by Daniel Lurker

After a string of deformed babies were born as a result of their mothers receiving the drug Thalidomide (which was prescribed primarily for morning sickness) the Food and Drug Administration began über-regulation of prescription drugs in response to public outcry. Over the years, this precedent has led to countless more death and injuries from life saving drugs being withheld from the market by the seemingly public spirited FDA.

"Lurker, you’re crazy" you say, "The FDA cares about me and you know it! We all know that the FDA saves lives and protects people from harmful side effects of drugs" I’ll be the first to admit that some drugs can have serious, sometimes life threatening side effects. I have personally had some very violent reactions to approved drugs, but those were risks I was willing to take, and should be able to take.

Let’s partake in a brief thought experiment; you have stage four pancreatic cancer. You’ve tried everything, and are making plans for your funeral after reading the less-than-promising two year median actuarial survival rate of zero (according to the Oncology Department of Johns Hopkins). You will die, but there’s a promising experimental new drug you read about online, if you are one of the lucky few resourceful and creative enough to find out that it even exists.

You ask your doctor about it, and ask if he can give you this drug. Your doctor replies "I can’t give it to you." You tell him that you understand it might be shady but you won’t report him to the state medical people. He replies "No, I’m not talking about my license, I’m talking about prison." If he has an M.A. in economics like my physician, he might even wax poetic about how stupid the law is, and how it’s pretty sad that you’re going to die at the hands of the State. If he really cares, he might tell you to go to Europe (one of the few areas where European regulation seems to be less harmful) or some other country in spite of the personal risks. Regardless, you’ll walk away from the office without the drug that might save your life.

"But the drug could kill someone" you exclaim because this has been drilled into your head since high school civics. You might also note that not every proposed drug treats ailments as serious as cancer. Take a breath and think deeply about these claims. If you had a sore throat, would you beg your doctor to do you the pleasure of removing your tonsils as a first step, or would you maybe take a Sucret? If you felt slightly depressed, would you beg your physician for a referral to a psychiatrist who would lock you up and give you as much Thorazine and Haldol as possible, and be quick about it? If you had a suspicious but likely benign lesion in your breast, would you say "lop ‘em off, that’ll take care of it no matter what". Of course, the answer to all of these questions is a strong "no". People seek progressively aggressive treatment for their ills. Sometimes, what we know is safe doesn’t work, and people are willing to face serious risks. There’s no reason to stop them from taking them – it is bad enough to face the risk of death, having the State wink at the Grim Reaper is sickening.

Thalidomide is now showing promise not only in the treatment of leprosy, but also in treating AIDS. The drug is now distributed through a stringent network of specially trained and approved doctors and pharmacists, and includes a warning label that reads in part

IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [1 CAPSULE (50 mg)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY CAN CAUSE SEVERE BIRTH DEFECTS.

There is no reason to think that pharmacists, doctors, and drug manufacturers wouldn’t voluntarily provide such a warning to avoid legal action, or comply with some mandated industry standard. The consumer would be able to chose, and I trust the choices that they make would be well informed. One could have a rating system, administered privately, that would feature warnings and a numerical or color ratings appropriate to the severity of sickness, and maybe even a list of drugs one might try before taking a marginally more substantial risk.

Some of these services already exist for other categories of items. Consumers Union offers advice on items ranging from condoms to automobiles to shoes in its well known publication "Consumer Reports". Underwriters Laboratory requires products it certifies, such as electrical devices and fire suppression equipment to meet certain standards for the privelage of using the UL mark.

The United States Pharmocopia even provides a systematic digest of information on drugs for use by health care professionals. Some of this information is gathered from in-house research, and research by USP and similar organizations could easily be reformatted towards consumers if government would resist the temptation to regulate in such a devastating way. Although it is impossible to say for sure exactly how information might be provided on a drug we need only realize that the private sector can offer contributions if they were allowed the freedom to help people through innovation.

I did, however see my grandmother die of a stroke at the age of seven back in 1992, a stroke that I now understand could have likely been prevented or treated with a then new generation of Beta Blockers. Beta Blockers that the FDA took almost ten years to approve, and then had the audacity to claim with great pomp that they ad saved 250,000 lives a year. You do the math- 2.5 million died at the hands of the state. That’s forty six times the number of causalities from the Korean War. At least their deaths were recognized– I dare any of my readers to find a memorial to victims of the FDA.

For a more damning indictment of the Food and Drug Administration, readers are encouraged to visit www.fdareview.org. The page is run by George Mason University’s Dr. Alex Tabarrok, who also serves as research director for the Independent Institute.