tag:blogger.com,1999:blog-107348802011-12-14T18:40:23.864-08:00Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.comBlogger321100tag:blogger.com,1999:blog-10734880.post-1110167001759274142005-03-06T19:16:00.000-08:002005-03-06T19:45:35.006-08:00A recent New York Times article that draws attention to the fact that up until 2002, it was a common practice for the pharmaceutical industry to ply physicians with free dinners, tickets or other high priced swag-- and that FDA Officers allegedly have proof that this practice has not stopped, but continues unabated.<br /><br />That's really bad, but hardly unexpected. Expect corporations to behave poorly. It's not like the government was working in conjunction with drug companies to approve unsafe drugs.<br /><br />Ahem.<br /><br />There is a much more interesting factoid further down in the article. It seems the FDA has 1000 staff members working to approve new drugs but only around 100 working on making sure existing drugs are safe.<br /><br /><span style="font-style:italic;"><blockquote>Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington, told the panel that the agency had become too focused on approving new drugs at the expense of making sure that approved ones were safe. This could make the upcoming Vioxx class action much more interesting.<br /><br />"In the office of new drugs, more than 1,000 employees work to review a few dozen new drugs per year," Dr. Psaty said. "In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market."<br /><br />He described the agency's structure as "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a postmarketing center."</blockquote></span><br /><br />[<a href="http://www.nytimes.com/2005/03/04/politics/04fda.html?oref=login">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-111016700175927414?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com19tag:blogger.com,1999:blog-10734880.post-1109781645842129332005-03-02T08:32:00.000-08:002005-03-02T08:40:45.850-08:00After the Food and Drug Administration insisted for months that it had done nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel Tuesday. <br /><br /><em><blockquote>Kweder said the agency had taken too long to get information about Vioxx's heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel's conclusion that those risks should be highlighted and the actual label changes, she said. <br /><br />Kweder blamed the delay on difficult negotiations with Vioxx's maker, Merck. "We don't have the authority to tell a company, 'This is how your label has to look,' " she said. "We have to negotiate with the company the specific language of how things should be worded." </blockquote></em><br /><br />[<a href="http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/03/02/MNGRMBITGM1.DTL">Read More</a>]<h4>Folksonomies</h4><h6><a href="http://technorati.com/tag/fda" rel="tag">fda</a> <a href="http://technorati.com/tag/vioxx" rel="tag">vioxx</a> <a href="http://technorati.com/tag/senate" rel="tag">senate</a> <a href="http://technorati.com/tag/washington" rel="tag">washington</a> <a href="http://technorati.com/tag/kweder" rel="tag">kweder</a> <a href="http://technorati.com/tag/health" rel="tag">health</a> <a href="http://technorati.com/tag/education" rel="tag">education</a> <a href="http://technorati.com/tag/stroke" rel="tag">stroke</a> <a href="http://technorati.com/tag/graham" rel="tag">graham</a> <a href="http://technorati.com/tag/stavropoulos" rel="tag">stavropoulos</a> <a href="http://technorati.com/tag/celebrex" rel="tag">celebrex</a> <a href="http://technorati.com/tag/bextra" rel="tag">bextra</a> <a href="http://technorati.com/tag/pfizer" rel="tag">pfizer</a> <a href="http://technorati.com/tag/merck" rel="tag">merck</a> <a href="http://technorati.com/tag/heart" rel="tag">heart</a> <a href="http://technorati.com/tag/grassley" rel="tag">grassley</a> <a href="http://technorati.com/tag/tysabri" rel="tag">tysabri</a> <a href="http://technorati.com/tag/sclerosis" rel="tag">sclerosis</a> <a href="http://technorati.com/tag/biogen" rel="tag">biogen</a> <a href="http://technorati.com/tag/idec" rel="tag">idec</a> <a href="http://technorati.com/tag/elan" rel="tag">elan</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110978164584212933?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109781068627785802005-03-02T07:54:00.000-08:002005-03-02T08:31:30.890-08:00The Bangor Daily News makes an interesting point. Dr. Erik Steele's opinion is that drug companies pin their hopes to a 'blockbuster' drug and in their one-mindedness to get the drug out the door and the profits rolling in, they may choose to overlook a few 'setbacks the drugs may have during clinical trials.