Naked Medicine

Let's Face It: Medicine is Business

Category: Doctors

CME and Pharma: Doctors Want Support That They Can’t Trust

“Doctors want CMEs paid for them but can’t trust the people they want to help pay for their continuing medical education.” That’s how I sum up the below survey published by Archives of Internal Medicine.

Look at what the conclusion said: “Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.”

If doctors are so concerned about ethics and bias, then they need to put up the money and pay for their own continuing education to stay current in their fields so that they can do their jobs. But based on “reality”, doctors are more concerned about their bottom-line and the survey suggests that their bottom-line trumps whatever concerns about bias they may have.

Clinician Attitudes About Commercial Support of Continuing Medical Education

Results of a Detailed Survey

Jeffrey A. Tabas, MD; Christy Boscardin, PhD; Donna M. Jacobsen, BS; Michael A. Steinman, MD; Paul A. Volberding, MD; Robert B. Baron, MD, MS

Arch Intern Med. 2011;171(9):840-846. doi:10.1001/archinternmed.2011.179

Background Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding.

Methods We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support.

Results Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding.

Conclusion Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.

Would You Cancel a Surgery if Your Surgeon is Getting a Kick-Back?

The specific question is about getting kickbacks as a surgeon using a medical device, and was originally asked on Quora. The explanation to the question (posted by the asker) said,

“The department of justice has investigated conflicts of interest, and the Pittsburgh Post Gazette has published on the topic. To quote from the gazette:

Payments to other Pittsburgh area physicians include:
• The Orthopaedic Group of Pittsburgh received $75,000 to $100,000 this year from Smith & Nephew, and two of its doctors, Ari Pressman and Allan Tissenbaum, received individual fees. Smith & Nephew reported paying the same range of fees to Carnegie Mellon University, and to Carnegie Mellon professor Dr. Jeffrey O. Hollinger, a bone tissue regeneration expert.

• Biomet has a relationship with the University of Pittsburgh Medical Center’s Department of Orthopaedic Surgery, through Dr. Freddie H. Fu and Dr. Christopher Harner, paying $75,000 to $100,000.

• DePuy’s largest payment went to Dr. Lawrence Crossett, a UPMC surgeon who has received $250,000 to $275,000. On Dec. 6, he’s scheduled to perform two knee replacement surgeries, which will be broadcast over the Internet by DePuy and viewed by doctors.

• Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.”

Regrettably, this is a relatively small fraction of the total physicians, giving the impression that most physicians have these conflicts of interest. Fortunately, the department of justice’s investigation has helped curtail these conflicts of interest. Having said that, if you discovered the night before your procedure that your surgeon has such a conflict, would you proceed with your surgical procedure or would you cancel it? Assume that the procedure is elective, not emergent.

I think there are various caveats to the question being asked, and perhaps, a different way of asking the question that can help the patient make better decisions about whether to stay with the surgeon or find another doctor:

Questions that came to my mind were:

  • Does the surgeon opt to cut when there is no clear benefit to surgery or when another therapy would give as good of a result?
  • Does the surgeon opt for one device over another device and is this decision based on a kickback or is it based on clinical data that suggests a benefit for the patient’s profile?
  • Is the surgeon an inventor or co-inventor of the device?*

Conflict of interest comes to light when surgeon has mostly a financial incentive to choose one device or another or to recommend surgery over nonsurgical alternative if there is no clear clinical benefit or if the recommendation introduces new side effects to the patient.

The last point that I marked with * warrants discussion because this is not so “clear cut” a conflict of interest as the first 2 bullets. In devices the physician may be an inventor or coinventor and then licenses the technology or device to a company.

Even though the physician may have a conflict of interest – by receiving royalty payments for example – the physician is also the best expert on the technology that s/he has invented, so the choice to go for one’s own device may have less to do with a kickback and more to do with the physician’s belief in the invention’s efficacy/benefit.

