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 19 September 1, 2002
PSORIATIC ARTHRITIS MEDICAL NEWS

THE AMERICAN MEDICAL SYSTEM IS NEARING COLLAPSE
By Tommy G. Thompson - U.S. Secretary of Health and Human Services.

This is excerpted and condensed from his remarks July 18 in Chicago to the American Medical Association.

We are living in the most amazing era of medicine in human history. Yet as we, all know too well, all is not well with American medicine. In point of fact, we are dealing with a system of healthcare delivery that is, at its root, dysfunctional.

The problem - the crisis - is the system by which care is delivered, which has simply not matured at the same pace as the technologies and treatments now available.

I've traveled all over the country. I've traveled to Spain and Germany. I've been to Canada. I've discussed healthcare with some of the leading policymakers and caregivers in the world. And sadly, I have to report that in Western society broadly, the various systems of care are eroding with ever-greater rapidity.

I've come to one central conclusion: The way we provide care is in jeopardy of collapse. It is clouded by regulatory burdens that are confusing, duplicative and extremely time-consuming. Physicians and nurses almost have to obtain advanced degrees in business administration, accounting and jurisprudence just to run their offices from day to day. Patients have to fill out endless forms; get transferred from place to place; worry about what insurance will pay for what treatment and at what cost.

We have to fundamentally change the current healthcare delivery system in our country. The myriad rules, regulations and restrictions that make obtaining good healthcare difficult, if not impossible, have to be reviewed carefully and, when necessary, jettisoned like useless ballast.

But there's another area of reform that must - I repeat, must - be among the highest priorities we can develop: malpractice reform. America is experiencing a medical malpractice insurance coverage crisis that is increasing the cost of healthcare, decreasing access to doctors and hospitals for many patients and lowering the overall quality of care provided to patients.

Editor's comment: Write your Senators or Congressmen, and let them know that how you feel about a potential failure of our healthcare system.

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POTENTIAL CAUSE OF ARTHRITIS DISCOVERED

Researchers at Brigham and Women's Hospital (BWH) and Harvard Medical School (HMS) have shown that certain types of naturally occurring carbohydrates in the body may cause rheumatoid arthritis, a debilitating, painful disease affecting hundreds of millions of people worldwide.

Although there have been promising advances in treating the symptoms of arthritis, the exact causes of arthritic inflammation, swelling, and destruction of the joints has remained elusive. Now, researchers at BWH have for the first time associated carbohydrates present naturally in the body with this disease.

Dr. Julia Ying Wang, the lead BWH researcher in the study, and an Assistant Professor of Medicine at HMS, has extensively examined the role of carbohydrates in diseases and infections.

Wang began wondering whether a particular class of carbohydrates, known as glycosaminoglycans (GAGs), triggered an immune response in the body. GAGs are naturally present as a major component of joint cartilage, joint fluid, connective tissue, and skin. In collaboration with Michael H. Roehrl, M.D., from HMS, Wang studied the effects GAGs had on mice, who subsequently experienced arthritic symptoms, including swelling, inflammation, and joint damage.

"This study shows that rheumatoid arthritis may result from the body's mishandling of its own carbohydrates that, under normal circumstances, would not be interpreted as a threat," said Wang. "We found that inflammatory cells that accumulate in arthritic joints attach themselves directly to the glycosaminoglycans. This accumulation of cells leads to painful inflammation and swelling in the affected tissue."

In addition to their work with mice, Wang and Roehrl also examined human tissue taken from arthritis patients. They discovered the same type of glycosaminoglycan-binding cells in the human tissue. This is the first direct demonstration of such cells in humans and animals.

"It leads us to believe that rheumatoid arthritis may be an unusual immune response," added Wang.

Given her findings, Wang said subsequent research would most likely focus on the development of drugs aimed at stopping the growth, expansion, or adhesion of immune cells that react to glycosaminoglycans. Wang will continue to investigate carbohydrates and how they affect the body's immune system.

