"You won't have bathroom lady to kick around anymore because, gentlemen, this is my last DTC appearance," said the iconic Detrol spokesperson.Yes, Detrol is joining the growing legion of off-patent medications. Pfizer, however, is replacing $1.2 billion blockbuster drug Detrol, with Toviaz, a "new" treatment for "overactive bladder."
Not only is Pfizer jettisoning the blue DTC icon, but it also intends to use a new marketing approach where drug reps won't be focused so much on the features of the product in discussions with physicians.
"In the old world, [sales reps] might have come to talk with the doctors about the features of the product," he [Jim Maffezzoli, senior director-marketing in Pfizer's new primary-care unit, which is marketing the drug] said. "Now they'll be talking about the product and also the YourWay plan." He added that it is "emblematic of the primary-care business unit to try and bring solutions to the physicians vs. simply coming to physicians with a new product." (See "Pfizer's Prescription for Patent Loss: New Drug").
Toviaz, however, is perhaps just a repackaging of Detrol and not really a "new" drug as the Advertising Age article cited above claims in its headline.
"Toviaz is structurally related to Detrol but has two doses instead of one, Mr. Maffezzoli said, giving physicians and patients more flexibility in treatment for the drug's efficacy and tolerability," said the article.
Taking advantage of my graduate degree in biochemistry from Columbia University, I decided to take a look at the molecular structures of these two drugs and see how similar they actually were. The following were copied from the package inserts:
Hope this doesn't bore you, but these two compounds are pretty closely related and it looks like it was a "no-brainer" to convert the Detrol molecule to the Toviaz molecule: merely an "esterization" of an -OH group and an oxidation of a H3C group to an ethyl alcohol group. The whole thing was then combined into a different salt configuration using the fumarate salt instead of the tartrate salt.
Not so "innovative" in terms of R&D. A college chemistry major could easily do the conversion in a minimally-equipped lab.
Marketing, however, is a whole 'nother story!
"The somewhat snarky Toviaz ads, which will appear in TV and print and as online banners, target women with questions such as 'Does running to the bathroom count for a good portion of your cardio?' and 'Do you feel like kids and careers are far less demanding than your bladder?'," says Advertising Age. "All feature the prominent tagline, 'Time out. It could be overactive bladder.' Pfizer will experiment with out of home, too, placing ads on grocery carts and in women's bathrooms. There is a consumer-facing informational website as well, at overactivebladder.com. Toviaz.com, the official website for the drug, is set to launch in May. A brand campaign for Toviaz will unfurl later this year, but Mr. Maffezzoli declined to furnish details."I am sure the brand campaign will make a big deal about how "new" and "improved" Toviaz is versus Detrol. And to think that the FDA's PRECIOUS time was wasted in approving this "new" drug! What a travesty!
The Detrol marketing was pretty remarkable too. Have a look at "Positioning Detrol: creating a disease" :
ReplyDeletehttp://healthyskepticism.org/gallery/showphoto.php/photo/83
Not a lot of pharma ads runnong on the search engines today. Maybe pharma and their ad agencies will now focus more on targeted displays using one of the Health or Medical advertising networks and reduce their dependence on search.
ReplyDeleteRobert Kadar
Good Health Advertising
www.GoodHealthAdvertising.com
Just so you are aware...Pfizer did not develop the drug. They bought it from Schwarz Pharma 2 years ago...the reason is because it was a more potent formulation that is hydrolized and does not go through first pass metabolism...thus the ability to titrate doses.
ReplyDeleteAlso this drug has no CNS side effects like ALL others on the market. It also has no QT Prolongation precaution..like ALL others on the market and has shown reductions in episodes for people suffering from OAB by up to 90% This data is unheard of in this marketplace.
It is quite appreciated to take a skeptical look at what pharma does, however, you must also take into consideration all of the facts, which it appears you ahve not done.
I am a physician, practicing for over 20 years and I am glad that pharma is trying to not push plans but look for solutions...we should all be thankful of that.
Get the facts straight please.
I beg to differ with you doc. Did I say that Pfizer developed Detrol? I did not.
ReplyDeleteYou have quoted some facts about this drug. May I ask where these came from? May I ask how these "facts" compare to Detrol?
