But now:

The recall was expanded to PIP implants exported to Italy, Australia, and Great Britain. It is initially estimated 35,000 to 45,000 women worldwide are affected, but the British Association of Aesthetic Plastic Surgeons estimated 50,000 British women have the implants.

AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.

Medicynical Note:  We have a “movement” in the U.S. that believes less regulation will lead to a thriving economy.  This despite evidence,  from the thalidomide problem in medicine and the S and L fiasco in the 80’s, the Enron disaster, and most recently the world wide banking crisis, that less regulation  can lead to abuses and disaster. 

In the case cited today, the FDA saved tens of thousands of U.S.  citizens from the problems of a substandard breast implant device.  In medicine as in other fields where profit overrules reason, regulation is essential.

It appears that we, the US, are in the midst of an orchestrated national devaluation–a downward spiral resulting in decreasing opportunity and increasing poverty. Economically, we’ve gone where we’ve never been. It’s peculiar because some segments of our population have never had it so good, while others have, in our lifetime, never had it so bad. Citing long dead economists as authority to justify the current situation is simply wrong minded–they never could anticipate the world we live in. We are in uncharted economic territory.

Like a failed corporation we have yet to realize that our operating assumptions are misguided. Perhaps Perot was right about the sucking sound from globalization? Maybe we needed to better finance our social programs? Going to war without good reason and without immediate pain (taxes to pay for it) seems dumb in retrospect. Deregulation of companies whose highest goal is to monopolize markets hasn’t worked. Remember the S and L fiasco, Enron, and most recently the banking derivative frauds. Maybe unfettering capitalists isn’t such a good idea?

Think banks learned anything from their downfall in 2007-2008? Check out last week’s MF Global collapse. Think Corzine is the only one now playing with highly leveraged debt? Think again.

Some believe there is a tension between democracy which by its nature supports equal rights and capitalism who ultimate goal is market domination and monopoly. These issues appear unresolved and still evolving.

Why has capitalism succeeded while democracy has steadily weakened? Democracy has become enfeebled largely because companies, in intensifying competition for global consumers and investors, have invested ever greater sums in lobbying, public relations, and even bribes and kickbacks, seeking laws that give them a competitive advantage over their rivals. The result is an arms race for political influence that is drowning out the voices of average citizens

Consider the move to hiring contract employees. Cheaper, probably not–given the hiring contractor’s slice of the money and their need for profit. For the worker, lower salaries and no benefits.

Ginny Townsend, 41, took a job in January as a nursing assistant in the state-run home for veterans here. Technically, she works for a private company that supplies some employees to the veterans home under a state contract. She makes $10 an hour, about half the wage of the public employees working at the facility.

We can argue whether the lower salaried employees offer the same quality services as the previous government direct hires and probably find examples both ways. What we can’t argue about is the impact of such low salaries on the ability of these employees to support themselves and families. On $10/hour they can’t. At $10/hour they will be unable to afford to save for retirement and provide their family’s health care–yes, our republican friends think that high deductible health savings accounts are the answer, but the question is for whom?

The greatest irony of this move is that it probably doesn’t save money!

Economists and other academics who study outsourcing are divided about whether it usually saves a government money. Recent data from Arizona shows that privately operated prisons often cost more to operate than state-run facilities. A study by the Project on Government Oversight, a nonprofit Washington group, found that in 33 of 35 occupations, using contractors cost the federal government billions of dollars more than using government employees.

Medicynical Note: The privatization movement removes income from those who need it most. The policy adds to the cost of the social safety net–consider WALMART’S contract employees who no longer have health care coverage going to emergency rooms for “free care” and needing MEDICAID for health services. Consider how much these minimum wage employees will be able save for retirement? Contracting doesn’t pass the smell test in that it does not result in a net savings and removes money from the economy.

It is but one part of our race to the bottom.

Another study of bevacizumab (Avastin) in Metastatic Breast Cancer :

Median PFS increased from 5.1 to 7.2 months (stratified hazard ratio for PFS (Progression Free Survival), 0.78; 95% CI, 0.64 to 0.93; P 􏰁 .0072). The 10% improvement in ORR (Objective Response Rate) between the placebo- and bevacizumab-containing arms (39.5% v 29.6%; P: .0193), although not statistically significant, was consistent with previous trials. There was no statistically significant difference in overall survival.

As noted in the discussion the improvement in ORR is not statistically significant and there is no improvement in survival. This, in a drug, with costs in the $5000- $10,000/month range.

Medicynical Note: The FDA has removed the breast cancer indication for this drug because of lack of objective efficacy. This study confirms their decision.

