Monthly Archives: September 2010

New Deaths Linked to Gardasil Use

Gardasil, Merck & Co.’s vaccine designed to prevent certain forms of the human papillomavirus, has been linked to 16 deaths. The new information about the dangers of Gardasil has been reported by Judicial Watch, a consumer watchdog group that obtained the information from the FDA. The deaths occurred between May 2009 and September 2010. The report includes nearly 4,000 adverse reactions to Gardasil including 213 involving permanent disability. Additionally, the report includes 25 cases of young girls contracting Guillian Barre Syndrome, an autoimmune disorder affecting the peripheral nervous system. The Syndrome is one of the leading causes of non-trauma-induced paralysis in the world.
“To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch,” said Judicial Watch President Tom Fitton. “In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children.”

Avandia Restricted in US, Banned in Europe

Avandia, GlaxoSmithKline’s controversial diabetes drug, will have its sales restricted in the US and altogether removed from the European marketplace. The moves come after a long series of reports and studies that Avandia increases the risk of heart attacks and strokes in diabetes patients. Some reports have also expressed concerns about Avandia’s effectiveness especially in comparison with other diabetes drugs such as rival Actos.
According to the Wall St. Journal, “The FDA will require GlaxoSmithKline to develop a restricted access program for Avandia that would make it available only if other types of drugs fail to properly treat diabetes. Patients currently taking Avandia can continue on the medication.”

DePuy Hip Defects Were Known in 2007

“It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people,” that’s according to Professor Stephen Graves, head of the Australian National Joint Replacement Registry. Graves was speaking on the record with the Independent, a United Kingdom media outlet about the recent recall of DePuy’s ASR hip replacement medical devices.
According to Professor Graves, the Australian Registry had sent DePuy, a subsidiary of Johnson & Johnson, had sent DePuy seven reports concerning defects with their ASR hip product back in 2007. The DePuy hips were taken off the Australian market in December 2009.
Graves believes the medical device company is liable for the needless suffering of thousands of patients who’ve since received DePuy hips. According to him, the fact that DePuy neglected to publicly announce the problems with the defective hips until recently is irresponsible.

Johnson & Johnson Investigated for a Drug Recall that Wasn’t

The House on Oversight and Government Reform is investigating whether Johnson & Johnson avoided a recall of its product Motrin by having a private contractor buy the product off store shelves. The pharmaceutical company and medical device manufacturing company has been rocked by drug recalls as well as medical device product defects the last few years including the DePuy ASR hip replacements that were recently recalled due to defects.
The issue involving Motrin has the FDA and J&J in a “he said she said” standoff. J&J officials maintain that they kept the FDA informed of the Motrin purchases while the FDA claims they were never informed of such a decision.
A hearing is scheduled for September 30 and the committee chair, Rep. Edolphus Towns plans to call J&J CEO William Weldon to testify as to what actions were taken and if the company was trying to evade a recall of its popular drug Motrin.
The Motrin problem began in November 2008 when J&J discovered that certain Motrin pills were not dissolving properly due to a manufacturing problem in the company’s San Juan Puerto Rico plant.
Besides the DePuy hip recall and this latest problem with Motrin, the company has also faced scrutiny and criticism for manufacturing defects that forced the recall of its popular Tylenol products.

DePuy Hip Lawsuits May Be Consolidated

DePuy Hip lawsuits against the manufacturer Johnson & Johnson may be consolidated into a multidistrict litigation. A motion for such consolidation was filed on September 3rd with the US Judicial Panel on Multidistrict Litigation.
Lawsuits that are consolidated into an MDL are normally approved if they have similar fact patterns, the same defendant, and demonstrate that such consolidation will expedite the lawsuits through the court system.
The hip manufacturer, Johnson & Johnson recently announced a DePuy hip recall of the device after data from the National Joint Registry of England showed that 12-13% of DePuy hips have had to be replaced within 5 years of implantation. Approximately 93,000 DePuy hips have been implanted worldwide.
Because Johnson & Johnson does not maintain a database of DePuy hip transplant patients, those who’ve undergone a hip transplant since July 2003 have been advised to check with their surgeon about their hip implant. Even those patients who are not experiencing any symptoms of hip implant failure have been encouraged to check with their surgeon for further testing in order to determine if their hip is defective.

7 MRI Drugs Get Tougher FDA Warnings

Certain drugs used as contrast agents in MRIs will get new, tougher warnings from the FDA due to their association with a dangerous skin condition known as nephrogenic systemic fibrosis. The drugs are gadolinium-based contrast agents which pose a higher risk when used in patients with kidney disease.
In announcing the new warnings for the MRI contrast agents, the FDA also noted that three gadolinium-based contrast agents should not be used at all in patients with kidney disease. They are Covidien PLC’s Optimark, Bayer AG’s Magnevist, and General Electric Co.’s Omniscan.
NSF is a rare but potentially fatal skin disease characterized by excessive fibrous connective tissue in the skin, eyes, joints, and internal organs. The FDA also stated that there have been no known cases of NSF in patients who have no kidney problems.

