Generics Are Good As Brand-Name Meds: Study
14 CommentsBy Ed Silverman // December 2nd, 2008 // 4:08 pm
Despite concerns expressed by some doctors and patients that generics are inferior products, there is no evidence brand-name meds are clinically superior, according to a meta-analysis of 47 studies of various cardiovascular drugs published in the Journal of the American Medical Association.
Researchers from Brigham and Women’s Hospital in Boston looked at studies published from 1984 to August 2008, as well the content of editorials published during that time to gauge expert opinion. Of the 47 articles, 38 (or 81 percent) were randomized controlled trials, according to a JAMA statement. Here’s what they found…
Clinical equivalence was noted in 100 percent of RCTs of beta-blockers; 91 percent of RCTs of diuretics; 71 percent of RCTs of calcium-channel blockers; 100 percent of RCTs of antiplatelet agents; 100 perent of RCTs of statins; 100 percent of RCTs of angiotensin-converting enzyme (ACE) inhibitors, and 100 percent of RCTs of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT of class 1 anti-arrhythmic agents and five out of five RCTs of warfarin.
Meanwhile, of 43 editorials and commentaries that met study criteria, 23 (or 53 percent) expressed a negative view of the interchangeability of generic drugs compared with 12 (or 28 percent) that encouraged generic substitution (the remaining 8 did not reach a conclusion on interchangeability). Among editorials addressing NTI drugs specifically, 12 (or 67 percent) expressed a negative view while only four (or 22 percent) supported substitution.
“One explanation for this discordance between the data and editorial opinion is that commentaries may be more likely to highlight physicians’ concerns based on anecdotal experience or other nonclinical trial settings. Another possible explanation is that the conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed. Approximately half of the trials in our sample (23/47, 49 percent), and nearly all of the editorials and commentaries, did not identify sources of funding,” the researchers wrote.
“Our results suggest that it is reasonable for physicians and patients to rely on FDA bioequivalence rating as a proxy for clinical equivalence among a number of important cardiovascular drugs, even in higher-risk contexts such as the NTI drug warfarin,” they conclude. “These findings also support the use of formulary designs aimed at stimulating appropriate generic drug use.” And to limit mistrust of generics, they suggest media and medical journals should be more selective about running pieces that are based on anecdotal evidence in which generics are downplayed as ineffective or too risky.
Stephanie
I still am wary of Generics. Some of the companies are just not ethical (does Able or Ranbaxy ring any bells?) in their production of meds.
pharma PR hack
Stephanie,
The reality is the ethical lapses can happen in either a brand or a generic… Most of the ethical lapses occur downstream in the supply chain just like heparin earlier this year.
And both generic and brand are made to the same standard enforced by the FDA.
What the American public probably doesn’t understand as the multinational pharmaceutical companies continue to outsource with such a great degree in countries where the workplace regulations are more lenient then sometimes what you may be buying from a brand name may not be as quality controlled as say Hospira that manufactures here in the US. Food for thought.
George
What about Paxil CR? A brand name drug. Remember when it was unavailable for months because the FDA had shut doen it’s factories. I believe they had found many “defects” in the production, and after many warnings, they ignored the FDA.
PaulGGG
This study makes absolutely no sense. It is a meta analysis of studies published over decades. Many of those studies were conducted on brand name drugs before they became generics. They are generic now but were not then.
Just A Thought
The FDA criteria for a generic drug is not generally as tight as with a branded drug manufacturer’s own in house protocol. ANDAs are approved on very few comparisons and often with one dose human studies to establish those few numbers.
Depending on the type of medication that may or may not be an issue.
Then I learned that the FDA criteria for gaining approval for reformulated branded drugs is the same as for an ANDA for a generic drug (I’d have to locate the CDER comment on that again). A branded drug only has to meet the FDAs looser bioequivalency to itself.
It makes no sense to toss the complete testing that gained the approval under a new drug application- but it is what it is. Branded drugs can strive to be of equal quality to a generic. No one seems to be able to explain what that means for comparisons to the reference product when the reference product is changed.
This study is probably more accurate than you want to believe. Not because generic drugs are just as good- but because branded drugs are allowed to be equally loose upon reformulation.
The problem that arrises is with a larger swing between lot numbers based on the looser FDA criteria- in either instance. Some drugs require more precise dosing to be safe and effective.
pharma PR Hack
Just a Thought
you are partially right.. but you are missing a key component when a drug goes off patent there is a public standard that the US pharmacopeia makes that the FDA enforces for both branded and generic so the molecule is truly bioequivalent.
