Category Archives: Uncategorized

It’s too bad this didn’t work.

It would appear that the effects of diet on established disease are limited. It may work better to prevent disease than it’s recurrence.

Pricing based on outcomes, yes a money back guarantee, sounds like an attractive marketing idea but probably is unworkable in medicine, cancer medicine in particular

We’re talking big money here. The NEJM (Volume 352: 2546-2548. June 15, 2005) notes the cost comparison between bortezomib (Velcade) and dexamethasone in multiple myeloma is:

“The final consideration of “tolerability” is one of cost. The charge by the pharmacy at my center (Mayo Clinic, Rochester, Minn.) to a patient with a body-surface area of 2 m² for the nine months of therapy as outlined in the APEX trial would be $45,760 for bortezomib and $170 for dexamethasone. Though no price can be placed on the value of an effective drug to a patient or his or her family and doctor, this differential is sobering.”

From the NY Times article of July 15:

“Johnson and Johnson has proposed that Britain’s national health service pay for the cancer drug Velcade, but only for people who benefit from the medicine, which can cost $48,000 a patient. The company would refund any money spent on patients whose tumors do not shrink sufficiently after a trial treatment.”

There are problems determining the “benefit” of a cancer drug that is not curative. When bortezomib (Velcade) is given with other cancer drugs, as it is most of the time, a response to therapy does not prove Velcade’s efficacy. Improved length of response or time to survival may be a valid measure in groups of patients comparing treatment approaches but is difficult to evaluate in a single patient. Similarly, how does one assess a benefit when the stage of disease at diagnosis, tumor biology and it’s inherent aggressiveness or lack thereof also influence survival?

Patients, physicians, drug companies and insurers have their biases. It would appear to medicynic that accurately determining the contribution of bortezomib (Velcade), or other cancer drugs, to any benefit in a single case will require wisdom beyond our capability.

A better idea would be to to price drugs more fairly so that the decision to treat does not bankrupt patients, insurers and indeed the health care system.

Sicko makes Canada feel good about itself.

Some interesting insights:

“For this dysfunctional system, the United States spends more than any other country in the world, about $2 trillion a year.”

“Even though that sum represents about 14 per cent of the U.S. gross domestic product, 44 million U.S. residents are uninsured, and as Moore shows, even those who are insured have difficulty getting care. In Canada, he points out, nine per cent of our GDP is enough (or almost enough) to provide health care to 100 per cent of the population.”

“In a systematic review of 38 studies published in Open Medicine in May, 17 leading Canadian and U.S. researchers confirmed the Canadian system leads to health outcomes as good, or better, than the U.S. private system, at less than 50 per cent of the cost.”

In regard to BIG PHARMA:

“is that [Cuba, Canada and Britain] get cheap drugs only because they are free-riding off the massive profits made in the American market.”

“This is a standard U.S. brush-off to suggestions other countries might have useful ideas: The United States has done the heavy lifting and everyone else is piggybacking on its efforts. The only reason countries like Canada and Britain can afford universal health care is because they’re freeloaders.”

“In Britain, drug companies invested proportionately more of their revenues from domestic sales in research and development than U.S. companies. In Canada, in 2004, brand-name drug companies reported income from their domestic sales was about 10 times higher than their R&D costs, despite prices about 40 per cent lower than in the United States.”

Think this has anything to do with the billions spent on drug marketing in the U.S.? These expenses exceed those of drug research by a wide margin. Guess who pays?

The Manhattan Institute, an organization with the goal “\to develop and disseminate new ideas that foster greater economic choice and individual responsibility.” has reported that thanks to new drugs we are living longer. The organization has the support of Vice President Cheney as a “place of tremendous creativity, of original thinking, and of intellectual rigor.” He continued: “The scholars of the Manhattan Institute have shown, time and again, the power of good ideas to shape public policy and to have an impact on the lives of people here in New York and across the nation.” It should be noted that Cheney is an expert at shaping public policy by misstating facts.

