FDA Opposes Medical Marijuana

Medical Marijuana at the U.S. Federal level.

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FDA Opposes Medical Marijuana

Postby palmspringsbum » Sat Apr 22, 2006 10:52 am

The New York Times wrote:F.D.A.'s Report Illuminates Wide Divide on Marijuana

The New York Times
By KATE ZERNIKE
Published: April 22, 2006



A Food and Drug Administration statement on Thursday denying any medical benefits of marijuana reinforced the divide between federal officials and the states that have approved the drug's use to ease some medical conditions.

"It's consistent with the long-held federal view on this medicine, and that is that marijuana is the equivalent of heroin and cocaine," said Nathan Barankin, a spokesman for California's attorney general, Bill Lockyer. "California voters disagree."

State officials said the announcement would not affect their laws. But they and federal officials said it clarified the federal government's intention to continue enforcing its laws against marijuana, even in states that allow it for medical purposes.

"It's a very good statement so that people can clearly see what the policy of the United States government is," said Rogene Waite, a spokeswoman for the Drug Enforcement Administration.

While it has always been the drug enforcement agency's policy to enforce laws against marijuana, Ms. Waite said, "now it's clearly out there, so that people don't have to look everywhere to figure this out."

Several officials in the 11 states that allow medical marijuana disputed the F.D.A.'s contention that there was no research supporting the drug's medical use. They noted, in particular, a 1999 review by the National Institute of Medicine, part of the National Academy of Sciences, the nation's most prestigious scientific advisory panel, which found marijuana to be "moderately well-suited" to some conditions, including wasting disease from AIDS and the nausea that often results from chemotherapy.

State officials said that most of their laws had been passed by citizen initiatives.

"The decision was made by the voters. It's not based on any conditions," said James M. Cameron, assistant attorney general in Maine, where the law allowing marijuana use under some conditions took effect in December 1999. "Really, there's nothing that's going to happen — any third parties judging whether these substances are effective — that is going to change Maine law."

But Mr. Cameron and other officials said they had warned people who used marijuana that they were protected under state law only, and could be prosecuted under federal laws.

"The Vermont attorney general's office had always been concerned about the message that the med marijuana program gave that it was legalizing it, when it remains illegal under federal law," said John Treadwell, an assistant attorney general in that office.

A United States Supreme Court decision last year affirmed the federal government's right to enforce those laws in those states.

State officials said they did not believe that the ruling would increase the number of federal prosecutions.

"There's sort of a détente," Mr. Barankin said, in California. "Both sides respect that we have laws that differ. Federal law enforcement agencies for the most part have shown some respect for California law by only going after those individuals who seem to be clearly not in the medical marijuana business for the medical part of it — which are the same people the state law is going after."

The Food and Drug Administration issued its announcement in response to calls from opponents of medical marijuana in Congress, and it was welcomed by the White House Office of National Drug Control Policy, which has long made marijuana its top priority.

Advocates of medical marijuana said the real impact would be in trying to pass new legislation in states like Connecticut, New Jersey and New Mexico.

"We're going to have members of state legislatures say, 'But even the F.D.A. has said there's no medical value,' " said Ethan Nadelmann, executive director of the Drug Policy Alliance, which works to loosen drug laws. "That's where it's going to hurt."

The Supreme Court decision killed efforts to allow medical marijuana in Connecticut, Mr. Nadelmann said, adding, "It had no legal impact, but it created a perception."

Others said the decision would continue to frustrate efforts to research the potential medical benefits of marijuana.

In Vermont, for example, a statute enacted several years ago called for a research program on the therapeutic effects of marijuana. When a legislative group asked more recently why that had not been conducted, the Vermont Health Department said it could not be done under federal law, Mr. Treadwell said.

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Postby palmspringsbum » Sat Apr 22, 2006 11:28 am

turnto10.com wrote:State Reacts To FDA Medical Marijuana Statement
Health Department Still Instituting Program


POSTED: 10:23 pm EDT April 21, 2006
UPDATED: 10:57 pm EDT April 21, 2006
turnto10.com

PROVIDENCE -- The U.S. Food and Drug Administration published a statement this week criticizing state measures to legalize the medical use of marijuana.

NBC 10's Michelle Brown reported that Rhode Island's Department of Health said no decisions, if any, will be made regarding the state's medical marijuana program until more details from the FDA announcement are obtained.

The FDA said it does not support the use of marijuana for medical purposes. The FDA said there are no sound studies to prove that marijuana serves any medical purpose.

The statement contradicts a 1999 finding from the Institute of Medicine that found marijuana does relieve symptoms for some patients.

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Postby palmspringsbum » Thu Apr 27, 2006 7:04 pm

Alternet wrote:FDA Plays Politics with Pot

By Michelle Chen, The NewStandard. Posted April 26, 2006.
AlterNet


Last week's ludicrous governmental report, which denied the efficacy of medical marijuana, is the Bush administration's latest attempt to divorce science from policy.

Clashing with drug-policy reform groups and a growing body of scientific research, the federal government has stepped up its effort to invalidate marijuana as medicine.

The Food and Drug Administration issued a statement last Thursday asserting that smoked marijuana has no proven medical benefits. The assessment sparked criticism from both the scientific community and activists pushing for changes in drug laws, who say it exposes the White House's effort to spin science in order to push its agenda of criminalizing drug use.

The statement concluded that based on existing research, "no sound scientific studies supported medical use of marijuana for treatment in the United States." The agency further argued that laws permitting marijuana use as a medical treatment "are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process."

Reform groups call the declaration a thinly veiled attempt to preempt both state and federal initiatives to de-criminalize the use of medical marijuana to relieve symptoms related to glaucoma, cancer and other illnesses.

Bruce Mirken, director of communications with the reform group Marijuana Policy Project, told The NewStandard that the FDA's position is "the final proof, if anybody still needed it, that the FDA has become completely politicized, that they're doing politics instead of science. And that, frankly, should frighten everybody, whatever your feelings about medical marijuana."

Organizations advocating for drug-policy reform have railed on the government for ignoring a wealth of clinical studies demonstrating the positive impacts of the drug. In a 1999 report, the federal Institute of Medicine recommended further research on risks and benefits of smoked marijuana, but concluded overall, "Scientific data indicate the potential therapeutic value of cannabinoid drugs for pain relief, control of nausea and vomiting, and appetite stimulation," particularly for AIDS and chemotherapy patients.

The FDA's opinion folds into an intensifying discussion in Congress over the potential benefits of medical marijuana and the costs of trying to control the drug.

Representative Mark Souder (R-Indiana) has led the push for tightening federal restrictions on medical marijuana through stringent FDA regulation. "Denying the federal government the power to set and enforce uniform standards would simply open up an alternative route for illegal drug trafficking and abuse," he said in a statement following a Supreme Court ruling last June that permitted federal crackdowns on medical marijuana.

But a spate of recent raids on medical-marijuana distribution centers has also sparked resistance from lawmakers and the public. In each legislative session since 1997, Representative Barney Frank (D-Massachusetts) has introduced the States' Rights to Medical Marijuana Act, which would relax the ban on marijuana under the federal Controlled Substances Act and bar federal penalties on patients or medical professionals involved in the administration of medical marijuana.

Representative Maurice Hinchey (D-New York) plans to reintroduce later this year an amendment to House appropriations legislation that would prevent the spending of federal dollars to prosecute medical-marijuana use.

Currently, state laws allow the cultivation and use of medical marijuana in Alaska, California, Colorado, Hawaii, Maine, Maryland, Montana, Nevada, Oregon, Rhode Island, Vermont and Washington. In total, about 35 states have at some point enacted supportive legislation, including laws authorizing clinical research, or expressing support for medical marijuana without actually shielding patients from arrest.

In 2005, a two-fold Supreme Court ruling established states' prerogative to legalize marijuana for medicinal purposes, but also reaffirmed federal authority to prosecute sick people who use marijuana treatment in states that allow it.

In recent years, the Drug Enforcement Administration has led over 20 raids of medical-marijuana distribution centers in California and other states, according to a December 2005 Congressional Research Service report.

Critics say that in its efforts to criminalize marijuana despite evidence of its therapeutic benefits, the government has even resorted to stonewalling further scientific investigation of the drug's safety and effectiveness.

The Multidisciplinary Association for Psychedelic Studies, an organization that supports research on marijuana and similar drugs used for medical or spiritual purposes, has spent several years in a bureaucratic battle -- and now a lawsuit -- over the licensing of a proposed growing facility at the University of Massachusetts-Amherst. The organization argues that federal regulators have since 2001 "unreasonably delayed" the review procedure for the project, which is intended to supply researchers with high-potency marijuana.

Ethan Nadelmann, executive director of the Drug Policy Alliance, said in a statement on Friday, "It is shameful to see the FDA talking out of both sides of its mouth on this issue by declaring there is no sound research on the medical benefits of medical marijuana, but at the same time, denying researchers the opportunity to study the efficacy of cannabis."

Mirken of the Marijuana Policy Project commented that in the broader debate over drug-policy reform, the FDA's statement strikes at a particularly vulnerable population swept up in the drug war. "From our point of view," he said, "as long as we have a 'war on drugs,' can we please at least remove the sick and wounded from the battlefield?"

Michelle Chen is a staff journalist for The NewStandard.

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Postby palmspringsbum » Thu Apr 27, 2006 7:12 pm

The Bay Area Reporter wrote:From ebar.com Issue: Vol. 36 / No. 17 / 27 April 2006

Originally published by Bay Area Reporter
Copyright © 2005 Bay Area Reporter, a division of Benro Enterprises, Inc.



