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Prof Trevor Marshall
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Those of you who have tried to get Benicar approved through Merck, and its spinoff Medco, will know that it is almost impossible.

I have suspected for some time that the MP is on a 'hit list' with these companies, as a pattern emerged in their handling of inquiries from myself, and MP members.

Previously, I noted when a Federal judge stated that this was the most inethical company ever to be in his courtroom.

Well, now some emails have now surfaced which show that Merck specifically drew up 'hit-lists' of academics and doctors who they disagreed with. In the case of the MP, they contacted me (many years ago) to see if I would substitute the Merck drug 'Cozaar' instead of Benicar, and, when I explained why their drug was inferior, you all started having trouble getting insurance claims approved.

Here is the article:
http://www.theaustralian.news.com.au/story/0,25197,25272600-2702,00.html

So it is best to avoid any insurer who uses Medco to process their benefits, and enclose a copy of this news article with any appeal you might lodge with your insurer if you have been denied in the past, noting that Medco has apparently singled out the use of Benicar in the MP for 'special treatment' and, IMO, put Doctors through the wringer if they tried to advocate for their patients :)
 

TikBitten
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To all-

For whatever this is worth, I recently switched to Olmecip (generic Benicar here in the U.S. market, not sure of its trade name in other countries) and it seems, frankly, more effective/productive/potent than Benicar on the 6 hr cycle.  And the great thing, it costs (if purchased online @ planetdrugsdirect.com) 1/4th to 1/6th of typical monthly "Brand" Benicar prescriptions.  Also, if I'm not mistaken, it's the generic alternative to Benciar in many countries, including Canada, so there's probably little doubt as to its chemical equivalency....

Q1) But I am wondering have any other MP'ers had similar experiences? 

Q2) Also, for those involved or employed in the pharmaceutical industry, can we confirm as to whether Olmecip is "AB" or "BIO" compatible?  

I'm under the impression "AB" is considered the higher standard so the answer would be interesting, but clearly not definitive, as Olmesartan's immediate effects (rather then delayed effects) may be more desirable under MP dosing schedules...

Regards,
TB

 

Last edited on Tue Apr 28th, 2009 00:07 by TikBitten

Prof Trevor Marshall
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TB, while I was in Prague, I had the opportunity to meet somebody who had imported 5Kg of bulk Olmesartan Medoxomil from one of the Chinese manufacturers, and I have the Chinese quality control assay details in from of me.

The impurities they expect are primarily residual solvents. Acetone, Ethyl Acetate and DMF were not detectable, while Butanone (MEK) was at the 2088ppm level in this batch. Loss on drying was 0.27%, residual after ignition was 0.14%, and Chromatographic purity 99.4%

Impurities using HPLC were measured at 0.18% for any individual component, 0.60% max.

It would be interesting to find out what impurity causes the 'butter' smell in Sankyo's product, and at least we now have guidance from this assay. I haven't personally noted any similar smell in any of the batches of the Indian Olmecip tablets.

The big difference between the Olmecip and Benicar formulations is the coating which Sankyo put on their tablets to slow dissolution until it enters the GI tract. For people with really disturbed GI tracts, like mine has been from time to time, it does help not to have the Olmecip pill dissolve in the Trachea and 'get stuck' there. Conversely, the Olmecip does dissolve more quickly once it gets to the stomach.

For years I have broken my Benicar in halves before swallowing them, as I found this gives the best chance they will quickly get to the stomach and start doing their job...

So you raise some interesting questions, and these are topics which I have on the agenda for my next round of discussions at West China Hospital. I would dearly like to be able to get slow-release and injectable formulations made available there, so that their patients would not suffer from the problems we have been encountering in the West.

Sankyo did sue one of the Chinese Olmesartan manufacturers a few years ago, and the Chinese Court ruled that Olmesartan Medoxomil could be manufactured in China, but only if it was used for 'research' purposes. My understanding is that there are currently ten manufacturers of Olmesartan Medoxomil in China.

