Marketing Nexium As Superior To Prilosec Was OK
15 CommentsBy Ed Silverman // November 6th, 2009 // 7:58 am
For years, there has been controversy over whether AstraZeneca pulled a fast one by touting Nexium as superior to Prilosec. Nexium and Prilosec, of course, are both sold by AstraZeneca and used to treat gastro-esophageal reflux disease (GERD), or heartburn. Many people bought the new prescription pill, but not everyone bought the marketing pitch. In fact, some filed lawsuits.
Nine consumers contended the drugmaker positioned Nexium as a “new” drug in order to cause them to pay a higher price than they had been paying for Prilosec, which was switched to over-the-counter status. They cited FDA medical reviews indicating there was no scientific basis to suggest Nexium was better than Prilosec at relieving symptoms or offering treatment.
Nexium ads, however, claimed the pill was more powerful and clinically proven to heal faster. When they filed their suit in 2004, a Nexium pill cost an average of $4.46, while Prilosec sold for just 59 cents. But the Arkansas Supreme Court ruled that AstraZeneca didn’t hookwink anyone and found there was nothing fraudulent or deceptive about the marketing, according to Leagle.com.
In reaching its decision, the court supported what a circuit court wrote earlier: “While the plaintiffs’ entire complaint appears to be well researched, it is convincing only to the point that a giant corporation has flexible power to control and enhance its own profits. It offers little or no proof that the defendants committed an actionable tort against the plaintiffs in…Arkansas, or anywhere. The complaint would perhaps make an excellent article in a scientific magazine, but it fails as a legal pleading.” (Here’s the decision).
hugh paton
Bring on the scientific article writers, and the health science writers, and the point will be proven there.
"Bile"-ey the Kid
The JUDGE said:
“it is convincing only to the point that a giant corporation has flexible power to control and enhance its own profits.”
Thanks Judge, you’ve certainly done your country a service by burying your head in the sand. Nice work.
The substance (drug) behind the commercial names work identically, and for all physiological purposes are the same. Prilosec comes in 10mg doses x1/day, and Nexium comes in 20mg doses x1/day. You need to do your own accounting, but if you take 1 Nexium per day and it is more expensive for you to take 2 Prilosec per day, try the latter. And don’t assume that generic Prilosec (i.e. a brand marketed by “Wright Aids” pharmacies or the like is equivalent to brand name Prilosec.
Ed, lower those horns and attack the fact that the FDA allows a generic alternative to be 80% + or - a certain percentage of potency than brand name drugs. Millions are currently misled.
Compliance Analyst
“Ed, lower those horns and attack the fact that the FDA allows a generic alternative to be 80% + or - a certain percentage of potency than brand name drugs. Millions are currently misled.”
I am really sick of people spouting this as “fact”. Manufacturers (both branded and generic) typically run two different tests, assay and content uniformity. Assay tells you the average API in a grouping of tablets (say 20), while content uniformity tells you how well it is distributed individually (sigle tablet measured). Typical assay limits allow 5% leeway, while CU is ~15%.
Generic pharmaceuticals have to meet the monograph or approved FDA specification, which typically matches the approved specification from the brand product.
The big difference between generics and branded products is how they are formulated. You don’t have to use the same binders, fillers, lubricant, or disintegrant. This can often change how the drug acts within the body for people. See Wellbutrin issues….
Talking out of one’s bottom is not very becoming.
Jackson Roe
Regardless a patient may receive a generic prescription where each individual pill can be up to 15% different than the brand name. Also, if the pharmacy buys from different manufacturers of the generic, the patient gets even more variability. While this may not be an issuse for some drugs, drugs that cross the blood brain barrier or drugs that need to be taken to control life-threatening illnesses potentially can do damage when there is this type of difference.
We can discuss assay amounts, etc ad naseum; however, the public is not aware of these differences between the brand and generic meds and should be educated.
Compliance Analyst
A brand can be up to 15% different if you are talking about active ingredient. If you are talking about excipients, it could be more than that.
A generic tries to go as close to the brand name as possible, but certain ingredients can and will be substituted.
My company manufactures both brand names and generics. For the most part everyone uses the same ingredients because they are plentiful and tend to be consistent, ex. mag stearate as a lube, povidone as a binder, starch or lactose as a filler, etc. The important sections that the generics aim for is having the same thickness, hardness, weight, friability, and dissolution. A good generic company will do clinicals to prove its efficacy…I know we do.
Red Fraggle
Compliance Analyst,
Give it a rest. My own doctors who know insiders in the FDA admittedly purport this to be the case. And you know for sure when you take a meducation for say, migraines, and the brand name works far better than the generics. Some generic companies have purchased expired medication from the original source, put a fresh coat of paint on it, and give it’s stamp of approval.
And I’ve seen how CU tests can be twisted without tractability.
Put your time to a better topic.
Frump Pumpkin
“Generic pharmaceuticals have to meet the monograph or approved FDA specification, which typically matches the approved specification from the brand product.”
Yeah, typically….. Typically, it’s not warm in November…. Would you want your child to take a seizure preventative, brand name drug, then suddenly switch to a generic that could legally be 20% less potent than the brand name drug he or she has been on for a year?
Typically is a word without a home with regard to this issue.
And keep your damn safety glasses on!
JaT
Frump,
You failed to mention that the FDA criteria for generics allows for a wide +/- swing in a drug that requires precise dosing and lengthy titration periods. Allowing for dangerous changes from lot to lot.
