pharmaceuticals

According to internal documents, the pharmaceutical company Wyeth "paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro." As early as 1997, Wyeth paid the "medical writing firm" DesignWrite to publish favorable journal articles about Prempro under academics' names. "Company executives came up with ideas" for the articles, "titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles -- all without disclosing the companies' roles to journal editors or readers." Wyeth previously claimed that authors had "played significant roles" in journal articles. The American Journal of Obstetrics and Gynecology published one ghostwritten article in May 2003, a year after Wyeth's Prempro was linked to breast cancer (which recent findings confirmed). The ghostwritten article, published under the name of Australian professor John Eden, claimed there was "no definitive evidence" linking hormone therapy to cancer. Just before the federal study linking Prempro to cancer was published, a Wyeth executive asked DesignWrite "to increase the number of positive journal articles" on Premarin, another Wyeth hormone replacement drug.

The Canadian Association of University Teachers has strongly condemned a new lawsuit by the Apotex pharmaceutical company against Dr. Nancy Olivieri. As a liver specialist at the University of Toronto, Olivieri first came under attack from Apotex in 1996 when she notified her patients that she had detected toxic side effects while conducting an Apotex-sponsored study of the company's drug, deferiphone. Claiming that Olivieri's actions violated their nondisclosure agreement, the company threatened her with legal action, and she was fired from her hospital (a recipient of hundreds of thousands of dollars each year in research funding from Apotex). After years of lawsuits, Apotex and Olivieri reached a legal settlement in 2004 in which the company agreed to pay $800,000 to Olivieri, while both sides were to refrain from further public "disparagement" of each other. Now Apotex is suing again, claiming that Olivieri has disparaged the company simply by participating at conferences on the relationship between universities and the pharmaceutical industry (even if she doesn't mention Apotex by name). Its legal filing also claims that she has engaged in disparagement when other people have written about her in newspaper stories and on Wikipedia. "This would appear to be a baldfaced attempt to muzzle a critic of the pharmaceutical industry," comments medical ethicist Howard Brody, author of the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry.

Doctors Frederick Goodwin and Joseph Biederman are counterattacking in an effort to defend their reputations following disclosures that they took millions of dollars from pharmaceutical companies while promoting the drug companies' products. Biederman, whose industry-funded research contributed to a 40-fold increase in the use of antipsychotic medicines in children, has written a letter to the Boston Globe insisting that he was "transparent" about his funding and that his sole concern has been "the treatment of children and families experiencing great suffering." Goodwin, who talked up psychiatric drugs on his PBS program, has blasted the New York Times and psychiatrist Daniel Carlat for their reports on his failure to disclose $1.3 million in pharma payments. Carlat in turn has replied that Goodwin should "stop blaming everybody else for this mess. ... This entire fiasco could have been averted if you had chosen to inform NPR listeners of your financial conflicts of interests at the beginning of shows focusing on pharmaceuticals."

Psychiatrist Frederick K. Goodwin, who hosts a popular show on National Public Radio called "The Infinite Mind," earned "at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program," reports Gardiner Harris. This revelation and other news about Goodwin's consulting work makes him "the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. ... Mr. Grassley is systematically asking some of the nation’s leading researchers and doctors to provide their conflict-of-interest disclosures, and he is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly." Goodwin claims he informed his program's producer, Bill Lichtenstein, of his consulting work for drug companies, a claim that Lichtenstein strongly denies.

Statins Cholesterol-reducing drugs called statins have been in the news lately following the release of a major medical study that found that statins can prevent heart disease and stroke in people with no previous history of heart disease.

Statins are among the biggest-selling family of drugs of all time. Many articles about the study mentioned above, including one on the credible web site WebMD, also mention the specific drug used in the study: Crestor.

The study has generated hundreds of articles, most of which repeat the same basic framing of the issue: if heart disease is the problem, a drug is the answer.

