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.
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.