News & Views Newletter
edited by Jack Nicholas, cornishpro@aol.co

PSORIATIC ARTHRITIS NEWS AND VIEWS
VOL. 2 ISSUE 22 October 15, 2002
PSORIATIC ARTHRITIS MEDICAL NEWS

ANTIOXIDANTS AND RHEUMATOID ARTHRITIS
By Lidia Wasowicz UPI Senior Science Writer

Two studies show the promise of an antioxidant in reliving symptoms of carpal tunnel syndrome and rheumatoid arthritis. The supplement BioAstin contains the active ingredient astaxanthin, an antioxidant studies show to be more 500 times stronger than vitamin E and 10 times stronger than beta carotene. In testing the effects on carpal tunnel syndrome, 20 participants received the extract or a placebo for eight weeks. Twenty-one volonteers took part in the rheumatoid arthritis part of the study at the Health Research Studies Center in Los Altos, Calif. The study subjects reported pain relief after using the over-the-counter dietary supplement derived from micro-algae, said principle investigator Dr. Gene Spiller. The findings will be presented at the scientific meeting of the American College of Nutrition in San Antonio, Texas. "One of the most exciting results was that the carpal tunnel syndrome sufferers who used BioAstin experienced such improvement that they were able to take part in activities that they had once given up," Spiller said. Participants in the rheumatoid arthritis clinical trial also showed improvement in symptoms.

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FDA ISSUES ACETAMINOPHEN WARNING Silver Spring Md. (AP)

Marcus Trunk took a prescription painkiller containing acetaminophen for 10 days, and then over-the-counter acetaminophen for another week to numb the pain of an injured wrist. Suddenly nausea and vomiting hit - the popular painkiller was destroying his liver, and the 23-year-old died.

Trunk was one of thousands of Americans who may unwittingly take toxic doses of acetaminophen every year, at least 100 of whom die. Now the government is debating whether stronger warning labels or other measures are needed to prevent these unintentional poisonings.

"You cannot allow more innocent men, women and children to suffer," Trunk's mother, Kate, told government scientists Thursday, demanding to know why consumers aren't warned about the risk. "Death is not an acceptable side effect."

Some 100 million people a year take acetaminophen, and serious liver damage is very rare, manufacturers insist. Although best known by the Tylenol brand, acetaminophen is in almost 200 different branded and generic products, from headache relievers to cold-and-cough remedies. While mostly sold without a prescription, it's also in a few prescription painkillers such as Percocet and Vicodin.

Acetaminophen bottles currently recommend taking no more than 4 grams a day, or eight extra-strength pills, and to seek help for overdoses. Yet in 1977, the Food and Drug Administration's advisers recommended more explicit warnings not to exceed the dose or take acetaminophen for more than 10 days "because severe liver damage may occur." The FDA never followed that advice.

People often attempt suicide by swallowing handfuls of acetaminophen. That got to be such a problem in Britain that it now restricts how many tablets are sold at once.

But unintentional overdoses also can destroy the liver. Consumers often swallow a few extra pills in hopes of faster pain relief, falsely thinking that over-the-counter medications are safe enough to push the dose. Because acetaminophen is in so many products - often listed merely in the fine print - taking a few different remedies the same day can mean unknowingly ingesting potentially toxic amounts.

And some scientists warn that even taking the maximum safe dose for a long period, instead of the recommended day or two, may be risky. The question is how to tell who is at risk. "It's very clear the average dose for the average person is very safe. But we are not all average people," said FDA senior scientist Dr. John Senior.

Regardless, unintentional poisonings should be preventable, critics argue. The FDA asked its scientific advisers Thursday what steps it should take.

Acetaminophen appears to be the leading single cause of acute liver failure, the most severe type of liver damage, contends Dr. William Lee of the University of Texas Southwestern Medical Center. His database of 395 patients linked 40 percent to the painkiller, more than any other liver-harming medication or disease.

