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Confessions of a Drug Killer
TCS Daily ^ | May 8, 2007 | Charles L Hooper

Posted on 05/10/2007 9:38:40 AM PDT by Wuli

I'll just come out and say it. I'm a drug killer. I persuade companies to stop developing uneconomical new medicines. This is part of what my consulting company, Objective Insights, does to help pharmaceutical and biotech companies make good decisions about their business opportunities. Say that a drug company is developing a scientifically exciting new drug for breast cancer. We analyze that drug and tell the company whether it makes economic sense to continue development. In the past, we have suggested that drug companies pull the plug many times. We have helped kill drugs for brain cancer, ovarian cancer, melanoma, hemophilia, and other important conditions. It breaks my heart.

To understand how we work, you first have to understand how the Food and Drug Administration approves new drugs. In short, the FDA treats all new medicines as guilty until proven innocent. How does a sponsor company "prove" innocence for its new medicine?


At the end of the day, it will be my company that kills a new drug. So, yes, I'm a drug killer. But the FDA is the true drug killer. I'm merely acting out the FDA's script.

(Excerpt) Read more at ...

TOPICS: Business/Economy; Culture/Society; Editorial; Government
KEYWORDS: biotech; drugs; fda; health; medicine
The author is instructive on the processes by which the FDA drug approval/rejection system works/fails to work.
1 posted on 05/10/2007 9:38:43 AM PDT by Wuli
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To: Wuli

I’m not in the slightest bit surprised. The least studied diseases and the most undiagnosed diseases in this country are diseases that have no long-term pharmacuetical or surgical treatment.

The most profitable drugs are anti-depressents and pain-killers because they do not actually address the underlying cause of disease, but they do make living with it more bareable. They must be taken perpetually, and eventually dosages must be increased to offset growing tolerance and progressive physical decline.

And while I know socialization isn’t the answer, I don’t think the profit motive makes very much sense in medicine either. In fact, despite my strong pro-business pro-trade pro-international trade stances, I fail to see how research science can really thrive in a profit driven environment. So I have no answer, but I do see a problem..

2 posted on 05/10/2007 9:48:22 AM PDT by AntiFed
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To: Wuli
It's as if the FDA is our parent and, after a long drive to the beach, is telling us not to swim in the water because he/she isn't convinced the water is warm enough. We nod agreement and then look out to see 63 other kids happily swimming. Hmmm. Maybe we're old enough to decide for ourselves.

In 1996, I went to South America to get LASIK surgery performed on my eyes because the FDA had not approved the most modern equipment for use in the US - clinical trials on LASIK were still underway, though the technique was in widespread use outside of the US. I can foresee having to go overseas to obtain the most current treatment as I get older.
3 posted on 05/10/2007 10:04:25 AM PDT by AnotherUnixGeek
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To: AnotherUnixGeek

The FDA needs to be taken out back and put to sleep. Drug testing is a service better performed by multiple, competing private organizations hired by insurance companies. That’s exactly how most other potentially dangerous products are tested.

4 posted on 05/10/2007 11:00:17 AM PDT by BlazingArizona
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To: AnotherUnixGeek

To add to your comments, note that legislation making its way through Congress now, with high bi-partisan support, increases the FDA’s legal tools to demand reconsideration and market interventions on drugs it has already approved and which are already in use.

It’s time to have a private industry of “Drug Consumer Union” type organizations who are funded donations from the health care industry to do the independent research needed to inform doctors and patients about the efficacy and risks of any and all medicines. That’s all the doctors and patients need - the information for making an informed decision.

Over time, health care providers and practitioners and will promote themselves as institutions that only use medicines that meet approval of the “Better Medicine Bureau” (pick any name you want) - a private, not-for-profit organization with a respected history in the field.

5 posted on 05/10/2007 11:13:00 AM PDT by Wuli
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To: AntiFed

“I fail to see how research science can really thrive in a profit driven environment.”

While I fail to see how research science can really thrive in a “politically” driven environment, which is what would happen if medical drug research was mostly directed by legislation.

In fact, my point is demonstrated with current events in which the private research world continues to demonstrate, with increasing frequency, how ADULT stem cells are proving themselves in new medical treatments all the time, while the politicians and the media hide and ignore those facts while insisting that stem cell research is dead unless the public funds EMBRYONIC stem cell research.

Yet, I do recognize that “orphan diseases” have always had a hard time achieving the attention that seriously fighting them would require (diseases and medical problems where the R&D for their “cures” will be astronomical on a patient-by-patient basis - because the portion of the population with those ailments is small), but legislation has been passed, previously, to specifically fund R&D for such ailments. But, as noted in my first comment above, the choices of which “orphans” get those R&D dollars comes down to political decisions over a tax-payer funded budget for them - which would be the case, no matter what that budget amount was.

The case for those “orphan” ailments could be given greater support if it was pointed out, more forcefully and more often, that, as science often demonstrates, the process of finding solutions for them can/may/might include the discovery of basic scientific knowledge that can/may/might prove useful in as yet unforeseen areas of medical concern.

Morally, all medical practice is some form of triage - available resources + number and severity of cases = sequence in which doctors can and should (morally) give their attention to the cases they have - because, there are never perfect solutions, perfect levels of resources to at every single moment “save” everyone.

6 posted on 05/10/2007 11:36:34 AM PDT by Wuli
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