PSORIATIC ARTHRITIS NEWS AND VIEWS
VOLUME- 4 ISSUE- 13
September 15, 2004
PSORIATIC ARTHRITIS MEDICAL NEWS
AMA TO WEIGH INFLUENCE OF DRUG COMPANIES
CHICAGO (AP) -- Drug companies' influence on medical research and on doctors
themselves will be under the microscope as the nation's largest group of
physicians gathered for its annual meeting in June.
Proposals facing the American Medical Association include a measure seeking
to make all drug study results public, even unpublished research funded by
pharmaceutical companies that might reflect poorly on their products.
The measure stems partly from concern over unpublished data linking some
antidepressants with suicidal behavior in children. Government officials are
investigating the potential link.
Another measure would strengthen a policy the AMA adopted last year on
"shadowing," the practice of drug company representatives sitting in on
patients'
visits with their doctors.
Critics say the practice is an attempt to influence what medicines are
prescribed. Drug companies say the practice is educational, but they sometimes
pay
hundreds of dollars a day to the doctors for these visiting rights -- money
the new measure says doctors should refuse.
The more than 250 proposals prepared for the meeting, also asked the AMA to
take a stand on issues that include the obesity epidemic, the execution of
juvenile criminals and the harvesting of organs from patients who haven't
explicitly given consent.
The generally cautious AMA frequently avoids taking bold stands on
controversial issues, and many proposals at the five-day meeting will be
rejected or
revised before being sent to the group's delegates, who begin voting on
policies to adopt.
A new financial report touts the group's fiscal health, showing a $20.1
million operating profit in 2003 -- the fourth consecutive year of operating in
the black. The increase from $11.7 million in 2002 was attributed partly to
revenues from publishing and sources other than AMA dues, which have been
declining along with membership.
The AMA had 250,830 members in 2003, down from 260,455 in 2002, representing
about a third of the nation's doctors and medical students.
Still, any AMA support could lend credence to the meeting's proposals,
including the move to make all drug study results public.
As drafted, the measure would ask the U.S. Department of Health and Human
Services to consider forming a national registry of all drug studies, possibly
available over the Internet.
Alan Goldhammer of the industry group Pharmaceutical Research and
Manufacturers of America said a public research registry could lead to
misinterpretation.
"Those are the kinds of things that we'd have to look at and discuss before
endorsing or rejecting any proposal," Goldhammer said.
Calls for publicizing all drug studies also have come from the American
Psychiatric Association, the American Academy of Child and Adolescent Psychiatry
and bioethicists concerned about industry influence on doctors.
"It would be good to see the AMA get on board," said Merrill Goozner of the
Center for Science in the Public Interest. "Medical professionals who are
after all the prescribers and the primary users of these tools ... should be
the
guys in the forefront" of the issue, Goozner said.
It is critical for doctors to have all information on tested drugs so they
can make informed prescribing decisions, said Dr. David Fassler, a Vermont
psychiatrist.
Drug companies aren't required to publish study results, and medical journal
editors "are at the mercy of what is sent in the mail," said Dr. Catherine
DeAngelis, editor of the Journal of the American Medical Association.
Drug company-funded submissions more often than not have positive results, a
phenomenon called publication bias.
DeAngelis voiced support for the push for a national registry, as did Dr.
Jeffrey Drazen, editor of the New England Journal of Medicine. Copyright 2004
The Associated Press. All rights reserved.
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CONSUMER GROUP URGES BAN OF CHOLESTEROL DRUG
CONCERN OVER SIDE EFFECTS OF CRESTOR GROWS
By Robert Bazell-Correspondent NBC News
Otis Elliott started taking the cholesterol-lowering drug Crestor and
developed severe muscle pains within days.
â(I) just couldnât stand it anymore, the pain was too severe,â says
Elliott. However, by then it was nearly too late; Elliott went into kidney
failure,
which doctors say almost killed him.
In a recently published letter published in the medical journal The Lancet,
a consumer advocacy group warns that the danger of such life-threatening side
effects is unacceptably high with Crestor, a statin that was approved by the
Food and Drug Administration last August.
