No Custom Meds for You!

The FDA and lawyers make promising treatments impossible.

One of the trickiest exercises in governance is finding the right balance between liberty and license.

Although many liberals who favor more government intervention in the economy and in our personal lives will admit that the United States is not as free as it used to be, they'll generally claim that increased population has brought a need for more rules.  There would be nothing wrong with someone playing a stereo as loud as possible if nobody else lived within earshot, the argument goes, but with more and more people loving closer and closer together, government has to get involved with regulations such as zoning to keep the peace.  "Your right to swing your arms ends where my nose beings," as an old saying has it.

We've noted how zoning regulations are getting out of hand to the point that the City of Milwaukee took a house away from a citizen who had failed to pay a fine for parking his own car in his own driveway.  We've also lamented the fact that the FAA's efforts to rearrange air routes around new York City in order to reduce airport congestion all across the nation are tied up in lawsuits.

There are more and more indications that the balance between letting people try new things and restrictions on what citizens are permitted to do has gone too far in the direction of holding back technical progress.  This is an important issue because our whole lifestyle is based on being more productive than other countries.  Regardless of government policy, average consumption in America can't exceed the average of what we produce here; things imported from overseas must be paid for by goods or services that we produce for export.

Traditionally, we've created new innovations and sold them abroad.  That's the only way known for us to pay for what we want to import from countries like China and India.  Thus, anything that forces our innovators to go overseas is cause for concern.

Unfortunately, medical research rests at the conjunction of both opposing forces: it is a major potential source of valuable innovation for the future and it's also an area utterly infested with intrusive and onerous regulations and lawsuits which retard innovation.  As CNET pointed out in an article about an interview with Microsoft's top intellectual property lawyer, "It's generally thought that if you want to kill a good technical discussion, just bring in the lawyers."  Nowhere is this problem more acute than in cutting-edge drug research.

The Promise of Custom Drugs

One of the reasons scientists were so interested in sequencing the human genome was that they thought that if they understood what all the various genes do in each person, they might be able to analyze your DNA and design medicine just for you

People react differently to different drugs, unfortunately.  If your doctors analyzed your heredity, they might be better able to choose drugs for you or better yet, formulate a special cocktail that took account of a) the specific details of your disease and b) your unique genetic makeup.

Making custom medicines is an active area of interest, but the way the FDA approves drugs makes this difficult.  Remember that the FDA is responsible for ensuring that drugs are both safe and effectiveThis article explains how they do that - give the drug to many, many people and see if the drug helps them, in comparison with people who didn't get the new drug.

Massive drug studies are extremely expensive; a study may cost as much as $20,000 per patient, takes a long time, and is utterly inapplicable to a custom drug which is made for just one patient.

If a drug is being mixed up just for you, the only way to test it is for you to take it, but suppose you get well?  Did the drug cure you or was it just an accident?  Cancers go into "spontaneous remission" for no reason anyone understands.  Just because you took the drug and got well doesn't mean the drug did it.

Statistics on standard drugs are meaningless to you anyway.  What difference does it make to you that the drug helps 99% of the people who take it?  All you care about is, "Does it help me?" If you're not in the 99%, if you're a statistical outlier and the drug doesn't help you, why take it?

Every time you take a drug, you're an experiment with a sample size of one.  That doesn't bother the FDA, of course, they have their methodology involving huge samples at great expense; if a drug doesn't help you, no skin off their nose.  Following their process means they can approve the drug with a clear conscience.  How can they approve a treatment which is different for each person?

In spite of the minor difficulty that their entire methodology is utterly unsuited to approving one-patient treatments, the FDA permits a few experimental treatments with "custom drugs," but you have to be really in the medical mainstream to get permission to do that; no out-of-the-box thinkers need apply.

Even if you can get permission to do unusual drug tests, there may be another obstacle - the American legal system.

There's a treatment for heart disease that involves drawing significant amounts of your blood, doing custom magic to it, and putting it back in.  Each treatment is quite different because it's highly customized for each patient.

One of my consulting clients works with the innovator who's developing this technology.  My friend wasn't given many details because the inventor hasn't yet filed for patents and has no protection for his intellectual property.  That may or may not matter as we'll see later, but for the moment, the innovator is playing his cards close to his chest.

Given the data this inventor has obtained so far, 2/3 of the patients are cured completely.  This is good, but the other 1/3 of the patients die immediately.  This is not good.

Why would you take a treatment when there's a 1/3 chance you'd die?  If you were convinced that there was a 100% chance you'd die if you didn't get the treatment, taking the treatment would be a no-brainer.  That's the logic the Army used when it forced penicillin on to the market during World War II over the FDA's protests.

Let's assume that everyone who takes the treatment is fully informed and signs a notarized consent agreement drawn up by the finest lawyers in the world.  Why can't the treatment be tested in the US?

We've written how the American legal system has lost all sight of doing justice and has turned into a mechanism for making lawyers rich.  Our courts accept just about any lawsuit, no matter how ridiculous.

