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WASHINGTON, Sep 30, 2004 (United Press International via COMTEX) -- Merck said Thursday it did the right thing by voluntarily withdrawing Vioxx from the market because of an increased risk of heart attack and stroke -- but the decision is painful, both for patients and the pharmaceutical industry.
Does the as-yet-unknown problem with Vioxx -- a Cox 2 inhibitor for pain and arthritis -- extend to Pfizer's Celebrex and Bextra, competitors in the same drug class, and what does it mean for NSAID drugs in general? Will patients return to taking older medications that have a better, long-term safety profile and may be cheaper, but also do not provide the protection against gastrointestinal distress the new Cox 2 inhibitors offer?
This argument's beginnings could be traced back before 1999, when clinical trials on then yet-to-be approved Vioxx -- set against the NSAID naproxen -- showed at least twice the risk for heart events when people took 50 mg doses.
Researchers at the time -- and Merck officials now -- stood by claims that naproxen has a definite heart-protective effect, which justified the medication's risk.
That was 50 mg, and Vioxx was not recommended for long-term use at that level. The test that ultimately took the drug off the market actually was using the standard 25 mg dosage and attempting to see if Vioxx would help prevent colon polyps. In monitoring patients, it was found after 18 months there was a doubled risk of heart attack and stroke compared to people taking a placebo.
"Results of clinical studies with one particular drug do not necessarily apply to other molecules in that class," Kenneth Frazier, senor vice president at Merck, told reporters Thursday. The impact on other similar medications is "unknown," he added.
Dr. Steven Galson, director of the Food and Drug Administration's Center for Drug Evaluation and Research, told reporters, "We think Merck is doing the right thing here ... although the risk ... is small this risk doubled compared to patients taking a placebo in this trial."
FDA will be monitoring Celebrex and other medications for any similar problems and Galson said "all NSAID drugs" have risks for gastrointestinal and cardiovascular problems, such as high blood pressure.
Peter Kim, president of Merck Research Laboratories, said the company is going to work with regulatory agencies in countries where Arcoxia, the second-generation version of Vioxx, already is approved and will continue to seek FDA approval for it in the United States.
The financial impact of pulling Vioxx for Merck, the No. 3 pharmaceutical company in the world, will be 50-cents to 60-cents per share this year, said President and Chief Executive Officer Ray Gilmartin.
Sales of Vioxx had reached more than $2 billion with more than 2 million people taking the drug, but sales have been dropping this year over increased worries and new, troublesome data under FDA review about its safety profile.
Frazier said while litigation from patients who have taken Vioxx and suffered a cardiac event is possible he "cannot speculate on the magnitude of that impact" and added the company has acted responsibly and has "substantial and vigorous defenses to mount."
WHEN POLICY, POLITICS CLASH -- THINK SCIENCE
When politics clash with healthcare policy "I try to resolve it as best I can based on the science," Dr. Mark McClellan, head of the Centers for Medicare and Medicaid Services, told an interactive Web Q&A this week.
A physician and an economist who has worked for both the Republican Bush administration and the Democratic Clinton administration, said that rule helps him get beyond the politics on healthcare issues.
It's a tool he used during his tenure as head of the Food and Drug Administration, where he was before coming to CMS in March.
He said he's found that despite the political environment -- which often is the public face of Washington -- below the surface "there are a lot of people here on both sides of the aisle, Republicans and Democrats, who really want to get something done."
It was that spirit, he said that allowed some organizations outside of the Washington Beltway -- groups opposed to the Medicare prescription drug discount card -- to actually work hardest to make sure low-income and other beneficiaries who could benefit from the savings enrolled in the program.
He said "some of the best ideas" on implementing the drug card have, in fact, come from its opponents, such as some members of the Access to Benefits Coalition, which is working closely with CMS on low-income registration outreach.
He said one key change from his time at FDA is the media.
"I kind of felt I was stepping into a tough political minefield," McClellan said, because of the different way reporters who cover CMS approach their stories. He said reporters who cover FDA are generally consumer reporters who begin with what the agency did, while reporters who cover CMS write with more of a political bent and the actual who did what is buried down below the political reactions. He said it's made it more difficult to get information on the drug cards out to the public.
PEDIATRICIANS ATTACK BUSH POLICY
A statement signed by 36 of the nation's more prominent pediatricians sharply criticizes President Bush's healthcare policies affecting children.
The physicians briefed reporters on the letter and publicly stated their preference for the healthcare plans proposed by Democratic presidential hopeful John Kerry, which rely heavily on an expanded Medicaid program to insure some 17 million currently uninsured children.
"The words 'no child left behind' ring hollow when so many children are left out," said Dr. Joel Alpert, a Boston pediatrician and past president of the American Academy of Pediatrics.
"The Bush Administration's policies are moving us away from effective and longstanding federal commitments that improved the health of children, commitments proudly initiated and supported by previous Republican and Democratic presidents," the statement said. "If not reversed, these ill-advised tax and budget policies will erode decades of hard-won health gains for children, while still leaving unaddressed such critical problems as child abuse, mental health, and alcohol and other drug abuse."
Bush has proposed tax credits and private sector insurance vehicles to help the uninsured but the White House also is allowing some $1.1 billion in unspent money in the State Children's Health Insurance Program to revert back to the general treasury.
The physicians urged Bush to allow the money to remain in SCHIP, a federal/state matching funds program, for states to use as needed. Bush has supported SCHIP in the past.
Dr. Steven Berman, a Denver pediatrician and past president of the American Academy of Pediatrics, said hospitals are having troubles getting physicians to treat uninsured patients and he called on Bush to better enforce laws that require states to provide to Medicaid children healthcare equal to that provided under commercial insurance plans.
Copyright 2004 by United Press International.