Health Canada cracks down on cell injection clinics

The glossy ad in arrived in my mailbox within days of reading that Health Canada was clamping down on private clinics offering cell injection treatments.  The ad was for a seminar on Regenerative Medicine at five interior B.C. locations. The one in Kamloops was on Monday, July 15, 2019.

image: The Mandarin

The ad didn’t make clear what Regenerative Medicine was but it looked like cell injection from the information given.

“Learn from the most significant medical breakthrough in natural medicine this century,” claimed the ad. They ask: “Do you suffer from knee pain, back pain, osteoarthritis neuropathy join pain, COPD.”

The ad provided disclaimers. “Regenerative Cellular Therapy is considered experimental. It has not been evaluated or approved by Health Canada. It is not offered as a cure for any condition, disease, or injury,” and “We want to be transparent with you and disclose that this therapy is experimental/unproven and not everyone responds to the therapy.”

Fair enough but what, exactly, are the treatments?

It was only after phoning the number in the ad that I was given a website where I could find out more about the Regenerative Medicine and Anti-Aging Institute. RMAAI appears to be located in Washington State. While thin on details, the website says:

“At RMAAI we offer premiere regenerative medicine. The foundation of regenerative medicine includes growth factors, cytokines, proteins and mesenchymal stem cells. These are a fundamental piece of our natural and holistic approach to your healthcare needs.”

According to Wikipedia, mesenchymal stem cells can grow into other cells such as bone cells, cartilage cells, muscle cells, fat cells.

Regenerative Medicine, it turns out, is the harvesting of your own stem cells and re-injecting them at the site of injury with the hope that they will replace injured cells. I guess if I had attended the seminar, I might have found this out.

Health Canada has declared cell injection clinics to be illegal.

While the therapy is promising, Health Canada has a number of issues with the way cell therapy is administered at commercial clinics.

Michael Rudnicki, director of Canada’s Stem Cell Network, agrees that while there stem cell research is promising, it is not ready for clinical use. Referring to the banned clinics, he says:

“These treatments are unproven. These clinics are for profit. They are not research enterprises (Globe and Mail, July 10, 2019).”

Health Canada’s has medical and legal issues with the clinics.

The transfer of my own cells back into my body seems safe. Not so, says Health Canada because the procedure can introduce bacteria or viruses and stimulate unwanted immune reactions and tumour formation. “Indeed, a number of serious adverse events have been associated with use of autologous [self] cell therapies and strategies to mitigate these risks are needed,” says Health Canada.

The legal issue is that cell injections fall under the Food and Drugs Act. As such, they are classified as drugs and must be authorized for use in Canada. In addition, principles for labelling and quality control must be adhered to and the devices used to process the cells have to be classified under the Act.

I asked if RMAAI by email if they intend to offer seminars on cell injection therapies. As of the time of publication, I had no reply.

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Sometimes it’s not easy being a pro-vaxxer

Despite the fact that vaccines have saved uncountable lives and virtually wiped out smallpox, polio, tetanus and rabies, vaccine risks exist. When those risks result in death, people lose trust in all vaccines.

image: Skeptical Raptor

Look at what happened in the Philippines. In 2015 they purchased three million doses of a new dengue vaccine.

Dengue is not as deadly as it might seem. Three-quarters of people infected by the mosquito-borne virus don’t notice anything. The remainder fall into three groups – symptoms similar to the common cold; or a fever accompanied by headache, pain behind the eyes, aching joints and bones that sometimes leads to internal bleeding; or the most deadly, dengue hemorrhagic fever and dengue shock syndrome where plasma seeps out of capillaries, liquid pools around organs, massive internal bleeding ensues. The brain, kidneys and liver begin to fail (Scientific American, April, 2018).

In the Philippines with a population of 105,000, dengue kills an average of 750 people a year. Any death is one too many but that number doesn’t even put dengue-deaths in the top ten list of killers. Of infectious diseases, many more die from pneumonia and tuberculosis.

