Unproven
Medical Claims and Practices


By Darrell Stoddard - Copyright 2007

Part 3 of 4 
Dictatorial Judgment
of the Federal Trade Commission against Darrell Stoddard

To find out how to buy Biotape or Biotape products,
You will have to do a Google search on the Internet.
I am forbidden to sell anything or even tell you where to buy.
 
Abstract:
•    Selective Justice of the FTC 
•    Spinal Surgery is Unproven
•    Four Hour Erection Warning is Unproven 
•    Lawsuits Against Pharmaceutical Companies
      for False Claims
•    Misleading Statin Drug Ads
•    Unbelievable Opportunity for Lawyers
•    Miracles of Modern Medicine

Selective Justice of the FTC    
       The most frequent criticism of any alternative treatment (outside of that performed by medical doctors) is that such treatments are "unproven" because randomized, double-blind, placebo controlled, crossover studies have not been done to prove effectiveness. Such criticisms (and the FTC) ignore the fact that most medical procedures routinely performed in the practice of medicine are also unproven using those same criteria.
     The Office of Technology Assessment, a branch of the United States Congress, with the help of an advisory board of eminent university faculty, has published a report with the conclusion that, " . . . only 10 to 20 percent of all procedures currently used in medical practice have been shown to be efficacious by controlled trial." Therefore, 80% to 90% of medical procedures routinely performed are unproven.
       The FDA (Food and Drug Administration) does regulate the pharmaceutical industry but it seems the lawsuits prosecuted by the FTC for making false and misleading medical claims are nearly always against people outside of the pharmaceutical industry and the American Medical Association.
     If someone from alternative medicine makes a medical claim, they must hire someone from mainstream medicine to do the research or it will not be accepted as “reliable medical evidence." This gives the AMA a monopoly and almost total control of everything related to health care.   
       
Such a monopoly was predicted by Benjamin Rush one of the signers of the Declaration of Independence: “Unless we put medical freedom into the constitution, the time will come when medicine will organize itself into an undercover dictatorship. To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic."
     When medical doctors read about judgments against those outside of mainstream medicine that have made medical claims, they will respond, “Medical doctors are the only ones who can make medical claims because  only those who have been to medical school are qualified to do so.”  I support this IF doctors and pharmaceutical companies are held to the same standards of proof as required of those outside of mainstream medicine.

    Medical claims from those outside of mainstream medicine are not accepted unless they are validated by placebo controlled studies. Claims and practices by medical doctors are accepted even when they are not supported by controlled studies.  Spinal surgery is an example of this double standard of proof.

Spinal Surgery is Unproven
   The FTC’s demand that everything be supported by scientific double-blind placebo controlled studies would be commendable if it applied to everyone.  Spinal surgery, as an example, is also only supported by anecdotal evidence.
     Contrary to what you may be thinking, blinded placebo controlled studies for surgery can be done. The Houston Veterans Medical Center did a study that was published in the July 11, 2001 New England Journal of Medicine. One hundred eighty patients with chronic knee pain were in the study. Ninety patients received a general anesthetic and arthroscopic knee surgery to clean out the arthritis in the knee joint believed to be the cause of their knee pain. The other ninety patients were put under a general anesthetic. An incision was made but nothing more was done. Neither group of patients knew who got the real surgery or who got the placebo surgery. For two years following, those receiving the real surgery had no less pain than those who received the sham surgery. This showed that more than three billion dollars of arthroscopic knee surgery for pain performed each year in the United States was no better than a placebo.  Would a blinded study of spinal surgery do any better?
     Recently I went to New York to help a lady with severe disabling pain after spinal surgery. There is even a name for such pain. It is called Failed Spine Surgery Syndrome (FSSS). Her operation cost $150,000. She was in more pain after the operation than before. When she told the surgeon, he said, “You’re just a complainer. DON’T YOU EVER COME BACK TO ME!” She was allowed to see the doctor for only four minutes. He has refused talk to her since.
        I am not alone in questioning the medical necessity or even the wisdom of unproven and unsubstantiated spinal surgery:
        “Never get back surgery for back pain! It’s the wrong treatment and it doesn’t work! – Martin Samuels, MD, Founder Chair of the Department of Neurology at Brigham and Women’s Hospital, Harvard Medical School.
   “Surgical successes unfortunately only apply to approximately one percent of patients with low back pain. Bulging disks are found and taken as an excuse to do a lot of surgery and percutaneous discectomy. Disks are made to bulge; that is a normal finding.” – Alf Nachemson, MD., editor of the medical journal Spine.
    The largest study ever done on the diagnosis and treatment of acute low back pain analyzed 3,900 scientific studies and concluded that, “Surgery has been found to be helpful in only one in 100 cases of low back problems. In some people surgery can even cause more problems. This is especially true if your only symptom is back pain.” (You can read more about this study in my book Pain Free for Life.)
      Everyone is equal under the law but it seems some are more equal than others. What would the reaction be if spinal surgeons were ordered to stop doing surgery no matter how many disclaimers they made and then fined the amount of their gross income from doing spinal surgery because their surgery is unproven and unsubstantiated by blinded placebo controlled studies? 
       I received this exact same order, judgment, and a  penalty more than 7 times my total gross income from selling Biotape which "does no harm." Spinal surgeons are not limited in any way.  Who is the FTC trying to protect?
      Is it possible that Biotape could help people who are told they must have spinal surgery for pain?  Following is an email from another “victim” of the Biotape “scam.”
       “Nine years ago I had two ruptured cervical spine disks that two neurologists insisted would compromise my life style if I did NOT have a laminectomy (spinal fusion). ONE treatment with Biotape along with life style changes described in your book - mainly hydration - and I have been doing everything the doctors insisted I would never do again.” - John Liammari (If this is just the placebo effect of Biotape, then we need a lot more placebos!)