FDA: Marijuana not a medicine
By by Bob Roehr

The Food and Drug Administration rejected any claims that smoked marijuana is a medicine, saying, "No animal or human data supported the safety or efficacy of marijuana for general medical use." The April 20 statement came in response to inquires from Capitol Hill, most notably right-winger Representative Mark Souder (R-Indiana).

The FDA charged that state measures that allow for the use of marijuana for medical purposes "are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective."

However, the statement consistently referred to "smoked marijuana," perhaps leaving wiggle room for consideration of other forms of administration of the drug.

It cited several government evaluations of marijuana but it ignored a 1999 report by the independent and prestigious Institute of Medicine. That report noted promising anecdotal accounts of benefit and urged study of the product for a number of conditions including chemotherapy-induced nausea and AIDS-related wasting. Ironically, that report was commissioned by the White House drug czar, which paid $896,000 for the study.

Marijuana Policy Project spokesman Bruce Mirken called the FDA statement "an odd piece of work. They make no claim that they have any new data or new analysis of old data, so why are they doing it now?"

"It weirdly mischaracterizes what state medical marijuana laws are about. And the whole notion that this is some kind of end run around the FDA is just silly," Mirken said.

Eleven states have laws allowing for the medical use of marijuana that were passed either by voter initiative or the legislative process.

California has even gone so far as to establish the Center for Medicinal Cannabis Research within the state university system as a means by which to bypass reluctance on the part of federal agencies to study the possible beneficial aspects of marijuana.

Americans for Safe Access previously filed an administrative petition with the Department of Health and Human Services under the Data Quality Act, challenging the finding that marijuana has no medicinal value. By law, HHS is supposed to respond within 60 days, but it has taken six 60-day extensions, delaying its response by more than a year.

"If the agency believed that marijuana did not have medical value, they could have rejected the petition and provided their rationale," Bruce Levinson told the trade publication FDA Week . Levinson is with the Center for Regulatory Effectiveness, a nonprofit that pushed for the DQA but is not involved with the marijuana petition.

"My only conclusion is that the sixth extension reflects FDA unease with both their own formal position on the medical value of marijuana and with their legal position should the issue go to court," he said.

The pending confirmation hearing and vote on the nomination of Andrew von Eschenbach as FDA commissioner is a natural place to raise these issues, medical marijuana advocates said. Given that California voters overwhelmingly support the medical use of marijuana and even fund research in that area, U.S. Senators Dianne Feinstein and Barbara Boxer would seem to be logical persons to raise the issue during those hearings. Boxer already has suggested that she might place a hold on the nomination pending long-delayed approval of "Plan B," the so-called morning after birth control pill.

But Mirken is not optimistic. "I don't know of any issue that has such a disconnect between public opinion and the behavior of politicians. What else that has 78 percent support that politicians are so afraid of? Barbara Boxer has been entirely missing in action, and Feinstein actually opposed Proposition 215."

"We won long ago in the court of public opinion; don't we elect these people to represent us? A lot of politicians are laboring under the delusion that it is harmful to their career to be 'soft on drugs,' they just need to hear from people. Call, write, send e-mails," Mirken urged.

"The war in Iraq is bad enough. But the war on drugs has lasted longer and cost more money and more American lives," wrote libertarian David Boaz of the Cato Institute, online in the British newspaper the Guardian. "And neither Democrats nor Republicans are talking about withdrawal."


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Postby palmspringsbum » Fri Apr 28, 2006 11:15 am

The Economist wrote:Medical marijuana

Reefer madness

Apr 27th 2006
From The Economist print edition

Marijuana is medically useful, whether politicians like it or not


<img src=bin/economist-6849915.jpg align=right width=300>IF CANNABIS were unknown, and bioprospectors were suddenly to find it in some remote mountain crevice, its discovery would no doubt be hailed as a medical breakthrough. Scientists would praise its potential for treating everything from pain to cancer, and marvel at its rich pharmacopoeia—many of whose chemicals mimic vital molecules in the human body. In reality, cannabis has been with humanity for thousands of years and is considered by many governments (notably America's) to be a dangerous drug without utility. Any suggestion that the plant might be medically useful is politically controversial, whatever the science says. It is in this context that, on April 20th, America's Food and Drug Administration (FDA) issued a statement saying that smoked marijuana has no accepted medical use in treatment in the United States.

The 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.

This is important, because one of the objections to marijuana is that, when burned, its smoke contains many of the harmful things found in tobacco smoke, such as carcinogenic tar, cyanide and carbon monoxide. Yet the IOM report supports what some patients suffering from multiple sclerosis, AIDS and cancer—and their doctors—have known for a long time. This is that the drug gives them medicinal benefits over and above the medications they are already receiving, and despite the fact that the smoke has risks. That is probably why several studies show that many doctors recommend smoking cannabis to their patients, even though they are unable to prescribe it. Patients then turn to the black market for their supply.

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. For example, two of its long-advocated benefits are that it suppresses vomiting and enhances appetite—qualities that AIDS patients and those on anti-cancer chemotherapy find useful. So useful, in fact, that the FDA has licensed a drug called Marinol, a synthetic version of one of the active ingredients of marijuana—delta-9-tetrahydrocannabinol (THC). Unfortunately, many users of Marinol complain that it gets them high (which isn't what they actually want) and is not nearly as effective, nor cheap, as the real weed itself.

This may be because Marinol is ingested into the stomach, meaning that it is metabolised before being absorbed. Or it may be because the medicinal benefits of cannabis come from the synergistic effect of the multiplicity of chemicals it contains.

Just what have you been smoking?

THC is the best known active ingredient of cannabis, but by no means the only one. At the last count, marijuana was known to contain nearly 70 different cannabinoids, as THC and its cousins are collectively known. These chemicals activate receptor molecules in the human body, particularly the cannabinoid receptors on the surfaces of some nerve cells in the brain, and stimulate changes in biochemical activity. But the details often remain vague—in particular, the details of which molecules are having which clinical effects.

More clinical research would help. In particular, the breeding of different varieties of cannabis, with different mixtures of cannabinoids, would enable researchers to find out whether one variety works better for, say, multiple sclerosis-related spasticity while another works for AIDS-related nerve pain. However, in the United States, this kind of work has been inhibited by marijuana's illegality and the unwillingness of the Drug Enforcement Administration (DEA) to license researchers to grow it for research.

Since 2001, for example, Lyle Craker, a researcher at the University of Massachusetts, has been trying to obtain a licence from the DEA to grow cannabis for use in clinical research. After years of prevarication, and pressure on the DEA to make a decision, Dr Craker's application was turned down in 2004. Today, the saga continues and a DEA judge (who presides over a quasi-judicial process within the agency) is hearing an appeal, which could come to a close this summer. Dr Craker says that his situation is like that described in Joseph Heller's novel, “Catch 22”. “We can say that this has no medical benefit because no tests have been done, and then we refuse to let you do any tests. The US has gotten into a bind, it has made cannabis out to be such a villain that people blindly say ‘no’.”

Anjuli Verma, the advocacy director of the American Civil Liberties Union (ACLU), a group helping Dr Craker fight his appeal, says that even if the DEA judge rules in their favour, the agency's chief administrator can still decide whether to allow the application. And, as she points out, the DEA is a political organisation charged with enforcing the drug laws. So, she says, the ACLU is in this for the long haul, and is already prepared for another appeal—one that would be heard in a federal court in the normal judicial system.

Ms Verma's view of the FDA's statement is that other arms of government are putting pressure on the agency to make a public pronouncement that conforms with drug ideology as promulgated by the White House, the DEA and a number of vocal anti-cannabis congressmen. In particular, the federal government has been rattled in recent years by the fact that eleven states have passed laws allowing the medical use of marijuana. In this context it is notable that the FDA's statement emphasises that it is smoked marijuana which has not gone through the process necessary to make it a prescription drug. (Nor would it be likely to, with all of the harmful things in the smoke.) The statement's emphasis on smoked marijuana is important because it leaves the door open for the agency to approve other methods of delivery.

High hopes

Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, has been working on one such option. He is allowed by the National Institute on Drug Abuse (the only legal supplier of cannabis in the United States) to do research on a German nebuliser that heats cannabis to the point of vaporisation, where it releases its cannabinoids without any of the smoke of a spliff, and with fewer carcinogens.

That is encouraging. But it does not address the wider question of which cannabinoids are doing what. For that, researchers need to be able to do their own plant-breeding programmes.

In America, this is impossible. But it is happening in other countries. In 1997, for example, the British government asked Geoffrey Guy, the executive chairman and founder of GW Pharmaceuticals, to come up with a programme to develop cannabis into a pharmaceutical product.

In the intervening years, GW has assembled a “library” of more than 300 varieties of cannabis, and obtained plant-breeder's rights on between 30 and 40 of these. It has found the genes that control cannabinoid production and can specify within strict limits the seven or eight cannabinoids it is most interested in. And it knows how to crossbreed its strains to get the mixtures it wants.

Nor is this knowledge merely academic. Last year, GW gained approval in Canada for the use of its first drug, Sativex, which is an extract of cannabis sprayed under the tongue that is designed for the relief of neuropathic pain in multiple sclerosis. Sativex is also available to a more limited degree in Spain and Britain, and is in clinical trials for other uses, such as relieving the pain of rheumatoid arthritis.

At the start of this year, the company made the first step towards gaining regulatory approval for Sativex in America when the FDA accepted it as a legitimate candidate for clinical trials. But there is still a long way to go.

