FDA panel backs easing sale of diet pill
Xenical may become 1st such treatment sold over the counter
By Shannon Pettypiece and Catherine Larkin, Bloomberg News | January
24, 2006
WASHINGTON -- GlaxoSmithKline PLC won the support of a US advisory
panel to sell its Xenical diet pill without a doctor's prescription.
The Food and Drug Administration advisers voted 11 to 3 in favor of
allowing over-the-counter access to Xenical, known chemically as
orlistat, for use by overweight adults for up to six months.
The FDA usually follows the recommendations of its advisory panels,
without an obligation to do so.
If the agency ultimately approves the drug, it would be the first
prescription weight-loss drug to be approved for sale over the counter
at a time when two-thirds of Americans are overweight or obese.
The advisers overcame FDA staff concerns that patients might misuse the
drug, which has been available by prescription in the United States
since 1999. Orlistat would be the first weight-loss medication approved
for sale without the supervision of a doctor. Moderately overweight
patients who took 60 milligrams of orlistat in a four-month study had
an average weight-loss of 1.1 kilograms, or 2.4 pounds.
''It's a small amount of weight, it's a short-term usage," said
panelist Melanie Coffin, who served as a representative of patients,
during the meeting yesterday in Bethesda, Md. ''It's one more tool to
help folks."
London-based Glaxo would market the nonprescription version under the
brand name Alli at half of its current 120-milligram dosage. The
company is targeting some of the 65 percent of Americans who are
overweight, based on federal statistics. Xenical generated $497 million
of worldwide sales in 2004.
While about half of participants in focus groups experienced
gastrointestinal side effects from orlistat, only 9 percent of
participants discontinued use of the drug, Glaxo told the FDA panel.
The company said it would add warnings on its packaging and educate
pharmacists and transplant centers about risks for certain patients.
''There is no magic pill for weight loss, and orlistat is definitely
not a magic pill," John Dent, Glaxo's vice president of research and
development, told the panel. ''Orlistat is a tool that will help people
control their calorie intake."
Panel member Thomas Carpenter said additional levels of oversight by
pharmacists or others would be needed to spot ''red flags" in patients
who may experience complications from using the drug without a doctor's
prescription for a longer period of time than recommended.
Panelists also raised concerns that patients may lose the ability to
absorb critical vitamins while taking orlistat or regain the weight
they have lost after treatment is stopped. Glaxo has proposed that
patients take one or two of the over-the-counter tablets three times a
day for up to six months.
Xenical works by blocking about one-third of the fat in food from being
digested. The drug also can reduce the absorption of some fat-soluble
vitamins and has been linked to kidney stones, gallstone, hepatitis
and, perhaps, pancreatitis, FDA staff said in a report on the agency's
website last week.
''The challenge here is to somehow make a reasonable risk-benefit
assessment of a drug that, if available over the counter, will be used
by at least some people for cosmetic weight loss," said Eric Coleman,
medical team leader for the FDA's division of metabolism and
endocrinology products.
The FDA staff, in a report the agency posted Friday on its website in
preparation for the panel meeting, expressed concern that diabetics,
transplant patients and people taking blood- thinners may not use an
over-the-counter version of the weight-loss drug correctly.
*********
Endocrinologic and Metabolic Drugs Advisory Committee Roster
Chair
Nelson B. Watts, M.D.
Expertise: Endocrinology
Term: 02/13/03 - 06/30/06
Internal Medicine
Professor, Clinical Endocrinology
Director, UC Bone Health
Medical Arts Building, Suite 4300
222 Piedmont Avenue
Cincinnati, Ohio 45219 Executive Secretary
Cathy Groupe, RN, BSN
Advisors and Consultants Staff HFD-21
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
email: [email hidden]
(301) 827-7001, FAX (301) 827-6776
Thomas O. Carpenter, M.D.
Expertise: Pediatric Endocrinology
Term: 07/01/03 - 06/30/07
Professor of Endocrinology Pediatrics
Yale University School of Medicine
333 Cedar Street
New Haven, Connecticut 06510
Sonia Caprio, M.D.
[Word] [PDF]
Expertise: Pediatric Endocrinology
Term: 10/24/04 - 06/30/08
Professor of Pediatrics
Division of Endocrinology, Pediatrics
Yale University School of Medicine
333 Cedar Street
New Haven, Connecticut 06510
Dean Follman, Ph.D.
Expertise: Biostatistics
Term: 02/13/03 - 06/30/06
Assistant Institute Director for Biostatistics
National Institutes of Allergy and Infectious Diseases
6700B Rockledge Drive, MSC 7609, Room 5138
Bethesda, Maryland 20892
Michael R. McClung, M.D.
