What's the Problem with Health Canada?

The human body produces its own superhormones, one of which is called dehydroepiandrosterone (DHEA). DHEA is not a drug! It’s naturally manufactured by our adrenal glands, but unfortunately as we age, the body produces less and less.

Dr William Regelson, a biomedical scientist and professor of medicine at Commonwealth Virginia University, has researched DHEA for more than 20 years. He prescribes it to patients, calling it a "superstar of superhormones" (Superhormone Promise). According to Regelson, the hormone works wonders inside the body by rejuvenating almost every important organ system. "By taking DHEA," he writes, "you are not only undoing the damage inflicted over time on your body and mind, but you are seizing control of the aging process itself. You are no longer a helpless victim against the ravages of aging."

With this superhormone it’s possible to protect against both cancer and heart problems. Norman Shealy, MD, PhD, and author of DHEA: The Youth and Health Hormone, describes its useful role in the treatment of diabetes, atheroscelerosis, heart disease and stroke, menopause/andropause, autoimmune disease, obesity and depression. But Canadians are denied this helpful supplement because it has been prohibited for sale by our Health Protection Branch (HPB). The drug directorate claims that DHEA, though generally consumed as a dietary supplement like vitamins, must undergo the same study as a new drug before approval.

The problem is that no pharmaceutical company will undertake to fund a study of DHEA if there is no prospect of patenting it for sale. While the scientific process and review procedures appear sound, the ultimate results aren’t so satisfactory. Let’s consider a specific case where a drug was approved, ostensibly based on appropriate study.

Vanessa Young, a 15-year-old of Oakville, Ont., was prescribed Prepulsid for a gastrointestinal problem. But in March last year, she collapsed at home in front of her father and later died in hospital. The drug reportedly caused a disturbance in her heart rhythm and her death was caused by cardiac arrest. In the aftermath, her family launched a $11 million lawsuit against Health Canada and it was confirmed that this drug was associated with the deaths of 10 Canadians, including children. Prepulsid has since been withdrawn from the market.

In another example of how the drug-approval process can go wrong, 63 over-the-counter cough and cold drugs–a few of them well known such as Contac, Dimetapp, Sinutab–were recently taken off the market because they were found to increase the risk of stroke in young women.

Ironically, daily oral supplementation of DHEA, with amounts as high as 4,000 mg, has not shown any adverse effects. And yet, the HPB treats it as so dangerous that it’s unavailable without a doctor’s prescription! It’s considered an anabolic steroid and is likened to performance-enhancement drugs listed on Schedule IV of the Controlled Drugs and Substances Act.

This is absurd. DHEA has no realistic potential for abuse. Even the Dubin Inquiry, which came about after the Ben Johnson controversy, reported that the extent to which a substance is "open to abuse, with consequent health risks" is a proper consideration to determine the degree of regulation.

DHEA is a disease-preventing/ fighting hormone that is denied to Canadians in the name of protecting our health. In the USA, DHEA is considered a dietary supplement under the Dietary Supplements and Health Education Act of 1994. If the Food and Drug Administration wants to restrict its use, the onus is on them to demonstrate that it is potentially harmful. Our HPB has no such obligation. This difference is a dazzling eye-opener.

In medicine as in life, risk and benefit require balancing. Unlike the medications above, one of which took 10 lives, DHEA has little if any risk but could provide overwhelming benefit. In fact, Dr Regelson writes that DHEA is "safe and effective." Therefore, if Minister of Health Allan Rock deems a study necessary, it’s time he ordered one at public expense. Otherwise, he should scrap the current paternalistic policy and liberalize the availability of DHEA, including freedom of importation of small quantities for personal use. If readers value this superhormone or other restricted supplements, I strongly suggest they write Minister Rock and their MPs. It’s more than a matter of consumer action. It’s your health and should be your choice.