You might think that under the circumstances, the government would be pouring enormous resources into evaluating the hows and whys of prescription drug fatalities, but it is not. Industry-supported reforms have provided the FDA major resources to focus on the approval of new drugs, but once these drugs are out in the market, the picture changes dramatically. The group that keeps track of whether these drugs are hurting the people who are taking them is one of the agency’s weakest stepchildren. It has limited clout within the FDA. It scrapes by on between $10 and $15 million a year—less than what Eli Lilly was estimated to spend on its 1997 Prozac ad campaign according to The New York Times. It relies on voluntary and unreliable reporting by doctors for most of its information. In the words of Carol Scheman, an FDA deputy commissioner in the 1990s, the nation’s system for keeping track of the bad effects of prescription drugs is “appallingly bad.”
That’s particularly lousy news when you consider the speed at which new drugs are being approved and the remarkably aggressive, almost reckless, promotional efforts that go into making them sell. Consider that six new drugs approved since mid-1996 have been pulled off the market, one of the most recent being the diabetes drug Rezulin. Larry Sasich of Public Citizen’s Health Research Group points out that all six of them were “me too” drugs: They treated symptoms that were already treatable with existing medications. Nevertheless, millions of prescriptions were written, and more than 150 deaths were linked to these medicines before they were pulled off the market. And because reporting is unreliable, the actual body count could be up to 100 times greater.
Perhaps you’re thinking fine, if the system is imperfect, at least doctors are protecting their patients from unsafe new drugs. But drug companies may push doctors to prescribe their drugs even when they’re reported to be unsafe. Rezulin is a case in point. In January 1997, the FDA approved Rezulin under its accelerated “fast track” procedures following six months of testing. But it wasn’t long before users started dying, the United Kingdom’s Medicines Control Agency revoked its approval, and FDA insiders started working with the media—notably David Willman of the Los Angeles Times—to get the word out that Rezulin was just not safe.* In March 1999, with the death toll approaching 30, senior FDA epidemiologist David J. Graham publicly told an FDA advisory board that every single patient taking Rezulin was at risk of sudden liver failure. Given all this, and given that there were drugs on the market that treated the same type of diabetes as Rezulin and did not fry a patient’s liver, why would a doctor still prescribe Rezulin?
You’d hate to think the answer could be: “Knicks tickets.” In a fax that went out to select New York area physicians in spring 1999, Rezulin’s manufacturer, Parke- Davis (a Warner Lambert subsidiary) invited guests to attend a “special scientific lecture” at “the Club Bar and Grille … Madison Square Garden.” After a short lecture and Q & A over dinner, the guests would be ushered down to their seats in the stadium where they would watch a “BASKETBALL GAME!!!! New York Knicks vs. Toronto Raptors.” Perhaps you’re thinking that it takes a certain amount of chutzpah to throw what is effectively a basketball party for a product that is widely suspected of killing people, but chutzpah is often what good business is all about.
As the nation’s drug regulator, the Food and Drug Administration should be the first line of defense against drug companies that are pushing dangerous product. But asking the FDA to rein in the pharmaceuticals industry is a bit like sending someone out to catch Niagara Falls in a bucket. The industry has vastly greater resources to press its agenda. And changes in drug laws and regulations have encouraged a boom market for drugs that the agency is not equipped to police.
To get a feel for the mismatch in financial resources, consider the following: The FDA’s annual budget for approving, labeling, and monitoring drugs is roughly $290 million. To that figure, add the $2 or $3 million available to Public Citizen’s Health Research Group, which was formed to help even the balance between regulators and the drug industry. Now compare those numbers to the $11 billion promotional budget that the drug industry gives itself according to a recent article in the Journal of the American Medical Association.
