Celebrex recall imminent

If you are too confused by the information during last 24 hours, here is a brief summary of what you need to know. The details are provided below:

• Celebrex, a drug prescribed as pain relief medication after the recall of Vioxx, has been found to increase the risk of heart attacks in two studies. (Related article: Celebrex found to increase risk of heart attacks)
• FDA, which has just started to review the data from the studies, is advising that your doctor should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients.
• FDA also advises evaluating alternative therapy for pain relief.
• At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex.
• FDA is also saying that patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians while the agency tries to come up with the next steps. (Related article: Americans scared after Vioxx recall)

Developing story on imminent recall of Celebrex

The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). "Data from the report on rofecoxib (Vioxx) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so, said Elias A. Zerhouni, M.D., NIH Director. "Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials. We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug." (Related article: Vioxx recall exposes the mess at the FDA)

"The rigor of our clinical trials system has allowed us to find this problem," said NCI Director Andrew C. von Eschenbach, M.D. "We have a strong system that provides us with the opportunity to both find ways to effectively treat and prevent disease and to do so in a way that protects the lives and safety of the participants."

After this data was provided to Pfizer, the company immediately issued a press release mentioning the findings but Pfizer says it will not pull Celebrex off the market and is studying the results closely to determine what should be done. Pfizer CEO speaking to Paul Zahn on CNN mentioned that he himself is a Celebrex patient and has no plans to change his medication. In the usual confusing language that business-people typically use in such circumstances, he said that the data is not yet conclusive enough to pull the drug off the market. He also did not want to take a position if Celebrex was a 100% safe drug for patients to take. It is, therefore, very likely that Celebrex will be recalled next week since the FDA should not allow any more American lives to be lost so that a drug company can get rich.

The FDA comments, "While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for cardiovascular events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market. Although these are important findings, at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action."

Naturally the events leading up to how the data about Celebrex has been released has upset many. As early as two weeks ago, Pfizer was reaffirming the safety of its drugs Celebrex and Bextra. And in a press release on September 30, 2004 after the recall of Vioxx, Pfizer touted that Celebrex and Bextra were excellent alternatives to the drugs.

Consumer attorney Guerry R. Thornton is simply disgusted by the behavior of drug firms and the FDA. He thinks the system places too much emphasis on perceived benefits and not enough on the risks. "Like Vioxx, maybe the Celebrex review should have found that heart risks outweighed its benefits. The FDA relies on drug company data, and this needs to change," says Thornton.

AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, is calling upon the US government to implement an emergency ban on direct-to-consumer advertising by the pharmaceutical industry. It may be noted that the United States is only one of the two countries in the world to allow advertising of prescription drugs to consumers.

"The pharmaceutical industry continues to abuse and manipulate a fast-track drug approval process the FDA first implemented for drugs and treatments for genuine life-threatening illnesses such as AIDS in order to bring hugely profitable-and, as Celebrex and Vioxx demonstrate, increasingly deadly-drugs to market, said Michael Weinstein, AIDS Healthcare Foundation president. "While it may have been worth the risk for illnesses that are truly deadly, is it worth jeopardizing the American public's health in order to bring new, "me too" drugs that are really glorified aspirin compounds? And the drug industry then unleashes a barrage of slick, direct-to-consumer advertisements in order to convince a trusting public to buy and use these drugs that they really don't need. We are calling on the government to institute an emergency ban on such drug advertising until the process for approving, licensing and regulating our drug supply is fixed." (Related article: Vioxx recall leaves drug advertising unchanged)

"The FDA and NIH are clearly letting the American public-and the world at large-down with regard to their so-called roles as regulatory bodies overseeing the safety and efficacy of our drug supply," Weinstein went on. "The system is riddled with conflict of interest and needs to be fixed. This emergency ban on consumer adverting and creation of a new independent body to review all drug industry research would be a good first step. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust and one which the world can look to."

Related article: Vioxx recall shows how FDA became toothless