Public Comment Date Announced For Sale Of Behind The Counter Drugs

Thursday, October 18, 2007 by: Teri Lee Gruss

(NewsTarget) FDA announces public comment date for Behind the Counter (BTC) sales of prescription medications

On October 3, 2007 the FDA posted FDA Docket number 2007N-0356 announcing that it is open to public comment on November 14, 2007. According to the FDA this docket “regards the behind-the-counter (BTC) availability of drugs” and that “the FDA is interested in obtaining public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist.”

For details on how to make a comment: http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0356-nm00001.pdf

What are possible motivating factors behind this proposed, unprecedented (in the US) reclassification of certain prescription drugs? What possible public health risks may be associated with the availability of powerful drugs like statins being sold BTC? What are the real versus perceived health benefits of statin drugs?

A 2005 British Medical Journal article (Cohen et al) listed three possible reasons for the reclassification of prescription drugs to OTC status. These motives may apply to BTC sales as well.

• The main motives are pharmaceutical firms' desire to expand their market.
  
• Attempts by the healthcare system to reduce drug bills and
  
• The self care movement.

In January, 2007 Wendy Bodine, Assistant Editor for Pharmacytimes wrote “As more branded drugs go off patent and face generic competition in the "prescription-only" market, there may be more insistence from pharmaceutical companies to reopen the idea of a federally mandated third class of medicines”.

Bodine added that in 2005 the FDA turned down a request from Merck to reclassify their statin drug Mevacor to OTC status. However, at that time the FDA panel indicated that they "could support offering it to patients from behind the pharmacists' counter (BTC) without a prescription. It seems that many on the committee believe patients could accurately determine their own need for cholesterol- lowering medications without consulting their physicians". One FDA panel member stated that, "the BTC scenario would be a perfect solution" for Mevacor.

What statin drugs are losing patent protection in the near future?

In 2006 both Zocor™ (simvastatin) and Pravachol™ (pravastatin) lost patent protection. Lipitor™ doesn’t lose its patent protection until the year 2010. A MarketWatch article dated July 18, 2007 says that in the 2nd quarter of 2007, Pfizer, the manufacturer of Lipitor™ lost 13% in international sales and saw a drop of 25% in US sales.

In 2006, the New York Times reported that Lipitor™ is “the world’s most popular medicine (and) the most profitable drug ever invented”. This information should lead us to question the timing of the FDA’s move to reclassify certain prescription only statins for BTC sales. Remember, Lipitor™ loses its’ patent protection in just over two short years.

In 2004 the National Cholesterol Education Program made revisions to its Adult Treatment Panel guidelines, lowering "normal" lipid ranges for LDL. This move has had a major impact both on how people perceive their risk factors for CVD and in more "aggressive" drug treatment by doctors.

Also, consider what Dr. Robert Jarvik must charge to appear in those Lipitor ads.....Katie Watson from National Public Radio comments that "the timing of the ad -- and Dr. Jarvik's endorsement -- are both significant. As far as she can figure, it's the first time that a doctor has been paid to endorse a prescription drug in an ad."

The stage has been set to bring this unprecedented proposal to sell statins without a prescription to the public for comment. But will it be met with apathy, enthusiam or public indignation? Time will tell.

Who is responsible for the National Cholesterol Education Program and who funds their research?

The Agencies Involved:

National Institute of Health (NIH) > National Heart, Lung, Blood Institute (NHLBI) > National Cholesterol Education Program > Adult Treatment Panel III (Guidelines)

The National Heart, Lung and Blood Institute (NHLBI) says, “The guidelines for cholesterol management released on May 15, 2001 were developed by a panel of experts--the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III [ATP III])--convened by the National Cholesterol Education Program, an educational program coordinated by the National Heart, Lung and Blood Institute.”

“The ATP III panel is not an advisory committee to the NHLBI but rather a group of recognized experts providing their scientific judgment about cholesterol management to clinicians. The panel's recommendations for clinicians are based on a thorough review of the scientific evidence by the panel. The guidelines developed by the ATP III are not regulations and health professionals are not required to follow them."

In 2004 the National Cholesterol Education Program’s (NCEP) issued an update for “clinical practice guidelines on cholesterol management (advising) physicians to consider new, more intensive treatment options for people at high and moderately high risk for a heart attack. These options include setting lower treatment goals for LDL (“bad”) cholesterol and initiating cholesterol-lowering drug therapy at lower LDL thresholds.”

