GENERIC THREAT?: How do generic versions of drugs differ and does that pose any threat?
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As we cope with the economic recession, we've all had to make concessions. It's been "good-bye" to European vacations, organic milk and magazine subscriptions. But there are those things we can't give up without risking serious illness or death, one of which is prescription medication.
In 2004 the U.S. Centers for Disease Control estimated that at least 47 percent of Americans had a prescription filled each month. Besides ordering brand-name pills, powders and sprays from Canada, some people are trying to cut costs by turning to generic medications. But don't worry: unlike switching from a real Louis Vuitton purse to a knockoff bought in Chinatown, this isn't a switch that will leave you aching for the real thing in a few months time.
"In theory, generics are every bit as high quality as brand name," says William Hubbard, a former associate commissioner of the U.S. Food and Drug Administration (FDA). "I would readily take a generic if it was prescribed to me."
A generic drug contains the same active ingredient, which provides therapeutic benefit, as does the brand-name version. But having the same medicinal component does not mean the two pharmaceuticals are identical. They may contain different inactive ingredients, including those for pill coatings and color or to bind the constituents into tablet form. They also may vary in bioequivalency, which is the amount of drug that is available in the bloodstream at any point in time. In fact, a 2009 FDA study showed that of 2,070 orally administered generic drug products approved by the agency between 1996 to 2007, generics differ in bioequivalency from brand names, on average, by about 3.5 percent; less than two percent varied by more than 10 percent. For many, these differences are not significant enough to reduce therapeutic benefits or, on the other hand, cause toxicity.
"For the vast majority of patients, switching is not an issue," says Aaron Kesselheim, a physician and drug policy researcher at Harvard's Brigham and Women's Hospital. Kesselheim is author of a 2008 study that showed there are no statistically significant therapeutic differences among generic and brand-name heart medications.
The minority of patients for whom a switch might be problematic are those on narrow-margin therapeutic index drugs, such as anticoagulants and antihypertension meds for which there is a fine line between a dosage that is beneficial and one that is toxic. Even when using pioneer (or brand-name) drugs, doctors monitor patients on these types of medications until they find the precise dose that works with each person's physiology. Switching medication, especially if there's even a small bioequivalence variability, can introduce a change that throws off therapy.
"If a person is stable on narrow therapeutic index drug, it makes sense to think two times about changing to a generic or to a new brand-name drug," Kesselheim says.
Despite convincing scientific evidence that generic drugs are largely equivalent to pioneer meds, there remains an undercurrent of fear toward nonbrand names. In fact, as part of Kesselheim's 2008 study in JAMA The Journal of the American Medical Association, his team reviewed 43 editorials that had been published in peer-review health care journals between 1975 and 2008 concerning generic substitutions for branded cardiovascular disease pharmaceuticals. The study found that 53 percent expressed a negative view toward generics. There's myriad sources that could explain the worry, including patient case reports and antigeneric advertising by brand name drug companies. But to be fair, much of the concern is rooted in some scary generic drug scandals, in which toxic substances made it into a medication that was produced overseas, such as occurred with heparin in 2008. Today, more than 40 percent of the active ingredients in generic and over-the-counter pharmaceuticals are produced in India and China—and that number is only expected to increase: In the next few years a number of brand-name pharmaceuticals will be going off patent, with the expectation that within 10 years, 80 percent of the prescriptions Americans take will be generic.
And, although generics have thus far been shown to be as effective and safe as branded drugs, there is a concern that they are more likely than brand-name meds to be the target of adulteration with toxic substances, because some companies might be tempted to cut corners in efforts to keep them as cheap as possible.
"FDA requirements are pretty strict," Hubbard says, "but foreign firms don't have the same culture of safety and oversight—and they are interested in the lowest price."
