Thursday, April 28, 2011

The Troubling Tale of Tamiflu and the Drug Companies

Helen Epstein provides a description of the activities surrounding the recent “swine flu” scare in The New York Review of Books. Her article is aptly titled: Flu Warning: Beware the Drug Companies.

Epstein suggests the drug companies have been preparing for years for the opportunity to take advantage of a threatening new flu virus so they make large amounts of money selling drugs to frightened countries. She also suggests that the drug promoted for these emergencies, Tamiflu, is of unknown value in treating flu victims. It is of unknown value because the drug company that manufactures it has purchased influence and corrupted the drug approval process to such an extent that only it has the data available to evaluate the drug’s efficacy—and it has not released that data..

Here is the tale Epstein tells.
“In February 2009, a spike in influenza cases was detected in hospitals around Mexico City. Mexican government officials sent samples of throat cultures from patients to the US Centers for Disease Control (CDC) and the Canadian National Laboratory in Winnipeg, whose scientists found a new version of the H1N1 influenza virus, named for the type of hemagglutinin and neuraminidase molecules on its surface that enable it to spread within the body.”
The possibility of another flu pandemic such as the deadly on 1918 was suggested in news sources and the flu strain was labeled “swine flu.”
“Panic spread throughout the world. In Mexico schools and offices were closed, flights were canceled, and the country lost $2.2 billion within a few weeks. In the UK, the government’s swine flu website received 2,600 hits per second and crashed soon after it opened; in New York so many people panicked over any flu-like symptom that hospital emergency rooms were swamped with ten times more patients than normal, worsening care for those who really needed it.”

“In China and other countries, border nurses quarantined anyone with a fever seeking to enter the country. Even though direct pig-to-human influenza transmission is exceedingly rare, Egypt ordered the slaughter of all the pigs in Cairo, impoverishing thousands of Christian small-scale farmers. And in Afghanistan, the nation’s only pig was quarantined.”
In June of 2009 the World Health Organization (WHO) issued a statement claiming that “pandemic emergency”—a worldwide epidemic—was underway. This caused governments across the globe to scramble to obtain anti-flu drugs and vaccines—at great price.
“According to J.P. Morgan, up to $10 billion was spent globally on “influenza preparedness” in 2009, including over $4 billion by the US alone.”
And to what effect were this declaration of an emergency and the flood of money bestowed on the drug companies?
“The predicted dire emergency did not occur. In the 2009–2010 “influenza season” about 18,000 people died from the disease worldwide, fewer than in previous years, and the vast majority of victims had serious underlying conditions such as cancer, lung disease, AIDS, or severe obesity, which can impair breathing. Since one influenza strain usually dominates all others during a typical flu season, H1N1 may actually have saved lives by displacing more aggressive viruses.”
Fortunately, some people became suspicious of this whole process.
“In March 2010, a Council of Europe report concluded that the H1N1 virus was known to be mild well before the WHO issued the pandemic “declaration” and expressed concern about the influence of powerful pharmaceutical companies over decision-making at the agency. A draft of the WHO’s response was released in March 2011. It calls for more “transparency” but concludes that “no critic of WHO has produced any direct evidence of commercial influence on decision-making.” Unfortunately, the response does not account for the billions of dollars lost in the panic or for the lives that may have been put at risk by the agency’s hasty medical recommendations.”
When accused of being swayed by drug companies, WHO responds by saying: “You can’t prove it.” That is not exactly a declaration of innocence.

Are there reasons for being concerned about drug company influence? You bet!

In 1999 WHO began encouraging countries to prepare for the possibility of another pandemic by setting up emergency notification and mass vaccination procedures. This is not an unreasonable initiative for WHO, but in their documentation they included an annex.
“However, the document also contained an annex describing a new class of anti-influenza drugs known as “neuraminidase inhibitors” that might help control the pandemic.”

