Alternatives to drug screening

Jacob Sullum | November 2002 Print Edition

In the 1980s, when everyone was talking about the dangers posed by addicts in the workplace, Lewis Maltby was executive vice president and general counsel of Drexelbrook Engineering, a Pennsylvania company that designs and manufactures control systems for toxic chemicals. “This company makes a product that, if it doesn’t work properly, could cause a Bhopal in the United States,” says Maltby, now president of the National Workrights Institute. “Almost every job in the company is safety-sensitive.”

Not surprisingly, Drexelbrook considered drug testing. Maltby, long active with the American Civil Liberties Union, was leery of the idea, but he could not deny that the company needed to make sure that its products were assembled properly. Ultimately, he says, “we decided that drug testing was a red herring. The real issue was building an organization that inherently produces quality and reliability.”

That meant paying careful attention to every step of the process, including recruitment, hiring, training, supervision, and quality assurance. “We had a very systematic, company-wide program to make sure that everything we did was right,” Maltby says. “If we had drug testing, it just would have been a distraction from the real business of safety.”

Maltby’s experience at Drexelbrook convinced him that drug testing was not the right answer even for employers with serious safety concerns. As an alternative, he has tried to promote impairment testing. Unlike urinalysis, which detects traces of drugs long after their effects have worn off, impairment testing is aimed at assessing an employee’s current fitness for duty. The idea is to identify employees who are not up to snuff, whether the cause is illegal drugs, alcohol, medication, illness, personal troubles, or inadequate sleep.

Several different systems are currently available, including an electronic shape recognition test and a device that measures the eye’s response to light. But Maltby was able to identify only 18 employers that have ever used such systems, and he suspects the total is not more than 25.

One reason impairment testing has never caught on is its lack of a track record, which poses something of a Catch-22. Although it seems to address safety concerns more directly than urinalysis does, employers are not inclined to adopt a new technology without solid evidence that it works — unless, like drug testing, it has the government’s stamp of approval. That factor is especially important for federally regulated industries such as aviation and trucking, where employers who adopted impairment testing would still have to do drug tests.

Impairment testing also could raise new problems for employers, workers, and unions. “The information that impairment testing provides is the information that employers most need, but employers wouldn’t know what to do with it,” Maltby argues. “Running any kind of a business, you know 5 percent of your employees are showing up not really on the ball every day: sick kids, colds, divorces, death in the family, drugs, alcohol, hangovers. Figuring out what to do about 5 percent of your employees being unfit to work every day is a monumental challenge.”

Michael Walsh, a Maryland-based drug testing consultant, calls impairment testing “sort of a holy grail.” It’s a sound idea in theory, he says, but “I haven’t seen a good one that is usable….I have never seen any data that would convince a general audience of scientists that this is the way to go.” But then, the same could be said of drug testing.

Pharmaceutical freedom in an outpost of tyranny.

Kerry Howley | August/September 2005 Print Edition

Weeks before leaving for a year-long stint in Burma during the fall of 2003, I listened as a New York City travel doctor rattled off a list of sinister-sounding ailments. There was malaria to worry about; also typhoid, tetanus, tuberculosis, yellow fever, and something called Japanese encephalitis, not to mention the risk of rabies from wild monkeys. Eyes averted, I accepted vaccinations for no less than five diseases. I did no research, asked no questions, winced, and forked over $900.

Had she supplied vaccines for food poisoning, ear infections, and a dozen mystery illnesses I suffered while abroad, the story might end there. But living in a far-off country generally forces you to engage with its health care system, and Burma was no different. I was in a Rangoon doctor’s office within a week of my arrival, asking for pharmaceuticals by name and being met with a blank stare from a Burmese physician.

It wasn’t the language barrier. The doctor didn’t understand what I was doing in his clinic. Because Burma has no prescription requirements, I didn’t need his consent to self-medicate; I should have been at the supermarket asking for Cipro, an antibiotic, rather than wasting his time as others waited.

Freedoms are in short supply in Burma, a country run by a hardened military, yet the freedom to treat a bout of food poisoning with pharmaceuticals was new to me. The United States is the only country in the world that divides drugs into two rigid categories of prescription-only and over-the-counter. Most other developed nations allow for a third class of drugs to be dispensed by a pharmacist, and developing nations typically do not have prescription requirements or fail to enforce them.

My expatriate friends and I readily partook of Burma’s open medicine cabinet, and in the process our relationship to health care changed dramatically. Our local grocery store stocked an array of antimalarial medications (prescription only, stateside), and the visible surfeit of options prompted us to question the recommendations of our Western and Burmese physicians. Why this one and not that? This one gives you nightmares; this one shreds your liver; this one causes nausea. Our doctors, with rosters of other patients and ailments to consider, could hardly have made the informed and personalized decisions we made with the benefit of their help. Nor would they have been more cautious than we, who had most to lose from an overdose or misdiagnosis.

The simple privilege of looking over our pharmaceutical options was revolutionary, but more so was the sense that our relationship to doctors had shifted from paternalism to partnership. We bookended every doctor’s visit with our own research, Googled and re-Googled our symptoms, weighed differing opinions from Western and Burmese physicians. As the months wore on, we grew more confident of our ability to navigate our Asian maladies but continued to seek doctors–as consultants, not demigods –for advice.

In virtually all respects, Burma’s health care system is not one to emulate. (I have an enduring memory of watching a stray dog lick blood off an emergency room floor.) But in the U.S., a country where self-care is often regarded with suspicion–the result of misplaced faith in crackpot herbal remedies, perhaps, or just manipulative marketing–it’s worth noting that access to pharmaceuticals is not a prescription for social chaos. A doctor’s advice is a valuable resource, but nothing encourages passivity like an overzealous, though quite possibly underinformed, gatekeeper.

As it turns out, most of the vaccinations I’d received in New York were unnecessary, the result of either ignorance or over-caution on the part of my physician. Had I had less faith in my doctor’s expertise, I would have realized that a woman with a safe city job needn’t worry about Japanese encephalitis, yellow fever, or even rabid monkeys. “Men mistake medicine for magic,” the psychiatric critic Thomas Szasz has said, and it follows that we mistake doctors for magicians. If we were allowed to perform the tricks ourselves, we wouldn’t be so easily fooled.

Prescription laws make us sicker and poorer.

Kerry Howley | August/September 2005 Print Edition

At a time when blockbuster drugs are revolutionizing the treatment of high cholesterol, Janice Alston can feel the first effects of heart disease creeping up on her. The 51-year-old resident of North Carolina says a common drug called Zetia would help her fight the cholesterol clogging her arteries. But as an uninsured, low-income home care professional, Alston isn’t willing to pay for the doctor’s visit and associated tests it would take to get the prescription.

