Medicynic

Our Health Insurance System isn’t working–We MUST do something!!

July 9, 2009 · Leave a Comment

This from today’s Seattle Times:

“In what is becoming an annual ordeal for policyholders, Regence BlueShield is raising premiums for 135,000 individual health-plan members in Washington by an average 17 percent on Aug. 1.”

“And it comes after two other insurers, Group Health Cooperative and LifeWise Health Plan of Washington, recently imposed similarly steep premium increases.”

In yet another strong argument for health reform it was noted:

“Hensley said,Regence is losing money on its individual plans and subsidizes them with earnings from its group plans.”

One patient noted that her premium is now $1400/month and is going to rise to $1700.

In a letter to the editor of the same Seattle Times, a patient made these comparisons between what goes on here and in the health care system of Canada. Yes, I know it’s just an anecdote, but what do think the other side cites when damning health care reform.

“Canadian health care would be a welcome change”

“Opponents of a public-health-insurance option caution that such a plan would result in “Canadian-style” health care. In support of this, here is a true story.”

“A cautious, self-employed Seattleite, I pay for the best private health insurance available. Good thing, because at 43 years old, after being diagnosed with an aggressive breast cancer, I received treatment at two top regional facilities: surgery at University of Washington Medical Center and chemotherapy at Seattle Cancer Care Alliance.”

“Weeks after my diagnosis, a lifelong friend in Vancouver, B.C., was diagnosed with a virtually identical cancer — same tumor size and characteristics, same lymph node status, etc.”

“After tumor discovery, I received diagnostic tests after more than 30 days.

Her tests took three. I waited five weeks for surgery; she was scheduled in two. Post-surgery, I waited five weeks to begin chemotherapy. Her chemo started in three.”

“In the end, my out-of-pocket expenses exceeded $30,000. Her bills were in the hundreds of dollars.”

“The UW just hired my reconstructive surgeon from the University of Toronto for his education in pioneering techniques. My friend’s surgeon was Canadian, too.”

“So will a public plan result in Canadian-style health care? I truly hope so.”

Medicynical note: What we have costs more and does no better, maybe worse in some areas. We’re bankrupting individuals and the “system” (I use the term system very loosely here).

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Targeted therapy in Lung Cancer: Which offers more value, Avastin, Erbitux or NEITHER!

July 6, 2009 · Leave a Comment

Annotated abstract from the recent ASCO meetings.

This is a study comparing the cost of two very expensive, marginally effective treatments for lung cancer. The abstract purports to show that one of these drugs is less expensive and offers more “value” than the other. In fact neither is a “value” choice.

Title: A cost analysis (1) of treatment with bevacizumab plus cisplatin and gemcitabine (BCG) versus cetuximab plus vinorelbine and cisplatin (CVC) in patients with advanced or recurrent non-small cell lung cancer (NSCLC) in Germany

Authors: D. F. Heigener, C. Wiesner and R. Aultman

Affiliations: Krankenhaus Grosshansdorf, Grosshansdorf, Germany; Roche Pharma AG, Grenzach-Wyhlen, Germany; F. Hoffmann-La Roche, Basel, Switzerland

