Tag: industry

Uncategorized

The Impossibility of the Inert: Placebo and the Essence of Healing by Thomas J. Csordas

The concept of placebo is predicated on the opposition between active and inert, deploying this opposition to assert that an action or substance with no inherent active principle can have a paradoxical effect “as if” it were active.1 My thesis is that there is no such thing as the inert in human affairs, relationships, or experience. Think of the apparently simple retort of the bullied child that “sticks and stone may break my bones but names can never hurt me.” Contrary to this retort, names can indeed hurt. They are not inert, but carry an actual force identifiable as hate or disdain. And what of the retort itself? Is it a vain, desperate, and ultimately inert act of self-protection, effective only insofar as it taps into the “as if” logic of the placebo? I think not, though like any remedy it must be applied under the right conditions and with the understanding that it may not be uniformly effective in the degree to which it buffers the noxious influence of name-calling with an equivalent, self-confident force of self-esteem. There is also, however, an easily overlooked element of materiality in the retort. That is its rhythm: the fact that it is phrased in trochaic meter. It is not only that meter adds the force of incantation or song, but that it directly engages the embodied existential immediacy of the situation, contributing an element of jauntiness encompassing not only tone of voice but posture and gesture.

The notion of materiality as I have just used it is of value in reflecting on the impossibility of the inert.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

FDA Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed to it. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

Two Random Thoughts about Health Care Policy and Justice

I haven’t yet read the Senate Republicans’ draft health care bill, just out today.  Until I do I’m not going to comment about it directly.

The matter is a bioethics concern solely from the perspective of justice, really.  What is the wisest, most just policy?  And here one is forced, I think, into a fairly utilitarian assessment of what approach provides the best outcome for the country overall?  In that, we can allow for a “priority concern” for pool or relatively poor folks, allowing a weighting of factors in their favor.  In fact, I’m all for that.

But two thoughts.  First, I and others tend to argue that we should reform Medicare and Medicaid and not just leave them as they are, because to do so is to ratify their demise into bankruptcy or unaffordability.  That argument is open to two charges: that it assumes that forecasts of rapid demise are reliable, and that preserving the programs, in a sustainable form, favors future generations at the expense of the current ones.  On the latter, to wit:  Most people would agree that “my” (i.e., someone’s in general) duty to people close to them (like spouse, children) is greater than to a stranger.  But can we not say the same thing about generations?  Isn’t our duty to people already among us greater than, say, our envisioned duty to our grandchildren and great-grandchildren, even if they are ours and not someone else’s?  I suppose that one might argue that.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

Jeremy Howick, The Philosophy of Evidence-Based Medicine, Wiley-Blackwell, 2011

The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel concept of evidence-based medicine is based on hierarchies of evidence from opinions of respected authorities, mechanistic reasoning (pathophysiologic rationale), and reports of expert committees at the bottom to various levels of observational studies and finally to randomized clinical trials (RCTs) at the apex of the pyramid. Since RCTs provide the most rigorous testing of therapies, they are the gold standard. When treatments long believed to be safe and effective are subjected to RCTs, many turn out to be as useless as the quackery of snake oil or as harmful as mercury. So, attention to RCTs as the evidence informing clinical judgment and practice is perhaps analogous to results of rigorous experiments in physics which turn out to be very different from our intuitions. Everyone, it seems, is on the bandwagon, from medical societies and pharmaceutical companies to general practitioners and surgeons, in the quest for an evidence-based practice.

Since evidence-based medicine was conceived with the practical aim of improving the efficacy of medicine, it does not appear that there is much of philosophical interest in the concept until one raises the epistemological question, as Jeremy Howick does in this book: What is the evidence for evidence-based medicine philosophy of evidence (9)?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

by Craig Klugman, Ph.D.

Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies. The President’s “Drug Pricing Innovation Working Group” is staffed by many current and former industry lobbyists. While the federal government is deliberating, some states are already acting.

Last week, Nevada passed a law that requires pharmaceutical manufacturers to disclose the prices, profits, and discounts of insulin.…

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

Access to Physicians’ Prescription Habits

Jean-Christophe Bélisle-Pipon calls attention to issues of accessibility and transparency related to the collection and sale of physician prescribing data by data solution companies.

__________________________________________

QuintilesIMS is a data solution company that provides services to the pharmaceutical industry. In 2002, the company was authorized by the Commission d’accès à l’information du Québec to receive and make use of personal information held by Québec pharmacies about physician prescribing practices, provided that: 1) specific professional acts were not linked to specific professionals; 2) physicians could refuse to have their information used; and 3) use of the information was restricted to reaching out, informing and training physicians. Data related to physician prescribing practices is sold by Québec pharmacies to QuintilesIMS. In turn, QuintilesIMS collects, collates this data and sells it to pharmaceutical companies for marketing purposes.

Recently, information related to QuintilesIMS business practices were leaked to the media.

Allegations have been made suggesting that data detailing the prescribing practices of 7,000 Québec physicians (including identifying information) have been disclosed to pharmaceutical companies. If proven true, this would represent an unauthorized practice, that contravenes the Act respecting the protection of personal information in the private sector. The issue at stake in the allegations is not the disclosure to companies, but rather, the disclosure of identifying information.

