Friday, March 24, 2006

Fed’s medpot is schwag, says POT conference organizer

At high noon on April 7th, Patients Out of Time organizer Al Byrne will open a sealed can of U.S. government marijuana, to prove that what they have been sending to patients in their IND* program is mostly schwag—seeds, sticks, stems, etc.

This event, to which the public and the media are cordially invited, will take place on April 6-8 in Santa Barbara, California, at the Fourth National Conference on Cannabis Therapeutics, co-sponsored by the University of California, San Francisco, School of Medicine and the California Nurses Association—in conjunction with Patients Out of Time.

Byrne was accused by government agencies of “doctoring” photographs showing the poor quality of the federally supplied medicinal marijuana. This time the sealed can will be opened in front of witnesses.

The Food and Drug Administration (FDA) is responsible for supplying the drug to seven patients, including Barbara Douglass, Irv Rosenfeld, George McMahon and Elvy Musikka, who will be present at this event, and available for interviews.

So if you want to see egg on the faces of the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS), the two agencies that were questioning the authenticity of Byrne’s photographs, visit the campus of Santa Barbara City College on April 7th. Should be a barrel of laughs!

For further information, please visit the POT website at http://www.medicalcannabis.com/.


* The program under which seven patients are still receiving U.S. government marijuana was started under the Carter administration. It’s called the Compassionate Investigational New Drug (IND) program and is administered by the U.S. Food and Drug Administration (FDA).

Four of these patients are on the Board of Directors of the Virginia-based advocacy group, Patients Out of Time (POT). A fifth patient, Elvy Musikka, is the national spokesperson of POT. Their personal stories can be accessed through the POT website at www.medicalcannabis.com.

Ethan Russo, MD of Missoula, Montana, intensively examined four of the patients over a 3-day period in 2001, looking closely at every system in their bodies, to determine any effects of prolonged marijuana use.

The Missoula Chronic Use Study, as it is widely known, came to the conclusion that the subjects, after having used cannabis therapeutically for 11 to 27 years, depending on each case, were all in fine condition, considering their original illness and the effects of age.

Wednesday, March 15, 2006

THE FIGHT TO RESCHEDULE MARIJUANA

In 1970, the Nixon Administration passed the Controlled Substances Act that classified marijuana as a Schedule One drug.

President Nixon also ordered Mexican cannabis fields to be sprayed with toxic paraquat.

A commission in 1972 called for legalization of marijuana, but this was instantly rejected by the government. The organization.NORML launched a petition to have cannabis reclassified. That petition took 22 years to be reviewed and rejected. The second petition was launched by Jon Gettman and High Times magazine in 1995. This was dismissed on a technicality 7 years later.

The Coalition for Rescheduling Cannabis launched a third petition in 2002. The Department of Health and Human Services has to issue a ruling on the petition by 2007.

The Coalition includes the American Alliance for Medical Cannabis; California NORML; the National Organization for Reform of Marijuana Laws; Iowans for Medical Marijuana; Gettman and High Times; as well as Patients Out of Time.

Patients Out of Time (POT) are the Virginia-based organizers of the Fourth National Conference on Cannabis Therapeutics to be held in Santa Barbara, California on April 6-8, 2006. POT represents five IND patients who still receive medical pot from the U.S. government, under a program started during the Carter administration.

Cannabis is lumped with heroin, LSD, ecstasy, and qualuudes as a Schedule One drug, meaning that it "has a high potential for abuse, "has no currently accepted medical use," and exhibits a "lack of accepted safety.under medical supervision."

By comparison, morphine, cocaine, and methamphetamine are Schedule Two, meaning that they have a currently accepted medical use.

If cannabis is rescheduled to at least Schedule Two, its medical uses will be more easily accessible.The Drug Enforcement Administration (DEA) opposes rescheduling cannabis. DEA officials quote the 1999 report by the Institute of Medicine (IOM) that concluded that "smoked marijuana should generally not be recommended for medical use." The DEA conveniently omits mention of other parts of this IOM report. For instance, the report also says that "the accumulated data indicate a potential therapeutic value for cannabinoid drugs, particularly for symptoms such as pain relief, control of nausea and vomiting, and appetite stimulation." It specifically says that "cannabinoids would be moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS-wasting."

The IOM had more qualms about the negative effects of smoked marijuana rather than the effects of the drug itself. Even the DEA indirectly admitted that cannabinoids are therapeutic, when they classified Marinol, the synthetic THC drug, as Schedule Three.

Overwhelming evidence to the contrary, the DEA still insists that cannabis is not therapeutic, but POT has been instrumental in getting 13 Nurses Associations, including the prestigious American Nurses Association, to call for rescheduling of medical marijuana.

The oldest and largest health organization in the U.S., the American Public Health Association, followed suit, as did the legislatures of the 11 states that have legalized the use of medical cannabis within their borders.

POT representative Al Byrne says that the government has done a poor job of defending marijuana's Schedule One status, and that he and other rescheduling proponents believe that the case for rescheduling has already been made.

For further details, please visit the POT website, at http://www.medicalcannabis.com/.

Friday, March 10, 2006

TRUE GRIT AND COURAGE OF IND PATIENTS, “PATIENTS OUT OF TIME”

Barbara Douglass, George McMahon, Corrine Miller, and Irvin Rosenfeld have more than one thing in common. They not only receive legal pot from the U.S. government, but all four of them are on the Board of Directors of the Virginia-based medpot advocacy group, Patients Out of Time.

