Are Drug Reps and Free Samples Bad For Patients? It Depends

One of my favorite blogs, KevinMD, featured a post by Internist and fellow blogger Dr. Leslie Ramirez (founder of Leslie’s List, which helps the uninsured and underinsured find more affordable medications and health care services) on the true cost of free drug samples. Her point was that "free" drug samples may cost a patient in the long run if they are followed up with an expensive prescription that the patient can't afford. I posted a response on Kevin's site (more below) stating the issue was a little more complex, as Dr. Ramirez' example applied specifically to a patient who was paying out of pocket for medications, which is not usually the case. However, this post received numerous responses about the value/evils of both drug reps and the samples they provide. Below is an edited/expanded version of my replies.

The Benefit and Harm of Reps and Samples
Do drug reps/free samples…
-influence doctors? Absolutely.
-increase prescribing of non-generic meds? Absolutely.
-contribute to health care dollars spent on meds? Absolutely.
-harm or are bad for patients? It depends.

It is true that whenever a generic medication has equal safety and efficacy as a branded medication, the patient and public benefit when a generic is used. However, just because there are generic medications available, does not always mean that generics are the best choice for patients.

A good example is type 2 diabetes. The RECORD (see For the RECORD, Avandia does not cause heart attacks) study looked at cardiovascular safety of the much maligned drug Avandia. (RECORD showed it not to increase risk of CV death or hospitalization-something the media continues to ignore). The study took patients on a generic diabetes medication (either metformin or sulfonylurea) and randomized them to either an expensive, branded diabetes medicine (Avandia) or the other generic. Patients in the Avandia group who still had uncontrolled diabetes on Avandia + one generic could add the other generic. Patients in the other group who were uncontrolled on both generics had to go to insulin.


In addition to showing no difference in cardiovascular safety (primary endpoint), the patients in the Avandia group had better diabetes control, less weight gain, better cholesterol profiles, less hypoglycemia and less insulin use. In other words, though it certainly costs more money, (in this study) it was better to add Avandia then sticking with only generics. This should not be surprising since we know that the older diabetes drugs fail after a few years, and that TZD's like Avandia (seen now in ADOPT, RECORD, and BARI 2D) sustain glycemic control.



There are a few other examples where generic products exist, but branded products may be better. Branded statins (Crestor, Lipitor) are likely better then generics for patients with high cardiovascular risk who need to get their LDL (bad) cholesterol down more than 40%. In hypertension, losartan is the first generic angiotensin receptor blocker (ARB). Though there are several ACE inhibitors that are good once a day generics (lisinopril), up to 10% of patients will get a cough and need to be switched to an ARB. Now we finally have a generic ARB, except this one is not nearly as good as the other 4 branded products on the market. Because insurance companies will likely make it very difficult (higher co-pays and prior authorizations) to get one of the branded ARB's, patients will likely need to get a cough on an ACE and then fail losartan, before they are allowed to use the newer, better ARBs (and will still have a very high co-pay).



In addition, there are many medications that have no generics. All the respiratory medications (Advair, Symbicort, Spiriva, etc.) essentially have no generic equivalent. Having a drug rep provide samples of these meds will (as stated above) certainly increase prescriptions and therefore increase healthcare spending. However, asthma kills about 11 patients a day, COPD is the 4th leading cause of death, and both conditions are substantially under treated. Writing more prescriptions of these medications, and thus the reps that provide them, should therfore be a good thing. Even if the medicines are costly, their increased use will prevent exacerbations, hospitalizations, and even death (which have their own costs).



