VOL. 2 ISSUE 13 May 22, 2002

PSORIATIC ARTHRITIS MEDICAL NEWS

I hope you found the last newsletter interesting, informative and thought
provoking.

BAYER CORP. CLAIMS McNEIL - PPC USES FALSE AND MISLEADING ASPIRIN ADS NEW
YORK (AP) -- Bayer Corp. filed a lawsuit against McNeil-PPC Inc., a division
of Johnson & Johnson, alleging the company's ads for St. Joseph aspirin are
false, misleading and potentially harmful to consumers.
The lawsuit, filed Thursday in U.S. Southern District Court in New York,
seeks to stop the print ad campaign as well as unspecified damages.
Last year, McNeil resurrected the St. Joseph aspirin brand and began
promoting the orange-flavored 81 milligram tablets to reduce the risk of
heart attacks. St. Joseph was originally marketed for children but demand
slumped in the early 1980s when doctors reported a possible link between
giving children aspirin and Reye's Syndrome.
The suit alleges the ads mischaracterize scientific data and a recent medical
journal study to claim that 81 milligrams of aspirin is just as effective as
325 milligrams in reducing the risk of recurrent heart attacks. Bayer, which
invented aspirin, said the Food and Drug Administration has approved aspirin
doses ranging from 50 milligrams to 650 milligrams for heart disease. It
maintained the most frequently prescribed dose by doctors to prevent heart
attacks is 325 milligrams.
Last year, Bayer challenged St. Joseph advertising claims through the
National Advertising Division of the Council of Better Business Bureaus. Last
month, the Council recommended McNeil discontinue some if it claims.
McNeil spokesman Mark Gutsche said the company complied with the council's
request and will defend itself against the suit. Copyright 2002 The
Associated Press.

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CAN A NEW TREATMENT REVERSE AUTOIMMUNE DISEASES?
May 7, 2002 (Society for Women's Health Research) -- A new treatment has
cured type 1 diabetes in mice by stopping their own killer immune systems
from turning on themselves and allowing the insulin- producing cells of the
pancreas to regenerate. The research promises to yield improved therapies for
people afflicted by this and other autoimmune diseases including Crohn's
disease, lupus, and rheumatoid arthritis. "This is the first time anyone has
ever been able to reverse established diabetes and literally regrow the
affected organ," said Denise Faustman, M.D., Ph.D., of Harvard Medical
School, lead investigator of the study and chair of the board of directors of
the Society for Women's Health Research."This same therapy may be feasible in
humans."
The ABCs of Autoimmunity - The immune system normally springs to action when
bacteria, viruses and other unfamiliar cells invade the body. Yet in
autoimmune diseases the body attacks its own healthy tissue. For unexplained
reasons, women's immune systems are more likely than men's to turn on
themselves. In fact approximately 75 percent of autoimmune disease sufferers
are women.
In type 1 diabetes, the immune system attacks and destroys the pancreas,
leaving the body without ample insulin to control the level of blood sugar.
Uncontrolled diabetes wreaks havoc on blood vessels and organs leaving
sufferers at increased risk for heart disease, amputations, and blindness.
Type 1 diabetes usually sets in during puberty and affects more than 500,000
Americans.
New Treatment Reverses Type 1 Diabetes - Dr. Faustman and colleagues used a
two-pronged approach to halt the body's attack on itself. First they used a
naturally occurring chemical, TNF-alpha, to kill misdirected immune cells
programmed to attack the pancreas. Then, they trained immature immune cells
to correctly distinguish between self and non-self thus preventing future
attacks.
Approximately 75 percent of diabetic mice that received this treatment were
effectively cured of diabetes long after the therapy was discontinued. After
more than three months, the researchers killed the animals to examine their
pancreases. Autopsies revealed "beautiful, functional" pancreatic cells in
place of a defunct organ.
Dr. Faustman theorizes that killing off awry immune cells and thus providing
a nurturing environment for damaged organs to regrow may similarly eliminate
many other autoimmune diseases. She emphasizes, however, that researchers are
a long way off from determining whether the laboratory findings can translate
into new treatments for humans. The study was funded by a grant from the
Iacocca Foundation. (Society for Women's Health Research - 2002)

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EXPERTS RAISE ALARM OVER HEALTH INFORMATION ON INTERNET
By Patricia Reaney - LONDON, (Reuters) - Believing what you read on the
Internet could be bad for your health.

