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i LegalBackgrounder 0000 ~ SHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW • WASHINGTON, D.C. 20036 •(202) 588-0302 Vol. 9 No. 36 October 28, 1994 THE REAL PROBLEM WITH HEALTH CARE IN AMERICA: WHIILE DR. DAVID KESSLER' S FDA FIDDLES, MEDICAL APPROVALS LAG AND AMERICANS DIE by Alan M. Slobodin • With the way things are going at Dr. David Kessler's Food and Drug Administration (FDA), more Americans will be traveling out of the country - but not on vacation. Rather, these Americans, patients with life-threatening conditions, will be traveling overseas (as some already are doing) in search of life-saving treatments unavailable in America because of FDA inaction. For example, Dr. Michael Werner, a general surgeon from Wyoming, flew to Japan in fall 1993 and spent $60,000 for an experimental treatment on a rare form of brain cancer. The treatment, an unconventional form of radiation therapy, has not been approved for use in America. Meyers, Doctor went to Japan for treatment he couldn't receive in America, MINN. STAR TRig., June 26, 1994, at 12A. Werner said the Japanese have treated 120 patients with brain tumors like his and recently reported that 52 % of the patients survived five years and 19 % lived sixteen years after treatment. In contrast, after conventional treatment in the United States, 90 % of patients with the disease die within twelve months of diagnosis and 99 % die within five years. Id. The Japanese radiation treatment is not an isolated example of an FDA approval lag on American drugs and devices. Life-saving or life-enhancing medical devices or drugs are often available overseas for years before Americans get to use them. A recent study by the Tufts University's Center for the Study of Drug Development showed that 80% of drugs approved by the FDA between 1987 and 1989 were available earlier in other countries - by an average of about six years. Brimelow and Spencer, Food and drugs and politics, FoItBES, Nov. 22, 1993, at 117. In the United States, 400,000 men every year must undergo surgery to treat benign prostate swelling. But in Europe, men with the same problem have a third safer and painless alternative - a tiny coil, designed in the U.S., is implanted in urinary tracts to keep the passageway open permanently. Six months after the product was introduced in Europe, it still is not available here. A heart attack victim in Paris, Copenhagen, Sydney, or Capetown is likely to be resuscitated using a "cardiac pump" developed in the U.S. Ambulances in those cities are required to carry the portable Alan M. Slobodin is President of WLF's Legal Studies Division. WLF publications are available on the Mead Data Central LXUs/NEUs® online information service. • I 4 The Washington Legal Foundation ("WLF") is a 501(C)(3) tax exempt organization and is America's largest pro-free enterprise I I• . . - _. - o _ _c_. . _„_.... 'r";. 1 - 1 D...L...., -4- ;. ...,e n<-i rorioc nf nrinin'D I nllrwrc ~nnrtton acnPriallv fnr an/1 nj ihlichPr)

A , pump, which has shown success in clinical trials and in field use. Americans have no access to this technology. Hamburger and Meyers, Losing the Edge: Overseas patients reap the benefits of U.S. ~ research while those here wait, MINN. STAR TRIB., June 26, 1994, at 1A, 13A. A House Energy and Commerce Subcommittee investigation cited reports that 49 U.S.-made medical devices - many potentially life-saving - were tied up in FDA reviews while approvals were granted by regulators in Europe and Japan. "Doctors and patients in the U.S. face the daunting prospect of either having to travel to a foreign land to have access to the latest technology or having to accept a less effective and/or a higher risk treatment for their illness in the United States. " Less Than the Sum of Its Parts: Reforms Needed in the Organization, Management, and Resources of the Food and Drug Administration's Center for Devices and Radiological Health, A REPORT BY THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF HOUSE COMMTITEE ON ENERGY AND COMMERCE (May 1993), at 234. Regulatory approval for medical devices in the United States is estimated to take an average of two to three years versus six to eight months in Europe. MINN. STAR TRIB., supra, at 14A. Drugs face the same kind of delays. These delays are unnecessary and mean thousands of patients are dying who could have been saved during these lag times. Examples of FDA inaction and inconsistencies abound: • A 3.5 year delay in making Interleukin-2 available to certain patients with kidney cancer may have cost as many as 3,500 lives according to FDA's own figures. INVESTOR's Bus. DAILY, May 3, 1994, at 1. • The approval of the emergency blood-clotting drug TPA was delayed 1.5 years. The lives of more than 100,000 heart attack victims are potentially spared each year because of the availability of the drug. Id. ~• FDA is blocking approval of an implant that saves the lives of epileptics who have heart stoppages from