![\"Captain](\"http://distractible.org/wp-content/uploads/2008/06/captain-obvious-8-finished.jpg\")
They\’ve been doing it since I was a medical student. Drug companies\’ patents run out, so they make a new formulation of it and extend the patent.
It is a shell game, and the FDA has played along up to now. I call it the XP version of the drug – for eXtend Patent. These XP drugs are sometimes better, but usually not much. Here are some ways they have done this:
Use an isomer
Many molecules come in Left and Right hand shapes called stereoisomers (trust me on this one), and usually one of the hands does most of the work. The drug companies have been re-marketing the active component as a new drug – and have gotten away with it.
Examples:
- Nexium – Nexium is the Left-handed isomer of the drug Prilosec. Prilosec was the greatest thing in the world until it went off patent, so then came Nexium. Mysteriously (through drug reps wearing short skirts and direct to consumer marketing), the drug became a blockbuster, even as Prilosec went both generic and OTC at the same time.
- Lexapro – Related to Celexa (for depression) – very successful as well.
- Xopenex – The active component of albuterol (for asthma). Supposedly less side effects, but this is possibly due to just using a lower dose.
![\"shell_game\"](\"http://distractible.org/wp-content/uploads/2008/06/shell-game.jpg\")
Use a Metabolite
Some drugs are not effective until they are broken down by the body. There are often several active metabolites from a single drug.
Examples:
- Clarinex – This is the anti-Nexium. Unlike Nexium, Clarinex is another molecule altogether. It is a metabolite of Claritin, the blockbuster allergy drug. Just like Nexium, Clarinex came on the market just as Claritin went generic and OTC. Clarinex flopped. What is the difference? Marketing.
- Allegra – Metabolite of Seldane, the allergy drug that caused heart problems.
Change the dosage schedule
A twice a day drug becomes once a day, and the patent is extended.
Examples:
![\"soap](\"http://distractible.org/wp-content/uploads/2008/06/soap-300x300-thumb.jpg\")
Cardizem – used for blood pressure, it went from 4 to 2 to 1 time per day, each time extending the patent. Overall was a big winner for them.- Coreg – Newest boy on the block. Coreg CR is being pushed heavily as the twice-daily Coreg went generic.
- Effexor – Again, went from twice to once a day and became a much better seller at the new dose. There is a new version of Effexor called Pristiq that is a metabolite. Would it surprise you if I told you the patent for Effexor is running out?
- Ambien – I thought Ambien was a great drug…until the reps told me it didn\’t last long enough and my patients needed Ambien CR. This drug went from once a day to once a day (extended), and kept the patent alive. Cool trick!
- LOTS of others.
![\"soap](\"http://distractible.org/wp-content/uploads/2008/06/soap-300x300.jpg\")
Mix with other drugs
If patent expires, the drug can be mixed with other drugs whose patents have not expired, extending the life of the generic. This is more convenient for the patient and could be less expensive than giving the two drugs separately, but that may not be the case if the generics are cheap enough.
Examples:
- Glucovance – Diabetic drug that was mix of two meds. More potent together, but both meds available separately.
- Vytorin – The famous combination of Zocor (generic now) and Zetia (not generic). Works well for lowering LDL a bunch, although the jury is still out as to whether this means people actually live longer.
![\"lux_lrg\"](\"http://distractible.org/wp-content/uploads/2008/06/lux-lrg.jpg\")
I am sure there are other examples of this game, but you understand my point. The best marketers are able to get doctors to prescribe and consumers to buy the \”NEW AND IMPROVED\” version of a drug, even if they liked the \”OLD AND WAY WORSE\” version. It is the same ploy used by paper towel, laundry detergent, and shampoo manufacturers (My Pantene shampoo has \”Amino Proteins\” in it – kind of like having \”letter words\” as amino acids make up proteins).
The tactic is blatantly obvious, but has been winked at by the FDA…up to now. Recently the FDA has rebuffed some XP attempts. From the WSJ:
Rolling out an extended-release version of a drug a year or two before it goes generic is one of the oldest pages in the pharma brand-extension playbook. But, at least in the case of GlaxoSmithKline, the FDA doesn’t seem to be playing by the book.
Over the weekend, the agency approved Requip XL, an extended-release version of Glaxo’s drug for Parkinson’s. But the approval came only a long delay, and a generic version of regular Requip, or ropinirole, hit the market last month, the WSJ reports.
