March 2014 Round-Up of MS News and Research

Hot Topics include:
Statins Drugs Reduce Brain Atrophy in Secondary Progressive MS
Testosterone Treatment as Complementary Therapy in Men with MS
Disease-Modifying Therapy and Postpartum Relapses in Women with MS


Read this post in its entirety:
Hot Topics and MS Research News for March 2014

Cost of Medical Care and Tight Budgets in Our Economy

Hey, Great article in the Washington Post today discussing costs of health care and choices people make.  Two multiple sclerosis patients were interviewed and featured within this article which explains why I'm presenting it in full here.  Oh, and btw, one of those MS patients is ME!!


As Budgets Tighten, More People Decide Medical Care Can Wait
By Ceci Connolly and Kendra Marr
Washington Post Staff Writers
Thursday, October 16, 2008; A01

To monitor the multiple sclerosis attacking Ann Pietrangelo's central nervous system, her doctor recommends an annual MRI. Last year, the 49-year-old Winchester, Va., woman had to pay a $3,000 co-payment to get the imaging done.

This year, she's skipping the test. Even with insurance, it's more than her budget can tolerate, especially with the roller coaster on Wall Street devouring her retirement savings.

"I'm doing everything I can to avoid going to the doctor," she said.

From Park Avenue dental offices to the Arlington Free Clinic, the global economic crunch is forcing a growing number of Americans to scale back on medical care. Consumers are attempting their own form of triage, pushing off seemingly less-urgent services in the hope that their financial health will improve. But the danger, say physicians, is that the short-term savings may translate into more severe long-term health implications.

At the extreme are cases such as the Texas woman who went to the hospital complaining of back pain. Physician Doug Curran immediately spotted cancer on the X-ray.

"She'd had a lump in her breast for a while, but things were tight and she said she couldn't get it looked at," he recalled. "We're going to see more of that."

Nationwide, the number of consumers who went without a prescription, tapped into retirement savings to pay for health care or skipped a doctor visit for themselves or a child has risen since last year, according to a survey released this summer by the Rockefeller Foundation and Time magazine. One-quarter of the 2,000 respondents, for example, said they had decided not to see a doctor because of cost in 2008, up from 18 percent the year before. Ten percent said they did not take a child to the doctor for the same reason.

"When the economy is in the situation we have today, people make tough choices," said Kansas Insurance Commissioner Sandy Praeger, who is head of the National Association of Insurance Commissioners. "Things are just not going to get done."

After nearly a decade of steady -- often double-digit -- increases in drug spending, the research company IMS Health this summer recorded the first actual decline. And a survey by the Center for Studying Health System Change found that nearly 20 percent of Americans report having difficulty paying medical bills.

Layoffs, shrinking bank accounts, rising medical prices and widespread anxiety that the economy is likely to worsen are prompting people to split pills, forgo screening tests such as colonoscopies, delay elective procedures such as laser eye surgery and turn to home remedies as cheaper alternatives. Hospitals report that unpaid medical bills are on the rise, pharmacists see a spike in cheaper generics, and demand for low-cost care is climbing.

Falls Church music teacher Lisa Emrich is coping with a dwindling number of piano students by cutting back on physician visits.

"I have too many doctors and specialists who all wish to see me twice a year," said Emrich, who is being treated for multiple sclerosis and arthritis. "Sometimes I might skip one if I'm doing well in that area. . . . When I see my neurologist, I'll ask about my arthritis, which doesn't make much sense. But I try to get as much as possible out of my doctor visits."

For Sandra Harrington, a waitress from Oxon Hill, the trade-off comes in treatment for an infected eye. Her doctor prescribed administering steroid drops twice a day. But as her tips have shrunk, she has decided that applying the $100 medication once a day is all she can afford.

"It's a vicious cycle," she said, explaining that because it is too painful for her eye to be exposed to direct sunlight, she works only night shifts. "People cut back. Then people like me suffer."

In the past month, traffic on the five-year-old advice site JustAnswer.com rose 14 percent. The site, which allows customers to pose a health question and "bid" $9 to $30 for a doctor's or a nurse's response, had nearly 400,000 page views in 30 days, said chief executive and founder Andy Kurtzig. In a telling sign, inquiries related to stress, high blood pressure, drinking and heart pain jumped 33 percent.

At the Arlington Free Clinic, the surge in people seeking care has been overwhelming, said Executive Director Nancy Sanger Pallesen. Last week, the clinic provided free preventive screenings to 19 new patients, but it turned away 27 others, she said.

"Those numbers are higher than what we were seeing just this summer," she said. "Unfortunately, we can't take them all in."

Even free care may not be a good deal for people with limited means. For some, the price of transportation is prohibitive; others fear discovering an illness they do not have the money to treat.

Many are forced to juggle competing medical needs. Pietrangelo must balance the importance of the MRI, which detects brain lesions, and the costly medications that prevent her from relapsing. She pays co-payments of $500 per drug per month. There are no generic alternatives.

"I can't shop around," she said. "My hands are tied."

Most analysts expect the medical crunch to worsen.

"We know from past experience that an economic downturn drives more people to be uninsured," said Len Nichols, director of health policy at the nonprofit, nonpartisan New America Foundation, a think tank. "They lose their jobs, they lose their income and their insurance."

That is what happened to Tim Doss. On Sept. 18, after driving a cement truck for an Indiana company for 10 years, he was laid off.

"They told me, 'As of midnight, your insurance is lapsed,' " he said. Doss, 50, and his wife have illnesses that require medications, regular doctor visits and tests. Creditors have come to their home trying to collect the $3,000 they owe in hospital co-payments from when they did have insurance.

The couple decided that Doss's annual checkup took precedence because he needed it to keep his commercial driver's license. The checkup, plus blood work for a fatty liver and high cholesterol, cost $300. He persuaded his doctor to provide free samples of his liver medicine.