It is great to have this assay purity data, as the FDA file on Sankyo's purity is redacted almost in its entirety:
http://www.fda.gov/cder/foi/nda/2002/21-286_Benicar_chemr.pdf
 

Ruth Goold
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FWIW:  The Canadian olmesartan pills componded by Yetvart (I don't know where he imports the bulk olmesartan from) also have the (rancid!) butter smell, but it is much less potent than with the (newly-available in Canada) Sankyo formulation.  I have not noticed any difference in response to them, but I am not much use as a test case.  Have seldom needed or used extra for palliation,

Ruth

Prof Trevor Marshall
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This Aussie Vioxx trial is coming up with some real gems of information:

Merck Publishes Phony Peer-Review Journal
"many a primary care physician was given literature from Merck that said, "As published in Australasian Journal of Bone and Joint Medicine, Fosamax outperforms all other medications...." Said doctor, or even the average researcher wouldn't know that the journal is bogus. In fact, knowing that the journal is published by Elsevier gives it credibility! "

http://blog.bioethics.net/2009/05/merck-makes-phony-peerreview-journal/
 
 

danalyzer
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Hi ...I was reall interested in reading the article about the Merck/Medco hit list as I heve Medco as a PBM and have had considerable trouble. But the link comes up with an internal to the website as page not found .....maybe Medco got to them too.................

Santa Monica
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I hate, hate, hate Medco.  I hate talking to them on the phone, and I hate that I can never get what I need without a hassle.  I order from overseas and have told them so because they have never gotten an order right, for me or anyone in my family, and their computer calls my phone day and night.   :X

Joyful
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It's a fact. Some companies are not aware of how their policies and activities affect the consumer. At all.

danalyzer
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Does any one know if you can still access that article some where

Knochen
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The article is still up!
http://blog.bioethics.net/2009/05/merck-makes-phony-peerreview-journal/

I suggest you save a local copy of the web page "just in case" though.




danalyzer
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Thanks but I was looking for the one from the Australian news that is referenced at the top of this thread by Dr. Marshall

Santa Monica
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I wonder,  has anyone had any luck appealing to Sankyo directly?  It seems that if they knew their drug was on the verge of changing medical history forever, they would want to help subsidize the cost to the few who are in this study, and, I would imagine, be willing to sponsor a trial of the drug.

Frenchie
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Santa Monica wrote: I wonder,  has anyone had any luck appealing to Sankyo directly?  It seems that if they knew their drug was on the verge of changing medical history forever, they would want to help subsidize the cost to the few who are in this study, and, I would imagine, be willing to sponsor a trial of the drug.

If you meet certain criteria of poverty, Sankyo will give you 40mg per day, but no more.  For whatever reason, they are not investing in the MP.

Markt9452
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I wonder,  has anyone had any luck appealing to Sankyo directly?  It seems that if they knew their drug was on the verge of changing medical history forever, they would want to help subsidize the cost to the few who are in this study, and, I would imagine, be willing to sponsor a trial of the drug.
 

I called them a couple of times.  They didn't call back...

Cynthia S
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I seem to recall Dr. Marshall saying that the last thing Sankyo wants is for people to know that Benicar can cause immuno pathology and would prefer the MP would just go away.  Others have tried to get some help from Sankyo and have failed.  Remember that their patent runs out in a few years (7, 8 ?), and they have no reason to expect that the MP would ever be anything big soon, and in the mean time, they are making lots of money on it as a BP med, which a common knowledge of its potential to produce IP could end very abruptly.  Cynthia

Santa Monica
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Danalyzer,

How many Benicar are you getting from Medco?  I just got off the phone with them.  The woman "helping" me says it's against the law to prescribe more than one a day.  BS, I know.  So I am stuck with 90 tabs for 90 days; but I seem to recall last year they said they can't dispense more than 2 per day.  Grrr.   :X

