The FDA is considering halting medical device companies from allowing third parties to review their medical devices rather than the FDA. Initially, allowing third party review of medical devices was thought to quicken the process by which medical devices could be approved for market use. Third party medical device reviews were intended to save taxpayer money. However, the FDA is questioning the quality of the reviews as well as the expense of such processes.
Not all medical devices are eligible for a third party review. The FDA allows such reviews if the medical device in question is similar to a medical device already approved as well as those that pose low to moderate risk to the patient.
The FDA decision to re-consider this process is part of the federal agency’s re-evaluation of how it approves medical devices. Minutes from the December 2009 FDA meeting reveal critiques of the third party process that include a lack of proper expertise as well as a general lack of data analysis. The minutes note that the third party review submissions often regurgitate the content of the submission rather than a critical analysis of that data.
The FDA is expected to make a final determination sometime later this year.
Boston Scientific has suspended sales and recalled two of its most popular cardiac defibrillators because changes to manufacturing processes weren’t approved by the FDA. The suspension and recall affects seven Boston Scientific implantable defibrillators. Products affected by the move were the Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality brands. The action did not affect Boston Scientific’s pacemakers and other medical devices.
While they wouldn’t comment publicly on the issue, Boston Scientific officials will work with the FDA to resolve the problem in an expeditious manner. There is no evidence at this point that the Boston Scientific defibrillators pose any health risk to patients unlike the Sprint Fidelis defibrillator leads manufactured by Medtronic. These leads were recalled in late 2007 after they were found to break causing inconsistent electrical impulses to the heart muscle.
The FDA has ordered a black box warning for Plavix intended to advise healthcare practitioners of Plavix dangers in those patients who fail to metabolize the clot busting drug. This failure to metabolize may increase the risk of heart attacks and strokes in patients.
The warning is a blow to Bristol-Myers Squibb Co. and Sanofi-Aventis whose sales have topped $8 billion. The Plavix safety issue may affect 2 to 14% of Plavix users.
This is the second and more serious drug label change for Plavix. In November 2009, the FDA warned that those taking Plavix in combination with heartburn drugs such as Nexium, Prevacid, Prilosec OTC, and Protonix were 50% more likely to have a heart attack.
I’ve been representing survivors of priest sexual abuse for the better part of this decade now. I thought I had heard and seen just about everything concerning this tragedy but I was wrong. I’m witnessing a Pope being dragged into the middle of the Catholic priest abuse crisis. I’m not talking about his failure to discipline bishops or advocate for reform. I am talking about this Pope’s own personal involvement in sexual abuse. As the Archbishop of Munich in the early 1980’s, a priest working in the Archdiocese had been accused of the sexual abuse of at least one boy. This same priest was later allowed to return to pastoral ministry where he was later convicted of more sexual abuse crimes. As the sexual abuse scandals hits the Catholic Church in Germany, the Pope’s former archdiocese has been forced to deal with this scandal and the fact that a priest abuser had been re-assigned under Cardinal Ratzinger’s (now Pope Benedict) authority. Spokesmen for the Archdiocese of Munich moved quickly to squelch the news that the Pope himself was involved in allowing an abusive priest to continue in ministry. They even paraded Munich’s vicar general out in order that he could claim “full responsibility” for the ill advised transfer. Anyone familiar with the inner workings of the Catholic Church knows full well that the Archbishop had knowledge of this situation even if his name isn’t on any official document (see Cardinal Bernard Law’s depositions in Boston). Archbishops don’t cede authority over personnel decisions to lower ranking clerics. It is simply isn’t credible that the present pope didn’t know about this case.
If the Munich case wasn’t bad enough, Pope Benedict still has to deal with the letter he authored in 2001 as the Cardinal Secretary of the Doctrine for the Congregation of the Faith in which he instructed all Catholic bishops to refer all priest abuse cases to his office. In the letter, Ratzinger sternly warned the bishops that these matters were subject to the “pontifical secret”. The pontifical secret is a serious matter for Catholics in that it binds those who are subjected to it to complete and total secrecy. In essence, Ratzinger was telling the bishops that they couldn’t tell anyone (including civil authorities) about anything involving the particular sex abuse case. Isn’t that what we call in this country obstruction of justice?
This week hasn’t been a good one for Pope Benedict. He’s got a growing credibility problem. His past actions may be coming back to haunt him. We haven’t witnessed this before. We could say his predecessor John Paul II was inept in handling the issue or that he turned a blind eye. What we couldn’t say about John Paul was that he was personally implicated in the scandal.