Helen Doss does not plan to get an annual mammogram this year, even though her mother died of breast cancer at age 56. Doss was offered a free stress test at St. Vincent Indianapolis Hospital, but she is afraid it will turn up more problems that she can't take care of.

"I'm just holding off for a year and hoping nothing happens," she said.

Their primary-care physician, Steven Wilk, is devoting more time to helping patients decide what to postpone.

"Folks are asking us to try to limit what we order or pare it down to the bare-bones minimum," he said. "As a doctor, I worry about the risk of missing something at an early stage. It could lead to more serious problems down the road."

In past recessions, health-care spending briefly spiked -- as people raced to doctors before their insurance ran out -- and then fell sharply, according to industry analysts.

"Many times in health care there's a lag of three to six months before it hits really hard," said Donald Fisher, president of the American Medical Group Association, which represents large, multi-specialty providers. "If they have a problem, they get it fixed while they still have health insurance. Then we see a decline in elective procedures, and then we really see a drop-off."

In Plano, Tex., life feels like an endless downward spiral, Victoria Freudiger said, for herself and her husband. Losing jobs meant eliminating health insurance. No insurance meant Thomas Freudiger went to the hospital when he developed pneumonia this summer. That resulted in a $363 bill they couldn't pay. Now their credit is shot.

As the economy crumbled, both started canceling preventive screenings. She hasn't had a pap smear or a mammogram for close to two years; he is overdue for a colonoscopy. They use do-it-yourself dental cement to patch their teeth and put their best face forward in job interviews. And although her doctor prescribed Neurontin for her seizures, Victoria Freudiger tries calming techniques instead of the pills.

"Instead of taking them every day, I wait until I start feeling sick, and then I take them again," she said. "Both of us are suffering mentally, emotionally and physically."

Though the burden is especially heavy for uninsured Americans, even those who have coverage are feeling the pinch as employers shift higher deductibles and co-payments onto employees.

"The reason why health care was immune [to recessions] in the past was because most people were covered under good insurance plans," said Jean Mitchell, a professor of public policy at Georgetown University. Now, "people are realizing, 'Oh my gosh, I have to pay for this out of pocket.' "

In Durango, Colo., Marsha Porter-Norton and her husband, both entrepreneurs in their mid-40s, switched to a high-deductible plan when insurance premiums skyrocketed. Their new catastrophic policy costs $479 a month, but they have to pay the first $6,000 in expenses.

She is supposed to get ultrasounds twice a year to check on the fibroid tumors in her uterus. But the couple's retirement portfolio "has taken a massive hit," and they worry about their jobs, Porter-Norton said. So, for now, she's going to wait on the $500 ultrasound.

"I'm going to take a gamble," she said.

The New York Times highlights Rheumatoid Arthritis

These are some take-aways from the article which is shown below.

1. Encourage clinical trial participation and highlight RA patient (2002 article)  

2. Fear mongering of disability and premature death from lack of treatment

3. Early use of costly biologic drugs leading to cost-savings (Abbott)  

4. Combination use of biologic drugs and methotrexate: Humira (Abbott) and Enbrel (Wyeth)  

5. $16,000-18,000 is not expensive, if you consider the cost of disability, disease, and quality of life

6. Physicians need to refer early so patients can start treatment early

7. Fish oil and exercise are encouraged

Information regarding Rheumatoid Arthritis from Johns Hopkins.

Note to MSers: You CANNOT use the biologic drugs in fighting RA due to increased occurrence of demyelinating diseases seen. 

Living Better With Rheumatoid Arthritis
By JANE E. BRODY
Published: August 11, 2008

Alan Moore was 52 years old, teaching statistics at the University of Wyoming, playing the violin in the university’s symphony and accompanying soloists on the piano when his health took a nosedive in April 2001.

“I felt like I had the flu,” Mr. Moore recalled in an interview last month. “I was very weak and fatigued. I had extreme pain and swelling in a lot of my joints. I was in agony when I got up in the morning, so stiff I had to shuffle to the bathroom. I couldn’t peel a banana, turn the key in the ignition or even pull the tab of a tea bag. My wife, Cindy, had to help me with the simplest of tasks. Needless to say, I couldn’t play the violin or piano or use the computer.”

Doctors diagnosed it as rheumatoid arthritis.

“And I thought that my life as I knew it was over,” said Mr. Moore, now 59, of Laramie, Wyo.

But by enrolling in a clinical trial of one of the drugs and drug combinations that are revolutionizing the treatment of the disease, Mr. Moore got his life back.

Rheumatoid arthritis is the world’s most common autoimmune disease, striking up to 1 in 100 in the course of a lifetime. It is most often diagnosed in people ages 30 to 60 but it can occur at any time, including childhood.

As with other autoimmune diseases, women are three to four times likelier than men to develop rheumatoid arthritis. About 80 percent of Caucasians with the disease have a genetic marker, a gene sequence in the HLA-D region of chromosome 6 that is found in only about 35 percent of the general population.

The disease causes chronic joint inflammation and progressive destruction of the cartilage at the ends of bones, which can result in an inability to use the affected joints. Other effects include fatigue, malaise, anemia and damage to organs throughout the body, including the cardiovascular system.

Untreated, 20 to 30 percent of people become permanently disabled within three to five years of diagnosis. Life expectancy may be reduced by as much as 15 years, with half of patients succumbing to cardiovascular disease.

A Therapeutic Revolution

Doctors traditionally treated the symptoms of rheumatoid arthritis, usually with anti-inflammatory and pain-relieving medications. But the underlying destruction of tissues continued, leading to chronic disability and premature death.

The goal today is suppression of the disease and prevention of progressive joint destruction by treating patients early with synthetic or biologic agents called disease-modifying antirheumatic drugs.