Physician prescribing data must be clustered in groups of 30 that have similar prescribing profiles. Thus, it is impossible in Canada (contrary to the US) to have access to individual physician prescribing profiles. In Québec, physicians can opt out of this data collection, and those who allow their information to be used, freely have access to their own prescribing profile.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

“NOW’s interest in pharmaceutical gender equity seems to have disappeared with its funding.”

There’s a remarkable piece on the Hastings Center’s blog by Alycia Hogenmiller about a drug called Addyi.  Addyi is a drug that doesn’t work to treat a condition that doesn’t exist, pushed by campaigners who are actually industry shills.

Sprout Pharmaceuticals, run by Cindy and Robert Whitehead, was determined to obtain regulatory approval for flibanserin (Addyi), an antidepressant-turned-aphrodisiac that had already twice failed to gain approval by the FDA.  To create this fake feminist campaign, Sprout hired Blue Engine Media, a PR firm that created a sham organization called Even the Score. The campaign hired two feminists: a former director of the FDA Office of Women’s Health, and the former president of the Women’s Research and Education Institute – both well-known to women’s groups.  Even the Score recruited and paid consumer advocacy groups to pressure the FDA into approving flibanserin for Hypoactive Sexual Desire Disorder – a condition previously created by industry to sell another drug.

I want to know more about those people hired.  What were they thinking?  What did they think they were doing?  What weren’t they thinking?

It’s sad to see advocacy groups become mouthpieces for pharma.  It is even sadder when those mouthpieces are feminist groups that should be protecting the interest of women but instead are protecting a company’s bottom line.  Every single one of the advocacy groups that don’t take money from pharmaceutical companies opposed Addyi’s approval and use.  For example, the National Women’s Health Network, the Jacobs Institute for Women’s Health, the National Center for Health Research, the Reproductive Health Technologies Project, and the New View campaign all publicly opposed the drug before and after approval.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

Guest Post: Crispr Craze and Crispr Cares

Written by Robert Ranisch, Institute for Ethics and History of Medicine, University of Tuebingen

@RobRanisch

Newly discovered tools for the targeted editing of the genome have been generating talk of a revolution in gene technology for the last five years. The CRISPR/Cas9-method draws most of the attention by enabling a more simple and precise, cheaper and quicker modification of genes in a hitherto unknown measure. Since these so-called molecular scissors can be set to work in just about all organisms, hardly a week goes by without headlines regarding the latest scientific research: Genome editing could keep vegetables looking fresh, eliminate malaria from disease-carrying mosquitoes, replace antibiotics or bring mammoths back to life.

Naturally, the greatest hopes are put into its potential for various medical applications. Despite the media hype, there are no ready-to-use CRISPR gene therapies. However, the first clinical studies are under way in China and have been approved in the USA. Future therapy methods might allow eradicating hereditary illnesses, conquering cancer, or even cure HIV/AIDS. Just this May, results from experiments on mice gave reason to hope for this. In a similar vein, germline intervention is being reconsidered as a realistic option now, although it had long been considered taboo because of how its (side)effects are passed down the generations.

The developmental history of genome editing reveals itself as a recalibration of ethical standards in research. Two years ago, the first-time use of these new tools on (non-viable) embryos in China led to a solid scandal; in retrospect, it is not clear anymore whether the outrage was triggered by ethical concerns or by the circumstance that this (perceived) taboo was broken by China of all countries.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

In Calls for Repeal Comes Opportunity for Universal Coverage

by Craig Klugman, Ph.D.

According to the conservative press, the Affordable Care Act is failing. They point to the number of insurance companies that have withdrawn from the marketplaces including Ohio, where there are 20 counties with no plans available. They point to rising premiums and co-pays, and consider the experiment a failure that must be repealed. Of course, they are not considering the cost savings that preventive care provides in the longer term or the improved quality of life in having medical care. Those reports also ignore that the federal government has been giving confusing messages, rolling back the supportive regulations and subsidies, and that the healthcare industry is trying to adapt to a shifting landscape. Nor do they talk about the lowest rate of uninsured ever, the increase in people able to see doctors, the decrease in hospital’s unreimbursed care, the decrease in national health care spending, and the decreasing inflation rate of medical costs.

In a recent meeting between the executive and (Republican) legislative branches, there is a renewed call to repeal the Affordable Care Act. What is a state to do that has to create a budget and does not know what the health care laws will be or even what federal funds might be available for helping provide care? Some states are not waiting around for repeal and replace but are taking matters in their own hands. New York, California, and Nevada may soon be on the way to single payer health systems. And if Republicans are true to their states rights roots, then letting states design and run their own systems should be a good thing.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Uncategorized

A Drug Quintupled in Price.

Now, drug industry players are feuding over the windfall. Amid public concern over spiking drug prices, a powerful middleman is suing a tiny drugmaker over unpaid rebates and fees. The maker calls the suit baseless; analysts say the suit offers a window into an opaque world

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.