I. Official Apr. 20, 2006 Statement from the US Food and Drug Association (FDA)
FOR IMMEDIATE RELEASE Statement April 20, 2006
Media Inquiries: FDA Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-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 USC. 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). 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.
II. Pro and Con Reactions to the FDA's Apr. 20, 2006 Statement on Medical Marijuana
Pro FDA Apr. 20 Statement
Con FDA Apr. 20 Statement
Henry Miller, MSc, MD, Founding Director of the FDA Office of Biotechnology and a research fellow at the Hoover Institution, stated in a Apr. 28, 2006 editorial "Reefer Medicine" in the New York Times:
"Many news reports and commentaries accused the F.D.A. of contradicting a 1999 report by the Institute of Medicine that recommended further research on marijuana's medical potential. The regulators were denounced as elevating politics over science.
But the F.D.A. did no such thing. To be sure, its one-page statement was far shorter and less detailed than the institute's book-length report, but its conclusions were essentially the same. The F.D.A. also recently gave the go-ahead for clinical trials of a new drug derived from marijuana — further demonstrating that its position is both sensible and proper....
It is not the F.D.A. but the 11 states that have passed laws allowing the use of smoked marijuana for various medical problems that are at odds with the Institute of Medicine's position....
Smoked marijuana cannot be subjected to careful, well-controlled trials, because it does not come in a standard, reproducible formula or dose, and cannot meet the accepted standards for drug purity, potency and quality. Different strains of cannabis vary radically in their cannabinoid composition and in the contaminants — fungi, bacteria, pesticides, heavy metals and other substances — they contain. And smoking is not a precise way of delivering any substance to the bloodstream.
Other plant-derived drugs — morphine, codeine and Taxol, to name a few — have made it through the F.D.A.'s review process, and there is no reason drugs made from cannabis should not be required to meet the same standards.
Meanwhile, F.D.A. officials must ensure that the testing and potential approval of cannabinoid-containing drugs are not hindered by political agendas or other nonscientific considerations, inside or outside the agency. For the benefit of patients in need, this is something about which the F.D.A., the parts of our government waging the 'war on drugs' and other interested parties should be able to agree." Apr. 28, 2006 Henry Miller
US Office of National Drug Control Policy issued a press release on Apr. 21, 2006:
"Our Nation has the highest standards and most sophisticated institutions in the world for determining the safety and effectiveness of medication. Our national medical system relies on proven scientific research, not popular opinion. To date, science and research have not determined that smoking a crude plant is safe or effective. We have a responsibility as a civilized society to ensure that the medicine Americans receive from their doctors is effective, safe, and free from the pro-drug politics that are being promoted in America under the guise of medicine.
Too many of our citizens suffer from pain and chronic illnesses. Smoking illegal drugs may make some people "feel better." However, civilized societies and modern day medical practices differentiate between inebriation and the safe, supervised delivery of proven medicine by legitimate doctors. In 1999, the Institute of Medicine (IOM) published a review of the available scientific evidence in an effort to assess the potential health benefits of marijuana and its constituent cannabinoids. The review concluded that smoking marijuana is not recommended for any long-term medical use, and a subsequent IOM report declared, 'marijuana is not a modern medicine.'
For years, pro-drug groups seeking the legalization of marijuana and other drugs have preyed on the compassion of Americans to promote their political agenda and bypass F.D.A.'s rigorous standards which have safeguarded our medical supply for over 100 years. Marinol—the synthetic form of THC and the psychoactive ingredient contained in marijuana—is already legally available for prescription by physicians whose patients suffer from pain and chronic illness." Apr. 22, 2006 Office of National Drug Control Policy
US Drug Enforcement Administration (DEA) spokesman Rogene Waite stated in a Apr. 22, 2006 article in the New York Times:
"It's a very good statement so that people can clearly see what the policy of the United States government is.
While it has always been the drug enforcement agency's policy to enforce laws against marijuana, now it's clearly out there, so that people don't have to look everywhere to figure this out." Apr. 22, 2006 Drug Enforcement Administration
Nicholas A. Pace, MD, Clinical Associate Professor of Medicine, New York University Medical Center, stated in an Apr. 21, 2006 letter to the New York Times:
"I compliment the Food and Drug Administration for its truthful report indicating that are 'no sound scientific studies' supporting the medical use of marijuana.