#: e17553

Background: Although new treatment options for advanced NSCLC can offer improved survival over standard treatment with chemotherapy (CT) they should also offer value for money.(2) Bevacizumab (BEV), a humanized monoclonal antibody (MAb) directed against vascular endothelial growth factor when combined with CT increases overall survival (median 13.6 months in the AVAiL study) and progression-free survival (PFS) in patients with advanced NSCLC when compared with CT alone.(3) Cetuximab (CTX), an IgG1 MAb which targets the epidermal growth factor receptor achieved a median survival time of 11.3 months when combined with CT in the FLEX study (4) and marketing authorization is anticipated in 2009. The aim of this study was to compare the costs of treating NSCLC with BCG or CVC in Germany. Methods: A Markov model was used to compare drug and administration costs associated with treating advanced or recurrent NSCLC with either BCG or CVC. The model assumes patients move from non-progressive to progressed disease prior to death, according to transition probabilities derived from an indirect comparison of the efficacy of BCG and CVC in terms of PFS using data from the respective pivotal trials and appropriate indirect comparison methodology. Cost data were derived from local sources. Drug cost assumed CT was given for up to 6 cycles, that CTX was administered at an initial dose of 400 mg/m2 followed by 250 mg/m2 weekly until progression and that BEV was administered at 7.5 mg/kg until progression. The model estimated average drug and administration costs per patient treated with either BCG or CVC. Results: The mean total costs of BCG treatment was Euro 4713 less per patient when compared with CVC (Euro 28342 vs. Euro 33055). The addition of BEV to CT was less costly than the addition of CTX to CT ( Euro 18796 vs. Euro 29502) and the administration costs were also lower (Euro 391 vs. Euro 1179). Conclusions: Targeted therapy using BEV is less costly than CTX in Germany and thus, from a budget perspective, offers the best value for money strategy for improving outcomes in patients with advanced NSCLC. Furthermore, costs savings with BCG in Germany are likely to be increased when gemcitabine comes off-patent in 2009.

Medicynical Annotations:

1. Cost Analysis: This abstract hardly describes a cost analysis. It is an attempt to encourage the use of bevacimimab (Avastin) instead of cetuximab (Erbitux). The study was sponsored by a drug company and the authors were company employees or recipients of financial support.

2. Value for money. It’s ironic to hear pharmaceutical company’s spokespeople tout value. In this case we are talking about two medications that are priced in the $10,000/month range. That’s more on an annual basis than the median and average incomes in the U.S. Yet these medication appear to have minimal positive effect in the setting described. That sure doesn’t sound like value!

3. Survival Benefit: The AVAIL trial found :

“At 12.5 months of follow-up, progression- free survival was significantly improved with bevacizumab, from 6.2 months in the placebo arm to 6.8 months with the 7.5 mg/kg dose (P = .0003) and to 6.6 months with the 15 mg/kg dose (P = .0456), Dr. Manegold reported.”

It also noted:

“No differences were observed in overall survival.”

Medicynical Note: The abstract doesn’t comment on the lack of a survival benefit. This omission is similar to the drug company’s press releases (google AVAIL study–press release here , and here .) But the various press releases do imply such a benefit when they claim: “Only first-line treatment to demonstrate extended survival in over a decade.” A claim that is marginal at best.

Dr. Manegold also furthers the fiction that there might be a survival benefit by stating that the 13 months survival was the “longest” for advanced NSCLC. However, he didn’t note that the survival in the group not receiving targeted therapy in his study was just as long

The only proven benefit from this expensive drug in the AVAIL study was a .6 month delay in disease progress.

(4) Compared with FLEX study: The other study referred to in the abstract is an ECOG (Easter Cooperative Oncology) group trial ( ECOG 4599 N Engl J Med 355:2542-2550, 2006). They compared carboplatin and taxotere with and without cetuximab (Erbitux). They found overall survival was 11.3 months in the cetuximab group and 10.1 months in the controls , an improvement of just 1.2 months. One-year survival was 47% in the cetuximab group and 42% in the control group.

Medicynical note: The AVAIL trial resulted in a .6 month delay in progression and no improvement in overall survival. The cetuximab trial shows slight benefit. These are hardly revolutionary improvements in patient care from drugs priced in the range of $100,000/year.

For what it’s worth the FLEX trials patients’ overall survival with cetuximab and chemotherapy was less than the control group (the group only receiving conventional chemotherapy) in the AVAIL trial.

The small delay in progression and improvement in survival (only found in the FLEX study) in these studies may be explained by patient selection, first study bias or simply be an indication of the limited efficacy of these agents in advanced lung cancer. Something that you would not know from the abstract or the PR releases.

Comparing the costs of very expensive agents with small benefits obfuscates whether they should actually be used in the first place.