Here’s a link to an article a while back (and how I got the “mostly royalties” impression) from WSJ when device companies had to post what they’d paid to orthos – although the asker rightly pointed that that the medical device company engineers are probably the majority of inventors to the technology rather than the MDs themselves.

Yet there’s also the argument made by Andy Lemke on Quora (in the comments section) that a doctor who serves as consultants to several companies must know his/her stuff since s/he is so sought after by device companies, so it’s not necessarily going to hurt that physician’s integrity in the eyes of the patient.

Why I Chose NOT to be a Doctor

I was once a premed.

I chose not to become a doctor because I wasn’t truly interested in the profession, it was something I felt I “had” to do or “should” do because I happened to major in biology. And being a first generation Asian-American there was also pressure from being a “Tiger Cub”: we have limited career options: doctor, lawyer, engineer. I suck in math and was good in biology. Guess which option I had?

In my undergrad classes I was among other premeds; many of them went in for the Money, the Prestige, for their Parents. But they will all talk about how much they love helping people/patients on their applications.

I did consider taking the MCAT and even paid for one of those “prep courses”, in case I changed my mind. But I knew my grades weren’t good enough, I didn’t have “connections”, and I wasn’t going to throw good money after a bad risk, especially when that money was already borrowed money via student loans. I went to grad school instead.

Then I started working in the healthcare industry, first working for the pharma industry. Maybe the nature of my work in pharma predisposed me to witness the doctor-industry relationship in a way that brought out some of the unsavory traits of the medical profession.

I saw some of these doctors up close – their lives (and lack thereof), their values (and lack thereof), their character (and lack thereof), bedside manners (and lack thereof).

We are constantly reading about how “evil” the Pharmaceutical Industry is and how they corrupt doctors and so forth – that gets a lot of coverage in the presses. Well, I’ve seen it from the other side: there are doctors who have become savvier businessmen than they are savvy clinicians and they are perfectly capable of manipulating drug companies to fulfill their personal interests. I’ve had doctors asking me for favors that I knew had nothing to do with improving patient care. I’m not embarrassed to admit that my first year of working in industry had almost completely destroyed the trust I used to have in doctors.

I saw the state of Managed Care and the “healthcare business” that has made doctors more busy with administrative work than taking care of patients. A HMO doctor once explained to me that he goes through each day making sure he breaks even by seeing 50 patients. He knows how much $ he gets paid per patient from the HMO. So he has to see a certain # of patients to stay in business. Depending on the patient’s condition, say the patient has a cold, he’d spend a few seconds with the person, and knowing that the patient would expect “something” for the visit, the doctor would write a prescription for an antibiotic just to get that patient out of the office, so he could see the next patient.

The medical profession was not something I’d ever wanted for myself if I did not have a deep-rooted passion and conviction about going into the profession. In fact, the medical profession is one that I would not encourage my child to go into, unless again, he expresses a serious conviction about becoming a physician. I actually have to be careful about my own prejudices – that I do not vehemently discourage my child from considering this profession. That would be as bad as the Tiger Mothers who force their children into the medical profession.

I know this puts me in the “outlier” group of Asian mothers. But then again I’ve always been an outlier.

Which Side Are You Really On, Jane Chin?!

I received what is probably the most passionate email from a reader of this blog that I’ve ever gotten since creating NakedMedicine.com in 2006. The email concludes with this:

I can’t figure out what your agenda is Ms Chin. Are siding with the poor hard working physicians who are fighting a losing battle with their idiot patient’s lifestyles? Are you siding with the tirelessly industrious pharmaceutical scientists who are selflessly dedicating their efforts to cure our ills? Are you siding with the poor neglected suffering individuals who are bravely pushing onward in their lives, struggling with disease, possible disease, possible pandemics, or just plain plainness requiring cosmetic medicine? Doctors, business, persons, for whom are you advocating?

I was shocked by the email, because this reader “hit the nail on the head”! He can’t figure out what my agenda is, because my agenda is in NONE of those sides he described. In other words, if I were guilty of picking “a side”, it wasn’t part of the “usual suspects”.

