Medicynic

It’s amazing to see misleading and uninformed medical information not only on web sites but from the mouth of what can only be termed an elected ignoramus.

Avastin over time has been shown to be a very expensive placebo ($50,000-100,000/year for the drug alone). It adds little or nothing to other, I might add, much less expensive regimens in breast cancer. A reasonable view is that the FDA erred initially when approving the drug for this indication and it’s good practice to not continue using an expensive useless drug.

Unbelievably David Vitter a Senator from Louisiana recently found cavorting with a prostitute takes issue with the FDA decision. He rejects the negative recommendation as being tantamount to a “death panel.” Not only is Vitter hopelessly ignorant, he is politicizing health care setting a very dangerous precedent that does not bode well for politicians, the drug approval process and seriously ill patients.

Perhaps he is unaware of the waste and expense of our health care non-system. Or that we spend 50% to 100% more than other countries per capita on health care. Or that this drug alone costs more than the average salary in our country. Or that other countries have not allowed the use of Avastin for this purpose because it is ineffective.

Medicynical Note: Our non-system of health keeps taking stranger turns.

Fascinating article regarding Texas’ hypocritical reaction to health care reform.

In a perverse way one must admire the republican/conservative ability to sell positions that are not the consumer’s best interest. Thus they continue to oppose regulation (“set business free”) after ample evidence that business needs it to protect not our only our country’s financial interests but also to keep the industries themselves from imploding. Remember Enron, the S&L crisis, our current financial crisis, and our ongoing BP spill. True you need dedicated competent regulators but the notion we can do without regulation seems a recipe for our certain ruin.

After cutting taxes early in the Bush administration, they lead us into two credit card wars. Our grandchildren will be paying for our adventures in Iraq and Afganistan. This act alone created over a trillion dollars in debt which was further aggravated by the “Bush” tax cuts. Now our republican (and some democratic) friends oppose rescinding the the tax cuts that created much of the debt over which they now obsess–see article. Make sense? No!

In Texas, where the article points out the there are 6.1 million people without health coverage, the republican leadership is moving to challenge and demagogue the constitutionality (with other states attorney generals) of health reform.

Meanwhile the non-system of care in our country slowly implodes. And the jackals of health care feed on its’ carcass by raising prices, and rates and worrying most about their bottom line, not the care of our population. Quite amazing and literally only in America.

Parenthetically at the same time in the state of Texas, bureaucrats, presumably with the blessing of the conservative state government hedge:

“Sometimes it seems a little schizophrenic,” acknowledged State Representative John M. Zerwas, a Republican who favors the law’s repeal but also leads a House committee that seeks to maximize its benefits to Texas. “There are plenty of laws out there that I might not agree with. But if the law of the land says we have to do it, the last thing I want is for Texas to not be prepared or not put things in place to comply.”

It’s sad when people deny 80 years of progress and decide that scientific information does not meet their particular bias. No, I’m not talking about global warming (though I could be) but rather about the efficacy and utility of vaccination. For whatever reason there are groups who believe that these proven public health interventions cause harm. This despite the eradication of smallpox, the near eradication of polio and the marketed decrease in occurrence and fatalities from measles and pertussis and no good evidence that there is harm from vaccination other than transient occasional transient reactions.

Who pay? Their children.

The confirmation of the death — the sixth pertussis-related death this year in the state — comes a day after the California Department of Public Health expanded criteria for those who should be vaccinated against the highly contagious disease amid what is shaping up to be the worst outbreak in 50 years.

“This expanded set of recommendations is an appropriate response to the epidemic in Los Angeles County and statewide,” Dr. Jonathan E. Fielding, the county’s public health director, said in a statement. “Vaccination is our best defense against pertussis. This is a disease that is especially dangerous for infants under six months of age, who are not old enough to have received the number of vaccine doses needed to be protected against whooping cough.”

The utility of the vaccine is not only in preventing the disease in the individual vaccinated but in decreasing the prevalence of the bacterium in our society (herd immunity). With less vaccination babies still receiving the initial protection are more likely to be exposed and develop the disease, as in this case.

There is a correlation between lower vaccination rates and the occurrence of pertussis.

Researchers took a global look at how personal-belief waivers drive whooping cough in a 2006 article in the Journal of the American Medical Association. They found that states – like California – that have easy-to-obtain-vaccine waivers saw a 90 percent higher incidence of whooping cough than other states.

and

Marin has the state’s highest rate of whooping cough infections at 77 cases per 100,000 residents. And its personal-belief exemption rate is also more than twice the state average, with 7 percent of kindergartners showing up to school with no shots.

