PSORIATIC ARTHRITIS MEDICAL NEWS

Recently, there's been a great deal of publicity about medications. Some of
it is good news and some of it isn't. For many of us with Psoriatic Arthritis
and other related diseases, it becomes difficult to determine which of the
many medicines offered, become the medications we, along with our doctors,
decide to try. These are difficult decisions and the more we understand about
them, the better our choices can hopefully turn out to be.

STUDIES FIND ARTHRITIS DRUGS WORK FOR PSORIASIS
By DEENA BEASLEY - Reuters -LOS ANGELES (Feb. 22) -
Biologic drugs used to treat rheumatoid arthritis are also effective against
psoriasis, an incurable disease that leads to thick, scaly patches of skin,
according to new research.

The drugs -- Immunex Corp.'s Enbrel and Johnson & Johnson's Remicade -- are
bioengineered antibodies designed to inactivate proteins linked to
inflammation. In clinical trials to be presented next week at a meeting of
the American Academy of Dermatology in New Orleans, both drugs reduced
symptoms of moderate to severe psoriasis in about half of patients, Enbrel
after being injected twice weekly for six months and Remicade six months
after three initial infusions.

''The results are socko (impressive),'' said Dr. Alice Gottlieb, professor of
medicine at the Robert Wood Johnson Medical School in New Brunswick, New
Jersey, and the presenter of the studies. ''A 75 percent drop ... means these
people are wearing shorts and swimsuits and feeling good about themselves.''

Psoriasis, a chronic disease affecting more than seven million Americans,
occurs when skin grows faster than normal and old skin is not shed quickly
enough, causing inflamed, swollen and scaly patches. Drugs now most commonly
used to treat psoriasis --cyclosporine or methotrexate, can lead to kidney or
liver damage with repeated use.

Since psoriasis strikes many people when they are young adults, it is seen as
a lucrative market for biotech firms that could potentially sell their drugs
to patients for decades. Like rheumatoid arthritis, psoriasis seems to be a
disorder in which a person's immune cells attack his own body.

A mid-stage trial of 112 patients, injected twice a week for six months with
either Enbrel or placebo, found that 56 percent of patients treated with
Enbrel had at least a 75 percent improvement in their psoriasis at the
six-month point compared with 5 percent of patients on placebo. Thirty
percent of Enbrel patients achieved the trial's primary goal of a 75 percent
improvement at three months.
DRUGS BEING USED ''OFF LABEL'' - Enbrel was approved by the U.S. Food and
Drug Administration last month as the first treatment for psoriatic
arthritis, a disease that involves joints and skin. Gottlieb said side
effects seen most frequently in the Enbrel trial were mild upper respiratory
infections. She noted that the Enbrel trial was not designed to look at how
long the disease remissions would last and additional studies of both drugs
are needed.

A 29-patient trial of Johnson & Johnson's Remicade, which is given
intravenously, found that about half the psoriasis patients given three
infusions of the drug over six weeks maintained a 75 percent improvement in
symptoms six months after treatment.

The Remicade trial was an extension of an earlier study showing that 73
percent to 82 percent, depending on dose levels, of patients saw a 75 percent
symptom improvement 10 weeks after they were given the three infusions.

Immunex has said it plans to eventually file for U.S. Food and Drug
Administration (FDA) approval of Enbrel for treatment of psoriasis, but the
drug is already being used ''off-label'' for that purpose. ''I have already
written 15 prescriptions for Enbrel for my psoriasis patients,'' Gottlieb
said.

Several other companies are also developing biologic drugs for psoriasis.
Biogen Inc. filed last year for U.S. and European approval of its
experimental psoriasis drug, Amevive, which is designed to selectively target
a subset of T-cells. The drug can be given by injection or intravenously.
Amevive induces long-lived remissions, but two sets of doses are needed to
get to a 50 percent response level, Gottlieb said.

