Forcing Cancer Research Offshore

We've discussed the urgent necessity of finding new energy sources.  Maintaining our current levels of energy consumption is essential not only to maintaining our lifestyle, but to maintaining our food supply.  If we lose enough technology or we have to stop using fuels and have to go back to muscle-powered agricultural technology of 1935, half our population will starve.

We've also mourned that we're passing up an opportunity to become a space-going power because we can no longer muster the political will to undertake massive engineering projects.

Our science remains first-rate, for now, but we not only have fewer engineers than we need, our government has erected huge obstacles to doing anything new.  If we can't rearrange flight patterns around New York City without being tied up forever with lawsuits, if we can't build a new subway in New York that's been in the planning stages since the 1920's, how can we build anything of significance?

But engineering is not the only sort of innovative enterprises which we've driven overseas.  People who curse globalization act as if they believe that the only reason businesses or innovators move overseas is to cut wages and cheat American workers.  Today, some kinds of businesses must be founded overseas not because the founders wanted to cut costs but because the American regulatory climate made it impossible for these fledgling enterprises to do business here at all.

Cancer Treatment

In a previous article, we discussed a new cancer treatment that's being tested in China because it can't be tested here.  There's nothing exotic about the technology - it involves immersing the patient up to the neck in water and putting energy at various frequencies into the water; the trick is determining the optimal frequencies, power levels, and treatment intervals.

The treatment is based on the theory that we all have many, many teeny weenie cancer cells throughout our bodies.  These cancers are far too small to be detected and most of them never get big enough to do us any harm.

A cancer cell can't grow very big without a special network of blood vessels to feed it.  Most cancers can't get enough blood to grow, but when one of your cancer cells tricks your body into growing new blood vessels to feed it, there's no limit to how big it can get.  If your cancer grows big enough, it kills you.

It would be against federal law to test this treatment in the US because it's too far out of the medical mainstream.  In the late 1800's, a great many useless potions were sold as miracle drugs. Although snake oil is a traditional Chinese medicine, the term "snake oil" came to be used to describe bogus medicine because many of the ineffective compounds were said to contain snake oil.  Thus, in the United States, the term came to describe any useless nostrum of any type.

Many popular drugs of the day were ineffective; some were downright dangerous.  Congress passed the federal Food and Drugs Act in 1906 to give the FDA authority to regulate the sale and manufacture of drugs in the United States.  The FDA mission statement says:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs. [emphasis added]

There's no real debate about the desirability of "safety."  Nobody wants dangerous drugs on the market; it's a good thing that Coca-Cola no longer contains cocaine.  Efficacy is also important because many harmless, but ineffective, compounds were being sold. The law required the FDA to force drugs off the market if the manufacturer couldn't prove the benefits of the drug.

As for security, the FDA is responsible for ensuring that manufacturers don't use bad ingredients or let their factories become contaminated; the recent Chinese experience with poison being mixed into infant's milk shows what happens when food security is neglected.

There are problems with requiring "safety," of course.  When penicillin was introduced, about 10% of the population was found to be allergic to it.  That would normally have kept penicillin off the market as unsafe, but at the time, soldiers were being wounded in the Pacific jungles.

The jungles had bacteria to which the soldiers had no immunities; about 90% of the wounded died.  From the Army's point of view, having 10 soldiers out of 100 die from penicillin allergy instead of having 90 soldiers out of 100 die from jungle rot was a no-brainer; they forced penicillin into production over the objections of the FDA.  As we've noted before, the only time anyone can beat a bureaucracy is in time of war.

Putting penicillin on the market was clearly the right thing to do, but it rode roughshod over the FDA's charter to ensure drug safety.  Modern drugs are kept off the market with adverse reaction levels far lower than penicillin still exhibits but penicillin stays available because its benefits outweigh its risks - and most importantly, the bureaucracy has long since got used to having been dragged through a knothole backward by the military.

Safety is no problem with this new cancer treatment, as everybody admits there's no way it could hurt anything bigger than a cancer cell.  The problem revolves around "efficacy."  The law requires the FDA to keep ineffective treatments off the market.  Thus, no treatment can be offered anywhere in America unless the FDA believes that it works.

How do we get new treatments on the market if we can't test them?  The only way to get permission to test a new treatment is to argue, based on earlier treatments, that the new approach has a "good enough" chance of being better than what went before.

Any new treatment must be a derivative of an earlier treatment for the FDA to think it has enough of a chance of working to be tested at all.  Remember, it's a federal crime to administer any medical treatment without FDA approval; this effectively outlaws any medical experiments that are too far outside the mainstream.

When Einstein talked about atomic energy, the bomb designers thought he was nuts.  His approach to destroying cities was way outside the mainstream of military thought; serious politics and string pulling were required to get the Manhattan Project funded to build the first bomb.

