Tuesday, October 25, 2005

 

For Merck, second Vioxx trial off to inauspicious start

 

For Merck, second Vioxx trial off to inauspicious start
Miami Herald - FL,USA
ATLANTIC CITY, NJ - For Merck & Co., its second trial over failed painkiller Vioxx is another bitter pill. The beleaguered New Jersey ...

Drugmakers improve their image in NJ
Newark Star Ledger - Newark,NJ,USA
... verdict against Merck, in which a Texas jury last month held the company liable for $253.4 million in the wrongful death of a man who took the painkiller Vioxx ...

Merck's Vioxx Can Cause Heart Attack With One Dose, Expert Says
Bloomberg - USA
19 (Bloomberg) -- Merck & Co.'s painkiller Vioxx may cause heart attacks with one dose, a heart expert said at the second product-liability trial over the drug ...

Class action filed for NZers who took Vioxx
Stuff.co.nz - Wellington,New Zealand
American lawyers have filed a class action for all New Zealanders who took the potentially lethal painkilling drug Vioxx. The legal ...

Vioxx federal trial moved from New Orleans to Houston
Houston Business Journal - Houston,TX,USA
In the wake of Hurricane Katrina, the nation's first federal trial involving Vioxx, a painkiller manufactured by pharmaceutical giant Merck & Co., has been ...

Doctor: Vioxx Use Can Cause Heart Attack
Boonville Daily News - MO, USA
ATLANTIC CITY, NJ - Intermittent use of Vioxx or even a day's use of the painkiller could be enough to cause a heart attack, a prominent heart and medication ...

Big Pharma needs to overhaul risk assessment
Financial Times - London,England,UK
... The biggest is Merck's withdrawal of Vioxx a year ago after finding increased heart attack risk, forgoing $2bn in annual sales and potentially attracting ... 

Over-the-counter drugs have widespread safety problems, too
News Target - Taichung,Taiwan
... Although much attention has been paid recently to drug-safety problems that have emerged in newer prescription drugs, such as Vioxx, the same scrutiny hasn't ...

The bad news keeps coming for the painkillers
News Target - Taichung,Taiwan
With the news that Vioxx, Celebrex, Bextra, and Aleve all cause an increase in the risk of heart disease and stroke, there doesn't seem to be any good news for ...

Follow-up studies on medical devices are never completed 22 ...
News Target - Taichung,Taiwan
... After the difficulty that the FDA has faced with the approval of Vioxx and Celebrex, there may be shake-up in the medical device industry, as well. ...

Man-made snail venom offers pain relief
Scripps Howard News Service - USA
... FDA approval of Prialt, a non-opioid, comes at a time when other pain medications - such as Vioxx, which was withdrawn by its maker, Merck & Co., last September ...

Pfizer profits up 470% on year despite wilting Viagra sales
Guardian - UK
... profits yesterday as the company benefited from the woes of rivals such as Merck, which was sent reeling by the withdrawal of its arthritis treatment Vioxx. ... 
 


Thursday, October 13, 2005

 

Google's Matt Cutts Interviewed by Aaron Wall

 

Google's Matt Cutts Interviewed by Aaron Wall
Search Engine Journal - USA
Aaron Wall of SEOBook.com got the chance to conduct an interview with Google's Matt Cutts, Google Search Engineer, about topics ranging from SEO, Spam, SEM ...

WordPress Selling Links -- But Using AdBrite Solves Search Engine ...
Search Engine Watch - USA
Average CPC & Selling Ad Space from Aaron Wall over at SEO Book looks at how WordPress is now selling text links on its home page for $10,000 per day via ...  

Free Blog Counter  
Free counters for web sites and blogs. Fast, easy sign-up does not even require an email address. Several styles to choose from and they are easy to install with very little impact on your page's load time. Find out how your site or blog is really doing!

Blogs vs. the law
Rocklin and Roseville Today - Rocklin,CA,USA
State College, Pa.-based blogger Aaron Wall was sued in August for defamation and revealing the trade secrets of Traffic-Power.com, a company that helps Web ...  

Cutts Up Against The Wall
WebProNews - Lexington,KY,USA
Over the weekend, Aaron Wall got a chance to talk to Google's "Mick Jagger of Search", Matt Cutts, in an in depth interview. The ...

Search Engine Journal ยป Google's Matt Cutts Interviewed by Aaron Wall
Aaron Wall of SEOBook.com got the chance to conduct an interview with Google's
Matt Cutts, Google Search Engineer, about topics ranging from SEO, Spam, SEM, ...

Google Auctions to Rival eBay and Yahoo?
Search Engine Journal - USA
... Aaron Wall of the SEOBook wonders how such an auction service from Google would effect its advertising model, Google AdWords, which includes mega advertising ...  
 


Friday, October 07, 2005

 

St. Jude Medical Discovers Cosmic Radiation Can Affect Memory Chip in Limited Number of Older Generation ICDs

St. Jude Medical Discovers Cosmic Radiation Can Affect Memory Chip in Limited Number of Older Generation ICDs

ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 7, 2005--St. Jude Medical Inc. (NYSE:STJ) announced today that it has discovered that background levels of atmospheric ionizing cosmic radiation, more commonly known as cosmic rays, can affect a limited number of its older generation implantable cardioverter defibrillator (ICD) products.