With a history of hospitalization for heart disease, she knows she is taking a risk by avoiding the clinic, and as a licensed nurse’s assistant, she feels confident she can assess and treat her own symptoms. If the drug were available over the counter, she says, she would buy it.

“It’s just not worth it to me right now,” she says, listing the barriers–from taking time off from work to paying full price for a doctor’s visit– between her and the drug she’d like to take.

Alston is one of 90 million Americans suffering from high cholesterol. Six months ago, a cholesterol-lowering drug called Mevacor was set to be reclassified as an over-the-counter medicine, a move that would have made the drug physically and financially available to people like Alston. Mevacor, made by Merck, is a statin–a class of drugs so safe, with benefits so clear, that doctors joke about putting them in the water supply. Only about 13 million Americans are currently taking statins, but federal guidelines suggest 23 million more should be on a similar regime.

Hoping to encourage more widespread use, the United Kingdom dropped the prescription requirement for Zocor, another Merck statin, in 2004. But Merck has had no such luck on this side of the Atlantic.

Last January a Food and Drug Administration (FDA) advisory panel considered a proposal to put Mevacor within easier reach. As they had during previous hearings in 2000, members of the committee fretted that patients would muck up dosages, lose track of cholesterol levels, and make poor decisions about diet and exercise if popping a pill appeared to produce the same results as a healthy lifestyle. One of only three doctors who voted to put the drug over the counter–David Schade, a professor at the University of New Mexico Department of Internal Medicine–based his vote on lack of access for the uninsured. “I vote yes for the overriding reason that there are millions of Americans in this country with no health insurance and absolutely no access to a statin except, of course, to fly to Britain,” he said. “I think that these people deserve the right to lower their risk and prevent cardiovascular disease.”

Despite Schade’s opposition, the panel voted 20-3 to keep the drug’s prescription-only status. By keeping statins locked within the burdensome and, for some, inaccessible health care system, the decision dampened hopes that statins could find wider use among the millions of Americans who ought to be taking them. For the time being, access to these lifesaving drugs depends on the tiny percentage of the population legally empowered to dole them out.

Statins are not the only class of safe drugs still under lock and key. Medical information is available to more people than ever before, and Americans are buying more drugs and making more-sophisticated choices about their health. Yet access to everything from insulin to Viagra still requires a day off from work and a trip to the doctor’s office. For Americans growing more knowledgeable about the specifics of self-care, the prescription regime presents a significant and sometimes insurmountable barrier.

Faced with a growing conflict between the FDA’s excessive caution and patients’ eagerness to self-medicate, doctors have started to call for a different system–most notably, for “behind the counter” status, an approach that puts pharmacists between patients and drugs. But this downgrading of gatekeepers fails to address other issues keeping drugs out of reach. Only a system geared toward making drugs available over the counter automatically, whether directly after FDA approval or after a predetermined trial period, will ensure that patients’ treatment is determined by their interests, not those of government or industry.
Deputies and Spoilsmen

It was not always the case that a panel of 23 doctors could deny drugs to millions of potential consumers. Prior to 1938, Americans were free to obtain nonnarcotic drugs without a physician’s blessing. As the MIT economist Peter Temin recounted in a 1983 study published by the Journal of Health Economics, prescriptions were simply a practical way for doctors to communicate with pharmacists. It was not until a scandal prompted consumer safety legislation that prescriptions became a requirement rather than a convenience.

In 1937 an established pharmaceutical company, Massengill, killed 107 people by hawking a drug dissolved in anti-freeze as a flu treatment. Congress responded by passing the Food, Drug, and Cosmetic Act of 1938–legislation that would vest the relatively new FDA with far more power than it previously had. The act was meant not to restrict access but to better inform consumers through labeling requirements. FDA head W.G. Campbell reassured the Senate committee pondering the bill: “There is no issue, as I have told you previously, from the standpoint of the enforcement of the Food and Drugs Act about self-medication. This bill does not contemplate its prevention at all.” The House report on the bill reiterated that it was “not intended to restrict in any way the availability of drugs for medication” and was meant to “make self-medication safer and more effective.”

The law required that manufacturers label drugs with directions and warnings, but the FDA could excuse drugs from the requirements in cases where labeling was “not necessary for the protection of public health.” Rather than restrict this exemption to the most harmless drugs, the FDA exempted drugs labeled “prescription only” from label requirements. Further, the FDA insisted that manufacturers not provide clear labeling on these drugs. The new regulations stipulated that “All representations or suggestions contained in the labeling [must] appear only in such medical terms as are unlikely to be understood by the ordinary individual.” (Emphasis added.)

Abstruse labeling was intended to keep consumers safely in the dark, forcing them to consult doctors before ingesting anything labeled “prescription only.” Where Congress had apparently intended to empower consumers, the FDA sought to deprive them of information. The regulation was enshrined into law in 1951 as the Humphrey-Durham Amendments, which officially created a second class of drugs and brought about the modern prescription drug regime. As economists Daniel Klein and Alexander Tabarrok state in FDA Review, their Web site recounting the history of the agency, “Licensed doctors…became deputies and spoilsmen in the growing system of controls.”
Prescriptions, Patents, and Profits

Fifty years later, the prescription system is almost universally accepted as a policy vital to the protection of public health. The system is justified by the assumption that consumers can’t possibly know enough about powerful drugs to treat themselves safety and effectively, that they need to be monitored for progress, and that they need to be warned about potentially lethal drug interactions.

Yet a cursory look at the lists of drugs still requiring prescriptions and those available over the counter belies the notion that drugs are so classified based purely on safety concerns. Acetaminophen causes thousands of cases of liver damage every year yet is available over the counter; the birth control pill, for no conceivable medical reason, is not. Claritin, Schering-Plough’s popular antihistamine, has been over the counter for years; Clarinex, a virtually identical drug from the same maker, is prescription-only. Statins, remarkably safe by any standard, require a prescription, while patches packed with nicotine line drugstore shelves.

The system that puts drugs over the counter is driven by profits and patents. Patents–legal monopolies–exist to drive innovation in the drug industry. In order to protect the intellectual property packed in every pill, pharmaceutical companies are granted exclusivity for 20 years from the date they file for a patent. In an industry where the next big thing typically costs between $300 million and $500 million to deliver, patents help keep companies afloat. But as long as there’s no competition, drug companies have no incentive to put their products over the counter.

“Merck would never have even considered switching Mevacor before the patent ran out,” explains Joshua Cohen, a senior research fellow at the Tufts Center for the Study of Drug Development. “They want to ride the wave of that monopoly as long as they can.”

Due to the complexities of patents and health insurance, pharmaceutical companies often find it in their best interest to restrict access to their products. Keeping drugs prescription-only masks costs within the cloak of the insurance system, allowing drug makers to set prices based on what insurance companies, not individuals, will bear. Patients with health insurance, shielded by coverage for doctor’s visits and prescription drugs, never see the total bill for their medications, and prices are rarely a factor in their decisions.