In order to get a full picture of what the FDA is up against, however, you have to step back and see how dramatically the regulatory landscape has changed in the last decade. Back in the early 1990s, there was a widely shared perception that the FDA was too slow to approve new drugs even when they might offer desperately needed help for people who were dying. AIDS activists were particularly eager to light a fire under the approvals process out of concern that the FDA might be holding up life-saving or life-prolonging treatments. They were well connected and highly committed, and they had the support of an industry that wanted faster approvals for its own reasons. It therefore was no great surprise that in 1992 Congress passed a new law creating the blueprint for a faster approvals process. Under the new law, the FDA would hire more reviewers and take the other steps necessary to speed up reviews without sacrificing rigor, and industry would bear the additional costs by paying “user fees” with every new drug application.
But if AIDS helped to crack open the door for faster drug reviews, the pharmaceutical industry was standing right there to kick it wide open. The new law created a faster review process for all drugs—not just breakthrough treatments for diseases like AIDS. This meant that as approval times have dropped from 30 to 12 months on average, there has been a rush of newly approved drugs which do not offer the public any new treatment benefits, but which could pose new risks.
And to compound the impact of the newly-approved drugs, in 1997 the FDA yielded to years of industry pressure and loosened restrictions on consumer advertising. This made it possible for drug companies to advertise on television without spending huge chunks of time describing risks and side effects. Ads for new drugs like Viagra and Claritin became almost as familiar as Burger King commercials. New products generated blockbuster sales in a matter of months.
But while the changes have been a hit commercially, they have created some major problems in the FDA. Probably the biggest is that the changes do no permit the FDA to spend a single dollar of the industry fees it collects to track whether all those new drugs are safe once they hit the market. As a result, the FDA is in approval overdrive, while its safety side is stuck in low gear: The parts of the agency that review and approve new drugs (call them the “review teams”) have around 1,300 employees helping process new drug applications. By contrast, the part that tracks whether new drugs are hurting people (call it the “safety team”) has 72 employees, including only 13 with formal training in epidemiology—the science of spotting medical disasters.
Former FDA commissioner Donald Kennedy says that the FDA’s system for keeping tabs on how and when drugs hurt people is “terrible.” “We don’t know enough to know when drug problems arise,” he says. “And when we know enough, it takes a lot to get them off the market.” Part of the problem is that in today’s overheating promotional environment, new drugs are likely to generate huge sales more quickly than ever, and therefore may create more damage in a shorter amount of time. Unfortunately, the FDA’s safety team relies on tools that were designed at a time when speed wasn’t so important. Instead of looking for information, it waits for bad news to come in from doctors (who are not required to report bad drug reactions and therefore only do so sporadically) and drug companies (who are required to report adverse events but get most of their information from doctors). The system is ad hoc at best: Estimates are that only between one and 10 percent of adverse drug events get reported.
Moreover, even when the safety team identifies a problem drug, it has limited authority to act. It evaluates a drug’s riskiness and makes a recommendation about what the agency should do. But according to the head of the team, Dr. Peter Honig, it plays a “consulting” role. The review team that approved the drug in the first place analyzes its benefits, communicates with the manufacturer, and seems to have the upper hand in helping agency higher ups decide whether or not to withdraw it. Critics rightly argue that the safety team should be given more deference, first, because the review team that approved a drug may not be objective about whether to withdraw it and, second, because the rest of the agency lacks the epidemiological training that is crucial in order to “get” the risk analyses that the safety team produces.
But given that for now the safety team is low man on the FDA totem pole, can the regulators with more clout be relied on to keep the drug companies in line? It’s hard to respond with a confident yes. Although the agency’s review teams have a whistleblower tradition that dates back to Frances O. Kelsey (the heroine who blocked thalidomide from the U.S. market), a review officer who objected to Rezulin’s initial approval was taken off the case and a reviewer-turned-whistleblower during the Rezulin affair became the object of an internal affairs investigation. Drug company reps tend to hover over the agency’s approvals process and, according to a recent inhouse newsletter, may resort to tactics from name-calling to going over a reviewer’s head if problems arise. And in the wake of the Rezulin matter it has been suggested that management—particularly Commissioner Jane Henney and her drug deputies Janet Woodcock and Murray Lumpkin—may identify too strongly with industry.
