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Pharmaceutical Chemistry

The menopausal hormone therapy scam

The marketing malpractice of Wyeth has been exposed after the publication of a complete analysis of how this drug maker sold menopausal hormone therapy under false claims. It has been proven that the company commissioned and managed to publish articles in medical journals that promoted the unproven benefits of the drug and concealed or minimized the risks associated with breast cancer.

MALÉN RUIZ DE ELVIRA | SEPTEMBER 21ST, 2010

The first academic analysis of the 1,500 documents released at the hearing on the lawsuit brought by 14,000 women against Wyeth (which has since been bought by Pfizer) in the United States reveals such practices as using bogus authors to write dozens of articles on commission and then later adding the signature of scientists who were willing to participate in the farce. The practice was part of a highly structured strategy of the company, which was approved by management.

The analysis, carried out by Adriane Fugh-Berman of Georgetown University and published by the journal PLoS Medicine along with The New York Times, details the case of the 14,000 women who claim to have developed breast cancer due to the drug Prempro. As a result, the judge decided to release the documents, now available on a special section of PLoS Medicine.

The documents "provide data on unprecedented actions taken by this pharmaceutical company to promote drugs, including the use of specialized companies to produce false articles written by authors and to place them in medical journals," said Fugh-Berman, who testified at the trial.

Specialized company

Between 1996, when Prempro arrived to pharmacies in the United States, and 2004, Wyeth worked with several companies, but especially with DesignWrite, to promote its family of products. DesignWrite is a company that offers complete public relations services to pharmaceutical manufacturers and has carried out publicity campaigns for many other drugs. Its website states that in 12 years it has "... planned, created and/or directed hundreds of consulting jobs, a thousand abstracts and posters, 500 clinical articles, more than 10,000 programs, conferences, symposia at over 200 conferences, 60 international programs and dozens of Web sites,” amongst others.

The articles minimized the known risks of breast cancer associated with estrogen therapy
The articles for Wyeth were mainly reviews and reviews of clinical trials which were published in medical journals or supplements. They were then circulated heavily in the medical and pharmaceutical sectors thanks to the efforts of the company's marketing consultants.

The articles minimized the known risks of breast cancer associated with estrogen therapy, defended the drug's unproven cardiovascular health benefits and promoted the use of this therapy for other purposes such as preventing dementia, Parkinson's, vision problems and wrinkles, said Fugh-Berman. DesignWrite earned $25,000 for its articles on clinical trials and $20,000 per article for review, of which it produced 20.

Some examples of messages in the articles published in medical journals make clear the practice: "Estrogen, in particular, deserves more attention because its properties to improve cognitive abilities, which have been verified in several clinical trials, are complemented by its ability to prevent cardiovascular disease and osteoporosis and to reduce the risk of colorectal cancer and overall mortality in postmenopausal women." The quotation comes from a study published in the Journal of the American Geriatrics Society in the year 2000. And in 2003, a paper published in The American Journal of Obstetrics and Gynecology stated: "... the results of epidemiological studies are inconsistent and mechanistic studies have not provided a physiological basis involving progestina in the pathogenesis of breast cancer."

"Common side effects limit the usefulness of these drugs," said another study, published in 2005 in the Journal of Reproductive Medicine, while minimizing one of its major side effect: an increased risk of breast cancer.

FICTITIOUS AUTHORS

The thorny issue of authors who appear as such but have not written articles (at most they modified them without losing the message of promoting the drug) is quoted in the analysis but not thoroughly studied. In general, available data indicate that the "authors" mostly accepted simply to sign the articles written by ghost writers and only a few tried to get involved in the process and refused to sign articles with errors. It is notable, moreover, that the company DesignWrite considered that the "authors" were interchangeable. "I have transferred Dr. Creasman as author of the article on patients ... and I have left Horwitz and Boiman on the basic scientific article,” read a company document, even though ultimately Horwitz did not appear as an author in the published article. The conclusion of the analysis published in PLoS Medicine is a warning to the medical establishment: "Given the growing evidence that using the technique of articles written by others to promote hormonal therapy and other highly advertised drugs, the medical profession must take steps to ensure that doctors do not participate in these practices and that these unscrupulous relationships between industry and academia are avoided rather than accepted."

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