There is also the issue of direct cost to the patient (out of pocket costs) and the convenience factor. The FDA just approved a combination pill of Nexium and Naprosyn for rheumatoid arthritis. Many patients with rheumatoid arthritis need to take NSAIDs like naproxen on a regular basis. One of the side effects is stomach ulcers. Acid blocking proton pump inhibitors (PPI's) like Nexium can prevent these ulcers and guidelines recommend the use of PPI's with chronic NSAID therapy. The newly approved, branded pill will be an expensive, once a day pill that will treat the arthritis and protect the stomach. However, Prilosec (another PPI) and Naprosyn, are both over the counter. Why not just take two over the counter pills a day instead of an expensive branded pill? CVS brand naproxen would cost about 10 cents for two 22omg pills (prescription dose is 500mg), and one Prilosec 20mg OTC (not as strong as Nexium, but should do) is about 70 cents a day. Thus, a patient needing NSAIDs and stomach protection would need to take 3 pills at 80 cents/day, or $24/month. However, it is very likely that the drug company will provide coupons for patients that guarantee them that their co-pay is no more than $25/month. I would think that most patients would prefer the better, once a day pill than the 3 pills a day for about the same price. (There is also a potential safety benefit as combining the pills ensures the stomach is protected when taking an NSAID).

As already alluded to, the issue becomes further complicated when insurance coverage, samples and coupons create complex equations where decision making becomes a challenge. One example would be high cholesterol. Let’s say your bad cholesterol or LDL is 160 and your doctor tells you it needs to be under 100 based on your risk for heart attack and stroke. Simivastatin is generic and has been proven effective, but you will likely need the highest dose of 80mg to get to your goal (the higher the dose, the greater the likelihood of side effects). Generic simvastatin (no samples) costs you $10 month at your local CVS. There is also Lipitor, a branded drug that will get you to goal at a 20mg dose, but at a price of $25 per month. However, I can give you a four week sample of Lipitor to try (to make sure there are not side effects, etc.) and a coupon that will lower your monthly cost to $15. This will last for a year (at which point Lipitor should be generic). Using the branded product with samples and coupons, the additional out of pocket cost to the patient is only $50/year or an extra $4/month, but they get to try the med first, and received a drug that worked better, with fewer side effects. Which is better for the patient? (Before you say that $50/year is a lot for a poor person, keep in mind that very poor patients are on Medicaid and won't pay any difference for the medications, and people who do not have prescription coverage might have problems being able to afford either, as generic simvastatin 80mg is $33/month).


To be fair, there are PLENTY of examples where branded drugs are promoted heavily by the industry using drug reps and samples, where an equally safe and effective medications are available generically. Dr. Ramirez' post regarding generic citalopram and Lexapro is a great example. In addition, the argument can be made that drug companies should be putting their resources coming up with useful new agents, rather than re-packaging older medicines into one pill (like Naprosyn and Nexium).


The point is that the issue of the samples, drug reps and the industry is a complex one. The drug industry is one of the most profitable industries in the US. Their use of expensive, direct to consumer advertising may seem inappropriate to some, when so many in our country can not afford medications. Past excesses of lavish gifts to physicians (no longer allowed) and more recent settlements of off label promotions (see Pharma Should Not Settle Off-Label Promotional Suits) has certainly eroded trust in the industry from the public, patients and many physicians.

However, drugs save lives. Even in recent years, we have seen the remarkable difference prescriptions medications have made (HIV, cancer, heart attacks). Also, the majority of prescriptions being used today are now generic, and were made possible because they were once sold under a brand name. As stated above, generics are not always the best choice for patients, and while drug company promotional efforts will undoubtedly increase sales of expensive drugs, this is not necessarily a bad thing if patients' lives are improved. Finally, the way medications are covered and paid for create a sometime perverse set of circumstances where samples and coupons for expensive medicines may actually be in the patient's best interest even if similar medications are available generically or over the counter. Many (especially in the media) want to paint the influence of the pharmaceutical industry as black and white. However, this issue remains very, very grey.

How can a psychiatrist write 100,000 prescriptions a year, and why this matters to Primary Care?

The Miami Herald is reporting an investigation of a psychiatrist who wrote almost 100, 000 prescriptions a year. Sen. Grassley and the feds have halted payment to this Miami psychiatrist who stated that "he prescribes only what is medically necessary" and "works long hours, seeing patients for 10 minutes at a time and many of his patients need four or five medications."