Is that fair? Consumer advocates like Larry Sasich of Public Citizen argue that Henney “sold the farm” to get confirmed by a Republican Congress, and that the agency has been “completely coopted by industry.” But defenders insist that management’s mistakes are more innocent: They reflect the sort of tunnel vision that commonly afflicts bureaucrats who stake out positions and then can’t admit to getting them wrong. And former colleagues like ex-Deputy Commissioner Carol Scheman bristle at the suggestion that Henney’s team yields to industry pressure. “I don’t think it’s possible,” she says. “These are among the most rigidly moral people I know.”
A deliberate sell-out by FDA management is highly unlikely. But it is more probable that there is an unconscious tendency to hear the loudest voice. And in the context where they operate, that voice belongs to the drug industry. After all, the new drug laws have enhanced the industry’s role in the drug approval process. And every year FDA management has to seek appropriations from an anti-regulatory Republican Congress with many friends in the drug business. Under the circumstances it’s not hard to imagine how a person could find herself listening just a bit harder to the drug companies.
Given that the FDA’s safety team is anemic, reviewers feel like they’re being hassled, and management is whipsawed between science, politics, and industry, doctors are an increasingly important buffer between potentially dangerous drugs and the public. But if the basketball promotion that Parke-Davis put on for Rezulin is any indication, the drug industry is intent on wearing them down. And Knicks tickets are just the tip of the iceberg.
Finding a doctor who will confess outright to being influenced by pharmaceutical company promotions is a thankless proposition. But the general absence of Hippocratic self-awareness cannot change the facts. As noted above, the pharmaceutical industry spends $11 or $12 billion a year and a lot of brain power figuring out how to push doctors’ buttons. You don’t part with that kind of money unless you get some kind of return on your investment. And to put a finer point on it, a study published this January in the Journal of the American Medical Association (entitled, appropriately enough, “Is a Gift Ever Just a Gift?”) concluded that the various tools in the drug company sales kit do in fact influence doctors’ prescription practices and in some cases lead to “non-rational” prescribing.
The basic form of promotion is the sales call. Drug companies spend $5 billion a year sending representatives—called “detailmen”—to doctors’ offices. While the companies argue that detailing provides a valuable educational service by keeping physicians up-to-date on the latest changes in medical science, detailing (like any sales call) is more manipulation than education. Sales reps keep FBI-style dossiers on physicians that include info from the names of family members to golf handicaps to clothing preferences. A national service called IMS Health gives them database printouts on exactly what prescriptions the doctor has been writing. And detailmen are under intense competitive pressure to do what it takes to make a sale. Pharmaceutical Representative—a trade journal—features columns with sales tips on everything from how to handle a doctor who says that your product caused a terrible allergic reaction (“You might say, Wow! There’s only a 0.01% chance of that happening’”) to tricks for gaining access (“You must find ways to get in the physician’s face’”) to the more banal secrets of throwing a successful sales dinner (“Arrange in advance to cover valet parking and tips”).
Which brings us to the subject of bribes—otherwise known as “gifts,” “samples,” and “entertainment.” It’s true that drug representatives have toned down their peddling techniques a bit since 1990, when the FDA passed regulations forbidding “gifts of substantial value.” But what those regulations really seem to have accomplished has been to shift the emphasis from expensive hardware like stereos and fax machines to promotional trinkets and meals and travel. “Doctors are still going to dinners and on cruises and to baseball games,” says Dr. Bob Goodman, an internist at Columbia Presbyterian Hospital in New York who also runs “nofreelunch.org,” a Web site dedicated to the eradication of medical graft.