According to the FDA, the rules that it has set to regulate generic drugs are just as tough as for brand-name meds. But keep in mind that the federal agency was originally formed as a domestic watchdog—overseas expansion and the proliferation of pharmaceutical manufacturers have challenged their infrastructure. The New York Times reported that in 2007, out of 500 Chinese facilities the FDA only got around to checking 13. Acknowledging this situation, the agency is looking to expand overseas staff in an attempt to ramp up on-the-ground regulation of manufacturing facilities. In 2008 the FDA opened three offices in China and two in India, not to mention others in Costa Rica and Belgium. Hubbard further suggests that in the future, all foreign facilities with any role in the U.S. pharmaceutical industry should be required to register with the FDA, providing contact information as well as a list of their product lines.
Plus, the U.S. Pharmacopeia (USP), a standard-setting authority for prescription and over-the-counter meds, has recently changed some of the identification tests that manufacturers are required to run on products destined for the U.S. These newer, more stringent analyses are more sensitive to impurities than prior protocols were. (And, for what it's worth, the USP is also trying to organize momentum for establishing some tougher food tests—think: melamine.)
Today, however, Hubbard says that prescription-takers "don't need to panic": 67 percent of Americans take generic medication, and there are few adverse instances to recount. And studies have shown them to be just as effective as branded meds.
So, with the great recession raging, bring on the generics.
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20 Comments
Add CommentBrand name drugs are often used for the control of epilepsy. While generics may deivate from brand names by only 3-10%, in bioequivalency, you could go from 10% under and then go to 10% over with your next Rx if it comes from a different manufacturer. This would not be a problem if you could always order your generic from the same manufacturer, however, I don't think this is possible.
Reply | Report Abuse | Link to thisVery informative article, thank you.
Reply | Report Abuse | Link to thisIf you're looking for generic prescriptions, there is a great website called 'Medtipster' that enables you to locate low-cost generics from reputable pharmacies in your area. If you go to the homepage, you just type in the medication you need, the dosage and your zip code and Medtipster will direct you to the least expensive pharmacy. The site really makes finding affordable prescriptions easy...google search "Medtipster" and have a look
One thing I'm surprised the author didn't mention is the fac that the FDA does not require generic manufacturers to submit their formulas to the same testing for effectiveness and drug interaction. Once an active ingredient is approved it doesn't matter how others formulate it. So if a drug happened to work well with certain fillers and other such additions to make the "pill" and another manufacturer uses a different filler which negates the effectiveness, we would never know it because it would never be tested.
Reply | Report Abuse | Link to thisI agree with previous comment (main3167). I have experienced serious reduction of effectiveness on two occasions when my pharmacy switched me to a newly available generic. Both thyroid and antidpressant medications have to be dosed very carefully, and switching either from the brand to the generic or from one generic manufacturer to another must be medically monitored, not just interchanged by the pharmacist. This needs to become a ground rule with regard to filling prescriptions (and with regard to insurance coverage).
Reply | Report Abuse | Link to thisAs far as I m aware one a drug is validated by the FDA the manufactuers can change the bulking chemicals as often as they like, so in fairness this whole article is pretty pointless!
Reply | Report Abuse | Link to thisWhere to start? There have been books written in an effort to remove the obfuscation and scaremongering undertaken by the U.S. brand name drug companies.
Reply | Report Abuse | Link to this* Generic drugs reduce the cost of medicine by 30% to 50% for most citizens of the industrialized world.
* Generic drugs have the same active ingredient that brand name drugs have. Bioequivalence is a phony issue seized on by brand name companies because some small difference in the inactive ingredient can be demonstrated for a few drugs. (Well, not completely phony, but can easily be dealt with.)
* Most industrialized countries have programs equivalent to American Medicare and Medicaid. However, those foreign programs are allowed to use a Public Tendering process to establish the price of the drugs it uses. In most countries governments making bulk purchases without Public Tendering would be illegal. Only in the U.S. is bulk purchasing of drugs forbidden, thereby depriving US citizens of the competitive market forces that generic drugs can bring to a patient.
* Generics are not stealing brand name manufacturer's ownership of a drug. The patents for the active ingredients have run out. The brand name manufacturer has had 20 years to recoup their development costs.
