A Test For Older Eyes

I’m participating in a conference this week at Hofstra University on Long island that brought together a small group of experts from industry, academia and the government to discuss conflicts of interest in medicine and how it affects government regulation of the drug industry.

Last night, Rep. Maurice Hinchey (D-NY) spoke about his Food and Drug Administration reform bill (HB 2090) that would create an independent safety department within FDA (separating it from the new drug approval arm); put industry user fees in the treasury to insulate the agency from the subtle pressure that comes from having industry pay your salary; and ban conflicts of interest on Food and Drug Administration advisory committees, among its excellent, far-reaching provisions.

A major discussion point at several points during the sessions was the failure of the FDA to insist that industry carry out post-approval trials, which are required when there is some question about the long-term safety of a new drug prior to entering large-scale use. In addition, a number of physicians in the audience complained about the paucity of information that compares newer drugs to what’s already on the market so physicians can make the best and least costly prescribing decisions for their patients.

Borrowing a proposal made five years ago by Princeton University economist Uwe Reinhardt, I asked Hinchey if he would support a small levy on prescriptions to fund such trials, perhaps through a new institute at the National Institutes of Health.

A 1 percent surcharge would raise over $2 billion a year and go a long way toward covering the cost of the most pressing of these comparative effectiveness trials (a large scale trial on a widely used class of medicines can cost $100 million or more). While that sounds like a lot, it’s just 7 percent of what NIH spends every year.

A perfect example of the need for such trials was reported this morning in the New England Journal of Medicine. A new trial comparing Genentech’s new drug for macular degeneration (a condition that gradually robs the eyesight from about 155,000 senior citizens a year) to an older laser procedure showed the drug, ranibizumab or Lucentis, was vastly superior. Unfortunately, Genentech is charging $1,950 per shot for this biotech drug (it’s a monoclonal antibody that inhibits the formation of new blood vessels that cloud the eye). Even under the new Medicare drug plan, seniors will have to pay about $400 a month out of pocket for this treatment.

Ophthalmologists have discovered an interesting alternative to this new product. It’s one of Genentech’s old products. Avastin, which is also an anti-angiogenesis drug used for colon cancer, appears to work just as well. And while Avastin costs $4,400 per treatment as a cancer therapy, the vials used for chemo contain nearly 100 times the volume needed to treat macular degeneration. By using Avastin off-label, rather than Genentech’s newer drug, doctors can charge their patients just $17 to $50 a shot.

So far, the use of Avastin has spread through case reports in the medical literature and word of mouth (and some good reporting by Andrew Pollack of the New York Times). No one has conducted a controlled clinical trial proving that this blood vessel formation inhibitor works. No one has compard Avastin to Lucentis.

The company certainly isn’t interested in conducting such a trial. Here’s what Hal Barron, the Genentech’s chief medical officer, told the NEJM: "We have a huge database suggesting that Lucentis is very effective and very safe, so we are just not sure of the value of taking something that is not formulated for the eye and subjecting patients to a randomized trial when there is, in our opinion, a very low likelihood of its being superior.”

Writer Robert Steinbrook concluded:

Since late 2005, the National Eye Institute has been considering a proposal for a prospective multicenter trial that would compare ranibizumab directly with bevacizumab. Although the institute has signed off on the need for a trial, as of mid-September it was still considering the research design and how to pay for the study, which would probably cost tens of millions of dollars. If the study is to go forward, the federal government will probably have to buy both drugs from Genentech. And the investigators will probably have to submit to the FDA an investigational new drug application for intravitreal bevacizumab. Such a comparison might not ultimately affect the difference in price between the drugs, but it is certainly the only way to determine which drug is better for patients.

Last night, I asked Hinchey if he would support a small tax on prescription drugs to support such trials. Stupid me. I used the T-word (tax). Hinchey bristled and said he thought drug prices were high enough.

Even if this hadn’t come up during election season, I suspect even the most liberal members of the House and Senate will shy away new taxes for worthy trials, given the precarious state of the nation’s finances. Should the Democrats win back the House and Senate (which is a growing possibility because of the Foley scandal), those pushing for worthwhile programs – like comparative effectiveness testing for new and existing drugs – will need to eliminate some other programs.

To this morning, I’m officially changing my position, which I articulated in the last chapter of my book. I am no longer for a small tax on prescription drugs to fund comparative effectiveness trials. I think the NIH should eliminate some wasteful programs. Perhaps a good place to start would be the $2 billion NIH spends on researching cures for obscure potential bioterror agents since there is no evidence that anyone anywhere in the world (except the U.S. government) is doing research on these agents.

Posted by gooznews at October 5, 2006 07:37 AM