Genentech Inc. has said it plans to file a marketing application with the FDA
this summer for Xanelim, an antibody designed to block certain immune cells
from entering and binding to skin tissue. Once Xanelim, which is
self-administered subcutaneously, is out of a patient's system, relapse
occurs, so patients would need ''a once-a-week bolus pretty much forever,''
the researcher said. Reut15:16 02-22-02 Copyright 2002 Reuters Limited.
All rights reserved.

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WIDELY USED ARTHRITIS PILLS MAY BE NEW TREATMENT FOR CANCER April 4, 2002 -
BOSTON (AP) -- Scientists are hard at work recycling Celebrex and Vioxx, the
red-hot inflammation pills taken by tens of millions for arthritis. They have
an unlikely new use in mind, one maybe even more important than soothing
throbbing joints.
Their goal: Prove these medicines prevent cancer and perhaps even help cure
it.

While there are good scientific reasons to think they are onto something, the
experiments to settle it are not finished, and the optimists could be dead
wrong. Nevertheless, cancer researchers and pharmaceutical executives
entertain fantasies of a breakthrough role for an off-the-shelf medicine.

Among them is Dr. Philip Needleman, who has spent more than a decade - first
at Washington University and now at Pharmacia, where he is research director
- developing Celebrex as an arthritis medicine. Just three years on the
market, it is the 10th biggest selling prescription drug in the United
States.

But in his vision, that success is a mere warm-up. "People ask what gets me
juiced," Needleman says. "It's the possibility that in five or 10 years,
someone will say, 'Oh yes. Celebrex. That's also used in arthritis."'

Many in industry, government and medical schools seem to share his daydream.
In a world where people are used to disappointment, hopes run high that
Celebrex and its rivals can be redirected against the most feared disease of
all.

The drugs block production of a chemical called COX-2, which triggers pain
and inflammation and may also fuel the growth of cancer, where it is often
found in abundance.

The first big test will be in preventing colon cancer, second only to lung
cancer as a killer. Three big studies involving about 6,000 volunteers will
see if Celebrex and Vioxx stop pre-cancerous growths in the colon. The
results should be known within two years.

"If we could reduce the incidence of this disease by half, what an incredible
contribution that would be," muses Dr. Monica Bertagnolli of Brigham and
Women's Hospital in Boston, director of one of the studies. "That's what is
driving all of this."

But that might be just the start. Experiments on lab animals strongly suggest
the arthritis drugs could also help cure cancer, especially if combined with
chemotherapy or radiation. Whether the approach will actually work is
unclear, since testing Celebrex on cancer patients has just begun, but many
research teams are joining in.

In fact, Dr. Andrew Dannenberg, director of cancer prevention at Cornell's
Weill Medical College, estimates there may be as many as 100 separate cancer
studies involving these drugs worldwide.

"When in the history of drug development has a drug moved from arthritis to
cancer prevention and then been fast-tracked into cancer therapy?" he says.
"It's completely unprecedented."

One of these studies will examine whether Celebrex shows any sign of warding
off lung cancer in 20-year, pack-a-day smokers. Many others are testing the
drugs in people with cancer of the breast, lung, esophagus, skin, prostate
and bladder.

One reason for doctors' willingness to try the drugs is their apparent
safety. Celebrex and Vioxx - known as COX-2 inhibitors - were designed to be
easier on the stomach than aspirin and other inflammation fighters. Their
lack of frequent side effects makes them unique in cancer, a field not known
for gentle therapies.

"Everyone is looking to integrate COX-2 inhibitors into every aspect of
cancer treatment, because we don't expect them to be toxic," says Dr. Adam
Dicker of Jefferson Medical College in Philadelphia.

A major sponsor of this research is the National Cancer Institute, which
oversees Bertagnolli's colon cancer prevention study plus many of the smaller
treatment experiments with Celebrex.

Dr. Ernest Hawk, the agency's chief of gastrointestinal research, says the
government is betting on the drug because of the overlapping lines of
evidence - from epidemiology, animal experiments and more - that the approach
should work.