<br /><br /><em><blockquote>"...pharmaceutical companies are progressively dependent for their profits on the manufacture and sales of hot drugs such as Vioxx ($2.5 billion in annual sales for Merck) and similar drugs Celebrex and Bextra (combined $4.8 billion in annual sales for Pfizer). The companies are under tremendous pressure, primarily from stockholders, to make big profits, they have fewer drugs likely to make big profits in their research and development pipelines than in the past, and drugs such as Vioxx are corporate lifesavers. Vioxx sales alone accounted for 20 percent of Merck Pharmaceutical's profits in 2003.<br /><br />This reliance on a few blockbuster drugs means patient safety jockeys with corporate profits as the manufacturers' first priority in decisions about drug marketing. If Merck had highlighted a significant safety issue with Vioxx early on, the drug would have lost the main reason for its success over rivals, that being its lower risk of stomach bleeding as a side effect. Its side effects and its withdrawal from the market in September 2004 will cost Merck an estimated $14 billion in lawsuits and lost sales, and the company lost $28 billion in stock value when investors heard the bad news about Vioxx, according to a recent article in the New England Journal of Medicine (NEJM). Safety problems with a drug such as Vioxx can shake a drug company to its financial core."</blockquote></em><br /><br />[<a href="http://www.bangornews.com/news/templates/?a=109713">Read More</a>]<h4>Folksonomies</h4><h6><a href="http://technorati.com/tag/prescription" rel="tag">prescription</a> <a href="http://technorati.com/tag/drug" rel="tag">drug</a> <a href="http://technorati.com/tag/pharmaceutical" rel="tag">pharmaceutical</a> <a href="http://technorati.com/tag/marketing" rel="tag">marketing</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/blockbuster" rel="tag">blockbuster</a> <a href="http://technorati.com/tag/disaster" rel="tag">disaster</a> <a href="http://technorati.com/tag/Merck" rel="tag">Merck</a> <a href="http://technorati.com/tag/Celebrex" rel="tag">Celebrex</a> <a href="http://technorati.com/tag/Bextra" rel="tag">Bextra</a> <a href="http://technorati.com/tag/Pfizer" rel="tag">Pfizer</a> <a href="http://technorati.com/tag/NEJM" rel="tag">NEJM</a> <a href="http://technorati.com/tag/financial" rel="tag">financial</a> <a href="http://technorati.com/tag/Bayer" rel="tag">Bayer</a> <a href="http://technorati.com/tag/Cervistatin" rel="tag">Cervistatin</a> <a href="http://technorati.com/tag/FDA" rel="tag">FDA</a> <a href="http://technorati.com/tag/Steele" rel="tag">Steele</a> <a href="http://technorati.com/tag/Bangor" rel="tag">Bangor</a> <a href="http://technorati.com/tag/Maine" rel="tag">Maine</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110978106862778580?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com1tag:blogger.com,1999:blog-10734880.post-1109703268514428792005-03-01T10:45:00.000-08:002005-03-01T10:54:28.516-08:00Consumers Union, the advocacy group behind Consumer Reports Magazine, <a href="https://secure2.convio.net/cu/site/Advocacy?page=UserAction&cmd=display&id=357">has produced an animation</a> that calls attention to the fact that current FDA rules don't require drug companies to release their clinical trial results even if they show that the pill you're about to take could have dire consequences.<br /><br />The animated short is a tool to help promote the Fair Access to Clinical Trials Act (FACT Act)that will compel drug companies to release their clinical trial results to the public and create an independent office of drug safety in the Food and Drug Administration to ensure quick action is taken when safety concerns are raised.<br /><br /><em><blockquote>First we learn that Vioxx increases the risk of heart attacks. Now, we learn that Merck may have had research, as early as 2000, that uncovered these problems, but didn’t make it known to the public. It is time to end this secrecy. Lives depend on it.</blockquote></em><br /><br />[<a href="https://secure2.convio.net/cu/site/Advocacy?page=UserAction&cmd=display&id=357">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110970326851442879?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com1tag:blogger.com,1999:blog-10734880.post-1109651551333462842005-02-28T20:27:00.000-08:002005-02-28T20:32:31.336-08:00As painkiller scrutiny continues, some patients are turning to drug-free alternatives.<br /><br /><span style="font-style:italic;"><blockquote>In the wake of a highly publicized investigation into the safety of Cox-2 inhibitors, the class of painkillers that Vioxx belongs to, it appears more patients with arthritis and other forms of chronic pain are turning a curious eye to drug-free remedies, such as acupuncture, chiropractic, dietary supplements and exercise. Backed by a growing body of research, more doctors are too.