Medications and Religious Rituals

This morning as I put the pills I take into the pill container I fill each week, I thought about religious ritual.

On average, Americans over 65 take between 4-5 different medications each day. (See here and here for more information on pill-taking.) I noticed my feeling of pleasure as I put each of the 4 pills I take into the slots of the days of the week. I was carrying out an instrumental task, but the emotion I felt came from an entirely different realm.

I understood the rationale for each of the medications and found myself thinking of them as friendly presences, whose aim was to minister to my well-being. These thoughts led me to recall all the families I'd visited at home in my years of practice who showed me the Saints (Catholic) or Gods (Hindu) they prayed to and who they saw as crucial contributors to their health.

Although in theological terms I define myself as a "secular humanist," I respond to the pill-container filling with the same underlying emotions that my religiously observant patients felt about their Saints and Gods. It's important that I understand the medical rationale for the medications and their potential side effects, but I'm sure that a component of their efficacy comes from my attributing to them a benevolent intention to heal.

In the early 1970s I chose to work on the Jewish High Holidays, based on my lack of theological acceptance of the dogmas the holidays were based on. On Rosh Hashanah I was making a home visit to a Catholic family whose treatment I was involved with. They proudly showed me the little alter they used for prayer. It occurred to me that they might not have any more theological conviction about the Saints they prayed to than I did for Jewish theology. But unlike me, they were respecting the traditions and values they'd been brought up with.

From that day on, whether or not I was attending religious services, I didn't work on the High Holidays. I'm grateful to the family that taught me to distinguish between ritual, symbolic action, and literal theological beliefs.

In similar fashion, I'm grateful for the caretaking attitudes I associate with the medications I put into the pill container this morning.

(For a previous post on why religious language can be so valuable in clinical practice, see here, and for a discussion of physicians as "Counsellors," see here.)

How not to handle conscientious objection

On the evening of June 21, Nicole Mone Arteaga went to Walgreen's Pharmacy in Peoria, Arizona (a suburb of Phoenix) to fill a prescription for misoprostol. The 9 week fetus in her longed-for pregnancy had no heartbeat, and the pregnancy would end in a miscarriage. She chose a medical rather than surgical removal of the non-viable fetal tissue.

When she arrived at the pharmacy, staff pharmacist Brian Hreniuc asked if she was pregnant. On hearing the answer he told her his "ethical beliefs" forbade him from filling the prescription. According to Ms. Arteaga's Facebook post her 7 year old and five customers could hear the exchange. The result: "I left Walgreens in tears, ashamed and feeling humiliated by a man who knows nothing of my struggles but feels it is his right to deny medication prescribed to me by my doctor."

Next day Ms. Arteaga was able to fill the prescription at another branch of Walgreen's. 

Arizona law allows pharmacists to exercise conscience as Mr. Hreniuc did. And while reflective individuals differ on whether professional responsibility to serve one's patients or individual conscience should rule in situations like this, my Catholic friends have helped me understand how for Mr. Hreniuc, filling the prescription could make him feel complicit in what he might see as a mortal sin. But as experienced by Ms. Arteaga, he did not communicate in the right way.

Here's what needed to be done. (1) "I'm so sorry for what you are going through." (2) "I have to refer you to another pharmacy/pharmacist." (3) "I want to wish you the best for the future." The conversation should have been private, not audible to others. The tone should be warm, caring and apologetic, not self-righteous. Ideally, Walgreen’s would have systems in place so that patients would not encounter pharmacists who were not willing to fill their prescriptions. And for those like Mr. Hreniuc, there should be rigorous training in how to communicate in a manner that respects the needs of patients as well as the conscience claims of the staff.

It's not impossible that Mr. Hreniuc conducted himself this way. The pain of the situation could have prevented Ms. Arteaga from experiencing an effort at compassion. I know from experience that this can happen. Many years ago I came upon a distraught couple at the health center where I worked. They had just received bad news. The husband had cancer. I had recently taken a course on dealing with bad news. I sat down with the couple and spoke with them. I'm reasonably confident that a videotape would have shown that I applied what I had learned.

A week or two later a letter of complaint came to the administrator of the health center (me) from the couple. The letter described the cold, cruel person they had encountered (me). For me it was a chastening lesson in the potential difference between what is intended and said by the clinician and heard by the patient.

Arizona state Sen. John Kavanagh, co-sponsor of the 2009 law that allows pharmacists to refuse to fill abortion or emergency-contraceptive prescriptions based on moral or religious beliefs, showed a shameful defensiveness and lack of empathy in his comments on Ms. Arteaga's experience:

He said he was surprised that Arteaga wasn't more sympathetic with the pharmacist, given that she eventually was able to get the medicine from another Walgreen's location. "What's the problem?" he said. "She got what she wanted. The pharmacist complied with the law. I don't see why she doesn't respect the pharmacist's right to not do this," he said.

In her Facebook post Ms. Arteaga shows an admirable understanding of the situation: "I get it, we all have our beliefs." She appears to accept the issue of conscience but rightfully does not accept the way the conscience exception was carried out. In her response - a public post and a complaint to Walgreen's management - she is being an ideal advocate. Her complaint gives Walgreen's, and  professionals who might invoke conscience in not offering a medically indicated legal service, guidance in how to conduct themselves in a more ethically admirable manner.