I am an addiction specialist and practicing physician who has studied marijuana for three decades and who co-directed two conferences on marijuana, including a 1998 international conference at New York University.
At this conference, 51 papers presented failed to show that marijuana had any practical therapeutic value. This included use in anorexic H.I.V. patients, who continued to lose weight despite using marijuana.
Recent research shows that marijuana has detrimental effects on the brain, lungs, heart and fertility. The THC (the main ingredient in marijuana) content in marijuana used today is twice as strong as 30 years ago.
The false impression that there is a medical need for marijuana confuses and misleads a poorly informed compassionate public in believing that the medical profession is withholding helpful medication from the sick." Apr. 21, 2006 Nicholas Pace
Peter Provet, PhD, President, Odyssey House, stated in an Apr. 21, 2006 letter to the New York Times:
"As a treatment provider, I support the Food and Drug Administration's dismissal of medical benefit from marijuana.
Regardless of the heated political debate that swirls around this issue, the fact remains that despite the Institute of Medicine's claim to the contrary, for people vulnerable to addictive disease, marijuana is a gateway drug that leads to the use of more dangerous drugs like cocaine and heroin.
When residents in treatment at Odyssey House (more than 1,000 every day) are asked about their drug history, most adults say it began with marijuana, and virtually all teenagers report marijuana as their primary drug of abuse.
Not everyone who smokes marijuana will necessarily become an addict. But why open the gate to increased use for the sake of unproven medical benefits when we already know the harm that marijuana inflicts on millions of Americans?" Apr. 21, 2006 Peter Provet
Rush Limbaugh, nationally syndicated radio show host, stated on his talk show on Apr. 21, 2006:
"The FDA says there's no -- zilch, zero, nada -- shred of medicinal value to the evil weed marijuana. This is going to be a setback to the long-haired, maggot-infested, dope-smoking crowd." Apr. 21, 2006 Rush Limbaugh
US Congressman Maurice Hinchey (D-NY) led a bipartisan group of 24 House members in an Apr. 27, 2005 letter to the FDA, which stated in part:
"We are troubled by the FDA's April 20th press release... The timing and the lack of substantial information included in this release lead us to conclude that this was a politically motivated statement rather than one based on scientific evidence and fact.
Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise. We call on you to show us the purported scientific evidence for the basis of this response....
It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM's findings seven years after the study's publication date. Additionally, this release failed to make note of the FDA's Investigational New Drug (IND) Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana. Currently, seven people still enlisted in this program continue to receive marijuana through the federal government. The existence of this program is an example of how the FDA could allow for the legal use of a drug, such as medical marijuana, without going through the 'well-controlled' series of steps that other drugs have to go through if there is a compassionate need....
If, as the press release leads us to believe, there is in fact no evaluation, please let us know what motivated the FDA to write a release that lacks scientific review. It disheartens us to see the FDA veer off course in this area of public health especially at the expense of many terminally ill Americans."
Maurice Hinchey (D-NY) Ron Paul (R-TX) Barney Frank (D-MA) Sam Farr (D-CA) Tammy Baldwin (D-WI) Raul Grijalva (D-AZ) Robert Wexler (D-FL) Dennis Kucinich (D-OH)
John Conyers (D-MI) Maxine Waters (D-CA) Dana Rohrabacher (R-CA) Jim McDermott (D-WA) Tom Lantos (D-CA) Jerrold Nadler (D-NY) John Olver (D-MA) Lois Capps (D-CA)
Julia Carson (D-IN) Peter Stark (D-CA) Jan Schakowsky (D-IL) George Miller (D-CA) Zoe Lofgren (D-CA) Tom Allen (D-ME) Barbara Lee (D-CA) Gary Ackerman (D-NY)
Lester Grinspoon, MD, wrote in an opinion article "Puffing is The Best Medicine," published May 5, 2006 in the Los Angeles Times:
The Food and Drug Administration is contradicting itself. It recently reiterated its position that cannabis has no medical utility, but it also approved advanced clinical trials for a marijuana-derived drug called Sativex, a liquid preparation of two of the most therapeutically useful compounds of cannabis. This is the same agency that in 1985 approved Marinol, another oral cannabis-derived medicine....
But there is very little evidence that smoking marijuana as a means of taking it represents a significant health risk. Although cannabis has been smoked widely in Western countries for more than four decades, there have been no reported cases of lung cancer or emphysema attributed to marijuana.....
