The Unhealthy Side Effects of Mixing Medicare with Big Business

Cancer drug shortages in the United States are putting lives at risk, especially when treatments require regular dosages over extended periods of time.  Alice Park of Time Magazine writes:

In late February, when Divers called the hospital to confirm Alyssa’s upcoming chemotherapy treatment, the nurse informed her that there was a drug shortage. The hospital couldn’t be sure that there would be enough methotrexate — the cornerstone of therapy for some childhood cancers, including leukemia and osteosarcoma — to treat Alyssa, now 10. Divers was told she might have to reschedule the session; the hospital would let her know. “It made me sick to my stomach to hear that,” says Divers, a former chaplain from Palmyra, Va. “Alyssa was in treatment for over a year already, and the last thing you want to do is add unnecessary delays in treatment, which gives the cancer a chance to catch up.” Divers explains that her daughter’s cancer doubles in tumor load every 34 days, “so you need to hit it again and again to eradicate it.” (See article)

And this is just one of the many cases.  But what is causing these shortages?  Although this is not the whole story (since the big picture is a bit more complicated, including procedural issues with FDA inspections), a substantial portion of the problem is caused by the economics of drug supply.  One thread of the economic story goes something like this: in order to make chemotherapy treatments easier for patients, doctors began offering infusions in their offices rather than in hospitals.  The 2005 reimbursement scheme, however, allowed doctors to be reimbursed at a 6% profit.  The problem was that the reimbursement price lagged behind the market prices by six months, which made the reimbursements lower than what the doctors paid for the drug, essentially pushing some physicians to prescribe pricier brand name drugs.  This, in turn, amounted in lower orders of generic drugs, which further shrank the market.

“In order to gain market share, companies underbid the market to get the business, and it’s a race to the bottom,” says Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. “Whoever is the last company standing can’t charge enough to make a profit on the drug and to make needed investments to keep making the drug.” That’s what may have happened with the methotrexate that Alyssa Divers depends on. (See article)

To add to this incredible situation, once the drug shortages were publicized, doctors started receiving offers from distributors, with stockpiled stashes of the harder to get drugs, who were very happy to sell the medicines, charging “$800 to $900 per gram for a medication that normally costs $16” (see article).

I guess that one way to respond to this is to blame the government for its untimely reimbursement policy, which certainly makes me wonder (why is there a six month lag in the first place?).  What really puts a bad taste in my mouth, however, is how intimately the production of pharmaceuticals is linked to the administration of treatments that use certain drugs.  When a profession views itself as essentially helping humankind by caring for human well being and health and when the societal respect is accorded to this profession for such reasons, it is more than disheartening to find out how closely some such professionals can resemble mere pedlars of life when viewed in light of their business connections to pharmaceutical companies (which seem to have no moral qualms about charging 56 times the market worth of a life-saving medicine).

The DSM Drama (“Part V”)

Dr. Stefan P. Kruszewski, in an opinion piece written for ABC News entitled “Doctors’ Conflicting Interests Can Cost Money and Lives, and Hinder Medical Discoveries,” warns against the danger of medical practitioners recommending specific drugs as part of treatment while being paid to speak, advocate, and do research for the companies that manufacture them.

After writing a letter expressing concerns about such practices to the Journal of American Medical Association, the associate editor responded (via e-mail) by shrugging such concerns off as trivial.

During the review process, an associate editor at the journal asked the question (and inadvertently copied me on an email that had been sent to another associate editor), “What’s the big deal? What’s all this [expletive deleted] about conflicts of interest?” (see link)

Kruszewski, however, thinks such practices are actually very dangerous.  He writes:

But I do worry, because drug promotion and clinical decision-making that are brokered on the backs of dollar bills have a greater chance of causing serious adverse outcomes, including illnesses and death. If a physician embellishes the effectiveness of a drug or minimizes its risk, that directly hurts you and me.  Physicians who are heavily supported by pharmaceutical companies and medical device makers are not forming independent, unbiased decisions. Instead, their brains have been lined with gifts, perks and money, which influences their rose-colored opinions. (see link)

The conflict of interest does not stop at Dr. Kruszewski’s worries and the problem he points to can unfortunately be traced to the DSM (The Diagnostic and Statistical Manual), which is an authoritative taxonomy of mental disorders.  Worries of financial conflicts plagued the fourth installment of the DSM (the DSM IV) and with the DSM V on the horizon, similar criticisms are voiced.

