Cancer Treatment Centers of America: Billfold Biopsies and Skewed Data

This company has claimed better results from their treatment approach.  If it’s too good to be true, it probably isn’t.

It turns out their approach is to not accept patients unless their insurance is “preferable.”  They minimize Medicare and Medicaid patients in their population—unlike other facilities.  They arbitrarily don’t accept certain patients.  They don’t report on patients who do not receive all their treatment at their facility.  As a result when they report outcomes the results are skewed by small numbers and careful patient selection.  They are under pressure to change as noted in the article.

Hilborn had seen CTCA’s website touting survival rates better than national averages. His call secured Vicky an appointment at the for-profit, privately held company’s Philadelphia affiliate, Eastern Regional Medical Center. There, the oncologist who examined Vicky told the couple he had treated other cases of histiocytic sarcoma, the cancer of immune-system cells that she had.

“He said, ‘We’ll have you back on your feet in no time,'” Keith recalled.

Vicky’s cancer treatment was forestalled by an infection and other complications that kept her at Eastern Regional for three weeks. In July 2009, when she got back home, things changed. Despite Keith’s calls, he said, CTCA did not schedule another appointment. As his wife got sicker, Keith, a former deputy sheriff in western Pennsylvania, was reduced to begging.

Read the article to get the full flavor of this type for profit beast. 

Medicynical Note:  What’s missing is an accounting of cost of treatment at this facility that provides “free transport” and limos to their hospitals.  It’s little wonder that medical care is bankrupting us.  More on this in Brill’s recent Time essay

In fact there is no magic in cancer treatment.  The reality, bad cancers that have spread have bad outcomes, with few exceptions.

No this is not the “gospel of hope,” but it is the truth.

Johnson and Johnson ASR Hip: Fails 40% of the time within 5 years

It’s remarkable that so called “ethical” pharmaceutical companies are anything but…..ethical.  Johnson and Johnson and it’s DePuy Orthopedics division appear to have suppressed and/or ignored early information that the devices were faulty and would fail prematurely.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.

The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.

Medicynical Note:  As we’ve noted before these companies are not about patient care or good outcomes.  They are about the money.

America’s Exceptional Health Care Costs—We are Number 1

Brookings has an analysis of the impact of our uncontrolled health care costs:

By 2010 the U.S. health share was almost 7.2 percentage points of GDP (or 70 percent) higher than the health spending share in countries with comparable incomes. We can describe that estimate in a slightly different way: The United States spent about $7,500 per capita on health care compared to an average of $3,300 in other rich countries.

The article looks at income over the past 30 years including and omitting the cost of health benefits.  It notes that incomes have risen more than usual measures indicate when one includes the costs of health coverage for employees.

Medicynical Note:  The article notes that average income rose 35% in that time period while the cost of health benefits/capita rose 205% affecting the income increase when included in the calculation.  Of course we need a similar accounting of the increase in out of pocket medical expenditures to understand the full impact on disposable income.

Primum Eruere patiente (First gouge the patient)

It’s fascinating to watch the business of medicine work diligently to assure continued high prices and profits for medical “advances”—even long after earning back the cost of development.  The well-being of patients and affordability are considered least when profit and monopoly are involved.  Consider these recent examples, first

The language buried in Section 632 of the law delays a set of Medicare price restraints on a class of drugs that includes Sensipar, a lucrative Amgen pill used by kidney dialysis patients.

The provision gives Amgen an additional two years to sell Sensipar without government controls. The news was so welcome that the company’s chief executive quickly relayed it to investment analysts. But it is projected to cost Medicare up to $500 million over that period.

Read the rest of the article for details on Amgen’s recent illegal activities and the extent of it’s political bribery lobbying.

The second example, paying to delay a generic’s release

It would seem a business executive’s dream: legally pay a competitor to keep its product off the market for years.

Congress has failed to stop it, and for more than a decade generic drug makers and big-name pharmaceutical companies have been winning court rulings that allowed it.

Or lastly the extension of the patent because of a technicality as in the  Viagra

If you live in the United States and you have been waiting for generic Viagra to hit the market it looks like you will be waiting quite a while yet. Pfizer, the makers of Viagra, just had a crucial patent validated in a federal court of law.
It all started when the Israeli medical giant Teva received a tentative approval by the FDA for a pill using sildenafil, the active ingredient in Viagra. Teva were intending to start selling the pill in March 2012 when Pfizer’s sildenafil patent runs out.

Pfizer responded by suing Teva for patent infringement, based on a second patent. This patent runs until 2019 and is a so called method-of-treatment patent, meaning that even though sildenafil comes up for grabs in 2012 it would be until 2019 before anyone but Pfizer could market it as an impotence drug.

Medicynical Note:  As long as our system is dedicated to providing more protection to patent holders than patients we’ll continue to be gouged.  It should be noted that other countries don’t put up with such nonsense and they pay less for the patented drug as well as not allowing frivolous extensions. 

And When a Medicine (Revlimid) “Works” It’s Unaffordable: $132,000/year, $534/pill

Poignant piece in the NY Times magazine that highlights some of the flaws in our unsustainable health care non-system.  This paragraph outlines the problem

After making more than 70 phone calls to 16 organizations over the past few weeks, I’m still not totally sure what I will owe for my Revlimid, a derivative of thalidomide that is keeping my multiple myeloma in check. The drug is extremely expensive — about $11,000 retail for a four-week supply, $132,000 a year, $524 a pill. Time Warner, my former employer, has covered me for years under its Supplementary Medicare Program, a plan for retirees that included a special Writers Guild benefit capping my out-of-pocket prescription costs at $1,000 a year. That out-of-pocket limit is scheduled to expire on Jan. 1. So what will my Revlimid cost me next year?