Expertise: Endocrinology, Bone Mineral
Term: 02/13/03 - 06/30/06
Oregon Osteoporosis Center
5050 NE Hoyt Street, Suite #651
Portland, Oregon 97213
Jorge Plutzky, M.D.
Expertise: Epidemiology, Diabetes
Term: 10/25/04 - 06/30/08
Director
Vascular Disease Prevention Program
Cardiovascular Division
Harvard Medical School
77 Avenue Louis Pasteur, NRB 7
Boston, Massachusetts 02115
**Steven W. Ryder, M.D.
Expertise: Endocrinology
Term: 02/02/04 - 10/31/07
Senior Vice President
Pfizer Global Research & Development
50 Pequot Avenue
New London, Connecticut 06443
David S. Schade, M.D.
Expertise: Endocrinology, Metabolism
Term: 02/13/03 - 06/30/06
Professor of Medicine and Chief,
Division of Endocrinology
University of New Mexico School of Medicine
2211 Lomas Boulevard, NE 5-ACC
Albuquerque, New Mexico 87106
Morris Schambelan, M.D.
Expertise: Endocrinology
Term: 07/01/03 - 06/30/07
Chief, Division of Endocrinology
San Francisco General Hospital
Building 30, Room 350K
San Francisco, California 94110
Margaret E. Wierman, M.D.
Expertise: Endocrinology
Term: 07/01/03 - 06/30/07
Chief, Section of Endocrinology
Veterans Affairs Medical Center
1055 Clermont Street
Denver, Colorado 80220
Paul D. Woolf, M.D.
Expertise: Endocrinology
Term: 02/13/03 - 06/30/06
Chairman, Department of Medicine
Crozer Chester Medical Center
1 Medical Center Boulevard, 3 East
Upland, Pennsylvania 19013
********************
More about these advisors on this advisory panel:
Nelson B. Watts, M.D., Professor, Clinical Endocrinology; Director,
University of Cincinnati Bone Health. Received grant or research
support from Amgen, Aventis, Merck, Novartis, and Procter & Gamble.
Served on the speakers bureaus of Aventis, Eli Lilly, Merck, and
Procter & Gamble. Served as a consultant to Abbott, Aventis, Eli Lilly,
Merck, Novartis, Procter & Gamble, and Wyeth.
(http://64.233.161.104/search?q=cache:qFdM-z8JBVkJ:www.medscape.com/viewprogram/3422_authors+%22Nelson+B.+Watts%22+Squibb+OR+Pfizer+OR+Aventis+OR+Novartis+OR+Merck+OR+GlaxoSmithKline+OR+Schering&hl=en;
accessed 1/06/05) Hosted a program funded with an unrestricted
educational grant from Procter & Gamble called "Osteoporosis: New
Treatments for Bone Loss." ("Osteoporosis: New Treatments for Bone
Loss, A Cutting Edge Medical Report, iTV Special." PR NewsWire;
6/28/00)
Thomas O. Carpenter, M.D., Professor of Endocrinology Pediatrics, Yale
University School of Medicine, New Haven. Received less than $10,001
per year for serving on a data safety monitoring board for AstraZeneca.
(http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3968T1.htm;
accessed 1/06/05) Received consulting fees from Merck and Genzyme and a
grant from CuraGen. (New Engl J Med. 2003;348:1705-8.)
Michael R. McClung, M.D., Oregon Osteoporosis Center, Portland. Lead
author on Eli Lilly-sponsored trial comparing Lilly's Forteo
(teriparatide) to Merck's Fosamax (alendronate sodium) for treatment
of osteoporosis. (Arch Intern Med. 2005; 165(15):1762-8.) Served as a
consultant to Amgen, Aventis, Eli Lilly, Merck, Novartis, Pfizer,
Procter & Gamble, and Roche; received grant or research support from
Amgen, Aventis, Eli Lilly, Merck, Novartis, Pfizer, Procter & Gamble,
and Roche. (http://www. princetoncme.com/public/2003-21/index.html;
accessed 1/06/05) Received research grants from or honoraria for
speaking for or served as a consultant to Eli Lilly, Merck, Novartis,
and Procter & Gamble. (JAMA. 1999;282:687-9.) Study of the influence of
fat and lean mass on bone mineral content supported by Merck Research
Laboratories. (Am J Clin Nutr. 1996;64:354-60.)