The manual, published by the American Psychiatric Association, details the diagnostic criteria for each and every psychiatric disorder, many of which have pharmacological treatments. After the 1994 release of DSM-4, the APA instituted a policy requiring expert advisors to disclose drug industry ties. But the move toward transparency did little to cut down on conflicts, with nearly 70 percent of DSM-5 task force members reporting financial relationships with pharmaceutical companies — up from 57 percent for DSM-4. (see link)

The greatest risk of conflict of interest remains with the taxonomizing and eventual diagnosing of disorders that are intimately linked with the manufacturing of drugs intended to treat these disorders.  Katie Moisse writes:

Some of most conflicted panels are those for which drugs represent the first line of treatment, with two-thirds of the mood disorders panel, 83 percent of the psychotic disorders panel and 100 percent of the sleep disorders panel disclosing “ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry,” according to the study. (see link)

This is not to suggest, of course, that medical professionals have malicious intent or that they are only interested in the health of their own bank accounts.  However, there remains a serious worry about the taxonomy itself as well as about future diagnoses and treatment.  To add to the turbulent atmosphere surrounding the DSM V, the introduction of certain new diagnoses has also been criticized.

The DSM-5 has also drawn criticism for introducing new diagnoses that some experts argue lack scientific evidence. Dr. Allen Frances, who chaired the revisions committee for DSM-4, said the new additions would “radically and recklessly” expand the boundaries of psychiatry.  “They’re at the boundary of normality,” said Frances, who is professor emeritus of psychiatry at Duke University. “And these days, most diagnostic decisions are not made by psychiatrists trained to distinguish between the two. Most are made by primary care doctors who see a patient for about seven minutes and write a prescription.” (see link)

I think we have a serious problem on our hands if drug companies get to determine the taxonomy of mental disorders and medical doctors diagnose and prescribe drugs in accordance with the financial interests of these drug manufacturers.  Even if things are not as bad as they sound, they seem to be getting worse (“with nearly 70 percent of DSM-5 task force members reporting financial relationships with pharmaceutical companies — up from 57 percent for DSM-4”).  Should we start going to the accountants of pharmaceutical companies for advice?  Now that would be absurd, but if pharmaceutical companies have as much sway over what is defined as a mental disorder and what treatment is pursued as Moisse suggests, then perhaps we might as well just bypass the middleman (the local mental health professional) and go directly to the source!  Why are individuals who are directly funded by drug manufacturers allowed to make executive decisions on the DSM V?  James Scully, APA director, sees no other way.

APA medical director and CEO Dr. James Scully insisted the DSM-5 development process “is the most open and transparent of any previous edition of the DSM.”  “We wanted to include a wide variety of scientists and researchers with a range of expertise and viewpoints in the DSM-5 process. Excluding everyone with direct or indirect funding from the industry would unreasonably limit the participation of leading mental health experts in the DSM-5 development process,” he said in a statement. (see link)

Lisa Cosgrove, associate professor of clinical psychology at the University of Massachusetts-Boston is of a different opinion:

Cosgrove said she believes there are plenty mental health professionals with no financial ties to drug companies. If necessary, experts with conflicts could still participate in the process as non-voting advisors, she said.  “My best hope would be for the APA to respond in a substantive way to the concerns we’ve raised,” she said. “They have an opportunity here to make a correction that would give the appearance, if not the reality of developing a diagnostic instrument that’s objective and has integrity.” (see link)

I hardly think that the mental health professionals with no financial ties to drug companies live at or just above the poverty line, so why, unless a researcher is explicitly doing research for a certain pharmaceutical company, does the profession open itself to such criticisms by allowing the kinds of practices Kruszewski and Cosgrove object to?