And that delay raises an important point. Once available, a well-formulated and scientifically tested drug should knock a herbal medicine into a cocked hat. No one would argue for chewing willow bark when aspirin is available. But, 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.

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Postby palmspringsbum » Fri Apr 28, 2006 12:08 pm

The Drug War Chronicle wrote:Medical Marijuana: Bipartisan House Coalition Challenges FDA Medical Marijuana Finding

4/28/06
http://stopthedrugwar.org/chronicle/433/hinchey.shtml


<img src=bin/montel.jpg align=right title="Reps. Hinchey & Paul with Montel Williams and others,
at Capitol Hill press conference last year">A week after the US Food and Drug Adminstration (FDA) issued a one-page opinion claiming marijuana has no proven medical uses -- a position that ignores the much more comprehensive analysis done by the National Academy of Science's Institute of Medicine in 1999 -- a bipartisan group of 24 House members led by Rep. Maurice Hinchey (D-NY) has called on the agency to explain its reasoning and offer scientific proof for its position.

"Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise," the representatives wrote in a Thursday letter to FDA Acting Commissioner Andrew von Eschenbach. "We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. 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."

Last week, the FDA issued a one-page press release declaring 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." The press release did not point to any studies that supported its contention, and it has become an object of controversy among medical marijuana proponents and scientists who have actually done research on marijuana.

Hinchey accused the agency of playing politics with people's lives. "We saw it with the agency's decision on the emergency contraceptive, Plan B, and we're seeing it again with medical marijuana: the FDA is making decisions based on politics instead of science," Hinchey said. "The FDA should not be a political entity. Rather, the agency should be in the business of ensuring all Americans have access to safe and effective drugs, including medical marijuana."

Rep. Hinchey is one of the most ardent defenders of medical marijuana in the House. He has sponsored an amendment that would bar the federal government from prosecuting medical marijuana patients in three consecutive sessions, and he has vowed to offer it again later this year.


<center>-- END --</center>
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Postby palmspringsbum » Sat Apr 29, 2006 12:27 pm

Southwest Nebraska News wrote:Article Posted: 04/28/2006 11:17:58 AM
Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine

Southwest Nebraska News

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). 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.

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Postby palmspringsbum » Sun Apr 30, 2006 12:26 pm

The Daily News - Jacksonville, North Carolina wrote:Politics produces a cloud of smoke

April 28,2006
Editorial
The Daily News

Last week, the U.S. Food and Drug Administration, for reasons that are far from clear, chose to enter the debate over medical marijuana with a thoroughly unscientific — one might even say anti-scientific — blanket denial that marijuana has any medical value at all.Specifically, the grandiosely titled “Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine” referenced a “past examination” that “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.”

That is simply not true. As Scientific American magazine noted on its Web site the next day, the statement simply ignores “the existence of a 1999 report by the Institute of Medicine of the National Academy of Sciences, which concluded that marijuana was ‘moderately well-suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting.’”

The Institute of Medicine report, which was commissioned by the “drug czar” at the time, Gen. Barry McCaffrey, and included a series of hearings around the country as well as a complete review of the scientific literature worldwide, summarized its conclusions as follows:

“Advances in cannabinoid science of the past 16 years have given rise to a wealth of new opportunities for the development of medically useful cannabinoid-based drugs. The accumulated data suggest a variety of indications, particularly for pain relief, antiemesis and appetite stimulation. For patients such as those with AIDS or who are undergoing chemotherapy, and who suffer simultaneously from severe pain, nausea and appetite loss, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication. The data are weaker for muscle spasticity but moderately promising. The least-promising categories are movement disorders, epilepsy and glaucoma. Animal data are moderately supportive of a potential for cannabinoids in the treatment of movement disorders and might eventually yield stronger encouragement.”

The Institute of Medicine report does say that “it does not follow from this that smoking marijuana is good medicine,” which is the only sentence Gen. McCaffrey ever quoted.

That statement is followed, however, by noting that “patients who are currently suffering from debilitating conditions unrelieved by legally available drugs, and who might find relief with smoked marijuana, will find little comfort in a promise of a better drug 10 years from now.”

Therefore, “Until a nonsmoked rapid-onset cannabinoid drug-delivery system becomes available, we acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting.”

The FDA statement was not preceded by any new studies or surveys of the literature; it was simply posted on the agency’s Web site.

It represents a willful determination to ignore science to buttress the harmful policy of marijuana prohibition.

Politics over science. Sad.

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Postby palmspringsbum » Tue May 02, 2006 6:06 pm

Everyone seems to be focused on the part about 'smoked marijuana', while what really struck me when I read this is the phrase no sound scientific studies supported medical use of marijuana for treatment in the United States.

Seems to me this tacitly acknowledges the research, studies, and conclusions in Canada, Great Britain, Spain, India and elsewhere: that not just smoked marijuana, but other forms and even synthetic chemicals that resemble mariuana are effective medicine. I'll let them all argue over smoked vs. vaporized, or whatever.

Seems to me the real issue here is a blatant and massive 1st Amendment violation by the United States Government, and the real debate is why the United States refuses to acknowledge good science that is done elsewhere?
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Postby palmspringsbum » Tue May 02, 2006 6:59 pm

The L.A. Times wrote:One drug, two takes

Scientists and patients scoff at an FDA announcement that smoking marijuana has no medical benefits.


The Los Angeles Times
By Mary Beckman, Special to The Times
May 1, 2006


<img src=bin/marijuana_in_tupperware.jpg align=right width=300 title="Medical marijuana from the Alternative Herbal Health Services cannabis dispensary in San Francisco, California.
(Justin Sullivan / Getty Images)">As assistant district attorney in San Francisco, Keith Vines prosecuted one of the largest illicit drug busts the city had ever seen. Then he came down with AIDS wasting syndrome and lost 60 pounds over three years.

To stimulate his appetite, he started taking marinol, an FDA-approved drug containing THC, one of the active ingredients in marijuana. He says he couldn't control the dose of the drug, which must be swallowed. "I would be out of it for four or five hours," he says.

And so, instead of continuing with marinol, he started smoking medical marijuana, keeping his head clear by puffing only as much as he needed to get hungry. He gained back all his weight, he says.

Like many in his condition, Vines flatly disagrees with an April 20 announcement by the Food and Drug Administration and several other federal agencies that smoking marijuana confers no medical benefits.

So do physicians who write prescriptions for medical marijuana. (Doctors can't prescribe the plant.) They say the government hasn't done its homework — and cite a 1999 report by the Institute of Medicine, a prestigious organization that advises the government, that found otherwise.

That 1999 report concluded that smoked marijuana could stimulate appetite in some patients with AIDS wasting disease; lessen nausea and vomiting caused by chemotherapy for cancer; and alleviate pain.

"I'm disappointed that they haven't really read the research or spoken with people in the field," says Los Angeles internist Dr. Eve H. Elting, who recommends medical marijuana to treat patients with chronic pain due to cancer and injuries; nausea and vomiting caused by chemotherapy; and migraines.

"The FDA statement directly opposes what the [Institute of Medicine] said," says Dr. Jean Talleyrand of Ukiah, who also recommends medical marijuana. "My first question is, how did they come to that conclusion?"

Some scientists involved in crafting the 1999 report were more circumspect.

"I thought there was pretty good agreement among the panel that THC has good benefit, and it's in marijuana," says Billy R. Martin, a professor of pharmacology and toxicology at Virginia Commonwealth University.

But, he adds, "when you turn to the FDA, they require well-controlled studies showing efficacy."

Martin says in many ways the tussle between federal agencies such as the FDA and medical marijuana proponents boils down to politics — on both sides.

"I'm sad, but I don't think science is a factor," he says.

Dr. Howard Fields, a professor of neurology and psychology at UC San Francisco and another panel member, agrees. "There is so much distortion of the research on both ends of the spectrum," he says.

<b><u>FDA's statement</u></b>

According to FDA spokeswoman Kathleen Quinn, the agency's decision to issue a statement about marijuana was prompted by inquiries from individuals and members of Congress who were curious about "recent reports [that] have suggested that smoked marijuana may offer pain relief for [some] conditions," she wrote in an e-mail.

The FDA, she added, drew upon "the latest formal scientific evaluation of the government" of marijuana — a 2001 Drug Enforcement Agency report.

Some doctors and scientists say they trust science over drug laws. Scientists outside of law enforcement crafted the Institute of Medicine report. To write it, Martin, Fields and nine other clinical and basic researchers perused hundreds of studies on marijuana, consulted biomedical and social researchers in the field, held workshops with medical marijuana patients, and visited HIV/AIDS clinics.

The result was neither a blanket endorsement nor an utter dismissal of medical marijuana use — but something in-between.

<img src=bin/marijuana_joint align=right width=300 title="Some prefer the plant over the drug marinol.
(Justin Sullivan / Getty Images)">Some of the studies, the scientists found, lend support for Vines' experience with marinol and marijuana. Marinol pills release their contents slowly, taking 2.5 hours to maximize their levels in blood. Smoking delivers the chemicals in 2.5 minutes.

In addition, studies show that the chemicals delivered to the body differ, depending on whether marijuana's active compounds travel through the stomach (as they do when swallowed) or the liver (as they do when smoked).

"There's less of a psychoactive chemical when you inhale it," says Dr. Donald I. Abrams, a professor of hematology and oncology at UC San Francisco, who was not a member of the panel.