* Generics do not restrict research into new drugs. Generics are sold all over the world, yet there is more drug research than ever before. In any case, brand name drug companies actually do very little original research. That is carried out at Universities and Research Institutions. The patents for new discoveries are then sold or licensed to brand names.
* In reality, the number of active ingredients available to fight disease are relatively few -- about 1,000. And, most have been around for a long time -- 20 years plus. It is unfair that brand name manufacturers be allowed to own those cures 'in perpetuity'. Because of marketing and packaging it seems like a lot more.
* Most brand name manufacturers have subsidiaries that produce generic versions of their own (and other people's) brand name drugs in order to compete, mainly outside of the US, with other generic manufactures.
Kfreels, I'd be really interested to know your source for the "fact" that generics are treated more leniently than brand name drugs by the FDA, since the article states otherwise.
Reply | Report Abuse | Link to thisAnd to Arynix, I agree that dosage is very important especially with depression, but that goes both ways. Less can be too little, but more can be too much as well. The important thing is consistency. Implicit in some arguments against generics is that brand names provide higher bio-equivalency and that this is somehow always better. This may not be the case; switching between manufacturers can be deleterious either way.
As for overseas production, the article doesn't mention how many brand name drugs are produced wholly are partly overseas. I'd like to know.
Kfreels, I'd be really interested to know your source for the "fact" that generics are treated more leniently than brand name drugs by the FDA, since the article states otherwise.
Reply | Report Abuse | Link to thisAnd to Arynix, I agree that dosage is very important especially with depression, but that goes both ways. Less can be too little, but more can be too much as well. The important thing is consistency. Implicit in some arguments against generics is that brand names provide higher bio-equivalency and that this is somehow always better. This may not be the case; switching between manufacturers can be deleterious either way.
As for overseas production, the article doesn't mention how many brand name drugs are produced wholly are partly overseas. I'd like to know.
Kfreels. You are right in one respect. A generic drug does not have to be re-tested for the efficacy of the active ingredient. The active indgredient has already been well tested by the FDA and has had a twenty year clinical trial (so to speak).
Reply | Report Abuse | Link to thisThe properies of the various matrixes are well known and have been tested by other nation's equivalent of the FDA. All that is needed for sale of a generic in the US is a review of the world literature and some simple tests of the actual pill to be sold.
Most countries have an excape hatch for physicans concerned about the bioequivalence of a generic drug versus a brand name. All programs allow Doctors to bypass the generic drug and get permission to prescribe a brand name instead.
Most of the time, I get generics.I think as slong as you don't start out with hte brand then try to switch to a gneric, you'll be OK. But the latest issue is that you aren't guaranteed to always get the SAME generic. I recently got a new generic (for Ambien - zolpidem) but it does NOT work - I know because I can't sleep anymore even with the max dosage.
Reply | Report Abuse | Link to thisMy biggest fear is the lax process for accepting new generics - I just don't trust Chinese factories to self-certify anymore.
So, by all means, use generics. Often they're as good (or good enough since you can adjust the dose until it's right) but don't change. With brand names, you always et tehe same stuff from the same manufacturer. With generics, you get whatever your supplier could get for the cheapest. Therein lies the rub.
Jimboha
Absolutely my point- consistency is key. I currently take several generics, but the difference is that I started out on the generic, and therefore the dosage is adjusted to the generic. I do sometimes notice when the generic manuf. changes- for instance, I normally take one extended-release pantoprazole (generic Protonix) once a day, but sometimes the pills in a particular bottle don't last but about 8 or 10 hours, so I have to take a second pill. HOWEVER, my dr is aware of this problem, so my Rx is for 2 pills a day just in case! Can't do that with thyroid and antidepressants!
Reply | Report Abuse | Link to thisThe non-medicinal content of all drugs is something that should be given more attention. A patent-holding company for a common blood pressure medication has been using a pill making facility where some of the production lines are contaminated with mildew. As a result a random assortment of pills taste like the inside of a hockey change room. What is worse is that this is complicated by an environmental allergy to mold, fungus and mildew and the action of the medication is impeded by the allergic reaction. Effective dosage levels are never accurate. The drug company involved refuses to admit that there is a problem ... obviously because of financial and legal concerns ... and no processing plant will shut down production to clean a machine with pressurized CO2 ice (like sandblasting) in order to get rid of this type of contaminant.
