Might be of interest to some in the course!

http://www.msfaccess.org/about-us/media-room/press-releases/indian-supreme-court-delivers-verdict-novartis-case

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Pharmaceuticals have a more active social life than me.

Nathan Greenslit discusses the idea of a chemical drugs’ social identity. With the added lens of a drugs social life, there becomes two different statements you can make about a drug that has been remarketed. “Fluoxetine hydrochloride is an antidepressant later also marketed for use as a treatment for PMDD” or “Flouxetine hydrochloride was originally marketed as an antidepressant and later also marketed for treatment for PMDD.” Greenslit’s article unpacks the idea that the very identity of what a chemical compound if can be completely socially constructed. From the standpoint of the physician another distinction needs to be made, do different illnesses react differently to the drugs, making them equally effective, or is it the drug that happens to work for both. Does it work for either? Are the illnesses really different? Greenslit states that the deciding factor as to whether a drug is rebranded or just repurposed for a different illness is whether the illnesses have symbolic incompatibility. He notes that OCD, depression and anxiety seem to be conceptually related whereas depression and PMDD are kept in different categories. It seems so very unmedical, unscientific to have the uses of pharmaceuticals dictated by branding and marketing. It is hard to tell whether it would be more ethical, or just more intuitive to only use the generic brands and have physicians and studies dictate which individuals would benefit best from them.

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Prozac, Sarafem, and Philosophy of Language

The article by Greenslit presents an interesting case to which considerations from philosophy of language, especially Saul Kripke’s theory of names and rigid designation, is applicable. According to the article, ‘Prozac’ and ‘Sarafem’ are both names for the same pharmaceutical substance, fluoxetine hydrochloride, but while fluoxetine hydrochloride is marketed under the name ‘Prozac’ as an antidepressant, it is marketed under the name ‘Sarafem’ as a treatment for premenstrual dysphoric disorder (PMDD). Thus, while Prozac and Sarafem are chemically identical pharmaceutical products, they are marketed as treating different medical conditions, with the result that many consumers of Prozac are unaware that they are also technically consuming Sarafem, and vice versa. Now, if ‘Prozac’ and ‘Sarafem’ are reasonably treated as distinct proper names denoting the pharmaceutical substance fluoxetine hydrochloride, then according to Kripke’s philosophy of language, the names ‘Prozac’ and ‘Sarafem’ will be rigid designators that denote the same entity, fluoxetine hydrochloride, in every possible world (in which fluoxetine hydrochloride exists). In this way, it will be necessarily true that Prozac is Sarafem. But in the actual world, while the name ‘Prozac’ is associated with the definite description ‘the drug that treats depression’ (or something comparable), the name ‘Sarafem’ is associated with the distinct definite description ‘the drug that treats PMDD’, which explains the phenomenon (in terms of philosophy of language) of how individuals in the actual world can consume the denotation of ‘Prozac’ without knowing that it is also the denotation of ‘Sarafem’, and vice versa. In this way, the fact that Prozac and Sarafem are chemically identical but commercially different pharmaceutical substances can be described by means of ideas from Kripke’s philosophy of language.

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we really don’t need drugs…

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A Noteworthy Discrepancy

An interesting observation made by Jill Fisher in her article Ready-to-Recruit or Ready to Consent is the attempted shift in marketing bracket made by the CRO’s. The author notes that currently the Phase I of clinical testing tends to be dominated by low-income men, whereas Phase II and III is mainly composed of subjects without health insurance and particularly white women. It seems clear given the examples of television commercials promoting clinical testing, that the CRO’s are attempting to evolve their image in order to attract more middle class participants to the trials. The likely reason for this is that the main consumers of the pharmaceuticals will in all likelihood be affluent middle and upper class individuals, and so for this reason the best way to confirm their efficacy is to test them on the people who will be using them.
However I believe this attempt is unlikely to succeed because it stands in contrast to the conclusions the author comes to regarding the reasons people involve themselves in clinical testing. Fisher essentially concludes by stating that the majority of subjects involve themselves in the study because they do not have access to the necessary health insurance which would allow them standard treatment, they are excited about the prospect of access to medicine because they are uneducated about the nature of clinical testing, or they simply do it exclusively for the money. All of these are reasons which are unlikely to correspond to the situations of middle class individuals. For this reason it is almost inevitable that the new drugs will be clinically tested on the exact kinds of individuals who will not be using them, a fact which I can see having some affect on the eventual success of the drug in question.

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Comment on “Ready-to-Recruit” or “Ready-to-Consent” Populations?

A good introductory piece by Jill Fisher, and too much to comment on in 250 words. I’ve decided to focus on the significance of recruitment times and the state of accrual. In the clinical trial context, meeting accrual targets is make-or-break, regardless of the trial phase. The state of being: “ready-to-recruit” is valuable to the success of any given clinical trial. Investigators are under much pressure to accrue subjects. Sometimes there are financial gains in the form of per-case-funding, in other instances, investigators might have an invested interest in the success of the study and so they are eager to accrue. In all cases, if a trial doesn’t accrue quickly enough then it will likely stop before meeting its accrual targets. Sometimes the data can be salvaged, and sometimes currently enrolled subjects can continue receiving experimental treatment, but these are optimistic outcomes.

Potential subjects create an ethical dilemma in the clinical trial context. If a patient is terminally ill, and has exhausted standard treatment options, then participating in a clinical trial may be one of the few remaining options. There may be ‘promising data’ that suggests that this particular patient may benefit. An investigator is also likely aware of the significance this patient may have to the overall success of a trial. Technically, other patients who are currently participating are counting on more patients to join. Perhaps those patients aren’t aware of this, but they are in a way participating in a groupon like system, where the subjects only ‘benefit’ if others join in. It’s conceivable that an investigator’s role can be conflicted when balancing the interests of currently participating subjects, the potential success of a study, and the potential enrolment of a patient.

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Drug money

As we continue with our theme of clinical trials, Jill Fisher examines the recruitment practices for drug testing on human subjects. She does this through analyzing advertisements as well as three cases of why individuals choose to participate in these trials.  While there may be several reasons motivating the subjects to participate (mainly surrounding self-interest), her underlying argument is that informed consent is insufficient. She also maintains that by providing participants with some form of compensation, it creates an environment that attracts a vulnerable population.

While I do agree with Fisher in some respect, I argue however that her paper is somewhat overarching. She maintains that in order to solve this issue of (lack of) informed consent a, “reevaluation of the structural conditions in the United States that make clinical trial participation necessary for these groups” (890).  This entails a reconstruction of not only the United States medical system, but possibly the capitalist structure as a whole. I do understand the problematic nature of clinical trials with respect to the ready-to-recruit population, however, in order to change this, their either needs to be an abolishment of incentive or an abolishment of the poor. I believe that even if the problem of informed consent was solved in the manner Fisher proposes, incentive will continue to triumph as the motivating factor. The two major issues that Fisher outlines are thus too deeply entrenched in our society and cannot be solved within the medical community alone. 

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