At least I quote my sources.
I appreciate that this physician is willing to listen to sales pitches. However, this molecule will not work in the body unless it goes through the first pass metabolism. That is in the prescribing information. Also, that reduction in incontinence comes with a 35% incidence of dry mouth.
ReplyDeleteI'm more interested in the oxybutynin gel that is coming out soon. Excellent efficacy with very minimal side effects of any kind and it does not go through first pass metabolism. At least it offers a new vehicle, not just a way to prolong a company presence in a market when a product patent is going to expire soon.
I would like to know why Detrol, Ditropan & Vesicare all produce heart palpitations for me. I already have a slight heart arrhythmia. I'm afraid to take them, but need (at least 1 of) them desperately, when traveling!
ReplyDeleteJohn, I'm a practicing Urologist of 19 plus years now and my partner emailed me your article. Let's get some things out of the way first. I do not get paid by Pfizer or any of the drug companies to do talks or conduct research, so my opinion of Toviaz is solely based on the clinical outcomes of my patients. Second, although OAB (by many practitioners’ standards) is not considered a high priority amongst physician's diagnostic practices, it is debilitating to those who are wetting their pants multiple times a day. Now, the OAB market is diluted with various products to treat this disease but I will say that I've had exceptional results from Toviaz. And if data assists in formulating your opinion, there is a recent H2H trial comparing it to Detrol LA that demonstrates statistical significance in its PE. So before you begin to peck and hunt on your laptop for the next defamatory article that you can write against Big Pharma and their "me-to" drugs, do a little more research. Or, (sorry I have to go here) why don't you spend a little time in a residency and fellowship program to help validate your blog’s content. I recently had a patient come into my office who was crying her eyes out because she is wetting all over herself at her grandson’s bar mitzvah. I gave her the Toviaz samples and followed up with her 2 weeks later and to hear her say “thank you” multiple times makes me happy to know drug companies are continually researching new treatment options to help these folks out and enrages me that you just distort facts and spread propaganda. Good day John.
ReplyDeleteDear Dr. Anonymous,
ReplyDeleteSo why don't you give me the reference to that H2H study you quote? Obviously, it was a study paid for by Pfizer. Was it part of the FDA submission for TOVIAZ approval? Am I supposed to take the word of an ANONYMOUS commentator about how much MORE effective TOVIAZ is than DETROL?
Tell me doc, when prescribing TOVIAZ over DETROL are you taking the cost differential (brand vs. generic) in mind? Is the "statistical significant" difference you mention worth it? That question cannot be answered until I see the data. Until then, it is YOU NOT ME that is distorting "facts" by first NOT presenting any facts and then supplying only ANECDOTAL evidence!
You're being dishonest in your analysis here. There are many compounds with similar structures that have vastly different properties. Ethanol and Methanol come to mind. As a biochemist, you *know* this. However, you decided to be misleading to non-chemists by saying that the differences between the compounds are trivial.
ReplyDeleteIt is clear that you have an axe to grind with Pfizer's (Pharma's) marketing strategies. I won't comment on whether your points are right or not on these (as that is not my area of expertise), but let's be a little more honest about the science, shall we?
Still, no one offers any evidence that I am wrong about the difference being trivial. These compounds can have "vastly" different properties, but until I see the evidence I cannot take your word for it.
ReplyDeleteI may have an axe to grind re calling this "innovation", but my axe is really aimed at taking pharma at its word that it is innovative, when more and more we see slight modifications to existing drugs to get longer patent protection and maintain higher prices. Maybe TOVIAZ is not the right "poster boy" for this axe-grinding goal, but I think it qualifies.
Pfizer had to convince FDA of that. Its a matter of public record. Now if you have evidence that it was approved in spite of only nominal differences, please present those. However, your chemical structure argument is bankrupt.
ReplyDeleteThe fact that the FDA approves a drug, does not mean it is MORE effective than other drugs in the category or MORE effective than the generic version of the drug, if one exists. If it's a NME and is at least as effective as other products, FDA is practically REQUIRED to approve it. It cannot disallow approval because there are other drugs on the market UNLESS the new drug has significant side effect issues not seen in existing drugs in its class.
