Testosterone campaign by drug company raises concerns

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Do you ever fall asleep after dinner? Feel grumpy on occasion? Or experience a lack of energy?

Then you're just like most other middle-aged individuals juggling work and family life.

But a major pharmaceutical company says those symptoms in men may point to an undiagnosed medical condition that can be treated with a prescription product it sells.

Abbott Canada is running a campaign to raise awareness about low testosterone in men – what it describes as a "common medical condition" that's often undiagnosed. Advertisements feature a woman leaning over a man in bed, only she is separated from him by a huge block carrying the words "lack of energy" and "low sex drive." In big letters, the ad asks whether he's "lost that loving feeling" and directs consumers to a website where they are told low testosterone is common and can be treated with prescription drugs.

Abbott sells a gel containing testosterone, called AndroGel, to treat low testosterone.

Now, a group of concerned medical professionals is alleging that the campaign targets consumers by promoting a medical condition to sell products, pushing the broad use of a drug only approved to treat men who produce little or no testosterone, usually because of radiation therapy, autoimmune diseases or other problems.

"It ought to be banned as false advertising," said Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba.

Experts also point to the fact there is little evidence showing testosterone gels have a marked effect on improving sexual satisfaction or depression.

"I would see it as a classic example of … representing normal aging as a medical problem that needs to be treated," said Barbara Mintzes, assistant professor in the department of anesthesiology, pharmacology and therapeutics at the University of British Columbia.

They are also raising questions about Health Canada's relationship with the drug industry and its role in protecting consumers from certain forms of drug advertising after the department dismissed complaints over the Abbott campaign.

Their concerns are not without consequence: Children exposed to the drug through physical contact with a man who uses it have experienced serious side-effects, including advanced bone age, enlargement of the penis or clitoris, and premature development of pubic hair.

A testosterone gel study published last year involving men aged 65 and older was stopped early after thosetreated with the gel experienced higher risks of cardiovascular problems than those treated with placebo. The drug has also been tied to other side-effects in those who take it.

The issue has attracted attention around the world among experts concerned about the impact of pharmaceutical advertising on consumers.

In June, Prof. Mintzes and about two dozen medical experts from Canada, the U.S., Britain, Australia and other countries lodged a formal complaint with the Pharmaceutical Advertising Advisory Board about the Abbott campaign, charging it breaches Canada's ban on direct-to-consumer drug ads, is misleading and potentially dangerous.

In Canada, drug companies are allowed to use the name of a product in an ad so long as they don't include what it's used for. Conversely, ads are allowed to mention a particular condition and tell consumers to speak to their doctors so long as they don't mention a product name.

Critics say the AndroGel ad doesn't fall into either category, but it directs people to a website where they can take a quiz that, in many cases, creates the impression they have a medical condition that needs treatment.

The ad "has serious potential to lead to harm to public health," the complaint letter states. "It provides misleading and inaccurate information that would not withstand any serious test of truth in advertising, and it is likely to lead to unjustified increases in health-care costs."

In a response last month, Robert Liteplo, acting director of Health Canada's therapeutic effectiveness and policy bureau, said that because the advertising campaign doesn't mention AndroGel by name, it is "difficult to conclude" the message is an ad. The website provides "fairly balanced information," and doesn't promote the gel as the only treatment option, he wrote.

Critics of Abbott's campaign say the response shows blatant disregard for drug makers' use of "awareness raising" campaigns to encourage consumers to start taking a prescription treatment, and should prompt questions about Health Canada's ties to industry.

"[Health Canada is]placing the health of Canadians in a secondary position to the health of the Canadian economy as they would see it," Prof. Schafer said.

Both Health Canada and Abbott declined a request for an interview.