A study in the New Enlgand Journal of Medicine says that radiation from computed tomography scans may be responsible for as many as 2% of cancers, reports Bloomberg News. This does not mean that people should cease to have CT scans. The report says the chance of any one person contacting cancer from them is less than .1% in most cases. But because they emit much more radiation than an X-ray, and because their use has grown swiftly in recent years, physicians need to think before they order CT scans, say the report’s authors, who are from Columbia University Medical Center.
”Part of the issue is that physicians often view CT studies in the same light as other radiologic procedures, even though radiation doses are typically much higher,” they said.
This will require a shift in thinking. Doctors will have to ask themselves two questions when considering ordering a CT scan. First, is it medically necessary? Second, would a CT scan show something that couldn’t be detected by a less-radioactive technology like ultrasound?
As for the companies that make CT scanners, they probably shouldn’t worry too much about the business implications — as they tend to make X-ray, ultrasound and other imaging systems too.
UPDATE: The Medical Imaging and Technology Alliance released a statement citing that the benefits of CT scanning far outweigh the cancer-related risks. It also highlighted a report on reduced radiation doses.
Device giant Covidien and software firm Questra announced that they have launched the first remote-update system for the electrosurgical market. The Valleylab Exchange Software Update System allows hospitals to remotely update the software on the ForceTriad energy platform. That means they should be able to easily expand its capabilities and add support for new surgical instruments. The software is updated through secure electronic communications via RS-232 ports. Updates can also be done over the Internet at the hospital. Previously, these sorts of systems had to be sent out in order to receive software updates. The new way has the potential for significant cost savings.
An FDA staff report recommends approval of Abbott’s Xience drug-eluting stent, saying that it is safer than existing devices, reports Bloomberg News. The report comes in advance of this week’s Circulatory System Devices Advisory Panel meeting. If the panel agrees with the staff, chances for approval become very high.
The report said that over two years, patients with Xience were half as likely to die, suffer a heart attack, or need repeat surgery than patients with Boston Scientific’s Taxus. It also advocated longer studies after approval to ensure the device does not cause blood clots over time. This is no surprise; post-approval studies of Class III devices are almost de rigeur by this point.
UPDATE: On Thursday night Nov. 29, the advisory panel did indeed recommend Xience for approval.
Smith & Nephew has recalled 575 knee implants, mostly used and targeted for patients in Europe, because they contained higher-than-normal amounts of iron, reports Bloomberg News. The brands affected are TC-Plus, VKS, and RT-Plus, all marketed by a subsidiary, Plus Orthopedics. The products in question were manufactured in May and June. A company notice says the products should not pose any toxicity or biocompatibility dangers. This is the second recall for the firm this year; 185 hip implants were recalled in August.
Shoppers at Rite Aid drugstores in the West can now buy a DNA test for paternity. This alarms some in the scientific community who are opposed to the sale of DNA tests directly to the public because of concerns that they won’t know how to interpret the results, reports the New York Times. However, the Identigene paternity test from Sorenson Genomics produces results that are easy to understand. It is not as simple as paying the suggested retail price of $29.99 and then doing the necessary swabs, though. To have the samples analyzed by a laboratory costs an additional $119. And if you want to use the test for legal purposes, a chain of custody for the samples must be set up, and that costs an extra $200.
The United States is a free market, even for some aspects of healthcare these days. The solution is not to try to restrict access to these tests, but to make sure that they are based on sound science and that consumers know what the results mean.
Yesterday I paid a visit to Precision Medical Products, a contract manufacturer located in Pennsylvania. It has a state-of-the-art 106,000 sq ft facility opened in 2005. It enables the firm to perform just about every function needed for medical device manufacturing (except sterilization) in-house. You’d expect something like this from a large company, but PMP is relatively small compared to some of its competitors. So how were they able to pull it off? The story is very interesting. A predecessor company had been the primary manufacturer of a special kind of needles used for the smallpox vaccine, until the disease was virtually wiped out in the 1970s. But after 9/11, bioterrorism concerns came to the forefront, and the U.S. government decided it needed safeguards against a potential smallpox outbreak. Indeed, it decided that it needed to stockpile one needle for every American citizen. So it went to PMP, and despite its small size, the firm figured out a way to manufacture and package 400 million smallpox needles over the course of a year.
The revenues from that project enabled the firm to build its new facility and compete against larger competitors. And, says George Weaver, vice president of marketing, it continues to excel at figuring out how to develop manufacturing processes for projects that seem difficult. For example, a client that designed an ear thermometer which had a disposable part couldn’t figure out how to make the disposable. PMP designed a manufacturing process for it from scratch, said Weaver. Much is written about the ingenuity of medical device companies, but what’s often overlooked is that many times their supplier companies need similar ingenuity to succeed.
As part of its strategy to further focus on its arthroscopy portfolio, Smith & Nephew Endoscopy is selling its vascular business. According to Joe Metzger, the company’s spokesperson, the business segment has fewer than 20 employees and generates less than $5 million in annual sales. The Boston Globe is also reporting job cuts aren’t planned. Investor group InaVein LLC picked up the vascular business for an undisclosed amount.
Boston Scientific and the ECRI Institute have settled Boston Scientific’s lawsuit against the research firm, reports the New York Times. The device maker accused ECRI of violating its trade secrets as part of a price-consulting service it provides to hospital clients. ECRI collects data on prices of various medical devices and provides clients with the average and lowest prices for each device. Terms of the settlement were not disclosed.
The controversy over medical device pricing will not go away, though. Sen. Chuck Grassley wants to introduce a bill that would require device companies to disclose prices on a quarterly basis. The secrecy over device pricing is arousing suspicion because of the rising costs of healthcare. While making device pricing more transparent would not solve the bulk of the problem, it wouldn’t hurt, either. It just needs to be done in a way that doesn’t encourage hospitals to opt for price over quality.
At least when it comes to treating abdominal aortic aneurysms (AAA). Did you know that deaths as a result of AAA are just as common as those from prostate and breast cancer? New tools are raising the bar in terms of what doctors can do, making good surgeons excellent and excellent surgeons phenomenal ones, according to Mark Farber, a physician who spoke at a media and investor event held by Cook Medical yesterday afternoon in New York City.
Cook is one of three major companies leading the way in treating AAA. In fact, the company has exceeded its own expectations in global sales this year and now leads the worldwide market in endovascular aortic repair. By the end of the third quarter, Cook surpassed Gore and captured 40% of the U.S. market (Gore had 35% and Medtronic held 23%). In Europe, Cook took the top spot in AAA stent grafts at 42%. The company is working on several projects for its Zenith Endograft product family for 2008. We can expect to see several clinical trials, PMA submissions, and even product launches in the coming year as Cook tries to keep a tight grip on the market.
FDA announced it is taking steps to improve how its advisory panels are conducted, in accordance with recommendations from the Institute of Medicine.
One guidance document lays out how conflicts of interest will be disclosed from now on. All panelists must now publicly disclose any interests for which FDA has granted them a waiver. Another guidance recommends that panels adopt simultaneous voting, announce voting results immediately, and record how each member voted in the public record. Operating procedures for the panels have also been formalized. And the agency’s advisory panel Web site has been reworked to make it more understandable to the public.
Also of interest, the agency posted a report from a consultant that outlines how difficult it is to find experts who are totally free from conflicts, and proves that panelists who have received conflict waivers are usually more qualified than panelists without them. This is a long-overdue response to the mainstream media belief that all conflicts are by definition wrong. Let us hope it gets the coverage it deserves.