I have no personal knowledge, interaction, acquaintance with psychiatrist Dr. Mendez-Villamil. However, though this sounds fraudulent (which is why the fed likely pulled payment), how could this doctor personally benefit from all of these scripts? Doctors do not get paid by how many prescriptions they write (unless you count docs like oncologists who collect fees for administering chemotherapy). Drug companies are now forbidden to wine and dine doctors, so it is highly unlikely that some pharmaceutical rep is incentivizing this psychiatrist. Besides, these patients areMedicare and Medicaid, so they are likely getting generics in the first place.

So if there is no wrong doing or even an incentive to write all those scripts, is this even possible and why does it happen? If the good doctor is seeing patients every 10 minutes, and each patient needs 4-5 prescriptions (assuming an 8 hour day); that's 46 patients a day needing about 3 prescriptions on average to yield the 150 prescriptions a day that Dr. Mendez Villamil is "accused" of writing. Though this may not be good medicine, with that volume of patients, the numbers sound pretty reasonable, espescially since many chronic psychiatric patients are on multiple medicines. So it it possible that one psychiatrist sees almost 50 Medicare and Medicaid patients a day in 10 minute visits? If the psychiatrist accepts Medicare and Medicaid, then this is actually quite likely the case (and probably not the exception but the rule).

In a piece I wrote for KevinMd a year an a half ago, I described how there are two kinds of mental health care in the US: care for those who pay with insurance and care for those who pay out of pocket. The kind of care that you see in TV and movies where a patient talks to a psychiatrist and possible gets medication; that kind of care happens, but only if you are willing to pay out of pocket. In many cases fees for a regular sessions run over $200. For those paying with insurance, the experience is quite different. If a patient sees a psychiatrist, it is usually only for medication management and usually only in short (10 minute) visits. Any "talk therapy" is relegated to a psychologist or psychiatric social worker. I mean no disrespect to some of the excellent and well qualified non-physician therapist we have in the US. I am not even stating that having a short visit with a psychiatrist for medication management and counseling done by non-MD's is bad medicine. However, the public must be aware that this is how psychiatry is practiced in the US.

In the case of Dr. Mendez-Villamil, he probably is one of only a handful of psychiatrists in Miami that accepts Medicare and Medicaid. Patients probably wait months to see him. The Miami Herald makes him look like a criminal. However, think about the majority of his colleagues who only see patients who can pay $200 or more out of pocket per visit? Dr. Mendez-Villamil is probably a hero, and if he writes 100,000 prescriptions per year this should be seen not as a crime, but a sign of a broken system.

The piece I wrote for KevindMD was entitled, "As psychiatry goes, so will primary care." The reason why so many psychiatrist stopped taking insurance and the reason why those psychiatrist who accept insurance cram patients into 10 minute visits is because the reimbursement rate from insurers is ridiculously low. Many psychiatrist realized that accepting insurance just didn't make sense. The same thing is happening right now in primary care. More an more primary care physicians have stopped taking new Medicare or Medicaid patients, or any insurance altogether. Some have even gone beyond cash only, and started "concierge" practices which charge patients a retainer fee (sometimes well over the usual $1500 a year) in exchange for easy access to their primary care doctor.

Health care reform has focused on how to cover the uninsured and how to pay for this, but it has not focused on how to change the current reimbursement system that rewards "proceduralists" and punishes "congnitivists." If health legislation that covers the uninsured does eventually pass without addressing this fundamental crack in our health care system, there will likely be no primary care physicians to see all these newly insured patients (see what happened in Massachuesetts). The few primary care physicians that do accept the newly insured will likely have limited access and see more patients in less time....kind of like the good Dr. Mendez-Villamil. Whereas the typical psychiatric patient might be on 3-4 meds, the typical Medicaid and Medicare patient is on a great deal more medications. Primary care physicians, get your pens ready! 100,000 prescriptions a year will seem like nothing.