The quality of health information on the worldwide web varies from the
accurate and credible to the personal beliefs of unqualified people,
researchers said on Friday.

And consumers, who are taking more responsibility for their health, cannot
always spot the difference.

"You have completely different levels of information," said Chiara
Pandolfini, a Milan-based epidemiologist who has studied and compared medical
web sites.

"Somebody who doesn't know enough about a topic might think they have
everything they need when there might be certain crucial things missing. It
is very, very variable," she said in an interview.

In research reported in the British Medical Journal, Pandolfini and her
colleagues at the Institute of Pharmacology Research found that data on the
information superhighway has improved in the past four years but still has a
long way to go.

A separate study of 121 websites providing information on five health topics
found that information on apparently credible websites is not always
accurate.

"Our study shows that features of website credibility have only slight or at
best moderate correlation with accuracy of information in five common health
topics," said Khalid Khan, of Birmingham Women's Hospital in England.

Despite initiatives to improve the quality of data, Pandolfini said it may
never be possible to ensure the quality of information because sites are not
rated in any way.

"It would be important to study the effects on consumers -- what they think
about the information and how they change their behaviour," she said.

Scientists at the University of Heidelberg in Germany are trying to do just
that. They have launched what they say is the first attempt to systematically
collect information about the impact of cybermedicine and E-health, and any
harm caused to patients.

The Database of Adverse Events Related to the Internet (DAERI) is seeking
information on patients who may have been harmed psychologically or
physically because of information on the Internet or through web prescribing
of medicines, misdiagnosis or delays in seeing a doctor.

The researchers said they were not implying that the Internet is harmful to
patients or the patient-doctor relationship but more information is needed
about its impact on patients.

"We need qualitative data in order to suggest measures that may minimise the
risks involved in using the Internet by consumers for health information,"
the researchers said on the DAERI website (www.medcertain.org/daeri).
Copyright 2002 Reuters Limited. All rights reserved.

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BRAIN LINK TO FATIGUE SYNDROME - Sydney Morning Herald - May 03, 2002 An area
of the brain that controls the stomach receives substantially less blood in
some people with chronic fatigue syndrome, a study shows.

The finding adds more weight to the argument that the controversial illness
is biological, not psychological.

Brain scans of 40 chronic fatigue patients were carried out by Adelaide
scientists and compared against the scans of healthy people.

The director of nuclear medicine at Queen Elizabeth Hospital, Dr. Steven
Unger, who headed the study along with neurologist Dr Rey Casse, said:
``There was a very strong change in cerebral blood flow in patients.''

The study showed a reduction in blood flow to the brain's insula cortex,
which governs the smooth muscle in the gut. Unexplained stomach and bowel
symptoms are common complaints for chronic fatigue patients.

The findings also showed a 20 per cent reduction in blood flow to the left
lateral temporal lobe, which controls access to words, in younger chronic
fatigue patients. Severe sufferers often experience difficulty expressing
themselves.

In separate research, endocrinologist Dr Richard Burnett, of the Royal
Adelaide Hospital, has shown that chronic fatigue patients who report gastric
symptoms empty fluid from their guts at less than half the speed of people
who are well.

"Talking to patients, about half of them have some kind of [gut symptoms],
such as abdominal bloating after eating a small meal,'' he said. "A delay in
liquids means a central problem. It comes from the brain." Sydney Morning
Herald - 2002

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FDA OKs NEW BLOOD PRESSURE DRUG
April, 2002 WASHINGTON (AP) -- The Food and Drug Administration has approved
an additional drug for the treatment of high blood pressure.

Approval of Benicar, developed by Sankyo Pharma Inc. of Parsippany, N.J., was
announced Friday.

It is the latest drug in a type known as angiotensin II receptor blockers.
These drugs interfere with the activity of angiotensin, a peptide that causes
blood vessels to constrict, increasing blood pressure.