More Pharmaceutical Industry Price Gouging`

A recent New York Times article tells us that Lannett, a large generic drug maker, is echoing other companies I have written about in raising prices on its products by several hundred percent. Here's what Arthur Bedrosian, Lannett CEO, told a group of investors:

According to the investors, Mr. Bedrosian was asked if the price-hike business model in the drug industry was over. He chuckled and said no, adding that he had tripled the price of one of Lannett’s drugs that very morning. He did not identify which one, the investors said.

Mr. Bedrosian's "chuckle" may remind you of Donald Trump's cheerful boast about how he could grab women by the "pussy."

The market loves Lannett, which provides yet another example of market failure. In the future the market may ultimately punish Lannett the way it punished Valeant (see here and here) and Turing Pharmaceuticals, but by the time that happens patients will have been hurt and public and private payers will have been bilked of billions.

The NYT cites studies showing that when there are fewer than five competitors, our national theology of the wisdom of markets doesn't hold. That suggests a regulatory strategy that allows price regulation in the absence of adequate competition. Let's hope that Congress is prepared to act on the basis of protecting patients and the public from the kind of legal larceny the Mr. Bedrosian is chuckling about!

Robber Baron Capitalism victimizes Mother Theresa

Yesterday the Senate Special Committee on Aging held a feel-good hearing at which the Senators excoriated Michael Pearson, the soon-to-be ex-CEO of Valeant Pharmaceuticals, for rapacious drug pricing, and hedge fund manager William Ackman for making Valeant a darling of the Wall Street world.

It's a valuable truth about organizational life that every system is perfectly designed to achieve the results it actually produces. The two articles cited in the previous paragraph and a third about "The Complex Math Behind Spiraling Prescription Drug Prices" provide insight about how the current U.S. system inevitably produces stratospheric drug prices. Here's how it works:

1. The first step involves rewarding CEOs lavishly for short-term profits. It's important not to look too deeply into how the profits are made, as long as the method is - or appears to be - legal. My my previous post  about Michael Pearson's compensation shows how this first step towards moral corruption can best be carried out.
2. One variant of step two involves identifying a valuable old drug that is priced affordably. Make sure it has no competitors. Then, buy it and jack up the price by hundreds of percents. That's the route Michael Pearson at Valeant and Martin Shkreli at Turing Pharmaceuticals took.
3. As an alternative, identify a serious medical condition for which there is no effective treatment. Develop a new, better approach. This is the path of discovery and developing genuine new value. Up to the the point of setting a price, this step is morally admirable.
4. Recognizing that (a) we control a vital component for human health, and (b) health organizations are committed to human health, (c) set a stratospheric price, since (d) we have the health system over a barrel. 
5. If whoever is purchasing our stratospherically-priced drug protests, accuse them of (a) rationing care, (b) stifling innovation, or best (c) both.

This is how the fine-tuned medical-industrial complex facilitates runaway drug costs. Historically, providers have been governed by Mother Theresa's ethics - do what is needed for human health no matter what it costs. The Michael Pearsons and Martin Shkrelis may be acting within the law, but they're not acting within the ethics of care. Unlike Pearson and Shkreli, who simply recycle established products at new prices, pharmaceutical companies that develop treatments that create new possibilities for human healing are participating in the health care calling. But when they charge astronomical prices, they're joining with the Pearsons and Shkrelis in robber baron conduct.

Hard bargaining helps, but it isn't likely to be enough to lead to fair pricing. My guess is that some form of regulation or other change in law is likely to be required. How to do it is beyond my pay grade. But happily, we in Massachusetts elected Elizabeth Warren as Senator, and consumer protection is her specialty. I'm going to send this post to her office with a simple message: PLEASE HELP!

More Details on Disgraceful Pharmaceutical Practices

Two days ago I wrote about the dual agency problem pharmaceutical executives face: "They're clearly crucial participants in  the sacred calling of health care. At the same time, they're embedded in a highly competitive industry with strong profit demands. Pharmaceutical executives work in the jaws of a severe dual agency challenge: sacred calling vs the invisible hand of the market."

Today's New York Times offered a telling detail on how the jaws of money led Valeant Pharmaceuticals directly to disgraceful - though legal - "leadership" in the health care sector.

Valeant's legal but disgraceful strategy was to achieve monopoly power by buying rights to old drugs and then raising prices to stratospheric heights. I call this disgraceful because human health is not a commodity to be traded and sold. Valeant added "value" (money) for shareholders and staff, but subtracted value from the domain of human health - directly, via reducing access to needed drugs, and indirectly, by contributing to demoralization within and about health care through its sordid practices.

Here's the crucial detail. The CEO would only receive a bonus if the stock price rose by a specified amount each year, and the shares he was awarded would only vest if the stock rose by 15% in three consecutive years. Last year his salary was reduced to zero, making him totally dependent on stock price. These are legal incentives from the perspective of finance, but they're disgraceful incentives from the perspective of improving human health.