The report also points out that some chemotherapy patients would not be able to keep down pills long enough for the drugs to take effect.

"No doubt about it. Marijuana smoke is a great way to deliver drugs," says Martin.

The scientists also looked at few studies that tested the ability of THC-related compounds to quell chronic pain due to cancer or nerve damage.

For example, in one 1975 study, researchers gave either placebos or THC pills in a range of doses to 10 cancer pain patients averaging 51 years of age. They found that higher doses quelled the pain significantly.

Glaucoma patients have long valued marijuana's medicinal properties of reducing internal pressure of the eye. Such pressure can eventually cause blindness.

But Martin says the panel didn't recommend marijuana for glaucoma because the connection between eye pressure and nerve damage is not clear, and studies hadn't addressed whether marijuana is safe for the optic nerve.

Although eight studies which gauged eye measurements in people taking marijuana or THC support the idea that marijuana can reduce eyeball pressure, clinical studies are only now underway to test the effects of the drug more closely.

For nausea, the panel examined about a dozen studies that looked at THC or marijuana's ability to quell nausea during chemotherapy. For example, in one study, 56 cancer patients who did not respond to other anti-nausea and vomiting drugs were given marijuana. More than one-third rated the plant as moderately or highly effective.

The report pointed out, however, that these studies weren't well controlled — and controls, Martin says, are especially important in studying smoked marijuana. "There are a fair number of learned behaviors with marijuana — such as expecting to feel good," he says.

The report also stated that the benefits of smoking the plant must be weighed against the potential harm in the smoke. Marijuana smoke contains some of the same hazardous chemicals found in cigarette smoke.

Scientists say that there is no conclusive evidence that smoking marijuana causes cancer in people. Still, because of the potential carcinogenicity, the American Cancer Society does not advocate the use of inhaled marijuana or the legalization of marijuana, while agreeing that THC and cannabinoids in marijuana will help alleviate some symptoms, says ACS spokesman David Sampson.

<b><u>Nonsmoking options</u></b>

There could be ways to mitigate that risk. Both the Institute of Medicine report and the Drug Enforcement Agency report used by the FDA recommended that alternatives to smoking marijuana cigarettes be developed.

They cited vaporizers, available to medical marijuana users these days, that "toast" marijuana rather than burn it.

This lets the volatile THC and other active compounds escape the plant for inhalation, leaving behind some of the toxic chemicals, such as benzene and toluene. The appliances, however, can cost 20 times that of a conventional marijuana pipe.

In the midst of the impassioned debate, a lot of people overlook the fact that THC (although not marijuana's other active ingredients) is available in pill form, Fields says. The pain relief offered by marinol is comparable to that of aspirin, he says, "so why would anyone want to use cannabis?"

Fields does think that there are some people who could benefit from smoking marijuana. And Vines, for whom marinol did not work, says the government could erase many of the problems associated with medical marijuana use by altering its legal status so the drug can be obtained — but by prescription only.

"You can't help but scratch your head and wonder what the government is doing," he says.



<i>The FDA, she added, drew upon "the latest formal scientific evaluation of the government" of marijuana — a 2001 Drug Enforcement Agency report. </i>

So, now we learn the FDA's -conclusion- is based on a 2001 (FIVE YEARS AGO) report. :motz:
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Postby palmspringsbum » Tue May 02, 2006 7:33 pm

The Orange County Register wrote:Thursday, April 27, 2006

What were they smoking at the FDA?
Agency denies medical value of marijuana


The Orange County Register
Editorial


Last Thursday the U.S. Food and Drug Administration, for reasons that are far from clear, chose to enter the debate over medical marijuana with a thoroughly unscientific – one might even say anti-scientific – blanket denial that marijuana has any medical value at all.

Specifically, the grandiosely titled "Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine" referenced a "past examination" that "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."

That is simply not true. As Scientific American magazine noted on its Web site the next day, the statement simply ignores "the existence of a 1999 report by the Institute of Medicine of the National Academy of Sciences, which concluded that marijuana was 'moderately well-suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting.'"

The Institute of Medicine report, which was commissioned by the "drug czar" at the time, Gen. Barry McCaffrey, and included a series of hearings around the country as well as a complete review of the scientific literature worldwide, summarized its conclusions as follows:

"Advances in cannabinoid science of the past 16 years have given rise to a wealth of new opportunities for the development of medically useful cannabinoid-based drugs. The accumulated data suggest a variety of indications, particularly for pain relief, antiemesis and appetite stimulation. For patients such as those with AIDS or who are undergoing chemotherapy, and who suffer simultaneously from severe pain, nausea and appetite loss, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication. The data are weaker for muscle spasticity but moderately promising. The least-promising categories are movement disorders, epilepsy and glaucoma. Animal data are moderately supportive of a potential for cannabinoids in the treatment of movement disorders and might eventually yield stronger encouragement."

The Institute of Medicine report does say that "it does not follow from this that smoking marijuana is good medicine," which is the only sentence Gen. McCaffrey ever quoted. That statement is followed, however, by noting that "patients who are currently suffering from debilitating conditions unrelieved by legally available drugs, and who might find relief with smoked marijuana, will find little comfort in a promise of a better drug 10 years from now." Therefore, "Until a nonsmoked rapid-onset cannabinoid drug-delivery system becomes available, we acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting."

The FDA statement was not preceded by any new studies or surveys of the literature, it was simply posted on the agency's Web site. It represents a willful determination to ignore science to buttress the harmful policy of marijuana prohibition. Politics over science. Sad.

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Postby palmspringsbum » Thu May 04, 2006 10:40 am

The Knoxville Metro Voice wrote:Herbal Shmerbal
Easy to say when you’re not the one suffering


Thursday, May 4, 2006
The Knoxville Metro Voice
by Steve Dupree

I've been a little hard on my body. Nothing out of the ordinary, really, just the normal idiocy that comes from what a friend referred to as “testosterone poisoning.” I have been involved (read: injured) as operator, passenger or bystander in bicycle wrecks, motorcycle wrecks and car wrecks. I have been injured in sporting endeavors ranging from basketball and football to running and martial arts. I have been hurt in fights and hurt on the job.

As a matter of fact, the last major job-related injury I incurred, the result of falling off a roof (that was pretty much when I quit being a roofer), is the last major injury I had—knocks on wood. After the obligatory trip to the emergency room, when one does a sufficiently impressive job of injuring oneself, one must follow up with the appropriate specialist. So I was talking with the orthopedic specialist that lucked into me (well, mostly I was listening), and in the course of the examination he says “...when you get arthritis…” I must have said something to the effect of “Whoa! You mean if I get arthritis, don’t you?” The doc says, “No, I mean when.”

A few years down the road I saw what he meant. Actually, I felt what he meant. I experienced what we insiders know as “Delayed Onset Reaction to Stupid Choices.” I’ll just call it “pain” for short, although there was also some diminishment of range of motion and other symptoms.

Since I had been warned, I was pretty sure that I was seeing the effects of arthritis. It hurt, but I’m not much of one for taking pills, and needles scare the shit out of me, so I just dealt with it. At the ripe old age of about 45, I pretty much decided that pain was just one of the things I had to accept about getting older.

Then one day a friend suggested that I try ground flaxseed to improve my joint health. I read up a little on the alleged benefits of this stuff and went ahead and tried it. In less than two weeks, the difference was really obvious. Still, I’m a little stubborn, so initially I would sometimes quit taking it. Pain would reappear. I would start on the flaxseed again, and pain would recede. It only took me a few times to figure out that the flaxseed had something to do with the absence of pain.

Oddly enough, flaxseed isn’t an FDA-sanctioned treatment for arthritis. I have found no studies that verify the effectiveness of flaxseed in restoring flexibility and relieving pain in joints afflicted with arthritis. Perhaps such studies exist, and I simply haven’t seen them.

Why is this of interest to you? I’m so glad you asked.

The FDA recently ruled that “no sound scientific studies supported the medical use of marijuana.” Of all the things this (mis)administration has said that are absolutely meaningless to regular folk, this ranks near the top. They did not say that there aren’t tens of thousands of cancer and AIDS patients who haven’t claimed to benefit from the use of marijuana. They did not claim that the reduced nausea reported by chemotherapy patients is bogus. They never even pretended to shape their mouths to say that pain had not been diminished or appetite restored.

Given the FDA’s rather mealy-mouthed parsing of its support of the Bush administration’s position on the issue, why would anyone in pain or other medical need base his or her decision on what it says?

Personally, I hope no one does.

You see, unlike the alleged Christians in the White House, I have no desire to see needless suffering. Unlike those who would believe the government is the best entity to dictate what is best for their health, I typically want to do some research and take possession of my own health, maintenance and correction. Even though it isn’t widely reported on Fox News, herbal remedies have been used effectively since well before history started being recorded (well, if one can believe the archaeological record).

Perhaps the problem is the word “medical.” After all, I never used the word “medical” in my completely true anecdote about flaxseed. Whatever the problem, there surely must be a very good reason that this administration insists on demonizing the use of marijuana by people it cannot possibly hurt and, most probably, will help.

I can easily see a role for the FDA in establishing grades of herbals according to strength of the active ingredient(s). I can see the FDA doing testing and certification of herbals. I can see the FDA ensuring that approved herbals do not have additional substances added. What I can’t see is me ignoring things which have a long history of use as treatments for health conditions simply because a politically motivated bureaucracy has arbitrarily decided to ignore history, science and evidence.