Acetaminophen is safe, but "people misuse these products," acknowledged Dr. Anthony Temple, vice president of McNeil Consumer & Specialty Pharmaceuticals, Tylenol's maker. So McNeil is about to place new warnings on all its acetaminophen products to say that "taking an overdose may cause liver damage." In addition, even multi-ingredient products, like Tylenol Cold, will now display acetaminophen as an ingredient in large type on the box front.

This isn't the first time acetaminophen has drawn federal concern. Packages are required to warn not to use if it you consume more than three alcoholic drinks, because the combination can harm the liver. Copyright 2002 Associated Press.

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SCIENTISTS FIND HOW PAINKILLER DAMAGES LIVER
By Ed Edelson HealthScoutNews Reporter

THURSDAY, Oct. 10 (HealthScoutNews) -- Researchers say they have found a surprising mechanism by which acetaminophen causes liver damage and they are close to a better treatment for the overdoses that are the leading cause of liver failure.

Until now, the accepted picture has been that an overdose of the widely used painkiller sets off a series of molecular events that cause overproduction of a molecule called NAPQI that attacks liver cells, says David D. Moore, a professor of molecular and cell biology at Baylor College of Medicine. He is the leader of the group reporting the finding in tomorrow's issue of Science.

"What we add is that acetaminophen induces its own toxicity," Moore says. His research centers on a molecule called CAR, which regulates the response of the liver to a number of drugs. Working with mice, Moore and his colleagues show that high doses of acetaminophen activate CAR, increasing production of toxic substances.

The Baylor researchers have found a molecule, androstanol, which can block CAR activity if given within an hour of an acetaminophen overdose -- but only in mice. "CAR is different in mouse and humans," Moore says, different enough so that the treatment that works in rodents doesn't affect human liver cells. Research for an androstanol-like molecule that will be effective in humans is under way, he says.

"We haven't found anything very strong yet, but we are confident that we will be able to identify something," Moore says.

Acetaminophen overdoses now are treated with a compound that increases the body's production of glutathione, a naturally occurring molecule that neutralizes NAPQ1. Blocking CAR "would provide a completely different approach to acetaminophen toxicity and possibly to the toxicity of other agents for which no drug treatment is available," Moore says.

The discovery "provides a very clear and very elegant mechanism for how this damage occurs," says Steven Kliewer, a professor of molecular biology at the University of Texas Southwestern Medical Center who has done research in the field. "The more we understand about the mechanism, the better people will be able to treat it."

Until now, Kliewer says, "I don't think anybody has had a very good handle on how this happens."

The background to the research is concern about the possible dangers of acetaminophen, which is best known by the brand name Tylenol but which is found in more than 100 over-the-counter products. Last month, an advisory committee to the U. S. Food and Drug Administration (FDA) recommended a stronger warning on products containing acetaminophen, and there have been some calls for changing its over-the-counter status. The FDA has not yet acted.

"An important part of the debate is that acetaminophen never received regulatory approval, since it was already on the market when the FDA began to give approvals," Moore says. "Some people think it would be reasonable for it to go through the approval process."

If acetaminophen is taken in the recommended dose, there is no danger, Moore says. One problem is that many people are not aware that a specific product they are using contains acetaminophen, he says. Science Copyright © 2002 ScoutNews

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SWEDE RESEARCHERS APPLY FOR PSORIASIS GENE PATENT
October 4, 2002 STOCKHOLM (Reuters) -

Swedish researchers who have identified a gene that causes psoriasis, a skin disease affecting some 100 million people worldwide, said Friday they had applied for a global patent on their findings.

They hope the patent will help attract pharmaceutical companies that would like to use the gene for developing an efficient remedy against the skin disorder.

"The gene that has been found and the mechanisms it regulates give basis for a new way to think (about how) one develops drugs against psoriasis," said Professor Gunnar Swanbeck, who led the research group.

He said researchers could now see what changes in the gene were those leading to psoriasis, and then design drugs affecting the specific changes. Current treatment usually has severe side effects, he said.

