Who’s to Blame for High Drug Prices?

I received this comment today:

“Dr. Folk,I'm not following your logic about "Congress throwing a monkey wrench
into capitalism". It seems to me that this whole problem is Genetech's doing,
not that of any federal or government agency.”

Let me give you the short and unthoughtful answer first. Medicare will pay drug companies their asking price for new and unique drugs. If Apple had charged $4000 for the iphone, their sales would have decreased. If the iphone had been a Medicare benefit, however, Apple would have gotten the $4000. Genentech charges $2000 and they get it. Bausch & Lomb charges over $20,000 for the Retisert™ implant which is a small piece of plastic containing a tiny amount of steroid that is implanted into the eye. It is a ludicrous price but Medicare pays it which of course means that taxpayers pay for it.

The thoughtful answer though, is that Congress has sidled the FDA with a lot of new rules and regulations. The FDA demands that a drug company must prove their new drug is both safe and effective before they will approve it. Drug companies may have to spend a hundred million dollars or more to bring a drug to market and most of the drugs they develop never make it to market. The current system also delays the introduction of a new drug by years, and kills drugs that may be worthwhile but have a small market. Yes, drug companies could reduce the amount they spend on advertising or executive stock options or perks to doctors but we also want them to make enough money to keep developing new drugs. Lucentis® and Avastin® are miracle treatments for wet AMD and we should thank Genentech and their wonderful scientists.

Dr. Marianette Miller-Meeks, the Past President of the Iowa Medical Society and a practicing ophthalmologist, thinks the FDA should make sure that a drug is safe. That’s it. Safe. She thinks the market will prove whether the drug works.

This may sound risky but a drug company would be foolish to spend millions on a drug that doesn’t work. And doctors and patients would find out quickly if a drug didn’t work. There were no trials comparing Avastin with Macugen®, which was the first drug used for wet AMD. Macugen was FDA approved; Avastin wasn’t. Yet retinal doctors switched from Macugen to Avastin within weeks. Why? Because Avastin worked better. Should we have waited three or four years for the results of a clinical trial? Of course not.

We now are beginning the Comparison of AMD Treatment Trial which will compare Avastin to Lucentis in 1200 patients. This is an important trial but should the FDA wait two years for the results in these 1200 patients to give its approval when Avastin has already been used in hundreds of thousands of AMD patients world wide? Should the FDA wait even though articles documenting Avastin’s success in AMD appear almost monthly in peer reviewed journals? Of course not. The market has already shown that Avastin works.

Now we have Genentech trying to force retina doctors to use Lucentis and we have retina doctors who are very angry with Genentech. And the patient is stuck in the middle. The ophthalmology community should work with Genentech to get the FDA to fast track approval of Avastin as a treatment for AMD. Genentech can provide Avastin to ophthalmologists in a single dose vial at a reasonable charge. Genentech will still make a tidy sum. But most importantly, doctors and patients will have a choice, a choice they can make based on the best available evidence.