On July 31, 2015, Valeant's stock sold for $257.53. At 9:58 AM today it was selling for $28.89. I hope the 89% drop will convey to investors that financial performance should not be the key criterion for evaluating performance in the health sector.

The reason the Valeant story leads me to rant so vociferously is that for health care professionals pharmaceutical companies are partners in delivering health care. When a drug allows us to help a patient in a meaningful way, we're grateful to the pharmaceutical company. It's analogous to our relationship with consultants who help our patients achieve better outcomes.

The problem isn't that Valeant made an honest mistake. We all do that. It's that they were playing by rules that don't belong in health care. Disgraceful rules!

[See here for a previous post on Valeant. For a post on how I felt personally betrayed by a scandal involving the drug Abilify, see here. And for a post about Valeant in today's Pharmalot blog, see here.]

I believe I have reasonable understanding of all the benefits a market economy can provide. I'm writing on one right now. But there's a widespread feeling among clinicians and patients in health care that resonates with this cartoon:

Who Should be Seen as a "Healthcare Executive" and Why Does it Matter?

The American College of Healthcare Executives (ACHE) has as its vision "To be the premier professional society for healthcare executives dedicated to improving healthcare delivery." ACHE's excellent 2015 statement - Creating an Ethical Culture Within the Healthcare Organization - rests on an assertion I wholeheartedly support: namely, that "all healthcare executives have a professional obligation to create an ethical culture." (I added the emphasis)

If you agree with the ACHE assertion, and I'm prepared to go to the mat for it, the first question is: what counts as a "healthcare executive"? How wide is the scope of the term?

Clearly, executives at hospitals, medical groups, and other organizations that deal directly with patients carry major moral responsibilities. After all, health care is crucial for realizing all three of the "unalienable rights" put forward in the Declaration of Independence: life (sometimes health care saves our lives), liberty (we can't exercise our freedom without health), and pursuit of happiness (we can be happy without health, but it's more difficult, and severe enough pain makes it impossible).

ACHE deliberately leaves the scope of the term vague. It defines itself an an organization for "healthcare executives who lead hospitals, healthcare systems and other healthcare organizations." From my experience as a physician, administrator, and patient, I'd cast a wide net for defining "other healthcare organizations" and setting ethical expectations for them.

In the complex U.S. health system direct care organizations aren't the only important moral agents. Health plans and pharmaceutical companies are perhaps the two most important examples of indirect moral agents.

Over the years I've tried to encourage health plans to create ethics programs the way Harvard Pilgrim Health Care, where I have directed the ethics program for sixteen years, has done. I've had zero success. This doesn't mean that other health plans are unethical, but it does suggest that ethical performance is not seen as something that requires the kind of concerted leadership the ACHE statement on responsibility for creating an ethical culture calls for. (For a previous post about my quixotic efforts, see here.)

Executives in the pharmaceutical industry face especially difficult challenges in relation to the kinds of expectations the ACHE standards articulate. They're clearly crucial participants in  the sacred calling of health care. At the same time, they're embedded in a highly competitive industry with strong profit demands. Pharmaceutical executives work in the jaws of a severe dual agency challenge: sacred calling vs the invisible hand of the market.

More than forty years ago, Arnold Relman warned of the potentially disruptive moral impact of what he called "The New Medical-Industrial Complex." Since his prescient warning there have been efforts to establish a shared moral code for all participants in the world of health care. A distinguished U.S. and U.K. group articulated the "Tavistock Principles," but these, alas, seem to have been dead on arrival, and have not been heard from for fifteen years. And for a number of years the American Medical Association sponsored an "Ethical Force" program that sought to establish measurable ethical standards for the major players in the health sector. I had the privilege of being on the advisory panel on health benefits determination. The project produced some excellent materials and a book, but as with the Tavistock principles, the effort was relatively short-lived.

When I mulled over how to end this post I realized that I don't have a tidy upbeat ending. The image that came to mind was of Sisyphus, eternally pushing a rock up the hill. It seems to me that Arnold Relman's call to action points to an ongoing task captured in this cartoon:

I'll do more rock pushing in future posts!

Curing Depression with Light: Let the Sun Shine in

In an elegant Canadian study, light outdid Prozac in a head-to-head comparison as treatment for nonseasonal major depression.

The study design is fascinating. Patients were randomly assigned to one of four groups: (1) light and a placebo pill; (2) Prozac and placebo light (an ion emitter modified to hum softly but emit no ions); (3) light and Prozac; and, (4) placebo light and a placebo pill.

The informed consent process involved deception. Subjects were told that the researchers were comparing light to ion treatment, and that half of the devices would be inactive. They were not told that all of the supposed ion emitters were inactive and all of the light units were active. The ethical rationale for allowing deception was that (a) the study goals could not otherwise be pursued, (b) the study had significant scientific and clinical merit, and (c) the deception posed no significant risks to the subjects.

The most effective monotherapy was light. Prozac alone was barely better than placebo. Light combined with Prozac was the most effective arm of the study, but not by much.

Light has been recognized as an effective treatment for seasonal affective disorder (SAD), but has not been rigorously evaluated for non-seasonal depression. If I were still in practice and saw a non-suicidal depressed patient who preferred not to use medication, I would recommend light treatment as part of our initial approach, combined with whatever form of psychotherapy fit the patient best.

