How much money is at stake

According to an article on the CBC website, published December 19, 2004, entitled "Pfizer stock swoons on news of heart risk from painkiller Celebrex":

"Celebrex is the most widely prescribed drug for treating arthritis. Worldwide sales in the first nine months of this year more than doubled from a year earlier to $2.29 billion US, providing six per cent of Pfizer's total sales of $37.59 billion."

"Vioxx had been a blockbuster drug for Merck with annual global sales of $2.5 billion or 11 per cent of the company's revenue last year."

Bye-bye VIOXX

On September 30, 2004, Merck announced that it was recalling VIOXX because of an observed increase in the risk of "cardiac events" in experimental subjects taking it.

On October 3, 2004, Etopia Media Medical News Network published an article entitled "VIOXX® risks have been known for years, other COX-2 inhibitors may be equally dangerous."

This article made the point that whatever it was physiologically that was reducing inflammation in those taking VIOXX was also predisposing them to a higher risk of "cardiac events."

Or, in the words of Mr. David Sharpe, author of "Safety Scrutiny for New Class of Musculoskeletal Pain Drugs," published in the March/April 2002 issue of ScienceWatch®:

"Two-edged swords are often encountered in clinical pharmacology, and with the cyclooxygenases [cyclooxygenases put the "COX" in "COX-2 inhibitors"] the further complication, in cardiovascular terms, is that COX-2 inhibitors interfere with prostacyclin production in vessel walls, providing a possible explanation for any increase in cardiovascular risk with such drugs, were that to be confirmed. The other explanation offered for the VIGOR data is that naproxen (the control drug) was cardioprotective but a recent retrospective study of non-aspirin NSAIDs, including naproxen (see W.A. Ray, et al., Lancet, 359[9301]:118-23, 12 January 2002), casts some doubt on this."

In other words, if the COX-2 inhibitor VIOXX was bad for you, so would be the COX-2 inhibitor Celebrex, and also the COX-2 inhibitor Bextra.

Pfizer stands firmly behind Celebrex, and profits handsomely

On October 1, 2004, Pfizer issued a press release in which it said that "Data demonstrate that Celebrex does not increase the risk of heart attack or stroke in patients with arthritis and pain, even at higher-than-recommended doses."

During the following month, Pfizer benefited significantly from the VIOXX recall, as Celebrex's share of the market for COX-2 inhibitors rose almost 15%, from 48.7% in September, 2004, to 63.5% in October, 2004, on sales of $260 million, according to an article in The Economic Times (of India), by the AP, citing a report issued by IMS Health, a US pharmaceutical information company.

On November 1, 2004, in an article entitled "Pfizer says Celebrex safe following newspaper report," it was reported that "Pfizer Inc said on Thursday its arthritis drug Celebrex was safe after a report in a Canadian newspaper linked it to 14 deaths."

Some flies in the ointment

On November 24, 2004, according to an article attributed to the Associated Press (AP) and entitled, "Pfizer Temporarily Halts Celebrex Sales in Turkey in Dispute Over Warning Label," "Pfizer Inc. said Wednesday it has temporarily halted sales of its pain reliever Celebrex in Turkey because health authorities there sought to include very restrictive language concerning cardiovascular issues on its label."

On December 17, 2004, in an article entitled "Pfizer's Celebrex could have a problem," USA TODAY said that:

"Pfizer said Friday that it has found an increased risk of heart attacks for patients taking high dosages of its top-selling painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx.

"The company said it has no plans to remove Celebrex from the market, but the disclosure on Friday sent Pfizer's shares tumbling because of fears that it could cripple sales of what had been the most-prescribed drug for treating arthritis.

"The drug giant said one of two cancer trials demonstrated an increased cardiovascular risk over placebo, while the other trial revealed no greater cardiovascular risk."

How many lives are at stake

You can read the transcript of an October 28, 2004, segment of The NewsHour with Jim Lehrer in which NewsHour Health Correspondent Susan Dentzer and Dr. Janet Woodcock, Acting Deputy Commissioner for Operations, FDA, discuss the question of how many people may have died from taking VIOXX by clicking here.

That interview includes this set of exchanges between Ms. Dentzer and Dr. Woodcock:

DR. WOODCOCK: …So we can't really extrapolate hard numbers of how many people had heart attacks or strokes in excess from taking Vioxx from that kind of information. You might be able to do some calculation from the randomized controlled data from the approved trial. That might give you some indication.

SUSAN DENTZER: And indeed, people have done that, and just on a kind of a back of the envelope basis have said, well, clearly thousands of people died here.

