US health officials issue ALERT of severe pain re ACTONEL and FOSOMAX

US health officials issue ALERT of severe pain re ACTONEL and FOSOMAX

Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 5:45 pm #1

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<FONT size=3>http://www.guardian.co.uk/feedarticle?id=7204977</FONT>
"US warns of severe pain with osteoporosis drugs</DIV>
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<LI class=publication>Reuters
<LI class=date>Monday January 7 2008 </LI>[/list]
<DIV>WASHINGTON, Jan 7 (Reuters) - U.S. health officials issued an alert on Monday to highlight the possibility of severe bone, joint and muscle pain in patients who take certain osteoporosis medicines.</DIV>
<DIV>The prescription drugs are members of the class called bisphosphonates. They include Fosamax from Merck & Co Inc and Actonel, sold by Procter & Gamble and Sanofi-Aventis. (Reporting by Lisa Richwine, editing by John Wallace) "</DIV></DIV>
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 5:53 pm #2

<DIV class=story id=post-2326>
<H3 class=entry>
<P class="postmetadata alt">http://www.newsinferno.com/archives/2326
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"Actonel, Fosamax, other Osteoporosis Drugs Draw FDA Pain Warning</DIV>
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Actonel, Fosamax and other anti-osteoporosis drugs known as bisphosphonates have been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain, the Food & Drug Administration (FDA) warned today.&nbsp; Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the FDA said that the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and impairment, and necessitating the use of analgesics.

Bisphosphonate, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa,&nbsp; are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

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According to today’s FDA warning, the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate.&nbsp; Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.&nbsp; The FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

Bisphosphonates have been linked to a variety of other safety problems.&nbsp; In October, the FDA announced that it was reviewing the drugs after studies showed patients taking bisphosphonates ran a higher risk of irregular heartbeat.&nbsp; Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Fosamax has also been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

<P class="postmetadata alt"><SMALL>This entry was posted on Monday, January 7th, 2008 at 9:45 am and is filed under <A title="View all posts in Legal News" href="http://www.newsinferno.com/archives/category/legal-news/" rel="category tag">Legal News</A>, <A title="View all posts in Pharmaceuticals" href="http://www.newsinferno.com/archives/category/pharmaceuticals/" rel="category tag">Pharmaceuticals</A>. You can leave a response, or trackback from your own site. "</SMALL>

<P class="postmetadata alt"><SMALL></SMALL>&nbsp;

<P class="postmetadata alt"><SMALL><FONT size=3><STRONG>Re Actonel, and scientific misconduct during clinical trials see Dr Aubrey Blumsohn's account at:</STRONG></FONT></SMALL>

<P class="postmetadata alt"><SMALL><STRONG>http://scientific-misconduct.blogspot.com/search/label/Procter%20and%20Gamble</STRONG></SMALL>
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:00 pm #3


http://www.reuters.com/article/pressRel ... RN20080107

"...About Procter & Gamble (NYSE: PG)
&nbsp;&nbsp;&nbsp; Three billion times a day, P&G brands touch the lives of people around the
world.&nbsp; <STRONG><FONT size=4>P&G has one of the strongest portfolios of quality, leadership brands in consumer health and wellness, including Actonel(R), </FONT></STRONG>..."

&nbsp;

<H2 class=post-title><FONT color=#000066>Procter research shenanigans 7: Share your secret</FONT></H2>
<DIV class=post-body>
<DIV><FONT color=#000066><IMG height=241 hspace=10 src="http://www.thejabberwock.org/blog/secret3.jpg" width=179 align=left vspace=10 border=0></FONT>Procter & Gamble are proud winners of the 2006 "TRUSTe and Ponemon Institute" most trusted company for <STRONG><FONT color=#000066>Privacy Award</FONT></STRONG>.

So secret that prior to March 2006 <STRONG>P&G wasn't happy to allow authors of scientific papers about P&G drugs to see the raw data about which they were "writing"</STRONG> (backstory <STRONG><FONT color=#000066>here </FONT></STRONG>and <STRONG><FONT color=#000066>here</FONT></STRONG>).

<STRONG>Fortunately</STRONG> P&G have a deodorant for that.

Visit Secret.com and <STRONG><FONT color=#000066>Share Your Secret</FONT></STRONG> with P&G.