It is a truism that drug companies market for profit rather than patient benefit.

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Rationing in Healthcare? It’s the American way

July 5, 2009 · Leave a Comment

Nice summary of healthcare rationing in Economix.

Reinhardt notes:

“In short, free markets are not an alternative to rationing. They are just one particular form of rationing. Ever since the Fall from Grace, human beings have had to ration everything not available in unlimited quantities, and market forces do most of the rationing.”

“Let me remind rationing-phobes what they would find in the huge body of research literature and media reports on our health system, should they ever trouble themselves to read it:”

  • “Many Americans without health insurance or very high deductibles routinely forgo prescribed medicine or follow-up visits with a doctor because they cannot afford it, risking more serious illness later on.”
  • “A 2008 peer-reviewed study by researchers at the Urban Institute found that health spending for uninsured nonelderly Americans is only about 43 percent of health spending for similar, privately insured Americans. Unless one argues that the extra 57 percent received by insured Americans is all waste, these data imply rationing by price and ability to pay.”
  • “A few years ago, The Wall Street Journal featured a series of articles reporting how often uninsured middle-class Americans are charged the highest prices at pharmacies and in hospitals, and how sometimes they are hounded over medical bills to the point of being jailed for failed court appearances.”
  • “Studies have shown that solid middle-class American families – even ostensibly insured families -can lose all of their savings and sometimes their homes over mounting medical bills in the case of severe illness.”
  • “In its report Hidden Cost, Value Lost: The Uninsured in America, the prestigious Institute of Medicine a few years ago estimated that some 18,000 Americans yearly die prematurely for want of the timely health care that health insurance makes possible and that can prevent catastrophic illness.”
  • “A recent study by an M.I.T. professor found that uninsured victims of severe traffic accidents receive 20 percent less health care than equivalent, insured victims and are 37 percent more likely to die from their injuries.”

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Caution urged with selenium

July 4, 2009 · Leave a Comment

In 1996 a study looking at the effects of selenium supplements in prevention of skin cancer reported no effect on skin cancer but a decrease in the incidence of prostate cancer in the selenium group–parenthetically this same study showed less lymphoma in those who did not receive selenium. (Clark et al, JAMA 276:1957-1963, 1996)

For some reason, this very preliminary incidental finding was taken as gospel and since that time innumerable food and vitamin supplements purporting to support “prostate health”, whatever that is, have contained selenium.

In the June 15th Journal of Clinical Oncology comes an article and editorial with disturbing findings and a suggestion that perhaps less selenium supplementation would be better until more is know on all the potential effects.

“Selenium supplementation does not decrease risk except possibly in selenium-deficient populations. Supplementation possibly increases risk of prostate cancer, especially aggressive disease, in selenium-replete men or men with a particular genotype for antioxidant enzymes. These hypotheses and the questions posed above suggest the need for personalized risk prediction. At present, we do not know enough to determine how much selenium any man or woman should receive from the diet or a supplement.”

“This lack of knowledge supports the common public health recommendation of moderation with respect to supplements for men and women. Furthermore, we should encourage men and women to eat a wide array of foods, maintain normal weight, be physically active, not smoke, and drink in moderation if at all to prevent chronic diseases in general. Unlike the prospect of personalized chemo-prevention,”

Medicynical note: Sometimes less is better. It’s enough to make a medicynic smile!

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Ethics in Health Insurance–Only with Regulation, and/or a public option

July 1, 2009 · 3 Comments

Another article on inadequate health insurance coverage, this from the NY Times.

As noted in previous posts, the U.S. health care non-system is unique in the industrialized world. First, it’s does not provide for universal coverage. Furthermore, it allows, no it encourages, private for profit insurance companies to eliminate people who need coverage (the sick) from their roles.

I say encourages because the first responsibility of a private corporation is to make money. Having these people provide “health” insurance is an unstated sanction for them to cull their rolls of, or otherwise scam beneficiaries, particularly those who are sick and use health care. A paradox? No, it’s simply how insurers make money!