My Favorite quote is at the end of the article:
“Requip CR did not make it to market. Why? Not because it’s not safe. Not because it’s not efficacious. The FDA said, ‘Yeah, you’ve got all that. But tell me why you’re better than [Requip].’ Well, that was an unprecedented question from the FDA,” Christopher Viehbacher, president of North American pharmaceuticals, said at an investor conference last month, according to a transcript.
Why is it better? It is Requip XP! It\’s new and improved! It\’s Requip 2.0!
Anything for the shareholders.
I can\’t believe I am saying it, but Thank you, FDA.
There are no differences in side effects when equivalent doses of levalbuterol or albuterol are used. The FDA publicly warned Sepracor not to advertise less side effects.
There are no differences in side effects when equivalent doses of levalbuterol or albuterol are used. The FDA publicly warned Sepracor not to advertise less side effects.
I *KNEW* that xopenex was the same! I just knew it! I kept being told I shouldn’t be having the same side effects …but I was (am ..but often refuse to use) with a shock …because “but it doesn’t have the side effects” Um …check my pulse in 10 minutes and tell me it doesn’t …
I *KNEW* that xopenex was the same! I just knew it! I kept being told I shouldn’t be having the same side effects …but I was (am ..but often refuse to use) with a shock …because “but it doesn’t have the side effects” Um …check my pulse in 10 minutes and tell me it doesn’t …
He he. The last “new” drug I got detailed on was the next version of Lexapro (which as you noted, is the next version of Celexa). I don’t even remember the name now, (was this a dream?) but I suggested to the drug rep to rename it Nextapro, and that the marketing department at Forest could send me royalties.
He laughed and laughed. He must think I’m hilarious. Or, he’s kissing my behind to get me to prescribe. Hmm….
He he. The last “new” drug I got detailed on was the next version of Lexapro (which as you noted, is the next version of Celexa). I don’t even remember the name now, (was this a dream?) but I suggested to the drug rep to rename it Nextapro, and that the marketing department at Forest could send me royalties.
He laughed and laughed. He must think I’m hilarious. Or, he’s kissing my behind to get me to prescribe. Hmm….
Dr. Rob,
As someone who works in the healthcare industry I enjoy your medical perspective and your sense of humor (sometimes I wonder if we’re distantly related), but it amuses/confuses me somewhat to hear doctors complain about drug companies coming out with new drugs that are not meaningfully better than existing drugs. A few thoughts from an outsider looking in:
1) nobody is forcing doctors to prescribe drugs like Nexium. For argument’s sake, let’s assume that Nexium is no better than Prilosec – then why did it become a blockbuster? Captain Obvious would tell us that it’s because physicians wrote a lot of prescriptions for it. The simple truth is that every time a prescription is written for a drug like Nexium a physician like you is complicit in the very thing you are posting against. Blaming drug companies is a cop-out, you guys all went to medical school, do you mean to tell me most of you don’t have the wherewithall to stand up to every Joe Sixpack who is mesmerized by a dopey DTC ad or every trampy-looking drug rep who bats her eyelashes at you? Instead of blaming a lack of innovation from drug companies you should all look in the mirror. The ironic thing is that back in the 1990’s, when HMOs tried to rein in some of the excesses you’re referring to, you guys all screamed bloody murder.
2) do you think that drug companies are satisfied with products like Ambien CR or Prozac weekly? Of course not! Of course they’d prefer to make innovative products that solve unmet patient needs, after all, those tend to be the blockbuster products, but R&D is a roll of the dice and sometimes you come up with Lipitor and other times you come up with Symbyax (or, most of the time nothing at all!). But if you get a dog, you need to put lipstick on it and try to convince patients and physicians otherwise – otherwise profits go down and your company will end up laying people off. Going back to point #1, if you don’t feel a product is innovative then don’t prescribe it. That will provide a powerful disincentive for drug companies to bother allocating time and money toward promoting it to you.
3) finally, every patient is different. While it often makes sense to start on a generic if it has equal efficacy to branded products, everyone benefits from having more treatment options as in many therapeutic areas patients will cycle through treatments until they find the right treatment.
It’s easy to blame drug companies for churning out mediocre drugs but you would see fewer mediocre drugs (or at least less promotional effort behind them) if doctors did not write prescriptions for these drugs. Physicians heal thyselves!