Their personal stories of courage in the face of suffering are truly inspirational. You can read all about them and Patients Out of Time on the organization’s website, at http://www.medicalcannabis.com/.

A Florida stockbroker, Irv Rosenfeld has smoked over 220 pounds of government-supplied marijuana during the last 23 years. He suffers from chronic pain. The program under which he is allowed medicinal marijuana is called the Compassionate Investigational New Drug (IND) program of the U.S. Food and Drug Administration (FDA).

In 1978, Robert Randall filed a lawsuit demanding that the U.S. government acknowledge the medical necessity of cannabis therapy for his glaucoma. The Carter administration subsequently launched the IND program, and Randall was one of the few individuals who were supplied with government-grown marijuana. He smoked it for 23 years, before he died of AIDS-related complications.

George McMahon suffers from a very rare neurological condition, Nail Patella Syndrome (NPS). He was operated on 19 times and has been prescribed countless medications. He was rushed to hospital six times because of the side effects of the harsh drugs he was given. He was so drugged, that he couldn’t function normally, and his stomach refused to accept food, without feeling nausea.

George obtained marijuana illegally for 20 years, before he was admitted to the IND program. Now he can smoke it legally in any one of the fifty states. The beneficial cannabinoids in cannabis help to control the symptoms of his disease, and have enabled him to eat normally once again.

Looking like a banker in his three-piece suit, the 50-year old McMahon describes himself as a “regular family man who has had to make wide adjustments because of the propensity for illness.” His wife, Margaret, credits therapeutic cannabis for his survival. “If he did not receive the marijuana, George would probably be dead by now from all the other narcotics he would be taking for his pain.”

The reason IND patients remain active in the fight to decriminalize medical marijuana, is because they recognize their privileged position. George McMahon’s website refers to Todd McCormick, who received compassionate pot according to the laws of California, but was imprisoned by the federal government, regardless of his status as a cancer survivor with four fused vertebrae.

McCormick worked for Peter McWilliams, who was a New York Times best-selling author. Judge George King ordered both men off their medical marijuana, allegedly causing the death of McWilliams. During the trial, these men were instructed not to talk about medical marijuana and the state guidelines they were following.

The quality of the federally supplied marijuana is so poor, that a number of IND patients have had to supplement their supply from “private sources.” This weed is grown at the University of Mississippi, and is packaged and distributed by the National Institute of Drug Abuse (NIDA).

In 2001, Ethan Russo, MD’s Missoula Chronic Cannabis Use Study subjected four IND patients to a rigorous testing of all their bodily systems, and came to the conclusion that prolonged marijuana use had no adverse effects.

The Missoula Study also examined the quality of the federally supplied marijuana, and found that “a close inspection of NIDA supplied cigarettes reveals them to be a crude mixture of leaf with an abundance of stem and seed components.”

The IND patients are also involved in the effort to have Washington reclassify marijuana as a Schedule II or Schedule III drug, instead of the Schedule I classification where it was placed under the Nixon administration in 1970.

The Controlled Substances Act, which was passed that year, put cannabis in the same category as heroin and LSD, claiming that it has no accepted medical uses and has a potential for abuse. By contrast, morphine, cocaine, and metamphetamine are Schedule II, and Marinol is Schedule III, acknowledging their potential medical benefits.

Being reclassified would allow marijuana to be legally prescribed according to federal law, in the eleven states that allow medpot. Among thirteen other such organizations, the Illinois Nurses Association passed a Resolution in 2004 to “support legislation to remove criminal penalties including arrest and imprisonment for bona fide patients and prescribers of therapeutic cannabis.”

The national spokesperson of Patients Out of Time is another IND patient, Elvy Musikka. She suffers from glaucoma, and has made some wrong choices about surgeries. As a result, she is now blind in one eye. She finds that medpot helps ease the pressure in her functioning eyeball. “For 25 years, it has been the most efficient, reliable, and the safest part of my treatment.”

Musikka is passionate about her cause. “Millions of Americans use cannabis daily, thus I suspect that we are the largest minority in the United States. We come from every segment of society and every financial background. We are for the most part, responsible adults who maintain occupations, families, and contribute to our communities. (Still we arrest 700,000 people yearly, for choosing a ‘Wiser Bud.’) We consider hemp/cannabis/marijuana prohibition a blasphemy on the Creator’s work.”

Patients Out of Time is organizing the Fourth National Conference on Cannabis Therapeutics in Santa Barbara, California on April 6-8, 2006. The previous conference held in 2004 in Virginia, was attended by 250 health professionals, caregivers, and patients and featured the world’s finest cannabis researchers.

This year, the topics scheduled to be discussed include the use of cannabis in pain management and palliative care; the current status of cannabis research in Israel, Canada, Spain, the Netherlands, and the United Kingdom; treating MS and AIDS with cannabis; cannabis and mental health; therapeutic cannabis use in pregnancy; and the experiences of patients with medical marijuana.

Accredited by the University of California, San Francisco, hosted by the Santa Barbara City College, and co-sponsored by the California Nurses Association, this high-powered conference will once again challenge the U.S. government claim that cannabis has no medicinal value.

Wednesday, March 08, 2006

FOURTH NATIONAL CONFERENCE ON CANNABIS THERAPEUTICS

The latest instalment of the only series of nationally-recognized clinical conferences on medical marijuana is taking place in April in Santa, Barbara, California.

The latest conference is organized by the non-profit advocacy group Patients Out of Time; the Fourth National Conference on Cannabis Therapeutics will be held in Santa Barbara, California on April 6-8, 2006.