Reply | Report Abuse | Link to thisI can hardly wait for the generic medicine to come on the market in order to get clean medicines.
This comment refers to Tom O H's comment - a generic manufacturer CANNOT "change the bulking chemicals" as often as they like - if a generic manufacturer wants to change ANY ingredient in it's FDA approved ANDA it MUST submit (what is called) a PAS (prior approval supplement) to the FDA and CANNOT AT ANY TIME change ANYTHING about the make up of the drug until the FDA gives its approval of the PAS filed by the generic manufacturer - please do your homework before making false statements - all of this information and the requirements to have a drug or any of its chemical make ups approved can be found on the FDA CEDR website.
Reply | Report Abuse | Link to thisThe FDA does not require the same studies for efficacy because that would be a huge waste of resources. Generic manufacturers are required to show that their product releases the active substance in an equivalent manner to the branded product, and they are not allowed to change formulations without first demonstrating the equivalence of the new formulation. Some generics have a different release profile from brand names, and as mentioned that is a concern in specific, low therapeutic index products. For example, people who are on levothyroxine simply always get the same generic when they get refills. If you have a concern about your specific medication, I suggest you ask your pharmacist, but the vast majority are identical for all intents and purposes.
Reply | Report Abuse | Link to thisAs far as the Ambien issue, it's a lot more likely that you have developed tolerance. Ambien is a habit forming substance, and like any other potentially addictive drug, the longer you use it the more you need to achieve the same effect. Ambien is only effective for short term use because of the tolerance issue. The manufacturer has already shown that the product releases the drug substantially similarly to the brand product.
I have been using generics for more than two years. I don't find any issues with it. They are actually bio equivalents of brand medications. They have same active ingredients. inactive ingredients are little different. The working is same. I get generic medications from a pharmacy called International Drug Mart
Reply | Report Abuse | Link to thisI have been using generics for more than two years. I don't find any issues with it. They are actually bio equivalents of brand medications. They have same active ingredients. inactive ingredients are little different. The working is same. I get generic medications from a pharmacy called International Drug Mart
Reply | Report Abuse | Link to thisI have absolutely no problem with the notion of generic drugs per se, nor in the time limit on patent protection for pharmaceuticals. What I have a problem with is that the generic companies contribute essentially nothing to medicine other than making it somewhat cheaper (while making huge profits for themselves). Pharma companies pay their share because of the risk involved in developing novel medications (9/10 drugs fail in the clinic) and the huge cost of this development.In my view, generic companies should pay a hefty tax that could then be used to fund medical research.
Reply | Report Abuse | Link to thisThe state of American medical care and the doctor-patient relationship, whatever that means, have both been talked about for a while. There are accusations; however, doctors have been prescribing certain narcotics to patients because they receive kickbacks from pharmaceutical companies for doing this. The medical field is said to be almost wholly corrupted by this practice. Applying for an <a title="Apply here for an installment loan" href="http://personalmoneystore.com/installment-loans/">installment loan</a> for prescription is probably not the best thing for you after-all.
Reply | Report Abuse | Link to thisWhile I realize this is an older article, I wanted to mention what the article doesn't. The time release on this medications of the generics may also be different in compared with the name brand, and that can also affect the way a person reacts to it. There are 6 medications I can take genertics to with no problem but 1 that there is no way, and the same with my husband, he must have name brand on 3 of his, and the rest are generic. I always believe in trying the generic first, but if they don't work.....
Reply | Report Abuse | Link to thisThe policies of government of not letting generic drugs into market has create a problems for patients. The brand named drugs are available for hefty prices whereas generic drugs are available very cheap. For instance, drugs for sexual pleasure are not included into healthcare plan, so men have to pay extra fortune for it. If these drugs are available cheap, its good for people. So instead of purchasing Pfizer's " The Viagra" , they can try generic drugs containing sildenafil citrate.
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