From the Times:

“Last week, a former Cigna executive warned at a Senate hearing on health insurance that lawmakers should be careful about the role they gave private insurers in any new system, saying the companies were too prone to “confuse their customers and dump the sick.”"

“The number of uninsured people has increased as more have fallen victim to deceptive marketing practices and bought what essentially is fake insurance,” Wendell Potter, the former Cigna executive, testified.”

Also:

“He and the hospital say they were surprised to eventually learn that the $150,000 hospital coverage in the Aetna policy was mainly for room and board. Coverage was capped at $10,000 for “other hospital services,” which turned out to include nearly all routine hospital care – the expenses incurred in the operating room, for example, and the cost of any medication he received.”

Medicynical Note: The mythical free market in health care has never existed. And given the complexity of health care, the myriad conflicts of interest among the participants (patients, docs, institutions, patent holders, insurers), a so-called “free market”would never work to decrease costs. The proponents of such schemes inexplicably omit addressing the issues of the poor, the working poor, the sick and the asymmetry of information available (costs, options, outcomes) that would tend to distort such a “new” “free market” system.

So, if we are to reform health care coverage, we are left with what must be a highly regulated insurance scheme. Insurers would offering some standard government mandated clearly defined package of coverage using community rates (as opposed to individual ratings) with extra options at extra costs. They would compete with each other on price and service. To keep these people honest a competing public insurance program would provide an objective benchmark from which to rate the value of the private company’s offerings.

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Health Care Costs– Insurers really don’t Care

June 28, 2009 · Leave a Comment

This today in the Seattle Times emphasizes the holes in todays health insurance policies. Insurers, particularly the for profit ones, are not about financing care but about assuring profits. What’s happens when you really are sick? Where can we draw the line on care?

“”It’s not just the uninsured. It’s people who have insurance that doesn’t protect them” who are fueling the hunger for reform, said Sara Collins, an economist and a vice president at The Commonwealth Fund, a private health-care foundation in New York.”

“Until about a year ago, Moody and Krull lived comfortably on her earnings as an associate broker for Windermere Real Estate. But despite their income and his seemingly gold-plated coverage, he can’t get either a second organ transplant or an expensive drug that might eradicate his hepatitis C without risking financial peril.”

:When she first enrolled in a Premera plan in 1995 after a di”vorce, she remembers that it cost only a few hundred dollars a month.:

“In 2000, she married Moody and added him to her policy. Though affordable at first, their premiums kept rising sharply. Their combined monthly premiums now total $1,746.”

Read the article to get the full flavor of their predicament. These are not the working poor or the uninsured.

Medicynical note: It is ironic that the goal of health insurers is to limit services to those who need health care most.

Forcing people onto the individual market (as opposed to providing group based rates) is the first step. Individuals have no leverage and are rated by their medical need. Premiums are routinely raised to exorbitant levels. As noted in the article people who need the most services are offered policies with unrealistically low limits and find their premiums raised to unaffordable levels (in the case cited over $1700/month).

Any new system should require community ratings. and a standardized coverage structure. both of which are anathema to the private insurance crowd or alternatively mandate a government sponsored program that will offer same.

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More Comparison Studies: Capecitabine (Xeloda) vs Standard Chemotherapy

May 31, 2009 · Leave a Comment

In an attempt to prevent recurrence of breast cancer, chemotherapy is given after surgery. This is known as adjuvant chemotherapy.

One of the standard adjuvant regimens is CMF (cyclophosphamide, methotrexate, and 5-FU). Compared to other adjuvant regimens the toxicity is moderate but all the drugs are given intravenously. About 15 years ago Roche developed capecitabine (Xeloda) an oral drug that is simply 5FU in oral form. The cost of this drug is several hundred times (yes you read that correctly) that of the intravenous drug but the thought apparently was that the drug would save visits to infusion centers, which are also expensive.

Now, as reported in NEJM there is evidence that the use of capecitabine is inferior to CMF as adjuvant treatment of breast cancer in women over age 65. Unfortunately it’s taken 15 years to find this out.