<IMG style="MARGIN: 0px 10px 10px 0px; CURSOR: hand" alt="" src="http://photos1.blogger.com/blogger/6406 ... ecret2.jpg" border=0>

<STRONG><FONT color=#000066>Earlier</FONT></STRONG>|<STRONG><FONT color=#000066>Later</FONT></STRONG>|<STRONG><FONT color=#000066>Main Page</FONT></STRONG>
<P class=blogger-labels>Labels: <STRONG><FONT color=#000066>Access_to_data</FONT></STRONG>, <STRONG><FONT color=#000066>Amusement</FONT></STRONG>, <STRONG><FONT color=#000066>Procter and Gamble</FONT></STRONG>, <STRONG><FONT color=#000066>Raw_data</FONT></STRONG>
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Last edited by peagee on January 7th, 2008, 6:02 pm, edited 1 time in total.
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:08 pm #4

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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:11 pm #5

<DIV class=post><A name=115493355591258741></A>
<H2 class=post-title><FONT color=#000066>Procter research shenanigans 3: Research misconduct explained in one letter</FONT></H2>
<DIV class=post-body>
<DIV>"Background to the dilemma involving Actonel research in Sheffield is <STRONG><FONT color=#000066>here</FONT></STRONG>, <STRONG><FONT color=#000066>here</FONT></STRONG> and <STRONG><FONT color=#000066>here</FONT></STRONG>. The research involved a secondary endpoint in randomized trials used to demonstrate the efficacy of risedronate (Actonel) for regulatory approval. The company violated the norms of science under whose banner they claim to sell their products.

<STRONG>There were three elements to the problem:</STRONG>

<OL>
[*]A pharmaceutical benefactor (Proctor & Gamble) repeatedly refused to provide raw data including randomization codes to academic "collaborators". Data was required by the academics to verify scientific reports, statistical analyses, meeting abstracts (1,2), and draft publications "ghost written" in their names.

[*]Data was provided to authors 3 years later, in early 2006, following press exposure. "Fair" analysis of the data would not have yielded findings desired by the sponsor.

[*]There were multifaceted and intriguing attempts to prevent the problem from being raised or discussed.
</LI>[/list]<STRONG>A single letter summarizes problem 1:
</STRONG>
The writer is <STRONG><FONT color=#000066>Professor Richard Eastell</FONT></STRONG>, collaborator in this research, and then Research Dean of Sheffield Medical School. It was written after numerous attempts to gain access to data from the company, and after some information had emerged to suggest that the analysis performed by P&G was implausible. A publication based on overlapping data had already appeared in press (Eastell et al., 2003 J. Bone. Miner. Res. 18:1051-6) - the raw data underlying this overlapping paper had also not been disclosed to Sheffield authors (<STRONG><FONT color=#000066>BBC broadcast</FONT></STRONG>).

<STRONG>This letter from Professor Eastell was written in response to two letters from myself <FONT color=#000066>here</FONT> and <FONT color=#000066>here</FONT></STRONG>. Eastell's "response":

<OL>

[*]attempts to rationalize why it was appropriate for authors to be refused access to critical raw data

[*]suggests that the first author (Blumsohn) would be removed even as a coauthor unless prepared to sign a journal declaration in the absence of data
</LI>[/list]

<A onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://photos1.blogger.com/blogger/6406 ... .gif"><IMG style="DISPLAY: block; MARGIN: 0px auto 10px; CURSOR: hand; TEXT-ALIGN: center" alt="" src="http://photos1.blogger.com/blogger/6406 ... llv1.7.png" border=0></A><A onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://photos1.blogger.com/blogger/6406 ... .gif"><IMG style="DISPLAY: block; MARGIN: 0px auto 10px; CURSOR: hand; TEXT-ALIGN: center" alt="" src="http://photos1.blogger.com/blogger/6406 ... llv2.1.png" border=0></A>
Click <STRONG><FONT color=#000066>here</FONT></STRONG> for PDF version of letter or on images above to enlarge.

