Heart Drugs: Brand Names No Better Than Generics, Study
Featured ArticleMain Category: Cardiovascular / Cardiology
Also Included In: Pharma Industry / Biotech Industry; Pharmacy / Pharmacist; Clinical Trials / Drug Trials
Article Date: 03 Dec 2008 - 0:00 PDT
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US scientists reviewing 20 years of research and expert opinion on generic versus brand name drugs in the treatment of cardiovascular diseases found no clinical evidence showing brand names were superior to generic versions even though a substantial number of experts writing editorials advised against interchanging them.
The study was the work of Dr Aaron S Kesselheim, of Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, and colleagues, and is published online in the 3rd December issue of the Journal of the American Medical Association, JAMA.
When two drugs are bioequivalent it means that to all intents and purposes after they have been given to the patient they are biologically equivalent to each other, for example the composition, rate and extent to which their active ingredients are present at the target site inside the body are so similar that you can't tell the difference between them.
And yet there appears to be a general opinion among doctors and patients that despite the fact generic drugs are bioequivalent to brand name drugs, the brand names are clinically superior. But generic drugs are much cheaper, so Kesselheim and colleagues decided to investigate the available clinical evidence on generics versus brand names and the views of editorial writers on the subject with respect to cardiovascular treatments.
For the study, the researchers systematically searched for peer reviewed studies published between 1984 and 2008 and listed in a number of well known databases, including MEDLINE, EMBASE, and International Pharmaceutical Abstracts.
They selected those studies that compared the clinical effectiveness and safety of generic versus brand name cardiovascular drugs. In a separate exercise they also identified editorials that wrote about substituting brand names with generic versions.
Kesselheim and colleagues then used techniques commonly used in research that reviews other studies, whereby the design, setting, participants, results and funding of each study is extracted and put through a test that assesses the quality of the trial, whilst the results are pooled in such a way that they can then be viewed as if they had come from one giant trial (meta-analysis).
As a separate exercise they reviewed the editorials and classified them as negative, positive or neutral, depending on the authors' view on generic substitution.
They found a total of 47 clinical trials covering 9 subclasses of cardiovascular drugs, and established the following results:
- 38 of the 47 (81 per cent) trials were randomized controlled trials (considered to be higher quality).
- For beta-blockers, 7 out of 7 randomized controlled trials (100 per cent) found generics to be clinically equivalent to brand names.
- For diuretics, the figure was 10 out of 11 (91 per cent).
- For calcium channel blockers it was 5 out of 7 (71 per cent).
- For antiplatelet agents it was 3 of 3 (100 per cent).
- For statins it was 2 out of 2 (100 per cent).
- For angiotensin-converting enzyme inhibitors it was 1 out of 1 (100 per cent).
- And for alpha-blockers, 1 out 1 randomized controlled trial (100 per cent) found generics to be clinically equivalent to brand names.
- In drugs that have a narrow therapeutic index (where you have to be really careful to give the right dose so as not to injure the patient), clinical equivalence was found in 1 out of 1 randomized controlled trial (100 per cent) for class 1 antiarrhythmic agents, and in 5 out of 5 (100 per cent) for warfarin.
- Pooling the results of all the trials gave a total of 837 participants and an aggregate effect size of -0.03 (95 per cent confidence interval of -0.15 to 0.08), meaning that across the studies as a whole, there was no statistically significant evidence that brand names were superior to generic drugs.
- 23 of them (53 per cent), expressed a negative view about whether generic drugs could replace or be used instead of brand names.
- This compared with 12 (28 per cent) that encouraged substitution.
- The other 8 editorials did not reach a conclusion on interchangeability.
- Among editorials covering narrow therapeutic index drugs, 12 (67 per cent) expressed a negative view compared with 4 (22 per cent) in favour generic substitution.
They wrote that the rising cost of prescription drugs is a critical policy issue: it strains the budgets of patients and insurance providers, and leads to poorer health as it works against helping everyone to make sure patients can complete their medication schedules.
"The primary drivers of elevated drug costs are brand-name drugs, which are sold at high prices during a period of patent protection and market exclusivity after approval by the Food and Drug Administration (FDA)," they added.
The idea of generics is to help people afford drugs, and these become available after the brand names have had their period of being the only ones on the market, the so called exclusivity period. Many doctors and payers encourage this.
However, some patients and doctors have been concerned that the generic versions may not be as effective. As Kesselheim and colleagues explained:
"Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts. Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs."
Kesselheim and colleagues suggested that one explanation for the discordance between the clinical evidence and the opinion expressed by experts in the editorials could be that:
"Commentaries may be more likely to highlight physicians' concerns based on anecdotal experience or other nonclinical trial settings."
Another explanation they suggested was that the:
"Conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed."
Nearly half the trials (23 out of 47) and nearly all the editorials and commentaries they reviewed did not reveal where the funding came from, noted Kesselheim and colleagues, who also wrote that:
"We identified numerous studies that evaluated differences in clinical outcomes with generic and brand-name medications. 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."
"These findings also support the use of formulary designs aimed at stimulating appropriate generic drug use. To limit unfounded distrust of generic medications, popular media and scientific journals could choose to be more selective about publishing perspective pieces based on anecdotal evidence of diminished clinical efficacy or greater risk of adverse effects with generic medications. Such publications may enhance barriers to appropriate generic drug use that increase unnecessary spending without improving clinical outcomes," they added.
"Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease: A Systematic Review and Meta- analysis."
Aaron S. Kesselheim; Alexander S. Misono; Joy L. Lee; Margaret R. Stedman; M. Alan Brookhart; Niteesh K. Choudhry; William H. Shrank.
JAMA. Vol 300, No 21, pp 2514-2526, December 3, 2008.
Click here for Abstract.
Sources: JAMA.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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Therapeutically Equivalent
posted by Dan on 3 Dec 2008 at 5:44 amThe Benefits of Generic Medications
More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost of branded medications in certain cases, and yet are therapeutically equivalent. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med.
Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients to generic medications, if possible. This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements, yet the companies paying doctors is remarkably legal, and therefore allowed to occur. Yet I find this process inappropriate and unethical in regards to patient health.
Not long ago, generic meds 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 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 included in the approval process that is required by branded medications to be completely developed and approved by the FDA. This reduced cost of generic production 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, which is called evergreening, of their meds, which allows for them to continue the lifespan of their branded medication.
Also, such tactics implemented by pharmaceuticals, such as frivolous patent infringement lawsuits, which delays generic availability for a longer period. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication.
Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. 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.
Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has been replicated by the generic medication. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- with possibly safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
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. I consider this device rather innovative.
Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. 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. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
Considering the health care crisis in our country (USA) and the over-priced treatment methods in our health care system, such as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.
“What good fortune for those in power that the people do not think.” --- Adolph Hitler
Dan Abshear
Authors note: What has been composed above is based upon information and belief
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