Psoriatic Arthritis List NEWSLETTER

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

PSORIATIC ARTHRITIS NEWS AND VIEWS
VOL. 2 ISSUE 21 October 1, 2002
PSORIATIC ARTHRITIS MEDICAL NEWS

BIOTECH FIRM GIVES MORE DATA ON ARTHRITIS DRUG
September 27, 2002 (The Los Angeles Daily News) --

Biotechnology giant Amgen Inc. has submitted additional clinical data about Enbrel to U.S. regulators, a move that could eventually broaden the rheumatoid arthritis drug's marketing breadth.

While the drug is already approved to treat patients with moderate to severe rheumatoid arthritis, the Thousand Oaks-based company would like the label to include that "Enbrel showed an improvement in physical functioning."

"Enbrel will be facing stiff competition from D2E7 (a drug developed by Abbott Laboratories) in the near future," said Jennifer Chao, analyst with RBC Capital Markets in New York. "And the strategy is to try to get as broad of a label as possible."

Last month, Amgen applied for regulatory approval of an Enbrel manufacturing facility in Rhode Island - an important step to alleviate shortages of the arthritis drug. The 250,000-square-foot facility stems from Amgen's $14 million purchase of Seattle-based Immunex Corp., which received approval from U.S. regulators in July.

The surge in Enbrel's popularity has ultimately led to its scant supply. Dr. Daniel Burge, a vice president of clinical research at Amgen, said the data submitted to the Food and Drug Administration prove Enbrel's efficacy.

"And we frequently hear from patients that they've been able to resume many of their daily activities, such as brushing their hair or picking up their child, that had become impossible due to their rheumatoid arthritis," Burge said.

Last year, Enbrel sales accounted for $800 million, but with Amgen's marketing backing the product, the drug could generate sales of $3 billion by 2005. Immunex projected that Enbrel sales would surge as high as $4 billion by 2005.

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FIGHTING THE DRUG (AD) WARS by Marc Siegel, Faculty of Internal Medicine at New York University.

Back in 1981 Ira, a journalist who had been suffering from arthritis of the hips for many years, saw the first television ad for a pharmaceutical. At the time Ira, who is now my patient, had no inkling that he was witness to the inception of an insidious process that in twenty years' time would threaten to undermine the fabric of medical discourse between doctor and patient.

This first ad glamorized Motrin, one of the original arthritis drugs, and Ira became one of many who asked his physician at the time, Dr. Peter Berczeller, to prescribe it.

"It helped me," Ira says now. "But I thought it was supposed to cure me."

"When I was in practice, these ads weren't really in vogue yet," says Dr. Berczeller, retired professor of medicine at New York University. "But I was worried that they would remove the doctor as a filter, an essential provider of information. Prescribing drugs was intended to be a medical function, not a capitalistic stratagem. It's wrong for us to be pressured to prescribe by a patient dazzled by a slick ad."

It is not only wrong, it is unnecessarily inflating medical costs. In February, the New England Journal of Medicine published a study showing that direct-to-consumer advertising was 16 percent of drug promotion spending. At the same time, the National Institute for Health Care Management released a study showing that 2001 drug costs were up 17.1 percent from the year before, with most of the increases in four heavily advertised categories: arthritis, cholesterol, depression and allergy.

The Kaiser Family Foundation has demonstrated an association between consumer advertising expenditures and drugs that are growing the fastest. Pfizer has practically monopolized the cholesterol market over the past few years by heavily promoting Lipitor to the public as the drug to lower cholesterol and somehow bring about a healthier lifestyle.

The result is a $3-billion-a-year drug. This advertising strategy is now being copied by an even more expensive drug, Zocor (Merck), which is less potent at the same dose. Meanwhile, another drug that may have fewer side effects, Pravachol (Bristol-Myers Squibb), is overlooked.

In 1983, the Food and Drug Administration, sensing a controversy, requested a voluntary moratorium on all drug ads until it could determine its position. This moratorium was lifted in 1985. At first, drug companies were hamstrung by the need for an extensive summary of side effects whenever brand names were mentioned.