Medicynical note: This experience is yet another example of why we need to compare treatment regimens. It’s counter intuitive to argue against this notion unless you are a drug company. Or an insecure physician who’s ego can’t deal with another source of information, besides the bias offered by pharmaceutical companies.

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Finally, ASCO has a concern about costs? The Need for Comparison Studies

May 31, 2009 · Leave a Comment

From Forbes:

“But many companies seem to be maximizing cancer profit instead. Big drug companies are making big money off smaller and smaller improvements in cancer care. Newfangled cancer drugs can cost $50,000 a year, and that doesn’t mean they will add a year to the patient’s life–you might spend $50,000 for a year and extend the patient’s life by only weeks.”

Regarding Avastin:

“The hope was that further studies of Avastin in other types of cancer or in earlier stages of the disease would show even greater survival benefits. But they haven’t. In several breast-cancer trials–including a new one being presented at the meeting this weekend–Avastin slowed the progression of disease but did not extend patient survival at all. But doctors still use the drug in treating breast cancer because they figure it helps symptoms, even if patients don’t live longer. Avastin costs up to $55,000 a year.”

More:

“Roche is also combining other expensive drugs with Avastin. One study at the meeting showed that adding Tarceva……. delayed by one month the median time it takes lung tumors to grow. “

Medicynical note: ONE MONTH delay for $50,000. Terrific.

Where is the value? Meanwhile the drumbeat of studies showing very limited improvement but very high costs continues.

Also regarding Avastin:

“Avastin failed to prevent colon cancer from recurring after surgery. In the first year of treatment, more patients who got Avastin remained free of detectable cancer. But after a year, the drug was stopped, and by the end of the study, the apparent initial benefit had faded completely.”

In fact most people who receive drugs after surgery have no risk at all for recurrence. For those with what’s called Duke’s C disease the risk of recurrence is about 35-40%. Treatment with chemotherapy with or without Avasatin decreases the risk of recurrence by 15%. That means 20-25% recur no matter what we do. That also means that around 80% of people receiving these drugs get no benefit at all from chemo (the 60% without risk of recurrence and the 20% who recur no matter what we do).

The costs of these type treatments are astronomical. The drug company’s hopes of having $50,000/year drugs used on all patients are deal busters. I can’t think of a better poster child for comparison studies than those cited above.

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Comparison Study of Taxanes (Taxotere) in Early Breast Cancer Shows no Survival Benefit

May 29, 2009 · Leave a Comment

It’s fascinating to consider the reasons why anyone opposes the concept of comparison studies to determine the benefit of a treatment. In cancer treatments are extremely expensive, and toxic. Launching patients into therapy without considering the benefit and costs is reckless.

In the May 16th Lancet a study showed no survival improvement when Taxotere was added to standard anthracycline (Epirubicin in this case) adjuvant chemotherapy (the TACT trial).

“At a median follow-up of 62 months, 75.6% of patients who received docetaxel plus anthracycline chemotherapy remained disease free, compared with 74.3% who did not receive docetaxel. The proportion of patients who reported any acute grade 3 or 4 adverse event was significantly greater among patients who received docetaxel.”

But it does add to toxicity:

“The proportion of patients reporting any acute grade 3 or 4 toxicity that occurred during treatment and up to 30 days afterward was significantly greater among those receiving docetaxel.”

The authors do point out that there may be subgroups who benefit. But given the cost and toxicity, adding a Taxane to standard chemotherapy needs further study and verification of efficacy.

Comparing treatments is part of the scientific method. Using this information to inform treatment options is rational medicine and should be encouraged.

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It’s the Money

May 28, 2009 · Leave a Comment

Fascinating article in The New Yorker (June 1, 2009) on the variations in health care costs. Atul Gawande visits one of the the most expensive Health Care Markets, McAllen Texas, and looks at the reasons.

No surprises here, but nice documentation and explanation of the issues.

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