Monday, January 16, 2017

Interesting book on the pharmaceutical industry

First, a disclaimer. I have not read the whole book--and am excerpting from a story on it.

Second, I am using this because the new president is already lining the industry up in his Twitter crosshairs. So this industry will come up again, I bet. Maybe a little background will provide context.

The book is Prescription for Change by Michael Kinch, director of the Center for Research Innovation in Biotechnology at Washington University in St Louis.

The book starts with early research--primitive then--just to determine that a drug was not a poison. One early antibiotic was mixed with antifreeze--106 children died.

Then began the struggle between innovation and regulation--and the world of patent extensions, me-too drugs, generics, pay-for-delay, orphan drugs, and compendum expansion.

For example, companies gamed the system by gaining FDA approval for an orphan drug (to treat a rare condition) and then did a small clinical trial, leading to its being approved for a larger population (market)--this is call compendium expansion.

Still, Kinch contends this is not dark--that the high cost of bringing a new drug to maker--$2.6 billion--is to make sure the drug is safe.

But these high costs led to companies buying each other and dismantling their own research, Instead they get new drugs from the biotech sector--where 2/3 of the drugs have originated in the last decade.

Now, those biotech companies are failing.,

At the same time, three crises are looming:

--Antibiotic resistance. If one drug stops "working," and there is no other, then what.

--Resistance to AIDS drugs. One in five patients on the drug cocktail keeping them alive has a virus resistant to one of the five drugs in the cocktail. Even of the 10 drug companies doing this research have stopped.

--Alzheimer's. Fully 99.6% of drugs to treat this failed clinical trials. Many companies have pulled back on this research.

So now what? We need to look at all aspects of how drugs are created. One idea is to eliminate costly Phase III clinical trials. Bad idea? Worth the risk? What IS the risk? And toxicity is only one aspect--what about effectiveness?

I would add--would the new president's vow to negotiate lower prices with these companies under some new health scheme he has play into this mix--which many in the industry call "The Valley of Death"?

Still, I see more research into individualized treatment keyed to genetics, new methods of  pain control. We cannot give up, that's for sure.

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