Accredited by the University of California, San Francisco, hosted by the Santa Barbara City College, and co-sponsored by the California Nurses Association, this professional conference challenges the government’s claim that cannabis has no medicinal value at all.

Many prominent physicians and researchers will head panels and deliver papers. Donald Abrams, MD will greet the participants. He is Professor of Clinical Medicine and Head of the Hematology-Oncology Section, of UCSC, San Francisco General Hospital. He will also deliver a lecture on “Cannabis in Pain and Palliative Care.”

Natalya Kogan, PhD will talk on “The Current Status of Cannabinoid Research in Israel.” Mark Wallace, MD will address the “Efficacy of Smoked Cannabis on Human Experimental Pain.” Daniele Piomelli, PhD, a Professor of Pharmacology and Biological Chemistry at the University of California, Irvine, will enlighten participants with “Cannabis: Synthetic vs. Natural.”

The Santa Barbara conference will feature around 30 different sessions over a two-day period. Presenters will talk about treating Multiple Sclerosis, HIV and other conditions using cannabis. They will discuss medicinal cannabis in the UK, Canada, the Netherlands, and Spain, therapeutic cannabis use in pregnancy, cannabis and mental health; there will be patients talking about their experiences with medical marijuana.

Patients Out of Time (http://www.medicalcannabis.com/) was founded by the partnership of a highly regarded Registered Nurse and a retired Naval Officer. Mary Lynn Mathre, RN, MSN, CARN is President of the organization, whose primary purpose is to educate health professionals and the general public with regard to the medical uses of marijuana.

Co-founder and Secretary-Treasurer of Patients Out of Time is Al Byrne, the son of a cancer patient who had used cannabis in 1966 to relieve the negative side-effects of cancer chemotherapy. Byrne served for 24 years as a Naval Officer, and for 5 years as an outreach counsellor in Appalachia for Vietnam vet victims of Agent Orange.

His activism on behalf of medicinal marijuana led him to serve on the Board of Directors (from 1989 to 1994) of the National Organization for the Reform of Marijuana Laws (NORML). During some of that time he also became Managing Director and National Secretary of that organization. Mathre also served on the NORML board. Byrne and Mathre left NORML after they suspected financial irregularities that many investigators believed originated from the then-executive director of NORML, who later resigned under a cloud of suspicion and now lives in Canada.

Mathre worked as an addictions consultant for the University of Virginia Health System. As a practicing nurse, she made a presentation to the Virginia Nurses Association in 1994, which resulted in that organization passing a Resolution in support of medical cannabis. They were the first of 13 state nursing associations to do so, thanks to the work of Patients Out of Time.

Mathre and Byrne worked intensively from 1990 to 1995, when they incorporated Patients Out of Time as a Virginia non-profit charity. Since then, their medpot gospel has been heard and heeded by the oldest and largest health organization in the U.S., the American Public Health Association, the American Nurses Association, and the powerful Institute of Medicine.

An award-winning video, “Marijuana as Medicine,” was the first major project undertaken by Patients Out of Time. Patients were portrayed as ordinary folks who were ill and were helped by cannabis in coping with their illness. Although only 18-minutes-long, this video was viewed by thousands of people in 20 different countries.

Then Mathre edited a major work, entitled “Cannabis in Medical Practice: A Legal and Pharmacological Overview of the Therapeutic Use of Marijuana” in 1997. It featured contributions by 17 different experts from such diverse places as Jamaica, the Netherlands, Brazil, and the U.S., and it continues to be referenced.

The First National Conference on Cannabis Therapeutics was held in April, 2000 at the University of Iowa. It was transmitted by satellite to remote sites in the U.S. and Canada. It was the first accredited cannabis educational program to be held in the U.S. since 1860.

The second of these conferences was held in May, 2002 in Portland, Oregon, co-sponsored by the Oregon Department of Human and Health Services, the Oregon Nurses Association, Mothers Against Misuse and Abuse, and the Portland Community College Institute of Health Professionals. Because of the accreditation involved, these conferences had and have to meet the highest academic standards.

The third conference followed the success of the first two. It took place in Charlottesville, Virginia, in 2004, co-sponsored by the Medical, Law, and Nursing Schools of the University of Virginia, the Pain Management Center, and the Virginia Nurses Association. Another sponsor was Advanced Nutrients.

The upcoming Santa Barbara conference has attracted a lot of attention because of the political climate surrounding medical cannabis. As the federal government continues to attack medical cannabis providers and patients in states that have legalized medpot, a growing majority of Americans tell pollsters that they support the medicinal use of marijuana. Patients awaiting legal marijuana in states that don’t allow it are realizing that they are being deprived of valuable medicine.

The Board of Directors of Patients Out of Time includes four of the seven U.S. federal cannabis patients who are legally supplied with medicinal marijuana by the American government by the “Compassionate Investigational New Drug” (IND) program of the Food and Drug Administration (FDA), which was initiated by President Carter in the 1970’s and closed to new patients by a Republican administration. A fifth patient in this program, Elvy Musikka, suffers from glaucoma, and is the national spokesperson of the organization.

The personal histories of these five patients (2 of the 7 prefer to remain anonymous) will form the basis of our next blog submission. Nurse Mathre works with these individuals and Ethan Russo, MD of Missoula, Montana, intensively examined four of the patients over a 3-day period in 2001, looking closely at every system in their bodies, to determine any effects of prolonged marijuana use.

