MSNBC has picked up on a study that has otherwise not generated a great deal of media attention, but that I think is rather important. The study, published in today's issue of JAMA was systematic review (look for all possible studies) and meta-analysis (analyzes data from multiple studies) that compared generic to brand name medications for common heart conditions such as high blood pressure and high cholesterol. They essentially found no difference in both the efficacy and safety of generic medicines compared to the same brand name medications.
This study is very important because there still exists a common misconception that generics are just not as good as the real thing. This misconception is held by both physicians and patients. In fact, in their analysis, the authors of the JAMA study looked at the conclusions of the individual studies which similarly suggest (despite the data showing otherwise) that generics might not be a great substitute. The authors suggest that one possible reason could be potential conflicts of interest from the individual investigators, and about half the studies analyzed did not disclose any conflicts of interest.
As health care cost continue to rise and the economy seems to get worse by the day, patients are becoming more used to taking generic medications, especially when many are available at Walmart for $4. However, the belief that generics do not work as well likely still persists. As I mentioned in an earlier post regarding the nocebo effect, if a patient doesn't think a medications is going to work, there is at least a 30% chance that it won't. In addition, patients who value their health care and believe generics to be inferior, may needlessly waste their out of pocket health care dollars paying expensive co-pays.
When a new medication is approved by the FDA, the drug company must prove that it is both safe and effective. When the drug company loses exclusivity on their patent, generic manufactures can duplicate the drug. Unlike the original brand drug, all the generic manufacturer has to prove to the FDA is that the blood levels of the drug are virtually equivalent to the original branded product, which is much easier to do. This is why generics are so cheap: the generic companies have virtually no investment in research, and they have very little in expenses to get their drug approved by the FDA (and they also don't spend a lot of money on marketing to physicians).
This study confirms that there is really no difference between generic pills and branded pills when it comes to safety and efficacy. Since the pills are not exactly the same, rarely patients might have an adverse event when switching such as an allergic reaction to a dye in the pill. However, this is very rare. The only time a difference really matters is when a pill has a narrow therapeutic window, which means a tiny change in dose can have a big effect. Common drugs with narrow therapeutic windows are hormones (like thyroid replacement medications), blood thinners (coumadin/warfarin), and pills whose levels need to be monitored (like tegretol). However, in the JAMA study even warfarin/coumadin performed similarly. Thus, even these switches are safe, though more careful monitoring is needed.
This does not necessarily mean that you should always use generics. Some branded products which are not yet available in generic form, are often needed to achieve the desired effect where a generic would likely fail. A good example is cholesterol lowering medications. The generic statins, simvistatin in particular, will get you close to a 40% reduction in bad cholesterol at the maxium dose, but for those patients who need much greater lowering of their cholesterol, drugs like Lipitor (which goes generic in 2011) or Crestor will be needed.
Bottom Line: If a generic will do the trick for your particular disease, then you should take the generic confidently. Though the study did not specifically address this, the same principle applies to over the counter medications. Doesn't make sense to spend $8.99 on extra strength Tylenol, when you can get the CVS brand for $6.99.
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The Benefits of Generic Medications
Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present, cure the disease, as with the case regarding antibiotics, or the provider may prescribe medications to delay the progression of a disease that may exist with their patient.
The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:
More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate. Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned. Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.
Generic medications are copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost
Why aren’t generic medications prescribed all the time, then? The branded drugs have representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result. Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.
Around 4 billion prescriptions filled every year, so cost savings is rather important. Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market. However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.
With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs. Finally, about half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.
Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible. This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications. Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.
Not long ago, generic drugs were not prescribed that often, or produced to a great degree, because of the cost of bringing such a med to the market, which at the time required the same clinical trial protocols as branded meds.
Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA. This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.
Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds through such tactics as reformulation or combining their branded medication with another generic drug to create a new combination medication, which is called evergreening, of their meds, which allows for them to continue the patent lifespan of their branded medication.
Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication.
The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs. So delays will not prevent the utilization of generics, overall, or for a long period of time.
Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics, or have acquired generic pharmaceutical companies entirely because of the progressive impact generic drugs are having on the business of branded drug companies.
Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.
Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- as safety of these new drugs have not been overall established. This is concerning to several different health care providers. The familiarity of the generic drug accessible to them after the patent expiration of possibly the branded drug the health care provider had prescribed in the past assures the provider often that there will not be any safety or efficacy concerns by selecting such a generic drug.
Many clinical studies have proven that generics are as effective compared with branded medications for particular disease states. The ALLHAT trial showed this, with generic diuretics showed equivalence if not superiority over the branded medications it was compared with during this 4 year trial funded mostly by the NIH. Drugs utilized in this trial were cardiovascular drugs, and the examination of these both branded and generic drugs showed that the least expensive drugs, the generic drugs, provided the most benefit for the patients studied in this trial.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers directly. Both mechanisms for obtaining samples of generic drugs by a health care provider remain quite rare, however.
Then there are some health care providers who insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic medications. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. However, there may be some truth to decreased efficacy of generic drugs over their previously branded equivalents, yet not to a the point where it is a clinical concern.
In the U.S. Health Care System, cost is a rather large concern for members of the public health, and those who attempt to restore their health as it needs to be at times. Generic medications provide financial relief for patients in need of drugs to improve their health. And both the health care provider as well as the patient can be assured that a generic drug prescribed to, and taken by, a patient will provide the efficacy needed to address the medical problems of the patient. More importantly, the patient saves money, without compromising their safety,
Dan Abshear
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