Dismantling the Marketing Machine
The legal psychiatric drugs industry has thrived through the aggressive spread of misinformation. Big Pharma has almost unlimited financial resources, political punch, marketing prowess, and greed in the pursuit of new markets and bigger profits.7 But all this could be reversed on a dime if politicians had the motivation to do so. None of the following policy changes would be hard to enforce. Most of them are already in place in the rest of the world and work well to better contain, if not entirely eliminate, the excessive use of prescription drugs.
FOURTEEN WAYS TO TAME PHARMA
• No more direct-to-consumer advertising on TV, in magazines, or on the Internet
• No more drug company–sponsored junkets, dinners, promotional gifts, or continuing medical education for doctors or medical students8
• No more financial support for medical professional organizations
• No more beautiful salespeople congregating in the doctors’ waiting room
• No more free samples9
• No more off-label marketing10
• No more co-opting of thought leaders11
• No more drug company funding for the Food and Drug Administration
• Bigger fines and criminal penalties for malfeasance that are directed against the executives as well as the companies12
• Shortened patent protection for companies that break the law.
• No more financial aid for consumer advocacy groups13
• No more disease-awareness campaigns14
• No more unlimited and undisclosed contributions to politicians
• A three-year quarantine before politicians, staffers, and bureaucrats involved in setting or monitoring drug company regulations can join a drug company as officer or employee
We can’t expect the drug companies to reform spontaneously. They simply have no motivation to change as long as the profits are pouring in and their shareholders are happy. Their corporate mission is to make as much money as possible. Despite whatever protestations are made to the contrary, serving the public weal is low on their list of priorities. The public has to be protected from misleading information and monopoly pricing. And having laws on the books is not enough to contain greed unless the financial costs of breaking them exceed the gain—or a few executives do some jail time. Pharma will gorge as much as it can for as long as it can until it is stopped from without. Other countries do a much better job of containing Pharma’s excesses than we have, probably because money doesn’t convert so readily into political power in most other democracies. The best hope of reform is sustained public outrage at being ripped off. As Abraham Lincoln said, “You can fool some of the people all of the time, and all of the people some of the time, but you can’t fool all of the people all of the time.”
Controlling Distribution: Borrowing Tips from MasterCard
Diagnostic inflation and polypharmacy go hand in hand and can be a lethal combination. How remarkable that so little is being done to stop this almost completely preventable cause of death and disability—especially since there is an easy technical fix to end the glut of dangerous overprescription.
Any time a suspicious purchase is charged to your credit card, it gets picked up immediately and your card is temporarily suspended until the purchase is approved by you. This sometimes annoyingly efficient system is triggered if, for instance, you try to use your card in a foreign country without first having informed MasterCard that you are traveling. Why isn’t a similarly efficient and proactive, real-time alert system in place to help control the rampant overprescription and overdispensing of psychotropic and pain medicines? If we have the technology to prevent a hundred-dollar fraud, it is silly not to apply it to prevent deaths from overdose with prescription drugs.
The distribution of illegal drugs has proven to be impossible to control despite determined and expensive law enforcement efforts at the borders and on the streets. The distribution of prescription drugs is a cinch to control because they are dispensed by pharmacies that could be linked by all-seeing computers. Guidelines could be established to tag all suspicious transactions (e.g., too many different drugs prescribed in tandem, or doses that are too high, or prescriptions that are filled too often and/or come from different doctors) and to identify doctors in the habit of serial overprescribing. If there was a good rationale for a given outlier, it would be allowed to go forward (equivalent to explaining to MasterCard the reason for the purchase that tickled their fraud alert). But potentially deadly drug cocktails and deadly doctors would be identified and stopped dead in their tracks.
I can think of only three possible objections, and none hold any water. The first is expense—who will pay for it? This is silly. We spend a fortune failing to interdict illegal drugs at the border because it is so impossible to seal. But our pharmacies, equivalent to the border as distribution points for licit drugs, are easy and cheap to patrol with never-sleeping computers. It is also a no-brainer who should pay for the sentinel system—the monitoring money should come from a tiny tax on Pharma’s gigantic drug revenue.
Second concern—how do we get all the drug companies and all the pharmacies to participate in such a system? Isn’t the prescription and dispensing of medicine too fragmentary to allow for central control? Not at all. Pharmacy chains and large Internet mail-order delivery systems could easily be compelled to comply with a prescription drug abuse interdiction system.
The third objection is the only one with any merit: Isn’t a warning system a potential Big Brother invasion of individual privacy that in the wrong hands could lead to abuses? This argument would have more traction if the need to protect from legal drug overdosing weren’t so urgent and if privacy in prescribing wasn’t already quite vulnerable, given the record-keeping and surveillance systems already in place. Adding a universal alarm system with teeth would provide enormous benefit, while incurring very little additional risk.
Would this have much impact on diagnostic inflation? Yes, because this tail wags the dog. Whenever a diagnosis is an easy ticket to getting a desired drug, it is made much more frequently. Loose diagnosing/high-prescribing doctors will tighten up on both counts when they know that the computer’s eagle eye is fixed relentlessly upon them.