"What stands out is the weight of the evidence," Hawk says. "I can't think of
any class of drugs that have this much going for them, especially in colon
cancer. It's the consistency of the story."

Some of the most intriguing evidence comes from big population studies. At
least 25 of them involving about 2 million people have examined whether colon
cancer is less common in people who take aspirin, which works similarly to
the new arthritis drugs. Together they suggest that regular users are about
40 percent less likely than expected to have precancerous polyps or to die
from colon cancer.

Results of the first carefully controlled experiment of aspirin in colon
cancer will be made public at a cancer conference in April. Dr. John Baron of
Dartmouth Medical School said it will show aspirin in fact does slow the
return of precancerous polyps after their removal, although the benefit is
modest.

"There may be a tendency for people to hope for a magic bullet and not get
it," Baron cautions. Nevertheless, "the idea that aspirin is effective opens
the door for the COX-2 agents," which are safer and may be more powerful,
too, as experiments on lab animals seem to show.

Celebrex is already approved to help block polyp formation in people with a
rare genetic condition who develop tens of thousands of polyps and invariably
get colon cancer by their 40s. Bertagnolli's study and two others, sponsored
by Merck, Pharmacia and Pfizer, will settle whether the drugs can do the same
for garden-variety polyps.

Some believe Baron's results are a strong hint they can, although the
researchers hope for a more powerful effect than Baron saw with aspirin. In
the end, they say, aspirin may turn out to be the best choice for people at
risk of both heart attacks and colon cancer; the COX-2 blockers may make more
sense for those worried solely about cancer.

Still, safety is likely to be a concern for the new drugs, too, since even
rare side effects could outweigh the benefits when taken lifelong by large
numbers of healthy people at average risk of cancer.

Aspirin, ibuprofen and similar nonsteroidal anti-inflammatory drugs shut off
production of prostaglandins, substances that cause inflammation but also
have benefits. They do this by interfering with an enzyme called
cyclooxygenase, or COX, which the body needs to make prostaglandins.

In the late 1980s, Needleman and others found there actually are two
varieties of COX: COX-1 promotes normal body functions, making blood clot and
protecting the lining of the stomach. COX-2 comes into play in response to
injury and illness and causes pain and inflammation.

The discovery led to the design of drugs that stop inflammation in a more
precise way - by blocking only COX-2 rather than both kinds of COX, as
aspirin does. The result is medicines that relieve arthritis while having
little effect, either good or bad, on the heart or the stomach.

An inkling that the same drugs might also ward off cancer emerged from rat
and mouse experiments in the 1990s. In one, scientists looked for a way to
change the fate of mutant rodents that typically grow 600 colon polyps. When
they knocked out the gene that makes COX-2, they found the animals' polyp
counts fell to 90.

In another, they grew mice that make vastly elevated amounts of COX-2 in
their mammary glands. The result: They got cancer.

In tumor-prone animals, Celebrex and Vioxx can suppress or prevent cancer of
the colon, prostate, intestines, breast, skin, lungs, bladder and tongue.
Many other anti-inflammatory drugs can do this, too, but the COX-2 blockers
seem to be the most potent, at least in animal experiments.

Translating such discoveries into treatments for people is always tricky. But
scientists say there is plenty of circumstantial evidence that COX-2 does bad
things in humans, as well. For instance, levels of the enzyme are unusually
high in some pre-malignant growths, such as colon polyps, as well as in many
kinds of cancer.

Scientists are trying to learn exactly why, but they believe the process
probably starts harmlessly enough. The body makes COX-2 as a normal response
to injury but sometimes doesn't know when to stop.

"In those cells that go on to become cancers, the ability to turn off
production of COX-2 may be lost," says Dr. Steven Dubinett, UCLA's chief of
lung cancer research.

