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Cheaper drugs don't always drive out brands

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We've heard a lot about insurers and other payers pushing patients to use generics rather than brand-name meds, and how that pressure hampers Big Pharma. But there's a flip side to that coin. Sometimes, getting patients and doctors to switch is well nigh impossible.

Take a federally funded study pitting old blood pressure meds--the diuretics--against newer, more expensive drugs such as beta blockers. Published in the Journal of the American Medical Association in 2002, the study clearly showed that patients with high blood pressure and other heart risks did better on the older, cheaper drugs. And the researchers mounted an all-out effort to promote those findings.

But, according to the New York Times, that research created only a tiny ripple in the drug market. Diuretic use increased initially, but then it leveled off. Researchers said drugmakers fought back against their publicity efforts, trying to discredit the study. Plus, pharma continued to roll out new meds, which weren't available for the comparative effectiveness study, robbing diuretics of their head-to-head advantage.

So, if Congress actually goes through with setting up a comparative effectiveness bureau of some kind, will that really end up reining in healthcare costs? We'll have to wait and see. But if this study is any indication, the WSJ Health Blog notes, skepticism could be in order. Particularly if that bureau produces FYI-type data, rather than info that government payers, such as Medicare and Medicaid, are required to act upon.

- read the Health Blog post
- see the article in the NYT

Related Article:
Newer BP drugs no better than diuretics
Make generic-switching bonuses illegal?
Insurers pay docs for generic-switching
Switching to generic statins not so healthy

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Cardiovascular disease, I surmise, is very concerning to both patients and their care givers. Furthermore, this disease is likely a cause of distress for many who seek the best treatment once the disease presents itself. As a result, there are increasingly many treatment options available to delay if not prevent such diseases, yet many health care providers were understandably unclear as to which option is the most effective with these deadly disease states manifested by substandard cardiovascular function.
Potential reassurance was made available with the results of the ALLHAT trial, which were published in the Journal of the American Medical Association in 2002, which was conceptualized and implemented by the National Institute of Health. This trial was the largest study to date addressing, among other variables, those with hypertension. In addition, the ALLHAT trial included over 40,000 subjects over the age of 55 who were evaluated in over 600 clinics during the course of this trial. While Pfizer financially contributed a small portion to support this trial, ALLHAT was conceptualized and implemented by the National Institutes of Health at a cost of around 130 million dollars to determine the best medicinal treatment for the patients that were studied in this trial.
The ALLHAT trial, as a result, was largely if not completely void of bias and commercial interference, as there was no relevant association between the trial investigators and the makers of the drugs studied in the trial. Because of the ideal way in which this trial was conducted and completed, most concur the results of this trial are quite accurate and valid.
ALLHAT actualized a true comparative analysis of various classes of drugs for hypertension, which included calcium channel blockers, ACE inhibitors, Alpha Blockers, and Beta Blockers, and diuretics. The researchers examined the action of these classes of medications on the subjects who possessed cardiovascular disease states, with a focus on hypertension. As the trial was completed with data collected over a 4 year period, the trial concluded that one particular class of medications included in this study proved to be the most advantageous for the subjects as it relates to efficacy and cost for those who require treatment for the disease states studied. Amazingly, this one drug class in this study is in fact nearly as old as the subjects involved in the trial.
ALLHAT results specifically and clearly concluded that thiazide diuretics are, overall, the preferred choice of initial medicinal therapy, as this class of drugs overall proved to be more beneficial in many ways compared with the other classes of drugs in the study, which proved to be not any better or safer than diuretics. Diuretics offered great protection against cardiovascular disease, and proved that diuretics should be the first line drug of choice in such patients..
This class of medication has been available in the United States for well over 50 years, and presently costs about 25 dollars a year, instead of a few dollars a day for many if not most branded medications for CV conditions that were examined in the ALLHAT trial. So this finding, of course, concludes that diuretics, which are far less expensive than the other classes of medications that will be addressed in this article, not only provide equivalent if not superior benefits for cardiovascular disease patients, but provide cost savings as well as determined in this trial. The ALLHAT trial was rare and unique in that it compared diuretics to these other classes of medications directly, which is not done frequently with clinical trials involving branded pharmaceuticals.
The ALLHAT study was the largest study ever performed utilizing this comparative effectiveness protocol. To reiterate, the medications included in this trial that compared various classes of medications for the cardiovascular benefits they may provide included calcium channel blockers, ACE inhibitors, and Alpha Blockers, beta blockers, and, thankfully, thiazide diuretics, as this class also reduced the risk of myocardial infarctions, strokes, and heart failure as well as reducing the blood pressure of the hypertension patients in the trial. Diuretics were superior in comparison with calcium channel blockers and beta blockers with such disease states as strokes and heart failure, for example, as well.
Yet, even though this trial was potentially beneficial for so many who are involved with the treatment of patients with cardiovascular disorders, the acknowledgement of diuretics as being superior never really materialized following the release of the results of the ALLHAT trial by the medical community and their utilization of diuretics based on this trial. Even after the researchers of the ALLHAT trial implemented an ALLHAT dissemination plan from the years 2003 to 2006, at a cost of close to 4 million dollars to educate health care providers about the ALLHAT results, and the significance of the findings, the acknowledgement of the benefits of diuretics continued to be unrecognized by health care providers. And the reasons for this may be many.
Of no great surprise, these results of the ALLHAT study appeared to be of notable concern with those pharmaceutical companies who promote the other classes of medications in the ALLHAT trial. Reportedly, these companies increased their promotional spending in order to blunt the potential effects this trial may have on the usage of their cardiovascular medications that belong to the classes that were involved in the ALLHAT trial. Sampling of their medications to health care providers increased noticeably as well.
Furthermore, drugs combining two medications from different classes of medications for hypertension and other cardiovascular disease states are increasingly preferred by many health care providers for understandable reasons presently- depending on the severity of the cardiovascular disease states that may exist, along with the risk of developing these cardiovascular conditions. It is not unusual, for example, for a branded pharmaceutical company to combine their medication for hypertension with a diuretic for those patients that may have a stage of hypertension that requires simply more than just one drug for reduction of their high blood pressure. Yet diuretics remain the first line choice of treatment based on the results of the ALLHAT trial.
I’m comfortable as a layperson in suggesting that the cardiovascular experts should and in fact obligated to continue to make others aware of the results of the ALLHAT trial, and convince others that diuretics should be the preferred choice of medicinal therapy for the medical conditions illustrated and treated in the ALLHAT trial when they happen to exist in such patients, of which there are many. This would ensure that these patients would receive the proven and ideal treatment to delay the progression, if not the prevention, of these cardiovascular events addressed in this trial. Furthermore, billions of dollars would potentially be saved with greater utilization of diuretics instead of more expensive medications that are of no greater benefit. Unfortunately, it appears what may be one of the most authentic trials conducted has been and continues to be largely disregarded- possibly due to the forces of others whose objectives are of a different nature besides the restoration of the health of others as it relates to the diseases addressed in the ALLHAT trial.

Dan Abshear

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