âSo everywhere you turn there are ads for Crestor and there is no question
that those ads help to sell drugs, but what patients have not known and what I
think a lot of doctors have not known is that the drug has unique risks,"
says Dr. Sidney Wolfe of the nonprofit group Public Citizen. All statins carry
a
slight risk of muscle damage, but the consumer group says the danger is
higher with Crestor, and only Crestor threatens the kidneys.
Ever since Crestor was approved by the FDA, the manufacturer, AstraZeneca,
has been heavily advertising the drug.
AstraZeneca says the concern about side effects is just flat-out wrong. âWe
believe the safety profile for Crestor has been very, very extensively studied
and weâre confident that it is comparable to the other statins," says David
Brennan, the company's CEO.
What is at stake is a potential portion of an enormous market â and human
lives. Sales of statin drugs in the United States now total $14 billion a year,
with 13 million people taking them. In addition, experts say the number of
people who should be taking the drugs is triple the numbers who are currently
taking them.
FDA officials say they agree with the manufacturer that Crestor is safe and
effective, but add that they will continue to study reports of harmful side
effects, such as Elliottâs case, to see if they reveal an unusual pattern. ©
2004 MSNBC Interactive
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YOUR GENES CAN AFFECT DRUG ACTIVITY
By Ed Edelson - HealthDay Reporter
A study showing that an individual's genetic makeup affects the response to
a cholesterol-lowering drug heralds a new medical discipline, researchers say:
pharmacogenetics.
It's not something that will change medical practice just yet, says Dr. Paul
M. Ridker, chief of the Center for Cardiovascular Disease Prevention at
Brigham and Women's Hospital in Boston and lead author of a new study appearing
in the June 16 Journal of the American Medical Association. But "over the next
10 years we will see a lot of studies of this kind that will help address the
issue of how we treat our patients."
"Burgeoning" is the word Ridker used for the field of pharmacogenetics,
while Susanne B. Haga, project director of human genetics at the Center for the
Advancement of Genomics, a private research group, said knowledge about the
interaction between genes and drugs "is growing by leaps and bounds."
Over the long run, said Haga, co-author of an editorial accompanying the
report, "information on how genetic variation affects drug efficacy and drug
safety will become a basic part of drug development." But right now, she said,
"the commercial ability to test for these variations is not available."
Still, the study "will be a real eye-opener for physicians and patients,"
Ridker said.
He and his colleagues did detailed genetic studies of 1,563 people taking
pravastatin (Pravachol), one of several statin medications being prescribed to
lower cholesterol levels. The researchers looked for individual variations
called single-nucleotide polymorphisms (SNPs) in genes that play a role in the
metabolism of cholesterol and other lipids.
One of those genes produces a molecule called HMG-CoA reductase. Two common
and closely linked SNPs in that gene "were significantly associated with a 22
percent smaller reduction in total cholesterol and a 19 percent smaller
reduction in LDL cholesterol following 24 weeks of pravastatin therapy," the
report said.
That gene-based reduced activity was found in about 8 percent of the people
studied, Ridker said, adding that the finding was more or less expected.
"We've known for some time that some patients get a greater reduction than
others," he said. "We were looking for evidence that genetic variation played a
role. We found it on the basis of genes that are the target of the drug
itself."
The finding doesn't call for any major change in treatment of patients with
the specific SNPs, at least now, Ridker said. "It could well be that just a
higher dose will overcome this problem," he said.
What is important is that the effect of genetic variation on the effects of
drugs used to treat cancer now has been verified for at least one drug used in
cardiology, Ridker said. It's not known yet whether genetic variation acts
in the same way on other statins, he said, and many more studies are needed to
determine the role played by pharmacogenetics in drug therapy.
"This paper is important because it is a first demonstration, but we are in
no way there yet," Ridker said.