The dengue vaccine wasn’t cheap. Made by the pharmaceutical company Sanofi Pasteur, Dengvaxia cost more than the entire national vaccination program for 2015, which covered pneumonia, tuberculosis, polio, diphtheria, tetanus, pertussis, measles, mumps and rubella. And it would reach less than one percent of the population.

Some wondered if the vaccine Dengvaxia had been oversold to the Philippine government in a panic mode.

Here’s where the nightmare for pro-vaxxers comes in.

Internist Antonio Dans and paediatrician Leonila Dans at the University of the Philippines Manila College of Medicine discovered some startling results: young children who were vaccinated were more like likely to suffer from dengue that those who weren’t vaccinated.

They found this out by studying publications by the makers of the vaccine, Sanofi Pasteur. While it worked for older children, for younger ones, the vaccine made things worse.

The two Dans warned the Philippine secretary of health in 2016 of their findings but in the meantime, the World Health Organization said that there was no problem.

“It was either believe us or believe the WHO,” said Antonio Dans. “If I were them, I’d believe the WHO. I mean, who were we? We were just teachers in a small medical school.”

The Philippine secretary of health responded with her own warning: doctors who engaged in “misinformation” on the vaccine would be responsible for every death from dengue that could have been prevented.

Then Eva Harris, a dengue expert at the University of California, Berkeley, found strong evidence in 2017 to support the Dans:

Harris’s evidence made the world take notice. Now Sanofi Pasteur and the WHO don’t recommend Dengvaxia for young children who have not been previously infected.

The reasons why Dengvaxia makes matters worse for children who have not been infected and better for those who have is puzzling. There are a few theories but it’s debatable.

The confusion has led to lack of confidence in vaccinations. In 2015, 93 per cent of Filipinos strongly agreed that vaccines are important.  In 2018, less than a third thought so.

Now, Filipinos suspicious of vaccines aren’t getting kids vaccinated and several outbreaks of measles have occurred.

Vaccines save lives but in a rush to save lives at any cost, the rollout of Dengvaxia was too soon and the cost was a loss of confidence of all vaccines.

Ditch the stoner image of cannabis users

Now that cannabis is legal in Canada a more accurate picture of users is emerging. Cannabis users are coming out into the daylight and they don’t look like what’s depicted in the movies.

image: GFarma.news

The Hollywood portrayal of marijuana users usually involves a bumbling buffoon who sits on a couch, smokes weed and binge watches TV. He can barely remember where he left his car keys, much less hold down a job or do well in school.

In Fast Times at Ridgemont High, Jeff Spicoli is a carefree stoner and surfer with little regard for school. In Cheech & Chong’s movies like Up in Smoke, a couple of stoners take meandering road trips in smoke-filled van.

The stigma of cannabis use is historical. “Marijuana” was first used as a pejorative term to describe what U.S. blacks and Mexican used in the 1930s. Leafly.ca says:

“The Great Depression had just hit the United States, and Americans were searching for someone to blame. Due to the influx of immigrants and the rise of suggestive jazz music, many white Americans began to treat cannabis (and, arguably, the Blacks and Mexican immigrants who consumed it) as a foreign substance used to corrupt the minds and bodies of low-class individuals.”

With such an image of degenerate and low-life users, cannabis consumers have been reluctant to admit use even after legalization. Some still feel like they have to be secretive about it. A friend emailed me:

“However, nothing has changed for me, somehow I still feel like I have to hide in my back yard if I want to smoke a joint…..how weird is that!!!!”

That reluctance is reflected in surveys. Health Canada’s Canadian Cannabis Survey asked respondents about their willingness to disclose use. Even once cannabis is legal, 25 per cent said that they would not disclose that they use it. While not a majority, it reflects reluctance to be judged by the stereotypical image of befuddled fools.

That connection is also reflected when respondents were asked about social acceptability of cannabis use. Less than half, 45 per cent, said that recreational use was socially acceptable.

Another study by Starbuds Canada done before legalization found that 27 percent of Canadians, or about 10 million people, currently consume cannabis. Another 17 percent said they would consider using it.

The largest growing demographic of users and those curious about using, are older, more affluent consumers. While Canadians over the age of 65 use the least, they are the most interested in trying it.

