(UPDATED: See below.)

genentech-logo.jpgCommitting your biotechnology giant to “the best interests of patients [and] the medical profession,” as Genentech CEO Arthur Levinson does on its his company’s Web page, is certainly a fine sentiment. When you subsequently decide to restrict use of a drug used by many elderly individuals to ward off encroaching blindness, however, you probably shouldn’t be surprised if people begin wondering whether that commitment is anything more than an empty slogan.

Restricting access to such a drug, of course, exactly what Genentech did last week, when it announced new limitations on the distribution of its cancer drug Avastin. That drug, a certifiable hit in treating colon, lung and breast cancer, has recently taken on a new role as an apparently effective — and dirt cheap — way of treating wet age-related macular degeneration, a progressive eye disease of the elderly that generally leads to near-total blindness.

The problem for Genentech is that it also sells a newer and far more expensive AMD drug called Lucentis, which runs close to $2,000 per monthly shot. By contrast, Avastin — a close biochemical cousin to Lucentis — is priced for use in far larger doses as a cancer treatment, so the tiny amount needed for injections into the eye costs only about $40 a shot.

For more than two years, retinal specialists have obtained Avastin through compounding pharmacies, which can safely divide up a large vial of Avastin into syringes for individual eye injections. Last Thursday, however, Genentech announced that it would no longer permit compounding pharmacies to obtain the drug. (Avastin is still available through wholesale distributors.) The move will almost certainly crimp the availability of the drug for the roughly half of elderly AMD patients who have been using it as an alternative to Lucentis. That drug, even when covered by Medicare or private insurance, can still cost patients $400 or more in co-payments for every shot.

Genentech dressed its decision in the corporate doublespeak that’s long been associated more with Big Pharma than Big Biotech, saying it was prompted by FDA concerns about the sterility and repackaging of Avastin. (Last time I checked, there were no actual case reports of sterility problems with Avastin use in AMD — and if there are any now, surely Genentech would have cited them.) The company also notes in its letter that “Avastin has not undergone any formal, randomized, controlled clinical trials for ocular use.” This is true, but it’s pretty rich to hear that objection coming from Genentech, which has refused to cooperate with a head-to-head trial of Avastin and Lucentis planned by the National Eye Institute.

This item ended up longer than I expected, so it continues below the fold:

More to the point, Genentech said it was taking this step because Lucentis is widely available — as if the drug giant couldn’t possibly comprehend why many patients might prefer an alternative that is both cheaper, easier to use in other eye conditions (such as diabetic retinopathy) and available without the need to deal with Genentech’s own access-program bureaucracy. In other words, of course, it’s all about money. There’s no need to take my word for it, either — Eric Schmidt, a Cowen & Co. analyst, calculated that Genentech could pull in an additional $800 million to $900 million a year should Avastin simply disappear as an eye treatment, and told the San Francisco Chronicle: “I think this is all about money…. I don’t think it’s about safety.”

It’s depressing to see Genentech — still one of the most admired biotechs in the world, with a largely justified reputation for solid science, openness and overall decency — head down this path. Unfortunately, it’s not the first time that the company has succumbed to the lure of the dark side. Starting in the late 1990s and into the early years of this decade, Genentech waged a no-holds-barred and ultimately successful legal fight to prevent its corporate partner Tanox, a small Houston biotech, from developing a drug to prevent severe peanut-allergy reactions simply because it might have one day competed with a similar Genentech drug for asthma. (I wrote about the case here. I’d use the WSJ link, but it’s subscription only.) Tanox not only ended up crushed in arbitration, it was also snapped up by Genentech — the big company’s first and only acquisition in its 31 year history, by the way — last year.

I mention the peanut case mostly because there, just as in the current situation, it’s not too hard to imagine how a softer touch might have resulted in a conflagration-defusing compromise. In the Tanox case, a settlement that preserved Tanox’s right to develop the peanut-allergy drug, but barred it from pursuing it as an asthma treatment — seemingly Genentech’s major concern — might have done the trick.

Where Avastin and Lucentis are concerned, a company that truly emphasized “the best interests of patients” would probably find a way to tolerate the status quo until results of the NEI study are ready in another two years or so. Should the data prove Avastin and Lucentis generally equivalent, a patient-centered company might even acknowledge that it bet on the wrong horse and lower the price of Lucentis in order to narrow the gap with Avastin while still maintaining an alternative for patients who don’t respond to Avastin. (This would also clearly offer a pharmacoeconomic benefit to patients, something that companies like Genentech generally favor so long as it doesn’t cut against their economic interests.)

All that, of course, might be asking a lot of a company that increasingly acts more as if it’s run by profit-maximizing bean counters than the scientist Art Levinson once was (he headed up Genentech’s research labs in the mid-1990s before getting the CEO job). If so, perhaps more people ought to point out to Levinson that his company is is starting to resemble Amgen (or the Big Pharma counterpart of your choice) in this respect — although that assumes that the company’s increasingly hermit-like CEO is still open to contrary opinion these days.

For more background, check out the NYT and WSJ stories, or this summary in the WSJ Health blog and this post at Pharmalot. The new Forbes blog offers a mildly contrarian view, although it doesn’t address the basic conundrum of being patient-centered and investor-centered at the same time.