We're a pill-happy society, and psychiatry, alas, has tilted away from non-pharmacological approaches to care. If Cazorp (Prozac spelled backwards) were a new pill that beat Prozac as decisively as light did in the Canadian study, the Cazorp company's stock would go through the roof. If further research confirms the Canadian findings, light should become a standard part of the initial response to depression. But although there's some financial opportunity for device manufacturers, inexpensive do-it-yourself light boxes are relatively easy to construct, so we're not likely to see a light boom analogous to the dominant pill boom.

Money talks, so pills thrive. Light cures, but produces little financial (as opposed to clinical) profit. Ergo, pill-popping wins hands down.

The Invisible Hand Slaps Valeant Pharmaceuticals and the Sequoia Fund

Over the years I've been a staunch critic of seeing the health care "industry" as a commodity that should be governed by market forces. But fairness and honesty compel acknowledgement when the invisible hand acts wisely and supports good ethics.

Today the New York Times reported that two of the five independent directors of the Sequoia Fund resigned in protest over the Fund's decision to increase its already large stake in Valeant Pharmaceuticals, a company whose entirely legal but ethically disgraceful business strategy is to buy drugs and impose huge price increases. When Valeant's business practices hit the front page its stock fell from $260 to $75, and Sequoia's shares fell 22%.

Here's what David Poppe, president of the firm that manages the Sequoia Fund, said about Valeant: "...we thought Valeant was aggressive but stayed within the lines. To say they're immoral is pretty strong."

Sometimes statements that are "pretty strong" are also "pretty true." Let's hope that the lesson the market is sending about exploitative pharmaceutical business practices is widely heard. So far the invisible hand has been dealing out slaps. Next time - the fist!

More About Unethical Drug Prices

As if the example of Turing Pharmaceuticals and the 5,000% price increase for Daraprim weren't enough, two days ago the New York Times described another example of blatantly unethical - but entirely legal - drug  pricing.

Horizon Pharma has combined the generic equivalents of Motrin and Pepcid into a single pill, Duexis. Taking one of each would cost no more than $40 per month. For the single pill that combines the two ingredients, Horizon asks for $1,500! To circumvent the stunned look a pharmacist would give to a patient who brings the Duexis prescription into the pharmacy, Horizon encourages physicians to send the gold-plated prescription directly to a mail order pharmacy that will send the medication to the patient and deal directly with insurers.

Several decades ago I saw a patient for whom I wanted to prescribe a low dose (25 milligrams) of the antidepressant Zoloft. At the time the two available dosages - 50 and 100 milligrams - were priced the same. The patient was a thoughtful person and I was interested in the relevant ethical issues, so I asked if he thought it was fair for me to prescribe the 100 milligram pill and ask him to divide it into four pieces. He initially said "no," and I prescribed the 50 milligram pill to be broken in half.

Some minutes later he returned to my office. "I've been thinking," he said. "I survived the Nazis during World War II because other people took risks to protect me. I want to do this little bit for the public good. Why should the people who help pay for my insurance spend more than is necessary for me to get my medication?"

Unfortunately, Horizon does not share my patient's moral vision. Although its actions are legal, if Hippocrates were reincarnated, here's the dialogue that might ensue:

Hippocrates: "Didn't I make 'first, do no harm' clear in my teaching?"
Horizon: "What harm are we doing? Duexis is a good medication. And the patient isn't paying - it's the insurance company!"
Hippocrates: "We didn't have insurance companies in my day. But even an old timer like me can understand that the insurer's money comes from all the working people who pay into the insurance pool. For every patient who uses Duexis instead of the two generic ingredients separately, you are taking $1,460 per month out of the pocket of working people. That's harm! You should be ashamed of yourself!"

When I Googled Horizon a few minutes ago I was happy to see that the revelation of its legal but unethical practice has sent its stock tumbling. The invisible hand is giving the company a well-deserved slap!

How Three Competing Ethics Frameworks Let Drug Prices Run Wild

A few weeks ago I gave a talk about the ethics of high cost pharmaceuticals at a Connecticut Health Council event. After I accepted the invitation I was initially at a loss about what to say. Simply excoriating Turing Pharmaceuticals for raising the price of Daraprim by 5,000% would be too easy. But when I asked myself what allowed Turing's actions to be grossly unethical but completely legal, I saw that three competing ethical frameworks - "good vs good" conflicts - help explain why we've been so impotent in relation to drug prices.

1. Free market theology vs ethics of care. A teaching from Milton Friedman's Capitalism and Freedom has achieved the status of unquestionable religious truth for many: "There is one and only one social responsibility of business - to use its resources and engage in activities designed to increase its profits so long as it...engages in open and free competition, without deception or fraud." But many of those who are deeply involved in health care, including many in the pharmaceutical industry, see their work as a calling, in the spirit of Hippocrates, who articulated the ethics of care 2500 years ago. Both frameworks embody ethically admirable values. But in many sectors of the US health system, with the current pharmaceutical industry as a prime example, the theological commitment to free markets is overly dominant.
2. Life is priceless vs opportunity costs matter. More than 30 years ago, in  his deservedly admired evocation of the ethics of care, Norman Levinsky invited physicians to believe that the sacredness of their calling meant that the opportunity costs of our interventions should not be considered: "physicians are required to do everything  that they believe may benefit each patient without regard to costs or other societal considerations. In caring for an individual patient, the doctor must act solely as that patient's advocate, against the apparent interests of society as a whole, if necessary...When practicing medicine, doctors cannot serve two masters...The doctor's master must be the patient."
   