Once a patent runs out, however, the situation changes, and the FDA–not the self-interest of the pharmaceutical company–becomes the major hurdle to going over the counter. With a patent expiration looming, pharmaceutical companies can profit from a switch to over-the-counter status by regaining control of the market before generic makers jump in and gobble market share. They then must appeal to the FDA for permission to take their drugs to consumers.

While only 10 percent of health care costs derive from prescription drugs, the potential savings from over-the-counter switches are huge. When Claritin went over the counter in 2002, the price for a year’s supply plummeted from $1,066 to $365. The cost was still more than the direct price most patients with drug coverage paid when a prescription was required, but the switch made the drug available to people who otherwise could not afford it, especially given the cost of a doctor’s visit. Furthermore, wiping out unnecessary doctor’s visits, eliminating the paperwork involved with unnecessary prescriptions, and putting drug prices in front of consumers, thereby forcing them to be cost-conscious, lowers overall health care costs and ultimately reduces insurance premiums. A 1997 study by Kline & Company, a market research firm, found that American consumers saved almost $13 billion a year by using over-the-counter medicines switched from prescription-only status. In his 1983 study, MIT economist Peter Temin found that doctor visits for the common cold fell by 110,000 a year between 1976 and 1989 as the FDA switched cough and cold medicines to over-the-counter status.
Locked Out

The prescription system is inefficient at every turn, but its costs weigh on no one harder than the 24 percent of Americans without drug coverage. In addition to paying full price for doctors’ visits, those without health insurance are most exposed to the dramatic difference in price between over-the-counter and prescription drugs. The full retail price for Mevacor is about $800 per year. Patients with insurance that includes drug coverage don’t see the full price, usually paying only a nominal fee. Nor do insurance companies, who receive huge rebates from manufacturers in exchange for buying in bulk. Sky-high prices are a problem for the 15 percent of Americans who lack health insurance and the 9 percent who are insured without drug coverage.

According to a 2001 survey by the Washington, D.C.-based Center for Studying Health System Change (HSC), about 23 million American adults–12 percent of the adult population–had to forgo at least one prescription medication because of cost concerns that year. Kenneth Thorpe, chair of the Department of Health Policy and Management at Emory University, says the system is especially hard on those with chronic conditions. “We know patients with cancer who don’t have insurance use far fewer prescription drugs than those who do,” he says. “It’s plausible that if the drugs were cheaper and over the counter, they would use them.”

As the system stands today, drugs for chronic conditions, such as insulin and statins, are almost universally prescription-only. Over-the-counter drugs are typically intended for less serious, more easily diagnosable ailments, such as allergies or headaches. “We live in an age where more people are living with chronic conditions, and the uninsured just have a ton more hurdles that they have to get over to get the care they need,” says Alwyn Cassil, spokesperson for the HSC.

Back in 1998, WellPoint Health Networks, a California-based HMO, got tired of paying inflated prices for Claritin. The HMO filed an unprecedented “citizen’s petition” with the FDA to force the drug into over-the-counter status, in a move that could have saved the health care system $2 billion. Schering-Plough had been touting the safety of Claritin for years; the company’s ads explicitly state that the side effects are those of a sugar pill. Robert Seidman, WellPoint’s chief pharmaceutical officer, reasoned, “If they’re marketing these like candy, then they should be sold like candy.”

Schering-Plough countered by claiming that over-the-counter Claritin would be a “major health risk.” In a New York Times report, a company spokesman earnestly chastised WellPoint for “trivializing the importance of the patient-physician relationship.”

An FDA advisory committee agreed with WellPoint, voting 19-4 that nonsedating antihistamines like Claritin, Aventis SA’s Allegra, and Pfizer’s Zyrtec were sufficiently safe and effective for over-the-counter consumption. The safety issue was thus off the table, but legal issues remained. WellPoint insisted that the FDA was legally required to convert the drug to over-the-counter status. Schering-Plough’s attorneys argued that drug companies possess a property right in a drug’s approval and forcing the switch would violate that right.

Stuck between the interests of pharmaceutical companies and insurers, the FDA did nothing for four years. It was Schering-Plough that ultimately brought Claritin over the counter as its patent expiration neared, but not until the company had exhausted every avenue trying to extend the duration of its monopoly. The Hatch-Waxman Act, passed in 1984, gave Claritin two more years of exclusivity past the original expiration date of 1998. An addendum to the 1994 GATT treaty tacked on another 22 months. The FDA added six more months when Schering-Plough agreed to conduct pediatric trials of the drug. Between 1996 and 2002, Schering-Plough attempted a half dozen dilatory legislative tactics. But in 2002 the game was up. Schering-Plough, suddenly less concerned about the “major health risks” it had cited earlier, asked the FDA to make Claritin an over-the-counter drug.
No Risks, Please–We’re Bureaucrats

While patent expiration encourages pharmaceutical companies to bring drugs to a wider audience, a risk-averse FDA has little to gain from loosening the chains. Once it’s ready to ask for over-the-counter status, a drug maker must prove that its medication meets three criteria: The indicated condition can be self-diagnosed, the drug must be safe for use without a doctor’s supervision, and the label must convey proper usage to consumers. Each test hinges on how intelligent the FDA deems consumers to be. To judge from some recent decisions, it thinks we’re pretty dense.

The FDA’s hearings on statins demonstrate how the agency weighs factors far removed from the side effects of a drug itself. Alistair Wood, an associate dean at Vanderbilt University School of Medicine who chaired the hearings, says his fellow panelists were unsure that consumers could be trusted to identify and treat high cholesterol levels. “The issue for many on the committee was that they weren’t sure you could articulate the potential benefit to consumers well enough for them to make an informed choice,” he reports. “I thought that was a bit paternalistic, frankly.”

The statin hearings were rife with contempt for consumers. The committee discussion veered from a study of the risks and benefits of Mevacor to the question of whether Americans were responsible enough to follow directions. A number of doctors fretted that over-the-counter statins would turn even more Americans into trans-fat-scarfing, exercise-eschewing gluttons. Frank Davidoff, a member of the advisory committee, echoed many of the other panelists when he predicted, “There may very, very well be people in the general public who begin to use over-the-counter statins who, in fact, would feel that this was a magic pill and they wouldn’t have to continue to diet and exercise.”

Statements like these obscure the life-saving potential of drugs like statins. According to David Silverman, a Harvard-educated cardiologist at the University of Connecticut, the drugs have set new standards for health in middle-aged Americans. “We’re talking about the thing that kills more people than any other disease in America,” he says. “We’re talking about millions of lives saved.”