“According to the annex, these drugs, by blocking the action of the neuraminidase protein, prevent the influenza viruses from spreading through the body, reducing the severity of symptoms. The drugs would also protect people who had been exposed to the disease, such as health care workers and relatives of patients, from becoming sick, or so the document suggested. In 1999, the manufacturers of these new drugs were still seeking approval from government regulators including the US Food and Drug Administration, but later editions of the WHO’s influenza pandemic guidance documents urged governments to “stockpile” them, because in an emergency their manufacturers might not have time to produce enough to meet demand.”
Here we have WHO recommending that governments invest large amounts of money in drugs whose utility had yet to be determined.
“When H5N1 “avian flu” broke out again in Asia in 2003, this ‘stockpiling’ recommendation led to a surge in influenza ‘pandemic preparedness’ spending. In 2005–2006, the US and European governments stockpiled nearly $3 billion worth of the most popular neuraminidase inhibitor, known as Tamiflu. At $10–$15 a dose, few developing countries in Africa, Asia, and Latin America would be able to afford Tamiflu, but Margaret Chan, then assistant director-general of the WHO in charge of influenza pandemic coordination, joined by representatives from Hoffman–La Roche, Tamiflu’s Swiss manufacturer, urged Western governments to contribute to a Tamiflu stockpile fund for the developing world.”
It is comforting to know that the drug companies are so concerned with our well being that they are willing to travel the world selling their product.

This drug, Tamiflu, that is being pushed must really be good stuff! Right?
“The active ingredient in Tamiflu was discovered in 1989 by an Australian biotechnology company that licensed it to the British firm GlaxoSmithKline (GSK). The company gave it the trade name Relenza, carried out clinical trials, and submitted the results to the FDA in 1999. The FDA scientific panel that reviewed this evidence was unimpressed; it noted that the drug—a powder for oral inhalation—had little effect on influenza symptoms and seemed to worsen breathing problems in people with asthma. The panel members voted 13–4 against approval, but the agency overruled them and approved the drug anyway. The head of the FDA’s antiviral drug program, Heidi Jolson, justified this decision on the grounds that Relenza might be useful for some patients, and even a weakly effective drug was better than nothing, given the fears then circulating about “avian flu.” Relenza was approved the same year. By the end of 2000, a preliminary investigation suggested that Relenza might have been a factor in twenty-two deaths of influenza patients with asthma or other preexisting lung conditions. Yet the drug remains on the market.”

“Shortly after Relenza’s discovery, the hunt was on for a pill version of the drug that would not carry these respiratory risks. In the early 1990s, researchers at Gilead, a US biotech company, developed one and licensed it to Hoffman–La Roche, which gave it the trade name Tamiflu. Because Relenza had already been approved, the FDA gave Tamiflu “fast-track” status, meaning that the clinical evidence was even less stringently reviewed than Relenza’s was. According to the FDA’s own review documents, the results of the largest Tamiflu trial, involving some 1,500 patients, were never carefully analyzed by the agency, even though its officials knew of the study’s existence.”
The world community is being encouraged to purchase billions of dollars worth of a drug whose active ingredient was deemed by scientists to be not worth allowing in the market place. FDA administrators were “convinced” that this was not the appropriate decision and unleashed it on the populace.

But this new version, Tamiflu, must be better. Right? Studies must have been done to prove its value—right?

Tamiflu has been widely used in Japan since around 2000. Doctors there began to notice adverse reactions in some cases when the drug was used.
“Dr. Rokuro Hama runs the Japan Institute of Pharmacovigilance, an Osaka-based nonprofit group that monitors pharmaceutical product safety. In 2002, shortly after Tamiflu was introduced in Japan, he received a number of case reports of children who had begun behaving strangely within hours of taking it. A fourteen-year-old boy wandered out of his family’s ninth-floor apartment and jumped over an exterior railing to his death; a seventeen-year-old boy ran out of his house onto a nearby freeway, where he was killed by a speeding truck; a thirty-nine-year-old man and two three-year-old boys died suddenly in their sleep.”

“....when Hama studied the cases carefully, he realized that the neurological symptoms differed from those sometimes seen in severe influenza cases; rather, they more closely resembled symptoms associated with overdoses of drugs that suppress the central nervous system, such as Valium.... Hama....estimated that Tamiflu resulted in a fourfold increase in the frequency of hallucinations and other neuropsychiatric side effects in children with influenza.”
The Japanese findings resulted in a desire to relook at the scientific data on Tamiflu by researchers in several countries. What they discovered was that the only research available had been funded by Roche, the manufacturer. After obtaining internal documents from Roche they discovered discrepancies between data presented there and what was published in the open scientific literature.
“In 2008, an article in the journal Drug Safety, signed by a group of Roche authors, claimed that rats and mice, both given a very high dose of Tamiflu, showed no ill effect. But according to documents submitted to the Japanese Ministry of Health, Labor, and Welfare by Chugai, the Japanese Roche subsidiary, the exact same dose of Tamiflu killed more than half of the animals. As they died, the rats exhibited many of the same central nervous system symptoms that Hama had described in his case series on the Japanese children.”
Surely we can rest easy because outright fraud could never make its way into the scientific literature?
“Most medical journals receive half or more of their income from pharmaceutical company advertising and reprint orders, and dozens of others are owned by companies like Wolters Kluwer, a medical publisher that also provides marketing services to the pharmaceutical industry.”