The Manhattan Institute, from a medicynical point of view, has a checkered history and has been associated with the tobacco industry and does receive funding from Big PHARMA.” A 1997 R.J. Reynolds memo reveals RJR’s intent to use the Manhattan Institute as a third party to help the company reduce the public’s perception of danger from exposure to secondhand smoke.” The Institute, FYI, receives hundreds of thousands of dollars in drug company funding. The author of the study, Frank Lichtenberg, has received unrestricted grants from (Merck) and has worked as a consultant to Pfizer–there may be other unreported associations.

In the current study he notes:

• From 1991 to 2004, nationwide, life expectancy at birth increased 2.33 years; life expectancy at age 65 increased by 1.29 years.

• The states with the largest increases in life expectancy were the District of Columbia (5.7 years), New York (4.3 years), California (3.4 years), New Jersey (3.3 years), and Illinois (3.0 years).

• The states with the smallest increases in life expectancy were Oklahoma (0.3 years), Tennessee (0.8 years), Utah (0.9 years), Alabama (1.0 years), and West Virginia (1.0 years).

• In the eight states with the smallest increases, life expectancy increased by 0.31-1.16 years. In the eight states with the largest increases, life expectancy increased by 2.60-4.33 years.

What’s remarkable about the study is that it attributes the improvement in longevity almost entirely to the availability of expensive, often copy-cat, “newer” drugs of limited efficacy–rather than changes in life style (smoking cessation and diet for example) or medical practice. The data cited shows wide variation in each state’s longevity some of which seems more likely to be due to sample error rather than medical intervention. Who can believe, for example, an improvement of 5.7 years in the District of Columbia over 14 years. It doesn’t seem reasonable that this was due mainly to access to “new drugs.” The cited example of Lipitor is noteworthy in that the drug will decrease cholesterol but there is precious little data to indicate at this time that the drug will have a major effect on longevity–studies are in progress.

Given the contributions of the pharmaceutical industry to the Institute and the author, it seems to a medicynic that the study provides accolades for a financial supporter rather than serious scientifically defensible information.

The facts are:

“Despite spending over $2 trillion a year on health care — 18% of the U.S. GDP and twice as much as any other nation — the United States ranks only 45th in life expectancy and 37th in a World Health Organization study on the performance of national health systems. The U.S. federal government currently spends more on health care than on Social Security and national defense combined, the next most expensive items, but Americans get the right treatment only 55% of the time. Expenditures on health care in the United States — already the highest per person in the world — are predicted to nearly double by 2016, to $4.1 trillion, or 20% of GDP. That means, if this trajectory is not altered, in less than a decade, 20 cents out of every dollar produced in America will be spent on health care. Currently, more than 75% of health care dollars are spent on patients with chronic diseases, yet an estimated 80% of all chronic diseases are caused by preventable factors, such as smoking, obesity, and physical inactivity.4,5 But despite these statistics, less than 5 cents of every health care dollar is spent on prevention and public health.” (medicynical emphasis)

It should be noted that these other countries with better health outcomes than the U.S. all have LESS access to the wonder drugs flogged in the Manhattan Institute’s so-called report.

Tomatoes taste good but don’t prevent cancer:

“But after a painstaking analysis of 145 studies, the agency concluded there’s no scientific evidence of any cancer-fighting benefit from lycopene and only limited evidence for any benefit from tomatoes themselves. (See FDA Tomato Ruling May Make Pizza a Health Food)”

“All of the 81 observational studies of lycopene and cancer were rejected as failing to meet the scientific standards for a claim of a cancer prevention benefit, Dr. Kavanaugh and colleagues said.”

By all means continue to eat tomatoes but you can stop those supplements with lycopene. There is not a shred of evidence that they prevent anything.

Selenium has been touted as a way to prevent prostate cancer in one small study of skin cancer. It didn’t prevent skin cancer but appeared to decrease the incidence of prostate cancer. The study was small and is currently being repeated. Now comes the news, in a similar small study that Selenium may increase the occurrence of type 2 diabetes.