Medicynical note:  Anyone believing our non-system is the best in the world should need such drugs.  While  drug companies  spend a great deal to develop medications,  their costs are inflated and overstated.  Efficiency is simply not on their agenda.  Nor is patient well being, access or for that matter outcomes. 

It’s the money stupid!  Charging more than twice the median U.S. income for a single drug that patients in life-threatening situation, any single drug,  is simple blackmail.  It reflects an industry and economy gone mad.

Cabozantinib: A Miracle Cancer Drug without Survival Benefit

The FDA recently approved cabozantinib for use in medullary carcinoma.  What’s noteworthy about this drug is that it will likely be very expensive and that it does not, repeat does not improve the patients survival. 

Read the following for an extremely biased assessment of the drug’s efficacy: (likely from the drug companies PR info)

Below are some data showing Cometriq’s superiority over placebo:

  • Those on Cometriq survived 11.2 months (average) with no tumor growth
  • Patients in the placebo group survived 4 months (average) with no tumor growth
  • 27% of those in the placebo group experienced tumor reductions which lasted an average of almost 15 months
  • None of the participants in the placebo group experienced tumor reduction

What’s obscured in the above is that this drug results in 0 months increased longevity, that is, it had no effect on the longevity of the patients.

The ORR (overall remission rate:  Medicynical clarification) was significantly higher in the cabozantinib arm (27% versus 0%; p<0.0001) and all were partial responses.  The median response duration was 14.7 months (95% CI: 11.1, 19.3). No statistically significant difference in overall survival was observed between the treatment arms at the planned interim analysis and in an updated survival analysis requested by FDA.

Medicynical Note:  This is a new one for me.  Other new miracle agents often have limited efficacy with say two months median survival improvement.  But this is the first such drug being actively promoted, that I can recall, that has no survival benefit. 

Maybe this is yet another reason we spend more on health care than any other country in the world….by a wide margin. 

Disabilities Treaty: Voted down by Republicans

Is it any wonder that the world is looking elsewhere for leadership?  155 nations approved this treaty which protects the rights of those with disabilities and which was based on our own Americans with Disabilities act of 22 years ago.  But our Senate sort of voted it down.  38 members opposed, enough to keep the legislation from the necessary 2/3rd majority.

Why, you may ask?

Other conservatives were deeply suspicious of the United Nations, which would oversee treaty obligations. Those who opposed the treaty included former senator and Republican presidential candidate Rick Santorum, the father of a developmentally disabled child who had traveled to Capitol Hill last week to encourage fellow Republicans to vote no.

He and other conservatives argued that the treaty could relinquish U.S. sovereignty to a U.N. committee charged with overseeing a ban on discrimination and determining how the disabled, including children, should be treated. They particularly worried that the committee could violate the rights of parents who choose to home school their disabled children.

And:

Supporters dismissed those fears as paranoid, noting that the treaty would change nothing in U.S. law without further approval from Congress.

Medicynical Note:  We are so wimpishly paranoid that republicans actually believe that “outsiders” can sneakily  “force” actions on us without our consent.  This  from the “leader” of the free world.

Refused Abortion, Woman Dies: It Could Happen Here!

It’s sad and a bit disconcerting that this happens

“On the Saturday night everything changed, she started experiencing back pain so we called into the hospital, the university hospital.”

He said she continued to experience pain and asked a consultant if she could be induced.

“They said unfortunately she can’t because it’s a Catholic country,” Mr Halappanavar said.

“Savita said to her she is not Catholic, she is Hindu, and why impose the law on her.

“But she said ‘I’m sorry, unfortunately it’s a Catholic country’ and it’s the law that they can’t abort when the foetus is live.”

Medicynical Note:  Medical decisions in pregnancy should be under the complete control of the patient and her doctor.   There is no role in the processes for outsiders, including religious true believers and politicians.

Regarding “freedom of religion” it is enough that a person can apply their own beliefs to their own situation, without forcing the on others.  That is true freedom of religion.

It’s all about healthcare: “It’s” is the Economy Stupid

Read this

Medicynical Note:  This is where we find out if in a democracy we can control health care costs by choosing the most cost efficient approaches.  Markets won’t work.  The rub is the influence of the big moneyed lobbies of the Medical Industrial Complex….the game is on!

Why markets won’t work in health care was discussed 50 years ago by Kenneth Arrow and nothing seems to have disproven his contentions since them.  Read this for an introduction… and this for the original discussion. 

GlaxoSmithKline Malaria Vaccine Disappointment

Developing an effective  malaria vaccine is a challenge because of the complexity of the organism; the inability of an infection to confer lasting immunity; the polymorphism of the organism; and because of prevalance of the infection in lesser developed areas.  It’s not surprising that test vaccines are not fully effective.

The latest clinical trial of the world’s leading malaria vaccine candidate produced disappointing results on Friday. The infants it was given to had only about a third fewer infections than a control group.

But researchers said they wanted to press on, assuming they keep getting financial support, because the number of children who die of malaria is so great that even an inefficient vaccine can save thousands of lives.

Medicynical Note:  Another problem with the vaccine is that three shots are required to obtain some immunity.  It still remains to determined whether this “immunity” is durable.