Blame Innovation!

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  • 07/07/2011

Blame innovation!

According to an editorial in today’s New York Times, “A prime driver of our escalating health care costs is the advance of medical technology …”

Indeed. 

The driver of the Gray Lady’s oration is the decision by Medicare to pay for both Provenge (advanced prostate cancer) and Avastin (for breast cancer – even if the FDA removes this as an on-label indication).

The Times objects to both treatments “staggering high cost” and “modest help to the typical patient.”

Are these treatments “too expensive?” Well, as they say inside the Beltway, where you stand depends on where you sit.”  Too expensive for whom?  And there lies the rub.

When our nation’s biggest health insurance provider – Uncle Sam – is footing the bill, the real payer is the American tax payer.  You and me.

That being the case, how do we feel about spending our tax dollars on end-of-life care for our fellow citizens?  After all, these treatments aren’t cures.  They extend patient life. Some gain months, others years. 

This is a tough and timely question for both public and private debate – and not just amongst policy wonks and editorialists. Do we want a health care system that is cost-based or patient-centric? Should end-of-life care be rationed?  If so, by whom and by what measure?

And if we decide not to pay for new medicines, the clear signal to the pharmaceutical industry is “cease research and development for new treatments for killer diseases."

Blame innovation? Consider:

Innovation is slow.  As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time.

Innovation is hard.  Today it takes about 10,000 new molecules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.

Innovation is expensive.  In 2003, researchers at Tufts Center for the Study of Drug Development estimated the costs to bring a new medicine to market to be $802 million, and others suggest that the total cost is closer to $1.7 billion

Innovation is under attack.  From accusations of the “me-too” variety, to crackpot schemes to replace pharmaceutical patents with a “prize” system, life for innovator pharmaceutical companies is rough and tough. 

But innovation is importantand not just for pharmaceutical industry profits. Increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. In 1974, cardiovascular disease was the cause of 39 percent of all deaths. Today it is about 25 percent. Cerebrovascular diseases were responsible for 11 percent of deaths back then. In 2004 they caused 6.3 percent of deaths. Kidney diseases were linked to 10.4 percent of deaths and now they are associated with 1.8 percent. And that’s just for the United States.

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "The average person aged 45 will live three years longer than he used to solely because medical care for cardiovascular disease has improved. Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

Blame innovation – because now we are living long enough to suffer in larger numbers from cancer and Alzheimer’s disease. Diseases that cannot be cured (at least not yet) and are expensive to treat.

And what of the “typical” patient?  The current gold standard of drug testing, the randomized controlled clinical trial, isn’t specifically designed to identify patient subpopulations who might benefit from a treatment that does not aid the general population. According to the folks at our nation’s newspaper of record, Avastin “provides almost no benefit for the typical woman with advanced breast cancer.” Well – true, except for the subpopulation of women for whom it does.  The problem isn’t that Avastin “doesn’t work,” it’s that we have no way of identifying which women it will work for.

The solution isn’t to carp on cost – it’s to develop better diagnostics to help physicians identify the “four rights” – the right drug in the right dose for the right patient at the right time.  We need to focus not on cost effectiveness but on clinical effectiveness.

But nowhere in the Times’ editorial is there a call for increased FDA funding for the development and regulation of molecular diagnostics – something that is urgently needed and, alas, rarely discussed.

Rather the Times’ editorial ends as follows, “Whether the drug is worth its high price is a question our health care system is currently unprepared to answer.”

Really?  It seems that Medicare is not only prepared to answer the question – but that, via their decision to reimburse for both Provenge and  Avastin, they have.

At least for now.  After all, we're entering into a Presidential election cycle.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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