Category Archives: Ethics

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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Unitedhealth–Scamming doctors, scamming patients, the American Health care system

United Health has agreed to pay 50 million dollars

“Ending a practice doctors say underpaid them and led to higher costs for patients, UnitedHealth Group Inc. on Tuesday agreed to pay $50 million to establish a new database that will be used to determine rates for patients who choose physicians outside the insurance giant’s network.”

But of course while paying the money Unitedhealth denied wrong doing.

What’s remarkable about this is that other insurers use this database and also have underpaid for services, so the problem is broader than Unitedhealth:

“But because other health plans, such as Blue Cross and Blue Shield of Illinois, use the Ingenix database to determine their rates for out-of-network care, the impact is much broader”

Medicynical note; Unitedhealth and other insurers have single-mined devotion to making money. Whether that requires scamming doctors as above, scamming patients, or increasing Unitedhealth executive salaries,

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Samuelson’s solution to Healthcare– Increase taxes

It’s fascinating to watch the health care debate develop. This today in the Post:

“We could charge the elderly more for Medicare. We could tax employer-provided health insurance as ordinary income. We could create a dedicated federal tax to cover government health costs — if health spending increased more than revenue, the tax would automatically rise. People would quickly feel the costs of our present system. Of course, that would be unpopular, because it would compel Americans to face a discomforting issue — how important is health care compared with other priorities?”

Medicynical note: Mr. Samuelson seems to think we need to increase the costs to people by increasing taxes on health care. His proposal, however, will increase those who cannot afford health care much less more expensive insurance. He believes this will decrease use of the health care system and decrease costs. A little like the “let them eat cake” solution.

Free market approaches in health care simply don’t work. Patients are not in a position to comparison shop and cannot be fully aware of cost implications and all the options. Health insurance, for example, has been a “free market” for years and failed to providing affordable comprehensive care. Insurers are more concerned with their bottom line than quality care.

As noted by the McKinsey study, health care has become unaffordable. Insurance is overpriced; cost effectiveness is not a consideration; and utilization in some areas is excessive. Overpricing, as advocated by Samuelson, increases the uninsured, the tendency to delay preventive medical services and the use of expensive inefficient emergency rooms. His solution is more of the same and does nothing to decrease inefficiency and waste in the system.

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PacifiCare (UnitedHealth) Fined for Denying Claims without reason

In Oregon, PacifiCare, a division of United Health, has been fined for denying claims without investigating whether the patient’s problem was covered by their policy.

“The consumer and business services’ insurance division found that PacifiCare Life Assurance had refused to pay for claims without first contacting enrollees or their health-care providers, Martinis said.”

“State officials also determined that PacifiCare failed to act promptly on claims and made enrollees with pre-existing medical conditions wait one year for coverage. Oregon law requires insurance companies to cover pre-existing conditions after a person has been enrolled in a health plan for six months.”

“As a result of the state’s investigation, PacifiCare Life Assurance performed an internal review and paid nearly 5,000 claims that it previously denied without first conducting an investigation.”

“The insurer also took corrective action and paid more than 2,000 claims to which it had applied a 12-month pre-existing conditions provision.”

Medicynical Note: This company insures only 13,000 people in Oregon. They apparently denied 7,000 claims from this small population. Does anyone believe that these practices are limited? Are limited only to Oregon? Only to this division of UnitedHealth?

Private insurers are not there to provide coverage for or access to quality health care, they are in it for the money. The sooner we understand that the fiduciary responsibility of these companies is not to do good, the sooner we will be able to have a better, more responsive, possibly less expensive health care system.

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Paying for Healthcare: who pays the costs of the uninsured

Our non-system of health care has institutionalized the most inefficient, most costly and least effective way of paying for and delivering health care. The problem is most extreme for those who are indigent and/or have no health insurance coverage. They/we pay more for lousy health care. No wonder our health care outcomes are so mediocre.

People who are uninsured and have no access to health care are forced to delay care. Minor problems become major and costs for care, when sought, are higher. Guess who pays these higher costs when the uninsured can’t pay their bills?

When the uninsured and/or indigent become sick their problems are handled inefficiently (at ER’s for example) and other higher cost facilities. Guess who gets to pay for these excess costs when the uninsured are unable to pay?

