Naked Medicine

Dan Abshear

Lately in the media, others have said and expressed concern about the apparent shortage of primary care doctors, most notably. Typically, the main reason stated for this shortage is lack of pay of this particular specialty compared with others chosen by potential physicians.

Yet considering the additional attention of shortages of students in some medical schools, one may ask the question as to whether or not people want to be any type of doctor in the first place in the United States. About one third of their lives are spent achieving the requirements of this profession. Reasons for not choosing to enter this profession are several and valid.

There is the issue of long hours- with primary care in particular because of the apparent lack of doctors of this specialty. Such doctors may be over-worked without an expected pay reflecting the work they do. Furthermore, those doctors employed by health care systems are required to see a certain number of patients a day, and receive a monetary bonus if this expectation is exceeded. It seems that most doctors are members of such health care systems. So burnout certainly may occur. And I consider such a requirement mandated by health care systems demeaning to this profession, and leaves the doctor without the control that the doctor is entitled to due to their training and experience.

However, the recent increases in hospitalists, who are those doctors that are usually Internal Medicine doctors who specialize in patients presently under hospital care, and they have lessened the load for all doctor specialties for the work they do that the admitting doctors would have to do without their presence. This in itself makes a doctor possibly more effective and efficient in their practice outside of the medical institution.

All doctors, I presume, face a high degree of emotional and physical stress associated with their profession, as stated in the previous paragraph, for example. And this is not to mention the incredible stress associated with patient care in the first place, with some patient cases causing more stress than others

Doctors, due to the changes that have occurred recently in the U.S. health care system, not only have the issue of money to deal with, but also a loss of autonomy regarding patient care combined with loss of respect that may be due in large part to others dictating on how they practice medicine. Ironically and often, these others are not as qualified as the doctor in the first place. This is complicated by the perception that the public, with some who view doctors as having the easy life with their pay and profession, which does not seem to be the case presently.

There are also reasons of malpractice insurance, which is why doctors choose to join health care systems, it is believed, to pick up the tab for this necessity, along with eliminating the concerns of running a practice in a private manner, which historically has been the case, as their offices are owned by the health care system as well.

Up to 90 percent of malpractice cases against a doctor are baseless and without merit, so they are unsuccessful for the plaintiff, yet this still affects the rate the doctor has to pay for malpractice insurance. I understand that simply filing a lawsuit against a doctor, as frivolous as it may be, still increases the malpractice premium of that doctor. This is combined with the amount the doctor has to spend to defend themselves in such cases, which approaches about 100,000 dollars over the course of about 4 years for such cases. A tort reform in Texas in 2004 resulted in annual malpractice premiums reduced by about a third of what they were. Soon afterwards, claims against doctors remarkably dropped by about 50 percent. Some specialties of doctors pay more premiums for malpractice than others. For example, OB/GYN doctors have been known to pay around 300 thousand dollars a year for this insurance. Certain types of surgeons experience a similar high rate of malpractice premiums.

Also, about a third of the U.S. is insured by Medicare, which progressively has lowered what they will reimburse a doctor for regarding the care they give a patient they treat. This fact is recognized by other insurance companies who will eventually follow the recommendations of Medicare, usually, regarding the reimbursement issue, so it seems. This will lead to a doctor having to see even more patients in order to make it financially with their profession, as this has resulted in the overall income of a doctor experiencing a decline of about 10 percent over the last decade.

Furthermore, doctors normally have to pay off the debt acquired from attending medical school, which averages well over 100,000 dollars today after their training. About 20 years ago, that debt was only about a fifth of what it is today. Paying this debt off is typically about 2 thousand dollars a month that doctors on average have to pay in order to eliminate this debt in a timely fashion. There are some who believe that doctors in the U.S. are over-paid. This may be true, but they are not absent of financial concerns as with any other profession.

Most doctors do not recommend their profession to others for such reasons stated in this article, and perhaps others not mentioned. This is somewhat understandable, yet extremely unfortunate for the health of the public in the future, especially. There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession. Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall.