Do these folks feed on suffering, are they afraid of someone knowing more than they do, or do they simply have stock in pharmaceutical firms? I don’t know, but I do know that if I am already suffering, the minor illegality of an herbal is not going to stop me from using it.

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Postby palmspringsbum » Fri May 05, 2006 11:44 am

The L.A. Times wrote:Opinion: Op-ED

Puffing is the best medicine


By Lester Grinspoon, LESTER GRINSPOON is an emeritus professor of psychiatry at Harvard Medical School and the author of "Marijuana, the Forbidden Medicine" (Yale University Press, 1997).

May 5, 2006


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.

Both Sativex and Marinol represent the "pharmaceuticalization" of marijuana. They are attempts to make available its quite obvious medicinal properties — to treat pain, appetite loss and many other ailments — while at the same time prohibiting it for any other use. Clinicians know that the herb — because it can be smoked or inhaled via a vaporizer — is a much more useful and reliable medicine than oral preparations. So it might be wise to consider exactly what Sativex can and can't do before it's marketed here.

A few years ago, the British firm GW Pharmaceuticals convinced Britain's Home Office that it should be allowed to develop Sativex because the drug could provide all of the medical benefits of cannabis without burdening patients with its "dangerous" effects — those of smoking and getting high.

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. I suspect that a day's breathing in any city with poor air quality poses more of a threat than inhaling a day's dose — which for many ailments is just a portion of a joint — of marijuana.

Further, those who are concerned about the toxic effects of smoking can now use a vaporizer, which frees the cannabinoid molecules from the plant material without burning it and producing smoke.

As for getting high, I am not convinced that the therapeutic benefits of cannabis can always be separated from its psychoactive effects. For example, many patients with multiple sclerosis who use marijuana speak of "feeling better" as well as of the relief from muscle spasms and other symptoms. If cannabis contributes to this mood elevation, should patients be deprived of it?

The statement that Sativex, "when taken properly," won't cause intoxication hinges on the phrase "when taken properly." "Properly" here merely means taking a dose — by holding a few drops of liquid under the tongue — that is under the level required for the psychoactive effect. As with Marinol, people who want to use Sativex to get high will certainly be able to do so.

One of the most important characteristics of cannabis is how fast it acts when it is inhaled, which allows patients to easily determine the right dose for symptom relief. Sativex's sublingual absorption is more efficient than orally administered Marinol (which requires 1 1/2 to two hours to take effect), but it's still not nearly as fast as smoking or inhaling the herb.

That means "self-titration," or self-dosage, is difficult if not impossible. Further, many patients cannot hold Sativex, which has an unpleasant taste, under the tongue long enough for it to be absorbed. As a consequence, varying amounts trickle down the esophagus. It then behaves like orally administered cannabis, with the consequent delay in the therapeutic effect.

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. Even now, good-quality illicit or homegrown marijuana, which is, at the very least, no less useful a medicine than Sativex, is less expensive than Sativex or Marinol.

The "pharmaceuticalization" of marijuana has promise. No doubt the industry could produce unique analogs of the naturally occurring cannabinoids that would be useful in ways smoked cannabis is not. But for now, medicines such as Sativex provide only one advantage over the herb: They're legal.

I have yet to see a patient who preferred Marinol to smoked marijuana. Similarly, the commercial success of Sativex will largely depend on how vigorously the marijuana laws are enforced. It is not unreasonable to believe that drug companies have an interest in sustaining the prohibition against the herb.

Geoffrey Guy, who founded GW Pharmaceuticals, claims his aim was to keep people who find marijuana useful out of court. There is, of course, a way to do this that would be much less expensive — both economically and in terms of human suffering.

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Postby palmspringsbum » Thu May 11, 2006 2:56 pm

Los Angeles CityBeat wrote:THE 4/20 ADVISORY

The FDA’s recent pronouncement that pot has no medical value has generated outrage from Congress to ‘The New York Times’

~ By MICK FARREN ~
Los Angeles CityBeat


When the U.S. Food and Drug Administration (FDA) issued its recent one-page “inter-agency advisory,” stating that “marijuana has no currently accepted or proven medical use in the United States,” the outcry was immediate. Doctors, patients, and medical marijuana advocates angrily charged the FDA with walking roughshod over current research data. The FDA’s only response was that of spokeswoman Susan Bro, who claimed the advisory was “a combined review by federal drug enforcement, regulatory and research agencies.”

Only comedian and longtime pot defender Bill Maher seemed cynically amused by the advisory, and noted it had been leaked to The New York Times on April 20 – the “4/20” of stoner code – and then wondered, during his monologue on Real Time with Bill Maher, if the FDA had picked the date because even the feds knew their pronouncements were nonsensical.

The FDA statement evoked major fury because it totally ignored the 1999 review by the Institute of Medicine, a part of the prestigious National Academy of Sciences, that found marijuana “moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting,” and also confirmed marijuana’s effectiveness in treating anorexia and nerve pain, while dismissing the canard that marijuana acted as a “gateway” to harder drugs.

The New York Times followed its initial 4/20 story with a scathing editorial. “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.” Protests also came from a bipartisan group of 24 House members led by Rep. Maurice Hinchey (D-N.Y.), who called on the agency to offer scientific proof for its position. In a letter to FDA Acting Commissioner Andrew von Eschenbach, the group demanded to be shown “evidence that you have new scientific proof or that you oversaw clinical trials.” Hinchey also accused the agency of playing politics with people’s lives. “We saw it with the agency’s decision on the emergency contraceptive, Plan B, and we’re seeing it again with medical marijuana: the FDA is making decisions based on politics instead of science.”

The FDA’s motives also came under fire from Caren Woodson, Director of Affairs at Americans for Safe Access (ASA), the leading medical marijuana coalition. “Even with polls showing an 80 percent approval for medical marijuana use, politics is trumping science, ignoring the evidence while sick people are suffering.” With medicinal marijuana now legal in 11 states, but the DEA continuing to arrest and harass users and distributors, the FDA has been under pressure to make a definitive statement. Woodson, however, says of the 4/20 statement, “The government is circulating misinformation that ignores scientific data.”

Misinformation has, of course, been a major weapon in the war on pot since Harry Anslinger demonized weed in the 1930s, with tales of homicidal hopheads, to provide employment for G-men made redundant by the repeal of alcohol prohibition. The FDA’s new statement not only continues that tradition, but caves to traditionalist drug warriors like Rep. Mark Souder (R-In.), who firmly believes efforts to legalize medicinal marijuana are an evil front for full recreational decriminalization.

The release of a document as contemptuously dismissive as this one, however, may backfire on the feds. On May 2, lawyers for thousands of patients suffering from cancer, AIDS, and multiple sclerosis demanded that the Department of Health and Human Services respond to an ASA petition filed 18 months ago claiming federal policies on medical marijuana are in violation of the Data Quality Act (DQA). The legal maneuvers are complex, but it’s essentially a squeeze play to force the reclassification and recognition of reefer as legitimately therapeutic.

Also, the FDA may have undermined their 4/20 position when they gave the OK for human testing by the British company, GW Pharmaceutical, of a drug called Sativex: a cannabis extract already approved for sale in Canada that could ultimately be packaged as an inhaler, not unlike the familiar pocket aerosols for asthma relief. By approving Sativex, the FDA has not only opened the door to definitively testing a form of marijuana, but also demonstrated that Washington bureaucrats may be more impressed by packaging than either science, common sense, or public opinion.


05-11-06

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Postby palmspringsbum » Wed May 17, 2006 3:31 pm

News-Medical.Net wrote:OK from the FDA for synthetic marijuana drug

News-Medical.Net
Pharmaceutical News
Published: Wednesday, 17-May-2006


Despite saying quite recently that it does not support the use of marijuana for medical purposes, the U.S. Food and Drug Administration (FDA) has given marketing approval for a drug which is a synthetic version of the active ingredient in marijuana.

The drug Cesamet is intended for use in treating the nausea and vomiting resulting from cancer chemotherapy and in particular for those patients who have failed to respond to conventional anti-emetic treatments.

The approval comes seventeen years after the drug was withdrawn from U.S. markets.

Cesamet is a synthetic cannabinoid that is thought to work by interacting with the cannabinoid receptor, CB1, which is present throughout the nervous system and regulates nausea and vomiting.

Cesamet is significantly different from conventional anti-emetics and has a long duration of action, which allows for less frequent dosing, typically twice daily.

It is a Schedule II drug, indicating a high potential for abuse.

The 1-milligram tablets are meant to be taken twice daily before cancer patients undergo chemotherapy and up to 48 hours following treatment.

The side effects can include euphoria, drowsiness, vertigo and dry mouth.

Valeant Pharmaceuticals International who manufacture Cesamet hope the drug will be on sale shortly.

Cesamet is already on sale in Canada under the name Nabilone.

The drug will be in competition with Marinol, made by Belgium company Solvay. Marinol is synthetic version of tetrahydrocannabinol, the active ingredient in marijuana which is more commonly known as THC.

The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006.

Approximately 70 to 80 percent of patients receiving chemotherapy experience stomach upset and a strong urge to vomit and though the use of anti-emetic agents decreases the incidence and severity of the symptoms, they continue to occur in 40 to 60 percent of patients.


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Postby palmspringsbum » Thu May 18, 2006 10:15 am

KESQ wrote:Valley reacts to Marijuana pill approval

May 17, 2006, 06:39 PM
By Stella Inger
NewsChannel 3

A pill containing the active ingredient found naturally in marijuana will be available in weeks to patients suffering from the effects of chemotherapy. We first told you about the pot-like pill Tuesday night on Live at 5. Tonight, we continue our coverage with reaction from those who say they need it the most.

