Category Archives: Ethics

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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A Poorly Conceived Study Ends Badly–Erbitux and Avastin in Colon Cancer

Erbitux (cetuximab) targets epidermal growth factor receptor (EGFr). Avastin (bevacizumab) is an antiangiogenic drug that inhibits new vessel growth in tumors. Using the drugs together with conventional chemotherapeutic drugs was thought to offer a way to improve colon cancer outcomes.

While innovative, in studying the combination the investigators seem to have forgotten reality. First, each of these agents, used with conventional chemotherapeutic drugs in advanced colon cancer has limited efficacy– a slight delay in time to progression and up to 2 months improved survival. Each is also among the most expensive drugs ever manufactured costing up to and over $100,000/year for a year’s therapy.

If the two are combined in a regimen with other chemotherapeutic agents the costs would break the system and bankrupt individuals. Yet the investigators, grant recipients and paid consultants for the companies producing these drugs, combined them in a trial. The results showed:

“There was no benefit derived among any endpoint for patients treated with the addition of Erbitux; in fact, progression-free survival was significantly reduced among patients treated with Erbitux (9.6 months versus 10.7 months, HR for progression 1.21, P=0.018).”

“Overall survival was similar between the two groups at approximately 20 months (P=0.21).”

“Both groups achieved a 44% combined complete and partial response rate (P=0.88).”

“There was no significant difference between treatment groups in terms of disease stabilization.”

“Even when KRAS status and the presence of grade 3 rash were included in the statistical analysis, no benefit was noted among the group of patients who received the addition of Erbitux over the control group.”

What’s amazing about this study is that it was done. As noted above, each agent combined with various conventional chemotherapy regimens results in modest improvement. The cost of a year of the survival benefit in these studies (2 months survival/pt at a cost of $50,000-$100,000/pt) would be in the neighborhood of $300,000- $600,000, hardly a cost effective intervention. It seems inescapable that the cost of both of these very expensive,modestly effective agents in one regimen is unaffordable.

Medicynical Note: Cost needs to be factored cost into decision making, both in research and at the therapeutic level. Research on a financially impractical regimen leads nowhere. This would change if the drug industry priced their agents rationally.

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Daschle NO!

It appears that Tom Daschle is not the right person to reinvigorate anything. This from the Times:

“he had failed to pay $128,000 in taxes on the car and driver Mr. Hindery’s firm provided him, threatening to derail his confirmation as secretary of health and human services.”

“Beyond the ramifications for Mr. Daschle’s ascent to the cabinet, the disclosures about Mr. Hindery and the many clients Mr. Daschle advised on public policy offers a new window into how Washington works. It shows how in just four years an influential former senator was able to make $5 million and live a lavish lifestyle by dint of his name, connections and knowledge of the town’s inner workings.”

More from Rolling Stone’s Matt Tabbi:

“Regarding Daschle, remember, we’re talking about a guy who not only was a consultant for one of the top health-care law firms in the country, but a board member of the Mayo Clinic (a major recipient of NIH grants) and the husband of one of America’s biggest defense lobbyists – wife Linda Hall lobbies for Lockheed-Martin and Boeing. Does anyone really think that this person is going to come up with a health care proposal that in any way cuts into the profits of the major health care companies?”

There’s more in Glenn Greenwald’s column in Salon. And more in this NY times editorial.

Daschle doesn’t pass the smell test. We need someone with fewer industry ties and a genuine commitment to change.

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Corrupt Industry Practices– Lilly pays 1.42 Billion in fines

Drug companies spend more on marketing drugs than they do on research. Lilly is pleading guilty to illegally promoting it’s anti-psychotic agent Zyprexa for other uses.

“Lilly admits it promoted Zyprexa in elderly people to treat dementia, a use not approved by “the Food and Drug Administration,

“Zyprexa, used to treat schizophrenia and bipolar disorder, had sales of $4.76 billion in 2007, accounting for about a quarter of Lilly’s revenue. The drug, part of a class of medications called atypical antipsychotics, has been linked to excessive weight gain and diabetes.” \

This is not the first settlement for Lilly regarding this drug. It has also paid over a billion dollars to patients for harm caused by inappropriate use of this drug.

“The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to develop diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.”

“Internal Lilly marketing documents and e-mail messages showed that Lilly wanted to persuade doctors to prescribe Zyprexa for patients with age-related dementia or relatively mild bipolar disorder.”

Earlier Lilly had a marketing scheme to doctors “Viva Zyprexa” (sound familiar?) aimed at urging the sue of the drug in dementia.

“In one document, an unidentified Lilly marketing executive wrote that primary care doctors “do treat dementia” but leave schizophrenia and bipolar disorder to psychiatrists. As a result, sales representatives should discuss dementia with primary care doctors”

Zyprexa costs in the range of $4000-$6000/year or more depending on the dose.

Medicynical note: Corrupt insurer (see yesterday’s post on Unitedhealth) and pharmaceutical company practices go away with a national health care program. In that new world which is reality in other industrialized nations, health insurance, drug utilization and pricing would be more carefully reviewed and supervised.

One wonders what happened to the “ethical” pharmaceutical industry, as it was called in the 60’s?

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