- Residency Match Results Bad for Primary Care (Again)
- Choose Wisely when Choosing Wisely
- The Future of Health Care is Now Clear
- No Medicare "Doc Fix" Could Result in Over 50% Salary Cut to Primary Care Physicians
- Why Primary Care is the Future of Health Care
- A Health Care System to be Proud Of
- What if IVIG really worked for Alzheimer's?
- The Harm of Not Seeing Drug Reps
- Postinfectious Cough
- Prior Authorizations Suck
- How the Government Plans to Lower Cost by Eliminating Doctors and Shifting Costs to Patients
- Questions Are the Answer
- Do Not Stop Your Statins
- Your Fired! Can Doctors Fire Their Patients?
- I'm Your Cook, Not Your Doctor
- Nicotine Patches Do Work!
- Retainer, Concierge and Boutique Medicine are Not the Same Thing
- Statins and Prostate Cancer
- More Evidence that Lantus Causes Cancer
- Industry Funded Studies
- PSA: To Screen or Not to Screen
- Is meaningful use the right incentive to get physician's to use EMR's?
- Disappointing Results for Crestor
- All In For Crestor
- Why OTC Lipitor is a Bad Idea
Once again, though not trumpeted as much as in previous years, reports of this years residency match results are in, and some media outlets are claiming this to be good news for primary care. The LA Times claimed Match Day 2013 results are good for future internal-medicine patients, stating "America’s future doctors are increasingly interested in become primary-care physicians -- good news for America’s future patients." OBGYN News claim was my favorite: Primary care spots are hot in largest-ever Match Day. They are basing this on a few things. First, the actual numbers of US medical student graduates going into primary care fields such as internal medicine have in fact increase. For example, 3,135 students will be going into internal medicine, which is a 19% increase from 2009 and 6.6% increase from last year. However, the main source of positive news is coming from the NRMP (the folks who do the match) themselves. According to their press release: Match results can be an indicator of career interests among U.S. medical school seniors. Among the notable trends this year: • 3,135 U.S. seniors matched to internal medicine, an increase of 194 over last year. • 1,837 U.S. seniors matched to pediatrics, an increase of 105 over last year.
• Family medicine matched 1,355 U.S. seniors, 33 more than last year. More than 95
percent of family medicine positions were filled.
Based on these numbers it would seem that more students are choosing careers in primary care. However, this is not the case, AND IN SOME INSTANCES THINGS ARE ACTUALLY WORSE.You have to look at the total number of slots as well as the percent that our US students are choosing primary care fields. Below is a table that has the match results for the last three years. It is important to note that there was almost 1000 more US seniors graduating, which according to the NRMP they attribute to the rising number of U.S. students to three new medical schools graduating their first classes as well as enrollment expansions in existing medical schools. 2% OF SENIORS plan to go into primary care. I blogged about this in 2011, when the media seemed to decry a boom for primary care. What I said two years ago is even more true today. THIS IS A CRISIS. Many of the few primary care docs we have are retiring, leaving practice, or going cash only or retainer. If something is not done to increase the value, reimbursement, and job satisfaction of our primary care doctors; we will have no one left to care for our sick and aging population. (And before you post a comment about NPs and PAs filling this gap, those students arent going into primary care either. A surgical PA makes more money than a primary care MD).
Yesterday, the media was a buzz with the latest recommendations from lead medical organizations about overused tests and treatments. Maggie Fox from NBC news states, "You don’t need an MRI for lower back pain. You don’t need antibiotics for a sinus infection. And you don’t need to be screened for osteoporosis, either, if you’re under 65. " The Washington Posts headline reads "Group releases list of 90 medical ‘don’ts.’" The New York Times similarly describes this report as a list of "donts." All this stems from the Choosing Wisely initiative from the non-profit American Board of Internal Medicine foundation in conjunction with Consumer Reports. The group ask most of the major physician specialty societies to come up with al list of the most common unnecessary things done in medicine. Each group came up with the top 5, to comprise a list of 90 commonly overused tests and treatments. A few examples include: •A feeding tube in patients with advanced dementia. (American Academy of Hospice and Palliative Medicine and American Geriatrics Society) •A routine annual Pap test if you’re 30 or older, or under 21. (American College of Obstetricians and Gynecologists). •DEXA (dual-energy X-ray absorptiometry) screening for osteoporosis in women under 65 or men under 70, unless there’s a suspicion of bone loss. •A CT scan for a child with a minor head injury. (American Academy of Pediatrics) This work is important as due to our fee for service system that reimburses for ordering tests and treatments whether or not they are effective or worthwhile, has proven to be costly and inefficient. Thus, cutting unnecessary testing or treatment in medicine will both save money and potentially reduce harm. For example, in many ERs across the country, almost all children that come in after a head injury get a CT scan. Not only has this not been proven to be effective, but radiating a childs head can increase the risk for cancer. However, a word of caution..... Based on the headlines, one might think that these tests or treatments should never be done. Two major media outlets call these a list of "donts." However, this is not what the experts were saying. These are commonly overused tests and treatments, not useless. There might be very good reasons to get a CT scan after a head injury in a child that outweigh the very small potential increase risk for cancer. It is very important to understand this because it is possible that insurances and/or the government will use these recommendations to determine reimbursement. While it is correct that physicians and patients should question the routine use of these tests or treatments, patients and doctors shouldnt have to fight with insurance companies to use these tests and treatments when they feel it is necessary. Finally, if as a patient you question your physician about a test or treatment they recommend (which is the entire purpose of the Choosing Wisely campaign), be prepared to sign something that states you wont sue them should your refusal of their recommendation turn out to be wrong. While the Choosing Wisely campaign starts to address the problems with our fee for service reimbursement system, it fails to address the other major driver of health care costs- malpractice. Many physicians would likely gladly give up these over-used tests and treatments, but will not for fear of being sued.
As a physician who is involved in educating medical students, I am often asked for career advice. Medical students are by nature smart and ask very good questions. "Will I be able to pay of my student loans if I choose primary care?" "Will I have a balanced lifestyle if I decide to go into primary care?" I try to be both encouraging and realistic. However, far too often I have found myself telling students that the future of medicine, primary care in particular is not clear. That is no longer true. The future of health care, and particularly primary care is now very clear. Several recent events along with trends that have been in place for the last few years have clarified the future of health care over the next few years. The passage of the Affordable Care Act (ACA), the decision of the Supreme Court to uphold the constitutionality of the individual mandate, the re-election of President Obama, and the fiscal cliff/sequester have all set into motion changes to our health care system that are likely irreversible and clarify the future of health care. Essentially, there are two paths: 1. HEALTH CARE IN LARGE INTEGRATED SYSTEMS. Health care costs are skyrocketing. The major fixes to the problem that are accepted on both sides of the aisle are an end to fee for service, bundled payments, and incentives for improving quality at lower costs. Accountable Care Organizations (ACOs) are one model being tested. However, even if the ACO turns out to be HMO 2.0, and ultimately fails; health care will be delivered in large integrated systems. This trend is already occurring with hospitals, academic medical centers and other health care systems gobbling up (through incorporation or outright purchase) smaller private practices. Because payment will be linked to performance, and performance must be measured and reported; the only way physicians will be able to make money is to not only have a large, robust electronic medical records, but also a staff that can help collect, process and report the important data. Even large private practices dont have the economies of scale to make this happen. Thus, private practice as we know it will cease to exist. This trend is already happening. According to a report by Accenture, over the past decade, the number of independent U.S. physicians has dropped dramatically, from 57 percent in 2000 to 39 percent in 2012. The move to large, integrated is not necessarily a bad thing. Integrated systems allow for quality improvement. Large integrated systems like Mayo, Kaiser, and the VA have some of the best outcomes for health care in our country, usually at significantly lower costs. For physicians, being a salaried employee also has its benefits which include a guaranteed paycheck, reasonable hours, good benefits and no worries about running a practice. The current generation of medical students tend to value work life balance over the potential opportunities seen in private practice. The down side of large integrated systems is less personalized attention. Rather than seeing your doctor when you are sick, a patient will likely wind up seeing a member of the doctors care team.Other modalities such as group appointments might be employed. 2. HEALTH CARE OUTSIDE THE SYSTEM. Some doctors (likely the ones currently in practice) will refuse to join these large integrated groups. Some patients may decide that access to their own personal physician has some value. These patients are tired of waiting forever to get an appointment or a call back from their doctor, and want to see their doctor when they are sick, not a team member. They are even willing to pay beyond what their insurance premiums cover. These patients and providers will go outside the system. Growth of retainer (often called concierge) practices, cash-only practice, or direct primary care demonstrate that going outside the system is already happening. This will likely be limited to primary care, as one might be able to pay cash for a doctors appointment, but not a colonoscopy or cardiac catheterization. Health care delivery is already occurring in large integrated systems as well as outside the system. The aforementioned changes will cause these trends to continue, squeezing out the current physicians who are still in an insurance based private practice. These changes are certain. What is unclear is the proportion of health care that will be delivered in either model. Will large integrated systems become so effective, that only the very wealthy will deem it worthwhile to get their care outside the system? Or, will large integrated systems become so impersonal and inconvenient that only those with modest incomes will be forced to get their care in these systems? The truth is likely somewhere in between, i.e. 70/30, 50/50 or 30/70. Regardless, medical students and residents who are trying to determine a career path should now have a clearer vision of the future health care. Patients who are currently receiving their care by a private practice physician who accepts their insurance should also realize that their current situation will likely not exist in the next few years.
