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