New Practice

After 20 years of serving as full time faculty at The George Washington University School of Medicine, I will be starting my own Internal Medicine practice in Bethesda, Maryland.  My location is still being finalized, but I plan to see patients starting early July.  Current patients can still reach me at my regular number.  New patients may register to see me and request appointments by clicking on the link below.

CLICK HERE TO REGISTER AND RESERVE AN APPOINTMENT

My new office number is 855-MINTZMD  (855-646-8963) 

Update on Cipro

I initially started this blog as way to communicate information to patients concerned about certain medical topics, specifically those that hit the media.  With our 24/7 news cycle, multiple TV and cable channels, as well as blogs, social media, etc. there is always some new study or finding about a disease or drug.  However, patients or family members with that disease or who take that drug are often confused, because reporting on these topics tends to be confusing.  
Unfortunately, with new job responsibilities over the past several years, I have been unable to keep up with this blog.  While I have greatly enjoyed sharing information with patients, it takes a tremendous amount of time to write the type of posts on this blog, which cite multiple sources and attempt to interpret data.
However, despite not writing posts for three years, I have kept the blog active on the web.  I still get many hits, so I assume the information is still useful to some.  I continue to get inquires about popular topics.  In addition, for some posts, patients have used my blog as a forum to share experiences.
By far, the most popular post on my blog was written in July of 2008, called Tendon rupture with Cipro? FDA caves to Public Citizen.  The post has 163 comments and has over 46,000 views. Clearly, I stumbled on to something with this post.

The initial post was in response to media reports about a boxed warning placed on Cipro and other flouroquinolone antibiotics by the FDA in response to a letter by watchdog group Public Citizen.  My opinion at the time was that while Cipro was probably overused, the safety data from Public Citizen's report was actually not so bad, and came from a flawed event reporting system. Thus, I felt that the FDA was probably "caving" to public pressure. I saw this as a problem because there are many examples of FDA "warnings" that scare patients and the public unnecessarily, as well as lead to TV commercials from lawyers that scare patients from taking almost any treatment.    Most importantly, I stated that "the FDA stated it had recently done its own "new" analysis, which is why it added the boxed warning. However, they do not present the details of their findings. To me, this implies that they simply caved from public pressure and/or from law suit threats."  As a physician, it is hard to make decisions without looking at the data.  I thought it wasn't very responsible of the FDA to make such a warning without releasing any data.

The response to this post was overwhelming.  Patient after patient, commented on my post with horror story after horror story about problems they had with Cipro.  While this contrasted my experience with patients I had prescribed Cipro to, the sheer volume of posts told me that there really must be more to this flouroquinolone issue.  One affected patient who responded to my post actually obtained some of the aforementioned FDA "new" data through the Freedom of Information Act. He shared some of this data with me, confirming my suspicion.  Thus, I reversed my opinion.  Cipro is clearly not the safe drug I thought it was.  I stopped prescribing it for my patients, and I had indicated my position change in comments section of the post.  (I probably should have written a new post, since I would occasionally get angry responses to the original post and would need to indicate that the post was old and my position had changed).

Finally, yesterday, three years later after the boxed warning, the FDA states that these drugs are indeed dangerous.  Specifically, " The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options."  While it again would have been nice for the FDA to present more of the data (which was discussed in a meeting back in November, which eventually led to this announcement), I am glad to see that the FDA continued to pursue the issue and has communicated this issue to the public.

I want to thank all of the respondents to my original post who correctly challenged my viewpoint.  In doing so, you:
1. Changed my opinion and my practice.  While I never prescribed a lot of quinolones before, by stopping their use, I am sure I spared someone potentially dangerous side effects.
2. You created a forum for patients to share their stories
3. You kept the conversation going and my have helped keep pressure on the FDA to continue to focus on this issue.

I do hope that my schedule allows me to blog again in the future.

Why the FDA Should Lift Warnings on Avandia, Even if No One Will Use It

Today was day #1 of the FDA's two day hearing on Avandia. The reason for the meeting is a review of the controversial RECORD trial.  I have blogged about Avandia extensively. In case you are not up to speed on what's happening, Matthew Herper at Forbes has one of the best summaries I have read called "Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes."

The decision by tomorrow's FDA advisory committee could range from lifting restrictions, to removing Avandia from the market entirely, to doing absolutely nothing.  And regardless of their recommendation, the FDA may do something different.  However, even if Avandia is cleared of all harm, and restored as a safe product in the eyes of the FDA, few doctors will likely ever prescribe this medication.  Since rosiglitazone is off patent, it could be generic, but it is unlikely that any generic company will invest in bringing it to market. For the same reason, it is unlikely the GSK will start marketing the medication again.  However, I believe there are important reasons why Avandia should be exonerated, even if few additional patients end up taking it.