The FDA’s turn from safety organization to morals watchdog is especially disturbing to women’s health groups, which have been waiting for emergency contraception to be made available without a prescription for years. Barr Pharmaceuticals’ Plan B, a nonabortifacient morning-after pill, has been languishing in FDA limbo since 2003, despite the absence of any credible safety concerns. In December of that year, an FDA advisory committee recommended the drug as safe and effective enough to go over the counter. Forty-nine Republicans sent a letter to President Bush opposing the switch, based on the presumption that it would encourage promiscuity in young women. The FDA then announced it would delay putting the drug over the counter indefinitely.

The battle over emergency contraception has energized powerful lobbies, including Planned Parenthood and the National Organization for Women, and has led Sen. Hillary Clinton (D-N.Y.) to provoke a battle over the nomination of President Bush’s pick for FDA head. Yet Plan B is just a high dose of the birth control pill, which has been prescription-only in America for more than 40 years. According to a 2004 survey by the Pharmacy Access Partnership, an advocacy group working to make contraception more accessible, one in five women report that the cost of a doctor’s visit has been an obstacle to obtaining a prescription contraceptive.
A Third Way?

Drugs like Mevacor and Plan B have prompted many to ask whether America needs an option somewhere between the extremes of prescription-only and over-the-counter status. Canada, the U.K., and many European countries offer “behind the counter” options, which require patients to approach pharmacists before getting certain drugs. Statins are distributed in the U.K. this way; in France, emergency contraception is. Several panelists in the FDA statin hearings said they wouldn’t vote for over-the-counter access but would happily go for a behind-the-counter option if one were available.

The FDA has said it doesn’t have the authority to christen a third class of drugs. That would require congressional action, and right now there is little impetus for such legislation in the face of certain opposition from retailers such as Wal-Mart, which would object to being kept from dispensing drugs available at pharmacies. But to some extent, states are creating a de facto third class of drugs by extending limited prescribing rights to pharmacists. Alaska, California, Hawaii, Maine, New Mexico, and Washington currently offer emergency contraception behind the counter, and similar bills are pending in several other states.

In the absence of any evidence that behind-the-counter screening increases consumer caution, some doctors see this option as little more than a way to make skittish regulators more comfortable with the transition to over-the-counter status. In 1995, when the General Accounting Office (GAO) weighed the possible benefits of a third class of drugs, it found no evidence that such a regime increases consumer safety.

State rules for emergency contraception are a way of skirting restrictive federal laws, but they’re far from perfect; some pharmacists have roused the ire of women’s groups by refusing to fill prescriptions on moral grounds. And while the behind-the-counter trend seems to be moving toward easier access, it can also lurch backward. In January Sens. Dianne Feinstein (D-Calif.) and Jim Talent (R-Mo.) introduced a bill that would put Sudafed and other cold and allergy remedies containing pseudoephedrine behind the counter and require pharmacists to keep a log book of purchasers to combat the production of methamphetamine. Oklahoma, Illinois, and Iowa already have laws restricting the sale of such medicines, and similar legislation is pending in 20 states across the South and Southwest.

A behind-the-counter option won’t address the fact that it’s generally not in drug manufacturers’ interests to increase access to their products as long as patents are in force. Were insurance companies and advocacy groups permitted to force a switch for drugs that meet FDA criteria for over-the-counter medications, far more hard-to-get drugs might be lining pharmacy shelves. But that’s a thorny issue the FDA doesn’t want to address. “It’s not clear whether that’s legal,” explains David Hilfiker, a project manager at the FDA’s over-the-counter drugs division.

FDA spokesperson Kathleen Quinn says a decision is pending, but Hilfiker says he knows of no decision-making body currently trying to clarify the issue. Without a definitive answer, the situation remains static.

An alternate system would automatically switch a drug once it’s become an accepted part of the health care system. University of Chicago economist Sam Peltzman has suggested that there be a “rebuttable presumption” that any drug that has been prescribed 100 million times should go over the counter. Drugs like antibiotics–for which there are valid concerns that overuse would threaten public health–might stay prescription-only, but most heavily used drugs would be freely available after a defined period.

To ease fears at the FDA, pharmacists have suggested a “transition class” in which drugs would be sold behind the counter for a predetermined period of time and later granted full nonprescription status. There is some precedent for this in the Australian state of Victoria, where officials watch for adverse effects while drugs are sold only in pharmacies and then consider whether to shift a drug to full nonprescription status. But drugs tend to get stuck in the transition class. According to the GAO report, there is no extant prescription regime in which a transition class facilitates a timely jump to nonprescription status.
Power to the Consumers

For individuals in the throes of chronic illness to couples looking to energize their sex lives, self-care is an increasingly popular option. American consumers have voiced their desire for more options by supporting a $15 billion industry in over-the-counter meds, responding strongly to direct-to-consumer drug ads, and encouraging a robust generic drug industry.

“People are asking for more prescription drugs by name, and buying more over the counter,” says Tamu Johnson, an analyst with marketing research group Mintel International. “People are becoming more confident about their ability to treat themselves.”

Yet lifesaving and lifestyle drugs trickle onto pharmacy shelves remarkably slowly. The last switch was made in 2003, when the heartburn treatment Prilosec went over the counter. Since then only two drugs have been proposed for the switch, and both were rejected. Until Americans demand more say in what drugs they can buy and where they can buy them, they’ll be forced to pay more, get less, and restrict notions of self-care to a few medicines that the pharmaceutical industry and the FDA let fall from their grip.

FDA regulations force companies to wait four years before reapplying for over-the-counter status, so Mevacor will be available only by prescription until at least 2008. Meanwhile, the country is saddled with a massive cholesterol problem.

“There is clear evidence that [statins] are effective in lowering cholesterol, clear evidence that they are effective in lowering the risk of heart disease, and there is clear evidence that large numbers of people right now are not taking the drugs who appropriately should be taking these drugs,” explains Wood, who chaired the FDA panel that rejected Mevacor but dissented from the majority opinion. “Lowering the population’s cholesterol by just a little bit produces a huge public health advantage.”

For Janice Alston, the uninsured nurse’s assistant, the barriers to medication aren’t about public health advantages or macroeconomic efficiency; they’re about a lack of control over her medical care, and a system, purportedly in her interest, that places barriers between her and lifesaving medication.

“I’m just waiting until the time comes when I can afford the medicine I need,” she says.

Facing a system fraught with its own afflictions, the wait may be a long one.

Doggie-style Fourth Amendment.

Julian Sanchez | July 2004 Print Edition

In an upcoming case, Illinois v. Caballes, the Supreme Court will decide whether the use of a drug dog to conduct a suspicionless search passes the smell test.

