The Pill: 50 Years of Unintended Bureaucratic Consequences

It gave the FDA far too much power.

The birth control pill was approved on Mothers' Day 50 years ago.  Although there was a great deal of controversy about the pill's effect on morality, sexual behavior, and family structure, nobody seems to have realized at the time that the pill represented a major change in how the government regulated the practice of medicine.  In a recent retrospective, the New York Times reported:

But the pill also led to profound changes in the F.D.A. itself - a revolution in what Dr. Margaret Hamburg, the current food and drug commissioner, calls regulatory science. Many of the steps that underlie modern drug approvals - extensive clinical trials, routine referrals to panels of outside experts, continuing assessments of a medicine's safety, and direct communications between the F.D.A. and patients - were pioneered to deal with evolving concerns about the pill's safety.

The trials for the pill enrolled only 897 women and were far cheaper and faster than drug trials today.  Whether the fact that modern drug trials are so much more expensive and time-consuming represents improved science or is simply a vivid example of bureaucratic bloat is a matter of intense debate.

The pill also represented a new direction in the management of medical treatment:

In regulatory terms, the pill brought about a kind of reformation: just as Martin Luther insisted that individual Christians could communicate directly with God without the mediation of priests, the pill eventually led the F.D.A. to communicate directly with patients without going through doctors.

That change, fiercely resisted by some physician groups, is now firmly entrenched; the F.D.A. now routinely requires that many medicines carry significant and sometimes complex warnings that patients are expected to read and understand. [emphasis added]

It's All About Control

The battle over control of information goes back well before the medieval guilds which tried to monopolize information about their skills.  The Hippocratic Oath, which doctors swore allegiance to in the 5th century BC, says:

All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal[emphasis added]

The urge to keep professional secrets to create barriers to entry, suppress competition, and keep prices high is as old as mankind.  Doctors resented the FDA moving in on their turf, but no more so than other professions.  You can go to jail for practicing law without a license, or cutting hair, or for any number of other activities whose practitioners have lobbied to keep outsiders away from their market.

As millions started taking the pill for long periods of time, women became concerned about blood clots and other dangers from taking such potent drugs even though the pill was far safer than pregnancy and childbirth.  This public demand for more information helped the FDA in its battle with the doctors over who'd control information about drugs.

When the FDA gained the right to specify what information drug manufacturers had to provide to patients, control of information simply moved from one self-centered group to another and patients gained little if anything.  If the FDA were really concerned about benefiting patients, they'd force hospitals and other medical providers to publicize their records of successful and unsuccessful medical treatments so patients would have more information when selecting medical providers.

The case of Wyeth Pharmacy v Levine makes it clear that the FDA is more concerned with its power over information than with patient protection.  Wyeth wanted to make warnings against misuse stronger but the FDA wouldn't let them, saying that the label was strong enough.

Sure enough, a hospital misused the drug.  The victim sued the hospital and Wyeth, claiming that the label wasn't explicit enough.  The fact that Wyeth could prove that they'd tried to make the label stronger was no defense - the jury decided that Wyeth had to pay.

Other Effects

As the FDA gained control over information flow, businesses found it practical to either lobby the FDA or sue to win the right to advertise their products directly to consumers.  Patients often come to doctors with their minds made up; a doctor who won't prescribe what patients want tends to lose customers.  It's one thing for patients to be involved in making decisions about health care, it's another matter when they take control based on advertising.

Giving patients information also helped destroy antibiotics as effective tools to fight infection.  When we were in the kid biz, we'd talk to our doctors about current issues.  Our pediatricians told us of having to prescribe antibiotics to kids with colds or flu.  The pills wouldn't help at all, but unless they prescribed, mothers went elsewhere.  This not only wasted a great deal of money, overuse selected for bacteria which weren't killed, which led to many antibiotics becoming virtually useless.

The most invidious effect of the government taking control of medicine was making the medical system more susceptible to lobbying.  As the federal government got more and more involved in funding highway construction, for example, politicians found they could exact campaign contributions in return for directing money at highways which benefited specific contributors.  It's no surprise that lobbying gets more intense as government gets more involved in health - the more money government controls, the better lobbying pays.

Killing People with Regulation

Except for eventually destroying our economy, over-regulation might not be so bad if all it cost us was money, but regulation is going to start killing more and more people.  Popular Mechanics, whose readers venture into snake habitat more often than most of us, reports that the government has banned the only medicine which helps people survive coral snake bites.  Coral snakes aren't particularly aggressive - only about 100 Americans are bitten each year - but anyone who encounters coral snake venom is in trouble.

But the effects begin to show within hours, with symptoms such as tingling sensations in the extremities, dysarthria (slurred speech) and ptosis (droopy eyelids). Then a victim's lungs shut down. "The venom acts as a neuromuscular blockade to the lungs," University of Florida professor of medicine Craig Kitchens says. "Without antivenom, you need artificial respiration or you die." [emphasis added]

The only coral snake anti-venom on the market is made by Wyeth, the same Wyeth who wanted to strengthen their warning label but was prevented by the FDA.  Their anti-venom drug was approved in 1967.  Wyeth kept making it for nearly 40 years, but it was never a big seller, and the legal climate is such that keeping it on the market risks getting sued.

Wyeth shut down their venom plant in 2003. The remaining anti-venom expires this year, appropriately, on Oct. 31, All Hallow's Eve, after which it will be illegal to use it even to save someone who's about to die.

There's a Mexican anti-venom which seems to be even more effective than the retiring Wyeth drug.  Even under accelerated procedures, it would cost $3 to $5 million to get the drug approved in the US though it's been used safely in Mexico for years.  At 100 doses sold per year, how long would it take for the manufacturer to get back $5 million?

Without an anti-venom, coral snake victims will have to be kept on ventilators for weeks or months as the venom wears off, just as polio victims were kept alive in "iron lungs."  It would be cheaper to fly them to Mexico to receive treatment there, but what ailing patient is going to want to do that?

The true irony is that the birth control pill, which introduced the first real clinical trials of effectiveness, was tested in Haiti and Puerto Rico.  Even back then, the American legal system had developed to the point that it was risky to test pregnancy-related drugs in the US.  Should anything go wrong with a child born to a woman who'd taken the new pill, American juries would go into Santa Claus mode; foreign courts were much more predictable.  Back then, the FDA was willing to accept test results when the pill was tested in other countries, but they won't accept snake bite tests from Mexico today.

Unintended Consequences

The advent of the pill has been lauded for giving women more influence over their fertility, but it also reduced doctors' control of medicine while giving the FDA a great deal more influence over American medicine.  Doctors have at least a marginal interest in curing people so they'll come back again; the FDA has shown over and over that they have no concern whatsoever for patient welfare.

On balance, the advent of the pill itself is probably a net positive, but the power granted the FDA thereby has done a lot more harm than good.  At least you can sue a doctor; you can't sue the FDA.

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 Bureaucracy.
Reader Comments
Has anyone tried to sue the FDA? First person to die of a coral snake bite perhaps?
May 20, 2010 12:48 PM
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