Six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association.
Among authors of 630 articles who responded anonymously to an online questionnaire created for the study, 7.8 percent acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed.
Read the full article at http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=2&ref=health
10/9/9, New York Times
Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from “developing a topic,” to “submitting the manuscript for publication.”
http://www.latimes.com/business/nationworld/wire/sns-ap-us-glaxosmithkline-ghostwriting,0,7584289.story
In July 2009, a US federal court decision resulted in the release of approximately 1500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but “authored” by academics, are strategically placed in the medical literature - a practice known as ghostwriting. To release these documents, PLoS Medicine, represented by the public interest law firm Public Justice, and the New York Times, acted as “intervenors” in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones. PLoS Medicine argued that sealed documents identified during the discovery process for the court case, demonstrating the practice of ghostwriting, should be made available to the public. As PLoS Medicine Chief Editor Ginny Barbour stated in the motion to intervene, ghostwriting “gives corporate research a veneer of independence and credibility” and may “substantially distort the scientific record”; “threaten[ing] the validity and credibility of medical knowledge.” On July 24, 2009, U.S. District Judge William Wilson, Jr., in Little Rock, Arkansas, granted the motion to make discovery materials public as of July 31, 2009.
PLoS has created this web page to make the released documents publicly available without delay.
http://www.plosmedicine.org/static/ghostwriting.action
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.
The articles did not disclose Wyeth’s role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.
4/8/9 http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1
Paying doctors for their expertise is perfectly legal and gets results: For every $1 paid to physicians, drugmakers see a return of $12 in prescription sales, according to industry analysts. But critics, including some leading members of Congress, say the relationships create an unnecessary conflict of interest and ultimately drive up health costs for patients.
6/9/9
One of the key health care overhaul bills being considered in Congress requires drug companies to begin reporting on their doctor compensation - with details as small as whom the firms give drug samples to - by March 2011. Facing increasing pressure, several drugmakers voluntarily have pledged to start reporting their financial relationships soon.
Eli Lilly and Co. didn’t have a choice. The maker of Prozac, Cymbalta and Cialis, the Indianapolis-based firm was forced to begin publishing the names and compensation of its paid consultants as part of a $1.4 billion settlement with the federal government in January.
The company published the information on its Web site in July and plans to continue doing so each quarter; the next update is expected in October. If the first quarter is any indication, the numbers will be staggering: Nationwide, Lilly spent about $22 million on nearly 3,400 providers.
US drugmaker Pfizer has agreed to pay $2.3bn (£1.4bn) in the largest healthcare fraud settlement in the history of the Department of Justice.
It comes after the firm was found to have illegally promoted four drugs for uses which had not been approved by medical regulators.
A subsidiary of the firm pleaded guilty to misbranding drugs “with the intent to defraud or mislead”.
US officials said Pfizer would have to enter a corporate integrity agreement.
It will be subject to additional public scrutiny by requiring it to make “detailed disclosures” on its website.
Pfizer’s general counsel said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls.”
BBC 2/9/9
http://news.bbc.co.uk/1/hi/business/8234533.stm
This interesting review looks at the ethics of th SCOT trial (Standard Care versus Celecoxib Outcome trial), both through sign up of GP practices and research design.
BMJ 2009;339:b3443
http://www.bmj.com/cgi/content/full/339/sep02_1/b3443
Europe’s member states are at loggerheads over plans to relax current restrictions on pharma communicating with patients.
The plans tabled by Commissioner Verheugen would allow pharma to communicate directly with patients via mediums like the internet, though through a strict vetting system. This would end current rules which outlaw any communication with patients, but Europe is deeply divided on the issue.
The various governments divide into two broad camps those who favour a more liberal approach to regulating pharmas communications, and those who demand more restrictions.
The UK, Sweden, and Denmark are among the most prominent countries who want a more liberal approach, while Germany, France and Spain take a more conservative approach.
The pharma industry’s European body EFPIA is keen to see a change to the status quo, but spokesman Colin Mackay is not optimistic of a breakthrough any time soon: “We probably wont see much happening this or next year,” he said.
Tuesday , September 01, 2009
http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0-SEP_2009-focus_news_detail-0-493131,00.html
The September 2009 issue of Drug and Therapeutics Bulletin (DTB) contains an editorial and two articles. The editorial discusses the recent policy and possible consequences of widespread access to Tamiflu in the current flu pandemic. An associated podcast discussing the wider issues associated with this topic is available via our website www.dtb.bmj.com. The issue also includes a review of the management of self-monitoring INR in patients on warfarin, and an article on the non-drug management of chronic low back pain. A podcast outlining what is in the September issue is also available via our website.