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Posts Tagged ‘lawsuit’

How to Manufacture a Disease

Posted by Admin on December 27, 2010

http://inthesetimes.com/article/6740/

By TERRY J. ALLEN

Disasters can spark lawsuits. Faced with litigation, pharmaceutical corporations must cough up data—and sometimes choke on it.

After the FDA approves a new drug, it rarely faces follow-up studies that might reveal serious and possibly fatal side effects. Some dangers remain hidden for years until an accumulation of disasters sparks lawsuits. Faced with litigation, corporations must cough up data—and sometimes choke on it.

A suit against drug maker Wyeth freed 1,500 documents that yielded “unprecedented insights into how pharmaceutical companies promote drugs,” wrote Adrianne Fugh-Berman in a September study in PLoS Medicine. The 14,000 plaintiffs who took the menopausal hormone therapy (HT) Prempro claim that Wyeth distorted study results and hid evidence of harm. Some patients traded the temporary inconvenience of hot flashes for the permanent inconvenience of death.

It was not as if Wyeth didn’t have reason to suspect serious risk. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use. To counter this side effect, Wyeth added progesterone and created Prempro. But the new combo not only failed to prevent cardiovascular disease, it increased the risk of breast cancer, stroke, dementia and incontinence, according to the 2002 Women’s Health Initiative study.

For decades Wyeth had promoted HT and the diseasification of menopause through tried and true schemes: First, it redefined a normal process—in this case aging and menopause—as an illness treatable with drugs. After cherry picking studies, some conducted off-shore, it hired specialized companies to ghostwrite favorable articles for medical journals, and paid doctors to sign their names—thus creating the impression that independent researchers, not hacks-for-hire, had authored the articles.

“Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ‘benefits’ of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles,” Fugh-Berman concluded.

DesignWrite, Wyeth’s hired ghostwriting outfit, boasts “long experience in blending scientific and clinical issues with marketing needs.” It cranked out more than 100 articles and presentations for journals and symposia touting Prempro’s virtues, and then paid prominent doctors and researchers who contributed little more than their names.

A particularly lucrative medical market, with a history of recalls and scandal, is the $200 billion U.S. medical device industry for replacement joints, pacemakers and CT scanners. Fugh-Berman’s study of conflicts of interest, using disclosures forced by government investigations, revealed that in the year ending in January 2009, five medical device companies doled out 1,654 payments to orthopedic surgeons and researchers that totaled more than $248 million. Fewer than half the experts who published articles dealing with the “donor” company’s products disclosed their financial relationship.

Big pharma’s stake in cooking the books is obvious, but why are medical journals complicit? One reason is that unlike most of the web, most medical journal sites protect their material behind a sturdy pay wall, and may charge up to $40 per reprint. Drug companies sometimes buy up thousands of product-favorable reprints to distribute free to doctors, thereby providing a cash incentive to journals that publish articles likely to be reprinted.

If journal articles are insufficiently laudatory as marketing vehicles, drug companies can turn to supplements. Separately bound, these publications bear the journal’s name, but are industry produced and rarely peer-reviewed. Wyeth, for example, mailed its pro-Prempro supplement with the journal Women’s Health in Primary Care to 128,000 physicians.

In 2000, big pharma firms spent more than $15.7 billion promoting prescription drugs in the United States. Like other mega corporations, they have great advantages over citizens: They are rich, powerful, protected by laws and tax rules, and given the rights of people while shielded from many of the responsibilities. On our side, we have timid or weak politicians and bureaucrats, activist organizations and the ability to sue. Unfortunately, lawsuits tend to punish rather than prevent. But the deterrent effect of large settlements, the bad PR and the discovery of data and records are nonetheless components in mitigating the epidemic of corporate greed.

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Terry J. Allen, an In These Times senior editor, has written the magazine’s monthly investigative health and science column since 2005. how_to_manufacture_a_disease/

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World’s biggest coal company brings U.S. government to court in climate fraud

Posted by Admin on February 22, 2010

World’s biggest coal company brings U.S. government to court in climate fraud

John O’Sullivan

Feb. 17, 2010

The world’s largest private sector coal business, the Peabody Energy Company (PEC) has filed a mammoth 240-page “Petition for Reconsideration,” a full-blown legal challenge against the U.S. Environmental Protection Agency.

The petition must be answered and covers the entire body of leaked emails from ‘Climategate’ as well as those other ‘gate’ revelations including the frauds allegedly perpetrated under such sub-headings as ‘Himalayan Glaciers,’ ‘African Agricultural Production,’ ‘Amazon Rain Forests,’ ‘Melting Mountain Ice,’ ‘Netherlands Below Sea Level’ as well as those much-publicized abuses of the peer-review literature and so called ‘gray literature.’ These powerful litigants also draw attention to the proven criminal conduct by climate scientists in refusing to honor Freedom of Information law (FOIA) requests.

Peabody is, in effect, challenging the right of the current U.S. federal government to introduce cap and trade regulations by the ‘back door.’ In this article we summarize Peabody’s legal writ.

PEC has pulled out all the stops to overturn the EPA findings ‘Endangerment and Cause or Contribute Findings for Greenhouse Gases under Section 202(a) of the Clean Air Act’ made on December 7, 2009. Those findings were in turn premised on the Supreme Court decision of April 2, 2007 of Massachusetts v. EPA, 549 U.S. 497 (2007), where the court ruled that greenhouse gases are air pollutants covered by the Clean Air Act.

PEC argues inter alia that the law requires that the federal agency must articulate a “rational connection between the facts found and the choice made” as per the case of Motor Vehicle Mfrs. Ass’n of the United States, Inc. v. State Farm Mutual Auto Ins. Co., 463 U.S. 29, 43 (1983).

The PEC arguments are based primarily on the release of email and other information from the University of East Anglia (“UEA”) Climatic Research Unit (“CRU”) in November of last year. Their civil action lists most of the principle scientists such as Professor Phil Jones, of the UK’s Climatic Research Unit, who recently admitted there has been no ‘statistically significant’ global warming for 15 years and agreed the Medieval Warm Period may have been just as warm, if not warmer than current global temperatures.

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