The FDA Will Kill Us All*

* with the help of the Trial Lawyers.

[All posts in The FDA Will Kill Us All series are collected in the FDA archives.]

This post is less about the FDA than the entire Medical Treatment Liability Complex which makes Medical innovation more difficult and costly and threatens to destroy the Golden Goose completely by insisting upon a risk-free world.  The Precautionary Principle privileges an illusion of safety over every other consideration and in practice seems to be the animating principle of the litigation industry.

On Sunday the New York Times reported on an escalation of the fight against innovation, although it was certainly not discussed in such terms:

Investors Put Money on Lawsuits to Get Payouts

Large banks, hedge funds and private investors hungry for new and lucrative opportunities are bankrolling other people’s lawsuits, pumping hundreds of millions of dollars into medical malpractice claims, divorce battles and class actions against corporations — all in the hope of sharing in the potential winnings.

The loans are propelling large and prominent cases. Lenders including Counsel Financial, a Buffalo company financed by Citigroup, provided $35 million for the lawsuits brought by ground zero workers that were settled tentatively in June for $712.5 million. The lenders earned about $11 million.

Most investments are in the smaller cases that fill court dockets. Ardec Funding, a New York lender backed by a hedge fund, lent $45,000 in June to a Manhattan lawyer hired by the parents of a baby brain-damaged at birth. The lawyer hired two doctors, a physical therapist and an economist to testify at a July trial. The jury ordered the delivering doctor and hospital to pay the baby $510,000. Ardec is collecting interest at an annual rate of 24 percent, or $900 a month, until the award is paid.

It is a long article and you should read the whole thing to get the full flavor of the level to which modern ambulance chasers have stooped in the pursuit of immense sums of money which they can extract from the system.  I would like to point out that a large meta-analysis many years ago by the esteemed New England Journal of Medicine determined that most incidents of birth trauma which involved significant damage to the infant, in fact had nothing to do with the actual birth trauma but almost certainly had to do with pre-existing problems with the baby that precipitated premature birth or problematic births.  That did not stop people like John Edwards from making millions of dollars representing such damaged individuals and anyone who could object to the lottery winnings of such children and their families would have to have a heart of stone, but the damage to the greater medical system caused by such litigation is profound. 

We need to reorient our approach to risk assessment and tolerance in Health Care to more closely match the reality.  As I pointed out in Obamacare's Faulty Premise:

With the exception of some limited, mature, areas of medicine, all of modern medical practice represents a naturalistic experiment.

We have more proof of this in the news this week:

Docs Reassess Long-Term Use of Osteoporosis Drugs

Doctors are reassessing the long-term use of osteoporosis drugs because of the possible risk of side effects, including jaw necrosis and esophageal cancer, according to an article in the LA Times. The first osteoporosis drugs were launched about 15 years ago and are taken by millions to offset the bone-thinning disease. Doctors are recommending that some patients take a “drug holiday” by stopping their use for a period of time.

This is how Medicine works.  We identify a problem: Osteoporosis leads to premature morbidity and mortality, especially for women.  The much maligned Pharmaceutical industry invents or finds a wonder drug that can  treat Osteoporosis.  The FDA forces the Pharmaceutical industry to spend an average of $1.4 billion to show the drug is "safe and effective"; their findings are typically based on between 1000-3000 people using the drug for less than 3 months duration.  The findings of "safe and effective" are a mirage; $1.4 billion dollars later, we start the actual naturalistic experiment as first thousands and then millions begin to take the drug every day for years at a time.  Anywhere from 1-10 years down the road we discover that some subset of patients, unidentifiable by our current measures, can be severely damaged by the treatment.  Lawyers then sue, occasionally winning lottery settlements for themselves and a few "lucky" patients, many patients unnecessarily stop useful and life prolonging treatments out of fears promoted by the legal and media companies and their Doctors' worries about malpractice, and some patients find drugs that were uniquely valuable become no longer available (Vioxx.)  This is no way to run a health care system than is capable of amazing innovations.

[I don't watch much TV but over the last few weeks I have seen numerous commercials asking for Patients who have been harmed by Avandia or Chantix to contact some lawyers to sue for damages.  My "favorite" commercial was for patients or their families who have suffered Stevens-Johnson Syndrome to contact lawyers to sue for damages.  This is nearly the perfect example of the idiocy of our system.  Stevens-Johnson Syndrome is a very rare but potentially fatal skin reaction to any of a number of drugs.  I have seen one patient in the last 20 years develop Stevens-Johnson Syndrome and it is alarming.  After she failed a trial of an SSRI (Zoloft) I gave her Wellbutrin, an antidepressant that is almost unique in its mode of action and particularly helpful for certain kinds of major depression.  She had an initial excellent response and then over a weekend developed a rash near her mouth which then spread into her mouth; by the end of the weekend she was in the hospital; luckily she recovered uneventfully.  SJS is impossible to predict; there are no known tests for susceptibility, although perhaps soon we will be able to isolate the genetic variants that predispose one to developing the Syndrome.  Nonetheless, people are damaged by a treatment that is life saving for many more.  Now we have lawyers trolling for victims who they can leverage into a large class action suit against the makers of Wellbutrin and its generic offspring.  It will add to the cost of healthcare while doing nothing to increase the "safety and efficacy" of our treatments.]

We need tort reform and for the American people to demand to be treated like adults, capable of making their own risk assessments based on as much of the available data as they desire.  This does not mean that every drug should be available without any safety or efficacy testing; however, the FDA currently operates under the belief that the Precautionary Principle protects us whereas in reality it more often slows innovation and singularly fails to protect us from the rare terrible side effects of our treatments.  The belief that Medicine advances by exponential leaps rather than by incremental steps, underlies the FDA's faith int he Precautionary Principle.  Medicine rarely jumps by exponential leaps; it is rare for a new paradigm to sweep medicine and when new paradigms arise, for all the wonderful good they do, there are some who suffer:

Penicillin revolutionized how we treat life threatening infections yet some people still suffer and die from allergic prophylaxis from Penicillin.

Thorazine revolutionized the treatment of Schizophrenia, yet was eventually found to cause a terrible neurological condition, Tardive Dyskinesia, in as many as 30% of patients with long term use.

Meprobamate was the first effective medication treatment for anxiety yet it, and its offspring, the Benzodiazepines, were found to cause dependency and mental status changes in many who relied upon them long term.

Zyprexa was the first real anti-psychotic that helped with the negative symptoms of Schizophrenia (withdrawal, apathy) and was not dysthymic, yet with long term use as many as 30% who use Zyprexa, while no longer risking Tardive Dyskinesia, are at increased risk of developing Diabetes.

In Medicine when we attempt to manipulate our biochemistry, there is no free lunch.  We do not yet have the fine control of our proteome to pre-determine the best treatment for any particular patient or to guarantee a risk free treatment for any condition.  Let us deal with the reality of risk without the illusion, fostered by the FDA and leveraged by the Tort Bar, that we can live risk-free lives and that all medical care can be risk free.  All we are doing now is rewarding a few parasites and fewer unfortunates while preventing the majority from aging more slowly and gracefully.  It is past time for us to act like, and be treated like, adults.