severe, uncontrollable seizures and lets them live normal lives. Neergaard, Is Red Tape Sacrificing U.S. Medicine? Doctors, Companies Battle the FDA, THE LEGAL INTELLIGENCER, Aug. 30, 1994, at 1. • It took seven years for the Alzheimer's drug tacrine (also known as THA or Cognex) to go through testing and approval. Thousands of patients gradually lost their memories and their minds while FDA deliberated. No one knows how many died. Graedon, Alzheimer's Treatment Helps Some Patients, THE BALTIMORE SUN, May 10, 1994, at 1. Another promising drug for Alzheimer's Disease, Mentane, was scuttled by the FDA. Driscol, et al., We Need An FDA Leader, Not a Regulatory Czar, L.A. TnviFS, Feb. 10, 1993, at 1. • Balloon implants used to plug life-threatening holes in brain arteries were rejected by the FDA because the developers did not properly document their benefits. Some neurosurgeons call the balloons "the world's standard of care. " Neergaard, Is Red Tape Sacrificing U. S. Medicine? Doctors, Companies battle the FDA, THE LEGAL INTELLIGENCER, Aug. 30, 1994, at 3. • Laerdal's defibrillators, which help save people having heart attacks, were prohibited from ~ being shipped by the FDA because of paperwork problems even though the device has 0 already been approved. Laerdal eventually fought the FDA successfully in court. But, µ~ according to Dr. Richard Cumm;ns of the American Heart Association, at least 1,000 lives q~ were lost unnecessarily. ABC News, 20/20, Aug. 12, 1994, Transcript at 5. W Copyright 1994 ® Washington Legal Foundation 2 ISSN 1056 1137 ~

• • • • Because of paperwork issues, hospitals were ordered by the FDA to stop using specialized baby ventilators. These ventilators are irreplaceable in saving very sick infants because they provide uniquely tiny breaths of air. Dr. Martin Kessler of Georgetown University Medical Center estimates scores of babies died as a result. Protests from doctors persuaded the FDA to allow some use of the ventilators. Id. at 7. • Baxter's portable device that helps a heart pump blood, created in the U.S. and readily available in Germany, is unavailable to heart patients here. Result: Many Americans must be tethered to a device carried on a cart; 35,000 to 70,000 patients waiting for heart transplants would benefit from this technology. Hamburger, Losing the Edge: Overseas patients reap the benefits of U.S. research while those here wait, MINN. STAR TRIB., June 26, 1994, at 1,6. • Summit Technology (Mass.) produced equipment to perform laser surgery on the cornea to improve patients' vision. This equipment, which has been mired in FDA's approval process for three years, would benefit 20,000 patients. Id. at 5. • The cardiopump, a cardiopulminary resuscitation device for heart-attack victims is available in Europe, but not the U.S. Early U.S. tests (from 1992 to early 1993) showed promising results: the survival rate was 35 % greater among heart-attack victims on whom the device was used. Extrapolated nationwide, use of the cardiopump works out to about 7,000 lives saved per year. However, FDA shut down the tests in 1993, because patients were not (for obvious reasons) giving informed consent before the device was used on them. FDA is negotiating with the manufacturer to work out an acceptable test procedure; in the meantime, it will be years before enough "informed consent" patients can be tested to allow for FDA approval. Volokh, Feel a Heart Attack Coming? Go to France, WALL ST. J., Aug. 2, 1994 at A14. Much of this deadly delay is a function of the FDA statutory framework. The current foundation of FDA regulation is the Kefauver-Harris Amendment, which was enacted after Thalidomide, a drug prescribed in Europe to treat morning sickness, was discovered to cause birth defects. The Kefauver-Harris Amendment of 1962 requires the FDA to prohibit the sale of a new drug in interstate commerce unless the drug is proven safe and effective. Pub. L. No. 87-781, 76 Stat. 780 (codified at 21 U.S.C. §§ 301-394 (1988)). The lengthy FDA approval process is defended as necessary to act cautiously in adequately testing drugs and devices for safety. But there is little justification for denying promising (but unapproved) drugs to terminally ill patients when the alternative is that the patient will receive no treatment. Moreover, investigation into the FDA approval process raises doubts that the lengthy process produces any corresponding gain in safety. A 1993 report on medical devices concluded: "It is unclear why medical devices that have undergone both regulatory scrutiny and actual market use in Europe, Canada and Japan are not also approved in the United States within a similar timeframe, particularly since U.S. medical device firms generally seek to first market their products in the United States. There is no evidence which indicates that products available in these major overseas markets are any less safe than products available in the United States. " A REPORT BY THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF HOUSE COMMITIBE ON ENERGY AND COMMERCE, supra, at 237. A comparative study between the regulation of new drugs in Great Britain and the United States concluded that FDA policies did not significantly improve the safety of the United States drug market, but instead resulted in a "drug lag" in which the marketing of otherwise efficacious drugs was delayed because of the time required to receive FDA approval. William M. Wardell, Developments in the Introduction of New Drugs in the United States and Britain, 1971-74, DRUG DEVELOPMENT AND MARKETING 165, 165-181 (Robert P. Helms, ed., Copyright 1994 © Washington Legal Foundation 3 ISSN 1056 1137

