Friday, December 09, 2005

VIOXX, THE GOVERNMENT, AND "BAD" DRUGS

By Ralph Erinbo

Courtesy of the Advance Nutrients hydroponic plant food website, www.advancednutrientsmedical.ca.

I read about Vioxx the drug and its maker, Merck, and how the drug hurt people and how the government that is so dedicated to protecting us from drugs, didn’t protect us.

I read about it on the http://www.advancednutrientsmedical.ca/ website before, about how the government agency called the Food and Drug Administration that is supposed to screen drugs before they are sold to the public, well the FDA is not screening them and is in bed with the companies that make the drugs. Now I see new reports about Vioxx and how the government helped Merck cover up the harms.

It makes me pissed off. I am into marijuana, and they won’t let us grow that, but they will let Merck sell us a pill that causes heart attacks, apparently, and they also have business connections with the very same people they are supposed to regulate.

Vioxx is a pain killer and anti-inflammatory; so is marijuana, which works a lot better and doesn’t cause heart attacks. So guess which one is legal? The fatal one, of course. Makes perfect sense to me.

Now I just read that the New England Journal of Medicine has said that Merck concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller; the alleged concealment tainted a report on the Vioxx study that was published in the New England Journal of Medicine in 2000.

The Journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor alleges that the study’s authors deleted other relevant data before submitting their article to the Journal for publication.

“Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article,” the Journal's editorial leadership wrote.

Adverse cardiovascular events attributed to Vioxx include heart attacks, strokes and deaths, the Journal said.

Findings of the year 2000 study were key parts of testimony in the three product liability trials to date over the withdrawn drug, including one being deliberated by a federal jury in Texas.

The exclusion of the three heart attacks “made certain calculations and conclusions in the article incorrect,” the doctors wrote in the Journal, adding that they have asked the report’s authors to submit a corrected article.

The Journal, in its statement labeled "Expression of Concern," said it had made the discovery of the alleged deletions as part of preparations for the recent deposition of the executive editor of the Journal in connection with Vioxx-related litigation.

The Journal said Merck had submitted its manuscript both on paper and on a computer diskette, but that the Journal’s pre-publication review and editing of the story were done only on the printed version of the manuscript.

The Journal said it did not review the diskette until October 5, 2004, several days after Vioxx was pulled from the market after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use.

"In reviewing the diskette, we learned that data on cardiovascular events had been deleted from the manuscript before it was submitted," the Journal said.

This is outrageous. It looks to me like Merck deliberate hid negative data, just to protect profits. But who would ever suspect a drug company of doing something like that?

One of the study’s authors was Dr. Alise Reicin, Merck’s vice president for clinical research. Reicin testified in court that Merck never misled doctors and the public about studies linking heart attacks to Vioxx, but what do you expect him to say when his company faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated at up to $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.

A former Merck scientist testified today that he initially concluded an internal study of Vioxx linked the drug to an increase in heart attacks and strokes less than a year after it was approved for sale.

In a videotaped deposition shown to a Houston jury, Dr. Edward M. Scolnick, the former president of Merck Research Labs until 2002, acknowledged writing a company e-mail in which he noted that the cardiovascular links to Vioxx were "clearly there." What a surprise that he testified that he changed his mind about Vioxx only a few days later, suddenly to believe that Vioxx doesn’t cause health problems. Still, the cardiovascular issue continued to bother him even after Merck's marketing department put out a press release claiming that Vioxx was totally safe, Scolnick said.

"I will tell you that my worry quotient is high," he wrote in an e-mail to the Vioxx project team. "I am actually in minor agony."

Vioxx, a profitable painkiller, was approved in 1999 after the FDA deemed it safe and effective. In September 2004, after repeated rumors of Vioxx-caused health problems, Merck pulled it from the market after a study showed it doubled the risk of heart attack and strokes in patients who took it for 18 months or longer.

Merck is facing 7,000 lawsuits by former Vioxx users or their families. In August, 2005, a Brazoria County jury awarded the widow of a former marathon runner who died of a heart attack after taking the drug $253 million.

In a federal trial in Houston taking place in December, 2005 as this blog is being written, the jury has to decide if Vioxx contributed to the blood clot and death of 53-year-old Richard "Dicky" Irvin, a Florida seafood salesman and former college football player.

Also today, Scolnick acknowledged in his deposition that he called federal regulators "bastards" in an internal e-mail because they were considering adding a warning label to Vioxx following the VIGOR study's release.

Scolnick said he strongly disagreed with the FDA’s insistence that the label should be added to Vioxx.

"Be assured, we will not accept this label," Scolnick said in an e-mail to other Merck officials in October 2001.