<br /><br />"Some people really need to take medication and I certainly don't want them to feel bad about that," stressed Andrea Montoya, a certified physician assistant with Boulder Valley Rheumatology in Longmont. "But I think in general, people have thought more about 'what else can I do in addition to taking medication for my pain.' I think that it's great. I definitely encourage it." </blockquote></span><br /><br />[<a href="http://www.dailycamera.com/bdc/cda/article_print/0,1983,BDC_2431_3576093_ARTICLE-DETAIL-PRINT,00.html">Read More</a>]<h4>Folksonomies</h4><h6> <a href="http://technorati.com/tag/scandal" rel="tag">scandal</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/medical" rel="tag">medical</a> <a href="http://technorati.com/tag/trial" rel="tag">trial</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110965155133346284?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com4tag:blogger.com,1999:blog-10734880.post-1109567133402950432005-02-27T21:02:00.000-08:002005-02-27T21:05:33.403-08:00The federal Judicial Panel on Multidistrict Litigation granted motions by several parties, including Merck, to transfer all Vioxx shareholder suits pending in federal courts nationwide into one consolidated Multidistrict Litigation (MDL) for coordinated pre-trial proceedings. <br /><br />[<a href="http://www.medicalnewstoday.com/medicalnews.php?newsid=20415">Read More</a>]<h4>Folksonomies</h4><h6> <a href="http://technorati.com/tag/scandal" rel="tag">scandal</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/medical" rel="tag">medical</a> <a href="http://technorati.com/tag/trial" rel="tag">trial</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110956713340295043?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109437042018598962005-02-26T08:51:00.000-08:002005-02-26T08:57:22.020-08:00The makers of the popular painkiller Vioxx say they are "perplexed" by harsh allegations from the federal Health Minister that they have withheld safety data from the Canadian government.<br /><br /><span style="font-style:italic;"><blockquote>In a statement, Ms. Gauthier added: "The Company responded in writing to Health Canada's request for information and has offered to meet with Health Canada officials at their convenience. We had not received any verbal or written feedback to our letter until we saw the Minister's comments in the newspaper."<br /><br />Mr. Dosanjh had told The Globe that he is considering boosting Health Canada's legal authority to force a drug company to turn over information the department requests.</blockquote></span><br /><br />[<a href="http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/LAC/20050226/VIOXX26/TPHealth/">Read More</a>]<h4>Folksonomies</h4><h6> <a href="http://technorati.com/tag/scandal" rel="tag">scandal</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/canada" rel="tag">Canada</a> <a href="http://technorati.com/tag/dosanjh" rel="tag">Dosanjh</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110943704201859896?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109352411816514112005-02-25T09:23:00.000-08:002005-02-26T08:55:41.103-08:00Almost a third of the members of a government panel that voted last week to let the pain pills Celebrex, Bextra and Vioxx stay on the market recently consulted for the makers of the drugs. Without the votes of those 10 members, the committee would have voted 12 to 8 for Bextra's withdrawal and 14 to 8 against Vioxx.<br /><br /><em><blockquote>According to the report, disclosures in medical journals and other public records show that ten of the 32 panel members have done some work for Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying to sell Prexige, a similar type of medication. <br /><br />Without the votes of those 10 members, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return. </blockquote></em><h4>Folksonomies</h4><h6> <a href="http://technorati.com/tag/scandal" rel="tag">scandal</a> <a href="http://technorati.com/tag/vote" rel="tag">Vote</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/FDA" rel="tag">FDA</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110935241181651411?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109282820542707832005-02-24T14:05:00.000-08:002005-02-24T14:07:00.546-08:00<em><blockquote>Dr. David Graham, the FDA's associate safety director, says the agency had attempted to suppress a recent study on the drugs that he conducted with Dr. Gurkirpal Singh of Stanford University. "They don't want safety information (to go) out to the public," Graham charged in an interview, "because it will only highlight how inadequate their assessment of safety has been before the drugs have gotten onto the market." <br /><br />The FDA veteran said he was "told in very clear, emphatic and very terse, unfriendly tone of voice and terms, we were not to present these data. These data could not be presented." Last year, Graham led a study on Merck's Vioxx that indicated 30,000 to 55,000 Vioxx-related deaths in the United States, and more still globally. Similar questions about cardiovascular problems have been raised about Pfizer's Celebrex and Bextra. </blockquote></em><br /><br />[<a href="http://www.commondreams.org/views05/0223-35.htm">Read More</a>]<br /><h4>Folksonomies</h4><br /><h6><a href="http://technorati.com/tag/Graham" rel="tag">Graham</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/FDA" rel="tag">FDA</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110928282054270783?