Robert Langschied is a cancer survivor. He's one of millions who undergo cancer treatment each year. And now the federal government has approved the sale of a new pill. It's expected to ease the vomiting and nausea associated with chemotherapy.

“I think it's a great idea 'cause I just got over cancer. I wish i could take a pill like that.”

The new pot-pill is called Cesamet. The drug was first on the market 17 years ago, but taken off shelves. The pill will include the "manmade" version of the active ingredient in marijuana.

Langschied says it will help decrease the sale of marijuana.

“One out of every three people gets cancer and they're hurting. Really hurting. This pill, I think, would help them. I don't want to legalize marijuana cause I know people will take advantage of it.”

While some are excited about the pill, there are those who say the federal government should legalize marijuana.

“This drug is synthetic marijuana. It works. It controls the nausea from the chemotherapy, but so does marijuana. Why can't they just use natural marijuana?”

Lanny Swerdlow is part of the marijuana anti-prohibition project. He says he uses the drug for medical reasons. He's concerned the approval of the new pill is more about the bottom line and less about patient care.

“This is, once again, a case of the FDA in bed with the pharmaceutical companies to keep marijuana illegal so the pharmaceutical companies can make artificial marijuana and make billions of dollars out of ill and sick patients.”

Valeant Pharmaceuticals is expected to sell the prescription pill within a few weeks.

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Postby palmspringsbum » Tue Jun 13, 2006 9:43 am

The Valley Advocate News wrote:Pot Politics

by Salim Muwakkil - June 1, 2006
Valley Advocate

<blockquote>In opposing the medical use of marijuana, the Food and Drug Administration ignores mountains of credible research and joins the Bush administration's war on science. </blockquote><b>Between the Lines </b>

The war on drugs is an attack on rationality. Reason lost yet another skirmish when the Food and Drug Administration (FDA) announced on April 20 that "no sound scientific studies" supported the medical use of marijuana. The announcement flatly contradicts the conclusion of virtually every major study on the efficacy of medical marijuana, including two performed by the government. In a New York Times article, Dr. Jerry Avorn of Harvard Medical School said, "This is yet another example of the FDA making pronouncements that seem to be driven more by ideology than science."

Avorn's criticism is one regularly leveled at the Bush administration--that it is using politics to trump science. Last year the American Civil Liberties Union released a report titled "Science Under Siege" that detailed efforts by the Bush administration to hamper scientific inquiry in the name of ideology and national security. The report found the that administration has censored and prescreened scientific articles before publication, suppressed environmental and public health information, and increased restrictions on materials used in basic scientific research.

For two years the Union of Concerned Scientists has circulated a petition statement which now contains the signatures of 9,000 U.S. scientists, including 49 Nobel Prize winners and 63 National Medal of Science recipients. The statement complains that the Bush administration advocates "policies that are not scientifically sound," and sometimes has "misrepresented scientific knowledge and misled the public about the implication of its politics." This comes on the heels of a host of other accusations against the administration--charges of censoring a NASA scientist on issues of global warming and burying data on the morning-after Plan B contraceptive.

But the FDA announcement on marijuana is perhaps the most blatant effort to ignore scientific reality. Critics charge that it was issued to undercut medical marijuana initiatives that have passed in 11 states.

The Drug Enforcement Administration (DEA) and John P. Walters, the director of national drug control policy (the Drug Czar), oppose the use of medical marijuana. The

Times quoted Walters' spokesman Tom Riley, who said the FDA's statement would put to rest what he called "the bizarre public discussion" that has helped legalize medical marijuana. But Riley failed to note that some of that discussion was sparked by an exhaustive DEA investigation into cannabis (the scientific name for marijuana) from 1986 to 1988. That study examined evidence from doctors, patients and thousands of documents regarding marijuana's medical utility.

Following a hearing on the study's findings, the DEA's administrative judge Francis L. Young released a ruling in 1988 that noted, "Nearly all medicines have toxic, potentially lethal effects. But marijuana is not such a substance " Marijuana in its natural form, he said, "is one of the safest therapeutically active substances known to man. By any measure of rational analysis, marijuana can be safely used within a supervised routine of medical care. ... It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance."

The New England Journal of Medicine , the American Academy of Family Physicians, the American Public Health Association, AIDS Action Council and dozens of other medical groups have endorsed medical marijuana. Despite this and a growing wealth of new information about the therapeutic value of pot and its analogues (particularly new research on cannabanoid medicine by Dr. Raphael Mechoulam of Hebrew University in Jerusalem), the U.S. government refuses to alter its prohibitionist restrictions on marijuana use or research.

Isn't it a sign of mental disorder when distorted reasoning is unchanged by empirical evidence? What is it about marijuana that drives our politicians insane?

Salim Muwakkil is a senior editor of In These Times, and an op-ed columnist for the Chicago Tribune.

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Postby budman » Tue Jun 27, 2006 4:25 pm

Center for Science in the Public Interest wrote:FOR IMMEDIATE RELEASE
JUNE 27, 2006
9:08 AM

CONTACT:Center for Science in the Public Interest
202.332.9110


FDA Fails to Protect Americans from Dangerous Drugs and Unsafe Foods
Agency Captured by Industries It Should Be Regulating

WASHINGTON - June 27 - While the Food and Drug Administration (FDA) is in the self-congratulatory throes of its 100th anniversary, leading independent experts on nutrition, food safety, and drug safety say the agency is failing to protect Americans. While the beleaguered agency obediently rushes expensive new drug therapies on the market, it does virtually nothing to help reduce the toll of diet-related and drug-induced disease in America, according to Public Citizen’s Health Research Group and the Center for Science in the Public Interest (CSPI).

The FDA is scheduled to mark the 100th anniversary of the passage of the 1906 Pure Food and Drug Act at a June 30 ceremony at the Harvey Wiley Federal Building in College Park, MD. That building is named for the reform-minded U.S. Department of Agriculture chemist who became the first director of the Bureau of Chemistry, which later became the FDA.

“FDA was our country’s first consumer protection agency and Americans have relied on FDA to ensure the safety of their food and drugs for 100 years,” said Representative Henry A. Waxman. “Under the Bush Administration, FDA has undermined enforcement and betrayed its consumer-first legacy. FDA must start enforcing the law and return to a culture that places public health concerns ahead of industry profits.”

“The FDA’s centennial is not so much a time to celebrate, but to mourn the FDA’s gradual descent into irrelevancy,” said CSPI executive director Michael F. Jacobson. “The great Republican president Theodore Roosevelt would be sick to his stomach if he could see how Harvey Wiley’s hard-charging tiger of an agency became such a pliant pussycat.”

According to Public Citizen’s Health Research Group, some of the problems and failures at the FDA include:

• User fees. The FDA’s increasing reliance on so-called user fees from drug and medical device companies encourages the agency to treat those companies more like fee-paying customers. Instead of being fully funded by the government, FDA took in $380 million in user fees in the 2006 fiscal year. Former FDA official Janet Woodcock stated that the law authorizing such fees creates a “sweatshop mentality” at the agency’s Centers for Drug Evaluation and Research.

• No Learning from Drug Mistakes. In testimony before the Institute of Medicine, Public Citizen Health Research Group director Sidney M. Wolfe, MD, cited 13 instances of drug approvals which either should not have been approved (including Crestor, Rezulin, and others), or should have been restricted (Accutane and others) or withdrawn (Baycol, Seldane, and others) earlier than they were.

• Tobacco Failures. Five companies illegally market and promote laser treatment for smoking cessation. Public Citizen last week petitioned the FDA to crack down on those companies, since the FDA hasn’t approved the device and there’s no evidence the treatment works. Consumers who are convinced to pay up to $399 for laser treatment may be diverted from real programs that work, such as nicotine gum or patches—thus fewer smokers will be helped to quit. And, though it had essentially removed nicotine-containing beverages from the market in 2002, those drinks have reappeared. Just this month, NICLite, which the company breathlessly says is the “World’s only Nicotine Replacement Drink!,” and that it is “classified as a Dietary Supplement by the FDA,” began a marketing campaign. According to Wolfe, either the company is lying about the status of these products or the FDA inexplicably reversed itself and declared that they can legally be sold as dietary supplements. Either way, it represents a failure of the FDA to enforce the law of the land.

“The FDA’s 100th anniversary propaganda campaign hides and denies the many ways the agency is engaging in an unprecedented assault on the American public on behalf of its drug, device, food, and other industry ‘clients,’” said Wolfe.

CSPI says failures on the food side of the FDA include:

• Obesity. Over the past three decades, rates of obesity have doubled in young children and adults, and tripled in teenagers. In 2003, then-Commissioner Mark B. McClellan declared FDA’s intention to “confront the obesity epidemic ... to help consumers lead healthier lives through better nutrition.” Three years later, according to CSPI, the agency has done essentially nothing. Even with a food that’s a major contributor to obesity—soda—FDA has declined to place health notices on cans and bottles, require added sugars to be listed separately on labels, or to require multi-serving containers to list the number of calories for the whole container.

• Heart Disease. One of the most potent promoters of heart disease is the trans fat in partially hydrogenated oil. Though after a 10-year slog the FDA finally required trans fat to be listed on nutrition labels—spurring some manufacturers to abandon the oil—the FDA has done nothing to get restaurants to disclose or eliminate it. In 2004 CSPI petitioned the agency to ban partially hydrogenated oil and, until such a ban, to [url=http://cspinet.org/new/200407221.htmlrequire disclosure in restaurants[/url], but the FDA has not acted. The result: thousands of unnecessary premature deaths every year.

