Dr. Anchors' Presentation to the Florida State Medical Board

On February 2, Dr. Anchors attended the meeting of the Florida State Board of Medicine seeking to get the board to repeal its regulation, unique in the nation, banning phen-pro. Here is a copy of Dr. A's speech

Good morning, colleagues, ladies and gentlemen. Thank you for your rapid response to my letter of December 1 and the opportunity to address you. I am seeking to strike paragraph 2 from Rule 64B8-9.012 of the Florida Administrative Code. The whole Rule 64B8 deals with the manner in which weight-loss doctors, i.e. bariatricians, in Florida treat their patients. It is my understanding that the rule was put in place in 1997 to deal with the problem of large "pill-mill" phen-fen type clinics dispensing medications without properly qualifying patients, examining or instructing them. Rule 64B8 shut down that abuse. But one part of the rule, paragraph #2, has lost its relevance as a result of subsequent research and clinical experience. Its existence hinders the ability of Florida bariatricians to combat obesity, and it puts true physicians in legal jeopardy. Paragraph #2 states...

Physicians in Florida are prohibited from prescribing, ordering, dispensing, or administering any weight loss enhancer that is both a serotonergic and anorexic agent unless the drug has been approved by the Food and Drug Administration (FDA) specifically for use in weight loss management. Selective serotonin re-uptake inhibitors (SSRIS) that have not been approved by the FDA for weight loss may not be prescribed, ordered, dispensed, or administered for such purposes.

I would like to strike out this entire paragraph, leaving the rest of the rule intact. It would be appropriate to do it today, but I donÕt expect that. The cautious approach is to appoint a committee to consult with me, my colleagues, and my critics, to determine the truth of my claims and report back to the board.

I am Dr. Michael Anchors. I was raised in Jacksonville, Florida. My MD degree is from the University of Miami, Coral Gables and my PhD in biochemistry from Harvard Medical School. I did research at UCLA and the NIH for seven years. I have been in the private practice of internal medicine in Maryland for 16 years. I am on the adjunct faculty of Georgetown Medical School. I published letters regarding the Òphen-proÓ combination of phentermine and Prozac in Archives of Internal Medicine and in my book Safer Than Phen-Fen [Prima Press, 1997] I own the patent on phen-pro, though I have never charged for it. I have appeared on ABC, NBC, Fox and CNN News, "Montel", "Hard Copy" and "Good Morning, America", in "Newsweek" magazine, radio and newspapers.

I will not benefit financially from my effort here today; my book is no longer in print and my patent is near the end. I am here today only because some Florida physicians and obese patients who wish to use phen-pro asked me to seek the elimination of paragraph #2.IÕll be the first to admit that medicines are not the most important part of weight control. The most important job is to tell people that overeating is destroying America. Obesity is the first or second most common preventable cause of death, but Americans have no respect for it. Television suppresses the story in order to sell food commercials, and most physicians have even given up. Meanwhile, 300,000 people die from obesity each year.

The simple truth of the matter is that doctors who use safe diet pills get more people to lose weight and keep weight off than doctors who do not; and the phen-pro combination is the most effective medical plan available. Since March 1995, I have treated 1972 obese patients with the result that 548 reached ideal body weight. Fifteen lost 100 lb, four lost 150. Diabetics saw their diabetes go away (two in January, four last year). Hundreds who would have had diabetes, never will.

There are FDA-approved diet pills, Meridia and Xenical, but they are less effective. Eli Lilly, the manufacturer of Prozac, financed a large retrospective study of phen-pro [828 patients], sending a statistician and data collectors to my office, to Dennis Padla's in Michigan and Bonny Lee's in Virginia, to collect all the data from the charts of all the patients on phen-pro. The study will be published in Obesity Research Update. I have given you a copy.

I am not alone in prescribing phen-pro. Hundreds of doctors around the country prescribe it, too. I have brought letters from doctors in other states. These are not slouch doctors. Richard Atkinson is president of the American Obesity Association. Richard Rothman chief of psychopharmacology at the NIDA. Steve Van Ore former president of the Arkansas Bariatric Society. Alan Schulman prominent gastroenterologist & past president of Shady Grove Hospital. There are so many I canÕt name them all.

LetÕs consider paragraph #2 specifically. The scientific rationale for the paragraph is unclear. It may have been a misunderstanding of the cases of heart valve disease seen in 1997. The important thing for you to know is that ALL the cases of heart valve disease and primary pulmonary hypertension (PPH) associated with phen-fen were due to the fenfluramine part of the combination alone, NOT the phentermine part, NOT Prozac, and NOT the combination of medicines. Lucien Abenhaim, who originally published the association between fenfluramine and PPH, wrote in the New England Journal of Medicine in 2000 that Prozac was protectiveÐ-it prevented PPH and heart valve disease. Doctors Una McCann at Johns Hopkins, Rothman at the N.I.H and Raiteri in Genoa, Italy, are in agreement. I have the scientific references. Please listen closely . . .

There has not been a single case of heart valve disease associated with Prozac or phentermine, despite intense scrutiny by the FDA and a zillion lawyers.

- Not one malpractice case has been filed against a phen-pro doctor.

- No manufacturer of phentermine or Prozac has paid out a penny in settlements or damages.

- There is not a single scientific theory left standing by which Prozac or phentermine could cause heart valve disease.

If you are waiting for the FDA to approve phen-pro, you will never see it happen, because no pharmaceutical company will ever ask the FDA. Prozac and phentermine are generic drugs. No company has a sufficient financial interest.

But Florida allows doctors to prescribe medicines off-label. The FDA itself has written, and I quote, ÒThe FDA recognizes that off-label use of drugs by prescribers is often appropriate and may represent the standard of practice.Ó Consider that Prozac itself is regularly used for anxiety, PMS, ADD, premature ejaculation, irritable bowel syndrome and autism--none of these are FDA-approved indications. Florida allows Prozac to be prescribed off-label for all those indications. Why not for obesity? If there is no scientific reason why not, then why not?