The New York Times on Sunday printed a long, long, long article about the overuse of CT heart scans. It says that while they are much more expensive than older methods of heart imaging, they have not been proven to be more effective. Yet doctors, especially those in practices that have invested in the machines, are eager to use them anyway. The article goes on to blame “the American devotion to the newest, most expensive technology” for rising healthcare costs. And once again, the Times rages about the alleged inadequacies of the 510(k) process.
While people in the device industry may not take these sorts of conclusions seriously, undoubtedly there are politicians and opinion leaders who will. So it’s important to pay attention to pieces like this.
The Medical Device Safety Act of 2008 would overturn the “federal preemption” clause in the 1976 Medical Device Amendments that allowed Medtronic to win a Supreme Court case earlier this year. AdvaMed late yesterday issued a statement against it. “A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients,” said AdvaMed President Stephen J. Ubl.
The case, Riegel v. Medtronic, concerned a patient who was injured by a Medtronic catheter in 1996. The 1976 law stated that makers of PMA products cannot be sued in state courts if the products did not violate federal laws and regulations. It established FDA as the sole arbiter of safety and effectiveness of PMA products. This “preemption” of lawsuits in state courts does not apply to 510(k) products, nor to PMA products that are found to be adulterated or misbranded. (The Medtronic catheter was neither. Instead, it was misused by the patient’s doctor.)
The consequences of allowing such cases to proceed in state courts could allow states to set their own standards for safety and effectiveness of PMA products, which would be chaotic, Ubl said. “The Supreme Court’s 8-1 decision in Riegel v. Medtronic re-affirmed what most Federal courts have regarded as settled law since 1976 — that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology,” he said. “This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.â€
Regulators in California have barred 13 firms from selling genetic tests directly to consumers, the New York Times reports. This follows a similar issued by New York officials to 31 firms in November. The federal government is also considering whether to intervene. The Department of Health and Human Services will hold hearings on that matter on July 7 and 8. And the Federal Trade Commission is looking in to whether some of these firms have used deceptive advertising and marketing.
The firms say people have a right to know their genetic information so they can use it in health and lifestyle planning. Some of them say they are not in the business of medical testing, but of personal information services. But critics and some government officials say that the test results inevitably constitute medical advice, and that there needs to be a way to determine whether the genetic tests used are valid. The firms run the samples at labs that are regulated by CMS, but critics say that only proves that the tests are analytically valid, not clinically valid.
Some of these firms appear to be legitimate businesses, and some appear to be fronts to sell dietary advice and supplements. That means finding the right balance could be difficult.
A group of patients who have been harmed by complications from surgical mesh have formed an advocacy group, Truth in Medicine. One of its aims is to move surgeons away from synthetic meshes, which it says cause more harm than doctors and device companies let on, and towards biocompatible ones.
According to Lana Keeton, one of the founders of the group, its goals are:
* To stop the implantation of all petroleum-based synthetic medical meshes in humans. To get Congress involved because it is unlikely the device industry would take the initiative on its own.
* To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a PMA or 510(k) product; results of clinical trials, if any; and all known risks and complications.
* To provide patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital.
* To set up a fund to help those harmed by surgical meshes, which would alleviate the need for some patients to sue.
“Every single day, there are new victims,” Keeton wrote. “This has to be stopped.”
Today’s The Journal of the American Medical Association includes a study that points to the possible dangerous effect of RFID devices on critical care medical equipment. The physician authors concluded that these devices resulted in “potentially hazardous incidents” in medical devices in a controlled nonclinical setting. It also suggested onsite EMI testing be conducted when using RFID devices in a critical care environment, along with updating international standards. “The intensity of electronic life-supporting medical devices in this area requires careful management of the introduction of new wireless communications such as RFID,” the authors note. Devices that were tested included external pacemakers, defibrillators, infusion pumps, anesthesia devices, and mechanical ventilators. The tests were performed in a nonclinical setting, and incidents of EMI were put into categories of hazardous, significant, or light.
The Office of Device Evaluation annual report released Monday shows that CDRH was much faster in reviewing PMAs in fiscal year 2006 than in FY 2005, Reuters reports. The report attributed the improvement — PMA reviews dropped from an average of 438 days in FY ‘05 to an average of 335 days in FY ‘06 — to reforms implemented from the Medical Device User Fee and Modernization Act of 2002. Statistics for FY 2007 are not yet available.
However, average 510(k) review time rose slightly, from 87 days in FY ‘05 to 95 days in FY ‘06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.
Since October, four patients have died within two hours after receiving the Definity imaging agent, which is used to enhance ultrasound images, according to an FDA document reported on by Bloomberg News. A fifth patient suffered cardiac arrest but was revived after receiving Definity, which is made by Lantheus Medical Imaging, a unit of Avista Capital Partners.
Warnings for Definity and a competitor, GE’s Optison, have been strengthened, and an FDA advisory panel is meeting tomorrow to further discuss safety issues associated with contrast agents. Lantheus will present a paper to the panel claiming that there is no difference between patients who received Definity and patients who received no contrast agent at all. The agency has not made any conclusions regarding the safety of Definity. A paper presented at the American College of Cardiology meeting in March argued that warnings for Definity and Optison may do more harm than good, as they could lead to less use of contrast agents, whose benefits outweigh their risks.
Boston Scientific said it will sell off pieces of its investment portfolio in two separate deals to help reduce debt it took on when it acquired Guidant, reports the Boston Globe. The deals are expected to raise about $140 million, but will also trigger a loss against second-quarter results. In the first deal, the firm will sell off its stake in 54 companies to Saints Capital, which buys venture-capital and private-equity investments, for $100 million. In the second deal, the firm will sell its investment in a portfolio of venture funds and companies to Paul Capital Partners, a private equity firm, for about $40 million. These moves come in addition to those announced earlier, including selling off non-core businesses and laying off employees.
Big device companies can be a source of investment capital for start-up device companies. So start-ups shouldn’t be expecting any boost from Boston Scientific anytime soon.
FDA has approved a device that allows some spinal cord-injury patients to breathe for up to four hours a day without a ventilator. The NeuRx DPS RA/4 Respiratory Stimulation System is an implantable electronic device that works by stimulating the diaphragm. The diaphragm, a muscle located in the lower abdomen, is essential for breathing, but some paralyzed patients may not be able to control it. The NeuRx, made by Synapse Biomedical, consists of four electrodes implanted in the muscle of the diaphragm that electronically stimulate contraction. It was approved on a Humanitarian Device Exemption, as it is not expected to be used on more than 4000 patients per year.
A Canadian study has found that doctors are denying candidates (and possibly weaker patients) for joint replacement surgery simply because they might lack access to treatments for recovery like home care or rehab services. Other pressures on physicians in Canada include long waiting lists and limited access to operating rooms. According to the study, which was published in the journal Medical Decision Making, some Canadian doctors didn’t refer patients on the grounds that they couldn’t get rehab treatment. This also raises a problem for older patients who are more frail. The healthcare system will need to address this issue soon, as the demand for joint replacements continues to rise.
