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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?


To: jopawa who wrote (561)11/17/1998 4:10:00 PM
From: John F Beule  Respond to of 2539
 
More pressure on the FDA:

California Empowers Its Seniors to Help Reduce Risk of Ulcers and BleedingCaused by Pain Relievers

State Groups Launch Unprecedented Public Health Campaign on NSAID Risks

LOS ANGELES, Nov. 17 /PRNewswire/ -- For the first time in the country, a
powerful alliance of senior groups, medical societies, healthcare
organizations, corporations, government representatives and consumer advocates
in California has rallied to combat what has been described in medical
journals as one of the most prevalent serious drug toxicities in the United
States.(1)

Stomach ulcers, bleeding and other complications caused by prolonged use
of non-steroidal anti-inflammatory drugs (NSAIDs) are responsible for the
deaths of more Americans each year than skin cancer.(2) Particularly hard-hit
are people over age 60. With California's ever-expanding elderly population
already the largest in the nation, NSAID complications pose a growing public
health concern.

"We have the responsibility and the opportunity to empower our senior
citizens to help reduce hospitalizations and deaths due to the complications
of prolonged NSAID use," said John Kehoe, Executive Director of the California
Commission on Aging. "We are pleased to announce the formation of the
California REDUCE Coalition (CRC), a group organized specifically to conduct
the largest statewide public health campaign ever to educate and mobilize
seniors to discuss NSAID risks."

In recognition of the CRC's agenda and the launch of the statewide REDUCE
campaign, the California State Legislature has declared November 17, 1998
"NSAID Risk Awareness Day" in a resolution sponsored by California Assembly
Member Elaine Alquist.

What are NSAIDs?

NSAIDs are non-steroidal anti-inflammatory drugs available by prescription
or over-the-counter. They are commonly used to treat pain, arthritis, and/or
inflammation. Examples of NSAIDs include ibuprofen, naproxen, ketoprofen, and
aspirin.(3) They are among the most relied upon pain relievers in the world,
used extensively by the 40 million Americans with arthritis. In California
alone, an estimated four million prescriptions are written for NSAIDs yearly.
Unfortunately, people who take NSAIDs are frequently at greater risk of
developing stomach complications, such as ulcers and bleeding.(4) NSAIDs
damage the protective lining of the stomach, and over time, these
complications may develop. Older people are at increased risk because the
normal protective mechanisms of the stomach decline with age, making the
stomach more vulnerable to the effects of NSAIDs. NSAID complications are the
second most common cause of ulcers and result in approximately
107,000 hospitalizations and 16,500 deaths annually in the U.S.(5)

"This issue is so important to the CRC members because our constituents
are seniors who have a high prevalence of arthritis and are among the highest
users of NSAIDs," said Lois Wellington, President of the Congress of
California Seniors. "Now the CRC provides the platform from which we can
effectively raise awareness about NSAID safety among a very broad audience."

About CRC

CRC is the first statewide extension of the national REDUCE (Risk
Education to Decrease Ulcer Complications and their Effects from NSAIDs)
campaign begun earlier this year by the American Gastroenterological
Association (AGA) and Searle, a pharmaceutical company specializing in
arthritis therapy. A national consumer survey conducted for the REDUCE
campaign revealed that most Americans are unaware or unconcerned that NSAIDs
may cause serious stomach problems.(6)

"Only one in five people who develops a serious stomach complication
related to NSAID-use experiences any prior warning sign," said AGA President
Donald O. Castell, MD, Kimbel Professor and chair of the department of
Medicine at Allegheny University Hospitals, Graduate. "We have documented
many misperceptions about NSAIDs; almost everyone underestimates their
personal risk of developing an NSAID-related complication. Unfortunately,
those most likely to underestimate their risk are over age 60 -- the very
group that is most vulnerable."

The dramatic knowledge gap about NSAIDs among the over-60 age group is a
red flag pointing to the need for more intervention and is the driving
principle behind the formation of CRC.

What Can Be Done

Beginning this fall, the CRC member organizations will conduct free Ulcer
Risk Screening & Awareness Events utilizing a powerful new medical screening
test developed by Gurkirpal Singh, MD, a nationally-renowned rheumatologist
and clinical assistant professor of medicine in the Division of Immunology and
Rheumatology at Stanford University School of Medicine.