Many manufacturers tried to get around this by resorting to ads that increased consumer awareness of target medical conditions without mentioning brand names. The few drug ads on television that did mention specific products included a prohibitively long trailer of side effects. In 1996 an ad for Depo-Provera, a gynecological medicine, ran almost three minutes and contained almost two minutes of warnings.

However, in 1997 the FDA issued a series of limited guidelines that essentially allowed TV ads with only a brief mention of side effects. The drug companies refer to this as "liberation day."

The FDA now receives approximately 32,000 notifications of pending product advertisements a year, but generally deals with these over the telephone or with brief correspondences within an eight-week period before the ad is to appear. The actual ad is not seen prior to its appearance on television or in print, and the FDA almost never demands a correction or issues a reprimand.

Bob Ehrlich, chairperson of Rx Insight, a company that advises drug companies on direct-to-consumer advertising, administers a yearly survey course to drug representatives. He admits, "Like it or not, direct-to-consumer advertising has come to symbolize a drug industry hungry for sales and profits at a time when drug access and affordability are key social and political issues."

Over the past five years, the drug companies have struggled to create name recognition using extensive television and magazine ads. The major effect of this full-court press has been to raise drug prices and overall costs as patients pressure doctors to prescribe drugs that often aren't needed. Doctors find themselves compelled to respond to ad-driven questions rather than those of fundamental medical importance.

A report from UCLA last year concluded that doctor/patient roles might be damaged. "We will have a world of aggressive, distrustful and only partially informed patients and cowed physicians," it says. Surveys by the FDA in 1999 and by Kaiser in 2001 showed that between 20 and 30 percent of consumers, or more than 50 million people, responded to these ads by questioning their doctors.

But the same two studies revealed that almost 60 percent of consumers felt that the warnings of potential side effects communicated by these ads were inadequate. It's no wonder that advertising of prescription drugs directly to the consumer is banned in every country in the world except the United States and New Zealand.

This year, several of my patients with acid reflux disease have been affected because the patent on Prilosec (AstraZeneca)--recently the number-one-selling prescription drug in the United States--is being challenged by generic equivalents. AstraZeneca is mightily promoting Nexium (an almost identical drug) to take its place.

Of course, the generic Prilosec will be a lot cheaper than the brand Nexium, and as far as I can tell, having tried both, just as good. Certainly most patients responding to the flashy Nexium ad wouldn't be able to tell the difference between the drugs, except in terms of the price.

Perhaps the most blatant advertising war is occurring in the world of allergy. After years of sniffling miserably, most of my patients have settled on Claritin (Schering-Plough) as the antihistamine that provides the most relief without making them drowsy. But the patent on Claritin is expiring this year, and it is also about to go over the counter at one-third the price, two major defeats for Schering after it spent a fortune successfully marketing this drug and turning it into a $3-billion-a-year product.

Monopolizing the over-the-counter market for antihistamines might be a consolation, but Johnson & Johnson has already applied for approval of its generic product and is beating Schering to the punch. So Schering has now developed Clarinex, a more potent drug it claims doesn't make patients any sleepier than Claritin (patients who have tried the new drug tend to disagree). Schering--desperately attempting to hold on to its customers--has just entered Clarinex into a multimedia advertising face-off with Zyrtec (Pfizer) and Allegra (Aventis), a several-hundred-million-dollar exchange the likes of which may never before have graced the airwaves.

Meanwhile, drug prices skyrocket, transferring the costs of these massive advertising wars over almost identical drugs to the consumer. Last year the AMA protested impotently that the ads did nothing to educate either patients or physicians. Consumer advocacy groups and even HMOs lobby Congress, but the drug-company lobbyists outnumber their opposition eleven to one. The FDA turns a blind eye.

"I saw an ad for an antidepressant during halftime of the Super Bowl," Ira says. "It showed a beautiful person smiling, saying how much the medicine helped. Soon you'll have people asking you for the drug who aren't even depressed."

"Until they find out it affects their sex lives, which they don't bother to say on TV."