There was not an “open” meeting when cholesterol guidelines were revised and the guidelines were not published in the Federal Register.

Who are these experts responsible for setting cholesterol guidelines for us, for our parents and our children? Full financial disclosure from the primary researchers is readily available at the NHLBI/NIH website.

Dr. Scott Grundy, one of the lead researchers of the NCEP and the ATPIII guidelines has received funding from pharmaceutical companies that make statin drugs. He received “honoraria” and/or grants from Merck, Pfizer and AstraZenaca just to name a few.

The Integrity in Science Database additionally notes that Dr. Scott Grundy “served from 1973-present on the American Egg Board grant review committee”. What’s that all about? Haven’t we been indoctrinated to believe that we need to limit our consumption of eggs because they are high cholesterol foods?

The financial disclosure information includes nine researchers responsible for setting NCEP guidelines. Eight of the nine disclose receiving honoraria/grants from pharmaceutical companies that manufacture statins.

To read the disclosure in full: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm

Three years ago a CBS News report quoted Harvard Medical School clinical instructor, Dr John Abramson, author of Overdosed America as saying of the revised National Cholesterol Education Program guidelines, “their resulting advice on statins flies in the face of science.”

"There's a theory that statin drugs help women and elderly people who do not yet have heart disease. That theory has been tested in studies so far and disproved."

CBS reported that,” Abramson and 30 other doctors and scientists are now asking the NIH for a new, independent review of the cholesterol guidelines promoting statins. They cite one study showing women using statins got slightly more heart disease, not less. Another showed the elderly got no real heart benefits, but did develop more cancer. "

In November 2003, Smart Money, a publication of the Wall Street Journal ran a story titled “The Lipitor Dilemma” by Eleanor Laise. In the article Laise questioned “Is America overdosing on Pfizer’s wonder drug”? “In research patients taking statins experience significant adverse effect from these drugs” according to Dr.Beatrice Golomb. Memory loss and “crippling” muscle pain are two of the most debilitating of these adverse effects.

In the Smart Money article, one doctor at Pfizer denied Lipitor’s association with memory loss, saying “That’s not to say the odd case hasn’t been reported”. Instead this doctor said that Lipitor “may have some serious benefit to cognition”.

One has to ask why the disconnect? What are valid, unbiased scientific studies telling us about the adverse effects of statins? Laise's article is a valuable source of information for all that want a better understanding of the effects of Lipitor and how it has been marketed.

Unbiased researchers within the scientific community and at the FDA need to carefully weigh risk versus benefit when determining the reclassification of statins to BTC status. Unfortunately such research appears to be increasingly hard to come by.

Is it in the best interest of public health that the FDA approve BTC sales of statin drugs? What do you think?
Again, public comment on FDA docket number 2007N-0356 is November 14th.
References:

BMJ 2005;330:39-41 (1 January), doi:10.1136/bmj.330.7481.39
Education and debate
Switching prescription drugs to over the counter
Joshua P Cohen, senior research fellow1, Cherie Paquette, research coordinator1, Catherine P Cairns, research coordinator1
1 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 192 South Street, Suite 550, Boston MA 02111, USA

Wendy K. Bodine, Assistant Editor, A Third Category? Medicines Go Behind the Counter

http://pharmacytimes.com/Article.cfm?Menu=1&ID=4302

About the Integrity in Science database:

The Integrity in Science (ISS) Project combats corporate influence on science and science-based public policy. We scrutinize more than 200 science-based federal advisory committees for undisclosed conflicts of interest, monitor the media and scientific literature for failure to disclose, and encourage the adoption of strong disclosure policies. ISS publishes the weekly Integrity in Science Watch e-Newsletter and maintains an open database of public records of scientists' ties to industry. http://www.cspinet.org/integrity/

More about Dr. John Abramson:
http://www.ahrp.org/infomail/05/12/11a.php

Pfizer's profit plunges on generic competition
Drugmaker reiterates 2007 financial forecast-
Val Brickates Kennedy, MarketWatch

http://www.cbsnews.com/stories/2004/10/11/eveningnews/main648685.shtml

The Lipitor Dilemma, Elaine Laise, Smart Money Magazine 11/2003
(reprint) Link: http://www.harrischiro.com/Lipitor%20Delimma%20Article.pdf

About the author Teri Lee Gruss, MS Human Nutrition

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