This is the one battle that the war against drugs can and should win.
Sunsetting Bad Drugs
The Food and Drug Administration goes to considerable (though not nearly sufficient) lengths to vet new drugs before they are approved for market. But once invited to the party, a drug gets pretty much a free ride for the rest of its life. Unless a drug is blatant in its complications or actually kills people, it is likely to fly under the radar for decades. The FDA’s postapproval surveillance program is greatly underfunded and not up to the task of monitoring all the useless and/or harmful drugs that have made it to market.
Take Xanax. Introduced in the 1980s as a wonder drug to replace Valium and Librium, it is loved by patients and used frequently by primary care physicians. But Xanax has been more a wonder of profitability and longevity than a useful medication. Its therapeutic dosage is often high enough to be addicting, and its severe withdrawal anxiety is enough to keep patients hooked for life. Attempts at withdrawal may bring on severe panic or anxiety symptoms that are worse than the problems the patient started with.15 Xanax is also a frequent collaborator with other prescription drugs and alcohol in iatrogenic overdoses and deaths.16 It has little role, if any, in the proper practice of medicine. If there was a proper war against prescription drug misuse, Xanax would be an early casualty—but under current policies the FDA has no mechanism to rein in drugs that do more harm than good. We need a better way to identify and sunset bad drugs.
Taming the Doctors
Most doctors try to be responsible in the way they prescribe medication, but the few really bad apples can do a whole lot of damage. They are to the licit drug trade what the corner boy is to the illicit. It is extremely easy to identify these “highflier
s” by medical monitoring and audit. They see the most patients for the shortest number of minutes. In the limited time allotted, they give the most psychiatric diagnoses—and often these are the same diagnoses and medications for every patient. They write the most prescriptions for multiple medications per patient at the highest average doses, and every patient may be on the same drug cocktail. They also probably charge the most per visit but may have trouble remembering the patient’s name or problem. They attend drug company events religiously and may sometimes speak at them, extolling the latest new wonder drug. Their office is a magnet for drug salespeople, all of whom are on a chummy first-name basis with the secretary. The office is strewn with drug company presents and paraphernalia. Our highflier probably drives the best car and lives in the best house. Every so often, a patient dies of a drug overdose of the medicine he has prescribed (perhaps helped along a bit by alcohol), but he has never been disciplined, is a pillar of the professional community, and thinks highly of his or her clinical skills. (I have written another book, Essentials of Psychiatric Diagnosis, which provides tips to the accurate diagnosis of each of the mental disorders and cautions on how to avoid diagnostic inflation.)
The most primitive of computerized drug-monitoring systems can easily spot highfliers and brand them as dramatic outliers to proper medical practice. The most elementary of quality control measures would force them to justify their decisions, which immediately would take some of the wind out of their sails. Professional disciplining of one highflier would bring the others into line, and public shaming would ground them all. It can be done and would be done as part of a comprehensive War on Licit Drug Misuse. It is now being done almost not at all. Most medical corner boys ply their trade with impunity, and patients pay the price in disability, sometimes death. Improper polypharmacy could be stopped within months if proper monitoring and quality control were put in place.
Taming DSM
The loose DSM criteria that encourage diagnostic inflation need tightening. This won’t be easy—the problem has taken thirty years to build up and has been aggravated by DSM-5. But errors do have a way of correcting with time, and now is the time to begin this correction. Thresholds for many existing diagnoses should be changed to require more symptoms and/or longer durations and/or more impairment. And we need to stop adding new diagnoses unless there are very compelling reasons to do so.
DSM should also gradually be relieved of some of its responsibility, decoupling it from decisions that have been tied exclusively to the presence or absence of a psychiatric diagnosis. School services should be based on a thorough evaluation of educational need, not just on the presence or absence of a diagnosis. Autism and attention deficit disorder were defined for clinical, not educational, purposes and don’t work very well as determinants of classroom decisions. Levels of educational impairment can vary very widely in people who have the same diagnosis. Similarly, eligibility for disability and other benefits should depend more on the person’s actual level of functional impairment, less on whether or not he has a psychiatric diagnosis. And DSMs should not be relied on so heavily in legal proceedings.
Psychiatric diagnosis used to be just a modest clinical tool having little outside influence. Now that the reach of DSM has grown out of all proportion, it is the sole arbiter of all sorts of decisions not always within its competence. This adds more weight than the diagnostic system can comfortably carry and increases diagnostic inflation as clinicians up-diagnose their patients to get them added services and benefits. A less important DSM will be a better DSM and result in more accurate diagnosis.
Psychiatric Diagnosis Is Too Important to Be Left to the Psychiatrists
The American Psychiatric Association has held a guild monopoly on psychiatric diagnosis for the past century. This happened only by historical accident, not by design. Until 1980 and DSM-III, no one else much cared about DSM—its management was a burden that APA assumed only because it was too unimportant to warrant more official sponsorship. Things have since dramatically changed—psychiatric diagnosis has grown greatly in importance and the APA has shrunk in its competence.