Of course you can’t just offer a self-respecting professional a bribe. One of the key arts in pharmaceutical salesmanship is to convince the doctor that he somehow deserves what he’s getting. Dr. Jerry Avorn, a professor at Harvard Medical School, says that salesmen often couch their dinner invitations in flattering terms like “Come on—you’re a busy guy and you’ve gotta eat anyway; I’ll just pick up the tab.” And to cover docs who’d rather eat with their families, Dr. John Mohrer says that detailmen in Queens, New York have inaugurated a tradition called “Dash-‘n-Dine.” It involves going for Chinese takeout and sitting with a detailman and maybe an invited guest while your order is being prepared. “You go in and schmooze with them, they buy you a drink, and they tell the cook to take it slow,” says Mohrer. “The last time I was there they’d brought in an endocrinologist from 75 miles away to talk about Rezulin.” After a half an hour or so of light, boozy sales patter, the cook produces the order, the detailman produces his wallet, and the doctor walks away with dinner for the whole family.
If the doctor is just a stick in the mud, then making inroads with the staff is another option. Abbey Meyers of New Fairfield, Connecticut recently emerged from an appointment with her arthritis doctor to find a detailwoman stocking the sample cabinet and chatting up the receptionist. “Say, how about I come by next week and take the staff to lunch,” asked the detailwoman. What about the doctors? “We’ll just bring them back takeout” came the reply. Meyers, who is attuned to these things as president of the National Association for Rare Disorders, notes that the advantages in targeting the rank and file are clear enough: Nurses and physician assistants have doctors’ ears and keys to the sample closets that reps like to stock with their wares.
Of course samples aren’t quite the freebies that they seem. Although some are used for indigent patients, they’re more generally used like baited hooks. The patient who goes home with a pocket full of free medicine from his doctor may feel like he’s making out, but he’s really forming a debt of gratitude toward his doctor, who in turn feels gratitude toward the drug company. It’s easy to see how through all this warm feeling a doctor can become more inclined to prescribe the medicine and the patient can be more inclined to ask for it.
Of course one of the easiest and most common gambits that sales reps use is to stock an office larder with small toys of insubstantial value that have the Manchurian Candidate effect of pricking a doctor’s subconscious when it’s prescription writing time. These paraphernalia—pens, pads, small toys with the company’s logo—are by design too small to provoke suspicion and yet can be deviously effective. “I did a study at North Shore 10 years ago,” wrote Dr. B. Robert Meyer in a recent email to the nofreelunch web site. “Drug lunch with pizza by the piperacillin rep. Gave out pipramints’ to the house staff and some info about their drug … Our piperacillin use went from $5,000 to $15,000 in the next month.”
But Meyer thinks that the doctors are to blame more than the detailmen for the graft element in pharmaceutical sales. He wrote to nofreelunch: “If you talk to the representatives and get them to let down their hair about things, they will tell you horrifying stories of out-right extortion by physicians, as in I won’t prescribe any more of your product unless you get me good seats to the Yankee game next Saturday. I used to think that these were few and far between, but the more reps I talk to, the more stories I hear.’” Other doctors confirmed that hold-ups of this nature are altogether too common. “Many of us are for sale,” concludes Meyer. “And therein lies the problem.”
To the extent Dr. Meyer is right, Yankee tickets may be the least of it. People both in and outside the pharmaceutical industry told me that if you really want to buy a doctor’s loyalty, then you need to get her on the company payroll. “Get them on the payroll and it’s amazing the prescribing they will do,” one pharmaceutical company insider told me. But how do you get them there?
One way is to take a page out of Searle Pharmaceuticals’ book. When Searle wanted to promote its new drug Celebrex, it invited 300 doctors and pharmacists to Orlando, Florida for a winter weekend getaway. According to Thomas J. Moore, who wrote about the episode in Washingtonian magazine, Searle had used IMS data and other sales rep info to pinpoint these particular individuals as opinion leaders who would be useful spreading the Celebrex gospel in their communities. The purpose of the Orlando weekend was therefore to recruit them to a national “speakers bureau” for the new drug. For their trouble, Searle paid the doctors $500 for coming to Florida and $500 for each speech on Celebrex they gave after becoming a member of the team. Plus, the company pulled out all the stops in Orlando.
