CD&D National Editors

Should a consultation with a cardiologist be a matter of promoting what is considered the best, state-of-the-art technology, or simply the presentation of facts – not just the benefits for some, but the risks, near-term and longer-term, for many?

A new study posted on the website of the German Cardiac Society (Düsseldorf, Germany) in mid-February suggests that the benefits of implantable cardioverter defibrillator (ICD) technology are being oversold to patients and thus the devices over-used.

Following an analysis of the various drawbacks of ICDs – including not really extending the lives of heart patients to any significant degree – the study concludes: "It is ethically imperative that we are honest with the data, so that we can be honest with our patients. A reappraisal of the benefits and potential hazards of ICD therapy will enable physicians to a have a more mutually informed and balanced dialogue with their patients."

The study says that while the shocks provided by ICDs are capable of preventing death as the result of a sudden arrhythmic disturbance, the heavy cost of the devices is not supported by the amount of additional years provided to patients.

It says that an ICD "only modestly prolongs life" and costs from e25,000 to e50,000 per year "for one to four years of additional life" and that the added years of life may come with "potential adverse effects on morbidity and quality of life."

Additionally, the authors note that "most patients" implanted with the devices never receive a "therapeutic" shock but are "exposed to ... inappropriate discharges and device failure."

The life-saving ability of the devices is duly noted by the study, citing studies showing a reduction of mortality of up to 20% reduction in "all-cause" mortality in a population of patients with New York Heart Association Class II or III symptoms and reductions of from 46% to 54% reduction in sudden death, this latter figure in "observational studies."

The authors qualify the results of the observation studies, however, by noting that the reduced rate of sudden death in these may have been the result of choosing healthier patients for implantation.

While acknowledging the efficacy of ICDs to shock and save lives, the bulk of the study focuses on two types of problems reducing the benefits of their use and potentially reducing a patient's quality of life. These problems are:

• What was referred to in the report as "mechanical complications," such as device malfunctions, lead problems and site infections, during the hospital stay in which the implant was made and then post-implant complications.

• Inappropriate shocks – described as "surprisingly high" – 19.1 per 100 patient years in randomized clinical trials and 4.9 per 100 patient years in observational studies.

The report says that the shocks "are commonly due to double counting, over-sensing, ectopy, and supraventricular tachycardias, ranging from sinus tachycardia to atrial fibrillation."

These inappropriate shocks increase morbidity, the study says, because they "have consistently been demonstrated to reduce overall quality of life and increase the incidence of depression and anxiety while obligating strict driving restrictions."

Also referred to are problems concerning implant leads that have recently been seen in some devices, and prompting recalls. The report cites the "long-term reliability of ICD leads, referencing a study that found a 15% failure rate in leads during follow-up.

"The estimated lead survival rates at five and eight years after implantation were 85% and 60%, respectively. The annual failure rate increased progressively with time after implantation and reached 20% in 10-year-old leads. The major lead complications were insulation defects (56%), lead fractures (12%), loss of ventricular capture (11%), abnormal lead impedance (10%), and sensing failure (10%)."

As an umbrella comment, the report authors compare ICD implantation to "an insurance policy" which may not benefit, but could harm, those not requiring shocks.

U.S. wants universal healthcare

Americans are gung ho for healthcare reform and they support the new president's efforts, even if they don't know the details of how it's all going to work out, according to a new poll by Harris Interactive (Rochester, New York) and syndicated health news service HealthDay (Norwalk, Connecticut).

"I was impressed with the percentage of Americans who were favorably inclined to get universal healthcare," HealthDay Editor-in-Chief Barry Hoffman told Cardiovascular Devices & Drugs. "As a citizen, I wasn't sure what role healthcare now played. The economy has overwhelmed everything else, so I didn't know if people really wanted universal health. But it appears there's a favorable inclination that they want some form of universal healthcare."

Of those polled, most know that Obama is proposing to reform the healthcare system, but 79% said they know only a little bit about the possible reforms to be proposed. Fewer, 17%, professed that they know a lot about Obama's game plan.

"We saw that a majority of Americans were favorably inclined to some reform in healthcare, but there was a small percentage actually aware of some specifics of the plan," Hoffman said. "Overall, they said they needed more information." He emphasized the fact that the poll revealed so many Americans have positive expectations.

