In a recent University of Cincinnati study published in Neurology, subjects with Parkinson’s Disease were given shots of two supposedly similar medications. They were told that the first was more expensive, and the second was similar in effectiveness but, because of differences in manufacturing, was much cheaper. The overall result was that patients’ motor skills after the first shot were improved 28% compared to the second shot. The one fact that the patients weren’t told: Both shots were actually just saline solution. Study authors believe patients got better because they had very high expectations, which translated into health benefits.
There has been a lot of debate about the use of generic drugs vs. brand names. Are generics really as effective? It pays to be informed since, according to the FDA, “nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015.”
What is the difference between generics and brand names? Is there a time when one is preferable over the other? We spoke with C. Michael White, Pharm.D., Professor and Head, Department of Pharmacy Practice, University of Connecticut, to get an explanation:
Q: Why are brand names so much more expensive than generics? A: "Unlike the generic manufacturer, the original pharmaceutical company has to pay for more than just the actual production of that medication. The Tufts Center for the Study of Drug Development estimates that the cost to develop and win marketing approval for a new drug is $2.6 billion. It also pays for research and development for medications that failed in trials and can’t be brought to market. According to the IMS Institute for Healthcare Informatics, generics have saved Americans one trillion dollars in health care savings over the past decade--a current rate of more than one billion dollars in savings every other day."
Q: What happens when a brand name goes generic? A: "At the end of an approximately seven-year period of exclusivity, the FDA allows one specific generic to be the first to market. That generic is given a period of time of exclusivity for about six months. At the end of that time period, any manufacturer that can prove that it can achieve the same drug concentrations in the blood that the brand name does can make a generic. Manufacturers of generics aren’t required to do studies in people to prove safety. It is assumed that if they can achieve same blood concentration, they will achieve same results."
Q: Do generics have to have the same recipe, effect, side effects? A: "The generics have to have the number of milligrams of drug that is included on the label in the pills. You can take it to the bank that that does not vary. In addition, the pill needs to get you within 10 percent above or below the blood concentrations achieved with the brand for the FDA to approve the generic, and in reality, they only usually vary by 3-4 percent in one direction or another. So yes, they are very similar in terms of the active ingredient. It is possible that one generic will get you a 3 percent lower concentration than the brand and another can get you a concentration that is 3 percent above the brand and therefore the two generics can be 6% different from each other. Most people will never notice a difference.
"According to the FDA, generic drugs do not need to contain the same inactive ingredients as the brand name product. Inactive ingredients are those that have nothing to do with the therapeutic action of the drug; binding materials, dyes, preservatives, and flavoring agents. That’s why sometimes a pill you have been taking will suddenly look different. It usually means a different manufacturer has made that pill than the one you had before. Also, given individual variations, a person can have an allergic reaction to an inactive ingredient in one generic and not another."
Q: Is this true for over-the-counter, as well as prescription meds? A: "Yes. The Food and Drug Administration has very strict criteria so over-the-counter store brands must achieve very similar blood concentrations as name brands. Most people don’t notice a difference. I strongly recommend that patients start out on generic medications or switch to generic medications if they are available, since they almost always work as well and can save people a lot of money. Why throw away money to get a brand name when the generic will give you what you need for a fraction of the cost?"
Q: So, will you always achieve the same effect with a generic as with a brand name? A: "Keep in mind that there is a lot of diversity among people. When they do the blood concentration studies, they do them in “average” people, but because the inactive ingredients and process of manufacturing are different, they can’t assure that everyone will achieve same blood concentrations. For example, if you have a shorter colon or disease that makes food pass through your intestines faster or slower, that might make a difference. Other people are just very sensitive to small changes in blood concentrations and notice a difference."
Q: Are there other instances when you should opt for a brand name? A: "NTI (narrow therapeutic index) drugs can be tricky because the blood concentrations you need to achieve a therapeutic dose and the concentrations that will cause harm are very close together. Small changes in concentrations can lead to ineffective or toxic responses. Medications for seizures, heart arrhythmias, thyroid hormone, warfarin (blood thinner), and lithium are all NTIs. With these, you need to talk to your physician about switching to generic, make sure you understand the risks and rewards, and that you are more closely monitored for the first couple of weeks afterwards.
"Of these NTI drugs, patients with anti-epilepsy drugs are a unique group that do equally well when started on brand or generic drugs but during the couple of weeks after switching from brand to generic or generic to brand, they are more likely to go to the emergency department or their doctor’s office. Epileptic patients should not be routinely changing between forms of the drug for this reason.
"Some patients will tolerate a brand name medication but when they switch medications, they simply do not do as well. The reason may be that that while the blood concentrations of the brand name medication are very similar, what the tablets are made out of can vary. So while the average patient does as well, not everyone will. If you are that outlier, you are better off on the branded medication or another generic. I usually recommend trying two generic versions before giving up and moving back to a brand name drug because again, the costs are much cheaper.
"There’s been a lot of consolidation in the generic manufacturing industry (companies merging with other companies, leaving less competition in the field). In very rare cases, we are left with only one generic manufacturer, so the generic is more expensive than the brand name. Supply and demand also happens in generic drugs and it’s all what the market will bear. Insurance companies may stipulate that you get a lower co-pay with generic than with a brand name even if brand name is less expensive. Patients with very expensive generics should ask their pharmacists if brand name medications are actually cheaper and if they are, switch back to the brand."
Q: Is it dangerous to your health to switch back and forth? A: "Most people taking almost all drugs would not notice a perceptible difference in efficacy or safety when switching between brands and generics or between generics, except in the case of NTIs, which are trickier. If you are on a NTI drug, talk with your doctors about the risks and rewards of switching. For all the other drugs, if you switch and you have mild symptoms, there is a chance that those things will resolve and you should stay the course. If it’s more than a mild inconvenience, then you need to let your doctor know right away."