The Wall Street Journal reports:

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. …

FDA officials “are too cozy with the companies they regulate,” Sen. Chuck Grassley (R., Iowa) said, adding that new leadership must “fix the culture.” …

“There’s a total inability of the FDA to carry out” its mission,” said Rep. John Dingell (D., Mich.)

Meantime, the folks at the Center for Media & Democracy on their PRWatch.org website caught a couple of things I had missed regarding Big Pharma and Big Politics.

Pushing Prescriptions

Source: Center for Public Integrity, June 24, 2008

“Washington’s largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort,” reports M. Asif Ismail. The spending, from companies and trade associations including Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, jumped 36 percent over the previous year. Much of the increase went to Democrats, after they became the majority party in Congress. “In the current election cycle so far, for the first time on record, the pharmaceutical and health products industry has given slightly more money to Democrats than Republicans,” Ismail notes. Just two years earlier, “Democrats received only 31 percent of the contributions from the industry, while the Republicans received 67 percent.” The industry’s lobbying successes have included “thwarting congressional efforts to restrict media ads for prescription drugs,” “blocking the importation of inexpensive drugs from other countries,” and “ensuring greater market access for pharmaceutical companies in international free trade agreements.”

If You Can’t Beat ‘em, Hire ‘em

Source: Wall Street Journal (sub req’d) July 23, 2008

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy “fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices.” He was also an active litigator who worked against consumer interests. “Representing the Washington Legal Foundation, an industry-supported business think tank, Mr. Troy argued for the protection of commercial speech. … He was also part of the winning team representing Brown & Williamson in a suit against the FDA regarding tobacco advertising.” At the FDA, he was known as a loyal friend of the very industries the regulatory agency is charged with monitoring. “Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical-device makers, saying that having met the FDA’s approval and labeling standards, manufacturers should be protected from state-based suits for damages.” His move to GSK is another example of the revolving door between government and industry. GSK said of Troy, “His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients.”

The World Gastroenterology Organization (WGO) recently released new digestive health guidelines. In the United States, the Foundation for Digestive Health and Nutrition (FDHN), which is the foundation of the American Gastroenterological Association (AGA), interpreted these new guidelines into a graphic (see below).



The guidelines are designed to reduce symptoms of digestive discomfort and help people achieve optimal digestive health – meaning the body is working properly to break down food and turn it into energy. The WGO says a person with good digestive health weighs a normal amount and rarely experiences digestive problems like nausea, bloating, constipation, stomach pain, diarrhea, heartburn, gas or irregularity.



“Digestive health has become a widespread concern among Americans, especially since digestive problems can pervade all aspects of a person’s life,” said Robert Sandler, M.D., MPH, AGAF, president of the AGA Institute. “The new guidelines outline ways that people can improve their digestive health by making simple lifestyle modifications.”



Here are the WGO’s Ten Nutritional Recommendations to Improve Digestive Health

1. Eat small, frequent meals. To achieve optimal digestion, eat 4-5 small meals per day without increasing overall caloric intake.
   
2. Include foods rich in fiber. Fiber is important for the health of the digestive system and can be found in fresh fruits, raw vegetables, whole grain breads and cereals, nuts, and beans.
   
3. Consume fish 3-5 times per week. Fish contain omega 3 fatty acids that can improve digestive abnormalities by stabilizing cell walls, reducing inflammation and restoring balance.
   
4. Reduce intake of fried, fattening foods. Cutting back on greasy, fried foods that are high in fat and hard to digest will reduces your stomach’s workload.
   
5. Incorporate fermented dairy products into your diet. Certain probiotics, or the good bacteria that is found in dairy products like yogurt and cottage cheese, may improve intestinal function and overall digestive health.
   
6. Select lean meats. Leaner cuts of meat – pork, chicken and turkey – contain less fat, which may reduce digestive discomfort.
   
7. Drink plenty of fluids. Fluids are needed to alleviate and prevent constipation and ease digestion of foods through the digestive tract. A good way to make sure you’re getting enough fluids is to drink a glass of water with every meal.
   
8. Don’t rush eating. Eating slowly and chewing food properly encourages a “full” feeling, which prevents the overeating that can upset the digestive tract.
   
