Payment to doctors was an important part of the Act to Promote Cost Containment, Transparency and Ef­ficiency in the Delivery of Quality Health Care. The bill contains a section that requires pharmaceutical and medical device manufacturing companies to report any gifts to healthcare professionals of $50 or more. The state Department of Public Health will record such payments and make them publicly available on the state’s website: http://www.mass.gov.

State Senator Mark Montigny was one of the first to compliment the governor on signing this bill into law. He had been the author of earlier legislation aimed at banning all such gifts. The legislation that did pass at the $50 mark represented a compromise between members of the state’s House of Representatives and the Senate.

“Biased marketing and financial inducements are destructive to the sacred doctor-patient relationship,” Senator Montigny said. “Cost controls, disclosure and transparency are imperative as we demand universal ac­cess to quality healthcare. I commend the governor for standing firmly on the side of the patient and the tax­payer.”

Many states are getting more involved in working to control the rising costs of healthcare and it is likely that more restrictions will be forthcoming on the doctor and pharmaceutical industry relationships in the fu­ture. Massachusetts has taken the lead in implementing such reforms according to Senate President Therese Murray. “Massachusetts is known around the world for cutting-edge, top notch healthcare and medical re­search. We are leading the way, and this legislation allows us to continue that leadership, while proving the best healthcare possible for the people of the Commonwealth.”

Governor Patrick added his thoughts on the expectations he has for doctors and suppliers as a result of this bill. “This measure will set a marketing code of conduct to help ensure healthcare providers make choices about prescription drugs and medical devices for their patients based on therapeutic benefits and cost-effective­ness.”

Also included in this bill along with the transparency measures were an adoption of uniform billing and electronic health records, incentives for medical students and nurses to continue their education, and awards to hospitals who wish to upgrade their computer technology. It also gives the state more influence over curtail­ing the rising cost of health insurance.

Source: The State of Massachusetts Office of the Governor.
“Governor Patrick Signs Bill Enhancing Quality, Cost-Effectiveness and Transparency of Health Care.” August 2008.
http://www.mass.govfipageID=gov3pressreleasediL=18t1.0=Homedtsid=Agov3dtb=pressreleasedtf=080811_dr_gifts&csid=Ag

Dr. Joseph Biederman of the Harvard Psychiatry Department has been known to be very involved in research with powerful antipsychotic medicines. According to Senator Grassley’s report, Dr. Biederman has taken and failed to properly report at least $1.6 million in drug com­pany income. The payments were received between the years 2000 and 2007. During this time, the doctor failed to follow the proper reporting procedures as set out by the university regarding payments from drug companies.

Dr. Timothy E. Wilens of the Harvard Medical School is a second person cited by Senator Grassley as circumventing the reporting system. His unreported income is also in the area of $1.6 million. A third colleague of the two doctors, Dr. Thomas Spencer, has unreported income of over $1 million.

In beginning the investigation, Senator Grassley said he had asked to see the report forms the doctors had presented to the University regarding drug company payments. He said the forms were a mess and his staff had a hard time even reading them. That’s when he asked the University to have a second look at the monies received from drug companies, and this is when things got interesting, he said. This is when Drs. Biederman and Wilens belatedly disclosed their $1.6 mil­lion each, and Dr. Spencer admitted to over $1 million.

Speaking to the Congressional Record, Sen. Grassley said, “What makes all of this even more interesting is that Drs. Biederman and Wilens were awarded grants from the National Institutes of Health to study the drug Strattera^®. Obviously, if a researcher is taking money from a drug company while also receiving Federal dollars to research that company’s product, then there is a conflict of interest. That is why I am asking the National Institutes of Health to take a closer look at the grants they give to researchers.”

Senators Grassley and Herb Kohl of Wisconsin are co-sponsors of the Physician Payments Sunshine Act, a bill introduced into Congress in September 2007. The aim of the bill is to pro­vide for transparency in relationships between physicians and drug manufacturers for which pay­ments are made under government programs. It is aimed at doctors and drug companies making honest disclosures and discovering when conflicts of interest exist. The bill is currently being con­sidered by the Senate Finance Committee.

In the meantime, Sen. Grassley’s investigators continue to look into matters such as this one at Harvard. Likely what they are discovering is only the tip of the iceberg in terms of payments made, received and hidden from view.

