Medtronic Sued by 1,000 Infuse Patients
by John FauberMedtronic said about 1,000 people have sued the company over its bone morphogenetic protein-2 (BMP-2) product, Infuse, and that many more lawsuits may be coming.In addition, several states now are looking into sales and marketing practices involving Infuse, which is used in spine surgery.In a statement, company spokesperson Cindy Resman said the cases are in early procedural stages, and none have resulted in a finding of liability against Medtronic.Some court rulings have led to dismissals and others have limited claims."Medtronic stands behind Infuse bone graft and will vigorously defend it in cour...
Source: PharmaGossip - March 5, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
With vaccines…Is there no middle ground, no room for questions?
“We should be as demanding of ourselves as we are of those who challenge us.”
Dr. Jerome Groopman, writing in the New Rupublic
Writing about the medical decision-making surrounding vaccines proved to be sketchy. Yesterday’s post brought stinging criticism from both sides of the debate. A pediatrician felt the structure of the post was patronizing. Just an hour later, a skeptic sent me the same message–patronizing. This was educational.
Criticism is taken seriously here, especially when it comes from both sides of an argument. The reflex: Perhaps its useful to write more on the matter? (It’s f...
Source: Dr John M - December 6, 2013 Category: Cardiology Authors: Dr John Source Type: blogs
Pfizer Peels Back The Curtain On Clinical Trial Data
In response to the growing debate over disclosure of clinical trial data, Pfizer has announced an updated policy and web site that will publish large amounts of information and offer a procedure for independent researchers to obtain study data for analysis. And the drugmaker boasts that its effort exceeds the voluntary aims recently articulated by industry trade groups in the US and Europe.
“Pfizer’s expanded policy, which you can read here, is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient priva...
Source: Pharmalot - December 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Fading Vertex Drug Was Also Fastest To Become A Blockbuster
How is this for irony? The same week that Vertex Pharmaceuticals (VRTX) cuts 15 percent of its workforce due to plunging sales of its Incivek treatment for hepatitis C, the drug has been identified as having achieved blockbuster status faster than any other medicine. Incivek was launched in 2011, by the way, and surpassed Celebrex, which is sold by Pfizer (PFE) but was launched in 1999 by Pharmacia.
The analysis was conducted by EvaluatePharma which reviewed quarterly US products sales and aggregated the first four full quarters after each drug launch in the region. Only five drugs have ever achieved blockbuster status in ...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
AllTrials - The Harvard Way
Report Proposes Ways to Expand Access to Clinical Trial DataResearchers from Harvard, together with members of a group created by the Multi-Regional Clinical Trials Center, released a report last week that proposed ways to expand access to clinical trial data.The report--published online in The New England Journal of Medicine--outlined the possible benefits and risks, ethical and legal issues, and logistical questions associated with expanding access to participant-level data, which have, in the past, been considered confidential by the Food and Drug Administration, which regulates clinical tr...
Source: PharmaGossip - October 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Can Rx Drug Trash Talk - Litany of Side Effects - in DTC Ads Increase Sales?
"Warnings of serious side effects in drug advertising can actually improve consumers’ opinions and increase sales, rather than frightening them away, new research finds." That was the opening statement in a recent PharmaTimes article ("Serious side-effects warnings can increase drug sales: study").All you have to do -- which a LOT of people NEVER do -- to discover that this statement is rubbish -- i.e., a non-sequitur conclusion based on a faulty interpretation of the data -- is to read the original research paper or even just the abstract, which you can find here in case you actually care to read it. Here, let me force ...
Source: Pharma Marketing Blog - September 25, 2013 Category: Pharma Commentators Tags: Drug Safety DTC Advertising side effects Source Type: blogs
Opioid Use Soared, But Pain Treatment Did Not Improve: Study
The use of opioid painkillers may have rocketed over the years, but the beneficial effect these controversial prescription drugs have actually had on pain treatment appears to have been inconsequential, according to a new study. Meanwhile, the use of safer alternatives – specifically, non-opioid analgesic painkillers that do not include opioids – was essentially flat.
The researchers reviewed ambulatory care data between 2000 and 2010 for people who sought medical treatment for pain not associated with cancer and found no significant change in the proportion of visits in which pain relievers were used for treatment –...
Source: Pharmalot - September 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and welcome to another working week. Yes, the weekend has come and gone, although we hope you had a chance to relax and refresh yourselves, because that familiar routine of meetings and deadlines and what-not has resumed. This calls, of course, for a cup or two of needed stimulation and, as always, we invite you to join us. Our flavor today is Pumpkin Spice. Meanwhile, here is the usual menu of tidbits to get you going. We hope you have a grand day and drop us a line if you hear something interesting...