9. Exercise regularly and abstain from smoking. While most people know that exercise offers overall health benefits, most people don’t know that it’s good for your digestive tract, too.
   
10. Maintain a healthy body weight. A Body Mass Index that indicates obesity or unintentional weight loss may have a negative impact on digestive health.
    

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A few days ago, the Star Tribune reported on plans for still another diagnostic imaging center in a Minneapolis suburb that has more MRI machines than in many entire countries. Excerpt:

Along a two-mile stretch of France Avenue in Edina, medical providers have installed so many powerful magnetic resonance imaging (MRI) scanners that radiologists joke that anyone driving through with a pacemaker should beware.

Come September, there’ll be a new one. …

Its opening is likely to reignite a debate on whether Minnesota has too many diagnostic imaging facilities, encouraging doctors to order unnecessary procedures and pushing up medical costs. It’s also likely to raise the ethically thorny question of whether doctors should refer patients to a facility in which they have a financial stake.

“Imaging has been an area of concern for a long time,” said Julie Sonier, director of the Minnesota Department of Health’s health economics program, which does reviews of major medical investments. “Issues about the concentration in Edina have also been a concern for some time.”

A 2007 Health Department report said there was anecdotal evidence in Minnesota that physician investments in facilities led to financial conflicts of interest and overuse.

Among the reader responses are these:

• As a patient, how do you know that you really need a test that may be uncomfortable, that might have some risk associated, that might have radiation exposure associated, and that you might have to pay for when you know that the person telling you you need it stands to make up to $1000 just for suggesting it? The answer is you can’t. This practice is a pox on medicine.

• There are as many MRI scanners in the Twin Cities as in all of Canada. Is the health of Canadians compromised by fewer imaging studies? Obviously not. There is no relationship between the number of tests and procedures performed in medical care and the health outcomes of the patients.
More medical care is not better care. The Health Department should carefully examine the merits of this expansion of imaging services.

Non smokers don’t understand why smokers don’t simply throw away their cigarettes and be done with it. Smokers do not do this because smoking tobacco isn’t simply a bad habit. It is incredibly addictive. Health professionals believe that it is just as addictive as any street drug, and because it is legal, people tend to believe that it is less harmful then it really is.

When the chemicals in cigarettes are inhaled, they reach the smoker’s bloodstream, lungs and brain, which has long lasting effects that are very addictive. One of the primary chemicals in cigarettes is nicotine. Nicotine is extremely habit forming, both physically and psychologically. It isn’t just nicotine, but arsenic, hydrogen cyanide, carbon monoxide and carbon dioxide, all dangerous chemicals, can also be found in cigarettes.

Nicotine affects the central nervous system by stimulating it. The chemicals in the cigarettes cause the blood pressure to rise and the heart rate to speed up. It also restricts the blood vessels, which puts smokers at a greater risk of heart problems. Smoking also leads to premature aging, wrinkles, a lower ability to taste and smell. With all of these negative affects, it’s a wonder why people continue to smoke. However, they do. In fact, millions of individuals want to stop smoking but can not. This is because it is more then a simple bad habit, but is a very real addiction.

When individuals smoke, their brains begin to associate it with pleasure and release the brain chemical, dopamine. Dopamine helps you feel relaxed and good. When individuals stop smoking, this chemical is not as released as often. This can cause the individual to want to start smoking again because they miss these good feelings. It usually takes at least three weeks for the brain to re-train itself. Besides, the issue of brain chemistry, nicotine is also very addicting.

It generally takes about 100 hours or about 4-5 days for nicotine to leave your system, however, if you have smoked cigarettes for a long period of time, then it will take longer for your body to get over the effects and you still may be physically and psychologically addicted. Generally the first 3-4 months are crucial to one quitting smoking. If an individual can stop smoking for this amount of time, they should be able to outlast both the physical and mental addictive factors.

George Key is the owner of an QuitSmokingAid.net, a website which aims to provide information about the effects of smoking, the benefits of Quit Smoking and the most effective Quit Smoking Tips to help you stop smoking and change your life.

