After years of complaints about the dangers of Avandia, the FDA has decided to remove it from the marketplace, except in special circumstances beginning in November 2011. Avandia use has been associated with increased risk for heart attacks and other cardiovascular problems.
The FDA decision is widely viewed as a compromise position between doing nothing and removing the diabetes altogether. Avandia will remain available for those who’ve shown a demonstrable benefit from use of the drug.
First introduced in 1998, Avandia came under increased scrutiny after a 2007 New England Journal of Medicine highlighted the potential dangers of the drug.

Recently, the FDA has issued a letter to the manufacturers of metal-on-metal hip replacements. The letter states that the FDA will require the medical device companies to report hip replacement failures as well as test the level of metal in hip replacement patients, among other things.
The letter was issued because so many of these types of hips such as the DePuy ASR XL, the DePuy Pinnacle, Smith & Nephew’s Birmingham hip replacement to name a few, were fast tracked to the marketplace without having to undergo rigorous pre-market screening and testing. The logic behind the decision was that these metal-on-metal hips were substantially similar to previously approved hip replacements. Obviously, that logic was flawed and as a result many metal-on-metal patients will have to undergo painful and complicated revision surgeries.
Hip replacement patients have to rely on their doctors for guidance as to the type of hip replacement they receive. Doctors, in turn, rely on agencies such as the FDA to know which hips are appropriate for the individual hip replacement candidate. When the system breaks down as it has in this case, doctors are left in the dark and the patients suffer.
Hip replacement manufacturers want to make a profit and the faster they receive approval to move a product to market, the better. However, such short-sightedness comes at a cost, a cost borne by the patient and the medical community. It’s time that all such medical devices undergo rigorous and thorough scientific review PRIOR to their approval for market. Patients deserve it and so does the medical community.

The NY Times has published a story this morning about the US Catholic bishops 5-year study on the root causes of the priest sex abuse scandal. The John Jay College of Criminal Justice conducted the study and concluded that the abuse scandal can neither be blamed on celibacy or homosexuals. Rather, the study concluded, the tumultuous period of the 1960’s and 1970’s contributed to the overall social upheaval that led to the priest abuse scandal.
This conclusion neither angers the traditional crowd who oppose any loosening of the celibacy requirements for priests nor the homosexual community who perceive themselves as unjustly targeted by those who want to blame somebody for the priest abuse scandal.
It’s a cynical stroke of genius. Once again, the Catholic Church gets to show us all how concerned they are by issuing a comprehensive report that took five years to compile. They also get to blame a decade (not a person or institution) for causing the scandal.
Just like those who want to blame drugs and sex on the 60’s, the Catholic bishops get to heap their woes on the decade of “peace and love”.
However, it’s simply not true. The 60’s didn’t cause or create the pederast priests to terrorize children. A closer inspection of the US Catholic Church in the 1960’s reveals a Church still celebrating the sacraments in Latin. The Second Vatican Council didn’t end until 1965. Nuns were still, for the most part, wearing their traditional habits. Nothing had changed culturally in US Catholicism in the 1960’s. The Church, apart from a courageous lot who participated in the Civil Rights Movements, looked no different in 1965 than it did in 1945. Sorry, but you can’t blame this on the 60’s. That decade deserves much better.
I would have been hopeful if the John Jay study had actually examined the insular culture of the institution that preferred to protect predatory priests than children. I would have been interested in a study that examined the mindset of bishops who colluded with these abusive priests by transferring them and covering for them. Finally, I would have liked to have seen a study that looked at a Church that stubbornly refused to report crimes to law enforcement.
We didn’t get such a report and we many never receive such from a Church sponsored study. The John Jay study is another ecclesial exercise in navel gazing with its sole purpose to deflect blame and criticism. They still don’t get it.