   These are stirring words, and in my teaching I've found that most physicians embrace them with pride. But looked at closely, it's clear that Levinsky's passionate embrace of the ethics of care led him into the error of ignoring opportunity costs. When physicians indicated solidarity with Levinsky's position I sometimes responded as follows: "Doctor - congratulations on your altruism. If your patient needs a heart transplant and you are the only match, you're prepared to donate your own heart!"
   
   Until recently, the "life is priceless" ethic led us physicians to ignore the impact our interventions imposed on individuals and wider society. Nurses, social workers, and other health professionals have been more attuned to the way the over-costly health system harms population health by undermining income and other social determinants of health. Only now, with drug prices going through the roof, are we physicians beginning to see the limitations in Levinsky's noble and inspiring rhetoric.
3. Government is the problem vs government is [part of] the solution. My generation (I was born in 1939) was conceived in the New Deal era, came into adulthood during Lyndon Johnson's Great Society movement, and have watched the pendulum swing from inflated confidence in government action to the nihilism of the Tea Party and the Freedom Caucus.

The crucial point is that the three conflicting frameworks represent "good vs good" conflicts, not "good vs evil." As such they call for a political culture that is prepared to follow Winston Churchill's advice:

Nationally, we lack the courage to listen. This has led to a failure to balance the three competing ethical frameworks. Runaway pharmaceutical prices reflect our theological commitment to free markets, the reluctance of the medical community to consider the opportunity costs imposed by health care expenditures, and the national distrust of government action. Mature organizations speak and listen. At present, our political culture cannot do both. We see one result of the national skill deficit in our inability to rein in pharmaceutical pricing.

The Bias Towards Drugs in Psychiatry

Two days ago I posted about the bias towards drugs in treating depressed older patients. The next day the New York Times published a heartbreaking op ed on the same theme by Ted Gup, whose son died of a drug overdose 18 months ago.

Gup reflects with pain on his decision to allow his son to be put on stimulants for what was diagnosed as ADHD. In retrospect, he feels he contributed to his son's ultimate death:

In another age, David might have been called "rambunctious." His battery was a little too large for his body. And so he would leap over the couch, spring to reach the ceiling and show an exuberance for life that came in brilliant microbursts...

No one made him take the heroin and alcohol, and yet I cannot help but hold myself and others to account. I had unknowingly colluded with a system that devalues talking therapy and rushes to medicate, inadvertently sending a message that self-medication, too, is perfectly acceptable.

I had the good luck to have been allowed to outgrow my rambunctiousness. I remember my elementary school report card identifying "self control" as a "special need." I remember as well not understanding why it bothered my parents that when I spoke with them I went through the motions of a baseball pitcher. "Ants in your pants" was the "diagnosis" they gave me. After some years, the ants disappeared. The key interventions came from wise parents, teachers, and sports coaches.

Gup sees how the culture that contributed to the death of his son affects us at every stage of life:

I fear that being human is itself fast becoming a condition. It’s as if we are trying to contain grief, and the absolute pain of a loss like mine. We have become increasingly disassociated and estranged from the patterns of life and death, uncomfortable with the messiness of our own humanity, aging and, ultimately, mortality...Instead of enhancing our coping skills, we undermine them and seek shortcuts where there are none, eroding the resilience upon which each of us, at some point in our lives, must rely.

The young move too fast for our comfort and we give them drugs to slow them down. The elderly move too slowly for our comfort and we give them drugs to speed them up.

Ignoring Families Can be Fatal

Yesterday in Heathrow Airport on my way home from Singapore I wrote a post about how US medical ethics ignores families and overemphasizes individual "autonomy." When I got home I read a painful story in the New York Times that confirmed the potential harm from the way ethics and law lead clinicians to treat individuals as isolated units: "Drowned in a Stream of Prescriptions: Addict's Parents Couldn't Halt Flow of Attention Deficit Drug.

Richard Fee, an intelligent, popular student who hoped to go to medical school, became addicted to stimulants in college. He faked symptoms of ADHD and received increasing doses of stimulants over a two year period. He ultimately became psychotic, and when the stimulants were stopped, became depressed (not unusual during stimulant withdrawal) and hung himself. The central points of the story are (1) how psychiatry has degenerated into brief "med checks" in which prescriptions are written without adequate thought about what's really going on and (2) how the pharmaceutical industry has succeeded in pushing medication use way beyond what good health and good practice call for.