Though he did not know it at the time, Mr. Moore was randomly assigned to the study group that every two weeks self-injected a biologically derived drug called Humira, which acts to block a protein involved in the inflammation associated with rheumatoid arthritis. Humira is one of six federally approved biologic treatments for the disease. Three other biologic remedies are nearing approval by the Food and Drug Administration.

“Within days my symptoms declined to nearly zero,” Mr. Moore said, “and I’ve had no symptoms since.” He has continued the injections of Humira and participates in a registry of patients to help assess the drug’s long-term benefits and potential risks.

Combining Treatments

The costly biologic drugs are often used in combination with much cheaper synthetic disease-modifying drugs taken orally, like methotrexate. In some cases, oral medications are all that patients need to keep symptoms and joint destruction under control.

But well-designed clinical trials have typically shown that in patients facing moderate to severe disease, combining the treatments often results in fewer symptoms and less destruction of joints, especially if therapy begins early.

In a study published July 16 in The Lancet, researchers in Leeds, England, reported that among 542 patients randomly assigned to receive either methotrexate alone or in combination with Enbrel, another biologic agent, those receiving the combination were almost twice as likely to become symptom free and more likely to show no X-ray signs of progressive joint destruction a year later.

In a commentary with the Lancet report, Dr. Joel M. Kremer, a rheumatologist at Albany Medical College, said it was important to consider the long-term consequences and costs of the disease when deciding how much to spend on therapy.

“Most of the biologic agents cost in the range of $16,000 to $18,000 a year, whereas the oral medications cost only about a tenth that,” Dr. Kremer said in an interview.

But, he added, inadequately treated rheumatoid arthritis typically leads to a need for multiple joint replacements, lost productivity, lost tax revenue and a greatly diminished quality of life, as well as an increased risk of life-threatening infections and cardiovascular disease.

“Most patients diagnosed at age 45 will be disabled in five or six years,” Dr. Kremer said. “You have to consider what it costs to fix a bridge against what it will cost when the bridge collapses.”

Before the use of disease-modifying drugs, direct medical costs from rheumatoid arthritis were estimated at $5.5 billion, and that did not include the indirect costs of lost wages and productivity, the need for custodial care and the emotional and social consequences of chronic disability.

A Tailored Approach

While not everyone with rheumatoid arthritis responds to the new treatments as vividly as Mr. Moore did, many large studies have shown there is no longer any reason for pessimism about the diagnosis. But it is vitally important to begin treatment early.

The recent therapeutic developments, Dr. Kremer said, mean doctors in general practice need to remain alert to symptoms of the disease in its early stages and quickly refer patients to rheumatologists who can confirm the diagnosis and prescribe up-to-date treatment before irreparable damage to joints occurs. Treatment is most effective if begun within one year after symptoms appear.

There is no one treatment approach that works for everyone. Rather, studies have indicated that treatment should be tailored to individual patients: the nature and extent of their disease, their other health issues and how they respond to various therapies.

Dr. Kremer said many patients could be started on a single, low-cost drug like methotrexate, as long as their condition was closely monitored and the treatment adjusted if there are signs of progressive disease.

Regular exercise and physical and occupational therapy, along with medication, can help patients maintain function. In addition to antirheumatic drugs to reduce inflammation, Dr. Kremer recommends fish oil at a daily dose of 2 grams of EPA and DHA — about six capsules as they are currently formulated.

National Parks in Need of Congressional Support - NOW!

Below is an editorial from the New York Times which highlights an important bill just waiting for action in Congress. This reminds me that upcoming Congressional District Work Periods are June 30 - July 3 and August 11 - September 5. A good time to contact your elected officials while they are home.

'Stingy budget appropriations and decades of deferred maintenance have taken a toll on our national parks.'

Help the Parks
NYT Editorial, June 10, 2008

It is only June, but given a summer recess and the fall’s campaigning, the rest of the legislative year could well be wasted, and some good bills left to die, unless Congress starts working harder now.

One piece of legislation that deserves a serious push is the National Park Service Centennial Initiative. A brainchild of Dirk Kempthorne, the Interior secretary, the initiative would use the years leading up to the park system’s 100th birthday in 2016 to raise $1 billion in private money and match that with $1 billion in federal money — above and beyond normal appropriations — to rejuvenate the national parks.

As recent visitors can attest, the parks need all the help they can get. Stingy budget appropriations and decades of deferred maintenance have taken a toll on everything from park roads to day-to-day operations. In his brief tenure, Mr. Kempthorne has done several good things for the parks — including killing a potentially harmful rewrite of the service’s management policies that would have promoted inappropriate commercial and recreational activities at the expense of conservation. He wants now to provide a special revenue stream by using the promise of a federal match to entice private donors to help underwrite vital projects.

The idea was so appealing that the House Natural Resources Committee approved it by a voice vote. It has languished ever since, the victim of wrangling between House members who rightly demand offsetting revenue-raising measures to pay for the bill and the administration’s budget office, which says it can’t find such offsets. House Democrats who are loath to hand Mr. Bush anything he can celebrate have also been less than helpful.

The solution seems ridiculously obvious. The budget office should find the offsets (an increase in park concession fees would do the trick), and the Democratic leadership should schedule a vote. We predict that the verdict would be overwhelmingly positive, and the Senate would follow suit. The parks and their millions of visitors would be the winners, and Congress could show that it can get things done — even in an election year.

Universal Health Insurance Coverage a Significant Social Policy Issue says S.E.C.

This is an interesting approach to furthering the discussion of meaningful health reform on Wall Street. Shareholders exerting power to address domestic policy needs. Interesting article in the New York Times.

S.E.C. Backs Health Care Balloting
By ROBERT PEAR
Published: May 27, 2008

WASHINGTON — The Securities and Exchange Commission, shifting its position, has told companies they must allow shareholders to vote on a proposal for universal health insurance coverage.

