Bredeson NO!!

President Obama is apparently considering Gov. Phil Bredesen as secretary of HHS. The governor however disqualified himself with this quote in the Wall Street Journal:

“Anybody who’s got some real scars and experience is going to have their detractors,” the governor said Monday in an interview with The Wall Street Journal. “People at the White House are smart enough to be able to assess that.” And he took a swipe at his opponents, saying that “advocacy groups don’t matter nearly as much as the pharmaceutical groups, the hospitals, the doctors’ groups. There’s a lot of very powerful interest groups that will play in this thing.” (Medicynical emphasis)

Somehow I can’t imagine a useful HHS secretary who puts pharmaceutical interests above patient advocacy groups. That’s not CHANGE!!!

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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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Naturally Un-Natural OTC drugs

It’s alway puzzled me that taking innumerable vitamins, of dubious utility and origin, appealed to the “natural healthy food” crowd. These supplements are pushed, presumably for a fee, by various “experts” who are anything but expert–such as Kathie Gifford, various athletic types, Suzanne Somers and all manner of fading B-list celebrities. These people, and they include health gurus such as Andrew Weil, are willing to sell you their own brand supplements at a substantial profit to themselves.

Proponents of health lifestyles and “organic foods,” don’t hesitate literally ingest handfuls of these remedies and vitamins of uncertain origin and dubious efficacy. They take them to “stay healthy” while berating our health care system, ironically, for prescribing too many pills.

The use of vitamins to prevent disease is a little like the man from Sri Lanka I once met in Pennsylvania wearing flower in his vest. When asked why? He replied “it keeps the elephants away.” When I told him there were none here, he nodded and said, “see it works.” When he returns to Sri Lanka it won’t continue to work.

The best way to stay healthy is to eat well, exercise and not use tobacco products. There is little evidence that indiscriminate use of vitamins do much of anything. To true believer of vitamin use, however, vitamins appear work for most of their lives (most of us are healthy for most of our lives) and then they don’t.

In fact virtually all of these “health store” remedies are unproven and in many instances have been proven harmful to the health. Yet billions of dollars are wasted on them each year.

The FDA has been reviewing over the counter “natural” diet pills and found that they contain dangerous ingredients and may do significant harm to harm.

“And StarCaps are not the only culprits. In a continuing investigation that has prompted consumer warnings and recalls by some distributors, the F.D.A. has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs.”

“Doctors said undeclared drugs could cause problems on their own, like elevated blood pressure or seizures, could have toxic interactions with other medications and could make it difficult for physicians to diagnose patients.”

How do such products get on the market? In the 90’s when the use of over the counter (OTC) agents was accelerating, Orin Hatch of Utah, the home of many of the supplement companies, sponsored and got passed through the republican congress the Dietary Supplement Health Education Act of 1994 (DSHEA)–Clinton signed the bill. Before DSHEA manufacturers of OTC remedies had to prove to the FDA that their supplement was safe. The idea that they might have to prove that the remedy did anything was never a part of the FDA review process.

After the act was passed, the FDA, already short staffed and underfunded, had to discover and prove that a “dietary supplement” was unsafe before they could stop its sale. What followed was feeding frenzy of marketing of agents for such indications as “heart health”, “prostate health,” “male enhancement,” and all manner of vague indications. Just as a stopped clock is right two times a day there are occasional useful supplements. Unfortunately,however, most are useless and some as noted above cause significant problems.

The FDA has a list of potentially harmful dietary agents on their site.

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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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Autonomy or stupidity?

Patient Autonomy taken to a ridiculous level.

“The births were a hot topic of conversation Friday, with many people incredulous that a woman with six children would try to have more — and that a doctor would help her do so. Several doctors said it is not their role to dictate family size.”

“Nadya Suleman and her other six children, who range from age 2 to 7, live with her parents in Whittier, a Los Angeles suburb.”

“Angela Suleman said all the children are from the same sperm donor, but she did not identify him. She said that her daughter is divorced, but that the ex-husband is not the father.”

“Friends and family said Suleman worked as a psychiatric technician until she was injured on the job several years ago. Then she began having children and enrolled in college, earning a bachelor’s degree in child and adolescent development and returning to pursue a master’s in counseling before dropping out last year.”

Guess who is going to pay?

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Patient Autonomy, Health Care and Costs

Part of the ethical basis of our health care system is that patients have autonomy.

“The right of patients to make decisions about their medical care without their health care provider trying to influence the decision. Patient autonomy does allow for health care providers to educate the patient but does not allow the health care provider to make the decision for the patient.”

Ideally, physicians provide information, explain alternatives, options and implications but the patient makes the decision. However, despite this, patients often make bad decisions. For example, patients with terminal illness with little or no chance of response or recovery may decide on the most aggressive, toxic, and costly treatment option. As a result, he/she may have more problems in their last days and the expenses for care in the last six months of life may exceed the all the expenditures for health care in that person’s life.

The physician’s influence should not be discounted. Most doctor’s explanations and recommendations are in the best interest of patients. However, physicians because of the nature of fee for service can have conflicts of interest that influence their behavior. The more they do, the more they make. Other factors such as the physician’s research interest, or financial interest in laboratory or imaging facilities may also affect decisions.

Pharmaceutical companies and other providers of health care technology influence patient decisions through promotional activities. Drug companies spend more on advertising than on research. Physicians are barraged with advertisements, “educational” opportunities and company propaganda. Lay people are deluged with media advertisements touting the benefits, with scant disclosure of toxicity and cost, of new drugs and technological advances. In many instances the new products are no better than older more cost effective agents. All of this is about influencing patient autonomy.

The cost of patient decisions is buffered by our system of insurance. With an insurance based system after paying the insurance premium someone else pays. Costs are under-represented in the care decisions. The patient wants to live a full and healthy life. The physician runs a business and like all businesses it has to generate enough money to pay expenses and salaries. Suppliers of services and health technology have the fiduciary responsibility to make a profit. Insurers, in addition to paying for care of their beneficiaries, also want to make money for their stockholders. Nowhere in our system is an objective balance to the universal incentive to spend more.

Our republican friends want a system that places greater financial responsibility on the patient. That would certainly increase patient concern about costs. But it would also eliminate most people from the health care system because the price for care would exceed the ability to pay. This creates the ethical dilemma of people with diseases who are unable to afford health care. Are we as a country willing to allow these sick people to die because of lack of access? At this point only very wealthy very insensitive people seem to favor this solution.

The question then is how to raise the level of cost consciousness in an insurance based system. A system that maintains the concept of patient autonomy but also provides efficient affordable services. The answer is not simple and will be part of the challenge that faces Secretary Daschle and the Obama administration.

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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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