Free To Choose Medicine

[From: Bart Madden (2011.06.29.0700 CST)]

This is my first post on CSGNET. I have studied most all of the PCT books and have an interest in the application of PCT to economic problems in general, and in particular, the way of thinking about economic activity that PCT offers.

Briefly, my work has focused on financial economics and systems thinking, which was summarized in a 2010 book, Wealth Creation: A Systems Mindset for Building and Investing in Businesses for the Long Term, see www.LearningWhatWorks.com/papers/madden_9780470488683_rev.pdf.

Currently, I work on public policy issues with particular attention to a proposal to restructure the FDA to give patients far greater control of health options, while simultaneously making genuine progress in achieving the system goal of better drugs, sooner, at lower cost. For more background information, see www.freetochoosemedicine.com.

I would greatly appreciate comments/criticisms from a PCT perspective about the Free To Choose Medicine plan that is summarized in the paper listed below, available at http://ssrn.com/abstract=1868610.

Work is underway to introduce a Free To Choose Medicine bill in Congress along the lines of this paper. What have I missed?

Bart

SHARED VALUE FOR PATIENTS AND PHARMACEUTICAL COMPANIES

···

Bartley J. Madden

www.LearningWhatWorks.com



Abstract


The U.S. drugs-to-patients system fails to achieve its overall system goal of better drugs, sooner, at lower cost. The key constraint that impedes achieving this goal is the FDA’s enormously expensive and time consuming clinical testing process. Fixing this constraint should be a strategic objective of the pharmaceutical industry. This objective is achievable through the Free To Choose Medicine plan, which would empower patients, advised by their doctors, to make informed decisions about whether to use approved drugs or new drugs in late stage clinical testing. Free To Choose Medicine would, in general, greatly increase the pace and effectiveness of pharmaceutical industry
innovations, and in particular, shift resources to the most skilled firms in developing breakthrough medicines. Free To Choose Medicine legislation would implement a dynamic, self-adjusting system focused on benefiting patients through fast-paced learning in ways that the FDA’s randomized control trials cannot accommodate. The result would be substantial shared value for patients and pharmaceutical companies.

Please do not post this electronic file on the web. Instead, reference

http://ssrn.com/abstract=1868610. Readers will then receive the most recent version of this paper.

Thank you,

Bart Madden

[Martin Lewitt 2011 June 29 0720 PDT]

[From: Bart Madden (2011.06.29.0700 CST)]

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          Work is underway to introduce a Free To

Choose Medicine bill in Congress along the lines of this
paper. What have I missed?

The proposal looks like an improvement over the current system.  I

have concerns that pharmaceutical companies may be unwilling to ramp
up production prior to FDA approval, and that it may be difficult to
find doctors willing to take the time necessary to be informed.
I’ve already found that MDs are notoriously slow to become up to
date on newly approved drugs, or new off label uses of approved
drugs, so asking them to be informed drugs in clinical trials may be
burdensome to the MD and expensive for the patients and insurance
companies. Perhaps the proposal can be improved by making it clear
that the MDs role need be no more than agreeing to file the
paperwork and monitor for side effects. It would save the patients
considerable time educating their physicians, if the physicians role
did not have to be advisory.

The paper discusses the concerns raised by the FDA monopoly, but it

might help seed ideas, if other measures to reduce the negative
effects of that monopoly were also discussed. For instance, many
other medical systems around the world are nearly as respected as
the US medical system, perhaps physicians should be allowed to
prescribe or pharmacists to sell drugs approved in any one of a
specified set of other medical systems. The FDA will then be off
the hook politically in many instances, and risks irrelevancy if it
is too cumbersome.

-- Martin L

Bart

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On 6/29/2011 6:18 AM, Bart Madden wrote:

FROM [Bart Madden (2011.06.29.0920 CST)]

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From: Martin Lewitt mlewitt@COMCAST.NET
To: CSGNET@LISTSERV.ILLINOIS.EDU
Sent: Wed, June 29, 2011 8:33:38 AM
Subject: Re: Free To Choose Medicine

[Martin Lewitt 2011 June 29 0720 PDT]

On 6/29/2011 6:18 AM, Bart Madden wrote:

[From: Bart Madden (2011.06.29.0700 CST)]

*** snip ***

Work is underway to introduce a Free To Choose Medicine bill in Congress along the lines of this paper. What have I missed?

ML: The proposal looks like an improvement over the current system. I have concerns that pharmaceutical companies may be unwilling to ramp up production prior to FDA approval, and that it may be difficult to find doctors willing to take the time necessary to be informed. I’ve already found that MDs are notoriously slow to become up to date on newly approved drugs, or new off label uses of approved drugs, so asking them to be informed drugs in clinical trials may be burdensome to the MD and expensive for the patients and insurance companies. Perhaps the proposal can be improved by making it clear that the MDs role need be no more than agreeing to file the paperwork and monitor for side effects. It would save the patients considerable time educating their physicians, if the physicians role did not have to be advisory.

BJM: Firms are motivated to earn revenues up to five years before any FDA approval. This is especially important for small biotech firms with limited financial resources. Early demonstration of effectiveness with large Free To Choose Track usage would be reflected in higher stock prices of the drug developers; again, very important for small firms with high skill but limited financial resources.

Free To Choose Medicine (FTCM) is quite similar to off-label drug use in which doctors exchange information in an unregulated environment to their patients’ benefit. The proposed Tradeoff Evaluation Database would greatly facilitate the evaluation of not-yet-approved drugs. Moreover, firms like Google, IBM, and Microsoft would be motivated to priovide Consumer Report-type products that further aid pateints and doctors in making decisions.

I think it is important that doctors play a key role in advising their patients in order to obtain better treatment outcomes. Also, the FTCM legislation needs to grant immunity to drug developers and doctors due to adverse side effect from Free To Choose Track drug usage. It is critical that patients be fully informed as part of this process, which, in my opinion, involves the advice of their doctors.

ML:The paper discusses the concerns raised by the FDA monopoly, but it might help seed ideas, if other measures to reduce the negative effects of that monopoly were also discussed. For instance, many other medical systems around the world are nearly as respected as the US medical system, perhaps physicians should be allowed to prescribe or pharmacists to sell drugs approved in any one of a specified set of other medical systems. The FDA will then be off the hook politically in many instances, and risks irrelevancy if it is too cumbersome.

BJM: There have been many proposals to reform the current system, including your suggestion of using foreign country approval. The FDA is not receptive to these ideas, or any ideas that dilute their control over the process. The history of fast track… accelerated approval… etc. is that the FDA “interprets” legislation with regulations that invariably serve its need to control the clinical testing process. The result being ever more extensive and expensive randomized control trials. FTCM differs from other reform proposals in that it would be operated independently of the FDA. It is plausible that once people experience much greater control over their health treatment decisions, it would be extraordinarily difficult for politicans to remove that freedom. The faster the pace of medical innovation, the higher the
opportunity costs from the FDA’s extraordinarily slow approval process. That cost is currently hidden, but would be plainly visible if FTCM were functioning

– Martin L

Bart

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