Shareholders, including religious groups and labor unions, have offered the proposal in an effort to draw the nation’s largest corporations deeper into a debate over the future of health care, fast emerging as one of the most important issue in domestic policy.

The S.E.C. has told Boeing, General Motors, United Technologies, Wendy’s International and Xcel Energy over the last several months that they may not omit the health care proposal from their proxy materials.

This came as a surprise to many executives, who said the agency had allowed companies to exclude similar proposals in the past.

Many companies say the health care principles are not a proper matter for shareholders to vote on, and they have tried to keep the proposal out of proxy statements prepared for their 2008 annual meetings.

Some, like General Electric and Medco Health Solutions, have explicitly adopted principles that include the goal of universal coverage. Some, like Boeing and Reynolds American, have opposed the shareholder initiatives. At least a dozen companies, like Wal-Mart and I.B.M., have negotiated with shareholders in the belief they can find common ground.

The shareholder proposal asks companies to adopt “principles for comprehensive health care reform” like those devised by the Institute of Medicine, an arm of the National Academy of Sciences.

The institute says health insurance should be universal, continuous, “affordable to individuals and families,” and “affordable and sustainable for society.”

Employers frequently complain about the cost of health benefits for employees and retirees. The shareholder proposal would not require companies to provide health benefits for employees, but asks top corporate executives to view the issue in a broader context, as a question of social policy.

“We are doing what we can as shareholders,” said the Rev. Michael H. Crosby, a 68-year-old Capuchin priest who has had discussions with nine companies on behalf of 20 Roman Catholic orders this year. “We come out of a religious tradition, but we are not engaged in a messianic enterprise. We are one voice among many seeking equitable access to health care for all.”

Religious groups and labor unions hold billions of dollars worth of stock in their pension and health benefit plans. They submitted the same basic health care proposal to three dozen large companies, and they say they have received respectful hearings at many.

“We are working for a national policy that provides universal access to health care, and we do hold more than 30,000 shares of General Electric stock,” said Barbara Kraemer, a Roman Catholic nun who is national president of the School Sisters of St. Francis. “As we pursued the proposal with G. E., the company requested a dialogue in lieu of the shareholder resolution, so we withdrew it. The dialogue was productive, resulting in G. E.’s public endorsement of the Institute of Medicine principles.”

Labor unions and religious groups said they intended to broaden the proxy campaign by bringing in more pension plans next year. If the dialogue between companies and shareholders were to continue, as expected, it could help bridge the divide that has frustrated earlier efforts to cover the uninsured.

Opposition from businesses was one of the major factors that sank President Bill Clinton’s proposal for universal coverage in 1994. But businesses of all sizes are clamoring for relief from high health costs and have concluded they cannot solve the problem by themselves.

Under the commission’s rules, a company does not have to allow shareholders to vote on a proposal if it “deals with a matter relating to the company’s ordinary business operations,” for which management is responsible.

But the commission said it was appropriate for shareholders to express their views to company management by voting on “significant social policy issues” beyond day-to-day business matters.

Over the years, the commission said, it had reversed its position on certain issues to reflect “changing societal views,” and that now appears to be the case with respect to health care.

One of the more bizarre proxy battles occurred at UnitedHealth, an insurer that covers more than 70 million people.

Dr. Reed Tuckson, an executive vice president of UnitedHealth, was a member of the panel that drafted the principles for universal coverage issued by the Institute of Medicine in 2004. But when the Oneida Tribe of Indians, which owns 800 shares of company stock, asked for a formal endorsement of the principles this year, the company resisted.

Lawyers from O’Melveny & Myers, representing UnitedHealth, told the S.E.C., “The proposal provides that ‘health care should be universal,’ dictating to whom the company should provide coverage.” Moreover, they said, by asserting that “health care coverage should be affordable,” the proposal usurps the company’s right to decide what prices to charge for its policies.

Even after the commission told UnitedHealth to include the proposal in its proxy statement on April 2, the company urged the agency to reconsider, saying, “The proposal does not relate to a ‘significant social policy issue,’ as that term has been defined” by the commission.

UnitedHealth mollified shareholders by posting a statement on its Web site that endorsed the goal of “access to health care for all Americans” and the principles of the Institute of Medicine.

“We like to work with our shareholders,” said Donald H. Nathan, senior vice president of UnitedHealth. “It was better to deal with the issue in a dialogue, rather than through the proxy process.”

Exxon Mobil reached a similar conclusion after the staff of the S.E.C. ruled in February in favor of shareholders seeking a vote on the health care proposal. The shareholders, from the Sisters of St. Francis in Minnesota, withdrew the proposal after Exxon agreed to a dialogue.

The United States Chamber of Commerce has complained bitterly about the shareholder campaign waged by the A.F.L.-C.I.O. and other organizations. In response, the Labor Department declared recently that trustees of a pension fund risk violating their fiduciary duties when they try to “further legislative, regulatory or public policy issues through the proxy process.”

Labor unions and religious groups say the proxy is justified because it advances the potential to enhance their investments.

Companies have offered various reasons for resisting the health care proposal. Boeing said it would “not benefit the company or its shareholders.”

General Motors said that “adoption of these health care principles will not advance the legislative debate or facilitate the enactment of federal legislation that would benefit the corporation, its stockholders or the country.”

Reynolds American, the cigarette maker, expressed concern that universal coverage would be financed by more tobacco taxes.

Music Heals, Body and Soul

I found this NYT article to be rather interesting. I'd like to see more research into the effects of various genres of music and typical sounds we encounter in our urban jungle and their influence on inflammatory processes, especially those at work in autoimmune diseases.

A Musician Who Performs With a Scalpel
By DAVID DOBBS
Published: May 20, 2008

For Claudius Conrad, a 30-year-old surgeon who has played the piano seriously since he was 5, music and medicine are entwined — from the academic realm down to the level of the fine-fingered dexterity required at the piano bench and the operating table.

