In 1980, as an incentive to get American scientists to work harder, U.S. lawmakers passed a measure that allowed researchers recieving federal grants to patent and profit from their discoveries. The law was known as the Bayh-Dole Act...it reversed decades of policy. Before this law, any discoveries made during studies paid for by the federal government had been in the public domain- that is, they had been owned and controlled by the taxpayers who paid for them.
In the same year the Supreme Court unleashed a deluge of industrial science by allowing the first patent to be placed on a living organism..reversing the ruling of the U.S. patent Office and opening the door to the patenting of genes, cell lines, tissues and organs..
These two changes put dollar signs in the eyes of college administrators and their faculties. Between 1980 and 1995 University researchers helped start 1,633 new companies. In 1997 alone researchers at Stanford Univ. filed 128 new patents, created 15 companies and earned $52 million from licenses of its products... the role of the academic as a referee to the drug companies' clinical trials became a minor one. And the moderating force that kept scientific studies honest and impartial began to disappear.
When the FDA decided in 1997 to allow prescription drug commercials on TV Omnicon and the other ad agencies grew rich from a new stream of advertising revenue, one worth millions of dollars a year, At the same time, the pharmaceutical industry had been paying ad firms to ghostwrite publications, to organize dinners and meetings for physicians, to create medical education courses, and for public relations work they called "managing the media" Now the ad firms were expanding their services to include scientific research and clinical drug trials,
with ghostwriters and pharmaceutical executives editing the papers submitted to medical journals each step of the way, picking certain words and phrases that helped boost the image of the product. Dangers of a medicine could be toned down. Benefits of a drug could be pumped up. A serious injury in a patient taking a drug in a trial might be referred to simply as "an event". The words "adverse reaction" might be changed to the more benign "side effects". A drug that worked only slightly better than a sugar pill might be described as having "proven efficacy". It was all a matter of degree. The ghostwriters were like photographers who airbrushed family portraits, softening blemishes and facial lines until their subjects looked far better on paper than in real life.
The pharmaceutical companies and their ad firms developed a publication planning strategy, flooding the world's medical journals with articles and clinical studies that, when taken together, would create an image of a product so safe that doctors would be convinced to prescribe it. As the pharmaceutical companies realized the powwer of this marketing technique, they increased spending on what they called research and development, although it would have been more accurately decribed as "selling and promotion."... at the same time they gradually took control of most of the country's medical research. In 1980 the pharmaceutical industry paid for just 32 % of the nation's medical research. By 2000 the companie's share of total research spending had grown to 62%.
By the mid-1990's, many American doctors had grown frustrated with the financial limits imposed on them by health maintenance organizations and other forms of managed care that became popular in the 1980's and 1990's as a way of restraining medical costs. Watching their salaries stall, the doctors were easily seduced by the welcoming arms of the drug industry, where the money still flowed. They found they could significantly boost their bank accounts and upgrade their lifestyles by winning favor with the pharmaceutical sales representative and joining a company's payroll as a speaker, consultant, researcher, or advisor or by serving all these functions at the same time.
For example, Dr. Martin Keller, the chief of the psychiatric department at Brown University, earned more than $500,000 in consulting fees in 1998, mostly from companies whose drugs he touted at medical conferences and in published reports. In 2004 the written contract between Dr. Arnold Klein, a Bevery Hills dermatologist, and Allergan, the company that makes Botox, became public when he was sued by a patient. The contract paid him $25 thousand every three months for consulting and as much as $10 thousand a day for meetings, plus expeses for airfare, hotel and meals.
By 2003 the drug companies had even recruited and hired many of the physicians and scientists at the federal government's esteemed National Institutes of Health. For instance, Pfizer paid Dr. P.Trey Sunderland, an expert on Alzheimer's disease, more than $500,000 between 1998 and 2004 for dozens of speaking appearances all over the world.
Only about 10% of the price of most brand name pills goes to cover the cost of the raw chemicals and manufacturing, the pharmaceutical industry has plenty left even after paying for advertisements, research and the high salaries and expensive perks of its executives. From 1995 to 2002 they were the nation's most profitable industry. In 2004 the pharmaceutical companies tirned nearly sixteen cents of each dollar of revenue into profit, according to Fortune magazine. That compares with the median profit earned by America's five hundred largest public companies that year of a little more than five cents.
Pharmaceutical executives talk about their company's medicines as if they were Hollywood producers about to release a new film. They speak of "launching their next blockbuster", which they define as a medicine that could bring in sales of one billion dollars. Sellinmg medicines is an odd business. Disease meant money. Suffering brought profit. When I visited the phramaceutical executives I often heard something like this;" Our respiratory business is doing extremely well, as is our cholesterol business. The depression business has performed better than expected. Parts of that business are really growing strongly. It is the migraine market that is the problem."
By the year 2005 Americans were spending $250 billion on prescription drugs, more in 2004 than they did on gasoline and fast food, twice as much in that year as they spent on either higher education or automobiles. They spend more on medicines than do all the people of Japan, Germany, France, Spain, the U.K., Australia, New Zealand, Canada, Mexico, Brazil and Argentina combined.