The majority of users have higher education degrees, including 43 percent university and 32 percent college. Most users are under the age of 54 and one-third of them have children.

Dave Martyn, president of Starbuds Canada says:

“With cannabis going mainstream, the ’stoner’ stereotype is dying. Cannabis isn’t just for intoxication, people are using it to relax, unwind, like they would a glass of wine at the end of the day. The average cannabis consumer is more likely to resemble your neighbour than any portrayal in pop culture.”

Three profiles of opioid users

The fish-bowl lives of drug users on the streets of downtown East Vancouver provides an easy, but distorted, window to drug use. That picture is as distorted now as it was 139 years ago when B.C.’s second premier, Amor De Cosmos, headed a commission to investigate opium use.

The window to most drug overdose deaths is closed. Typical victims are single men, in the prime of their life, who die alone from opioids containing fentanyl according to a report from the BC Coroners Service released last Thursday.

Michael Strange. image: Globe and Mail

Even reports of typical deaths are somewhat distorted. For some opioid users, the drug is a godsend. Take the case of Michael Strange. He injured his back while working as a cameraman and found opioids to be the only treatment that provided relief.

“I’ve tried so many different things for my pain,” said Strange. “People say, ‘Have you tried acupuncture?’ Yeah. I’ve had two different kinds of laser therapy. I had doctors and friends say I had to try marijuana. I got the vaporizer and it did nothing for my pain (Globe and Mail, September 7, 2018).”

It wasn’t easy but Michael Strange finally found a doctor who would treat him. Many doctors were “running scared” because they didn’t want to be seen to be contributing to addiction. Now his pain specialist gives him a two-month prescription and before renewing, asks: “Michael, how are you? Are you OK with the drugs? Do you need more? Do you need less?”

Self-medication turned deadly for Chris Willie, a university lecturer with a PhD in environmental physiology from UBC Okanagan. He wrote memoirs about his recovery from fentanyl addiction but he died from an overdose before they were published. With the approval of his family, his memoirs were published in the September, 2018, edition of the Walrus. He describes his mental pain as a child and the calm he found in taking dangerous risks:

“I have never excelled at coping. I was that infant child who hammered his head on the ground when frustrated by anything at all. It must have been embarrassing to parent the son with the ever-present forehead scabs. Perhaps I found it soothing, because, thirty years later, I still find serenity in chaos and derive calm from risk. By fighting to live through near-death situations, I could find the high I needed to briefly escape the pain.”

Like Michael Strange, Emily Wharton lived a productive life with opiates. The twenty-year old opium smoker from Victoria, told a House of Commons Select Committee on Chinese Immigration of her use. The federal committee was initiated by John A. Macdonald in 1879 and headed by B.C.’s second premier, Amor De Cosmos (a.k.a. William Alexander Smith).

Back then, the stereotypical opium user was Chinese. They lured good white women into lives of depravity in opium dens. The real agenda of the committee was to rid Canada of Chinese immigrants.

Wharton’s testimony 139 years ago is recorded in Dan Malleck’s book, When Good Drugs Go Bad. She told the committee that she had been using opium for four years and suffered no ill effects. Wharton testified that opium’s “somnolence and complete rest” left her productive. Chinese men in opium dens treated her well and she objected to the characterization of the dens as depraved. She suggested that if the government legalized opium, “one need not have to come into such holes as this to smoke (p. 102).”

Medical-grade opioids are not the problem. The social stigma of drug use that drives users to overdose, and the lack of pain-treatment specialists, leads mostly young single men to self-medicate, and to die, alone.

Advice to TRU: educate, don’t prohibit cannabis

Thompson Rivers University plans to prohibit the recreational use of cannabis on campus. This, despite the failure of prohibition to deter use for the last 95 years in Canada.

image: SchoolFinder

Cannabis is not harmless. Inhaling smoke, be it from wildfires, tobacco, or cannabis carries risks. But banning cannabis is not the way to control those risks.

Education is. Education has reduced the consumption of tobacco. Reductions have been especially greater for those with a higher education according to a report from Statistics Canada.