IN TUNE Dr. Conrad, a pianist and surgeon, says that he works better when he listens to music and that music is helpful to patients.

“If I don’t play for a couple of days,” said Dr. Conrad, a third-year surgical resident at Harvard Medical School who also holds doctorates in stem cell biology and music philosophy, “I cannot feel things as well in surgery. My hands are not as tender with the tissue. They are not as sensitive to the feedback that the tissue gives you.”

Like many surgeons, Dr. Conrad says he works better when he listens to music. And he cites studies, including some of his own, showing that music is helpful to patients as well — bringing relaxation and reducing blood pressure, heart rate, stress hormones, pain and the need for pain medication.

But to the extent that music heals, how does it heal? The physiological pathways responsible have remained obscure, and the search for an underlying mechanism has moved slowly.

Now Dr. Conrad is trying to change that. He recently published a provocative paper suggesting that music may exert healing and sedative effects partly through a paradoxical stimulation of a growth hormone generally associated with stress rather than healing.

This jump in growth hormone, said Dr. John Morley, an endocrinologist at St. Louis University Medical Center who was not involved with the study, “is not what you’d expect, and it’s not precisely clear what it means.”

But he said it raised “some wonderful new possibilities about the physiology of healing,” and added: “And of course it has a nice sort of metaphorical ring. We used to talk about the neuroendocrine system being a sort of neuronal orchestra conductor directing the immune system. Here we have music stimulating this conductor to get the healing process started.”

Born in Munich, Dr. Conrad took up the piano when he was 5 and trained in elite music schools in Munich, Augsburg and Salzburg, Austria. After high school he served his obligatory military service as a sniper in the German Army’s mountain corps, where his commander found every opportunity to fly him out of the Alps for some piano time.

After his service he decided to pursue medicine while continuing to study music. He earned a bachelor’s degree at the University of Munich and then, more or less simultaneously, two doctorates and a medical degree.

Dr. Conrad’s music dissertation examined why and how Mozart’s music seemed to ease the pain of intensive-care patients. He concentrated not on physiological mechanisms but on mechanisms within Mozart’s music.

“It is still a controversial idea,” he said recently, “whether Mozart has more of this sort of effect than other composers. But as a musician I wanted to look at how it might.”

Dr. Conrad noted that Mozart used distinctive phrases that are fairly short, often only four or even two measures long, and then repeated these phrases to build larger sections. Yet he changed these figures often in ways the listener may not notice — a change in left-hand arpeggios or chord structures, for instance, that slips by unremarked while the ear attends the right hand’s melody, which itself may be slightly embellished.

These intricate variations are absorbed as part of a melodic accessibility so well organized that even a sonata for two pianos never feels crowded in the ear, even when it grows dense on the page. The melody lulls and delights while the underlying complexity stimulates.

But even if this explains the music’s power to stimulate and relax, “an obvious question that comes up,” Dr. Conrad said, “is why Mozart would write music that is so soothing.”

Mozart’s letters and biographies, Dr. Conrad said, portray a man almost constantly sick, constantly fending off one infection or ailment after another.

“Whether he did it intentionally or not,” Dr. Conrad said, “I think he composed music the way he did partly because it made him feel better.”

Recently, Dr. Conrad has focused on specific mechanisms that may help explain music’s effects on the body.

In a paper published last December in the journal Critical Care Medicine, he and colleagues revealed an unexpected element in distressed patients’ physiological response to music: a jump in pituitary growth hormone, which is known to be crucial in healing. “It’s a sort of quickening,” he said, “that produces a calming effect.” Accelerando produces tranquillo.

The study itself was fairly simple. The researchers fitted 10 postsurgical intensive-care patients with headphones, and in the hour just after the patients’ sedation was lifted, 5 were treated to gentle Mozart piano music while 5 heard nothing.

The patients listening to music showed several responses that Dr. Conrad expected, based on other studies: reduced blood pressure and heart rate, less need for pain medication and a 20 percent drop in two important stress hormones, epinephrine and interleukin-6, or IL-6. Amid these expected responses was the study’s new finding: a 50 percent jump in pituitary growth hormone.

No one conducting these studies had yet measured growth hormone, whose work includes driving growth, responding to threats to the immune system and promoting healing. Dr. Conrad included it because research over the last five years has shown that growth hormone generally rises with stress and falls with relaxation.

“This means you would expect G.H., like epinephrine and IL-6, to go down in this case,” Dr. Morley, of St. Louis University, said of growth hormone. “Yet here it goes up.”

He added, “The question is whether the jump in growth hormone actually drives the sedative effect or is part of something else going on.”

Dr. Conrad argues that the growth hormone does have a sedative effect. In his paper he cites a 2005 study showing that growth hormone releasing factor, a chemical messenger that essentially calls growth hormone to duty, reduced activity of interleukin-6. This suggests, he said, that growth hormone itself may reduce the interleukin-6 and epinephrine levels that produce inflammation that in turn causes pain and raises blood pressure and the heart rate.

This explanation gets a mixed reception among stress researchers. “The two dynamics aren’t necessarily the same,” said Dr. Keith W. Kelley, an endocrinologist at the University of Illinois at Urbana-Champaign and an expert on inflammatory responses. “I personally don’t buy the particular cellular mechanism he’s proposing.”

Yet Dr. Kelley and other stress-response experts, including Dr. Morley and Dr. Bruce S. McEwen of Rockefeller University in New York, say Dr. Conrad’s study clearly suggests that a rise in growth hormone may somehow dampen inflammation and stress responses.

“This is a really intriguing possibility that bears a closer look,” Dr. McEwen said.

For Dr. Conrad, the finding offers a sort of scientifico-musical elegance: Here, it seems, may be a hormonal parallel to music’s power to simultaneously rouse and soothe.