Article Source: http://EzineArticles.com/?expert=George_Key

A new University of Michigan study in mice suggests that a drug recently approved to fight cancer tumors is also able to reduce the effects of graft-versus-host disease, a common and sometimes fatal complication for people who have had bone marrow transplants. Plans are under way at U-M for an initial trial of the drug in people as a new way to prevent graft-versus-host disease. Scientists expect to begin a trial within a year……..

Research involving large Middle Eastern families, sophisticated genetic analysis and groundbreaking neuroscience has implicated a half-dozen new genes in autism. More importantly, it strongly supports the emerging idea that autism stems from disruptions in the brain’s ability to form new connections in response to experience consistent with autism’s onset during the first year of life, when a number of of these connections are normally made……..

The AP reports that a new report on Alzheimer’s says that it is much more common than previously thought with a million Americans sliding into “mild impairment” annually.

A milder type of mental decline that often precedes Alzheimer’s disease is alarmingly more common than has been believed, and in men more than women, doctors reported Monday.



Nearly a million older Americans slide from normal memory into mild impairment each year, researchers estimate, based on a Mayo Clinic study of Minnesota residents.



That’s on top of the half million Americans who develop full-blown Alzheimer’s or other forms of dementia – a problem sure to grow as baby boomers age. The oldest boomers turn 62 this year.

The same article says that an experimental nose spray has helped improve some memory function in people listed as “midly impaired.”

But that may be changing. Researchers on Monday reported early, somewhat encouraging results from an experimental nose spray that seemed to improve certain memory measures in a study of mildly impaired people.



The drug, for now just called AL-108, needs testing in a longer, larger study. It is being developed by Allon Therapeutics Inc., based in Vancouver, B.C.



Doctors said it shows the potential for new types of medicines that target the protein tangles that kill nerve cells, instead of targeting the sticky brain deposits that have gotten most of the attention up to now.

The BBC also has an article about another promising Alzheimer’s drug. These drugs will all be needed as Alzheimer appears to be a disease that will impact a wide swath of our aging population.



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Bloomberg reports:

“Insurers, led by WellPoint Inc. and Magellan Health Services Inc., are increasingly rejecting imaging procedures recommended by U.S. doctors as the companies work to trim $30 billion a year they say is wasted on the tests.

CT and MRI scans that allow doctors to peer inside the body can cost as much as $2,000 each. Almost 50 percent of scans for some conditions fail to improve patients’ diagnoses or treatment, according to a report issued today by America’s Health Insurance Plans, a Washington-based trade group.

With U.S. health costs projected to grow to 25 percent of the economy in 2025 from 16 percent now, insurers are turning to so-called radiology benefit managers who can reject scans determined to be unneeded, said Shay Pratt of the Advisory Board Co., a Washington-based consultant to hospitals. Doctors ordered 115 million of the procedures last year. More than 80 million Americans already must get advance approval for the tests, and that may grow to 120 million in two years, Pratt said. …

Almost $100 billion a year is spent on imaging in the U.S. and that may double by 2013 unless costs are reined in, according to the report today by America’s Health Insurance Plans. …

The Congressional Budget Office cited the “widespread diffusion of new medical technologies and services” as a leading cause of cost increases in its November report forecasting that health care will grow from 16 percent of the U.S. economy to 25 percent by 2025 unless changes are made. Health spending is currently $2.4 trillion, according to U.S. estimates.

Medicare, the U.S. health-care program for the elderly and disabled, has taken an initial step by reducing payments for scanning facilities when they perform more than one procedure on the same patient in the same day. …

The Government Accountability Office, the investigative arm of Congress, said last month that Medicare should consider requiring pre-authorization for outpatient imaging of its 44 million beneficiaries.”

Hearing about a human being who snores can be funny, it can still be hilarious. But if you are staying with somebody who snores, a relative or a family associate conceivably, then the noise may turn out to be very troubling. If you cannot get a nice sleep at night and constantly have to [...]

The AP reports on a Government Accountability Office analysis of FDA monitoring of off-label drug promotion – which means marketing of drugs for purposes for which they are not approved. Excerpt:

“The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said in a statement. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements.”