Thursday, November 3, 2011

"Don't Medical Marijuana Laws Subvert the FDA Drug Approval Process?"

     Cannabis is NOT medicine. At least that is what the FDA would have you to believe from a *statement* released in April 2006.  The provided link in the previous sentence takes you right to the FDA website's archived copy of this said statement.  Let me pull a quote from it: "A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use."  Here is another quote: "FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country."  Let me show you why the FDA either (1) has no clue, (2) has a political agenda, or (3) a conflation of the two.  
     The FDA failed to use or cite any scientific studies that contradicted federal policy, such as the 1999 Institute of Medicine report.  That’s why IOM co-author Dr. John A. Benson told The New York Times that the government “loves to ignore our report ... They would rather it never happened."  The FDA statement was immediately denounced by health experts and newspaper editorial boards around the country as being political and unscientific.
     State medical marijuana laws do not have anything to do with the FDA in the slightest.  Those laws are in place to protect patients and caregivers from state and local criminal prosecution - not to decide for the public if cannabis is safe or recommended for medicine.  Besides, many Americans are already using substances that claim some sort of medicinal benefit in spite of the fact that they are labeled with this statement: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."  The FDA does not bar Americans from growing, using, and possessing a wide variety of medical herbs that it has not approved as prescription drugs, including echinacea, ginseng, St. John’s Wort, and many others.
     There is already substantial evidence that marijuana is safe and effective for some patients, including new studies published after the FDA’s statement.  However, the federal government has blocked researchers from doing the specific types of studies that would be required for licensing, labeling, and marketing marijuana as a prescription drug. They've created a perfect Catch-22: Federal officials say “Marijuana isn't a medicine because the FDA hasn't approved it,” while making sure that the studies needed for FDA approval never happen.
     Marijuana was already on the market (in some two dozen preparations -such as tinctures and lozenges- many marketed by well-known pharmaceutical companies) before the 1938 Food, Drug, and Cosmetics Act was passed, creating the FDA. Under the terms of the Act, marijuana should not be considered a “new” drug, subject to the FDA drug-approval requirements that new drugs must meet. Many older drugs, including aspirin and morphine, were “grandfathered in” under this provision, without ever being submitted for new-drug approval by the FDA.  Marijuana didn't get a "fair shake" because it was all but outlawed by The Marijuana Tax Act of 1937.  I have other articles on my blog that go into more detail about that!
     Half of current prescriptions have never been declared safe and effective by the FDA. Between 40-60% of all drug prescriptions in this country are for drugs not approved by the FDA for the condition they’re being prescribed for - also known as "off-label". We know much more about marijuana’s safety and efficacy in cancer, AIDS, MS, and many other conditions than we know about most off-label prescriptions.
     The FDA is not infallible.  For instance, FDA-approved Vioxx is estimated to have caused between 26,000 and 55,000 needless deaths before it was taken off the market. And David Graham, associate director of the FDA’s Office of Drug Safety, has told Congress that the FDA is “virtually defenseless” against another Vioxx-type disaster. In contrast, 5,000 years of real world experience with marijuana show that it is safe and effective for many patients.  Are we not grown-up enough to make wise decisions for our own health and well-being -whether that be through using prescription drugs available on the market or self-medicating with an herb like echinacea or cannabis- or must we depend on the "guidance" of a select few who may not have our best interests in mind?


  1. merriwanna afex my vokabewlarry.... onother realatee

  2. Maybe you should consider other options...