In an online marketplace packed with natural-health products of dubious value, Zenbev has a definite leg-up: the sleep aid was created and touted by a psychiatrist, a medical doctor with scientific credentials.
But that connection has also landed Dr. Craig Hudson in hot water, with Ontario’s medical regulator reprimanding him for violating the group’s strict rules on physician advertising.
Hudson argued the College of Physicians and Surgeons regulations barring him from using his own name to flog the product violated his constitutional right to free speech.
But an appeal board has just rejected that assertion, saying the edicts are justified as a way to ensure doctors aren’t tainted by “association with commercial interests.” Hudson now faces an oral caution.
“The heavy reliance by the public on health advice provided to them by medical professionals at a time when they may be most vulnerable engages the need for a high degree of public trust in (doctor) advertising,” said the Health Professions Appeal and Review Board. “There is a risk that patients may draw concerning conclusions based on physician advertising or promotion of products.”
The case underscores the fine line Canadian physicians often have to tread as private operators in a largely public system, allowed to advertise and run health-care businesses, but limited in how they can do that.
Hudson is considering whether to launch a judicial review — a type of appeal — of the board’s ruling, said his lawyer, Mark Handelman.
He and Hudson declined any further comment. But in written arguments to the appeal board, they suggested the regulator had veered way outside its mandate in restricting Hudson’s freedom of expression — potentially affecting consumers in other provinces and countries.
“In effect, the College is attempting to regulate the content of the internet and the marketing and sale of Zenbev — everywhere,” said the brief. “Dr. Hudson’s affiliation with, and invention of, Zenbev is part of the product’s story and excluding it precludes the public from obtaining full information about it.”
The substance in question, sold here, in the U.S. and Europe, is a powder that customers are supposed to mix with a warm liquid and drink before bed.
Its key ingredient is pumpkin seed, a rich source of tryptophan. The amino acid converts in the dark to melatonin, a hormone that helps regulate the wake-sleep cycle. Evidence suggests that boosting its levels can enhance sleep.
The Toronto-based psychiatrist created the product in 1997, and it was approved by Health Canada as a natural health product in 2009.
In effect, the College is attempting to regulate the content of the internet and the marketing and sale of Zenbev – everywhere
Hudson and his wife, Susan, have published two studies, one looking at Zenbev’s effect on social anxiety disorder, the other a small double-blind trial that concluded the product “significantly reduced” time awake for those who took it.
Joe Schwarcz, a McGill University chemist whose blog assesses alternative medicine, called those papers inconclusive “pilot studies,” but said the theory behind the product is sound. It “may actually work,” and is unlikely to do any harm, he concluded.
Hudson wound up before the college because of a complaint from a patient, who accused the psychiatrist of trying to sell him on using Zenbev.
The college said it found no evidence to back up that or other charges from the patient, but took issue with the doctor’s own website, which promotes Zenbev, and that of his company Bioessence, which touts Hudson’s role in developing it.
The regulator eventually charged him with breaking rules against doctors advertising a drug, or marketing any product other than their own medical services.
But Hudson argued the ads promote something unrelated to his clinical practice, so are not covered by the college’s rules.
The college responded that there were numerous examples online where his clinical practice was “inextricably linked” to promotion of Zenbev.