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109282673204688242005-02-24T14:02:00.000-08:002005-02-24T14:04:33.206-08:00<em><blockquote>A federal judge in Trenton will be handling all lawsuits filed by Merck & Co. Inc. shareholders stemming from the recall of the company's blockbuster arthritis drug Vioxx, a judicial panel has ruled.<br /><br />The consolidated cases include securities, shareholder derivative and Employee Retirement Income Security Act lawsuits, and generally accuse company officers of making misleading statements about Vioxx, ultimately leading to a sharp decline in its stock price. The company's stock plunged nearly 27 percent immediately after the drug's recall, which amounted to a $28 billion loss in shareholder value.</blockquote></em><br /><br />[<a href="http://www.kansascity.com/mld/kansascity/business/10981968.htm?1c">Read More</a>]<br /><br /><h4>Folksonomies</h4><br /><h6><a href="http://technorati.com/tag/NJ" rel="tag">NJ</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/legal" rel="tag">legal</a> <a href="http://technorati.com/tag/government" rel="tag">government</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/FDA" rel="tag">FDA</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110928267320468824?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109282525057204122005-02-24T13:58:00.000-08:002005-02-24T14:02:05.060-08:00<em><blockquote>Finally, a doctor was called in to look at her knee and realized that this swelling was not routine. She was rushed back to the hospital where doctors confirmed that she had developed a blood clot, which had it dislodged, would have most likely had dire effects, and might even have killed her. <br /><br />She was confined to bed rest, given blood thinners and her recovery was set back two weeks. Once she was released, she had to endure more therapy but the knee had already set up and even now, a year later, she is still not able to use it normally. <br /><br />Why did this happen? The doctors had no answers, but when her history was studied, they determined that it may have been due to her participating in a drug trial several years prior. She had been in a test group for Vioxx, but never learned whether she had been given the drug or a placebo. Those records weren't available but, considering what has been learned about this drug since, it is not a stretch to think that this was the case. </blockquote></em><br /><br />[<a href="http://www.elitestv.com/pub/2005/Feb/EEN421dd28768a0f.html">Read More</a>]<br /><h4>Folksonomies</h4><br /><h6><a href="http://technorati.com/tag/Texas" rel="tag">Texas</a> <a href="http://technorati.com/tag/Vioxx" rel="tag">Vioxx</a> <a href="http://technorati.com/tag/COX-2" rel="tag">COX-2</a> <a href="http://technorati.com/tag/arthritis" rel="tag">Arthritis</a> <a href="http://technorati.com/tag/legislation" rel="tag">legislation</a> <a href="http://technorati.com/tag/liability" rel="tag">liability</a> <a href="http://technorati.com/tag/FDA" rel="tag">FDA</a></h6><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110928252505720412?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109215383721599002005-02-23T19:21:00.000-08:002005-02-23T19:23:03.723-08:00<span style="font-style:italic;"><blockquote>After an FDA panel recently recommended that Vioxx could return to the marketplace, investors pushed Merck's stock up 13%. The reason for investor optimism is that this recommendation may limit Merck's legal liability, estimated at as much as $20 billion.<br /><br />Even though Merck may have dodged a legal liability bullet, it still will take a large hit to future revenue because of the negative publicity. Better communicating Vioxx's clinical trial results and indicating potential cardiovascular problems earlier could have avoided the negative fallout from the voluntary recall.</blockquote></span><br /><br />[<a href="http://biz.yahoo.com/prnews/050223/clw027_1.html">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110921538372159900?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109215252839394862005-02-23T19:19:00.000-08:002005-02-23T19:20:52.840-08:00<span style="font-style:italic;"><blockquote>The largest prospective trial ever examining the anti-inflammatory drug Vioxx as a chemoprevention agent found that the risk of developing a cardiovascular “event” –– heart attacks and/or strokes –– was almost double in patients who received the drug, compared to patients who took the placebo, according to a study out Feb. 15 online in The New England Journal of Medicine.</blockquote></span><br /><br />[<a href="http://www.sciencedaily.com/releases/2005/02/050218131255.htm">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110921525283939486?