Recently in Life Sciences & Biotech Category

This was a great cover story on Freeman Dyson in last week's New York Times Magazine. While much of the piece focuses on his critique of global warming theory, I think this passage draws out a much more profound, and more interesting, rift that gets far too little attention:

Beyond the specific points of factual dispute, Dyson has said that it all boils down to "a deeper disagreement about values" between those who think "nature knows best" and that "any gross human disruption of the natural environment is evil," and "humanists," like himself, who contend that protecting the existing biosphere is not as important as fighting more repugnant evils like war, poverty and unemployment.

Lost in much of the discussion about climate change and energy policy is a true accounting of the benefits of low cost and plentiful energy from the humanist perspective. We may take plentiful energy for granted in the West, but others around the world, such as the Chinese who are confronted with need to lift millions out of poverty, simply cannot afford to do the same.

This is stunning:

"As many as 195,000 people a year could be dying in U.S. hospitals because of easily prevented errors, a company said on Tuesday in an estimate that doubles previous figures."

I have to believe that a large component of this is that very few people in this country actually directly contract for their medical services. Most healthcare is paid for by government or insurance, which is in turn paid for in large part by employers. Most people think this is a good and necessary thing, but few consider the unintended consequences of this approach. Few are willing even to honestly access, acknowledge, and properly weigh these costs against the presumed benefits of 3rd payer system. But it does have costs, and IMO those costs outweigh the benefits on the whole. Milton Friedman made the case for why in this interview. Here's an excerpt:

But the government has introduced the major complication. The major complication is caused by third party payments. The fact that you have more complexity in medicine is a good thing. During the whole of the past 100 years, life expectancy has been going up. It was going up before there were these government programs, it's been going up since. But life expectancy actually went up faster before these programs were introduced than since.

In 1946, just after World War 2, total medical expenditures was about 5% of national income. Today, it's 17%. And life expectancy increased far more rapidly in the 50 years before World War 2 than it is increasing today. I believe that the progress and the quality of medical care has increased independent of the amount we spend on it through government. The relationship between your father and the doctor he paid at the door could work well in our time. It doesn't work well when your father doesn't pay the doctor directly but calls in a third party, and some third party has to judge whether that medical procedure is necessary. That's what causes the complication.

There are four ways in which you can spend money. You can spend your own money on yourself. When you do that, why then you really watch out what you're doing, and you try to get the most for your money.

Then you can spend your own money on somebody else. For example, I buy a birthday present for someone. Well, then I'm not so careful about the content of the present, but I'm very careful about the cost.

Then, I can spend somebody else's money on myself. And if I spend somebody else's money on myself, then I'm sure going to have a good lunch!

Finally, I can spend somebody else's money on somebody else. And if I spend somebody else's money on somebody else, I'm not concerned about how much it is, and I'm not concerned about what I get. And that's government. And that's close to 40% of our national income.

What hospital goes out of business for killing its patients? There needs to be a competitive market in healthcare services in which the END CONSUMER, not their proxies, are making the choice. We like to complain that the insurance companies don't make the right decisions on our behalf, and many are quick to demonize them. But it is a delusion that even if medical insurance companies were run by saints and angels that they could even muster the bureaucratic talents to make more appropriate decisions for people on their behalf more often than people could make them for themselves. The third party payer system in this country, indoctrinated by government, will inevitably, IMO, get worse results than if the end consumers, who might take greater note of which hospitals are the worst at killing people and use their power of the purse to go elsewhere, made those decisions on their own behalf.

Yet another case of big business using government to build barriers to innovative, new, and potentially commercially threatening business, aided and abbetted by paranoid radicals. Henry Miller and Gregory Conko point out that the biotech industry is now reaping what it helped sew. Excerpt:

Long before the first gene-spliced plants were ready for commercialization, a few agrochemical and biotechnology companies, led by Monsanto and Calgene and supported by BIO (and its precursors), approached policy-makers in the Reagan administration in the mid-1980s and asked that the Environmental Protection Agency, Department of Agriculture and Food and Drug Administration create a regulatory framework specific to gene-spliced products.

The policies recommended by the biotechnology industry, predicated on the myth that there is something fundamentally novel and worrisome about gene- splicing techniques, were far more restrictive than could be justified on scientific grounds and often even more burdensome than proposals by regulators.