With the Fiscal Cliff looming, I have re-posted this entry from November 2011, the last time Congress was against a deadline, and what got us into the mess we are in today. Hopefully, Congress will come together and in addition to putting together a package that will spare most Americans tax increases, will eliminate the 27% cuts in payments to physicians that are set to go into effect on Jan 1, 2013. From November, 2011: Fortunately, the 27% reduction in Medicare payments to physicians that is set to take place in a matter of weeks unless congress acts is getting some press. Fox News published this piece yesterday, as did the Washington Post. Writer Merrill Goozner breaks things down nicely in his article, "Is There a Doctor Fix in the House...and Senate?" However, one thing that seems to be getting confused in all the media reports is the difference between physician payments and physician salary. A doctors income is what he takes in (payments) minus expenses or overhead. Physician overhead (staff, office space, electricity, malpractice, equipment,etc.) is very expensive. One of the reasons, but not the only reason, a doctors overhead is so high is because we need to hire extra staff just to deal with the insurance bureaucracy. (See "Your 10 minute office visit needs 8 people and 45 minutes of work" via KevinMD.) While payments from Medicare to physicians have not really increased over time, overhead has gone up dramatically. PHYSICIANS, PATIENTS, AND POLICY MAKERS NEED TO UNDERSTAND THAT A 27% CUT IN PHYSICIAN PAYMENT WILL HAVE A FAR GREATER IMPACT ON PHYSICIAN SALARY BECAUSE OF THIS OVERHEAD. An article from the AMA News discussing the issue of the "doc fix" has an interesting table with current payments and proposed payments. Lets say a family physician sees 25 Medicare patients a day, 5 days a week for 50 weeks out of the year. At the current rate of $68.97 per visit, this generates $431,062 in revenue. At 60% overhead of $258,637, this family physicians income would be $172,425 per year. Now any doctor reading this will tell you that 1) no physician would see exclusively Medicare patients because they just dont pay enough (at current rates) to sustain a practice and 2) you cant see 25 Medicare patients in a day because patients 65 and up have multiple medical problems and you simple couldnt see them all in 15-20 minute visits. However, the income is very close to$168,550 which is the average salary for a family physician. Thus, the numbers are good for the purpose of discussing the impact of Medicare cuts on not just payments but salary. Now, if the 27% Medicare costs go into effect, Medicare will only pay $51.07 for that same visit. Using the same numbers, the revenue generated is only $319,187 (26% decrease in Medicare payments), but the $258,687 in overhead stays the same. This leaves the primary care physicians with a $60,550 annual income. THATS A 65% CUT IN PHYSICIAN SALARY. Even if my numbers are off, its clearly more than a 27% cut to salary, and much greater than 50%. The bottom line is that if these cuts take place, primary care physicians will certainly stop seeing new Medicare patients, and many will stop taking Medicare patients altogether.Many already have!!! Now, most pundits seem to think that since seniors vote, and Medicare is a big issue for them, and that the election is less than a year away; Congress will find a way (like they have for the past few years) to find the money to cover the cuts for at least another year. However, I wouldnt be so sure. I would advise anyone who is on Medicare, has a loved on on Medicare, or who plans on having Medicare in the future to call their representatives and ask them to ensure that these payment cuts not go into affect.
Primary Care Progress is a non-profit organization of doctors, students, advocates, etc who have a vision for revitalizing the primary care workforce pipeline through strategic local advocacy that promotes primary care and transforms care delivery and training in academic settings. This OCTOBER 8-12, Primary Care Progress is co-sponsoring NATIONAL PRIMARY CARE WEEK with the American Medical Student Association (AMSA). In preparation for this they have asked some of their contributors, myself included, to answer the question "Why is primary care the future of health care?" Here is my attempt to answer this very important question. First, I am glad the question was not "What it the future or primary care?" as this is a much harder question to answer. The American Academy of Family Physicians just today put out their vision for the future of primary care. In their Primary Care for the 21st Century, a personal physician coordinates with other health care providers within a Patient Centered Medical Home model of care, where quality and safety are hallmarks, and patients and their families actively participate in decision making. They envision enhanced access to care through open and same-day scheduling, expanded clinical hours, and new options for communication. This sounds like a lovely vision, but whether or not this or other models, such as Accountable Care Organizations, will save Primary Care is unclear. However, the to the question of whether Primary Care is the future of health care is crystal clear. Our health care system and the health care of our country can not survive without Primary Care. Here are three reasons why, in my opinion, Primary Care is the future of health care. 1. PRIMARY CARE IS HIGH VALUE CARE. Health care spending is out of control. We are spending about 18% of the GDP on health care. We are essentially at the tipping point of health care spending in that if the percent of GDP spent on health care grows any higher, we are going to have make substantial cuts to spending in other places that are deemed essential to the functioning of our country such as social security, education and defense. It would be like if the amount you were spending on your electricity bill was starting to equal the amount you were spending on your monthly mortgage. When that happens, you cant live in that house much longer. Yet, despite spending so much money on health care, we are not getting a great value. A large segment of our country is currently uninsured or under-insured, and health indicators which are used to compare health across countries (mortality,access,safety) show that the US underperforms compared to others. So, our current spending is crushing our economy but at the same time we are not getting a good return on our investment. Thus, the future of health care is going to have to be about value. We need to get much more for the precious health care dollars we spent. And there is no better health care dollar value than Primary Care. There are many studies that demonstrate a strong primary care sector is associated with lower costs in improved quality. Countries that have a more robust primary care infrastructure have healthier citizens at lower costs. Therefore, the future of health care has to be Primary Care, because we need better value in our health care system if our country is to survive. 2. PRIMARY CARE IS CRITICAL IN REDUCING WASTE. The Institute of Medicine just released a report that shows we waste $750 billion in health care. This is more than what we spend on defense! There are many sources of waste. * $210 billion on overuse and unnecessary care. * $130 billion in inefficiency, including mistakes and harm. * $190 billion in excess administrative costs. The reasons behind all this waste are complicated, and there is no "magic bullet" solution. Yet, one likely reason behind some of the waste is that there are"too many cooks in the kitchen." Medicine has gotten incredibly complex. Because of this sub-specialization in medicine is rampant. Instead of just going to a specialist (cardiologist for example), patients need to go to a sub-specialist (interventional cardiologist vs. an electrophysiology cardiologist). A 2007 student in the New England Journal looking at practice patterns about a decade ago noted that int the course of two years, Medicare patients saw a median of two primary care physicians and five specialists working in four different practices. My guess is that today these numbers would likely be much worse. In addition, as more care is being delivered in the outpatient setting, there is an increase in other health care providers (home care, rehabilitation, physical therapy, etc.) involved in a single patients care. The more health care professionals that care for an individual patient, the more likely for errors in communication, duplication, and administration. Having a Primary Care physician as the leader of the health care team is therefore critical in terms of reducing the number of potential errors. It is not that we dont need so many players on the team. We actually do as, advances in health care have made things more complex. However, we need better coordination in care to prevent potential waste. Primary Care is perfectly positioned to do this, which is why it is the future of heath care. 3. INCREASING TECHNOLOGY AND ACCESS TO INFORMATION REQUIRES NAVIGATION AND EXPERIENCE. We live in a DIY world. Cable TV shows about remodelling your own house or preparing a gourmet meal on your own are numerous. One can find a "how to" YouTube video on virtually any subject. (I have personally used You Tube to help me cook a Thanksgiving Turkey and fix a toilet.) There are even legal web sites that allow you to create your own will or incorporate your own business. With so much health information now available on the web, you would think that the DIY mindset would translate to health care, but it has not. Even though the latest study published in major medical journals is now on the web and a sound byte on the morning news well before I have even had a chance to read it, patients who have access to this information still want their personal physicians interpretation. The reason for this is that, in most cases, the more we learn (research) the more complicated decisions become. For example, prostate cancer screening has been in the news lately. More evidence suggests that screening for prostate cancer may not only be unnecessary but also potentially harmful. The current US government guidelines now recommend against this practice. What should you do? Though most of this data is fully accessible to the public, how to interpret the data and apply it to an individual patient requires expertise. Not only does one need expertise to interpret and apply data, but experience in practicing medicine. DIY projects gone wrong might lead to a burnt dinner or having to call the plumber anyway. However, DIY health, in many cases, is a life and death decision that most people dont want to make on their own. Health care in the future promises not only more innovations in diagnostics and therapies, but also more difficulty in how to apply these tests and treatments to individual patients. Advances in technology, even with unprecedented access to this information, requires a skilled navigator and interpreter. Because of their breath of knowledge, holistic approach and familiarity with patients they have known for some time, no other health care professional is better suited for this role than the Primary Care physician.
I was not able to watch the 2012 Olympic opening ceremonies until last night. Though we are only half way through the spectacle on our DVR, I was remarkably surprised to find that featured among some of the UKs proud traditions (the Queen, James Bond, Sir Paul McCartney, etc.) was a significant tribute to their national health service or NHS. According to the media guide, “The NHS is the institution which more than any other unites our nation." Founded after World War II, the NHS offers universal health care to all of the UKs citizens. This is not meant to be a post that necessarily supports a government run, single payer system or even the Affordable Care Act. Rather, this is simply a musing on "what if" the US had a health care system that we could truly be so proud of that we too thought it worthy of such a national mention. Once can imagine that an opening ceremony in the US would likely feature similar historical events and sources of national pride such as our farmlands, Hollywood, "mountains and prairies," jazz music and maybe even Elvis; but probably not Medicare and Medicaid. Yet, our we really that far off? We have some of the best trained doctors, skilled health care workers and the most technologically advanced hospitals in the entire world. People travel from all over just to received their health care in the US. Yet, despite the many marvels of the US health care system; not all of our citizens have access to it, many that do can not afford it, and the escalating costs of care will likely cause our country to go bankrupt if something is not done done. Part of the problem, in my opinion, is that we arent seeing this as a national problem to be solved. Our health care crisis has become so politicized, that nothing seems to be getting done (despite the ACAs passage). Not only have Republicans blocked Democratic health reform initiatives at every step of the way, but also remember that it was in-fighting among Democrats the lead to the failure of passing health care reform with a Democratic controlled House, Senate and Oval Office. In addition, all stakeholders including doctors, hospitals, insurance companies, pharmaceutical manufactures, patient groups, etc. seem so entrenched in their positions; that no one is willing to budge and nothing appears to be getting any better. But what if we saw our countrys health care crisis as a national priority? What if politicians, stakeholders, and citizens all came together and decided that we as a country needed a solution now and, like "The Manhattan Project" got the greatest minds working together to create a uniquely American solution to health care? Surely that would be worthy of an opening ceremony mention. I recognize that this vision is likely very unrealistic. However, the way in which the NHS was featured during the Olympic opening ceremonies in London certainly gave me pause, even if just for a moment, to wonder "what if."
