Category Archives: Ethics

Lilly Gross Profit of 84%– Show No Mercy

Lilly announced an earnings increase of 23% over last year’s results.

“Lilly, which reiterated its 2009 earnings target, is among a slew of pharmaceutical firms that have raised some prices aggressively.” in recent months even as government and private insurers struggle to rein in health care costs.”

“Gross margin rose to 83.8% from 76.9% (Medicynical emphasis) as the stronger dollar eased international sales costs. Total sales costs slumped 27%.”

Investopedia defines gross margin as “A financial metric used to assess a firm’s financial health by revealing the proportion of money left over from revenues after accounting for the cost of goods sold.Gross Profit = Revenue − Cost of Goods Sold.”

Medicynical Note: Big profits, seemingly defying the pull of gravity (the current financial crisis). It would seem to me that 86% margin is excessive. But then what is excess profits in a capitalistic society? The larger question is can we afford this level of profits in health care? How to limit? Should we limit?

New advances that we cannot afford have the same impact as trees falling in the woods.

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Arguing Against Comparison Studies– Anti-intellectualism or Greed?

It’s hard to believe that one can argue against learning what works. But that’s exactly the position of drug and device makers in this article in the Wall Street Journal. It’s hard to believe that this is an issue.

At a minimum such studies will guide physicians in explaining benefits of, risks from and alternatives to various treatments. Comparisons will also help with analyzing the cost-effectiveness of various interventions. Whether insurers will use such data to decide what they will and will not cover is an open question.

My question is when new drugs are prohibitively expensive and have minimal effect on disease course, should insurers pay for their use? Should doctors recommend their use? Should there be limits on “choice” in health care when someone else is paying?

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Medical abuse?–Torture and strip searches

While not as egregious, the school nurse supervised strip search of a 13 year old school girl has parallels in the torture of suspected terrorists.

The CIA medical staff:

“monitored prisoners undergoing water boarding, apparently to make sure they did not drown. Medical workers were also present when guards confined prisoners in small boxes, shackled their arms to the ceiling, kept them in frigid cells and slammed them repeatedly into walls, the report said.”

“Facilitating such practices, which the Red Cross described as torture, was a violation of medical ethics even if the medical workers’ intentions had been to prevent death or permanent injury, the report said. But it found that the medical professionals’ role was primarily to support the interrogators, not to protect the prisoners, and that the professionals had “condoned and participated in ill treatment.”

The Arizona school’s behavior is similar to the CIA’s in intent and misuse of medical staff. It raises questions both for what is allowable in the context of a school situation and how the medical profession can be used to facilitate such actions. First strip searching a 13 year old without the permission and/or presence of a parent is untenable. Using medical staff undermines the original functions of that staff in the school setting.

“Vice Principal Wilson removed her from class and brought her to his office. She gave permission for a search of her backpack, which turned up nothing.”

So far so good, appropriate use of the principal’s authority.

“Then Wilson told her to go to the nurse’s office with two female staffers. They told her to remove her socks and shoes, her stretch pants and pink T-shirt. They told her to move her bra from side to side, which exposed her breasts, and pull out the waistband of her underwear.”

In my view this is inappropriate use of the school’s authority and the medical staff. It eerily parallels the use of CIA staff to “to support the interrogators, not to protect the prisoners, and that the professionals had “condoned and participated in ill treatment.”

It’s amazing and a bit revealing that such a case would get to the Supreme Court without a resounding rejection of the use of a strip search. Any reasonable person, and that might even include a judge, should be offended by the school official’s behavior (and the CIA’s).

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Natasha Richardson, Was her death avoidable?

Many of our conservative pundit types want to blame the Canadian healthcare system for the lack of helicopter tranport in the Natasha Richardson case. In fact, Quebec is the only Province that lacks such system. As such the lack of helicopter transport appears more a local political financial decision.

A helicopter medevac, if available, would have been quicker, presuming patient cooperation and immediate availability of the equipment.

Ms. Richardson, however, refused an ambulance about 1 hour post accident. If there were a helicopter based system it’s likely that she would have refused that as well.

A second call for an ambulance went out about 3 hours after the fall at which point her condition was deteriorating. That ambulance responded within 45 minutes (about the same response time or less than a helicopter called from another locale). Within a few minutes she was at the local hospital which lacked neurosurgical facilities. It took another two and 1/2 hours to get her to the referral center in Montreal.

With a helicopter the last two and 1/2 hour transit time could have been cut in half and the outcome possibly altered, but that is uncertain considering the initial delay and her deteriorating condition.

