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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 

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From The Vancouver Sun:


Many family doctors are not being warned about the dangerous side effects of new drugs before they start prescribing them to patients, according to new research from the University of B.C.

More than half (59 per cent) of pharmaceutical sales representatives failed to tell the doctors about common or serious side effects. The numbers were highest in Vancouver, where 66 per cent failed to disclose harmful side effects.

The international UBC-led study, published today in the Journal of Internal Medicine, involved Canadian, U.S. and French physicians in Vancouver, Montreal, Sacramento and Toulouse. More than 250 doctors who were asked to fill out a questionnaire following each sales visit provided information on nearly 1,700 drug promotions between May 2009 and June 2010.

The threat of serious harm or death was disclosed in only five per cent of pitches for drugs that carried such a warning in Vancouver and Montreal, slightly less often than in Toulouse and Sacramento.

Significant contraindications — warnings about potential drug interactions and patient exclusions based on age or other factors — were disclosed only 14 per cent of the time in Vancouver and Montreal, compared with 17 per cent of the time in Sacramento and 40 per cent of the time in Toulouse.

"Our results suggest a serious lack of information on harmful effects of promoted medicines," the researchers wrote. "Such omissions may threaten patient health."

Dr. Tom Perry, an internal medicine and clinical pharmacology specialist at the UBC Hospital in Vancouver, who was not part of the study, expressed concern about the findings.

"Doctors learn relatively little about drugs in medical school, and much of their exposure to pharmacology after graduation may be in the form of advertising. If they are unaware of the potential harms from drugs they prescribe, patients inevitably suffer the consequences."

Perry also called for much stricter control of drug advertising in Canada.

Drug marketing in Canada is regulated by the industry, based on Health Canada guidelines, said lead author and UBC researcher Barbara Mintzes. "But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion."

Marketing in France and the United States is scrutinized by government agencies and their physicians were more likely to hear of common side effects, she said.

"In Canada, we delegate (oversight) to the code of ethics committee of the pharmaceutical industry association Rx&D and they are very vague about what kinds of information should be provided," Mintzes told The Sun.

Physicians should always consult outside sources for information about any new drug before prescribing it, according to physician Shelley Ross, president of the B.C. Medical Association.

"You need to know the benefits, whether it's the best drug for your patient, is it going to interact with other meds," said Ross. "You need to know the downside and any side effects that you should warn the patient about. You have to know these things before you talk to a patient about a medicine."

Ross was surprised side effects were discussed by so few sales representatives.

"I've seen hundreds of reps in my time and you often have a relationship for years and years," said Ross. "They know not to try something like that, because if you can't trust them they never get another visit."

"There is a very old maxim that says physicians should strive to be neither the first nor the last to implement a new therapy," said physician Galt Wilson, deputy registrar of the College of Physicians and Surgeons of B.C. "Due diligence includes carefully considering the product monograph and consulting unbiased references."

Serious risks were mentioned in only six per cent of the promotions, the study says, even though 57 per cent of the medications involved came with U.S. Food and Drug Administration "black box" or Health Canada boxed warnings — the strongest drug warning that can be issued by both countries.

"The majority of time, the doctors weren't getting any information about a single harmful effect," said Mintzes, who studies drug advertising at UBC's School of Population and Public Health.

Doctors in Toulouse were more likely to be told of a harmful effect in a promotional visit, compared to doctors in Canada and the U.S., according to the study.

Researchers suggested that this may reflect stricter regulatory standards for promotion of medicines in France.

The Canadian Medical Association has published voluntary guidelines for physician interactions with industry, which includes a provision that any mention of a product or service must be balanced "based on the prevailing body of scientific information" and a ban on accepting gifts. Canadian physicians are permitted to accept free product samples, a practise that is banned in France.

In the UBC-led study, all physicians were asked to report the sales reps' key messages for each visit. For the diabetic drug rosiglitazone, or Avandia — withdrawn in Europe and restricted in the U.S. and Canada because of an increased risk of heart attack and stroke — "nearly all were claims of safety," the researchers wrote.

Among the messages the doctors took away: "Avandia is safe even in patients with heart disease, as long as they don't have heart failure," "Avandia is not as dangerous as the public makes it out to be," and "new studies indicate safety."

Overall, even though doctors said they were rarely informed about serious side effects, most judged the quality of the information provided by the reps as "good" or "excellent." Nearly two-thirds said they were "somewhat" or "very likely" to start or increase prescribing of the drug after the visit.

Link to The Vancouver Sun.

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From ABC News:

The federal government will continue to rank marijuana as one of the most dangerous drugs after an appeals court on Tuesday rejected an effort to change the classification.

The ruling keeps marijuana in the same pool as drugs like heroin and LSD, which the Drug Enforcement Administration (DEA) say have a "high potential for abuse" and "no currently accepted medical use."

The Los Angeles Times quoted one of the appeals court judges about the decision:

Judge Harry Edwards, writing for the Court of Appeals for the District of Columbia, said the judges did not dispute that "marijuana could have some medical benefits." Instead, he said, they were not willing to overrule the DEA because they had not seen large "well-controlled studies" that proved the medical value of marijuana.