Psoriasis is a chronic skin condition that affects around 2% to 3% of the population. It occurs when the body's immune system attacks its own healthy cells, and may appear as red patches on the skin, mainly in areas such as the armpits, groin or lower abdomen.

Swanbeck said he had not yet been contacted by pharmaceutical groups interested in using the gene in their research.

Several pharmaceutical and biotechnology companies, including Biogen Inc. and Genentech Inc., have identified psoriasis as a potentially lucrative market and are testing drugs for treatment of the disorder.

Swanbeck's study group sent questionnaires to around 14,000 Swedish psoriasis patients to ask about occurrence of the disease in their close relatives. Psoriasis can be hereditary.

It then picked around 1,000 families to study closer and published its research in the magazine Genomics in March this year.

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MEDICATION EFFECTS ON YOUR HEARING

Commonly used medications--both over-the-counter and prescribed--can damage hearing or aggravate an already existing problem.

Any drug with the potential to cause toxic reactions to structures of the inner ear are considered ototoxic. "Oto-" means ear. "Toxic" mean poisonous. Therefore, ototoxic" means poisonous to the ear.

Hearing problems caused by ototoxic medications are often reversible if the drug is discontinued. Sometimes, however, hearing loss is permanent. When a decision is made to treat an illness or medical condition with a drug known to be ototoxic, the health care team should consider the effects that hearing and balance problems may have on the person's quality of life after the drug therapy.

If a drug is known to cause permanent hearing loss or even deafness, why is it used ?

Sometimes there is little choice. A particular drug may be the only known medication available to cure a life-threatening disease or to stop a life-threatening infection.

What drugs are ototoxic?

Approximately 200 drugs have been labeled as ototoxic. Different ototoxic drugs can cause either permanent or temporary structural damage in the inner ear. The damage can be of varying degree and reversibility.

Those drugs known to cause permanent damage are the aminoglycoside antibiotics and the cancer chemotherapeutic agents cisplatin and carbo-platin.

Those known to cause temporary damage are salicylate analgesics, quinine, and loop diuretics. In some instances, exposure to damaging noise while taking certain drugs will increase their ototoxicity.

There are other categories of drugs known to be ototoxic including anesthetics, cardiac medications, glucocorticosteroids (cortisone, steroids), mood altering drugs, and some vapors and solvents.

It is important to discuss the potential for ototoxicity of any drug you are taking with your physician and/or pharmacist.

Can the use of a known ototoxic drug be monitored to determine if hearing loss is occurring?

Yes, audiologists can perform hearing tests before, during, and after the administration of medications to detect the progression of ototoxic hearing loss. This evaluation usually involves testing hearing in very high frequency ranges--9,000 to 20,000 Hz--because ototoxic drugs affect these frequencies first. (Typical hearing tests only test frequencies as high as 6,000 or 8,000 Hz.)

Hearing tests are done before the administration of the drug to obtain baseline information. Monitoring is done at scheduled intervals to detect threshold changes as early as possible. Data gathered through monitoring helps the physician to make a decision to stop or change the drug therapy before hearing in the frequencies critical for speech is damaged. In cases where hearing loss is inevitable and "planned for," the audiologist can plan and institute rehabilitation measures.

Monitoring of hearing usually continues as part of rehabilitation to determine if the hearing loss is stable. Rehabilitation may include fitting hearing aids, assistive listening devices, and communication management.

Self-Test
The following questions will help you determine if you have a hearing loss and need to have your hearing evaluated:

Do you have a problem hearing over the telephone?

Do you hear better on one ear than the other when you are on the telephone?

Do you have trouble following the conversation with two or more people are talking at the same time?

Do people complain that you turn the TV volume up too high?

Do you have to strain to understand conversation?

Do you have trouble hearing in a noisy background?

Do you have trouble hearing in restaurants?

Do you have dizziness, pain, or ringing in your ears?

Do you find yourself asking people to repeat themselves?

Do family members or co-workers remark about your missing what has been said?

Do many people you talk to seem to mumble (or not speak clearly)?