Medicynical Note: in this case ignorance is not bliss.

Only in America.

A 61-year-old man was jailed Saturday afternoon after he allegedly shot a man who aggressively begged for money outside a McDonald’s in downtown Everett, according to Everett police.

Medicynical Note: Our national obsession. Is this freedom?

America can be presumed the world leader in health care inefficiency simply by the fact that our health care outcomes, while mainly quite good, are not at all better than those attained in the rest of the world, but our costs are 1.5 to 2 times as much.

Why? In other parts of the world insurance coverage is streamlined, fewer more efficient insurers lead to less costly health care. The U.S. for example spends about three times as much as Canada on administrative expenses in our respective health care systems.

A major reason why it is so difficult to reduce costs is that every dollar of health care spending is a dollar of income to someone involved in providing health insurance or health care. Administrative costs are undoubtedly too high, and insurance companies taking excess profits and executives with high salaries are frequently blamed. But they are only a small part of the story. The biggest part consists of payments to tens of thousands of telephone and computer operators, claim payers, insurance salespersons, actuaries, benefit managers, consultants, and other low- and middle-income workers. Overutilization of care is another problem that is not easily solved, partly because unnecessary or marginally useful tests, prescriptions, operations, and visits generate income for providers.

One would think the industry would recognize the unsustainability of the current system and be working to improve efficiency to assure their future. However in America long term sustainability is not a priority or particular virtue compared with short term profit. We are short timers. Gaming the system is the rule if it will yield a few bucks as noted here. To refresh your memory health care reform requires expenditure of at least 80% of premiums on actual health care. A modest requirement given that Medicare spends between 5 and 10% of on administration but:

But state regulators are only now deciding what precisely that means, as they draft the rules to enact the law. WellPoint, which operates Blue Cross plans in more than a dozen states, wants to include the cost of verifying the credentials of doctors in its networks. Insurance companies like Aetna argue that ferreting out fraud by identifying doctors performing unnecessary operations should count the same way as programs that keep people who have diabetes out of emergency rooms.

Some insurers even insist that typical business expenses — like sales commissions for insurance agents and taxes paid on investments — should not be considered part of insurance premiums, which would make it easier for them to meet the 80-cent minimum.

Medicynical note: Gaming the system is the rule in the U.S. whether you are trying to corner the market on energy, mislabeling junk investments as high quality, denying global warming or digging a deep water oil well. It is part of the reason our economy has soured and has few prospects for recovery.

Homeopathy is placebo. Consider this from XKCD!

When huge sums of money are involved you can count on companies to fudge results, shift risk to the ignorant, and go for short term gains. That’s history and if we ignore it, as we have, we face disaster.

Consider a drug company with millions, perhaps hundreds of millions, of dollars “invested” and riding on the results of a study evaluating safety and/or efficacy. What are the chances that the result will be subtly skewed towards the company’s advantage?

I don’t know but consider the FDA’s review of GlaxoSmithKline’s study on the risks of Avandia. The WSJ noted:

The scientists said that patients taking Avandia had a 27% greater chance of suffering a stroke, a 25% increased risk of suffering heart failure and a 13% greater chance of dying. Avandia increased the overall risk of experiencing heart attack, stroke, heart failure or death by 17%, the study said.

Medicare patients in the U.S. who took GlaxoSmithKline PLC’s diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, a Food and Drug Administration scientist contends in a new study.

Glaxo’s response seems to minimize the findings.

In an emailed statement, Glaxo said it was “unclear whether this study has been peer-reviewed, and until then, it would be premature to comment.” However, the company cited “inherent limitations” with retrospective studies such as Dr. Graham’s and said the limitations “can significantly impact the validity of the data.” Glaxo added that results from six clinical trials have shown that Avandia “does not increase the overall risk of heart attack, stroke or death.”

Part of the problem was that the drug company designed study was poorly done.

A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.

And:

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.

Medicynical Note: Money makes people do funny things. We have drugs, making billions for drug companies, that offer minimal improvement in outcomes, survival and/or patient comfort. How confident are you that drug companies with facing the loss of their investment and profits will honestly evaluate risk and efficacy? Does anyone think these companies should be deregulated? Can the “free” market sort out these subtleties? If you think so I want you to know that I have some AAA rated mortgage bonds that Bear-Stearns sold me for sale.

This seems a strong argument for objective evaluation of studies and indeed for comparison studies to determine the safest most effective drug.

Addendum July 13: It’s worse than it seemed. It appears that there was information as far back as 1999 that this drug had problems. From the NY Times:

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Amazing but apparently true!