Monday, February 22, 2010

False Advertising

We don’t usually watch TV at our house, so are a bit out of touch with TV advertising. However, with the Olympics, we dug up an antenna and suddenly the TV is back on. And what we’ve been watching is pretty amazing.

It’s not just that there seems to be more time spent on advertisements than on the Olympics itself. It’s the number of medically related advertisements as well as the misleading information they contain that made my jaw drop.

“High technology is best,” and “the more technology the better,” are clear messages in the advertisements for hospitals and medical devices. Hospitals are luring patients with the promise that they have the newest facilities and the most technology. The reality is, though, that when patients do need hospitalization, it is the amount of experience that the physicians have with the technology that makes the difference. New technology in inexperienced hands is a recipe for waste and bad outcomes. None of the hospital advertisements mentioned the actual complication rates for their facilities nor the number of doctors, if any, who had significant enough experience with the promised technology to actually be competent using it. There is no data out there that proves that a new building leads to better patient outcomes. Sure, patients like a nice, clean, facility. But don’t let the new gloss make you think that you will get higher quality care. You will, however, be getting higher cost care. The new hospitals imply that those pesky poor and uninsured patients won’t be showing up at their new facilities located in the wealthiest suburbs. They don’t mention that even if you have insurance, their higher charges will be reflected in your higher premiums. They make a profit. Your insurance company makes a profit. In the long term, though, everyone suffers.

A device manufacturer is advertising its hand held portable ultrasound machine to the public. They show a series of people who supposedly have abdominal pain; different health care providers, from ancient times to the present, come up to these patients and say, “let’s take a look.” No one actually examines the patients or even seems to talk with them. They go immediately to the “lets take a look” behavior. Finally, the current, modern doctor pulls up the patient’s shirt and does an ultrasound.

The message that technology brings us out of the dark ages and is far superior to “just taking a look” is very clear. What is not apparent, though, is the fact that the vast majority of diagnoses (up to 85%, as I was taught in medical school) are made on the basis of the medical history alone. In other words, if you want to know what is wrong with your patient, you talk to them. You ask them about their symptoms, when they started, what makes them better and worse, whether they are constant or come and go, that kind of thing. With a thorough history, a characteristic pattern emerges. For instance, the patient with pain in the upper right abdomen that comes on suddenly after a fatty meal, doubles them over, is so painful they can’t find a comfortable position, gets more and less severe in waves, lasts a couple of hours and goes away, is associated with dark urine and light colored stools, and may have shoulder pain associated with it, is most certainly gall bladder disease. A totally different pattern of symptoms characterizes a stomach ulcer or appendicitis or ulcerative colitis. When the history is classic, the diagnosis is certain.

Another 7% of diagnoses are made on the basis of the physical exam. In case the history may have been a bit ambiguous, the physical exam may not be. The patient with pain in the upper middle abdomen who jumps when you press on their lower right abdomen probably has early appendicitis. The patient with middle abdomen symptoms who has exquisite pain when you press under the right ribs probably has gallbladder disease.

After the history and the physical, laboratory and radiology tests simply confirm what the physician already knows. Once you’ve made the diagnosis of gallstones, it is just a matter of form to find them on an ultrasound. Funny thing, though. A normal test does not mean you don’t have the disorder suspected. An ultrasound isn’t going to show appendicitis. It may be normal if you’ve already passed the gallstone or kidney stone. It is rare, indeed, that a test shows something that you had no idea would be there. How convenient that the advertisers don’t bother to mention just how limited the usefulness of their tests really are. How frustrating for us that we are led to believe that we should pay several hundred dollars to have an ultrasound when our diagnosis can be made without it.

And then there are the pharmaceutical advertisements. These are illegal in most countries, and until a few years ago were illegal here. Just like the hospital and device advertisements, they are also misleading. They imply that your life will be better if you use their medication. For instance, a new lipid lowering agent implies that you need to take it to live longer and avoid heart disease. They do not mention that you actually will have results just as good if you take the generic version of medications already out there. And that you won’t have any adverse side effects if you lose weight and exercise. And that their medication costs 10 or 20 times what a generic costs.