Carl Elliott on Human Subjects and Big Pharma

from the NYT, July 28th, an Op-Ed piece by bioethicist Carl Elliott:

LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not?

Here is the complete article.

Euthanasia Hearings Begin in Quebec

Euthanasia, always a controversial topic, is about to get alot of media attention again…

From CTV.ca

As public hearings on the controversial topic of dying with dignity get underway in Quebec, the chair of the committee expects debate to become emotional.

Quebec Liberal MNA Geoff Kelley says it’s been 17 years since B.C.’s Sue Rodriguez brought the issues of mercy killing to the fore, when she fought all the way to the Supreme Court for the right to kill herself. And though the court eventually ruled against her, the debate has never gone away, he says. Continue reading

Experimenting on the vulnerable at Columbia University

Last week the New York Times and LA Times reported violations of FDA mandated dosage levels in the chemicals used in clinical PET (positron emission tomography) studies at a major lab, the Kreitchman PET Center, at the Columbia University Medical Center.

Most people who participate in experimental studies of drug treatments are vulnerable–either via poverty, mental illness, other disability, race–and while they consent to participate.  That consent carries with it an acknowledgment of a higher risk, but it’s also based on the basic trust that the studies are at least in accord with federal and other regulations (e.g., university research ethics boards approvals, when done in university environments).

The practice of chasing “willing subjects” to all corners of the globe became widespread as these approvals onshore became harder to gain for domestic populations, a story told in The Constant Gardener that had at least one kind of less-than-fully-evil outcome, as reported last year by The Independent.

So what is going on at Columbia University? (apart from damage control by their administration)  Below the fold is the LA Times article; here’s the link to the original article, and here’s a h/t link to the AHRP blog post by Vera on this story. Continue reading

What sorts on psychiatry

Here are a few What sorts posts on psychiatry

Does anyone remember “lobotomy”?

Is your dog on prozac?

Marcia Angell on Big Pharma

NYT on DSM-V

Defending Electroshock

What sorts of people?  Empathy deficit disorder–do you suffer from it?

Pride in maddness–the new visibility

Lennard Davis on SSRIs

Over at his blog column at Psychology Today, distinguished disability theorist Lennard Davis has just posted “Five Reasons Not to Take SSRIs”. Selective Serotonin Reuptake Inhibitors, the best-known of which is Prozac, have been massively prescribed for the past 15-20 years by doctors and psychiatrists, especially for depression. Davis begins:

For the past five years, and in my recent book OBSESSION: A HISTORY, I have been questioning the effectiveness of Prozac-like drugs known as SSRIs. I’ve pointed out that when the drugs first came out in the early 1990’s there was a wildly enthusiastic uptake in the prescribing of such drugs. Doctors were jubilantly claiming that the drugs were 80-90 per cent effective in treating depression and related conditions like OCD. In the last few years those success rates have been going down, with the NY Times pointing out that the initial numbers had been inflated by drug companies supressing the studies that were less encouraging. But few if any doctors or patients were willing to hear anything disparaging said about these “wonder” drugs.

Now the tune has changed. …

To read the full post, click here.

Regenerative Medicine

In this post, I pointed to a new technique for regrowing limbs that makes use of “Pixie Dust” to accomplish the seemingly impossible: regrowing the entire tip of a man’s finger.  It prompted the question, “Could we do more?”  To find out, watch this short video from Newsweek.  It features Shilo Harris, a man who suffered the loss of two fingers and extensive burns durring an IED explosion and a discussion of both the treatment he received and the progress that was made.

An End to Disability?

Well, some kinds anyway.

Current medical technologies in the field of regenerative medicine have regrown the severed tip of a man’s finger (about a 1/2 inch) in 10 days.  With some refinement those who have lost entire limbs or who have suffered severe burns and/or scarring may also be given new hope… or would they?  I don’t think this is as clear cut an issue as it may first appear.