1. The un-blinded RECORD analysis is enough reassurance
What we learned today was that the re-analysis of RECORD was consistent with the original findings that Avandia did not lead to cardiovascular death or heart attacks. In addition, the Duke group that did the re-analysis did a pretty darn thorough job.  Thus, the central issue in tomorrow's discussion will be whether an un-blinded, large randomized trial is enough to prove safety and negate the results of a meta-analysis.
The gold standard for science is the double-blinded, randomized control trial.  Double blinded means that when the researchers are analyzing the data, they don't know which group is the treatment group and which is the control, and patients don't know whether they are taking the experimental drug or a placebo.  The reason for blinding is that it reduces potential bias.  When patients are enrolled in a study, if they think they are taking a medication that will help them, it will help them, even if the drug is a placebo. The more they think the drug is helping the more it is likely to help. So, if you did a headache study and gave half the patients Tylenol and half the patients nothing, the patients taking Tylenol would surely do better, but you couldn't prove that Tylenol relieves headaches because your results might have just been due to the placebo effect. In other words, in a study of efficacy, not blinding patients to a treatment may bias a study in favor of that treatment. 
In the RECORD study, the investigators were blinded to the results (single blinded), but patients knew whether or not they were taking Avandia. There were several reasons the investigators did this, one being that in Europe (RECORD was an international study), Avandia was not indicated with insulin.  However, having open label treatments in RECORD should not effect the results, primarily because record is a safety study. If anything, if you are patient in a safety study and you know you are taking the drug they are studying (must be something wrong with it if they are studying safety), you would be more likely to have adverse events.  This is known as the nocebo effect. It is the reason why if you read the all the information they give you at the pharmacy when picking up a prescription, you are much more likely to think you have one of the millions of side effects listed. In other words, in a study of safety, not blinding patients to a treatment may bias a study in favor of the control. However, in spite of this bias, the RECORD study still showed no harmful effects of Avandia. Thus, if anything, the un-blinded design of the RECORD study should lead the FDA to be even more assured about Avandia's safety.

2. The TZD class is good for treatment of diabetes.
When the Nissen publication was released and the Avandia storm began, patients got worried.  Some patients simply stopped taking Avandia altogether, without substitution.  Many doctors switched their patients to Actos, the other thiazolidinedione or TZD available. Merck got lucky and launched Januvia around this time, so when physicians were looking to add a medication to metformin, due to TZD fear, and presumed safety of a new class of medications, they started prescribing Januvia.  In other words, while Actos ended up getting most of the TZD scripts, fewer doctors were writing for TZD's. This is a shame because the TZD's are the only class of medications to show that they keep a diabetics sugar under control for many years.  Older drugs like metformin and sulfonylureas usually fail after three to six years.  TZD's also don't cause hypoglycemia.  They also have positive benefits on lipids (raising good cholesterol and lower tirglycerides). The TZD's are not perfect drugs.  They increase fluid retention and can lead to congestive heart failure in patients who have decreased heart function.  There is a small risk of osteoporosis, and with Actos there may be an increase in bladder cancer. Yet, while not perfect, most of these risks are manageable.  Heart attacks are not, and so due the Avandia fiasco, the TZD class is likely underutilized.  Pioglitazone is available without restrictions and is now generic. Thus, exoneration of Avandia would likely (and appropriately) increase prescriptions of this medications.

3. Other options may be less safe than once thought.  
There are two reasons why in 2010, the FDA chose to severely restrict Avandia.  The first was due to concerns of missing data and a non-independent analysis in the RECORD trial (which we now know was unfounded).  Second was the notion that Actos seemed just as good as Avandia, but didn't have the risks, and therefore many saw no reason to keep Avandia on the market. However, what we now know is that Actos may be associated with bladder cancer.  (In fact the FDA knew about this in 2010, but brushed it under the rug at the July meeting- see page 213 of the original transcript).  While pioglitazone may have a slight edge over rosiglitazone in a number of areas, in patients with a higher risk of bladder cancer (smokers), I might use Avandia over Actos.
Also, the new agents (DPP4's like Januvia and GLP-1's like Victoza) were new at the time.  We now know that these agents may have risks of their own including pancreatitis, and the FDA is even looking into pancreatic cancer as highlighted by a recent New York times article. Now there are pro's and con's to all agents.  A physician's job is to weigh the risks and benefits of each medication and choose the most appropriate product. However, this is made particularly difficult for diabetes when the specter of heart attack looms over the TZD class.  Lifting the heart attack risk from Avandia will truly give diabetics more options (even if they don't take Avandia).