<STRONG>Abstracts underlying intended publications</STRONG>
<OL>
[*]A. Blumsohn, IP Barton, A Chines, R Eastell Relative Contributions Of The Early Changes In Bone Resorption And Later Changes In Hip Bone Mineral Density To The Reduction In Vertebral Fracture Risk With Risedronate. [J Bone Miner Res 2003;18(S2):S157 Abst#SA337

[*]A. Blumsohn, IP Barton, A Chines, R Eastell. Relationship Of Early Changes In Bone Turnover To The Reduction In Vertebral Fracture Risk With Risedronate - The HIP Study. [J Bone Miner Res 2003;18(S2):S89 Abst#F338</LI>[/list]
<STRONG><FONT color=#000066>Earlier</FONT></STRONG>|<STRONG><FONT color=#000066>Later</FONT></STRONG>|<STRONG><FONT color=#000066>Main Page</FONT></STRONG>
<P class=blogger-labels>Labels: <STRONG><FONT color=#000066>Access_to_data</FONT></STRONG>, <STRONG><FONT color=#000066>Procter and Gamble</FONT></STRONG>, <STRONG><FONT color=#000066>Raw_data</FONT></STRONG>
</DIV></DIV>
<P class=post-footer>Posted by Aubrey Blumsohn 8/07/2006 06:29:00 AM | <STRONG><FONT color=#000066>Permalink</FONT></STRONG> | <A href="http://del.icio.us/post?url=http://scie ... le=Procter research shenanigans 3: Research misconduct explained in one letter"><STRONG><FONT color=#000066>del.icio.us</FONT></STRONG></A>|<A href="http://digg.com/submit?phase=2&url=http ... le=Procter research shenanigans 3: Research misconduct explained in one letter"><STRONG><FONT color=#000066>Digg it</FONT></STRONG></A>|<A href="http://www.stumbleupon.com/submit?url=h ... le=Procter research shenanigans 3: Research misconduct explained in one letter"><STRONG><FONT color=#000066>StumbleUpon</FONT></STRONG></A>| <SPAN class=item-action><A title="Email Post" href="http://www.blogger.com/email-post.g?blo ... 8741"><IMG class=icon-action alt="" src="http://www.blogger.com/img/icon18_email ... SPAN><SPAN class="item-control blog-admin pid-2126567453"><A title="Edit Post" style="BORDER-TOP-STYLE: none; BORDER-RIGHT-STYLE: none; BORDER-LEFT-STYLE: none; BORDER-BOTTOM-STYLE: none" href="http://www.blogger.com/post-edit.g?blog ... 8741"><IMG class=icon-action alt="" src="http://www.blogger.com/img/icon18_edit_ ... sp;"</SPAN>
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:21 pm #6


http://www.newsinferno.com/archives/2326

Bisphosphonates have been linked to a variety of other safety problems.&nbsp; <STRONG><FONT size=4>In October, the FDA announced that it was reviewing the drugs </FONT></STRONG>after studies showed <STRONG><FONT size=4>patients taking bisphosphonates ran a</FONT></STRONG> <STRONG><FONT size=4>higher risk of irregular heartbeat</FONT></STRONG>.&nbsp; Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase <STRONG><FONT size=4>the risk of irregular heartbeats in some older women</FONT></STRONG>. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Fosamax has also been linked to <STRONG><FONT size=4>Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed.</FONT></STRONG> The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ. ..."

&nbsp;

Maybe they'd have had more information on ACTONEL at least had SHEFFIELD UNIVERSITY not bullied an academic who wanted to see the RAW DATA before 'authoring' a publication for Procter & Gamble.

&nbsp;

http://www.bbc.co.uk/radio4/youandyours/items/01/2006_08_thu.shtml


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Last edited by peagee on January 7th, 2008, 6:24 pm, edited 1 time in total.
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:34 pm #7

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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:44 pm #8


and many universities are willing to sell out science for pharmaceutical funding.

Its rare though that researchers such as Dr Blumsohn have the courage to put their careers on the line and expose what is happening.

Because there are so few researchers willing to do so, and so much cover up within research about scientific misconduct in research, that Universities like Sheffield feel confident enough to fire good academics when they DO speak up.

&nbsp;

<IMG alt=honestycostsfunding.jpg src="http://www.network54.com/Realm/peageedo ... jpg">&nbsp;

&nbsp;
Last edited by peagee on January 7th, 2008, 10:20 pm, edited 1 time in total.
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 6:54 pm #9


and other researchers who speak out thus:

<STRONG>PUTTING "SCIENCE" and patient safety before funding or their own careers.</STRONG>
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Joined: January 1st, 1970, 12:00 am

January 7th, 2008, 7:20 pm #10


Debate:

How can scientific integrity be maintained when scientific research&nbsp;depends on&nbsp;funding from the drug industry and yet&nbsp;drug industry&nbsp;funding depends on giving way to scientific misconduct?

2,000 words maximum.
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