Category Archives: Health Economics

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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Wellpoint typifies our failed health insurance system

Bloomberg’s comments about Wellpoint amplify the faults of our insurance system. Remember we’re not talking about a company supplying widgets.

“WellPoint recorded $543.2 million in pretax investment losses in the fourth quarter and $1.1 billion for the year. Mistakes in setting rates, which the company blamed on computer errors, also hurt earnings. The company additionally faulted computer foul-ups for keeping elderly customers from getting drugs, leading the government to block WellPoint this month from adding Medicare customers. Layoffs by customers fed a decline of 288,000 in enrollment in the quarter.”

Wellpoint appears to have misplaced a billion dollars. What in the world are they investing in that gave them this magnitude of loss? Remember they are supposed to be holding this money in a safe place to be able to pay for our health care–and their bonuses! (they only pay 83% of revenues to patients)

After being in business for over 50 years Wellpoint still makes major errors, in their favor of course, when it comes to paying for care. In this case they blocked elderly patients from receiving their medications and overcharged others. Amazing.

Lastly, and this is not Wellpoint’s problem, when people get sick and can’t work and they lose their insurance. What happens to these people? They stop seeking preventive medical services and in emergent situations seek care through ERs and public clinics.

Guess who ultimately pays? This goes away with a national health scheme.

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No such thing as Cost Effectiveness in U.S. medicine

Medicare has bowed to industry pressure and expanded the use of non FDA approved treatments for cancer. That means very expensive medications with little evidence of effectiveness will be used to treat cancers.

As noted in the article:

“One of the many drugs whose use is likely to expand is the Eli Lilly product Gemzar, which costs $2,500 to $5,000 a month. The F.D.A. has approved it to treat only four types of cancer. But the new rules will virtually guarantee that Medicare will pay for its use for about a dozen other cancers, including advanced cervical cancer – even though the evidence supporting Gemzar for that use is “inconclusive,” according to one of the reference guides Medicare will now be consulting.”

“Under the new rules, Avastin (medicynical note: one of the most expensive medication on the market at $10,000/month) will be routinely covered for ovarian cancer – as will at least some other off-label uses, including for brain and kidney cancer.”

“The new policy, which took effect in November, makes it much easier to get even questionable treatments paid for, critics of the changes say. Medicare is providing “carte blanche in treatment for cancers,” said Steven Findlay, a health policy analyst for Consumers Union. He said overly expansive coverage encourages doctors to use patients as guinea pigs for unproved therapies.”

Medicare has decided that cost effectiveness and value is not a consideration in cancer treatment. Without such analysis any system of health care is a goner.

We need a non-biased organization to review the effectiveness of medications. This evaluation would factor in such issues as whether the drug works for the indication, cost effectiveness and the value to the patient and health care system.

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More Technology, Higher Costs

We have a slavish reliance on technology to get us out of fixes. It’s almost an irrational belief system. We’re counting on technology to fix global warming, inefficient automobiles, to cure diseases and so on. But in our patent-bound world technology may not be the answer to all our problems and may actually costs without changing anything.

President Obama seems to think technology is the answer to our medical non-system’s problems. For example, integrated electronic medical records are a technological tour de force. They improve communication between physicians and marginally makes life easier in the paperless physician’s office, but do they improve patient care? That remains to be seen. The cost of the new technology, however, is tremendous both for the initial installation and the yearly maintenance. Guess who gets to pay? Savings, I doubt it.

Scientific American has doubts as well and cites this article in Health Affairs by Lawrence Baker. The abstract notes;

“As anticipated by previous research, increases in the supply of technology tend to be related to higher utilization and spending on the service in question. In some cases, notably diagnostic imaging, increases in availability appear associated with incremental utilization rather than substitution for other services.”

Consider PET scan technology. This diagnostic test does add to our information for certain cancers at a cost of $5000/test. Previously a patient had a CAT scan and/or MRI to image the tumor. With the advent of the PET, we now, in many instances, do all three. Figuring about $1000 for the CAT scan, an average of $2000 for an MRI and $4000-$6000 for an MRI, the cost of imaging alone today exceeds what it cost for the entire treatment, including surgery, 25 years ago. It’s debatable whether patient outcomes (survival) are better but what is not debatable is that costs are higher. We need better guidelines for use of these procedures.

The same can be said for other technology in the medical field, including new drugs. Their use may not improve outcomes but they will increase costs. This has to change.

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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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Market Based Health Care, Patent Reform

George Will and Mike Leavitt think buying health care should be like buying a car:

“Leavitt says that until health care recipients of common procedures can get, up front, prices they can understand and compare, there will be little accountability or discipline in the system: “In the auto industry, if the steering-wheel maker charges an exorbitant price, the car company finds a more competitive supplier. In health care, if the medical equipment supplier charges an exorbitant price, none of the other medical participants care.””

Price should be part of the health care equation. The cost of everything should be up front and open to scrutiny. Insurers should bargain for the best deal for their customers. These negotiated prices should be common knowledge so that all needing health care can benefit.

