The Patient's Right to KnowSome years ago the Food & Drug Administration concluded that a grown woman can handle learning that she's pregnant all by herself. She may therefore buy a pregnancy detection dipstick from a pharmacy without a prescription. But the agency won't let her buy a dipstick that reports whether she's infected with HIV. That news must come from a doctor or approved counselor, in person or by phone.
July 24, 2006
This can't be right, and it can't last. Diagnostic technology is on a collision course with the FDA.
A dipstick (or something much like one) is coming to diagnose just about anything: infectious disease, disease caused by your own cells gone haywire or the threat of disease caused by imperfect genes. Want to know what's lurking inside your own body? There will be a cheap, simple and completely private way to find out. A drop or swab of urine, blood, saliva or mucus will supply the answer. No doctor, nurse or lab technician will be needed.
The pregnancy kit detects a specific protein—the hormone that choreographs pregnancy. Proteins and nucleic acids define pretty much all the biochemistry of life. Every person—and every disease—leaves behind unique biochemical fingerprints. The FBI uses them to track thugs, medical labs to track bugs.
In the last 30 years we have mastered the chemistry of these two families of life–defining molecules. The discovery of the key chemical protocols earned three Nobel Prizes—in medicine (1978 and 1984) and chemistry (1993). For almost any protein or nucleic acid of interest, we now know how to build an exact antiprotein or antiacid that interacts very specifically with its twin. It's also quite easy to graft on a more colorful chemical or two, so that when the protein antibody gloms onto the protein body the gray dipstick turns blue.
The chemistry is as sensitive, discriminating and reliable as a bloodhound's nose. And it is—or soon will be—at the point where we can mass–produce it, put it on a stick and detect—at a few dollars a dip—the infinitesimal traces of whatever may be eating you.
If the FDA will allow it. Drug companies developed an inexpensive, five–minute HIV test kit very soon after the cluster of symptoms called AIDS was traced to a new infectious virus. But home testing was vigorously opposed by the American Medical Association, the Centers for Disease Control & Prevention and the gay community. The FDA eventually licensed a "home collection" kit, which required mailing a pinpricked blood sample to a laboratory and then phoning in for results and counseling, but it stopped there. It was viewed as essential that HIV–positive patients be properly advised about what to do next. Some might be distressed to the point of suicide. Some might not grasp that positive test results are sometimes wrong. The public interest was also invoked—the uncounseled, it was said, might not know how to avoid infecting others.
Will similar things be said about home test kits for gonorrhea? Prostate cancer? The genetic defect that causes cystic fibrosis? Now ask yourself: Why should you have to wait for the FDA to decide whether you can be trusted to learn about such things outside a doctor's office? It is easy to accept that many drugs are too dangerous to be administered without expert supervision. But diagnosis is just communication. In your own home, at least, you have more right to leer at (or couple with) the body of a stranger than to interrogate your own. The doctor–patient relationship hinges on informed consent, but the FDA says only a doctor may do some of the informing.
Americans put a high premium on privacy. Legal scholars and Supreme Court justices have disagreed whether a broad right to privacy is implied by Fourth Amendment language that prohibits unreasonable "search or seizure" of "persons, houses, papers, and effects." However broad or narrow that right may be, it ought to protect your right to dip a stick at least as fully as it protects your right to consult a doctor.
Some people treasure privacy too much even to talk to a doctor. Or they may simply lack perfect faith in the what–happens–in–Vegas–stays–in–Vegas promises that doctors make. The IRS, the Veterans Administration and financial institutions make such promises, too, but sometimes forget the laptop in the taxi. A used dipstick, by contrast, can be flushed straight down the toilet. If the Constitution protects privacy at all, it ought to protect the go–it–alone privacy of a dipstick at least as much as show–and–tell privacy in an office.
Peter Huber is a senior fellow of the Manhattan Institute and coauthor of The Bottomless Well (Basic Books, January 2005).