No all doctors are saints. Like others, some are greedy and corrupt, which complicates others in this profession. Personally, I believe that the intentions of most physicians are bona fide. Yet in time, due to the nature of the current health care system, doctors frequently become cynical and apathetic, and this may be considered a significant concern to the well-being of those in need of restoration of their health.

Not long ago, the medical profession that has been discussed had honor and an element of nobility. Such traits are not as visible anymore, which saddens many intimate with the profession needed by many.

“In nothing do me more nearly approach the Gods then in giving health to men.” — Cicero

Disclosure: The author was formerly an employee of the pharmaceutical industry (sales) and is currently seeking employment in the same industry.

By Dan Abshear

Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.

As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.

Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons.

First, I’ll offer a definition of a retail clinic: A retail clinic is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen t o go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic:

They are quick. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients.

You actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day, as this is coerced and dictated by the health care system that employs these primary care doctors you may have seen in the past, which is typically the case.

The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic, is usually about ¾ the cost of a typical primary care doctor visit.

You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level.

Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf.

If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will be referred to a location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely relationships with the hospitals and others in the medical community for which they serve.

So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept is new, so only time will tell regarding their popularity with various communities.

The clinics provide a response to the shortage of primary care doctors, and possibly are an answer to other problems that exist in the health care system in the U.S. The clinics are more authentic, and are therefore more beneficial for public health in many different ways.

“Follow where reason leads.” — Zeno of Citium

Disclosure: Author Mr. Shear was formerly an employee of the pharmaceutical industry (sales) and is currently seeking employment in the same industry.

By Dan Abshear

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.

Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men who have prostate cancer in the United States. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA (Prostate Specific Antigen) blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.

Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxotere (Sanofi Aventis, docetaxel). The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.

Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as urologists and oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.

Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!

Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.

Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.

The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.

“Facts do not cease to exist because they are ignored.” — Aldous Huxley

Welcome to this carnival edition of Brain Fitness, where NakedMedicine.com is a guest host. Those of you familiar with my carnival styles will know that I weave entries with my own comments and wherever possible, create a theme for a cohesive reading experience. Thus you will not find a mere listing of entries here, nor will you find every single entry that has been submitted to the carnival. Be assured that even if all entries are not selected for this carnival, I personally visit and read each article.

Mind.
According to Rich, power naps help you reap the benefits of sleep in about 20 to 30 minutes without migrating into the “sleep inertia” zone that can render you sluggish and tired. Psychologist Deb Serani had also written about the benefits of power napping previously on NakedMedicine.com. I’m curious whether power naps have the same level of benefit for someone who gets enough sleep each day. I know this is a rarity – most of us seem to be sleep deprived on way or another – both on a quantitative and qualitative sleep level, but it will make an interesting experiment.

I also knew there is a perfectly reasonable scientific explanation on why multitasking is a myth! Now, if we can get the corporate world to stop embracing multitasking like it’s a virtue instead of the dangerous assumption that it is. Dr. JC also notes a NYT article that discusses the multitasking myth.

Matter.
This a really interesting looking exercise for balance and posture. I have pretty good balance, but my posture can use a lot of work.

Caroline at Sharp Brains said that the 4 essential pillars for a healthy brain are: 1) Physical Exercise, 2) Mental Exercise, 3) Good Nutrition, and 4) Stress Management. I like the way this included a “if you could only do one thing, do this…” For physical exercise – do something cardiovascular. For mental exercise – learn something new every day. For good nutrition – eat more green, leafy vegetables. For stress management – take 5-10 minutes each day and breathe deeply.

Greg’s article on the physical aspects of brain aging is a good primer for those interested in understanding how their brain physically ages, and what may be done to manage the aging process. You’ll find this article complementary to Caroline’s article on brain fitness.

