Parker Waichman LLP

Glaxo Apologizes for Paid Journal Supplement

GlaxoSmithKline has apologized for failing to disclose its role in preparing content for a paid supplement to a medical journal last year. According to Dow Jones Newswires, the company has also admitted the supplement, which appeared in the May 2009 edition of the journal Urology, improperly discussed unapproved uses of its prostate-shrinking drug Avodart. While […]

GlaxoSmithKline has apologized for failing to disclose its role in preparing content for a paid supplement to a medical journal last year. According to Dow Jones Newswires, the company has also admitted the supplement, which appeared in the May 2009 edition of the journal Urology, improperly discussed unapproved uses of its prostate-shrinking drug <"https://www.yourlawyer.com/practice_areas/defective_drugs">Avodart.

While doctors are permitted to prescribe approved drugs in anyway they see fit, drug makers are forbidden from promoting unapproved, or “off label”, uses of their medications.

The Glaxo-funded supplement that appeared in Urology contained articles on prostate cancer written by several doctors. Glaxo helped develop the supplement’s content and select the doctors who were listed as authors of the articles, Dow Jones said. Some of those included information regarding clinical testing of Avodart as a treatment for men at high risk for the disease. One article also went so far as to state that Avodart “might prove to be more effective than” a competing drug, Merck & Co. Proscar, in prostate-cancer risk reduction.

Avodart is currently approved as a treatment for enlarged prostate, but the Food & Drug Administration (FDA) is still considering Glaxo’s application to market it for reduction of prostate-cancer risk, Dow Jones said.

Shortly after it was published, Glaxo’s compliance department investigated the supplement, Dow Jones said, and concluded the company should have been more up-front about its role. In July 2009, the president of Glaxo’s North American pharmaceuticals sent a letter of apology to Urology’s subscribers, saying the company should have made clear that it helped develop the supplement’s content and select the authors, and clarified its role as the supplement’s sole financial sponsor. The letter also said the article comparing Avodart to Proscar shouldn’t have made such comparisons because the two drugs never went head-to-head in clinical trials.

According to Dow Jones, Glaxo also disciplined the employees involved in creating the supplement, and made a report to the U.S. Department of Health and Human Services’ inspector general’s office. Under previous settlements with the federal government involving its marketing practices, Glaxo is required to report any possible violations of certain federal laws to HHS, Dow Jones said.

Glaxo’s advertising and marketing of Avodart has caused problems for the drug maker in the past. In February 2009, the FDA sent Glaxo a warning letter regarding a space-themed ad for the drug. At one point in the spot, an actor makes the claim that that “other medicines, they don’t treat the cause, because they don’t shrink the prostate.”

The FDA warning letter pointed out that Merck’s Proscar reduces the size of the prostate, and “has a similar indication” as Avodart. “Nothing in the labeling for Avodart suggests any specific advantage,” the FDA said.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker Waichman are the best. Thank you for being so helpful with my husband's case. They explained the case step by step. Jorge Peniche thank you so much for caring and being so nice.
Olga Dejesus
4 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value P&W worked on my 9/11 VCF claim and in retrospect I am so happy I chose them over the other firms who do the same. Ashley L. handled my claim and she was wonderful to work with. She was knowledgeable, responsive, and compassionate.
Shoshana Dornhelm
3 years ago
5 Star Reviews 150
The firm was professional, always keeping me updated on the process of the case until it was finalized. I would recommend their services.
Overta Smith
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038