To The Editor

FDA Consumer, March, 2001

Liposuction

The article "Planning to Look Flab-U-Less? Know the Facts About Liposuction" (November-December 2000 FDA Consumer) failed to mention the most important fact: When liposuction is performed under local anesthesia by board-certified dermatologic surgeons in an outpatient setting, the procedure carries a phenomenal safety record. In fact, dermatologic surgeons pioneered tumescent liposuction and developed guidelines of care for the procedure nearly 10 years ago.

Accordingly, the American Society for Dermatologic Surgery takes exception to the article's suggestions that one specialty group or medical board has exclusive domain over performing liposuction surgery. And, the suggestion that the chief criterion for selecting a surgeon should be whether the physician has hospital privileges is similarly incorrect and prejudiced.

The simple facts are that no deaths were reported from office-based tumescent liposuction performed by dermatologic surgeons based on a study of the last five years experience. Moreover, independent physician insurance data demonstrate that patients undergoing liposuction in a hospital accounted for the majority of malpractice claims.

The public deserves to know thee truth--hospital operating rooms are not the answer to safe liposuction surgery. Rather, patient safety is best ensured when the skin surgery experts who originally developed liposuction as an outpatient procedure under local anesthesia perform the procedure.

Harold J. Brody, MD
President, American Society
for Dermatologic Surgery

Perspective on Medical Errors

Thank you for providing a forum for such timely articles ("Make No Mistake: Medical Errors Can Be Deadly Serious," September-October 2000 FDA Consumer). It is imperative that the public as well as health professionals be updated and informed. With the rapid changes that occur in health delivery and the tremendous cutbacks in health insurance coverage, situations and practices arise that warrant investigation.

I am writing regarding the practice of mandating health-care professionals to work up to and beyond 16 to 18 hours in a given workday. In the state of Pennsylvania, this is "not uncommon," according to the Pennsylvania State Nurses Association.

I have witnessed RNs literally falling asleep on their feet in their 15th hour. It is not uncommon that RNs are mandated beyond 16 hours and with less than one hour notice. This is done in lieu of closing beds when staffing is at low levels. This takes a toll physiologically and psychologically in rendering care for our patients.

This is a public health issue and a hazard. I encourage nurses to lobby for reform as we must not add injury to insult by continuing to allow this to occur.

A. Shackelford, RN, CCRN Danville, Pa.

Concerta for ADHD

In your article on Once-a-Day Concerta (Updates, November-December 2000 FDA Consumer), you indicate that Ritalin "must be taken two or three times a day when given in the immediate-release form; the new extended-release formulation requires only a single daily dose." Then, in the second paragraph, "Concerta is administered once in the morning, as opposed to current immediate-release forms of methylphenidate, which must be taken two or three times daily."

Is Concerta then the same thing as Ritalin-SR, which is a sustained release form of methylphenidate, and if so, why is it being compared to the Ritalin that is prescribed in the immediate-release form? Is it or is it not the same drug as Ritalin-SR? The article makes it sound as if this were a new drug, and in fact, my primary care physician has indicated there is a new "one dosage" medicine on the market for ADD.

This is all very misleading and unclear for the consumer.

Kathleen Miller Durham, N.C.

Editor's note: The FDA medical officer who reviewed the Concerta application explains, "The active ingredient in all three is, of course, methylphenidate. Both Ritalin SR and Concerta are formulations of methylphenidate approved for once a day dosing. The method of formulating the pills to provide a prolonged release of methylphenidate is different, however."

Health Fraud

In your article "How to Spot Health Fraud" (November-December 1999 FDA Consumer), you quote Marjorie Powell of the Pharmaceutical Research and Manufacturers of America under "Paranoid Accusations," someone from the drug industry's trade association. Your own Web site lists hundreds of violations on the part of this industry for misleading the public and doctors with their ads. How about a more objective source next time?

Maryann Napoli
Center for Medical Consumers
New York