On November 12, 1998, Illinois State Police Trooper Dan Gillete stopped Roy Caballes for driving six miles per hour over the speed limit. When Gillete radioed in the routine traffic stop, fellow officer Craig Graham volunteered to come by with a drug-sniffing dog. The pooch found a hefty stash of marijuana in the trunk. Caballes tried to have the pot suppressed as evidence because, despite the officers’ testimony that Caballes had appeared “nervous,” the dog was brought in without “reasonable articulable suspicion” that the car contained drugs. While the trial judge allowed the evidence, the Illinois Supreme Court reversed.

In 1983 the U.S. Supreme Court ruled that a canine sniff “does not constitute a ‘search’ within the meaning of the Fourth Amendment,” on the grounds that dog sniffing doesn’t require a physical intrusion into a subject’s possession and (unlike, say, wiretapping) doesn’t involve the exposure of incidental information — it only reveals the presence or absence of contraband. Under that doctrine, so long as the officers did not unduly prolong an otherwise legitimate stop, a drug dog search might not be expected to trigger any additional scrutiny at all. But the Illinois court held that “calling in a canine unit unjustifiably broadened the scope of an otherwise routine traffic stop into a drug investigation.”

If the Supreme Court accepts that reasoning when it hears the case in the fall, it could bolster the beleaguered Fourth Amendment rights of motorists, long a casualty of the war on drugs.

Jacob Sullum | June 5, 2002

“Court OKs Use of Religious Pot on Federal Lands,” announced the headline in the San Francisco Chronicle. The article clarified that it’s the religion of the pot smoker, not the pot itself, that matters. “If you’re a Rastafarian who considers marijuana holy,” the Chronicle reported, “it’s legal to light up in Guam–and maybe in any national park on the West Coast.”

Before they rush to reserve campsites at Yosemite, Rastafarians should take a closer look at the decision the Chronicle was talking about. In People of Guam v. Benny Toves Guerrero, the U.S. Court of Appeals for the 9th Circuit actually rejected a Rastafarian’s claim that the federal Religious Freedom Restoration Act (RFRA) protected him from prosecution for bringing marijuana into Guam.

Guerrero (who goes by the Rastafarian name Iyah Ben Makahna) was arrested at the Guam International Airport with five ounces of pot and 10 grams of marijuana seeds. At his trial, he successfully argued that his prosecution violated RFRA, which says a law that substantially burdens the free exercise of religion is invalid unless the government shows that it is the least restrictive means of serving a compelling state interest.

Until 1990, that was the standard the U.S. Supreme Court applied to laws that impinge on religious freedom. That year, in a case involving peyote use by members of the Native American Church, the Court held that such laws do not violate the First Amendment as long as they impose “neutral rules of general applicability.” RFRA, which Congress passed in 1993, was intended to restore the stricter “compelling interest” test.

Although the Supreme Court ruled in 1997 that Congress did not have the authority to impose this standard on the states, it did not address the law’s operation in federal territories such as Guam or on federal lands such as national parks. In Guerrero, the 9th Circuit ruled that RFRA does apply in the “federal realm.”

But the court concluded that Guam’s law against importing marijuana does not “substantially burden” the religious practices of Rastafarians, since they can smoke their sacramental herb without bringing it into the territory (presumably by growing their own or buying it locally). Hence the court never addressed the issue of whether the law meets the “compelling interest” test. In finding that it did not, the Supreme Court of Guam had noted simply that “no evidence on this score was presented.”

Why the Protect America Act Is a Bad Idea

Tim Lee | February 7, 2008

In his State of the Union address, President Bush pressed Congress to quickly pass legislation to make permanent the sweeping spying powers that Congress granted last August. Those powers, which include the ability to eavesdrop on foreign-to-domestic communications without meaningful judicial oversight, were due to expire later this week. Congress passed a two-week extension of the law on Tuesday, but that barely gives Congress time to catch its breath before the White House resumes its campaign to make it permanent.

The lone virtue of the Protect America Act is that the powers it granted are now set to expire in mid-February. As this revised deadline approaches, Speaker Nancy Pelosi and Majority Leader Harry Reid will once again face pressure to rush the White House’s preferred legislation out the door. The president will claim that failure to act before the Protect America Act sunsets will undermine the government’s ability to eavesdrop on terrorists.

It’s an ominous claim, but it’s not true. The Protect America Act allows the administration to “authorize” eavesdropping programs for a year at a time. That means that the government’s various warrantless surveillance activities will continue to operate at least through August. And of course, if the need for new wiretaps arises after the act sunsets, the administration still has the opportunity to file for warrants under the Foreign Intelligence Surveillance Act (FISA). FISA even allows the government to begin surveillance first and apply for an emergency warrant after the fact.

Bush’s predecessor was also an ardent supporter of increased wiretapping authority. For example, on July 29, 1996, Bill Clinton unveiled a proposal to expand government surveillance by permitting the use of “roving wiretaps.” The nation was still reeling from terrorist attacks on the Atlanta Olympics and American barracks in Saudi Arabia, and many suspected that the explosion of TWA Flight 800 was also the work of terrorists. Clinton argued that these tragedies highlighted the need for legislative changes, and he pressed Congress to act before its August recess.

But Congress had a bipartisan tradition of its own to defend. As they had done since Watergate, Congressional leaders raised concerns about civil liberties. Then-Speaker Newt Gingrich said he was willing to consider changes to the law, but vowed to do so “in a methodical way that preserves our freedoms.” Senate Majority Leader Trent Lott vowed that Congress would not “rush to a final judgment” before going on vacation. In the end, the 104th Congress finished its term without giving President Clinton the wiretapping authority he sought.

Today’s Democratic Congress has been far less protective of Americans’ privacy rights. Last August, in a virtual repeat of the events of 1996, Bush demanded that Congress approve expanded wiretapping powers before going on vacation. This time, Congressional leaders showed few qualms about “rushing to judgment.” Indeed, both houses of Congress approved the White House’s preferred legislation with minimal changes within three days of its introduction.

Why are today’s Democrats less concerned with civil liberties than Republicans were a decade ago? Democratic leaders would doubtless point to the 9/11 attacks. Those attacks have certainly contributed to a changed political climate, but they don’t justify Congress’s panicky reaction to the president’s demands. Congress had already expanded eavesdropping powers several times since 9/11. Congress approved new wiretapping authority with the Patriot Act in 2001, and approved further expansions later in 2001 and in 2002, 2004, and 2006. If the new powers the president was seeking weren’t urgent enough to include in those revisions to the law, it’s hard to believe they were an emergency in August 2007.

Moreover, the powers Congress granted last summer are far broader those sought by the Clinton administration in 1996. The “roving wiretaps” Clinton requested in 1996 and finally received in 1998 merely allowed investigators to obtain a single warrant to bug multiple phones used by a specific individual. In contrast, the Protect America Act completely eliminates the warrant requirement for surveillance “concerning persons reasonably believed to be outside of the United States”—even if one party to a call is an American citizen and the wiretap occurs on American soil. The attorney general is required to disclose to a secret court the general procedures used to choose wiretapping targets, but no judge reviews the list of specific targets to verify that the law is being followed. This evisceration of judicial review is an invitation to future abuses.

