Monthly Archives: July 2010

New Sex Abuse Laws and Women’s Ordination

I purposely waited to blog on this subject for a few weeks hoping Church officials might offer a coherent explanation of why it would bundle the issue of women’s ordination into the same document in which it announced new laws governing the sexual abuse of minors by Catholic priests.
The coherent explanation never came so I will speculate and offer my own thoughts on the subject. The document was published in order to discuss what the Church calls “delicta graviora” or the worst sins. While I would agree that the child sexual abuse by priests would clearly fall into that category, it’s hard to understand why the Church would consider women’s ordination a “delicta graviora”. The Vatican’s subsequent explanation doesn’t help matters. According to Msgr. Charles Scicluna, the priest in charge of punishing sexually abusive priests, “”There are two types of `delicta graviora’: those concerning the celebration of sacraments, and those concerning morals,” Scicluna told reporters at the Vatican. “The two types are essentially different, and their gravity is on different levels.”
The document has been received with a mixture of ridicule and ire. Some of the Catholic faithful are stunned by the move.
“Sometimes you wonder what they are thinking,” said Sister Christine Schenk, executive director of Cleveland-based group FutureChurch, which advocates for increased lay leadership in the Catholic Church.
“This is apples and oranges. The phenomenon of women wanting to serve God does not belong in same category as priests abusing children. I am frankly stunned.”
The portion of the document dealing with sexually abusive priests makes it easier for abusive priests to be removed from the priesthood. However, it neglects to deal with the larger, more important problem-the bishops who have transferred, covered up and lied for these priests. Anyone who has followed the Catholic priest scandal and the sex abuse crisis knows that there would be no scandal or crisis if the bishops hadn’t been complicit in their cover-up and cooperation with the abusers. This is the heart of the problem which remains unaddressed by the Vatican. The new laws don’t deal with the institutional, systemic problem of sexual abuse.
That’s why the civil justice system has played and continues to play a significant role in shaping public opinion and changing laws in order to protect children from further and future sexual abuse.

FDA Stops Avandia Study

A week after an FDA advisory panel voted to allow Avandia to remain on the market, the same regulatory agency put a halt to a controversial study in which Avandia was compared to its chief rival Actos in terms of effectiveness in treating diabetes. The FDA ordered Avandia manufacturer GlaxoSmithKline to stop enrolling candidates for the study.
The Boston Globe reported that the Avandia study was halted because the FDA needed more time to study the risks associated with Avandia. This may strike some as odd since Avandia risks have been well documented since the 2007 Cleveland Clinic study first determined that Avandia was a risky drug that was not effective in treating diabetes.

Zimmer Durom Hip Recall Lawsuit

In July 2008, Zimmer Holdings Inc., the manufacturer of the Zimmer Durom cup hip replacement device, suspended the product for what the FDA later called its “use/surgical technique instructions are inadequate”. Essentially, the Zimmer Durom cup hip replacement was recalled because the acetabular cup has shown signs of loosening and dislodging in a number of Zimmer hip clients. The Zimmer hip was designed so that the acetabular cup would allow for bony ingrowth which in turn would keep the cup component in place.
If you’ve had a Zimmer Durom hip replacement and have experienced pain, you should consult your surgeon. Some of the failed Zimmer hips have required revision surgeries in order for the loose hip component to be repaired or removed altogether.

Avandia’s Safety Issues Began from the Outset

The NY Times is reporting this morning that as early as 1999 GlaxoSmithKline were secretly trying to determine the safety and effectiveness of its blockbuster diabetes drug Avandia. In the spring of 1999, the pharmaceutical company ordered a secret study comparing Avandia with rival Actos made by Takeda. The results were not good. The study showed that Avandia was no better than Actos in treating diabetes. However, it did beat Actos in one category-it was much more dangerous for the heart.
According to the NY Times, GlaxoSmithKline spent the next 11 years trying to hide the results of these early tests. Rather informing the public of Avandia’s risks, the pharmaceutical company decided to bury the report and engage the public and the federal government in a massive cover-up. Funds that could’ve been spent on research and development to improve the poor-performing Avandia went instead to a PR campaign built on lies and obfuscation.
Today, the NY Times published an excerpt from one of the emails that discusses the cover-up, “Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.
It would take another six years before the first public critique of Avandia saw the light of day. In the interim, thousands of unsuspecting doctors and diabetes patients took Avandia not knowing they were putting themselves at an increased risk of heart attacks.
Avandia Class Action Lawsuit

Avandia Safety Hearing Set for Next Week

The Food and Drug Administration will hold hearings in Washington beginning next Wednesday concerning the safety and effectiveness of GlaxoSmithKline’s diabetes drug Avandia. It is not clear if the federal agency is inclined to remove the drug from the market after some research has shown the drug to significantly increase the risk of heart attacks. Other research has called into question the drug’s effectiveness in comparison with similar drugs on the market.
“There is not complete unanimity within the FDA about the interpretation of these data,” Dr. Janet Woodcock, head of the FDA’s drugs center, told reporters on Thursday.
Issues with the drug’s safety began when a 2007 Cleveland Clinic study found that the diabetes drug was associated with a higher heart attack risk in Avandia users.
After hearing expert testimony, the FDA has several options which it will consider: a)removing Avandia from the market, b)restricting its use, c)adding stronger warnings, or d)removing the heart attack warnings altogether. The last option seems the least likely given the controversy over the drug and the influence of those researchers clamoring for the drug’s removal.
Avandia Class Action Lawsuit