The American Vascular Association (AVA) reported recently that more than 10 million of the nation's vascular disease sufferers have not been diagnosed, signaling a need for increased public education on the issue. The results of the AVA's nationwide screening were announced at the 30th annual Veith Symposium International Vascular Surgery Conference in New York. In May of last year, the AVA sponsored a free nationwide public service screening program in which nearly 3,100 persons over 50 years old, in 22 states, received a non-invasive, ultrasound test for several vascular diseases, including abdominal aortic aneurysms (AAA), carotid artery disease, and peripheral arterial disease (PAD). If left untreated, such disease can result in stroke or even death.

The testing showed that 10% of older Americans have PAD, including 11% of men vs. 7.5% of women; 7.5% have carotid artery disease, including 8% of men vs. 5.8% of women; and nearly 5% of men have AAAs vs. 1% of women. Strokes due to carotid artery disease are the No. 1 cause of disability in the U.S. and the third-leading cause of death; rupture of abdominal aortic aneurysms is the 10th-leading cause of death in men over 50; peripheral arterial disease may cause crippling leg problems and increased risk for heart attack and stroke.

The AVA said that while the potential repercussions of heart disease are widely known, few people understand the seriousness of major non-cardiac vascular diseases. Even fewer are aware of the simple, non-invasive procedures widely available to detect AAA, PAD and carotid artery disease.

"The results of this screening program illustrate the pressing need for public and physician education regarding vascular disease," said William Flinn, MD, head of vascular surgery at the Maryland Vascular Center and the University of Maryland School of Medicine (Baltimore, Maryland). "The more Americans and primary care physicians know about vascular disease, the more we in the vascular specialist community can help those who suffer from it. There is a tremendous opportunity to reduce or even eliminate many of the most tragic outcomes in these cases."

The tests all of which are non-invasive, painless and simple to administer included a carotid duplex ultrasound scan, an ultrasound aortic scan, and a Doppler test for PAD. Participants also had their blood pressure measured and their heart rhythm recorded. Educational materials on vascular diseases and their prevention and treatment were distributed to patients after the screenings.

The American Vascular Association's screening program is designed to educate the public about major, non-cardiac vascular healthcare problems, risk factors, and prevention and treatment options. Sixty specialized vascular centers across the country took part in the nationwide screening program.

Medical liability affecting specialty choices

Medical students are thinking twice before signing on to practice a high-risk specialty due to the nation's medical liability crisis, according to a new survey. What's more, medical students are hesitant to apply for a residency in one of the 19 states currently affected by the crisis. The survey, conducted by the American Medical Association (AMA; Chicago, Illinois), included responses from 4,000 students from 49 states and the District of Columbia. This is the first survey conducted to determine what impact the nation's medical liability environment is having on medical students' decision-making, according to the AMA.

A vast majority of the respondents - 96% - said the medical liability situation was a crisis or major problem. Furthermore, 61% said they were "extremely concerned" it was decreasing the ability of physicians to provide quality medical care. Half of the respondents indicated the medical liability environment was a factor in their specialty choice, and 39% indicated it was a factor in their choice of states for residency training. "It's very sad that our nation's medical students are being forced to make career decisions based on factors other than their passion for medicine and where they would receive the best training," said medical student trustee David Rosman in a statement. "We watched, horrified, as the crisis was forcing our nation's experienced mentors to stop performing high-risk procedures or providing care in crisis states. It is frightening to realize that because this crisis is affecting specialty choice, there may not be anyone to take their place."

Donald Palmisano, president of the AMA, said the survey is an important benchmark to monitor the medical liability crisis. The survey helps to gauge how the crisis affects patients' access to medical care, he added. "The students' responses underscore the need for America's lawmakers to listen," Palmisano said. "Fix the crisis now. Enact meaningful medical liability reform legislation." The AMA has been vocal in its support for a Senate bill, The Patients First Act of 2003 (S. 11), which would place monetary caps on jury awards for non-economic damages. The bill did not come up for a vote before the Senate adjourned for the year prior to Christmas, however. A similar bill passed the House earlier in 2003.

MDMA fears user fee increases

FDA officials should commit to small manufacturers that it will modify the user fee program because small companies simply cannot sustain a continued escalation in fees, according to the Medical Device Manufacturers Association (MDMA; Washington). industry association. Officials with the MDMA voiced their concerns last month to FDA officials during the first Medical Device User Fee and Modernization Act (MDUFMA) stakeholders meeting, held in Gaithersburg, Maryland. Small manufacturers cannot afford the significant increases due to shortfalls in the FDA budget, Paul Touhey, president of Fujirebio Diagnostics (Malvern, Pennsylvania), told officials attending the meeting. Touhey is immediate past president of MDMA's board of directors.

Shortfalls in the FDA's MDUFMA budget both this year and in the future require the industry to make up the difference through increased user fees, Touhey said. User fees increased an average of 35% from FY03 to FY04, which is a direct result of a MDUFMA compensating adjustment, he added. "MDMA has long argued the compensating adjustments and workload adjustments do not make practical sense and result in ongoing massive increases in fees," Touhey said. "These two provisions render the first attempt at user fees unworkable. To ensure we have a strong, viable user fee program, these two provisions must be eliminated. This will ensure the skyrocketing fee increases planned for 2004 will not be replicated in future years."

The device industry has "kept its part of the bargain" to pay user fees imposed by MDUFMA, Touhey reminded FDA officials. He asked them to commit to work with the industry "to modify MDUFMA with the benefit of a year's experience, so that we have a viable, sustainable user fee program moving forward."

The medical device industry doesn't want an unequal fee increase between it and Congress such as the pharmaceutical industry has faced, Mark Leahey, executive director of MDMA, told the FDA during its discussion of user fees. A government report published last year documented an unequal burden on fee increases between pharmaceutical manufacturers and Congress, Leahey told Cardiovascular Device Update. The General Accounting Office (GAO; Washington) concluded in a report last year that pharmaceutical manufacturers contributed far more than Congress as a result of the Prescription Drug User Fee Act, which was re-authorized for the third time in 2002. The report, "Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals and Other Agency Activities," was published by the GAO in September 2002.

In 1993, for example, the drug industry contributed $9 million in user fees, Leahey noted. By 2002, that figure rose to $170 million. Industry user fee contributions in FY04 will increase to more than $240 million, he said. "Over the past 12 years, the industry's contribution rose over 2,600%. During the same period, Congress increased funding from $127 million to roughly $185 million. That's less than a 50% increase on Congress' part." He added: "If MDUFMA fees follow suit, the application fee for a PMA will climb to $871,000 within 12 years, and 510(k) fees will increase to $12,500."

Despite the debate over whether MDUFMA will ultimately improve operations within the FDA, there is some good news. Before its Thanksgiving recess, the Senate passed a technical correction to MDUFMA, which will give manufacturers additional time on branding devices. The "Medical Devices Technical Corrections of 2003" creates an 18-month moratorium on the implementation of section 301 of MDUFMA, which requires manufacturers to place their names or brands on devices, when feasible.

The moratorium is intended to give both Congress and the FDA more time to consider the implications section 301 would have on manufacturers, and whether a change in policy is needed.