Source: GovTrack.US. “Payments to Physicians. The United States Senate.” June 2008. http://www.govtrack.us/congress/record.xpd?id=110-s20080604-268zperson=300048

Hormones, Health, and Happiness.

The thyroid gland is located in the neck. It produces hormones secreted into the body that cause the increased use of glucose. Very simply, they are very involved in releasing the energy that keeps the body humming along at a healthy rate. Hypothyroidism is the condition of insufficient thyroid hormone production.

There are many symptoms of hypothyroidism, but it is far from undetectable by a doctor willing to take a look at a patient’s condition and history. Fatigue, weight gain, and sensitivity to cold are com­mon patient complaints since hypothyroidism reduces the ability to metabolize glucose for energy. Additionally, many hypothyroid victims suffer from depression, concentration difficulties, blood pres­sure problems and loss of sex drive. In women, hypothyroidism can also impair fertility, cause a mis­carriage and even premature delivery or still birth. Incidentally, seven times more women suffer from hypothyroidism than do men, according to Dr. Hotze.

In his book, Dr. Hotze is often quite critical of his fellow medical practitioners who place an over-importance on lab results instead of listening to the patient, understanding symptoms and considering prior treatment history. “Most American women who have hypothyroidism remain undiagnosed. Even those who suspect that low thyroid function is the underlying cause of their fatigue, weight gain, depressed mood, brain fog, and other symptoms seldom get help from their physicians. The reason for this is that most physicians have been influenced by a herd mentality. They don’t treat patients, they treat lab values.”

Even when lab results point a doctor in the direction of correct diagnosis, the synthetic form of thy­roid hormone widely prescribed by the medical profession is ineffective in fully treating a patient, according to Dr. Hotze. The thyroid replacement Synthroid^® is the number one prescribed treatment for hypothyroidism. In fact, in 2002 it was the fourth most prescribed drug in the United States. Without going into a lengthy explanation of its deficiencies, suffice it to say that it is lacking in a full comple­ment of hormones needed to get the body running smoothly on all cylinders.

Dr. Hotze prefers to administer a natural thyroid hormone extract with proven results dating back to 1939. The product he utilizes is called Armour^® Thyroid which is obtained from the thyroid gland of pigs. He has seen remarkable results with this product mainly because it contains the very same thyroid hormone molecules that the body produces.

Dr. Hotze warns that women suspecting they have a hypothyroid condition may have to visit several doctors to find one who will listen to their concerns, recognize the problem and then prescribe the cor­rect natural hormone replacement product. Time doing this will be well spent in terms of proper diag­nosis and treatment. A reading of Dr. Hotze’s book, Hormones, Health, and Happiness will provide some excellent advice and ammunition to help in the search.

Source: Hormones, Health, and Happiness, by Steven F. Hotze, M.D. with Kelly Griffin, Greenleaf Book Group LP, Austin, Texas, 2005.

The FDA has received reports that the drug is responsible for causing behavior/mood changes, suicidality (suicide thinking and behavior) and suicide. The agency has issued a warning to healthcare professionals and users of the drug that it is conducting an investigation even though it is not telling people to immediately stop using the medication.

Singulair is a drug that is used to treat asthma and the symptoms of rhinitis including runny nose, itching of the nose, sneezing and stuffy nose. It is also pre­scribed to prevent asthma that is induced by exercise.

Reports to the drug maker have already caused Merck to take action to update pre­scribing information to doctors and usage information to patients. These updates fall under the area of “post-marketing adverse effects.”

Here are the adversely reported effects for which Merck already executed a series of informational updates in the past year for the prescribing of Singular:

• Tremor, March 2007.
• Depression, April 2007.
• Suicidality, October 2007.
• Anxiousness, February 2008.

The FDA has indicated that it may take up to 9 months to determine the results of this investigation. Regardless of the FDA’s position on Singulair, it is warning both to doctors and to users to be alert to the risk of altered behavior and suicidal thinking.

Singular falls into a category of drugs known as “leukotriene receptor antagonists.” (Leukotriene is a compound that works to regulate allergic and inflammatory reac­tions.) Additional leukotriene modifying medications include the drugs Accolate^®, Zyflo^® and Zyflo CR^®.