But before you go all ‘No Generics’ you may want to read this article, as branded drugs are allowed that same loose criteria upon reformulation (according to CDER). Without warning to the consumers, and despite doctors writing DAW or no substitutions on your prescriptions. In fact, a pharmacist is required to fill those prescriptions with the altered branded product based on the DAW.
http://www.pharmalot.com/2008/05/a-new-version-of-dilantin-is-giving-pfizer-fits/
There is a group that carries Ed’s article on them at all times, for their safety, in case of emergency. He deserves an award. Someone needed to inform people.
Red Fraggle
Then explain the physically noticeable differences between brand name and generics? Why the hell is there a checkbox on your doctors prescription slips that says “DO NOT SUBSTITUTE”.
Say what you say, but it is what it is.
Take your views up with my doctors. Don’t waste any more of my time. This is a no brainer, moot issue.
Compliance Analyst
“Some generic companies have purchased expired medication from the original source, put a fresh coat of paint on it, and give it’s stamp of approval.”
–Not since the generic scandal of the 80’s. And because that is so price effective to buy something that is more expensive and sell it for less, that makes total sense.
I have in no way discounted that branded meds may work better than some generics due to formulation. And I could probably find people that the inverse is also true. I know when we ran clinicals next to a branded product, we actually had better efficacy and bioavailability from reformulating.
Fraggle, do you have experience developing and manufacturing of pharmaceuticals or are you basing your knowledge on what other people tell you? Is your knowledge of medicine is second hand? Well I have a friend that knows a friend at the FDA that says your Doc is full of it.
Pumpkin….you missed the entire point….a branded medication can have the same differences! There are branded meds that have a spec difference for CU at +/-25%…..and it meets specification. And I used the word “typically” since the FDA has the authority to require that the specs are tighter….thus not making the specs exactly the same. So I use the word typically since it is not 100% of the time that specs match for branded vs. generic.
pharma pr hack
Your doc writes “no substitute” because the reps are telling him to write no substitute, the pharma funded patient groups are mining for anyone with an adverse reaction to thyroid, epileptic and antidepressant medications and attributing it to the switch from generic versus brand. There has been no peer review clinical trials data published that show a variability in API between brand and generic cause issues. Actually the most recent data shows the exact opposite. Link is generic heart medicine found equal to brand counterparts.
http://www.bloomberg.com/apps/news?pid=20601124&sid=aQPqqyXr2lYU&refer=home
The reality is both the brand and the generic have the same scale-up issues from laboratory to manufacturing. There is a dearth of publicly available good manufacturing science… And the variability that your physician speaks of is the same as the variability the BRAND has batch to batch. Without it, a drug would never be approved. Everyone is within the same monograph when the generics come to market so there is not the issues beyond the binders and fillers.
Not every drug works for every body and one day personalized medicine may tell us why but it could lie in the binders and fillers for both generic and brand. Or it could lie in the fact that drugs are over-hyped to down play side effects.
JaT
There is much truth to that, pharma pr hack, considering that FDA doesn’t insists that a drug remain consistent with the more thorough studies conducted to gain NDA approval.
Generic drugs are allowed to be considered bioequivalent to the innovator product. This gets interesting when it IS the innovator product (making the branded drug a generic because they no longer adhere to their own tighter In House Protocol). Branded drug makers are basically tossing the more complete science, under which they were scrutinized when they gained NDA approvals.
Honestly, if I were a chemist that worked hard to make a safe and effective product, I’d be insulted that my hard work had been reduced to a couple of blood draws to determine dissolution.
Bioequivalency does not mean that some drugs are exchangable. Here is why…
There may be the same amount of active ingredient in all of the products, but the excipients determine dissolution.
One dose studies to determine dissolution cannot begin to examine a product that requires titration. The result of those one dose studies are not even required to remain in tact, based on the loose FDA criteia.
If a product is made with a more dense form of lactose (for instance) it is going to be delivered more slowly. Consistency being a major concern in some medications, we cannot have people switching products, nor can we have drug makers changing the delivery of medications based on that loose FDA criteria for generic drugs (or branded generics) in drugs that require precise dosing.
We cannot have drug makers switching things like Magnesium Srearate from a bovine to a vegetable based product and expect the same result.
I don’t belong to any group to promote the pharmaceutical industry. In fact, I am disgusted with their willingness to reduce the quality of their medications without consideration for the consumer.
I do understand their need to be able to compete when their product goes off patent or off an insurers list of allowed branded medications.
I now take a generic (not Pfizers), which is different from lot to lot. I have to titrate every few months and it is sometimes extremely difficult. Before Pfizer reduced the quality of Dilantin there were no horribly noticable changes in their medication. Their In House Protocol (or that of PD) was much tighter. This article is a MUST READ…
http://www.medscape.com/viewarticle/414647
Keep in mind that the article relates to Dilantin as it was before the reformulation.
Maybe this address to FDA by a highly accredited Neuro is more clear…
http://www.fda.gov/ohrms/dockets/ac/99/slides/3547s1i.pdf
Sorry I went long, again, but this is so simple that it has become difficult.
JaT
Nevermind. Geez, I’m starting to sound like Fraggle.
:/
pharma pr hack
JaT —
There were no noticeable changes because they didn’t have changes in suppliers or they didn’t change manufacturing locations or they didn’t change formulations that you were privy to. But the reality is the variability exists in both brand to generic- batch to batch.. There just is not a great deal of science in drug manufacturing but there is a great deal in drug development–hence the scale-up issues. And most drugs aren’t even made here anymore. Pfizer’s newest plants after their bloodletting in New Jersey, etc. are outside the US in “developing countries!” Genentech’s newest plant is in Singapore. Making Teva in India look positively cutting edge…
Compliance Analyst
FYI…most companies switched from animal sourced mag stearate because of mad cow.
As a side note pharma companies sometimes get flustered by excipient manufacturers that change their manufacturing process without telling them. The trick is finding good and consistent suppliers, which can be tough for certain ingredients.