Four Hour Erection Warning is Unproven 
      I was charged and convicted of making a “false and misleading medical claim.” You hear a false and misleading medical claim (unproven and unsubstantiated by double-blind placebo controlled studies) every time you turn on the TV. It is the “four hour erection warning” spoken of in the Erectile Dysfuntion (“ED”) ads for Viagra, Cialis and Levitra. This affliction is a rare event known medically as priapism that can cause permanent injury if not treated. It may occur when taking the drugs, but it can also happen to men at any age (even to baby boys) that don’t take the drugs.
        There are no double-blind studies to show that priapism happens more often to men taking the drugs than it happens to the same number of men having erections that do not take the drugs. No one really knows.
       Could it be that the warning is given to sell drugs? An M.D. who is a very highly paid consultant for the pharmaceutical companies said it better than I can, "Drug companies are like lions. For lions, it's their nature to kill zebras and eat them. For drug companies, it's their nature to make money. They're not really trying to improve anybody's health except if it makes them money.”
        Do you think the Pharmaceutical companies are really worried about someone having a four hour erection? If the ED ads were truthful and not misleading they would state: “Four hour erections can also happen to men not taking Viagra, Cialis or Levitra. It is a serious medical condition that may cause permanent damage. The only sure way not to be injured by a four hour erection is to NOT HAVE ANY ERECTIONS.”
     I suggest a class action lawsuit against the erectile dysfunction drug companies with the monetary award going to victims of child abuse, sexual abuse, and deserted or battered wives. Aside from being misleading, should adolescents be exposed to four hour erection warnings and erectile dysfunction ads?    

Lawsuits Against Pharmaceutical Companies for False and Misleading Claims
        Could lawsuits against the ED drug companies ever be won? The answer is yes.
        But you say, “No one has ever been harmed by the four hour erection warning.” That is not necessary. Not one person was harmed by a Qray bracelet but the company still paid a 22 million dollar fine. I know that no one was ever harmed by Biotape, and I have been ordered to pay a fine of $112617.20.  The charges were never made that anyone was harmed.

Misleading Statin Drug Ads
      The TV ads for cholesterol lowering statin drugs (the biggest selling class of drugs in history) are also false and misleading.  The ads state that we get cholesterol from two sources, our ancestors and from our food. We inherit life and cholesterol required by the billions of cells that make our bodies from our ancestors. Food is also a source of cholesterol. What the ads don’t say is that cholesterol is produced by our liver to supply the bodies need for cholesterol.
       We are misled into believing that cholesterol is always bad, but it is an indisputable biological fact that we cannot live without cholesterol. Cells (the foundation of life) cannot divide or even function without cholesterol.  “Misled” is the understatement of the century.
 
         In contrast to lawsuits by the FTC for making false and misleading medical claims for products that do no harm, statin drugs can and do cause harm.  Millions of people could die as a result of being misled. (See No. 10 “Statin Drug Pain Warning” at www.healpain.net )

      In addition to the above, if I live long enough, I will present statistical evidence to show that the harmful side effects of statin drugs are grossly understated. I am motivated to do this because my best friend, who was on cholesterol lowering statin drug, died on the operating table. I am confident that he would not have died if the doctors had just remembered their high school biology. His doctors knew only what the pharmaceutical companies and the media had taught them about cholesterol being bad.
   Any surgeon that performs surgery on patients taking cholesterol lowering drugs, without taking them off the drugs first, is ignorant of basic biological facts – cellular division (healing) cannot take place without cholesterol. To recover from surgery and the effects of the anesthesia, the patient needs all of the cholesterol he or she can get!
      It is a tragic fact but pharmaceutical companies do the thinking for most medical doctors. (See No. 17.5 “Do Doctors Think for Themselves?” at www.healpain.net )


Unbelivable Opportunity for Lawyers
       In contrast to medical malpractice lawsuits, and wrongful death and injury lawsuits against drug companies that have harmed someone, this whole scenario of lawsuits against anyone making false and misleading medical claims opens up an incredible opportunity for attorneys. Imagine winning a medical lawsuit without ever having to show that one person was harmed! Judgments awarded could be for enormous sums of money, even for amounts equal to or more than the gross income of the services provided or the goods sold.
      Previous legal precedents and case law for making false and misleading medical claims, reveals that such lawsuits have been won and could be won. In fact, as far as I know, 100% of such lawsuits filed against people outside of the AMA, have been won. Why could they not as well be won against medical doctors and pharmaceutical companies?

Miracles of Modern Medicine
       To be balanced and fair we must give credit where credit is due: Small pox has been eliminated from the face of the Earth by moderm medicine.  Infantile Paralysis (Polio) is now unknown in the United States. (I’m old enough to remember rows and rows of iron lungs in the hospital. My cousin died while in one of them.) Unless you are over 70 years old, you have probably never seen a goiter (because of iodized salt). I remember a large hospital called a tuberculosis sanitarium. Does such a thing even exist today in the United States? My own life was saved when I contracted Rocky Mountain Spotted Fever in a time and place when it was 90% fatal.
   Just as approved drugs are not always safe; some alternative medical practices can be very harmful.  I will tell what these harmful practices are in my new book. We must be “wise as serpents and harmless as doves.”


Darrell Stoddard,
Founder - Pain Research Institute www.healpain.net
Author – Pain Free for Life
and a future book

         Cure Pain
And other Diseases for a Dime
           
(Read about my new book in Part 4 of this paper.)

Go to Part 4 by clicking here

Email: [email protected]
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Phone 801-377-3891