Scientists theorize too much COX-2 may help cancers flourish in several ways:
It promotes the growth of new blood vessels, which tumors need for
nourishment. It makes them less likely to die on cue, as ordinary cells do
when they become hurt or defective. And it protects the tumor from the usual
surveillance of the immune system.

By using drugs like Celebrex to turn down COX-2 production, scientists
believe they may take away one of cancer's shields, making it more prone to
killing by chemotherapy and radiation treatment.

"Often new drugs have surprising effects not initially anticipated, and they
may be good or bad," says Dartmouth's Baron. "This whole story illustrates
this perfectly." Copyright 2002 The Associated Press. All rights reserved.

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RHEUMATOID DRUG MAY PROLONG LIFE April 5, 2002 LONDON (AP) -- Methotrexate, a
key drug for rheumatoid arthritis, could help people with the crippling
disease live longer, new research suggests.

Methotrexate, originally a cancer drug, has been used to fight rheumatoid
arthritis for about 15 years. Since then it has been proven to slow
progression of the inflammatory disease and to make patients feel better, but
a new study provides the first hint it may also save lives.

Experts said the study, published this week in The Lancet medical journal,
were encouraging but did not provide definitive proof. Rheumatoid arthritis
strikes about 1 percent of people, usually in middle age.

People with the disease tend to die about 10 years sooner than normal,
according to Dr. Theodore Pincus, a prominent rheumatoid arthritis researcher
from Vanderbilt University in Nashville, Tenn.

It is not the type of arthritis common in the elderly because of the
wear-and-tear of aging. It occurs when the immune system goes awry and
attacks the joints, causing severe inflammation in the lining of the joints,
pain and stiffness. It is also linked to an increased risk of heart disease.

Scientists believe people with rheumatoid arthritis have shorter life spans
partly because they face increased chances of getting heart disease and dying
from it.

The latest study, led by Dr. Frederick Wolfe of the Arthritis Research Center
Foundation at the University of Kansas School of Medicine, found that
patients on methotrexate were 60 percent less likely to die prematurely than
those not getting the drug.

They were 70 percent less likely than people not on the drug to die from
heart disease.

Experts said that finding bolsters the growing body of evidence that
inflammation might play a role in heart attacks and that anti-inflammatory
medication might ward them off.

Methotrexate works by switching off the underlying inflammation caused by the
immune response.

Dr. David Scott, professor of clinical rheumatology at Guy's, King's and St.
Thomas' Medical School in London, said the survival findings echo what
doctors have suspected.

"If you go back 20 years when people had little treatment for their
rheumatoid arthritis, they did very badly. Death was common," said Scott, who
was not connected with the research. "There's no doubt that nowadays it seems
a lot better, inasmuch as not so many people seem to be dying and patients
seem to be doing a lot better overall."

The biggest change in the last decade in rheumatoid arthritis has been the
widespread use of methotrexate, he said.

"This would seem to be a drug treatment effect, but you can never be certain
that it isn't that the disease is getting milder," he said.

Part of the uncertainty comes from the way the study was conducted, other
experts said.

It involved 1,240 people with rheumatoid arthritis seen at a specialist
arthritis center between January 1981 and December 1999. A total of 588 of
the patients were put on methotrexate, at their doctors' discretion. Those
more ill tended to get the drug. By the end of the study, 191 of the patients
had died, 72 of whom were on methotrexate.

Wolfe adjusted his statistics to take account of the fact that the
methotrexate group was sicker, but experts say the study's method could not
rule out that factors other than methotrexate could have been at work.

A more robust approach is to randomly assign patients to either methotrexate
or a dummy pill so that not even the doctors know who's had what.

"He's adjusted for all the confounders that he can think of," said Dr. Marc
Hochberg, head of rheumatology and clinical immunology at the University of
Maryland School of Medicine. "But you still wouldn't be comfortable
concluding, based on this one study, that methotrexate is the reason that the
patients have a lower mortality rate."

