Patients with abdominal aortic aneurysms are four times less likely to die if they have a stent-graft procedure than if they have a surgical repair, according to a new study by CMS and doctors at the Harvard Medical School. However, the study, which appears in the New England Journal of Medicine, also found that surgery is more likely to provide a permanent fix for the problem, reports the Wall Street Journal. Many patients and surgeons prefer endovascular repair to surgery because it is much less invasive and recovery is about four times faster.
FDA is so understaffed that it would, at its present pace, take 27 years to inspect each foreign plant manufacturing medical devices for the U.S. market, according to a Government Accountability Office report. This adds fuel to the criticism that FDA is a “fundamentally broken” agency that can no longer be counted on to protect the public health, reports the New York Times. The number of foreign plants making medical devices for the U.S. market has soared in recent years, especially in China. But FDA has not had the resources to keep up.
It is time for Congress and the Bush Administration to stop fidding around and give the agency what it needs to accomplish its mission.
UPDATE: Some in Congress are calling for a substantial increase in FDA’s budget.
UPDATE 2: The New York Times agrees.
Eastman Chemical Co., which provides materials used in medical devices, tubing, and packaging, has introduced a new Web site, named the Online Medical Technical Center, that enables users to more easily find information about materials. Information available includes technical specifications, sterilization compatibility, and processing information. “Nowadays, our customers are more technical savvy. They want to do research on their own before they decide to call someone,” said Gary Hawkins, technical platform manager for medical packaging and tubing. “Before, a sales, marketing, or technical person had to navigate them through things.
A Minnesota company has developed a device that uses electric currents to treat degenerative eye diseases, reports the Star Tribune of Minneapolis. It operates on the same theory as pacemakers and stimulators — that electricity can be used to modify conditions present in the human body. ScyFix was founded by Thomas Harold, a former General Mills executive with no medical background, who was interested in studies that found that electricity could restore sight. (Drugs can’t; they can only prevent further sight loss.) He recruited a team of doctors and engineers who designed a device that uses electrodes to release low-intensity electrical currents into the eyelids. An algorithm tells the device what the amount and frequency of the charges should be. The device has been tested in about 1000 patients in 29 countries since 2002. The company says 95% of them experienced no further sight loss, and 80% of them experienced improved vision. Full-scale trials are now being conducted in the United States and India, and the firm is raising money to fully fund them.
Drug-eluting stents are more effective than bare-metal stents for off-label uses, and they don’t present significant safety issues, a new study finds. The University of Pittsburgh study, published in the New England Journal of Medicine, looked at patients who received stents in tricky areas such as where arteries branch or in grafts from previous surgeries. (Drug-eluting stents are only approved for use in short and straight artery segments.) While restenosis (re-narrowing of the artery) occurred more often in off-label uses than on-label ones, it occurred less often with drug-eluting stents than bare-metal ones. There was no difference in death rates. Another study in the same NEJM issue found almost no difference in survival rate between patients who received stents and those who had bypass surgery. However, bypass had better overall results for patients with multiple lesions.
A stent coated with a polymer that is 25,000 times thinner than a human hair could be a promising alternative to drug-eluting stents (DES). According to its manufacturer, CeloNova BioSciences Inc., the Polyzene-F coating isn’t a drug, but rather an inert chemical compound. It is supposed to “hide” the stent from the body so that the body doesn’t react to it being a foreign object, as can be the case with bare-metal stents. Preliminary data from a study presented at the International Symposium on Endovascular Therapy demonstrates that Polyzene-F allows the inside of the blood vessel to heal “almost perfectly” in 30 days. When DES are implanted, blood vessel healing can take several months, if healing even occurs at all, according to the study’s principal investigator. This study is the first instance that the coated stent has been used in humans. Made of cobalt chromium, the stent has a modified open-cell design, and its 40-nm thick coating is supposed to prevent thrombosis. Polyzene-F has already been used to coat particles that block arteries to treat liver cancer, uterine fibroids, and malformed arteries. The material could also have use on dental, orthopedic, and breast implants, as well as catheters.
