Ever wonder how some drugs get on the market and get prescribed extensively only to find out they are either ineffective or potentially harmful?
Despite the dearth of comparative effectiveness studies, the available published literature would suggest that all drugs to treat a particular indication are not created equal. From apparent, if not proven, efficacy differences to disparate adverse reactions and dosing regimens, patients may not be getting the best product available for their particular situation.
In fact, some drugs with questionable efficacy and considerable safety concerns (I'll label as "mediocre" for this discussion) still provide drug companies with healthy revenues and profit. So why do these mediocre drugs even get used at all?
1. They work well for some patients
Whether it is because of the placebo effect or individual biologic response, these drugs may appear to work and seem perfectly well tolerated by some patients. There may be other products that are more effective, have more convenient dosing or are safer for a patient, but the drug they have been taking is working well for them.
They and their physician feel no need to change. These patient responses also reinforce the physicians' prescribing choice (and habit) for these drugs.
2. Some physicians like the drugs and are in the habit of prescribing them
Some physicians jump on new products (we called these early adopters) just because "they must be better, if they're new." Perfectly good and often better treatments can often be found among "tried and true" older generic drugs.
On the other hand, changing physician prescribing habit is one of the hardest sales challenges for new products. Regardless of the proof of efficacy or safety provided or the magnitude of improvement in patient dosing convenience, physician prescribing habit is difficult to change.
Many physicians are just conservative by nature and are late (we called them laggards) to accept new products until they have been extensively used and validated by others. This is especially true when the physician has years of experience with patients responding favorably to the mediocre drug.
3. Effective marketing and sales
Nothing demonstrates the power of pharmaceutical marketing and sales more than off-label marketing. That means the ability of drug company marketing and sales to establish drugs as treatments of choice for indications for which they have no FDA approval or even credible clinical data to support.
Drug companies continue to prove that you don't need the best drug on the market to be successful. But you do need effective marketing and sales whether you have the best drug.
4. Patient demand for a product
It should be no surprise that the pharmaceutical industry has jumped into direct-to-consumer (DTC) advertising. Patient demand for products became another marketing channel to reach increasingly difficult-to-see physicians and influence prescribing.
Despite some public and healthcare concerns about advertising to patients about prescription drugs, it has no doubt raised patient awareness to diseases they may not have considered treatable and to drugs their doctors have never mentioned as options. A receptive, desperate patient and a willing prescriber make for a market opportunity for a mediocre product that might otherwise not satisfy a sophisticated comparative assessment.
5. CMS requirements for availability
Medicare Part D, which provides prescription drug coverage for U.S. citizens over the age of 65, has significantly improved access and affordability to prescription drugs for the elderly. Regardless of the relative effectiveness or safety, as long as a drug is FDA approved and is prescribed as medically necessary (what doctor will admit to prescribing a drug that isn't medically necessary?), the Medicare patient must have reasonable access to that drug.
As a result, drug companies with products that might have a tough time passing the scrutiny of a rigorous formulary review or subjected to traditional control tactics may still have an opportunity in the large and lucrative Medicare Part D market.
So what's the point of this discussion? Well, the availability and prescribing of "mediocre" drugs has two distinct effects.
First, patients may not be getting the best treatments available for their particular situation, and in some cases this has been shown to be detrimental (i.e., drugs finally pulled off the market due to safety concerns).
Second, the prescription drug market is cumulative, adding more drugs to the list of available treatments with few withdrawals from the market. An exhaustive list of drug treatment options can mask both the inferiority of "mediocre" drugs and compromises the visibility of better treatments — especially if they happen to be older generic drugs with less drug company advertising and promotion behind them.
