Stop the presses! The FDA doesn’t support medicinal marijuana, imagine everyone’s shock and suprise.
WASHINGTON – The Food and Drug Administration said Thursday that it does not support the use of marijuana for medical purposes. ADVERTISEMENT The FDA said in a statement that it and other agencies with the Health and Human Services Department had “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.” A number of states have passed legislation allowing marijuana use for medical purposes, but the FDA said, “These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective.” The statement contradicts a 1999 finding from the Institute of Medicine, part of the National Academy of Sciences, which reported that “marijuana’s active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting and other symptoms, and should be tested rigorously in clinical trials.” Bruce Mirken, director of communications for the Marijuana Policy Project, said Thursday: “If anybody needed proof that the FDA has become totally politicized, this is it. This isn’t a scientific statement; it’s a political statement.” Mirken said “a rabid congressional opponent of medical marijuana,” Rep. Mark Souder (news, bio, voting record), R-Ind., asked the FDA to make the statement. Souder, chairman of the House Government Reform subcommittee on drug policy, has said the promotion of medical marijuana “is simply a red herring for the legalization of marijuana for recreational use. Studies have continually rejected the notion that marijuana is suitable for medical use because it adversely impacts concentration and memory, the lungs, motor coordination and the immune system.” The FDA statement noted “there is currently sound evidence that smoked marijuana is harmful.” It also said, “There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.” Mirken responded, “There is abundant evidence that marijuana can help cancer patients, multiple sclerosis patients and AIDS patients. There is no scientific doubt that marijuana relieves nausea, vomiting, certain kinds of pain and other symptoms that don’t respond well to conventional drugs, and does it more safely than other drugs. “For the FDA to ignore all that evidence is embarrassing,” Mirken said. “They should be red-faced.”
And another article from yesterday:
WASHINGTON (Reuters) – The U.S. Food and Drug Administration will publish a statement on Friday criticizing state measures to legalize the medical use of marijuana, calling them attempts to bypass scientific review.
The agency said it was posting the statement in response to requests from lawmakers and others, but advocates for legalizing marijuana said the FDA was making an unusual and inappropriate foray into politics.
“In response to inquiries, including from Congress, we are clarifying our position on the science,” said FDA spokeswoman Susan Bro in an interview.
“The FDA continues to support medical researchers whose intention is to undertake rigorous, peer-reviewed investigations and well-controlled clinical trials, in line with the FDA’s drug approval process,” she added in an e-mail.
Peer-reviewed. Read FDA oversight of the study, so they can get the conclusions they want.
But Bruce Mirken of the Marijuana Policy Project said he was puzzled by the FDA’s decision. “It’s fascinating that they are making what strikes me as essentially a political move here,” said Mirken in an interview.
“There are plenty of herbal products that people use … that are not FDA-approved. It really sounds to me like the FDA is inappropriately intruding itself into a political process and I have to say I find it very sad.”
The issue of the medical use of marijuana has been long contested on the state and federal level. Some patients with diseases such as cancer, multiple sclerosis and glaucoma say only the herb provides relief, and sometimes their doctors agree.
But the federal government maintains that FDA-approved drugs, including a synthetic form of the active ingredient in marijuana, are adequate for these patients. The Drug Enforcement Administration and prosecutors say the medical marijuana movement is a thinly disguised effort to allow for recreational use of the illegal drug.
I can’t understand why, given the spectacular success of the Drug Warâ„¢, they would want to legalize it.
STRICT LEGAL CONTROL
Marijuana is a Schedule I drug under the Controlled Substances Act, the most restrictive schedule.
Last June, the U.S. House of Representatives rejected a bill that would allow the medical use of marijuana.
But 11 states have rebelled, most recently the Rhode Island state legislature which in January overrode Gov. Don Carcieri’s veto of a law legalizing marijuana used for symptom relief.
Efforts are underway in several other states, including Minnesota and Illinois, to legalize marijuana use.
The FDA expressed concern about this.
I can’t imagine why, I mean, what’s the point of the FDA if we eliminate the current prohibition? Do you think they would get much funding for being the FA (not that they should get any, they need to go away completely, but I’ll take one step at a time).
“These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective,” it says in the statement, made available to Reuters.
The interagency statement is to be posted at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html.
Tom Riley from the White House Office of National Drug Control Policy applauded the move.
“Why does it get a special get-out-of-jail-free card by plebiscite?” he asked. “The medical marijuana ballot initiatives have been attempts to do an end-run around science. Let’s takes it out the political realm and put it back into science where it belongs.”
Update, here’s more from the FDA:
Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine
Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor’s recommendation, even though it is not an approved drug.
Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision).
Under these guidelines, why aren’t cigarettes, or alcohol Schedule 1 substances as well? Could it be because that was already tried (with alcohol anyway), and because more people were affected, the results weren’t exactly what were wanted, and that when prohibition was lifted, it was found that it had created many more problems than it solved?
Furthermore, there is currently sound evidence that smoked marijuana is harmful. 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. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.
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. FDA’s drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.
A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor’s recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.
Why can’t our government get out of the business of persecuting victimless crimes?