But having just come from a conference on  "The Ethics of Family Involvement in Healthcare," I was transfixed by what happened when Richard's father, who was terrified about his son's deterioration, and who understood the addiction problem, tried to talk with Richard's psychiatrist: 

In late December, Mr. Fee drove to Dominion Psychiatric and asked to see Dr. Ellison, who explained that federal privacy laws forbade any discussion of an adult patient, even with the patient’s father. Mr. Fee said he had tried unsuccessfully to detail Richard’s bizarre behavior, assuming that Richard had not shared such details with his doctor.


“I can’t talk to you,” Mr. Fee recalled Dr. Ellison telling him. “I did this one time with another family, sat down and talked with them, and I ended up getting sued. I can’t talk with you unless your son comes with you.”

Mr. Fee said he had turned to leave but distinctly recalls warning Dr. Ellison, “You keep giving Adderall to my son, you’re going to kill him.”

I heard about situations like this again and again during my years of psychiatric practice. Whereas in Singapore respect for the family can lead to ignoring the patient, in the US respect for the individual can lead to grotesque stonewalling of the family. Dr. Ellison was not wrong that privacy laws emphasize the individual's right to privacy and to control access to information about him, but skillful clinicians learn how to (a) recognize the law but (b) do what's right for the patient. Law precluded Dr. Ellison from giving information to Richard's father, but it did not preclude listening to his father, explaining why he would not give out information without Richard's permission, thanking the father for his concern, and creating an opportunity for further connection.

Years ago I had a patient who (a) was in a suicidal crisis, (b) hated the hospital and had not benefitted from previous admissions, and (c) had responsible, caring friends who (d) were able to provide support and (e) would want to do so. My patient and I had a version of the following dialogue:

Patient: I won't go to the hospital!
Me: I don't want you in the hospital, but we have to keep you safe, and we'll need help from XYZ.
Patient: You can't talk with them.
Me: Since I know how much you hate the hospital and believe we can get you better without it, I'm going to talk with XYZ, but I want to do it with your permission.
Patient: You can't talk with XYZ - what about privacy and my rights?
Me: Your most important right is to be alive until  your time comes. I'd like to have your permission to talk with XYZ, but I'm going to do it one way or the other...

My  patient ultimately grudging agreed, XYZ came to the office, and we got through the crisis. But I'd meant what I'd said - if my patient had not given me permission I would have contacted XYZ. It made no sense for law to give me the power to impose involuntary hospital commitment but to forbid me from getting help from caring and competent friends without permission.

As Dr. Johnson taught us, the law can be an ass. US laws surrounding informational privacy are well-intended, but they're too simple-minded to apply to all human situations. Richard Fee might be alive if the medical establishment had not treated him as an isolated atom suffering from a deficiency of stimulant medication.

Sex isn't the only lust that physicians succumb to

Money and power can also lead to ethical collapse.

A sad story today's New York Times tells how Dr. Sidney Gilman, a respected teacher and researcher on drugs for Alzheimer's disease, has been nailed for warning a hedge fund manager he'd been dealing with to dump a pharmaceutical stock before news of a failed drug trial became public. Gilman had access to the information from his role on an FDA panel.

From responses to a number of the posts I've written about doctor-patient sex, it's clear that physicians who violate basic ethical standards can be superb caretakers for their other patients. Dr. Gilman, now 80, apparently had an exemplary career in teaching and research. A neurology lecture series at University of Michigan Medical School is named for him. And a colleague reported that he frequently turned to Dr. Gilman for advice about ethical issues:

He always gave me rock-solid advice and counseled me to maintain transparency so as to avoid even the appearance of a conflict of interest.

Re Dr. Gilman's teaching about transparency, the Times reports that to avoid arousing suspicion about his consultation to the hedge fund about the Alzheimer's drug, Gilman asked his co-conspirator to label the consultations as about other, unrelated topics.

Dr. Gilman could do a service to medicine and medical ethics by sharing the inside story about how a physician who apparently conducted himself in an admirable manner for most of his career descended into obvious unethicality (and criminality) as he did. What steps led from honorable conduct to dishonor? Did he delude himself as to what he was doing, or did he make a Faustian bargain to proceed? Better understanding of the "mechanisms" that facilitate serious ethical lapses can help educators work more effectively towards prevention.

(For an interesting post from a hedge fund insider, see here.)

Allowing import of needed drugs from Canada

Last year I wrote about a well-intended FDA policy about colchicine, a drug used since ancient times for gout, and now for other serious conditions, such as Familial Mediterranean Fever. As an ancient treatment widely used prior to formation of the FDA, colchicine did not require FDA approval as a new drug. Then in 2009, the FDA granted approval to URL Pharma for Colcrys, its version of colchicine, based on randomized controlled trials the company conducted. Because colchicine had never been subjected to the FDA approval process, Colcrys was, in a technical sense, a "new" drug approved for a "new" indication - treatment of gout and FMF - despite the centuries of prior use, and by regulation was entitled to market exclusivity. In 2010 the FDA ordered all other manufacturers to cease production and marketing of their versions of colchicine.

Unfortunately, Colcrys is not effective for some patients with Familial Mediterranean Fever. To maintain their health these patients need the generic form, which must be imported from abroad. A friend recently told me about the new roadblock a family member is encountering. Here's the letter that went to the patient's senators:

I am writing with regards to the recently passed Food and Drug Administration Safety and Innovation Act (S. 3187). The bill includes a provision (Section 708) that may prevent me from being able to import my prescription from Canada, which I depend on for my health and quality of life.