"This research is extremely promising," said John Mekalanos, Professor and Chairman of Microbiology and Molecular Genetics at HMS. "This study also suggests plausible models for how bacterial infection might trigger arthritis and how we might go about reversing these debilitating conditions with new therapies." Mekalanos added, "We are clearly a step closer to understanding the causes of a disease that has left the medical community with unanswered questions and many patients with discomfort and pain."

BWH is a 716-bed nonprofit teaching affiliate of Harvard Medical School.

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JUST SAY, "STOP" WHEN YOU PUT YOURSELF DOWN
from (Cox News Service)

You might remember the old joke that goes something like this: "Don't worry if you're talking to yourself. It's when you start answering yourself that you have a problem."

The truth of the matter is, self-talk can be a very positive and powerful tool in improving one's mental health.

In fact, we all talk to ourselves all day long. During these mental conversations we may be planning, worrying, rehearsing, and/or remembering. Additionally, we are also judging ourselves, often negatively.

For example, if you're planning a trip you might be thinking to yourself, "I have never been to this place before, and I probably won't get there without getting lost."

While remembering, you might play a tape in your mind that goes something like "I was always unhappy as a child, and therefore I will probably never be happy as an adult."

A mental rehearsal might include "I never seem to be able to win the big one, so I will probably lose today in the finals."

These examples of negative self-talk and harsh subjective judgment of us lead to low self-esteem. What we say to ourselves affects how we feel about ourselves.

This pattern of negative thinking often becomes more pervasive and frequent over time. A self-fulfilling prophecy develops so that as the biblical scripture states, "As a man thinketh, so is he."

To combat these ruminations and obsessive-negative thought patterns, the techniques of "thought stopping" is often found to be helpful. In this procedure, the individual is advised to yell the word "no" or "stop" several times in succession each time a negative thought occurs. This is to be repeated on every occurrence of any negative, self-defeating and depressing thought as a way to interfere and stop this destructive pattern.

In public, the individual is advised to whisper or think the word "no" or "stop" repeatedly when negative thoughts occur.

Although this technique may sound rather trite and simplistic, it is often very effective in helping disrupt a pattern of negative thinking. Remember, most of us have had years of practice with negative thinking. Thus, any system of disrupting such pattern has to be practiced consistently to produce beneficial results.

With some practice, you will become very good at blowing the whistle on yourself. You can then begin replacing the negative judgmental thought with positive self-talk.

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RESEARCHERS FIND A NEW ENEMY OF THE HEART (AP) - Boston

Worse than cholesterol? Hard to believe, perhaps, but the top health concern of millions of Americans is about to be trumped by what doctors say is an even bigger trigger of heart attacks.

The condition is low-grade inflammation, which may originate in a variety of unlikely places throughout the body, including even excess fat. New federal recommendations are being written that will urge doctors to test millions of middle-aged Americans for it.

The discovery of its surprising ill effects is causing a top-to-bottom rethinking of the origins and prevention of heart trouble. Doctors call it a revolutionary departure from viewing the world's top killer as largely a plumbing problem blamed on cholesterol-clogged arteries, the standard theory through the modern era of cardiology.

"The implications of this are enormous," says Dr. Paul Ridker of Boston's Brigham and Women's Hospital. "It means we have an entire other way of treating, targeting and preventing heart disease that was essentially missed because of our focus solely on cholesterol."

In the past year or two, experts say, the evidence has become overwhelming that inflammation hidden deep in the body is a common trigger of heart attacks, even when clogging in the arteries is minimal. Now the main question is: How aggressively should otherwise healthy people be tested to find and treat it?

The new recommendations are still being drawn up, but they will offer the first formal blueprint to answer this, probably sometime in the fall. Doctors writing them say they will almost certainly recommend broad testing.

Inflammation can be measured with a generic $10 test that looks for high levels of a chemical called C-reactive protein, one of many that increase during inflammation. Experts expect it to quickly become a standard part of physical exams. As a result, many people ordinarily considered at low risk will probably be put on statin drugs, which lower inflammation as well as cholesterol.