The new medical screening test, known as SCORE (Standardized Calculator of
Risk for Events), was based on data from the Arthritis, Rheumatism and Aging
Medical Information System (ARAMIS) database. The SCORE calculator poses a
series of simple questions concerning risk factors, including age, overall
health, development of rheumatoid arthritis, use of oral corticosteroids,
history of ulcers or other gastrointestinal (GI) complications, and past
stomach upset related to NSAIDs. Each answer is given a score and the
cumulative total at the end of the screening gives the responder's risk level
for developing ulcers or other GI complications.

SCORE results, personal risk profiles, and alternative therapies to
protect against NSAID-induced ulcers should be discussed with a medical
professional before making any medical decisions in response to these
materials.

The Ulcer Risk Screening & Awareness Events will take place at local
senior, medical and community centers throughout California, and will be
complemented by a direct mail program to 25,000 seniors. Additionally, the
national REDUCE campaign is offering free interactive ulcer risk screening and
counseling to anyone in the country via the toll-free number 877-REDUCE1
(877-733-8231); callers can speak live with a trained operator. Screening
also is available via the Internet at www.seniors.org, the web site for the
California Congress of Seniors.

More About CRC

The California REDUCE Coalition was founded to address the need for
improved awareness about NSAID-induced ulcer risk, particularly among
high-risk groups such as arthritis sufferers. The CRC is a group of concerned
organizations which have come together to focus their resources on a single,
critical public health issue -- NSAID-related stomach ulcers and bleeding.
Through its efforts, the CRC seeks to empower seniors to understand their
risks and work with health professionals to decrease them.

About AGA

Founded in 1897, the American Gastroenterological Association is one of
the oldest medical specialty societies in the United States. Its members are
physicians and scientists whose practice and research involves the functioning
and disorders of the gastrointestinal system.

The AGA fosters the development of knowledge of digestive functions and
diseases and the improvement of care for patients who suffer from digestive
disorders. For more information about the AGA, visit the organization's
website: www.gastro.org.

About Searle

Searle, the pharmaceutical sector of Monsanto Company, is a research-based
company that develops, manufactures and markets prescription pharmaceuticals
worldwide. Based in Skokie, Illinois, it is the world's third-largest
marketer of arthritis treatments. For more information on Searle, visit the
company's website: www.searlehealthnet.com.

(1) Singh G et al. Gastrointestinal Tract Complications of Non-steroidal
Anti-inflammatory Drug Treatment in Rheumatoid Arthritis. Archives of
Internal Medicine. 1996; 156: 1530-1536.

(2) Anderson RN et al. Centers for Disease Control and
Prevention/National Center for Health Statistics Report of Final Mortality
Statistics, 1995. Monthly Vital Statistics Report. 1997; 45 (11) (suppl 2).

(3) Note: Acetaminophen is not an NSAID.

(4) Bocanegra TS et al Diclofenac/Misoprostol Compared with Diclofenac
in Treatment of Osteoarthritis of the Knee or Hip: A Randomized, Placebo-
Controlled Trial. J Rheumatology. 1998: 25; 1602-1611.

(5) Singh G. Recent Considerations in Nonsteroidal Anti-Inflammatory
Drug Gastropathy. The American Journal of Medicine. 1998; 105 (1B).

(6) Roper Starch Worldwide NSAID Risk Survey, January 1998.'

SOURCE Searle

CO: California REDUCE Coalition; American Gastroenterological Association;
Searle; Monsanto Company

ST: California

IN: HEA MTC

SU:

11/17/98 10:22 EST prnewswire.com



To: jopawa who wrote (561)11/17/1998 6:53:00 PM
From: Anthony Wong  Read Replies (2) | Respond to of 2539
 
Health Insurers Study New Arthritis Drugs From Monsanto, Merck

Bloomberg News
November 17, 1998, 4:10 p.m. ET

Health Insurers Study New Arthritis Drugs From Monsanto, Merck

San Diego, Nov. 17 (Bloomberg) -- Monsanto Co. and Merck &
Co., working to bring new arthritis pills to market, face a
challenge convincing health insurers that it's worth paying more
for painkillers that could be free of dangerous side effects.

Their success in making that case will determine whether
their drugs, the first two in a new class known as Cox-2
inhibitors, will meet analyst expectations for combined annual
sales of as much as $5 billion.

