Cut the ties of off-label use NOW

Sep/04/2008 02:58

When an industries are under scrutiny, such as pharma and medical devices, it's means that all interventions, whether patient or physician, have to go above and beyond guidelines. I was therefore extremely puzzled this morning to read an article on the front page of the Wall Street Journal about the off-label use of Medtronic's Infuse Bone Graft. According to the article "Medtronic says it abides by federal regulations that prohibit it from promoting Infuse for off-label purposes. But doctors paid by Medtronic are under no such restriction. They are free to discuss unapproved uses of the product. Surgeons can use the product as they see fit". The real question here is who benefits more from off-label use; patients, physicians or the company?

I really don't understand how some decisions are made. According to the article: Doctors with financial relationships with Medtronic have written favorably about off-label uses of Infuse on Web sites, in medical journals and at educational meetings. Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings. If this isn't an accident waiting to happen I don't want is and is extremely bad judgement to let this happen at a time when ANY healthcare industry is under scrutiny.

Medtronic says all payments to doctors are "fully compliant with the law," and that the company has "rigorous processes" to ensure that all physician compensation is fair and at market value. But when physicians benefit financially through royalty payments there is the potential for mistakes and abuse.

The lawsuit says the doctors promoted the off-label use through training sessions and educational meetings, and during "VIP" visits by physicians to Memphis, where the spine unit of Medtronic is located. The federal government has declined to intervene in the matter. Declined to intervene?

A favorable buzz about off-label use began shortly after the product was approved. In May 2003, four surgeons wrote a report for the Web site Spine Universe, which provides educational material for spine surgeons. The report, "New Technologies in Anterior Cervical Spine Fixation," cited favorable results from using Infuse in the neck area and for fusing larger numbers of vertebrae.

The authors, who included Atlanta surgeon Regis W. Haid Jr. and Emory University surgeon Gerald Rodts, wrote that they had used Infuse "in the cervical spine with very good results." The doctors did not provide data related to the cervical-spine results. The report, like many others like it, is accessible on the Internet. At least three of the four authors have financial relationships with Medtronic, according to disclosures they have made in medical journals and at conferences, although that was not noted in the report.

Training sessions and web sites may fall under promotion and unapproved uses and off-label use is clearly not allowed to be discussed in these venues. It’s hard to say what exactly happened as not enough detail is given in the article to draw full conclusions. Still, it casts unfavorable light on Medtronic and the medical device industry at a time when a lot of people are calling for changes in the healthcare industry.

This author did work for Medtronic Diabetes and I can tell you that I had to go through a very stringent process just to get some thought leaders to provide Website content. However, the medical device industry surely needs to review promotional and training seminars to ensure that no discussions on off-label use are promoted or mentioned. The Wall Street Journal should have also done a better job in reporting more facts and less allegations to ensure balanced reporting.