SOURCES: Paul M. Ridker, M.D., MPH, director, Center for Cardiovascular
Disease Prevention, Brigham and Women's Hospital, Boston; Susanne B. Haga, Ph.D,
project director of human genetics, Center for the Advancement of Genomics,
Rockville, Md.; June 16, 2004 Journal of the American Medical Association.
Copyright © 2004 ScoutNews LLC.
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BLOOD CLOT RISK NOT TREATED PREVENTIVELY, STUDY FINDS
DURHAM, NC â In a nationwide study of hospitalized patients, researchers at
Duke University Medical Center and Brigham and Women's Hospital found that
individuals at risk for developing deep vein thrombosis (DVT) -- a disorder
characterized by the formation of blood clots in the deep veins of the legs --
often fail to receive preventive medications. DVT can cause death when leg
clots break free and lodge in the lungs, a condition known as pulmonary
embolism.
The study found that, of more than 5,000 patients who developed DVT, the
majority failed to receive prophylactic therapy in the 30-day period prior to
their diagnosis. What's more, said the researchers, in patients with DVT,
physicians often failed to prescribe the drugs proven most effective for
treating
the disorder, opting instead for older treatment methods.
"Clearly, there is a disconnect between evidence and execution as it relates
to DVT prevention and treatment," said co-lead investigator Victor Tapson,
M.D., associate professor of medicine at Duke University Medical Center. "The
bottom line is that every patient admitted to a hospital ought to be
considered for preventive measures."
Tapson and study first author Samuel Goldhaber, M.D., of Brigham and Women's
Hospital, report their findings in the Jan. 15, 2004, issue of The American
Journal of Cardiology. The study was supported by Aventis Pharmaceuticals,
which manufactures low molecular weight heparin, a drug that can treat and
prevent DVT. Tapson is a paid consultant and has conducted research for
Aventis.
Those who most often develop DVT include patients with cancer, obesity and
heart failure. Also at increased risk for DVT are elderly patients and those
who have had surgery within the previous three months or who have been immobile
in the previous 30 days.
Symptoms of DVT can be mild to severe, and include swelling and discomfort
in the extremities. Administration of low-dose anticoagulants, including
unfractionated heparin, low molecular weight heparin and warfarin, have been
found
to significantly reduce the risk of DVT. Once clots have formed, higher
doses of the drugs act as effective treatments.
Left untreated, leg vein clots can enter the bloodstream and travel to the
lungs causing pulmonary embolism, a condition that can affect lung function.
Pulmonary embolism is responsible for more than 100,000 deaths in the U.S. each
year -- more than the number of breast cancer deaths, highway fatalities or
deaths from AIDS, Tapson noted.
For the study, over a period of six months, physicians at 183 sites
nationwide enrolled 5,451 patients with DVT in the registry. The study
investigators
obtained information about patients' histories from medical records.
Less than 30 percent of patients enrolled in the registry received
preventive blood thinning drugs within 30 days prior to their diagnosis of DVT.
Of the
2,726 patients who developed DVT while in the hospital, 42 percent failed to
receive prophylaxis within 30 days prior to diagnosis, the team reported.
Furthermore, said Tapson, physicians often treated patients diagnosed with
DVT with unfractionated heparin rather than low molecular weight heparin,
despite clear advantages of the latter drug. For example, low molecular weight
heparin is administered by subcutaneous injection, while unfractionated heparin
generally requires intravenous infusion. Patients receiving low molecular
weight heparin can often be discharged while receiving treatment, he added,
while those receiving unfractionated heparin require longer hospital stays.
"Studies like this allow us to look at real life in terms of the treatment
that patients are receiving," Tapson said. "Clearly, anticoagulants proven to
aid in the prevention of DVT are being underused by physicians in the United
States for both medical and surgical patients, despite a very low risk of side
effects."
The solution, said Tapson, is to educate physicians that all hospitalized
patients should be evaluated with regard to their DVT risk and those at risk
provided prophylaxis. Source: Duke University Medical Center news release.
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CAN AUTOIMMUNE DISEASE BE DETECTED EARLY?