Abuse in God’s Country

Last weekend I was driving through the Blue Ridge Mountains on a trip from my home in Florida to the funeral of an old friend in Kingsport, Tennessee. The weather was clear and cool and the wilderness of the mountains was beautiful. Some people refer to such areas of natural splendor as God’s Country. As I drove down the rural road into the town of Kingsport, Tennessee past the abandoned mills and the farmers market I drove past St. Dominic’s Catholic School in Kingsport. The school was dark as it was Saturday but I could not help wondering whether children had been abused in that school. I tried to dismiss this dark thought from my mind as bias from all of the survivors of abuse by catholic clergy that I had represented over the years. I was not working this weekend so I went back to thoughts of times with my deceased friend in the past.
I stopped at a local cafe in Kingsport for breakfast. I did not want to go to a chain restaurant that could be anywhere in the U.S. so I found a friendly local establishment. I enjoyed hearing the local residents at the cafe greet each other and discuss local events. I then picked up a local newspaper to see if my friend’s obituary was printed. The headline on the front page above the fold stated: Former Kingsport priest to face charges in Sullivan County .
The story in the Kingsport Times News reported a grand jury indictment of former catholic priest William “Bill” Casey for horrible child sexual assault and rapes that began in 1975 at St. Dominick’s Catholic School against a 5th grade student. Casey was also indicted in Virginia on August 2, 2010 for forcible sodomy and indecent liberties on a minor that occurred in 1978. Casey has pled guilty to North Carolina charges of crimes against nature in July, 2010. I admire the survivor of the abuse who had the great courage to come forward with his report after all of these years. He was assisted and supported by brother and sister survivors in SNAP, the Survivors Network of those Abused by Priests, an organization dedicated to assisting survivors recover from abuse and protecting children.
I also admire the prosecutors who were willing to listen to the survivors and take action. Many prosecutors are hesitant to bring charges where many years have passed and survivors have been fearful or unable to come forward.
It appears that William Casey was a serial child abuser for decades and likely abused scores of children. Where are his Bishops and the church leaders who allowed this to continue? The Statutes of Limitation will likely prevent any civil lawsuit that could find out what the Bishops knew and when they knew it. Holding former father William Casey accountable for his crimes is only a beginning to the dark secrets that lurk at St. Dominic’s School in Kingsport, Tennessee.

In Latest Defective Hip Recall, Company Wants the Hips

DePuy Orthopaedics has told patients fitted with their defective DePuy ASR AX acetabular system that the company will pay for corrective surgery only if the patients give the company the defective hips as well as the corresponding medical records.
While it’s not known exactly how many US patients have suffered as a result of the DePuy defective hip, there are 3,516 Irish patients who’ve been fitted with the defective hip replacement parts. Patients who’ve received the recalled DePuy hips are encouraged to consult with their doctors and ask for blood tests in order to determine the extent of the damage caused by the hip replacement system. The DePuy hip replacement parts cause high levels of metal ion to be released into the patient which has an adverse affect on the surrounding tissue. This makes any revision surgery to fix or replace the hip very complicated.

Diet Drug Meridia Shown to Increase Heart Attack and Stroke Risk

Another diet drug has been shown in a clinical trial to significantly increase the risk for heart attack and stroke among its users. Abbott, the maker of diet drug Meridia, sponsored the study which showed the increased heart attack and stroke risk among those with underlying heart disease. However, the drug generically known as sibutramine has been banned in Europe. The brand name in Europe was Reductil.
An FDA panel will meet later this month to decide if Meridia should remain on the US market. The FDA decision will have to deal with conflicting testimony since the study’s authors, including W. Philip T. James, MD, DSc, of the London School of Hygiene and Tropical Medicine, believe Meridia should remain on the market as long as it is not used by those with underlying heart conditions. However, the editors of the influential New England Journal of Medicine disagree and are calling for an outright ban of the diet drug. The two conflicting points of view have been published in the September 2nd edition of the New England Journal of Medicine.
The Journal’s editorial opinion seems compelling in that it reasons many patients who are obese have undiagnosed heart issues and that Meridia has not shown significant benefit to those trying to lose weight. According to WebMD which quotes the Journal editorial, “Since “the modest weight loss with [Meridia] did not translate into clinical benefit,” the editors say, “it is difficult to discern a credible rationale for keeping this medication on the market.”
The FDA panel is scheduled to make its decision by September 15.