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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 16 of 16. This is the beginning of the thread.
Posted by ed_uk on January 25, 2007, at 14:23:39
Wyeth Pharmaceuticals has announced that they have received an approvable letter from the U.S. Food and Drug Administration (US FDA) for desvenlafaxine succinate (Pristiq) for the treatment of adults with major depressive disorder (MDD).
However, the final approval will be based on the following conditions being fulfilled:
• A satisfactory FDA inspection of the Company's Puerto Rico facility, which is where Pristiq will be manufactured
• Several post-marketing commitments, including submission of long-term relapse prevention, low dose and paediatric studies
• Additional clarity around the Company's product education plan for physicians and patients
.................................................................................................................
Desvenlafaxine (Pristiq) is the active metabolite of venlafaxine (Effexor). I have not read anything which indicates that desvenlafaxine will offer any advantages over venlafaxine whatsoever. In short, Pristiq is a patent-extender. Its introduction will not be of benefit to patients. The directors at Wyeth will be the only people to benefit. It is very disappointing that major pharmaceutical companies are putting so much money into bringing out 'new' drugs which are completely lacking in innovation. Such drugs are not really new drugs at all.......offering no advantages over existing products, they certainly don't bring any hope to the treatment-resistant.
In the process of trying to find effective ways to market their 'new' drug, Wyeth is hoping that Pristiq will also be approved for the relief of menopausal vasomotor symptoms.
Wyeth claims......
'Women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology'
Ed
Posted by djmmm on January 25, 2007, at 15:53:16
In reply to Wyeth gets approvable letter from FDA for Pristiq, posted by ed_uk on January 25, 2007, at 14:23:39
> Wyeth Pharmaceuticals has announced that they have received an approvable letter from the U.S. Food and Drug Administration (US FDA) for desvenlafaxine succinate (Pristiq) for the treatment of adults with major depressive disorder (MDD).
>
> However, the final approval will be based on the following conditions being fulfilled:
>
> • A satisfactory FDA inspection of the Company's Puerto Rico facility, which is where Pristiq will be manufactured
>
> • Several post-marketing commitments, including submission of long-term relapse prevention, low dose and paediatric studies
>
> • Additional clarity around the Company's product education plan for physicians and patients
>
> .................................................................................................................
>
> Desvenlafaxine (Pristiq) is the active metabolite of venlafaxine (Effexor). I have not read anything which indicates that desvenlafaxine will offer any advantages over venlafaxine whatsoever. In short, Pristiq is a patent-extender. Its introduction will not be of benefit to patients. The directors at Wyeth will be the only people to benefit. It is very disappointing that major pharmaceutical companies are putting so much money into bringing out 'new' drugs which are completely lacking in innovation. Such drugs are not really new drugs at all.......offering no advantages over existing products, they certainly don't bring any hope to the treatment-resistant.
>
> In the process of trying to find effective ways to market their 'new' drug, Wyeth is hoping that Pristiq will also be approved for the relief of menopausal vasomotor symptoms.
>
> Wyeth claims......
>
> 'Women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology'
>
> Ed
>
Pristiq comes just as Effexor loses patent exclusivity in 2008. Sooner or later these companies will have to invest in new medication research. Flooding the market with selective isomers and various metabolites of current drugs is NOT the answer.
Posted by valene on January 25, 2007, at 16:13:16
In reply to Wyeth gets approvable letter from FDA for Pristiq, posted by ed_uk on January 25, 2007, at 14:23:39
How low-down sneaky and conniving can they get? This is sickening. And it's done time and time again, such as Xanax XR, many others. Sorry for the rant but I am so angry at big pharma and the politicians that are in each other's pockets!!!! I hate them all! Someone should print your message Ed on the front page of every newspaper in the country! GRRRR.....
> Wyeth Pharmaceuticals has announced that they have received an approvable letter from the U.S. Food and Drug Administration (US FDA) for desvenlafaxine succinate (Pristiq) for the treatment of adults with major depressive disorder (MDD).
>
> However, the final approval will be based on the following conditions being fulfilled:
>
> • A satisfactory FDA inspection of the Company's Puerto Rico facility, which is where Pristiq will be manufactured
>
> • Several post-marketing commitments, including submission of long-term relapse prevention, low dose and paediatric studies
>
> • Additional clarity around the Company's product education plan for physicians and patients
>
> .................................................................................................................
>
> Desvenlafaxine (Pristiq) is the active metabolite of venlafaxine (Effexor). I have not read anything which indicates that desvenlafaxine will offer any advantages over venlafaxine whatsoever. In short, Pristiq is a patent-extender. Its introduction will not be of benefit to patients. The directors at Wyeth will be the only people to benefit. It is very disappointing that major pharmaceutical companies are putting so much money into bringing out 'new' drugs which are completely lacking in innovation. Such drugs are not really new drugs at all.......offering no advantages over existing products, they certainly don't bring any hope to the treatment-resistant.
>
> In the process of trying to find effective ways to market their 'new' drug, Wyeth is hoping that Pristiq will also be approved for the relief of menopausal vasomotor symptoms.