Benicar is expected to be available next month, the company said. The dose is
one pill daily and the wholesale price will be $1.05 per pill.

In clinical trials the only side effect noted was dizziness, affecting about
3 percent of the patients. Benicar is also known by the chemical name
olmesartan medoxomil.
Copyright 2002 The Associated Press. All rights reserved.

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FDA OKs SPEEDIER MEDICATION REVIEWS
By LAURAN NEERGAARD .c The Associated Press WASHINGTON (AP) - The Food and
Drug Administration has reached agreement with the drug companies it
regulates on steps that might speed review of new medications, in return for
tens of millions in new industry fees.

The industry has long funded a significant portion of the FDA's drug review
work. But for the first time, Wednesday's agreement would allow some of that
money to go to improved safety monitoring of new drugs - allowing the FDA to
eventually double its number of staffers who oversee the risks of newly sold
therapies.

Health and Human Services Secretary Tommy Thompson called that part of the
deal essential to protecting public health.

``The measures described in these recommendations would benefit all concerned
- the FDA, the companies developing new therapeutics and, most importantly,
the patients waiting for those new products,'' said Carl Feldbaum of the
Biotechnology Industry Organization.

But drug safety advocates say some of the proposal is worrisome. In wake of a
dozen drugs pulled off the market because of dangers in recent years, critics
say the FDA already is approving drugs too fast and doesn't adequately
monitor problems that can arise when new ones hit the market.

Rep. Henry Waxman, D-Calif., is concerned that the new agreement doesn't
provide enough money for drug safety. His office notes that industry already
isn't keeping promises to FDA to conduct further safety studies of newly
marketed drugs: A report delivered to Congress Wednesday shows that happens
with only 37 percent of regular drugs and 15 percent of biotech ones.

And Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said the
FDA should be keeping drugs off the market until they're proven safe instead
of letting companies try to manage risks with warnings that too often go
unheeded.

Drug companies have paid millions in user fees that help fund FDA's review of
their products since 1992, under a law called the Prescription Drug User Fee
Act, or PDUFA. That law expires on Sept. 30 and Congress is beginning debate
on how to renew it.

At the same time, it is costing more to review ever more complex drugs - and
companies are discovering fewer of them, meaning the FDA is getting fewer
industry payments. The result is a shortfall that reached $30 million this
year, the FDA told Congress last week.

Wednesday, the FDA sent Congress a letter outlining agreements with industry
on how it would spend fees if Congress renews the law - fees that would
increase from $160 million last year to $223 million next year and nearly
$260 million by 2007.

If the new fees are approved, the drug industry says it will be paying more
than 51 percent of the costs of reviewing and approving medications.

The FDA says it already reviews lifesaving drugs in six months and most
others in 10. But in return for the funds, the FDA agreed to some changes
that might add more speed, including ``rolling reviews'' where the FDA
renders a decision on one part of a new drug application even as final
studies of the medicine are still under way.
The Associated Press. -2002

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MOST DOCTORS GET FREEBIES FROM DRUG FIRMS
By Maggie Fox - WASHINGTON, (Reuters) - From free samples of drugs to tickets
to ball games, most doctors in the United States say they have received a
giveaway from a drug company, according to a survey released on Tuesday.

Virtually all get free samples of drugs, and 61 percent say they have
received meals, tickets to events, or free travel, according to the survey by
the Kaiser Family Foundation, a nonprofit group that researches health and
family issues.

Drug companies spend far more on spending to influence doctors than on
research and development, or even on advertising to consumers, the foundation
found.

"It is an issue that raises concern and that warrants real public scrutiny
because you have got commercial interests trying to influence the behavior of
doctors and patients," said foundation President Drew Altman.

What is not clear is how much these perks influence doctors, Altman said. "It
requires a close look," he said, adding that he plans more studies on the
subject.

"It's bad because it undoubtedly drives up health-care costs and because some
people will get drugs they don't need, and it is potentially good because
some people will get drugs that they need."

Altman said it will be hard to measure actual influence, although clearly the
drug companies believe they are influencing doctors or else they would not
spend so much trying.