Cannabis will one day be seen as a wonder drug, as was penicillin in the 1940s. Like penicillin, herbal marijuana is remarkably nontoxic, has a wide range of therapeutic applications and would be quite inexpensive if it were legal." May 5, 2006 Lester Grinspoon
The Economist wrote in their Apr. 27, 2006 article "Reefer Madness":
"Marijuana is medically useful, whether politicians like it or not...
The [FDA] statement is curious in a number of ways. For one thing, it overlooks a report made in 1999 by the Institute of Medicine (IOM), part of the National Academy of Sciences, which came to a different conclusion. John Benson, a professor of medicine at the University of Nebraska who co-chaired the committee that drew up the report, found some sound scientific information that supports the medical use of marijuana for certain patients for short periods—even for smoked marijuana....
Another reason the FDA statement is odd is that it seems to lack common sense. Cannabis has been used as a medicinal plant for millennia. In fact, the American government actually supplied cannabis as a medicine for some time, before the scheme was shut down in the early 1990s. Today, cannabis is used all over the world, despite its illegality, to relieve pain and anxiety, to aid sleep, and to prevent seizures and muscle spasms.... in the meantime, there is unmet medical need that, as the IOM report pointed out, could easily and cheaply be met -- if the American government cared more about suffering and less about posturing." 4/27/06 The Economist
Marijuana Policy Project (MPP) stated in an Apr. 21, 2006 article by the Associated Press:
"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....
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. They should be red-faced." Apr. 21, 2006 Marijuana Policy Project
The New York Times stated in a Apr. 22, 2006 editorial, "The Politics of Pot":
"The Bush administration's habit of politicizing its scientific agencies was on display again this week when the Food and Drug Administration, for no compelling reason, unexpectedly issued a brief, poorly documented statement disputing the therapeutic value of marijuana. The statement was described as a response to numerous inquiries from Capitol Hill, but its likely intent was to buttress a crackdown on people who smoke marijuana for medical purposes and to counteract state efforts to legalize the practice.
Ordinarily, when the F.D.A. addresses a thorny issue, it convenes a panel of experts who wade through the latest evidence and then render an opinion as to whether a substance is safe and effective to use. This time the agency simply issued a skimpy one-page statement asserting that 'no sound scientific studies' supported the medical use of marijuana....
It's obviously easier and safer to issue a brief, dismissive statement than to back research that might undermine the administration's inflexible opposition to the medical use of marijuana." Apr. 22, 2006 New York Times
Stephen Sidney, MD, Associate Director for Clinical Research for Kaiser Permanente and Bruce Mirken, Communications Director for Marijuana Policy Project, stated in an Apr. 26, 2006 article published in the San Diego Union-Tribune:
"The FDA's pronouncement tells us little about medical marijuana, but it says much about how politics appears to be trumping science at the agency we all depend on to protect our health....
The federal government has not only refused to fund medical marijuana research, it has put in place a set of legal and bureaucratic obstacles that have kept the flow of even privately funded medical marijuana studies to a trickle. So with one hand, our government tells us 'there's no data,' while with the other hand it works to ensure there will never be enough data.
So why did the FDA issue this questionable document, containing no new information whatever, at this particular moment? The only apparent explanation is politics.... Science, it appears, took a back seat. For the FDA to do its job as protector of our nation's health, it must be free from commercial or political pressure. When politics trumps science at the FDA, we are all in danger." Apr. 26, 2006 Stephen Sidney and Bruce Mirken
John Rennie, Editor-in-Chief of Scientific American, stated on Apr. 21, 2006 in the magazine's "Observations" blog in an article titled "Medical Marijuana's Catch-22":
"What is completely wrong about the FDA's position, however, is that in effect it continues to impede not just the medical use of marijuana but also medical research on marijuana, which could lead to superior therapies that don't involve smoking or getting high at all....
Medical marijuana is caught in a classic Catch-22 situation: It is banned because the federal government dismisses the evidence of therapeutic benefit as insufficient. But because marijuana is banned, scientists can't easily gather more evidence to make the case. And new drugs based on marijuana are casualties of the same policies. Meanwhile, patients continue to suffer despite strong evidence that work in this area could lead to better medicines.
How does this seem like a good arrangement? Seriously, what are the feds smoking?" Apr. 21, 2006 John Rennie