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.

Tuesday, December 06, 2005

CANNABIS HELPS PEOPLE WITH ARTHRITIS AND OTHER MEDICAL PROBLEMS, BUT…

As I read the Advanced Nutrients hydroponic plant food website I see a very honest series of articles talking about the medical effects of cannabis.

When I say honest I mean that instead of a one-sided approach that either lies in favor of cannabis or lies to make a case against it, the articles contain a refreshing sense of candor and balance that shows me a lot of credibility and an intelligent approach to this very controversial and confusing topic.

Other than news from the United States about cannabis, which is usually all bad because the United States government and its social-medical establishment is very much against cannabis, there is interesting news about cannabis from around the world.

From Australia comes a study that says that four out of five people who were studied who were suffering from severe schizophrenia were pot smokers when they were young.

Some people would read this study and conclude that cannabis is a causal factor in development of schizophrenia. Other studies, conducted in the UK, Australia, Denmark, Sweden and Holland, also could indicate mild evidence of a causal link between cannabis and mental disorders.

A causal link means that the use of cannabis partially or wholly causes a disease or condition, not just that somebody who uses cannabis also happens to suffer from a disease or condition.

Perhaps the most famous “causal link” that has ever been asserted is the “gateway theory” which asserts that cannabis causes people to want to use other illegal drugs. The drug warriors would often say, “Almost everybody we’ve met who uses heroin tells us that the first illegal drug they ever used is cannabis. Therefore, there’s a link between cannabis and heroin use.”

Cannabis advocates have offered a humorous rebuttal to this assertion, stating that people who use heroin drank milk when they were young, but that doesn’t prove that milk causes heroin use!

It is the same situation with the alleged causal relationship between pot and mental illness. Somebody smokes pot when they are young and has schizophrenia later, so somebody proposes that the pot caused the schizophrenia. There is no real way to prove it. Statistics do lie, and it may well be that people smoke pot because they have mental problems anyway, rather than that the people were totally mentally healthy and then smoked pot and suddenly they went bonkers!

Nevertheless, if we are to be honest about cannabis, we must acknowledge research that indicates that when young people with mental illness risk factors use cannabis, it can destabilize them and lead to mental illness.

A Danish study in the British Journal of Psychiatry found that almost half of patients treated for a cannabis-related mental disorder go on to develop a schizophrenic illness. People who had used cannabis developed schizophrenia earlier than those with the illness who had not smoked marijuana.

Unlike drug warriors who will spin the study to back up the reefer madness/causal effect hypothesis, the Danish researchers emphasized that the study did not show that cannabis caused psychosis, because factors such as heredity, other drug use and socio-economic status had not been taken into account, and these factors are known to influence whether a person develops mental problems. However, an American study using sophisticated imaging techniques found abnormalities in the brains of adolescents with schizophrenia that are similar to those found in adolescents who use cannabis on a daily basis, but those who do not use cannabis daily had no such abnormalities.

"These findings suggest that, in addition to interfering with normal brain development, heavy marijuana use in adolescents may also lead to an earlier onset of schizophrenia in individuals who are genetically predisposed to the disorder," says Dr Sanjiv Kumra, assistant professor of psychiatry at the Albert Einstein College of Medicine, New York, who worked on the study.

According to Robin Murray, professor of psychiatry at the Institute of Psychiatry in London, one person in four has the genes that make them susceptible to developing cannabis-induced psychosis.

The cause and effect relationship in how cannabis benefits people is a bit easier to explore and predict than whether it causes mental illness. For example, when GW Pharmaceuticals in England gave organic cannabis extracts to hundreds of multiple sclerosis (MS) patients, and most of those patients reported beneficial effects; when those effects were also observed and proven by clinical observation and study, then it is possible to legitimately say that cannabis is causing specific effects. In this case, the effects are beneficial.

Last month, the UK Government announced that GW’s Sativex, an oral extract spray derived from cannabis that is licensed in Canada but not yet in the UK, could be prescribed on a "named patient" basis for pain relief in patients with MS.

GW announces that it has been informed by the Home Office that the Drugs Minister, Paul Goggins, has confirmed that Sativex® oromucosal spray, its cannabis-based medicine, may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.

In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfill the special needs of an individual patient under a physician’s direct personal responsibility. The basis on which Sativex may be imported, therefore, is the clinical judgment of doctors in relation to specific nominated patients.

This development follows the approval of Sativex by Health Canada in April 2005. The medicine has been available on prescription in Canada since late June, 2005.

More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued to GW a Wholesale Dealer’s (Importation from non-EU countries) License, and has not objected to the importation of Sativex under the regulations for importation of medicines unlicensed in the UK.

Sativex will remain a Schedule 1 controlled drug in the UK in line with stated government policy. This means that the prescribing of Sativex can only be permitted under Home Office license. The Home Office will therefore be developing a licensing regime to fit these circumstances. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.