He hopes to expand his study of music’s effects on growth hormone in intensive-care patients. He is also planning roughly similar studies of how music affects a surgeon’s performance. That line of study goes way back — at least to 1914, when The Journal of the American Medical Association published “The Phonograph in the Operating Room,” by E. Kane.

More recent studies have shown that surgeons perform math calculations faster and more accurately when they listen to music they like. Dr. Conrad hopes to find neurophysiological dynamics related to this performance enhancer.

In short, he will continue to carry his study of music into the operating room — along with his music itself.

“When I was a resident, you just picked a radio station,” said Dr. Randall Gaz, an attending surgeon at Massachusetts General Hospital who is one of Dr. Conrad’s teachers in the operating room, and an amateur pianist, oboist and church organist as well.

“This new wave of surgeons bring their iPods,” he continued. “They bring whole mixes. It’s like they have the whole thing choreographed.”

When Dr. Conrad operates, he brings an iPod stocked not just with Mozart, Liszt and Scarlatti but also with gigabytes of European techno-rap bands his colleagues have never heard of (and cannot understand), including Klee, M.C. Solaar and Armin van Buuren.

Asked if he could actually work with that kind of music, he replied, slightly sheepishly: “Well, that’s not the music you want when you’re in the middle of a delicate procedure. But once you’re through that part and you’re closing up” — he shrugged — “it’s a good time to liven things up.”

Occasionally, his operating room colleagues do give him grief. Then, he said with a grin, “I remind them that there is only one person in the room with a doctorate in music philosophy, so if you don’t like the music, the expertise is on my side.”

Yippee! Yay! Go Federal Trade Commission!!

It's rare when I read about government lawsuit filings and I simply want to cheer and jump up and down. Well, it's happened.

Here's some background information first. In 2005, I was finally diagnosed with multiple sclerosis. One of the many problems I was experiencing was MS fatigue - not the I'm just a little tired fatigue, but I'm DEAD TIRED, USELESS, and UNCONSCIOUS at 2:00pm fatigue.

So my neurologist gave me some samples of Provigil (modafinil) to try. And it did help. He was able to give me more samples, but explained that eventually I'd have to fill a prescription. In 2006, I did just that for a 3-month supply.

What I didn't expect was that it would exhaust almost an entire year's allowance for prescription medication from my health insurance!!

$1442 for 3 months!! and that was the 'negotiated' rate with BCBS.

So research Cephalon did I.

Prescription Assistance? No way they said and NORD agreed.

Generic Options? uh-uh

News? Interestingly, yes. A deal with TEVA - maker of Copaxone and many other generic drugs.

Well, I was already peeved at TEVA and NORD, so this just sparked more research. I discovered where to read TEVA news and announcements which I did endlessly.

I also discovered that TEVA and three other generic drug makers were 'paid-off' by Cephalon to settle patent litigation filed to enter the generic market for modafinil. At the time, details of the deals were not disclosed so I didn't know how much money was involved. Now we know that the payments exceeded $200 million and that Cephalon sales of Provigil in 2007 exceeded $800 million. That's just insane.

You see, drug companies file suit to get a chance to enter the generic market of a drug which approaches coming off-patent and the first to receive the go-ahead gets 6 months exclusivity to market and sell their generic version of the drug. TEVA is one company which often races to the front of the line and is able to sell their generic version of a new drug at a price equal to the brand-name drug for those 6 months. This is what TEVA did with sertraline (generic of Zoloft.)

But back to the present -

The Federal Trade Commission has filed suit against Cephalon for anticompetitive conduct. A brief article on the WSJ Health Blog summed it up nicely:

"Governments have been worked up for a while over the prospect that the sellers of branded drugs can keep charging high prices by paying generics manufacturers to stay out of the market. Regulators have suggested that the branded manufacturers are basically gaming the system and forcing consumers to pay inflated prices."

The Antitrust Review has an easy-to-follow summary as well.

And today -

Dr. Wes discusses the recommendations of some bureaucrats who believe that the answer to improving cardiac care during the night shift is...
can you guess...here it comes...modafinil. Yep, that's it, dope the doctors.

But an angle which I hadn't thought of related to this Cephalon debacle comes from John Mack of the Pharma Marketing Blog. John discusses how we may benefit from the War in Iraq through increased generic pharmaceutical competition.

SCHIP in the News AGAIN!!

If you're someone interested in health policy or someone who happened to follow the whole SCHIP debacle last fall, you might be interested in this little tidbit of information.

Bush administration now willing to increase SCHIP spending by $19.3 billion only weeks after vetoing a bipartisan compromise by Robert Laszewski

and

Bush's SCHIP measure called overdue and underfunded by Farah Kahn

Now it appears that the Bush administration has "recalculated things saying, 'We have better estimates now.'"

So this is what happens when folks in charge, who have a personal agenda and narrow view of situations, don't listen to the very ones who KNOW the situation, ie. the states' health departments and the very citizens who need their services.

Recently a fellow blogger discussed the complicated redtape involved with receiving services for her son. It doesn't matter through which agency these services are funded, the point remains that citizens in the trenches are not being heard when their needs are clearly expressed.

I want to say to Bush and the presidential candidates...

Listen to your citizens, listen to the people, listen to the little guy who is too busy in the trenches of life and surviving to come lobby you or flatter you or rah-rah in the crowds.

Attend to the needs of those less fortunate and struggling day-to-day to find breathing room between the challenges of life. And I do thank you for finally conceding (somewhat) that more funding is necessary to maintain a vital program for the health of our country.

To my reader, I recommend the above articles. They are short but highly informational.

'Scientific' Studies are NOT Infallible

Whether you...

• support democrats or republicans
• prefer evidence-based medicine to reiki, or reverse
• read the Washington Post or the New York Times
• watch CNN or the View
• believe ads which state '3 out of 5 dentists prefer...'
• think Bush has been a great president or deserves impeachment
• have health insurance at work or qualify for Medicaid
• 'care enough to send the very best'

You should know that...