ABC News and other media outlets are reporting the results of a small, but very important study regarding a new treatment for Alzheimers Disease. Most Americans are familiar with Alzheimers because it is so common (President Reagan had it), so devastating, and without a cure. This new study gives hope to people who have or are at risk for the disease. This week at the Alzheimers Association International Conference 2012 in Vancouver, researchers presented the positive results of a study using intravenous immunoglobulin, or IVIG, to successfully keep Alzheimers disease at bay. Controversy exists because the study was very small (16 patients total), of which 11 patients took IVIG for three years and showed improvement thinking, memory, daily functions and mood. Immunoglobulins are part of the human immune system. They are made naturally and help ward of a variety of infections and disease. IVIG has been used to treat a variety of auto-immune disease. Though no one is 100% sure how IVIG works, it is though to have antibodies against amyloid. Amyloid is a protein which accumulates in the brains of patients who who have Alzheimers. Though most experts caution current use in the general public and are clear that more research is needed, many believe this is a very good sign indeed. However, lets assume that the research is proven correct, and that IVIG actually does work well for most patients to treat Alzheimers disease. One of the problems is that IVIG is not cheap. Since it is a blood product it is expensive- you need to get it from human donors, you need a nurse to administer it, and it must be given in a doctors office or hospital. It is given once every two weeks, with an estimated to cost a patient $2,000 to $5,000. According to data from Alzheimer’s Association, there are 5.4 millions American’s with Alzheimer’s. If we take the low estimate of $2000 every other week, it would cost $280 billion each year to treat patients with Alzheimers. In 2012, the direct costs of caring for those with Alzheimer’s to American society will total an estimated $200 billion, including $140 billion in costs to Medicare and Medicaid. Essentially what this means is that it would cost nearly $100 billion dollars more each year to treat patients with IVIG and prevent Alzheimers progression, than to simply treat this very expensive disease. Though in some instances, like vaccines, an ounce of prevention is worth a pound of cure. However, in many examples, medical treatment is very expensive and keeping people alive and well cost more in the long run. It is our skyrocketing health care costs that plague our health care system and if we dont fix the problem soon, it could bankrupt our country. Resources are not limitless. Since much of our health care is funded with taxpayer dollars, we as a society are going to have to make some very important decisions. If we decide that we think it is worth paying for everyone who has Alzheimers to get IVIG for example, we are going to need to decide what we are not going to pay for to keep costs down. These are difficult decisions. The problem is that these types of conversations or not really happening today because the health care debate has become more about who will be the next President than actually solving our countrys problems.
Now more than ever, the growing consensus among many is that doctors should avoid seeing pharmaceutical sales representatives, otherwise known as drug reps. A position statement from the AAMC, the head organization of all
USmedical schools and residency programs, recommends that all academic health centers avoid having drug reps on their campuses, hospital and clinics. Many medical institutions including the VA and Kaiser have also enacted similar policies banning drug reps. In fact, the number of doctors willing to see reps has declined about 20 percent since 2008. In 2010, about 11 percent of American physicians had “severe” or “no-see” restrictions on drug rep access, while 34 percent had “some” restrictions.
The rationale for such bans is that drug reps are really marketing agents for the drug companies they represent, and their mere presence will cause physicians to write unnecessary prescriptions. It is not only the sales pitches that certain stakeholders are concerned about, but also drug samples and often times food that comes with them. The idea is that gifts from the industry (which other than meals have not been around for some time) as well as samples of medicines, marketing material and sales pitches from drug reps will influence physicians to write medications that they might not normally write.
There is certainly some data to support this rationale. It is indisputable that marketing from drug companies increases sales of their products. Not only are there studies to back this up, but also at face value, if it didn’t work, the industry wouldn’t do it. The real question is whether or not this is good or bad for patients. Certainly, if a doctor writes for an expensive brand name medication, when a generic medication would have worked just as well for a lot less money, then pharmaceutical marketing is harmful. On the other hand, if a doctor is not prescribing a medication that he should be writing for or the current cheap, generic medication the patient is taking is not working or is causing unnecessary side effects, then drug company marketing which would change those prescribing practice might actually be helping the patient. There are probably several examples of both extremes. For example, Singulair is a $3 billion dollar product for Merck and the single best selling controller medication for asthma, but it doesn’t work any better than over the counter generic medications for allergies, and the NIH guidelines consider Singulair alternative therapy for asthma (inhaled corticosteroids are first line, yet rarely prescribed). Marketing and subsequent sales of Singulair are probably not good for patients. On the other hand, cardiovascular disease is the single leading cause of death in the
US. However, many physicians had been prescribing less effective, generic statins to patients at risk for heart attacks, and in many cases not meeting therapy goals and causing side effects. Recently, the FDA released warnings about using higher doses of generic simvastatin. Thus, the Pfizer rep promoting branded Lipitor (it has since gone generic and is no longer promoted) with their $4 coupon cards was probably helping patients.
The overall benefit or harm of pharmaceutical marketing is unclear. At issue is whether or not a pretty drug rep, with slick marketing material, a drug sample and a slice of pizza is enough to sway a physician to write for a prescription that is not in the patient’s best interest. Despite many claims that this is indeed the case, there is no real evidence to back this up. Part of the reason for this is such studies are incredibly challenging to design and implement. The one review paper that is often quoted in support of this claim actually never really showed this. Their one example was a study done in the
Netherlandswhere physicians read hypothetical marketing material and picked a therapy.
However, what about the harm of NOT seeing drug reps? Do the restrictive policies enacted in the last few years have any unintended consequences? Though there is no question that the motivation of the drug reps and the industries they represent is to sell prescriptions, they also provide physicians with information about new products and new data on existing products. Given the complexity of medicine and the vast amount of new data available each day, it is difficult for physicians to keep up to date, especially in primary care. Thus, a benefit of the drug reps is providing physicians with important new information. Therefore, the potential risk of not having drug reps is not having, or more importantly doctors not acting on, new information.
Though it has (surprisingly) drawn very little attention, a recent study looked at this very issue. In a study recently published in The Journal of the American Society of Hypertension called “Can Access Limits on Sales Representatives to PhysiciansAffect Clinical Prescription Decisions? A Study of Recent Events With Diabetesand Lipid Drugs,” the authors used a very sophisticated methodology and study design to look at the potential harm of physicians not seeing drug reps. They decided to look at three prescribing practices:
1. Adoption of a new, first in class diabetes medicine (Januvia) in 2006 (sample size over 65,000 physicians)
2. Decreases in prescribing Avandia after the FDA placed a box warning on it in 2007 (sample size over 58,000 physicians)
3. Decreases in prescribing Vytorin (a combination of simvastatin and Zetia) when a 2008 study was released that showed no benefit over simvastatin alone in a large, randomized trial (sample size over 72,000 physicians).
The researchers used IMS data of actual physician prescriptions to analyze prescribing patterns of the specific drugs in questions. They used a consulting firm data base of how many times a drug rep saw 300,000 physicians to determine access level (drug reps keep very careful records of their sales calls, since this is how they are paid), and divided physicians into four categories: very low access, low access, medium access and high access. They also only used docs who were high prescribers of diabetes and cholesterol medicines to control for the fact that low prescribing doctors are often not targeted by sales representatives. They also controlled for other variables such as specialty and geography.
What they found were that physicians with very low access to representatives had
the lowest adoption of the new diabetes medicine, taking 1.4 times longer to prescribe than the low access physicians and 4.6 times longer to prescribe than the medium access physicians. In response to the Avandia box warning, docs with very low access were 4.0
times slower to reduce their use of Avandia than those with low access. Similar numbers were seen with prescriptions of Vytorin after negative data was released. The study also showed that the physicians who were most sensitive to the effects of the pharmaceutical reps were primary care physicians. Cardiologists were least affected. In other words, docs who didn’t see drug reps were about 4 times less likely to respond to either positive (new drug available) or negative (safety issues, lack of efficacy) information than docs who allowed some access to pharmaceutical representatives.
BOTTOM LINE: Pharmaceutical marketing increases pharmaceutical sales which ultimately increases what we spend on health care. Whether or not this is good or bad for the individual patient or society is debatable. While there may be overuse of some branded prescription products, there is certainly under use of branded products as well. After all, prescriptions drugs do cost money but they also save lives. Unfortunately, there is no clear evidence to determine the overall risk or benefit of pharmaceutical marketing one way or another. However, while restricting drug reps may decrease pharmaceutical sales, it may also have the unintended consequence of decreasing access to new and important information for physicians. In this first of its kind study, docs who didn’t see drug reps were more likely to prescribe less effective and potentially more dangerous drugs to their patients after new data was available.
Medical information comes from many sources. Though information provided by drug companies is intended to increase sales, it doesn’t mean that it is not valuable. The question is whether you want your physician to have the most up to date information and trust him or her to interpret the data, regardless of who is providing it, and use it in the best interest of the patient; or whether you don’t trust physicians (especially when pizza or pens are involved) with any information provided by drug companies, so you restrict access to this information. We at least have one study suggesting that there are some potential harms to restricting access to information that drug companies provide, and so maybe we should trust doctors a little more.
