FDA Approval: Scientifically Based?

  FDA Approval: Scientifically Based?

Posted by CN Staff on May 08, 2006 at 14:11:36 PT
By Megan Durham, Staff Writer  
Source: UCSD Guardian 

California -- The mission of the Food and Drug Administration is to protect the public health by assuring the safety, efficacy and security of drug and food supplies, as well as helping the consumers get the accurate, science-based information they need to “use medicines and foods to improve their health.” Perhaps this statement would be easier to swallow if we ignored two of the recent FDA statements regarding medical marijuana and Plan B, also known as the “morning-after pill.”
In an April 20 press release, the FDA argued that “no sound scientific studies supported medical use of marijuana,” and went on to use some of the most common anti-marijuana arguments: that other medications have exactly the same effects, and smoking marijuana has the same negative side effects of tobacco smoke. By far the most interesting part of the discussion is not the fact that the FDA decided against supporting medical marijuana, but the extent to which their decision seems to be politically driven. In fact, in making this statement they are ignoring several well-known studies that have supported the use of marijuana for medical purposes The most notorious of these is a 1999 study by the Institute of Medicine, part of the National Academy of Sciences, which is described by the New York Times as being the “nation’s most prestigious scientific advisory agency.” There have been other studies as well, including several state-sponsored ones in the 1980s, and a 1998 House of Lords report. All of these studies are different, but many propose that the risks associated with marijuana’s “gateway” and psychological effects, as well as its dependency issues, are overestimated. In fact, many of the studies showed that there are possible benefits to the drug, especially when used as an appetite inducer for cancer and AIDS patients, or as a pain reliever for multiple sclerosis and glaucoma sufferers. But more importantly, each of the studies stressed the need for more research to be done before a conclusion about marijuana could be reached. But therein lies the problem. The Drug Enforcement Agency lists marijuana as a schedule I drug, on par with drugs such as heroin and methamphetamines. Because of this classification it is extremely hard to receive permission for a study — and even harder to obtain the necessary funding. Dr. Donald Abrams, a professor at UC San Francisco, complains that the National Institutes of Health refused to finance or support his work, and that he has also had trouble even getting the results of his studies published. He believes that it is almost impossible to “fulfill the Food and Drug Administration’s request for well-controlled trials to prove marijuana’s benefits.” But many scientists have pushed past the governmental regulations and are trying to research marijuana as best as they can. To have the FDA say that there are no sound scientific studies supporting the medical use of marijuana is a slap in the face to these researchers. It means that studies that are currently being conducted, like ones at the Center for Medicinal Cannabis Research at the University of California, aren’t recognized by the FDA. And the fact that the FDA refuses to acknowledge these studies is disturbing, especially when one looks at the recent history of the organization concerning Plan B. In 2004, the New England Journal of Medicine discussed the fact that emergency contraception is overwhelmingly demonstrated as “safe and effective when available without a prescription” and that “evidence shows that the availability of emergency contraception does not result in a change in the usual behavior of the women who are its potential users.” So since the drug had proven to be both safe and effective, the FDA went ahead with the approval, right? Of course not. In spite of the recommendation of the FDA’s own Nonprescription Drugs Advisory Council that it do so, the FDA balked at allowing the drug to be used over-the-counter. A new court case involving the fiasco recently surfaced memos by Dr. Curtis Rosebraugh where he wrote that the FDA could not “anticipate, or prevent extreme promiscuous behaviors such as the medication taking on an ‘urban legend’ status that would lead adolescents to form sex-based cults centered around the use of Plan B.” In response to the FDA’s decision, Susan F. Wood, the FDA’s top women’s health officer, and Dr. Frank Davidoff, consultant to the aforementioned council, resigned over this seemingly political decision. And even though the resignations happened a while ago, Wood is still worried about the stance the FDA is taking. She recently complained about the fact that the FDA has grown more political, telling the Rochester Democrat and Chronicle in January that one shouldn’t “have to be of a particular persuasion or a particular party to care about science in our health policy.” Wood and Davidoff were right to resign. The FDA is a scientific organization charged with determining the safety, efficacy and toxicity of consumed substances, and should not be concerning itself with politics or morality. In a world where some prescription drug companies market pills that have only been proven effective in biased studies, it is important to have a governmental organization that provides health information that the public and the medical community knows to be trustworthy. The fact that the FDA has ignored the repeated attempts of the medical community to research marijuana’s medicinal uses and the scientific value of the Plan B pill seem interconnected. Both appear to stem from a political agenda, displaying a willingness to ignore scientific evidence and focus instead on issues of morality and value. This should not be the FDA’s choice to make, because by doing so it makes the FDA into a policy-making entity rather than a science-based safety organization. Let such decisions be made by the organizations entrusted with policy concerns, namely the state and federal legislatures. Overstep those bounds and risk losing any credibility you once had.Complete Title: FDA Approval: Scientifically Based or Ideologically Driven?  Source: UCSD Guardian, The (CA Edu)Author: Megan Durham, Staff Writer Published: May 8, 2006Copyright: 2006 UCSD GuardianContact: editor ucsdguardian.orgWebsite: Articles & Web Site:IOM Report Advocates Slam ‘Politicized’ FDA Report Loses Credibility With Jab at Medical Pot 

