Health insurance companies tout generic medicines as the equivalent of brand-name medicines—just as effective, only cheaper. Generics are said to be a huge win; not only do the health insurance companies save money, but Americans save roughly $200 million dollars a year, according to the Generic Pharmaceutical Association, a trade association of producers and distributors of generic meds. That is a substantial savings, and it is generally assumed that when generics are available, that’s the way to go. Insurance companies, in fact, will often penalize consumers if they buy a brand name when a generic equivalent is available. It is estimated that more than 8 in 10 prescriptions are filled with generic drugs.
But here is the truth: Some generics are not as effective as brand name, are not quite "equivalent," and some are even dangerous and ineffective. Adding insult to injury, the cost of many generics is rising, in some cases steeply, as the New York Times recently reported. Generic buyers, beware.
Brand-name medicines cost a lot of money. It costs anywhere from $1 billion to $4 billion for each new drug brought on the market. It can take up to 15 years to develop a drug, and even then, there is an enormous failure rate. Statistically, only 1 in 10 drugs pass muster and make it to market. The consumer who buys a patented drug (or “innovator” as it is called) is paying for research costs, safety testing, marketing, transport, and of course, the profit markup to make the drug development worthwhile.
The government, in order to provide incentive to pharmaceutical companies, gives the drug company a patent (i.e. an exclusive right) on medicines it has developed. That patent typically lasts 20 years (although effectively only 8 to 10 years because the company must apply for the patent before clinical trials are performed). Once the patent is up, other companies may rush in, and using the pharmaceutical company’s research, produce generic “equivalents” to the innovator drug. Because the generic drug companies have not had to spend years and billions of dollars on development, the cost for the generic medicines is usually significantly lower than the original brand name.
Generics, though, are not always the simple money-saving solution they seem. The common belief is that generics are identical to the brand-name drug. Sometimes that is true, when the original drug company decides to market a generic version of its own drug. But more often than not, separate companies, usually overseas, produce generics. These companies are not given a blueprint for how the innovator drug was made. They are given the ingredients, and through a sort of reverse engineering, must come up with a close approximation of the original drug. So, the generic must contain the same active ingredients the innovator drug has.
According to Food and Drug Administration regulations, a generic manufacturer must prove that the active ingredient has 80% to 125% “bioequivalence” to the original drug (i.e. 80% to 125% of the generic active ingredient reaches the bloodstream when compared to the amount of active ingredient that reached the bloodstream in the original drug). This obviously can pose problems for some drug consumers. Getting 20% less active ingredient, or 25% more active ingredient makes a huge difference for conditions that have a “narrow therapeutic window.” Not enough medicine and it loses efficacy; too much and there could be harmful effects. Given this 45% potential range of difference, the claim that a generic medicine is the same as the brand name should invite a bit of skepticism. Some meds that have a narrow window include those that treat blood clots, (Warfarin), lung diseases (Theophylline), seizures (Phenytoin), blood pressure (Clonidine), heart rhythm (Quinidine), and thyroid function (Levothyroxine). In these cases, small differences could be potentially life threatening.
Medicines are also made up of inactive ingredients, the binders and fillers (also known as excipients) that make up the pill or injectable medicine. The excipients in generics can, and sometimes are, of a lower quality or are completely different from the excipients in the original drug. As the American Heart Association has noted, “Some additives traditionally thought to be inert…may alter a drug’s dissolution, thereby impacting its bioavailability.” Bioavailability refers to the amount of medicine that is actually available to be absorbed into the body’s systems. The FDA does not regulate how fast a medicine reaches peak concentration in the body. Especially in the case of time-released medicines, the excipients may release the active ingredient faster or slower than the brand name.
A case in point is Wellbutrin, a popular brand-name antidepressant with an expired patent protection. A generic equivalent, Budeprion XL 300 went to market and complaints quickly arose. In 2007, one user told ABC News, "I would have a lot of energy, but by middle of the day I would have no energy, I would crash, and it wasn't really controlling my depression symptoms either. My outlook on life was different in a matter of hours." Nausea, dizziness, insomnia, and suicidal thoughts were among the other complaints.
A pharmacologist, Joe Graedon, host of an NPR radio program, began hearing these complaints and decided to investigate. In 2008, Graedon had an independent laboratory, ConsumerLab, test Budeprion. What it found was that the generic drug dissolved into the bloodstream four times faster in the first two hours than the brand-name Wellbutrin.
"What we found was shocking," Tod Cooperman, the president of ConsumerLab, told ABC. "The generic released its ingredient very quickly. In fact after just two hours, 34 percent of the ingredient had come out into solution. The original product had only released 8 percent at that time.... so you're getting a burst of medication coming out very early on with the generic that you shouldn't be getting."
Despite the test findings and complaints, it took the FDA five years, until 2012, to remove the generic from the market.
There are other safety issues with generics:
- Since the original drug has already been tested for safety, the FDA only requires that the generic produce the same level of medicine in the bloodstream (within the 80-125% range), i.e. bioequivalence, as the brand name. The testing for this is done not on actual patients, but on a small number of healthy volunteers (between 24 and 36 people). Many critics point out the need to test the generics on actual patients in order to determine efficacy.
- 80% of active ingredients and 40% of finished product comes from overseas. Given this volume, it is impossible for the FDA to closely inspect the quality of product coming in. In 2012, for instance, 480,000 bottles of a generic brand of Lipitor, a cholesterol medicine, were recalled due to glass shards being discovered inside the pills.
- Labels on generics give the consumer information based on the brand-name drug, misleading the consumer since the tests were never conducted on the generic itself.
Then there is the issue of cost. The bottom-line reason for the attractiveness of generics is that they are relatively cheap. In the past year, even that is coming into question, as some generic drugs have increased as much as 6000% according to a survey by the National Community Pharmacists Association. A report by the National Journal found that several meds increased over 10 times their former rate. Some have suspected this is due to Big Pharma playing arbitrary games with the cost. In one case, the price of a 150 mg prescription blood pressure pill was almost $280 for 90 pills. Yet those same 90 pills in higher 300 mg doses were about $31, and the same 90 pills in 75 mg doses were under $11.
A number of other generic drugs, like generic versions of Fiorinal (for migraines), Synthroid (for thyroid conditions), and Prednisolone (to treat inflammation and other auto-immune conditions) have more than doubled in the past year, according to the New York Times. Other people have stated that the prices of some generic drugs have gone up due to high demand. “This is an unregulated market in the sense that no one is telling them (the generic drug companies) what to charge,” Dan Mendelson of health consulting firm Avalere Health told Breitbart.com. “You’re going to see them cozy up to the price of the brand name product for competition reasons.”
The price hikes of generic medications have affected smaller pharmacies more than larger chains, which can negotiate lower prices. Nevertheless, some of these larger chains are taking advantage. Target despite being able to negotiate lower prices from the drug company, has not been beyond charging $455 for a cancer drug Costco charged $11 for. When asked about the huge price discrepancy, Target never directly responded except to cite insurance plans, deductibles and other issues not really related to the inflated price. Consumer watchdogs have stepped in to inform the general public of price discrepancies, and one website can help compare costs at different pharmacies.
Many, maybe even most, generics are safe and effective. Consumer watchdogs like Joe Graedon and Tod Cooperman believe that is the case. However, “We suspect there are at least dozens if not scores of generic drugs that may not live up to the standards that the American public expects,” says Graedon. Even Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research has acknowledged, “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.”
by Larry Schwartz
October 11, 2014
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Some Generic Drugs Are Not Equivalent To The Brand Name And Could Be Dangerous