I am not a huge baseball fan to begin with, and when I am, I route for the Nationals. Thus, I pay little attention to the New York Yankees, and was not aware that Yankee player Mark Teixeira had been suffering with a cough for the past month until it the story from the New York Times came through one of my Twitter feeds. According to the story: "Mark Teixeira had a battery of tests performed Wednesday to determine the nature of his violent and persistent cough, and he received good news. Teixeira, who has been wracked by the cough for about a month, said he was found to have nothing more serious than severe congestion in his bronchial passageways." Mr. Teixeira was prescribed prednisone (not something I would recommend for this) and is expected to recover soon. In addition, the doctors at New York-Presbyterian/Columbia hospital in Manhattan performed a CT scan, a lung function tests, blood tests and cultures during their work up (though I am sure the Yankees can afford this). The Times does not mention the diagnosis other than to say that the baseball player had "severe inflammation in my bronchial passageways." I blog about this because this is one of the most common things I see in the primary care setting, it is often misunderstood and therefore misdiagnosed, it is very easily treated and there is virtually no research on this disease. Mr. Teixeira likely has what is known as postinfectious cough. Heres the typical patient presentation: Young healthy patient gets a typical upper respiratory tract infection (URI): cough and congestion, headache, feels ill and low grade fever. URI resolves in a matter of days, but there is a persistent cough that is getting worse, and wont go away. Cough is usually worse at night, and the patient cant exercise because it makes them cough. On occasion the cough is so bad that the patient is winded easily and sometimes the patient thinks they may be wheezing, though they have no history of asthma. According to the American College of Chest Physician which published evidence-based clinical practice guidelines back in 2008, the diagnosis of post infectious cough should be considered when a patient complains of cough that has been present following symptoms of an acute respiratory infection for at least 3 weeks,but not more than 8 weeks. And while the cause of the postinfectious cough is not known, it has been thought to be due to the extensive damage of cells lining the lung and widespread airway iinflammation of the upper and/or lower airways. The good news is that this usually goes away by itself, the bad news is that it can take weeks or even months, and can be quite disruptive to patients lives; desk jockeys and baseball players alike. To me one of the most incredible things about this illness is the lack of data on effective treatments. The ACCP review cited above did an extensive review of the literature and found very few studies that looked which treatments worked best. Given the lack of data, here is my take on the appropriate diagnosis and treatment: Diagnosis can be made without an extensive workup when the clinical presentation is consistent with that described above and there are no other complicating factors that would indicate other possibilities. A chest X-ray may be all that is necessary to rule out any underlying severe disease and is reasonable in a patient who has been coughing for more than two weeks. Since symptoms are caused primarily by inflammation and hyperresponsiveness/bronchoconstriction in the lungs (which is what we see in asthma), then treatment is likely best with something that treats both inflammation and bronchoconstriction in the lungs, such as an inhaled corticosteroid/long-acting beta agonist like Advair (which is commonly used in asthma). Of note, Advair (or other ICS/LABA combinations) have not been approved by the FDA for the treatment postinfectious cough and there is no data on the use of ICS/LABAs for the treatment of postinfectious cough. However, this is a common sense approach to the problem based on what we know about the cause, and from clinical experience I can tell you this approach works remarkably well. Use of Advair for postinfectious cough may be the single most common off-label use of any prescription product. There are two additional important points. First, since inflammation can persist for weeks, it is important that Advair be used for at least 4 weeks. If stopped too soon, before inflammation has completely resolved, symptoms may return. This is very important, because primary care physicians who decide to use ICS/LABA inhalers for postinfectious cough may give patients a medication sample rather than a prescription. Though the drug companies that make these products used to make samples with a months supply of medication, most inhaler samples today have only 1-2 weeks of therapy. Secondly, if symptoms have resolved and the patient has taken the inhaler for 4-6 weeks, the patient can safely stop the inhaler. If symptoms return, the patient should be brought back for pulmonary function testing as this may be a new presentation of asthma.
"Suck" is a word I seldom use. Its a word I ask my children not to use. However, in this case the word is appropriate. If as a patient, you have ever had a delay in getting a medication or a test your doctor ordered, it was probably due to a prior authorization. A prior authorization is a bureaucratic hurdle (sometimes a phone call, sometimes a fax, sometimes a letter) that is required by your physician to get you the test or treatment he or she believes is right for you. A prior authorization is essentially a mechanism that insurance companies put in place to make ordering more expensive tests or medications more difficult for you to get. The decision maker on the insurance companys end who decides whether your doctor (regardless of specialty or years in practice) is justified in requesting the medication or test that your insurance company is obligated to provide for you is often a 20-something college grad with no clinical experience. Prior authorizations are probably one of the most frustrating things about being a primary care physician. I am far from alone in this opinion. My medical society, The Medical Society of the District of Columbia or MSDC actually did a survey of their members examining the impact of health insurance prior authorization protocols on patient care in Washington, D.C. The study reveals widespread concern among area physicians, with over 93% of respondents saying that insurance company requirements are having a negative impact on their ability to treat patients.In their press release, Dr. James Cobey, President of MSDC stated that “Doctors, not insurance companies, know best how to care for their patients, yet prior authorization and other insurer protocols are dictating how physicians provide treatment. Prior authorization requirements put D.C. patients at risk by causing unnecessary and potentially dangerous delays for medications and care while preventing doctors from providing the most appropriate forms of treatment.” SPECIFIC FINDINGS OF THE MSDC SURVEY INCLUDE: * 93.1% of D.C. physicians Surveyed Said That Insurance Company Requirements Such As Prior Authorization, Pre-certification, Therapeutic Switching, And Step Therapy Are Having A NEGATIVE IMPACT ON THEIR ABILITY TO TREAT PATIENTS; * Nearly 90% of Those Surveyed Said That They Have Been FORCED TO CHANGE THE WAY THEY TREATED A PATIENT, Including Changing Prescription Medications, Due To Restrictions Imposed By An Insurance Company; * Over 76% of Physicians Also Reported That They Have SWITCHED TREATMENTS IN ORDER TO AVOID DEALING WITH PRIOR AUTHORIZATION requirements; * 94.8% of Physicians Surveyed Said That INSURANCE COMPANIES HAVE DELAYED OR DENIED TREATMENTS for Their Patients, Such As Prescription Medications, Diagnostic Testing, Or Other Services; * 84.6% of Physicians Said That Is It DIFFICULT TO DETERMINE which Prescription Drugs Or Medical Procedures Require Prior Authorization; * About HALF (47.2%) Of MSDC Members Surveyed Said That On Average, Prior Authorization Requests Take SEVERAL DAYS OR MORE TO BE RESOLVED; * 89.7% of Respondents Confirmed That Completing And CLARIFYING INSURANCE REQUIREMENTS IMPOSES “HIDDEN” COSTS—such As Extra Staff Time For The Additional Paperwork And Phone Calls—that Have A Negative Impact On Their Medical Practice.
Folks at the MSDC are trying to get laws passed to implement a standardized system across the District, with uniform requirements for filing and processing prior authorization requests which would expedite this onerous process and allow doctors to finally focus on what really matters—treating patients. Every medical society should follow their lead.
In our world of 24/7 media, where we seem to hear about the next big cure, important dietary change or very dangerous drug virtually every day, it is hard to believe that the news people, tweeters and bloggers could miss anything that is going on in health care today. However, it appears most everyone missed a big one. This might be one of the most important stories in health care today, that no one seems to have picked up on. No mention in the Times, Wall Street Journal, Washington Post, etc. Only US News mentioned this by re purposing material from Health Day. Its how the government, through the FDA, plans cut health care costs by eliminating the need to see a doctor and shift the costs of medications to the patient. And you should be afraid....very afraid!!! What I am referring to is a public hearing that was held on March 22 and 23rd; the notice was placed online only a few weeks before on 2/28. The meeting was entitled: Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription What was the purpose of such a meeting? According to the briefing document: "The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined health care settings, such as a pharmacy." You have to read between the lines here, but essentially what this is saying is that the FDA is thinking about a completely new way to approve or classify drugs, so that some drugs if dispensed in a pharmacy would be allowed to be purchased over the counter/without a prescription. Their rationale which I have extracted (the bolding and underlining are mine): " Undertreatment of many common diseases..is a well recognized public health problem..... The requirement to obtain a prescription ... may contribute to undertreatment of ...hyperlipidemia (high cholesterol), hypertension (high blood pressure), migraine headaches, and asthma. For instance, some consumers do not seek necessary medical care...because of the cost and time required to visit a health care practitioner for an initial diagnosis and an initial prescription. Some patients who obtain an initial prescription do not continue on necessary medication because they would need to make additional visits....Some prescription medications require routine monitoring through the prescribing practitioner such as blood tests..... FDA BELIEVES THAT SOME OF THESE VISITS COULD BE ELIMINATED BY MAKING CERTAIN PRESCRIPTION MEDICATIONS AVAILABLE WITHOUT A PRESCRIPTION but with certain other conditions of safe use that would ensure they could be used safely and effectively WITHOUT THE INITIAL INVOLVEMENT OF A HEALTH CARE PRACTITIONER... In addition to improved health outcomes .... ELIMINATING OR REDUCING THE NUMBER OF ROUTINE VISITS could free up prescribers to spend time with more seriously ill patients, REDUCE THE BURDENS ON THE ALREADY OVERBURDENED HEALTH CARE SYSTEM, AND REDUCE HEALTH CARE COSTS. Now, on the surface, this might sound like a good thing. Wouldnt it be great if we could find easier ways for patients to get their needed medicines? After all, as our nation gets older (and more overweight), chronic diseases are going to be main issue in health care. It all about improving health, right? UNFORTUNATELY, THE BOTTOM LINE HERE IS THAT INSTEAD OF FINDING A REAL SOLUTION TO IMPROVING ACCESS TO PRIMARY CARE PHYSICIANS OR FINDING REAL WAYS OF REDUCING HEALTH CARE COSTS, THE GOVERNMENT (THROUGH THE FDA) HAS COME UP WITH A SIMPLE PLAN: TAKE THE DOC OUT OF THE PICTURE AND SHIFT COSTS TO THE PATIENTS. The fact of the matter is that though medications are expensive, they only represent about 10 cents of every dollar spent. The two biggest costs are doctors and hospitals. Thus, if we are trying to cut costs, the most economical solution would be to eliminate or at least curtail a visit to the doctor. Since prescription medications require a prescription which requires a doctors visit (or at least phone call); the FDA can just make certain medications available over the counter and we no longer need those annoying, inconvenient, and expensive visits to your primary care provider. Now there are already lots of medications available over the counter. These medications are considered safe enough to use, and a medical degree is not required to figure out that you take cold medicines for your cold and heartburn medicines for your heartburn. However, what the FDA is talking about are medications to treat chronic diseases like asthma, high blood pressure, high cholesterol and though not mentioned, probably diabetes. It was only back in 2005 when the FDA rejected Merks bid to make their cholesterol medicine Zocor (simvastatin) OTC. At that time, they knew that even drugs that seemed relatively safe and could benefit many people required expertise to properly diagnose and treat high cholesterol safely and effectively. More recently, Pfizer also tried to get their patent expiring Lipitor to be sold over the counter (see my post Why OTC Lipitor is a Bad Idea). How can medicines that were only a few years ago considered too dangerous to be taken over the counter, would now be considered safe? According to the briefing document: "The conditions of use could include requiring pharmacist intervention to ensure appropriate nonprescription use. Additionally, conditions of safe use could involve the use of innovative technologies, such as diagnostics approved or cleared by FDA for use in the pharmacy or other setting." In other words, for certain (particularly expensive) chronic diseases such as asthma, high blood pressure and high cholesterol; the FDA would consider these medications safe by allowing the pharmacist, not the doctor, to determine which medication is right for you. And if you needed any blood work, the FDA might clear the way for this to be done in the pharmacy as well. But my favorite part is about the kiosks:
"For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product."