Do you misunderstand what others are saying and respond inappropriately?

Do you have trouble understanding the speech of women and children?

Do people get annoyed because you misunderstand what they say?

If you have answered yes to more than two of these questions, you should have your hearing tested by an ASHA certified audiologist.
The American Speech-Language-Hearing Association
10801 Rockville Pike
Rockville, MD 20852
Phone: 800-638-8255 or 301-897-8682 (Voice or TTY) actioncenter@asha.org

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FEDS WARN DRUG MAKERS: GIFTS TO DOCTORS MAY BE ILLEGAL
By Julie Appleby, USA TODAY

The Bush administration told doctors Tuesday essentially: Buy your own golf balls, concert tickets and vacations because drug makers who offer such incentives risk running afoul of the law.

In a draft meant to offer guidance to the industry, the Office of the Inspector General took aim at some common practices and said they could lead to civil or criminal charges.

Suspect activities include:

Paying doctors to act as consultants or researchers in marketing efforts. Paying pharmacies or doctors to switch patients from one drug to a competitor.

Providing scholarships, grants for research or other gifts with more than nominal value to doctors.

The guidance comes after years of concern about some drug industry marketing practices. Critics say such tactics influence doctors to prescribe certain drugs and lead to higher costs for consumers. The draft lays out for the first time in one document what the government expects.

The draft - now up for 60 days of public comment - says some nominal-cost gifts are OK but does not give specifics. Instead, it says a voluntary ethics code adopted this summer by the Pharmaceutical Research and Manufacturers of America should be considered a "minimum standard."

That code says sales reps can buy doctors meals on occasion but only in conjunction with medical education. Golf balls or bags emblazoned with drug company logos are not allowed. Neither are tickets to entertainment events, cash payments or other incentives given for prescribing products.

The draft guidance also says drug companies can face charges for reporting average wholesale prices that differ substantially from what is actually charged - and touting those prices in marketing.

That's because the government uses those prices on the few drugs covered by Medicare. If the drugs are sold for less, doctors can bill for the higher amount and keep the difference. It is a tactic drug makers use to lure doctors to their products, costing taxpayers $1 billion annually, the government estimates.

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DRUG COMPANIES WAR OVER GENERICS BILL
October 2, 2002 WASHINGTON (AP) --

Large brand-name pharmaceutical companies are waging what appears to be a successful lobbying and public relations battle to prevent the House from taking up a bill that would make it easier for generic drugs to enter the marketplace.

The Senate already passed the legislation, but none of the Republican sponsors of a House companion measure have signed on to a Democratic-led effort to force a vote. At least one Democrat, Rep. Bart Gordon of Tennessee, has asked that his name be removed from the petition drive.

As of Tuesday, Democrats had 141 signatures on a petition to force a vote this year, but 218 are needed.

"We definitely had expected to see a little more momentum," said Janell Mayo Duncan, legislative counsel for Consumers Union. "We're kind of perplexed."

The fight is over a bill that would limit brand-name pharmaceutical companies' usage of patent laws to thwart generic competition. The Senate passed the legislation in July, with sponsors saying it was to help Americans cope with rising prescription drug costs.

The trade group representing brand-name companies, the Pharmaceutical Research and Manufacturers of America, has had under way for several weeks a massive advertising campaign opposing the bill.

Tuesday, the group, known as Phrma, raised the ante by pulling out celebrity advocates to urge lawmakers to reject the bill. Among those visiting lawmakers' offices were talk show hosts Montel Williams and Leeza Gibbons.

"If today we stop the ability to do this, there will be no hope for a cure for me," said Williams, who has multiple schlerosis.

Gibbons, whose mother has Alzheimer's disease, said, "The current system that's in place is working. New drugs, innovative therapies are happening. We want to encourage lawmakers to just pause for a moment."

Both said they were visiting Congress at their own expense.

"It is time for the Bush administration and House Republicans to start paying more attention to the medical needs of senior citizens and less to the profit margins of big drug companies that are abusing the system," said Sen. Edward Kennedy, D-Mass., chairman of the Senate's Health, Education, Labor and Pensions Committee.