>
> Wyeth claims......
>
> 'Women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology'
>
> Ed
>
Posted by ed_uk on January 25, 2007, at 16:28:24
In reply to Re: Wyeth gets approvable letter from FDA for Pristiq, posted by djmmm on January 25, 2007, at 15:53:16
>Pristiq comes just as Effexor loses patent exclusivity in 2008.
Exactly. Pristiq will no doubt be very expensive. Gullable doctors will be quick to prescribe it when their offices are flooded with samples. Patients will ultimately pay the price of being on an *expensive* 'new' med.
Ed
Posted by Phillipa on January 25, 2007, at 16:42:28
In reply to Re: Wyeth gets approvable letter from FDA for Pristiq » djmmm, posted by ed_uk on January 25, 2007, at 16:28:24
Ed so how will they explain the liver problems and withdrawal problems of effexor. Heard this was coming out. What we need not that we know seroquel can cause depression is an antianxiety med that works and is not addictive. Love PJ O
Posted by valene on January 25, 2007, at 16:45:58
In reply to Re: Wyeth gets approvable letter from FDA for Pristiq » djmmm, posted by ed_uk on January 25, 2007, at 16:28:24
> >Pristiq comes just as Effexor loses patent exclusivity in 2008.
>
> Exactly. Pristiq will no doubt be very expensive. Gullable doctors will be quick to prescribe it when their offices are flooded with samples. Patients will ultimately pay the price of being on an *expensive* 'new' med.
>Exactly, but are doctors that stupid? They get kick-backs from the pharm companies all the time for pushing their expensive drugs. I think most of them know exactly what they are doing! They get vacations, trips, all kinds of perks. I am very skeptical.
Posted by Crazy Horse on January 25, 2007, at 19:55:45
In reply to Wyeth gets approvable letter from FDA for Pristiq, posted by ed_uk on January 25, 2007, at 14:23:39
> Wyeth Pharmaceuticals has announced that they have received an approvable letter from the U.S. Food and Drug Administration (US FDA) for desvenlafaxine succinate (Pristiq) for the treatment of adults with major depressive disorder (MDD).
>
> However, the final approval will be based on the following conditions being fulfilled:
>
> • A satisfactory FDA inspection of the Company's Puerto Rico facility, which is where Pristiq will be manufactured
>
> • Several post-marketing commitments, including submission of long-term relapse prevention, low dose and paediatric studies
>
> • Additional clarity around the Company's product education plan for physicians and patients
>
> .................................................................................................................
>
> Desvenlafaxine (Pristiq) is the active metabolite of venlafaxine (Effexor). I have not read anything which indicates that desvenlafaxine will offer any advantages over venlafaxine whatsoever. In short, Pristiq is a patent-extender. Its introduction will not be of benefit to patients. The directors at Wyeth will be the only people to benefit. It is very disappointing that major pharmaceutical companies are putting so much money into bringing out 'new' drugs which are completely lacking in innovation. Such drugs are not really new drugs at all.......offering no advantages over existing products, they certainly don't bring any hope to the treatment-resistant.
>
> In the process of trying to find effective ways to market their 'new' drug, Wyeth is hoping that Pristiq will also be approved for the relief of menopausal vasomotor symptoms.
>
> Wyeth claims......
>
> 'Women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology'
>
> Ed
>Thanks Ed..dissapointing but good to know.
-Monte
Posted by saturn on January 25, 2007, at 20:01:11
In reply to Wyeth gets approvable letter from FDA for Pristiq, posted by ed_uk on January 25, 2007, at 14:23:39
It's a shame all of the resources spent on R&D, clinical trials, FDA-approval, advertisement and promotion aren't better placed (at least from a patient perspective).
Posted by notfred on January 25, 2007, at 23:38:05
In reply to Re: Wyeth gets approvable letter from FDA for Pristiq » djmmm, posted by ed_uk on January 25, 2007, at 16:28:24
"Patients will ultimately pay the price of being on an *expensive* 'new' med."
Where does the NHS stand on cases such as this ?
HMO's enforce a strict formulary on patients,
I suspect this one may not be allowed by many HMO's.
Unless Wyeth finds a side effect that is significant enough to pull Effexor from the market, just in time for the patent to expire. Just like Seldane -> Allegra
Posted by Quintal on January 26, 2007, at 1:10:01
In reply to Re: Wyeth gets approvable letter from FDA for Pris, posted by notfred on January 25, 2007, at 23:38:05
>Where does the NHS stand on cases such as this ?
British doctors seem to have a healthy scepticism of this type of patent extender. They will prescribe some of the new single-isomer meds such as escitalopram (Cipralex here in the UK) but they are generally reserved as second-line treatments mainly for treatment resistant patients and for people having unacceptable side effects on the racemic mixtures. In other words they're available to people who might really benefit from them, but they're not foisted upon patients as superior products unless the doctors see superior results from them, and they rarely do.
Q
Posted by notfred on January 26, 2007, at 12:39:45
In reply to Re: Wyeth gets approvable letter from FDA for Pris » notfred, posted by Quintal on January 26, 2007, at 1:10:01
> >Where does the NHS stand on cases such as this ?