t 1975). r • raised its visibility and increased its resources, but its delays and inactions have worsened. On medical devices, concern focuses on two categories of approval by the agency. The first is for devices under the 510(k) process (a process reserved for devices that are "substantially equivalent" to devices already on the market). If the FDA agrees with the manufacturers' contention that the modification is slight, FDA guidelines require approval within 90 days. According to the Health Industry Manufacturers Association as of October 1994, 768 510(k) applications had been awaiting approval longer than the mandated 90-day period. Paik, Makers of Medical Devices Seen Posting Higher Sales, Profit for Latest Quarter, WALL ST. J., Oct. 10, 1994, at A9. By comparison, at the beginning of November 1991, only two applications took longer than the allotted three months. Editorial, Kessler's Devices, WALL ST. J., Feb. 10, 1993, at A14. The second category of approval is for new devices, those unlike anything now used in medicine. In 1990, 47 devices received FDA approval within the requisite 180-day approval period. In 1992, only twelve products were authorized all year while hundreds of others were required to supply more information, which extended well over the 180-day period. During the same period, FDA's staff grew from 7,600 to 8,700 and its budget from $598 million to $760 million. Brimelow and Spencer, Food and Drugs and Politics, FoxBES, Nov. 22, 1993, at 117. In 1993, approval doubled to 24. MINN. STAR TRIB., June 26, 1994, at A14. In an August 20 speech before the International Medical Devices Congress, Dr. Kessler conceded, "Our process for reviewing new devices has been too slow and unpredictable. Despite our management improvements ... our basic problem remains the same." If Congress provides more resources through proposed new user-fee legislation, he said, his agency would reduce 90-95 % percent of the backlog within two years. Hamburger and Meyers, FDA Chief Pledges to Step Up Approvals, MIrrN. STAR 'IRm., Sept. 1, 1994, at 7A. . But Kessler's rhetoric is belied by the FDA record. Consider the case of the Sensor Pad. The device, consisting of two soft sheets of plastic with silicone inside, is designed to magnify sensation. The Sensor Pad allows women to feel lumps as small as a grain of salt in their breasts. One would think there would be some urgency at FDA to approve this device since in the U. S. there are 182,000 new cases of breast cancer and 46,000 deaths a year. Best, Cancer Battle Raises Penny Severns' Profile, ST. LOUIS POST-DISPATCH, Sept. 2, 1994, at 1. Yet the inventor, Earl Wright, and his son have spent nine years and $2 million trying to get FDA approval to market it. In Canada, the product was approved in less than 60 days. Following criticism of FDA's obstructionism on the Sensor Pad in the WALL STREET JOURNAL and the August 12 ABC News program "20/20, " Kessler's FDA attempted to respond by deciding to bring issues related to the Sensor Pad before its Obstetrics and Gynecological Devices Advisory Panel. At a September 1 meeting, the panel concluded that the Sensor Pad should undergo clinical trials to determine whether it might "mask" or prevent detection of breast cancer. Cimons, Panel Sides with FDA, Agrees Studies Needed for Breast Pad, HOUSTON CHRONICLE, September 2, 1994 at A20. However, the "20/20" program noted that when doctors tried the pad in their practices two women found lumps they did not know they had. The program also featured Mary Gorman of Chevy Chase, Maryland who used the Sensor Pad and found a pea-sized malignant tumor that a mammogram missed. FDA management must be accountable for these delays. The Kessler FDA has expedited approvals for drugs when it has been politic do so. If ever there was a federal agency that should be "reinvented," it is the FDA - a bureaucracy that not only wastes the taxpayers' money, it can ~ rnct Amarirranc t3iair livec - C3 in ~ ~ ~ 0 Copyright 1994 © Washington Legal Foundation 4 ISSN 1056 1137 W ~ To receive information about previous Washington Legal Foundation publications contact Alan M. Slobodin, President, Legal Studies Division. Material concerning WLF's other legal activities may be obtained by contacting Daniel J. Popeo, Chairman. W W Ironically, since Dr. Kessler became FDA Commissioner in 1990, the FDA has successfully