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109215183133170042005-02-23T19:16:00.000-08:002005-02-23T19:19:43.136-08:00<span style="font-style:italic;"><blockquote>A Webster law firm has filed seven federal cases against Merck and Company, alleging the painkiller Vioxx caused South Dakota patients to suffer strokes or heart attacks.<br /><br />Attorney Lonnie Vander Linden says the cases are individual complaints and are not part of a class action lawsuit. He says his law firm is planning to file 40 to 50 more lawsuit against Merck in U.S. District Court.</blockquote></span><br /><br />[<a href="http://www.keloland.com/News/NewsDetail4514.cfm?ID=22,37967">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110921518313317004?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com1tag:blogger.com,1999:blog-10734880.post-1109137409459649732005-02-22T21:39:00.000-08:002005-02-22T21:43:29.460-08:00Hundreds of Vioxx lawsuits, individual and class actions, will be consolidated in a federal court in New Orleans before Judge Eldon E. Fallon, favored by many plaintiffs' lawyers, the New York Times reported last week.<br /><br /><span style="font-style:italic;"><blockquote>According to the New York Times, Fallon was selected because of his schedule availability and experience. "He is overseeing a proposed settlement reached in his court last year for all federal injury claims related to Propulsid, a heartburn drug made by a Johnson & Johnson subsidiary."</blockquote></span><br /><br />[<a href="http://www.legalnewswatch.com/news_539.html">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110913740945964973?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com3tag:blogger.com,1999:blog-10734880.post-1109137168699161202005-02-22T21:36:00.000-08:002005-02-22T21:39:28.700-08:00<span style="font-style:italic;"><blockquote>Marianne Snyder had to miss work cleaning houses on Friday because her knees were so sore from rheumatoid arthritis, she couldn't bear getting on them to scrub floors.<br /><br />The 64-year-old West Valley City woman has felt immense pain since September, when Merck & Co. Inc. pulled Vioxx from the market after a study showed the drug increased patients' risk for heart attack and stroke.<br /><br />But after a committee with the Food and Drug Administration said Friday that Vioxx and other drugs known as COX-2 inhibitors should remain on the market, she might not have to suffer so much.<br /><br />"Vioxx was a life saver," she said. "Other drugs gave me ulcers, and Celebrex didn't do anything to touch the pain. I probably will go back on Vioxx."</blockquote></span><span style="font-style:italic;"></span><br /><br />[<a href="http://www.rednova.com/news/display/?id=129805">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110913716869916120?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com1tag:blogger.com,1999:blog-10734880.post-1109109999504383152005-02-22T14:05:00.000-08:002005-02-22T14:06:39.506-08:00Last week's regulatory triumphs at Merck and Pfizer do not eliminate the legal risk to either company, Smith Barney argued in a research note Monday.<br /><br /><em><blockquote>The brokerage warned that it sees "little upside" for either after both rallied on votes to clear Merck's Vioxx and Pfizer's Celebrex and Bextra for continued sale in U.S. prescription drug markets. Merck added 13% on the ruling and was recently changing hands at $32.52 on Instinet, while Pfizer added 6% and currently fetches $27. <br /><br />"While the panel's vote on Vioxx might marginally improve the litigation picture, Merck's stock appears to be discounting minimal (if any) litigation risk," Smith Barney wrote. "Vioxx litigation will likely continue to create volatility to the Merck story as a steady stream of cases go to trial in 2005." </blockquote></em><br /><br />[<a href="http://www.thestreet.com/_googlen/stocks/biotech/10209863.html?cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110910999950438315?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com1tag:blogger.com,1999:blog-10734880.post-1109007753242919492005-02-21T09:40:00.000-08:002005-02-21T09:42:33.243-08:00<span style="font-style:italic;"><blockquote>"Following Merck Co.'s decision to withdraw its blockbuster COX-2 Vioxx (rofecoxib) from the market and Pfizer's concerns regarding its Celebrex, FDA is set to determine the future of COX-2s. The agency will collect and analyse all available information from the most recent studies of COX-2 selective and nonselective NSAID products to determine the need for additional regulatory requirements. With a meeting planned this month, an FDA advisory committee will provide a full public discussion and decide whether or not COX-2s should continue to be marketed. Should FDA decide against withdrawing COX-2s, Datamonitor predicts that sales will still be adversely affected as knocked confidences will take time to recover. Companies will have to use this as an opportunity to prove both themselves and their products to customers."