The Missoula Chronic Use Study, as it is widely known, came to the conclusion that the subjects, after having used cannabis therapeutically for 11 to 27 years, depending on each case, were all in fine condition, considering their original illness and the effects of age.

Byrne and Mathre, along with other medical cannabis experts, believe that federal officials never initiated a long-term study because they knew that such a study would scientifically validate the efficacy of cannabis.

Anyone interested in medical marijuana, health, justice, civil liberties, patient care, medicine, and related issues is encouraged to attend the Santa Barbara POT conference and to contribute funding and other assistance to POT, which is the most statured, ethical and effective medical cannabis lobbying organization in the world.

Tuesday, January 03, 2006

MEDICAL MARIJUANA IN AMERICA WINS AGAIN

The New Year began with a belated Christmas present for medical marijuana users in Rhode Island on January 3, when the Rhode Island House of Representatives voted to override a veto of a medical marijuana law passed in 2005 by both houses of the state legislature.

The override of Governor Don Carcieri’s veto means that Rhode Island is the eleventh state to legalize medical marijuana.

The other states that have legalized marijuana for medical use are Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont and Washington.

According to John Evans, a Rhode Island cancer patient who wants to grow medical marijuana to ease the discomfort of chemotherapy and cancer pain, the override of the governor’s veto proves that more and more politicians are showing “compassion and sanity” regarding use of the medical herb.

“Upon hearing this great news I am ordering some growing equipment and nutrients from this company where I chat with other patients who grow or use medical marijuana,” he said. “I made three phone calls, wrote letters and visited my legislator’s offices, so I feel like democracy worked pretty well here and now I am going to send thank you letters.”

The House overrode a veto by Gov. Don Carcieri, 59-13, allowing people with illnesses such as cancer and AIDS to grow up to 12 marijuana plants or buy 2.5 ounces of marijuana to relieve their symptoms. Those who do are required to register with the state and get an identification card. The Senate had previously voted to override the veto.

The bill was first passed by the Rhode Island House and Senate in June 2005, but Carcieri vetoed it, claiming that an earlier anti-marijuana ruling by the U.S. Supreme Court in the Raich case would make Rhode Island’s legalization of medical marijuana an unwise law.

Carcieri and other opponents of the law said that the medical marijuana law would encourage Rhode Islanders to break federal marijuana laws and could put them at risk of federal prosecution.

The Raich decision authorized federal agents to continue to prosecute bona fide medpot patients, even in states where medical marijuana is legal. Indeed, the DEA and other federal agents have continued to attack medical cannabis users, growers and providers in states where medical cannabis is legal, most notably in California.

Rhode Island is the first state to legalize medical marijuana since the Raich decision. The timing of the vote, just prior to the start of the state's 2006 legislative session, means that the new law will be able to take effect immediately.

“I'm sure everybody in this room knows at least one person who would have benefited from medical marijuana," Rep. Thomas Slater, who has cancer, told fellow lawmakers before the vote. Slater said he does not use marijuana now, but it could become part of his treatment in the future.

Carcieri’s response to the veto override was to claim that the law doesn’t provide ways for users to buy marijuana legally and leaves Rhode Islanders open to federal prosecution.

"Users will be forced to purchase marijuana in the illegal street market, putting them at risk and complicating the difficult jobs that our law enforcement personnel must do every day," the governor said.

Tom Riley, a spokesman for the White House Office of National Drug Control Policy (ONDCP) in Washington, said the vote showed "misguided and out-of-touch" views on the harms of marijuana.

"There's this notion from the '60s or the '70s that marijuana is a harmless drug," Riley said. "It's not."

Evans, who said he had been forced to procure medical marijuana at $500 an ounce from the black market, said that Riley and Carcieri “have no idea what they are talking about.”

“The fact is, the pharmaceutical drugs and the chemo and the cigarettes that gave me cancer are a lot worse for me than marijuana ever could be,” he said. “I don’t know what the marijuana from the 60’s and 70’s was like, and I don’t care. It’s irrelevant. What is relevant is that I can take a couple of puffs or eat some brownies, and I feel better than when they had me on morphine.”

Friday, December 16, 2005

MEDICAL MARIJUANA AND DEMOCRACY IN CALIFORNIA

I’m lucky to live in sunny California, the first state to legalize medical marijuana in the United States. That was in 1996. We all were naïve to think that when we passed the law by voting that it meant that we would immediately have the law put into effect. If that had happened then we could grow marijuana for ourselves and have it in our possession and nobody would be able to arrest us as long as. Or at least that was the way it was supposed to work. In reality, it depended on where you lived in California. If you lived in Frisco, medical marijuana was already legal, with Peron’s big medical marijuana club one of the biggest nightclubs in town, although they shut him down soon after he financed Prop. 215, the medical marijuana law. But if you lived in Southern Cal, then you could still get busted for a roach, even if you were dying of cancer. It was a big joke, how they enforced the law differently in different places. You had to hope that you were lucky enough to be sick in the right place, or else you could get arrested by the locals, and of course you could always get arrested by the feds, because they don’t believe that our law is valid.

There’s been a lot of court cases and arrests for medical marijuana, and it always shocks me and my friends. Recently the feds and locals swooped in on medical marijuana clubs in San Diego. You would think that San Diego and the federal government would have bigger things to worry about.

But this week, only a couple of weeks before Christmas, the DEA raided 13 San Diego-area marijuana dispensaries.