If an uninsured person is fully indigent he/she may qualify for Medicaid. Guess whose taxes pay for this insurance?

Finally, w hen an uninsured person shows up at a hospital or other facility he/she pays retail. That is, their charges do not reflect the discount that insurers and industry insiders negotiate. So those least able to pay end up paying the most. That’s the reason one of the leading causes of bankruptcy in the U.S. is medical bills. Guess who pays for these unpaid bills with increased charges for their own services?

All of this goes away with universal coverage in a national insurance program. We need that change, now!

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PET Scans, Very Costly but Becoming Routine–does it always improve outcomes?

At a tumor board today we discussed a case of a 80 year old woman, with a 55 year smoking history that continues to today. She presented with moderately severe chronic lung disease and a lung mass that impinged on her bronchi. A biopsy showed this to be a non small cell lung caqncer. There were several small indeterminate satellite lesions that were thought likely to be tumor–too small to biopsy.

The pulmonologists thought her poor breathing capacity eliminated the possibility of surgery to remove the tumor. The surgeons also didn’t think the tumor was resectable. The radiation oncologist thought she should have a PET scan to see if her disease was curable with radiation treatment–highly unlikely in similar cases even in the best of circumstances. His thinking was that he would use different technique if the disease were not local–though the CAT scans already showed several suspicious lesions away from the original tumor site.

It should be noted that PET scans often miss small metastatic lesions and if positive require biopsy confirmation. So a negative PET showing no spread would have a good chance of being incorrect. And a postive PET would require some confirmation to act on it. All this in an 80 year old with non-resectable lung cancer.

That decision to do a PET scan costs about $4000 in our institution. The range of cost around the country is between $3000 and $6000.

In no other endeavor involving individuals are such expenses incurred, with so little consideration of expense and in this case with so little expectation of a successful outcome. It’s one of the reasons our healthcare costs in the last year of life are excessive.

In the woman’s case above it could be reasonably argued that the chance that this tumor was local was virtually nil and that she should be palliated with local irradiation to relieve the tumor related respiratory symptoms and then treated symptomatically.

In my view she has no chance of cure whether she has the PET scan or not.

Can we afford such testing? Where do guidelines end and physician judgment begin? Don’t we pay physicians to excercise judgment and don’t they need to include cost efficacy in their patient care decisions?

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Unitedhealth It’s all about the MONEY

The Wall Street Journal (behind the wall) notes this about recent SEC rulings on Unitedhealth backdating options for executives.

“The company’s former General Counsel, David J. Lubben, agreed to a $575,000 penalty in the case.”

“Mr. Lubben also will repay $1.4 million in gains and $347,211 in prejudgment interest. In addition, he agreed to an order barring him from serving as an officer or director of a public company for five years and from appearing before the SEC as an attorney for three years.”

This is not the first time this company has moved money from patient care to executive compensation:

“A year ago, in one of the largest executive-pay givebacks in history, former UnitedHealth Chief Executive William McGuire agreed to forfeit about $620 million in stock-options gains and retirement pay to settle civil and federal-government claims related to stock-option backdating.”

This type fraud while not on the Madoff level does raise the question of who the company is in business to serve. Patients or executives? Until now it appears to be the latter and Medicynic is not optimistic that this will change.

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Sin vs The Wonders of Technology

I have a wonderful grandchild, the product of in-vitro fertilization and am grateful for his life.

However, the medical experts of the Catholic Church, (more here) in their wisdom seem to believe that the in-vitro technique that helped bring him into existence is somehow sinful. In their latest guidelines on bioethics they:

“condemned artificial fertilization, embryonic stem-cell research, human cloning and drugs which block pregnancy from taking hold.”

“A long-awaited document on bioethics by the Vatican’s doctrinal body also said the so-called “morning after pill” and the drug RU-486, which blocks the action of hormones needed to keep a fertilized egg implanted in the uterus, fall “within the sin of abortion” and are gravely immoral.”

I can presume it remains a sin to use conventional birth control as well. Also not mentioned is the sensitive issue of abortion even in cases of rape and incest.

In places where Catholic Institutions dominate health care as in my home town, (one hospital and many physicians directly employed) these limits present major issues of access for those of us who disagree.

Most of us will ignore such medieval top down pontification and I for one will honor the effort of my kids to become parents of a wonderful truly miracle child.

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