UPDATE: Sen. Herb Kohl, a Minnesota Democrat, has asked Medicare how much it will end up spending if AMD patients on Avastin have to be moved to Lucentis (h/t to the WSJ health blog).

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  1. The biggest biotech newest this last week involves a company and greed, wait, this is not news! « HIPPOCRATech said:

    [...] can read more about the story here, here, here, here, here and [...]

  2. VentureBeat » Genentech, and the temptation of the dark side said:

    [...] which runs close to $2,000 per monthly shot. By contrast, Avastin, only cost about $40 a shot. Read the story about why Genentech has limited the use of that cheaper, very successful  drug, by David Hamilton, [...]

  3. VentureBeat » Genentech takes a step back from the dark side, delays Avastin restrictions said:

    [...] Almost two weeks ago, Genentech angered doctors and elderly patients when it announced plans to restrict access to Avastin, a cancer drug that doubles as an unapproved, but quite inexpensive, treatment for eye disease. In those conditions, which can lead to encroaching blindness when left untreated, Avastin competes with a much more costly Genentech drug called Lucentis. (For background and our take on the situation, click here.) [...]

10 Comments

  1. piotr said:

    Very interesting, if very sad, piece.
    Regeneron Pharmaceuticals and Bayer have a Phase 3 trial for their VEGF Trap in wet AMD, in direct comparison with Lucentis. Assuming things work out for them, doesn’t it mean that DNA is just trying to make a few extra bucks while it can, but the price will eventually go down?

  2. Steve Cowen said:

    This is the most one sided article I’ve seen in awhile. So much for fair balance news reporting. What’s sad is the the writer of this article who thinks this is good journalism.

    This is trash!

  3. David P. Hamilton said:

    OK, fair enough to anyone who accuses me of being shocked that a drug company might be interested in making money. Look, I wrote for the WSJ for 14 years — of course I understand that drug companies need to make a profit, and I have no problem with that. I do object to the lofty humanitarianism some companies adopt — which, in fact, frequently leads to them being offended if you don’t accept it at face value — when in fact their actions are often at odds with the “patient-centered” values they claim to hold. Maybe their corporate mission statements should all bear an asterisk referring to a footnote that reads, “So long as it doesn’t conflict with the interests of our shareholders.” At least that would be truth in advertising.

    Steve Cowen — no relation to the S.G. Cowen who founded the firm Eric Schmidt works for, I assume — I’d be happy to address your argument on the merits, if in fact you were to offer any. If you’d like to state your objections more specifically, I’d be more than pleased to address them.

  4. Irv Arons said:

    It looks like Senator Herb Kohl may come to the rescue. As Chairman of the Senate’s Special Committee on Aging, he has asked the CMS to look into the price differential between Avastin and Lucentis. (This comes from the WSJ’s Health Blog, which I have reproduced on my web Journal — on which I have been following the Avistan vs Lucentis controversy for over a year. I now have 19 postings on the subject.)

    The link to the Sen. Kohl update (No. 19) is:

    http://irvaronsjournal.blogspot.com/2007/10/avastinlucentis-update-19-us-senator.html

    David, with your publishers permission, I have also reproduced your commentary on my blog. It is Update No. 18.

    Dr. Philip Rosenfeld, the initiator of the use of Avastin for AMD thought that your writeup was particularly good — he remembers talking to you two years ago.

    Irv Arons

  5. David P. Hamilton said:

    Thanks, Irv. I’ll check it out.

    Piotr, I apologize for not responding to you earlier. The Regeneron drug could be a direct competitor to Lucentis, although it’s worth remembering that other VEGF inhibitors — specifically Eyetech’s Macugen — appear not to have worked anywhere near as well as either Lucentis or Avastin. Even if VEGF Trap is effective in wet AMD, I’d be surprised if a real price war breaks out, since we very rarely see those in the pharma and biotech industries. But that’s a subject for another day.

  6. David P. Hamilton said:

    Piotr: That’s what I get for not following your link prior to commenting. D’oh!

    Anyway, the VEGF Trap phase II data do look pretty interesting, although I believe Macugen also had some pretty impressive phase II results involving vision improvement that the company was never able to replicate in phase III. So the cautionary tales still abound.

  7. piotr said:

    I guess it is not easy to balance the best interests of patients and shareholders. I am really happy to see this discussion here, because in my view biotech and pharma are overdue for a little paradigm adjustment. Hopefully I am not the only one who is sick and tired of all the drug commercials claiming the unconditional love of the poor patient, while the real motivation is the multimillion compensation packages for top executives.

  8. Joe said:

    “The move will almost certainly crimp the availability of the drug for the roughly half of elderly AMD patients who have been using it as an alternative to Lucentis.”

    David, what was your source on this? Just curious…

  9. David P. Hamilton said:

    Joe, Genentech said in its most recent conference call that 55 percent of wet AMD patients are using Lucentis; retinal specialists estimate that the remainder are using Avastin. See the NYT link I gave at the end of the post for more.

  10. Barry Wheeler said:

    It is very interesting now to see that GenenTech’s sales of Lucentis, the FDA approved drug as a treatment for macular degeneration has declined by 6% and the sale of avastin has gone up by 13%. Having their cake and eat it too, while trying to limit avastin as a drug that can be used to treat wet macular degeneration. Corporate greed or sound business practice?

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