We shouldn’t be too certain that speed of transfer would be better in the U.S. In Illinois, for example the mean time to transfer emergent cases is a mean of 5 hours 42 minutes as noted below:

“Two-hundred thirty emergent neurosurgical transfers occurred during the study period. The most common diagnoses were parenchymal intracerebral hemorrhage (33%) and subarachnoid hemorrhage (28%). Sixty-six percent of neurosurgical transfers to academic medical facilities originated at hospitals without full-time coverage. The mean time to transfer for all patients was 5 hours 10 minutes (standard deviation, 3 h 42 min; range, 1-20 h 12 min). A decline in Glasgow Coma Scale score was seen in 29 patients. A shortage of neurosurgical intensive care unit beds occurred on 55% of the days in the study. only 19% of emergency cases were related to cranial trauma, and only 3% of transfers came from level 1 trauma”

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Costs, the elephant in the universal health care closet

The Massachusetts health plan is looking at better ways to finance their universal system. With universal coverage expenditures/capita have risen above the already outrageous national average of about $8,000/year.

“They want a new payment method that rewards prevention and the effective control of chronic disease, instead of the current system, which pays according to the quantity of care provided.

It appears it was a mistake not to control costs in the first place:

“Those who led the 2006 effort said it would not have been feasible to enact universal coverage if the legislation had required heavy cost controls. The very stakeholders who were coaxed into the tent – doctors, hospitals, insurers and consumer groups – would probably have been driven into opposition by efforts to reduce their revenues and constrain their medical practices, they said.”

Some good things are happening:

“Frankly, it’s very hard for the average consumer, or frankly the average governor, to understand how some of these companies can have the margins they do and the annual increases in premiums that they do,”

“Insurers seeking to participate in the state’s subsidized insurance program, Commonwealth Care, recently submitted bids so low that officials announced last week that they would keep premiums flat in the coming year.”

But:

“Some health policy experts argue that changes in payment practices will not be enough to slow the growth in spending, even when combined with other cost-cutting strategies. To truly change course, they say, the state and federal governments may need to place actual limits on health spending, which could lead to rationing of care.”

Medicynical note: In a system that has institutionalized excess expenditure at every level change is difficult. We need to look at every level in the supply chain and question costs and demand more efficiency. Cutting some of the fat out of the insurance business is a start. I’ve focused on reforming patents in the past and that’s also a possibility.

Lastly we already ration care by cost. In oncology for example, patient delay is a significant cause of morbidity and mortality. People who can’t afford to pay simply delay or completely forgo treatments.

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Patents and Generic Drugs

President Obama is addressing the issue of moving generic drugs more quickly to market. Big PHARMA has had it’s way for the last 60 years with cost increases for medications far above the inflation rate. We now have drugs, single medications, that cost more than automobiles and over a lifetime more than the average home. Imagine, a single drug being the most expensive purchase of a lifetime. That’s the unsustainable monster we’ve created. More here from the Washington Monthly.

A medicynical approach would be to have market based patent durations. If priced reasonably a full patent would be awarded, if priced excessively the length of patent would be proportionally reduced. The devil, of course, is in the details.

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A Corrupt System of Care

This, in the Wall Street Journal, describes the reality of the uninsured and under-insured. Guess who will ultimately pay?

“Hospitals are adopting a policy to improve their finances: making medical care contingent on upfront payments.”

“The bad debt is driven by a larger number of Americans who are uninsured or who don’t have enough insurance to cover medical costs if catastrophe strikes. Even among those with adequate insurance, deductibles and co-payments are growing so big that insured patients also have trouble paying hospitals.”

“Asking patients to pay after they’ve received treatment is “like asking someone to pay for the car after they’ve driven off the lot,” says John Tietjen, vice president for patient financial services at M.D. Anderson. “The time that the patient is most receptive is before the care is delivered.”

Medicynical note: For these patients with cancer it is pay or die. One can only speculate on what happens to those who can’t pay. Is this what we, as a society, desire?

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Corrupt Practices vs Corruption–Conflicts of Interest

Marcia Angell during and after her tenure as editor of the New England Journal of Medicine has decried pharmaceutical industry practices. Her recent review of three books in the NY Review of books has gotten the attention of industry.

The books were Side Effects: A Prosecutor, a Whistleblower and a Best Selling Antidepressant on trial by Alison Bass, Our Daily Meds: How the Pharmaceutical Companies Transformed themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen, and Shyness: How Normal Behavior became a Sickness by Christopher Lee.

In the article Angell highlighted the practice of having researchers on payrolls of companies whose products they were evaluating. She called the practice corrupt and urged:

“But there is clearly also a need for the medical profession to wean itself from industry money almost entirely. Although industry-academic collaboration can make important scientific contributions, it is usually in carrying out basic research, not clinical trials, and even here, it is arguable whether it necessitates the personal enrichment of investigators. Members of medical school faculties who conduct clinical trials should not accept any payments from drug companies except research support, and that support should have no strings attached, including control by drug companies over the design, interpretation, and publication of research results.”

Dr. Alvin Shatzberg and his University (Stanford) took issue with calling conflicts of interest a corrupt practice and had an exchange of correspondence with Dr. Angell in the February 26, 2009 issue of NY Review of Books. The major point of Dr. Shatzberg and the University appears to be:

“The exchange of money or other items of value between the medical community and medically related industries should be transparent and limited to payment for legitimate services.”

