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Dirty medicine - Ranbaxy fraud

edited May 2013 in Off-Topic
I am sorry but this is way off topic. But I thought there is common good in posting it here for public service. It is a long article but well worth reading...

http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

Please take your 15 minutes to read this article. It is exposing the extend of fraud in operations of Indian Generic Drug Manufacturer Ranbaxy.

Unbelievable but sadly true! They have done it all. Fabricated data or simply did not provide any data in less stringent regulatory environments, destroyed data that did not confirm. Ignored consumer complaints and did not forward to FDA. Lied in every possible way!

They produced drugs under unacceptable conditions. Submitted original drug for testing instead of their own supposedly equivalent. Broken import/export laws.

Despite all that this company was recently given approval to produce generic lipitor by FDA.

Inspectors and executives says they would not use any Ranbaxy manufactured drug. I never questions the source of generic drug. Now, I have to be selective. I am not sure if my pharmacy can tell me their source.

Comments

  • Thank you, Investor. At the very least, one should consider the OT area of MFO as a community service area for broadbased knowledge and information to be presented and discussed.
    Additionally, Ranbaxy is a public stock and likely within Pharma and related mutual fund holdings.
    Ranbaxy/Japan ownership info
  • edited May 2013
    Wow. And after all of that the FDA caved on the Lipitor. (I wonder if Ranbaxy is making mine?) "Plant specific" my ass... that entire company is suspect. We can only hope that the Japanese clean up the place, but after the pathetic performance with their atomic power supervision of TEPCO I have lost most of my respect for them also.
  • Unfortunately, none of this is particularly surprising (except to those who feel that the market would be better served with fewer regulations, just as Alan Greenspan was shocked by banks not acting to keep their own houses clean).

    What's particularly galling is seeing things like this get through the FDA, while they argue that you can't import drugs from Canada - they're not safe.

    To OJ - my experience with standard size prescriptions of generics is that the pharmacy takes the real bottle, slaps their own label on top, and says they are providing you a service. If you can pull off that label, you can read the real one underneath. Watson seems to use squareish (well, cubish) shaped bottles for atorvastatin. BTW, all Watson is doing is relabeling Lipitor manufactured by Pfizer (just as many store brands are just repackaged brand name products). So if you got Watson, you "hit the jackpot".

    There has been so many shady deals done with the marketing of "generic" Lipitor that I haven't been able to keep track. Ranbaxy had a 180 day exclusive, but cut a deal where they paid Teva (speculation was as a backup, in case they couldn't meet demand). Pfizer, as I mentioned, was providing Watson a "white label" version of Lipitor to market. Ranbaxy, in order to get FDA approval, arranged for its atorvastatin to be manufactured by Ohm Labs in NJ (which, depending on what you read, is either a privately held company or a partner of Ranbaxy, or a subsidiary of Ranbaxy). Pfizer cut deals with insurers to treat Lipitor (brand name) as a generic and not to pay for the "real" generics.

    IBD Dec 2011: Teva might serve as insurance for Ranbaxy if it didn't get FDA approval; Teva gets cut of profits (unknown reason); Ohm Labs privately held.

    Philly.com Dec 2011: Watson markets Pfizer-manufactured Lipitor as generic; Ohm Labs a Ranbaxy subsidiary; Teva could serve as capacity backup for Ranbaxy.

    FirstWord Reports Dec 2011: Teva deal might be to provide Lipitor ingredients, and Ohm only doing final assembly; Teva deal might be for distribution network.

    eMedTv: Pfizer cuts deals with insurers to treat Lipitor as generic, and not cover real generic atorvastatin.

    ThePharmaLetter Dec 2011:Ohm deal with Ranbaxy a "partnership"; Pfizer cuts deals with insurance companies and drugstores to charge less for Lipitor than for atorvastatin.
  • Hey there msf- thanks for the input. Unfortunately Safeway doesn't seem to do that "Relabel & Markup" routine. They must get a 50 gallon drum (probably previously holding toxic waste and then recycled via China after rinsing with polluted water) full of (maybe fake, who knows?) Lipitor and then reload them into their own containers. The pills themselves have "PD155" stamped into them, whatever that may mean.
  • edited May 2013
    Reply to @Old_Joe:

    I found that you can identify the pill manufacturer or distributor using those codes. Here is a search site I found:

    http://www.drugs.com/pill_identification.html

    I found that my Pravastatin is manufactured by Glenmark Generics. Ranbaxy is one of the generic manufacturers for Pravastatin (there was a mention in the article) but I am lucky that my pharmacy is not using them)