4. Clearing Avandia may help restore public confidence in the FDA, and possibly pharma. 
The problem with the whole Avandia fiasco was it decreased the public's confidence in both the FDA and the pharmaceutical industry.  The heavily marketed Vioxx was a lesson in caution.  However, certain doctors and journalists made a name for themselves looking for the next Vioxx, and Avandia was a great target.  The FDA knew about the risk seen in their own meta-analysis but wisely chose to wait on any restrictions or warnings until other trials, including RECORD, were complete.  We now know that this was the correct decision.  However, some inside the FDA were not happen with this decision and made sure that the data got to the public. Hysteria ensued.
While industry watchdogs are necessary, they can sometimes to more harm than good. Ask any physician, and they will tell you that, in general, most patients are afraid to take any medications. This was not nearly as true 10 years ago. Today, patients don't trust drug companies or the FDA. The Avandia fiasco played a major role in this.  The FDA can now right this wrong.

Residency Match Results Bad for Primary Care (Again)

Once again, though not trumpeted as much as in previous years, reports of this year's 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.

Despite having almost 1000 new graduating medical students, the addition of these students to the primary care fields are limited.  The real way to see what are students are choosing it to look at the percent of graduating students choosing a specific field (% US grads matching in my table).  The results are pretty bleak. 




There is virtually no change in student choosing internal medicine from 2011 to 2013 (18.9% to 19.1%). Family medicine, which looked to have a slight bump last year is actually down from 2011 to 2013 (8.35% to 8.26%). Peds is up from last year, but still down from 2011 (11.34% to 11.2%).  One also needs to look at how many of the positions that were offered (a major increase from prior years) were filled by graduating US seniors.  Internal medicine, which was filled by 57% of US seniors dropped significantly to just below half!. Family dipped from 48% in 2011 to 44.6% in 2013. Peds dropped by 1%. 

In other words....

• More residency slots were offered across the board in primary care specialties, but more of these new slots were being filled by non-US graduates, than use graduates
• Despite having three new medical schools worth of graduates, the pool of newly minted primary care physicians isn't really expanding that much
• Our US seniors ARE NOT choosing primary care as a career, and if anything, are choosing primary care slightly less than previously, and certainly not more.

While internal medicine hasn't really changed, it is important to note that of those going into internal medicine, only 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 NP's and PA's filling this gap, those students aren't going into primary care either. A surgical PA makes more money than a primary care MD).

Choose Wisely when Choosing Wisely

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 Post's headline reads "Group releases list of 90 medical ‘don’ts.’"  The New York Times similarly describes this report as a list of "don'ts."

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 ER's 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 child's 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 "don'ts."  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 shouldn't 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 won't 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.

The Future of Health Care is Now Clear

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 (ACO's) 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 don't 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 doctor's 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 doctor's 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.

No Medicare "Doc Fix" Could Result in Over 50% Salary Cut to Primary Care Physicians

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 doctor's 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 doctor's 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.  Let's 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 physician's 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 don't pay enough (at current rates) to sustain a practice and 2) you can't see 25 Medicare patients in a day because patients 65 and up have multiple medical problems and you simple couldn't 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. That's 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 wouldn't 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.

Why Primary Care is the Future of Health Care

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 can't 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 patient's 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 don't 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 physician's 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 don't 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.

A Health Care System to be Proud Of

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 UK's 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 UK's 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 aren't 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 ACA's 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 country's 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."

What if IVIG really worked for Alzheimer's?

ABC News and other media outlets are reporting the results of a small, but very important study regarding a new treatment for Alzheimer's Disease.  Most Americans are familiar with Alzheimer's 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 Alzheimer's Association International Conference 2012 in Vancouver, researchers presented the positive results of a study using intravenous immunoglobulin, or IVIG, to successfully keep Alzheimer's 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 Alzheimer's.


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, let's assume that the research is proven correct, and that IVIG actually does work well for most patients to treat Alzheimer's 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 doctor's 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 Alzheimer's. 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 Alzheimer's 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 don't 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 Alzheimer's 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 country's problems.

The Harm of Not Seeing Drug Reps

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 US medical 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 Netherlands where 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. 

Postinfectious Cough

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. Here's 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 won't go away.  Cough is usually worse at night, and the patient can't 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/LABA's 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 month's 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.

Prior Authorizations Suck

"Suck" is a word I seldom use. It's 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 company's 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. 

How the Government Plans to Lower Cost by Eliminating Doctors and Shifting Costs to Patients

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.  It's 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.  Wouldn't 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 Merk's 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?

