Boston Doctors Getting Paid to Switch Patients to Generics

Interesting video from WCVB in Boston about doctors getting kick backs from the insurance company to switch patients from branded medications to generic medications. New Rules To Protect Prescription Drug Customers

If people were concerned about undue influence when drug companies used to give physicians pens and other novelties (now currently banned by most companies), they should really be concerned about actually monetary payments. The patient interviewed in the Boston piece stated his doctor wanted to switch him from Lipitor to generic simvastatin (cholesterol lowering medications) but did not mention that he was being payed by his insurance company to do so.

Though this is the first case I have heard of doctors being incentivized to switch patients to generics, it happens in pharmacies all the time. What is horrible is that some pharmacies may switch patients to alternative medications even if that switch costs the patient more money. The example I am familiar with is albuterol inhalers (see FDA Announces End for CFC-Propelled Inhalers).

Switching to generics is itself not a bad things. I have blogged before that, for most medicines, generics are just as good as brand name medicines. For example, if the patient were on Zocor, a switch to the generic simvastatin would probably make a lot of sense, since the medications are basically equivalent and it would likely save the patient some money. However, in some cases, the small differences may actually make a difference. Back in November, I discussed this in more detail (see Generic and Therapeutic Substitutions ).

In this particular case, the therapeutic switch from Lipitor to simvastatin might have been devastating since Lipitor is a much stronger medication. The piece does not say what dose the patient was on, but if the patient required Lipitor 40mg or 80mg, no dose of simvastatin would have given him the cholesterol lowering he needed.

What should you do?
1. If you are on a branded medication, ask your doctor if there is a generic equivalent of the exact same medicine, or one that works just as well.
2. If you are on a branded medicine and asked to switch to a generic by your doctor, find out why he or she wants to switch.
3. If you are on a branded medicine and asked to switch to a generic by your pharmacy, find out why they want you to switch. Is your insurance company asking for the switch? Is the medicine the same (generic substitution) or slightly different (therapeutic substitution)? Regardless, make sure that you check with your doctor before switching any medicine.

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.

Where have all the journalists gone? More bad reporting on Avandia

I thought journalists were supposed to be impartial, report multiple sides of the story, and only use facts. At least in the case of reporting on prescription medications, Avandia in particular, it seems those "rules" no longer apply.

Today the Wall Street Journal announced that the FDA Weights Halting Avandia Safety Study .
They are basing this report on a Letter written to Sen. Grassley on 3/30 by the FDA commissioner in response to Grassley's findings on the FDA's handling of Avandia. If I were a journalist (and I don't pretend to be one), after reading this letter, the headlines I might have suggested to my editor would have been:

FDA to Grassley: You Have to Wait Until July or
FDA seeks Big Gun in Institute of Medicine to Help with Avandia

Nowhere in the 5 page letter does it say ANYTHING about the FDA considering halting an ongoing study. Here is the particular section that the journalists from the Wall Street Journal are basing their headline on:

"I recognize that head to head safety trials can pose challenging ethical questions. On the one hand, such a trial, by its very nature, must be conducted in the face of a safety concern. One the other hand, if one therapy is clearly inferior to the other, then such a trial should not be conducted, because it would place one group of patients at unnecessary risk."

Though the next paragraph mentions that some experts believe that Avandia is inferior to Actos, the paragraph concludes that some experts, in particular the American College of Cardiology and the American Heart Association, have not come to these conclusions.

I implore you to read the entire letter, and read it in the context that the head of the FDA is writing this letter in response to a Senator who wrote a very public and scathing report on how their operation is run. The report does not read, "thank you senator, we were wrong and will consider stopping this dangerous trial." Rather, what the report actually says is that safety is important to the FDA, in 2005 they became aware of a questionable safety issue but decided it did not warrant going public, when it did (with pressure from Sen. Grassley) the FDA met in July 2007 and decided to keep Avandia on the market, there has been new, more robust data since 2007 which seems to indicate that Avandia is safe, and we have already planned (even before the Grassley report came out) to meet this July to review all the data again.

Read in its entirety, the FDA had already planned to review all of the Avandia data, including the TIDE study in July. The letter to Grassley, that the Wall Street Journal is reporting on, gives no indications that these plans have changed or that the FDA is now considering stopping an Avandia study. If anything, in a very subtle way, the FDA is telling Grassley why the study is needed.