Surgical ablation devices have been approved by the FDA to cauterize tissue in order to stop bleeding in wounds. However, a front-page Wall St. Journal article notes that 25,000 patients last year were treated with the ablation device in order to treat atrial fibrillation. The medical device used in these procedures has not been approved by the FDA. Doctors have been treating “A-fib” with these ablation devices in order to re-route the electrical impulses of the heart. While doctors may use medical devices and pharmaceutical drugs for off-label treatments, medical device and pharmaceutical companies may not market their products for off-label uses.
This is where the issue becomes complicated. The Journal cites doctors and industry executives to note that the surgical ablation devices are almost exclusively being used to treat atrial fibrillation and the market is a lucrative one for medical device companies-$100 million a year.
A former medical device sales executive, Elaine George, has filed lawsuits in which she contends that medical device companies are indeed marketing the ablation devices for purposes not approved by the FDA. She’s won two lawsuits against medical device makers AtriCure and Estech. The settlement with AtriCure cost the company $3.8 million while the lawsuit against Estech was resolved for $1.5 million. As a whistle blower, Ms. George has received $688,000 and $226,000. By law, she is entitled to 15% to 30% of any recovery as a whistle blower. George has three other lawsuits pending against Boston Scientific, Medtronic, and St. Jude Medical. All the lawsuits allege that these medical device companies marketed their products to doctors for uses which aren’t approved by the FDA.
FDA approval for medical devices is a costly process that requires medical trials and lengthy submissions to the FDA. Medical device companies argue that they want to get their devices to market to provide the maximum benefit to the patient.
The surgical ablation devices were approved by the FDA under a provision that allows their approval if they are similar to devices already approved by the federal agency. However, surgical ablation devices have not been approved to treat atrial fibrillation and there is no study available to determine is such use is safe or more beneficial than approved forms of treatment for “A-fib”.
“The misuse of medical devices has the potential of exposing patients to dangerous procedures,” said Tim Johnson, U.S. Attorney for the Southern District of Texas, after settling with AtriCure Inc. in January. As a result of the lawsuits, the FDA is considering revising the provision that allows similar medical devices to be approved for use.
The Journal article notes that 80% of atrial fibrillation patients are treated effectively with drugs. However, the medical device industry sees the growth of surgical ablation devices as a profitable new opportunity. The article provides excerpts of industry executive comments at two trade conferences last year, “Medtronic, at an investor conference last year, called it a “fast growing, underpenetrated market.” St. Jude, also at a 2009 investor conference, said atrial fibrillation “may be the best growth market in the medical device space for the next 5-7 years.”
Elaine George was an industry insider and participated in these conferences as well as medical device marketing seminars for 17 years before being fired by her last employer Boston Scientific after calling into question the marketing presentations she witnessed. During one training session, a presenter showed participants how to sell the surgical ablation devices to doctors for use in atrial fibrillation cases. Later during the conference, regulatory officials cautioned salespeople to be cautious not to market devices for unapproved uses. Understandably, she was confused by the contradictory messages. So she asked the trainer if there were legal uses for which she could promote the product. The response, according to the Wall St. Journal was, “Don’t worry about that. This is how you sell it.”
Soon after the training seminar, she received a letter from her supervisor critical of her job performance. Two months later she was fired by Boston Scientific. That’s when she decided to sue the company for wrongful termination and retaliation. The lawsuits sparked interest in the Department of Justice which is now investigating the medical device companies for illegally marketing medical devices to doctors for uses which haven’t been approved by the FDA.
The DOJ investigation is ongoing and will be interesting in terms of what they discover. It will be more interesting to see how the medical device companies respond to these allegations. This is a $100 million a year market. Will $3 million dollar settlements deter companies who stand to make $100 million?
DePuy, a unit of Johnson & Johnson, has announced that it has warned doctors that its artificial hip device known as ASR has a higher early failure rate in some patients. Months before this latest announcement, DePuy had said it planned to phase out the ASR hip device due to poor sales.
ASR is a metal on metal artificial hip device that has shown an early failure rate that has led to painful and complicated revision surgery in some hip replacement patients. DePuy officials have disputed the safety issues although an Australian doctor, Dr. Stephen Graves, found that data has shown for some time that the ASR has a higher early failure rate than those of ASR’s competitors. Dr. Graves is the director of an implant database in Australia. ASR was removed from the Australian marketplace in December 2009. Graves and other physicians have criticized DePuy for its failure to remove the hip device sooner.
According to the NY Times, DePuy officials cited poor sales figures for the phase out of ASR in spite of Dr. Graves’ contention that there are safety issues with the artificial hip.