Ira thinks this over. "So then they'll ask you for another billion-dollar drug, Viagra, to compensate," he says, catching on to how the whole process works. from The Nation - June 17, 2002

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HMO EXODUS MAY AFFECT MANY
September 10, 2002 WASHINGTON (AP) --

Nearly 200,000 people may have to change health plans next year as health maintenance organizations continue their exodus from the Medicare program, according to a survey by an HMO trade group.

The American Association of Health Plans said Monday that HMOs are continuing to pull out of Medicare's managed care program because they don't get enough money to care for each patient amid rising health care costs.

Federal officials have said that the overall cost of the nation's health care rose 6.9 percent in 2000. But the amount of money that an HMO gets to care for patients has risen by just 2 percent, said Susan Pisano, spokeswoman for AAHP, which represents health plans.

"That's arithmetic that can't be sustained over time," she said.

Last year, 58 health plans withdrew or cut services. That meant 536,000 seniors -- about 10 percent of the 5.6 million in Medicare HMOs -- had to find a new way to receive Medicare benefits.

Medicare HMOs typically provide benefits that traditional Medicare does not, including prescription drug coverage. But the program has struggled in recent years to keep HMOs involved.

Over 5 million seniors are now enrolled in HMOs through Medicare.

The drop in enrolled plans means some seniors will have to choose a different program or depend on traditional Medicare, in which they can choose any doctor but must pay more for drug coverage.

"Certainly, we think that this is far too many beneficiaries to be affected, but we are hopeful because there seems to be an environment in which we could see a turnaround," Pisano said.

Health plans had until midnight Tuesday to opt out of Medicare Plus Choice for 2003, but the survey is probably accurate, said Tom Scully, administrator for the Centers for Medicare and Medicaid Services.

"I'd say the good news is that most people expected the number to be much higher," Scully said. "The bad news is the program is still shrinking."

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KIDS USING PRESCRIPTION DRUGS MORE
September 19, 2002 NEW YORK (AP) --

When Christy Olson's daughter developed asthma as a toddler 12 years ago, she was reluctant to put her on prescription drugs.

"I was so worried about side effects. I didn't want to give it to her unless I had to," said Olson, who lives in Rochester, Minn., and is a nurse herself. She decided it was a necessary move, and her daughter, now 15, still takes medicine for her condition.

While parents then and now are often nervous about medicating children, it is becoming more common. Use of prescription drugs is growing faster among children than it is among senior citizens and baby boomers, the two traditionally high consumer groups, according to a new study.

Spending on prescription drugs for those under 19 grew 28 percent last year, according to the survey by Medco Health Solutions, a Franklin, N.J.-based pharmacy benefits manager.

Meanwhile, spending per patient rose 23 percent for those between the ages of 35 and 49 and less than 10 percent for those above 65.

Children are also spending 34 percent more time on medication than they were five years ago, the study found.

Treating children is still relatively inexpensive, costing an average of $84.72 per patient each year. That compares to an average expense of $944.40 per year for people aged 65 to 79.

The Centers for Medicare and Medicaid Services, a government agency, estimates that overall spending on prescription drugs rose 16.4 percent to $142 billion last year.

Among children, the most prescribed drugs were for allergies, asthma and infections. Prescriptions for Ritalin and other medicines for neurological and psychological disorders were also substantial - a finding that renewed concern among some experts who worry that such drugs may be over-prescribed for children.

Some doctors also were alarmed that spending on prescription drugs to treat heartburn and other gastrointestinal disorders surged 660 percent over five years, according to the study. The jump was seen as linked to the increasing number of overweight children in the United States.

Some of the findings on prescription drugs mirrored trends seen in disease patterns. For example, the incidence of asthma and allergies are generally increasing, so doctors said it wasn't surprising that children's prescriptions for such ailments would also grow.

"It is good news that more kids are getting treated for asthma because it means less trips to emergency rooms and hospitals," said Dr. Robert Epstein, chief medical officer of Medco Health.

About 7 percent of children have asthma and 25 percent have allergies, approximately double the incidence 25 years ago, according to Dr. Michael Blaiss, a pediatrician who specializes in such ailments.

Olson, the Minnesota nurse, also has a 13-year-old son who has asthma and is receiving medicine. She suffers from asthma herself.

