John Stossel of FOX News is waging a one-man tea party against the FDA and its very existence. He wants to do away with it. Is he a stray, radical tea partier? No, John Stossel is a Libertarian and this stance fits in snugly into a way of thinking. This was taken on directly by
Janet Woodcock, M.D., Director, CDER – Center for Drug and Evaluation Research
I don’t think it’s in the government’s best interest to stand between people, especially those who are desperately ill, and their desire to take medicine. But that libertarian issue shouldn’t be confused with the scientific issue of whether patients can tell what medicines work, because with almost any drug treatment we use today, they can’t tell.[Woodward, FDA]
Stossel is a libertarian and their view is that private entities such as Underwriters laboratories are just as competent at doing the job.
And what enforcement capabilities would the private firm have to ensure that proper procedures were being followed in testing and production of the products.
Would their tests have safety and efficacy, both of which are essential?
Would their labeling be sufficient to let patients and doctors know how to prescribe?
How would the average consumer himself go about measuring the most effective drug for his/her condition and a drug that would not interact negatively in the human body with other drugs or with previously existing conditions?
Stossel focuses on one thing: Fear keeping private drug producing firms in line.
Fear of losing business and fear of lawsuits (some lawsuits are useful) “coerce them into honesty.” American food makers rarely poison us today not because of government regulation, which is largely ineffectual, but because they know that if they poison their customers, they’ll go out of business.
But Stossel is most concerned that the FDA has a monopoly on new drug approval and that they “deprive free people of the right to medicate themselves. If I am dying, how dare the FDA tell me I may not take an experimental medication! If I am in terrible pain, how dare the DEA limit the pain reliever that I take. It’s my body. Leave me alone.”
John, it’s not that simple and there is not time in the space of this article or in several debate forums to undo the damage you may have caused. The FDA was founded because of several specific and measurable cases of people having been harmed by drugs produced privately over time.
The FDA is here to protect us not to hamper our freedoms.
NOTE: SamHenry worked as an information scientist in a large Pharmaceutical House that has just been sold to Pfizer. To complete the job of liaison between the Global Regulatory Affairs Department end-users of databases for retrieval of needed information and the IT department developers of the databases, SamHenry took law and clinical trial courses at Temple University’s School of Law.
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Diary of a Mad Conservative – Too much information for the wrong people
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dancingczars
February 27, 2010
Well Sam Henry: We appear to have a very similar background and possibly worked in similar positions for the same company.
I’m not as enthusiastic as you about the regulatory ability of the FDA.
Their track record is some what checkered.
Ketek’s Liver-Injuries and Deaths: FDA Warnings Come too Late for Dangerous Drug
Ketek, an antibiotic originally approved for treating a number of lung and sinus infections, has been the subject of major controversy and an ongoing Congressional investigation into FDA’s fast track approval process. In February 2007, FDA added a black box warning (FDA’s strongest safety warning before drug recall) after researchers had found that Ketek was 3.5-11 times more likely than other antibiotics to cause acute liver failure. Read more about the controversy behind Ketek’s approval, why FDA may recall the drug Ketek, and how Consumer Justice Group lawyers can help recover the damages from liver injuries caused by Ketek
Vioxx Doubles Risk of Heart Attack
Data from a three-year study shows that use of Vioxx noticeably increases the risk of heart attack, stroke, and serious blood clots. People who use Vioxx for more than 18 months have been shown to carry twice the risk of heart attack when compared to people who took a sugar pill. On September 30, Merck, the corporation that makes the anti-arthritis drug Vioxx, recalled their product. Vioxx has been taken by an estimated 84 million people since the drug was released in 1999. Vioxx has been taken by an estimated 84 million people since the drug was released in 1999, and estimates vary how many have suffered injuries from this dangerous drug medication.
Bextra Recall – Bextra Withdrawn From Market – What Should You Do …
It came as a surprise when the U.S. Food and Drug Administration asked Pfizer to withdraw Bextra (valdecoxib) from the market on April 7, 2005. ..
Brand name Accutane Acne Medicine Is Being Removed From U.S. Market By Roche
The government demonizes the industry for the cost of the drugs it finally brings to market. The zombie like pace at which the FDA works is directly reflected in the cost of US pharmaceuticals.
Many of the drugs developed in this country are on the market years before in other countries and receive approval from their regulatory agencies. Of course we want safe and effective drugs, nobody could argue that. The drugs listed above failed to be caught by the strict regulations used by the FDA. Could a non governmental agency do a better job? Would there be conflicts of interests? Are there conflicts of interest now? My experience happens to be with ODAC. To say that politics isn’t involved is some decisions is a joke.