According to the FDA, “Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.”

Source: The U.S. Food and Drug Administration. “Early Communication about an Ongoing Safety Review of Singulair.” April 2008. http://www.fda.gov/cder/drug/early_comm/montelukast.htm and http://www.fda.gov/medwAtch/safety/2008/safety08.htmitSingulair

The ongoing campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries from the FDA’s Center for Food Safety and Applied Nutrition. The letters sent to marketers and makers of products for which cures are claimed are warned they have 15 days to remove all such claims. Failure to do so can lead to seizures of product, prosecu­tions and fines. The letter offers no advice, help or encouragement for testing the product.

“We will continue working with our partners in the U.S. and internationally to make sure scammers have no place to hide,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection.

FTC has also launched a campaign to teach consumers how to avoid phony diabetes cures. The materials encourage consumers to “Be smart, be skeptical!” and will be available in English, Spanish, and French. One component is a “teaser” Web site available at http://wemarket4u.net/glucobate/index.html. At first glance, the site appears to be advertising a cure for diabetes called Glucobate, but when consumers click for more information on ordering the prod­uct, it reveals information about avoiding ads for phony cure-alls in the future.

The FDA/FTC uses the terms “scammers”, “deceptive advertisements”, “misrepresented as cures” and “fraudulent cures and treatments” to describe any claims to alleviate any physical or mental condi­tions or illnesses for substances or procedures of any kind that have not been through the approvals process of the FDA.

Claims that a substance can cure anything automatically classifies that substance as a drug, accord­ing to the Federal Food, Drug, and Cosmetic Act, and drugs must be approved by the FDA. Unfortunately, there are very few FDA-approved drugs that claim cures, since cures are not popular with the big pharmaceutical companies that can afford the elaborate scientific testing needed for approvals.

It’s good that we have a government working to protect us from potential dangers. But in a more perfect world, the government would also have well-financed systems in place that would help facili­tate testing all reasonable avenues and ideas for cures for disease.

Instead, our government’s health agencies appear to be in league with rich and powerful pharma­ceutical companies whose stock in trade is maintaining disease, not producing cures and health. There’s no future profit in healthy people.

SOURCE: http://www.fda.govibbs/topics/NEWS/2006/NEW01494.html

The comprehensive study examined reviews from the U.S. Food and Drug Administration (FDA) for trials of 12 widely prescribed antidepressant drugs approved between 1981 and 2004. A total of 12,564 patients were involved. In addition, researchers also conducted a sys­tematic literature search to identify whether results of studies had been published in any other medical journals. For those that were published, the researchers continued on to determine if the published versions of the results matched the FDA’s version of the results.

Basically, what researchers found was that the publishing of results and how the results were reported depended entirely on the outcome of each trial. This information comes from Erick Turner, M.D., who is an assistant professor of psychiatry, physiology and pharmacolo­gy at Oregon Health & Science University and the Medical Director of the Portland Veterans Affairs Medical Center’s Mood Disorders Program.

Dr. Turner and his group found that according to the published literature, nearly all of the studies conducted (94%) had positive treatment results. This figure varies considerably from data provided to the FDA which showed, in fact, that only about half of the studies (51%) had positive results.

Unsurprisingly, drug companies were found to be very selective in the studies they did publish and were found to engage in deceptive and inaccurate reporting as well. Positive studies, with one exception, were all published. Additionally, 33 of 36 studies that were not positive were either not published or published deceptively as if they were positive, the researchers found. These 33 studies involved 5,212 patients.

“Selective publication can lead doctors and patients to believe drugs are more effective than they really are, which can influence prescribing decisions,” said Dr. Turner. While the doctor did mention that a failure of a study author or sponsor to submit a non-positive manu­script or an editor’s decision not to publish it could have some affect on the process, there was very clear bias in the reporting of some findings and failure to report others. “Doctors and patients must have access to evidence that is complete and unbiased when they are weighing the risks and the benefits of treatment,” he said.

Source: ScienceDaily, Press Release, January, 2008. http://www.sciencedaily.com/releases/2008/01/080116202037.htm

Fibromyalgia is a disorder that is characterized by chronic aches and tenderness in the muscles, fatigue and sleep problems. Pain usually occurs in the neck, shoulders, back, hands and pelvis. While there is no permanent damage to the joints or muscles associated with it, the pain it brings can be quite intense and difficult to live with. It is estimated that between 3 to 6 million people in the United States suffer from it each year. Statistics show that more women than men are affected, typically starting in early-to-middle adulthood.

