will not recommend the market withdrawal of COX-2 inhibitors, but they might call for "black box"
warnings on their labels or restrictions on marketing (Vrazo et al., Philadelphia Inquirer, 2/15). Elizabeth Tindall, a clinical professor of
medicine at the Oregon Health and Science University and president of the American College of Rheumatology, said, "I'm hopeful at least Celebrex may be left alone." Tindall, who will
testify at the meetings, added that if FDA officials do not take action on COX-2 inhibitors "they are going to be viewed as ineffectual and weak." She
added, "That would certainly be the easiest thing for them to do, just say, 'Well, the heck with this, we did fine without these drugs.' But I don't think it would
be the right thing to do" (Boston Globe, 2/15). FDA advisory committee member Arthur Levin, director of the nonpartisan Center for Medical Consumers, said that committee members might "diverge on what to do," the
Inquirer reports (Philadelphia Inquirer, 2/15).
Meetings Could Affect Vioxx Lawsuits
Although the "spotlight
is likely to be on Pfizer" at the FDA advisory committee meetings on COX-2 inhibitors, Wall Street analysts and "battalions of lawyers will be intently
watching testimony by and about Merck" to determine whether the meetings affect the "hundreds of lawsuits" the company faces related to the Vioxx
withdrawal, the New York Times reports. The
meetings likely will include "extensive testimony" about Vioxx, although Merck officials said that the company would not provide the FDA advisory
committees with "significant documents that have not already been made public" or were not included in pretrial discovery phases, other than an analysis
of the last month of the clinical trial that prompted the company to withdraw Vioxx from the market, the Times reports. According to the
Times, the new analysis likely will not "alter significantly" the Vioxx lawsuits. Theodore Mayer, an attorney for Merck, said that the meetings
could highlight significant inconsistencies in available research on Vioxx prior to the decision by the company to withdraw the medication from the market.
Mayer said that if FDA advisory committee members "are looking for a blockbuster in terms of new data from the past or how Merck analyzed it, they are
going to be disappointed," adding, "The company's done an excellent job of disclosing the history." Christopher Seeger, an attorney who represents
plaintiffs in some Vioxx lawsuits, said, "Anything short of an outright condemnation of how Merck handled this drug will disappoint me." He added, "If they
aren't criticized, Merck will stand up in court and say the FDA looked at this again and said it did nothing wrong" (Feder, New York Times, 2/
15).
Clinical Trial Study
Vioxx, Celebrex and Arcoxia, a COX-2 inhibitor manufactured by Merck that received "tentative approval" from
FDA last fall, cause a "somewhat greater" elevation in blood pressure than placebos and older pain medications, according to a study published on
Tuesday in the Archives of Internal Medicine, the Globe reports. The study analyzed 19 clinical trials published before May
2004. According to the Globe, the study also found "possible bias in industry-financed studies." Eric Topol, chair of the department of
cardiovascular medicine at the Cleveland Clinic, said, "The new analysis supports the concept that blood pressure elevation, especially pronounced with
Vioxx, is in part responsible for the excess in heart attacks and strokes" (Boston Globe, 2/15).
Sidney Wolfe Profile
The
Times on Tuesday profiled Sidney Wolfe,
director of the health research group at Public Citizen, who over the past 34 years has "condemned dozens of high-priced medicines and denounced their
makers," fought "companies rich and poor and ... angered just about every constituency in the health care industry." Wolfe, who in April 2001 raised safety
concerns over Vioxx and Celebrex, "has been shouting about deficiencies at the FDA since the first Nixon administration," the Times reports.
Wolfe has petitioned FDA to withdraw 27 medications, 16 of which were later removed from the market. According to the Times, the "knock
on Dr. Wolfe" -- who takes no prescription or over-the-counter medications, although "his cholesterol is about 230" -- is that he "hates all drugs." Wolfe
said that he has supported approval for important medications and that he considers many prescription drugs beneficial. Alan Goldhammer, associate
vice president of the Pharmaceutical Research and Manufacturers of America, said, "Unfortunately, Dr. Wolfe often presents a distorted picture of today's
innovative industry and its medicines. He ignores important benefits that new drugs bring to millions of patients." Michael Jacobson, executive director of
the Center for Science in the Public Interest, said that Wolfe is "almost unique in the world of drugs. He spends his life systematically looking for
problems, and he finds a remarkable number" (Harris, New York Times, 2/15).
"Reprinted with permission from kaisernetwork kaisernetwork. You can
view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for
kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board
Company and Kaiser Family Foundation. All rights reserved.
View drug information on Bextra; Vioxx.
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