As always, the feds have easy answers for why they do what they do. John Fernandes, a DEA spokesperson, said that the medical clubs were “nothing more than a front for distributing marijuana.” Well, yes, that’s what medical pot clinics do, they distribute pot. Some of us believe that Prop. 215 requires the government to provide safe access to marijuana. Some counties and cities have created regulations that authorize medical marijuana clinics. They don’t want old people or sick people to have to buy pot from street dealers. The dispensaries do the buying and weighing and sorting, so sick people can just come in, buy and leave. Apparently, that offends the DEA and some local politicians.

Last month, San Diego County became the first county in California to defy a state-ordered medical marijuana identification card and registry program. The order was contained in 2004 legislation, SB 420, which ordered counties to provide pot ID cards to qualified patients as part of what the state believed was required by Prop. 215 language. The county supervisors, who apparently do not believe in democracy, told the state that they would not comply with the card and registry program, even though the county’s attorneys told them the county would get sued if they failed to comply. And on Tuesday, Dec. 6, 2005, the San Diego County Board of Supervisors defied the Senate bill at the same time they voted to seek to overturn Prop. 215 using a court challenge that could invalidate it statewide!

County Counsel John Sansone said his office expects to file a federal lawsuit against Prop. 215 in 2006. The lawsuit, Sansone said, will argue that the Controlled Substances Act, the law passed by Congress in 1970 that classified marijuana as a Schedule I drug in the same category as heroin, supercedes any state law that legalizes marijuana for medical use. The US Supreme Court has already ruled that federal prohibition trumps California law.

“The question is whether or not Prop. 215 is written in such a way that it conflicts with federal law,” Sansone said. “Our argument is going to be that we believe they conflict to the point of crossing the line.”

Sansone said he advised the supervisors on the pros and cons of filing such a lawsuit but wouldn’t comment further, citing attorney-client privilege. He said that from the beginning, when the supervisors were only going to challenge SB 420, he’d told them it would be an “uphill battle.”

“But we’ve had difficult uphill battles before and won them, and some we’ve lost,” Sansone said, adding that his own staff would handle the case. “Taxpayers aren’t going to pay any more or any less for the attorney staff time.”

Maybe not, but taxpayer money will be used to help the feds squash a state law that the taxpayers voted for, and will divert resources away from other cases that Sansone’s office could be prosecuting.

California Attorney General Bill Lockyer has supported Prop. 215 in the past, arguing that “States are in, by far, the best position to determine whether and under what circumstances the use of cannabis by seriously ill patients should be permitted.”

Dale Gieringer, who heads California NORML (National Organization to Reform Marijuana Laws), said that a previous attorney general who opposed 215, Dan Lungren, consulted with federal officials and ultimately decided not to challenge the law. “Lungren declared that 215 was constitutional, since states have a right to decide which laws to enforce,” Gieringer said. He added that a subsequent challenge targeting doctors who recommended marijuana to patients (Conant v. Walters) was struck down in federal court in 2002. In 2003, Angel Raich and Diane Monson sued the federal government to block DEA agents from seizing marijuana from qualified patients. In June, the U.S. Supreme Court upheld the federal government’s right to do so, but Raich attorney Randy Barnett said that the ruling in no way affected California’s medical-marijuana laws.

California legal expert Glenn Smith told the media that the feds cannot challenge 215- it has to be done from within the state. Looks like the feds can thank San Diego politicians for doing the fed's work for them.

“The federal government can’t bring a lawsuit to stop an unconstitutional state law. It has to be somebody who is affected by that law and injured by it,” he said.

Smith said the challenge to 215 can’t be about whether 215 is legal according to federal law. The county supervisors will have to prove someone is negatively affected by the law. The supervisors might argue that SB 420’s requirement of participation in a registry and card program could negatively affect the county because “they’re being required to spend money by this state law in a way that is a waste to taxpayers’ money.”

Of course, one might instead argue that challenging a voter-approved law is a waste of tax money. One might argue that helping sick people avoid the use of harmful pharmaceutical drugs by using safe medical cannabis is a way of SAVING tax money. But don't try those arguments on Republican County Supervisor Bill Horn, easily the most vocal critic of medical marijuana, who says that any county support for Prop. 215 or SB 420 would send the wrong message, especially to kids. He compares his opposition to medical-marijuana laws as being similar to Rosa Parks’ stand against segregation laws, which makes no sense at all. Rosa Parks stood up against racism. Prop. 215 stands up against federal prohibition and for state's rights. There is no realistic analogy between Rosa Parks and anti-marijuana politicians like Republican Horn. In June, a county grand jury criticized supervisors for failing to implement SB 420, saying the board had been “blinded by its prejudices against medical marijuana.”

The December raids against medpot clinics was carried out by federal agents and San Diego police. Assistant Police Chief Cheryl Meyers said that the raids were not the federal government’s idea.

“We were convinced that the evidence was there” that the 13 locations raided were acting outside the boundaries of Prop. 215 and the city’s medical-marijuana guidelines, Meyers alleged. She said state and city laws do not allow for “caregivers,” which is what the dispensaries are supposed to be, to make a profit.

“They’re jacking up the prices so steep that they’re making a profit off of illness, and they were very loose in who they sold the marijuana to.” She added that in most cases, the dispensaries had more pot on hand than city law allows. The guidelines allow caregivers to have two pounds of pot and 48 plants. Most dispensaries had more that that, she said. One had psychedelic mushrooms; several had hashish. My reaction is, so what, who cares? Big deal. This is what warrants a federal raid??

Meyers said that the dispensaries were magnets for guns, greed and violent crime. Even local pot activists said that too many fast-buck dealers had moved in to the San Diego medpot club scene to sell pot for high prices.

