FDA-approved Lawsuit Preemption

By Darrel Crain, D.C.

Everyone seems to be picking on the poor Food and Drug Administration (FDA) these days, but for vastly different reasons. To the hundreds of thousands of victims (including dead ones) of adverse prescription drug reactions each year, and their families, the FDA is failing to protect the public. These people believe the agency should spend more time and effort making sure drugs are safe and effective before approval. Meanwhile, the pharmaceutical companies feel the FDA is a nuisance, way too fussy about drug safety details and terribly slow with approval. This, they say, deprives consumers of the latest drugs, not to mention delaying company profits.

Drug companies have long insisted that going to all the trouble and expense of obtaining FDA approval for their drugs and medical devices should entitle them to complete immunity from all product liability lawsuits. In other words, if FDA-approved drugs destroy your health or kill a loved one, get over it.

A few years ago Dr. Allen Roses, an executive vice president with drug maker GlaxoSmithKline admitted in an interview that prescription drugs are irrelevant to the health of most people, most of the time. “The vast majority of drugs – more than 90 per cent – only work in 30 or 50 percent of the people,” he said.

A much different story is relentlessly beaten into the minds of the public every day by aggressive, multi-billion-dollar-a-year drug marketing. That story tells us that every human illness is a drug deficiency disease that can only be “cured” by taking the latest drug every single day for the rest of one”s life.

Pills Purple and Orange PillsImagine if those billions were instead spent on a massive public education campaign teaching the two basic, unchanging principles of human life and health: 1) Lifestyle and environmental factors account for the vast majority of health disorders, and 2) For most people the body is perfectly capable of healing itself when underlying nutritional deficiencies are corrected, toxins are cleared and lifestyle improved. But I digress.

President Bush has long pushed for preemption of lawsuits for drug companies, arguing that the expert doctors at the FDA are the only people in the country smart enough to understand these complicated matters, and the courts should not try and second-guess the all-wise FDA.

Gee, did someone forget to tell the president that the experts over at the FDA have already given notice that the agency is completely incompetent? The FDA’s science board spent a year studying problems at the agency, and concluded that a lack of resources and personnel “is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.”

The new protocol for public safety seems pretty obvious: Avoid taking anything approved by the FDA.

As if things weren”t bad enough already, the U.S. Supreme Court is poised to rule in favor of drug-maker Wyeth in a case that will likely usher in total preemption of lawsuits for all products approved by the FDA.

Johnson and Johnson is only one of the drug giants salivating at the enormous windfall in store once the courtroom doors are locked to drug-injured parties. J&J lawyers are already using the preemption argument to defend the company from 3,000 women suing for serious health problems caused by its birth control patch. Injuries to women who have used the patch include heart attacks, strokes and at least 40 deaths.

One scientist within Johnson and Johnson urged the company to conduct a formal evidence-based review following FDA approval because of “an abnormally high number of ‘spontaneous cases’ of clotting disorders, as well as death,” associated with the patch. The company never performed such a study.

To its credit, Johnson and Johnson does admit that initial drug safety data on the patch was altered using a “correction factor.” This is another way of saying “we made up the numbers.” But J&J lawyers swear this kind of monkey business is normal and standard procedure for safety trials, and I believe them.

Apparently it has also become normal to delete negative drug reactions from safety reports submitted to the FDA, and lie about who wrote the reports, as we discovered with the Vioxx debacle. Since the FDA does not carry out drug safety research itself, its decisions are based on whatever selective and biased reporting the companies decide to hand in.

Before being pulled from the market, Merck & Company’s drug Vioxx, a pain medication described as no more effective than over-the-counter pain relievers, caused more than 100,000 heart attacks and at least 50,000 deaths in the United States, according to senior FDA researcher Dr. David Graham. The public did not learn details about Merck”s massive data doctoring until forced to open up its cooked books in courtroom proceedings.

Even when lawsuits force some companies to come clean on their dirty secrets, we must remember that the gold standard of clinical science itself, the placebo-controlled randomized trial, has been downgraded to a fool’s gold standard. Over recent decades, drug companies have “streamlined” standard clinical procedures to improve chances for FDA approval.

Randomization of patient selection has been replaced with “run-up” and “pre-trial adjustment” periods, in which test subjects are removed from the study whose responses make placebos look too good or the drug too toxic. This prevents the data from being “skewed” by real-world responses.

Many of today’s placebos are also fakes, doctored with chemicals that mimic the side effects caused by the drug being tested. Obviously, if the “placebo” causes adverse reactions similar to the tested drug, the drug looks much better.

In modern vaccine trials, so-called placebos can contain toxic chemical cocktails that are part of the tested vaccine, including aluminum. The adverse reactions people have to such neurotoxins are then counted as placebo responses.

As any first year student of science can tell you, a scientifically valid clinical trial demands the use of a control group receiving a placebo with zero active ingredients, without exception.

In any other industry, these kinds of creative “improvements” to established scientific protocol would be called “cheating.” Drug companies have their own word for drug safety trials that violate basic rules of science, “profitable.”

Lawsuits have traditionally served as the only check and balance available to shore up the shortcomings of the FDA. As things stand, if preemption wins the day and lawsuits are forbidden, the drug companies will be free to get away with murder more than ever because they will never be forced to disclose exactly how the numbers were fudged or what data was withheld to gain approval.

While preemption is a spiffy idea for the drug companies, it is grossly unfair to the rest of us and violates the constitutional right of citizens to due process of law. Perhaps there is another, more equitable strategy to pull us out of the regulatory quagmire at the FDA.

What about leaving it up to the free market? As Thomas Jefferson once pointed out, “It is error alone which needs the support of government. Truth can stand by itself.”

An absolutely free, unfettered, lassieze-faire market may be the most suitable solution for the business of making and selling prescription drugs. Why not completely dismantle the entire regulatory process of the FDA? What good are lengthy and expensive drug safety trials when they get falsified in the end anyway?

Dispense with the corrupt approval process and the money saved from the trials can be reallocated to pay for courtroom expenses and settlements. This is the kind of feedback that forces companies to make safer products.

Let the pharmaceutical companies quit their whining and swallow their own bitter pill of legal accountability. Let every drug company large or small concoct whatever chemical drug it wants to, advertise whatever miraculous benefits sound good, and then leave it to the marketplace to decide what really works, what harms and what kills.

If a company profits from a drug that turns human liver to a quivering glob of goo, or kills a few hundred or a few thousand people, that company deserves to be righteously sued in a court of law. Directors at the top of any company selling deadly goods should be held criminally liable for damages. Why should dangerous and deadly medical products be treated differently than dangerous and deadly tires, toasters, tainted food, or anything else?

To the drug lords hiding in the boardrooms of the pharmaceutical houses, I say if you are afraid to stand up for the integrity of your products and face your victims in the courtroom, then switch to the pesticide business where chemicals for sale are fully intended to cause death and disability.

The time has come to unleash the free market on the pharmaceutical industry and leave it to the invisible hand of supply and demand to sort things out. But first let’s make sure we preserve the time-honored tradition of due process in a court of law for those consumers harmed by bad goods.

planetc1.com-news @ 8:40 pm | Article ID: 1209094879