“Some of the Tamiflu articles were composed by “ghostwriters” associated with Adis, a Wolters Kluwer subsidiary that specializes in producing brochures and professional-looking articles for pharmaceutical company clients. This may help explain why some of the authors of the Tamiflu articles....didn’t have the original clinical trial data upon which those articles were based: some of them may never have seen it. The Tamiflu ghostwriters told Deborah Cohen, a BMJ reporter, that neither they nor the named authors on the articles had handled the Tamiflu data themselves—they had just been given the tables and figures by Roche officials and instructed to emphasize both the dangers of influenza and the benefits of Tamiflu in the articles.”
Roche has thus far refused to make enough data available to researchers so that an independent evaluation of its performance could be made. Based on what is currently available
“ December 2009 the researchers published an article in the British Medical Journal (BMJ) indicating that it was impossible to say whether Tamiflu reduced severe complications from influenza or not.”
At question is the integrity of the process by which government agencies make decisions in this arena.
“The many contradictions in the evidence concerning Tamiflu and Relenza raise questions about the WHO’s decision to declare an influenza “pandemic emergency” in 2009 and promote these drugs to fight it. In May 2009, a month before the pandemic declaration was issued, Roy Anderson, a prominent British epidemiologist and adviser to both the WHO and the UK government, gravely warned a BBC radio audience that only Relenza and Tamiflu would prevent a catastrophe on the scale of the 1918 influenza pandemic. At the time, Anderson was receiving £116,000 per year from GlaxoSmithKline, manufacturer of Relenza. Calls for Anderson to resign from the UK government’s Scientific Advisory Group for Emergencies soon followed. A few months later, Anderson, citing a desire to concentrate on research, stepped down from his post as rector of Imperial College London, but he remains an adviser to both the UK government and the WHO.”

“During the ten years leading up to the pandemic declaration of 2009, scientists associated with the companies that were to profit from the WHO’s ‘pandemic preparedness’ programs, including Roche and GlaxoSmithKline, were involved at virtually every stage of the development of those programs. The companies funded the documents giving guidance on preparing for the influenza pandemic, in which the WHO recommended the stockpiling of Tamiflu and Relenza. Consultants drafted parts of these documents and joined WHO officials in fund-raising for the Tamiflu stockpile. Industry-supported scientists were also on the committee that issued the “pandemic emergency declaration.” That announcement caused developing countries to request assistance from the WHO’s Tamiflu stockpile fund, and these requests contributed to a tripling of the drug’s sales in 2009. By declaring a pandemic and linking the response to Tamiflu stockpiling, the WHO could not have done a better job of promoting Roche’s interests. Until Roche shares more information on Tamiflu with independent researchers, we won’t know whether the agency did so at the expense of the rest of us.”
Money from the drug companies goes to support every area of the medical community—even the government agencies intended to regulate the industry. It is not clear that there is an honest broker left out there. Epstein makes clear the folly of allowing the current system to continue on.

“The FDA also relies increasingly upon fees and other payments from the pharmaceutical companies whose products the agency is supposed to regulate. This could contribute to the growing number of scandals in which the dangers of widely prescribed drugs have been discovered too late. Last year, GlaxoSmithKline’s diabetes drug Avandia was linked to thousands of heart attacks, and earlier in the decade, the company’s antidepressant Paxil was discovered to exacerbate the risk of suicide in young people. Merck’s painkiller Vioxx was also linked to thousands of heart disease deaths. In each case, the scientific literature gave little hint of these dangers. The companies have agreed to pay settlements in class action lawsuits amounting to far less than the profits the drugs earned on the market. These precedents could be creating incentives for reduced vigilance concerning the side effects of prescription drugs in general.”

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