It is interesting to note from the FDA commentary on Lyrica that while some test patients experi­enced a lessening of pain, not all experienced relief from the product. According to Steven Galson, M.D., the director of FDA’s Center for Drug Evaluation and Research, “Consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder.”

Also interesting is that it was approved even though the maker of the drug, Pfizer Inc., and the FDA were not able to provide detailed information of just how it works. According to the FDA, “Individuals with Fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which Lyrica produces such an effect is unknown.”

Finally, the FDA included the following warning to people using Lyrica: “The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and atten­tion. FDA advises that patients talk to their doctor or other healthcare professional about whether use of Lyrica may impair their ability to drive.”

Also interesting is that the FDA made no mention of possible alternative methods for treating Fibromyalgia symptoms. These would include a healthy diet, adequate rest, exercise, stretching of affect­ed areas, physical therapy, Chiropractic adjustments or Acupuncture treatments. It’s also noteworthy that this drug was originally targeted toward handling nerve pain associated with diabetes. When its approval was declined, it was retargeted toward Fibromyalgia pain and thus received FDA approval.

Persons suffering from the symptoms of Fibromyalgia should be thoroughly examined by a chiro­practor and/or an acupuncturist given healthy treatment options. This should be done long before consid­ering a drug that showed marginal test results and requires a slew of FDA warnings to consumers.

Source: The U.S. Food and Drug Administration, June 2007. http://www.fda.govibbs/topics/NEWS/2007/NEW01656.html and http://www.fda.goviconsumer/updates/fibromyalgia062107.html

To counter problems associated with the stomach, the pharmaceutical industry developed and has for many years promoted coated aspirin products. The aim of this product is to minimize these potential difficulties by allowing the tablet to sail right through the stomach and into the small intestine before it begins dissolving.

Armed with this information, many people have been taking coated or buffered aspirin in the belief that their risks of stomach problems and discomforts will be less­ened. Now, however, a new report recently published in the Harvard Heart Letter notes that this is mistaken information. The risks are just as great in taking coated aspirin as when ingesting non-coated aspirin.

According to the report, aspirin does not have to be in direct contact with the stom­ach cells to cause them harm. The reason for this has to do with the fact that even though the tablet dissolves in the intestine, the medicine gets into the blood stream where it is pumped to all parts of the body. This would include being transported directly back to the cells of the lining of the stomach.

Aspirin has the effect of blocking the COX-1 enzyme in the stomach. (Cox-1 is Cyclooxygenase-1, a protein that speeds up certain chemical messengers in the stom­ach.) When Cox-1 is inhibited, it can have the effect of reducing the natural protective mucus lining of the stomach and can cause nausea, intestinal bleeding and ulcers.

Many people use aspirin products regularly and have no adverse reactions. Many older people include taking it as part of their daily health regimen. Regardless, health care professionals and users of aspirin should be advised that taking a coated product offers no advantages to the user who may be experiencing stomach problems. In fact, according to the report, coated aspirin products hold the same potential as non-coated aspirin in causing problems of the stomach and the stomach lining.

Source: Harvard Publications, The Harvard Heart Letter, August 2007.

http://www.health.harvard.edu/press_releases/gastrointestinal-bleeding-from-coated-aspirin.htm

Until now, wastewater testing was generally done after the water left the sewage treatment plant. Now, a team of researchers has developed an automated monitoring method that makes it possible to detect drugs, from cocaine to caffeine and from Paxil to Prozac, before they enter municipal wastewater plants. In effect, it can locate and monitor patterns of drug use in entire communities as they enter treat­ment facilities.

The research group was lead by Oregon State University chemist Jennifer Field, and she reported her findings recently at the American Chemical Society meeting held in Boston, Mass. “It’s like taking a very diluted urine sample collected from an entire community,” said Ms. Field.

