OB-GYN-L Messages for May, 2004: Re: UK Approves OTC Status For Statins

Re: UK Approves OTC Status For Statins

From: art fougner, md

evsono@pipeline.com

Fri May 14 06:54:26 2004

Statins and multiple sclerosis

"Oral simvastatin might inhibit inflammatory components of multiple sclerosis that lead to neurological disability"

Many drugs have been approved for relapsing-remitting multiple sclerosis, but are only partly effective, need regular injections, and are expensive. Timothy Vollmer and co-workers did a single-arm, open-label study to assess the effects of oral simvastatin in 30 patients with this form of multiple sclerosis. Brain MRI scans showed that the number and volume of gadolinium-enhancing lesions declined over 6 months by 44% and 41%, respectively, compared with pretreatment. The authors conclude that these results lend support to the case for randomised, controlled, clinical trials to establish the safety and efficacy of statins for multiple sclerosis. In a Commentary, Chris Polman and Joep Killestein discuss the therapeutic potential offered by statins, but warn that the current findings should be interpreted cautiously in view of the small number of patients and the study design.

art

At Thu, 13 May 2004, Terrence.Jones@kp.org wrote: >
>This is a multipart message in MIME format.
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>Content-Transfer-Encoding: quoted-printable
>
>Maybe a local population effect secondary to inherited (and/or acquired)
>diminished CYP 3A4? Try an alternate metabolic pathway
>(Fluvastatin/Pravastatin), or lower the dose of Lovastatin and add Zetia?
>Interesting presentation at SGI on statins and androgen production in PCO.
>(Of course, patients enrolling MUST be on effective contraception.) tj
>
>annam@uic.edu (Anna Meenan, MD)
>Sent by: ob-gyn-l@obgyn.net
>05/12/2004 07:28 PM
>Please respond to ob-gyn-l
>
> To: Multiple recipients of list OB-GYN-L <ob-gyn-l@dns.obgyn.n t>
> cc:
> Subject: Re: UK Approves OTC Status For Statins
>
>I don't think OTC sales would matter in our small town. Statins seem to
>have gotten themselves a bad rep around town. It seems like everyone we
>put on them develops myalgias. Everyone. Of course, it's mostly
>small-town gossip and the power of suggestion, but it's getting to be a
>big problem. I've got folks with cholesterol levels over 350 who are
>refusing to take any meds for it and look at me like I'm trying to kill
>them if I even suggest it. Oh well, that's life.
>
> Anna Meenan, MD
>
>At Wed, 12 May 2004, art fougner, md wrote:
>>
>>Britain to Approve
>>Cholesterol Drugs
>>For OTC Sale
>>
>>REUTERS NEWS SERVICE
>>May 11, 2004; Page D5
>>
>>LONDON -- Statin drugs, widely taken to cut cholesterol and reduce the
>>risk of heart attacks, are set to be approved for sale in Britain
>>without a doctor's prescription.
>>
>>The move would make Britain the first country in the world to sell
>>statins over the counter. Experts recommended last year that
>>pharmacists should be able to supply them without a prescription
>>following simple health checks carried out on the spot. An advisory
>>panel to the U.S. Food and Drug Administration may consider data in
>>support of allowing nonprescription sales of statins within the next
>>year.
>>
>>"There will be an announcement on Thursday," said a spokeswoman for
>>Britain's department of health, following weekend reports that Health
>>Secretary John Reid was about to give a green light to over-the-counter
>>sales of the drugs.
>>
>>Merck & Co.'s Zocor, generically called simvastatin, will be the first
>>cholesterol fighter to be sold over the counter, in doses of 10
>>milligrams. Zocor was once Merck's top-selling product, but it lost
>>patent protection in Britain last year, and the company, based in
>>Whitehouse Station, N.J., is eager to make up for lost sales by
>>switching into the nonprescription market.
>>
>>McNeil Europe, a unit of Johnson & Johnson that specializes in European
>>OTC drugs, is expected to launch Zocor Heart-Pro -- as the product will
>>be known -- at the end of June or early July. It will be priced between
>>Ł10 and Ł15 (about $18 to $27) per 28-day pack.
>>
>>The company said it was still waiting for the formal license but had
>>been preparing for the launch for several months. In the U.S., a joint
>>venture of Merck and Johnson & Johnson, based in New Brunswick, N.J., is
>>hoping to eventually sell its Mevacor statin without a prescription.
>>
>>The British government has said that it would like pharmaceutical
>>companies to apply for the right to sell statins without a prescription
