September 17, 2008

The Process of Bringing New Drugs To Market


An interview with Alan J. Milbauer, a retired vice president from AstraZeneca and partly responsible for Seroquel, about what goes into the process we're all angry about.





How were decisions made about which drug should be developed?

Mr. Milbauer: We were a company dedicated to finding breakthrough drugs, but we could not afford to put all of our eggs in that basket. So, we needed to consider many factors beyond the breakthrough potential when we chose a drug for further clinical development.

...One example is the drug Zoladex (goserelin) a one- or three-month injectable depot used to treat prostate cancer. This injectable LH/RH analogue suppresses testosterone and might obviate the need for surgery in some cases. Initially, we thought our market would be the oncologists but quickly realized that our real targeted physician group was urologists. Well, urologists are surgeons and we were introducing a treatment that was an alternative to surgery! Although we believed we had a treatment that was good for patients, we had to convince the urologists to store an injectable drug, get reimbursement from third-party insurers, including the Federal government, and forego surgery.

Observe that in this example, the actual efficacy of Zoladex worked against it: the doctors who would use it were, in fact, least likely to want to use it.  Do you think they were bad doctors, corrupt and only out to make money?  No.  their paradigm was cut, cut, cut, even though easy efficacy in a medication was staring them right in the face, they couldn't see it, really see it.  Like trying to convince a vegeterian to try a burger.  "No way can this be as good as what's been working for me.  I'll stick to what's worked for me so far."

But that's the problem, exactly: medicine is practiced by what works for the doctor, not the patient.

How do you change a mini-paradigm like this, when doctors are resistant to data, journal articles, logic?  What has to be done is this:

We identified key opinion leaders to work with our drug and ultimately we changed some of their perceptions and practices.
Medicine is not science, it is politics.  It is no different than a lobbyist convincing a senator to vote for ANWAR drilling vs wind power subsidies, or both.

The most poignant part of the interview was at the end:

Looking back on your years in the pharmaceutical industry, what was the most challenging part of your job?

Mr. Milbauer: Sometimes I had to convince senior management to drop a drug from development because, in our commercial judgment, the product was unlikely to be successful. The reasons could have been competitive positioning or the amount of commercial resources required, pricing issues, dosing or safety issues, or patient acceptance...but those reasons frequently did not matter to the scientists who had been advocating for the drug. I found myself having to persuade people who had spent many years developing "their" compound that it was not in the company's best interest to pursue the drug, and often these people had difficulty accepting the corporate perspective. But, it was a business after all.

Before you misread this as "money trumps science" go back and re-read the rest of this post.  These scientists are not advocating for the cure for AIDS.  It could be another Zoloft, or another Celebrex, or another Viagra.  What matters to the scientists was that it was their drug, their discovery, their child, sometimes the scientists were vehemently advocating for a drug that was neither important nor profitable.

Part of the problem is that scientists are incentivized on gaining FDA approval, and not future sales OR usefulness.

And that's why the model must change.














Comments

Fascinating, thank you!... (Below threshold)

September 17, 2008 5:53 PM | Posted by Joanne Cacciatore: | Reply

Fascinating, thank you!

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Well, I think the more I po... (Below threshold)

September 18, 2008 4:09 PM | Posted by unkommon sense: | Reply

Well, I think the more I post on here the more I seem pro pharm. For the record. I am just a resident and have NO finicial ties to anyone.( I barely have finances.) I think there is plenty wrong with the pharm-medicine relationship, I just think we focus entirely on the wrong problems.

But what I dont understand is how do we change this model of development you are talking about? It seems to me that if drug companies wanted to develop a new market or break a drug into an existing market i.e a certain specialty, the best way would be to educate the doctors on the promise of their product. But the general train of thought is that if pharm says so it must be biased and faulty info, regardless of the strength of the data.

How are you supposed to get new drugs or medical techniques to the doctors who use them when doctors are discouraged to have any involment with the people who manufacture these therapies?

Its like wanting a better built house, but not wanting Lowes to advertise to carpenters.

Check out www.nokommonsense.blogspot.com

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Whistleblowers, I think the... (Below threshold)

September 19, 2008 11:24 PM | Posted by therapyfirst: | Reply

Whistleblowers, I think they are one of the true heroes in our society. And we treat them like shit, because they get labeled as traitors or selfish because they allegely have some agenda to go against their former employers/leaders.

honesty, integrity, and directness. Not the traits we sell as a culture and society in this millenium, eh?

When the full, true story of what the pharmaceutical industry wound up pursuing is told, shame will be the leading example.

Sad, isn't it, doctors? And I am one.

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the whole saga of the pharm... (Below threshold)

September 23, 2008 10:02 AM | Posted by Diane Abus: | Reply

the whole saga of the pharma hype,promotion and pressure on folks to accept this skewed "reality"(including in some places and with some drugs)forcing these is a national scandal in America and elsewhere.i wait for this one to errupt as force(violence) only can
end in scandal.

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"But that's the problem, ex... (Below threshold)

September 28, 2008 12:05 PM | Posted by BipolarBunny: | Reply

"But that's the problem, exactly: medicine is practiced by what works for the doctor, not the patient."

I don't like a lot of what you write here, some of it is irrelevant to me, but it's little gems like this, reading a doctor actually admitting something like this, that's what keeps me coming back. It makes me feel a little less insane to read you as a doctor making the same observations I as a patient have made and shared with psych doctors only to have them deny every single time face to face. I'm sure they knew I was right as well and that's why I've gotten so much attitude. If they believed that I was wrong and there was no truth to it, I doubt I would have been on the recieving end of so much defensive BS.

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so good .Thanks for the inf... (Below threshold)

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its absurd that people brin... (Below threshold)

November 4, 2011 2:32 AM | Posted by Railroading : | Reply

its absurd that people bring in new medicines and focuses on the market instead of helpingrailroading on the sickness.

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