There are ads for antipsychotic agents that imply that you need to take them with your antidepressant if you are depressed. They fail to mention that the best treatment for depression is therapy coupled with traditional antidepressants, and that there is no antidepressant out there superior in effectiveness to any other antidepressant. Further, there is no evidence that in those few patients who do not do well on an antidepressant alone that the antipsychotic they are advertising, which costs in the range of $800 a month, would be any more effective than any other available augmentation strategy, like a second antidepressant from a different class or low dose thyroid, both of which can cost under $10 a month and do not have the serious side effects that antipsychotics can have.

It would be wonderful if all medical advertising is eliminated. It leads patients to demand newer technology, meds, and facilities, which raise the cost of medical care in this country without resulting in ANY improved outcomes. Instead of medical advertising, we should have public service announcements that discuss the actual risks and benefits of treatments, the times that tests might be helpful, and presentation of evidence based recommendations for screening or treatments.

In the meantime, TV watchers sit there slack jawed, soaking in all that false information, wanting, even demanding, to have what they are told they want. In our house, though, we are taking down the antenna and turning off the TV. We will get to bed earlier, avoid brainwashing from all that advertising, and if we really need to watch the Olympics, instead of just reading about the results, we can watch it on the internet for free the next day. After all, the results don’t depend on whether or not we are on the other side of the TV watching. And they will be just as exciting, and probably more so, when not interrupted by the interminable ads. Now if I can just figure out how to avoid those pesky internet advertisements, too.

Wednesday, February 3, 2010

The marketing of Seroquel

The marketing of Seroquel


Seroquel is one of several medications called atypical antipsychotics that have changed psychiatric practice over the last decade. While older, “typical” antipsychotics, like thorazine, mellaril, and haldol, were very effective in the treatment of psychosis and schizophrenia, their use was limited by their serious side effects, especially movement disorders, which sometimes progressed to permanent disability. When the atypical antipsychotics were invented, they were heralded as safer medications without the risk of movement disorders, drug interactions, mental status changes, and other problems.

While there reportedly are 2.4 million patients in the US who have a diagnosis of schizophrenia, in most outpatient, private psychiatry practices, psychosis makes up only a small minority of patient problems, dwarfed in scale by depression, anxiety, and bipolar disorder, among other problems. Yet, over the last decade, the atypical antipsychotics, with Seroquel leading the pack, have come to dominate psychiatric prescribing in both the public and private sectors. According to Reuters, Seroquel generated $4 million in sales world wide, and is the leading seller of all antipsychotics.

AstroZeneca, the maker of Seroquel, has conducted a masterful marketing campaign for its product. Not only does it represent Seroquel as safer than typical antipsychotics, in marketing to physicians, Seroquel is promoted as not only being effective for psychosis, but also for bipolar disorder and as an adjust for depression. Some family doctors even use it as a sleeping pill and for anxiety.

Many physicians, including psychiatrists, get much of their pharmaceutical education from drug representatives. These salesmen and women are trained to appear concerned, compassionate, and well informed about their product. However, they conveniently neglect to mention, and the physicians seem unaware of, the CATIE trial, sponsored by the National Institute for Mental Health, and published in 2005. This large trial compared the newer antipsychotic medications with the older class of antipsychotic drugs, and showed that :

Contrary to expectations, movement side effects (rigidity, stiff movements, tremor, and muscle restlessness) primarily associated with the older medications, were not seen more frequently with perphenazine (Trilafon) (the drug used to represent the class of older medications) than with the newer drugs. The older medication was as well tolerated as the newer drugs (Including Seroquel) and was equally effective as three of the newer medications (including Seroquel). … Thus, taken as a whole, the newer medications have no substantial advantage over the older medication used in this study. NIMH

Also according to the NIMH, “about 80 percent of the prescriptions for antipsychotics are paid via the public sector. The new atypical medications, representing 90 percent of the current market, are approximately 10 times the cost of the older conventional antipsychotics.”

For regular folks who pay for medications out of pocket, perphenazine, which comes in generic, costs about $20 month, regardless of the strength. Older antipsychotics like thoridizine and haloperidol can be purchased at chain stores like Walmart or Target for $4 a month. Lithium, for bipolar disorder costs $4. Citalopram for depression costs $4. Seroquel costs $400 to $800 a month or more. For the non- public sector patient, that represents a 100 fold increase in the cost of their medications.