By Steven Reinberg HealthDay Reporter
Study: Antibodies can foretell problems long before symptoms
For many autoimmune diseases, such as type 1 diabetes, lupus, multiple
sclerosis, Addison's disease and rheumatoid arthritis, antibodies to the
diseases
appear years before symptoms.
Knowing that antibodies are present before the disease develops, doctors can
alert patients to symptoms to watch out for, and researchers may be able to
develop early treatments, according to a report in the May 8 issue of The
Lancet.
Antibodies are specific proteins made by the body's immune system to fight
infection or harmful foreign substances.
However, in autoimmune disease, the body makes autoantibodies that attack
the body itself, said study author Dr. Hal Scofield, an associate member of the
Oklahoma Medical Research Foundation.
"It is now clear that these antibodies, which are markers of autoimmune
diseases, appear in people's blood long before the clinical illnesses begin," he
added.
These autoantibodies are preclinical markers to the disease, and that
appears to be true for almost every autoimmune disease, Scofield explained.
"It may be possible to identify people with the potential of developing
these diseases before they get sick," Scofield said. "As we can identify many of
these diseases before people get sick, you can imagine prevention trials
taking place."
This approach is being done now in a trial of type 1 diabetes in children
with autoantibodies that are markers for the disease. The children are being
administered nasal insulin to try to prevent diabetes from developing, Scofield
said.
In addition, Scofield believes, if patients knew they were at risk for an
autoimmune disease, they could be told what to watch out for. They might also be
able to avoid some of the most serious complications, such as diabetic coma
or Addisonian crisis, a life-threatening condition that happens when the
adrenal gland fails to produce enough of the hormone cortisol.
The next step, according to Scofield, is to study large groups of people
with autoantibodies to various diseases to see how predictive these
autoantibodies are in determining who develops a disease and how long it takes
symptoms
to appear.
Scofield cautioned that right now the benefit of identifying autoantibodies
has little practical application. "There is the potential in the next few
years to identify people who go on to get an autoimmune disease, and that kind
of
identification may lead to preventive therapies," he said.
"I am very enthusiastic about this approach," said Dr. Noel Rose, director
of the Center for Autoimmune Disease Research at Johns Hopkins University.
"This is an extremely important report."
"These autoantibodies are a warning sign of impending disease, and it opens
the possibility of predicting disease and possibly benefiting patients by
early treatment or even interrupting the autoimmune responses," he added.
"Antibodies in diseases such as lupus, rheumatoid arthritis, multiple
sclerosis, diabetes and others can be measured and should allow the development
of
patient-specific therapies," said Dr. Paul J. Utz, an assistant professor of
medicine at Stanford University School of Medicine.
"As newer technologies are developed, we will be able to measure thousands
of unique antibodies at one time. Their measurement will be an important
component of future drug development for biotechnology and pharmaceutical
companies," Utz said.
"This paper really shows the importance of early screening, particularly in
people with early symptoms," said Virginia Ladd, the president of the American
Autoimmune Related Diseases Association.
Earlier diagnosis will lead to preventing major organ damage, she added.
Today, even when patients have autoantibodies, doctors dismiss them, Ladd
said, "but this paper says that it is important to follow patients who have low
levels of autoantibodies."
SOURCES: Hal Scofield M.D., associate member, Oklahoma Medical Research
Foundation, and professor, medicine, University of Oklahoma Health Science
Center, Oklahoma City; Noel Rose, M.D., Ph.D., director, Center for Autoimmune
Disease Research, Johns Hopkins University, Baltimore; Paul J. Utz, M.D.,
assistant professor, medicine, Stanford University School of Medicine, Palo
Alto,
Calif.; Virginia Ladd, president, American Autoimmune Related Diseases
Association, Detroit; May 8, 2004, The Lancet. Copyright © 2004 ScoutNews, LLC.
All
rights reserved.
