Don't back down on disclosure: Drug companies' payments to doctors

The Boston Globe published an editorial yesterday encouraging the Massachusetts Department of Public Health to stand firm in its regulations that limit the gifts and money that drug companies give to doctors.

Calvin Timberlake would probably agree. Calvin’s story appeared in this blog here. His surgeon had invested in the manufacturer of Prodisc, and he chose to install a Prodisc in Calvin's spine to relieve his lower back pain. The Prodisc later came apart, requiring an immediate operation to remove it, and leaving Calvin permanently in pain. The surgeons who had written the medical journal articles that persuaded the FDA to approve the device had large investments in its manufacturer.

Doctors should disclose their investments to medical journal editors and to their patients, and state government regulators should insist they do so.

Advice: Ask the officials in your state government’s public health department to require disclosure of funds that doctors receive for all purposes other than direct medical care, including everything from pens and pads of paper to research funding.

He's suing the device maker: Prodisc artificial spinal disk lawsuits

Calvin Timberlake, a 50-year-old former forklift operator who lives in Texas, had a Prodisc implanted in his spine four months after the US Food and Drug Administration approved it. Prodisc is an artificial metal and plastic spinal disk that is meant to relieve lower back pain by replacing a damaged disk between vertebrae of the spine. Calvin's surgeon was not involved in the clinical trial, though he apparently had invested in Prodisc. The Prodisc soon came apart, requiring an emergency operation to remove it. Calvin remains in extreme pain, and has to take medication to control the pain.

Calvin is suing Synthes, the Prodisc's maker, but not his surgeon, whom he does not blame for the problems.

Many of the surgeons who co-authored articles in peer-reviewed medical journals had major investments in the Prodisc, and at least some of them did not disclose their investments to the journal editors when they submitted their manuscripts for publication. They stood to profit financially if the Prodisc succeeded in the market, according to confidential information from a patient's lawsuit that was settled last year.

Advice to people who may have surgery to implant a medical device: Ask your surgeon's office manager if the surgeon has a financial stake in the device.

Browse for related stories in the index at the very bottom of this page, or read another Texas spinal surgery lawsuit story.

Thanks to Reed Abelson for the source article in the Jan. 30 issue of the NY Times.