Similarly, this cancer treatment is so unconventional that the oncology establishment doesn't think it could possibly work.  Since it isn't derived from any prior treatment and the establishment rejects it, there's no basis for the FDA permitting it be used in American medical facilities.  That's why it has to be tested in China.

As it turns out, the limited data we have show that treatment won't work on cancers once they're big enough to be detected; it isn't a cure for cancer once you know you have cancer.  The problem with many cancer treatments, of course, is that the cancer often comes back.

The theory that everybody has lots of cancers but that most cancers don't grow suggests that when your cancer comes back, it might not be the same cancer.  If one of your cancer cells decides to grow, other cancer cells might decide to grow after the first cancer is killed.  It seems that the original cancer has come back because your cancers are so much alike that nobody can tell the difference.

Experiments have shown that people who have this treatment after the original cancer has been killed off by conventional methods don't have cancer come back nearly as often.  Although the treatment won't work once a cancer is big enough to detect, it seems to help keep the cancer from coming after it's been shrunk by conventional treatment.

What does that mean?  Suppose that the effect of keeping cancer from coming back once the original cancer's been cured turns out to be real.  This suggests that the treatment works on tiny cancers but not on big ones.

Suppose you've never had cancer but you think you might in the future.  Wouldn't you want to have the treatment just in case so that any little cancers you had would go away before they could get big enough to detect?

But if we can't detect your itty-bitty cancers, how can we prove that treating you cured any cancers?  Again, there's no way to prove that the treatment works in normal people.

The Chinese believe in statistics, of course.  They'll give the treatment to as many people as they can - all it takes is a $40,000 hot tub which can treat one person every 3 or 4 hours - and see how many cancers develop.  Suppose that out of 1,000 people, half as many of the people who got the treatment develop cancer as in the group that didn't get the treatment.  That would mean that the treatment would reduce your risk of getting cancer by 50%.  Would you want the treatment under those circumstances?

The Chinese aren't stupid.  They understand how our FDA works.  If treating people who don't have detectable cancer means they develop fewer cancers, they'll never publish enough data for the FDA to approve it.  They'll advertise the treatment on Chinese web sites, sell you package tours, and charge you a bunch.

So long as our FDA doesn't have data to show that the treatment works, they can't allow the treatment in the US.  Thus, the FDA will helpfully protect the Chinese monopoly once it's established and you'll have to go overseas if you want it.

But if it doesn't work except on people who're recovering from cancer, on the other hand, forbidding its general use in the US will save medical consumers a lot of money.  To sum up, this treatment may or may not work for the general population but it seems to reduce cancer recurrence once people have been "cured" conventionally.

Shouldn't it be at least possible to experiment with unconventional treatments in the US?  We'll never know unless we try... and the FDA won't let us.

It's the Business Climate, Stupid!

One of the reasons the United States has built such a lavish lifestyle as compared to the rest of the world is that we've made it very easy for innovative people to start and operate new businesses. Development agencies all over the world have begun to realize that the legal and cultural climate in which business operate has a profound effect on how vast businesses grow and on how much tax revenue the government is able to collect.

• It used to be extremely simple to start up and operate a new business. It's still simple to incorporate a new enterprise, but it's getting harder and harder to operate it.
• Zoning regulations keep entrepreneurs from operating businesses out of their garages in the early days.  Apple Computer and Hewlett-Packard, two major firms which started in garages, could not get off the ground today because zoning authorities would shut them down.
• It used to be easy to take a start-up public so that investors could cash out.  With the new regulations imposed by the Sarbanes-Oxley law which was passed to prevent a future Enron, the number of Initial Public Offerings has plummeted in the United States while rising in London.  Our entrepreneurs not only test their inventions overseas because of our regulations, they fund them overseas too.
• Our regulatory climate has turned against innovation.  Greens snarl that anything new must be proved to be safe before it can be used; their Luddite mind-set aligns perfectly with the bureaucratic mind-set of not wanting to allow anything not provided for in their manuals and procedures.
• Any nation needs a functioning court system to enforce business contracts in a predictable manner.  If a businessman has no assurance of getting paid, he can't do business with people he doesn't know well.  Americans think nothing of making Internet purchases from people they'll never meet.  Unfortunately, our criminal court system is being used to advance the careers of ambitious politicians and our civil court system has become so expensive and so unpredictable that Europeans would rather be sued in Russia or China than in the US.  Legal uncertainties add to the risks of starting a business.

Our culture and our lavish lifestyle are based on the idea that creative people are free to introduce innovations which will make them rich while benefiting us all.  As a society, we're turning against that idea - not only do our liberals politicians want to tax away all the gains in the name of "fairness," they also want to pass rules and regulations which make it impossible to succeed in the first place.

Fortunately, other countries are catching on and are welcoming our innovators.  The great brain drain which favored the United States for so long is beginning to run in reverse; our best and our brightest are being forced offshore.  That may be good for the countries which will benefit from their creativity, but what will happen to America?