“With declining sales of this particular product in its market segment, we are focusing on newer technologies,” Sally Hunter, DePuy’s worldwide vice president for regulatory affairs, said last month.
The Times reports that the FDA has received 300 complaints from ASR patients since the beginning of 2008. The majority of those patients have undergone a revision surgery to replace the failed ASR hip with a new hip device.
Some orthopedic surgeons, including the ASR’s co-developer, Dr. Thomas P. Schmalzreid, have admitted to issues with the ASR device. “The window for component position that is consistent for good, long-term clinical function is smaller for the ASR,” stated Schmalzreid. When notified of Dr. Schmalzreid’s comments concerning ASR, DePuy officials expressed surprise.
The problems to which Dr. Schmalzreid was referring concerning the positioning and placement of the cup.
DePuy is not the only artificial hip device manufacturer to experience safety problems in the past few years. Stryker Corp. and Zimmer Holdings Inc. have had design defect issues that have led to hip recalls or the suspension of sales of these products.
In spite of their best efforts, Matrixx Initiatives, Inc. has failed to persuade the FDA to withdraw its warning letter concerning the homeopathic cold remedy Zicam. Last June, the FDA issued a warning letter to Zicam’s manufacturer’s after certain Zicam products were linked to a loss of the sense of smell (anosmia). As a result of the warning letter, Matrixx Initiatives pulled the Zicam products in question off the market.
The FDA has refused to rescind the warning letter because no new evidence has demonstrated that the Zicam nasal swabs and gels are not associated with the loss of the sense of smell. According to the FDA, the federal agency has received 130 reports of issues with the nasal products. These Zicam products contain zinc gluconate a compound that has been linked to nasal cavity damage.
“Loss of sense of smell is a serious risk for people who use these products,” the FDA said in its letter.
GlaxoSmithKline’s Super Poligrip with Zinc has been recalled in Japan. The American Dental Association has issued a warning about denture creams that contain zinc. The ADA has acknowledged that use of denture creams that rely on excessive use of zinc have been linked to neurological and hematological issues. Zinc reacts with copper by lowering copper levels and thus a higher instance of neurological and hematological problems.
As a precautionary measure, GlaxoSmithKline has decided to stop using zinc in the following products: Super Poligrip Original, Super Poligrip Ultra Fresh and Super Poligrip Extra Care.
In spite of the Japanese recall, no FDA action regarding denture creams has been taken in the United States.
Avandia, GlaxoSmithKline’s diabetes drug, has topped the list of most reported adverse events for the third quarter of 2009. The report was published by The Institute for Safe Medication Practices. Avandia has been plagued by adverse events such as an increased risk of heart attacks since 2007 when Dr. Nissen of the Cleveland Clinic first linked the drug to cardiac problems.
GlaxoSmithKline received more bad news today about Avandia. UBS, one of the world’s largest financial firms forecast a potential $6 billion loss as a result of Avandia lawsuits in the United States. The financial firm noted that there are already more than 13,000 Avandia lawsuits with more expected as public awareness of Avandia’s safety concerns grow.
The first Avandia federal bellwether trial is scheduled to begin in Pennsylvania June 1. Last week a US Senate report was highly critical of GlaxoSmithKline for understating Avandia’s safety risks as well as its failure to report drug data to the FDA. There are also allegations that company officials coerced experts to downplay the Avandia risks.
Once thought to be more durable and effective, metal on metal hip replacements are being questioned by orthopedic surgeons who are finding that these artificial hips are not lasting as long. The metal on metal devices are wearing out and causing metallic debris, bone loss, and the destruction of soft tissue. Such devices are also used in so-called hip resurfacing procedures. The problem has become significant enough that a recent editorial in The Journal of Arthroplasty has suggested that doctors use the metal on metal devices with “great caution, if at all.”
These devices are relatively new since they’ve only been used in the last decade and some studies suggest that 1 to 3% of the hip replacement population may be affected by the problem. Still, that may account for thousands of hip patients in the US.
According to the NY Times, surgeons at Rush University Medical Center have performed two dozen revision surgeries in the past year. The Mayo Clinic reports similar numbers of patients with problems resulting from metal debris. The metal debris, primarily cobalt and chromium, can be absorbed in surrounding tissue or enter the blood stream. Symptoms of metal on metal problems include inflammation of the joint, bone loss, and pain in the groin area.
According to the Times article, all major hip device makers sell these metal and metal devices and some have responded to the concern over them. Zimmer Holdings, one of the country’s largest hip device manufacturers, has sought to downplay to significance of the issue as well as the potential risk to patients.