not hardly…

Posted on Thursday 25 December 2014

Ben Goldacre tweeted a document, a letter to UK doctors from Pfizer. I don’t know the specifics of the UK regulatory agencies and how they differ from the FDA. I don’t know what a CCG is. But I don’t think we need to  know those things to get what Pfizer is trying to get said in their letter – their unimaginable letter. He posted a jpeg that was too small to read, so I transcribed it for all to experience first hand.

ben goldacre @bengoldacre
This @pfizer threat at UK doctors is especially amusing given they were done for off-patent promotion of pregabalin.
ben goldacre ‏@bengoldacre
This threatening letter to UK drs from @pfizer is farcical copyright fearmongering. Always use scientific drug names.

Pfizer             Worldwide Biopharmaceutical Businesses


[CCG Address]

Dear [NAME]

Re: Lyrica® (pregabalin) pain patient

I am writing to ensure thay  you are informed about the relatively unususl issues surrounding the loss of exclusivity situation for the Pfizer product Lyrica® (pregabalin) so you can take necessary action to prevent patent infringement by your organization.

An appendix is attached describing the factual aspects of the situation in detail to ensure that you have the full information available. You will see that, whilst tyhe basic patent for pregabalin has expired and regulatory data for pregabalin has expired in July 2014, Pfizer has a second medical use patent protecting pregabalin’s use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin’s other indications for generalized anxiety disorder (GAD) or epilepsy.

As a result of the pain patent, we expect that generic manufacturers will only seek authorization of their pregabalin products for use in epilepsy and generalized anxiety disorder and not for pain, whilst Pfizer’s pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected tro carry so-called "skinny labels" and will not be licensed for use in pain.

In the circumstances dwscribed above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer’s patent rights.This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is inccumbant on those involved to ensure that slinny labeled generic products are not dispensed and used for pain.

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indications. Without information, guidance, and practical solutions from the authorities. Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government’s established policy of rewarding additional research by granting a second medical use patent.

We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing ans dispensing in your area. We believe these powers must be exercised responsibly and with a view to avoiding the infringement  of Pfizer’s pain patent.

In view of the above, Pfizer requests that you use appropriate guidance to prescribing clinicians withing your CCG to help ensure that our pain patent is respected and that all prescribing clinicians are aware of the pain patent situation. There are a number of ways in which this might be achieved, but the simplest solution, we believe, is for clinicians to be advised to prescribe Lyrica® by brand when prescribing pregabalin to treat neuropathic pain. Pharmacists will then be able to dispense Lyrica® against such prescriptions and this will ensure that they do not infringe the pain patent. In addition this will mean that patients with pain will be provided with a PIL that describes the use of pregabalin in pain.

Your CCG may also consider reviewing patient records retrospectively (in advance of the availability of generic drugs) and use prescribing decisions support mechanisms such as Scriptwatch to support appropriate ongoing prescribing. We are willing to discuss, or assist CCG’s with, the development of other solutions.

We should also note that, in our view,(i) CCG guidance instructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act); and (ii) your CCG is under an obligation to address the risk of wide scale infringement of Pfizer’s patent rights. Pfizer therefore formally reserves all of its legal rights in this regard.

If you have any questions in relation to the above please contact Pfizer LTD on 01304 616161.

Yours Sincerely,

Ruth Coles
Legal Director


ben goldacre @bengoldacre
So @Pfizer UK press office are being very coy about whether this threatening letter to GPs is genuine. Embarrassed?
    hu·bris ‘hyu br?s
    Overbearing pride or presumption; arrogance:

After being fined $2.3B for off-brand promotion with their non-product Neurontin®, Pfizer brought out Lyrica®, a molecular clone, ran it for its patent life, and now want to extend the exclusivity for a secondary patent for the same use they got fined for in the first place. And the way they propose to do that is threaten GPs and Pharmacists.

I’ve never prescribed Lyrica®, and only refilled Neurontin®. The thing I’ve noticed is that patients are reticent to stop Neurontin®, and I suspect it is because it has a mild Benzo-like antianxiety effect. The problem with this system is contained in this letter. "This runs contrary to the government’s established policy of rewarding additional research by granting a second medical use patent". That’s built on the notion that pharmaceutical companies should be rewarded in return for developing new drugs for the betterment of our patient’s lives. They’ve turned that into a mechanism to make gajillions off of medications that have a minimal effect [if that] and then sell that effect to the public that clamors for the drug so they can be like the pretty lady on the television dancing her way through an exotic vacation.