During the raids, police officers allegedly found a man in a Loma Portal dispensary parking lot who had two pounds of pot, $2,600 in cash and a firearm on him, and another guy coming into a Kearny Mesa dispensary with two pounds of pot who said he’d picked the stuff up in Palm Springs and had heard he could unload it at the dispensary for $3,000 and an $800 profit. Police say that pot clubs draw people who want to rob them. Whoa. Big deal. Bars and 7-11’s are magnets for robbers and gun crime a lot more than pot clubs are. Instead of busting the medical dispensaries, the police should guard them!! If you want to shut down businesses that are magnets for crime, shut down the bars, the whorehouses, the crack houses and the convenience stores. And banks too, there are often robberies at banks, so they ought to be shut down so that the public isn't endangered by robbers.

Authorities began investigating San Diego's dispensaries six months ago, prompted by complaints from neighbors. Instead of providing marijuana to seriously ill patients as voters had intended, dispensaries allegedly sold marijuana to healthy young adults, police alleged, and there have also been armed robberies of clinics.

"The message here is to essentially notify the community through our actions that these dispensaries posed a severe public hazard," said the DEA’s Fernandes.

But how severe a public hazard do they pose? I used to go swimming off San Diego, until the ocean filled up with defecation from LA and Tijuana. I got tired of swimming with Mr. Turdman and Mr. Floaty, but nobody enforces the pollution laws. And there’s a bunch of gangs operating in the San Diego metro area and they will steal your car and cd’s and break into your house. There’s a bunch of illegal people coming across the border every night and sometimes they break into your house because they are hungry. I guess those situations are potential public hazards but the DEA and police are more interested in protecting us from pot-smoking paraplegics and the people who provide herb to them.

And isn’t it a severe public hazard to those who need medical marijuana, people dying of cancer, HIV and other diseases, who now have to go without their marijuana or try to score it on the street, because the DEA and the San Diego cops have shut down the pot clubs? Seems like that’s a pretty big hazard. Medical marijuana helps people, you can see that from the http://www.advancednutrientsmedical.ca/ website, where there are articles about medical marijuana. It's some website that sells Advanced Nutrients hydroponic plant food for people with hydroponics gardens, which is used by medical growers so they can get really kickass medicine out of their gardens.

It's a bit puzzling that the city council of San Diego has nothing better to do with their time except try to overturn the will of the voters of California, by challenging Prop. 215, what’s up with that? Seems to me like those politicians need to find a better job, maybe caring for sick and dying people, so they learn compassion. Why do some people in America seem so intent on harming others? Why do people with power use it to harm innocent and harmless people?

Friday, December 09, 2005

VIOXX, THE GOVERNMENT, AND "BAD" DRUGS

By Ralph Erinbo

Courtesy of the Advance Nutrients hydroponic plant food website, www.advancednutrientsmedical.ca.

I read about Vioxx the drug and its maker, Merck, and how the drug hurt people and how the government that is so dedicated to protecting us from drugs, didn’t protect us.

I read about it on the http://www.advancednutrientsmedical.ca/ website before, about how the government agency called the Food and Drug Administration that is supposed to screen drugs before they are sold to the public, well the FDA is not screening them and is in bed with the companies that make the drugs. Now I see new reports about Vioxx and how the government helped Merck cover up the harms.

It makes me pissed off. I am into marijuana, and they won’t let us grow that, but they will let Merck sell us a pill that causes heart attacks, apparently, and they also have business connections with the very same people they are supposed to regulate.

Vioxx is a pain killer and anti-inflammatory; so is marijuana, which works a lot better and doesn’t cause heart attacks. So guess which one is legal? The fatal one, of course. Makes perfect sense to me.

Now I just read that the New England Journal of Medicine has said that Merck concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller; the alleged concealment tainted a report on the Vioxx study that was published in the New England Journal of Medicine in 2000.

The Journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor alleges that the study’s authors deleted other relevant data before submitting their article to the Journal for publication.

“Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article,” the Journal's editorial leadership wrote.

Adverse cardiovascular events attributed to Vioxx include heart attacks, strokes and deaths, the Journal said.

Findings of the year 2000 study were key parts of testimony in the three product liability trials to date over the withdrawn drug, including one being deliberated by a federal jury in Texas.

The exclusion of the three heart attacks “made certain calculations and conclusions in the article incorrect,” the doctors wrote in the Journal, adding that they have asked the report’s authors to submit a corrected article.

The Journal, in its statement labeled "Expression of Concern," said it had made the discovery of the alleged deletions as part of preparations for the recent deposition of the executive editor of the Journal in connection with Vioxx-related litigation.

The Journal said Merck had submitted its manuscript both on paper and on a computer diskette, but that the Journal’s pre-publication review and editing of the story were done only on the printed version of the manuscript.

The Journal said it did not review the diskette until October 5, 2004, several days after Vioxx was pulled from the market after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use.

"In reviewing the diskette, we learned that data on cardiovascular events had been deleted from the manuscript before it was submitted," the Journal said.

This is outrageous. It looks to me like Merck deliberate hid negative data, just to protect profits. But who would ever suspect a drug company of doing something like that?

One of the study’s authors was Dr. Alise Reicin, Merck’s vice president for clinical research. Reicin testified in court that Merck never misled doctors and the public about studies linking heart attacks to Vioxx, but what do you expect him to say when his company faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated at up to $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.