TRU has nine designated locations where tobacco and medical marijuana can be smoked. Once cannabis is legalized on October 17, those locations would be a logical place for recreational cannabis smokers as well.

TRU’s Joint Occupational Health and Safety Committee voted on March 5, 2018, to ban all smoking of recreational marijuana on campus for health and safety reasons. Chris Montoya, committee member and Senior Lecturer in Psychology, says not all of the 20-member committee agreed:

“Pro-marijuana smokers on the TRU committee argued that marijuana smoke is no different than cigarette smoke and that smoking areas designated for cigarette smoke should also be used for marijuana.”

But they were apparently swayed by arguments  presented by Montoya: cannabis is more potent than ever before, bystanders can get stoned from second-hand smoke, and marijuana has been linked with psychoses.

Montoya is a member of the National Advisory Council (2016-18) and the Partnership for a Drug Free Canada. He repeated some of his claims to Kamloops This Week:

“A student cannot get drunk walking next to another student drinking a beer. However, students, staff and faculty can get stoned breathing in second-hand smoke.”

Ian Mitchell, Kamloops Emergency Physician, disagrees:

“There have been a series of studies in which non-smokers are shut into a small room with cannabis smokers and tested for both impairment and positive urine tests. While these things can happen, it is only under the most extreme circumstances,” he told me by message.

A doctoral student in clinical psychology at UBC Okanagan also disagrees with Montoya:

“Researchers at John Hopkins University have been conducting studies on the effects of cannabis smoke exposure to non-users and have found that, under regular indoor conditions, non-smokers did not experience changes in cognitive ability –i.e. ’get high,’” says Michelle Thiessen in a letter to KTW.

There are places on campus for students and staff to drink alcohol as well as smoke cigarettes. TRU spokesperson, Darshan Lindsay, told CFJC Today: “There are a lot of regulations, systems in place to promote responsible use of alcohol. We just don’t have that in place for cannabis. For the university, recognizing that we are a place of education and that we want to promote an environment that’s safe and healthy for everyone, our position is that recreational cannabis should not be present on campus.”

Failing to have a “place for cannabis” perpetuates the notion that prohibition will reduce cannabis use. Banning cannabis has a predictable effect -it simply drives consumption into the shadows and prevents dealing with the risks.

TRU should become a model in harm reduction, as “a place of education.”

Prohibition is futile: TRU might as well prohibit wildfires -it would be as effective.

 

How to reduce drug overdose deaths

There is no easy way to reduce drug overdose deaths but a simple first step is to provide users with safe opioids. The hard part will take time.

 North Vancouver couple die of fentanyl-linked overdose. Image:Vancouver Sun

The grim toll of deaths –of community leaders and ordinary citizens -marches on relentlessly. In just eight months of 2017, more British Columbians died of drug overdoses than the whole year before.

Lots of things don’t work. Still, politicians persist in the tried and unproven. B.C. Solicitor-General Mike Farnworth echoed concerns that rose in meetings with federal and provincial public safety ministers:

“We strongly believe that if you’re dealing fentanyl, you’re dealing death, and you should be facing much more severe penalties such as manslaughter charges,” Farnworth said (Globe and Mail, October 19, 2017.)

Tough talk has failed in the past. The divide between pushers and users is not as clear as Farnworth might think. Provincial Health Officer Perry Kendall says there is a risk that “the policy implementation will not be able to distinguish between importers or non-user, large-scale dealers and the easier-to-apprehend street-level user/dealer.”

“Our attempts to destigmatize,” adds Kendall, “through decriminalizing the user and treating him or her as a person with an illness rather than a criminal, could be jeopardized.”

Restrictions on importation will fail as well. LifeLabs in B.C. has been testing urine samples of patients screened for fentanyl and found that these patients also tested positive for the even more powerful carfentanil. Now another synthetic opioid, U-47700, has been detected. More synthetic opioids could be on the way. Garth Graham, director for LifeLabs says:

“Are we two steps ahead? No, we’re not. In my opinion, there’s more of this coming … I think it is difficult. We’re working with provincial stakeholders . . . They mentioned another fentanyl analogue, and we are now trying to work that up so we can look for that.”