Jorge Plutzky, M.D., Director, Vascular Disease Prevention Program,
Harvard Medical School, Boston. Consultant for Abbott, AstraZeneca,
Bristol-Myers Squibb, GlaxoSmithKline, Laboratories Fournier, Merck,
Pfizer, and Takeda; member of the speakers bureau for AstraZeneca,
GlaxoSmithKline, Merck, Pfizer, Schering-Plough, and Takeda; received
research grants from AstraZeneca, GlaxoSmithKline and Takeda.
(http://www.ndei.org/v2/website/content/index.cfm?MiscContent_ID=386;
accessed 9/19/05) Received research funding from Takeda Pharmaceuticals
for his work on lipoprotein lipase for which he was awarded a patent.
(http:// appft1.uspto.gov/ netahtml/PTO/search-bool.html; accessed
9/09/05) Spoke positively about Paragluva (muraglitazar) at a satellite
symposium sponsored by Bristol-Myers Squibb and Merck held during the
American Association of Clinical Endocrinologists meeting.
("Monotherapy option for type 2 diabetes patients: muraglitazar
effectively lowered hemoglobin [.sub.1c] and triglycerides while
raising HDL cholesterol levels," Family Practice News, 07/01/05, p.
20) Co-author of "Effect of a peroxisome proliferator-activated
receptor-[amma]agonist on myocardial blood flow in type 2 diabetes"
supported by Takeda Pharmaceuticals which makes Actos (pioglitazone),
the subject of the study. (Diabetes Care. 2005;28(5):1145-50.) Sued Eli
Lilly in August 2003, accusing the company of fraud, conversion, false
advertising, and breach of contract and fiduciary duty for failing to
name him and a colleague the sole or co-inventors of the drug Xigris.
(Olson, Scott. "Big money at stake in drug patent cases; Researchers
take on pharmaceutical giants Eli Lilly and Co. and Merck in lawsuits
pending in Indianapolis," Indianapolis Business Journal, 4/26/04,
p.19)
David S. Schade, M.D., Professor of Medicine and Chief, Division of
Endocrinology, University of New Mexico School of Medicine,
Albuquerque. Received grant funding and honoraria from Pfizer. (JAMA.
1998;279:137-43.) Study on hypoglycemia in elderly patients with Type
II diabetes was partially funded by Pfizer. (JAMA. 1999;281:12.)
Morris Schambelan, M.D., Professor of Medicine, University of
California at San Francisco and Chief, Division of Endocrinology, San
Francisco General Hospital. Lead investigator for a Phase II clinical
trial of SomatoKind, Insmed's investigative new drug for treating
metabolic disorders in HIV/AIDS patients. ("Insmed Initiates Phase II
HIV-Associated Lipodystrophy Trial With Somatokind," PR
Newswire-FirstCall, 4/20/05) Received research support and/or funding
from Serono Laboratories, which provided the growth hormone for a study
of its impact on fat accumulation on HIV-infected men. (Clin Infect
Dis. 2004;39(5):732-5.) Was a consultant, and/or scientific advisor,
and/or speaker, and/or had research grants from Abbott, Agouron, Bayer,
Biochem Pharma, Biotechnology General, Boehringer Ingelheim,
Bristol-Myers Squibb, Celgene, Chiron, DuPont, Gilead, GlaxoSmithKline,
Hoffmann-La Roche, Janssen, Merck, Ortho Biotech, Pfizer, Pharmacia and
Upjohn, Roche, Schering, Serono, Triangle, and Trimeris.
(http://www.iasusa.org/pub/topics/2002/issue1/metabolic-complications.pdf;
accessed 1/06/05)
Margaret E. Wierman, M.D., Chief, Section of Endocrinology, Veterans
Affairs Medical Center, Denver. Received between $10,001 and $50,000 a
year annually for her membership on the speakers bureau of a competitor
of AstraZeneca. Less than $5,000 is paid directly to Wierman's employer
for her research accounts.
(http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3968T1.htm;
accessed 1/06/05)
Paul D. Woolf, M.D., Professor of Medicine, Temple University School of
Medicine and Chairman, Department of Medicine, Crozer Chester Medical
Center, Upland, PA. Owned between $25,001 and $50,000 of stock in one
of Crestor's (a cholesterol-lowering drug made by AstraZeneca)
competitors.(http://www.fda.gov/ohrms/dockets /ac/03
/transcripts/3968T1.htm; accessed 1/06/05)
*****
Where is the press on this? Why are these things not reported and made
public in the media? Do Americans have no concept at all about
corruption and ethics? I guess not.
TC