For many people their physical abilities and physical form are a huge part of who they are.  Giving this up to become “normal” may not be the obvious choice that many likely believe.  Nor is it clear that this would be a good thing, either for those facing the choice or the rest of us.  A richness of perspective and a host of other benefits are brought to the world as a consequence of there being people of differing abilities.  Whether it is something as commonplace as the installation of a wheelchair ramp that doubles as a bike jump or as world changing as the rise of the modern intensive care unit in response to the polio epidemic of the twentieth century* there are benefits to heterogeneity that would be lost in a world of normals.

I think the first response of our world would be to “heal the suffering” and to “save those in need”.  We’d see those who would refuse treatment as being slightly crazy, in the same way that parents who choose to keep children classed as severely disabled as being crazy (see this previous post for a chilling example), thereby giving us cause to step in an take make the choice that they are not in the right mind to make.  I admit that this is my initial response.  But in my gut I also have another hope, namely that some of those whom we would force our help on, either physically or through subtler forms of violence and oppression, will have the strength to hold us off—we never know what’s coming for us and if we should have learned anything at all from studying evolution it should have been that a diversity of ideas and people are the best way to play the odds.  Or perhaps I’m totally out to lunch?

Medical technology really does open a Pandora’s Box of ethical questions and moral trials, doesn’t it?

To read the original article about regrowing a finger with “Pixie Dust” as reported by the BBC, just click Continue reading

CFP: Disorderly Conduct (July 24-26, 2009)

CALL FOR PAPERS
Interdisciplinary Conference
July 24-26, 2009
Wilfrid Laurier University and University of Waterloo
Waterloo, Ontario, Canada

Keynote speaker: Dr. Steven Angelides, Department of Women’s Studies, Monash University

Other featured speakers will be confirmed for the release of the official conference announcement to follow.

DEADLINE FOR SUBMISSIONS: February 27, 2009
The conference, “Disorderly Conduct” will bring together scholars from around the world and from such disciplines as sociology, philosophy, health studies, history, women’s studies, and medicine to explore and problematize the notion of a “disorder”. The conference seeks to bring front-line medical and mental health personnel who treat various “disorders” together with humanities, social science and health and disability studies scholars who work (in one way or another) on theoretical questions related both to specific “disorders” and to the notion of a disorder simpliciter. In workshops and symposia, conference participants will engage questions like the following: Continue reading

Marcia Angell on Big Pharma

From the latest NYRB, here’s the start of Marcia Angell’s review of three recent books on medicine and money, with a focus on psychiatry, DSM, and Big Pharma:

Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn’t had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard’s Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age. Continue reading

NYT on DSM-V

A few snippets from Benedict Carey’s recent New York Times article Psychiatrists Revise the Book of Human Troubles on the ongoing revisions to the Diagnostic and Statistical Manual of Mental Disorders, expected to be published in 2012:

Is compulsive shopping a mental problem? Do children who continually recoil from sights and sounds suffer from sensory problems — or just need extra attention? Should a fetish be considered a mental disorder, as many now are? Panels of psychiatrists are hashing out just such questions, and their answers — to be published in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders — will have consequences for insurance reimbursement, research and individuals’ psychological identity for years to come. The process has become such a contentious social and scientific exercise that for the first time the book’s publisher, the American Psychiatric Association, has required its contributors to sign a nondisclosure agreement.

You can read the whole article right here.

Call for Contributions: Feminist Disability Studies and/in Feminist Bioethics

NOTE FROM ST: Readers of the blog may notice that I have posted this cfp to the blog several times.  Please excuse the repetition, but I am keen to get many submissions for the issue which should be pathbreaking.

 

CALL FOR CONTRIBUTIONS

TO A SPECIAL ISSUE OF

 

INTERNATIONAL JOURNAL OF FEMINIST

APPROACHES TO BIOETHICS (IJFAB)

Vol. 3, no. 2, Fall, 2010        

 

From the Margins to the Center:

Feminist Disability Studies and/in Feminist Bioethics

 

Guest Editor,  Shelley Tremain

 

In recent years, work done in mainstream bioethics has been challenged by the emerging field of disability studies.  A growing number of disability theorists and activists point out that the views about disability and disabled people that mainstream bioethicists have articulated on matters such as prenatal testing, stem cell research, and physician-assisted suicide incorporate significant misunderstandings about them and amount to an institutionalized form of their oppression. 