A former Merck scientist testified today that he initially concluded an internal study of Vioxx linked the drug to an increase in heart attacks and strokes less than a year after it was approved for sale.

In a videotaped deposition shown to a Houston jury, Dr. Edward M. Scolnick, the former president of Merck Research Labs until 2002, acknowledged writing a company e-mail in which he noted that the cardiovascular links to Vioxx were "clearly there." What a surprise that he testified that he changed his mind about Vioxx only a few days later, suddenly to believe that Vioxx doesn’t cause health problems. Still, the cardiovascular issue continued to bother him even after Merck's marketing department put out a press release claiming that Vioxx was totally safe, Scolnick said.

"I will tell you that my worry quotient is high," he wrote in an e-mail to the Vioxx project team. "I am actually in minor agony."

Vioxx, a profitable painkiller, was approved in 1999 after the FDA deemed it safe and effective. In September 2004, after repeated rumors of Vioxx-caused health problems, Merck pulled it from the market after a study showed it doubled the risk of heart attack and strokes in patients who took it for 18 months or longer.

Merck is facing 7,000 lawsuits by former Vioxx users or their families. In August, 2005, a Brazoria County jury awarded the widow of a former marathon runner who died of a heart attack after taking the drug $253 million.

In a federal trial in Houston taking place in December, 2005 as this blog is being written, the jury has to decide if Vioxx contributed to the blood clot and death of 53-year-old Richard "Dicky" Irvin, a Florida seafood salesman and former college football player.

Also today, Scolnick acknowledged in his deposition that he called federal regulators "bastards" in an internal e-mail because they were considering adding a warning label to Vioxx following the VIGOR study's release.

Scolnick said he strongly disagreed with the FDA’s insistence that the label should be added to Vioxx.

"Be assured, we will not accept this label," Scolnick said in an e-mail to other Merck officials in October 2001.

Of regulators asking for additional safety information, he said, "They are bastards." Later he called them "devious."

Scolnick also testified that at the time Merck was developing Vioxx, patents were running out on two of the company's largest revenue-producing medicines. Asked if that put pressure on Merck to come up with a big drug to fill the void, Scolnick said, "Vioxx was going to fill the void."

Also, Monday, Irvin's widow Evelyn Irvin Plunkett testified that her husband of 30 years was a healthy, hard-working man who rarely got sick and took Vioxx for a back strain he got from lifting a box of shrimp.

She said she was stunned when she received a call from her husband's boss on the morning of May 15, 2001 telling her that Irvin had suffered a heart attack and had been rushed to the hospital.

Shortly after arriving there, she said, a doctor talked to her and two of her four children in the waiting room.

"She said 'We worked on your husband for over an hour and we couldn't save him,'" said Plunkett, who has since remarried.

"It was like my whole life went up in the air," she said.

The Vioxx problems involving the goverment's unwillingness to regulate pharma drugs are the tip of the iceberg. The FDA’s own drug safety offices said to Congress that, “The FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless."

Several scientists testifying before the Senate in November, 2005 provided substantial evidence that the drug company Merck and the US Food and Drug Administration (FDA) knew of safety problems years before the drug Vioxx was withdrawn from the market.

Vioxx, which was used to treat arthritis and severe pain, was withdrawn by Merck on September 30, 2005 after evidence emerged that it greatly increased the risk of heart attacks and strokes. Some 80 million prescriptions of the drug have been filled around the world, most of them in the US, since it was approved in May 1999.

Damning testimony was given by Dr. David Graham, the associate director for science and medicine at the FDA’s own Office of Drug Safety. The ODS, responsible for monitoring the safety of drugs already on the market, is part of the Center for Drug Evaluation and Research (CDER), which also includes the Office of New Drugs (OND), responsible for approving new drugs for the market. Graham said he came into repeated conflict with the OND as he sought to raise concerns about the safety of Vioxx.

The OND is one of the branches of the FDA that is most closely tied to the giant drug companies it is responsible for regulating. Since 1992, the office gets much of its funding directly from drug companies, in the form of new drug application fees of more than $500,000 per application. Most of this money goes toward speeding up the approval of new drugs. It is a recipe for disaster, as the Vioxx case has proven.

Graham said that the OND has a higher position in the FDA hierarchy than the ODS, and is reluctant to issue stricter regulations for drugs already on the market or order mandatory withdrawals of unsafe drugs that the office has approved. In the case of Vioxx, the drug was pulled from the market only after its producer, Merck, decided that the evidence of harmful consequences was overwhelming. It was not withdrawn as a result of any regulatory action by the FDA!

A study led by Graham that was concluded in the summer of 2004 found that Vioxx was responsible for an estimated 38,000 excess heart attacks and sudden cardiac deaths. In his testimony, Graham said this was a conservative estimate. He said that “a more realistic and likely range of estimates for the number of excess cases in the US” was between 88,000 and 139,000. “Of these,” he added, “30-40 percent probably died. For the survivors, their lives were changed forever.”

To dramatize the number of people affected, Graham noted that “this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past five years.”

Graham testified that as his team concluded its study and prepared to present its results, it was attacked by the Office of New Drugs and other sections of the FDA. “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present” the paper reporting his study’s conclusions. “An email from the director for the entire Office of New Drugs was revealing. He suggested that since FDA was ‘not contemplating’ a warning against the use of high-dose Vioxx, my conclusions should be changed.”

Up to a week before the drug was pulled from the market by Merck, FDA management, according to Graham, was attempting to undermine Graham’s conclusions.