</blockquote></span><br /><br />[<a href="http://www.ptemag.com/pharmtecheurope/article/articleDetail.jsp?id=148046">Via</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110900775324291949?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109007586510328562005-02-21T09:37:00.000-08:002005-02-21T09:39:46.513-08:00After months of riding a regulatory roller coaster, and three days of intensive hearings, an FDA review panel Friday recommend that three specific brands of the so-called COX-2 inhibitor pain relievers - Celebrex, Bextra and Vioxx - be returned to the market.<br /><br /><span style="font-style:italic;"><blockquote>The COX-2 drugs, the experts said, should only be used when a patient's severe or chronic pain is not addressed by other, older families of drugs, or when a patient has demonstrated or is susceptible to stomach or liver damage such that those older drugs - primarily the one marketed as Aleve - clearly pose a serious risk of their own.</blockquote></span><br /><br />[<a href="http://www.sltrib.com/opinion/ci_2579379">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110900758651032856?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1109007437467663582005-02-21T09:35:00.000-08:002005-02-21T09:37:17.470-08:00European drugmaker stocks may gain after Merck & Co. was allowed to reintroduce the Vioxx painkiller. American depositary receipts of Sanofi-Aventis SA and Roche Holding rose.<br /><br /><span style="font-style:italic;"><blockquote> Merck surged 13 percent for the biggest gain in the Dow average and the S&P 500. The company's Vioxx painkiller, withdrawn Sept. 30 in the biggest drug recall ever, may be sold again in the U.S. with the strictest safety warning on its label, a government advisory panel ruled.<br /><br />ADRs of Roche, the world's biggest maker of cancer drugs and diagnostic tests, increased 1.2 percent from their close in Switzerland. ADRs of Sanofi, the world's No. 3 drugmaker, climbed 0.8 percent from their close in Paris. The Bank of New York European ADR Index advanced 0.4 percent to 128.86. </blockquote></span><br /><br />[<a href="http://www.bloomberg.com/apps/news?pid=10000085&sid=aYMJRlAe6S0o&refer=europe">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110900743746766358?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108961869647009232005-02-20T20:51:00.000-08:002005-02-20T20:58:38.106-08:00The 17-15 vote on Vioxx's safety to go to market electrified Merck shares, which closed up 13 percent at $32.61 on the New York Stock Exchange. Pfizer gained 6.9 percent to close at $26.80.<br /><br /><span style="font-style:italic;"><blockquote>Most of the advisers said Vioxx, Celebrex and Bextra should all have "black box" warnings - the strongest warnings used for prescription drugs - on their heart risks.<br /><br />Many panelists also urged restrictions on Vioxx if it did return to the market, such as limiting sales to only the lowest dose and recommending that it be a second choice after patients tried another pain reliever.</blockquote></span><br /><br />[<a href="http://www.busrep.co.za/index.php?fSectionId=&fArticleId=2418094">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110896186964700923?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108961294688374372005-02-20T20:31:00.000-08:002005-02-20T20:48:14.690-08:00Derek Lowe over ate Corante muses about the reintroduction of COX-2 drugs like Vioxx:<br /><br /><span style="font-style:italic;"><blockquote>This all should make Merck's path forward in their Vioxx lawsuits a little easier. They could still face a punitive-damages avalanche, of course, and a lot of lawyers will be working to get the snowpack loosened up. I assume that the first case will be tried in Mississippi, Texas, or some other jury award paradise - picking the right venue is part of the art.</blockquote></span><br /><br />[<a href="http://www.corante.com/pipeline/archives/2005/02/20/cox2_aftermath.php">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110896129468837437?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108949533495474442005-02-20T17:30:00.000-08:002005-02-20T17:32:13.496-08:00After the control board of medical experts gave a very cautious nod to the use of the painkillers Celebrex, Vioxx and Bextra on Friday, pain management experts said they expect to see the same caution transform the way the painkillers are prescribed.<br /> <br />They said the drugs, extremely popular for people with both short-term and chronic pain would be prescribed much less readily, for a smaller group of patients, at lower doses and for shorter periods.<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110894953349547444?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108927096448085862005-02-20T11:12:00.000-08:002005-02-20T11:18:16.450-08:00Vioxx, the popular pain pill that Merck & Co. Inc. recalled 41/2 months ago, narrowly got a green light Friday from U.S. Food and Drug Administration advisers to go back on sale under tight prescribing rules and marketing limitations.