The Congregation for the Doctrine of the Faith, the Vatican department presently in charge of priest sex abuse cases, has issued a circular letter to all the bishops of the world with its suggestions for dealing with the worldwide crisis of sexual abuse. The letter focuses its suggestions on five specific areas of concern to the Vatican. Here they are:
* Listening to the victims of abuse and offering “spiritual and psychological assistance”.
* Creating “safe environment” programs to prevent future abuse.
* Promoting “a healthy human and spiritual formation” of future priests, including “an appreciation of chastity and celibacy.” The guidelines also call for “an exchange of information” when candidates transfer from one seminary to another, or between dioceses or religious orders.
* Upholding the presumption of innocence when a priest is accused, yet conforming that a bishop or religious superior “is always able to limit the exercise of the cleric’s ministry” while the case is investigated.
* Stressing that “the prescriptions of civil law regarding the reporting of such crimes to the designated authority should always be followed.”
The letter is widely available on the web and anyone who reads it will be puzzled by its publication and not clear as to what the Vatican hopes to accomplish. There is nothing new in the letter as far as the Church’s rhetoric. The fact that they really don’t say anything new leads one to believe the Vatican has still not come to grips with the depths of the problem or the severity of the suffering of the survivors.
Ultimate authority remains with the bishops who have acted in the view of many as the keystone cops. (Others may apply more sinister analogies especially after the Philadelphia debacle.) There is still no universal reporting requirement and there’s nary a mention of what to do with priests who move from one diocese to another after being accused of sexual abuse.
All in all, this isn’t news at all. It’s a weak and tardy response to a critical problem that needs radical measures. So far, the Church hierarchy is unwilling to consider such moves. That’s why civil authorities must continue to drag the Church to justice and accountability.

The FDA has ordered a comprehensive review of all metal-on-metal artificial hips, irrespective of the model or the manufacturer. The order was communicated in an FDA letter sent this past Friday to all hip device manufacturers including Stryker, Johnson & Johnson’s Depuy Orthopaedics, Biomet and Wright Medical, according to the NY Times.
The broad study comes in the wake of mounting concern that the problems with metal-on-metal hip implants is not isolated to a particular design or a particular manufacturer. The FDA is concerned that the problem may be much wider spread than previously thought. In the FDA letter, hip device manufacturers were told the FDA was invoking a federal rule requiring postmarket studies of each metal-on-metal hip implant device. Some analysts believe that such a postmarket study reflects a failure on the part of the FDA for allowing such metal-on-metal hip implants move to market without rigorous premarket testing.
The FDA order compels manufacturers to test their hip device products as well as conduct an extensive study of patients who’ve received these metal-on-metal artificial hips. The manufacturers will have to submit failure rates for their hip devices as well.
The patient study will focus on whether patients have experienced hip failure as well as whether the artificial metal hips are shedding high levels of cobalt into the bloodstream which can lead to a condition known as metallosis. The FDA is requiring hip device companies to provide blood tests to hip implant patients in order to determine the level of metallic debris in their bloodstream.
The NY Times interviewed Dr. William H. Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health. Maisel commented that “Our concern is the product, not about a manufacturer.” He acknowledged that the hip review is significant in that it marks the broadest review of any medical device after the device has already gone to market.
Until news of potential failure issues with the metal-on-metal hips began surfacing a few years ago, the metal hip devices had accounted for nearly one-third of the 250,000 hips implanted annually in the United States.
Unlike other countries, the United States has no medical device registry. This will make the FDA’s order more difficult for medical device manufacturers to track the hips and the patients who received them. The FDA has given the manufacturers 30 days in which to propose their review plan to the federal agency.
Some metal hips have been subject to scientific scrutiny as well as hip device lawsuits already. Johnson & Johnson’s subsidiary DePuy Orthopaedics is the subject of a class of lawsuits for which a multidistrict litigation has been formed in Ohio.
This past March, British Orthopaedic Association estimated that the DePuy ASR XL had a failure rate of 50% within the first six years of implantation. They also believe that other manufacturers of the metal-on-metal hip implants have a higher than expected and reported hip failure rate.
The metal-on-metal hip implants had been touted as an improvement over the older hip devices since they were purportedly able to offer more flexibility and resilience for those seeking to maintain an active lifestyle.