Hochberg noted that studies designed similarly to this one had shown that
estrogen therapy was linked with a lower risk of heart disease death in
post-menopausal women, but that when researchers finally tested the idea by
randomly giving estrogen and dummy medication, no death prevention was
apparent. Copyright 2002 The Associated Press.

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VIOXX AND MENINGITIS A popular painkiller may have a rare but serious side
effect. A U.S. Food and Drug Administration report published in the Archives
of Internal Medicine links the non-steroidal anti- inflammatory drug Vioxx to
a non-infectious form of meningitis. Five cases of aseptic meningitis in
people aged 16 to 67 have been investigated and linked to Vioxx use, the FDA
says. None of the cases were fatal. The FDA is requiring that meningitis be
added to the list of potential side effects of the drug, Symptoms of
meningitis include, headache, stiff neck, eye pain, fever and chills, the AP
says. Copyright - The Associated Press 2002

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OSTEOPOROSIS DRUG EVISTA NOW BEING PROMOTED FOR HEART DISEASE
The osteoporosis drug Evista (raloxifene) does not seem to increase the risk
of heart attack and other heart problems in women with cardiovascular
disease. In fact, raloxifene may offer some protection to women with
cardiovascular disease or who are at high risk.

Raloxifene was designed to battle osteoporosis by boosting bone density.
Overall, raloxifene did not affect the risk of heart attack, heart-related
chest pain called unstable angina and other so-called coronary events. Nor
did the drug affect the overall risk of stroke or mini-stroke.

But among women at high risk of cardiovascular disease, those taking
raloxifene had a 40% lower risk of heart attack, stroke and other events.
JAMA February 20, 2002 ;287:847-857

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MORE INFORMATION ON EVISTA FROM UNIVERSITY OF ILLINOIS
SCHOOL OF PUBLIC HEALTH by Dr. Samuel Epstein MD
There is a confusion with Evista. Most people think of it as an estrogen
substitute. It is not meant to be an estrogen substitute, and it's not being
marketed as such.

It is being marketed as an alternative to women who cannot take estrogen, who
would like to prevent osteoporosis.

The drug's manufacturer, Lilly, with FDA's complicity, has suppressed
critical information that this drug poses major risks of ovarian cancer.

In a study specifically designed by Lilly to prove the drug's safety, Evista
was shown to induce ovarian cancer in both mice and rats. Moreover,
carcinogenic effects were noted at dosages extending below the therapeutic.

However, the study concluded: "The clinical relevance of these tumor findings
is not known." Lilly reached this conclusion despite the scientific consensus
that the induction of cancer in well-designed studies in two species creates
the strong presumption of human risk.

Nevertheless, Lilly failed to disclose this critical information in its
"Warning" to women. Furthermore, no reference at all is made to these risks
in a Lilly-sponsored publication on Evista in the December 4, 1997 issue of
the New England Journal of Medicine.

Ovarian cancer is recognized as an uncommon complication of long-term hormone
replacement therapy in the post-menopausal. Ovarian cancer strikes about
24,000 U.S. women every year, accounting for 4% of all their cancers. About
15,000 women die from ovarian cancer annually, making it the most lethal
female reproductive cancer.

Lilly's suppression of the evidence of ovarian cancer risks from Evista is as
reckless as is FDA's marketing approval, conduct which merits congressional
and legal scrutiny.

This drug should be withdrawn from the world market immediately. As
importantly, a 'Cancer Alert' should be sent to the over 12,000 women who
have participated in U.S. and international clinical trials in the absence of
informed consent. These women should also be offered lifelong bi-annual
surveillance for the early detection of ovarian cancer at Eli Lilly's
expense."
Samuel S. Epstein, M.D. Professor of Environmental Medicine at University of
Illinois School of Public Health, Chicago - Chairman of the Cancer Prevention
Coalition ©Copyright 1997-2002 Dr. Joseph Mercola

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ARTHRITIS DRUG MAY CAUSE LIVER DAMAGE
March 29, 2002 WASHINGTON (AP) -- A prescription drug for rheumatoid
arthritis has been linked to dozens of serious liver injuries and 12 deaths
and should be banned, a consumer advocacy group told the government Thursday.