Marijuana's classification as a Schedule I drug -- the most serious designation -- means that there are more restrictions for conducting research into its potential medical benefits.

Proponents of medical and recreational marijuana say that the restrictions make it hard for researchers to perform the types of studies that would convince the DEA to move the drug into a less serious category. Tamar Todd, senior staff attorney for the Drug Policy Alliance, spoke to The Daily Chronic, a pro-cannabis website, about the hurdles:

"We're stuck in a Catch-22 – the DEA is saying that marijuana needs FDA approval to be removed from Schedule I, but at the same time they are obstructing that very research," she said. "While there is a plethora of scientific evidence establishing marijuana's safety and efficacy, the specific clinical trials necessary to gain FDA approval have long been obstructed by the federal government itself."

Rusty Payne, a spokesperson for the DEA, says that there are "many" ongoing studies looking into the medical value of marijuana, but said he could not specify the exact number.

In any case, studies need to be approved by the agency, something that activists like Todd think is a conflict of interest. "The scheduling is made within the context of a law enforcement agency and that law enforcement agency has an interest in keeping drugs illegal and maintaining the status quo," she said.

The DEA isn't the only body with the power to reclassify marijuana. Congress could amend the Controlled Substances Act, which designated pot as one of the most dangerous drugs in 1970.

A change to the law would affect the way the DEA treats the drug, Payne said: "If it's signed into law, it's law and that's what we would enforce."

As it stands, the DEA devotes substantial resources to combating marijuana sales. Pound-for-pound, cannabis makes up the vast majority of drug seizures by the agency, accounting for 94 percent of captured drugs in 2011.

Payne says that the DEA doesn't use the drug rankings to determine what drugs to go after, but concedes that the majority of the agency's counternarcotics operations deal with drugs classified in the top two tiers of dangerous drugs, including cocaine, heroin, methamphetamines and marijuana.

"We go after drug trafficking organizations," Payne said. "Any drug trafficking organizations are involved in multi-drugs."

A reclassification of marijuana could have a major impact on the way the drug is used in the U.S. Drugs ranked as less dangerous by the DEA, like Xanax or cough syrup, can be distributed with a prescription or over the counter. Marijuana legalization advocates would like to see pot classified in the same way, but they say the system is created in a way that makes it difficult for the drug to move away from the Schedule I category, and that the DEA has an interest in keeping that way.

Kris Hermes, a spokesperson for Americans for Safe Access, the pro-legalization group that brought the suit against the DEA, said the burden is on the agency to change the situation.

"They are the ones that grant or deny petitions to reschedule," he said. "So it is ultimately up to the DEA."

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From ABC News

For decades, Colombia has been searching for ways to treat people who are addicted to basuco, the nation's version of crack cocaine.

Now, the country's capital, Bogota, is considering a new approach: transition users to marijuana.
The mayor's office in Bogota is considering a pilot program that would look to transition
drug addicts from hard drugs to marijuana. 
(Doug Menuez/Getty Im


BBC Mundo reports that the city is interested in trying a pilot program to see if pot helps mitigate the symptoms of withdrawal that basuco users experience. The goal is to minimize the social and health risks that accompany the drug.

Basuco isn't the same as crack, but it's an apt comparison. Like crack, it's smokable and more common among a poorer segment of society.

When it comes to quality, basuco is some of the least pure cocaine out there. The base of the drug is an intermediary product that you get if you're turning coca leaves into cocaine, and it can contain residue from the solvents used in that process, including kerosene. Dealers add things like ash and crushed bricks to give it bulk. For less than a dollar, you can get a short but powerful high.

One expert in Bogota estimates that the city has at least 7,000 "problem users," which means they might take up to 15-20 hits a day, according to BBC Mundo.

To confront the issue, the city is planning to test out "controlled consumption centers," where addicts of hard drugs will be able to consume in a safer environment, with the goal of kicking the habit.

Julián Quintero, from the Bogota-based non-profit organization Acción Técnica Social, which works on drug policy, told BBC Mundo how such centers will work:

"The first thing you do is to start to reduce the dose. After that, you begin to change the way that it's administered: if you were injecting heroin, you move to smoking heroin; after smoking heroin, you move to combining it with cannabis; after that, you're staying with the cannabis," he said. "What you're looking for is for the person to reach a point where they can stabilize the consumption and that the consumption doesn't prevent them from being functional."

Is anyone in the U.S. trying this kind of approach to hard drugs?

No, according to Amanda Reiman, a policy manager with the Drug Policy Alliance, a group that favors alternatives to current drug laws.

"Unfortunately, universities rely on grants from the federal government for research, so most of what they do is what the feds want done," she said in an email. "As you can probably guess, the feds are not too interested in beneficial uses for marijuana, and even less interested in how to help people who are addicted to substances, so most of the research in this area occurs outside the U.S. or through private funding."

Link to ABC News.

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