No one disputes the importance of cholesterol. Yet half of all heart attack victims have levels that are normal or even low. Clearly, something big was missing from the equation, and that appears to be inflammation.

Ridker estimates that between 25 million and 35 million healthy middle-aged Americans have normal cholesterol but above-average inflammation, putting them at unusual risk of heart attacks and strokes.

A series of landmark studies by his team, beginning in 1997, suggest inflammation is more important than cholesterol at triggering heart attacks. They found those with high levels of C-reactive protein have twice the risk of people with elevated cholesterol.

High amounts of the protein also predict increased risk of heart attacks and strokes years before they occur, even when cholesterol levels are low. Having both inflammation and high cholesterol together is especially ominous, resulting in a nine-fold increase in risk.

Everyone who reaches middle age has some degree of fatty buildup, called plaque, in the heart arteries. The new evidence suggests it becomes threatening if weakened by inflammation, which makes it squishy and fragile. Even a small lump of plaque can burst like an overripe pimple, prompting the formation of a clot that in turn chokes off blood flow and causes a heart attack.

Many people with no outward signs of anything wrong have high levels of internal inflammation. It is exactly the same sort that causes swelling, heat and redness during infections or allergic rashes.

Doctors believe the internal inflammation has many possible sources. Often, the plaque itself becomes inflamed as white blood cells invade in a misguided defense attempt. But inflammation that arises elsewhere apparently can be as bad, for it bombards the plaque with damaging chemicals.

For instance, fat cells churn out these inflammatory proteins, which helps explain why being overweight is so bad for the heart. Other possible triggers include high blood pressure, smoking and lingering low-level infections, such as chronic gum disease.

Although many chemicals increase during inflammation, C-reactive protein, or CRP, is particularly easy to measure. Some already test for it, including White House doctors, who checked President Bush's CRP level last summer (his was extremely low).

In March, the Centers for Disease Control and Prevention and the American Heart Association held a meeting of 50 experts in Atlanta to review the scientific evidence on inflammation and make recommendations.

These are still being discussed, but some doctors involved say they are likely to urge CRP screening for people already considered at mild to moderate risk of heart attacks. These include smokers and those with a combination of other less ominous risks, such as being middle-aged and having borderline high cholesterol or blood pressure. For instance, they might recommend CRP testing for a 45-year-old man with cholesterol in the low 200s and blood pressure just below the cutoff for treatment.

However, others believe CRP should measured in everyone over age 40, just like cholesterol, regardless of their other risk factors.

"It begins to look like a standard risk factor that one would evaluate at least once in middle age in most people," says Dr. Wayne Alexander of Emory University, one member of the recommendations committee. "This is a very important concept for the general public to be aware of and to think about for their own health."

Doctors hope to have the recommendations ready for publication in the journal Circulation in November, followed by a campaign to teach doctors and ordinary people about it. "Our goal is to have a broad-based consensus and use all available means to disseminate that information widely," says Dr. George Mensah, the CDC's chief of cardiovascular health.

Many hospitals can already do the test. However, until the recommendations come out, most doctors are unlikely to know exactly whom to test or what to make of the results. In fact, the White House doctors who checked Bush had to call Ridker to figure out how to interpret his numbers.

CRP probably will not matter much for heart attack survivors and others who already know they have heart disease, since presumably doctors are already doing everything they can to keep their condition from getting worse.

"We believe the niche for C-reactive protein -- and it is a large niche -- is the healthy population who want to do what they can to lower their risk of cardiovascular disease," says Dr. Richard Cannon of the National Heart, Lung and Blood Institute.

Screening is important because inflammation can be readily lowered in several ways. One of the most powerful is losing weight. Exercise also helps, as does moderate alcohol intake, giving up smoking and lowering blood pressure.

Of course, this amounts to the same healthy living advice that doctors have long dispensed. But now they have a much better understanding of why it works so well. Furthermore, they are likely to urge these habits on people with bad CRP readings who until now would have seemed to be at no special risk of heart problems.

Many of the standard heart medicines also lower inflammation. These include aspirin, Plavix, ACE inhibitors and the statin drugs, such as Lipitor and Zocor.

