Cost-Effectiveness of Cancer Drugs Is Question

"The widespread use of expensive cancer drugs to prolong patients’ lives by just weeks or months was called into question by an article published Monday in the Journal of the National Cancer Institute.

Crunching data from published studies, the authors found that treating a lung-cancer patient with Erbitux, a drug that costs $80,000 for an 18-week regimen, prolongs survival by only 1.2 months.

Based on that estimate, extending the lives of the 550,000 Americans who die of cancer annually by one year would then cost $440 billion, they extrapolated."

Let it be noted that the authors Tito Fojo and Christine Grady work at the National Cancer Institute where, we hope, they are nowhere near patients or even lab rats.  This is multiplication by morons... Most cancer drugs don't cost that much, extend life by more, often add to quality of life even if they don't add to length,  and by doing so add value and wealth to the economy.  And then there is the obvious -- one would hope -- shift in cancer care towards personalized treatment, providing medicines to those who can benefit, which brings the 1.2 survival way up.  

"How to control escalating spending on end-of-life care is one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system.

Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S."

Here's how Tito and Company -- trained bioethicists as well as having advanced degrees in multiplication - deal with these sensitive issues...

“Many Americans would not regard a 1.2-month survival advantage as ‘significant’ progress,” the authors wrote. “But would an individual patient disagree? Although we lack the answer to that question, we would suggest that the death of a mother of four at age 37 years would be no less painful were it to occur at age 37 years and 1 month, nor would the passing of a 67-year-old who planned to travel after retiring be any less difficult for the spouse were it to have occurred one month later.”

How does one respond to such wisdom and compassion?  Perhaps by suggesting that the authors follow their own sagacious advice when faced with a similar situation and voluntarily refuse treatments that -- on average --  increase survival by 1.2 months but could also do so by 4 years or more.  

They would be  making such a contribution to science and humanity.  

Samson, my yellow labrador and constant companion for 14 years, passed away this morning.   Just wanted to share a couple of photos and one of my favorite poems to let everyone know who he was and what he meant...

The House Dog's Grave (Haig, an English bulldog)

I've changed my ways a little; I cannot now
Run with you in the evenings along the shore,
Except in a kind of dream; and you, if you dream a moment,
You see me there.

So leave awhile the paw-marks on the front door
Where I used to scratch to go out or in,
And you'd soon open; leave on the kitchen floor
The marks of my drinking-pan.

I cannot lie by your fire as I used to do
On the warm stone,
Nor at the foot of your bed; no, all the night through
I lie alone.

But your kind thought has laid me less than six feet
Outside your window where firelight so often plays,
And where you sit to read--and I fear often grieving for me--
Every night your lamplight lies on my place.

You, man and woman, live so long, it is hard
To think of you ever dying
A little dog would get tired, living so long.
I hope than when you are lying

Under the ground like me your lives will appear
As good and joyful as mine.
No, dear, that's too much hope: you are not so well cared for
As I have been.

And never have known the passionate undivided
Fidelities that I knew.
Your minds are perhaps too active, too many-sided. . . .
But to me you were true.

You were never masters, but friends. I was your friend.
I loved you well, and was loved. Deep love endures
To the end and far past the end. If this is my end,
I am not lonely. I am not afraid. I am still yours.


Robinson Jeffers, 1941

Looks like the FDA is getting down to some serious social science

According to the Pink Sheet, a study proposed by FDA to evaluate how benefit information is conveyed through direct to consumer advertisements could end up showing drug marketers how to describe "high" and "low" efficacy drugs.

The proposed study will evaluate how consumers' interpretations of a drug's efficacy after viewing DTC ads compare to the efficacy data in the product's label.

The study will be conducted in two concurrent parts - one looking at print ads and one at TV ads - and examine three factors: drug efficacy, visual format, and type of statistic.

The agency defines drug efficacy as a quantifiable, objective metric that can be conveyed in graphical representations of the drug versus placebo, with "high efficacy" meaning "noticeably better than placebo" and "low efficacy" meaning "minimally better than placebo."

The agency traditionally has discouraged companies from making such qualitative claims - or even making too much of quantitative numbers - in its advertising. But the proposed study endpoints suggest a growing FDA comfort with, and even an interest in, consumers receiving this kind of information.

Testing Pfizer-like pictographs

The study will examine graphs, pictographs and pie charts as ways to visually present that efficacy information, and whether statistical information is best conveyed as frequency, relative frequency, or percentage.

The test product will be for a cholesterol treatment and modeled on an actual drug, such as Pfizer's Lipitor (atorvastatin), with labeling used as the reference for defining efficacy levels and the objective metrics for clinical performances.

The study will include 4,500 participants, 2,250 in each group (television or print). The subjects will read or view one advertisement version, and then make a series of judgments about the drug in a 20-minute interview.

FDA first will test whether, within each format, the participants were able to distinguish between low- and high-efficacy drugs. Then, it will look at whether the participants' efficacy estimates differ across formats and how accurate the estimates are.

Comments on the proposed study, called "Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisement for Prescription Drugs," are due by Aug. 21.

All to the good.  And it sure beats the ignorant "drug facts box" – the a la nutrition facts panel idea,that’s being kept alive via legislation introduced by Senators Jack Reed (D, RI) and Barbara Mikulski, (D, MD) which, BTW, would also require comparative effectiveness information to be included in product labeling.

Vey izmir.

Officials said Saturday that the White House, lawmakers and the pharmaceutical industry had struck a deal to have drug companies pay $80 billion to help narrow a gap in coverage in the prescription drug program for Medicare. The officials said that the agreement would have drug companies pay part of the cost of brand name drugs for lower and middle-income older people in the "doughnut hole." That term refers to a feature of the current drug program that requires beneficiaries to pay the entire cost of prescriptions after initial coverage is exhausted but before catastrophic coverage begins.

Obama seized on the deal as evidence that his efforts are gaining momentum.

"Key sectors of the health care industry acknowledge what American families and businesses already know — that the status quo is no longer sustainable," the president said, and noted: "We are at a turning point in America's journey toward health care reform."

So drug and biotech companies are finally being permitted what they wanted to do all along but were banned from doing -- giving seniors a discount to give them a seamless drug benefit.  That makes sense since the decision about what drug to take should be what works, not the price or cost.  At least that is what the evidence says.  And making that decision on clinical evidence leads to value based benefit designs which focus on overall health outcomes...

All to the good.  And the rationale, in part, to Medicare Advantage pay more for prescription drugs. 

But what is Obama proposing to fill the nearly $2 trillion gap to shove 25 million people into  public health plans.

"Obama has proposed cuts in Medicare spending on hospitals, prescription drugs and other services, but a political consensus is far from certain."

He has proposed eliminating Medicare advantage, which has primarliy benefited the chronically ill and minorities...  Leaving them with what?  

So just as the private sector provides seniors with a solution that moves us towards a preventive approach to health care Obama is pillaging the one part of Medicare that provides just that to prop up a health plan that cannot even support paying for preventive care....

The cynicism is breathtaking and the mainstream media is too busy fawning to take note. Real health care reform is within reach but not the way the President wants to take us...

Read article here.