Bad reporting on this subject is not new. In my post More Avandia Scare- Again, Unwarranted back in February, I wrote about New York Times piece that broke the story on the Grassely report. While I do believe the story was worth reporting, the Times failed to mention that everything in the report was from 2007. Both the Grassley report and the Times failed to mention that there was new data, specifically the RECORD trial (see For the RECORD, Avandia does not cause heart attacks, Avandia Vindicated, ) which seems to exhonerate Avandia from any heart risk. This is the real story, that a good diabetes drug continues to get bashed in the media, when a very well done study presented almost a year ago has shown in to be safe.

As referenced above, I believe the real story in the FDA commissioner's letter to Grassley is the fact that they are asking the Institute of Medicine to look into the matter. More importantly, they seem to indicate that the IOM's report will be ready by the July 2010 advisory board. My read on this is that the FDA, based on the scientific data available, feels that Avandia is actually a safe drug. However, given the scrutiny and political pressure they are under, likely believes that anything less than a "pull it from the market" recommendation from the July advisory committee will keep it under fire. Thus, they have brought the impartial and well respected IOM on board. The only reason I can think of for doing this is to back them up on a decision in favor of Avandia.

Here's something to think about:
Because of the media storm caused by Avandia, the FDA now requires any new diabetes drug to prove that it does not cause heart attacks before being approved (see Rough Times for New Diabetes Drugs: The Diabetes Conspiracy Part III ). These criteria are not surprisingly pretty strict. Based on the results of the RECORD trial, Avandia has now met this new standard of cardiovascular safety, now required of all new diabetes drugs. How will the FDA be able to continue to say that there might be a risk, let alone pull the drug and stop a safety study, when Avandia has now met the FDA's rigid cardiovascular safety criteria?

Generic and Therapeutic Substitutions

I was on the local DC news today regarding generic substitution.

Generic substitution is when your doctor writes for a prescription medication, but the pharmacists substitutes this with a generic medication. This is perfectly legal and, in general, a good thing for patients. For the most part, and for most drugs, the generic is just as good as the brand drug. However, as the news piece points out, there are some instances where the small difference between the generic and the brand name medication may make a difference. These are usually medicines where doses are very small such as hormones (thyroid medications, birth control pills) and medicines that have to be closely monitored. This does not necessarily mean that the generic is worse than the branded medication, but that switching from one to the other could have potential adverse effects.

One of the things that I spoke with the reporter about that is not in the above video (I have control over what I say, but not what they choose to sue), and only got a brief mention by the new anchor after the video was shown was about therapeutic substitution. This is a completely different ball game and a major concern of mine.

Therapeutic substitution is when your doctor writes a prescription for a branded drug and the pharmacist substitutes it not with the generic equivalent, but with a completely different generic drug in the same class. In this case, you are getting a totally different medication. For example, let's say your doctor writes a prescription for Crestor or Lipitor, both very potent cholesterol lowering drugs. You bring this prescription to the pharmacist, but instead of getting Crestor or Lipitor, you get simvastatin, a generic cholesterol medication. The difference here is that where the brand and generic equivalent will work about the same, this is not the case with a therapeutic substitution. Simvastatin will work in many patients but is not nearly as good as lowering cholesterol as Crestor or Lipitor. Thus, if the patient got switched and needed more cholesterol lowering than the simvastatin could provide (which is why I would write Crestor or Lipitor in the first place), that patient's cholesterol levels could be too high despite medication, potentially leading to heart attack and strokes. This is just one of many examples.

The practice of therapeutic substitution is currently illegal, but this could change. In Washington, DC where I practice, there is current legislation pending that would not only allow, but might compel a pharmacist to switch patients to cheaper medication, whether or not they were the same. In the case of DC, this is designed to save the government money from the millions of dollars its spends on prescription medications for our Medicaid patients.