“The researchers found that 58 out of 600 people in the selenium group and 39 of the 602 in the placebo group developed type 2 diabetes. During 7.7 years of follow-up, Stranges’ team noted that the risk of developing type 2 diabetes was approximately 50 percent higher among those taking selenium compared with those taking a placebo.”

This may or may not be a valid conclusion but we’ll have to await the outcome of the prostate prevention trial to find out–they will likely add the occurrence of diabetes to their study.

Highly touted vitamins and supplements such as selenium in high doses are not the answer to anything, except the financial well-being of the the companies and practitioners that market and sell them. Speaking of health hoaxes, what is bigger than the U.S. public’s use of these nostrums.

This says it all:

“Despite spending over $2 trillion a year on health care — 18% of the U.S. GDP and twice as much as any other nation — the United States ranks only 45th in life expectancy and 37th in a World Health Organization study on the performance of national health systems. The U.S. federal government currently spends more on health care than on Social Security and national defense combined, the next most expensive items, but Americans get the right treatment only 55% of the time. Expenditures on health care in the United States — already the highest per person in the world — are predicted to nearly double by 2016, to $4.1 trillion, or 20% of GDP. That means, if this trajectory is not altered, in less than a decade, 20 cents out of every dollar produced in America will be spent on health care. Currently, more than 75% of health care dollars are spent on patients with chronic diseases, yet an estimated 80% of all chronic diseases are caused by preventable factors, such as smoking, obesity, and physical inactivity.4,5 But despite these statistics, less than 5 cents of every health care dollar is spent on prevention and public health.” (medicynical emphasis)

In my specialty the expense of treatment is astronomical while the benefits, at best, moderate. There are a few exceptions to this but the great majority of cancers if beyond a local lesion remain incurable. Costs of new treatments to extend life just a few months exceed that of most automobiles and can be more than the cost of most homes. We hypermarket mediocrity and ignore the basics–so what else is new?

As implied above one key to improving health care is assured access to preventive and basic health care services, not fancy costly aggressive therapies for advanced disease.

A few weeks ago two sets of sextuplets were delivered within one day. Both pregnancies were assisted by drugs and/or invitro fertilization.

The Arizona babies seem to be doing better though the mother was reported to almost have died of heart problems after delivery.

Both couples were informed of the multiple birth pregnancy and its risks and decided to proceed because of “ethical” considerations. Now after delivery three of the six Minnesota babies have died and the other three are in critical condition–a forth child has subsequently died.

The Minnesota couple noted: “We continue to trust in the Lord and are hopeful for a good outcome for Cadence, Lucia and Sylas,” The Arizona dad intoned “We’re blessed and excited,” he said. “I keep coming back to the Bible verse that says, ‘God will never leave or forsake us.'”,

These are risky pregnancies, 1/3 of these children died, with abundant problems for both the mother and the children.

Parents should have the right to choose to accept exceptional risk in pregnancy and given the exceptionally high fetal and maternal morbidity they should also be able to decide not to accept such risk. \

There’s a lot in the media, here too, here, about health care thanks to the upcoming presidential campaign, the movie Sicko, and a dawning realization that we pay more and get less for our health care than many similar nations.

Consider:

“As early as 2000, the World Health Organization made the first attempt at ranking all the world’s health-care systems. The United States came in 37th out of 190 nations in the provision of health care. (France, according to the report, was first.) The report was criticized for using inconsistent comparison measures and for failing to note that some countries deny expensive care to very sick patients. Americans could still reasonably cling to their long-held pride.”

“But in 2006, the Organization for Economic Cooperation and Development, an international organization that aims to lift living standards by promoting economic development, compared health spending and health statistics in its 30 member nations. Its report was more detailed than the WHO rankings, and had more controlled and consistent measures. The data, taken more seriously than the WHO rankings, left Americans with little to brag about.”

“another report released by the Commonwealth Fund, which supports independent research into health-care issues, found the United States at the bottom among six industrialized nations on measures of safe and coordinated care.”