Here’s my very long response to my reader, to whom I’m grateful, because he took the time and effort to share with me this question that obviously is frustrating him.

******

You wrote what you felt, and I don’t fault you for that. I can sense a real feeling of frustration from you, and I don’t blame you for feeling frustrated about the healthcare system that seems to be broken in many ways.

I want to address specific points you brought up – first one being ‘cures’. I genuinely don’t think that the drug industry is prevented from, or are resistant to, discovering cures for diseases. It’s not about ‘cure’ versus ‘not the cure’ that is the problem. It is often the economy of scale that is the problem, and a very understandable one when you consider that the drug industry is – and has to run like a business – in order to remain in business. I have no doubt that the drug industry would love to find a cure – because they can charge for the price of a ‘cure’ and be justified in charging such a price.

The problem on the one hand is that many times we simply cannot find ONE underlying factor of a disease, especially the chronic diseases like diabetes and heart disease (in fact, many diabetics die of a heart attack and don’t live long enough to die of diabetes complications, especially those consuming a western diet). It is not like a bacterial infection where we can pinpoint ONE origin of the disease and target that specifically, the way we can target an infecting bacteria with an antibiotic and ‘cure’ the patient.

The other problem is about the number of people with a certain disease. For example, there may be fewer companies willing to research rare diseases that may be ‘repaired’ let alone ‘cured’, simply because the companies need to get the money somehow to do all the experiments and clinical trials necessary to jump through regulatory hurdles to even get the drug approved. When i was a graduate student, doing what are pretty simple experiments (and not even in people – i worked off the petri dishes), i was often using reagents that cost my employer thousands of dollars to purchase from reagent companies. Each of my experiments has to cost at least a thousand bucks, and many of my experiments failed and produced no result.

These prices are nothing compared to the amount of money it costs to run a clinical trial at the scale required by the FDA. Now the drug companies have to pay for the drugs, the cost of mountains of paperwork needed to get the clinical trials started, the doctors who do the clinical trials (and some doctors get really snobby and brag to each other about how much $ they can muscle out of drug companies “per patient” to enroll in the drug companies’ trials), not to mention the “overhead” that the academic institutions charge the drug companies because their doctors work there (and these overhead costs can mean more than 50% of the total study budget).

And then most of the drugs end up not passing the FDA’s requirements and fail to get approved. So if you’re running a company, you will tend to want to go into areas where you will likely have more customers – heart disease for example – just so you stand a better chance of keeping your company operating should it succeed in getting a drug treating that disease approved. This is also why the government has to create incentives for companies that are willing to go into rare or “orphan” diseases – for example, Gaucher’s disease is a rare lysosomal storage disease affecting maybe 1 in 40,000 people. A drug company that competes in this market will be happy selling 1 prescription every 3 months.

I honestly do not view drug companies as entities that profit from the suffering of others, because of the logic of this assumption: If drug companies are creating diseases in people in order to make drugs for the very diseases they created, then that to me qualifies for the statement. However, drug companies happen to offer the tools to treat the disease, not unlike device companies making scalpels and surgical tools to allow doctors to cut us open should our illnesses demand it. It seems illogical to me to accuse device companies for profiting from people having tumors that require scalpels to operate and excise the tumors – unless we’re also implying that the scalpel companies are putting tumors in people that only their brand of scalpel can remove.

Additionally, I have observed that for the most part, people in our society today tend to prefer that we “have a pill to treat XYZ”, so that they do not have to do the hard work required to get their own health back on track. And then you add to the fire media agencies that charge pharma companies millions of dollars to come up with brainless gimmicky advertisements, and it is no wonder why many people feel like the drug companies are “profiteers of suffering.” Some years ago, there was a government funded study that shows that rigorous diet and exercise will help reduce diabetes risk at a very real level – in fact – the study patients who had diet and exercise regimen did as well in reducing their diabetes symptoms as study patients who took an anti-diabetic drug.