Do we really want to reward companies for developing life-style drugs?  What is the point of trying to rein in escalating healthcare costs if what we’re doing is making it easier to go to the doctor and get the made for t.v. "ask your doctor if Lyrica® is right for you" drug with a prescription plan? And when they come up with something that may be a life-saver for some, like the new Hepatitis-C drugs, do we really want to let them use their patent exclusivity to sell the 90 day treatment at $1000/day? And with this silly ploy, do we really want to let Pfizer intimidate doctors and pharmacists by using patent laws to insist on their writing Brand prescriptions? or the NHS? or anybody? Not hardly…
    Steve Lucas
    December 25, 2014 | 9:36 AM

    In making the holiday rounds my wife’s sister is in a bind as she has to take a licensing exam to maintain her counseling license. She was a not-traditional student starting school about four years ago and building on an undergraduate degree in art to receive an art therapy degree.

    The problem is her exam is only one topic, the DSM. This is how this and drug letters such as this become institutionalized, and drug companies and leadership maintain their control of the market and medical care.

    Her other big complaint is bureaucracy. A bureaucrats only function is to process, not finish. The combination of these two realities will be this letter will receive some weight in some circles.

    As this link we see what happens when doctors go by the book:

    Steve Lucas

    December 25, 2014 | 9:51 AM

    Speaking of lifestyle drugs:

    James O'Brien, M.D.
    December 25, 2014 | 2:02 PM

    Well, duh, anyone who has ever had nitrous at a dentist’s office could have told you that. Or any college student who ever did whippets. Wasn’t the result kind of obvious?

    So what’s application for psychiatry? Constant stream of nitrous oxide through nasal cannula and tank?

    December 25, 2014 | 9:01 PM

    Sandra, James…

    I’ve been thinking about Medical Models lately. There are 3 mainstream models

    • the claasic model [signs and symptoms are external manifestations of an internal disease]
    • the preventive model(s)
    • the symptomatic model (treat the symptom itself ie morphine for a kidney stone]

    Most of the psychiatric medications are the latter [symptomatic medications]. And that’s just that. So clinical trials are based on symptom questionnaires. Now that the “pipeline has run dry of atypicals, SSRIs, SNRIs, etc, they are getting into drugs that change how you feel. So now we have Ketamine, Nitrous, David Nutt’s tv experiment with Ecstasy etc.

    That has always been true of most psychiatric medications [symptomatic]. These experiments with “street drugs” are something we should have expected [but it’s kind of embarrassing]. It seems like a desperate trek down the wrong road, leading us to nowhere good…

    December 25, 2014 | 9:35 PM

    I just wrote a blog that runs along the same lines. It should be posted soon. This is why I like Joanna Moncreiff’s distinction between a drug centered vs disease centered model.

    James O'Brien, M.D.
    December 26, 2014 | 11:51 AM

    The MDMA research is interesting to me. Most of the problem with it as a club drug is street drug toxicity. In reviewing the literature on it that goes back many decades the drug might have some potential. I have an old book called Ecstasy the MDMA Story by Eisner that is probably out of print but it is a good read. It was actually used a psychotherapy facilitator before its eighties FDA ban. I think Medical Univ of So Carolina has done some decent work on veterans with MDMA assisted psychotherapy for PTSD. Since drugs don’t work that well for PTSD anyway, I don’t have a big problem with this frankly. Psychotherapy under the influence of an empathogen makes more sense than Paxil.

    The idea of MDMA use in this context clearly makes a lot more sense than intranasal nitrous oxide of bimonthy ketamine treatments. However, given that it’s next to impossible to hospitalize anyone today for severe depression, an ER ketamine treatment for resistant depression might be the best alternative in a screwed up system. It pains me to say that but this is the system we have and patients don’t want to wait 4-6 weeks.

    I’m not as bothered by well done psychedelic research because it is a sort of logical starting point. The origins of common drugs are often sketchy…look at how lithium was discovered in Australia.