FDA Grants Breakthrough Status To Glaxo And Genmab Leukemia Drug (Pharma Times)
Merck Settles False Viox...
Source: Pharmalot - September 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Medication management
There is all kinds of advice out there on how to safeguard and manage prescriptions. One article I read recently even advised keeping them in a safe. I thought that was a bit of overkill but I am careful.I have several issues with my medications. One of them is toxicity to others. My cat can't recognize a chipmunk under his nose these days but there is a family joke about the vioxx incident* that he survivied. I wouldn't put it past him to try to ingest something he finds on the floor. I am currently on methotrexate which is actually a chemotherapy drug which comes in little sealed bottles and has all sorts of warnings.I m...
Source: Caroline's Breast Cancer Blog - September 16, 2013 Category: Cancer Tags: prescriptions medication Source Type: blogs
Pharma Blasts EMA Draft Policy On Disclosing Clinical Trial Data
In the latest bid to thwart the European Medicines Agency from proceeding with a new policy for disclosing clinical trial data, the pharmaceutical industry has openly challenged the effort by arguing the suggested approach would weaken safeguards for protecting patient privacy, undermine trust in the regulatory system, increase the risk data would be misinterpreted and weaken incentives for research.
The European Federation of Pharmaceutical Industries and Associations “has serious concerns about the EMA draft policy, which carries negative implications for public health in its failure to adequately protect the interests...
Source: Pharmalot - September 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Bad Break: Merck Faces Hundreds Of Individual Fosamax Trials
In a setback for Merck, a federal judge late last week ordered hundreds of lawsuits over its Fosamax osteoporosis drug be dispersed to courts around the country for trial. The move means the drugmaker can be expected to face higher costs associated with litigating the lawsuits instead having them remain consolidated before just one judge in a mass-tort litigation.
The order by US District Court Judge John Keenan involves shifting 200 cases per month back to courts where they were initially filed, beginning with the oldest suits. He has overseen about 20 percent of the 5,075 lawsuits filed in federal and state courts around...
Source: Pharmalot - September 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Hundreds of Fosamax lawsuits vs. Merck ordered readied for trial
Aug 30 (Reuters) - A federal judge overseeing consolidated litigation against Merck & Co over jaw injuries allegedly caused by the osteoporosis drug Fosamax has ordered hundreds of cases be dispersed to courts across the country for trial.
The decision by U.S. District Judge John Keenan in Manhattan marks an unusual and potentially costly development for Merck.
Companies often find it easier to reach settlements in mass tort cases that are consolidated before one judge.
"It's a big deal as it changes the cost paradigm for Merck exponentially," said Timothy O'Brien, a partner at Levin, Papantonio, Thomas, Mitchell, R...
Source: PharmaGossip - August 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Patients Should Beware When New Drug for Overactive Bladder Soon
Becomes Available Over-the-Counter
Advisory Committee Rejected Increased Availability but Was Ignored by FDA; Story Told in New Issue of Public Citizen’s Worst Pills, Best Pills NewsWASHINGTON, D.C. – When a new over-the-counter (OTC) version of a drug for overactive bladder becomes available without a prescription in the fall, people should avoid it if they haven’t first talked with their doctor, Public Citizen advises in the latest edition of Worst Pills, Best Pills News (WorstPills.org), Public Citizen’s drug safety newsletter and website.The manufacturer of oxybutynin (Oxytrol for Women), a drug for overactive bladder (O...
Source: PharmaGossip - August 3, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
Once again, another working week is about to draw to a close. And not a moment too soon. After a long week of high temperatures, we are ready to daydream about weekend plans. In fact, we are getting a head start, since we are rolling in the sidewalks this morning in order to take a few hours off to spend with Mrs. Pharmalot and one or more short people. We are also looking forward to catching up on some reading, puttering around the official Pharmalot grounds and socializing with other humans. And what about you? Perhaps the great outdoors are beckoning or this is an opportunity to reach out to someone special. You could a...
Source: Pharmalot - July 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Can Merck Finally Get Past the Vioxx Scandal?
Merck & Co. (NYSE:MRK) has already doled out $4.85 billion to resolve lawsuits related to its Vioxx painkiller, and the company has been ordered to pay an additional $23 million on charges that it mislead customers about the drug’s safety and efficacy.Save Time Make Money! A new stock idea each week for less than the cost of a trade. CLICK HERE for your Weekly Stock Cheat Sheets NOW!Litigation over the drug has been ongoing since 2005, when 87 people filed a lawsuit against the pharmaceutical company alleging that Vioxx caused heart attacks and other injuries. A settlement of those charg...
Source: PharmaGossip - July 19, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