The statins are now prescribed to lower cholesterol, and they do so dramatically. But studies have shown they ward off heart attacks much more powerfully than would be expected from their effects on cholesterol alone. In fact, people with moderate cholesterol seem to benefit just like those with readings off the charts. Lowering inflammation probably explains why.

Still, some important details remain to be settled. One is population-wide data on CRP levels and their connection to heart disease. Ridker is finishing a large study, to be released later this year, which traces this relationship with CRP readings from tens of thousands of people.

"Paul has got data now that slam-dunks it," says Dr. Richard Milani of the Ochsner Clinic in New Orleans.

Another gap is rock-solid evidence that lowering inflammation truly prevents heart attacks and saves lives. Ridker hopes to prove this with a study to begin this fall that will compare statin drugs and dummy pills in 15,000 middle-aged men and women with normal cholesterol and above average CRP.

The new thinking about inflammation "will change everything we do in heart disease," predicts Dr. Eric Topol, cardiology chief at the Cleveland Clinic.

"In the last decade, people talked about their cholesterol levels," he says. "In the next decade, the cocktail chatter will be, 'What's your C-reactive protein?' Everyone will need to know that." Copyright 2002 the Associated Press. All rights reserved.

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FRAUD PROBE TARGETS U.S. DRUG FIRMS - SALES TACTICS, PRICING UNDER JURY'S SCRUTINY By Alice Dembner and Shelley Murphy, Boston Globe

State and federal prosecutors nationwide are expanding their investigations into alleged pricing fraud and kickbacks in the pharmaceutical industry, after a record $885 million settlement won by the US attorney in Boston last fall.

In Massachusetts alone, grand juries at the state and federal level are examining whether 20 companies defrauded the Medicaid and Medicare insurance programs for the poor and elderly, law enforcement officials said.

Across the country, several lawsuits have been filed, and many major drug companies are under investigation as prosecutors take aim at drug pricing and sales tactics they allege have defrauded the public of billions and driven up the nation's medical bills.

''The lens is widening,'' said David Nalven, chief of the business and labor protection bureau at the Massachusetts attorney general's office. ''The focus is not only on the manufacturers, but also on wholesalers, pharmacy benefit managers, and all the way down to retail pharmacies. The goal is to recover money for governmental programs like Medicaid, but a secondary goal is broad industry-wide reform.''

While pharmaceutical companies have been under scrutiny by law enforcement since the late 1990s, the efforts got a boost last fall when federal prosecutors in Boston won a record $885 million settlement from TAP Pharmaceutical Products, in a combined criminal and civil case that alleged the company inflated the price of Lupron, the top-selling drug for prostate cancer. TAP officials were also accused of giving kickbacks to doctors to induce them to prescribe Lupron.

Since then, Boston prosecutors have expanded their investigation to another drug made by TAP, the heartburn medication Prevacid, and recently indicted a dozen current and former employees of the company, as well as a handful of doctors who allegedly billed Medicare for drugs that they received as free samples.

TAP spokesperson Kim Modory said the company has ''consistently provided accurate information to the government'' on the pricing of its drugs. ''Our stance is, Medicare is complex, and it needs reform,'' she added. But she also said, ''We have strengthened our commitment to ethics and compliance to ensure that TAP operates ethically.''

In a suit typical of the wave of fraud cases, the Texas attorney general is alleging that Warrick Pharmaceuticals cornered 65 percent of the Medicaid market for albuterol, an asthma drug, by charging pharmacists only $13.50 per Medicaid and Medicare prescription, while getting the government to reimburse pharmacists based on a list price of $40.30. Together with two other generic drug companies, Warrick allegedly bilked the government out of $20 million that went to pharmacists instead.

Warrick denies the charge. William O'Donnell, a spokesperson for Warrick's parent company, Schering-Plough, said, ''We are vigorously defending ourselves.''

