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John Stossel and Truth, Justice and the American WayMarianne Skolek Salem-News.com
Stossel buys the marketing ploy of a shrewd criminally convicted pharmaceutical company.
(MYRTLE BEACH, S.C.) - This week John Stossel of ABC-TV 20/20 fame, a consumer reporter, investigative journalist, libertarian columnist and Fox Network journalist, posted the following information as a plug for his new television show:
"People who are desperate to try different medicines and treatments run into a wall of FDA bureaucracy. People suffer and die because the government 'protects' us. It should protect us less and respect our liberty more."
The libertarian Stossel further asks -- Why, in our "free" country, do Americans meekly stand aside and let the state limit our choices, even when we are dying? This week’s show includes Stossel's confrontation with Terry Toigo of the FDA. She calmly explained that such restrictions are necessary to protect the integrity of the government’s safety review process -- until Stossel shouted: "Why are you even involved? Let people try things!" Toigo replied, "We don’t think that’s the best system for patients, to enable people to just take whatever they want with little information available about a drug." Fortunately for us, Stossel wasn't defending the use of the drug Thalidomide, used by pregnant women who were experiencing sleep problems back in the early 1960's. Thalidomide was sold in a number of countries across the world from 1957 until 1961 when it was withdrawn from the market after being found to be a cause of birth defects in what has been called "one of the biggest medical tragedies of modern times". The Thalidomide tragedy led to much stricter testing being required for drugs and pesticides before they can be licensed. Maybe Stossel should go into the FDA website and read up on something under the heading - Can any individual patient qualify for expanded access to any drug? It reads as follows: FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. They also permit expanded access for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials.
Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug.
In order for a patient to gain access to an investigational drug outside of a clinical trial, the patient must have a serious or immediately life-threatening disease or condition and no comparable or satisfactory therapeutic alternatives. Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. These safeguards are in place to avoid exposing patients to unnecessary risks. Manufacturers may not always be willing or able to provide access to a drug outside of their clinical trials. Physicians may not always be able to seek expanded access for patients, depending on a patient’s medical history and the risks associated with taking an investigational drug. The physician must determine that the probable risk from the drug is not greater than the probable risk from the disease. Not all physicians are willing to manage the use of an investigational drug for patients in their care.
Although arrangements for these investigative drugs must be authorized by the FDA, the "manufacturer and patient's doctor must make special arrangements to obtain the drug for the patient." I wonder how many drug manufacturers and doctors are willing to risk the liability of exposing patients to a drug unapproved for use by the FDA? You might want to consider that Mr. Stossel. And then Stossel attacks the Drug Enforcement Agency because as he says, they "watch pain-management doctors like hawks. Drugs like Vicodin and OxyContin provide wonderful pain relief. But because they are also taken by 'recreational' drug users, doctors go to jail for prescribing quantities that the DEA considers 'inappropriate.' As a result, pain specialists are scared into underprescribing painkillers. Sick people suffer horrible pain needlessly."
Look up the meaning of the words "pill mills" Mr. Stossel and look into the doctors the DEA "watch like hawks" before you spew the nonsense you have been hand fed by pain societies in existence because the maker of OxyContin, Purdue Pharma keeps them financially fat. Stossel further writes that "The DEA told us that good doctors have nothing to worry about. But Siobhan Reynolds, who started the Pain Relief Network after her late husband was unable to get sufficient pain medicine, says the DEA’s cherry-picked medical experts persuade juries that they should jail any doctor who administers higher doses of pain relief than the DEA’s zealots think appropriate. News of those jail terms spreads. Doctors learn to be stingy with pain meds."
No, Mr. Stossel doctors go to jail because patients are dying under their care and in large numbers. Look at the "pill mills" or pain clinics who have lines of people waiting to have their OxyContin prescriptions filled by physicians who do not follow any standard of care for their patients. Ask the DEA how many patients have died as a result of these physicians being charged for their over zealous prescribing of OxyContin. No one should suffer pain needlessly in this country and no one should die in a motel room when any emergency room will treat any patient with a physical condition needing proper medical attention. In case you're not aware, Mr. Stossel, scores of parents all over the country are dealing with the death and addiction of their children because of the criminal "overmarketing" of OxyContin and not the "undertreatment of pain" marketing ploy you bought into by a very shrewd criminally convicted pharmaceutical company and their heavily funded pain societies. I wonder what Mr. Stossel's next investigative reporting will cover in order to protect us less and respect our liberty more. How about the elimination of speed limit signs -- after all we're sick of being protected. Somehow I hear Perry White shouting "Don't call me chief" -- but it is John Stossel, cub reporter being yelled at -- and not Jimmy Olsen.
Salem-News.com Reporter Marianne Skolek, is an Activist for Victims of OxyContin throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's who pled guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 7-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.
Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.
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