Monday, May 11, 2009

Pharma and Biotech: No Practical Solution Yet

I concluded my last blog piece on this downbeat note:

So, where are the new meds going to come from? Don't bank on Pharma. They got out of drug development - assuming they were ever in it - at least a decade ago. Hopefully, new players looking to make profits based on innovation will fill the vacuum.

In the meantime, it's as if Pharma doesn't exist. Those meds you are taking right now? Probably generic from generic suppliers. Get used to them - these will be your only choices for quite some time.

An article by NY Times business journalist Lawrence Fisher appearing in the quarterly publication, The Milken Institute Review, provides the lowdown:

In theory, "biotech" is where the innovation is supposed to be coming from. As opposed to Pharma, which is rooted in ancient chemistry, biotech is all about sexy proteins and genes and stuff. These are your go-go companies founded by brainy people using smart-money venture capital. Think Genentech, Amgen, Gilead.

One catch: Take these three companies out of the mix "and the cumulative return on investment over the life of the sector was negative even before the financial markets' collapse."

In hindsight, it's easy to see why. It takes ten years to bring a new drug to market, but the way the game is set up investors need to see returns in five years. We're talking on average a billion-dollar stake in a high-risk crap shoot where nine out of ten compounds in development fail.

Not surprisingly, innovation-rich and cash-strapped biotech turned to innovation-poor and cash-rich Pharma. Unfortunately, the marriage didn't quite work out as planned. As Lawrence Fisher explains:

"Pharma ideally seeks companies with products on the market close to receiving approval. But most biotechs are risk years away from that goal, and those that are closest often come with substantial infrastructure and big employee bases that the majors neither need nor want."

Then, there's the matter of niche vs one-size-fits-all drugs. It's a question I have been asking virtually the entire ten years I have been writing on mental health, and I have yet to receive a satisfactory answer.

We know, for instance, that antidepressants work really well for about one-third of those who take them. But what about the other two-thirds? We need more flavors aimed at different palates. But Pharma is not set up for that. Plain vanilla spells blockbuster, their license to print money.

Biotech is all about the sophisticated niche meds we badly need. But who wants to roll the dice on a high-risk, low return product? Thus, when biotech meets Pharma worlds collide.

The two somehow need to figure out how to work together, most likely with government partnership. Foundation money and NIH grants are keeping the biotechs on a Ramen noodle diet for the time being, but this isn't going to last forever. Meanwhile, Pharma has run out of products, together with its license to print money.

And here we are, stuck with meds based on technologies that were considered new when Eisenhower was President.


Gina Pera said...

Interesting post, John. Thank you.

You wrote: "We know, for instance, that antidepressants work really well for about one-third of those who take them. But what about the other two-thirds? We need more flavors aimed at different palates."


The irony here is that many of the (alleged) clinicians posting at blogs such as Carlat's are making things worse. They criticize new medications as being a cynical pharma marketing plot. These (alleged) clinicians betray their utter incompetence, not to mention lack of compassion for patients who are "atypical" and who just might be helped by that new variant.

I wonder what will happen with discovery at Genentech with the Roche merger. I understand that lay-offs are planned at the Palo Alto division.

John McManamy said...

Hey, Gina. Agree. My big complaint with Pharma is they haven't come up with the next-generation meds (say, a "smart" dopamine med as opposed to all the "dumb" dopamine meds we've got).

But rather than the same tedious whining and complaining you see on all these blogs, we need to be setting our own agenda and agitating for more research dollars, government support of new meds development, etc.

Mental health advocates are a pretty sorry lot when compared to other health advocates. Imagine if the cancer advocates were to put out shit that cancer doesn't exist. Then cancer research funding would be as pathetic as ours.

Read the comment by Pat Risser on my piece about Top Mental Health Stories. There he is, a leading advocate making the astounding claim that mental illness doesn't exist.

No wonder we are where we are.

Gina Pera said...

Sorry John, I am creating a new moratorium on responding to attention-seekers such as the one you mention. What's that about trying to teach a pig to sing? ;-)

They aren't interested in compassion or reality. They are interested in their own conflict-provoking, self-medicating agendae, IMHO, and exploiting vulnerable people in the process. Frankly, they've worn me out. But I resent like heck how they are populating the Internet like rabbits.

Don't even get me started on the social-science academics who still subscribe to the "blank slate" theory and churn out books on how-they-took-X-normal-human-behavior-and-turned-it-into -a-disorder.

They must feel so marginalized, obviously not having many science courses under their belts. And, frankly, they probably don't get out much and talk to real people.

Actually, I don't know which is worse....these academics or prescribing psychiatrists who are too lazy to learn about effective medication protocols. They've "winged it" all these years, letting Big Pharma ply their egos and pay for their lunches and education (as if we EVER get a well-rounded view of a product from ANY marketing department). Then when they didn't get good treatment outcomes, they decide to blame Big Pharma! That would be an improvement over blaming the patient ("treatment resistance") but they do that, too!

Consequently, people who had held out hope from these medications were sorely disappointed. And, no doubt, they are the more vocal members of the anti-psychiatry/anti-pharma army. I feel for them -- their rage is often justified if misplaced and misinformed -- but they are making it worse for everyone else.

Keep up the good work, John. Love your blog.

John McManamy said...

Many thanks, Gina. Interesting twist. In my experience, psychiatrists listen to the drug reps way more than they listen to their patients. Of course, when the med doesn't work, they blame the patient. It never occurred to me that these lazy doctors might turn around and blame Pharma.

Never themselves, of course.

And, of course, the patient loses. Bad psychiatry, unfortunately, is antipsychiatry's best friend. There are too many bad psychiatrists, which means a lot of disenchanted patients.

I've heard their stories. I fully empathize. My beef is with the people who exploit their rage. I want psychiatry to succeed. The nihilists want psychiatry to fail.

Glad you're on my side.