“It was truly disgusting the money they spent,” said one participant to Moore. “Shrimp the size of your finger. Would you like the filet mignon or the salmon? Open bar all the time. It wasn’t just scotch—it was Chivas Regal.” In addition, Searle was thoughtful enough to rent out Universal Studios theme park for an evening, and far-sighted enough to have attendants standing by with umbrellas when a cloudburst threatened to ruin the fun.
Of course it’s hard to say how much the three hundred Orlando conventioneers contributed to the success of Celebrex, but it’s worth noting that the drug generated roughly a billion dollars in sales during its first year on the market-the first drug ever to attain that mark in its first year out. And what great breakthrough did Celebrex offer to merit these results? Actually, it’s a painkiller—like aspirin, acetaminophen, and ibuprofen, but with a slightly different chemical action. Moore notes one other difference too: In some of the tests performed for FDA approval, Celebrex actually turned out to be less effective than painkillers already on the market.
Some doctors argue that detailing gimmicks and promotional trips are just advertising and can be discounted as such by a discriminating professional. If you buy that (and the studies suggest you shouldn’t), then there are still other forms of promotion to be concerned about. One of the most pernicious is industry-funded research and training.
The funding game works like this: In one corner are academics, who need to get published and to get grants. In the other corner are companies, which like studies that make their products look good. And in the background, as Eyal Press and Jennifer Washburn recently described in The Atlantic Monthly, is the fact that industry funding for academic research octupled between 1980 and 1997, as research costs climbed, and the rate of growth of federal support declined. So it’s not a great surprise that researchers often look to companies for grants, and companies often look to researchers for studies that will make their products look good.
How do they know that these studies will in fact make their products look good? They just do. In the first place it turns out that even when sponsors aren’t involved, the great majority of drug studies shed favorable light on the products being examined. In a 1996 study in the Annals of Internal Medicine, Stanford University’s Mildred Cho found that on average 79 percent of papers on unsponsored research reflected favorably on the drug in question. While that’s a pretty impressive number, it’s almost modest compared to Cho’s finding that the percentage went up to 98 percent for papers on industry-sponsored research. (This doesn’t seem to bother most medical journals, which will publish sponsored research so long as the conflict has been disclosed; the New England Journal of Medicine has a rule that it won’t publish sponsored research at all, but in February it admitted to breaking it 19 times in the past three years.)
Why are researchers so favorably disposed to the drugs they’re peering at? Perhaps they’ve had friends who learned that coming forward with negative results can land you in a heap of trouble. Indeed, some researchers who have tried to publish unflattering findings have been threatened with lawsuits. In one troubling case from the mid-’90s, a U.K. drug company called Boots threatened legal action against University of California researcher Betty Dong in order to keep her from publishing a study that they had funded on one of their products. The study showed three Boots competitors to have products just as good—which apparently was not the finding the company had been hoping for. Dong eventually got the right to publish, but by that time, Boots had assembled another research team that reached the opposite conclusion and published it elsewhere.
By contrast, if you publish a couple of papers that a drug company likes, they may decide to put you on the symposium circuit. Dr. Michael Gorback recalls that several years ago, when he was on the faculty of Duke Medical School, Smith Kline asked him to do a presentation on an antacid they were marketing called Tagamet. According to Gorback, for the occasion the manufacturer “pulled together a panel of myself, a Harvard med school professor, and a chairman from one of the University of California medical schools.”
Gorback says he was flattered by the invitation until one day he went to the mailbox and found that Smith Kline had sent him an entire precooked presentation, complete with lecture script and slides. He says he complained to the company that he had his own ideas but quickly learned he was swimming against the tide when the company flew him up to Boston for a pre-meeting that ended up more like a rehearsal. According to Gorback, they were just getting started when the Harvard professor come running in, late and out of breath, and shuffling the script; he announced that he hadn’t gone through it yet, but that was O.K.—they should do a read-through to gauge the time.
