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Statement of Robert Jarvik, MD, President and CEO of Jarvik Heart, Inc. Regarding the Lipitor DTC Advertisements

NEW YORK, Feb. 26 /PRNewswire/ -- The following is a statement being issued by Robert Jarvik, MD:

A lifetime career in heart disease

I remain deeply committed to alleviating suffering from heart disease, and I assure the public, from the bottom of my heart, that I have been sincere and honest in my role as Lipitor spokesman. The record needs to show that the ad campaign Pfizer tastefully presented to the public, using beautiful natural settings and high tech modern architecture, fairly represents me as a world recognized heart expert.

As spokesman for Lipitor, I have been an advocate of preventive medicine in addition to my work with the Jarvik 2000 Heart, which has rescued people from death and sustained a patient with a normal, mobile lifestyle for seven and a half years -- the longest in the world. The Jarvik 2000 Heart is in clinical trials at 18 medical centers in the U.S., is fully approved for use in Europe, and is also used in Australia and Japan.

Over 30 years ago, I invented an improvement to previous artificial hearts that extended the durability from weeks to years and enabled the first human application of any permanent total artificial heart -- the Jarvik 7. The more recent Jarvik 2000 is much less well known to the public than the Jarvik 7 was, but has been successfully miniaturized to the size of a c-cell battery with a belt-worn portable power system weighing only 2-1/2 lbs, compared to the four hundred pound console developed decades ago for the Jarvik 7. The improvement in patient quality of life is outstanding.

I am in fact a medical doctor; I am a world expert in mechanical heart technology; and I am an athletically fit man who takes care of his own health through diet and exercise, including frequent five mile runs.

Qualifications to endorse Lipitor

As a medical doctor who chose a career in artificial heart technology rather than clinical practice, I decided not to take an internship, which is required for licensing. Instead, I work with invention, manufacturing, regulatory affairs, and clinical application of artificial hearts. I also work directly with many leading cardiologists and cardiac surgeons, as an advisor concerning management of their patients. My credibility as a heart expert is fully justified and is fairly represented. As an MD medical scientist I am well qualified to understand the conclusions of the extensive clinical trials and FDA review by which Lipitor was proven safe and effective. In the ads I educate the public about the risks and benefits of Lipitor. My recommendation to viewers is to take their own doctor's advice, and nothing else.

Concerning the rowing ad: I spent most of my summer vacation time during high school on the water, sailing, rowing, fishing, and scuba diving. At the time the ad was filmed, I was certainly fit enough to row for the shoot. I trained to row for it, and I intended to do so. But at the last minute, I was informed that the insurance carrier for the shoot would not permit me to row because the water temperature in the mountain lake at that time of year was about 40 degrees -- so cold that if I had an accident, I could drown within minutes because of hypothermia. So the production company hired a rower experienced with that kind of racing shell for the distant shots. It never occurred to me that anyone would consider this dishonest.

The message remains: heart health.

Recently, Pfizer chose to stop running the ads, through which I was able to appeal to so many viewers to pay attention to their heart health and to ask their doctors about Lipitor. My message has been sincere and correct -- Lipitor can indeed help prevent heart disease in many millions of people, a great many of whom are not presently taking any cholesterol-lowering medication.

The United States has an active pharmaceutical industry that has brought huge benefits to the U.S. public. Most Americans, who benefit from these advances, have little understanding of how difficult it is to create an important new medical therapy and make it available to improve public health. I appreciate that difficulty, and praise Pfizer for the immeasurable good they have done for all of us, through talent, persistence, and hard work.

The FDA is also working for the public good, shouldering a great responsibility, to oversee top quality science sufficient to assure safe and effective medications. It is not humanly possible to foresee all potential side effects, and it is all too easy to criticize the FDA in retrospect. Once the FDA completes the scientific study of a new drug, and approves it through a rigorous scientific review process, then we know that the benefits outweigh the risks, unless unexpected problems emerge later. Lipitor is a medication where the benefits outweigh the risks in the patients for whom it is prescribed; and Lipitor remains a foundation of preventive medicine for our nation's number one killer.

SOURCE Jarvik Heart, Inc.
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