Of regulators asking for additional safety information, he said, "They are bastards." Later he called them "devious."

Scolnick also testified that at the time Merck was developing Vioxx, patents were running out on two of the company's largest revenue-producing medicines. Asked if that put pressure on Merck to come up with a big drug to fill the void, Scolnick said, "Vioxx was going to fill the void."

Also, Monday, Irvin's widow Evelyn Irvin Plunkett testified that her husband of 30 years was a healthy, hard-working man who rarely got sick and took Vioxx for a back strain he got from lifting a box of shrimp.

She said she was stunned when she received a call from her husband's boss on the morning of May 15, 2001 telling her that Irvin had suffered a heart attack and had been rushed to the hospital.

Shortly after arriving there, she said, a doctor talked to her and two of her four children in the waiting room.

"She said 'We worked on your husband for over an hour and we couldn't save him,'" said Plunkett, who has since remarried.

"It was like my whole life went up in the air," she said.

The Vioxx problems involving the goverment's unwillingness to regulate pharma drugs are the tip of the iceberg. The FDA’s own drug safety offices said to Congress that, “The FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless."

Several scientists testifying before the Senate in November, 2005 provided substantial evidence that the drug company Merck and the US Food and Drug Administration (FDA) knew of safety problems years before the drug Vioxx was withdrawn from the market.

Vioxx, which was used to treat arthritis and severe pain, was withdrawn by Merck on September 30, 2005 after evidence emerged that it greatly increased the risk of heart attacks and strokes. Some 80 million prescriptions of the drug have been filled around the world, most of them in the US, since it was approved in May 1999.

Damning testimony was given by Dr. David Graham, the associate director for science and medicine at the FDA’s own Office of Drug Safety. The ODS, responsible for monitoring the safety of drugs already on the market, is part of the Center for Drug Evaluation and Research (CDER), which also includes the Office of New Drugs (OND), responsible for approving new drugs for the market. Graham said he came into repeated conflict with the OND as he sought to raise concerns about the safety of Vioxx.

The OND is one of the branches of the FDA that is most closely tied to the giant drug companies it is responsible for regulating. Since 1992, the office gets much of its funding directly from drug companies, in the form of new drug application fees of more than $500,000 per application. Most of this money goes toward speeding up the approval of new drugs. It is a recipe for disaster, as the Vioxx case has proven.

Graham said that the OND has a higher position in the FDA hierarchy than the ODS, and is reluctant to issue stricter regulations for drugs already on the market or order mandatory withdrawals of unsafe drugs that the office has approved. In the case of Vioxx, the drug was pulled from the market only after its producer, Merck, decided that the evidence of harmful consequences was overwhelming. It was not withdrawn as a result of any regulatory action by the FDA!

A study led by Graham that was concluded in the summer of 2004 found that Vioxx was responsible for an estimated 38,000 excess heart attacks and sudden cardiac deaths. In his testimony, Graham said this was a conservative estimate. He said that “a more realistic and likely range of estimates for the number of excess cases in the US” was between 88,000 and 139,000. “Of these,” he added, “30-40 percent probably died. For the survivors, their lives were changed forever.”

To dramatize the number of people affected, Graham noted that “this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past five years.”

Graham testified that as his team concluded its study and prepared to present its results, it was attacked by the Office of New Drugs and other sections of the FDA. “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present” the paper reporting his study’s conclusions. “An email from the director for the entire Office of New Drugs was revealing. He suggested that since FDA was ‘not contemplating’ a warning against the use of high-dose Vioxx, my conclusions should be changed.”

Up to a week before the drug was pulled from the market by Merck, FDA management, according to Graham, was attempting to undermine Graham’s conclusions.

Graham said, “[W]e are virtually defenseless” against another catastrophe on the scale of Vioxx. “The organization structure within CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is ‘safe and effective.’ When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and attack. At the same time, the Office of Drug Safety has no regulatory power and must first convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done.”

The prevailing sentiment at the FDA, said Graham, is one that views “the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the dugs it approves, and seriously under-values, disregards and disrespects drug safety.” When it comes to drug safety, he said, the operating principle is that the drug is safe unless it is proven to be unsafe beyond a shadow of a doubt. New drugs, including Vioxx, are pushed through the approval phase in a matter of months, before sufficient tests are done to ensure their safety. Independent clinical testing is rarely carried out by the FDA, and indications of safety problems are ignored or deliberately undermined.

Later, Graham pointed to five drugs currently on the market that he felt were potentially dangerous: Acutane, which is used to treat acne; Bextra, a painkiller; Crestor, used to lower cholesterol; Meridia, used to treat weight loss; and Serevent, used to treat asthma. All of these can cause dangerous side effects and have not been adequately tested for their safety, Graham asserted.