Medicating her children has at times been a difficult process. Her daughter, when she was nine, had a severe reaction to steroid she was taking and went into shock. It took 18 months of experimenting to find a correct dosage.

Even so, she's more comfortable now than she was at first with having her daughter taking drugs. "I feel differently now because I see that she needs it and she is better because of it," Olson said.

"I know things have gotten better since that time, but drugs are such an important part of treatment that we need more studies," she said.

The survey also found that spending on antibiotics among children increased 42 percent. Doctors say antibiotic resistance is a widespread problem.

Spending on drugs for Attention Deficit Hyperactivity Disorder increased 122 percent over the past four years and accounted for 8 percent of the total spent on prescription drugs for children, up from 7 percent in 1997. Spending for depression medicines held steady at 5 percent of the total.

Dr. Lawrence Diller, author of "Should I Medicate My Child?" worries that such drugs are over-prescribed. He also pointed out that, while Ritalin and other drugs for ADHD are generally seen as safe for children, there haven't been many studies of the effects of antidepressants on children.

"The antidepressants are known to have sexual side effects. I wonder what the long-term effects of that are going to be on adolescents," Diller said.

The vast majority of prescription drugs are developed for adults, and drug makers are not obliged to test them on children. In 1997, Congress passed legislation that gave drug companies an additional six months of market exclusivity if they tested their drugs on children. That has sparked more tests, but experts say more studies are needed.

"I think practitioners feel more confident now that there is more data to back up prescription patterns," said Dr. John Ring, who sits on the American Academy of Pediatrics' Committee on Drugs.

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HERBS AND ALTERNATIVES: THEY'RE HERE TO STAY By Lisa Ellis InteliHealth News Service

Most Americans are using some form of alternative medicine, and if a Harvard Medical School survey is any indication, our interest in non-traditional treatments isn't going to go away.

Young adults are by far the most likely to use alternative treatments, the survey finds. This trend "suggests a continuing increased demand for complementary and alternative medicine therapies that will affect all facets of health care delivery over the next 25 years," the authors write in the August 2001 issue of the Annals Of Internal Medicine.

Complementary and alternative medicine, as measured in the survey, includes a wide variety of therapies -- from acupuncture, massage and chiropractic care to spiritual healing, aromatherapy and imagery.

Some of these techniques are recommended by some doctors. In general, alternative therapies are not used in mainstream medicine because they have not been adequately tested in controlled clinical trials, says Ronald C. Kessler, Ph.D., principal author of the report. Most of the therapies are not taught routinely in medical schools or widely available in U.S. hospitals, according to the article.

When enough people use an alternative therapy, mainstream medicine becomes interested enough to carry out these clinical trials to see if the treatments can be proven effective, says Kessler, a professor of health-care policy at Harvard Medical School.

"This is occurring right now, for example, in a series of rigorous clinical studies of the effects of (the herb) St. John's wort as a treatment for depression," he says. "At the end of these trials, this therapy will no longer be alternative. It will either be accepted as a proven (mainstream) therapy or it will be proven to be ineffective."

The article about alternative medicine is based on a 1997-98 telephone survey of 2,055 people in a nationally representative household sample. People were asked whether they ever had used any of 20 complementary and alternative therapies, their age at first use, and whether they continued to use the therapies.

In an earlier article about the survey, Kessler and his colleagues reported that the most popular alternative therapies were relaxation techniques (used by 16 percent of respondents), herbal medicines (12 percent), massage and chiropractic techniques (11 percent each).

The new report analyzes growth trends by decade and age group. Three of 10 respondents who were born before the baby boom had used an alternative therapy by age 33, compared with half of baby boomers and seven of 10 younger adults. One-third used some sort of alternative therapy at the time of the survey, and two-thirds had done so at some time in their lives.

"The post-baby boom respondents had a higher rate of lifetime use by age 33 years than the pre-baby boom respondents had by age 79 years," the researchers write.

The therapies with the largest increase in popularity during the 1960s were commercial and other diet programs, megavitamin therapy, and self-help groups, according to the survey. During the '70s, biofeedback, energy healing, folk remedies, herbal medicine, homeopathy, hypnosis, imagery and spiritual healing grew faster than in any other decade.

