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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: BigKNY3 who wrote (6440)12/8/1998 1:13:00 PM
From: Anthony Wong  Respond to of 9523
 
AHA SCIENTIFIC SESSIONS: Norvasc Demonstrates 31% Reduction In Cardiovascular Events

DALLAS, TX -- Dec. 8, 1998 -- Patients with coronary artery disease taking
Pfizer's calcium channel blocker, Norvasc (amlodipine besylate), had 31 percent
fewer cardiovascular events than patients treated with placebo, according to
results from the 825-patient Prospective Randomized Evaluation of the Vascular
Effects of Norvasc Trial (PREVENT).

Cardiovascular morbidity and mortality events include heart attacks, strokes,
deaths, angioplasty, bypass surgery, hospitalisations for severe angina and heart
failure. The reduction for angioplasty and bypass surgery was 46 percent and the
patients treated with Norvasc also had 35 percent fewer hospitalisations for
severe chest pain.

"This is an unexpected, highly favourable result that is in keeping with our
favourable experience with this drug," said John Mancini, M. D., professor and
head of the department of medicine at the University of British Columbia and the
Vancouver Hospital and Health Sciences Centre who directed the primary
analyses for the PREVENT trial. "The major importance of PREVENT is that
the drug amlodipine showed dramatic effect for reducing hospitalisations for
angina, angioplasty and bypass surgery in patients with coronary disease."

The PREVENT trial, which was presented today at the American Heart
Association meeting November 11th, enrolled patients who had coronary artery
disease at the start of the trial and were treated with standard medications for
their cardiovascular conditions as necessary. In addition, half the patients
received Norvasc, a long-acting calcium channel blocker characterised by a
gradual onset of action and a long half-life.

In PREVENT, angiographic analysis of coronary arteries in Norvasc patients,
the primary endpoint of the study, showed no discernible difference in the
progression of atherosclerosis compared to placebo patients. However,
researchers observed a significant reduction in plaque build-up in the carotid (the
major artery found in the neck that supplies the brain) in Norvasc patients
compared with placebo. This evaluation used imaging technology known as
ultrasound while the coronary artery measurement was based on angiography.
Researchers believe that ultrasound technology is much more sensitive in
measuring plaque progression or reduction.

High blood pressure, diabetes and high cholesterol are risk factors associated
with the development of atherosclerosis that affects the coronary and carotid
arteries. Cardiovascular disease claims the lives of approximately 79,000
Canadians annually and is the leading cause of death in Canada.

pslgroup.com




To: BigKNY3 who wrote (6440)12/8/1998 1:18:00 PM
From: Anthony Wong  Respond to of 9523
 
Viagra: the little blue pill that shook the world in 1998
Yahoo Asia - Tuesday December 8, 9:33 PM
yahoo.com.sg



To: BigKNY3 who wrote (6440)12/8/1998 2:00:00 PM
From: Anthony Wong  Respond to of 9523
 
13:48 Pfizer Says It Won't Sell Viagra In India

NEW DELHI (AP)--Pfizer Inc. (PFE) won't market its impotency drug Viagra in
India because of slack local patent laws, a senior company official reportedly
said Tuesday.

"It makes no commercial sense to market Viagra or any other of Pfizer's new
drugs in India in the absence of patent protection," Simon Campbell, who heads
the U.S. company's research wing, was quoted as saying in New Delhi by Press
Trust of India.

India's ruling coalition has announced it will reform its decades-old patents
law to being it in line with the World Trade Organization. But Campbell said
his company was apprehensive of the provision of exclusive marketing rights for
five years.

"Five years is too short a period for any drug firm to recover its
investments," he added.

Viagra has received wide publicity in India, and a local drug manufacturing
company is offering a herbal preparation to men that it says is much more
effective than the Pfizer discovery.

(END) DOW JONES NEWS 12-08-98
01:48 PM



To: BigKNY3 who wrote (6440)12/8/1998 3:18:00 PM
From: Anthony Wong  Respond to of 9523
 
Boston Globe - Little heed to women's sexual problems
December 7, 1998

By Alisa ValdÉS-Rodr Iguez, Globe Staff, 12/07/98

For Bonnie Myers, 41, Viagra is the miracle drug that rescued her
libido. No, her husband Russell doesn't swallow the blue pills. Bonnie
does. And for the first time in 10 years, the Maryland day-care worker is
having orgasms.

Preliminary studies, including one at Boston University, show Viagra can
affect sexual response in women much the same way it affects men. Spurred
by requests from women for the drug, scientists said they have come up with
a Viagra-like topical gel for women.

While these efforts represent a beginning in addressing female sexual
dysfunction, they are just that, and no product is likely to get FDA approval
before 2002. Even though drug companies and medical device makers have
worked for years to devise ways to treat male impotence, female sexual
dysfunction is only now being seen as a medical and not just emotional
problem.