Harris conducted the online survey of a national cross-section of 2,491 adults age 18 and older in late January. Hoffman said it's the first in what will be a series to keep close tabs on American's attitudes over time.

Hoffman said he was most surprised to learn that Americans are keen to have the government negotiate with drug companies to get better deals on prescription medications. A majority, 78%, are in favor of the idea, 7% are opposed and 15% are unsure.

Another popular proposal is to require that all children be covered by insurance. Sixty-nine percent of adults, including majorities of all parties (87% Democrat, 53% Republican and 62% Independent) favor universal coverage for children.

As the poll delved into more specifics, the issue of a national health insurance exchange – considered a partial step toward universal coverage – was addressed and met with mostly positive responses. Sixty percent favored this model. It's based on a system currently in place in Massachusetts, whereby an exchange would offer a range of private insurance options as well as a new public plan that will allow individuals and small businesses to buy affordable healthcare coverage.

"This concept (an exchange) is sometimes associated with socialized medicine, which is a phrase often used to attack healthcare reform in the U.S.," said Humphrey Taylor, chairman of the Harris Poll. "The fact that majorities of all parties support it shows a real desire for change in the American public."

In the past, the exchange wasn't considered appealing, particularly among Republications. The poll revealed that attitudes on the right are morphing. Republicans (49%), Independents (56%) and three-fourths (73%) of Democrats now are reacting favorably to this reform idea.

Most participants (61%) say that reform would be good if the key benefit is to provide more people with adequate health insurance coverage, closely followed by making healthcare more cost-effective (54%) and then only 20% believe that reforms would be bad for the quality of medical care in America.

In general, the survey revealed that the more people know about the president's proposals, the more positive they are about reform in general and to specific ideas. Cost to the individual is of great concern, particularly given the nation's current downward economic spiral.

"One thing is certain, these attitudes will surely change as reform proposals are presented, debated, supported and attacked," Taylor said.

People indicated that they are cautious about whether positive changes to healthcare in America would have a good impact on the overall economy. The question: "Even if you don't know the details of his plan, do you believe that President Obama's proposals for healthcare reforms, if implemented, would be good or bad for strengthening the economy?" was met with 42% who thought it would be good for the economy. Fifty-five percent of people who had lower incomes (less than $15,000) thought healthcare reform would have a positive impact on the economy while only 39% of people with high incomes (more than $75,000) agreed with the concept.

FDA is 'ramping up' on imports

Timothy Ulatowski, director of the Office of Compliance (OC) at FDA's Center for Devices and Radiological Health (CDRH), said in a recent interview with Cardiovascular Devices & Drugs that the import action plan – a response to the variety of problematic imports – is a central point of emphasis at FDA. "The agency as a whole is working on implementing the plan," he said. Devices imported from overseas plants that fall short of the agency's standards have previously faced detention, which Ulatowski said is still an option.

"The import action plan is looking at other aspects of import detention that may be applied," he said, but he noted that the threshold for detention "is dictated by statute. We have not at this point in time sought to lower the threshold in regard to that, but ... there are proposals" to that effect in the plan.

The Office of Enforcement is working with China's State Food and Drug Administration. "We have had several FDA folk, including myself, provide training to SFDA, and that will continue and be expanded," Ulatowski said, but he does not anticipate a personnel crunch.

"FDA has been, because of the efforts of our previous commissioner, provided with resources that in my experience are unprecedented," he said, noting that the inspectional staff has expanded for foreign and domestic inspections. "It will take a little time to get them trained, but the result will be much improved coverage of facilities." The additional personnel "will mean better coverage and in some cases, more enforcement action because of more inspections. FDA as a whole is ramping up and we appreciate the resources that have been provided," he commented.

Many at FDA are approaching retirement, but Ulatowski could not say whether his office would feel the crunch. "We've hired ... a spectrum of people, from people right out of college to people who have a good deal of experience as investigators, in quality systems in industry," but he could offer no specifics.

Industry has long chafed over the word "recall" because it encompasses a wide range of activities and situations. However, firms should not look for any changes to that verbiage. He noted that FDA "initiated a recall communications effort to look at how the agency deals with" such events. "Although I have not seen the final outcome of that communications initiative, we understand that there can be instances – for implantable devices particularly – where the term recall, depending on how the communication is structured, can provide some public angst."