Others providing testimony included Gurkirpal Singh, from the Stanford University School of Medicine, and Bruce Psaty, co-director of the Cardiovascular Health Research Unit at the University of Washington. The two scientists reviewed some of the history of the testing of Vioxx and concluded that, even with the limited data available, the drug should have been pulled from the market long before it was withdrawn.

Singh noted that there was evidence of serious heart problems associated with Vioxx before it was approved in 1999. “In 1998, Dr. Doug Watson, a Merck scientist, presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs. This analysis concluded that men taking Vioxx had a 28 percent greater risk (not statistically significant), but in women, the risk was more than double (216 percent, statistically significant) compared to people not taking any drug in other Merck studies. To the best of my knowledge, these data were never made public.”

Merck has continually asserted that at the time of Vioxx’s approval, no evidence existed indicating that the drug caused additional heart attacks. The main study carried out by Merck, known as VIGOR, showed a fivefold increase in serious heart conditions relative to another drug, naproxen (the generic form of Aleve). Merck explained these results as a consequence of naproxen’s beneficial effects, rather than Vioxx’s harmful ones. However, in 1999 a scientist at the FDA remarked that “thromboembolic events [such as heart attack and stroke] are more frequent in patients receiving Vioxx than placebo.” Singh noted, “This meant that not only did Vioxx not [have the benefits of naproxen], but for some reason, it was likely to promote heart attacks directly.”

The evidence was still limited, Singh said. “There were not adequate data to make a firm conclusion one way or another. In fact, the FDA reviewer went on to point out that ‘[w]ith the available data, it is impossible to answer with complete certainty whether the risk of cardiovascular and thromboembolic events is increased in patients on rofecoxib [Vioxx]. A large database will be needed to answer this and other safety comparison questions.’ ”

Instead of carrying out a larger study, the FDA quickly approved the drug for use. This was in spite of the fact that the drug's availability did not meet an urgent medical necessity- there were already drugs on the market that performed the same function as Vioxx, which is suppoed to relieve inflammation without causing stomach problems. It is interesting to note that medical marijuana relieves inflammation and stomach problems, and is not fatal.

The FDA did not even require a caution on the drug’s label about the increased risk of hear attacks until April 2002.

Nor did Merck attempt a larger study. The New York Times reported on November 14 that such a study was contemplated in May 2000, but management rejected the idea. According to the Times, a slide prepared for an executives’ meeting stated, “At present, there is no compelling marketing need for such a study.... The implied message is not favorable.”

In their defense, Sandra Kweder, the deputy director of the Office of New Drugs, and Raymond Gilmartin, chairman and CEO of Merck, simply repeated the claim that everything was done to determine the safety of Vioxx as quickly as possible, and that the drug was immediately withdrawn as soon as safety problems became evident.

What is even more astounding than the lies told by Merck is that marijuana does all the same things that Vioxx does and does not cause heart attacks. That’s why the war on drugs is stupid.

When a scientist tries to fight the pharmaceutical industry, he or she often gets stomped. According to the Chicago Tribune, FDA officials tried to silence an independent scientist whose unique research project for detecting rare adverse drug reactions has uncovered potentially fatal side effects of 17 currently marketed drugs.

Dr. Charles Bennett, a Northwestern University researcher, developed a proactive method for detecting adverse drug effects by examining adverse drug reports submitted to FDA’s database and reports from reports by pharmaceutical companies and independent groups of researchers throughout the US and Canada. The project is called the Research on Adverse Drug Events and Reports (RADAR).

For example, Dr. Bennett discovered that the widely used anti-clotting drug, Plavix, can cause “a catastrophic collapse of the blood system.” He urged the FDA to issue Black Box warnings, but the FDA refused, but did add a less prominent warning.

Dr. Bennett published a paper in the journal Stroke (February) in which he compared the effectiveness of various systems for detecting adverse drug effects. The FDA system ranked at the very bottom:

“The study assessed how the FDA, Plavix's manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent.”

The Tribune reports that The FDA retaliated against Dr. Bennett for publishing the results by cutting off his access to FDA’s post marketing surveillance database—as if the agency were a private contractor. FDA's Christine M. Bechtel wrote:


"While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your group’s special status."

This kind of bureaucratic cover-up, and the constant attempts by the drug industry and government lackeys to fool us, are crimes.

While the government spends billions of dollars a year to protect us from a plant drug that we want to use, it protects companies that market deadly prescription drugs.

What has happened to the concept of morality? It sure seems to be a concept forgotten by the FDA and the drug companies.

5 Comments:

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