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DRUG PRICES OUTSTRIP MEDICARE DISCOUNTS
Discounts: A report from the AARP Public Policy Institute presents the
results of a study of changes in manufacturersâ prescription drug prices from
2000-2003 for the nearly 200 brand name prescription drugs most widely used by
Americans age 50 and older. This report compares price changes to the rate of
general inflation. It focuses on the price that drug manufacturers charge
wholesalers because that is a substantial component of the final retail price. A
change in the price the drug manufacturers charge to wholesalers generally
results in a similar percentage change in the price that the consumer pays.
On average, prices charged by drug manufacturers for widely used brand name
prescription drugs in 2003 increased three times the rate of inflation. Ranked
by their volume of sales, the price for Fosamax (alendronate) was up 5.6%,
the price for Lipitor (atorvastatin) was up 6.0% and the price for Plavix
(clopidogrel) was up 7.8%.
Comment: This report is more evidence that drug prices are continuing to
escalate and that they are not even being kept within the rate of overall
inflat
ion. The report also confirms what we all already know. Something has to be
done to control the ever-increasing prices of drugs in the US. Barbara K.
Hecht, Ph.D., Frederick Hecht, M.D.,Medical Editors, MedicineNet.com
DRUG PRICE INCREASES TRIPLE THE RATE OF INFLATION
By Karen Pallarito, HealthDay Reporter
(HealthDayNews) -- Prices for the most popular brand-name medications used
by older Americans increased at three times the rate of inflation last year,
claims a new AARP study.
"That's a pretty substantial increase," said study co-author Steven W.
Schondelmeyer, head of the department of pharmaceutical care and health systems
at
the University of Minnesota.
The study, released Tuesday, measured changes in the prices that drug
manufacturers charged wholesalers over a four-year period starting in the year
2000. The authors said the underlying price fluctuations are significant because
they affect the actual prices seniors pay at their local drugstore or by mail.
"These price increases typically pass straight through to the consumer,"
Schondelmeyer said.
Prices for widely used brands rose 4.1 percent, on average, in 2000, and 6.9
percent in 2003, while inflation fell from 3.3 percent to 2.2 percent over
the same period, the report said.
And the average cost to consumers for top brands nearly doubled from 2000 to
2003 -- rising from $33.76 to $60.38, the authors estimate. This means the
typical older American who takes three drugs would have paid $101 more in 2000
and $181 more in 2003 if the higher prices were passed along, AARP noted.
When it came to individual brand names, a 10-milligram dose of the
cholesterol medication Lipitor rose 6 percent in 2003, almost triple the 2.2
inflation
rate that same year. A 75-milligram dose of the blood thinner Plavix rose
7.8 percent each year covered by the study.
Large increases were also seen in estrogen drugs and thyroid medications,
checking in at 10 times and six times the rate of inflation, respectively, in
2003.
Pharmaceutical Research and Manufacturers of America, the brand name drug
industry's lobbying group, did not respond to a request for comment on the
findings.
AARP's Public Policy Institute tracked prices for the top 200 drugs used by
seniors, based on both annual sales volume and the number of prescriptions
dispensed each year. The analysis yielded a combined list of the 291 most widely
used drugs, including 197 brands -- the focus of this report.
At some future date, AARP said it intends to issue a separate report
examining price changes for the top 94 generic drugs used by seniors.
The new report is the latest step in a larger campaign by the senior citizen
advocacy group to put pressure on the pharmaceutical industry to lower drug
prices. The effort comes in the wake of sharp criticism of AARP leaders for
supporting last year a Medicare prescription drug benefit program that bars the
federal government from negotiating lower prices from drug makers.
As part of that legislation, seniors may take advantage of a new drug
discount card program effective June 1. Federal Medicare officials say the
program
will give cardholders price breaks averaging 11 percent to 18 percent off
average retail prices. But critics of the program say the discounts are
meaningless if drug prices continue to escalate.
"The new prescription benefit in Medicare was an important step, but our
members have made it clear that they want AARP to continue to push for
affordable drugs," AARP Chief Executive Officer Bill Novelli said in a
statement.