A $13.2 million ad campaign thanks 28 members of Congress, 25 of whom are Democrats, "for supporting a children's health-care bill vetoed twice by President George W. Bush in 2007." The ads are by America's Agenda: Health Care for Kids, a new non-profit group whose sole funder is the Pharmaceutical Research and Manufacturers of America (PhRMA). The ads are one example of the drug industry group's attempts to adjust to a Democratic-controlled Congress. PhRMA's also "working with unions through another America's Agenda group to push universal-health-care bills in states and cities across the country," and "is now splitting campaign contributions between the political parties." In addition, PhRMA's trying "to restore the drug industry's tattered image," through its own ads "touting programs to help needy patients pay for their medicines; hurricane hotlines for drug supplies; and the syndicated TV show 'Sharing Miracles,'" which features PhRMA president Billy Tauzin.

"Documents and emails released this week ... suggest Pfizer's marketers influenced" research on the drug Neurontin "by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions," reports Keith Winstein. The Food and Drug Administration approved Neurontin for epilepsy and shingles. In 2004, Pfizer's Warner-Lambert unit admitted to promoting "off-label" uses. Companies can't promote drugs for unapproved uses, though doctors can prescribe off-label. Pfizer paid $430 million for the offense and claimed it ensured "there was no improper marketing after it purchased Warner-Lambert in 2000." But the new documents, which were submitted in a lawsuit against Pfizer, detail more recent attempts to boost off-label sales. After one study showed Neurontin didn't lessen diabetic nerve pain, a marketer suggested "delaying the publication for as long as possible." One researcher emailed that she was told "not to publish anything that damages Neurontin's marketing success." Pfizer also failed to publish results that Neurontin didn't ease post-operative nerve pain. Lastly, after the drug was shown to have no effect on bipolar disorder, a Pfizer consultant writing up the study excluded 16 patients and changed how other patients were characterized, thus "turning a failure into a success."

Medical research conflicts of interest are in the news lately, thanks to recent congressional hearings by Senator Charles Grassley. But are journalists part of the problem? A new study in the Journal of the American Medical Association (JAMA) found that reporters for print and online media outlets failed 42 percent of the time to mention drug company funding of research cited in their stories. When asked, however, 88 percent of newspaper editors insisted that their publications "always or often" included funding information in their stories -- even though only 3 percent actually had a policy requiring such disclosure. "If you're wondering about professional standards," comments Merrill Goozner, "the Association of Health Care Journalists lists reporting the financing of research and conflicts of interest of researchers as its number one guideline for health care reporters. This latest survey shows that the word has yet to filter down to the majority of reporters out there." The JAMA study also found that 67 percent of news stories mentioned the brand names of drugs rather than their generic names, further reinforcing pharmaceutical industry marketing campaigns. Once again, editors of the offending publications claimed that their reporting practices were better than they actually were, with 77 percent of editors insisting that they always or often reported only the generic names of medications.

The National Institute for Clinical Excellence (NICE), a UK government agency charged with deciding whether drugs should be subsidized by the British government, has been criticized by some patient groups for refusing to approve new and expensive drugs. Groups including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society have all objected against NICE decisions. "All of these charities received sums of up to six figures from drug companies in 2007," reports Jeremy Laurance, the health editor with The Independent. "A positive decision by NICE on a drug not only guarantees sales to the NHS but can influence global markets worth billions of pounds. Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns," he wrote.

The pharmaceutical company Eli Lilly has announced that it will begin reporting its payments to doctors in late 2009, using an online database. But the disclosure is limited to payments of more than $500 made for giving talks or advice to the company; payments for other services or gifts will not be included. Payments made before 2009 will also not be disclosed. Eli Lilly president and CEO John Lechleiter explained the move by stating, "We've learned that letting people see for themselves what we're doing is the best way to build trust." In mid-2007, as the U.S. Senate Finance Committee was investigating drug company grants to patient groups, Eli Lilly began disclosing its grants to U.S. nonprofit groups and educational institutions. Its new registry of payments to doctors comes as Congress considers the Physician Payments Sunshine Act. The bill would require disclosure of any drug company payment to doctors of more than $25, whether the payment was for food, travel, entertainment, gifts, consulting fees or any other purpose.