 

While some feminist bioethicists have paid greater attention to the perspectives and arguments of disabled people than other bioethicists, these perspectives and arguments are rarely made central.  Feminist disability theory remains marginalized even within feminist bioethics.  This issue of IJFAB will go some distance to move feminist disability studies from the margins to the center of feminist bioethics by highlighting the contributions to and interventions in bioethics that feminist disability studies is uniquely situated to make.

 

The guest editor seeks contributions to the issue on any topic related to feminist disability studies and bioethics, including (but not limited to): 

Continue reading

Call for papers: Skin, Culture and Psychoanalysis

Edited by Sheila L. Cavanagh, Rachel Hurst and Angela Failler
Deadline for submissions: 15 February 2009
Email:  psychoanalysisandskin@gmail.com

The editors of Skin, Culture and Psychoanalysis invite contributions for an interdisciplinary collection on the cultural politics and psychoanalysis of skin. We welcome papers that unhinge skin from the biological sciences to examine its layers of significance by way of social and psychoanalytic critique. Skin is the first and enduring medium through which we encounter the world. It delimits interiority and exteriority and, consequently, our relationships to self and others. Skin is laden with unconscious meanings and those we attach to it with respect to gender, sexuality, ‘race’ and racialization, religion, nationality, class, and dis/ability. Moreover, as both “screen” and “container,” skin functions to simultaneously reveal and hide the ways we negotiate identity, body and culture. Perhaps due to these complexities, skin remains an under-theorized yet productive site of inquiry.     Continue reading

Medical Humanities: Health and Disease in Culture: CFP

Medical Humanities: Health and Disease in Culture
POPULAR CULTURE AND AMERICAN CULTURE ASSOCIATIONS
NATIONAL CONFERENCE
New Orleans Marriott, New Orleans, Louisiana
April 8-April 11, 2009

The “Medical Humanities: Health and Disease in Culture” PCA/ACA area examines a wide variety of topics related to the experiences of human beings pursuing health and living with illness. Interdisciplinary proposals representing humanities and the arts (e.g., literature, history, film, visual arts) or social sciences (e.g., anthropology, cultural studies, sociology) perspectives through historical or contemporary contexts are welcome. This area emphasizes the pursuit of humane health care and the exploration of the social and cultural contexts in which health care is delivered for individuals or specific groups. Subject areas might include: Continue reading

What’s in a Name? Well, Everything.

The Wall Street Journal has an article this week on a regulation being drafted by the Bush Administration regarding pregnancy, stating that the

proposed definition of pregnancy that has the effect of classifying some of the most widely used methods of contraception as abortion.

A draft regulation, still being revised and debated, treats most birth-control pills and intrauterine devices as abortion because they can work by preventing fertilized eggs from implanting in the uterus. The regulation considers that destroying ‘the life of a human being.’

Continue reading

Is your dog on Prozac?

Suppose that there is a problem case–let’s call it the Zoey case–of extreme, uncontrolled biting behaviors that pose serious risks to others. Then we might imagine the following snippet from a clinician’s consultation with Zoey’s guardians:

If we were to ask Zoey: ‘Look, if you slip up in the future, and you bite someone like that again, the chances are you’re not going to come out of it alive. But we can make you feel better if we give you some medicine like, for example, Prozac. Would you like to have the medicine that might save your life?’

Your dog on drugs

Your dog on drugs

Perhaps melodramatic? Not so, given that Zoey is a 5-year old, muzzled dog brought in to the office of Nicholas Dodman by her concerned owners for a psychiatric evaluation! The quote above contains words of advice that Dodman begins his consultation with.

This comes from a recent New York Times Magazine article by James Vlahos, Pill-Popping Pets. Although it rambles in places, bringing in everything from the origins of cognitive ethology to Thomas Nagel’s “What’s it like to be a bat?”, it’s worth a read, especially if it’s a rainy Sunday afternoon. Continue reading