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Healthy Skepticism Library item: 14066

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Kleiss K.
Trucker's death uncovers drug in herbal remedy
The Edmonton Journal 2008 Jul 31
http://www.canada.com/edmontonjournal/news/story.html?id=625923fc-21f3-4ac5-9d6a-48561a6dac59


Abstract:

Tranquilizer found in blood of Alberta father of four who used natural supplements


Full text:

At first there was nothing suspicious about Michael Berggren’s death.
The veteran trucker was making his first run of the morning on Boxing Day 2006. He rumbled out of Hines Creek, lost control of his tandem truck, hit a snowbank and rolled. He wasn’t wearing his seat belt and died at the scene.
Had the crash happened six months earlier, his widow and four children would have mourned him and believed it to be an accident.

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But Alberta’s Medical Examiner’s office had just changed its policies before his death and started routinely testing dead drivers for drugs.
When the tests came back, chief toxicologist Dr. Graham Jones was puzzled. The powerful tranquilizer in Berggren’s blood was exceedingly rare. He knew it wasn’t commonly available in Canada or the U.S.
“The red flags went up at that point,” Jones said in an interview. “I thought, I have to find out how this drug got into this man’s body.”
He learned Health Canada had already pulled three herbal concoctions from shelves because they contained a prescription drug, called estazolam, and didn’t list it on the label. The drug is regulated because it belongs to a class of potent, addictive sedatives called benzodiazepines, which can cause drowsiness, dizziness and confusion.
Jones contacted Berggren’s widow, Tina Miller, and she confirmed her husband had been taking an herbal sleeping aid called Eden Herbal Formulations Serenity II Pills. Jones alerted authorities.
Five months later, Alberta Justice called a fatality inquiry.
There are questions over what role, if any, the drug played in Berggren’s death. And how did a rare, powerful sedative come to be in the body of a fit 55-year-old northern Alberta health nut, who was planning to teach his grandchildren how to ski the day he died?
Jones discovered the pills Berggren was taking came from a store in Calgary.
Four months after the fatal crash, Health Canada issued an advisory that said the pills were sold at the Evergreen Acupuncture Clinic.
The clinic had also been responsible for distributing Sleep Ease dietary supplements, which Health Canada pulled off its shelves weeks before Berggren’s death because they, too, contained estazolam.
Two more products, Sleepees and Sleep Well, had been recalled from other stores for the same reason.
Health Canada said nothing more about the source of the drugs. But according to a CTV W5 investigation earlier this year, all four products came from a single supplier in Richmond, B.C.
It wasn’t the first time a B.C. company was the source of hidden pharmaceuticals. In 1998, the United States Food and Drug Administration warned consumers not to purchase or consume a product known as Sleeping Buddha, which also contained estazolam.
The FDA had traced the drug to a company in Burnaby, B.C.
Like Health Canada, the FDA warned of possible health risks and went further: “Because this product is a sedative, it poses a special risk to consumers who take the drug while driving,” it said.
At least two of the herbal products — Sleeping Buddha and Sleep Well — were made in China and not permitted for sale in Canada.

The other two were sold at clinics offering traditional Chinese medicine.
On Wednesday, a spokesman for Health Canada could not say where the drugs were ultimately traced to, how they got into Canada or how many supplements containing undeclared pharmaceuticals are thought to be entering the country.
He could not say whether officials are investigating the trend.

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He did say, however, that the government hopes to soon have answers for the public.
Provincial Court Judge McIntosh presided over the fatality inquiry into Berggren’s death earlier this week in Fairview.
He heard from Jones, an RCMP constable, and Klara Richer, a Health Canada drug strategy compliance officer. She did not return calls seeking comment.
Fatality inquiries are open to the public, but McIntosh has instructed court administrators not to release transcripts of the testimony to the media until he renders a decision. There is no scheduled release date for the decision.
Barb Ponto worked with Berggren for three decades. She said he was a loving father and grandfather, and that the deadly collision was a shock to the small community.
Berggren was a healthy man who loved to cycle, snowboard and hike, she said, and she wasn’t surprised to learn he chose a herbal supplement over prescription sleeping pills.
She said that in the moments before he left on his last run, he seemed rested, alert and content.
The weather was good and the roads were clear.
There is some evidence the truck drove along the shoulder before it hit the snowbank, but nobody knows for sure.
“I think it will be tough to say exactly how the accident happened,” she said. “We may never know why he died.”
kkleiss@thejournal.canwest.com
REDUCING THE RISKS
Health Canada reports that 71 per cent of Canadians regularly use natural health products.
In January 2004, Canada’s new Natural Health Products Regulation came into effect to oversee the sale of vitamins and minerals, herbal remedies, homeopathic medicines, traditional Chinese medicines and other non-prescription health-care items.
As a result, all natural health products in Canada will be licensed by 2010.
According to Health Canada, businesses will have to submit detailed information in order to obtain a licence, including a list of medicinal ingredients, source, potency, non-medicinal ingredients and recommended use.
After approval, the product will bear an eight-digit product licence number preceded by the letters NPN or, for homeopathic medicines, DIN-HM. The system is similar to the current licensing system, which uses a drug identification number, or DIN.
The presence of a DIN, NPN or DIN-HM means the product has been authorized for sale in Canada and is safe and effective when used in accordance with the instructions on the label.
In the meantime, natural health products that have been registered are marked with a DIN.
The government hopes to launch a Licensed Natural Health Products Database this summer.

 

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