• High Blood Pressure. Perhaps the single most harmful substance in the food supply gets zero attention from the FDA—sodium chloride, or [url=http://www.cspinet.org/salt/]salt[/url]. CSPI and the American Medical Association want FDA to revoke the “Generally Regarded as Safe” status of salt and to treat it as a food additive, subject to reasonable upper limits in packaged foods. In 2004, the head of the National Heart, Lung, and Blood Institute estimated that cutting the sodium content of the food supply in half would save 150,000 lives per year.

• Fraudulent Labels. Of 11,000 employees, the FDA tasks a grand total of four people at headquarters to police food labels. Thus, supermarket shelves are graced with carrot cake virtually without carrots, fruitless “fruit snacks” made with high fructose corn syrup, “whole wheat” products with a lot of white flour, and so on. CSPI says the most significant FDA labeling initiative in recent years was an industry-written initiative to let manufacturers place misleading “qualified health claims” on food labels. FDA’s own research found that the program confused consumers, but the program, championed by food companies, continues.

• Food Safety. Faced with the emergence of dangerous chemicals (such as mercury or acrylamide) in food, the FDA takes years before acting—and even then, its response is typically tepid. Faced with outbreaks of bacterial pathogens in food, FDA is similarly nonresponsive: Salmonella in eggs could be all but eliminated with finalized on-farm regulations to control the hazard, but those have been delayed for years. Shellfish contaminated with deadly Vibrio vulnificus kill 20 or so people every summer, but FDA relies on an industry-funded partnership with state governments to ensure shellfish safety.

“A scrappy nonprofit like CSPI, with one litigator on staff, forced labeling changes from major companies like Tropicana, Frito-Lay, and Pinnacle Foods,” said Jacobson. “Yet when we hand the FDA neatly wrapped complaints on a silver platter, it just ignores them.”

• Industry Capture. The FDA often relies on advisory committees made up of outside experts to offer science-based advice, particularly on approvals of drugs and medical devices. But those panels often include—and are sometimes dominated by—scientists or researchers who have direct financial relationships with the companies whose products are under scrutiny. In recent years, FDA advisory committees evaluating antihypertensives, various diabetes drugs, and the pediatric use of anti-depressants, have all included industry-funded scientists. On one committee, 10 of 32 panelists investigating the controversial painkillers known as COX-2 inhibitors, including Vioxx, had ties to the makers of those drugs.

CSPI and Public Citizen acknowledge that the FDA has many hard-working, diligent civil servants who need more resources to do their jobs effectively. But both the Administration and Congress have hampered the agency: the Administration, by leaving the agency rudderless and without a permanent commissioner for roughly 70 percent of the Bush presidency; and Congress, by abdicating much of its oversight responsibility, and by slashing the headquarters staffing of the food side of the agency by 11 percent since 1978.

Much of the attention the Administration does pay to the agency comes in the form of unwelcome political interference, the groups say. The FDA’s failure to approve the over-the-counter use of the contraceptive Plan B is one case where the agency has been accused of letting politics, rather than science, rule the day. (Susan Wood, the assistant FDA commissioner for women’s health, resigned over the matter, citing political interference from then-Commissioner Lester Crawford). In April, an out-of-the-blue FDA declaration that marijuana has no medical benefit seemed politically motivated, since it contradicted the findings of a 1999 science panel that said it did.

“As we celebrate the 100th anniversary of this important agency, there are too many instances in which it appears to be moving back to the 19th century, when industry did whatever it wanted,” said Wolfe. “All too often, the FDA seems to forget that it is a regulatory agency with legally mandated responsibilities to protect the public.”

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The FDA's Marijuana Problem

Postby budman » Fri Aug 18, 2006 3:27 pm

The Technology Commerce Society wrote:
The FDA's Marijuana Problem

By Charles L. Hooper : BIO | 18 Aug 2006
The Technology Commerce Society Daily



The U.S. Food and Drug Administration has a marijuana problem. On April 20 of this year, the FDA rejected marijuana for medical uses. The FDA said, "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."

This conclusion contradicts a lot of other scientific research and expert conclusions, including that of the National Academy of Sciences and the FDA itself. In 1985, the FDA was so convinced of marijuana's medical benefits that it approved Marinol and Cesamet, both synthetic versions of delta-9-tetrahydrocannabinol (THC), the main active ingredient in marijuana.

Here's what the FDA has to say about Marinol. "MARINOL® (Dronabinol) Capsules is indicated for the treatment of: (1) anorexia associated with weight loss in patients with AIDS; and (2) nausea and vomiting associated with cancer chemotherapy in patents who have failed to respond adequately to conventional antiemetic treatments."

The FDA obviously thinks that Marinol and Cesamet are safe and efficacious drugs or else it wouldn't have approved them. If the synthetic versions are so good, why hasn't the FDA embraced the natural version? After all, in the Marinol statements above, the FDA is basically agreeing with marijuana advocates.

Two reasons that might come to mind are dosing and delivery mechanism. Although it may seem that an inability to pin down the ideal dose is a problem, the FDA is fully aware that the gold standard of analgesia in hospitals is patient-controlled analgesia (PCA), in which the patient pushes a button as often as desired to get I.V. doses of morphine. In other words, there is no one-size-fits-all dose with PCA. Empirical evidence shows that PCA produces better pain control with less morphine consumed. Marijuana can be used in much the same way as PCA.

The delivery mechanism of marijuana is usually smoke, which can irritate soft tissues and perhaps precipitate cancer. While certainly a problem, I estimate that marijuana smokers consume about one-percent as much per day as do tobacco smokers. Marijuana smokers take a few puffs ("hits") while tobacco smokers may smoke 20 or 40 entire cigarettes per day. Also, many AIDS and chemotherapy patients will be on short-term therapy or won't live long enough to worry about marijuana-induced lung cancer. Many of them would love to live long enough to have such a problem.

Look at the FDA's statements critically. The FDA isn't saying that marijuana doesn't have health benefits; it's saying that no good studies exist to prove that conclusion. In 2004, the FDA stated, "FDA will continue to be receptive to sound, scientifically based research into the medicinal uses of botanical marijuana and other cannabinoids." The key term is "sound research." The FDA recognizes only medicines that have gone through its long, expensive, and exhaustive investigational new drug (IND) application process -- its idea of "sound research."

The FDA is blind to anything that hasn't been through its process. What's worse, marijuana is highly unlikely ever to clear such hurdles. Why? The FDA requires controlled and consistent production batches and it wants to inspect each manufacturing facility. This would be very difficult for a dried weed that is grown in thousands of different places under thousands of different conditions. The FDA also requires placebo-controlled clinical trials with thousands or tens of thousands of patients. What placebo could possibly be used? I doubt that any other safe and medically inactive plant would smell and taste like smoked marijuana. Last, these clinical trials, I estimate, would cost tens if not hundreds of millions of dollars. Who would pay for them? Not the FDA. Not drug companies. Not self-medicating AIDS and cancer patients.

Drugs like marijuana almost certainly do have some health benefits for certain patients. But to put marijuana through the IND process would involve paying for clinical trials, manufacturing facilities, data analysis, legal fees, administrative staff, and FDA face-time, which are all private costs that someone must bear. Marinol's and Cesamet's manufacturers were willing to bear these costs due to the prospect of profits that accrue to the patent holder. For a widespread weed that's been around for millennia, how would anyone garner and enforce such patent protection?

Some say this is a weakness of the private enterprise system. The proponents of government spending on medical research use cases like this as an argument for the role of government. They shouldn't be too optimistic about their solution because that's what we have right now and it has failed miserably. Why? Certain parts of the federal government haven't allowed this scientific process to happen. Remember that, above all else, the government is a political organization and the U.S. government is fighting a war against the production, sale, and usage of marijuana.

The federal government maintains marijuana's status as a Schedule I controlled substance, keeping company with infamous drugs like heroin and PCP. A Schedule I drug is defined as having a very high potential for abuse, no accepted medical use in the United States, and a lack of accepted safety data for use under medical supervision. Interestingly, Marinol is rated as only Schedule III (less dangerous), just like, for example, Tylenol with Codeine.

Just recently, the FDA has landed in more hot water over its marijuana ruling. In 2000, Congress passed what is known as the Data Quality Act to help ensure that regulations are based on solid science. The two-paragraph Data Quality Act wasn't written by a member of Congress, but by James J. Tozzi, and included in a longer appropriations bill. Now Tozzi, who is founder of the Center for Regulatory Effectiveness, is suing the government because the FDA's marijuana ruling has ignored data showing that marijuana is helpful to some patients.

Should we pity the FDA? In some ways, yes, we should. The FDA behaves as a bureaucratic scientist. The FDA will always to be too slow and conservative and require too much data.

I am happy that there are such careful and plodding people in the world. I am not happy that they have the power to prohibit drugs like marijuana. In some cases, like this one, the FDA is the wrong tool for the job. Americans shouldn't rely on the FDA to control widely used and naturally occurring botanicals such as marijuana. The FDA is simply unable to effectively assess the medical value of natural plants like marijuana in any reasonable timeframe. AIDS and cancer are deadly serious diseases and the FDA's approach is fatally flawed. AIDS and cancer patients deserve a better path to useful medicines and than through the FDA's benediction.

