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?