Gorback was astonished. “This is a guy who trained me,” he says. “He has an international reputation. And he was going to put his seal of approval on script without reading it.” Moreover, symposium papers often travel further than the symposia where they’re read. They may be reprinted in bound “supplements” to medical journals (which have the same livery and typeface as the journals themselves). These supplements can then be passed out by detailmen in the hopes that doc will ignore the small print making clear that this isn’t exactly pure science.
When Gorback describes the Tagamet event as “one of the most disgusting experiences of my career” he’s talking about the ethics on the dais. But he may have missed other, more earthy, forms of seaminess out in the crowd. In an earlier article in these pages, Alexander Kippen wrote about how a former Texas detailman named Jody Perez who sold for a Johnson & Johnson subsidiary would work a symposium crowd. (“Doctored Results,” October 1990) First, he’d suck up to his targets by letting them win phony contests (like guessing the number of pills in a jar). Then, once he got close enough, “I’d find out what their hot button was.” It might be booze; easy enough. It might be women; when on familiar turf, Perez kept a list of local nurses, secretaries, and receptionists who liked to entertain visiting doctors. And it might be, surprise, drugs. Some of Perez’s customers had a real fondness for codeine-laced Tylenol IV (liquid formula), which Perez called “juice” and which the docs liked to put in their cocktails to give them an extra kick.
If codeine won’t do it, another way to get to doctors is through their patients. And that’s why consumer advertising has become so important. Television advertising has exploded since 1997 when the FDA eased regulations. Drug companies spent $900 million on consumer ads in the first half of 1999 alone. What’s wrong with more ads? Primarily the fact that they’re so effective.
If a television ad convinces you that you need (or simply want) a drug, there’s a good chance you will be able to convince your doctor to prescribe it. A recent study published in Health Affairs magazine reported that three-quarters of the respondents saw a drug on TV and asked their doctors for it were successful. In part that’s because most doctors won’t argue with a patient’s prescription preferences unless the medication is going to hurt him. In part it’s because they don’t have time to argue: In today’s HMO-driven world, appointments are so short that a doctor may give you the damn Viagra prescription just so that he can get your cooperation on whatever more important issue is at hand. And it may also be because your doctor sees the ads as a way to drum up business, and wants to encourage you to drop by whenever one captures your fancy.
This can’t be a good development. In the first place, the most heavily promoted drugs are often the new ones, which the drug makers are hoping to turn into Celebrex-style blockbusters. These drugs may be FDA-approved—but the FDA only requires clinical testing in populations of about 3,000 people. If this turns out to be a drug that kills one in every 10,000 people, you probably only want to be one of the first 10,000 if you’re pretty seriously afflicted and don’t see many alternatives. Ten years ago when the FDA was more sluggish with the approvals and drugs tended to go on the market in Europe before here, you might have tried to find out whether 10,000 Germans had survived the experience. But now, 60 percent of new drugs come on the market in the U.S. first, making us the world’s guinea pigs. And even if a new drug is safe, there’s a more pedestrian consideration: It may not be any better than the invariably cheaper stuff that’s been around for ages and gone generic.
In addition to consumer advertising, drug companies get through to consumers by sponsoring “patient groups” that consume whatever drug the company is pushing. For example, it was revealed several years ago that the non-profit group CHADD (Children and Adults with Attention Deficit Disorder), which offers encouraging information on using Ritalin and other psychotropic meds to control hyperactive kids, is partly funded by Ritalin’s manufacturer—Novartis. It has also been reported that the Boots company, which manufactures a thyroid product, has at various times provided 60 percent of the funding for the American Thyroid Association. And the list goes on. What’s irritating, if not outright dangerous, is that at least some patient groups wind up effectively advertising sponsors’ products either by endorsing them directly or by lending credibility to the sometimes fuzzily defined syndromes (e.g., ADD) that the products “treat.” Even people in the industry will concede off the record that groups acting as advertising agents for manufacturers should be subject to FDA regulation. But they’re not.