ReplyDeleteI quick search for fesoterodine and tolterodine on PubMed pulled up the following article: Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial (http://www.ncbi.nlm.nih.gov/pubmed/20132103).
ReplyDeleteNot having read the article in full to check for any 'tricks', it would appear that Toviaz is slightly more effective than Detrol XL, but with perhaps slightly more side effects...
On this evidence (and there are only 23 articles that come up with these search terms), it would seem that the 'this is better than that' claim can be either true or false, depending on your point of view... ;-)
They need to demonstrate that it the new drug's risk/benefit profile is *at least as good* as existing therapies. It is very difficult to get approval on new drugs. Aspirin would be unlikely to receive approval.
ReplyDeleteManu,
ReplyDeleteThanks for that insight. We can all now claim vindication! ;-)
OK Gentlemen and anonymous, I can help settle this easily. Iam a 49 y/o woman with Multiple Sclerosis. MS causes major loss of bladder control. Believe me I know. I take Detrol XL without much success. I am about to embark on TOVIAZ. I'll let you know MY results. And to all the chemists out there, why can't someone concock a drug similar to codeine but without addictive qualities? Ever take a pain pill? You can go hours without urinating.
ReplyDeleteAlthough changing a single methyl group to a hydroxyl can mean the difference between a potent compound and one that is totally inactive, John's juxtaposition of the two chemical structures for "SAR"-like analysis is valid.
ReplyDeleteJohn asked some valid questions that all of the anonymous responders some to be avoiding. Even if Toviaz is "better" than Detrol in terms of safety or efficacy, are either of these two factors improved enough to justify the cost differential between the two drugs. Until a drug has been tested in a substantially large population, any statements about it being safer than existing drugs is mere speculation.
John, this is Dr. Anonymous. I'm not going to associate my name with such a website or else I’d probably get ran out of town by my patients and colleagues. That being said, you'll have to take my word that I am a practicing Urologist of 19 (20 in June) years. The H2H data is public knowledge so look it up yourself if you want to find it. Furthermore, of course Pfizer sponsored the study. I'm pretty sure the FDA is not going to dip into their cash reserves and give drug companies millions in funds to conduct H2H trials. Have you ever heard of such a thing? I haven’t.
ReplyDeleteFor such a smart guy that you tout to be, you of all people should know that the FDA has to rigorously review and monitor every phase of such a study. Drug companies don't have a lot of "wiggle room” to distort data even if that were their intentions.
John, in all seriousness, my patients with OAB respond differently to various meds. Toviaz has been great for me. And to answer your question concerning cost, I don't recall anywhere in my previous commentary that I blanketed all my patients as being on Toviaz. In my state, it is preferred on a few of the bigger healthcare plans. We use the co pay cards the drug reps leave us and it is often $10-15 more than a generic. I clearly explain the cost of this med will be more than a generic and I thoroughly explain the pros and cons of each. I put the decision making power in the hands of my patients. If cost is a serious issue, off to CVS or Walgreens you go for the $8 generic.
And for the record, once again, I do not get paid by Pfizer, Astellas, J&J, Novartis, or any of the manufacturers that produce bladder meds. You ask for the data? I have real world data everyday that comes into my office. I know what’s going on in Urology. You don’t.
I have an 86 year old mom with Alzheimer's disease. She used to take detrol la but when she started aricept, the detrol became less effective. I read an article that said detrol and aricept worked in opposite ways and could, in effect, cancel each other out. I discontinued the detrol but her urinary accidents are worse than ever. Now her doctor is prescribing Toviaz but it seems to have the same properties as detrol. Does anyone have any suggestions? Thanks.
ReplyDeleteIn a urology practice, how hard would it be to take a patient that has been on Detrol for a long time and then try the new drug toviaz and then keep a record of the improvement. The more a urologist or a group would do that they would get beyond anecdotal.
ReplyDeleteThe insurance companies and Medicare etc will be looking at that matter I am quite sure so why not get a head start?
What $8 generic? I'm paying huge bucks for Detrol and was told there is no generic. I buy my drugs from my drug insurance company.