Northstar Neuroscience’s stock price dropped 83.6% yesterday. But it had little to do with the worldwide stock market plunge. Instead, the cause was results from a clinical trial that showed its neurostimulation device failed to help stroke victims recover the use of their arms and hands, the New York Times reports. Unlike deep-brain stimulation devices on the market, Northstar’s device stimulates the cortex, the outer layer of the brain. The device has been investigated for a number of uses, but initial positive data had driven the company toward pursuing an indication for stroke victims. Unfortunately, after 24 weeks there was little difference between patients who used the device along with physical therapy and patients who underwent aggressive physical therapy. If anything, the trial showed that physical therapy is quite beneficial for stroke patients.
Today’s Star-Ledger of Newark, NJ has an extensive piece on what some advocacy groups see as a troubling trend toward more direct-to-consumer ads for medical devices. “You would think they were buying candy when it involves serious surgery,” said a spokeswoman for one. The article goes on to note that CDRH has few resources to devote to scrutinizing DTC device ads, and most are looked at only glancingly by the agency before airing.
But there is good reason why drug ads need to be heavily scrutinized before airing, and device ads don’t: the role that the doctor plays in the process. If a patient comes in and asks for a specific drug, it doesn’t take much effort on the doctor’s part to grant the patient’s wishes. All the doctor has to do is write a prescription. And there is a risk that he or she will do so even if not fully aware of the drug’s risks and benefits. The doctor usually doesn’t notice them unless the patient comes back with a problem.
But surgery is different. The doctor is intimately involved and must be familiar with all the available products that could be used. The doctor’s opinion of the available devices matters greatly; if he or she is not comfortable with using a product in surgery, it won’t be used, regardless of the patient’s wishes. And if a problem or complication arises, the doctor knows about it, for sure. And certainly remembers it the next time the device is being considered for use. The responsibility and potential liability is too great to leave these decisions to the whims of marketers and those who listen to them.
The comments in the article by the National Research Center for Women and Families and the petition sent to FDA by the Consumers Union imply that doctors, or at least some of them, are stupid enough to let commercial messages override medical judgment when it comes to performing risky surgical procedures. It is a rather insulting stance. And it is also insulting for a media outlet to give that stance such prominence.
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Last year, FDA convened the device firms that make biliary stents and reminded them not to promote off-label uses. But off-label use is still rampant, according to an article published yesterday in the Journal of Therapeutics. More than one million patients received them for off-label uses between 2003 and 2006, reports the New York Times. They have 510(k) approval for draining digestive fluids from cancer patients’ bile ducts. Yet they are constantly used for clogged arteries and veins in the arms and legs, a use that does not have FDA approval. While 88 of the 561 problems with the products reported to FDA between 2003 and 2006 involved off-label uses, the number of actual problems is likely much, much higher, say the article’s authors, Drs. William Maisel and Jonathan Bridges. This is because adverse events are always underreported, and particularly so when an off-label use is concerned, because of liability fears.
The market for the products’ approved usage is only about $35 million a year, yet the field has a number of players, and new competitors continue to enter the market. Now is not the time for full-blown hysteria — even the article authors acknowledge that biliary stents are probably the best treatment for many patients with clots in their arms and legs. But the companies, doctors, and patients involved with the product could benefit from knowing more about the risks and benefits of biliary stents as a treatment for clogged arm and leg arteries and veins. EV3 Inc. has started trials. It is time for other players to step up, too. Imagine how much money could be made if the procedure was proven safe and effective and the firms could legally market their stents for it.
Singapore’s Biosensors International Group announced that it has received a CE Mark for its BioMatrix drug-eluting stent, which will allow it to be sold in Europe, Reuters reports. BioMatrix is the first DES for which one firm owns the patents for the drug, the stent, and the bioresorbable polymer. This could enable the firm to have a financial turnaround; it posted a $3 million loss for the first half of its current fiscal year. Company officials say they expect the firm to post a profit in the next fiscal year. The firm also expects to expand sales in Asia after recently acquiring a Chinese device firm. Biosensors International was named one of MD&DI’s 50 Companies to Watch in 2006.