At the root of all of the problems in America’s prescription drug culture is the fact that the pharmaceutical companies have seemingly bottomless resources to get their message out and the regulators don’t have enough to ride herd. It’s time to change that by finding new ways to put out objective information about drugs and rein in the misleading stuff that the drug companies release. But most importantly, we need to pour resources into developing a system that can actually detect bad drugs in the market before they become full-flown public health disasters. A few recommendations:
First, no more gifts or entertainment. It’s time to tighten the rules again: If detailmen want to hand out reprints, fine. But there’s no reason for them to be picking up meals, leaving pens and mints, and engaging in other forms of small-bore thought control that serve no redeeming medical purpose. And as for samples, these should only be permitted to the extent they’re given out to the indigent or uninsured.
Second, increase federal funding for unbiased research. The more resources the government can provide, the more balance there is likely to be in the scientific literature that doctors use to form their medical judgments.
Third, go back to the old rules for TV advertising and regulate patient group promotions. Television drug ads seem to be more capable of harm than good, so let’s go back to the old system: Sponsors should have to recite a generous description of a drug’s risks if they wish to advertise it on TV. Even if patients tune out this part of the ad, the weightiness of the description is helpful in conveying that this is a potentially dangerous product. This in turn would likely have a chilling effect on drug companies’ inclinations to advertise on the small screen. As for patient groups that shill for sponsors—their promotional efforts should be regulated by the FDA as though they were agents for the manufacturer.
Fourth, organize “academic” detailing. Doctors need to get information from people other than salesmen and hired guns like Dr. Gorback and his co-panelists. A few years back, Harvard med school profs Jerry Avorn and Stephen Soumerai came up with a way to achieve this called “academic detailing.” The basic idea is that medical schools would send their impartial detailers without any drug company ties to brief doctors on the latest drug advances. They found that doctors were more receptive and willing to spend time with detailers who had no economic interest in the treatments they were describing. How would the system work in real life? Soumerai says that Australia presents one possible model. There, the government organizes and funds detailing of this nature. Our government should do the same.
Finally, and most important, create a drug safety system that can effectively track what all of the drugs rushing on to the marketplace are doing to Americans’ health. That the drug companies are allowed to fund a souped up approval process without putting some money into the FDA’s safety team is troubling. That this safety team has to monitor the effects of more than 3,000 prescription drugs on 200 million people with a budget of around $15 million a year is just scary. It is an open secret in Congress and within the FDA that these resources are totally inadequate, so it’s time to pony up. Congress should amend the user fee legislation to provide that more money goes to building a real safety system. If this means the review teams won’t be able to meet their current targets for new drug approvals, they should put non-breakthrough drugs on a slower track: A number of reviewers would surely applaud this outcome. In the event that additional funds are required, Congress should appropriate them.
What would the safety system look like? It would be capable of collecting the information required to figure out how drugs are being used and whether they’re causing harm, much as the Centers for Disease Control keep tabs on the spread of diseases. And it should play a much more substantial role in the process by which drugs are removed from the market. It should not be required to take a back seat to the original review team when it comes to deciding whether or not to pull a drug off the market. And some have suggested that it might even be formed outside the agency, in the same way the National Transportation Safety Board exists outside the Federal Aviation Administration, to give it some objective distance from the politics and matters of professional pride that impact decision-making.
Creating such a system, and taking the other four steps recommended above, could go a long way toward compensating for the wretched excesses of America’s prescription drug culture. And who knows, they may lessen the chance that your doctor prescribes a drug that shouldn’t be on the market for reasons that aren’t quite rational—like the fact that the Knicks took the Raptors in overtime. Now, don’t you feel better already? l