In short, the administration will have ample authority to intercept terrorist communications for at least the next six months. As they shepherd FISA reform through Congress, Pelosi and Reid would do well to heed the advice of one of Pelosi’s predecessors: “The goal here is not to allow the terrorists to pressure us into suspending the very freedoms that make America precious.” Those words are as true today as when Newt Gingrich said them in 1996.

Timothy B. Lee is an adjunct scholar at the Cato Institute.

The Bush administration’s ever-shifting story about the need for new surveillance powers

Jacob Sullum | February 6, 2008

Last August, panicked at the prospect of an imminent terrorist attack that could be averted only by granting the executive branch new surveillance powers, Congress passed the Protect America Act. With the law scheduled to expire this month, the Bush administration is trying to scare Congress into making the powers permanent.

The alleged crisis is an artificial one created by a president who waited until last summer to seek congressional approval for the illegal surveillance his administration conducted after 9/11. Bush took his time, and so should Congress.

After The New York Times revealed, in December 2005, that the National Security Agency had been eavesdropping on international communications involving people in the U.S. without the warrants required by the Foreign Intelligence Surveillance Act (FISA), the Bush administration insisted the program was perfectly legal. The Justice Department claimed Congress (apparently without realizing it) had implicitly amended FISA when it authorized the use of military force against Al Qaeda and its Taliban allies in Afghanistan.

At the same time, then-Attorney General Alberto Gonzales said the White House had not asked Congress to change FISA because Congress probably would have said no. That explanation was inconsistent not only with the claim that Congress already had legalized the surveillance program but also with the fact that Congress had amended FISA in other ways by passing the PATRIOT Act in October 2001. If any doubt remained that Congress would have been receptive to the administration’s request for further FISA amendments, it was dispelled by the hasty passage of the Protect America Act.

Even at this late date, it’s not clear why FISA needs to be amended. The administration said it violated the law for years because it could not conduct the surveillance necessary to prevent terrorist attacks while complying with FISA’s warrant requirements. But in January 2007, Gonzales suddenly announced that the irresolvable conflict somehow had been resolved and that all anti-terrorist surveillance thenceforth would be conducted in compliance with FISA.

A few months later, what had been impossible and then briefly possible became impossible again, supposedly because of a secret ruling by the Foreign Intelligence Surveillance Court. Acccording to the administration, a judge on the court interpreted FISA as requiring a warrant for surveillance of foreign-to-foreign communications that happen to pass through U.S. wires.

“International communications are on a wire, so all of a sudden we were in a position because of the wording in the law that we had to have a warrant to do that,” Director of National Intelligence Mike McConnell told the El Paso Times in August. “If it were wireless, we would not be required to get a warrant….My argument was that the intelligence community should not be restricted when we are conducting foreign surveillance against a foreigner in a foreign country, just by dint of the fact that it happened to touch a wire.”

It’s hard to see how a judge could have interpreted FISA this way. But even if one did, the administration has never explained why this decision (which it inexplicably did not appeal) required Congress to authorize warrantless surveillance of communications that not only traverse U.S. wires but involve people in the United States.

Instead the administration has obscured the breadth of the powers granted by the Protect America Act. In the El Paso Times interview, McConnell falsely asserted that the communications at issue are “all foreign to foreign.”

The administration has contradicted itself even on the question of how urgently needed the FISA changes are. Last summer they were so crucial to national security that McConnell claimed pausing to debate the issue meant “some Americans are going to die.” More recently, Bush has threatened to let these absolutely essential powers lapse by vetoing extension bills that do not meet his specifications.

An administration that cannot tell a consistent story in public about why it needs new extrajudicial surveillance powers cannot be trusted to exercise those powers in secret.

Techno-optimistic environmentalists still stuck with old-fashioned, top-down thinking.

Ronald Bailey | February 5, 2008

In November, I commended techno-optimistic environmentalists Michael Shellenberger and Ted Nordhaus for pointing out the intellectual exhaustion of traditional ideological environmentalism. Shellenberger and Nordhaus outlined their scathing critique of special-interest environmentalism in their new book, Break Through: From the Death of Environmentalism to the Politics of Possibility (2007). They pointed out that environmentalism’s doomsday predictions and limits-to-growth policy recommendations are political dead ends.

In a world in which billions of people remain mired in poverty and lack access to modern sources of energy, a positive environmental program stressing technological innovation and economic growth is far more politically viable. However, Shellenberger and Nordhaus argue that the threat of potentially catastrophic man-made climate change can only be addressed by massive government research and development initiatives that aim to create low-carbon energy supplies. How massive? To the tune of $300 billion per year over the next 10 years.

Now in a new New Republic article Shellenberger and Nordhaus are calling out “conservatives” for not supporting such initiatives. They note:

At the libertarian reason magazine, Ronald Bailey endorsed our critique of nature-centered environmentalism–which sees regulation as the best solution–but then concluded, “Shellenberger’s and Nordhaus’ naïve trust in wise government bureaucrats guiding technological innovation is problematic, to say the least.” For conservatives to be taken seriously, they’ll need to ditch their knee-jerk opposition to government intervention in the economy and recognize that government has long played a critical role in investing in transformational technologies.

Conservative? No. Opposition, yes. Knee-jerk, hardly. What transformational technologies do Shellenberger and Nordhaus claim that the federal government has brought about? They point to the railways in the 19th century, the Manhattan Project during World War II, the Interstate highway system in 20th century, the Apollo moon shots, and the Internet. Most of the technologies they cite were subsidized by government for military reasons, not for reasons of technological or commercial development, much less out of concern for the environment.

In 1862, Congress justified passing the Pacific Railroad Act as a way to forestall a secessionist movement in California during the Civil War. The government subsidized the Union Pacific and Central Pacific railroads at $16,000 per mile over an easy grade and up to $48,000 in the mountains. In addition, the government offered substantial land grants along the right-of-way. Despite these government subsidies, both companies were bankrupt in the early 1870s.

As an example of how government subsidies distort incentives, both railroad construction crews worked past each other building an extra 200 miles of parallel rail lines grades (and some parallel tracks) instead of linking up so their companies could earn more subsidy payments and land grants. The fact that government subsidies were not necessary for building a transcontinental railroad was proved when James J. Hill built the highly profitable Great Northern Railway from Minnesota to Seattle completely without them or land grants.