Growth was slower in the 1980s, with only massage and naturopathy increasing faster than in earlier decades. In the '90s, "aromatherapy had the most dramatic growth," and energy healing, herbal medicine, massage and yoga also grew faster than they had during the '80s.

At this point, Kessler says, none of the therapies in the survey can be considered "mainstream" -- that is, accepted as proven by most doctors. But a few of these techniques are covered by health insurance, with chiropractic care being the most common, Kessler says. Most medical schools are teaching about at least some alternative therapies, according to the article.

"In the past, mainstream medicine tried to ignore alternative therapies and hope they went away," Kessler says. "It's now clear that they are not going away. They have to be studied seriously."

As more clinical trials occur, he predicts, some therapies will become more accepted and others will disappear. But there always will be new alternatives, he says. "People will continue to want to use new therapies before they are adequately tested."

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U.S. LIFE EXPECTANCY HITS NEW HIGH
September 13, 2002 WASHINGTON (AP) --

Life expectancy is at an all-time high, and the gaps between blacks and whites, men and women are continuing to narrow, the government reported in its annual look at American health.

Overall, the death rate is on the decline for babies, adults and older people alike, with AIDS, homicide, cancer and heart disease all claiming fewer lives, according to the report released Thursday, which examines health trends spanning the second half of the 20th century and finds improvement on almost every measure.

"When you take the long view, you see clearly how far we've come," said Health and Human Services Secretary Tommy Thompson.

With better medical care and a drop in smoking rates, death rates for heart disease have been cut in more than half, and they have declined even more dramatically for stroke and other cerebrovascular disease.

Death rates from injuries, particularly motor vehicle crashes, have also fallen since about 1970, with safer cars on the road and more people wearing seat belts.

It's not all-good news. Death rates for diabetes, along with the number of cases, are climbing, largely the result of a sharp increase in obesity.

All of these factors contribute to life expectancy, and people are certainly living longer.

The average baby born in 1900 could expect to live 47.3 years and that gauge has been climbing ever since. By 1950, life expectancy had risen to 68.2, and it reached 76.9 in 2000.

Throughout the century, women and whites have lived longer, but those gaps are closing, the report shows.

In 1950, whites lived 8.3 years longer than blacks did. By 2000, that gap was 5.6 years.

For gender, the gap was at its peak in 1970, when women lived 7.6 years longer than men. By 2000, the gap was 5.4 years.

The report, produced by the National Center for Health Statistics, found drops in death at every stage of life and for many diseases. Specifically:

-Infant mortality: The portion of babies dying before their first birthday was at a record low in 2000, 6.9 per 1,000 live births. That rate has fallen 75 percent since 1950.

-Young deaths: Mortality among children and young adults, between 12 months and 24 years, declined by more than half since 1950. Researchers credited drops in death rates in accidents, cancer, heart disease and infectious diseases. Homicide and suicide rates generally increased over the half century, though they have been falling since the mid-1990s.

-Adults: Death among adults age 25 to 44 declined by more than 40 percent between 1950 and 1999. During the mid-1990s, HIV was the leading cause of death for this age group, but these rates have fallen significantly.

-Older adults: Mortality among adults age 45 to 64 fell by nearly 50 percent, including drops in heart disease, stroke and injury. Cancer is the leading cause of death in this group, and those death rates rose slowly through the 1980s and then began to decline.

-Heart disease: Much of the improvement in life expectancy is traced to falling heart disease rates. In 1950, just over 585 people in the United States developed heart disease for every 100,000. By 1999, that had been more than cut in half, falling to just under 268 people per 100,000.

-Stroke: In 1950, nearly 181 of every 100,000 people died of stroke and other cerebrovascular disease. By 1999, it was just 62 per 100,000.

The report, which also examines trends in the use of hospitals, found fewer people being admitted and shorter stays for those who do go in. It found a sharp drop in use of home health care, a reaction to new Medicare payment restrictions.