• studies can (if so desired) prove or disprove almost any theory which the authors choose
• who conducts the study is very important to consider when examining the results
• how results are stated can influence the reader's opinion
• many, many PR companies exist to conduct studies with the intent of meeting their clients (see KRC Research who works for PhRMA)
• At KRC Research, our goal is to provide information and insights that can build, drive and enhance communications. Our approach rests on the following principles:
• Good research is well-planned. That means our research planning process is as rigorous as our research implementation, seeking clarity and consensus on research goals and parameters.
• Good research is useable. That means our research is designed to provide clear answers to communications questions—what should be communicated, how, and to whom.
• Good research is understandable. That means we deliver debriefs and reports that are not only thorough and insightful, but clear in meaning and accompanied by clear recommendations.
• evidence is sometimes a hard thing to prove

Read "Survey Says: Big Pharma's Getting Better" at the WSJ Health Blog

and please read...

"Lancet Speared" at The Doctor is In (opening paragraph below)

Remember the Lancet study? You know, the one which came out days before the 2006 election, reporting that the Iraq war had caused about 655,000 excess civilian deaths — a number about 20 times larger than most other estimates? It was widely reported in the mainstream media, echoed by politicians and pundits who were quick to use it to further damage the Bush administration politically and heighten opposition to an already
unpopular war. It was also widely cited in Europe and the Middle East as evidence of American brutality and callousness in the execution of the war. Because it was published in a prestigious medical journal, those who were skeptical of its findings were left arguing about arcane epidemiological and statistical flaws which virtually guaranteed that no one would listen. The idea that a medical journal would publish a document almost purely political in nature was, of course, pooh-poohed by all the right people.

Read the rest of this post at The Doctor Is In here.

Read the original article "Data Bomb" in the National Journal.

Finally, keep in mind that messages you hear or read are almost always shared with a purpose.

The purpose in this message from me at this time is to encourage you to question reports and clever studies and to think things over for yourself.

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Big Pharma and Bad Press Go Hand-in Hand?

Can't the Big Bad Drug Industry do anything right?

Today I came across a PharmaFraud article - The Old "Two Sets of Books" Scam - which discusses a little provision buried within the Medicare Modernization Act (MMA) which Big Pharma helped to get passed. This little item allowed Pharma Manufacturers to send one set of drug price data to the federal government, and another set to the States.

The MMA requires Pharma Manufacturers to report average drug prices to the Federal Government, but the Federal Government is not allowed to give this pricing information to the States. There is only one reason that Big Pharma pushed through such a ridiculous clause; to defraud the government.

Big Pharma sends false drug prices to the federal government, the States send utilization data to the federal government, and the federal government verifies the URA (Unit Rebate Amount), calculated by the Manufacturers; a calculation that is based on the Pharma Manufacturers phony prices.

A recent document made public in Re: Pharma Industry AWP Litigation, reveals Abbott's use of "two sets of books" (For additional background, review PF's post; The Five Sets of Books Methodology for Covering-up Fraud and Hiding Drug Diversion). Recently, the DOJ issued a subpoena seeking unit, price, and rebate data for several drugs made by Abbott. The State of Texas had previously served Abbott with a subpoena in which they requested and received the same data. But guess what; Abbott sent one set of data to Texas, and a different set of data to the Feds.

Humm...doesn't sound too good for Abbott.

Then, I find an announcement which PhRMA released today regarding the wonderful goodwill which the pharmaceutical companies are providing to those in need.

The Pharmaceutical Industry provides Relief to Mexican Flood Victims

The pharmaceutical industry has quickly come to the aid of over one million people who have been affected by the flooding caused by Tropical Storm Noel in late October and early November in the Tabasco and Chiapas regions of southern Mexico.“The flooding in Mexico has caused serious damage to the Chiapas and Tabasco regions, which puts the many people who live there in danger,” said Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin. “Our member companies are supporting the aid workers in their fight against potential diseases and other health related problems that could arise as a result of the flood.”PhRMA member company contributions have included:

Abbott’s donation consists of 28,000 boxes of antibiotics, 94,000 bottles of serum, 7,000 packages of infant formula, 46,000 nutritional supplements, and 100 glucose meters with 10,000 reactive strips. In addition, Abbott has donated the resources for HIV and Hepatitis A, B and C exams and
blood tests. It has also provided the materials to reactivate the operation of the blood bank that services several hospitals in Villahermosa.

GlaxoSmithKline (GSK) has made a donation of medicines and OTC products valued at more than $580,000. The contribution comprises quantities of Ceftin and Bactroban, which is valued at around $100,000, as well as Septrin, Amoxil, Zentel, Virlix and Zovira. GSK will be working with its donations partner, AmeriCares, and its in-country partners, the Mexican Order of Malta, to distribute the products.

Johnson & Johnson is distributing OTC drugs, antibiotics, wound care products, and food and water through its disaster relief partner, AmeriCares. It also guarantees that any U.S. based employee of Johnson & Johnson will have their contributions to the flood victims matched 2-for-1
through their Matching Gifts Program.

Merck is donating $50,000 in cash to the American Red Cross and working closely with their partners on the ground to assess the situation and provide any medicine and support that will be requested in the future.

Pfizer contributed $17,000 from its disaster relief fund which was matched by Corporate Affairs Mexico for a sum total of $34,000 allocated for reconstruction works. It also donated drinking water as well as other needed supplies and contributed medicines worth $80,000 channeled through the Ministry of Health. To its Tobasco based peers, Pfizer donated a sum total of $17,000.

Schering-Plough is distributing to its colleagues in Mexico cash donations and medicines for adults and children, such as antibiotics, antifungals, pain medicines, and treatments for colds and flu. Moreover, it is delivering supplies such as groceries medical supplies, cleaning agents, house
wares, as well as other items.