Earlier this year, AARP asked the pharmaceutical industry to hold its price
increases to the rate of general inflation. The new data provide a benchmark
against which to monitor the industry's future performance, the group said.
Overall, the new prescription drug report showed the average rate of growth
in manufacturers' drug prices has accelerated in recent years, said study
co-author David J. Gross, a senior policy adviser with AARP's Public Policy
Institute.
On a cumulative basis, prices for the 155 brand-name drugs on the market for
the entire four-year period rose 27.6 percent, on average. That compares
with a general inflation rate of 10.4 percent for the four-year period, the
report said.
Only four drugs had price increases below the four-year average rate of
inflation, according to the report.
The rapid price increases for estrogens and thyroid hormones may be due to
the fact that few generics have cropped up to compete against these drugs, the
study authors said.
These medications have been on the market since World War II, noted
Schondelmeyer, who suspects drug makers are raising prices to reflect current
pricing
trends. "They're drugs that have not had the same kind of generic
competition that we see (elsewhere)," he added.
Also Tuesday, AARP unveiled a new quarterly report to consumers on
prescription drug prices. The "Rx Watchdog Report" will update consumers on drug
maker
activities, their pricing policies, quarterly profits and spending on
lobbying and advertising, the group said.
SOURCES: David J. Gross, senior policy adviser, AARP Public Policy
Institute, Washington, D.C.; Steven W. Schondelmeyer, Pharm.D., Ph.D.,
professor,
pharmaceutical management and economics, head, department of pharmaceutical
care
and health systems, and director of Prime Institute, College of Pharmacy,
University of Minnesota; May 25, 2004, AARP report, Trends in Manufacturer
Prices of Brand Name Prescription Drugs Used by Older Americans, 2000 Through
2003
- Copyright © 2004 ScoutNews LLC. All rights reserved.
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LACK OF VITAMIN âDâ LINKED TO PAIN
By Salynn Boyles WebMD Medical News Reviewed By Brunilda Nazario, MD
Study Shows Limited Sun Exposure Has Health Benefits
There is new evidence that small amounts of unprotected sun exposure could
be good for you. Earlier studies have linked vitamin D deficiency with an
increased risk for several cancers. Now comes word that it may also be a major
cause of unexplained muscle and bone pain.
In a study involving 150 children and adults with unexplained muscle and
bone pain, almost all were found to be vitamin D deficient; many were severely
deficient with extremely low levels of vitamin D in their bodies.
Humans tend to get most of their vitamin D from exposure to sunlight, so
those who avoid the sun completely or who always wear sunscreen to protect
themselves against skin cancers are at risk for vitamin D deficiencies, says
Michael Holick, MD. Holick runs the Vitamin D Research Lab at Boston University
Medical Center.
"I think the current message that all unprotected sun exposure is bad for
you is too extreme," he tells WebMD. "The original message was that people
should limit their sun exposure, not that they should avoid the sun entirely. I
do believe that some unprotected exposure to the sun is important for health."
Dermatologists Disagree
Holick claims there is now a strong epidemiological case linking vitamin D
deficiency with a host of cancers including those of the prostate, colon, and
breast; and he says vitamin D may also help protect against heart disease,
autoimmune diseases, and even type 1 diabetes.
He will present the evidence in a book scheduled for publication next
spring, but the nation's largest dermatology group remains unconvinced. In a
recent
press release, American Academy of Dermatology officials wrote that they
were "deeply concerned" that the message that unprotected sun exposure may have
health benefits could "mislead the public about the very real danger of sun
exposure, the leading cause of skin cancer."
Patients Should Be Tested
In the latest study, Gregory A. Plotnikoff, MD, of the University of
Minnesota Medical School found a much higher incidence of vitamin D deficiency
in
the patients with unexplained muscle and skeletal pain than expected,
regardless of their ages.
All of the African Americans, East Africans, Hispanics, and Native Americans
who participated in the study were vitamin D deficient, as were all of the
patients under the age of 30.
The researcher says it was a big surprise that the worst vitamin D
deficiencies occurred in young people -- especially women of childbearing age.