Sen. Charles Schumer, D-N.Y., the measure's Senate sponsor, said, "Obviously, if there were no Phrma, this bill would be law by now. Phrma pulls out all the stops."

House Republican sponsors of the measure said they oppose the Democratic effort to bring the bill to the floor immediately because House committees have not worked on it.

"Let's not play election year politics with such an important piece of legislation," Reps. Jo Ann Emerson, R-Mo., and John Thune, R-S.D., wrote in a letter to lawmakers.

Meanwhile, Phrma's ads opposing the bill have drawn the ire of the generic drug industry.

One of those ads shows a sick child with the headline, "Pray for a Miracle, Because Generic Drugs Will Never Cure Him." The ad charges that the bill, if passed, will stifle pharmaceutical innovation.

Kathleen Jaeger, president of the Generic Pharmaceutical Association, demanded that Phrma pull the ad. "The juxtaposition of a critically ill child with America's penchant for innovative cures is indeed nothing more than a shameless public relations tactic designed to obfuscate the real issues and ignore other realities," Jaeger wrote in a letter to Phrma president Alan Holmer.

For his part, Holmer replied in a letter that the ad highlights an important issue for Congress to consider: "The fact that brand-name pharmaceutical companies discover new medicines that offer patients hope of better medical care and better lives, while generic copies never represent even the smallest of improvements in medical care." Copyright 2002 The Associated Press.

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INSURER OK'S FOREIGN DRUGS VIA AARP NEW YORK (AP) -- The country's biggest health insurer has informed members of the senior citizens lobbying group AARP that it will reimburse them for prescriptions filled in Canada and elsewhere abroad. UnitedHealth Group Inc. sent a letter to the 97,000 people who purchased insurance with a drug benefit through AARP telling them about the coverage.

Buying prescription drugs outside the country for use at home violates federal regulations but is a growing practice among some older Americans seeking relief from high prices. Insurance policies generally cover drugs purchased abroad if a person is traveling there and has forgotten their medicine or becomes ill.

Both UnitedHealth and AARP appeared to want to keep the measure low-key, but it was certain to meet with approval from both AARP plan members and others of the many thousands of senior citizens who purchase their drugs in Canada and Mexico, where they are drastically cheaper than in local pharmacies.

Viola Qurion, 76, a retired garment worker who lives in Waterville, Maine, on $1,027 a month, makes an annual pilgrimage to Canada to buy medicine. She said otherwise she would have to choose between drugs and food.

"We don't like to go," she said in a telephone interview. "It is hard for a lot of us to get around, but what choice do we have?"

She said she saved about $500 on the medicines for allergies and indigestion she bought in her most recent trip, made earlier this week. Moreover, she doesn't feel bad if that cost U.S. companies some income.

"The pharmaceutical companies spend millions keeping drug prices high. It is shameful," she said.

AARP said it is not advocating purchasing drugs from abroad. It described the letter as a reminder of policy, and called its timing "unfortunate," coming so soon after a failed effort at legislation to allow people to import prescription drugs for their own use. Currently, U.S. law prohibits Americans from importing medicines that are available in the United States.

"The letter was just an informational letter to members letting them know that we would be paying claims for all drug purchases," said Julie Alexis, manager of member health products at the AARP.

Alexis added that the policies covered by the letter are designed to fill gaps in Medicare, the government health plan for the elderly, and are consequently scrutinized by both federal and state regulators. Neither has expressed any concern over covering drugs purchased abroad, she said.

UnitedHealth said its letter did not reflect a change in coverage but was meant to clarify a misunderstanding. It also said it was not trying to encourage anyone to violate Food and Drug Administration regulations.

"If someone is driving at a high rate of speed and they get in accident we cover them, but it not like we advocate such behavior," said UnitedHealth spokesman Mark Lindsay.

Lindsay says the insurer doesn't know how many of the 97,000 individuals get their drugs from abroad to save money.