Wyeth is donating 18,600 units of nutritional products (SMA, Promil and Progres), as part of a national “United for Them” relief initiative, which includes other major companies as well as Televisa, Mexico’s main TV network.

If I'm not mistaken, aren't these the same Big Pharma companies which have been getting a lot of bad press and are just a little in trouble with the feds right now?

But hey, at least that may actually be helping some folks who need the help right now.

I'm glad for that.

Is Montel Williams disturbed by Big Pharma?

Controversial behavior by Montel Williams, spokesman for PhRMA's Partnership for Prescription Assistance, may bring unwanted attention to Big Pharma's great PR machine. (h/t Cary Byrd at eDrugSearch Blog)

As reported, the 'Help is Here Express' blew through Savannah Georgia to promote the hope of 'free or nearly free' drugs to qualified individuals. This Orange Bus travels the country promising that it's program helps to save lives...by providing medications to uninsured patients.

Montel Williams has multiple sclerosis, as do I, and has been the visible image of PPArx since . Now I've got my own opinions as to the quality of assistance which Billy Tauzin and his Orange Bus purport to provide needy individuals. [see PhRMA and PPArx: How much are they really helping patients in need?]

Previously, I've given Williams the benefit of the doubt regarding the use of his image to promote a glossed-over PR concoction. I have no doubt wondered as to the level of compensation the Big Pharma lobby may be providing him, but I've let it go.

Last Friday, Courtney Scott, a high school intern at the Savannah Morning News, interviewed Williams for the paper. But apparently her 2nd question touched a raw nerve.

Excerpt from Savannah Morning News online:

Before the rally in Johnson Square, Williams stood for an interview with Scott.

With her second question she asked, "Do you think pharmaceutical companies would be discouraged from research and development if their profits were restricted?"

It was a question she came up with after discussing the issue with her Advanced Placement English teacher.

Williams bristled.

"I'm trying to figure out exactly why you are here and what the interview is about," he replied.

He asked if she suffered from any illness, to which she answered no.

"I'm here as a patient advocate talking about the fact that medications available today are saving people's lives, that's what saving mine and after that, this interview is done."

He snapped his fingers, said thanks and walked away.

"That's an absolutely fair question to someone who represents the pharmaceutical industry," said Savannah Morning News Executive Editor Susan Catron.

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said the question would have been better directed to himself because he represents the drug industry, and Williams is paid to raise awareness of the drug program.

Yup, that's it. A paid endorser is not in any way responsible for having an opinion on the item being endorsed. However, I believe that any paid spokesperson should be educated and well versed on the subject of that endorsement. Williams could have simply responded that the question presented be directed to the individuals representing Big Pharma itself, not to the star of the Orange Bus Circus.

Later that day, Scott was at the Westin Hotel preparing for an unrelated interview when Williams approached her and delivered a threat. MSNBC reports Montel threatens to 'blow up' teen reporter. Savannah Morning News says Montel 'blows up' at local reporters. My favorite is from eDrugSearch Blog Big Pharma Flack Montel Williams can't take the heat -- from a high school interrogator!

But I guess that all should be excused as Williams offers On-Air Apology to Teen Reporter (AP Press). Scott may take the offer, but she should be prepared to face numerous slick-talking representatives of PhRMA. And representatives are numerous indeed as Big Money is being spent by Big Pharma to represent and educate many of us, including our lawmakers in Congress.

As far as PhRMA's Partnership for Prescription Assistance goes, here's a brief rundown of my personal experience, excerpted from a previous post - Rx Outreach Rocks!

I have spoken before about PPArx and not much has changed.

When I called their number this summer, I was 'assisted' by a man who didn't really speak English at all. In fact, we had to resort to spelling everything in 'alpha, beta, charlie, echo' lingo. Now just think about most medications....that's extremely tedious at best.

Then I waited....and waited...and waited...and finally received their specially-prepared 'package' almost two months later. Ironically, the 'package' omitted applications for programs which I knew were available (I was instructed to contact the program directly for more information) and included applications to programs for which I knew I was not even remotely eligible.

What a waste of time, energy, and resources.

Perhaps PhRMA and Montel Williams need to lower their perceived risk of personal attack by actually doing a better job of providing the information and services which they are promoting.

And to the companies and lobbyists of Big Pharma, please use your resources for real R & D and stop spending so much money, time and energy on 'educating' and 'selling' us of your wonderful intentions, products, and services. We'd all be better off for it.

UPDATE: Prescription Access Litigation discussed Montel and PhRMA on their own blog, sharing my views. Expert below:

So why was Montel so angered by this question, a question which arguably invited a stock answer that PhRMA reps repeat dozens of times a day? It’s not as if the reporter asked “Why doesn’t the pharmaceutical industry make its Guiding Principles on Drug Advertising mandatory and enforceable?” And it’s not as if the reporter asked some obscure question on some obtuse point of, say, patent law or the issue of follow-on biologic drugs. It’s surprising that the industry’s main spokesperson for its patient assistance program was so poorly prepared to answer such an easy question.

But perhaps all this is beside the point. Does it ultimately matter if Montel Williams answers questions about the industry’s priorities and policies, or any questions beyond the mechanics of this patient assistance program?

The answer is, yes, it does. Montel Williams has become one of the most visible spokespeople for the industry. He lends his name and his credibility to the cause of burnishing the image of America’s pharmaceutical companies, and is paid (presumably handsomely) to do so. So it’s entirely fair that he be asked questions about the industry. Although perhaps Ken Johnson, PhRMA’s Senior Vice President of Communications, is the better person to ask this kind of question, Montel is fair game as well — by accepting the industry’s money, and acting as his spokesperson, he has to take what comes with that — including fair questions about the industry’s misplaced priorities.