Last week, just one week before the opening of Michael Moore’s new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while – that its approval of the Menaflex device in December, 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex.  In issuing its approval, the FDA overrode the agency’s scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation.  This was the first time that the agency publicly questioned the process behind one of its approvals, admitted that a regulatory decision was influenced by politics, and accused a former commissioner of questionable conduct.  You have to know it’s really bad. (more…)

A principal underlying assumption regarding limits on and ethics guidelines addressing pharmaceutical promotion is that smaller gifts are unlikely to exert influence on prescribing decisions. Nonetheless, a substantial body of marketing and psychology literature suggests that even trivial items can exert influence irrespective of economic value. Adding a small gift such as personalized mailing labels, a pen or a coffee mug to a solicitation for donations has been shown to significantly increase donations. These types of gifts can also influence prescribing behavior, according to a study that appears in The Archives of Internal Medicine. (Arch Intern Med. 2009;169(9):887-893). The experiment found that exposure to these items results in more favorable attitudes toward marketed products and that medical school policies that restrict pharmaceutical marketing mitigate this effect. (more…)

In the event that the Supreme Court applies the federal doctrine of preemption to permit the pharmaceutical industry to avoid accountability for the harm dangerous drugs cause, the only remedy would be for Congress to pass a law expressly stating that preemption does not preclude state court lawsuits for compensation. And that, hopefully, is the goal of the process engaged in by Chairman Rep. Henry A. Waxman of the Committee on Oversight and Government Reform of the U.S. House of Representatives this past Wednesday, May 14, 2008. Similarly, Reps. Frank Pallone (D-N.J.) and Waxman (D-Calif.) have drafted legislation, the Medical Device Safety Act of 2008, to ensure federal law does not preempt state law when people harmed by medical devices sue. (more…)

When patients are considering treatment options, there is often”blind faith” in the doctor’s recommendations, as he is viewed as a concerned, educated and neutral provider.  Perhaps, this view is naïve.   In reality, doctors are often financially motivated in the varying courses of treatment offered.  Instead of acting as neutral gatekeepers of potentially harmful drugs and procedures and “neutral scientists “investigating a procedure’s safety, at times they are in actuality financially motivated advocates for the same.  For instance, Dr. Joseph E. Zigler, a well known spine specialist, and an advocate of Prodisc, an artificial spinal disk for the lower back, has been found to have a financial stake in  success of the same.   In fact, The New York TImes has reported that doctors at about half the research centers involved in the study of Prodisc had a direct financial interest in the device’s success. (more…)

The U.S. Attorney for New Jersey directed that a no-bid 18-month contract worth $28 million to $52 million contract be awarded to The Ashcroft Group, the consulting firm of former Attorney General John Ashcroft, to monitor a large settlement of criminal accusations against medical device manufacturer Zimmer Holdings and four smaller companies accused of paying kickbacks to doctors who recommended and used the company’s knee and hip implants. U.S. Attorney Christopher J. Christie directed that the contract be awarded to his former boss with no public notice. (more…)

Not long after Medtronic pulled a flawed Sprint Fidelis leads off the market because of an apparent tendency to break, there are concerns that similar leads sold by St. Jude Medical may in rare cases puncture holes in patients’ hearts. Both cases concern wires, known as leads, that monitor the heart and transmit an electrical jolt to restore normal heartbeats. (more…)

Financial disclosures by five manufacturers of artificial joints have revealed that this year the companies have paid more than $200 million to doctors and hospitals who are often the same ones who are deciding which company’s joints to buy, according to an Associated Press calculation of the disclosures.  The disclosure was required by a settlement the manufacturers reached with the U.S. attorney’s office in New Jersey over an investigation that they gave money and trips to surgeons who used their products. (more…)

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was voluntarily urging doctors to stop using a family of leads known as the Sprint Fidelis, a crucial component in its most recent implantable defibrillator models, because the leads break too often.  Medtronic told doctors to stop using the Sprint Fidelis wires after linking five deaths to breaks in them. The company said the Fidelis wires failed slightly more often than the thicker wires they were meant to replace.  

A lead is a wire that connects the heart to a defibrillator, a device implanted near the shoulder that shocks faltering hearts back into normal rhythm.   An estimated 235,000 patients are thought to have Fidelis leads, and the company estimates that 4,000 to 5,000 patients – or about 2.3 percent – will experience fractures in the leads that can make the device misread heart-rhythm data.  (more…)