Seroquel is not a benign medication. There have been over 14,000 reports of Seroquel being associated with weight gain, diabetes, oversedation, movement disorders, and a myriad of other problems. AstroZeneca paid over $500 million to settle claims in 2009. And still, despite all the side effects, lack of superiority over traditional antipsychotics, lack of superiority over mood stabilizer for bipolar disorder, and lack of indications for sleep or anxiety, Seroquel continues to dominate the field among all antipsychotics. Because the company will lose its patent over Seroquel in 2012, it has already developed and patented a long acting form of the drug, which acts in the same way with the same side effects and is no more effective than Seroquel. They are aggressively marketing that form of the medication with the expectation that their new medication will have captured the market by the time Seroquel goes generic.

What I see now among the psychiatrists that work with patients in my statewide, managed practice, is that patients are frequently, if not usually, put on Seroquel or other atypical antipsychotics, and continued indefinitely, even in the face of unclear diagnoses. And these patients suffer the consequences. They get salivary gland infections and dry mouth, painful sustained erections, constipation, abdominal pain, acid reflux, weight gain, new diabetes, poor control of pre existing diabetes, medication interactions, and a host of other major and minor side effects. Even more frustrating is that when the prescribing psychiatrist is asked by the medical provider to reassess the use of Seroquel, invariably the psychiatrist simply switches the patient to a different, equally expensive, equally problematic antipsychotic. I suspect that the majority of these patients never needed an antipsychotic in the first place. Antipsychotics have become convenient medications for the management of problem patient behaviors even when the patients don’t have clear psychiatric diagnoses.

Certainly as patients, we all need to pay attention to unnecessary prescribing by our physicians, by asking for evidence-based information, by asking for generic medications, and for a treatment plan that is patient and diagnosis specific. This means that you not only know what you are being treated with and why, but how long the treatment is for and what you need to do in order to be able to get off the medication in the future.

And as citizens, we need to care about the enormous waste of money being generated by the undue influence of pharmaceutical companies. In order that our money is not continuing to be wasted on unnecessarily expensive medication that do not improve outcomes:

1. Drug companies should not be allowed to advertise prescription medications to the public. That practice is illegal everywhere else in the world and should be illegal here.

2. Drug company marketing to physicians should also be halted. They should not be allowed to sample medications to physicians, provide lunches or other sales pitches, and really should have no direct contact with the medical profession at all.

3. Access for physicians to accurate and evidence based information about drugs should be more accessible. Perhaps the AMA should get involved in informing physicians about reliable sources of information; perhaps licensing boards can require that physicians obtain unbiased pharmaceutical education for relicensing.

4. There needs to be oversight and regulation of medication use in public programs, including medicare, medicaid, community mental health, and others.

5. Physicians should be rewarded for practicing cost effective and evidence based medicine.

6. A national health program should include pricing limitations for pharmaceutical companies, federally supported and unbiased drug comparison research, and evaluation and monitoring of physician and hospital prescribing practices.

Saturday, January 30, 2010

More isn't better

Every day I see doctors, physicians assistants, and nurse practitioners relentlessly ordering medication after medication and test after test. Since I work in a closed and managed system, I can monitor and direct these providers to some extent. It seems, though, that the more I restrict/control the referrals, the more the providers order inappropriate laboratory tests and prescribe inappropriate medications. Those are harder to track and harder to put the brakes on.

Many people believe there is no harm to “a little blood test.” And many patients find comfort in getting lots of tests. Ordering tests must mean the doctor is thorough, is “looking for everything.” And if the patient gets a prescription doesn’t that mean the doctor knows what is wrong and is DOING SOMETHING for it?

Let’s look more closely at these suppositions. Say a patient comes to the doctor because he’s worried about some pain and burning in his upper abdomen and under his sternum. Many doctors would do a quick history and poke a bit on the patient’s stomach. They might order a bunch of lab tests, thinking they are being thorough. They might order a test, like an EGD (looking through a long tube at the patient’s esophagus and stomach), or a CT scan. Maybe they’d order a stress test to look at his heart. And an EKG. Maybe a chest x-ray. They probably would prescribe some medication.