Pharmacists weren't the only ones accused of cashing in on drug company sales strategies. At a California hospital, doctors allegedly pressured TAP Pharmaceutical Products to pay $30,000 to get its heartburn remedy on the list of drugs the hospital turned to first. The doctors explained that a competing company had already paid that much, according to a Boston federal indictment.

Investigators nationwide are also looking at whether perks that drug companies have long given doctors - such as golf outings, consulting contracts, expensive dinners, and educational grants - were illegal kickbacks used to woo business.

Doctors, hospitals, and drug companies are all targets of a ''long-term investigation'' underway in Boston, said Charles Prouty, the special agent in charge of the FBI's Boston office, who is working with the US attorney and the Department of Health and Human Services. Prouty said health-care fraud is an FBI priority.

''Probably the most serious victim is the patient,'' Prouty said. ''Instead of the doctor prescribing what he may believe is the best drug, he is being induced by these kickbacks to prescribe the drug that these companies are manufacturing. It shakes your faith in the medical profession.''

In addition to the government action, 20 suits filed by citizens and states across the country were recently combined in federal court in Boston. The case alleges that two dozen companies inflated the prices the government paid for prescriptions for the elderly and disabled through the Medicare and Medicaid programs.

The companies targeted in Boston and elsewhere have denied any wrongdoing, saying that discounts and rebates are a legitimate form of marketing. Ethan Posner, a Washington, D.C., lawyer who represents some of the companies under investigation, called the pricing suits ''an effort by the state governments to litigate policy choices that are now before Congress.''

Congress has periodically debated how much the government should reimburse drug companies, pharmacies, and doctors for prescription drugs provided through Medicare and Medicaid. Lawmakers are currently discussing expansion of the Medicare program to cover all drugs for seniors. A congressional report last fall estimated that taxpayers and seniors were paying $1 billion a year in inflated drug prices because of fraud and loopholes in the Medicare system.

Posner said the government has been aware for years of the discrepancy between the published ''average wholesale price'' for drugs and the actual price paid by pharmacies and doctors. ''The government is not getting deceived,'' he said.

But Stephen Schondelmeyer, a University of Minnesota professor who studies the drug industry, said the suits and investigations grow out of a drug market characterized by secrecy and lack of accountability. ''This market is structured to create reverse and perverse economics, such as doctors being paid more for doing the wrong thing,'' such as prescribing a higher-priced drug. ''The suits are one piece of an appropriate response.''

Boston lawyer Thomas Sobol, who represents the consumer coalition and Nevada and Montana in the consolidated Boston civil case, said he is seeking reimbursement, estimated to be in the hundreds of millions, for overcharges to the elderly and disabled in the form of co-payments, Sobol said.

Some of the companies under scrutiny in parallel investigations by federal and state prosecutors in Boston include:

Pfizer, for the way it promoted its epilepsy drug Neurontin with doctors and for pricing of its popular cholesterol drug Lipitor.

Bristol-Myers Squibb, for its marketing and billing practices regarding anticancer drugs.

Serono, for the way it promoted its growth hormone Serostim with doctors.

The state has also subpoenaed records from Barr Laboratories and Eli Lilly, and federal officials subpoenaed three health maintenance organizations and two pharmacy benefit managers in the spring for records on their dealings with TAP.

All the companies have denied any wrongdoing.

A Texas official, who requested anonymity, said the investigations have much in common nationwide. ''The fraud may not be exactly the same in every state, but manufacturers will do whatever they can to compete on something other than market price,'' he said.

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REMICADE SHOWS IMPACT ON SEVERE SPONDYOARTHROPATHY - GHENT, BELGIUM - 2002

For the first time, there may be an effective therapeutic option for severe cases of spondyloarthropathies (SpA), a group of rheumatic inflammatory diseases that affect the spinal column, peripheral joints and tendons. A study, published in the March 6 issue of Arthritis and Rheumatism, found that patients treated with infliximab (also known as Remicade®) monotherapy, experienced median improvements in disease activity of 73 and 78 percent as determined by validated patient and physician global assessment measurement tools, respectively. In comparison, patients treated with placebo experienced virtually no response.