DR. WOODCOCK: Yes. Well, we know that thousands of people die every year from the gastrointestinal effects of the nonsteroidal anti-inflammatory agents, and the whole goal of developing the Cox-2 inhibitors was to try and mitigate some of that mortality and a tremendous amount of hospitalizations and so forth that result from GI bleeding and so forth from this class of drugs. So perhaps we were trading in this case one toxicity for another, and that's something we learned in the APPROVe trial.

But we can't take the attitude that if you weren't taking Vioxx you would not have had any adverse events happen to you, unless you actually didn't need a nonsteroidal anti-inflammatory drug.

SUSAN DENTZER: Does that mean that we'll never know the answer about how many people actually died from taking this drug?

DR. WOODCOCK: I think that would be a very difficult figure to come up with.

SUSAN DENTZER: Except to say that it's reasonable to assume some meaningful number did?

DR. WOODCOCK: It's meaning--it's reasonable to assume that some people died from taking this drug, but it's also known fact, say in the late '90s it was extrapolated that maybe 15,000 people a year might die from GI toxicity from the NSAID class of drugs.

Joseph Kay, in an article entitled "The Vioxx recall: cover-up of health risks may have resulted in thousands of deaths," published on November 10, 2004, on the World Socialist Web Site, was more direct, writing that:

"There is mounting evidence that the drug giant Merck was aware of the safety risks associated with use of its arthritis drug Vioxx years before it announced a recall on September 30. The company’s attempts to cover up these risks may have resulted in the unnecessary deaths of thousands of patients around the world.

"Evidence of a cover-up was documented in a November 1 article in the Wall Street Journal, citing internal company e-mails and marketing materials. This material has been supplemented by a paper posted November 5 on the Internet site of the British medical journal, The Lancet. The paper found that by 2000, scientific evidence existed of an increased risk of heart attacks and strokes due to use of Vioxx.

”The record indicates that the actions of both Merck and the US Food and Drug Administration (FDA) contributed to the nearly 30,000 excess cases of heart attacks and sudden cardiac deaths that resulted from the use of the drug between 1999 and 2003. While Merck sought to cover up the danger of its own drug to protect its bottom line, the US government aided the company by approving sale of the drug without conducting any serious investigation into potential harmful consequences of its use."

This article cites specific figures on excess deaths due to VIOXX calculated by Dr. David Graham, an FDA researcher who testified before the Senate Finance Committee on November 18, 2004 and called the VIOXX case "a profound regulatory failure" and said that the FDA was "'incapable of protecting America' from another dangerous drug.".

At that time, before the Senate panel, Dr. Graham specifically cited these five medications as such potentially dangerous drugs: "the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent."

You can find the transcript of Dr. Graham's remarks to the Senate committee on November 18, 2004, by clicking here.

The article on the World Socialist Web Site goes on to say that:

"According to a preliminary memo written by FDA researcher David Graham and posted on the FDA web site last week, 'From 1999 to 2003, there were an estimated 92,791,000 prescriptions for rofecoxib [the medical name for Vioxx], of which 17.6% were high-dose. Combing this with data on mean prescription length, we estimate that the increased rofecoxib risk observed in this study would yield an excess of 27,785 cases of AMI [acute myocardial infarction or heart attacks] and SCD [sudden cardiac death] in the US over the years 1999-2003.'

"According to Graham, the fatality rate from these incidents is approximately 27 percent. This would indicate that Vioxx use was responsible for an estimated 7,500 deaths between 1999 and 2004."

Senator Grassley calls for a "9/11-like" commission to investigate drug oversight operations, and defends FDA whistle-blower Dr. David Graham

Senator Chuck Grassley, chair of the Senate finance committee, which oversees the FDA, on Friday, December 17, 2004, said that:

"It seems the time has come for a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs.

"Today, Pfizer released information about an increased risk of heart attack for its drug Celebrex, and Eli Lilly issued a new warning about liver problems with the drug Strattera. The last year revealed serious problems involving children and anti-depressants, painkillers like Vioxx, Bextra and Celebrex, the flu vaccine, and the AIDS drug nevirapine.

"At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us."

Senator Grassley comes to the defense of Dr. Graham in an article entitled "FDA Silenced Expert on Safety Warnings for Vioxx, Senator Grassley Says," dated October 9, 2004.

In a report from the Dow Jones News Service, Senator Grassley is said to have called for "a panel like the 9-11 Commission" to investigate the drug approval and monitoring process at FDA.

 

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