The title of this blog post is a warning to all those who don’t want to read stories about Catholic bishops destroying documents. The National Catholic Reporter published a story about the Archbishop of Denver, Charles Chaput who recently visited an Australian diocese purportedly to report back to Rome about his findings. The bishop there, Charles Morris, has been fired for his opinions on clerical celibacy and women’s ordination. According to NCR, “NCR Editor at Large has been following the story and reports on today’s Web site that Morris, referring to a report written by Archbishop Charles Chaput, said to Roberts he knows it exists because Chaput sent him an e-mail ‘telling me that he’d sent an electronic copy as well as a hard copy to the dicastery for bishops, and then he did what he was supposed to do. He destroyed both the electronic copy and the hard copy, so he didn’t have a copy any more.”
Chaput, a loyal Roman foot soldier followed the instructions of a Roman dicastery which, in turn, follows the direct orders of the Pope, instructed Chaput to destroy the evidence.
The incident should be deeply disturbing to all of us. However, it’s revealing in that it shows the institutional culture that weeds out those whom the institutional protectors consider dangerous. If the Church acts in such a fashion in these matters, why would one think it wouldn’t do the same in matters involving clergy sex abuse?
In both instances, scandal is the primary thing to be avoided, and at all costs. Destruction of documents serves that end. Wouldn’t anyone who’s unswervingly loyal to the institution act in such a manner?

Almost a decade after the latest sex abuse scandal cycle rocked the Catholic Church, the Vatican is finally getting around to issuing guidelines for sex abuse cases. It’s tardiness and the Church’s bad record on policing its own regarding the abuse of minors, has left many to ridicule the news of such guidelines. In many corners of the world, the Vatican’s announcement is a “little too late” to say the least. Such guidelines won’t help to alleviate the notion that the Catholic Church has done everything in its power to protect the institution rather than protecting children.

Merck Serono SA, one of the world’s largest pharmaceutical companies, has settled its drug kickback case with the US Justice Department by agreeing to pay $44.3 million. Federal prosecutors were pursuing charges against Merck that the drug maker illegally paid doctors to prescribe their multiple sclerosis drug Rebif to patients. The investigation concerned the company’s activities from 2002-2009. The Justice Department found that Merck paid doctors to go to training conferences and seminars at upscale, posh resorts in exchange for prescribing the MS drug.
“The health care of our seniors and other vulnerable citizens under the Medicare and Medicaid programs should be based upon sound medical decisions, not upon decisions tainted by influence and corruption,” said Tony West, assistant attorney for the Justice Department’s civil division.
Merck is not the only pharmaceutical company to have legal issues with the Justice Department. Both Eli Lilly and Pfizer have paid similar penalties for kickback schemes. Unfortunately, such financial penalties don’t deter such large companies from engaging in illegal activity. The profits the companies stand to make far outweighs the financial penalties they face if the federal government investigates them.

Lawyers for survivors of Dr. Reardon’s sexual abuse finished closing arguments yesterday. The trial is now in the hands of the jury. The survivors have contended that St. Francis Hospital and Medical Center failed to supervise and monitor so-called “growth” studies performed by Dr. George Reardon who has been accused of abusing hundreds of young boys under the guise of medical exams.
According to the Hartford Courant, “The jury began considering a verdict at about 4 p.m. Thursday, after the hourlong summations and after Superior Court Judge Dan Shaban, presiding over the trial’s fifth week, gave them instructions in applicable law.
Doe’s suit against the hospital contains two counts for the jury to consider. Both accuse St. Francis Hospital and Medical Center of negligence that contributed substantially to Reardon’s ability to abuse children.
The first contends that the hospital’s failure to apply generally accepted scientific standards of review to research by Reardon resulted in the abuse of Doe. It also claims that St. Francis failed in a special duty under state law to provide care to vulnerable children in its custody, including Doe.”

A 28 year old middle school teacher, Joel A. Huddleston, has been arrested on charges of lewd and lascivious molestation of a child. In addition to his teaching duties, Huddleston coaches the girls’ basketball team.
According to the local CBS affiliate, “Joel A. Huddleston, of 3844 NW 30 Ave., also is youth pastor at the Buckhead Ridge Christian Church, according to the Okeechobee County Sheriff’s Office.”