Prof Trevor Marshall
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It is "against the law" for Medco to second-guess a physician's dosing instructions, not the other way around. The FDA-approved Prescribing Instructions clearly say "dosing must be individualized" along with the "doses above 40mg do not appear to have greater effect" (section 2.1).  Medco can adopt their own guidelines, regardless of what the FDA say, although Medco should have the guts to take the responsibility for doing that, and not try to blame the FDA for something which the FDA is not culpable...

http://Marshallprotocol.com/prescribing_information_2010.pdf

We brought up the safety issue with the FDA during a meeting in 2007, and FDA confirmed that there is no unsafe dosing level set by the FDA for Benicar, as no dosing-related adverse events have been reported.

But you will have trouble arguing with Medco. A Federal Judge once described Medco as the most inethical company to have ever appeared before him.
 

Santa Monica
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David and Goliath.  Makes me want to call my lawyer.  I might just do that.

danalyzer
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Hi Santa Monica,

Well, long story but prior to Jan 1st 2010 my plan paid for Benicar with no plan established daily dose limit. Regardless of this Medco would not dispense by mail order more than one a day.Went round and round on the Medco merry go round trying to find out why. Never did find out except for one pharmacist at Medco told me over the phone that they just didn't feel comfortable with it. I replied that I didn't feel comfortable dying a slow death from lung fibrosis. He offered to transfer me to a supervisor on that one. Anyway I was able to purchase 4 times a day at a local retail pharmacy with copay and Medco picking up the rest of the tab. Although after the 3rd refill the copay went up another 10 percent. Meanwhile the cap on mail order copay was $200.00 so I was paying an additional $100 a quarter for the Benicar. Well after Jan 1st 2010 my plan decided that I should be taking Cozaar or Diovan and would not pay for Benicar at all unless I trialed thier preferred plan drugs and had theraputic failure. Well I went round and round again and finally talked my DR into a trialing for affect. So we jumped the hoops and I experienced theraputic failure (wink wink) and just 2 ago I was again approved by my plan for Benicar. I have refilled my Benicar at Costco with a little flack for Medco but they did after a call from the pharmacist pay for 4 times a day. I have again mail in a script to Medco for the 90 day mail order supply. I don't know yet if it will fly. Although I did include with the script a letter from my DR endorsing the 4 times a day dosing......We will see if they go for it. I need to creat my signature line but I have about 40% of my lung capacity gone to fibrosis. I am almost done with phase 1 .At 100mg mino and will start phase 2 in about a month if things go as they have in the past.

Good luck to you,

Dan

danalyzer
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Well as usual Medco shot down my script for Benicar 4xday. A pharmacist at medcco said she would ask for another clinical evaluation when I directd her to this pubmed link.

http://www.ncbi.nlm.nih.gov/pubmed/11361048

Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects.

CS-866 (benicar) was safe and well tolerated at doses of up to 160 mg/day.

I can still get it at costco for $100 copay for 120 tabs ....a months supply.So it is Medco and not a my plan having a limitation on dosage.

I also obtained a 3 month supply of Olvance (olmesartan 40mg) for planetdrugs.com. It came via Germany from the Canadian pharmacy. Olvance is licenced to Ranbaxy by Sankyo so I'm sure it is good stuff.

Hope all goes well,Dan

Joyful
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Looks like you are working out alternatives instead of hitting a wall & giving up. Good for you! :cool:

If you type "olvance" in the search box (click on the link to "MP Search" in my signature line), there has been some recent discussion on the sites. :)

Grateful Survivor
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Hi Danalyzer,

Hats off to you for your resourcefulness in finding alternative sources for Benicar. It is ironic that some plans are making it so hard to obtain such a beneficial medicine, that is so safe--while TV commercials constantly hawk new drugs of questionable benefit with often dire side effects.

Best wishes, Dody



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