    Your PD155 identifies the manufacturer as Pfizer or Watson. Watson is "authorized generic" distributor for Lipitor. In other words, it seems that you are getting the real Lipitor as generic.
  • Reply to @Investor: Huge thanks to both you and msf. Nice going, fellas!
  • Reply to @Old_Joe:
    Yeah, I know about Safeway. Years ago, my insurer offered me a deal where they'd charge a lower co-pay if I'd get a 2x dosage pill and split it. They'd even pay for the pill splitter, but it had to be one of two models. Safeway carried one of the models - if they sold it as a prescribed item (which the insurer would pay for), it cost something like $10, but if they sold it retail (and taxable, not as a medical device), their price was around $3.
  • Reply to @msf: "you can't import drugs from Canada - they're not safe"

    So, we get our drugs through an Express Scripts plan and, for a long time, they were having trouble supplying my husband's atorvastatin so they dribbled it to him in smaller quantities. Recently it seemed to go back to normal. When I checked to discover who the current supplier was based on the pill code, it was Apotex Corp., a Canadian generic drug company. (I don't know if they make their own, admittedly.) This is the same drug plan the Congress critters use to get theirs. I must amuse myself by changing what you said to "you can't import drugs from Canada - they are reserved for your critters and their minions."

    On a serious note, it does make me wonder what the supply problem was all about.
  • Reply to @Anna:
    We also use Express Scripts (old Medco by Mail) and my last atorvastatin refill was supplied by...you guessed it...Ranbaxy. I think somethings gonna have to change here. A physician I used to go to up until 2 years ago always specified Lipitor, no generics. I wonder what he knew...
  • Reply to @hawkmountain: I'll have to remember to check the next time we get a supply but it sounds like Express Scripts may be an equal opportunity buyer. On the other hand, whatever their supply problem was, it also makes sense that Canada was just a temporary solution to the supply problem and their normal supplier is the cheapest bidder.
  • edited May 2013
    Reply to @Anna:

    I do not know if Canada has the same prescription drug codes. But I believe Apotex, a canadian company, is licensed to supply generics in the USA by FDA.
  • Reply to @Investor:
    Although Watson lives in Corona CA, their stuff shows up on the East Coast (PA) at Wal-Mart. It seems when Pfizer's patent for Lipitor expired they dumped the tractor-trailer load of excess on Watson and perhaps others. So, yes, pharmacist asserts my new prescription is the 'real thing'. When the supply is exhausted Watson will probably start making their own, an improvement over Ranbaxy in any case.
    BTW, the ID code on mine is PD156 - still Pfizer.
    Thanks all...you guys are the best!
  • Reply to @Anna:
    Sorry, I wasn't being clear. I was speaking about reimporation - the process of getting lower retail prices by purchasing internationally (specifically, from Canadian pharmacies). Sort of like grey market.

    There have been various attempts by Congress to pass laws (always failing) to permit this. That's somewhat of a cop out. Instead of regulating prices in the US, or at least allowing Medicare to negotiate prices, Congress cowers before PhRMA, and the best it can propose (let alone pass) is to delegate regulation to Canada.

    Of course foreign drug manufacturers can sell their wares directly to US customers so long as they've been approved by the FDA, like, say, Ranbaxy.

    FDA: Is it legal for me to personally import drugs: Answer - no, but they won't prosecute in most cases.

    WSJ: FDA questions reimporation of drugs: In 2009, when there was a big push to allow it.

    FiredogLake (???): Prescription Drug Reimportation Amendment Fails Again In Senate: 2012 attempt; gets only 43 votes; opposed by Menendez (NJ - home of many pharma companies along US 1)
  • Reply to @hawkmountain: Looks like PD155 is for 10mg, PD156 is for 20mg version
  • Since we are on the topic of fraud, China has old tainted baby formula with melamine in 2008. A number of Chinese baby died as a result. The heads of these companies were convicted and harsh sentence was handed down. Problem many companies sold their baby formula under their their brands.

    Now the fear is back again.
    bbc.co.uk/news/business-22088977
  • Reply to @Sven: Yes, once trust is broken it is hard to regain.
  • Reply to @Investor:
    BTW, Investor, it seemed to easy to get the generic mfg name, I found out this morning. Just ask. I hit Rite Aid, a grocery pharmacy, and Wal-Mart (where I found the Watson 'generic'). In 2 out of 3, they actually showed me the packaging. The other read from the computer screen. Nobody looked at me like I had 2 heads which made for a nice shopping experience:)
  • Reply to @hawkmountain:

    From Forbes:
    The authorized generic will be manufactured by Pfizer and supplied to Watson in all dosage strengths.

    Watson will market and distribute the product in the U.S., and Pfizer will receive a share of the net sales. The agreement runs through November 2016.
    I've read elsewhere that Pfizer gets a 70% cut, though I don't know if that was just for the first 180 days (when Ranbaxy was allowed to be the only independent generic manufacturer), or for the whole period of the deal.
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