Arava began selling in 1998 as a competitor to the gold-standard treatment
for rheumatoid arthritis, called methotrexate. When the Food and Drug
Administration approved Arava, the agency noted Arava worked no better than
the older drug, but said patients needed some different options.

Since then, the FDA has received at least 130 reports of severe liver
toxicity linked to Arava use, including 56 hospitalizations and 12 deaths,
said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Two of the deaths were people in their 20s.

Since Arava and methotrexate work equally well, and methotrexate also bears a
warning about possible liver damage, Wolfe compared the two. The FDA has six
times more reports of liver damage among Arava users than methotrexate users
- even though thousands more people use methotrexate, he said.

Citing similar reactions abroad, the European Union last year warned patients
and doctors about Arava's toxicity, Wolfe said. He wants the FDA to go
further and ban Arava's sales.

The FDA said it would carefully consider Wolfe's petition.

A spokeswoman for Arava manufacturer Aventis Pharma said she had not seen the
petition and declined comment about liver damage. Lise Geduldig said Arava
was "an important therapeutic option" taken by 200,000 people.

The American College of Rheumatology last summer warned doctors to take
special care in prescribing Arava, by repeatedly testing patients' livers for
signs of harm.

But it is impossible to predict which patients will be at risk, said Dr.
David Yocum of Arizona Health Sciences Center, who recently had an Arava
patient die. Yocum is a former scientific adviser to the FDA who joined
Wolfe's call for a ban.

Unlike other drugs that can clear the body shortly after patients swallow a
dose, Arava can takes months to dissipate. Yocum said that means there is not
much doctors can do if a patient shows signs of trouble.

Yet some insurance companies pay only for Arava, not more expensive newer
therapies that do not come with the same risks, Yocum complained.

"I do not believe that the general rheumatologist understands or has any
knowledge about these serious and potentially life-threatening
complications," he said.

Rheumatoid arthritis affects about 2 million Americans, the vast majority of
them women. It is not the kind of arthritis that plagues the elderly as their
joints essentially wear out. Instead, the immune system goes awry and attacks
patients' own cartilage. It typically strikes between ages 25 and 50.

Liver damage is not the only Arava concern, Wolfe said. FDA records show more
reports of lymphoma, high blood pressure and a life-threatening autoimmune
disorder called Stevens-Johnson syndrome among Arava users compared with
methotrexate, he said. Copyright 2002 The Associated Press. All rights
reserved.

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AUTOIMMUNE DISEASE MORE LIKELY WITH ENDOMETRIOSIS
By Kathleen Doheny - SAN DIEGO, Feb 26 (Reuters Health) - Women with
endometriosis, in which tissue normally found inside the uterus begins to
grow elsewhere in the body, are more likely than women without the condition
to suffer from autoimmune diseases such as rheumatoid arthritis or lupus,
according to survey findings presented here Monday.

The researchers found that women with endometriosis were also more likely to
have asthma and allergies, to have abnormally low thyroid function and to
have either chronic fatigue syndrome or fibromyalgia, National Institutes of
Health research fellow Ninet Sinaii reported at the VIII World Congress on
Endometriosis, sponsored by the American Society for Reproductive Medicine.

"While other studies have shown there may be some autoimmune dysregulation in
women with endometriosis, this is probably the first population-based,
epidemiological study" to look at the issue, Sinaii said.

Sinaii and colleagues from the NIH and George Washington University in
Washington, DC, polled 3,680 women with surgically diagnosed endometriosis,
asking them if they had ever been diagnosed with an autoimmune disorder, an
endocrine disorder, allergies, asthma, chronic fatigue syndrome or
fibromyalgia. The women ranged in age from 14 to 89, and their average age
was about 36.