DSM-5 has been the last straw and the loud wake-up call. The APA governance structure proved itself incapable of governance. Reckless changes suggested by researchers pushing their pet theories were insufficiently vetted for real world impact. Experts in clinical care, epidemiology, health economics, forensics, and public policy were left out of the loop. Decisions were mostly made by and for psychiatrists—ignoring the fact that they constitute only 7 percent of all mental health clinicians and now write only a small minority of prescriptions for all psychotropic drugs. APA has not acted as if DSM-5 is a public trust, treating it instead like a publishing product and profit center.
The DSM-5 follies prove that psychiatric diagnosis has outgrown APA—becoming too important in too many aspects of life to be left in the hands of one small professional organization with its limited skill set and no public accountability. Psychiatrists will always be an important part of the mix, but the APA should no longer be calling the shots. Its exclusive monopoly over psychiatric diagnosis should end now.
Next obvious question—if the APA has permanently disqualified itself as keeper of the flame, who should step in to mind it? Regrettably, no existing structure is ready to take on this responsibility. Psychiatric diagnosis should not become the monopoly of a different mental health association—the psychologists would muck it up just as badly (if in different ways). The National Institute of Mental Health has the resources, intellectual firepower, and moral authority, but its emphasis and expertise are increasingly focused almost exclusively on basic science research. NIMH has little concern about, or skill in, handling practical clinical questions. Its DSM would be a researcher’s dream list but a nightmare for clinicians, patients, and public policy. The World Health Organization might be a contender, but its spotty past performance in producing its own manual of mental disorders does not inspire any great confidence. There are no other organizational structures off-the-shelf ready to fill the breach.
I think that psychiatric diagnosis requires and deserves its own new regulatory structure. The Food and Drug Administration is the closest existing model. This is not as far-fetched as it may seem. New diagnoses in psychiatry are potentially much more dangerous than new drugs because they can lead to massive overtreatment (with all the possible side effects), while new drugs are generally no more than “me too” lookalikes of current drugs. The FDA vets new drugs with reasonable care, but we now allow the creation of potentially dangerous new diagnoses without first having any careful and independent review. Changes in the diagnostic system should be subjected to a vetting process every bit as thorough and careful as for new drugs.
But who should do it? Probably a new structure within the Department of Health and Human Services that is broadly interdisciplinary—combining all the clinical professions with experts in public mental health, service delivery, health economics, forensics, and education. It could have a staff to conduct evidence-based reviews of the scientific literature—or perhaps better, should outsource such reviews to existing independent groups that will have no stake in the outcomes. Decisions should be based on open, explicit risk-benefit analyses that anticipate possible unintended consequences and also include impact on costs and allocation of resources. Consumers should be part of the vetting team. Everything should be posted in real time and completely transparent. New diagnoses should be subject to continued surveillance to ensure they are not being misused and do not have harmful unintended consequences.
Changes need to be gradual and incremental. It makes no sense to continue the practice of changing the entire diagnostic system at arbitrarily chosen intervals. Each diagnosis should be taken up individually in turns that are decided by the emergence of new research evidence. Change should not be just for the sake of change and must be supported by solid evidence and consensus approval. For the immediate future, changes in the diagnostic system will likely be
determined much more by health services than by brain research. The neuroscience revolution is far sexier and more intellectually stimulating but, except for Alzheimer’s, is very far from producing laboratory evidence to support diagnostic decisions.
Stepped Diagnosis: A Surefire Inflation Cure
We need to teach mental health clinicians and primary care physicians a completely different approach to psychiatric diagnosis. The current practice is to make a diagnosis on the first visit, based usually on very incomplete information obtained in a very brief interview with a patient who is going through one of the worst days of his life (and who may recently have been using substances that befuddle the clinical picture even more). The presentation on visit two is often quite different than it was on visit one. By visit five or six, things have usually stabilized and clarified enough so that an accurate diagnosis is a pretty good bet. Furthermore, many people naturally get better by then. The first visit is the worst time imaginable to make a definitive diagnosis, and diagnoses made in this way are often wrong.
So why do doctors routinely spring so prematurely? Why not watch, wait, learn more, see how things develop? Simple answer—insurance will often pay for a visit only if there is a DSM diagnosis generated during it. This is remarkably penny wise but pound foolish for the company—as well as being hazardous to the health of the patient. Once a definitive diagnosis is made, a definitive treatment is usually begun—and both are likely to be unneeded, harmful, and expensive. After all, people with milder problems have a fifty-fifty chance of being back to their usual selves within a few weeks without needing any diagnosis or treatment.
The best bet would be for insurance here to do what is done in many other countries—no diagnosis needed for the initial evaluation visits. This would save money and prevent mistakes. The second best and currently necessary solution—clinicians should underdiagnose and feel comfortable using “Not Otherwise Specified” categories that are less likely to carry stigma, to convey an aura of pseudoprecision, and to lead to unnecessary treatment.
Saving Normal : An Insider's Revolt Against Out-of-control Psychiatric Diagnosis, Dsm-5, Big Pharma, and the Medicalization of Ordinary Life (9780062229274) Page 23