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PROSTATE CANCER OVER - TREATED WASHINGTON (AP) --

Many men over 60 are receiving unnecessary surgery and other treatments for prostate cancer even though the disease is unlikely to progress far enough to cause health problems, according to one analysis.

A study in the Journal of the National Cancer Institute examined the use of a blood test to find prostate cancer in a group of patients 60-84 over a 10-year period. It concluded that 29 percent to 44 percent of the men were "over-diagnosed."

Those patients may have received surgery or radiation treatment for prostate cancer that would never have progressed so far that it threatened their health, said Ruth Etzioni, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle.

"Over those 10 years, of the men diagnosed as a result of the PSA test, up to 30 percent may have been treated unnecessarily," said Etzioni.

The PSA test measures the level of a prostate-specific antigen in the blood. A high number may suggest prostate cancer.

Etzioni said prostate cancer is a slow-moving disease. Many older men may have prostate tumors that will never become life threatening because they will die of other causes before the cancer has a chance to spread.

Over-diagnosis for prostate cancer is a concern because active treatment - surgery or radiation - can have debilitating side effects. Etzioni said that about 80 percent of men who have prostate cancer surgery experience impotence, often permanently. For those treated with exterior beam radiation, the impotence rate three years later is about 43 percent. About 10 percent are incontinent after surgery, she said.

The study is based on a computer model of 2 million men. It projected the long-term effect on those men of early diagnosis of prostate cancer as the result of using the PSA test.

The projections from the computer study were then compared with NCI cancer registry data. The computer estimate of over-diagnosis was consistent with the observed data, the authors said.

Dr. Darracott Vaughan, a New York urologist and a recent president of the American Urological Association, said that the Etzioni study fails to address the effect of PSA tests on the rate of survival among prostate cancer patients. Such studies are not yet complete, he said, and until they are "it's anybody's guess" about whether prostate cancer is being over-diagnosed.

He said some prostate cancer patients - those who have low PSA tests or who may be expected to die within 10 years - are now treated with "watchful waiting" instead of aggressive surgery or radiation. But he said the level of treatment should be a patient decision.

Vaughan said that PSA tests help find patients when they have a 75 percent chance of being cured of the disease. Without the test, the cancer is often not detected until symptoms develop; by then, it is 75 to 80 percent incurable because it has spread to the bones or other organs, he said.

"Our position on PSA is that we find out and then inform the patient," said Vaughan. "We give them the data about being at low risk, intermediate risk or high risk" and let them make the treatment decision. Copyright 2002 The Associated Press.

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NEW ARTHRITIS DRUG LESS LIKELY TO CAUSE SIDE EFFECTS
September 20, 2002 (British Medical Journal) --

A new group of arthritis drugs recommended by NICE for patients at risk of gastrointestinal complications may be safer than traditional drugs, research in this week's BMJ suggests.

Claims that the drugs, known as selective COX2 inhibitors, caused fewer gastrointestinal problems than traditional arthritis drugs led to an increase in their use, but the research on which they were based was criticized.

Two studies in this week's BMJ, however, show that the risk of gastrointestinal complications associated with selective COX 2 inhibitors is lower than that associated with conventional non-steroidal anti-inflammatory drugs (NSAIDs).

In the first study researchers in Oxford reviewed all trials of the safety and effectiveness of celecoxib, a COX 2 inhibitor used in the treatment of rheumatoid arthritis and osteoarthritis. It was found to be as effective as other NSAIDs and less likely to cause problems such as ulcers.

In the second, researchers in Toronto compared the rates of upper gastrointestinal hemorrhage in elderly users of COX2 inhibitors with those of users of other NSAIDs and a group not using NSAIDs at all. They found that the risk of hemorrhage with the COX2 inhibitors was significantly lower than with conventional NSAIDs. In users of celecoxib, the risk was as similar to that of the group not using NSAIDs at all.

In an accompanying editorial, Dr Roger Jones welcomes the findings but points out that many questions remain unanswered. Neither study comments on death rates and it may not be appropriate to view COX 2 inhibitors as a homogeneous group. More research is needed before doctors can make rational decisions about the drugs, he concludes.

Good Health to All

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com
Issue 2002 10/01/02 -21