So what is so wrong with practicing like this? In the medical field, it is called a “shotgun approach.” You just order every test to assess every possible diagnosis so as not to miss anything. After all, the blood work might suggest hidden bleeding or liver disease. And cardiovascular disease is extremely common. And what harm can there be in ordering a CT scan or in prescribing a pill?

In reality, talking with the patient, looking into his medical history and risk factors, should determine whether or not he is at risk of less obvious problems, not the blood work or other tests. There are risk tables published which doctors can use to assess whether a patient has a cardiovascular risk, for instance. Unfortunately, doctors rarely are trained in their use and don’t use them. Ordering lab tests is not a benign choice. The more lab tests done, especially in patients who are at low risk of a disease, the more likely the tests will not be accurate. Then the abnormal test results lead to more testing, more expense, more worry, more interventions.

These problems with laboratory testing apply to radiologic and other testing as well. Many doctors might do testing for our guy with heartburn, just to “rule out” more serious pathology. Again, in a patient with few or no suggestive symptoms, this testing is unlikely to be productive and often causes harm. For instance, a significant proportion of people who get CT scans of the abdomen have small tumors found in their adrenal glands. This finding is so common these tumors are nicknamed incidentalomas. The vast majority of these are benign, but you can’t tell if they are benign or cancerous on the CT scan. So then what do you do? You can repeat the CT scan in a few months to see if the tumor is growing. That doubles the patient’s already high exposure to radiation. You could do some other test, an MRI perhaps, at exponentially increasing cost, without much improving the quality of the information obtained. Or you could get a biopsy by doing surgery. That gets you a definitive diagnosis, proving, probably, that it is indeed, not cancer, but at a cost of $10,000 or more, and exposes the patient to all the side effects and risks that go with surgery. Yikes. All because of heartburn.

So doctors need to go back to being doctors. Since each diagnosis has a typical set of symptoms, a doctor should be able to match up his patient’s symptoms with the spectrum of symptoms that goes with a particular disease. In this case, if the patient eats fatty foods and gets pain under his lower right rib cage, that goes with gall bladder disease. If he gets heartburn after he eats a big meal and lies down in bed, that suggests acid reflux. If he gets upper abdominal pain after a drinking binge, that is probably gastritis. If he gets heartburn or pain under his sternum after eating spicy or acidic food or drinking coffee, that is probably acid reflux. If he gets crampy, lower left abdominal pain with alternating diarrhea and constipation, he most likely has irritable bowel syndrome. Of course you can’t count on patients having all the classic symptoms of a particular disorder, but when they do, there is no reason to do tons of testing to make the diagnosis. Taking the time to ask careful questions goes a tremendously long way towards making an accurate diagnosis.

So in our patient above, let’s assume he eats certain foods or lies down after a heavy meal and gets heartburn or pain under his sternum. There is absolutely no reason at that point to draw lab tests or order xrays or CT scans. The proper, safe, cost effective, and correct approach is to teach the patient about what is causing his symptoms (acid from the stomach sloshes into the esophagus and causes pain or spasm), and how his diet and behavior makes these symptoms worse (fatty foods and a full stomach cause the sphincter at the bottom of the esophagus to relax so the acid can slosh up there). Then you teach the patient what to do about these symptoms – like avoiding big meals in the evening, cutting down on fatty foods, avoiding caffeine, spicy foods, or acidic foods that may be aggravating his symptoms.

So why not start right out with medication and not waste time with all the diet change stuff? He’s probably not going to do it anyway. It would be a quick fix. The patient never needs to come back and the doctor has cured him. Perhaps the major down side to relying on medications rather than behavior change is that once the patient’s symptoms are relieved by a pill, he has no motivation to change the behaviors, like his diet choices, that lead to the problem in the first place. The doctor feels better writing the medication; the patient feels better taking it; but the cause of the problem is never addressed. His stomach contents still slosh into his esophagus but now they are not acidic enough to cause symptoms. Stop the medication, the symptoms start right up again.

And what if the patient is already taking four or five other pills for his diabetes and blood pressure and cholesterol? It is clear that the more medications you take the more likely it is they will interact in adverse ways. The more medications prescribed, the more difficult it is to be compliant with taking them all. And while the consequences of missing his medication for heartburn might not be serious, missing the blood pressure or diabetes medications could be disastrous.