This legislation authorizes the seizure and destruction of safe prescription drug imports valued under $2500. I have a prescription for generic colchicine for a rare genetic disease which I have, Familial Mediterranean Fever. When I tried the US brand of colchicine, Colcrys, I experienced extreme side effects and a relapse of symptoms, resulting in a month of illness, including an overnight stay in the hospital with high fevers and dehydration. Through this experience, my doctor and I discovered that it is essential that I be able to access an alternative brand of colchicine. Due to an FDA ruling, all brands of colchicine except Colcrys were taken off the US market several years ago. I now depend on my prescription from Canada for my health and well being.

When I am able to take colchicine imported from Canada, I have no symptoms and live a normal, healthy life. Without access to this medication, I will experience fever episodes lasting from several days to a month, pain, and inability to eat. It will compromise my ability to finish graduate school, where I am currently working on a challenging program. It will put me at risk of future complications from my genetic disorder.

I am extremely concerned that when Section 708 of Act 3187 is implemented, I will lose access to my direly needed medication. Please let me know what you plan to do to change Act 3187 to allow me to continue my life. Thank you for your time and consideration.

I don't fault the FDA's intentions. But in a country of 300 million people, it will be the rare policy that applies to all in a fair manner. Justice requires a robust exception process in situations like the dilemma of FMF patients who require the generic drug.

The patient did her part in putting the issue onto the public table. Now it's up to the FDA to respond.

Bereavement, Depression and DSM-V

In January I criticized the American Psychiatric Association (APA) for planning to drop the "bereavement exclusion" from the definition of major depressive disorder in the forthcoming new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Under the exclusion, the diagnosis of depression is not made if:

The symptoms are not better accounted for by Bereavement, i.e., after the loss of a loved one, the symptoms persist for longer than 2 months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation.

In a recent issue of the New England Journal of Medicine, Richard Friedman, a distinguished psychiatrist at Cornell who writes excellent New York Times columns for general readers, adds to the voices criticizing the APA for medicalizing normal grief (see here). Here's the essence of Friedman's argument:

In removing the so-called bereavement exclusion, the DSM-5 would encourage clinicians to diagnose major depression in persons with normal bereavement after only 2 weeks of mild depressive symptoms. Unfortunately, the effect of this proposed change would be to medicalize normal grief and erroneously label healthy people with a psychiatric diagnosis. And it will no doubt be a boon to the pharmaceutical industry, because it will encourage unnecessary treatment with antidepressants and antipsychotics, both of which are increasingly used to treat depression and anxiety...The medical profession should normalize, not medicalize, grief.

Despite criticism the DSM-V working group has not changed its plan to eliminate the bereavement exclusion, but it has added a footnote that at least acknowledges the challenge of distinguishing normal grief from the illness of depression:

The normal and expected response to an event involving significant loss (e.g, bereavement, financial ruin, natural disaster), including feelings of intense sadness, rumination about the loss, insomnia, poor appetite and weight loss, may resemble a depressive episode. The presence of symptoms such as feelings of worthlessness, suicidal ideas (as distinct from wanting to join a deceased loved one), psychomotor retardation, and severe impairment of overall function suggest the presence of a Major Depressive Episode in addition to the normal response to a significant loss.

I don't know if Dr. Friedman would be mollified by this footnote, but I'm not. For those who want to delve more deeply into the research, the working group presents its rationale here.

To my eye, clinical and epidemiological research relevant to distinguishing the illness of depression from the painful but not unhealthy state of grieving doesn't settle the controversy. The DSM-V working group has chosen to drop the bereavement exclusion out of fear that it might lead to misdiagnosis of some depressive episodes as normal grief. I, along with Dr. Friedman and other critics, see the potential for medicalizing normal grief as a significantly greater danger.

Years ago, when I was teaching a group of primary care physicians about use of antidepressant medication, one of the PCPs commented in the form of a two-line poem:

I know what to do when they're dying,
But not what to do when they're crying.

Between the degree to which harried physicians have become less skilled at dealing with existential concerns like grief and the seductive pharmaceutical marketing that will emerge with the death of the bereavement exclusion, before too long we'll be seeing patients experiencing normal grief being flogged with unwarranted diagnoses and unneeded medication.

Grief typically lifts on its own without medical intervention. Some of these patients and their physicians will conclude that they have been "cured" by the unneeded medication and will remain on it, exposing them to pharmacological side effects. In addition, some will experience an altered self image - "I'm a 'weak' person who got sick when X died and needed medicine to get over it" - rather than "I miss X terribly and experienced severe grief after the death."

The DSM-V working group is factually correct in its belief that loss can trigger the illness of depression and that it's important for clinicians not to miss the diagnosis when this happens. But dropping the bereavement exclusion won't eliminate this risk, and eliminating the exclusion will add to a destructive cultural trend of over-medicalization and excessive use of pharmaceuticals.