What’s missing from Mr. Will’s analysis is an understanding that patients are not in a position to shop health care. Finding the “best price” for emergency care and most other health care needs is simply not possible and the patient has to take whatever is available from the local supplier at the demanded price. Furthermore, health care is not like other commodities that people can take or leave as they wish. Buying a car or even a new home is an optional expenditure, health care is not. Yet health care costs/year for an individual can now approach and exceed these large expenditures.

Patient’s health care decisions reflect their anxiety, personal bias, financial status and understanding of the situation. This last factor should not be underestimated. Patients in the majority of instances cannot fully understand the risks and/or benefits of treatments and the alternatives, much less concern themselves with cost efficiency data. He/she is thus greatly influenced by physicians, manufacturers, insurers, etc. all with superior knowledge of the situation. All these advisors have extreme conflicts of interest that interfere with unbiased advice and undermine the notion of a “free health care market”–it doesn’t exist.

Our health care market doesn’t encourage efficiency, but rather it promotes over utilization. Providers and suppliers make more when there is consumption of health care services and products. One only has to experience inaccurate and highly deceptive TV ads for pharmaceuticals and procedures to understand that consumption is the name of the game, not cost efficiency.

The failure of free market forces in health care is graphically demonstrated in the insurance market. Insurers, in the U.S., spend an estimated 30% of revenue on administrative costs while other industrialized countries manage with between 7 and 15% for administrative costs–that’s over 100 billion dollars wasted. Our expenditures/capita are similarly elevated. Even with these excess expenditures, 50 million of our citizens are uninsured. CEO’s of insurance companies understand they are in business to make money and not deliver and/or pay for quality economical care. Much less provide health care for all.

There is even worse inefficiency in the pharmaceutical industry where products are given generation long monopolies (patents) that eliminate price competition. Companies price drugs based on the severity of the condition rather than their costs of development. They figure more seriously ill people can be coerced into paying more. They have been correct thus far. In the U.S. free markets are interpreted to mean free to make maximum profit.

Ewe Reinhard correctly believes part of the problem is the inefficiency of physicians and their inherent conflict of interest. He proposes a very complex system to control payments to physicians and encourage the right pricing and monitoring of utilization of health care resources.

“Studies have shown that physicians are not impervious to the financial incentives inherent in fee-for-service payments. For example, on average, physicians who have a direct financial interest in the use of imaging services, like CAT scans or M.R.I. scans, recommend far more such services for their patients than do physicians without such financial interest.”

He also notes that:

“there is now a worldwide movement to replace the system with so-called “evidence-based case reimbursement”. Under this approach, one single payment would cover all of the supplies and services that are needed, under best, evidence-based clinical practices, to respond adequately to well-defined medical conditions.”

and:

“For example, it is technically feasible to capture electronically every supply and service requisitioned by every doctor in a hospital for every patient, by type of supply or service ordered. It is also feasible to electronically capture detailed information on the health status of every patient admitted to a hospital.”

With due respect for Dr. Reinhardt, such a system seems likely to have unintended consequences because of it’s complexity. We are violating the KISS principle (Keep it Simple Stupid).

Paying a fixed amount per diagnosis seems simple and unbureaucratic. But it sounds suspiciously like the the DRG payment system currently used by Medicare other insurers. That system is an administrative nightmare that underpays providers and forces them to maximize diagnoses to increase reimbursement. Often providers decide that they cannot afford to provide care for the payment offered and increasingly are refusing patients covered by this limited rigid reimbursement system.

Similarly, scrutinizing every expenditure seems unreasonable and not really possible.

An additional problem with reimbursements is that the system as it is currently organized rewards proceduralists and doesn’t pay enough for patient contact time and intellectual effort. Most physicians have large debt from medical education; their office overhead and data collection requirements all cost big bucks; billing is complex as physicians are forced to justify their approach to each patient problems. As a result the underpaid primary care specialists are literally disappearing. This doesn’t change in Reinhardt’s proposed reimbursement system, and may actually worsen with the added billing oversight.

Health care expenditures will continue to rise as long as pharmaceutical and technology companies have patent protection for a generation and are not scrutinized for excessive pricing. These players are literally sucking the system dry.

I would favor providing support for medical education in return for some quid pro quo, whether several years working on salary or participation in government health care programs or a commitment to accept the fees offered by government sponsored programs. I certainly agree we must include methods of scrutinizing health care expenditures but also think the primary emphasis should be to provide incentives that promote careful cost-effective primary care, with appropriate use of new advances, while maintaining productivity.

Patent reform must also be part of the mix and I would suggest a market based reform. New technology’s pricing would be scrutinized by a board during the patent process. The product or procedure would be compared others. Companies pricing their new product or procedure reasonably would be rewarded with a patent for the full time period. Companies pricing their “advances” excessively,(based on efficacy, costs of development and comparable product cost) would still get patents but they would be for a proportionall
y shorter period of time –proportional to the excess pricing of their product. Price increases once the product is marketed would be limited to the cost of living or else the patent length would be reduced.

The greatest challenge is lining up incentives in the system to reward cost effective high quality medical care.

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