Back in the 1990’s Charelton Heston spoke at an NRA meeting and said that the mainstream media packaged Hate and sold it as news. With all due respect to Mr. Heston, your Intrepid Pharmacist finds this statement incorrect. The mass media, in fact, packages Fear with a smattering of fact and a lot of misinterpretation, supposition, and insinuation and packages it as news, and thus Fact.
ABC News recently put up a report on its website regarding statin cholesterol drugs that is rife with misinformation of the kind that will send patients screaming into their physician’s office demanding expensive Brand drugs for no good reason. In the course of the article, the writer asserts that problems arise (and your Intrepid Pharmacist is quoting here) “Because of differences in potency between brand-name statins and generic versions.” The writer then goes on to cite a dizzying array of numbers between two statins that involve statistical models and essentially concludes that it is best to stay on brand name Lipitor. In fact, the article reads more like a brand drug promo ad than an actual piece of journalism, though much of this appears as a result of the writer’s confusion about brand drugs and their generic counterparts. So, let’s take a look at the mountain of medical misinformation ABC News has put forth and attempt some corrections.
The biggest GFE (that’s journalism speak for Gross Factual Error) is the above quoted assertion that generics are less potent than the brand. This says two things: 1) the writer has not bothered to look at FDA approval requirements for generics, and 2) the writer has confused and equated the generic of one Brand drug as being equivalent to the generic of a different brand drug. Had the writer couched the article in terms of physicians needing better training when switching from one drug to a different one, the whole piece would have had a different and been more factually correct.
When a molecule is discovered and patented (that’s a fancy inventor’s term for copyright) no one can copy the molecule—at least legally. This is the Brand drug, be it Zocor, Lipitor, Viagra, Imitrex or Valtrex. When the patent expires, other companies may then copy the molecule and produce a comparable pill, which is then sold under the drug’s informal chemical name. The copy must function the same as the original brand drug. In fact, when such applications for generics are submitted to the FDA, the brand drug is the comparator against which the generic manufacturer’s data results are matched. If they do not match they do not get the generic equivalent rating.
As with all things scientific there is an acceptable range the FDA uses for generics, but it is the same variance range that is applied to brand drugs. And the fact is, even brand drugs vary slightly from Lot to Lot. A “Lot” is a fancy manufacturer’s term for a single “batch” of the drug. Kind of like when you make cookies; each batch you mix will vary slightly, though you won’t notice it in the final result. In short, if a generic does not match a brand drug using the same parameters, it will not get approved as a generic equivalent.
That said, it does not mean quality issues cannot arise. In 2008, the generic drug maker Ranbaxy found itself in hot water with the FDA for having forged some of its stability data. End result: the drugs involved were recalled and held off the market until the problems were corrected. But lest people think such problems are limited to the generics, your Intrepid Pharmacist can assure that many drug recalls happen annually among brand and generic drugs that no one outside a pharmacy knows about because they happen after that Lot of the drug has been shipped, but usually before it has had time to be sold. The climb in recalls was noted recently in a cnnmoney.com article.
This year, however, the maker of brand Tylenol demonstrated publically that brands are just as susceptible to quality problems as generics. The result: the FDA announced that piles of Tylenol products were pulled from the shelf. In fact, your Intrepid Pharmacist has not seen such bare shelves in the Tylenol section since the Chicago poisonings in 1982 caused a nationwide recall (leading to the invention of the tamper-proof caplet to replace the capsule in OTC products). And now people are discovering that the acetaminophen 500mg in the store brand pain reliever is the same acetaminophen 500mg in the Tylenol brand. In chemistry there is no sliding scale of quality like with TV sets and cars; something either is the molecule or it is not.
Where patients most often see quality issues without realizing it are when a medication goes on manufacturer’s backorder. At this point the drug often is not available from any source or if it is, the other drug makers have to try meet the demands of their regular customers, plus all the pharmacies who were using the backordered manufacturer’s drug…leading to a drug shortage overall.
Now that we’ve clarified the generic-brand equivalent issue, let’s consider the rest of the article.
The reader is treated to a dizzying array of numbers and a “statistical model” that would lead to a 5.6% increase in LDL. And here is where most journalists get lost in medicine since they never took biostatistics (or medicine). In any given study, the aim is to prove that the results are probably related to the factors in the study rather than to chance happening. A favorable outcome between the experimental and control groups is termed “statistically significant” if it meets a predetermined percentage difference. While such significances are nice, they can still be meaningless in application. That is, the result may be statistically significant, but not clinically significant in that the overall effect that difference has on the patient’s clinical course is negligible to non-existent.
And what is a 5.6% increase anyways? That could be HUGE! Or it could be NOTHING! If you have an LDL of 100, that means you have gone up to 105.6. An LDL of 150 means it is now 158.4. They writer quotes the study that the 5.6% translates into a 3% increase in cardiovascular risk. Is any of that statistically significant? Probably. Is it clinically significant? Doubtful. And even if it is clinically significant, other drugs can still do the same job when dosed correctly, which is the point the writer misses.
Dosing correctly when converting a patient from one drug to the other is the central problem. In the cited study, 66% of the patients received adequate or higher comparative doses when moving between atorvastatin and simvastatin. One must wonder though, why is a physician starting someone on an expensive brand only drug (Lipitor’s patent is not up yet, so no generics)? And what is some physician’s obsession with starting patients on expensive brand only drugs no matter what else is available (more on that in an upcoming column series on Insurance Prior Approvals and Step Therapy)?
A balance between the patient’s pocketbook and therapeutic efficacy can be achieved. Were your Intrepid Pharmacist to list the number of times he encountered patients refusing to pay for expensive medications for which viable alternatives existed while their physicians refused to change the drug, this column would be the size of book. And the end result there, the patent receives zero medical benefit since they do not get the medication.
To be fair though, your Intrepid Pharmacist also knows plenty of physicians who know nothing about drug costs, but who are happy to utilize alternatives when such costs are brought to their attention so that the patient will get and take the medication. As one physician said to him a few months back, “I used to be shocked when you guys called and said some drug costs a several hundred dollars. Now, I’m no longer surprised, I just roll with it and pick something else when I can.” There are cases where alternatives are lacking--Plavix is an example where it’s the expensive brand or nothing.
Yes, we do know brand Lipitor and Crestor in lower doses are more powerful than generic Zocor or generic Pravachol at the same dose, but to say that clinically the brand only drugs are more significantly effective for most patients when compared to those available in generic is a stretch, especially when the dose of generic Zocor or Pravachol can be changed to achieve the same effect. As yet, your Intrepid Pharmacist has seen no outcomes studies showing that by taking the costly brands, patients lived significantly longer and had less related health problems compared to those taking a drug now available in generic.
The focus of this article should have been that some physicians need to be better informed about correct dosing when converting form one statin to another. Instead, ABC News produced a wildly misinformed piece of writing that using a few mangled facts and essentially scares patients into taking costly brand name drugs and avoiding generic versions in the same class that will, in fact, be effective. Your Intrepid Pharmacist extends a warm thank you to that writer for making the job of patient education for those of us in medicine a little more difficult.