Issues

IS PHARMA DEAD TO US

 

I WROTE this back in 2009, with references that relate to events around that time. Neverthesess the article still reads fresh and current. Thus ...

Everything seemed to happen at once: Patients and doctors seeing through the Pharma hype, blockbuster meds losing their patent protection, and no new meds coming out of the pipeline. No longer with any financial interest in influencing psychiatry, Pharma virtually backed out of the game. And with mega lost revenues from loss of patent protection, Pharma may lack the resources to ever get back in it.

Bottom line: Due to their arrogance and stupidity, Pharma fully deserves what's coming, but do we?

In short, how the mighty have fallen. Until just a short time ago, it seemed that Pharma would remain forever at the top of the mental health food chain. Technically, they still are, but we are clearly witnessing the beginning of the end.

I started to see the signs around 2006 at the American Psychiatric Association's annual meetings. Certain manufacturers were not exhibiting, nor were they sponsoring symposia. The reason was clear: Their current stock of meds had gone off-patent, with no new ones on offer.

The handwriting turned up on the wall even earlier at DBSA conferences I attended. Gone were the frills, such as the canvas conference bags with the GSK logo and the ice cream breaks. A quick comparison of DBSA annual reports two years apart reveals an obvious stampede to the exits.

The DBSA 2005 report lists one $500,000-plus donor - Wyeth. The 2007 report lists none. Over the same period and earlier, DBSA has been weaning itself off of Pharma, casting further afield for funding and grants, but the result has been a starvation diet.

Psychiatry's make-over may prove far more beneficial. Not too long ago, you couldn't throw a stone in the direction of a psychiatrist without it bouncing off at least 10 Pharma hacks. Their tentacles were everywhere: In research, in publishing, in professional education and continuing education, in universities, in hospitals, right into the very sanctity of the psychiatrist's office.

Now, on all fronts, they are disengaging. We are already beginning to see signs of reform in the profession. It's going to take time, but one hopes the final outcome translates into patients being able to take the word of their doctors at face value.

I know what you're thinking: With Pharma gone, where are all the new meds going to come from? Let's define "new," namely something that is not an updated version of an old technology. By this criteria, Pharma has not come up with a new psychiatric med in the last 50 years. To give you one example: J&J's Invega is Son of Risperdal which in turn is based on the ancient Haldol.

It's as if the people running Detroit have been moonlighting as Pharma CEOs.

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.

Here's the Catch

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.

 

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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 more than 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 fairly 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.

A Smart Drug Company? Holy Crap!

A 2009 Business Week cover story featured Novartis, apparently the one drug company not as dumb as Detroit. The good news is that new smart management there may provide a new model for badly needed new drug development. The bad news is that none of these drugs are likely to be psychiatric meds.

Novartis is the one drug company headed by a medical doctor, Don Vasella. The others are dominated by lawyers and accountants and marketers who fail to appreciate science and who have forgotten who their true customers are. According to Business Week:

Most big drugmakers shower their research and development funds on diseases such as cancer or depression, where huge potential markets beckon despite a deficit of scientific understanding. In recent years this approach has led to high rates of failure when drugs are tested in clinical trials.

In contrast, seven years ago, Novartis embarked on a policy of pushing drugs through testing and development only if they were backed by proven science. It didn't matter that the particular diseases the drugs treated were rare. In the words of Dr Vasella: "If you are guided purely by financial estimates and not the science, you end up wasting time and money."

Novartis' Gleevec was initially approved for a rare blood cancer that strikes just a few thousand people a year, but has since proved effective against six other diseases. Last year, the drug pulled in $3.7 billion in sales.

The idea is that although there are 24,000 genes in the human genome, there are only a few dozen pathways that are shared by virtually all diseases. The trick is to track down all the links in a pathway, then locate the key signals that switch genes on and off.

In the development phase at Novartis is a drug to treat a rare inflammatory disorder called Muckle-Wells syndrome, involving a single gene variation that may be implicated in other illnesses. Thus, the rare diseases may shed light on a host of other illnesses and hold the key to future drug discovery.

Here's where the drug industry's blockbuster/me-too mentality has left us, according to Business Week:

Experts say drug companies have exhausted the easy targets. With patents on many older blockbusters starting to expire, the industry is poised to lose an estimated $140 billion in sales to generic competition over the next five years. Those revenue sources must be replaced.

Despite multibillion-dollar research budgets, none of the top companies has a wealth of promising compounds in its development pipeline. The industry also faces regulators more vigilant than ever about safety, as well as health insurers starting to balk at covering costly drugs that bring only modest benefits.

Dr Vasella shook things up when he moved Novartis' main global research operation from Basel, Switzerland to Cambridge, MA, and got a Harvard cardiologist to run it, with a brief to turn things upside down. Under the new order, scientists stared calling the shots rather than executives in sales and marketing.

The men and women in suits fought back hard, but ultimately more than a thousand sales and marketing execs were purged and medically trained scientists brought on board.

Here's the catch: Our current scientific understanding of mental illness would not meet Novartis' rigorous standards for green-lighting new drug development. According to its 2008 Annual Report: "Diseases affecting the brain and central nervous system pose exceptional hurdles in drug discovery."

All our current psychiatric meds are the result of serendipitous discovery, based on old technologies. They get some of the people somewhat better some of the time, and we have no idea why. The drug industry made vast sums of money essentially putting old pills in new bottles. That era is just about over.

The new era would involve finding the precise illness pathways that cause specific mental illness symptoms and figuring out which gene variations are involved. Forget about a treatment for all of depression. Rather, it might be more productive to uncover the underlying mechanisms to, say, lack of motivation. Maybe only a small percentage of depressions involve lack of motivation. But maybe such a drug would get a lot of these people a lot better a lot of the time.

Maybe, also, this motivation drug would help with other diseases and conditions that involve lack of motivation, such as various neurological ills. Maybe also various fatigue ills, and maybe even the flat affect symptoms of schizophrenia.

And maybe the best way of testing the drug would be to first try it on some really rare disease that only two people in the world know anything about, and then branch out.

Would your typical drug company be interested? No way.

Might Novartis be interested? Fingers crossed ...

See also: Sayonara Pharma.

First published as two separate blogs, Jan 2009, revised as an article Jan 14, 2011, reviewed Dec 2, 2016.

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