The drugs, which promise relief from arthritis pain without
the risk of dangerous gastric bleeding, are likely to be sold at
much higher prices than existing painkillers such as Roche
Holdings Ltd.'s Naprosyn and Novartis AG's Voltaren. Managed-care
companies are already asking whether they are worth the money.

''They don't provide additional pain relief,'' said Robert
Seidman, WellPoint Health Networks Inc.'s vice president for
pharmacy. ''The majority of patients don't have a problem with
gastric upset, so there's no reason to pay $4 a day when you can
pay $4 a month.''

While the drugmakers say they've yet to decide how they will
price the new treatments, they are already talking up the
benefits of these medicines.

Researchers from Monsanto and Merck last week presented data
on trials of the Cox-2s at a meeting of the American College of
Rheumatology, the world's largest annual gathering of arthritis
specialists.

The new drugs seek to target an enzyme linked to pain and
swelling, cyclooxygenase-2, without hampering a related enzyme
that helps protect the stomach from the acid it contains.

Older Patients

The drugs might be good for patients taking drugs that
predispose them to bleeding, Seidman said. Many older people take
such drugs, including DuPont's Coumadin, to prevent heart
attacks.

''If you're over 65, you can get the drug. If you have
rheumatoid arthritis, you can get the drug,'' Seidman said. ''If
you're out playing softball and you hurt your knee, you don't get
the drug.''

Brendan Healy, a health-care analyst at USAA Investment
Management Company, said he does expect the Cox-2 drugs to raise
costs for managed-care companies. USAA owns shares in both Merck
and Monsanto.

The drugs are largely expected to be used in place of non-
prescription medications for which managed-care companies don't
pay, said Healy, who follows managed-care companies including
Aetna Inc. and PacifiCare Health Systems Inc. and some
drugmakers.

The effect will likely be most pronounced in managed-care
companies with a heavy concentration of customers on Medicare,
the government health program for the elderly, Healy said.

Cost vs Benefit

''My guess initially is that it's going to cost more than
the benefits,'' Healy said. ''Arthritis isn't life threatening.
It's more a lifestyle type of thing -- you don't want to be in
pain all the time.''

Kaiser Permanente, the No. 1 U.S. operator of health
maintenance organizations, is drafting general guidelines for the
use of Celebrex and Merck's similar drug, called Vioxx.

Kaiser will likely only pay for the drugs for patients most
at risk, said David Campen, a rheumatologist who heads Kaiser's
formulary committee for Northern California.

''The issue is, to what degree do you spend to obtain a
benefit,'' Campen said. ''If we did a head scan of everybody in
the program every year, we'd pick up brain tumors. Are employer
groups that pay us willing to fund that sort of screening? Of
course not.''

Monsanto, which is scheduled to appear Dec. 1 before a Food
and Drug Administration panel studying its application for
approval of its Cox-2, dubbed Celebrex, or celecoxib, may try to
persuade insurers that they could save money by footing the bill
for its new drug.

Risks of Existing Drugs

Though the company declined to discuss its plans for
marketing the drug to insurers, a press release issued last week
pointed out concerns about the safety of existing arthritis drugs
-- known as non-steroidal anti-inflammatory drugs, or NSAIDs.

NSAIDs include Roche's Toradol, American Home Products
Corp.'s Orudis and SmithKline Beecham Plc's Relafen.

Recent research has found that upper gastrointestinal
complications from NSAID use lead to some 107,000
hospitalizations and 16,500 deaths each year in the U.S.,
according to Monsanto.

Managed-care companies also are looking at whether to pay
for new treatments for rheumatoid arthritis, a potentially
crippling form of the disease. The U.S. Food and Drug
Administration this month approved Enbrel, which was developed by
Immunex Corp., a biotech company majority owned by American Home
Products Corp.

Bioengineered Drugs

Bioengineered drugs are generally more expensive than
traditional pharmaceuticals like the Cox-2s because they're
tougher to develop and manufacture.

The wholesale cost of Immunex's Enbrel, which last week won
U.S. approval, is about $11,700 a year, versus about $3,500 for
the more toxic generic drug methotrexate, now the standard of
care for the disease, the company said.

''You've got to balance the cost difference with therapies
that are much more targeted -- giving them fewer side effects --
and are able to deliver much more than traditional
pharmaceuticals,'' said Peggy Phillips, Immunex senior vice
president for pharmaceutical development. ''It's all about
value.''

--Jim Finkle in Washington, Marion Gammill and Kerry Dooley in