It’s a cat-and-mouse game. As soon as one variety of fentanyl is identified, another is cooked up. Testing equipment for the new analogue has to be built and laws restricting it enacted.

Naloxone kits save lives but only if someone nearby is lucid enough to administer them. Bob Hughes, Executive Director of ASK Wellness, suggests an alternative:

“We’re not going to fix this with one approach, such as providing Naloxone. That they’ve got some other option like basically pharmaceutical-grade heroin for some of those folks who just can’t seem to shake it,” Hughes told Radio NL.

Providing heroin to drug addicts may seem like a bad idea because it enables an addiction. But if we’re concerned about saving lives rather than making moral judgements on users, then legal heroin or other opioids like hydromorphone is a good first step.

However, the hard part is not the supply of safe opioids. The hard part is the destigmatization of drug users. Deaths due to drug overdose are still seen as a moral failing rather than a disease or “a person with an illness” as Dr. Kendall put it.

Open discussions about mental illness have helped destigmatize what was once thought of as lunacy or possession by evil spirits. Now the conversation needs to start around addiction; not as a weakness of character; not an embarrassment to be hidden from public view by friends and family.

Help fentanyl labs make a safer drug

Illegal fentanyl lab operators don’t intend to kill users. They would prefer to have return customers. The problem, I suspect, is that the fentanyl used is so concentrated that it’s hard to dissolve to a uniform consistency. The resulting doses are uneven –from low to deadly. It’s a good idea to provide testing facilities for fentanyl cooks to let them know the potency of their product. Dr. Tyndall of the BC Centre for Disease Control says:

  fentanyl lab. image: Global news

“I’m still firmly of the belief that nobody’s actually trying to kill people. These manufacturers don’t know what they’re doing and they’re putting out ridiculous concentrations of these drugs.”

The BCCDC recommends an expansion of drug-checking services where anyone, including producers of illegal fentanyl, can have their drugs tested for toxicity. B.C.’s Minister of Health, Judy Darcy, endorses the expansion.

As it stands, drug policy is perverse because we tell users not to use street drugs but provide no other option when legal supplies fail.

“We strongly advise people to stop using street drugs,” says Dr. Tyndall, “and if they can’t do that, then we offer them … Suboxone or methadone, and if that doesn’t work, we basically tell them to go and find their own drugs even though there is a very real possibility of dying.”

The BCCDC suggests ten “areas of action.” If they were adopted, opioids would be essentially legalized much in the way that marijuana will be next year. Grower’s clubs and individuals would be allowed to make medical grade opiates. To clarify, opiates are derived from poppies whereas opioids include all synthetic and natural products.

Legal opioids are not likely to happen any time soon. I started lobbying for legalization of cannabis 40 years ago and look how long that took. Optimistically, with the model of legalized marijuana to be established soon, it won’t take another 40 years for the legalization of opioids.

Even without legalization, off-label uses of opioids are allowed. The BCCDC suggest dispensing take-home opioids such as oral hydromorphone which users could take home, grind up, and inject without supervision.

If the above recommendations only seem radical, it’s only because of a false sense of what criminalization can achieve. Criminal law can’t accomplish societal goals. If we want to stop people from using harmful drugs, criminalization has been a dismal failure. Instead, make drugs legal and educate people of the unhealthy consequences of use. It works with tobacco. If the goal is harm reduction, the recommendations don’t seem so radical.

Imagine that we are talking about baby strollers instead of drugs, and that some early models collapsed resulting in injury or death. An irrational solution would be to make strollers illegal. The sensible solution would be to regulate manufacture of the strollers to make them safe.

Prohibition of opioids isn’t working. It didn’t work for coffee, cigarettes or alcohol.

If the current trend continues, the death rate will continue to climb. More than 1,500 will die in British Columbia this year -ordinary people like friends, family and neighbours. Forget the stereotype of street people overdosing in alleys: 90 per cent of deaths are indoors. Isn’t it time to abandon prohibition and give harm-reduction a chance?