With health care costs so high, physicians should do their best to try and write generic medications when possible. In additions, our pharmacist colleagues can be a tremendous help in figuring out ways to lower the costs of medications by using generics, whether it be a direct generic substitution or even therapeutic substitution. Pharmacist and blogger Mr.Medsaver has been doing this for quite some time, and I routinely read his helpful posts. However, pharmacists are not trained clinicians and do not know (and can not know) all the details of the patient's history or the rationale for the doctor choosing one drug over another. Though the pharmacist's suggestions are always welcome, I do not believe the should be allowed, and certainly not compelled or heaven forbid incentivized, to switch medications within the same therapeutic class. This could be very dangerous for patients.

Prescription Drugs: Risk vs. Benefit vs Cost- The Chantix Example

When a physician prescribes a medication, a patient generally wants the most effective medication, with the least amount of side effects, that won't cost a lot of money. Unfortunately, this is often not the case. When determining which medication is right for you, all things need to be balanced. Obviously, for people with good prescription coverage and/or substantial wealth, cost likely does not play into the picture. However, for most patients, decisions need to be made. Should a patient take a generic medication that might not work as well or have potentially more side effects, but will cost substantially less than the branded medication? The choice is not always easy.

The Chantix example

I have posted several times about Chantix here, here, here, and here. The main reasons for these postings was due to the fact that the media (and some organizations) in my opinion were blowing out of proportion the risk of side effects of a very useful medication for the single leading preventable cause of death in our country.

Now, we have data in that seems to confirm that Chantix is the most effective agent available in the United States for smoking cessation. For those of you not familiar with the Cochrane group, they are international and free of any commercial bias. They review all data available in a systematic way, and are considered by most as some of the most unbiased and highest level of evidence available for therapeutics. The Cochrane review for Chantix (varenicline) is now in, and states that compared to placebo, nicotine replacement or bupropion (Wellbutrin, Zyban), that Chantix is the most effective agent, essentially doubling to tripling your chances of successfully quitting cigarettes.

Soon after Chantix had been on the market, reports of worsening of neuropsychiatric symptoms (depression, anxiety, suicidal ideation) surfaced, and the FDA took notice. Unfortunately, they went very public with this and the media had a field day scaring a lot of patients. In the original studies, patients with underlying depression and anxiety were purposefully excluded. Yet, patients with mental health disorders are much more likely to be smokers. We also know that stopping smoking, even without medication, can cause a worsening of these symptoms. In their final analysis, the FDA stated that it was not entirely clear whether Chantix was responsible for some of these adverse events. They appropriately added language to the drug information (package insert) to warn doctors and patients to look out for these side effects. This is a good thing, because even if Chantix is not the causative agent, it serves as a reminder that stopping smoking can cause worsening of neuropsychiatric symptoms.

Thus, the issue becomes efficacy vs. safety. Should you take a medication that is the most effective agent to help you stop smoking and risk a potential side effect that you could become depressed or even suicidal? One also has to consider the risks of NOT taking the drug. If I don't take Chantix, for example, and continue smoking, I am at risk for a lot of major problems! Given that it is unclear that Chantix has any more or less risk than other agents or no agents at all, in my opinion, since smoking increases risks for things like cancer, heart attack and stroke; in this case risk is outweighed by benefit.

Probably more troublesome is efficacy vs. cost. Chantix trumped bupropion (wellbutrin, zyban) and nicotine replacement (patch, gum, etc.). However, bupropion is generic and for most patients with prescription coverage, a relatively low out of pocket expense. Nicotine replacement is not covered by insurance, and thus the patch, gum or lozenge is a high out of pocket expense. Finally, many insurances still do not cover Chantix, and when covered the co-pay can be high. Thus, do you take the medicine is that is likely to be the most effective, but pay more, or do you try the generic which will likely work, though possibly not as well?

It would be great if all medicines were covered and at low costs to patients, worked incredibly well with virtually no side effects. However, in general this is just not the case. Many generics work just as well if not better than newer more expensive drugs. However, this is not always the situation. Furthermore, sometimes more effective drugs come to market but with increased risk. Doctors and patients must weigh cost, benefit, and risk with each prescription. Every patient's situation will be different. Thus, when being prescribed a new drug you need to take all of these into account.