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Comment #9 posted by FoM on May 09, 2006 at 08:25:41 PT

I'm sorry but I have to remove the article. Mapinc. has a list of papers that they and I must snip and USA Today is one of them. If you post a lead in and link that is fine.

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Comment #7 posted by whig on May 09, 2006 at 07:32:15 PT

I'm really looking forward to A Scanner Darkly. Among other things I've always been a big fan of Philip K. Dick.Alex Jones always reminds me of a more serious version of Bill Hicks:
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Comment #6 posted by mayan on May 09, 2006 at 05:43:11 PT

Alex Jones is awesome. He is going to appear in 'A Scanner Darkly', which will star Keanu Reeves, Robert Downy, Jr., Woody Harrelson & Winona Ryder. What a cast! I might even go to the theater to see it... Powerful New Film Expertly Exposes Phony Drug War & Police State: more unrelated happenings, as Bush and the neo-cons fall into oblivion...Bush approval rating hits new low: a terror attack can save them...EXCLUSIVE: New Al Qaeda Leader Planning Attack Against U.S. we have nothing to fear but fear itself...and maybe our own government...Is 'Al Qaeda' the Modern Incarnation of 'Emmanuel Goldstein'? beast is almost completed...Neocons Dismember the CIA:
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Comment #5 posted by afterburner on May 08, 2006 at 21:35:03 PT

Even UN Scheduling Fostered by USA Is Unravelling
UK: Edu: Oxford Don Speaks Out on Drug Classification
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Comment #4 posted by afterburner on May 08, 2006 at 20:39:01 PT

FDA credibility? Hah! 
"The Drug Enforcement Agency lists marijuana as a schedule I drug, on par with drugs such as heroin and methamphetamines."According to Erowid, methamphetamine is schedule II, not schedule I as reported above. However, as they indicate, this information should be verified independently, especially in light of panicky new legislation like Alaska's "meth-ijuana" nonsense. 
Erowid Methamphetamine Vault
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Comment #3 posted by whig on May 08, 2006 at 20:17:35 PT

Martial Law 9/11: Rise of the Police State:
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Comment #2 posted by mayan on May 08, 2006 at 18:17:47 PT

Thank You, FDA!
The FDA is a scientific organization charged with determining the safety, efficacy and toxicity of consumed substances, and should not be concerning itself with politics or morality.The FDA is concerned only with politics but obviously not the least bit concerned with morality! I would like to thank the FDA for putting it's foot in it's mouth and exposing it's own political agenda for the entire world to see. I can't wait for their next statement!THE WAY OUT IS THE WAY IN...UA 93: The Road to Shanksville (video): The Ultimate WMD: 9/11 Really Happened: Scraps and Lies – Bush’s Memorial to the 9/11 Families: Do We Want? InfoMedia interviews Dr. Robert Bowman (audio): Am 103 & 9/11 Connection: for 9/11 Truth:

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Comment #1 posted by FoM on May 08, 2006 at 15:22:50 PT

UPI: Study: Little Damage from Marijuana

NEW YORK, May 8 (UPI) -- In a preliminary study, U.S. researchers failed to find damage to the developing adolescent brain had occurred in those who had used marijuana moderately. Lynn DeLisi and colleagues from the Nathan S. Kline Institute for Psychiatric Research and New York University School of Medicine used diffusion tensor imaging to scan the brain of 10 young people who had smoked cannabis during adolescence. The participants were between 17 and 30 years old, and they said they had smoked at least two to three times a week for one or more years during adolescence and had no personal or family history of mental-health problems. The study subjects were matched for sex, age and social class of parents with 10 controls who had not smoked marijuana regularly as teenagers. DeLisi and colleagues found no significant differences in brain integrity and brain volume between cannabis smokers and non-smokers, but the study authors warn more research is necessary, both in a larger group of people and to see the effects of heavier use. The findings are published in Harm Reduction Journal. Copyright: 2006 United Press International
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