Suppose the jury saw a video of the patient saying she was doing it because she was convinced she'd die if she didn't.  Suppose the jury read the agreement where she said she knew she might die.  How would the doctor answer the heir's lawyers saying, "You knew there was a 1/3 chance of my client's mother dying if you injected that mixture into her, yet you did it anyway?  One zillion dollars, please."  John Edwards got rich enough to be able to afford $400 haircuts by suing people and companies for outlandish sums of money on virtually any pretext.

There's no guarantee that any medical release in the world would stand up in court; this treatment has to be tested overseas.

There are always uncertainties in medicine, it's called "medical practice" for a reason.  If you've never taken a particular drug before, nobody knows what will happen when you take it.  It may work for you, it may do nothing, or it may kill you.

How often has your doctor tried a medicine only to switch to another when the first treatment doesn't work?  In this case, "doesn't work" means you die immediately.

This treatment will get safer as the experimenters gather more data, of course, but will it ever be safe enough to be permitted in the US?  Again, you'll probably have to go overseas for this one.

In an example we explored earlier, the inventor of a cancer treatment being tested in China has a piece of the action, but the inventor of this heart disease treatment can't.  Our legal system keeps him from even owning stock.  Let's see why there's simply no way this potential medical genius can profit from his invention.

Lawyers Overseas

On December 3, 1984, a chemical plant owned by the Indian subsidiary of Union Carbide released poison gas into the air; between 3,000 and 20,000 people died.  Many lawyers brought suit against Union Carbide in American courts.  Union Carbide pointed out that

  • their subsidiary which owned the chemical plant was chartered under Indian law, not under American law
  • whatever happened had happened in India, not in the United States, and was therefore not under the jurisdiction of the US courts
  • India had a perfectly workable justice system and US courts had no right to pre-empt whatever might happen in India

The courts agreed; the suits were dismissed.

Since that time, however, US courts have begun to assert jurisdiction over acts of American citizens done overseas which are legal in the countries where they are done but which are illegal under US law.  US law used to stop at the water's edge.  Our courts, egged on by lawyers who want more fees and by environmentalists who want US law to apply everywhere, are beginning to assert jurisdiction over actions taken abroad.

In other words, if you do something overseas which is legal where you do it but isn't legal in the US, you can be sued for damages in the US.

Medical treatment and environmental law are two areas where US law is far more severe than foreign law.  Administering either of the "unsafe" treatments we've talked about is against US law and is therefore illegal in the US.

With today's extended reach of American courts, if an American owns shares in a company that uses this treatment in, say, Mexico, our courts might very well rule that he can be sued in an American court.  American personal injury juries play Santa Claus at the drop of a wet Kleenex; a patient's heirs can come after the owner with a rich law firm paying the legal fees in return for part of the settlement.  No sane entrepreneur would risk financial ruin.

Not only is this treatment being tested overseas to the greater glory of another nation's medical technology, the inventor has no part of the up-side.

We've not only made it impossible for an inventor of a truly revolutionary medical procedure to develop his invention here, we've made it impossible for him to get any benefit from it no matter where he might find a willing environment - that is, as long as he wishes to retain his American citizenship.  Is this any way to encourage the innovations we'll need in order to pay our bills?

Will Offensicht is a staff writer for and an internationally published author by a different name.  Read other articles by Will Offensicht or other articles on Economics.
Reader Comments
Research is continuing and data are being accumulated. 2/3 of the time, the patient grows enough new heart muscle to be OK. The problem with the 1/3 of the patients who die might be that the treatment is not offered until the patient is so close to death that death is practically certain without the treatment.

It takes time to make the appropriate genetic cocktail for each patient and the patient has to have enough energy to grow new muscle. A person sick enough to be offered the treatment at all can get a lot sicker and weaker while the dose cooks. The sicker the patient, the less likely that any treatment will work.

The death rate might go down if patients were offered the treatment a bit earlier, but there are ethical problems with offering such a risky treatment while there is still hope that more conventional treatment might work.

Catch 22 - if the basic problem really is trying to cure people who are too sick to grow new heart muscle, they can't get better statistics without offering the treatment to healthier patients, but they can't offer it to healthier people until the success rate improves.
August 2, 2009 4:16 PM
The Times points out that the ethical quandaries are getting more and more difficult

New Drugs Stir Debate on Basic Rules of Clinical Trials
Two cousins developed the same lethal cancer; only one could take part in an experimental drug trial. Critics say that new science behind the drugs has eclipsed the
old rules, and ethics, of testing them.

One of the cousins says he's benefited from the drug so the other cousin should get it regardless of how the randomized trial worked out. The guys running the trial say that it hasn't yet been proved that the new drug really helps, so the trial should go on until they get a credible answer.

This issue will get messier and messier as we get more drugs whose design is based on individual genetics.
September 19, 2010 12:55 PM
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