<br /><br /><span style="font-style:italic;"><br /><blockquote>"I think, frankly, Merck made a terrible mistake in withdrawing Vioxx," said George Ehrlick, a Philadelphia physician and a former chairman of the FDA arthritis advisory committee that met this week. "There is still a group of people it serves, and they could've restricted the group with better labeling."<br /><br />A group representing people with psoriasis called for keeping the drugs on the market.<br /><br />But at least one patient remained skeptical. "I probably won't take it, out of an abundance of caution," said Philadelphia lawyer Mike Ecker, 46, who said he had constant foot pain from damage to his arches.</blockquote></span><br /><br />[<a href="http://www.philly.com/mld/inquirer/10943664.htm?1c">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110892709644808586?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108926728751427842005-02-20T11:07:00.000-08:002005-02-20T11:12:08.753-08:00Like any government agency that has been around for almost a century, the U.S. Food and Drug Administration (FDA) has endured its share of rough patches. But "rough patch" hardly begins to describe all the bad news that has battered the agency over the past few months, from the possible suicide risks with antidepressants like Prozac, Paxil and Zoloft to the cardiac risks of pain-killers like Vioxx, Celebrex and Bextra.<br /><br /><span style="font-style:italic;"><blockquote>By late 1998, when the first of the cox-2 inhibitors won FDA approval, the stage was set for a debacle. The easiest side effects to detect, once a drug is used by large numbers of people, turn out to be the rare ones. Most doctors don't see very many cases of liver failure, for example. So they notice right away if more and more of their patients get hospitalized for it. The problem with cox-2 inhibitors like Vioxx is that they increase the risk of two very common ailments: heart attacks and strokes. It's much harder to tell, without careful statistical analyses, when common events become more common.</blockquote></span><br /><br />[<a href="http://www.time.com/time/covers/1101050228/scfda.html">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110892672875142784?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108881812310574542005-02-19T22:35:00.000-08:002005-02-19T22:43:32.313-08:00Nearly 50 New Zealanders have joined an Australian court action for compensation over the adverse effects of the pain relief drug.<br /><br /><span style="font-style:italic;"><blockquote>The IMMP is analysing figures from 60,000 patients taking Vioxx and a similar painkiller Celebrex to see which adverse events were caused by the drugs. Heart attacks and strokes had been reported in patients and some of them had been fatal but the numbers, and whether they were caused by the drugs, were not yet available.</blockquote></span><br /><br />[<a href="http://www.stuff.co.nz/stuff/manawatustandard/0,2106,3193543a6407,00.html">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110888181231057454?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108874617744793672005-02-19T20:37:00.000-08:002005-02-19T20:45:52.066-08:00The FDA may be giving <a href="http://vioxxdaily.blogspot.com/2005/02/fda-panel-says-vioxx-can-come-back.html">their stamp of approval to Merck for Vioxx</a>, but it may not protect them from European plantiffs. <br /><br /><span style="font-style:italic;"><blockquote>More than 100 British patients who suffered heart attacks or strokes while using the controversial painkiller Vioxx are pursuing its US manufacturer Merck in what could become the biggest legal action against a drugs company.<br /><br />Any relief from a decision on Friday by the US food and drugs watchdog to allow Mercks to return its drug to the shop shelves would likely be short-lived, The Business said, warning that claims against the firm could total more than 18 billion dollars over the next decade.</blockquote></span><br /><br />[<a href="http://www.khaleejtimes.com/DisplayArticle.asp?xfile=data/theworld/2005/February/theworld_February491.xml&section=theworld">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110887461774479367?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108858083930070122005-02-19T16:04:00.000-08:002005-02-19T16:08:03.930-08:00THE pharmaceutical industry, battered by safety concerns and regulatory scrutiny, was this weekend celebrating its first significant piece of good news in months.<br /><br /><span style="font-style:italic;"><blockquote>The advisers recognised the risks of Vioxx, and of the similar Pfizer drugs, Celebrex and Bextra, but a majority felt they should still be available to patients.<br /><br />The committee recommended the FDA should introduce a “black box” warning of the risks and ban advertising to restrict prescription. </blockquote></span><br /><br />[<a href="http://www.timesonline.co.uk/article/0,,2095-1491453,00.html">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110885808393007012?