A growing number of prescription drugs share the same chemical composition, but little else.
For example, Boehringer Ingelheim sells chlonidine under 2 separate brand names — Catapres is being marketed as an antihypertensive drug, Dixarit as a vascular stabilizer for treating menopausal flushing.
And Eli Lilly's fluoxetine (Prozac) has been repackaged in a pink-pill format and sold as Sarafem to treat “premenstrual dysphoric disorder,” although some politicians and journalists speculated that the launch was a patent-extending ploy. Rights to Sarafem have since been acquired by Galen Holdings PLC.
But GlaxoSmithKline (GSK) has taken the name game a step further with bupropion. At last count, it had given the drug 4 different names. It was first marketed as the antidepressant Wellbutrin, and then relaunched as Zyban, a smoking-cessation aid. The 2 products share an identical chemical structure, but were differentiated for marketing reasons. Now, GSK will be calling Wellbutrin by a new name, Prolev, and Zyban will be called Quomem.
This was news to Biovail Pharmaceuticals Canada, which recently acquired bupropion from GSK.
“I don't believe this is the case,” said Ken Howling, Biovail's vice-president of finance. “GSK does not own any bupropion products.”
After being directed to Health Canada's 2003 notice of compliance, which shows 2 renamed bupropion products listed for GSK, Howling halted the interview.
After consulting his legal department and GSK staff, he responded: “Biovail has exclusive rights to the brand names and to bupropion as well.”
Although GSK “got the new names approved, the company has no legal right to move forward on these products nor do they have the intention to do so.” Howling says the renaming manoeuvre is a regulatory strategy designed to expedite the product transfer.
But the reason for the strategy remains unclear, since products change hands all the time without companies applying for new names. “It's complicated and I'm not sure I'm the right person to explain it,” said Howling. “From what we've been told, this is a legal game.”
GSK declined CMAJ's requests for an interview, but it did issue a statement via email that the company does not intend to market Prolev or Quomem in Canada. The email did not specify whether these would be available elsewhere. “GlaxoSmithKline filed for the name changes for administrative purposes. … Any further detail would be proprietary.”
ESI Canada, a leading pharmacy benefit management company, recently reported in its newsletter for insurers that GSK's newly named bupropion products are expected to compete with Wellbutrin and Zyban for market share. Martine Carbonneau, a pharmacist and author of the newsletter, says that while it's possible the company won't launch these products here, it is important that her clients know the prospect exists.
Krista Apse, a spokesperson for Health Canada, says pharmaceutical companies seeking to rename a product must apply for permission. When GSK's request for different product names for Wellbutrin and Zyban was approved, the drugs were given fresh identification numbers, as though they were new products. Apse says this process helps Health Canada track changes.
Dr. Joel Lexchin, an emergency physician and associate professor at York University and the University of Toronto, says that if Health Canada is going to allow companies to change drug names, it must make the changes clear to doctors and pharmacists or it is “neglecting its duty to safeguard the public.”
Lexchin, who has dedicated much of his career to studying the pharmaceutical industry, points out that drugs are often renamed, occasionally to avoid confusion but most often for marketing purposes. “If companies are trying to sell the same drug for a completely different condition, they will give it a new name to reflect this new use,” Lexchin said. (Wellbutrin speaks to being “well,” while Zyban points to smoking cessation with “ban.”)
Michael Milloy, Biovail's product manager for Wellbutrin and Zyban, says he has never been involved with changing a drug's brand name, but “changes sometimes occur due to bad press in the marketplace.”
Lexchin is worried about the impact renaming and other changes introduced by the pharmaceutical industry have on health care. “Companies are trying to turn drugs into ordinary commodities.”
Dr. Barry Power, director of practice development for the Canadian Pharmacists Association, agrees there is a risk of duplicate therapy. “This is definitely something health care professionals and patients need to be aware of. It emphasizes the importance of having one physician and one pharmacy as much as possible.” — Allison Gandey, CMAJ