>
> British doctors seem to have a healthy scepticism of this type of patent extender. They will prescribe some of the new single-isomer meds such as escitalopram (Cipralex here in the UK) but they are generally reserved as second-line treatments mainly for treatment resistant patients and for people having unacceptable side effects on the racemic mixtures. In other words they're available to people who might really benefit from them, but they're not foisted upon patients as superior products unless the doctors see superior results from them, and they rarely do.
>
> Q
It is my understanding from this list that getting good psyco med treatment is difficult in the UK.
Scepticism is good, but if you across the board will not use benzos and limit yourself to SSRI's, this is something else than scepticism.
Posted by ed_uk on January 26, 2007, at 13:42:05
In reply to Re: Wyeth gets approvable letter from FDA for Pris, posted by notfred on January 25, 2007, at 23:38:05
Hi
>Where does the NHS stand on cases such as this?
Prescribing of such drugs is strongly discouraged in the UK. Although doctors *can* legally prescribe expensive new 'patent extenders' at NHS expense, they are generally expected to follow local or national guidelines RE which drugs are acceptable to prescribe. As an example, GPs in the UK are not expected to prescribe Cymbalta unless it has been initiated by a Consultant Psychiatrist.
Pharm reps in the UK do not give 'samples' to doctors, this is not considered to be acceptable practice. Advertising of new meds is always counteracted by critical reports by NHS organisations unless the new product has clear and important advantages over less expensive treatments.
Doctors in the UK are expected to prescribe most drugs by the generic name. Prescribing expensive brand names such as Prozac is frowned upon because it wastes a great deal of the tax-payers money when generic equivalents are available.
Ed
Posted by ed_uk on January 26, 2007, at 13:43:23
In reply to Re: Wyeth gets approvable letter from FDA for Pris, posted by valene on January 25, 2007, at 16:45:58
Hi V
>Exactly, but are doctors that stupid?
I do think some doctors are very susceptible to advertising!
Ed
Posted by Quintal on January 26, 2007, at 15:59:48
In reply to Re: Wyeth gets approvable letter from FDA for Pris, posted by notfred on January 26, 2007, at 12:39:45
>It is my understanding from this list that getting good psyco med treatment is difficult in the UK.
>Scepticism is good, but if you across the board will not use benzos and limit yourself to SSRI's, this is something else than scepticism.I'm not sure where you're coming from notfred. Psych care in the UK, like everywhere else, depends greatly on the compassion and wisdom of the individual pdoc treating you. They can be excellent, but if not the downside of the NHS is that we have little choice but to stick with the incompetent or lazy pdoc or pay for private treatment. I've never heard of anyone paying for private psychiatric treatment in the UK.
British GPs use benzos a lot. There are many legal benzo addicts in the UK but they are mostly middle aged or elderly women on maintenance prescriptions for benzos they've been taking since the 60's and 70's. Doctors here are reluctant to use benzos indiscriminately in young people, and with good reason. That said, I was prescribed benzos (including clonazepam which has no licence for anxiety in the UK) for four years on the NHS starting when I was 19.
Q
Posted by xbunny on January 27, 2007, at 19:32:26
In reply to Re: Wyeth gets approvable letter from FDA for Pris » notfred, posted by Quintal on January 26, 2007, at 15:59:48
> >It is my understanding from this list that getting good psyco med treatment is difficult in the UK.
> >Scepticism is good, but if you across the board will not use benzos and limit yourself to SSRI's, this is something else than scepticism.
>
> I'm not sure where you're coming from notfred. Psych care in the UK, like everywhere else, depends greatly on the compassion and wisdom of the individual pdoc treating you. They can be excellent, but if not the downside of the NHS is that we have little choice but to stick with the incompetent or lazy pdoc or pay for private treatment. I've never heard of anyone paying for private psychiatric treatment in the UK.Are the Priory Hospitals not private psychiatric treatment? Im sure some of thier patients are NHS funded but I doubt that many.
I saw a private psychiatrist once, he seemed professional (certainly he seemed to have rather different ideas for my treatment than the NHS consultants I had been seeing) but far too expensive to be used for ongoing treatment.>
> British GPs use benzos a lot. There are many legal benzo addicts in the UK but they are mostly middle aged or elderly women on maintenance prescriptions for benzos they've been taking since the 60's and 70's. Doctors here are reluctant to use benzos indiscriminately in young people, and with good reason. That said, I was prescribed benzos (including clonazepam which has no licence for anxiety in the UK) for four years on the NHS starting when I was 19.I have been prescribed benzos too by my GP and by in and out patient psychiatrists, it has never seemed like they were somehow off limits.
Bunny
Posted by jealibeanz on January 29, 2007, at 17:03:39
In reply to Re: Wyeth gets approvable letter from FDA for Pristiq, posted by djmmm on January 25, 2007, at 15:53:16
Just another "me too" drug. They do have there place, since every drug have different side effect profiles and efficacies with each person, but it's just annoying to have such limited choices.
This is the end of the thread.
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