 
When it comes to prescribing, physician is best
I have nothing against pharmacists.  I value pharmacists as part of the health care team.  In addition, I feel their role is substantially  underutilized. Part of the problem with chronic disease is adherence to medication, a large part which has to do with education.  Pharmacists are experts when it comes to informing patients about their medications, how to take them properly and why taking them is necessary.  They can monitor adherence to medication and can also serve on the front lines to alert physicians if their patients aren't doing well and need closer attention.
 
However, when it comes to making a diagnosis and determining which therapy is best, pharmacists do not have the depth and breadth of training that physicians receive.  As a primary care physician, I can tell you that even the most common conditions like asthma or sinusitis is not always that easy to diagnose, and even determining treatments for these conditions do not do well with cook book like algorithms.  
 
Another concern I have with pharmacist essentially prescribing medications is that they are employed by the pharmacy that dispenses these medications, and thus have a potential direct conflict of interest. Now, I am sure skeptical readers will say that drug reps have been given physicians gifts and samples for years, and this is conflict as well.  Though this may be true, a pen or a slice of pizza is a whole different level of conflict then direct money in your paycheck. Also realize that the pharmacy makes a bigger profit on generics, thus the pharmacist may be consciously or unconsciously biased to give you a generic when it may not be the best choice.
 
Patients Will Pay More
Usually when a drug goes OTC, it usually means the patient has to pay more.  This is because most insurances do not cover over the counter medications. Ask any patient who suffers from seasonal allergies.  OTC non-sedating antihistamines like Claritin, Zyrtec, and Allegra cost a lot more out of pocket, even when using the store brand, then when they were available by prescription.  This is because the out of pocket cost for co-pay for a preferred drug (even when branded) is often less then the out of pocket cost for and entire supply of over the counter medication, even when generic/store brand. The same is true for acid blocking medicines such as Prilosec. Generic OTC Prilosec (Omeprazole) is just over 50 cents a pill, which means a patient requiring a daily dose will pay over $15 for a 30 day supply. This is generally much more than patients pay for a generic prescription of omeprazole, some paying as little as a $5 co-pay. (Some insurers have actually made the co-pays for the generic omeprazole more expensive then the acid blocking medicines that are not yet over the counter, like Nexium, to steer patients to buying the over the counter medication (full out of pocket cost), rather then request a prescription!) 
 
 
Where is the Outcry?
What's most shocking to me is the lack of dialogue on this topic.  My guess is that this may be due to lack of awareness, since the FDA seemed to slip this past the media.  Physician representation at the March hearing was pretty poor. Few groups such as The America College of Physicians seem to be interested (or aware). The 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 don't 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:
"I've 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. That's 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 doctor's 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.

Questions Are the Answer

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 requester's 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 Quality's, and for those in the know, is pronounced "ark."  According to their web site AHRQ's mission is

"To improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As 1 of 12 agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services. AHRQ was formerly known as the Agency for Health Care Policy and Research"

As a primary care physician who spends a lot of time with patients trying to help them make the best decisions for their health, AHRQ is a group I like to get behind. Their latest campaign which thy contacted me about is "Questions Are the Answer." The essence of their campaign is to educate patients that the best way to take care of themselves is to ask their doctors questions. This may seem pretty obvious, but patients are often reluctant to ask us questions. They may be embarassed for asking something that they think we might think sounds stupid. They may feel that we should be the ones asking questions. They may think that is something is important, we would have told them. The reality is that health care done right is a two way communication between doctor and patient, with both parties listening and asking questions.

Thus, I have therefore broken my usual rule, and posted a solicitor's content on my site.  There content is below.  As the politician's say, "I have approved this message."


When patients become more actively involved in their own health, there’s a much stronger likelihood their health outcomes will be better.


That’s why “Questions are the Answer,” a new public education initiative from the U.S. Agency for Healthcare Research and Quality (AHRQ), encourages patients to have more effective two-way communication with their doctors and other clinicians.



“Questions are the Answer” features a website -- www.ahrq.gov/questions -- where you will find these free educational tools to use with your patients:




· A 7-minute video featuring real-life patients and clinicians who give firsthand accounts on the importance of asking questions and sharing information – this tool is ideal for a patient waiting room area and can be set to run on a continuous loop.

· A brochure, titled “Be More Involved in Your Health Care: Tips for Patients,” that offers helpful suggestions to follow before, during and after a medical visit.

· Notepads to help patients prioritize the top three questions they wish to ask during their medical appointment.



Clinicians can request a free supply of these materials by calling AHRQ at 1-800-358-9295 or sending an email to AHRQpubs@ahrq.hhs.gov.






View Campaign Website: http://www.ahrq.gov/questions/


View Featured PSAs: http://www.ahrq.gov/questions/psas.htm


View Original Video Series: http://www.ahrq.gov/questions/pcvideos.htm