The Manhattan Project was launched because President Franklin Roosevelt feared that the Nazis were developing their own atomic weaponry. The project was a great success in developing the technologies needed to produce atomic bombs. In the 1950s, President Dwight Eisenhower promoted the “Atoms for Peace” program which aimed to develop civilian uses for nuclear technologies. Under the Power Demonstration Reactor Program, private/public partnerships to build power-generating nuclear reactors began. In 1957, the first nuclear large-scale power reactor began operation at Shippingport, Pa. Two years later, the first nuclear power station built completely without government funding was fired up in Illinois. Today, 109 nuclear power plants produce about 16 percent of all the electricity used in the United States. On the other hand, no new nuclear power plants have been ordered in the last 30 years. Since 1972, orders for 117 nuclear plants have been cancelled. The growth of nuclear power stopped because of regulation, not technical issues. It may yet turn out to be a great commercial success and part of the answer to abating greenhouse gas emissions, but only if regulatory issues are resolved.

Even the Interstate highway system was justified on national defense grounds. As a young military officer, Eisenhower had led an army convoy of 300 men from Washington, D.C. to the West Coast in 1919. The convoy took 62 days to cross the country. He was also impressed by the German Autobahn system. So in 1956, Eisenhower championed the National Interstate and Defense Highways Act. The Interstate highway system was originally estimated to take 12 years and cost $25 billion to construct. It actually took 35 years and cost $114 billion (over $800 billion in current dollars). Building the Interstate system remains the largest public works project ever undertaken in the United States. By most accounts, Interstate highways lowered transportation costs and boosted American productivity. On the other hand, subsidizing highway construction doesn’t seem to be a good analogy to subsidizing energy research and development.

The motivation behind the Apollo moon shot program was largely geopolitical. The Soviets had launched the first artificial satellite in 1957 and orbited the first man around the planet in 1961. As a NASA history explains, “First, and probably most important, the Apollo program was successful in accomplishing the political goals for which it had been created. Kennedy had been dealing with a Cold War crisis in 1961 brought on by several separate factors—the Soviet orbiting of Yuri Gagarin and the disastrous Bay of Pigs invasion only two of them—that Apollo was designed to combat.” The Apollo program cost $25.4 billion (about $150 billion in current dollars) to land just 12 astronauts on the moon. It is curious that Shellenberger and Nordhaus cite the Apollo program as an example of transformative technologies since it was basically a technological dead end.

Shellenberger and Nordhaus argue, “The fact that some past public investments in energy failed is no more an argument against public investment than the failure of private firms to deliver cheap, clean energy is an argument against markets. It is true that government has made some lousy investments—but it has also made remarkable ones.” In fact, with the possible exception of nuclear power, just where are the “remarkable” government-financed energy production breakthroughs? Consider the case of the Synfuels Corporation, which was authorized to spend up to $88 billion dollars on developing energy sources as alternatives to imported oil. It was supposed to be an energy “Manhattan Project” that would produce the equivalent to 500,000 barrels of oil by 1987. Instead, Congress shut it down in 1986. And that’s not to mention one failed public/private partnership after another that were supposed to produce automobiles that run on something besides refined petroleum. Just last week, the Bush Administration pulled the plug on its flagship FutureGen demonstration project for capturing and burying carbon dioxide produced by coal-fired electric power plants.

Shellenberger and Nordhaus of course cite the Defense Advanced Research Projects Agency’s (DARPA) famous support for communications technology network research that evolved into the Internet. The ARPANET was established as a way to link the defense research community. In the 1980s, the National Science Foundation funded the NSFNET as a way to increase the linkage among a broader community of scholars. The Internet evolved into an open research and commercial environment. That wasn’t the way some technosavants preferred things 20 years ago. Remember the Minitel? Minitels were videotext terminals distributed by the millions by the French national telephone company. “The Minitel craze is one case where government intervention, frequently derided as an obstacle to economic change, seems to have helped technological innovation,” declared the Washington Post in December, 1986. By 1992, there were 6 million Minitel terminals offering 1,800 information sources. However, the bottom-up Internet handily beat the top-down Minitel. I suspect that the new government-financed energy research would result in technologies more like Minitel and less like the Internet.

Shellenberger and Nordhaus’s techno-optimistic environmentalism is still shackled by old style top-down thinking when it comes to technological development. Energy production, especially electricity generation, is one of the least technologically innovative industrial sectors, not least because it is one of the most heavily regulated sectors. The way forward is to encourage bottom up distributed creativity, not top down bureaucratic management. To give them their due, Shellenberger and Nordhaus recognize that throwing government money at energy research and development does not guarantee success. “To be sure, many of these technologies will fail,” they write. “But any venture capitalist will tell you that multiple failures are required to reap a single success, and that you can’t win if you don’t play.” The problem with Manhattan or Apollo Projects is that they were “silver bullet” programs aimed at a single technically difficult goal. The problem of developing low-carbon energy is a far more diffuse problem.

Since the problem is diffuse, a far better strategy would be to encourage venture capitalists and other entrepreneurs to finance new low-carbon energy development, rather than a centralized top-down crash research program directed by Department of Energy bureaucrats. One promising technique is to offer substantial prizes for energy production or utilization breakthroughs. A private example of how such prizes might work is the $10 million Automotive X Prize, which aims to promote the development of production-ready vehicles that get 100 miles per gallon of gas. One can imagine big government-financed prizes for various clean energy technologies such as long-lasting powerful rechargeable batteries, super-efficient solar power systems, or bacteria that eat sewage and excrete gasoline. However, the more narrowly the goal of a prize is defined, the more it will constrain the ingenuity of future innovators. In other words, bureaucrats could so narrowly define prizes that they would be engaging in top-down research management by other means.

Shellenberger and Nordhaus are absolutely right in a major way: People simply will not accept limits to growth. So the question is how best to harness human creativity to address the problem of man-made global warming? The simplest and best way to encourage the development of low-carbon energy technologies is to set a price on carbon emissions. Thousands of inventors and entrepreneurs would then have a huge incentive to develop cheap low-carbon energy technologies. The history of government-financed research and development, especially in the area of energy production, is not at all promising. Although Shellenberger and Nordhaus dismiss setting a price on carbon emissions as “a tired old trope,” it’s a lot less tired than yet another call for a “new Manhattan Project.” What’s next, an energy policy that’s the “moral equivalent of war”?

Ronald Bailey is reason’s science correspondent. His most recent book, Liberation Biology: The Scientific and Moral Case for the Biotech Revolution, is available from Prometheus Books.

Lately, Barack Obama has been quoting John F. Kennedy: “The world is changing. The old ways will not do.” For a few hours the other day, I was starting to think he really meant it.

On Thursday, The Washington Times reported that in 2004, as a candidate for the U.S. Senate, Obama came out for decriminalizing marijuana use. That usually means eliminating jail sentences and arrest records for anyone caught with a small amount for personal use, treating it more like a traffic offense than a violent crime. But in a show of hands at a debate last fall, he indicated that he opposed the idea.

When confronted on the issue by the Times, however, the senator defended his original ground. His campaign said he has “always” supported decriminalization.

