What’s In That Prescription Bottle and What Does It Do? Generic V. Brand
Posted Sep 05 2013 7:37pm
By Bob Aronson
What’s In That Prescription Bottle and What Does It Do?
The question asked by our headline would seem to have an obvious answer but it doesn’t because there isn’t one. We may know the medication that’s in the bottle but what It does is another story. Each drug has a primary effect and many side effects. Side effects can be minimal or dangerous and we are left to trusting our physicians. But, do they really know what they are prescribing?
According to Dr. Ben Goldacre they don’t because they don’t have all the information they need. Goldacre is a best-selling author, broadcaster, campaigner, medical doctor and academic who specialises in unpicking the misuse of science and statistics by journalists, politicians, quacks, drug companies, and more.
His first book “Bad Science” (4th Estate) has sold over 500,000 copies to date, is published in 18 countries, and reached #1 in the UK paperback non-fiction charts. Bad Pharm , just out, is on bad behaviour in the pharmaceutical industry and medicine more broadly: it is now a top ten UK best seller.
Here’s what Goldacre says about, “What’s in that Bottle?”
“Doctors need the results of clinical trials to make informed choices, with their patients, about which treatment to use. But the best currently available evidence estimates that half of all clinical trials, for the treatments we use today, have never been published. This problem is the same for industry-sponsored trials and independent academic studies, across all fields of medicine from surgery to oncology, and it represents an enormous hidden hole for everything we do. Doctors can’t make informed decisions, when half the evidence is missing.
Most people react to this situation with incredulity, because it’s so obviously absurd. How can medics, academics, and legislators have permitted such a huge problem to persist? The answer is simple. This territory has been policed — and aggressively — by the pharmaceutical industry. They have worked hard to shut down public discussion on the topic, for several decades, with great success.
They say, for example, that the problem is modest, and that critics have cherry picked the evidence: but this is a lie. The best evidence comes from the most current review of all the literature , published in 2010. It estimates that half of all completed trials are left unpublished, and that trials with negative results are about twice as likely to be buried.
Then they pretend that the problem is in the past, and that everything has been fixed. But in reality, none of these supposed fixes were subjected to any kind of routine public audit, and all have now been well-documented as failures . What’s more, they all shared one simple loophole: they only demanded information about new trials, and this is hopeless. Anything that only gets us the results of studies completing after 2008 does nothing to fix medicine today, because more than 80% of all treatments prescribed this year came to the market more than ten years ago. We need the results of clinical trials from 2007, 2003, 1999, and 1993, to make informed decisions about the medicines we use today. This isn’t about catching companies out for past misdemeanors, it’s a simple practical matter of making medicine optimally safe and effective.” (You can watch Dr. Ben in action here http://tinyurl.com/opvzsjn )
OK…having established that we need to force the FDA and big Pharma to release more information let’s turn to the subject of Generic drugs. Are they really the same as he band name? The answer is, “No, not entirely!” Did you know they aren’t even tested?
For more on the generic story let’s turn to Dr. Tod Cooperman. He is not only an MD but also the President of Consumerlab.com. Here’s what he says,
“More than 80 % of the drugs we take in the US are now generic versions of brand name medications. You may think that these drugs are equivalent to their branded counterparts, but that’s not always the case. Here are some important facts and tips to stay safe with generic drugs.”
Fact: You may get more or less active drug from a generic.
The FDA only requires that you get 80% to 125% of the drug into your bloodstream from a generic medication compared to the original drug. What’s even more concerning is that there are often many different generic versions of the same drug, and each of these may be different as well. Consider this: If you take a generic which only meets the minimum requirement and refill that prescription with one that’s at the maximum limit, you’ve potentially increased the amount you get into your body by as much as 45% percentage points – and you would have no way of knowing this from the labels, but it could certainly affect you. The opposite could also happen, and you would be getting a lot less drug than you were previously – which could also affect you.
This is particularly troubling for medications for which blood levels must be kept in a narrow range in order to be effective and/or to avoid toxicity. These can include:
Fact: Other than the active ingredient, a generic may contain very different other binders and fillers.
Most of the ingredients in a pill are not the active ingredient but other ingredients needed to hold the pill together, coat it, and control the way the pill delivers its drug in your body. These other ingredients can be different in a generic version of a drug. It is possible to have an allergic reaction or sensitivity to one of these ingredients. With some extended-release products, the brand name formula is still patented, so the generics may be completely different in their formulation. This can affect how fast or slow they release their drug and how this is affected by things like whether you take the pills with food or not. http://www.doctoroz.com/videos/what-you-need-know-about-generic-drugs
Fact: Generics are not tested like brand name medication.
While brand name medication is tested for safety and efficacy before being approved, generics are not. The only human test in people that is required is a bioequivalence test, conducted by the manufacturer in a small number of healthy individuals. This test must show that the product delivers approximately the same amount of drug into your blood stream and approximately the same rate.