Industry, Medicine and Medical Ethics

This morning I co-chaired a meeting of the Massachusetts Association of Health Plans (MAHP) Ethics Forum that used the Massachusetts Gift Ban law as an entry point for discussing the relationship between the medical products industry and the medical profession.

Marcia Hams, program director of the Community Catalyst Prescription Access and Quality Program and Tom Stossel, director of translational medicine at the Brigham & Women's Hospital, kicked off the discussion. Many pharmaceutical companies are affiliate members of MAHP, so participants included pharmaceutical folks as well as health plan medical staff.

What struck me most about the excellent discussion is how the absence of an overall budget for health care has tilted public discourse in a polarized black and white direction. Marcia Hams made a strong, thoughtful advocacy argument that pharmaceutical marketing activities contribute to increased costs and negative impacts on quality. Tom Stossel made a strong, thoughtful advocacy argument that pharmaceutical marketing activities contribute to decreased overall costs and quality improvements.

If we had an overall budget for our health system, or real budgets for components of the system, we'd be having a different set of discussions. Instead of arguing about whether industry influence on medical practice and health care costs is good or bad (it's both), we'd be discussing questions like whether a particular intervention created enough value to justify its use, and how its cost-effectiveness measured up against alternatives.

Many in the policy community argue that the U.S. population is unwilling to recognize and accept limits in health care. In my view, the scattered structure of our health system - most notably, the absence of overall budgets - has made it difficult for us to consider relative value, trade offs, and opportunity costs. By now we're habituated to not thinking about these questions, which makes us progressively immature as a body politic and vulnerable to nonsense like "death panels" and fear that the Affordable Care Act will lead to a government mandate that we all eat broccoli!

(This has been the longest time without a post since I started the blog almost five years ago. I've been unusually busy with teaching activities and a number of projects. It's good to be back!)

Fibromyalgia, Blaming the Victim, and Lyrica

Kristin Barker, a sociologist at Oregon State University, has a fascinating, fun to read article in a recent issue of Social Science & Medicine - "Listening to Lyrica: contested illnesses and pharmaceutical determinism."

In my psychiatric practice I was often asked to see patients with mysterious symptoms. Many of the patients resented being asked to see a psychiatrist, feeling they were being sloughed off as whiners, hypochondriacs, or malingerers and told that their symptoms were "all in the head." There was no doubt that they were suffering. But what were they suffering from?

Some of these patients had been diagnosed with fibromyalgia syndrome, a condition of unkown etiology characterized by chronic widespread musculoskeletal pain, multiple tender points, sleep disturbance, fatigue, and other "non-specific" symptoms. In June 2007 the FDA approved an antiseizure medication - appealingly branded as "Lyrica" - for treatment of fibromyalgia. Having a drug officially endorsed as treatment for their condition went a long way towards validating the symptoms as reflecting a "real" illness.

Barker makes three key points:

• Having a treatment strengthens belief in the disease. If there's a pill that helps, the person must be ill. From a sociological perspective, Lyrica wasn't simply treating a condition, it was validating the condition as real!
• Direct to consumer advertising (DTCA) has a powerful impact on social behavior. Insofar as Lyrica ads reduced the blame patients often experienced, the ads were a boon.
• But the ads, which helped make Lyrica a billion dollar blockbuster drug for Pfizer, did so in part by showing glamorous women (actresses) supposedly with the condition, and by portraying the drug as a magical cure. In real life Lyrica rarely acts in the magical way the ads suggest. Some women with the condition felt that the ads led to their being blamed for not getting fully well as the actress portrayed. (For an example of such an advertisement, see here.)

Barker concludes that Lyrica has been a decidedly mixed blessing. It contributed to diminished blaming of the victim. It gave physicians and patients an additional intervention to try. But it fostered false hopes and led to further medicalization - women who might have recovered from a bad spell without diagnosis or medical intervention were persuaded that they had an illness and needed a drug. And when Lyrica didn't perform as the ads suggested it would, some women were blamed for refusing to get better.

(For another post about blaming the victim, see here.)

Union Health Plans and Health System Ethics

On November 1 I blogged about how much I looked forward to meeting the next day with union leaders responsible for overseeing union health plans.

As I'd anticipated, the union leaders evinced a strong sense of solidarity with the insured population and, at the same time, a strong sense of the economic realities of the insurance fund. I presented a diagram I've often used to convey my view of the ethical framework that - ideally - patients, clinicians, purchasers and other stakeholders would use in their dealings with the health system:The idea that we should approach the health system committed to both fidelity to the needs of the individual and stewardship of the resources available for the care of the group was intuitively obvious to the group, as did the metaphor of numerator and denominator that I also like to use::Bringing about a health "system" that is more effective, equitable and efficient in a nation of more than 300 million and a bitterly divided national political process requires won't happen without multiple local initiatives. Oregon, Massachusetts and Vermont show what individual states can do.

The union leaders taught me that union health plans can make important contributions to the national learning curve. Unions are about solidarity on behalf of shared interests. As a population we should be solidly unified on behalf of achieving the best health we're capable of. Sadly, we're not. Union health plans provide a venue in which substantial components of our population are committed to the well-being of each person and, at the same time, to being realistic about how much resource can be devoted to health care. What they learn and demonstrate can help us all.