Wednesday, January 23, 2008

Avastin/Lucentis Update 21: Canadian Healthcare Struggles with Avastin vs. Lucentis Controversy

As reported in Tuesday’s Globe and Mail, Canadian federal officials from Health Canada are struggling with the decision of whether to approve Lucentis or Avastin for the treatment of wet AMD. The federal officials are facing pressure from Novartis Pharmaceuticals Canada Inc., which sells Lucentis in Canada, and other interest groups (funded by Novartis) to provide public coverage of Lucentis, despite the widespread use of Avastin by Canadian ophthalmologists.

A drug policy researcher at the University of Victoria, Alan Cassels, said, “What is in the public interest here conflicts with what is in the private interest.”

The Common Drug Review, a federal body responsible for determining whether drugs merit coverage on provincial health plans, rejected Lucentis for coverage late last year.

But the application is being reconsidered at Novartis' request, and a final decision is expected today Although the Common Drug Review makes recommendations about which drugs should qualify for coverage, provinces still make their own decisions.

Novartis said it's important for patients to have affordable access to Lucentis because it's the "first and only" treatment that can improve the vision and quality of life of those suffering from wet macular degeneration.

In an e-mail, the company responded to the use of Avastin to treat the eye disease by saying, "it is not approved for intraocular [in the eye] use and is not indicated for treatment of AMD [age-related macular degeneration]."

But to Mr. Cassels, an outspoken critic of the marketing practices of drug companies, the mounting pressure being placed on the government to fund expensive Lucentis treatments is a disturbing example of the industry's push for higher profits at the expense of affordable medication. "It would be reasonable to promote the use of the cheaper version," he said. "This is about public health versus private interest."

For the complete story, please follow the Globe and Mail link:

Macular degeneration: The battle over two drug treatments

CATT Study Update 5: First Official Listing of Clinical Trial Sites

Please see the update, posted on January 26, 2008, below.

The National Institute of Health officially listed the CATT Study on its web site today. The site contains information about the study, including its purpose; primary and secondary outcome measures; a description of the four treatment arms; eligibility; and a list of contacts and locations where the study will be undertaken.

However, the web site only lists 17 clinical trial sites, instead of the 46 or 47 that were supposed to participate. I have queried the principals to determine why the discrepancy.

In the meantime, here is the link to the web site:

Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

January 26, 2008

I have heard back from the sponsors of the CATT Study, who have provided me with updated information, current as of January 26, 2008.

The sites listed on the website were those with signed contracts with the University of Pennsylvania, the home of the CATT Coordinating Center, at the time of submission of information, January 3, 2008. UPenn currently has 24 centers under contract and the website will be updated shortly. It is my understanding that at least 45 clinical sites are expected to participate in the study.

I was also told that recruitment for the CATT Study will get underway on February 1st.

In addition, I was told that UPenn had received documentation that their first batch of re-packaged Avastin vials had passed all FDA-required release testing yesterday (January 25th) and the Center will begin shipping those vials on Monday. The Avastin was purchased through the UPenn Pharmacy and are using a cGMP facility that specializes in aseptic preparation of drugs. As previously noted, the CATT Study has not been affected by the changes in distribution proposed by Genentech.

I will keep providing updates as I receive them.