Mind Over Matter.
Dave Johnson claims that We Are Smart Enough To Make Ourselves Sick and cited a Stanford Neuroscientist who observed that baboons are good models for humans in self-induced stress. Given that baboons lead an otherwise idyllic life, one would be surprised that find that baboons can work themselves up into a stressful frenzy anyway. What is even more surprising is that it’s not only the “loser baboons” – those with low social ranking – that get stressed out. The type A baboons also get stressed out because they are threatened very easily. Another cited study looked at the linkage that can be formed between a concept and emotions associated with that concept; what is interesting is how easily this linkage may be manipulated to cause unfounded feelings (thereby eventually behaviors) of “like” and “dislike”. This is why I’m a big proponent of understanding how you truly think.

Now, if those baboons had read TherapyDoc’s essay, When the Little Things Go Wrong, they will realize that life is good, relatively speaking. The loser baboons will learn new things that can make them mentally smarter (per Caroline’s earlier advice). The type-A baboons can put things in perspective and realize that while the higher you go, the harder you may fall, at least you get the opportunity to go high enough to fall. Plus, from the looks of enlightened loser baboons, life looks enjoyable.

Hueina’s article on self-love is a comprehensive first look at what she calls “the most important relationship in your life”. What Hueina calls “gremlin messages”, I know first-hand. I even have an old book that personifies these critical self talk as gremlins (I forget the author’s name). What’s important to realize is that developing this relationship with yourself is going to take your commitment, which means it is going to take time and effort. This also tends to be most difficult when you most need it – for example – when you aren’t feeling good about yourself, you aren’t inclined to sit down and do exercises that develop your loving feeling toward yourself – yet this is when you need it the most.

Henrik shared a list of 14 ways to live a more relaxing life. My favorite tip is #7, watching your favorite TV show. I never used to watch King of the Hill when it was running, but now I watch re-runs of the cartoon. There’s something about a well-adjusted chubby kid and stoic work ethics (Hank Hill will not leave 10 minutes early on a Friday even if there are absolutely no customers, nothing to do, and a car full of friends waiting outside for him) that makes me feel like all is right with the world. I’d like to suggest a tip #15: “The World Will Go On, and So Will I.” I find this very effective on those nights when I toss and turn from lists of things I should have done and still have to do. I have to remind myself repeatedly that what I deem as critical from the filters of my stressed out mind won’t stop the world on its tracks, and that twenty years from now, I probably wouldn’t deem it as important, either.

Thank you, Alvaro, for the opportunity to host this carnival. The next Brain Fitness carnival will be hosted by Idealawg on May 21, 2007. Please support this upcoming edition with your posts!

Until next time – take care of yourself and your gray matter.
Jane

By Sally Satel, M.D.

On the front page of the Washington Post last week was a headline geared to spark the ire of those who have a congenital animus toward pharmaceutical companies–”Comparison of Schizophrenia Drugs Often Favors Firm Funding Study“.

The Post article noted that, according to a recent study, nine out of ten head-to-head company-funded clinical trials of antipsychotic medications were found to favor the drug whose maker funded the study.

The study, published in the February issue of the American Journal of Psychiatry by German and American psychiatrists, reviewed 30 drug trials of second-generation antipsychotics, also called atypicals, published between 1966 and 2004. Five drug companies were responsible for underwriting these 30 trials.

Aside from its headline, the Post article was well done and revealed important lessons from the study. For instance:

1. From a clinical standpoint today, it doesn’t matter much which drug wins a horse race.
2. The company studies provide useful information, not pabulum.
3. Most important, we need more research.

Let’s look at these points one by one.

In the real world of practice trial results are less important than you think. In modern psychiatry, there are no first-line drugs. Years ago, by contrast, lithium was the pharmaceutical of choice for maintenance treatment of the manic symptoms of bipolar illness. Today, the FDA has approved several mood–stabilizers (anticonvulsants) for treatment and suppression of mania, not to mention off–label drugs.[1] Take posttraumatic stress disorder. Today, only two SSRI–type drugs are FDA approved for PTSD but they are not dazzlingly effective. In fact, because the condition varies so much from patient to patient, other medications that are not approved for the condition (e.g., low-dose antipsychotics, anticonvulsants and benzodiazepines) can be very helpful in certain individuals.