But why hasn’t the government or the doctors (not the drug companies – their responsibility is in making drugs) done anything about this amazing result? Because the of costs involved to the clinics in order to make “diet and exercise” possible in patients at a therapeutic level. Clinics would need to hire case workers and nurses whose job is to counsel and support and follow each and every single patient who opts for this “natural and effective” treatment. OK then, how about asking patients themselves to do this? Seriously, if you are a patient at risk for diabetes (i.e. risk factors are there, but patient is still “pre-diabetic” and not yet requiring drugs to control their blood sugars), you have everything you need at your disposal to go for the natural and effective (and less expensive than prescription drugs) cure! why aren’t patients doing this? because willpower and discipline are key – and you’re going to need both for a lifetime to prolong the onset of disease.

I can share this true experience – my husband had prediabetic blood work results some years ago when I urged him to see an endocrinologist, because his side of the family also suffers from diabetes. the endocrinologist told him that because he was so young (not yet 40 at the time), she preferred that he try the old fashioned diet and exercise, and see if he could get the risk factors down, before she put him on a drug. He happens to have a level of willpower and discipline that even I don’t have – and he altered his lifestyle dramatically – and it was enormously difficult. 6 weeks later he went back and the endocrinologist was so impressed with his results that she told him that most of his blood work results were approaching normal numbers. But she also told us that not every patient she sees can make this happen – and often she is forced to give the patient drugs to make sure that the patient doesn’t end up with uncontrolled diabetes symptoms (resulting in all sorts of nasty things including death).

I see drugs as exactly what you said you wished to see – repairs and cures. However, the reality is, few are truly cures because of the complexities of most diseases, and repairs don’t always “fix” things without creating new problems (called side effects) EXACTLY because of the complexities of most diseases.

The doctors’ hands are tied not by pharma companies, but by insurance companies as well as their own malpractice lawsuit concerns. Your average primary care doctor has to track how many patients he sees everyday because he needs to make sure he breaks even. That’s not the drug companies doing, but the insurance companies that capitate how much doctors are paid for doing what. So you also have a system that don’t reward doctors for spending more time with patients – in fact – you’re making it very bad business for the doctor to spend too much time because then he’ll lose money that day – and this does not do well to cultivate trust with patients who then need to heed the doctors’ advice about doing the hard things they need to do to steer their health status back on track.

I hope my email begins to help you understand where I am coming from – perhaps I can’t take any sides because I don’t think there are any sides that I can reasonably take without acknowledging that there are other entities that also need to be held accountable. the healthcare ‘system” is truly a “system” and a staggering, complex one at that. the best I can do is to help the consumers – people like you and me – to think for ourselves about what is being “sold” to us whether it’s from the drug companies, insurance companies, the government, the doctors, even patient groups. If I am guilty of siding with anything, it will be on the side of “critical thinking” about the system of healthcare with all of its players.

Best wishes,
Jane Chin

Pharma Offering Lifestyle Drugs – Power will Shift to Patient Customers

You’ve probably seen it coming – smelled hints of it on TV – pharmaceutical companies are getting into what we call “lifestyle drugs”; products that focus on “enhancing” your life rather than “extending” it.

Yes, there is a big difference, and you may think that “extending” life pays big, “enhancing” life may pay even BIGGER. (just ask the Botox people.)

It’s only a matter of time before pharmaceutical companies shift their focus from “therapeutic intervention” to “lifestyle / recreation” because they now deal with a ready-and-willing customer base who are willing to pay.

This also creates a more dramatic shift: one of bargaining power from the physicians to the patients. Eventually, pharma’s customers will become the patients more directly than before, with doctors becoming more of a “broker” – the people who writes the drugs but apart from that having no real power. Doctors are already complaining about patients leaving them if they don’t do what they’re told by the patients – “if you don’t write me this drug, I’ll go to someone else who will!”