"I have a really hard time believing that any physician would ever prescribe
a drug because he or she is being influenced by drug companies when they felt
it was not in the patient's interest," he said.

"The problem is that a lot of medical situations are very gray and that is
where influence can come in."

DOCTORS KNOW DRUG COMPANIES WATCH THEM - The survey found that most doctors
are aware the drug companies keep track of what prescriptions they write, and
about a third are very bothered by this.

"They know the drug companies are monitoring them. They know the drug
companies are trying to influence them," Altman said. "But when you talk to
physicians anecdotally, they just shrug it off and laugh. They say 'I am
enjoying the free vacation but I am not affected by it."'

Kaiser surveyed more than 2,600 doctors across the country for its report,
which found only 12 percent said they got financial incentives to participate
in drug trials.

But drug companies try other routes to get a doctor's attention -- from
giving them pens, medical equipment and reference material embossed with a
drug's name, to paying for trips to vacation destinations for seminars.

"Of the $15.7 billion pharmaceutical companies spent on promotional
activities in 2000, $13.2 billion went to promotions directly to physicians,
including providing free drug samples, detailing by drug company
representatives, and journal advertising," the report, available on the
Internet at http:/www.kff.org/content/2002/20020321a/, reads.

"This is more than five times the $2.5 billion spent on direct-to-consumer
advertising."

Last year, the Kaiser foundation found that the $15.7 billion pharmaceutical
industry promotion budget equaled 14 percent of revenues. That compared to
3.7 percent of sales revenues spent on promotion by department stores, 3.9
percent for tobacco products and 10.7 percent for soap and detergent.

The earlier report found drug companies spend only 14 percent of revenues on
research and development, although they say drugs are expensive because they
cost so much to develop.

Doctors were lukewarm in their praise of the information they get from drug
companies on their frequent visits to physician offices or on the free trips.

Fifteen percent said it was "very" useful and 59 percent said the information
was "somewhat" useful. Copyright 2002 Reuters Limited. All rights reserved.

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PHARMACEUTICAL SPENDING CONTINUES STEADY INCREASE - A Few Heavily Advertised
and High-Priced 'Blockbuster' Medications Drive 17 Percent Increase
By Ceci Connolly - Washington Post Staff Writer

For the fourth straight year, prescription drug spending rose more than 17
percent in 2001, driven in large measure by a few heavily advertised,
high-priced medications, a nonpartisan study released yesterday found.

Sales of prescription medication at retail stores and through mail-order
companies totaled $175.2 billion last year, an increase of $27 billion over
2000, according to the National Institute for Health Care Management. The
institute is a private, nonprofit research organization led by physicians,
insurance executives and policymakers from both parties.

Overall, pharmaceutical costs continue to be the fastest-rising component of
health care expenditures, accounting for about 10 percent of spending.
Although price increases were part of the reason for the jump, the
researchers found that drug use and advertising were also prime factors. In
short, more doctors are writing more prescriptions for the most expensive,
heavily marketed drugs.

While the trend was criticized by some consumer advocates and politicians,
pharmaceutical makers and some economists said today's blockbuster drugs save
not only lives, but also dollars.

"Although we talk about how fast drug costs are going up, this is helping to
reduce the rate of growth of other medical costs," said Frank Lichtenberg, an
economist at Columbia University's business school.

In a number of studies, Lichtenberg has found that modern medications help
people live longer, with a better quality of life, so they spend less time in
hospitals and more time contributing to society.

"Ultimately, they provide tremendous benefits to society," he said.

Nevertheless, he said there is plenty of waste in the pharmaceutical industry
and "ridiculous" decisions by doctors and patients about which medication to
use when. Take the people who insist upon eating fatty foods late at night
and never exercise, he said.

"They don't want to lose weight or change their diet or take Tums. They're
pummeled by advertising, so they go to the doctor demanding" a prescription
medication such as Prilosec or Prevacid, he said. "That's a waste."

Frank Clemente, director of Public Citizen's Congress Watch, said few doubt
the value of the latest medical advances, but he believes it appears the
industry is price-gouging.

