This morning I started working on a new feature for my website. I started composing my article with this: “I have a confession to make. I have a mission on this website. Two missions really, to help you find happiness and a fulfilling life and to convince you to value your time more than money so that you work less. It’s a mission you’ll hear me repeat over and over.

Why? Why is this so important to me? It is my firm belief that all the ills of society can be eliminated if only we had more time. It is my belief that happiness comes not from having an oversized house and overpriced car to impress strangers, but from our personal accomplishments in making the world better, from fulfilling and meaningful relationships, and from the rewarding experience of creating strong communities.”

I made a list of all the things that I need to research and listed one of the ills that I hope we can eradicate, if only we had more time, is the widespread corruption in our government. With the most corrupt government in history since man evolved from the apes, we should be outraged. We should have twenty-four hour picket lines in front of the White House until someone is locked behind bars. But I digress…

After spending an hour documenting the page layouts and agenda, I decided to take a break and try to finish at least one of the magazines from my growing stack. To my utter dismay and disgust, I found even more evidence of how our government is failing to serve us in an October issue of Discover. The article discusses how funding for scientific research is increasingly from the private sector, that is, those who have an interest in suggesting a certain outcome from a study, an outcome that happens to maximize their profits.

It’s important for you to know, so I’ve included quotes from the article, as well as the link to it. I’ve also provided a link to help you find your own corrupt representative, to whom I hope you will write a letter expressing your distaste for his/her complete and utter lack of efficacy in instituting policies to protect our citizens. (Will November never get here??)

In the interest of space, I’m not indenting the quotes. I’m starting with two paragraphs that appear toward the end of the article because they elucidate just how disgusting and manipulative the corporate machine and politicians are. Please research and be skeptical about every pharmaceutical you are prescribed and please read the entire article.

Obama has his work cut out for him. Also, I’m sorry for such a depressing post.

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Discover Magazine, October 2007, Science Under Seige/Science’s Worst Enemy: Corporate Funding

…As a result of these trends, Lisa Bero says, science has become one of the most powerful tools that private companies can use to fight regulation. The strategy they most often deploy was pioneered by the tobacco industry, which learned to foment scientific uncertainty as a means of staving off regulation. A famous tobacco industry document from 1969 spells out the strategy succinctly: “Doubt is our product, since it is the best means of competing with the ‘body of fact’ that exists in the mind of the general public. It is also the means of establishing controversy.”

In 2003, Frank Luntz, a political consultant to the Republican Party, recommended using the same strategy to combat public environmental concerns. “Voters believe that there is no consensus about global warming within the scientific community,” he wrote. “Should the public come to believe the scientific issues are settled, their views about global warming will change accordingly. Therefore, you need to make the lack of scientific certainty a primary issue in the debate.”

Merrill Goozner argues…“In many precincts of the scientific enterprise, the needs of industry have become paramount,” he says, turning science into “a contested terrain” where facts are increasingly contingent on who is funding the research. “The whole scientific revolution, which was a product of the Enlightenment, is threatened when you commercialize science,” he warns.

“We can only make good decisions in science when all of the information is available for physicians, scientists, and patients to review,” he says. But drug companies are increasingly keeping physicians and their patients in the dark. Last year, Nissen grew suspicious about possible health risks associated with GlaxoSmithKline’s top-selling diabetes drug, Avandia. “We requested access to the original patient-level data,” he says, but “we were not afforded access.” Nissen wasn’t surprised; for years he has perceived a growing tendency by the drug industry to suppress negative research data.

Searching the Internet, Nissen stumbled upon a remarkable cache of data belonging to Glaxo. His search unearthed 42 Avandia clinical trials—only 15 of which had ever been published. Nissen didn’t know it at the time, but the reason Glaxo’s data were just sitting there on the Web was the outcome of a lawsuit filed by former New York attorney general (and current governor) Eliot Spitzer in 2004. The lawsuit alleged that Glaxo had concealed negative trial data associated with its popular antidepressant drug, Paxil. When the data were properly analyzed, they showed that children given Paxil were actually two times more likely to experience suicidal thinking and behavior than children given a placebo, or sugar pill. When Glaxo settled the suit, it denied having suppressed data and consented to posting results of all its clinical trials online—including its data on Avandia.

Nissen knew there were limitations to the public information he had. He lacked any original patient-level information, and a meta-analysis of prior drug studies is always less powerful than a large prospective, randomized clinical trial. This May, however, Nissen felt compelled to alert doctors and patients to what he had found.

Publishing in The New England Journal of Medicine, Nissen reported that Avandia raised the risk of heart attacks in patients by 43 percent. The news made front-page headlines. Two days later, the FDA, which had already been assessing the health risks of Avandia, imposed its toughest warning label, the “black box,” on the drug, as well as on Actos, another drug used to treat diabetes.

At a subsequent congressional hearing chaired by Representative Henry Waxman, it came to light that the FDA had known about Avandia’s risks for some time. Rosemary Johann-Liang, a former FDA drug safety supervisor, had recommended a black box warning label for Avandia due to its harmful effects on the heart one year prior to Nissen’s publication. Glaxo’s own meta-analysis, presented to the FDA in 2006, showed a 31 percent increased risk of heart attacks. Yet according to Johann-Liang, “my recommending a heart failure box warning was not well received by my superiors, and I was told that I would not be overseeing that project.” She was also told to obtain her supervisors’ approval before making any future black box recommendations. After the hearing, the FDA completed its own meta-analysis of the original patient data and found virtually the same heart risks Nissen had reported.