Although the incidence rate is low, and there have been no serious patient injuries or deaths reported to St. Jude Medical attributable to this anomaly, the Company is taking a conservative approach in advising the medical community and regulatory agencies.

Specifically, St. Jude Medical has identified through extensive investigation, including testing at an independent nuclear laboratory, that a particular vendor-supplied static random access memory (SRAM) chip can be affected, at a low frequency rate, by background levels of atmospheric ionizing cosmic radiation. A full copy of the physician communication, which includes a description of the anomaly and its related clinical risks, as well as St. Jude Medical's recommendations to physicians for patient monitoring, can be found at http://www.sjm.com/companyinformation/physicianletter.html.

This particular memory chip component was used in the following older generation St. Jude Medical ICDs:

-- Photon DR (Model V-230HV) (certain serial numbers)

-- Photon Micro VR/DR (Models V-194/V-232)

-- Atlas VR/DR (Models V-199/V-240)

To date, an incidence of only 0.00167 of the devices at issue (60 out of 36,000) have been found to have been affected by background levels of cosmic radiation. An estimated 26,000 of the device models remain in service. The estimated incidence of an anomaly of this type in the affected device models is 0.00257 over the five year projected life of the device.

"St. Jude Medical has taken a conservative, proactive approach in notifying the medical community of this anomaly," said Dr. Mark Carlson, Professor of Medicine at Case Western Reserve University in Cleveland, Ohio, and a member of an independent panel of physicians that reviewed the issue for St. Jude Medical. Dr. Carlson also recently served as Chairman of a joint Policy Conference on Pacemaker and ICD Performance.

Among the information provided in the physician advisory is St. Jude Medical's recommendation that, if it is not already their practice, physicians should perform routine device monitoring every three months for patients with these devices. St. Jude Medical is also offering its remote monitoring product Housecall Plus(TM), where available, at no charge for models compatible with the remote monitoring system.

"Because the incidence associated with this anomaly is low, St. Jude Medical's recommendation for monitoring at three-month intervals will be appropriate for the vast majority of patients," said Dr. Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at The Cleveland Clinic and Heart Center and a member of the St. Jude Medical independent Medical Advisory Board.

As part of a new ICD product platform introduced in 2002, and prior to St. Jude Medical having any knowledge of this particular anomaly, St. Jude Medical began using a different vendor and a different design of the SRAM memory chip component. Laboratory testing and clinical experience indicate that this newer generation memory chip component does not share the same susceptibility to background cosmic radiation as the earlier generation. Consequently, other St. Jude Medical ICDs and all models of CRT-D devices, including the Atlas DR model V-242 and all Epic, Epic HF, Epic +, Epic + HF, Atlas + and Atlas + HF product families, are NOT affected by this issue.

Overall reliability information about the affected ICDs and other St. Jude Medical products can be found in the company's Product Performance Report on the St. Jude Medical web site at www.sjm.com.

St. Jude Medical has notified the U.S. Food and Drug Administration (FDA) of this physician advisory. The FDA may determine this communication action to be a recall.

The Company does not expect this physician communication to have any material financial impact.

St. Jude Medical is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.

Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.

Contacts
St. Jude Medical, Inc.
Laura Merriam, 651-766-3029 (Investor Relations)
or
Angela Craig, 651-481-7789 (Media Relations)

Monday, October 03, 2005

 

Drugmaker ignored safety risks of Vioxx, heart expert testifies

 

Drugmaker ignored safety risks of Vioxx, heart expert testifies
Chicago Sun-Times - United States
BY JOHN CURRAN. ATLANTIC CITY, NJ -- A heart expert told jurors Friday that Vioxx manufacturer Merck & Co. ignored evidence the pain ...

Federal Vioxx trial moving to Houston
Bryan College Station Eagle - TX, United States
... Yet another Hurricane Katrina "evacuee" has a home in Houston - the nation's first federal civil trial involving Merck & Co.'s withdrawn painkiller, Vioxx. ...

Pharmaceutical companies have been ill for a long while
San Antonio Express (subscription) - San Antonio,TX,USA
The slide down the stock market started five years ago for big pharmaceutical companies -- long before the multimillion-dollar verdict over Vioxx and before ...

Judge intervenes in testy Vioxx witness, lawyer exchanges
Newsday - Long Island,NY,USA
... and a key plaintiff's witness escalated Tuesday and the judge told attorneys to calm down during the second trial over Merck & Co.'s withdrawn painkiller Vioxx ...

Judge intervenes in testy Vioxx witness, lawyer exchanges
Fort Wayne Journal Gazette - Fort Wayne,IN,USA
ATLANTIC CITY, NJ - A key witness for a man blaming use of Vioxx for his heart attack returned to the stand Tuesday, aggressively defending his prior testimony ...

FDA rejects Bextra-like drug
MarketWatch - USA
... Bextra and parecoxib are chemically related to Merck's pain reliever Vioxx, which was taken off the market last year after a study showed it could cause ...

Summary Box: Medical Reseach Spending
Washington Post - United States
... IN THE NEWS: More attention is being paid to medical research thanks to liability lawsuits over the painkiller Vioxx and the political debate over stem cell ...

 


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