“the United States had fewer practicing physicians, or 2.4 per 1,000 people, than the average of 3 per 1,000 people. Infant mortality rates have been falling in the United States, but are still higher, at 6.9 deaths per 1,000 live births, compared with less than 3.5 deaths per 1,000 live births in Japan, Iceland, Sweden, Norway and Finland.”

“The health-care picture is certainly not all bad. Emanuel knows, for example, that as an NIH employee, he works for the premier medical research institution in the world. Americans’ penchant for raising awareness, consciousness and money have helped the country shine in breast cancer treatment, preventive measures such as colonoscopies and world-class institutions such as the Joslin Diabetes Center. And America leads the world in the development of new drugs, in part, the pharmaceutical industry says, because there are no constraints here on what the industry can charge for patented medications.” (medicynical note: But unlimited pricing and aggressive marketing of drugs, most mediocre, are factors that contribute to our costs–see below.)

“the United States spends an annual $6,102 per person – more than any other country and more than twice the average of $2,571. Yet Americans have the 22nd highest life expectancy among those nations, at 77.2 years compared with the analysis’ average of 77.8 years. People in Japan, the world leader in longevity, live an average of 81.8 years.”

Despite the discussion I’m not at all sure anything will happen. Legislative inertia, financial insolvency, powerful lobbies and lack of leadership beyond political posturing, make significant change of our dysfunctional system unlikely. More bandaids when major surgery is required. The question is whether the patient will survive or whether we will eventually have to do surgery on a dead man.

Ten issues that go away with a national health insurance system:

1. The approximately 47,000,000 uninsured: All will have access to coverage with incentives for provider efficiency and the most cost efficient interventions.

2. The profit squeeze on employers who provide health insurance to employees: It’s estimated that U.S. car makers have expenses of over $1500/car related to health care coverage for employees. A national system, delinked from employer based insurance, allows our employers to compete on the same basis as those in other industrialized countries.

3. Our disgraceful system of health care for GI’s and their families: Incorporating the VA and military health care systems is into a National Health Insurance program provides more and better options for care. These will be community based and thus provide more convenient access.

4. The administrative duplication and fraudulent behavior of multiple insurance providers, each with their own administrative overhead and fiduciary responsibility to generate profits: It’s estimated that we spend 30% of our expenditures for health on administration ($1059/capita in U.S. vs $307/capita in Canada). That could easily be halved or more with a national health program.

5. The conflict of interest between insurers, providers and patients.

6. The crisis in emergency rooms: With insurance people will have a place, other than ER’s, to go with non-emergent medical issues

7. The dance of the veils billing system: There is no set price for services. Those with leverage, i.e. large insurers, are given large discounts while the individual pays the full amount. If everyone has insurance there will be one negotiated price.

8. Big PHARMA’s free ride: We pay more for medications than any other industrialized country. PHARMA’s mantra that they need profits to encourage creativity is bogus when one considers they spend more on promotion and advertising than research. In a national insurance scheme drug price negotiation will be the rule–as it is in the rest of the industrialized world. (see more below)

9. Bankruptcy due to enormous medical bills

10. Our mediocre health care outcomes: We spend more per capita than anyone, yet our outcomes are in the middle of the pack. With universal access we can expect this to change.

None of this will be automatic and actually having an efficient functioning system of care will require much due diligence and negotiation.

What won’t change is physician unhappiness with reimbursements and the continuing issues with intellectual property rights. No where in the world are physicians as well paid as here. We’ve made the profession entrepreneurial and money driven and in the current non-system reward procedures rather than primary care. It can be anticipated that a national health insurance scheme will want to flatten the disparities and redistribute, somewhat, the fees. One would hope this would guarantee all physicians reasonable reimbursement for their time and expenses. However, meeting the expectations of the profession will be almost impossible–as it is now.

We do need some type of protection for innovators in our system. We should not however delude ourselves that this is a “free market”. Patent protection creates monopoly and in health care that has resulted in a life threatening market distortion that we can no longer afford. We need to somehow require patent holders to price their products responsibly and to be efficient in their product development and marketing. Once again meeting the expectations of the industry and their stockholders will be almost impossible–as it is now.

But in both cases the status quo is not working.