The
findings are reported in the December issue of the journal Mayo Clinic
Proceedings.
"The message here is that unexplained pain may very well be linked to a
vitamin D deficiency," Plotnikoff tells WebMD. "My hope is that patients with
unexplained pain will be tested for vitamin D status, and treated, if
necessary."
Food and Pills
Although it is possible to get vitamin D through foods or supplements, both
researchers say it is not easy. A glass of fortified milk or fortified orange
juice has about 100 international units (IU) of vitamin D and a multivitamin
typically has 400 IU. Holick believes most people need about 1000 IU of
vitamin D each day. The recommended dietary allowance (RDA) for vitamin D
varies
with age, sex, and various medical conditions but in general is 200-600 IU
per day. Other sources of vitamin D include:
Cod Liver Oil. 1 tablespoon=1360 IU of vitamin D
Salmon. 3 ounces=425 IU of vitamin D
Herring. 3 ounces=765 IU of vitamin D
Sardines. Canned, 3 ounces=255 IU of vitamin D
Multivitamin supplements commonly provide 200-400 IU of vitamin D daily.
He says a light-skinned person wearing a swimsuit at the beach will have
absorbed about 20,000 IU of vitamin D in the time it takes their skin to get
lightly pink.
The amount of sun exposure needed to get the proper dose of vitamin D
depends on a person's skin type, where they live, and time of year, and time of
day
the exposure occurs. Holick says it is difficult for people living in
northern climates to get the vitamin D they need from the sun in the winter, but
in
the summer a light-skinned person at the beach should get all the vitamin D
they need in about five minutes.
"The trick is getting just enough sun to satisfy your body's vitamin D
requirement, without damaging the skin," he says. "It is difficult to believe
that
this kind of limited exposure significantly increases a person's risk of
skin cancer."
SOURCES: Plotnikoff, G. Mayo Clinic Proceedings, December 2003; vol. 78: pp.
1463-1470. Gregory A. Plotnikoff, MD, MTS, departments of internal medicine
and pediatrics, University of Minnesota Medical School, Minneapolis. Michael
Holick, MD, department of medicine, Boston University School of Medicine,
Boston. News release, American Academy of Dermatology, July 3, 2003; "Vitamin D
+ Sunshine + Bad Medicine." © 2003 WebMD Inc. All rights reserved.
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FDA SAYS REMICADE USERS SUFFER AILMENTS
August 24, 2004 - WASHINGTON (AP)
The Food and Drug Administration and manufacturer Centocor are warning
doctors that patients receiving the drug Remicade to treat rheumatoid arthritis
and Crohn's disease have suffered sometimes-fatal blood and central nervous
system disorders.
Centocor's Aug. 11 warning letter to doctors said the "causal relationship"
between the ailments and Remicade therapy "remains unclear."
The Malvern, Pa.-based company, working with the federal drug regulatory
agency, revised its label for the monoclonal antibody.
Patients receiving the drug suffered reductions in their red and white blood
cell, granulocyte and platelet counts, leaving them more vulnerable to
abnormal bleeding and infections. In some instances, patients died. In rare
instances, patients suffered central nervous system disorders, including
confusing
immune system responses that swelled, then decayed, blood vessels.
Remicade was approved for use in the United States on Aug. 24, 1998.
Worldwide, 509,000 patients have taken it. In late July, a European advisory
committee approved expanding its use for treating people with psoriatic
arthritis.
Copyright 2004 The Associated Press. All rights reserved.
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My âtime awayâ this summer was just what the doctor ordered, however I am
glad to be back in the newsletter business.
My computer has so many news items, articles, studies, etc, saved on it, I
could write newsletters forever. Since I havenât published since June, some
information you may have already seen or heard about from other sources,
however I will be including news item that could be vital knowledge for our
membership, particularly new members.
Good Health to All,
Jack Nicholas
Newsletter Editor
_Cornishpro@..._ (mailto:Cornishpro@...)
Issue 2004 09/15/04 -13