Dr. Rob,
As someone who works in the healthcare industry I enjoy your medical perspective and your sense of humor (sometimes I wonder if we’re distantly related), but it amuses/confuses me somewhat to hear doctors complain about drug companies coming out with new drugs that are not meaningfully better than existing drugs. A few thoughts from an outsider looking in:
1) nobody is forcing doctors to prescribe drugs like Nexium. For argument’s sake, let’s assume that Nexium is no better than Prilosec – then why did it become a blockbuster? Captain Obvious would tell us that it’s because physicians wrote a lot of prescriptions for it. The simple truth is that every time a prescription is written for a drug like Nexium a physician like you is complicit in the very thing you are posting against. Blaming drug companies is a cop-out, you guys all went to medical school, do you mean to tell me most of you don’t have the wherewithall to stand up to every Joe Sixpack who is mesmerized by a dopey DTC ad or every trampy-looking drug rep who bats her eyelashes at you? Instead of blaming a lack of innovation from drug companies you should all look in the mirror. The ironic thing is that back in the 1990’s, when HMOs tried to rein in some of the excesses you’re referring to, you guys all screamed bloody murder.
2) do you think that drug companies are satisfied with products like Ambien CR or Prozac weekly? Of course not! Of course they’d prefer to make innovative products that solve unmet patient needs, after all, those tend to be the blockbuster products, but R&D is a roll of the dice and sometimes you come up with Lipitor and other times you come up with Symbyax (or, most of the time nothing at all!). But if you get a dog, you need to put lipstick on it and try to convince patients and physicians otherwise – otherwise profits go down and your company will end up laying people off. Going back to point #1, if you don’t feel a product is innovative then don’t prescribe it. That will provide a powerful disincentive for drug companies to bother allocating time and money toward promoting it to you.
3) finally, every patient is different. While it often makes sense to start on a generic if it has equal efficacy to branded products, everyone benefits from having more treatment options as in many therapeutic areas patients will cycle through treatments until they find the right treatment.
It’s easy to blame drug companies for churning out mediocre drugs but you would see fewer mediocre drugs (or at least less promotional effort behind them) if doctors did not write prescriptions for these drugs. Physicians heal thyselves!
Excellent post – thank you.
Excellent post – thank you.
MSW, are you talking about me or that Pharma lover Pete?
Pete:
You are right that physicians need to not prescribe drugs that have a cheaper equivalent alternative, but my objections to the practice of the drug lords is the following:
1. There has been a practice of spacing a BID and once daily dosage simply so they can extend the patent. Bristol Myers also got in trouble for trying to use a new indication for pediatrics as a means to extend Glucophage’s patent. While I don’t blame the druggers, I do blame the FDA for winking at such a practice. The drug is the same, but the patent gets extended on and on.
2. It is easy to say that physicians should not prescribe, but the combination of a new drug form and DTC marketing makes it so patients are coming in asking regularly for the new medication. This is extremely annoying to us PCP’s. Should we ignore our patients? Perhaps, but it is not always easy. Ambien CR was the most recent one we got barraged with.
It is the FDA that has been to blame in all of this. Pharma has just been dancing to the tune they play.
By the way, are you from the Penfield that has the most wonderful store in the world: Wegmans??? My daddy used to hold me on his knee and tell me, “Eventually Dr. Rob, If you ever get to Penfield, make sure you go to Wegmans. It is a store flowing with milk and honey.”
Good points overall, though.
MSW, are you talking about me or that Pharma lover Pete?
Pete:
You are right that physicians need to not prescribe drugs that have a cheaper equivalent alternative, but my objections to the practice of the drug lords is the following:
1. There has been a practice of spacing a BID and once daily dosage simply so they can extend the patent. Bristol Myers also got in trouble for trying to use a new indication for pediatrics as a means to extend Glucophage’s patent. While I don’t blame the druggers, I do blame the FDA for winking at such a practice. The drug is the same, but the patent gets extended on and on.
2. It is easy to say that physicians should not prescribe, but the combination of a new drug form and DTC marketing makes it so patients are coming in asking regularly for the new medication. This is extremely annoying to us PCP’s. Should we ignore our patients? Perhaps, but it is not always easy. Ambien CR was the most recent one we got barraged with.
It is the FDA that has been to blame in all of this. Pharma has just been dancing to the tune they play.
By the way, are you from the Penfield that has the most wonderful store in the world: Wegmans??? My daddy used to hold me on his knee and tell me, “Eventually Dr. Rob, If you ever get to Penfield, make sure you go to Wegmans. It is a store flowing with milk and honey.”
Good points overall, though.