But if the doctor doesn’t opt for the quick fix, it is imperative that the patient is followed over time. An older family doctor at my residency program taught us that we should never let the patient leave our office without a plan for him to come back. That is really important. If the initial diagnosis was wrong – the patient gets worse, his symptoms change, the behavioral approach didn’t help – the doctor will be able to reassess the case. A change in treatment might be in order. Or a change in diagnosis. Often as the patient learns more about potential diagnoses, and pays more attention to his symptoms, the picture of what is wrong changes. Maybe then a test or medication may be justified.

While heartburn may seem like a trivial diagnosis here, a slower, deliberate, thoughtful approach to diagnosis and treatment applies to many, if not most, patient complaints. In the practices I supervise, many doctors, nurse practitioners, and physicians assistants order blood tests for everything from aches and pains to rashes. They order MRIs for chronic headaches; radionuclide cardiac stress tests for stable angina; and prescribe lotions, creams, laxatives, anti-inflammatory medications, aspirin, Tylenol, stool softeners, cortisone cream, etc, for chronic use with refills that go on forever. One provider alone has managed to generate $100,000 a month in excessive prescribing. Just think how much money is wasted nationally, as this practice is repeated millions of times over.

Fixing the habits of doctors will be difficult. Our current medical system provides no incentives to doctors to change their ordering and prescribing habits. Patients are influenced by drug company advertising that suggests every problem should be treated with a pill. Patients also have misperceptions that tests are infallible and necessary. Many medical providers who are employed by hospitals are tacitly encouraged to order expensive testing, as the hospital provides these services and makes a solid profit on them. And the systems that encourage doctors to see 30 or more patients a day drive the over prescribing as well. It takes less time to write a prescription than to carefully identify the problem and work with the patient on effective management. The patients get seen but very little gets solved.

My job enables me to chip away at these practices, to question doctors’ assumptions, to develop logical and cost effective approaches to diagnosis and treatment. Hopefully, as financial pressure in the health care realm escalate, this kind of supervision will become more common. I think it already is necessary.

Tuesday, January 26, 2010

Making sense of medicine

Don't be fooled; the health care in this country is NOT the best in the world. We may have more technology, fancier gadgets to do our surgeries for us, more expensive materials in our prosthetic devices. But our life expectancy is not the highest in the world. Our neonatal mortality rates are far from the best. Unwanted pregnancies cost us millions, even billions, in added costs - from poor birth outcomes to family violence, psychiatric problems, substance abuse, delinquincy. We die of obesity and cardiac disease at higher rates than anywhere else in the world. And we pay more than anywhere else in the world for the privilege.

Medicine doesn't make a lot of sense these days.  Patients are bombarded with information from all kinds of sources, and figuring out which are credible and which are not is a daunting task.  Physicians are also bombarded with information, just as their patients are, including pharmaceutical advertising, device manufacturers, well meaning patients, and the anecdotes they witness through the care of individual patients.. 

If they want to practice with integrity, physicians and other providers must find their own sources of education, take the time away from patient care to study and read and research in order to keep updated on the latest information.  They must be honest about the frequency of disease and the effectiveness of treatments, and objective about each individual patient.  Objectivity can be difficult to maintain in such an emotionally charged field as medicine.

  The cost of medicine is frequently secondary in the thought processes of physicians.  For the sake of expediency, they often prescribe the newest, most expensive medications because they have samples or because they honestly believe they are better, and not because they really understand how these medications compare to others on the market in terms of cost and effectiveness.  Primary care physicians make referrals to specialists sometimes because specialist care is needed.  More often, though, the referrals are made to speed patient flow in their office, to avoid having to take the time to research a medical problem, or because the physician honestly doesn't know how to proceed and can't afford the time to figure it out. 

It takes time for a physcian to practice thoughtfully.  And in our American world, money talks.  The patients with insurance get appointments.  The more appointments the more money.  The shorter the appointments, the more that can be scheduled.  Patients without insurance, or without the right insurance, can go elsewhere.  Or nowhere.

In my work, I advise primary care physicians and midlevel providers on how to manage the patients' medical problems in a cost effective way.  I research the problems when they cannot (or will not) and recommend management - treatment and/or testing that is supported by the medical evidence and that is cost effective.  I don't know everything there is to know.  But I do know how to find out many of the answers and how not to waste money.    And that is a start.