<hr class=postrule>
Charles L. Hooper is president of Objective Insights, a company that consults for pharmaceutical and biotech companies. He is a visiting fellow with the Hoover Institution and coauthor of Making Great Decisions in Business and Life (Chicago Park Press, 2006).

If you are a producer or reporter who is interested in receiving more information about this article or the author, please email your request to interview@tcsdaily.com

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U.S. Health-care system not the best in the world

Postby palmspringsbum » Mon Oct 09, 2006 1:28 pm

The Houston Chronicle wrote:Oct. 8, 2006, 10:34PM

U.S. Health-care system not the best in the world
BY JOE GRAEDON and TERESA GRAEDON
King Features Syndicate
The Houston Chronicle

Americans like to think they are No. 1 in everything. Our politicians frequently tell us that we have the best health-care system and the safest drugs in the world.

Myths die hard. In truth, we are nowhere near the top when it comes to providing health care for all our citizens. And a new report on the Food and Drug Administration suggests that this watchdog agency is in disarray.

The Institute of Medicine is a prestigious panel of experts that advises the nation on critical health matters. An institute committee was asked to review the FDA. The results of this analysis are shocking.

The committee observed, "There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry." That might be due to highly publicized drug scandals such as the Vioxx withdrawal.

The fact that the FDA did not catch this drug disaster itself and was slow to respond has left lingering doubts about the agency's ability to protect the public health.

The IOM found that the drug safety system in America is threatened by organizational problems such as poor management, infighting, low morale and unclear and insufficient regulatory authority.

These are aggravated because the FDA lacks adequate funds to carry out its mission. In recent years, the agency has taken huge sums from the pharmaceutical industry in the form of "user fees." This money goes mostly toward facilitating the drug approval process. Drug companies want their products moved through regulatory hurdles quickly. Very little funding, however, is available to monitor safety once these drugs hit the marketplace.

Perhaps most worrisome, the IOM committee concluded that the FDA does not "consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion." As a consequence, the FDA has lost the trust of the American people.

Patients who have lost confidence in the nation's medicines may be more likely to stop taking potentially lifesaving medicines. A study in the Archives of Internal Medicine (Sept. 25, 2006) shows that one patient in eight quit crucial heart medicines within a month of hospital discharge after a heart attack. Such patients increase the likelihood that they will die within the year.

To restore faith in the FDA, the IOM committee made a number of valuable recommendations. Physicians and patients need better information about both risks and benefits of medications. To this end, the committee suggested a moratorium on TV ads during the first two years after a drug is approved for sale.

When a drug first appears on pharmacy shelves, information is often missing about side effects and dangerous interactions. These may only be uncovered after many more people have taken it. The IOM suggested that during this critical early period, the packaging for a new medicine should have a special symbol. This would alert patients and physicians alike to the fact that it is new and may cause unexpected effects.

Until these new guidelines are adopted, the drug watchdog agency may not be up to its task. To stay safe, people need to be well informed and alert for the effects, both good and bad, of any medicine they take.

<span class=postbold>THE PEOPLE'S PHARMACY</span>

<span class=postbold>Q:</span> I just wanted to give you a heads-up that Acomplia is available online from the U.K. without a prescription. The trouble is that you run the risk of having the drug seized by U.S. Customs.

I know because when I ordered my second pack of 28 pills, the package was seized, and all I received for my $158 investment was a letter from U.S. Customs. I was really disappointed because I had lost seven pounds in my first month on the drug, with only mild side effects.

If I could find a safe way to order Acomplia, I would do it in a heartbeat. I read that this medication might be hazardous during pregnancy. Perhaps that is why the Food and Drug Administration is dragging its feet on approving Acomplia.

<span class=postbold>A:</span> Acomplia (rimonabant) is a new weight-loss medicine that has recently been approved in Europe. It is available in the U.K. and several other countries.

Acomplia is completely different from all prior weight-loss products. It blocks brain receptors that are activated by marijuana. This "anti-munchy" effect may partially explain the drug's ability to control appetite. In addition to weight loss, Acomplia increases good HDL cholesterol and improves insulin efficiency.

Side effects include dizziness, nausea, diarrhea, headache, anxiety and depression. The effects during pregnancy are unknown, but several investigators are concerned about a potential for harm. It is still so new that some adverse effects might not be known.

While Acomplia is being prescribed in the U.K., it is unlikely that a reputable online pharmacy would sell it without a prescription. Taking it without medical supervision would be inadvisable.

<span class=postbold>Q:</span> We are just getting home after three weeks on the road with our RV. But yesterday I began to sniffle with a head cold and sore throat. It's been years since I've had a head cold. What should I take to shorten it?

<span class=postbold>A:</span> If you act quickly, a Chinese herb popular in Sweden might help cut a cold short. Andrographis paniculata has been tested in a few clinical trials and was shown to shorten a cold by several days.

Zinc is another candidate for treating a cold. The research on zinc has given mixed results, though, and sucking on zinc lozenges can cause nausea.

Vitamin C, garlic, ginger tea and chicken soup might also be useful in easing cold symptoms. Sadly, the herb echinacea has not proven very effective in recent clinical trials.

We are sending you our Guides to Herbal and Cold Remedies with dynamite recipes for chicken soup, hot toddies and ginger tea. Anyone who would like copies, please send $2 in check or money order with a long (No. 10), stamped (63 cents), self-addressed envelope to: Graedons' People's Pharmacy, No. EQ-25, P.O. Box 52027, Durham, NC 27717-2027.

<span class=postbold>Q:</span> I take Xanax to sleep at night. I now understand that you can't eat grapefruit when you use Xanax. I've done that in the past before I learned about the issue. How long do I need to wait after drinking a grapefruit-flavored Shasta soda or a mixed drink with Smirnoff that also has grapefruit?

<span class=postbold>A:</span> You don't need to worry about grapefruit interacting with Xanax (alprazolam), but we sure are concerned about the Smirnoff. Mixing an anti-anxiety agent like Xanax with alcohol could cause excessive sedation. If you needed to go to the bathroom in the middle of the night, you might become dizzy and fall.

<span class=postbold>THE PEOPLE'S HERBAL PHARMACY</span>

<span class=postbold>Q:</span> I read about someone who wanted to know how to get rid of plantar warts. My grandson had one on his foot for quite some time and was going to a doctor for treatment.

His grandpa had him put a piece of raw bacon fat on the wart overnight, and in a couple of nights the wart was gone. To try this, use a fresh piece of bacon each night, and fasten it on with a bandage.

<span class=postbold>A:</span> Plantar warts (warts on the soles of the feet) are notoriously hard to treat. Readers have suggested duct tape, castor oil and hot-water soaks. Bacon fat is a new one for our collection.

<span class=postbold>Q:</span> For all of his 65 years, my partner has gotten seasick whenever he was on a boat. This was true even for two years serving on a ship in the Navy.

We just took an Alaskan cruise on which I served as a guide. He felt just fine, even though some others did not.

Why? Because we read your column about ginger capsules, available in health-food stores. He took the capsules with meals three times a day. He got great benefit and had no side effects. I am telling everyone I know!

<span class=postbold>A:</span> Thanks for sharing his experience. Ginger has a long history against motion sickness.

<span class=postbold>Q:</span> What is fenugreek? I have been diagnosed as borderline diabetic. The doctor said that with proper diet and exercise, I can beat the diabetes. My neighbor said this over-the-counter product helps keep blood sugar in check. Do you have any additional information?

<span class=postbold>A:</span> Fenugreek is an herb used as a culinary flavoring in Indian cooking. Research in animals shows that it can help lower blood sugar.

There are many other natural approaches to controlling blood sugar, including cinnamon, bitter melon, oolong tea and vinegar. Several years ago a physician shared a patient's success with nopal cactus (prickly pear) tea.

We have discussed these and many other practical ways of coping with type 2 diabetes in our new book, "Best Choices From The People's Pharmacy" (Rodale Books). Diet and exercise are the cornerstones of blood-sugar control. Whatever you try, make sure your doctor is supervising your progress.

<span class=postbold>Q:</span> I'm a woman who takes a multivitamin, a B-50 complex, a calcium tablet and a couple of prescription pills daily. Within a half-hour of taking my vitamins, I pee a bright yellow color. Doesn't this mean the dosage is excessive? Should I cut the tablets in half?

<span class=postbold>A:</span> Your vitamin B-50 complex contains riboflavin (vitamin B-2). This fluorescent yellow compound is rapidly eliminated through the urine and is responsible for the bright yellow color you have noticed. It's not dangerous, and you don't need to cut the pills in half, though if it bothers you, you could purchase a lower dose of B vitamins.

<span class=postbold>Q:</span> My wife had been taking black cohosh for menopausal symptoms for several months when an annual checkup showed that some of her liver enzymes were elevated. After ruling out various forms of hepatitis, fatty liver disease or other liver pathology, her doctors concluded that the black cohosh was probably the source of her problem. She discontinued the black cohosh, and her liver enzyme panel is back to normal. I just thought you should know that not everyone does well on this product.

<span class=postbold>A:</span> The British equivalent of the Food and Drug Administration (the Medicines and Healthcare products Regulatory Agency) issued a warning last summer that black cohosh may cause liver disorders. Such reactions are believed rare but can be very serious.

www.PeoplesPharmacy.com JOE GRAEDON AND TERESA GRAEDON King Features Syndicate 300 W. 57th Street, 15th Floor New York, NY 10019


<hr class=postrule>
HoustonChronicle.com -- http://www.HoustonChronicle.com | Section: Life
This article is: http://www.chron.com/disp/story.mpl/life/4244827.html

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