Ostensibly, the goal of these policies was to placate anti-biotech activists and provide reassurance to consumers that regulators had evaluated and cleared gene-spliced products, but the real motives were less benign. Industry representatives have admitted after the fact that the companies wanted excessive regulatory requirements to make biotech R&D too expensive for possible competitors such as start-ups and seed companies; in other words, regulatory expenses and delays would serve as a market-entry barrier.

The USDA and EPA in particular were glad to oblige industry, with draconian policies that focused specifically on and discriminated against plants and microorganisms crafted through gene splicing. As a result, a field trial on a gene-spliced organism today costs 10 to 20 times as much as the same trial with a plant that has virtually identical traits, but that has been modified with less precise and predictable conventional techniques.

Allow markets to work, of course. John Cogan, Glenn Hummard, and Daniel Kessler review what the root problem is with our health-care trouble is and what solutions naturally follow in this piece in the WSJ. Excerpt:

Free markets are a proven way to discipline costs, encourage innovation and increase quality. The starting point to fixing the health-care system is recognizing that a handful of existing public policies prevent markets from working, and then changing them. Poorly conceived federal tax policies, insurance regulation, and barriers to entry, in particular, have insulated consumers from costs and inhibited competition.

Rising costs lie at the heart of the health-care problem. Each percentage-point rise in health-insurance costs increases the number of uninsured by 300,000 people. This also creates a vicious cost spiral because when healthy individuals opt out of insurance, the costs for the remaining insured rise. The recent increase in costs also has impacts beyond the health-care market. For many employees, rising insurance costs have become a serious drain on their disposable income. The typical worker now pays $750 more per year for insurance than just three years ago. ...

Using third parties to pay for health care is so pervasive that we accept it as a natural part of the health-care system. Yet there's nothing natural about it. Food and shelter are even more basic to our well-being, but we don't use insurance to buy bread or repair broken windows. ...

Leveling the playing field between employer-provided insurance and out-of-pocket payments is an essential step to fixing health care. Either the tax exemption for employer-provided health insurance must be repealed or a broad-based tax deduction for out-of-pocket expenses must be created. The former faces enormous political barriers (it would add about $1,500 to the typical family's annual tax burden) and would ignore a positive effect of encouraging everyone to have private insurance coverage.

I'm very concerned about the personnel changes happening on the Bioethics council. But the bottom line is that the more we separate medical research from federal funding--and thereby federal oversight--the better.

Ignorance and irrationality can be scientific progress's greatest foe. Henry Miller on fighting the good fight. Excerpt:

Significant advances in the fight against cancer, diabetes, AIDS, Parkinson's and numerous other diseases have relied on biotechnology. If future research were to lead to development of a product that provides significant relief, or even a life-saving cure, Measure H would prohibit its use in Mendocino County. That alone is reason enough to defeat this poorly-worded and confusing measure.

California boasts a strong environmental movement, but by outlawing the cultivation of insect-resistant crops developed with the assistance of biotechnology, Measure H could lead to an increase in the levels of chemical pesticides in the area's ground and surface water (and would certainly cause increased occupational exposures).

Most important of all, Measure H would block sophisticated genetic approaches to the eradication of blights such as sudden oak death, phyloxera, powdery mildew and Pierce's Disease. ...

Like many Californians, I love the state's table grapes and wines, but California's vineyards are being threatened by Pierce's Disease, a bacterial infestation carried by an insect, the glassy-winged sharpshooter. Organic and conventional grape growers especially fear this devastating and lethal disease. Genetic improvement of grapevines may well prove to be the definitive solution to Pierce's Disease _ a solution that should not be denied to Mendocino County. The same applies to sudden oak death, which is destroying many of our glorious oak trees.

But there is a more important reason. I spent more than 15 years responsible for biotechnology regulatory policy at the U.S. Food and Drug Administration. I personally evaluated the first biopharmaceuticals in the early 1980s. During that time, I was a crusader for imposing only the amount of regulation that was necessary and sufficient, and for regulatory approaches that made scientific and common sense. I was on the side of neither the activists nor the industry, and that remains true today. I am convinced that flawed public policy _ especially when it is as nonsensical as Mendocino County's Measure H _ makes a mockery of government and diminishes us all. I have written or edited five books and published more than 500 articles, many in peer-reviewed journals, on various aspects of regulation.