"The prices are greatly in excess of what they need to have research and
development dollars," he said. On average over the past decade, the
pharmaceutical industry has been the most profitable by far, he said,
reporting profits about three times the size of other Fortune 500 industries.

With so much money at stake, both sides have invested heavily in shaping
public opinion.

The National Institute for Health Care Management, the author of the report,
receives funding from the federal government and insurers. Researchers such
as Lichtenberg and Vermeulen said they are subsidized by drug manufacturers.

Last year, about three dozen drugs were responsible for half the total
increase in expenditures, according to yesterday's study.

Americans consumed record quantities of well-known drugs such as Prozac,
Lipitor and Prilosec to treat depression, high cholesterol and heartburn,
respectively.

Antidepressants remain the top-selling therapeutic class, with $12.5 billion
in retail sales.

The average price for a prescription rose 10 percent, from $45.27 to $49.84,
the study found. The average price among the 50 best-selling drugs was
$71.56.

In many categories, two or three medications dominated the market. Nearly 75
percent of the prescriptions written to treat heartburn were for Prilosec or
Prevacid, for instance.

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RISKS OF ARTHRITIS DRUGS STUDIED - By LAURAN NEERGAARD
.c The Associated Press WASHINGTON (AP) - There's growing suspicion that
switching from aspirin to a more stomach-friendly arthritis drug could
increase some people's risk of heart attacks - and a study suggests the
reason: a drug-caused chemical imbalance that spurs blood clots.

The new research was in mice, not people. But the evidence is prompting
scientists to study users of new painkillers called cox-2 inhibitors to
determine whether their hearts are at risk.

At issue is whether people with heart disease - not healthy people - increase
their risk of heart attacks even more by taking the popular arthritis pain
relievers Vioxx or Celebrex.

The study by University of Pennsylvania researchers, in Friday's edition of
the Journal Science, suggests, biologically, how the drugs could cause such
side effects.

Vioxx maker Merck & Co. dismisses the study as irrelevant, because it is in
mice and presumes an effect in the human body far larger than the drug
actually causes.

A leading heart expert, however, called the new research a very important
step in explaining an earlier study that found certain Vioxx users suffered
twice the risk of heart attacks as users of an older painkiller.

``Now the only thing we're really missing is quantifying the magnitude of the
risk,'' said Dr. Eric Topol of the Cleveland Clinic, who wants more research
quickly to settle the issue.

Meanwhile, he said, ``If you have heart disease, it ought to be with
particular care and concern that you take these medications, ... because
there could be some risk.''

People's bodies harbor two forms of an enzyme that plays a role in
pain-causing inflammation and blood clotting. One of the enzymes, Cox-1,
makes thromboxane, which causes blood vessels to constrict and platelets to
become sticky, steps important in a heart attack or stroke. The other, Cox-2,
is a major source of prostacyclin, which dilates blood vessels and prevents
platelets from clumping together.

In a healthy person, the two coxes are thought to balance each other so blood
doesn't excessively clot.

In people at risk of heart attack, aspirin helps because it thins the blood
by blocking cox-1; it also slightly blocks cox-2.

Vioxx and Celebrex, in contrast, block only cox-2. Could that action let
cox-1's clotting tendencies run amok? The drugs' makers long dismissed that
idea, because other body chemicals also control clotting.

Then last summer, Topol and other doctors reported more Vioxx users than
users of the older painkiller naproxen suffered heart attacks. Vioxx maker
Merck & Co. argued Vioxx didn't cause illness, but naproxen, like aspirin,
thins the blood so naproxen users got an extra benefit.

The new study bolsters suspicion that Vioxx could play an active role.

In genetically engineered mice, researchers irritated an artery to spur
release of both clotting chemicals. Mice resistant to prostacyclin's effects,
a model of cox-2 inhibition, experienced more thromboxane-caused clotting
activity.

That's not proof people would be endangered, stressed lead scientist Dr.
Garret Fitzgerald, a University of Pennsylvania pharmacologist. After all, he
said, ``Mice aren't people.''

Still, ``the credibility of the hypothesis is enhanced'' enough that he plans
to begin studies in people to try to settle the issue.

