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February 18, 2011

How ObamaCare Kills Medical Innovation

By Fred N. Sauer
Now we know what rationing will look like under Obama Care, with the FDA's decision to ban doctors from prescribing the drug Avastin to patients with breast cancer. And it's only the beginning. 

This first step, impeding the use and development of life-saving medicines will lead to even more dramatic decisions to delay, prevent or withdraw care from those in real need of health care. 

But, there had to be a legitimate reason for the Obama Administration's Food and Drug Administration's decision to prevent the use of Avastin, right?  If rationing is a legitimate reason to you, then the answer is yes.     

Earlier this month, the Food and Drug Administration banned doctors from prescribing Avastin, a potent but costly drug, to patients with advanced-stage breast cancer. According to the FDA, the drug doesn't offer 'a sufficient benefit in slowing disease progression to outweigh the significant risk to patients . . . .'

Ponder the FDA's justification -- there wasn't "sufficient" benefit in relation to Avastin's risks.  Sufficient according to whom? For your wife, mother or daughter with terminal breast cancer, how much is an additional month of good-quality life worth?  Why shouldn't she be able to spend her own money on her health care to try to go forward another day, month or year?

All new medicines are expensive.  In fact, the first edition of practically every innovation is the most expensive version of whatever it is.  But as long as there are risk takers and people willing to pay higher prices, why shouldn't we let these forces try to advance progress in drugs and medicine?  Should we care that new drugs are so expensive?  The story of the discovery of penicillin is instructive.  Let's examine this FDA justification by posing the question, should we have stopped the advance of health care in 1945 when penicillin was discovered?

The discovery of penicillin is attributed to Scottish scientist and Nobel laureate Alexander Fleming in 1928.  He showed that, if Penicillium notatum were grown in the appropriate substrate, it would exude a substance with antibiotic properties, which he dubbed penicillin. This serendipitous observation began the modern era of antibiotic discovery . . . .

The challenge of mass-producing this drug was daunting. On March 14, 1942, the first patient was treated for streptococcal septicemia with U.S.-made penicillin produced by Merck & Co.  Half of the total supply produced at the time was used on that one patient.  By June 1942, there was just enough U.S. penicillin available to treat ten patients.  A moldy cantaloupe in a Peoria, Illinois, market in 1943 was found to contain the best and highest-quality penicillin after a worldwide search.  The discovery of the cantaloupe, and the results of fermentation research on corn steep liquor at the Northern Regional Research Laboratory at Peoria, Illinois, allowed the United States to produce 2.3 million doses in time for the invasion of Normandy in the spring of 1944. Large-scale production resulted from the development of deep-tank fermentation by chemical engineer Margaret Hutchinson Rousseau . . . .

Penicillin production emerged as an industry as a direct result of World War II. During the war, there was an abundance of jobs available in the U.S. on the home front. The War Production Board was founded to monitor job distribution and production.  Penicillin was produced in huge quantities during the war and the industry prospered. In July 1943, the War Production Board drew up a plan for the mass distribution of penicillin stocks to Allied troops fighting in Europe. At the time of this plan, 425 million units per year were being produced. As a direct result of the war and the War Production Board, by June 1945 over 646 billion units per year were being produced....

When you look at Penicillin, you see that everything going on in medical research then is the same today.  Huge and expensive efforts are needed to get the first cure: 

On March 14, 1942 . . . . Half of the total supply produced at that time was used on one patient . . . . A moldy cantaloupe in a Peoria, Illinois, market in 1943 was found to contain the best and highest-quality penicillin after a worldwide search . . . .

Penicillin production emerged as an industry as a direct result of World War II . . . . As a direct result of the War and the War Production Board, by June 1945 over 646 billion units per year were being produced . . . .

Talk about a decline in unit costs!  Production of penicillin dramatically increased from 2 doses in 1942 to over 646 billion doses in 1945 -- just three short years.  This is a declining unit cost curve in the extreme.  The discovery of Penicillin is a perfect example of how future beneficiaries benefit forever thereafter from the initial high cost and complications of perfecting drugs and medicines.

Unequal outcomes are what propel economic progress in every way.  The steam engine for ships and trains produced huge reductions in the cost of moving people and goods around the world or across the territory -- and unit costs are still dropping.

Unequal outcomes always result from huge increases in productivity.  And, productivity always results in lower long-term costs of the produced items.  Market economies create this rise in productivity and lower unit costs whereas Socialistic economies always "tax success" and destroy this process.  Why stop the progress of Avastin? 

Enforcing equal outcomes is the big ideology of Socialism.  It disguises itself so deceptively as a matter of so-called social justice.  The real injustice is that by denying early beneficiaries who can afford to buy early technology, you would destroy the opportunity for the inevitable drop in unit costs for the almost unlimited future beneficiaries at much lower costs as productivity continues.  Just consider the advances in agriculture over the last 100 years.   Yes, unequal outcomes propel economies forward.  Stopping the advances of technology arising from initial unequal outcomes, is a grave, if not, the gravest injustice of requiring equal outcomes.  Equal outcomes is an ideology of socialism that stops economic progress and discourages future producers from taking risks to advance productivity.  It creates untold future victims in exchange for government power now.

...The Avastin story is emblematic of the government's broader agenda to ration care based on cost and politics.  Once ObamaCare comes into full force, such rationing will be pervasive . . . .

Think it can't happen here?  Think again.  The 2009 stimulus bill spent $1.1 billion to research 'comparative effectiveness.'  That's the same approach used by Britain's National Health Service to ration care, weighing cost against factors such as the ever-elusive concept of quality of life.  And in an interview that year, President Obama confessed that 'the tougher issue . . . is what do you do around things like end-of-life care . . . .'

But when the government denies approval of a medication, there will often be no appeal and no escape . . . . The next time the FDA bans a drug because its benefits are not 'sufficient,' patients may not be so lucky.  FDA disapproval will be the equivalent of the emperor's thumbs-down.

This did not happen to penicillin.  And, this type of government disapproval kills medical research and those people in the future who could have otherwise used the medicine.

If government can limit Americans' choice of effective medical treatments, there's no limit to its control over our bodies, and the right to bodily autonomy is an illusion.  In the context of the new health law, the FDA's Avastin decision is the tip of a looming iceberg of government rationing. It must be challenged.

Fred N. Sauer is an American patriot, St. Louis resident, and businessman whose blog can be found at http://www.americasculturalstudies.com.
on "How ObamaCare Kills Medical Innovation"