I am as much of an environmentalist as any of the people who have criticized me, but letting ideology and misguided activism trample science and common sense is not the route to sound public policy.

David Henderson makes the case in the The Stanford Daily that it's time to end the FDA's monopoly. Here, here.

"The Food and Drug Administration's (FDA) recent ban on dietary supplements containing ephedra shows just how dysfunctional government regulation of drugs and dietary supplements is."

I posted about this topic earlier and it got a fair amount of attention, so here is an excerpt from a recent WSJ editorial on the subject. (Also read this more detailed piece and this piece as well, both from Tech Central Station on the subject.)

This is a story of politics and lawyers trumping science and medicine. It concerns thimerosal, a preservative that was used in vaccines for 60 years and has never been credibly linked to any health problems. Nonetheless, a small but vocal group of parents have taken to claiming that thimerosal causes autism, a brain disorder that impairs normal social interaction. The result has been an ugly legal and political spat that has spilled into Congress and is frightening some parents from vaccinating their children against such deadly diseases as tetanus and whooping cough.

Like night follows day, the dispute has also brought in the trial lawyers. Vaccine makers are supposed to be protected from lawsuits by 1986 legislation, but the lawyers are exploiting loopholes to file billion-dollar suits that threaten to punish the few companies that still make vaccines.

Congress tried to fix this by including a liability provision in homeland security legislation a year ago. But three Northeast Republican Senators -- Olympia Snowe, Susan Collins and Lincoln Chafee -- demanded it be taken out until Congress could have a full airing of the thimerosal-autism issue. The Senators haven't yet honored their side of that deal.

Perhaps that's because if they did their position would be exposed as scientifically untenable. The claim is that thimerosal, an organic mercury compound, can cause neurodevelopmental disorders. But study after study has shown that there is simply no such link.

A 2002 University of Rochester study compared the blood mercury levels of infants who'd received vaccines with and without thimerosal. All had levels well below the super-cautious EPA safety standard. This was followed last March by a study published in Pediatrics magazine, in which researchers compared the physical manifestations of autism and mercury poisoning. They found that the symptoms weren't the same, nor were the brain tissues similar.

Perhaps the best evidence comes from Denmark, one of those European nations that likes to monitor most everything about its citizens. Researchers recently examined the health records of all children born in Denmark from 1971 to 2000 for autism diagnoses. Though Denmark eliminated thimerosal from its vaccines in 1992, the researchers found that the incidence of autism continued to increase. A second research team reviewed the records of nearly 500,000 Danes vaccinated for pertussis. They also found that the risk of autism and related disorders didn't differ between those vaccinated with thimerosal and those without.

None of this is to deny that the incidence of autism may be rising, though there is a dispute about why. The definition of the disease has broadened in recent years, encompassing even mild learning disabilities, and doctors have become better at diagnosing it. Some statistics show that as autism diagnoses rise, those for mental retardation fall -- suggesting children were previously misdiagnosed. Parents are also more keen to have a proper diagnosis, because many schools now offer more extensive educational services for autism than they do for other disorders.

Much of the discussion about how to fix healthcare goes in the wrong direction--as it attempts to put the burden for our health on the state or our employers. This is the problem, not the solution, argues Hoover's Scott W. Atlas, building from many of Milton Friedman's ideas.

First and foremost, decisions to purchase medical care should be made by the patient desiring the care. People must spend money directly for medical care in order to become cost conscious. The current system encourages patients to neglect cost when they use medical care. Income allocated to health insurance costs is given special tax treatment if provided by the employer. Why is this done uniquely for health care costs? Other essential items, including even food and clothing, are not offered this exalted status. This was basically an accident of history, when companies began offering health benefits to lure employees during World War II. Because the tax code did not specify that these benefits were taxable, they were not taxed. Years later, this was codified.

The invaluable Henry Miller draws attention in this piece in Tech Central Station to the damaging and inconsistent regulations of biotech. Whether you prefer more or less regulation, we all should want regulations to be rational. We haven't got that. Even though gene slicing methods are more presice, they are discriminated against because the method, not the outcome. This creates a perverse regulatory regime.

The dirty little secret of U.S. biotech policy is that regulation at the USDA and EPA is internally inconsistent and contradicts the official overarching federal policy -- developed during the previous Bush administration with the formal agreement of the agencies -- which stipulates that regulation of biotechnology products should be "risk-based," "scientifically sound," and focused on "the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created."