Medicare, however, as I understand it, continues to pay for it. The big question is why we should have public funds, or pooled insurance money, used to pay for an exceptionally expensive drug that has no survival benefit? In the end we all pay.

It’s no wonder that health care is bankrupting individuals and our non-system of health care.

Using data from the European screening trial, researchers have estimated that $5.2 million would have to be spent on screening (and the interventions that follow it) to prevent one death from prostate cancer. (Medicynical emphasis) That estimate does not appear to include the costs of excessive serial PSA testing and repeated office-based encounters devoted to discussions about screening or interpretation of fluctuating PSA results. The extraordinary time, effort, and costs associated with the PSA-screening enterprise must be evaluated against other claims on health care spending and physicians’ time and energy. We believe that the current PSA-based screening paradigm does not compare favorably with competing health care priorities.

Adding to the critical view of screening was the recent NY Times magazine review Can Cancer Ever Be Ignored? The article notes:

Patients and their doctors are now faced with radically polarized views about the logic of routine testing. On one side are physicians like Mohler, who argue that the test can reduce a man’s chances of dying of prostate cancer, plain and simple. This side of the debate is passionate, backed by the persuasive conviction of men who have survived prostate cancer and well financed by the multibillion-dollar industry that has grown up around the testing and treatment of the disease.

The other camp makes a less emotionally satisfying argument: on balance, scientific studies do not support the claim that screening healthy men saves lives. Screening, Brawley and others argue, can lead healthy men into a cascade of further testing and treatments that end up injuring or even killing them. As Richard Ablin, who discovered a prostate-specific antigen, put it in an Op-Ed in The New York Times, using the P.S.A. test to screen for cancer has been “a public health disaster.”

What appears to be proven by two large studies of PSA published in 2009 is that there is no difference in deaths in groups of patients receiving PSA and those not receiving it. It appears that while there is reduced mortality from prostate cancer, there is increased mortality from other causes possible from the complications of the diagnostic procedures.

An analysis of six studies of screening involving nearly 400,000 men, published last year in the British medical journal BMJ, found no significant difference in overall mortality when screened men were compared with controls. Philipp Dahm, a professor of urology at the University of Florida College of Medicine and lead investigator for the analysis, says the study shows that P.S.A. screening “does not have a clinically important impact” on overall mortality.

There have been similar concerns raised about breast cancer screening:

A new analysis of mammography concluded that while mammograms find cancer in 138,000 women each year, as many as 120,000 to 134,000 of those women either have cancers that are already lethal or have cancers that grow so slowly they do not need to be treated.

And:

The problem is that the benefit is tiny and expensive. A recent cost–benefit analysis showed that adherence to the current guidelines from the American Cancer Society costs more than $680,000 per quality-adjusted life-year (QALY) gained, as compared with a proposed alternative costing only $35,000 per QALY. Statistician Donald Berry has calculated that for a woman in her 40s, a decade’s worth of mammograms would increase her lifespan by an average of 5 days — and this survival advantage would be lost if she rode a bicycle for 15 hours without a helmet (or 50 hours with a helmet).5 The key issue here, however, is that these figures represent population averages. For the small number of women whose lives are saved, the difference is literally as large as that between life and death.

It should be also noted that much of widely publicized improved outcomes of cancer treatment today can be attributed to earlier diagnosis of the disease (lead time bias); and from finding lesions that would not grow and spread not treatment.

In the end more judicious use of screening and finding ways to cut the cost of same would improve the value of such testing without adversely affecting outcomes.

For example: one solution is to cut the price of the test from its current $70 to $$400 (including phlebotomy costs) to a more reasonable amount ($10-20). Economies of scale and efficiency would increase the value (in a cost-effectiveness sense) for this test. Charging anywhere from $25 to $150 for phlebotomy, as is the current practice, seems excessive as well.

In breast cancer screening one approach would be to delay routine screening from 40 to 50 years of age. Which as noted by Susan Love:

“I really don’t think we should be routinely screening women under 50. There’s no data showing it works.”

Medicynical Note: We live in a country that is on the road to bankruptcy caused in great part by profligate health care costs. Controlling these costs is not optional but also is not widely discussed in our bizarre political atmosphere. In the stunted political debate conservatives roar that patients should be able to choose what they want (NO RATIONING, NO DEATH PANELS) but cogently leaves vague who pays when patients choose. Reading between the lines they oppose public funding of medical care, including Medicare and Medicaid. Their solution however, is tantamount to medical rationing by economic status.