Can you just imagine patients going up to an ATM-like machine, entering their conditions, allergies, blood levels, etc. and having the computer spit out exactly what dose of what medicine that they should be taking for their high blood pressure or high cholesterol? Would there be a soda-like machine right beside it that could dispense the appropriate medication?AMA did testify at the hearing, and according to their website: "While the increased availability of certain prescription-based antidotes, such as Epi-Pens, appear to have few if any safety concerns, the FDA has not offered evidence that patients with hypertension, hyperlipidemia, asthma, or migraine headaches can self-diagnose and manage these serious chronic medical conditions safely on their own. This sort of self-diagnosis and treatment conflicts with the kind of care coordination and disease management that both the administration and private sector are trying to achieve through the new health care payment and delivery models." To me the "conflicts with.....new health care payment and delivery models," is very interesting. This suggest to me that the government is trying to hedge their bets. In other words, if the new plans for health care reforms dont work, we can still lower cost and increase access simply by making many chronic disease drugs over the counter. Most commentary that can be found on this issue seems to be coming from the pharmacist groups, who are not surprisingly supportive. However, there is at least one pharmacist that remains skeptical. Pharmacist blogger Eric Durbin at his blog Eric, Pharmacist states: "Ive never known our government or any of its agencies to move quickly on issues, especially when it comes to our profession. But for this issue, the notification for the hearing was filed on February 27, published in the Federal Register on February 28, with a deadline to present oral comments & presentations of March 9. Thats less than two weeks. With the hearing being held less than two weeks after the deadline. 3-1/2 weeks from the notice of hearing in the Federal Register until the hearings begin seems to be moving rather quick to me. Which makes me skeptical" BOTTOM LINE: THOUGH THIS MAY SEEM LIKE AN INITIATIVE THAT COULD IMPROVE PATIENT ACCESS AND CHRONIC DISEASE OUTCOMES, ALLOWING CHRONIC DISEASE MEDICATIONS TO BE OVER THE COUNTER IS A WAY THE GOVERNMENT CAN CUT HEALTH CARE COSTS BY ELIMINATING EXPENSIVE DOCTORS VISITS AND SHIFT MEDICATION COSTS TO PATIENTS. WHAT CAN YOU DO? Though the hearing was over weeks ago, the website still allows visitors to submit comments (due May 7, 2012) online (CLICK HERE- also note the 20 minute lock out, so you may want to type in Word first and then copy/paste). You can also use the address below for regular mail: Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 In addition, you can send this post to those who know who might care about this issue and/or write your own post. You can Tweet, post to Facebook, etc. Social media has done wonders recently in getting the word out and making changes. However, time is of the essence.
One of the advantages of having a blog has given me incredible opportunities to works with so many doctors, patients and others interested in health care. However, one of the disadvantages is the solicitiations. I get at least one email a day from someone (usually who is trying to sell something) asking me to post content on their product or ad links on my blog to their web site. I almost always decline or just simply delete the request. I almost deleted the request the other day, when I quickly realized the requesters email ended in a ".gov." Apparently, AHRQ is using social media to try to reach out to people.
AHRQ stands for The Agency for Healthcare Research and Qualitys, and for those in the know, is pronounced "ark." According to their web site AHRQs mission is
As my tween daughter would say, "OMG!" The media is a buzz with the news that the FDA is changing the warnings on statins. The New York Times claims "Safety Alerts Cite Cholesterol Drugs’ Side Effects." According to the Wall Street Journal "FDA Warns on Statin Drugs." And the text on the bottom of the CNN report states "FDA places warning on statin labels."DIABETES- This is another topic that I have blogged about, and one that seems not to want to go away. You can see my post "Statins Dont Cause Diabetes" for all the details. Much of the concern came from a Crestor trial which actually showed Crestor to cut heart attack risk in half in patients that had relatively normal cholesterol. This study used a particularly high dose of Crestor, and the FDA warnings point to other studies using high dose statins with similar findings. It is important to note that in the Crestor study, about 40% of the patients were at risk for developing diabetes in the first place, that measures of diabetes in the study were really no different, but the physician reported (i.e. unconfirmed) rates of diabetes were increased. However, more importantly, if you look at the actual rates of developing diabetes it was 3% in the Crestor group an 2.4% in the placebo group. In other words, if statins increase your risk of developing diabetes, it increases it only by 6/10 of a percent (not as low a winning the lottery/memory loss, but pretty darn low). However, with millions taking a statin, even a small risk is something to consider. However, one must also note that diabetes is a disease process more than just an isolated sugar number, and it is unclear what actual risk a statin would cause by turning a pre-diabetic patient into a diabetic one. In fact, patients who are pre-diabetic have a 4 to 6 times greater risk of heart attacks and strokes, and statins have been used in pre-diabetic patients and shown to reduce their risk of heart attack and strokes. Conversely, no study has shown that reducing sugar in a diabetic reduces their risk of heart attack and stroke. BOTTOM LINE-statins may raise your sugar a tiny bit, and for those patients who are at risk for developing diabetes, taking a high dose statin may "push" that patient into having diabetes sooner than expected. However, even in that circumstance, the statin is probably still well worth the risk since it is potentially preventing a heart attack or stroke and slightly increasing the sugar probably has no clinical ramifications.
Statins, which are cholesterol lowering medications are now one of the most commonly prescribed medications in the US. If I were one of the millions of patients taking a statin, I would be pretty worried based on what I am hearing from the media.
FEAR NOT! THERE IS NOTHING TO WORRY ABOUT. DO NOT STOP YOUR STATINS!
Before getting in the details, it is important to note:
1. It is pretty irresponsible of the media to use scary headlines, when the warnings from the FDA werent really that bad. In addition, the warnings about liver problems (the one you hear about in all those TV commercials) were actually downgraded.
2. It is not entirely the medias fault. The FDA does a very poor job when releasing information. When they update something, they should make it clear to physicians and patients what the real risk is. Once again, the FDA failed miserably.
3. Statins are probably some of the safest medications we have. If patients could easily perform and interpret their own blood work, these might even be over the counter. Some have suggested that this might be a good idea. Moreover, statins reduce heart attacks and strokes (#1 and #4 killer in the US). Though no medication is perfectly safe, I can think of no other long term medication where the risk benefit ratio is so far in favor of the drug. Cardiologist John Mandrola put this best in his post (via KevinMD) "Lets close the chapter on statin safety."
Ok, now for the details.
Today the FDA released information that they were updating warning information on statins. Essentially, there are three areas where safety data was updated: liver enzymes, memory impairment and diabetes.
LIVER ENZYMES- This one is actually good news. Earlier statins caused some elevations in liver enzymes which were feared to potentially cause liver damage. After many years of usage, it doesnt seem this fear is warranted. Because they can affect the liver, patients with pre-existing liver disease should use statins cautiously. Even though statins can cause liver enzyme elevation, it is usually at the highest doses and usually returns to normal when the statin is stopped of the dosage is lowered. The routine monitoring of liver enzymes that was once recommended is now no longer required.
MEMORY LOSS- This is the one that makes me the most annoyed. First, because it really isnt true and second because the way the FDA communicated the data is useless at best and harmful at worst, since patients may stop taking statins because they are afraid that they will get Alzheimers.
According to the release the
"FDA reviewed the AERS database, the published medical literature (case reports and observational studies),4-13 and randomized clinical trials to evaluate the effect of statins on cognition.14-17"
The numbers above refer to references of studies they looked at. However, of the 13 studies they analyzed "did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline." In fact, most of these studies were looking at use of statins to PREVENT Alzheimers. Thus, most of the data they used to make this recommendation was from their own AERS database. It would have been really nice to release this data! However, one of the mentioned publications did look at MedWatch drug surveillance system of the Food and Drug Administration (FDA) from November 1997–February 2002 for reports of statin-associated memory loss. Of course we dont know the exact number of patients that took a statin during those 5 years, but it was in the millions. The authors were only able to find 60 reports, of which none was truly confirmed (just patient report) and more than half noted improvement when the statin was stopped.
I have previously blogged about this issue back in 2008 in my post Lipitor and Memory Loss as well as another post Lipitor: Responding to Spacedoc. Spacedoc is really Dr. Duane Graveline, MD, MPH, a family physician who became a NASAs scientist, but is better known for his book "Lipitor, Thief of Memory" which he wrote after having two episodes of something called transient global amnesia (TGA) which he states was associated with his use of Lipitor from 1999 - 2000. In fact, I actually became aware of TGA because the mother of a close friend had the exact same thing.
BOTTOM LINE- There may be some connection between Lipitor and memory loss. However, even if there is, it is extremely rare (you have a better chance of winning the lottery) and even if you get it, it usually goes away if you stop the medication. In other words, there is absolutely no reason to be alarmed, and no reason not to take the drug if you need it to control your cholesterol.
In today’s Wall Street Journal, and article that is getting a lot of attention is More Doctors Fire Vaccine Refusers. The article discussing the increasing frequency of pediatricians who are “firing” patients/families from their practices because they refuse to take recommended vaccines for fear of autism or other concerns (rampant on the internet, but all proven untrue). Many have started to blog or tweet about this. Richard Meyer at World of DTC Marketing.com poses the question Should doctors be able to fire patients ? This is an interesting question that I will attempt to answer. It is important to note that not only should physicians be able to fire patients, they must be able to fire patients. Physicians are allowed to choose which patients they accept (unless they work in the emergency room). This happens every day, when a physician refuses to accept a patient that does not have an insurance they contract with. However, it would not be illegal (or even unprofessional) for a physician to for example, not accept any patients who currently smoke. Many primary care physicians will not accept a new patient who is a chronic opioid user (or will only accept them under the circumstances that another provider manages their narcotic prescriptions). However, once a physician sees a patient, she has established a doctor-patient relationship. This is a legal and binding contract that comes with rights and responsibilities, such as confidentiality. In addition, if a doctor-patient relationship starts to sour, the physician cannot simply one day refuse to see the patient. This is called "abandonment" and is subject to legal action. Thus, physicians need to have a process to “fire” (terminate is the technical term) a patient from their practice, or they would become indentured to their patients indefinitely. The process of terminating a patient usually involves timeliness of notifying the patient, provision of care until a new provider is found in a reasonable amount of time, and assistance with finding a new provider (such as providing recommendations). The issue of pediatricians firing vaccine refusers is an interesting one, since the typical splits between doctors and patients are usually related to disruptive patients, unhappy patients or patients inability to pay. The issue of vaccine refusal is more of a philosophical one, though concern for the health and safety of other patients and staff is certainly a reasonable concern. However, another twist to this issue involves new models of health care where providers are rewarded for improvements in quality of care. Known as “pay for performance”, physicians get a bonus if they can deliver better quality. These bonuses are generally delivered on patient population data. For example, a target might be having 90% of diabetic patients getting annual eye exams or checking blood sugar control. Would it be acceptable/reasonable for a physician to “fire” a patient who refuses to follow the recommendation that the physician is being measured on? Patient satisfaction is also becoming a popular measure. Would it be acceptable/reasonable for a physician to “fire” a patient who is constantly unhappy and likely to give the physician a poor satisfaction rating that he or she is being measured on? Should there be laws against physicians firing non-adherent or unhappy patients? If not, and assuming most physicians will wind up incentivized by such measures, which physician would accept a known unhappy or non-adherent patient?