Fact: Labels on most generic drugs are incorrect.
The FDA requires that the package inserts for generic drugs show the data (the “pharmacokinetic” data) from the brand name medication as if it is were based on the performance of the generic drug. In actuality, the data for the generic is typically different, but the FDA does not release this information.
Fact: In 2012, the FDA conceded that several generic antidepressant medications had never been tested and one was pulled from the market.
These were generic versions of Wellbutrin XL 300. One of them, called Budeprion XL 300 (Teva), had been on the market since 2006. Four others remain on the market. ConsumerLab.com drew attention to problems with this group of drugs in 2007 when it showed the Teva product did not dissolve like the original drug and many people switched to the drug reported that it was not working and some reported becoming suicidal. (Access to ConsumerLab.com’s report is available through a 24-hour free pass to Dr. Oz viewers. Visit ConsumerLab.com/DoctorOz now and get immediate access.)
So, given all that information, what do you do with it. Here’s what Dr. Cooperman suggests.
Guidelines if you are going to take Generic drugs
Guideline 1:Consider brand names for extended-release generic drugs.
While the active ingredients may be identical, the pills and their other ingredients in extended-release medications may not be. This makes extended-release generics, which typically have XL, ER, or SR in their names, more susceptible to delivering lower or higher amounts of the drug into your blood stream and at faster or slower rates than the brand name medication. As noted, this has been an issue with generic Wellbutrin XL 300. Concerns have also been reported with generic versions of Toprol XL. ConsumerLab.com has published reports on these products.
Guideline 2: Identify the manufacturer for generic drugs.
Not all generics behave the same way. If your generic is working, you should request the same manufacturer each time you refill that prescription. You can find the name (sometimes an abbreviation) on the bottle. Don’t be shy. You can call around to try to find the same product. Pharmacists will tell you which version they are currently selling and may be able to get the version you want.
Guideline 3: Find out if an “authorized” generic exists for your drug.
These are generics typically made by the same manufacturer of the brand name medication but sold under a generic brand name. They are not “similar” to the brand name drug – they are identical to it. They just have a different imprint on them. Ask your pharmacist if one exists for your medication.
Guideline 4: When switching to a generic, monitor your condition carefully.
When switching from a brand name to a generic drug, or from one generic to another, note any changes you feel and tell your doctor immediately. It could be a difference in the medication causing the changes in you.
If you have experienced an unexpected and adverse change in your condition after being switched to a generic medication, you or your doctor may also want to report this to the FDA though its MedWatch program. You can also report this to ConsumerLab.com , which may choose to investigate the issue.
Bob’s Newheart will be watching closely as more brand names become generic and we’ll report significant developments to you as we discover them.
Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 3,000 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.
You may comment in the space provided or email your thoughts to me at email@example.com. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.
If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. JAgain, write to me and ask for “Life Pass It On.” I will email it to you immediately. This is NOT a stand-alone show; it needs a presenter but is professionally produced and factually sound. If you decide to use the show I will also send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to firstname.lastname@example.org and I will send the show and book ASAP.
Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative (OTI). The more members we get the greater our clout with decision makers.
Bob Aronson de Newheart de Bob es un centro receptor de trasplante 2007, el fundador de la Iniciativa de Facebook cerca de 3.000 miembros de trasplantes de órganos y el autor de la mayoría de estos blogs de donación / trasplante.
Usted puede dejar un comentario en el espacio proporcionado o por correo electrónico a sus pensamientos a mí en email@example.com. Y – por favor difundir la palabra acerca de la necesidad inmediata de más donantes de órganos. No hay nada que puedas hacer lo que es de mayor importancia. Si se convence a una persona para ser un donante de órganos y tejidos puede salvar o positivamente afectará a más de 60 vidas. Algunas de esas vidas puede haber gente que conoces y amas.
Si quieres correr la voz personal sobre la donación de órganos, tenemos otra presentación de PowerPoint para su uso gratuito y sin permiso. JAgain, escribir a mí y pedir “Life Pass It On.” Voy a enviar por correo electrónico a usted inmediatamente Esto no es un espectáculo independiente,. Necesita un presentador, pero es producido profesionalmente y objetivamente sonido Si usted decide utilizar el archivo. demuestro que también le enviará una copia gratuita de mi libro electrónico, “Cómo obtener un Standing” O “que le ayudará con habilidades de presentación. Sólo escribo firstname.lastname@example.org y enviaré el programa y el libro lo antes posible.
Además … hay más información sobre este sitio de blogs de otros temas de donación / trasplante. Además, nos encantaría que te unas a nuestro grupo de Facebook, la Iniciativa de Trasplante de Órganos (OTI). Cuantos más miembros que tienen la mayor influencia en nuestra toma de decisiones.