CDRH's reticence to change the nomenclature, Ulatowski argued, is well founded. "We're concerned about making sure that industry, the healthcare community and the public are aware of important messages when they come out. So if you dilute the message by using terms that are not as striking ... I think you run into problems." The agency's point, he said, is "what you tell the doctor or patient what they're supposed to do. What is the problem? Whom do I contact if I have a question? These are all important things that in certain communications are insufficient."

Ulatowski's message for industry: "No matter how big or small your company is, it's been proven time and time again that compliance with quality systems leads directly to the bottom line. You can have a short-term or long-term view and be half-hearted about quality systems and suffer consequences for poor-quality products and problems with your company down the road," he said.

So it's "pay me now or pay me later" where quality systems are concerned, he said, adding, "I'd rather they made an appropriate effort to maintain compliance, because it really is good for them."

Dems pledge health reform push

Sens. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, and Edward Kennedy, chairman of the Health, Education, Labor and Pensions Committee, told President Barack Obama in a letter last month that they were committed to getting a health reform bill passed and enacted this year, despite no longer having Tom Daschle at the head of the effort.

Kennedy and Baucus said they were "saddened" by Daschle's decision to withdraw from the nomination process. The two lawmakers said they continued to believe that Daschle was "highly qualified" to hold the position of secretary of the Department of Health and Human Services (HHS).

Daschle stepped aside on Feb. 3 after a draft Senate Finance Committee report was leaked to the media on Jan. 30 disclosing that he had failed to pay $128,000 in taxes for a limousine car service and consulting fees and also had inadvertently claimed deductions for ineligible donations.

Daschle, who Obama had nominated on Dec. 11, 2008 to serve as the secretary for HHS, submitted amended filings on Jan. 2 for 2005, 2006, and 2007 and paid the back taxes in addition to more than $11,000 in interest. He reportedly paid an additional $6,000 last week to the IRS.

Baucus and Kennedy said in their letter to the president that they were confident that Obama would "swiftly choose an exceptionally qualified and dedicated alternate nominee" for the HHS chief's job. "We must act now," the senators said, noting that the ranks of the uninsured are growing larger each day.

"We have a moral duty to ensure that every American can get quality healthcare," the lawmakers said. "We must act to contain the growth of healthcare costs to ensure our economic stability, to help American businesses deal with the healthcare challenge and to make sure that we are getting our money's worth."

Contradictory assessments of GAO report

Various citizen groups have charged that the FDA is lax in the operation of its 510(k) regulatory pathway, and is approving too many high-risk devices through that process. Supporting these critics, FDA reviewers in early January sent two letters to Rep. John Dingell (D-Michigan) and the incoming Obama administration to complain of alleged corruption of the 510(k) program at the Center for Devices and Radiological Health.

A report by the GAO – which was asked to analyze the agency's 510(k) and PMA processes – would appear to support the critics, or at minimum point to system flaws needing improvement. This, first of all was indicated by its title: "Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process," and the report when on to analyze FDA's reviews carried out in fiscal 2003 through 2007.

It said that though Congress "envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete."

The GAO recommended that the Secretary of Health and Human Services should direct the FDA Commissioner "expeditiously ... to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process" those regulations to include reclassification "of each device type into class I or class II, or keeping it in class III, and for those device types remaining in class III, to require approval for marketing through the PMA process.

GAO found that in the four years reviewed, the agency "cleared 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process."

The report noted that the agency 'is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so."

Sidney Wolfe, executive director of Public Citizen (Washington), in a statement said that the report highlighted "the dismal job" that the FDA does in regulating devices and showed "that the approval process at the FDA is irredeemably broken." He bemoaned that "many high-risk devices are going through a less-stringent review process before being used in patients."

Still supporting the FDA's processes was the Advanced Medical Technology Association (Advamed; Washington). Janet Trunzo, executive VP for technology and regulatory affairs at AdvaMed, in a statement said the association "is pleased the GAO report clearly supports the effectiveness of FDA's 510(k) premarket review process." She said that the GAO report "demonstrates that medical devices reviewed by FDA under the 510(k) process are subject to the appropriate level of regulation to ensure their safety and effectiveness."

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