Why do doctors struggle so much to find effective treatments? The state of the art in prescribing effective antipsychotic drugs is still pretty poor and, as a result, doctors are often forced to take a trial and error approach. When starting a depressed patient on an antidepressant or an antipsychotic, doctors typically choose the drug they are most skilled in using. This is a perfectly reasonable choice, given our rather slim knowledge about how to tailor medications for each patient.

The largest and most recent government–funded studies tend to be enormously humbling for physicians and companies alike. Data from the new STAR*D Study (Sequenced Treatment Alternatives to Relieve Depression) show that only 25-33% of subjects achieved full remission with antidepressants.[2] (Granted, a higher percentage of patients had partial relief, and sometimes that is enough to improve daily functioning significantly. Still, higher rates of full-remission are surely desirable.)

Another study, CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness Study) found that three-fourths of all subjects asked to stop their antipsychotic, either because it was not helping or because side-effects were unacceptable to them.[3] The CATIE study lasted an unprecedented duration (18 months) and enrolled an unprecedented number of subjects (nearly 1500), thus permitting a fuller picture than most other clinical trials.[4]

For the record, psychiatrists do have some guideposts in selecting drugs. In my own practice, I rely on four rules of thumb for using (or avoiding) a specific drug. I use a particular treatment (1) if the patient had a good response to it during a prior treatment episode, and (2) if a close relative benefited from that drug (aka: the pharmacogenetic rationale).

I avoid treatments if (1) the patient says he would find a side-effect totally unacceptable, such as weight gain. If the medication poses a sizeable risk of causing a medical complication, such as worsening hypotension, diabetes or high cholesterol, I still might use it but watch the patient very carefully. I also avoid treatments if (2) a drug is very expensive–and the patient has to pay out of pocket. In that case, I use a first generation, generic antipsychotic and follow for signs of tardive dyskinesia, a movement disorder that can emerge with long-term use.

Company funded studies still provide useful information. It is no mystery (or conspiracy) why studies comparing the same drug can come out differently. In short, they are conducted using different designs, different statistical tests, and/or different outcome measures. Anyone can read the published studies and see for themselves how they differ. There is transparency here, but the psychiatrist must take time to read the entire study, not just the abstract.

Some factors that can favor one or another drug are: the doses used (e.g., a low-dose of a clearly superior drug will make it seem lame when compared to a standard dose of an inferior one), the duration of the study (i.e., trials may be only four weeks long but different drugs may have different times to maximum effectiveness), and outcome measures (i.e., reduction of psychosis but not behavioral withdrawal, or vice-versa).

One can be forgiven for wondering whether some trials have been conveniently engineered to make the sponsor look better–for example, when a low dose of a competitor’s drug is used or when the researcher doesn’t seem to look too hard for side effects or doesn’t report all of them. On the other hand, often researchers truly don’t know to look for a novel side effect or do not know what the optimal duration of study should be. Why? Because we need to know more!

We need more research. This is the main conclusion physicians, patients, and the media should take away from February’s American Journal of Psychiatry study. The main limitation of so many clinical trails is that the data they yield don’t help the clinician with a specific patient. The kinds of information psychiatrists need are how to home in on a medication that will be best for a particular patient. Switching around medications and dealing with bad side-effects take large tolls on patients. Not only do they cause suffering or vast inconvenience, these adverse events problems can cause poor compliance or outright refusal to try any other drug. It is demoralizing to a patient to continue to be sick and to go from one drug to the next; he starts to fear he will never get better. And, of course, it is a problem, though a routine one, for the physician.

Legitimate concerns about clinical trials abound. For instance, how do the findings of clinical trials compare to patients that physicians see everyday (who are, generally speaking, more likely to have other mental and physical problems)? Clinical trials typically enroll subjects who have classic symptom constellations and are medically relatively healthy. As well, such subjects are able to give informed consent; very psychotic patients often cannot. Also, do differences in drugs justify differences in cost and how do those differences vary across patient subtypes? And, of vast importance, what drugs really help the patient get better, not in just alleviating symptoms, but in terms of day-to-day functioning?