    December 26, 2014 | 4:00 PM
    James O'Brien, M.D.
    December 26, 2014 | 6:38 PM

    Which is why I kind of like MDMA-AT in concept. It’s not correcting a theoretical chemical imbalance or disease state, it’s for permitting verbal therapy to work with less psychological resistance. You don’t stay on it once therapy is complete. The danger of course, is that they will want to…someone will screw this up even if it works…but that’s always the case…

    December 26, 2014 | 7:59 PM

    When you’re feeling low, get high.

    December 26, 2014 | 8:27 PM

    The V.A. gave me Gapapentin for nerve pain. It made the pain much, much worse. It works very well for about a third of the people who take it for neuropathic pain— a godsend for them, no doubt— so they should probably pay more for it, since most people are going to stop taking it and the stockholders are much, much more important than the people being prescribed these drugs (just trying to think from a profit motive).

    December 27, 2014 | 7:45 AM

    Interesting article on webmd regarding which supplements might work best for pain according to the evidence:

    And not to belabor the point on sleep apnea, but this article might be of interest to folks regarding SA and depression.

    Dr. O’Brien, Barry Krakow, a sleep medicine doctor, has done research claiming that because many people with PTSD end up developing sleep breathing disorders as the result of light sleep, that pap therapy has been very helpful. Have no idea whether he is right or not but it sounded pretty interesting to me.

    By the way, I tried to find a direct link to his research but was unsuccessful. But I am sure you can find it if you are interested.

    James O'Brien, M.D.
    December 27, 2014 | 10:57 AM

    Alpha 2 delta ligands such as Lyrica and Neurontin are modestly effective especially for neuropathic pain and some other conditions. I think their benefit in psychiatric disorders has been overstated.

    I wouldn’t get too down on them though. I’d much rather have pain patients taking those and some Elavil than loading up on Vicodin, Soma and Xanax. Because that’s what will happen if these more benign analgesics are restricted.

    I think the sleep medicine docs are like the blind man and the elephant on the issue of PTSD. They are seeing the part of the elephant that relates to the equipment they have in the back office. The problem with CPAP is compliance, but that is improving with some new designs. I’m not seeing the logic if there is no OSA. OSA and sleep medicine have become a bit of a cottage industry in their own right, so be careful. Prazosin off label is probably the best drug for PTSD right now. SSRIs don’t really touch it and benzos are a temporary measure at best.

    James O'Brien, M.D.
    December 27, 2014 | 11:01 AM

    BTW I would put the sleep apnea and depression study in the “duh of course” category of research along with the nitrous oxide research. Obviously not getting enough sleep is going to worsen your mood. Obviously taking a drug that makes you laugh is going to lessen depression.

    Research should be answering questions that are not yet answered.

    December 28, 2014 | 10:05 AM

    Dr. O’Brien, I definitely agree with you on the duh reaction regarding sleep apnea and depression. Still, I wanted to mention it for your uninformed colleagues. 🙂

    I know this is off topic but as I previously mentioned in a post, the reason compliance is so low is that followup regarding patients and problems they are having is horrible. Another reason is there is alot of ignorance among sleep professionals regarding advice such as erroneously stating that nasal pillow masks don’t work at high pressures. As a result, someone struggling with a full face mask will never know that perhaps another mask might work and will quit pap therapy.

    If it hadn’t been for, I would have quit pap therapy months ago as everything I learned was through that site. Learned absolutely nothing from the sleep doctors I have seen and interestingly, many of them are threatened by knowledgeable patients.

    I know doctors are understandably leery of patient support sites but this is one I highly recommend even though it has its downsides due to not being moderated.

    Well, Dr. Krakow is claiming that light sleep from PTDS leads to sleep breathing events so perhaps there may be a relationship. I will have to go back and look at his research.

    I thought there was data that some type of therapy was more effective than meds for PTSD. Anyone know what I am talking about?

    December 28, 2014 | 3:04 PM

    C C G is “clinical commissioning guidelines” (basically, best practice given to Primary Care for what should be prescribed for what indications as determined by local health authorities; often a source of encouragement to use generics rather than branded stuff, where a choice is available)

    January 2, 2015 | 3:21 PM

    Patients may be reluctant to discontinue gabapentin or pregabalin because either can have grueling withdrawal symptoms. Both need to be carefully tapered at the rate of individual tolerance, with monitoring for withdrawal symptoms.

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