JAMA study shows brand name and generic cardiovascular drugs are equivalent, but hedges in conclusion

by James Hubbard, M.D., M.P.H.

Some drugs have a narrow therapeutic index.  You need just the right amount in your system.  Too little and it doesn’t work; too much and you can have toxic effects.  Doctors worry about these and many hedge on the side of caution by using the more expensive but trustworthy brand-name medicine.  But are they really more reliable than the cheaper generic alternative?

The latest JAMA takes on this question by trying to make sense of all past studies that have looked at cardiovascular brand and generic therapeutic levels in patients.

They found no difference in brand name or generics of any of the medications tested.  The blood thinner Coumadin (warfarin) was of particular concern due to its narrow therapeutic index but levels were the same.

However, in their conclusion, they got a little confusing when they stated, “Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.”

Huh?   Can you say hedge?

I except doctors to weigh in on this one.  We have cost vs. safety vs. perceived safety and no one wants to mess up.

The pharmaceutical manufacturers issued a joint statement the day the study came out.  They did not dispute the findings but just rehashed how there would be no generics without the pharmaceutical industry research, time and expense, and how much we all benefit from modern medicines.

I am not anti-drug industry.  In fact, just the opposite.  Their new drugs keep us healthy, out of the hospital and the surgery suite.  My aunt died in the 1950s from a stroke due to high blood pressure.  There were no good treatments.  When I was in medical school in the late 1970s peptic ulcers were common and usually required surgical removal of part of the stomach.  Tagamet (first drug to treat ulcers) was just emerging.

But if a cheaper generic is just as safe and effective, then I will use it.  It’s capitalism and competition and the American way.  Now comes my hedge.  Talk to your doctor about specifics.

What is your take?

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7 Responses to “JAMA study shows brand name and generic cardiovascular drugs are equivalent, but hedges in conclusion”

  1. cathy Says:

    Well, that makes it all clear as mud! It is comforting to read that the generics were essentially the same as the name brand for the drugs tested, but their hedge is not comforting. And I agree with you about the drug industry. They get a bad rap for passing their research costs (along with making a profit) along to their consumers, but that research is important and has to be funded somehow!

    cathys last blog post..One of my favorite brands

  2. James Hubbard, M.D., M.P.H. Says:

    Thanks Cathy.

    I think most doctors are fine with generics for everything but those with a narrow therapeutic index. Fortunately those are few, and dosage can be monitered with blood levels.

  3. Tom Rooney Says:

    Dr. Hubbard,

    This is somewhat rhetorical, but if the generic equivalent works as well as the name brand, why is the price so far apart in many? Under the drug plan of my health insurance relies entirely on generic unless the physician can articulate (usually in writing) why the brand name must be used. The study above gives the insurance companies a wide area to decipher the statement in favor of the cheaper alternative. Wouldn’t this become an anti-incentive to not produce drugs since any profit will go to generics right after FDA approval?

    Tom Rooneys last blog post..Secrets of a Successful Weight Loss Diet

  4. James Hubbard, M.D., M.P.H. Says:

    Tom, the pharmaceutical companies will patent a new drug. If it goes to market they usually have about 7 years of protection before other companies can sell generic alternatives. During those years the pharmaceutical company needs to make back its research cost and cover part of the costs of other drugs that don’t make it to market (something like 2 out of 10 do I think. After that time they can still make the drug, but will not be the only one.

  5. Dan Says:

    The Benefits of Generic Medications

    More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Presently, it is believed that over 60 percent of prescriptions written in the United States are now for generic medications. 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.
    Considering over 130 million in the U.S. take prescribed medications every month. Nearly 4 billion prescriptions filled every year, cost savings is rather important. Also, over 125 thousand in the U.S. die every year from reactions or mistakes from taking pharmaceuticals. This pharmaceutical industry makes about 3 billion dollars every year in the United States, and this annual amount increases over ten percent every year. Yet generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market, however, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs. About 75 percent of the newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market. Finally, about half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course.
    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, as their objective is one of a profit motive more than actual cost saving for the patient.
    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 clinical trial 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 manufacturing and approval 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 generic prescriptions they fill for others as compared with branded drugs. 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. And some studies show that generics are as effective compared with branded medications for particular disease states. The ALLHAT trial showed this, with generic diuretics showed equivalence if not superiority over the branded medications it was compared with during this 4 year trial funded mostly by the NIH.
    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.
    If one considers the health care crisis in our country 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

  6. bangkok simon Says:

    We are coming out of the normal time of year when we have flu circulating in the UK so we don’t really know what size of epidemic there may be in the next couple of months.

  7. Almera Says:

    Great Post, Ever Heard about the documentary.. Who Killed the electric Car?

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