"The thing that gives this study statistical power is the sample size,"
Sinaii noted. "Our hypothesis was, if so many studies have shown autoimmune
dysregulation (in women with endometriosis), it makes sense that we would
also see other autoimmune diseases."

The team speculated that the fibromyalgia and chronic fatigue they found
among the survey respondents might be related to the pain caused by
endometriosis. More than 98% of the women surveyed reported pelvic pain, and
41% reported infertility.

The results: 12% of the women surveyed also had an autoimmune disorder such
as lupus or multiple sclerosis, while less than 2% of women in the general
population have either disease. And 42% of the women with endometriosis had
underactive thyroid glands, versus less than 5% of women in the general
population. Asthma affected 12% of the women with endometriosis, but strikes
only 5% of women overall. Sixty-one percent of the endometriosis patients
suffered from allergies, versus 18% of women overall.

Chronic fatigue syndrome and fibromyalgia, though not considered autoimmune
diseases, were also more common among women with endometriosis; 31% had
either condition, while 4% of women overall have fibromyalgia and less than
1% have chronic fatigue syndrome.

More than 5 million women in the US and Canada have endometriosis, according
to the Endometriosis Association, a Milwaukee-based nonprofit research and
education organization that supported the research. When the tissue begins
growing outside its normal site, for example along the fallopian tubes, there
can be chronic pelvic pain, disabling menstrual periods, pain during sex, and
infertility. Treatments include surgery, hormones and pain medicines.
Copyright © 2002 Reuters Limited.

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FDA SUSPENDS DRUG-TESTING ROLE March 19, 2002 WASHINGTON (AP) - The Food and
Drug Administration is suspending a rule that lets the government require
safety testing of adult medicines commonly given to children - from asthma
treatments to Prozac.

The reason: FDA says Congress recently reauthorized financial incentives for
manufacturers to do those studies. The FDA said it wants to see if the new
law makes the old mandate, which drug makers hated, unnecessary.

But three Democrats complained to President Bush on Monday that the action
was halting "an important regulation that protects children from potentially
unsafe and improperly dosed medications."

Adult medications are commonly given to children without studies of their
safety or proper dosing because doctors have no alternative.

Drug makers have used the financial incentives to focus their studies on more
expensive drugs, like Prozac, rather than cheaper ones that no longer have
patent protection, but are used as much if not more in children, wrote Reps.
Henry Waxman of California, John Dingell of Michigan and Sherrod Brown of
Ohio.

The FDA's so-called "pediatric rule" was adopted in 1998. A conservative
think tank and the Association of American Physicians and Surgeons
immediately filed suit against it, represented by an attorney recently
appointed to be the FDA's chief counsel. He reportedly has recused himself
from the government's debate of the issue.

Shortly after the pediatric rule's adoption, Congress passed the financial
incentives, so it's unclear to what extent the FDA ever forced manufacturers
into child drug studies.

The new Best Pharmaceuticals for Children Act, signed into law in January,
reauthorized the financial incentives, plus set up a grant program to allow
taxpayer dollars for pediatric studies of drugs their makers, despite the
incentives, won't do. During a two-year suspension of the older mandate, the
FDA will assess if the new law takes care of the problem, said spokeswoman
Susan Cruzan.

But the new law is "no substitute for requiring drug makers to perform safety
studies," said Waxman spokeswoman Karen Lightfoot. Copyright 2002 The
Associated Press. All rights reserved.

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What you just finished reading in this newsletter about drugs, is a tiny
amount of the information that gets issued day in and day out. I will
continue to select additional articles and notices regarding medications and
include them as time and space allow.

Please let me know what topics are most important to you. I will be glad to
research drug information, different treatments, unusual conditions,
alternative medicines, or any situation that you believe will benefit our
nearly 1,000 members around the world. Because we now have a new website
which archives our newsletters, new members can go back and read past issues
which can be helpful.

Good Health to all

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com

Issue 2002 4/10/2002 - 9