Nevertheless, Nissen found himself under attack, often by people with explicit financial ties to the drug industry. His challengers have included Valentin Fuster, who wrote a critique of Nissen’s work in Nature Clinical Practice Cardiovascular Medicine. Fuster receives Glaxo funding and serves as the chairman of Glaxo’s Research and Education Foundation. Peter Pitts wrote a stinging attack on Nissen in The Washington Times; he is a senior vice president at the PR firm Manning Selvage & Lee, which represents Big Pharma, including Glaxo. Douglas Arbesfeld, a senior communications consultant at the FDA, disparaged Nissen in a biting e-mail to the media. He formerly worked as a spokesman for Johnson & Johnson.

Press reports over the last 15 years detail how whistle-blowers inside academia and within the FDA who have attempted to expose drug-research and safety issues have been pressured. Some were threatened with legal action, others punished by their superiors and discredited. “Whenever we’ve raised safety questions about drugs,” Nissen says, “there’s always been a reaction like this. Exactly the same thing happened in 2001 when we published a manuscript that suggested that Vioxx might be causing excess heart attacks.” Nissen was coauthor of one of the first studies on the dangers of Vioxx. Three years later, Merck pulled the drug from the market. By that time, one FDA analyst estimates, the drug had contributed to up to 139,000 heart attacks. (A Merck representative states that the paper from which the estimate of 139,000 was derived had “serious limitations” and did not necessarily reflect the views of the FDA.)

“What academic institutions always argue is that they have sufficient safeguards in place to protect against any influences on the academic research,” Bero says. “Here at UCSF I sit on what’s called a conflict of interest advisory committee, and believe me, I’m familiar with our gazillion policies. Universities do have a lot of policies, but I would argue that they’re not sufficient.”

One meta-analysis published in BMJ (British Medical Journal) found that pharmaceutical-industry-funded research was four times more likely to reflect favorably on a drug than research not financed by industry. Even when Bero controls for a variety of other factors, she finds that the effect of industry funding on the research outcome is huge. Research on secondhand smoke conducted by researchers with industry ties is 88 times more likely to find no harm; industry-funded studies comparing cholesterol drugs are 20 times more likely to favor the sponsor’s drug.

This happens, Bero contends, because private industry has become increasingly sophisticated about how it uses “science” to achieve its commercial objectives. “We’ve looked at the tobacco and pharmaceutical industries, and now we’re looking at legal documents pertaining to the asbestos, vinyl chloride, and lead industries,” she reports. The techniques they use are remarkably similar: Positive research gets published; negative research doesn’t. The sponsor’s drug is given at a higher dosage than the competitor’s drug. The sponsors control study design, access to data, and statistical analysis. They ghostwrite articles and pay prominent academics to sign on as “authors.”

University policies governing conflicts of interest and research integrity vary widely from campus to campus—and most still have a lot of holes, Bero contends. One 2005 study examining more than 100 academic medical centers found that half would allow the corporate sponsor to write manuscripts reporting on study results and only allow faculty to “suggest revisions”—a policy basically authorizing commercial ghostwriting of academic research. Thirty-five percent allowed the sponsor to store clinical trial data and release only portions to the investigator; 62 percent allowed the sponsor to alter the study design after the researchers and the sponsor had signed an agreement.

Consider the Center for the Evaluation of Risks to Human Reproduction, part of the National Institutes of Health (NIH). The center has only two full-time employees and one part-time; until recently the rest of the center’s workforce was supplied by Sciences International (SI), a private consulting firm that has been funded by more than 40 chemical industry clients. For nearly a decade, the center had been outsourcing much of its work to SI, which assessed health risks and drafted reviews for 21 chemicals that the center was reviewing for their possible impact on human reproductive health. This April, NIH terminated its contract with SI after learning that the company or its employees had business ties to the chemical industry.

Another variant of privatization can be seen at the FDA, which currently draws more than 50 percent of its total drug review budget from user fees paid by the pharmaceutical industry. David Kessler, a former head of the FDA, recently told The Wall Street Journal, “There is no doubt that user fees give the industry leverage on setting the agency’s priorities. There are significant risks.” Marcia Angell, the former editor of The New England Journal of Medicine, puts it more bluntly: “The FDA has been captured by the industry it is supposed to regulate.”

At the EPA and the Occupational Safety and Health Administration, regulators do not have the authority to inquire as to who paid for the studies they receive. The Mine Safety and Health Administration, the Consumer Product Safety Commission, and the National Highway Traffic Safety Administration also lack any formal mechanisms for identifying potential conflicts of interest or for assessing the level of industry influence over the research.

In general, industry-funded studies are also subject to far less oversight than comparable federally funded studies. The data underlying private research do not have to be made public, unlike the data from federally sponsored research. A privately funded study can also avoid external scrutiny simply by being labeled “confidential business information.” One study by the Government Accountability Office found that a majority of the applications submitted to the EPA to market new chemicals contained science-based information that industry had labeled confidential.

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We need this to change. Link to the full article here.

Find Your Own Corrupt Member of Congress:
US Senate Shepherds of the Devil
US House Shepherds of the Devil

Related Books
Undermining Science
Doubt is Their Product

I haven’t read either one so I can’t attest to their quality.

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