"The future of patients suffering from spondyloarthropathy is hopeful," stated Professor Eric M. Veys, MD, Ghent University Hospital. "It seems as if all requirements have been met to allow us to hope that this treatment will be able to prevent the stiffening of the spinal column and the destruction of the peripheral joints, and that the quality of life of these patients will improve considerably."

Spondyloarthropathies are a group of chronic related disorders of the joints that include ankylosing spondylitis, psoriatic arthritis, and the arthritis associated with inflammatory bowel disease (Crohn's disease or ulcerative colitis). SpA may also include severe inflammation in the eye (uveitis). These diseases affect about 1 percent of the total population and often develop into seriously debilitating conditions with complete stiffening of the spinal column and destruction of the peripheral joints (hips, knees, wrists and/or fingers).

Thus far, treatment of these diseases has been limited to the administration of non-steroidal anti-inflammatory drugs. While these drugs may help to relieve pain for some patients, they do not impact the progression of the disease.

Tumor necrosis factor (TNF) is a messenger molecule (cytokine) that is released by stimulated immune cells when inflammation occurs and which, in the case of spondyloarthropathy, induces changes in the bone, joints and tendons. The objective of the 12-week double blind, placebo-controlled study was to confirm the safety and efficacy of infliximab, a monoclonal antibody that specifically targets TNF-alpha, in forty patients with several sub-types of spondyloarthropathies.

"The results were impressive with regard to subjective complaints, symptoms of inflammation of the spinal column and the peripheral joints, and inflammation markers measured in the blood," stated Prof. Veys.

These results confirm the findings of a separate, long-term, open-label study initiated by the department of rheumatology of the RUG [State University of Ghent, Belgium], involving intravenous injections of infliximab in 21 patients suffering from various forms SpA (E. Kruithof et al, Ann Rheum Dis, 2002; 61: 207-212).

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FEMALE MD'S TALK MORE WITH PATIENTS CHICAGO (AP) -

Female primary-care doctors spend more time with their patients than male doctors and engage in more patient-oriented, emotion-focused talk during office visits, a study found.

The results suggest that gender differences noted in conversational styles also occur in the medical arena, researchers said in Wednesday's Journal of the American Medical Association.

Whether the differences have any impact on patient health is not known, but the results suggest that female doctors may offer "a relatively more health-promoting therapeutic milieu," health policy specialist Debra Roter of Johns Hopkins University and colleagues reported.

They reviewed and pooled results from 26 studies involving an average of more than 3,000 doctors and doctors-in-training. Included were internists, family and general practice doctors, pediatricians, obstetrician/gynecologists and medical residents.

On average, women doctors spent 23 minutes with patients, compared with 21 minutes for men. They also spent more time talking about health-related lifestyle and social issues, engaging in positive, emotionally supportive talk and involving patients in their care.

The exception was male ob/gyns, who spent slightly more time overall with patients than their female counterparts did and more time in patient-oriented, emotion-focused talk.

Co-author Judith Hall, a Northeastern University psychology professor, said the gender-based differences "are a product of our society, but they are not unchangeable." v Patient-centered communication can be taught and both genders "can benefit from this instruction and improve their skill level," Roter said.

Dr. J. Edward Hill, a family practice doctor from Tupelo, Miss., and chair of the AMA's board of trustees, said the study confirms "what we already know -- men and women are a little bit different in their personal style. I don't think it has any bearing on the quality of medicine."

Still, he said the traits noted in female physicians are desirable and said many residency-training programs try to teach better communication skills.

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Editor's comments: In the last newsletter, I asked our membership to help with a survey of Pharmaceutical TV ads for both non-prescription and prescription products during the course of an evening of television viewing. Unfortunately, no responses were received.

The point I had hoped to make, was to shed more light on the amount of money being spent by the Pharma Industry for commercials, and their desire to influence the public and our doctors. The sad part about all of this, is the fact that more money is spent on advertising than on research.

I hope everyone is enjoying the Labor Day long weekend.

Good Health to All

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com
Issue 2002 9/01/02 - 19