I can’t get that Tai-Chi woman out of my head from the initial Celebrex ads way back when–remember those ads? Regardless, if you were buying Celebrex (or Bextra) back then, just a reminder…the deadline to file a claim (or opposition) for the Pfizer Bextra and Celebrex Settlement is October 23, 2009…16 days from now.
The lawsuit claimed that Pfizer marketed Bextra and Celebrex as having more benefit than non-selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen or naproxen (that you can find on drugstore and grocery store shelves), when such benefits had not been established. Additionally, the lawsuit claimed that Pfizer’s marketing of Bextra and Celebrex was inconsistent with their FDA-approved labels, and that these false marketing tactics made consumers pay more for Bextra and Celebrex than they might have been able to pay for OTC NSAIDs, or no medication at all.
The Bextra/Celebrex Settlement is $89 million, and will be paid out in the following manner: 70% to Third-Party Payors, and 30% to consumers.
If you paid for a Bextra or Celebrex prescription on or before July 29, 2005, you may be part of the class and eligible to file a claim. Read the rest of this entry »
What’s it going to take to make unscrupulous drug companies come clean? Now we have another drug scandal—this time it’s Seroquel. In 1997 Seroquel was approved by the FDA and at the same time, Study 15 showed that weight gain and diabetes were seen in study patients. But in its infinite wisdom, the FDA said it does not have the authority to place such studies in the public domain; instead the agency deemed the drug “safe and effective”. It’s mind-boggling how a drug company can manipulate a government agency and control publicly available research about their products.
Pharmaceutical companies are supposed to announce publicly when a clinical trial is underway and its goals, but according to a study by the Ottawa Hospital Research Institute, many tests are conducted without this disclosure and selective results—hiding the results of negative trials and only publishing studies that show their products in a positive light—is widespread. Read the rest of this entry »
It’s enough to make your blood boil.
Last week it was revealed that the US Food and Drug Administration (FDA) admitted that it bowed to political influence when it approved a medical device its own scientists had deemed repeatedly as affording little benefit to the patient.
The name, or indication of the device matters little. Neither does the identity of the manufacturer involved, or the four members of Congress who applied what was described as relentless pressure (read lobbying) to get a product approved. Who they are doesn’t matter.
What matters are the process, and the loss of principle.
In a nutshell, a device that was deemed unsafe by FDA scientists because it often failed was approved anyway by the agency. Behind the approval was the relentless lobbying of a handful of Congressmen who represented the state where the manufacturer involved calls home. The Congressmen involved also, according to a September 24th report in the New York Times (NYT), received political contributions from the executives of the manufacturer involved. Read the rest of this entry »
We’re approaching the two year anniversary of the FDA recall of all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. So why bring it up? Well, in light of the seemingly endless number of defective products that make their way onto the market every year, the CD Horizon provides a cautionary tale.
The device was developed to relieve spinal pain, and was surgically implanted. Sadly, the CD Horizon spinal system was prone to failure, causing patients more pain rather than less.
The device was approved on the strength of risk analyses by Medtronic which allegedly claimed Read the rest of this entry »
If you’re like me, you’ve already started to stockpile the usual meds for cold and flu and fever season. With kids back to school, back to daycare, and with all the frenzy over potential flu outbreaks, it’s almost a necessity. But check your medicine cabinets for this one: Johnson & Johnson’s McNeil division has voluntarily recalled 57 lots of infants’ and children’s liquid Tylenol products because of possible bacterial contamination.
According to J&J, an inactive ingredient didn’t meet internal testing requirements and B. cepacia bacteria were detected in a portion of raw material that went unused in the finished product. J&J went on to say that no bacteria were found in the finished product, and that the likelihood of a serious medical event is remote. However, in consultation with the FDA, the company decided to recall the products.
If you have questions, call the consumer call center at 1-800-962-5357.
(source: Tylenol.com) Read the rest of this entry »