Troubling Ghostwriting Survey Prompts New Medical Journal Policies

Don Greiwe — Tue, 06 Oct 2009 08:48:02 GMT

A survey released by The Journal of the American Medical Association (JAMA) concludes that six of the top medical journals in the U.S. published a “significant number” of ghostwritten articles in recent years, reports the NY Times. Ghostwriting in the medical profession generally means that the research or conclusions were not written by the credited author. A dangerously common practice in the medical industry is for a pharmaceutical company to pay a group of professional writers to produce papers, and then pay scientists or physicians to attach their names to these articles. Ghostwriting has been common for years, but has received harsh media attention, especially recently. In late July, a federal judge ordered the unsealing of confidential court documents revealing that the pharmaceutical giant Wyeth orchestrated dozens of ghostwritten articles to promote their line of hormone replacement drugs.

According to the anonymous survey of 630 published medical papers, 11% of the articles in the New England Journal of Medicine were ghostwritten. Likewise, 7.9% of the articles in JAMA, 5% of the articles in The Annals of Internal Medicine, and 2% of the articles in Nature Medicine were ghostwritten. In reality, these statistics may actually be much higher, because ghostwriting is difficult to track due to its covert nature.

Many are calling for medical journals to step up enforcement of anti-ghostwriting policies. In an article written in response to the survey, PLoS Medicine editors have made a call to the industry to institute a zero tolerance policy – identifying and retracting any ghostwritten articles and banning those authors from future publications. There’s been swift congressional support too, with Senator Chuck Grassley (R – IA) telling reporters “objective research is really at the heart of public trust in medicine.” Senator Grassley has led the Congressional charge against ghostwriting in Congress, and strongly encourages medical journals to adopt strong anti-ghostwriting policies.

Supporters of ghostwriting say that it allows articles to be released much sooner than otherwise, thus potentially getting medically sound data to the public as soon as possible. However, this data cannot, and should not, be relied upon to make medical decisions if there is a fundamental conflict of interest. The only way medical journals can protect their integrity is to take a very firm stance against ghostwriting, and institute strict policies to identify and combat it.

Originally posted at InjuryBoard by Don Greiwe

Medtronic Class I Recall of Kappa and Sigma Series Devices

C. Todd Alley — Mon, 22 Jun 2009 12:51:35 GMT

Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death - of the following lines of pacemakers:

· Medtronic Kappa Series 600/700/900

· Medtronic Sigma Series 100/200/300

The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.

Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.

Originally posted at InjuryBoard by C. Todd Alley

Tampa Bay Personal Injury Lawyer - Medical Devices & Implants

Troubling Ghostwriting Survey Prompts New Medical Journal Policies

Medtronic Class I Recall of Kappa and Sigma Series Devices