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108789187423984732005-02-18T20:54:00.000-08:002005-02-18T20:59:47.426-08:00A Food and Drug Administration panel decided Friday not to ban the popular painkillers Vioxx, Celebrex and Bextra, even though they found the drugs may carry significant health risks.<br /><br /><span style="font-style:italic;"><blockquote>Kim Frain of Anchorage,AK began taking Vioxx last year, to relieve arthritis pain in her knuckles and knees. “It'll feel like how you’re coming down with the flu,” she says. “Your body's real achy. That's what it would feel like, and Vioxx would take care of it within 20 minutes after taking it. And I don't have to take Vioxx every single day. And that's what I like about it, too. I can take it as needed.”<br /><br />Frain is ecstatic about today's FDA recommendation. It wraps up a three-day hearing by two Food and Drug Administration advisory committees. The arthritis drug Vioxx was pulled from the market after the company's research showed long-term users had an increased risk of heart attacks and strokes.</blockquote></span><br /><br />[<a href="http://www.ktuu.com/CMS/templates/master.asp?articleid=11789&zoneid=4">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110878918742398473?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108787678865071592005-02-18T20:31:00.000-08:002005-02-18T20:34:38.866-08:00Experts say these drugs -- members of a group called Cox-2 inhibitors -- should carry strict warnings that they can raise the risk of heart attacks and stroke.<br /><br /><span style="font-style:italic;"><blockquote>"Taking them out of the hands of physicians as though they were a smoking gun is probably too extreme," said Robert H. Dworkin, PhD, a professor and researcher at the University of Rochester School of Medicine and Dentistry in New York.<br /><br />But the FDA should also require strict "black box" warnings on all three Cox-2 drugs to alert patients and doctors to their risks, panel members said. A black box warning is the most serious warning placed on the labeling of a prescription medication.</blockquote></span><br /><br />[<a href="http://my.webmd.com/content/Article/101/105995.htm?printing=true">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110878767886507159?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com4tag:blogger.com,1999:blog-10734880.post-1108787484293407082005-02-18T20:27:00.000-08:002005-02-18T20:31:24.296-08:00Two New Brunswick lawyers are preparing to join a series of class-action lawsuits against Merck & Co., the pharmaceutical giant that pulled its arthritis drug Vioxx from the market last September.<br /><br /><span style="font-style:italic;"><br /><blockquote>Health Minister Ujjal Dosanjh said his department, which sent observers to the FDA hearings, will consider the evidence presented there when coming to its conclusions. But Health Canada's decisions may not mirror those of the U.S. regulator, he said.<br /><br />Meanwhile, other class actions have already been filed in Ontario, Quebec, British Columbia and Saskatchewan. </blockquote></span><br /><br />[<a href="http://www.canada.com/health/story.html?id=e6114a63-108e-4e62-a977-b74b58c3924c">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110878748429340708?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0tag:blogger.com,1999:blog-10734880.post-1108708929276648402005-02-17T22:34:00.000-08:002005-02-17T22:42:09.276-08:00Vioxx, the prescription painkiller implicated in the deaths of thousands of Americans and withdrawn from sale in September, may be reintroduced in the market if the Food and Drug Administration concludes that the benefits of the drug outweighs its hazards, an executive for Merck & Co. said Thursday.<br /><br /><span style="font-style:italic;"><blockquote>For all the concern about the potential hazards of Cox-2 drugs, patients with chronic pain and the physicians who treat them told the committees that those medications were all they had in some cases to make them feel better. They urged the committees recommend that they be kept on the market.<br /><br />"To limit choices based on evolving knowledge is not fair to millions of Americans who suffer arthritis pain," said Dr. W. Hayes Wilson, a rheumatologist from Atlanta. "We must consider both sides of the equation when we decide how to treat patients and what we treat them with. Most of my patients would accept considerable risk if provided with relief from arthritis pain."</blockquote></span><br /><br />[<a href="http://www.kansascity.com/mld/kansascity/news/politics/10928020.htm?1c">Read More</a>]<div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/10734880-110870892927664840?l=vioxxdaily.blogspot.com' alt='' /></div>Mike Grahamhttp://www.blogger.com/profile/01280407949940203774noreply@blogger.com0