Pharmaceutical companies may not be interested in these questions. Either the National Institutes of Health or some other government or non-profit entity could conduct these trials. Currently, only NIH can sponsor studies large enough to involve a sufficiently large number of patients that the results yield more clinically-relevant information. That’s a major weakness of company-sponsored trials, no matter how well done. An additional virtue of non-industry funding is that the specter of conflict of interest is erased.[5]

Schizophrenia is one of the most mysterious and vexing diseases in psychiatry. The most afflicted often give up their lives to it. They are desolately lonely and tormented by hallucinations and paranoia. Neuroscientists have made tangible progress but the etiology or etiologies of the disease (the most popular theory is that gene mutations lead to abnormal development of neural circuits, particularly in the context of external stress, but a number of respected researchers have even suggested a viral cause) remain murky. This makes it difficult for physiology to inform drug development.

There is no question that some patients have Lazarus-like recoveries when the right medication is found. The search, though, can be a time-consuming pharmaceutical odyssey. Worse, however, is that not enough patients get excellent results. Clearly, we need more evidence about the medications we have now and even better drugs in the future.

We shouldn’t become cynical about the companies pursuing these cures. Competition between competing therapies broadens our understanding of mental illness and can help researchers chart a course towards the next generation of treatments. In a sea of uncertainty, that’s the best we can hope for.

Dr. Sally Satel is a resident scholar at AEI.

Notes
[1] Some psychiatrists consider clozapine (now off patent) to be a first line drug for schizophrenia. It has been clearly demonstrated to be superior to other atypical antipsychotics but is not very popular because of the necessary blood monitoring. Also, because it is generic, there is no pharmaceutical advertising behind it. See Tamminga, C. Practical Treatment Information for Schizophrenia American Journal of Psychiatry 163:563-565, 2006. Of interest, now lithium is making a comeback. A number of new studies have shown that it has a significant suicide-prevention effect, see Tondo L., Hennen J., Baldessarini R.J Lower suicide risk with long-term lithium treatment in major affective illness: a meta-analysis. Acta Psychiatrica Scandinavica, vol. 104, Number 3, September 2001, pp. 163-172(10); Cipriani A, Pretty H, Hawton K, Geddes JR. Lithium in the prevention of suicidal behavior and all-cause mortality in patients with mood disorders: a systematic review of randomized trials. Am J Psychiatry. 2005 Oct;162(10):1805-19; Kessing LV, Sondergard L, Kvist K, Andersen PK. Suicide risk in patients treated with lithium. Arch Gen Psychiatry. 2005 Aug;62(8):860-6;Muller-Oerlinghausen B, Felber W, Berghofer A, Lauterbach E, Ahrens B.The impact of lithium long-term medication on suicidal behavior and mortality of bipolar patients. Arch Suicide Res. 2005;9(3):307-19.

[2] Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1305-7;Rubinow DR Treatment strategies after SSRI failure–good news and bad news. N Engl J Med. 2006 Mar 23;354(12):1305-7.

[3] Lieberman JA, Stroup TS, McEvoy JP, et. al. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia.N Engl J Med. 2005 Sep 22;353(12):1209-23.

[4] And, still, patients on first generation, or typical, antipsychotics were not followed long enough to track emergence of tardive dyskinesia, the major aversive side-effect from long term use.

[5] Other suggestions: perhaps the FDA could require a new medication be included in at least one large, long-term trial funded by the company and designed and conducted by an independent group at the expense of that company or jointly supported by NIH. Alternatively, one could have the FDA require that as part of Phase IV (post-FDA approval) that companies would be obligated to contribute to CATIE-like studies to see how effective medications are when used they way clinicians use them for the patients that they treat. Since these would be head-to-head studies, several companies would contribute and this would combat any bias that could be alleged when a single company pays.