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THE PRESIDENT’S NEW FREEDOM COMMISSION ON MENTAL HEALTH

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THE FINGER PRINTS OF PHARMA MARKETING STRATEGIES
Pharma's marketing strategies leave unmistakable fingerprints. For a more complete discussion of these fingerprints see Moynihan and Cassels 2005. The Pharma "miracle" is an alchemy predicated on expanding the definition disease itself, while narrowing the treatment of any given disease to a specific drug or class of drugs. By using these simple strategies, Pharma can redefine a risk factor, like osteoporosis (the natural reduction in bone density that occurs with age) as a dreaded disease that affects millions of women. The transformation of a disease usually takes place under the cover of an "expert consensus process." Pharma convenes a panel of "experts" under the banner of a prestigious university or organization. (Whitehead 2005) The experts reach a "consensus" about a particular disease or drug that favors the drug companies. The consensus then becomes the "standard of treatment" for the disease or drug in question. Moynihan & Cassels outline this process with osteoporosis. (2005) To put a favorable marketing spin on osteoporosis, Merck donated money to the World Health Organization (WHO) to "study" the "disease." In return, WHO allowed Merck to hand-pick a panel of friendly experts, who then created the definition of osteoporosis Merck wanted. That is, the panel concluded that the bone density of a healthy 30-year-old woman should be the diagnostic standard. This means any woman with a bone density less than that of a healthy 30-year-old can be said to be have osteoporosis. By raising the diagnostic standard, Merck was able to increase the number of women who could be "diagnosed" with the treatable "disease" of osteoporosis. The panel's consensus was written into the medical lore as a research project sponsored by WHO and is now the standard of practice for treating osteoporosis. Merck's guiding hand is invisible to the casual observer. (Moynihan & Cassels 2005)

But Merck did not stop there. In Western medicine there can be no treatment without diagnosis: a drug cannot be sold without a diagnosis to justify its use. In addition to expanding the definition of a disease, Merck also insured that the means to diagnose the millions of allegedly afflicted persons would also be available. Merck stacked the deck by promoting diagnostic procedures, which would lead to a dramatic increase in the number people actually diagnosed with a problem. For osteoporosis, x-rays are the means to determine bone density levels for individual diagnoses. Therefore, Merck subsidized the purchase of x-ray machines to conduct screening exams. Radiologists, who would benefit from a boom in business, were natural allies in promoting screening exams. (Moynihan & Cassels 2005, chapter 8)

Two distinctive fingerprints of Pharma marketing are: 1) The ability to redefine a "disease" and 2) the ability to develop the means for "diagnosis" of the newly expanded disease. These provide the rationale for "treatment," in this case, with a drug like Fosamax. Presto! With this alchemy Pharma can spin any disease/drug combination into a winner that insures billions of dollars in bottom line profits - - before the drug is even approved for sale!
The problem is, of course, that to achieve this goal everyday human unhappiness must be deliberately and wrongly transformed into a medical problem, and unnecessary, ineffective and even harmful drugs must be promoted to treat the new problem.

Seasonal Affective Disorder (SAD) is another example. SAD was a rare problem prior to its treatment by drug marketeers, who spun it into a major disease affecting millions of people and treatable by SSRI's. (Abramson 2004)

As I will show in a moment, these drug marketing strategies have been put to use in creating the NFC itself and in shaping its recommendations for universal mental health screening and making drug algorithms the standard for psychiatric treatment. However, before going on I want to review the Vioxx disaster. Most Americans know very little about this tragedy - - or how close it came to involving American children.

TARGETING CHILDREN: Anyone's Child Will Do
Following Gadsden's logic of selling drugs to "everyone" ultimately means selling unnecessary or dangerous drugs and it means selling them for children as well as adults. The marketing of the painkiller Vioxx by Merck offers a recent example of this ruthlessness pursuit of profit. It also illustrates how ineffective the FDA has become in protecting us from harm as it is mandated to do.

Nobody knows exactly how many people were killed and injured as a direct result of taking Vioxx as prescribed. However, the scale of human damage emerged in August 2004 through the research of FDA drug safety officer, Dr. David Graham. Graham estimated that Vioxx tripled the incidence of heart attack and stroke in high doses; and that it killed somewhere between 39,000 and 61,000 Americans. The lives of as many as 80,000 others were "forever changed" by nonfatal heart attacks and strokes. If Graham's high estimates are correct, more American's died from Vioxx than from combat in Vietnam. (Sherer 2005) Not surprisingly, Graham's work was dismissed by his boss at the FDA, Dr. Steven K. Galson. In fact Galson told him to shut up and tried to discredit his work as junk science. Then, only two weeks after Graham made his report, the FDA approved Vioxx for use with children!!!! Let there be no mistake about this: American children were spared harm only because Merck "voluntarily" removed the drug from the market in September 2004, when its own research showed the drug doubled heart attack and stroke risk - - even in low doses. However, as I will show later, atypical antipsychotic drugs have doubled the death rate of the typical antipsychotics and have not been removed from the market - - in fact, they are widely used with children.