ReplyDeleteAnon,
ReplyDeleteYou are correct. There is no generic Detrol at this time (2010). Detrol's basic patent is set to expire September 2012, and Detrol LA -- the long-acting version of Detrol -- has three patents set to expire between 2012 and 2020.
Toviaz is just another way to virtually extend the patent life of Detrol by tweaking the molecule into a new molecular entity. This allows Pfizer to continue to compete with generic Detrol when it becomes available after the patent expires in 2012.
Thank you John Mack for getting the correct information out there.
ReplyDeletethe change in formulation from Detrol LA to Toviaz meant that Pfizer could administer an 8mg dose instead of 4mgs, which was the limit with Detrol LA due to the associated adverse events. For that reason, efficacy of Toviaz is higher than Detrol LA - this is why in the H2H they compared 4mg Detrol with 8mg Toviaz.
ReplyDeleteIt isn't about it being a new drug as such, they have just found a way of dosing higher than they could with Detrol. In that sense, you could argue that the drug is justified, but I agree the difference in efficacy is only very slight when you consider placebo groups in OAB trials tend to have anywhere between 30-50% efficacy too based on the psychological impact of keeping diaries and monitoring urine output.
Thanks for the insight. If Toviaz was developed specifically to allow a higher dosage while limiting adverse events, then that would be a significant difference IF the efficacy was also significantly greater than placebo, which you imply is not the case.
ReplyDeleteI have been taking Detrol La for about a year. My insurance refuses to pay for it anymore so my Dr. changed me to Vesicare. The Vesicare within four days of taking it made me have chest pain and I thought I was having a heart attack. I stopped the Vesicare and the Dr. prescribed Toviaz. I am scared to death to take the Toviaz because of what the Vesicare did to me. Can anyone tell me since I was able to take the Detrol LA with no side effects if the Toviaz will do the same as the Detrol. I really need this medication but don't want to be scared to death thinking I am having a heart attack. I am only in my 40's and have been having this issue since I had my children. Really need help deciding to take the Toviaz or not.Thanks for any help
ReplyDeleteDear Anon: Except for this piece of advice, don't trust the advice you may get online! Talk to your doctor.
ReplyDeleteThe problem about asking my Dr. is he said the Vesicare was the same exact thing as Detrol LA because I was worried about taking it. I don't like to take medications. He failed to tell me that some of the side effects were chest pain with Vesicare. So I don't really trust what his opinions are on these meds due to that. Was hoping to get others opinions on if I should take the Toviaz since I was able to take the Detrol LA. Thanks for any input.
ReplyDeleteI have used both drugs and they reacted very differently. I too am one of those women who has taken Toviaz for two weeks. Who ever invented tweeked it or whatever thank you, thank you, thank you!!!!
ReplyDeleteI think that the so called head to head was not really a H to H because I dont recall reading about a control. From what I can tell in my practice its the same drug as DLA just to get any real benefits you have to push it to the 8 mg and with that you get more side effects. I have better results with Vesicare. i always start with the 5 mg. My biggest issue is the insurance companies forcing me to use oxybutinin.
ReplyDeleteMy my. In my line of work this is called a pissing contest (pun intended).
ReplyDeletehello folks, just thought I'd weigh in on this subject, first, I was curious to see if I could find out what the ingredients were that make Toviaz so dang expensive, and googled for it, came up with this website. Next, I am a 56 year old female , with multiple sclerosis, and I took Detrol LA for a year, had constant dry mouth, and limited success. I have been on Toviaz for a year and a half, started with the 4 mg as samples, there was marked improvement, so we tried the 8 mg, and that was a bit high dosage, now,for the last 9 months, back to the 4mg, this medication has changed my life, there are virtually no loss of control episodes. and there are NO side effects or discomfort with the 4mg dosage, while the 8 mg did have some dry mouth, and retention issues. So, as a patient, and as a PERSON, the product is definitely a huge benefit. I am still trying to figure out what ingredients make this product worth almost $700.00 for 30 tablets, but, that is another issue, big pharma, does know how to tilt the tables and squeeze the insurance companies, and my wallet... but this product is in a class of its own as far as efficacy. thanks for reading.
ReplyDelete