“As Angell notes, the provision of money and other valuables by pharmaceutical companies to medical schools, medical societies, and individual physicians has been widely accepted for many years. Some of the effects, such as the development of effective new treatments, have been positive. It is good that society and the profession are finally paying attention to the consequences that are negative. But standards-of diagnosis, research, and behavior-change over time. It is unfair to suggest physicians are “corrupt” for activities that were virtually universal when they occurred.”

Dr. Angell replied:

“My article was about the conflicts of interest that permeate medicine, not failures to disclose them. And nowhere did I state or imply that they were unlawful, as Schatzberg’s lawyer charges. My point was that pervasive conflicts of interest corrupt the medical profession, not in a criminal sense, but in the sense of undermining the impartiality that is essential both to medical research and clinical practice.”

Medicynical note: It’s necessary to read the original article to fully appreciate the issues. Medicine in my professional lifetime has compromised itself. Our profession no longer can be relied upon to put the patient’s interest first. We’ve monetarized the system and the choices made have corrupted it.

I’ve always felt that disclosure of a conflict of interest did not help. For example, what does it mean when the author of an article reveals he/she is being paid by and/or has a financial interest in the company whose drug, procedure, or medical device the doctor is evaluating. How much should we rely on the conclusions of an obviously biased source? The practice at best opens the door to doubt and at worst corrupts and irreversibly contaminates them.

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Deregulation and Patient Autonomy–two sides of the same coin

Without rules (regulation) banks seek ways to manipulate the system to maximize profits. The current financial mess was facilitated by banks’ ability to make bad loans and then pass the risk to someone else.

In health care we have similar situation. We insist on autonomy for patients (deregulation). It’s in our ethical code that patients and their providers are free to make health care decision that best fit the needs of the patient. Our system of insurance facilitates this by passing the financial ramifications (risk) of this decision on to someone else–insurers and ultimately government health programs.

In the financial system some form of regulation is apparently essential to prevent financial collapses–we’re had several major financial crises related to deregulation over the past 25 years. It appears that Friedman, Milton that is, was wrong and financial markets are unable to regulate themselves without collapsing.

In healthcare we need a similar check on poorly considered treatments. Our system is collapsing. It’s estimated that up to 30% of health care services are unnecessary. Many approaches are overpriced and not cost-effective–that is they have some efficacy but the cost is beyond which any health care system, much less most individual, can afford.

Conservatives believe that by passing costs on to the patient we will force them to make better decisions and the system will self regulate (Medicynical note: as effectively as our financial system? ). They propose health savings accounts and high deductible insurance plans, with an emphasis on patients sharing the cost. Not a bad idea if we all had high incomes and lots of savings. But it’s a fact that the median income in our country is just $50,000/household and most citizens have very limited savings. Believe me, most families cannot afford several thousand dollars/year more in health expenses (deductibles and cost sharing)–above and beyond the several thousand already paid for insurance. In such a system, if implemented, those who become sick and can’t afford their cost sharing will continue to seek care and gravitate, just as now, into the public system. The conservative solution leads to a dead end.

A better approach is more comprehensive health coverage with moderate deductibles but with a system that assesses health technology and advances for efficacy and cost effectiveness. Hopefully when developers of new approaches realize that the system won’t pay exorbitant prices for modest advances, value will become a part of health care.

We literally have to change the culture of medicine.

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The Financial Impact of Cancer on patients

The American Cancer Society and the Kaiser Foundation have published a report on the financial impact of cancer on patients and their families. It notes 5 major issues:

1. “High cost-sharing, caps on benefits leave cancer patients vulnerable. The various types of cost-sharing and limits on benefits found in some insurance plans may quickly lead to high out-of-pocket costs once cancer treatment begins.” Medicynical note Cost sharing does force patients to factor cost into decisions. However, because of the huge expenses to patients and their families, cost sharing may adversely affect the access of some patients to treatment. Thoughtlessly implemented cost sharing is a blunt instrument that is not appropriate as a strategy to limit costs.

2. “Those with employer-sponsored coverage may not be protected from catastrophically high health care costs if they become too sick to work.” Medicynical note: Our system is carefully designed to eliminate and/or downgrade patient insurance coverage if a person becomes so sick they can’t work. Marquis de Sade could not have done better.

3. “Cancer patients and survivors are often unable to find adequate and affordable coverage in the individual market.” Medicynical Note: Rating individuals rather than populations, a long standing goals of insurers, guarantees profits while undermining care. When you become sick, insurance rates increase to the point where you can’t afford it. We have a carefully calculated money making system for insurers, not a benevolent caring health care system.

4. “High-risk insurance pools are not available to all cancer patients, and some find the premiums difficult to afford.” Medicynical note: More of the same. We have more safeguards for insurers than patients.

5. “Waiting periods, strict restrictions on eligibility, or delayed application for public programs can leave people who are too ill to work without an affordable insurance option.” Medicynical note: Ditto. Even where our system has programs to fill gaps they are designed to limit access.

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