Today on NBCs today show, celebrity chef Paula Deen confirmed she had Type 2 diabetes. She was diagnosed 3 years ago, but only decided to come out today. She also mentioned that she is a paid spokesperson for drug company Novo Nordisk, maker of several diabetes drugs. (Click here to view Al Rokers interview). When the news started breaking earlier this week, I had mixed emotions about Deen as a spokesperson for diabetes. Blogger and health care marketer Richard Meyer at worldofdtcmarketing.com posted This is a spokesperson for Novo? Deen is of course known for her southern style of cooking, which typically involves very fattening ingredients. At one her restaurants she famously serves a hamburger with bacon and egg on a donut instead of a bun. What message does this send to people ? That it’s OK to eat really bad food because diabetes can be treated with Rx drugs ?" I commented on his blog that if Dean actually changes her ways, and focuses on healthier cooking, providing healthier recipes to her fans and other diabetics, she might actually make the perfect spokesperson. Americans have not been paying attention to what we eat and obesity has now become an epidemic, leading to increasing numbers of patients with type 2 diabetes. After seeing the Today show video, I remain on the fence. Her interview was not the redemption story I was hoping for. Give journalistic kudos to Al Roker who pressed Deen on whether she had changed her ways or changed her cooking. She responded essentially stating that she has always eaten (and suggested others eat) in moderation, claiming that her weekly cooking show is only 30 days out of a full year and that no one should eat that kind of food every day. According to Deen, when asked a similar line of questions from Oprah, she responded, "Im your cook, not your doctor." Deen did state that she and her sons would work to come up with lighter recipes (available on Novos web site) and recommended people go to their doctor, get tested and "get on a program." On the website diabetes in a new light, Deen does say that she had to give up sweet tea. In fact, rigid diet and exercise programs do not work all that well in reducing weight or improving diabetes, since patients have a hard time sticking to them, so her mantra "I wasnt about to change my life, but I have made simple changes in my life" may have some merit. However, I believe there is still a difference between promotion of healthy lifestyle and realistic changes in diet and exercise and "everything in moderation" and "its OK to have that little piece of pie." Paula doesnt have to become the next Richard Simmons or Jillian Michaels, but I would have liked to seen a little more "mea culpa." I am interested to see how this plays out in the media and in public opinion. This is a terrible disease and the prevalence is getting worse. Ms. Deen has the potential to make a major impact. I hope she takes her spokesperson role seriously.
Here is another example of less than responsible journalism. Both the Wall Street Journal and Fox News report "QUIT SMOKING: A NEW CASE FOR GOING COLD TURKEY." Even NPR asked Do Nicotine Patches And Gum Help Smokers Quit? Other reports similarly headline with questions regarding the effectiveness of the nicotine patch, which has been a tried and true treatment to help smokers quit. All these reports stem from a study done by researchers at the Harvard School of Public Health and the University of Massachusetts in Boston and published online in the journal _Tobacco Control_, that found that over a 5-year period, former smokers who used nicotine-replacement products were just as likely to relapse as those who quit on their own. This is indeed an important study because it shows that relapse rates are high, and nicotine patches may be insufficient to prevent quitters from relapsing. Indeed, other methods should be sought for recent quitters to prevent them from relapsing. The problem with the way the media is reporting the study is that it is confusing quitting and relapse. Countless studies show that nicotine replacement about doubles the chance that you will successful quit, which is usually defined as not one cigarette for 12 weeks (though better studies use 52 weeks to define quitting). In this study, all the people studied had recently quit. This study was not measuring whether or not the patch helped these folks quit, but whether people who had quit using the patch were any different than people who had quit without the patch in terms of relapse several years down the road. People interested in quitting smoking should not be confused by the reports in the media. Nicotine replacement will help you quit. The evidence for using medication (nicotine, bupropion, varenicline) is so strong that the US Surgeon Generals guidelines recommends that all smokers (even those at risk to medication side effects such as heart patients and pregnant women) be offered some form of medication, since it is so effective. Again, the study is an important one because it shows we need to look beyond nicotine replacement to prevent long term relapse. However, the journalists who reported on this study shouldnt have suggested that smokers consider going cold turkey.
Health care is in crisis. Reimbursements from insurance companies continue to dwindle, while the expenses of running an office continue to rise. Looming cuts in Medicare are only weeks away, and many physicians may stop taking Medicare. If these cuts go into affect, it is possible that primary care physicians could lose up to 50% of their salary. Just recently CNN reported that some doctors are going bankrupt.
How to fix our health care system is an ongoing debate, but not surprisingly, many physicians have decided not to wait for the government to solve this problem and have taken matters into their own hands. One solution is to simply stop taking insurance altogether. “Cash only” doctors are now commonplace in many major metropolitan areas. Another solution is charging a regular, out of pocket fee (usually) in addition to what insurance will pay for treatment. A version of this model that is becoming popular is called retainer medicine. Sometimes, retainer medicine is referred to a “boutique” or “concierge” even by physicians and others involved in health care (as evidenced by this article in the AMA News, which prompted me to post on this topic).
However, “retainer”, “concierge” and “boutique” are not the same thing. Names are important, and the terms “concierge” and “boutique” tend to have negative connotations. Thus, it is important to describe the differences.
In a retainer model, patients pay a fee (not covered by insurance) to be part of a physician’s practice. This is similar to clients paying a retainer fee to hire a specific lawyer. With reimbursements from insurance companies being so low, the only way an insurance based physician can increase revenues is to increase the volume of patients they see. Unfortunately, when physicians increase the number of patients they see, it leads to rushed patient visits, long waits in the waiting room, and decreased access to physicians including difficulty in getting appointments or responses phone call messages. By accepting a retainer fee, the physician no longer needs to rely on insurance revenue alone, and in fact can decrease the amount of patients he or she sees on a regular basis. This allows for increased access (usually same day or next day appointments and 24/7 phone access) and longer appointment times (usually 30-60 minutes) for patients willing to pay a retainer fee. The typical insurance based primary care physician has about 2500-3000 patients in their practice, and sees about 25 patients a day. The typical retainer physician has about 500 patients and sees only a handful of patients each day. Retainer fees and the amount of access patients get for what they pay vary widely, but the average retainer fee is about $1500 per year.
Some have argued that retainer medicine is unethical because not everyone can afford $1500 a year. First, the typical retainer fee amounts to about $4 a day, which is what many Americans pay (or more) for a Starbucks coffee. Secondly, one could also argue that it is also unethical for insurance based physicians to see complex patients in brief visits and/or not being able to see them in a timely fashion due to lack of access.
Concierge medicine is somewhat different, and in my opinion, should not be used synonymously with retainer medicine.
According to Wikipedia;
“A concierge is an employee who either works in shifts within, or lives on the premises of an apartment building or a hotel and serves guests with duties similar to those of a butler. The term "concierge" evolved from the French Comte Des Cierges, The Keeper of the Candles, who tended to visiting nobles in castles of the medieval era.”
Just like the concierge at a hotel, who can get you good seats at a ticketed event, a reservation at a popular restaurant, or even run an errand; a concierge physician can get you timely appointments with the best specialists, usually doing the scheduling themselves. Many concierge physicians will even accompany patients to procedures or diagnostics tests, and some will even make house calls. Though some retainer practice physicians may perform concierge services (usually the ones charging well over the usual $1500 fee), the terms are not the same. Many retainer physicians will assist in coordinating specialist appointments, but this is as far as they go. In fact, some “cash only” physicians perform concierge services to attract more patients, and some doctors (even insurances based physicians) will charge an extra-fee for some concierge services, such as a house call.
Boutique medicine is also completely different. Again, from Wikipedia:
“A boutique is a small shopping outlet, especially one that specializes in elite and fashionable items such as clothing and jewelry. It can also refer to a specialised firm such as a boutique investment bank or boutique law firm. In the strictest sense of the word, boutiques would be one-of-a-kind but more generally speaking, some chains can be referred to as boutiques if they specialize in particularly stylish offerings.”
I think the key words in this definition are “specilalized” “stylish” and “elite.” The first word is something commonplace in medicine, but the later two words are something usually not associated with medical practice. “Luxury” is also implied in the word “botique.” Thus, in my opinion, a boutique doctor is one that specializes in unique, often luxurious services, that are not offered by others and which will therefore cost a little extra. These services include, but are not limited to, cosmetic procedures (botox, laser hair removal), medical spa services, comprehensive screenings (i.e. body scans), and herbs or supplements. Though both retainer and concierge physicians may provide boutique services, this is generally not the norm. In fact, many insurance based primary care physicians have started to add these services as a way of keeping their practice running. (Ethics could be questioned here as well).
I am not arguing that retainer medicine is the solution for all of our nation’s health care woes. It certainly is not. However, given that it solves some of the issues with 3rd party payors, is a model that continues to grow, and patients and providers enrolled seem to be very satisfied; it is something that deserves attention. Another model that is garnering some attention is direct access primary care. In this model, patients pay a monthly fee (usually about $70/month) and receive enhanced access and communication as well as primary care and urgent care services. Though the cost is slightly less ($1500/yr vs. $840/yr) and access to your personal may not be 24/7, this is a similar model to the retainer concept. (Proponents have called this retainer medicine for the masses).