It’s a brave position, and therefore exceedingly rare among practicing politicians. Which may be why it didn’t last. Before the day was over, the Obama campaign issued a statement saying he thinks “we are sending far too many first-time non-violent drug users to prison for very long periods of time” but “does not believe that we should treat offenses involving marijuana with a simple fine or just by confiscating the drug.” Recently, he had told a New Hampshire newspaper, “I’m not in favor of decriminalization.”

This episode reveals that as a candidate, Obama is more fond of bold rhetoric than bold policies. But it also proves the impossibility of talking sense on the subject of illicit drugs during a political campaign. That course of action would mean admitting the inadmissible: that the prohibition of cannabis has been cruel, wasteful and fraudulent.

Cruel because it leads to the arrest of nearly 700,000 people a year for mere possession of a substance that is comparatively benign. Wasteful because it expends billions of dollars in police, court and correctional resources that could be deployed against dangerous predators. Fraudulent because it hasn’t solved anything: According to the federal government, nearly 100 million Americans have tried the stuff.

But in the political realm, a strangely disjointed view of drugs prevails. Past use is forgivable. Both George W. Bush and Bill Clinton admitted to smoking marijuana, as did Al Gore and John Kerry. Obama has admitted doing the same.

At the same time, no major party presidential nominee has advocated decriminalization (much less legalization) since Jimmy Carter did so in 1976. It would be considered political suicide. So we are now in a bizarre position: A candidate who spent his college days flouting our marijuana laws can be elected president, but an abstemious, button-downed candidate who proposes to change those laws has no hope.

Had we enforced our statutes more vigorously, of course, Bush, Clinton and the others would never have been elected anything, because they would be ex-convicts. Yet Bush, Clinton and the others were happy to put people behind bars for crimes they themselves committed.

One alternative to that approach is decriminalization, which is not exactly radical or untried. It’s already the norm in 12 different states—not just California and New York, but Mississippi, Ohio and Nebraska. About one of every three Americans lives in a state or city where pot users typically don’t go to jail.

Despite this lenient approach, Omaha and Cincinnati still would never be mistaken for Jamaica. One thing we know is that criminal penalties have little if any effect on the number of stoners. States that have decriminalized cannabis are largely indistinguishable from states that have not. A 1999 report by the National Academy of Sciences found “little evidence that decriminalization of marijuana use necessarily leads to a substantial increase in marijuana use.” In 2003, Boston University economist Jeffrey Miron surveyed the available data from here and abroad and agreed: “Existing evidence provides no indication that marijuana decriminalization causes increased marijuana use.”

This discovery should not be surprising. Cigarettes and beer are both legally available, but smoking and drinking have been declining for years. Freedom is not incompatible with enlightened self-restraint. In fact, it seems to foster it.

Politicians normally can’t say such things. But near the end of his administration, Bill Clinton confided to Rolling Stone magazine that he thought marijuana should be decriminalized. Maybe eight years from now, Obama will do likewise.

COPYRIGHT 2008 CREATORS SYNDICATE, INC.

Why honest people might run from a national ID card

Kerry Howley | February 1, 2008

When our sad pack of presidential candidates look you in the eye and tell you they can unite a divided America, believe them. The one thing each of them knows how to do—present the citizenry with unworkable, invasive, underfunded mandates—is the one sure way to bring together bizarre masses of humanity.Take the REAL ID Act, the sputtering effort to unite Americans under a common banner of department of motor vehicle regulations and porous databases. In common purpose, it has united the Amish, gun owners, and advocates for victims of domestic abuse, all of whom want to see it killed.

Though severely hobbled by a state-level revolt, REAL ID is set to enter its first phase in May, when states that have not applied for extensions will be required to comply with new requirements for issuing licenses. Amish groups and other religiously sensitive groups suggest that REAL ID portends the mark of the beast, and those who receive it will be thrown into eternal abyss. Appealing as it is to view REAL ID author Rep. James Sensenbrenner (R-Wis.) as an agent of Satan, it is probably the victims of domestic abuse who provide the best case study in the plan’s overreach. Organizations such as the National Network to End Domestic Violence contend that stores of half-guarded data would empower stalkers, violent exes, and obsessive abusers hunting for information. Abuse survivors are living repudiations of the assumption that only criminals need seek the comforts of anonymity.

But try telling that to the Department of Homeland Security. “Any state or territory that does not comply,” bellowed senior DHS official Richard C. Barth during Congressional testimony, “increases the risk of the rest of the nation.” This is easy to swallow if your chief conception of danger involves foreign evildoers bent on random slaughter of unidentified victims. It’s less so for women who fear actual human beings with whom they may share a history.

DMVs and local governments have always been vulnerable data dumps where a stalker with a good story could potentially score an address. But DMVs were at least limited in scope; you could move from your small town where your abuser knew a guy who knew a police officer who could demand confidential information to another state with another system. The REAL ID Act would interlink all of them, so an irresponsible or incompetent official in Arkansas could track a target in Missouri. “A data breach at one DMV will be a data breach in all of them,” says Guilherme Roschke of the Electronic Privacy Information Center.

DHS regulations also demand that a “residence of principal address” be printed on the cards in a machine-readable format, which presents an obvious danger to women trying to hide said residences. More recently, DHS conceded that women enrolled in state confidentiality programs can claim an exemption. According to Jill Morris of the Pennsylvania Coalition Against Rape, that’s not enough. Few women are actually enrolled in these programs, which sometimes require participants to provide verification of abuse such as police reports or restraining orders. “There are millions of women who won’t call the police,” says Morris. “And police can be abusers too.”

There are other loose ends that leave abuse victims hanging. One way women escape their histories is changing names and having the court record sealed. This will be more risky with REAL ID in that the history of the name change may be present in the various databases. The record threatens to stymie the task of starting over and erasing the past.

Proponents of REAL ID counter that we’re already living in an age of free information, a nationalized ID system being just a single droplet in the waves of revealing data washing over all of us all the time. But the wave itself is blessedly easy to get lost in, which is, after all, part of what scared our solons into passing REAL ID in 2005. The same technology that brings you the exhibitionism of Twitter-addicted teens is also a powerful force for anonymity. Women trying to avoid detection have benefited from the ability to pay bills online, to contact help undetected, to engage with the world from behind a veil of pixels.

The REAL ID concept poses myriad civil liberties issues, and survivors of domestic abuse pose a small–and perhaps surmountable–problem in a much larger debate over national idenfication. But their predicament lays bare the hubris of a government that thinks itself so completely just, so perfectly coordinated, that no honest person ever needs to hide. DHS officials may claim that no one can be secure so long as anyone remains off the grid, but they risk destroying the lives of people for whom the only real security remains anonymity itself.

Kerry Howley is a senior editor of reason.