The presence of pharmaceutical and illicit drugs in municipal wastewater has been known for sever­al years, beginning with groundbreaking studies in Europe that tracked the presence of drugs in sewage and river water. Ms. Field pointed out that she and her colleagues have developed new methods of chemical analysis so that detection is possible from very small samples. Such testing can be done auto­matically over a 24-hour period from wastewater as it enters a treatment plant.

This data can be used in several ways including providing information regarding community drug use. “This method is most useful for drug surveillance at the community level,” said Ms. Field. “Wastewater analysis is a more powerful indicator at the community level.”

For instance, in their preliminary studies, researchers found patterns of drug use with higher waste­water concentrations of recreational drugs (such as cocaine) on weekends. They found no change in con­centrations of either prescription drugs or methamphetamines in their samples, suggesting more consis­tent use.

This method of testing can have benefits for large cities and particularly smaller towns. Typically, drug use and abuse studies focus on the larger demographic areas. With both the ease and cost effective­ness of these new methods, data can be collected from smaller residential areas as well.

Researchers hope that the state of Oregon will benefit from their work. “The methods allow us to better understand the geographic differences in the abuse of drugs (particularly methamphetamine) with the state of Oregon,” said Daniel Sudakin, an Oregon State toxicologist who was one of the researchers. “We hope that these tools may be useful in identifying communities at risk and developing preventative interventions to reduce the adverse impact of methamphetamine throughout the state.”

And, hopefully, this information will help water treatment specialists to reduce the flow of drugs flowing through their plants that are now ending up in our lakes and rivers.

Source: Oregon State University, August 2007, http://oregonstate.edu/deptincs/newsarch/2007/Aug07/drugsinwastewater.html

IRS records say Merck & Co. held offshore accounts in Bermuda for several years to hold patents for two of its drugs, and then used the royalties from these patents as tax deductions in the United States. The Bermuda tax shelter meant Merck was essen­tially deducting money already used to pay itself.

The drugs involved were the popular and extremely profitable cholesterol medi­cines Zocor^® and Mevacor^®.

The settlement with Merck is less than the $3.8 billion the IRS was seeking, but it avoids a lengthy tax fraud lawsuit. It is also the second-largest tax settlement ever for the IRS.

The largest settlement in history was for a whopping $3.4 billion from another pharmaceutical megacompany, British-based GlaxoSmithKline.

The agreement will result in a payment to the government of approximately $2.3 billion in federal tax, net interest and penalties, and resolves all issues that had been in dispute between the parties for the tax years 1993-2001. Merck reported $22.6 bil­lion in sales for 2006, and said it does not expect its bottom line to be affected by the settlement.

Among the significant issues resolved were three issues that resulted from Merck’s use of minority equity interest financing transactions. The execution of these agreements should facilitate the ability of the IRS and the taxpayer to move forward and effectively address tax issues arising in subsequent examination years.

Merck & Co. is an American company with German origins – Merck came from Germany, but was seized by the United States and forcibly split from its parent com­pany at the end of World War I. Today, Merck & Co., Inc. has about 70,000 employ­ees in 120 countries and 31 factories worldwide. Its products are sold in more than 200 countries.

SOURCE: http://www.irs.govinewsroom/article/0„id=167773,00.html

Since the 1980s, the drug industry has been one of the most profitable industries in the world, on par with oil and banking industries. IMS Health, a company that heralds itself as “the one global source for pharmaceutical intelligence,” stated that in 2005, North American pharmaceutical sales stood at $265.7 billion.

Drug companies hammer us with propaganda about how much money is spent on research, and that out of the millions spent on research, few drugs make money.

Simple research shows that drug company earnings are not something to sneeze at, coming in at #2 — only a fraction below the banking industry, which is the most profitable and more than double the oil and gas industry — and more than double the average of all U.S. industry combined.

It’s a fact of life that the drug industry, like any other industry, exists to make money for its investors. That’s capitalism. That’s apple-pie American. But in the field of healthcare, maybe the emphasis needs some adjustments.

Big Pharma’s battle cry is “maximize profits,” not “serve the public good.” Issues such as serving humanity or actually healing people are just not profitable. If you teach people how to prevent cancer, heart disease or diabetes (and each of these is perhaps 90% preventable) or actually cure them, you lose billions of dollars in profits. As we all know, healthy people don’t need drugs.

SOURCE: http://www.americanchronical.com/articles/viewarticlte.asp?articleID=18805