Patient Self-Diagnosis: An Idea Whose Time Has Come

Peter Huber has a mind-boggling subscription-only piece in Forbes’ July 24 issue that really shouldn’t stay weblocked. It’s about patient self-diagnosis. The technology is here to achieve it, and it could revolutionize medicine as we know it:

The Patient’s Right to Know

Some 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.

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.

….. 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.

Huber then discusses how an HIV-detection kit was developed by drug companies but disallowed for true in-home use (samples are sent to a lab, a step that is technically superfluous), because of fears that people couldn’t handle learning the results in the privacy of their homes. Then he cuts to the nub of the argument, the fault line that divides those of us believe in personal responsibility and those who believe that people have to be coddled and taken care of:

….. 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. ….. 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.

The coming battles over self-diagnosis may be fierce. What if self-diagnosis eliminates the need for half or more of all doctor visits and lab tests? How will the massive bureaucracies known as Medicare, Medicaid, the health-insurance companies, and the nationalized health services in foreign countries deal with self-diagnosis? I fear that the answer is “probably as the FDA has,” with an excess of caution, and a nanny-state mentality that patients aren’t able to handle the truth or its implications.

This would seem to be an ideal opportunity for the “health care as a right” folks to unite with free marketeers to encourage rapid development of and minimal regulatory interference in the private creation of self-diagnostic tests. One interesting issue will be how much patent protection a privately-developed test deserves (or can maintain, even if granted).

When you think about it, there really is no good reason to leave diagnostic ability bottled up the medical-care community.
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UPDATE: There’s also the question of whether our “good friends” at the life insurance companies would insist on administering these “self”-diagnostic tests themselves, or demand that applicants reveal the results of all self-tests as a precondition for issuing a policy.