Graham said, “[W]e are virtually defenseless” against another catastrophe on the scale of Vioxx. “The organization structure within CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is ‘safe and effective.’ When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and attack. At the same time, the Office of Drug Safety has no regulatory power and must first convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done.”

The prevailing sentiment at the FDA, said Graham, is one that views “the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the dugs it approves, and seriously under-values, disregards and disrespects drug safety.” When it comes to drug safety, he said, the operating principle is that the drug is safe unless it is proven to be unsafe beyond a shadow of a doubt. New drugs, including Vioxx, are pushed through the approval phase in a matter of months, before sufficient tests are done to ensure their safety. Independent clinical testing is rarely carried out by the FDA, and indications of safety problems are ignored or deliberately undermined.

Later, Graham pointed to five drugs currently on the market that he felt were potentially dangerous: Acutane, which is used to treat acne; Bextra, a painkiller; Crestor, used to lower cholesterol; Meridia, used to treat weight loss; and Serevent, used to treat asthma. All of these can cause dangerous side effects and have not been adequately tested for their safety, Graham asserted.

Others providing testimony included Gurkirpal Singh, from the Stanford University School of Medicine, and Bruce Psaty, co-director of the Cardiovascular Health Research Unit at the University of Washington. The two scientists reviewed some of the history of the testing of Vioxx and concluded that, even with the limited data available, the drug should have been pulled from the market long before it was withdrawn.

Singh noted that there was evidence of serious heart problems associated with Vioxx before it was approved in 1999. “In 1998, Dr. Doug Watson, a Merck scientist, presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs. This analysis concluded that men taking Vioxx had a 28 percent greater risk (not statistically significant), but in women, the risk was more than double (216 percent, statistically significant) compared to people not taking any drug in other Merck studies. To the best of my knowledge, these data were never made public.”

Merck has continually asserted that at the time of Vioxx’s approval, no evidence existed indicating that the drug caused additional heart attacks. The main study carried out by Merck, known as VIGOR, showed a fivefold increase in serious heart conditions relative to another drug, naproxen (the generic form of Aleve). Merck explained these results as a consequence of naproxen’s beneficial effects, rather than Vioxx’s harmful ones. However, in 1999 a scientist at the FDA remarked that “thromboembolic events [such as heart attack and stroke] are more frequent in patients receiving Vioxx than placebo.” Singh noted, “This meant that not only did Vioxx not [have the benefits of naproxen], but for some reason, it was likely to promote heart attacks directly.”

The evidence was still limited, Singh said. “There were not adequate data to make a firm conclusion one way or another. In fact, the FDA reviewer went on to point out that ‘[w]ith the available data, it is impossible to answer with complete certainty whether the risk of cardiovascular and thromboembolic events is increased in patients on rofecoxib [Vioxx]. A large database will be needed to answer this and other safety comparison questions.’ ”

Instead of carrying out a larger study, the FDA quickly approved the drug for use. This was in spite of the fact that the drug's availability did not meet an urgent medical necessity- there were already drugs on the market that performed the same function as Vioxx, which is suppoed to relieve inflammation without causing stomach problems. It is interesting to note that medical marijuana relieves inflammation and stomach problems, and is not fatal.

The FDA did not even require a caution on the drug’s label about the increased risk of hear attacks until April 2002.

Nor did Merck attempt a larger study. The New York Times reported on November 14 that such a study was contemplated in May 2000, but management rejected the idea. According to the Times, a slide prepared for an executives’ meeting stated, “At present, there is no compelling marketing need for such a study.... The implied message is not favorable.”

In their defense, Sandra Kweder, the deputy director of the Office of New Drugs, and Raymond Gilmartin, chairman and CEO of Merck, simply repeated the claim that everything was done to determine the safety of Vioxx as quickly as possible, and that the drug was immediately withdrawn as soon as safety problems became evident.

What is even more astounding than the lies told by Merck is that marijuana does all the same things that Vioxx does and does not cause heart attacks. That’s why the war on drugs is stupid.

When a scientist tries to fight the pharmaceutical industry, he or she often gets stomped. According to the Chicago Tribune, FDA officials tried to silence an independent scientist whose unique research project for detecting rare adverse drug reactions has uncovered potentially fatal side effects of 17 currently marketed drugs.

Dr. Charles Bennett, a Northwestern University researcher, developed a proactive method for detecting adverse drug effects by examining adverse drug reports submitted to FDA’s database and reports from reports by pharmaceutical companies and independent groups of researchers throughout the US and Canada. The project is called the Research on Adverse Drug Events and Reports (RADAR).

For example, Dr. Bennett discovered that the widely used anti-clotting drug, Plavix, can cause “a catastrophic collapse of the blood system.” He urged the FDA to issue Black Box warnings, but the FDA refused, but did add a less prominent warning.

Dr. Bennett published a paper in the journal Stroke (February) in which he compared the effectiveness of various systems for detecting adverse drug effects. The FDA system ranked at the very bottom:

“The study assessed how the FDA, Plavix's manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent.”

The Tribune reports that The FDA retaliated against Dr. Bennett for publishing the results by cutting off his access to FDA’s post marketing surveillance database—as if the agency were a private contractor. FDA's Christine M. Bechtel wrote:


"While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your group’s special status."

This kind of bureaucratic cover-up, and the constant attempts by the drug industry and government lackeys to fool us, are crimes.

While the government spends billions of dollars a year to protect us from a plant drug that we want to use, it protects companies that market deadly prescription drugs.

What has happened to the concept of morality? It sure seems to be a concept forgotten by the FDA and the drug companies.