On the other side is the notion that all U.S. citizens should have access to a defined level of care. And those who want more can buy additional services (testing and procedures) as they wish.

Medicynical Note: What’s most striking are the poverty rates: 14% overall, 17% for children, 22% for the elderly and income inequality. Our comparative expenditures on pre-primary education and finally the health rating of our population are also not very encouraging. Exceptional yes, but in the wrong way.

Consider that over the years defects have been very commonly found in such implantable devices. In fact thousands of recall notices/year are the norm.

Meanwhile, the number of items implanted in people’s bodies is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in fiscal 2008, according to the Food and Drug Administration. That was nearly double the number reported the previous year and a 164 percent increase since 2000.

With all this, we now have legislators who have accepted campaign contributions from venture capitalists working to undermine the oversight process:

Over the following month, Mr. Paulsen’s campaign committee took in $74,000 from people with a stake in device regulation, much of it from executives affiliated with venture capital funds and their spouses. Now Mr. Paulsen, a two-term Republican, is a sponsor of a bill that would make it easier to bring new medical products to market.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

Further complicating the medical device business is the established fact that the gate keepers, medical providers, often take payment from device manufacturers to encourage use of their “innovations.” Without some brake in the system we have a recipe for development of faulty devices and their overuse and/or misuse.

Furthermore, these same forces want tort reform so as to protect these same manufacturers from being sued for bad outcomes from faults in the device and the selfsame overuse and misuse.

Note: Bringing devices to market without careful continuing oversight, when there is a money driven motivation, is a recipe for disaster.

A dozen pharmaceutical companies have given doctors and other healthcare providers more than $760 million over the past two years – and those companies’ sales comprise 40 percent of the U.S. market.

With bucks that big flying around, is the quality of care offered by providers accepting them compromised? “Absolutely,” said Dr. John Santa, head of the Consumer Reports Health Ratings Center.

Medicynical Note: Guess who pays for this largesse? Is it any wonder that drugs in the U.S. cost 30% more than elsewhere in the world. Drug companies are uninterested in efficiency and value. It’s about the money. Sad but true.

Some good news can be found in an exception to the overall pattern of U.S. performance: rapid progress on quality metrics that have been the focus of national initiatives and public reporting efforts. Hospitals, nursing homes, and home health care agencies are showing marked improvement in patient treatment and outcomes for which data are collected and reported nationally on federal Web sites and as part of improvement campaigns. There has also been significant improvement in the control of high blood pressure, a measure that is publicly reported by health plans; increasingly, physician groups are being rewarded for improving their treatment of this and other chronic conditions. Better management of chronic diseases also has likely contributed to reductions in rates of avoidable hospitalizations for certain conditions, though rates continue to vary substantially across the country.

Of great concern, access to health care significantly eroded since 2006. As of 2010, more than 81 million working-age adults—44 percent of those ages 19 to 64—were uninsured during the year or underinsured, up from 61 million (35%) in 2003. Further, the U.S. failed to keep pace with gains in health outcomes achieved by the leading countries. The U.S. ranks last out of 16 industrialized countries on a measure of mortality amenable to medical care (deaths that might have been prevented with timely and effective care), with premature death rates that are 68 percent higher than in the best-performing countries. As many as 91,000 fewer people would die prematurely if the U.S. could achieve the leading country rate.

The summary also notes the cost burden and the lack of improvement in many health system indicators:

such as preventive care, adults and children with strong primary care connections, and hospital readmissions—likely stems from the nation’s weak primary care foundation and from inadequate care coordination and teamwork both across sites of care and between providers. These gaps highlight the need for a whole-system approach, in which performance is measured and providers are held accountable for performance across the continuum of care.

A nice chart shows some of the savings that would accrue if we actually had a system:

Medicynical Note: We spend more and have worse health care. Only in the U.S.

Ewe Reinhardt observes:

In many ways, our health care system mirrors our tax code — especially in its financing and health insurance facets. These can be made so complex and have been made so complex in the health care system in the United States that many decision makers in health care — patients, physicians, hospitals, employers and so on — need in-house or external consultants to find their way through the maze.

and:

Consulting firms help physicians bill private and public insurers or help patients submit claims to insurers after an illness. Legions of insurance brokers help prospective clients through the maze of the nongroup or small-group health insurance market. Large employee-benefit consulting firms, helping large companies, establish what amount, in effect, to analogues of the health-insurance exchanges in the Affordable Care Act, and many more consultants of many stripes are involved.

Medicynical Note: Yes the U.S. has the number 1 health care system in the world–it’s the most inefficient by far.