The larger swing isn’t just based on the looser criteria- the larger swing is in the brand.. when a generic reverse engineers a drug they buy several lots and their formulation is geared within the swing variance of the brand..
The only way any of this will change is for the FDA to require complete characterization of a molecule (small or large) and to make drug companies invest in manufacturing so they aren’t using 20 year old technology that is actually let them manufacture in Bangladesh, Sri Lanka and all these areas where regulation is even farther behind.
atlex
Let’s face it, for the vast majority of drugs, generic substitution of with an AB rated equivalent is not big deal. As someone who works in big pharma, I understand that more than 90% of scripts for a brand product go away within a month or 2 of the loss of exclusivity. In general, I wouldn’t hesitate to make the switch myself.
However, there are a very few instances when I would hesitate–primarily in drug classes with very narrow therapeutic indexes (anti-epileptics, anticoagulants, etc.). The issue is not that the generics in these classes are bad; in both of the instances I mention, a patient can be titrated to the proper dose of a particularly generic manufacturer’s product. Unfortunately, it’s the potential of being switch from one generic to another at the whim of a purchasing agent for a drug store chain that causes concern. That inconsistency would cause me concern in those few drug classes. Personally, I would opt to stay with the brand in these few cases.
Atlex
wizened
Dear Atlex.
I agree to some extent on the NTI issue. if I were on coumadin or an anti-epileptic I would want to stay on the brand name. When I was at Boots, we tried to sell the NTI story as part of a marketing strategy to keep patients from switching to lower cost T4 preparations (in addition to suppressing for seven years the results of a BE study showing equivalence of these products). With major financial support to the societies, we enlisted the American Thyroid Association and the American Association of Clinical Endocrinologists to toe this party line of non-switchability. We said that the cost of generic switching would increase health care costa. The reality was that the cost of switching (MD visits plus lab tests) was less than one year’s cost of Synthroid, and remember this is a lifetime drug. My only suggestion is that if you switch to a generic NTI drug, you should stay with that generic, since generic-to-generic NTI switching can cause repeated need for retitration. Unfortunately some pharmacists don’t understand this.
Anne PME
Many states have automatic generic substitution without prescriber notification. This means that the prescriber often does not know that their patient has been substituted to a generic, or from one generic brand to another generic brand. If they don’t know about the substitution, chances are they are not going to diagnose issues or will misdiagnose generic issues and ascribe patient complaints and/or symptoms to noncompliance, disease progression, or other complications.
As many of us know, generic drug manufacturing is being outsourced to foreign countries, including countries that are documented to have much higher rates of product tampering, counterfeits and/or substandard medications.
Last but not least, it would be great if all conflicts were disclosed…for example, do any of the authors consult for brand name pharma, pharmacy chains, PBMs or health insurers or receive grants that may involve increasing prescription access?
Compliance Analyst
Buy American….(though it is more complicated than that).
Salmon
Wizened,
It’s not necessarily the pharmacist who don’t understand the need to maintain on whatever generic you’re on. They get their generics from their wholesaler who may be shipping whatever one they could get the best deal on that month.
Salmon
pharma pr hack
Anne- that is a very selective statement- generic manufacturing is being outourced to other countries?! You would only have to go back two weeks in Ed’s’archives to see pfizer/novartis, etc cutting manufacturing in US and outsourcing- don’t forget AZ’s goal to outsource 80 percent of manufacturing. The reality is all manufacturing is being outsourced to other countries
Dingle
George - good points, but one thing to take note of is that the FDA isn’t this all seeing eye. They occasionally do audit manufacturing sites, but not as frequently in foreign countries. The pharma companies are their own watchdogs when they outsource, as they are liable for the full supply chain. They have quality teams dedicated to ensuring quality supply. Who is there besides the FDA to monitor generic manufacturers, who run on hair thin margins? They have an incentive to let things slip a bit. Pharma doesn’t - margins are fat, and they can afford to make the necessary investments to keep up and exceed compliance with GMP, and would much rather make the investment than deal with any potential PR mess.
Just A Thought
Some generics are better than others and the brand name ones are not always the best.
My doctor DAWs a generic and my pharmacist will order it in if he doesn’t have it. They were mortified by how things went down with Dilantin.