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Cleveland Clinic Physician Testifies Before the U.S. Senate Committee on Health, Education, Labor and Pensions

Posted on: Thursday, 16 November 2006, 12:00 CST

WASHINGTON, Nov. 16 /PRNewswire/ -- Cleveland Clinic physician-scientist Steven E. Nissen, M.D., testified today before the U.S. Senate Committee on Health, Education, Labor and Pensions, (H.E.L.P.) to provide his independent perspective on drug safety.

Dr. Nissen is Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and President of the American College of Cardiology. His testimony was part of "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation," a hearing focused on current platforms for improving drug safety, including a bill introduced last August by H.E.L.P. Chairman Sen. Michael Enzi, R-Wyo and Ranking Member Sen. Edward Kennedy, D-Mass.

The bill, "Enhancing Drug Safety and Innovation Act of 2006" (S.3807), calls for improved drug safety and oversight. It outlines provisions that would require drug makers to engage in better drug safety planning before a drug is available to the public and proposes improving the FDA's response to risks identified once a drug is on the market. The legislation is co-sponsored by Sen. Mike Dewine, R-Ohio and Sen. Mark Dayton, D- Minn.

During his testimony, Dr. Nissen spoke of "a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety" and referred to the bill as a "major step forward."

"I am a strong supporter of this bipartisan effort to enhance the FDA's effectiveness and improve drug and device safety," Dr. Nissen said. "I believe that this legislation represents the best chance we have had in a long time to make a real difference for patients in this challenging area."

In his testimony, Dr. Nissen said that "strong and decisive" legislation was needed to improve drug safety and restore public confidence in the FDA. He spoke of the shortcomings in the current drug approval process, referring to a lack of information sharing that can hinder clinical trials and patient safety.

In his support of the legislation introduced last summer, Dr. Nissen also spoke of the need to better fund the FDA; offer "provisional approval," of drugs that would expire if safety issues were identified; and he raised the need to regulate the nutraceutical industry.

Dr. Nissen's testimony did not reflect the views of either Cleveland Clinic or the American College of Cardiology. The complete written testimony is attached.

Dr. Nissen has served on various FDA advisory panels and is actively leading clinical trials involved in drug development designed to explore drug safety. He is a strong advocate for innovative new therapies and is widely recognized for his perspective that the effectiveness of drugs and devices must be balanced by appropriate safety considerations.

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2005, there were 2.9 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were nearly 54,000 hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site address is http://www.clevelandclinic.org/.

Testimony to the U.S. Senate Committee on Health, Education, Labor and Pensions

My name is Steven E. Nissen, M.D. I am Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and the President of the American College of Cardiology (ACC). My testimony does not reflect the views of either Cleveland Clinic or the ACC. As an individual who has frequently served as the "point on the end of the spear" during the public debate on drug safety, I appreciate the opportunity to provide an independent perspective on the "Enhancing Drug Safety and Innovation Act of 2006" introduced by Chairman Enzi and Ranking Member Kennedy.

We face a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety. The American people no longer trust the FDA to protect their health. Unfortunately, patients are increasingly suspicious of new therapies and sometimes are reluctant to accept potentially life-saving medications or devices. Strong and decisive legislative action is now essential to improve the safety of drugs and medical devices and restore public confidence in this critically important regulatory agency.

The initiative now before you represents the best opportunity in many years to fix these chronic problems. We need new laws to strengthen the authority of the FDA. Currently, the Agency must "negotiate" with industry to make even simple changes in drug labels. I served on a 2001 Advisory Panel that recommended a warning label for Vioxx, but it took 14 months before the FDA could secure agreement from the company to accept a weakly written warning. Companies routinely make commitments to perform Phase IV studies, but never actually launch the promised clinical trials and the Agency is powerless to act. When drug studies reveal toxicity or lack of efficacy, the Agency is not permitted to release the results and the findings are often not published, thereby denying patients and physicians access to vitally important safety information.

This problem of "negative publication bias" -- the practice of suppressing and never publishing unfavorable studies has a catastrophic effect on the drug development system. When drugs show serious toxicity in patients, the results are rarely published. Accordingly, other companies subsequently expose patients to closely-related drugs without knowing that their competitors' study of a similar agent showed significant harm. I am aware of a class of drugs where more than a dozen compounds showed serious toxicity, resulting in termination of development, but without a single publication of results. In my view, when a patient volunteers to participate in a drug or device study, there is an implicit moral obligation that the patient's participation will benefit medical science. When studies are not published, we learn nothing from the experiment and make the same mistakes over and over again.

The post-marketing surveillance system for drugs and devices functions poorly. Adverse event reporting is voluntary and studies show that only 1 to 10% of serious adverse events are ever reported to the Agency. Accordingly, the actual incidence of serious or life-threatened complications cannot be calculated accurately.

The current legislation proposed by Senators Enzi and Kennedy addresses many of these problems in a thoughtful fashion. The bill's authors sought to simultaneously facilitate development of innovative therapies, while aggressively protecting public safety. The proposed Risk Evaluation and Mitigation Strategy is a step toward a more robust post-marketing surveillance system. The system for dispute resolution is fair to the industry, but makes certain that safety concerns are promptly addressed. The requirement to register clinical trials is essential and the establishment of a mandatory Clinical Trials Results Registry will guarantee that society reaps the benefits of knowledge, whenever a study is conducted in human subjects. Finally, the improvements in the Advisory Committee process will help to ensure that FDA consultants are less likely to be influenced by financial conflicts of interest.

Although this bill is a major step forward, I would like to see further legislative actions. The Agency should be better funded. Virtually, every American takes one or more medications, so drug safety affects every one of us. However, the annual expenditure for drug regulation approximates only about $500 million and is largely supported by user fees, creating a conflict in loyalty for FDA employees. We cannot expect outstanding performance for an Agency operating on a poverty budget.

For high-risk drugs, another approach to drug approval should be considered -- "provisional approval" -- a limited term approval that would automatically expire unless certain criteria for efficacy and safety are met.

I believe that Direct to Consumer (DTC) Advertising requires legislative action. The standard for acceptable DTC advertising should require demonstration of a compelling public health benefit for this type of communication. Drugs with an addiction potential, such as sleeping medication, should be specifically prohibited from consumer advertising.

Finally, there is an important drug safety problem not addressed in this bill -- the nutraceutical industry. I recognize that the H.E.L.P. committee has made progress by unanimously approving legislation requiring serious adverse event reporting for dietary supplements. However, more needs to be done. These products are often worthless and occasionally harmful. It must also be recognized that some patients take such dietary supplements instead of effective medications with negative implications for their health.

The current bill is an important step toward improving the safety of drugs and devices and restoring public confidence in the FDA. I strongly support its passage and commend the Senators for their bipartisan leadership.

Cleveland Clinic

CONTACT: Kate Nagel of Cleveland Clinic, +1-216-965-8562, ornagelk@ccf.org

Web site: http://www.clevelandclinic.org/

Source: PRNewswire

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