Merck's marketing slogan is, "Merck, where patients come first." The fact that the company "voluntarily" removed the drug seems to support its commitment to the slogan. However, in 2005, wrongful death litigation uncovered evidence that Merck researchers and executives knew as early as 1997 - - two years before Vioxx went on the market - - that the drug increased the risk of heart attack and stroke. They actively hid the facts from the medical community and the American public. (Berenson 2005) For example, in the famous Vigor trial of Vioxx published in the New England Journal of Medicine in 2000, Merck deleted data about three heart attacks among trial participants. (Pierson 2005)

Merck removed Vioxx to protect itself from liability, not to protect the American public from heart attack and stroke, and then only after its strenuous efforts to suppress harmful data failed. Meanwhile, the FDA was protecting Merck's marketing interests, not American consumers and their children. FDA officials demonstrated their willingness to put American children on the Vioxx chopping block, even after FDA officials knew how dangerous Vioxx was. Merck's CEO for 11 years, Gilmartin, resigned in May 2005 as a result of this scandal.

This kind of corporate and regulatory misconduct is criminal and demands prosecution, not just resignation. The Vioxx tragedy does not end with it being taken off the market in 2004. Unfortunately, it is a gift that keeps on giving: a clear pattern in the recent deaths of former Vioxx users shows the drug produces lingering and potentially fatal damage to the heart and circulatory system for at least one year after taking it. (KSKA 2006) Meanwhile, other dangerous drugs, such as the entire spectrum of psychiatric drugs, remain on the market. And new drugs are being developed. Will these be safe? How will we know if they are safe? The one thing we can be sure of is that all of us, including our children, remain in the drug marketeers cross hairs.

THE NEW FREEDOM COMMISSION: Sacrificing American Children
Rather than influencing an existing prestigious organization, like WHO, Pharma simply got the President of the United States to create a new, unimpeachable organization, to its exact specifications- - the President's New Freedom Commission on Mental Health (NFC). Pharma fingerprints are all over the development of the NFC in the familiar strategies of 1) an expert panel 2) broadening the scope of disease, while 3) narrowing treatment to a few drugs and 4) subsidizing screening/diagnosis to identify potential customers. Mr. Bush created and named the NFC and named the panel of experts that sat on it. This means that Pharma has captured control of U S public mental health policy. This scam is one of the biggest hijacking of public tax dollars in history. Since individuals citizens are unable and insurance companies are unwilling to pay for high priced psychiatric drugs, Pharma arranged that Uncle Sam foot the bill with public money.

The NFC recommendations I want to call your attention to are: 1) the universal mental health screening for all Americans, beginning with 52 million American school children, and 2) the use of the Texas Medication Algorithmic Program (TMAP) as the standard of treatment for mental illness.

The school mental health screening is based on a program called "TeenScreen," a computerized, self-administered psychological test. Once identified as mentally ill by the mental health screening, the children would be treated according to the algorithms of TMAP. TMAP is a pseudo-scientific list of the most expensive psychiatric drugs; its purpose is to insure that only the newest, most expensive drugs are used. Once TMAP is adopted by a state it becomes the standard of practice for treating mental illness in that state. Physicians must comply with that standard, which means they must prescribe the most expensive drugs on the market - - these drugs also happen to be the most dangerous and least effective on the market as well, as I will show in a moment.

What a sweetheart deal for Pharma: using TeenScreen insures massive screening to create new customers, while TMAP locks in the most expensive drugs as the standard of "treatment." What ever happened to the "Free Market" here?

I will show that these NFC recommendations are being made despite the fact that there is no scientific evidence to support them. On the contrary, the evidence is against them: there is no known valid and reliable mental health screening test available at this time, psychiatric drugs are ineffective and harmful. Only the power and prestige of the US presidency sustains them.

I find it disturbing (but not surprising) that this corrupt process is taking place in full public view, and is being presented as a scientifically based, cutting edge US Public Mental Health Policy. Furthermore, it is even more disturbing that both TMAP and the NFC were created under the stewardship of George W. Bush. He signed off on TMAP as governor of Texas, and on the NFC as President of the United States. He has been taken in by drug interests, which means he is stupid, or he is a knowing participant in this corrupt process. (Whitehead 2005) In either case, he is culpable; the system that created him must be examined and revised.

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George Stone has a master's degrees in anthropology and social work. He is a licensed clinical social worker with 35 years experience in therapy and supervision specializing in family & brief therapy and has practiced privately and publicly with (more...)
 
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