It is emblematic of medicine's neglect of female sexual dysfunction that an
October conference on the subject that the Boston University School of
Medicine sponsored was the first of its kind ever.

Dr. Irwin Goldstein, the Boston University urology professor who led
development of the gel, said that women's sexual dysfuntion is ''an immature
field. A naive field. Not because women don't have these problems, but
because medicine has not addressed their issues.''

It was not until the October meeting that the medical community even
reached consensus on what female sexual dysfunction is. Now there are
several new classifications, including one called sexual arousal disorder,
caused by hysterectomy, menopause, and vascular disorders like diabetes;
this is the condition apparently aided by Viagra.

Specialists in women's health, sexuality, and history say the ignorance of
female sexual dysfunction stems from a long history of fear, denial, and
misunderstanding of women's sexuality and anatomy.

''Our understanding of female sexual anatomy and physiology has really
lagged behind that of the male,'' said Dr. Jennifer Berman, a urologist at BU
Medical Center. Berman and her sister Laura, a sex therapist, teach at BU
and are leading one of the first studies of women and Viagra.

Said Jennifer Berman, ''There has been very little support for research from
universities and foundations. The reason is probably multifaceted, but stems
from social taboos about women's sexuality, and the myth that female sexual
dysfunction is an emotional issue rather than a physical problem.''

Even though women also become ''erect'' when sexually aroused, that fact is
less known, even by women themselves, according to Carol Queen, a San
Francisco author who has written about culture and sex and has taken
Viagra.

''Women's sexuality is less culturally important,'' Queen said. ''A woman can
have sex and procreate without being turned on. She might not like it, but it's
possible. Male sexual arousal, on the other hand, is quite obvious.''

Queen pointed out that the majority of men getting Viagra prescriptions do it
not to reproduce, but rather ''to have a good time.'' Queen doubted HMOs
would be as willing to pay for ''pleasure drugs'' for women, and said their
reluctance to cover birth control medication demonstrated her point.

The FDA took six months to approve Viagra for men. But a lack of basic
sexual dysfunction research in women means the FDA will not be in a
position to begin considering Viagra for women until 2001 or 2002, say
Goldstein and the Bermans.

Once Viagra for men was approved by the FDA, many insurance
companies sped through the approval process to pay for it. Tufts Health
Plan, for instance, took only one month to decide to cover Viagra for men,
citing demand as the reason. The usual drug approval time for the HMO is
three to six months.

But a spokeswoman for the HMO said it would likely take longer to
approve coverage for women, because of the lack of documented research.

The basic problem, the Bermans and others said, is that so little work has
been done on the physiology of female sexual response and orgasm.

''Most research on women's sexual dysfunction has been done in the field of
psychology,'' Jennifer Berman said. ''The thought of having women stimulate
themselves in a clinical setting has been very disturbing to people when
we've applied for grants.''

The reason such a prospect is disquieting to people is a cultural tradition of
desexualizing women, according to Mary Daly, a feminist author and
assistant professor of theology at Boston College.

Goldstein dismissed this view as ''a bunch of feminists making statements,''
saying most research in sexuality was done on women in the 1960s and
1970s. The focus shifted to male sexuality, he said, only with the advent of
the penile implant.

But Jennifer and Laura Berman agreed with Daly, saying modern attitudes
about women's sexuality date from the Victorian era.

The Bermans, Queen, and Daly said that when the topic of Viagra for
women has been discussed by the media, Victorian notions of women's
sexuality have surfaced with an obvious taboo surrounding the clitoris.

The clitoris, the external organ responsible for female orgasm, contains the
same number of nerve endings as the penis and also becomes erect with
arousal. In utero, the penis and clitoris form from the same tissue.

The Bermans have found in their research that Viagra makes orgasm easier
for women by increasing blood flow to the pelvic area, as it does in men,
and specifically by causing the clitoris to become erect, as well as by causing
other reactions.

But the Bermans say they have been forbidden to use the word in many
television interviews, including recent ones with network anchors Dan Rather
and Peter Jennings. They say they are annoyed that many print articles dance
around the scientific facts by using vague descriptions of women's sexual
response, while specifics about the penis seem to be fine.

''It's frustrating and difficult to speak about a medical topic without being
able to speak clinically and anatomically,'' said Jennifer Berman.

''There is a long history of the clitoris being despised,'' Daly said, noting that
forced removal of the organ is common practice in much of Africa and the
Mideast.

An estimated 130 million women alive today have experienced the removal
of their clitoris in a procedure its proponents liken to circumcision, but its
critics say is more analogous to castration.

Daly said, ''What not many people know is that an English gynecologist
named Isaac Baker Brown invented the clitoridectomy in 1858, as a cure for
female masturbation.'' The procedure was common in the United States and
England until the early 1900s.

''We're up against centuries of misinformation,'' said Jennifer Berman, adding
that the open discussion of women's sexuality is ''the final frontier feminism
has yet to cross.''

