cholesterol

Public Comment Date Announced for Sale of Behind the Counter Drugs

Thursday, October 18, 2007 by: Teri Lee Gruss
Tags: drug racket, health news, Natural News

eTrust Pro Certified

Delicious Pin It
(NaturalNews) 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, enthusiasm 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

Get breaking news alerts on GMOs, fluoride, superfoods, natural cures and more...
Join over four million monthly readers. Email privacy 100% protected. Unsubscribe at any time.


Have comments on this article? Post them here:

comments powered by Disqus

Take Action: Support NaturalNews.com

Email this article to a friend

Permalink to this article:

Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link.

Embed article link: (copy HTML code below):
Most Popular
Today | Week | Month | Year

See all Top Headlines...



GET SHOW DETAILS
+ a FREE GIFT

Now Available at ShopNaturalNews.com

O3 Essentials OraJuvenate™
A powerful, cleansing dental cream for maximum oral/dental health.
New Cancer Solutions
Over 3 hours of content covering today’s best cancer tests, how to kill cancer cells and the best diets and exercise routines.
Freeze-Dried 100% Organic Whole Corn
Our freeze-drying method preserves taste, texture and nutrients better than any other food preservation method ever invented.
Fenix TK35 Flashlight
Tough, waterproof, extremely bright and it’s touted to throw an 800+ lumen beam more than 1,000 feet into the night.
Inca Treasure Smoothie Pack
This pack of our four most popular superfoods from South America is the perfect combo pack for smoothie lovers.
Pink Himalayan Salt
This salt delivers significant levels of magnesium, zinc and selenium, with trace levels of dozens of other elements.
Pinhole Glasses - Aviator Style
Pinhole glasses are becoming famous for helping people improve their vision without the risks of laser surgery.
Oxy-Rich Facial Serum
O3 Essentials Jojoba Oxy-Rich Facial Serum is cellular nourishment for your skin. Helps smooth fine lines while enhancing tissue elasticity.
Freeze-Dried 100% Blackberry Halves
Our freeze-dried blackberry halves are grown in Serbia under strict organic standards.

Also on NaturalNews:

Health Ranger Videos
Activist music
CounterThink Cartoons
Food documentaries
FREE Special Reports
Podcasts
Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

Most Popular Stories

Flu shot kills 19-year-old, but vaccine industry still has total immunity against lawsuits
Here's a nutty fact: Eating more tree nuts lowers the risk of all-cause death by up to 20 percent
Six important facts you're not being told about lost Malaysia Airlines Flight 370
Malaysia Airlines Flight 370 now clearly a government cover-up: All evidence contradicts official story
10 other companies that use the same Subway yoga mat chemical in their buns
BLM fracking racket exposed! Armed siege and cattle theft from Bundy ranch really about fracking leases
High-dose vitamin C injections shown to annihilate cancer
U.S. treating meat with ammonia, bleach and antibiotics to kill the '24-hour sickness'
USDA to allow U.S. to be overrun with contaminated chicken from China
Vaccine fraud exposed: Measles and mumps making a huge comeback because vaccines are designed to fail, say Merck virologists
Battle for humanity nearly lost: global food supply deliberately engineered to end life, not nourish it
Diet soda, aspartame linked to premature deaths in women

25 Amazing Facts About Food

This FREE downloadable report unveils a collection of astonishing and little-known facts about the food we eat very day. Click here to read it now...

 

Resveratrol and its Effects on Human Health and Longevity - Myth or Miracle.

Unlock the secrets of cellular health with the "miracle" nutrient Resveratrol Click here to read it now...

 

Nutrition Can Save America

FREE online report shows how we can save America through a nutrition health care revolution. "Eating healthy is patriotic!" Click here to read it now...

The Healing Power of Sunlight and Vitamin D

In this exclusive interview, Dr. Michael Holick reveals fascinating facts on how vitamin D is created and used in the human body to ward off chronic diseases like cancer, osteoporosis, mental disorders and more. Click here to read it now...

Vaccines: Get the Full Story

The International Medical Council on Vaccination has released, exclusively through NaturalNews.com, a groundbreaking document containing the signatures of physicians, brain surgeons and professors, all of which have signed on to a document stating that vaccines pose a significant risk of harm to the health of children. Click here to read it now...

Health Ranger Storable Organics

GMO-free, chemical-free foods and superfoods for long-term storage and preparedness. See selection at www.StorableOrganics.com



Recommended Resources On:

Natural News trends
Health Ranger news
Natural News GMOs
Mike Adams tracker
Natural News photos
Natural News Global
Natural News in focus
Natural News connect
Natural News shocking stories
Natural News radar
GMOs
Quackwatch
Vaccines
Health freedom
Dr. Paul Offit

This site is part of the Natural News Network © 2014 All Rights Reserved. Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing International, LTD. is not responsible for content written by contributing authors. The information on this site is provided for educational and entertainment purposes only. It is not intended as a substitute for professional advice of any kind. Truth Publishing assumes no responsibility for the use or misuse of this material. Your use of this website indicates your agreement to these terms and those published here. All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners.

eTrust Pro Certified Android app on Google Play

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.