Thus, using terms “concierge” and “boutique” that have connotations of elitism, luxury and unnecessary care synonymously with retainer medicine discredits a potentially viable health care model for many Americans. I would request that physicians, policy makers and journalists no longer use these terms as if they were the same.
The Wall Street Journal is reporting on a study published in the journal Cancer, and described by Reuters that links statins to reducing the risk of prostate cancer. According to the report: The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group. Those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer. I would love for statins to reduce the risk of prostate cancer. Readers of this blog know I am relatively pro-statin, in the right patient population. However, this study is too limited to make an actual connection, and I would not recommend taking statins solely for prostate cancer prevention. WHAT DID THE RESEARCHERS DO? The looked at the medical records of 380 men who died of prostate cancer and matched them with the records of another 380 men who did not have prostate cancer. They use statistical techniques to adjust for difference such as age, weight and other medications. WHATS THE PROBLEM WITH THE STUDY? First, if the study findings are correct, such a study that uses medical records and then looks back in time can not prove causation. It only proves association. This means that the study doesnt prove that taking a statin will ward off prostate cancer. Rather, the results mean that men who had died of prostate cancer were less likely to take a statin. This is a big difference. There are multiple examples where a confirmed association did not result into a confirmed causation (Vitamin E/C and Folic Acid for preventing heart attacks). In addition, there are many reasons that the association is in fact not correct. Perhaps men who had been diagnosed with prostate cancer chose not to take statins, even if their doctors recommended it, because they were more concerned about the prostate cancer? Perhaps men who did not have prostate cancer were extremely health conscious and were more aggressive about both doing things to prevent cancer (exercise, diet, etc.) as well as being more aggressive about taking statin medications for high cholesterol? WHY THIS MIGHT BE TRUE? The only way to truly determine causation is to perform a randomized clinical trial (RCT). Only a RCT can both eliminate some of the confounding variables (i.e. were the men without prostate cancer more aggressive about their overall health) and demonstrate the primary ingredient for causation: that exposure always precedes the outcome. If factor "A" is believed to cause a disease, then it is clear that factor "A" must necessarily always precede the occurrence of the disease. However, there are two findings from this study that support causation. First, is dose-response relationship. Only the newer, more potent statins showed benefit. Taking a lower potency statin was not protective. The second is biologic plausibility. According to the Reuters report, Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasnt involved in the new study was quoted as stating that statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, mentioning that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing. BOTTOM LINE: This study is exciting and will hopefully lead to randomized trials which can prove whether or not taking a statin will prevent prostate cancer. For now, there is very limited evidence to suggest this would actually work, and men should not start taking a statin just to lower their risk of prostate cancer.
There is a new study reported in Bloomberg this morning that Sanofi’s Lantus Doubled Cancer Risk in Study of Diabetics. The study, which was presented yesterday at the San Antonio Breast Cancer Symposium retrospecitvely evaluated medical records of 23,266 patients in southern Sweden and determined that diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk. I have previously blogged about this back in 2009 when the first reports surfaced about the link between Lantus and cancer. (See A New Problem With Insulin: Cancer , Lantus Causes Cancer! Why Doesnt Anyone Seem Care? and Lantus and Cancer- A Closer Look Is Not Reassuring ) Back in 2009, when the story broke, the FDA acknowledged the potential link but stated that the data was insufficient and recommended that patients not stop taking Lantus, at least without discussing this with their physicians. They stated that they were "currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus." However, we didnt hear much until January, 2011 when they released an update declaring that they had reviewed the four 2009 studies and has "determined that the evidence presented in the studies is inconclusive", and in addition had reviewed results from a 5 year study (sponsored by the makers of Lantus) which did not show an increased risk but was "not specifically designed to evaluate cancer outcomes," concluding, "at this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial." With the new study reported today, it will be interesting to see whether the FDA chooses to give and update or reveals and additional information, such as a VA data set they are supposed to be evaluating. According to the Bloomberg article, a Sanofi study from Sweden, Norway, Finland, Denmark and Scotland is complete and will be submitted to health authorities this month. In addition, U.S. study will be finished in early 2012, while a final report from Europe will come later. All of these studies combined will involve more than a million patients, which will hopefully be enough to give a more conclusive answer. To be clear, I am not 100% convinced that Lantus causes cancer. However, there is another long acting insulin (Levemir) which has similar efficacy to Lantus, has not been associated with cancer, and has a substantially different affinity for the insulin like growth factor (IGF) receptors that are implicated in the possible connection. Given the mounting evidence of a cancer link with an equally effective product that appears to be safer, I cant see any reason to prescribe Lantus when Levemir is available.
One of the advantages of being a blogger is the comments, feedback and communications I receive from readers. Though not all of it is positive, many of these interactions with people from across the globe that I do not know has been quite enjoyable for me personally. One email I received from a reader had to do with industry funded studies. This is not an uncommon concern, and one that frequently shows up on this blog and others. The email encapsulates many peoples concerns with industry funded studies. _Dear Dr. Mintz,_ __ _I am staring at my computer unable to formulate the words to express my opinion on a very important subject. I do not want to come across as rude, condemning or complaining, yet I am compelled to share with the medical community my honest patient perspective._ _I view the medical profession as one of the most respected on earth. But it isnt perfect. As a patient I become very discouraged when I see a medical professional look towards industry funded drug studies to make medical decisions. _ _Now for the painfully honest part. When I see a Doctor subscribe to "results" from an industry funded drug study, my image of that physician goes to pot in a heartbeat. "How can he/she be so gullible" and "Incompetent" are thoughts that pass through my mind. I quickly lose trust in that physicians ability to make smart decisions in my health care, and the doctor loses my business._ _On on the contrary, I asked a physician what he thought about industry funded drug studies, he answered "I ignore them." This doctor won me over in three words. _ _Obviously it takes excellent academic ability to become a physician, but I look for more than that. I look for wisdom and integrity when choosing a physician. _ There is no question that industry studies are biased by nature. The drug company is beholden to its stockholders to increase sales. Therefore, they have a fiduciary obligation to make sure that their research puts their products in the best light. This is not unlike any product in the US where a manufacturer does research stating that people prefer it or it works better than a competitor. Unlike these products, medications are heavily regulated in the United States. Thus, for a medication to get approval or to make any claims, all studies, including ones funded by the industry have to go through the FDA. HERES THE REAL PROBLEM: ALMOST ALL RESEARCH DONE ON MEDICATIONS IS FUNDED BY THE INDUSTRY. I would love it if instead of relying on industry sponsored studies, I could rely on non-biased information. However, when it comes to medications, these studies are few and far between. In 2005, the industry spent close to $40 billion dollars on research. Compare this to the entire NIH budget that same year of less than $30 billion. Also, understand that the NIH spends very little money on actual drug studies. They focus more on finding a cure to cancer, not whether expensive medicine X is just as good as the older generic medication. When I want to know whether to buy product X vs. product Y, I can go to an independent source such as Consumer Reports, which does their own, independent research. There is really no such independent source for drug information. In fact, prescription drugs is one of the only areas that Consumer Reports does not do their own research. All their recommendations on which medicine is "right for you" come from drug company sponsored studies. If we ignored all industry funded studies, we be ignoring most of the data. In addition, since these studies are heavily regulated, we would be ignoring mainly good, helpful data, even if biased. The simple alternative is to fund the NIH or similar organization equally to the drug companies in order to do independent research. Of course this would likely require significant government spending, which is likely a non-starter. The good news is that independent comparisons of treatment, called comparative effective research, are starting to be done, and (whether you like health care reform or not), there is funding for this research in the Affordable Care Act. Unfortunately, this funding is not nearly enough to compete with the drug companies. Thus, unless you are willing to pay considerably more in taxes or drop some needed services, physicians and patients still need to rely on industry funded research. Many studies from the industry are actually quite good and useful, though, because of inherent bias, should always be looked at with a skeptical eye.
There has been much confusion/concern/media attention since the recent announcement (see the NY Times article US Panel Says No to Prostate Screening for Healthy Men) that PSA tesing was no longer recommended by the US Preventative Services Task Force. (Heres the full version of their draft recommendation.) There are many responses out there (Tara Parker Popes Answering Questions about the PSA test is a good one), but I believe there is still more to say on the issue.
Before answering the question regarding whether we should follow the USPSTFs new recommendation, please consider...
1. The USPSTF is the same group that says
-Women shouldnt get mammograms before 50
- Recommends against teaching self-breast examination
-States that screening for testicular cancer is harmful
-Only recommends screening for diabetes in patients with high blood pressure
-Recommends against screening for depression for most primary care doctors
(I am not stating that I necessarily disagree with these recommendations. However, it is important to understand where USPSTF is coming from when considering their PSA recommendation).
2. Prostate cancer is still a leading cancer killer for men in the US.
From NY Times:
One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis.
The new recommendations come from findings of two large studies. One in the US that showed no benefit in saving lives, and one in Europe that showed only some benefit. The US study have some major limitations, including that many of the men in the placebo/no-screening group actually got screened, so I will focus on the European study.
The European Randomized Study of Screening for Prostate Cancer looked at close to 200,000 men between 50-74 for about 9 years. Not surprisingly they found almost double the rate of prostate cancer in the screened group compared to the non-screened group (8.2% vs. 4.8%). More importantly, they reduced the rate of death by about 20%. Unfortunately, most of the men treated for prostate cancer did not benefit. They found that for every 1410 screened, there were 48 additional cases of prostate cancer found, that if treated would only prevent one death from prostate cancer. In other words, if you are treated for prostate cancer, theres only about 1/50 chance it will save your life. Now, if the treatment were without side effects, then besides costs, there would be no reason not to screen. (My friend Dr. Stewart Segal in his post PSA Confusion suggests covert rationing is one motivation behind the USPSTFs recommendation). The problem is that there are side effects with treatment, and not inconsequential ones. There is about a 20-30% chance of impotence, incontinence or both.
HOWEVER, THERE SEEMS TO BE TWO THINGS NOT DISCUSSED IN ANY OF THE REPORTS:
1. Though the writers of the guideline seem to give value/risk of the harms of treatment, they do not address the potential benefits of the piece of mind from a negative screen. In the European study, over 90% of men had a negative screening over the course of almost a decade. In other words, the vast majority of men screened had the piece of mind knowing that probably didnt have to worry about prostate cancer. (There is also additional evidence that men 65 and older with a very low PSA will likely never get prostate cancer, and screening should be stopped).
