THE "ORPHAN DRUG" FIASCO

In my recent posting on the vast government regulations that are supposed to protect us from drugs that have "side-effects" (any drug that has no side-effects has no main effects either!), I pointed to the deaths and years of suffering that result from the delays we now have to endure while a new drug is gaining bureaucratic approval. Sometimes, the red-tape is so deterring that many helpful drugs will NEVER gain approval, no matter how safe or effective the drug is. This is mainly where the drug is intended to treat a relatively rare illness and so has fewer "customers" to defray the approval costs. The USA introduced an "Orphan Drug Act" in 1983 to address this problem. Drugs intended to treat rare illness got special treatment to encourage their introduction.

But what was the special treatment? Was the burden of regulation lifted at all for such drugs? No way! All that happened was that drug companies were allowed to charge more for such drugs! As is says here:

Rather than reducing the FDA barriers to producing orphan drugs, the Orphan Drug Act was meant to stimulate the development of such drugs by granting sponsors new monopoly privileges. The exclusivity granted under the act differs from a patent. A patent protects against competition from a drug with the same chemical structure. Market exclusivity as implemented by the Orphan Drug Act grants protection for seven years against competition from any drug with a similar effect. The FDA thereby bars firms from marketing drugs that treat diseases also treated (and perhaps less effectively) by a drug granted exclusivity.
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A sponsor seeking orphan status for a drug need not be the creator of the drug, and the drug need not be new. The drug Oxandrolone had been used to treat wasting in hepatitis patients and had been available by prescription for thirty years. When body builders began to use it illegally to bulk up, the drug received bad publicity and was discontinued. Another company then gained the rights to the drug and presented it to the FDA as a new treatment for HIV-related wasting. Orphan status was granted. AIDS patients now paid a price 1,200 percent higher than when the manufacturer did not have monopoly rights (LeBlanc and Sabados 1996)

So rather than give up its precious regulations and bureaucracies, a Democrat-dominated Congress allowed drug companies to charge up to 12 times more than the drug really needed to cost! So don't blame the drug companies if what you need is unavailable in the USA or costs a fortune to buy! Put the blame where it usually rests: On big government.

Because of the insane U.S. regulations, many drugs are available in other countries up to 5 or 6 years before they become available in the USA. Isn't it great to be protected? It's not so great if you happen to need the drug concerned.

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THE ZERO RISK BRIGADE

Most ordinary sensible people know that there are various risks that we all run all the time in our lives. From a statistical point of view, one of the most dangerous things we can do is to get into our cars of a morning. But we do it. We take that risk because most of us are prepared to tolerate some level of risk in order to get the benefits of whatever it is that we do.

The Greenies and the consumer advocates such as Ralph Nader are, however, great enemies of any risk. Their gospel appears to be that if there is any risk in any thing at all then the government should ban it. That everything has its price they seem oblivious to. And unfortunately they often succeed in their Quixotic quest. They do manage to get things banned (such as DDT) that have tiny risks but great (and often livesaving) benefits.

There is now however a body of research that looks at how ordinary people operate and shows that we all have a level of risk that we are prepared to tolerate in our lives -- and that if someone makes our lives safer in some way we actually go out and do extra risky things to get our risk level back up! For instance, people who get a safer car (with ABS braking etc) tend to drive faster! They adjust their driving risk back to their own personal tolerance level.

So the zero risk brigade are not only defying commonsense in seeking zero risk but, as well as that, when they do suceeed in eliminating some risks, we just go out and take some new risks! The whole zero-risk crusade is then not only foolish but pointless.

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COMPULSORY SEATBELTS

One of the more alarming examples of bad results from bureaucratic attempts to make us behave more safely is the case of compulsory seatbelt wearing. Australia was one of the first countries to make it compulsory for car drivers to wear seatbelts so some of the earliest research on the results was done here. But similar results have since been found elsewhere. It was found that the major effect of wearing seatbelts was to make drivers feel safer -- so the drivers then drove more dangerously -- thus killing more pedestrians and cyclists than ever before. The number of dead pedestrians and cyclists outweighed any gain in survival among drivers! So bureaucracy merely killed the innocent!

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A BIT OF LEFTIST HILARITY

Well, we all know that denying reality is the stock in trade of the Left but how about this bit of wisdom from an ostensibly moderate Australian Leftist:

"The situation in the US is similar, but even more laughable because of the absence of anything even faintly resembling an organised political left."

The Left can even deny that it itself exists! Not even Descartes (�cogito ergo sum�) went that far!
Via Aaron Oakley

Aaron has had some good posts on the global warming myth lately too.

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ELSEWHERE

China Hand gives good reasons why the China/Taiwan problem does not allow simplistic solutions but thinks a solution is happening anyway.

There is what appears to be an inadvertent admission of racial differences documented on IQ & PC.

Michael Darby tells you why living near powerlines will NOT give you or your children cancer.

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