>>-- a move that could reduce the state's drug bill.
>>
>>Currently some 1.5 million Britons receive statin therapy and the
>>National Health Service spends around Ł750 million on the drugs each
>>year.
>>
>>Statins are among the most widely prescribed of all medicines, with
>>Pfizer Inc.'s market leader Lipitor generating world-wide sales of $9.23
>>billion in 2003.
>>
>>http://online.wsj.com/article/0,,SB108423039777807478,00.html?mod=healt %5Fhome%5Fstories
>>
>>--
>>art fougner, md
>>ich bin ein New Yorker
>>
>--=_alternative 007DF65788256E93 Content-Type: text/html; charset="iso-8859-1"
>Content-Transfer-Encoding: quoted-printable
>
> Maybe a local population effect sec ndary to inherited (and/or acquired) diminished CYP 3A4? Try an alternate etabolic pathway (Fluvastatin/Pravastatin), or lower the dose of Lovastati and add Zetia? Interesting presentation at SGI on statins and androgen pr duction in PCO. (Of course, patients enrolling MUST be on effective contra eption.) tj
> 
><table width0%>
><tr valign=top>
><td>
><td>annam@uic.edu (Anna Meenan, MD)
> Sent by: ob-gyn-l@obgyn.net
>05/12/2004 07:28 PM
> Please respond to ob-gyn-l
> 
><td> 
> To: &nb p; Multiple recipients of list OB-GYN-L <ob-gyn-l@d s.obgyn.net>
> cc: &nb p; 
> Subject Re: UK Approves OTC Status For Statins< table>
> 
> I don't think OTC sales would matt r in our small town. Statins seem to 
>have gotten themselves a bad rep around town. It seems like everyone we 
>put on them develops myalgias. Everyone. Of course, it's mostl 
>small-town gossip and the power of suggestion, but it's getting to be a 
>big problem. I've got folks with cholesterol levels over 350 who are br>
>refusing to take any meds for it and look at me like I'm trying to kill 
>them if I even suggest it. Oh well, that's life. 
> 
> Ann Meenan, MD 
> 
>At Wed, 12 May 2004, art fougner, md wrote: 
>> 
>>Britain to Approve 
>>Cholesterol Drugs 
>>For OTC Sale 
>> 
>>REUTERS NEWS SERVICE 
>>May 11, 2004; Page D5 
>> 
>>LONDON -- Statin drugs, widely taken to cut cholesterol and reduce the br>
>>risk of heart attacks, are set to be approved for sale in Britain 
>>without a doctor's prescription. 
>> 
>>The move would make Britain the first country in the world to sell 
>>statins over the counter. Experts recommended last year that 
>>pharmacists should be able to supply them without a prescription 
>>following simple health checks carried out on the spot. An advis ry 
>>panel to the U.S. Food and Drug Administration may consider data in 
>>support of allowing nonprescription sales of statins within the next 
>>year. 
>> 
>>"There will be an announcement on Thursday," said a spokeswo an for 
>>Britain's department of health, following weekend reports that Health< r>
>>Secretary John Reid was about to give a green light to over-the-counte 
>>sales of the drugs. 
>> 
>>Merck & Co.'s Zocor, generically called simvastatin, will be the f rst 
>>cholesterol fighter to be sold over the counter, in doses of 10 
>>milligrams. Zocor was once Merck's top-selling product, but it l st 
>>patent protection in Britain last year, and the company, based in 
>>Whitehouse Station, N.J., is eager to make up for lost sales by 
>>switching into the nonprescription market. 
>> 
>>McNeil Europe, a unit of Johnson & Johnson that specializes in Eur pean 
>>OTC drugs, is expected to launch Zocor Heart-Pro -- as the product wil 
>>be known -- at the end of June or early July. It will be priced etween 
>>Ł10 and Ł15 (about $18 to $27) per 28-day pack. 
>> 
>>The company said it was still waiting for the formal license but had 
>>been preparing for the launch for several months. In the U.S., a joint 
>>venture of Merck and Johnson & Johnson, based in New Brunswick, N. ., is 
>>hoping to eventually sell its Mevacor statin without a prescription. 
>> 
>>The British government has said that it would like pharmaceutical 
>>companies to apply for the right to sell statins without a prescriptio 
>>-- a move that could reduce the state's drug bill. 
>> 
>>Currently some 1.5 million Britons receive statin therapy and the 
>>National Health Service spends around Ł750 million on the drugs each br>
>>year. 
>> 
>>Statins are among the most widely prescribed of all medicines, with 
>>Pfizer Inc.'s market leader Lipitor generating world-wide sales of $9. 3 
>>billion in 2003. 
>> 
>>http://online.wsj.com/article/0,,SB108423039777807478,00.html?mod=he lth%5Fhome%5Fstories 
>> 
>>-- 
>>art fougner, md 
>>ich bin ein New Yorker 
>> 
> 
>
> 

-- art fougner, md ich bin ein New Yorker

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