2. Just because you are diagnosed with prostate cancer, doesnt mean you need to treat it. Given the complications as a result of prostate cancer treatment, and the fact that prostate cancer tends to progress slowly, especially after the first year, watchful waiting is a reasonable approach. If in fact, if the cancer remains stable, treatment can be deferred potentially indefinitely. However, without the diagnosis, watchful waiting can not occur.
BOTTOM LINE: THERE IS NO RIGHT ANSWER FOR EVERYONE. Patients, in consultation with their doctor, need to make a decision thats right for them. If you are a healthy person, with no cancer risks, worry about side effects and complications of medical treatment, and realize that theres a 98% chance that screening for prostate cancer will not save your life, you should not get a PSA test or prostate exam. However, if you are someone that is very fearful of cancer, would have substantial piece of mind if you were one of the 90% of men that tested negative, and if you did get diagnosed with prostate cancer are willing risk treatment knowing there is only a 1/50 chance it will save your life, but about a 20-30% chance you will get side effects from treatment, then you should get tested.
Before I took over one of the classes that now teach at the medical school, I asked students why the value of that class was so low. One of the reasons they gave was that it was so hard to do well in the class, and there were so many other things to study, students only put in enough effort to pass. In other words, incentives are only good if they are both valued and attainable. As this related to Electronic Medical Records (EMRs), achieving meaningful use is not easy. The technology for clinical decision support (a requirement) is not quite ready for prime time. Nor is there an easy way to share parts of the EMR with patients. In a study of almost 600 docs who had been using EMRs, most were confident that they would qualify for meaningful use and get bonuses for doing so. However, the survey also found that the majority of these physicians would not meet some of the criteria. Thus, though the financial incentive seems nice, the path to getting these incentive may be so unattainable that physicians wont waste the effort or expense. More importantly, some of the "stuff" thats meaningful in meaningful use, may not have value for physicians. Policy makers that developed these criteria were understandably thinking on a population level (lowering blood sugar in a population of diabetics). However, physicians are used to dealing with patients one on one. A recent survey of EMR using physicians was done over at Software Advice regarding the advantages of using EMRs. Granted 50 respondents may not accurately generalize to most physicians; however, some of the results are telling. What do doctors like about EMRs? Greater accessibility of charts, easier to read notes, more accurate patient information, and improved coordination of care by having the ability to share data. As a user of EMRs for well over a decade, I would concur with these findings. EMRs are far from perfect, but based on these advantages, I could never go back to paper. What "benefits" of EMRs did doctors not see as readily? Improving preventative care, opportunity to participate in pay for performance, improving clinical decision making, and reducing errors/improving patient safety. Thus, under the current plan to increase EMR use by physicians, the financial incentives may be too hard to achieve and the purported benefits may not be easily perceived. This combination does not bode well for the adoption of EMRs by most physicians. Instead, policy makers might want to consider a different approach. First, rather than create a financial carrot that will be too difficult to achieve for most, use that money to reduce barriers to adopting EMRs in the first place. Second, instead of focusing on the benefits important to policy makers, focus on benefits that are important to physicians, such as making our work easier and more productive. This is important because EMR vendors design their products on what they believe will meet their customers needs. The first EMR platforms focused on improvements in billing and coding to capture more revenue. Now, vendors are focused on helping physicians achieve meaningful use. If vendors focused on making a physicians work easier and more productive (and policy maker made it easier to adopt these tools), EMR adoption would be much greater than it is now.
In my recent post All in for Crestor, I discussed how the SATURN study comparing Crestor to Lipitor was likely a make or break study for AstraZencas cholesterol pill. As mentioned, because Lipitor will soon go generic in November, AZ needed to give insurance companies a reason to pay for the more expensive branded pill, then the soon to be generic and cheaper version of Lipitor, which has been the number one selling drug in the country. As reported in Pharmalots post Disappointing Crestor Results For AstraZeneca (see the official AstraZeneca statement here ), the just released results of SATURN show that the 40mg dose of Crestor was numerically but not statistically significantly better and reducing plaque build up (as measured by % change) as the 80mg dose of Lipitor. As secondary measure, plaque buildup as measured by volume was statistically significant, but since this was not the primary outcome of the study, it is likely enough for insurers to give Crestor a favorable status on their formulary lists. BOTTOM LINE: Crestor is a great drug. It reduces LDL better than Lipitor. We know that from outcome studies of all statins, that the lower the LDL with a statin, the more you decrease heart attacks and strokes. In addition, despite its potency, it has very good tolerability. Certain patients that might need 80mg of Lipitor, might not be able to tolerate side effects at that high of a dose, and might end up doing better on 20mg or 40mg of Crestor. That said, starting in 2012, unless AZ cuts the price on Crestor drastically, it may be a challenge to get the prescription approved for patients.
The American Heart Association will be holding its annual meeting this November. Cardiobrief.org just posted the announced "late-breaking" clinical trials. These are the big name trials that usually grab a lot of headlines. One of the trials is the AIM-HIGH trial which showed that Niacian didnt really do much in patients whose bad cholesterol or LDL was controlled with a statin (see my post What to do about Niacin? ) Another very important study will also be presented that same November 15th, 2011: Comparison of the Progression of Coronary Atherosclerosis for Two High Efficacy Statin Regimens with Different HDL Effects: SATURN Study Results. The SATURN study is the Astra Zeneca (makers of Crestor) study comparing high dose Crestor (40mg) with high dose Lipitor (80mg). Patients in the SATURN study will have known cardiac disease as indicated by a need for coronary angiography (angiogram) and angiographic evidence of coronary disease. The main end point is is IVUS-assessed change in the percent atheroma volume in a >40-mm segment of a single coronary artery; which is a "doctor" way of saying they are going to look for plaque build up in the artery. This is the same end point used in the famous (or infamous) ENHANCE trial which showed that adding Zetia to simvastatin (zetia + simvastatin = Vytorin) did absolutely nothing to plaque build up ( Vytorin and Zetia: What to do now? ) Whats interesting about SATURN is that the LDL lowering properties of the highest doses of Crestor and Lipitor are about the same. However, at those doses Crestor raises the HDL or good cholesterol by about 8% where Lipitor only raises HDL by 3%. Other studies have shown that plaque build up in the arteries (atherosclerosis) that causes heart attacks and strokes, is not just about LDL, but also about HDL. Other studies looking at high doses of Crestor when compared to placebo show that it can prevent plaque build up and possibly even lead to regression. The Lipitor data on this is less robust. The timing of the results at the AHA is particularly interesting, since it will coincide with Lipitor going generic. Zocor or simvastatin has been generic for a while, and works well in many patients. However, patients requiring more aggressive reduction in their cholesterol will not meet their goals on simvastatin and high dose simvastatin is associated with side effects, which prompted a recent FDA warning. (See Dont Take High Dose Simvastatin). Thus, the need for a generic potent statin like Lipitor is huge. However, this could mean that insurers will make it very, very difficult for patients to get Crestor. UNLESS......... SATURN proves that high dose Crestor compared to high dose Lipitor significant reduces plaque build up in high risk patients. Therefore, the SATURN trial is really a huge gamble for Astra Zeneca. When Mercks ENHANCE trial showed that Vytorin didnt really do more than the generic statin, prescribing rates dropped precipitously. Crestor likely faces the same fate is SATURN turns out to be a negative study.
As reported by the Wall Street Journal, Pfizer, the maker of one the best selling drugs ever, is trying to get the FDA to approve an Over the Counter (OTC) version of their blockbuster Lipitor, not coincidentally on the eve of Lipitor going generic. Readers of this blog know that I am a big proponent of cholesterol lowering medications like Lipitor (statins) for patients at moderate to high risk of cardiovascular disease. In particular, I am a fan of the more potent statins like Lipitor and Crestor, because of their increased efficacy with fewer side effects (see Dont Take High Dose Simvastatin). Finally having a generic version available of Lipitor will be a great thing for many patients. That said, making Lipitor OTC is a bad move. First, there is a difference between medications like Prilosec and Claritin that have gone over the counter and Lipitor. Diagnosis for GERD and allergic rhinitis for which those medications respectively treat are made mostly on symptoms alone. Patients dont need to go to medical school to suspect that they may suffer from heart burn or allergies. Starting treatment without seeing a physician is actually medically sound because more often then not the medications will relieve symptoms avoiding a physician office visit. In contrast, starting a patient on a statin is much more tricky. Patients need to know their individual risk for cardiovascular disease. Though there are tools available online to determine this (I use the NIHs risk calculator daily in my clinic), determining individual risk of disease, benefit of taking a medication and weighing this against potential side effects is best decided by a discussion between a doctor and patient. Secondly, before starting a statin medication, one needs to know their cholesterol levels. Though there are other methods (health fairs, work screenings) of determining cholesterol levels, getting a blood test usually requires a visit to the doctors office. In addition, follow up blood work (checking for medication efficacy, liver side effects) is warranted after starting treatment. Thus, the benefit of having a medication OTC is negated. Finally, Claritin and Prilosec are very safe. They are as safe or safer then other OTC medications. Lipitor is also very safe, but is associated with rare, but serious side effects. Taking Lipitor OTC without consultation with a physician creates the risks of patients developing these side effects without proper warnings and therefore potentially worse outcomes if attention is not sought. The second main reason that OTC Lipitor is a bad idea is that it will hurt more patients than it will help. The reason for this is that when a medication goes OTC, insurance companies usually will not pay for them. Now that Allegra is over the counter, it is virtually impossible for any of my patients to get a prescription version antihistamine. Though they can easily get this OTC, not having a prescription means they need to pay for it out of pocket. The cost of an OTC medication, even if the generic OTC version is used, is generally more than the co-pay for a generic prescription. It is unlikely that generic Lipitor will make the $4 Walmart or Target list, but after six month, the co-pay for generic Lipitor would still likely cost a lot less for most patients then paying for OTC Lipitor out-of-pocket. BOTTOM LINE: The reason why Pfizer wants Lipitor OTC is for one reason: to make more money. They can argue that cardiovascular disease is the number one killer in the US, and by having Lipitor OTC, it will be available to more patients. However, because statins require blood work and medical consultations, the risk of harm to patients outweighs the potential benefits of greater availability. In addition, this will result in cost-shifting to patients in order to boost Pfizers profits. Hopefully, the FDA will say what they said when Merk tried to pull this off: "No."