Unethical pharma - a non-kooky perspective
#1
I think many people here are aware of Ben Goldacre, the British doctor and Guardian writer and 'good-science' activist. He has written a new book, 'Bad Pharma' about bad scientific practices and lack of ethics in epidemiological research involving pharmas. Here is an edited extract from his book:

http://www.guardian.co.uk/business/2012/...sfeed=true

The article touches upon some specific examples of ethical lapses on the part of pharmas and the ineffectiveness of regulatory agencies in preventing these from happening. Now, such an article is likely to be co-opted by the kooks and anti-science/pseud-science activists like homoeopaths and naturopaths into their movement. However, we know very well that Ben Goldacre's point is entirely different. The conclusions of his article (and the TED talk below) are basically that there are problems in the regulatory framework for vetting new drugs before they are brought into the market. This is totally unrelated to the common the standard kooky-arguments of 'doctors are over-medicating us', etc. etc. So two questions:

1) How widespread is this 'bad science'? And ethical lapses?
2) To what extent do such problems affect patients?

This TED talk touches upon some of the same stuff:

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#2
This recently aired NDTV discussion addresses some related issues in the Indian context.

Clinical Trials: The Ethical Questions (NDTV We the People : 23rd September 2012)

Considerations:
Overarching question: How can the imperative of conducting research to address unmet medical needs and the imperative to protect vulnerable test participants, be met simultaneously?
- How informed is the consent of those volunteering as subjects in clinical trials?
- Which of the reported deaths of subjects in clinical trials are causally related to the trials?

Challenges:
- Weak regulatory framework (based on rules made in the 1940s) and weaker enforcement
- Inadequate compensation packages for 'serious adverse events' and casualties of trials
- Unfulfilled testing requirements by companies before sales (companies prefer paying fines!)
- Lack of any major discovery of drugs for India-centric diseases in the past few decades
- Alarmism and hostile judicial attitude towards clinical trials which is unmindful of the indispensability/urgency of trials

Solutions:
- Independent federal drug authority (along the lines of US FDA)
- Legal training and accreditation for practising physicians, investigators and ethics committees*
- Filming and vernacularization of the informed consent process
- Increased online availability of testing protocols

*Personal aside: Speaking of education, one thing that made my day while undergoing the mandatory training for human-subjects investigation at the university I attend, is that the tutorial featured an inset on Kant's categorical imperative! Incorporating Ethics into medical training which today seems to be viewed simply as skill-learning, is overdue.
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#3
(23-Sep-2012, 08:50 PM)karatalaamalaka Wrote: The conclusions of his article (and the TED talk below) are basically that there are problems in the regulatory framework for vetting new drugs before they are brought into the market.

Is this problem unique to big pharma? Don't we have similar problems in other industries. For instance,

Inadequate financial regulations lead to S&L crisis and the 2008 financial crash.
Lax accounting standards lead to Enron and Worldcom scandals.
Lax safety standards lead to Bhopal gas leak and BP oil spill.
And the list goes on...

IMO, the root cause of these problems lies in the gap between the goals of the corporation (maximization profits for its shareholders) and the goals of society.

May be it is time to rethink the goals of the corporation and align those with those of the society. Easier said than done because unlike the goals of the corporation the goals of society are not even clearly defined. So the gap will remain and there will be no real solution to this problem.
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#4
http://www.guardian.co.uk/science/audio/...bad-pharma

Goldacre was interviewed for an hour on guardians science weekly podcast (link above). This is more detailed than the TED talk. Thought some of you might be interested.
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#5
The following discussion, related to this thread on medical ethics, was occasioned by the movie Ship of Theseus, where one of the characters, says "Behind every medicine is animal cruelty". Historically, besides 'animal cruelty' there has been human cruelty as well that has tainted some medical knowledge (such as the contributions of Walther Birkmayer), either directly in the process of its acquisition or through association with organizations perpetrating crimes against humanity.

The following discussion is limited to a subset of the contributions of tainted discoverers, namely to discoveries of potential clinical utility. For now, let us exclude the likes of Heidegger whose work, if withdrawn from shelves citing historical taint, may not be missed in immediate workaday senses the way a missing pharmaceutical or treatment protocol maybe.

For the sake of illustration, if the community of clinicians adopts a simple utilitarian yardstick, then withdrawing or withholding treatment citing tainted origins is ruled out if such an exercise of scruples causes avoidable suffering to patients to whom it would have been potentially useful. In fact, a similar outcomes may result even from an application of the Categorical Imperative, where giving in to historical guilt and indulging in retrospective scruples to a patient's detriment may amount to a violation of the principle of treating the human person, here the patient, always as an end unto themselves and never the means. So, for the question of usage of medical knowledge acquired by whatever means, in the service of patients in most need of it, there seem to be similar conclusions reached on both categorical and consequentialist grounds.

This of course leaves unanswered the problem of whether such value-neutral adoption of 'blood-knowledge' (in the sense of 'blood diamond') amounts to participation in a retrospective amnesty-granting thus making the clinician also complicit in the outrages committed by the discoverer. Two options to respond the problem of blood-knowledge or criminal discoveries are:
(i) act as though the discovery was never made, and advocate a 'Never again!' stance towards the crimes associated with the discovery
(ii) separate the discovery from the crime, and advocate a 'Never again!' stance towards the crimes associated with the discovery

Acting according to (ii) will at least in theory do justice to both the imperative to prevent recurrence of the historical wrong, and the imperative to place all available knowledge in the service of patient care. Acting according to (i), which has in theory been found wanting already on both consequentialist and categorical grounds, is subject to a very questionable assumption that 'throwing out the discovery with the crime' is empirically more helpful that treating the crime and discovery separately on their own merits. In other words, there's no compelling reasoning to assume that 'punishing the discovery' reinforces 'punishing the crime'. The 'separation' in (ii), far from being implausible, has in fact been accomplished in recent decades by the medical fraternity through measures like the WMA Declaration of Helsinki that are informed and shaped by both the lessons of history and the demands of science.

Again this discussion has so far been limited to medical knowledge or similar life-critical settings, and one must be especially wary of 'separations' like the one recognized above, being extended conveniently and uncritically to areas like governance or wealth-creation.
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