Clearance for supply on an unlicensed basis does not affect GW’s plans to seek full regulatory approval from the MHRA for Sativex in the UK; the company has been trying to get full regulatoy approval for three years. GW is currently conducting many Phase III trials and is still planning to submit an application for Marketing Authorization to the MHRA during 2006. Only after such an approval is granted can the product be promoted in the UK. Many people are disappointed at the slowness of the MHRA, noting that Canada has already approved Sativex.

Sativex, which is the only medicine in the world derived directly from organically-grown cannabis plants, works by influencing the way pain messages are transmitted through the body.

"It's not that patients get high and stop caring about their pain," asserts Mark Rogerson, spokesman for GW Pharmaceuticals. "A person taking a normal dose will receive only a fraction of the tetrahydrocannabinol (THC) - the active ingredient in cannabis that causes a high - of a recreational user."

A recent study published in the journal Neurology showed that Sativex was significantly better than a placebo at reducing pain and sleep disturbances in MS patients.

Other new research shows that Sativex relieves pain and slows the progression of rheumatoid arthritis for patients who suffer from that disease.

Researchers from the Royal National Hospital for Rheumatic Diseases, in Bath, England, say significant pain-relieving effects were observed and disease activity was significantly suppressed following Sativex treatment.

They say that while the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation.

Of the 56 patients in the five-week randomized study, 31 were given Sativex daily by fixed delivery oromucosal spray and 27 received placebo.

Each spray of Sativex delivers Tetrahydrocannabinol (2.7mg) and cannabidiol (2.5mg). The balancing of THC and CBD are crucial to the success of Sativex, according to GW scientists, who say that one of their main goals is to achieve medical benefits without getting people stoned. If THC was used solo, or if a person smokes a joint of whole cannabis, they are likely to get dosed with “too much” THC, which causes cannabis “intoxication.”

GW’s goal is to create medicine that has medical effects but no psychological effects. It doesn’t want to be accused of “getting people high,” because the euphoric and mind-altering effects of cannabis are seen as negative side-effects by people who only want relief from diseases or disease symptoms. While many of us who enjoy cannabis for recreation and medical use might think that people who don’t want to get high are weird, we must be open-minded enough to realize that some people want to stay “sober.” They don’t want a drug affecting the way they think, feel and perceive. For them, GW’s cannabis extracts are an ideal way to get medical effects without getting high.

In the rheumatoid arthritis study, the patients were tested for how cannabis affected their movement ability, as well as their stiffness in the morning, and their ability to sleep. GW’s extracts produced statistically significant improvements in pain of movement, pain at rest, quality of sleep, and disease activity. Better yet, GW’s Sativex appears to be safer and more effective than the prescription drugs it competes with. This is the case with most situations wherein cannabis competes with pharmaceuticals.

The GW arthritis study found that most Sativex “side effects” were mild or moderate and the treatment group showed no serious adverse effects or withdrawals due to side effects. Three patients (11 percent) withdrew from the placebo group after experiencing adverse events such as mild dizziness, light-headedness, and dry mouth.

In light of the “evidence” that cannabis might influence the onset of mental illness, a GW spokesperson felt the need to offer his company’s view of whether Sativex could cause mental problems.

According to Mark Rogerson of GW Pharmaceuticals: "We have found no evidence that Sativex causes psychosis. Such side effects as there are - and no drug is without them - are generally mild, reversible and well tolerated. There may be a temporary intoxication-like reaction, and, for this reason, we have always excluded people with serious mental illness from our trials."

Rogerson also noted that there’s plenty of momentum for Sativex to be used worldwide. GW is set to supply Sativex to the Health department of the Catalonia Government in Spain. Sativex will be used to treat 600 patients suffering from multiple sclerosis and other conditions under a compassionate access program.

The contract will mark the first time that patients in Europe have had access to Sativex outside a clinical trial.

Dr Geoffrey Guy, executive chairman of GW, said: “This initiative represents a pragmatic and compassionate approach for seriously ill patients with little alternative therapy. At the same time, it will provide a useful additional source of revenue for GW as we continue to invest in developing Sativex to bring it to the UK and other international markets through regulatory approval processes.”

Guy has his money goals, and patients want relief. Some people want the freedom to grow their own medicine; others want to use cannabis derivatives without getting high. What all of us need to focus on is that cannabis contains many compounds that are miraculously helpful.

Cannabis is a gift from the God of Nature. Whole smoked cannabis, orally ingested cannabis extracts and foods, and topically applied cannabis ointments grown with quality plant foods have all helped hundreds of thousands of people.

Despite all the divisive rhetoric, the fact is that when cannabis is intelligently used, it’s fantastic medicine!