Here are some questions to ask:
1. What are the side effects of the drug, and what is the chance that I will get these side effects?
2. What are the benefits of this drug, and how much and how likely will I benefit if I take this drug?
3. What are the risks if I don't take this drug, and how likely am I to get these consequences?
4. Are there alternatives available for this drug? If so, what would my out of pocket costs be for each one?
5. What are the differences in risk and benefits between all my options, including not taking any medication?

4 Things the FDA Should Go After Besides Cheerios

As reported by the Wall Street Journal, the FDA has decided to go after the makers of Cheerios. You can read their warning letter to General Mills here. The issue the FDA has is not that Cheerios doesn't really lower your cholesterol, but that the language on the box, specifically that eating Cheerios can "lower your cholesterol 4% in six weeks" means that Cheerios is intended for the use of lowering cholesterol, and is therefor a drug. Former FDA chair Dr. David Kessler's book "A Question of Intent" covers this topic nicely. He describes his struggle to try and regulate big tobacco. Since tobacco grows naturally, the argument was that it could not have been intended for a specific use. However, Kessler's fight was to show that the companies manipulated natural tobacco and the way it was delivered to cause an intended response, i.e satisfaction and addiction.





There are other foods that can make health claims, and the FDA's letter to Cheerios points out that soluble fiber products can talk about health benefits, as long as they add an "as part of" clause to the packaging. Though Cheerios has this, they feel the more prominent claim on the box (though not stated in the letter, it's basically their entire marketing campaign) is much stronger.





Since Cheerios does have clinical data to support a 4% reduction in total cholesterol, I am less worried about the stating this, but more concerned about patient's perception about what that does to cardiovascular risk. I have so many patients that are at risk for heart disease, warrant lipid lowering medications by any guideline, and yet are so affraid of medications ask if we give something like Cheerios a try first. The problem is that even though Cheerios may lower your cholesterol by 4%, this probably has no impact on your risk for heart attack or stroke. If you look at all of the cholesterol studies (any drug in any population) it is clear that to derive benefit you need at least around a 25% reduction in bad cholesterol to get any gain. Thus, my problem with Cheerios is not their claim to lower cholesterol, but the implication that this will make a bit of difference when it comes to heart attack or stroke.





However, there are several things that the FDA could focus on that, in my opinion, would serve a much greater purpose.





1. Medications approved not as drugs, but devices, so they seem like they work.


My favorite pharmacist blogger Mr. Medsaver recently gave a great example of this in his post regarding Allergen which is marketed under the names Chloraseptic Allergen Block and Little Allergies. These products are approved by the FDA, not as drugs but as devices. There is actually no active medical ingredients. These products are essentially petroleum jelly that you put under your nose. Their is absolutely no data whatsovere to suggest that these products do anything at all. Yet, patients wanting to help themselves or children who suffer from allergies and are affraid of side effects from actual medication will likely spend millions of dollars this year on a product which has never been shown to be effective, and is likely not. The FDA needs to work on this loop hole.





2. Supplements that imply health claims
To me this is a much greater problem. At CVS.com you can get Ez Diet Carb Suppressor Capsules which have no real ingredients that have been shown to actually lose weight. The name implies they work, but a claim is not being officially made. At GNC.com, a reputable supplement company, their Mega Men 50 supplement is a "healthy aging program for men over 50" and should be taken to "support prostate health" "support eye health" and "provides antioxidant protection." The FDA does not consider these claims as serious apparently as Cheerios, because they are stating that they support eye health for example, and not improving your vision. However, I betting that more people spend their dollars on supplements then Cheerios for health improvement. In addition, unlike Cheerios which at least provides breakfast, the evidence for vitamins and supplements are poor. I discuss this more in my previous post Which Vitamin Should I Take?




3. Homeopathic agents that imply anything
Airborne, Head On, etc. Enough said. At least vitamins and supplements have some potential value. These products have no potential benefit, clearly are making claims, and do absolutely nothing. Innocent patients are wasting millions of dollars on these products.




4. e-cigarettes

These products are drugs without question. They ought to be regulated by the FDA and they have not been proven safe in humans. Though the FDA may not be able to do much about products sold over the Internet, e-cigarettes, which are nictoine inhalers marketed as safer alternatives to cigarettes and smoking cessation aids, are being sold in U.S. shopping malls. There sale in the U.S. should be abruptly halted. See more on my previous post.