By Curt Cherewayko
A class action lawsuit filed in B.C. last week against pharmaceutical giant Merck & Co. Inc. (NYSE:MRK) claims that the company’s baldness treatment is causing long-lasting sexual dysfunction in Canadian men.
The January 24 BC Supreme Court suit addresses a number of contentious issues regarding how drugs are marketed in Canada. They range from consumer exposure to United States-based drug advertising to how drugs are labelled here.
Plaintiff Michael Miller was prescribed Merck’s drug Proscar for nine months to treat male baldness.
The Vancouverite claims that he continues to suffer from sexual dysfunction today as a result of taking the drug.
Testosterone suppressant finasteride is the active ingredient in Proscar and Propecia, its sister drug.
While the two drugs are prescribed for hair loss, Proscar, which is sold in larger pills, is also prescribed to men suffering from enlarged prostate glands.
Both drugs received Health Canada market approval in the 1990s.
While the labels on the drugs in Canada warn that men might experience such side effects as decreased libido and erectile dysfunction, they say the effects are not permanent.
“We’re not saying that the drug should not be on the market,” said Miller’s lawyer, David Klein, a partner at Vancouver-based Klein Lyons. “We’re saying that the warnings should be truthful.”
Miller’s claim says that, after investigations in Sweden, Italy and the United Kingdom, Merck added permanent sexual dysfunction as a risk on the drugs’ labels in those countries, but not in Canada.
“Information has been available to and conveyed to the manufacturers for years that some men will have sexual dysfunction as a result of using this drug,” said Klein, “and some of those men will continue having the problem after they stop using the drug.”
Alan Cassels, a drug policy researcher affiliated with the school of health information sciences at the University of Victoria, said drugs are labelled in different countries according to government-regulated approval processes and the influence and interest that a pharmaceutical company has in each market
“You have different regulatory systems,” said Cassels, “and you have different ways that companies work around regulations.”
Don Enns, president of LifeSciences BC, wasn’t familiar enough with the Merck case to comment on it, but said that, even after a drug makes it through clinical trials and is approved, its developer has a responsibility to monitor its effects on consumers.
Such monitoring is called post-marketing surveillance.
“This type of monitoring is absolutely critical to the effectiveness of a drug in the long term,” said Enns.
But Cassels sees another issue in Miller’s suit: how drugs are marketed to consumers and physicians.
Canada and the United States have different policies regarding advertising drugs to consumers. Canada allows “reminder ads” that state a drug’s brand name, but exclude additional information or health claims. Drug advertising standards in the United States allow companies to provide more information about a drug’s possible benefits.
While split-run magazines ensure that magazine ads follow ad standards in each country, many U.S. television ads make it north of the border.
“They do [split-runs] with magazines, [so] there’s no reason why they couldn’t do it in television as well,” said Cassels, noting that the average American is exposed to 14 drug ads a day on TV.
In a 2001 newsletter, the Therapeutics Initiative, an independent body at the University of British Columbia that aims to provide physicians and pharmacists with unbiased information about prescription drugs, said Propecia is one of the drugs most advertised to consumers.
It also noted that the U.S.’s Food and Drug Administration found two ads for Propecia in Time magazine to be misleading.
“We’re taking a look at the advertising that the parent company Merck has done in the U.S. and the extent to which that is deceptive or misleading and has reached Canadian consumers,” said Klein. “We don’t have sense of that yet.”
According to TNS Media Intelligence, in 1998, the year that Propecia was approved in Canada, Merck spent $174,672 and $44,107 on two outdoor advertising campaigns. TNS does not state what the campaigns were for.
Merck Canada, which is named as a defendant in Miller’s suit alongside its New Jersey-based parent, told Business in Vancouver it would be inappropriate for it to comment on the case while it’s before the courts.
A man who claims to continue suffer from the side effects of Propecia operates two websites (www.propeciasideeffects.com and www.propeciaclassaction.com) through which he helps others who claim to suffer from Propecia and Proscar side effects to tell their story.
Klein said about 80 men have thus far expressed interest on the websites in joining the class action.
“We think many more will come forward now that the lawsuit been filed and word gets out,” he said.
He added that there aren’t similar suits in other jurisdictions setting a precedent in the case. Klein’s law firm has previously represented people who were infected with hepatitis C-tainted blood and, more recently, women who received false positives or false negatives during breast cancer testing at a Newfoundland hospital.