The vast majority of drugs-more than 90% only work in 30 to 50 percent of the people....across all drug categories today an average of 50 percent of the people treated with individual drugs are recieving treatments that are not efficacious for them.
1946 George Orwell observed that language can corrupt our thoughts. The' invasion of one's mind by ready-made phrases...can only be prevented if one is constantly on guard against them, and every such phrase anaesthetizes a portion of one's brain"..
ReplyDeletethere was no question that the drug companies are attempting such an invasion...
IN 2005 researchers at Oregon Health & Science University set out to evaluate the scientific evidence that had been published on the medicines prescribed for attention deficit disorders. The oregon group included some of the few academic drug experts in the country who had refused to take money from the pharmaceutical industry. The Oregon researchers combed through the medical literature dating back to the 1970's, looking for studies involving Ritalin the other ADHD meds. They found 2,433 articles, an amazing amount of research on one type of drug. Yet the numbers were decieving. Many of the trials were far too brief to provide reliable information. More troubling, some of the clinical studies had been designed in ways that biased their results so that the medicines appeared to be safer and more effective than they actually were (removing people who responded well to placebos, or had adverse reactions from preliminary studies, only publishing results from the second trials.).
"I spent the first several years of my career doing full-time reseach on brain serotonin meabolism, but I never saw any convincing evidence that any psychiatric disorder, including depression (and ADD), results from a deficiency of brain serontonin," said David Burns, an adjunct clinical professor of psychiatry and behavioral sciences at Stanford University.."In fact we cannot measure brain serotonin levels in living human beings there is no way to test this theory" Some neuoscientistics would question whether the theory(mental illness is caused by a chemical imbalance in the brain) is even viable, since the brain does not function in this way, as a hydrolic system.
ReplyDeleteIn the mid 1990's the market for drugs for people who accidentally wet themselves was small. Many doctors believed incontinence was not a disease that should be treated with prescription medicine but a normal part of aging that could be managed by changing one's habits. They suggested patients avoid caffeine and drink less fluid before bed or on a trip to the store. Patients who nevertheless wanted a prescription drug could choose from an array of cheap medicines that had been on the market for decades and worked in a similiar way to Pharmacia & UpJohn's potential "blockbuster" Detrol.
ReplyDeletePharmacatia & UpJohn launched their marketing campaign; by 2006 "overactive bladder' had become part of the American lexicon and Pfizer (which bought Pharmacia in 2002) was selling a billion dollars of Detrol and Ditropan (a companion touted as even more effective) a year.
The FDA regulators found time and time again that that company claims about their remedies for "overactive bladder" were not backed by scientific studies. They found that the studies conducted by the drug companies and their marketing firms were manipulated to make their products more effective than they really were. Celebrities, patient advocacy groups and doctors are free to make any claim they like about the efficacy of any drug, even for uses not approved by the FDA, which explains why drug companies hire them as consultants and marketing agents. THe FDA's actions had little effect. The agency's small staff charged with monitoring the industry's marketing campaigns, which were growing ever more sophisticated and secretative and so extensive they could cost hundreds of millions of dollars for a single drug, were like a couple of cops trying to enforce the NO HONKING signs posted on street corners in Manhattan.
It was not until academic researchers at Emory University reported that Detrol and Ditropan could harm the memories of the patients taking them, a study by British researchers in 2003 that found the cognition of patient's Alzheimer's grew worse when using these drugs, became widely known, that Pfizer's sales began to decline.
Both bladder drugs have what doctors call anticholinergic effects, which mean they block the action of acetycholine, a neurotransmitter. Many drugs, including some used to treat allergies, anxiety, blood pressure, convulsions, depression, Parkinson's disease and psychosis, have been found to have anticholinergic effects. So many medicines have anticholinergic effects that some people may be taking two or more of these drugs at the same time.
Hampering efforts to understand how many people die from their medicines is the fact that hospitals no longer perform autopsies on most patients..the autopsy rate in the nation's hospitals has plummetted, from 50% after WWII to less than 8% today. Some perform no autopsies...That decline in the rate of autopsies, which are considered one of the most powerful tools in the history of medicine, has had tragic consequences. Without an autopsy to verify what a doctor writes on the death certificate, diagnosis like "cardiac disease" or "Alzheimer's disease" have become death causes of convenience.
ReplyDeleteYet some studies indicate a serious problem. Researchers reported that 51 % of the cases of liver failure at some two dozen American medical centers in 2003 were caused by a single drug, acetaminophen (Tylenol), which is also included in a wide array of other medicines. But dozens of other drugs can cause the liver to fail.
Expensive blood-testing done in West Virginia suggests that prescription drugs are contributing factors in highway accidents with a frequency equal to that of alcohol.
Our Daily Meds by Melody Petersen, who reported on the pharmaceutical companies for the N.Y. Times for four years
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