Racing To Nowhere

Merrill Goozner

Posted 2/7/12 on Gooz News

I had dinner over the weekend with a close friend who is a breast cancer survivor (her word) and a former avid participant in the annual marathons sponsored by the Susan B. Komen Foundation. Her status as a former activist was new. “Is this what we were racing for?” she said. She is skeptical by nature, and the brouhaha over Komen’s back-and-forth over funding Planned Parenthood last week didn’t make her angry. It merely flipped the switch that changes skepticism into cynicism. To paraphrase the old Phil Ochs song, she ain’t a marchin’ anymore.

Continue reading “Racing To Nowhere”

We Will Pay For Avastin

Merrill Goozner

First published 6/30/11 in The Fiscal Times:

How much should you, your insurer or the government pay for an extra month of life? How much is an extra month of hope worth, even if doesn’t extend life?

Those questions never came up during this week’s Food and Drug Administration appeal hearing on the agency’s decision to withdraw approval from the Roche-Genentech drug Avastin for advanced metastatic breast cancer. But they will be front and center in the years ahead as medical science and the drug industry continue to bring advanced cancer therapeutics to market that have only marginal effects on a devastating disease that takes half million lives a year, most of whom are elderly and receive treatment through Medicare.

Continue reading “We Will Pay For Avastin”

Lawyers and Medical Decision-Making

Merrill Goozner

First posted 6/28/11 on Gooz News

We’ve heard a lot over the years about the inappropriate role of lawyers in the medical system. The complaints usually center on trial lawyers who sue physicians for malpractice and drug companies for failure to warn consumers about unsafe drugs and devices. We’ve heard much less about lawyers who work for drug companies and try to game the regulatory system.

This latter problem was in full display this afternoon at the FDA hearing on Roche/Genentech’s appeal of the FDA’s decision to remove breast cancer from Avastin’s label.  Paul Schmidt, a Covington & Burling attorney representing Genentech, repeatedly tried to pin down FDA oncology drugs chief Richard Pazdur and his colleagues as to whether they had ever specified that replicating the progression free survival benefit seen in the first trial that led to accelerated approval would satisfy the FDA and therefore lead to permanent approval.

Continue reading “Lawyers and Medical Decision-Making”

It’s Avastin, In A Tie!

Merrill Goozner

First published 4/28/11 on Gooz News

first noted the controversy surrounding the use of Genentech’s Avastin instead of Genentech’s Lucentis for advanced macular degeneration (AMD) in 2006, shortly after the Guardian in the UK broke the story about how ophthalmologists around the world were opting for the cheaper version of what was essentially the same drug. Long story short: Genentech in the early 2000s began selling large vials of Avastin to block the formation of new blood vessels when treating colon and other cancers. Ophthamologists quickly discovered minute injections of Avastin were extremely effective in treating AMD, which involves excess blood vessel formation in the eye. The cost of small injections to break up those blood vessels was about $50 a shot. Genentech then developed a variation of Avastin called Lucentis, ran a clinical trial testing it in AMD patients, got it approved by the Food and Drug Administration, and began charging nearly $2,000 for the shots, which are needed monthly. The co-pays for seniors alone could run into the thousands of dollars a year. The National Institutes of Health, responding to a cost-driven controversy, authorized a clinical trial comparing the two.

Continue reading “It’s Avastin, In A Tie!”

The Avastin Decision: A Rational Decision Or Rationing?

JONATHAN COHN

This column is a collaboration between KHN and The New Republic.

Originally published 1/04/11 on Kaiser Health News

I respect honest disagreements about policy. You think health care reform is a bad idea? That it will run up the deficit or make it harder to find a doctor? I think you’re wrong, but that’s a reasonable debate and I’m happy to have it, just as long as you’re truthful about what you are arguing and make some good faith effort to learn the facts.

Continue reading “The Avastin Decision: A Rational Decision Or Rationing?”