Reimbursement is frequently allowed when a drug is prescribed for the exact indication that the drug was intended. Off label use is frequently not reimbursed. This is not a rule by the FDA but has been adopted in some circles as dogma.
Cancer patients are rarely treated with mono therapy, combination regimens are frequently the methods of choice. Should these medications not be covered because they were not studied in a particular disease but used as the result of massive phase IV trials after the drugs were approved.
Then we have drugs that were approved that ended up being used for an entirely different indication. Monoxidil comes to mind. Used for malignant hypertension, the main side effect was hair growth. The wizzards at the Upjohn company put it into a solution, a spray, etc. showed there was no systemic absorption, yet were required to repeat studies already done in the original IND. Is this a cost effective way to bring drugs to the market place? Remember a company has roughly 7 years to recoup it’s investment from the time the chemical entity was first mentioned in the most obscure of journals.
Is it possible a private for profit consortium could achieve similar results as the FDA in a faster manner? What safeguards would be put in place to keep them from the reaches of lobbyists or participating in outright fraud. Do we currently have the same procedures in place with the FDA?
In reality does the Federal Government do much of anything more effectively and less expensively than is done in the private sector?
In closing, if a drug has been shown to be safe and effective that was manufactured by a US company and is already on the market for life threatening illnesses, where in the Constitution does it say these drugs can’t be used by people that are dying in our country.
All reasonable questions before declaring John Stossel, Nuts;-)
samhenry
February 27, 2010
All excellent points. Of course there are inefficiencies and downright criminal activities in the current system. Generally, no matter what or who approves a drug for release for public use, the final clinical trial is in the general public and everyone in the industry knows this. You simply cannot include every kind of individual in a controlled clinical trial to ensure that changes the drug causes in the body of one person the same reaction as in another. Aspirin is safe for one person; deadly for another and is abused by many. The key is getting the watchdog agency, FDA, to act in a timely fashion to get the drug removed from market through order to the maker. Off-label use is the fault of the doctors; how fast you remove the drug because off-label use is killing people is another. The bottom line for me it this. If you give the job of regulation to a private body, that would be an anti-trust issue. The next problem would be that it would be too many steps removed from Congressional oversight.
I would far rather have an imperfect government agency built upon regulations devised over time than by a private company. The checks and balances now are government and a private company of manufacture/distribution. If private – then all of the horses are out of the barn. No, I would want our legislative body to oversee the development of the regulations and their implementation than to trust in going out after a private company after the fact.
This is one area where big government is beneficial IMO. The force of an FDA regulation is still better than a list of procedures conceived at a company not being overseen as closely as the FDA. I want the FDA responsible for the safety and efficacy of the drugs I take. I am too aware of the history of the FDA and why it does what it does not to feel that way. This is not easily explained to Mr. and Mrs. American Consumer. And of course that black box warning – the wheels of the government may turn slowly but at least they turn.
Oh and there is the other thing, I like the fact that the FDA has standardized how companies retain their correspondence and other records involved in the new drug development and approval process.
dancingczars
February 28, 2010
We can agree to disagree. Off label use is not the “fault” of the physician, it’s the standard of care. As I said the FDA doesn’t require it, once a drug is approve the physician may use it as he chooses. The FDA act in a timely fashion? Are you receiving a grant to make pigs fly? LOL If you feel strongly that the FDA is one area that is the FDA is beneficial, well what about the medicines the U.S. develops that are on the market two years before they are here? Again, I question the authority that would prohibit me to take a potentially life saving medicine because the FDA tells me I cant. As to your assertion, “I would want our legislative body to oversee the development of the regulations and their implementation than to trust in going out after a private company after the fact.” The FDA isn’t a legislative body, they are an agency with government workers with zero incentive to put on their gitty up boots.:-) One thing we can agree on if things become computerized as constantly discussed, it woulld certainly be helpful to understand drug drug interactions, the average older person take about 16 different meds. They do so because the go to different doctors and they have no idea what the others prescribe. Better physicians will request patients to bring everything in they are taking and look for stuff that obviously is duplicative, may have known side effects etc. Enjoy the banter Sam, Jim
samhenry
February 28, 2010
“I would want our legislative body to oversee the development of the regulations and their implementation than to trust in going out after a private company after the fact.”
When I say “legislative body” above, I am referring to Congress. Congress created the FDA by law and gave it regulatory powers. The Congress still oversees what they do whenever there are problems.