''But that's what's really exciting about the hype around Viagra,'' she said.
''It's opening up lines of communication. If nothing else, we're talking about it
now.''

This story ran on page E01 of the Boston Globe on 12/07/98.
© Copyright 1998 Globe Newspaper Company.

boston.com



To: BigKNY3 who wrote (6440)12/10/1998 4:53:00 AM
From: Mick Mørmøny  Respond to of 9523
 
Stop, You're Killing Me

By Nicholas Regush
ABCNEWS.com

The killers are cutting off blood flow to a federal agency that's entrusted with ensuring the safety and effectiveness of pharmaceuticals, medical devices and other health products, and warning the public about their potential risks.

Congress is crippling the U.S. Food and Drug Administration on behalf of powerful manufacturers who want their products rubber-stamped quickly so they can get them to market. And when some of these highly profitable, hastily evaluated products fail and people die, these same manufacturers can rest assured that the FDA will move like a snail, and sometimes not at all, to ban their further sale.

Sometimes it takes ages before the FDA even gets involved and issues warnings about a troublesome product. A classic recent example of FDA foot-dragging were the delayed warnings, in the face of mounting evidence, about the risky use of Viagra by people with certain heart problems.

Thready Pulse
But since the FDA still has some twitch left, there are occasional desperate cries from within, from employees who still care about the Public Interest. The latest example: when the Washington-based Public Citizen Health Research Group surveyed 19 FDA medical officers anonymously, they identified 27 new drugs that they believed should never have been approved. These FDA employees, who oversee drug safety reviews, attributed the risky-drug OKs to pressure from Congress and manufacturers to speed up the process.

(Only a handful of the scores of drugs approved each year are truly life-saving, giving the lie to the supposed need to speed up drug evaluation rather than carefully consider potential dangers.)
Naturally, the drug industry lit into the Public Citizen survey of FDA medical officers, calling it biased, and thus championing the FDA speed-up policies of their congressional pals whom they help to re-elect.

Risking Jobs And Lives
One product that flew through the FDA “fast-track” process was the diabetes drug Rezulin, now associated with at least 33 deaths in this country and Japan due to liver damage. There is strong medical opinion that the world could have lived without Rezulin or, at least, that its prescription should have been restricted to a small number of special cases. But due to promotional efforts by medical “product champions,” more than 1 million Americans now take Rezulin.

This week, in a two-part series, The Los Angeles Times reported that FDA senior officials dismissed the concerns of a medical reviewer who warned of strong evidence that Rezulin could cause liver damage and opposed its approval. The FDA took the reviewer off the case.

Why am I not surprised? Disputes between product reviewers and senior officials at the FDA are really old news. This agency, which bills itself as the best of its kind in the world, actually has a dubious track record. A number of government oversight reports have blasted the agency for miserably failing to do its job of protecting consumers.

Decline and Fall

In 1991, for example, a 15-member panel headed by Charles Edwards, president of Scripps Clinic and Research Foundation and a former FDA commissioner, concluded that the FDA's problems were so severe that they posed a threat to Americans' health. The panel said the FDA needed stronger enforcement powers, better management, better-trained employees, more funds, improved laboratory equipment and more authority in government.

During 12 years of Reagan and Bush, the FDA had the stuffing knocked out of it. Since the late 1970s, seizures, injunctions and prosecutions by the agency have slowed to a trickle. Its reputation was further tarnished in 1989 when some of its drug reviewers were found to have taken bribes.

By the time Dr. David Kessler settled into running the FDA, senior managers didn't even have proper records of proposed regulations: some 400 — ranging from the size of type on drug packages to standards for defibrilators — had never been acted on.

And a 1992 congressional hearing produced evidence that medical-device reviewers were often undercut or ignored when they failed to recommend approval of a product, because some managers viewed non-approvals as jeopardizing their goal — a high approval rate.

Kessler the (Anti) Hero
For much of his reign, Kessler was viewed as an American hero. Carefully orchestrated FDA media campaigns set in motion several crusades, targeting food safety violations, improper drug advertising, breast implants and tobacco. This did give some new life to the FDA, raising morale and self-confidence half a notch in dealing with certain sectors of industry, which had grown accustomed to having a freer hand.

With the help of key members of Congress, however, industry fought back, arguing that the FDA was, in effect, killing people by moving slowly on the evaluation of drugs and medical devices. This was, and still is, pure bull, but the media and the public bought it and so did numerous organizations of patients with life-threatening diseases, which, in some cases, are funded by drug manufacturers.

Now that Kessler is gone to the Ivory Tower (Yale Medical School) and the White House feeds on its political victory on tobacco and ignores a dying FDA, the agency is in the doldrums, and some of its better employees are looking elsewhere for jobs.

The FDA has a new commissioner, Dr. Jane Henney, but she's not likely to fight the big boys and girls on the Hill. At this rate, the FDA will soon become a corpse.

abcnews.com