Healthy Skepticism Library item: 9352
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Pettypiece S.
Merck's Arcoxia Shouldn't Be Sold in U.S., Panel Says
Bloomberg.com 2007 Apr 12
http://www.bloomberg.com/apps/news?pid=20601202&sid=aMYRw5ivazos&refer=healthcare
Full text:
Merck & Co.‘s experimental arthritis drug Arcoxia shouldn’t be allowed on the U.S. market, an advisory panel said, citing some of the same risks that led to the withdrawal of the similar treatment Vioxx.
The committee voted 20-1 today to recommend that the Food and Drug Administration reject Arcoxia because its benefits in reducing pain and minimizing stomach irritation don’t outweigh potential damage to the heart.
Failure to win clearance for Arcoxia would dash Merck’s plans to recoup some of the $2.5 billion in annual revenue lost when its drug Vioxx was withdrawn in 2004 after being linked to heart attacks and strokes. Those dangers were cited by the FDA advisers meeting in Gaithersburg, Maryland, to review the new product.
``There is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period,’‘ said David Felson, a member of the advisory committee and a professor of medicine at Boston University.
The FDA usually follows the recommendations of its advisers, although it isn’t required to do so. The agency must make a final decision by April 27.
Arcoxia could have $1 billion in annual sales if approved in the U.S, according to analysts, some of whom had said they weren’t expecting approval based on previously published data on the drug’s risks.
Merck shares gained 71 cents, or 1.6 percent, to $46.36 at 4:25 p.m. in New York Stock Exchange composite trading. Shares of the Whitehouse Station, New Jersey-based company have gained 37 percent in the past 12 months.
Study Results
Studies showed Arcoxia caused more blood clots than the painkiller naproxen and is more likely to cause increased blood pressure, fluid retention and congestive heart failure than another arthritis drug, diclofenac, an FDA official, David Graham, told the advisory panel.
``What you are talking about is a potential public health disaster,’‘ said Graham, associate director of science and medicine for the FDA’s Office of Surveillance and Epidemiology.
Graham, who raised doubts about Vioxx long before it was pulled from the market, said Arcoxia would be ``a repeat of what we had’‘ with the previous drug. Arcoxia would cause an additional 6,800 deaths, heart attacks and strokes a year per million patients if it were prescribed instead of naproxen, Graham said.
Merck’s Position
Arcoxia is needed to provide a new option for patients unable to control their pain with current treatments and is easier on the stomach, Merck has said. Arcoxia had the same risk of blood clots, which can lead to heart attacks and stroke, as the decades-old diclofenac, according to company executives.
``We continue to believe Arcoxia has the potential to become a valuable treatment option for the many patients suffering from osteoarthritis,’‘ said Merck spokeswoman Kyra Lindemann after the advisory panel’s action. ``We will continue to work with the FDA.’‘
Arcoxia and diclofenac are part of a category of arthritis medicines called non-steroidal anti-inflammatory drugs, or NSAIDs, which also includes naproxen, aspirin, ibuprofen and Pfizer Inc.‘s Celebrex.
Diclofenac, which Merck used for comparison against Arcoxia in a 34,000-patient study, was an ``inappropriate’‘ choice because it has a higher risk of heart attack than other NSAIDs, the FDA’s Graham said. Merck said it chose to study diclofenac because it’s the world’s most widely used drug in the class and doesn’t interfere with the benefit aspirin has for the heart.
Arcoxia has already been approved for use in 62 countries and had $265 million in sales last year.
Tests in 44,000 Patients
Merck tested Arcoxia in more than 44,000 osteoarthritis patients since 1998, the year before Vioxx sales began.
The FDA delayed Merck’s application for Arcoxia in 2004, asking for more safety information.
In 2005, after Vioxx was pulled from the market, all of the remaining NSAIDs were given the agency’s strictest warning about an increased risk of heart attacks, strokes and death. Only high doses of naproxen may have a lower risk of heart attacks and strokes, some studies have found.
U.S. regulators have set a special standard for any new drug in the class to come on the market, saying these products must be safer or significantly more effective than existing treatments.
``I feel like we got very clear advice from the committee,’‘ said Robert Meyers, director of the FDA’s Office of Drug Evaluation II. ``Simply having another drug on the market didn’t seem like enough.’‘
More than two years after Vioxx was pulled from the market the FDA still doesn’t have enough data to determine if certain NSAIDs pose a greater risk than others, Meyers said.
Arcoxia is different from some other NSAIDs because it eases pain by blocking only the Cox-2 enzyme, leaving untouched the Cox-1 enzyme, which may play a role in protecting the stomach. Vioxx and Pfizer Inc.‘s Celebrex, which is still on the market, also block only Cox-2.
To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net