An FDA official said the agency couldn't comment on the coverage because it doesn't know the details.

The AARP, formerly known as the American Association of Retired Persons, is critical of the pharmaceutical industry. It also has supported bills, so far unsuccessfully, to create a Medicare drug benefit and to make it easier for generic drugs to reach the market.

Experts said it was unlikely that either the drug makers or government officials would take issue with UnitedHealth or AARP over the drug reimbursements.

"No one wants to be seen like they are going after grandmothers," said Jonathan Wiener, professor of health policy and management at the Johns Hopkins School of Public Health in Baltimore.

He called the reimbursement policy "a warning shot at the pharmaceutical industry and Congress. I think they want to add to the outcry about drug prices and hit the pharmaceutical industry in the pocketbook."

The 97,000 members of the seniors group represent a negligible amount of the pharmaceutical industry's sales. The industry would likely see profits threatened only if the reimbursement policy spread to other insured groups such as company employees, which wasn't seen as likely. "A local tool and dye shop is not the AARP," Wiener said.

Copyright 2002 The Associated Press.

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HEART ATTACK SYMPTOMS - DIFFERENT IN WOMEN

Heart disease and heart attacks claim the lives of more American women than men each year, and pose a greater threat to American women than all forms of cancer combined. Unfortunately, many women do not know that the symptoms of a woman having a heart attack can be significantly different from those of a man. C. Noel Bairey Merz, M.D., Chair of the American College of Cardiology's Prevention and Cardiovascular Diseases Committee is offering a dozen important heart tips for women.

Women take notice of these 12 Important Heart Tips!

If you're over age 18, have your blood pressure checked annually; over age 45, have your blood cholesterol and blood sugar checked each year; and if you have a family history of heart disease in a relative prior to the age of 60, especially in a female relative, ask your physician to do these tests at earlier ages and to consider additional tests such as treadmill testing and other heart disease screening tests.

Be aware that the symptoms for women having a heart attack are often different from those of a man, but any of the following symptoms can occur in men and women:
Classic Symptoms
Squeezing chest pain or pressure
Shortness of breath
Sweating
Tightness in chest
Pain spreading to shoulders, neck or arm

Symptoms More Likely in Women:
Indigestion or gas-like pain
Dizziness, nausea or vomiting
Unexplained weakness, fatigue
Discomfort/pain between shoulder blades
Recurring chest discomfort
Sense of impending doom

Talk to your doctor or gynecologist regularly about your heart health. Be proactive in bringing this topic up for discussion. Ask for a thorough assessment of your heart disease risk factors: family history, cholesterol - especially LDL, HDL and triglycerides - glucose (blood sugar) levels, blood pressure, smoking history, weight, stress and exercise. If you have risk factors, formulate a plan with your doctor to reduce or eliminate or reduce them.

If you have one or more risk factors, ask your doctor or gynecologist if you should have an electrocardiogram (ECG) or exercise stress test.

Ask your doctor or gynecologist to review risk factors for heart disease and heart attack symptoms during your annual check-up. Discuss these with your family and friends, along with the importance of calling 9-1-1 if these symptoms occur.

Tell your doctor or gynecologist about any personal or family history of heart disease.

Make sure you understand any medications or special instructions your doctor has given you, including when you need to have follow-up tests.

Be aware of your diet and lifestyle. Read labels and avoid foods that are high in saturated fats. Aim to eat 5-9 servings of fruits and vegetables each day. Whenever possible, take the stairs instead of the elevator, and look for other ways to get more exercise.

Don't smoke If you do smoke, stop.

If you are experiencing symptoms that could be a signal of a heart attack, call 9-1-1 and get to the emergency room quickly to minimize possible damage to your heart.

Consider taking aspirin at the first sign of heart attack symptoms.

Check out nearby cardiac rehabilitation centers and community programs to help you stop smoking, get regular exercise, lose weight and reduce stress.

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Good Health to All

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com
Issue 2002 10/15/02-22