There’s a bit of theatrical irony if this happens, because doctors will get a taste of what pharma sales reps have dealt with for years: being punted to the position of a measly “order taker” or “human sample dropper”. How about doctors eventually becoming “order takers” and “human Rx writers”?

Pharma Industry’s Job is NOT Disease Prevention. THAT’S YOUR JOB.

I’ve heard the argument, so have you.

“Those evil pharma companies aren’t interested in prevention! They want people to get sick and stay sick because that’s how they make their money! On the drugs!”

Recently I had railed against the pharma companies that are capitalizing on increasing trends of people using certain prescription drugs as “lifestyle drugs” – not to mention appearing on the Wall Street Journal this past Friday to rail against pharma companies that abuse the role of medical science liaisons, so I have my own pet peeves and criticisms with pharma. What irks me is when a criticism about any industry is not based on a fundamental flaw in that industry, but is simply born of politicking sensationalizing this-is-how-I-get-more-readers/viewers tactic.

Most of these people have taken a basic science class at some point in their lives and learned about a phenomenon called “entropy”. How things in a system tend to go toward disorder, and to halt this “natural” occurrence from occurring, you have to add in a great deal of energy, and even that won’t ultimately stop the inevitable.

Kind of like the idea of life and death, which is relevant to the assessment of this dimension of our hostility towards the pharmaceutical industry.

Obviously, pharma companies want you to stay alive, preferably as long as possible. This is not so they can capitalize on you dying (a dead person is no longer a customer)! The pharmaceutical industry is a business that capitalizes on your DESIRE to PROLONG YOUR LIFE AND MINIMIZE PHYSICAL PAIN AND SUFFERING. If you aren’t interested in prolonging life and minimizing physical pain and suffering, the pharma industry ain’t gonna benefit from YOU since you’re not a customer to begin with!

Let’s say you are sick from complications of heart disease.

Pharma companies that are in the heart disease business is not responsible for PREVENTING YOU from getting heart disease. YOU ARE RESPONSIBLE for making sure you do what you’re supposed to do to reduce your risk of getting heart disease, unless somehow you have signed the claim to your physical existence over to another person who is legally responsible for your physical survival and health.

Your family doctor may have a responsibility to educate you on mitigating the risks of getting heart disease, so those who want to rant about prevention may want to point their antennae to the medical profession, but ultimately YOU are STILL RESPONSIBLE for the behaviors and actions YOU TAKE that lead to the result of heart disease or no-heart disease. Your doctors can be the best doctors they can be and even give you a diet and exercise regimen that will lower your cholesterol, reduce your blood pressure, and take down your diabetes risk factors a few notches – but if you DON’T DO WHAT YOU’RE SUPPOSED TO, then you will end up with the health consequences. Actually, this is EXACTLY what happens in many obesity and heart disease cases today. Doctors themselves will admit that many of their patients won’t heed their advice, and most will lack the discipline required to stick with a rigorous healthy lifestyle to make a lifesaving change.

Are we saying that it’s the pharma industry’s job to PREVENT us from assuming behaviors that will put our health at risk? If there’s a pill for stopping us from risky behaviors, and pharma makes it commercially available, then we’ll simply turn around and say “now pharma wants to control our thoughts and actions!” (I think we already have those kind of pills, and there are activists and lawyers jumping on that bandwagon.)

Seriously, if you take care of your body, do everything healthy like you’re inundated by all media outlets to do (don’t drink, don’t smoke, don’t go out in the sun without wearing sunscreen, eat more fruits and vegetables, exercise at least 30 minutes a day, etc…), then you’re probably not going to need all those pharmaceuticals until the inevitable process of aging occurs, where your cells can’t care less what you’ve done because they’re all getting old and breaking down as a natural part of the decline of “life” in your physical human existence.

Most Doctors Don’t Recommend Their Own Profession

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.

Retail Clinics: Quick When You’re Sick

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.

Provenge and FDA’s Etiology For Not Approving

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

Patients Adrift in a Sea of Clinical Trials

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.

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