But the study looked at mice that had completely inhibited prostacyclin,
while cox-2 drugs inhibit the chemical only half as much, said Merck
scientist Dr. Alise Reicin.

She said the study contributed no new information to the debate, but Merck
plans further safety studies to deal with the issue, although she would not
provide details.

Settling the issue is crucial because millions use cox-2 inhibitors. That
means, Topol said, that even if the risk is very small, it could result in
lots of heart attacks.
Copyright 2002 The Associated Press.

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STUDY; NEW DRUGS HAVE SIDE EFFECTS May 1, 2002 CHICAGO (AP) -- New research
estimating that 20 percent of recently approved prescription drugs have
serious and even life-threatening side effects suggests doctors should
prescribe older medication whenever possible.

"It's like playing Russian roulette when a doctor prescribes a newly approved
drug that doesn't have a big breakthrough," said Dr. Sidney Wolfe of Public
Citizen Health Research Group, a co-author of the study.

The findings, published in Wednesday's Journal of the American Medical
Association, should prompt the Food and Drug Administration to consider
raising its threshold for approving new drugs when safe and effective
alternatives exist, the researchers said. They said pressure from
pharmaceutical companies and doctors' failure to closely read warning labels
are partly to blame.

An accompanying editorial by two FDA experts said the analysis overstates the
problem.

Safety studies that are conducted before a drug wins approval typically
involve a few thousand patients and may not detect all side effects,
especially relatively rare ones, Drs. Robert Temple and Martin Himmel said.

"Frequent post-marketing label changes are therefore inevitable and should be
anticipated," they wrote.

Temple also noted that some medications cause side effects in only certain
groups of patients, such as pregnant women, which does not mean a drug is
dangerous for everyone.

The researchers, led by Dr. Karen Lasser of Cambridge Hospital and Harvard
Medical School, analyzed 548 drugs approved from 1975 through 1999. Of these,
56, or more than 10 percent, were later given a serious-side-effect warning
or taken off the market for safety reasons. The number climbed to about 20
percent when the researchers took into account drugs that were approved
toward the end of the period studied.

"When a drug that comes on the market has a 1-in-5 chance that it's going to
have to be banned or get a black-box warning is pretty worrisome," Wolfe
said.

Most troublesome new drugs do not represent any advance in treatment and are
at best no better than older, safer drugs already on the market, he said.

The study analyzed what are known as "black-box" warnings listed in the
Physicians Desk Reference, a compendium of drugs and labeling information
published annually. Black-box warnings highlight the most serious side
effects.

Sixteen drugs studied were withdrawn from the market, about half of them
within two years after winning FDA approval.

They include the diabetes drug Rezulin, which was approved in 1997 but has
been linked to dozens of cases of fatal liver damage. Lasser said doctors
continued to prescribe it in an unsafe manner even after it was given a
black-box warning, and it was ultimately withdrawn from the market in 2000.

Two allergy drugs, Seldane and Hismanal, were linked with potentially fatal
heart problems in certain patients but were not removed from the market until
several years after receiving black-box warnings.

The FDA is correct in saying doctors don't pay enough attention to warning
labels, but that is "all the more reason to do the right thing on the front
end," Wolfe said. "The remedy should be don't put the drug on the market
unless it's a breakthrough drug."

The FDA has said that while its drug review process has gotten shorter in
recent years, the procedure is still adequate. But the agency has expressed
concern over doctors not reading drug warning labels closely.

Temple said that while doctors are getting better at reporting side effects
to the FDA and drug companies, the agency is seeking further improvements,
including a proposal to include a drug's approval date on packaging inserts.

"I don't think anybody believes that we're absolutely at the best we can do,
but it's better," Temple said.

The study "adds" to the body of evidence that we really have to enhance our
system of risk management and evaluation of drug safety and effectiveness,"
said Christopher Milne, assistant director of Tufts Center for the Study of
Drug Development, who was not involved in the research.

But it also risks "going overboard" and making all patients on new drugs
think they should stop taking them, which could be harmful, Milne said.
Copyright 2002 The Associated Press. All rights reserved.

Good Health to All

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com

Issue 2002 5/22/2002 - 13