Yesterday, The Wall St. Journal published an op-ed piece by the commissioner of the Food and Drug Administration Margaret Hamburg. As to be expected, it was an apologia for the beleaguered federal agency. It should come as no surprise that it was published in the Wall St. Journal rather than the NY Times. However, to be fair, the Journal has been balanced in its reporting of FDA shortcomings and controversies, especially concerning their 510(k) approval process for medical devices.
Commissioner Hamburg does not have an easy task in overseeing the FDA. On one hand, it’s critical for an appropriately expedient approval of drugs that benefit the consumer and may save lives. On the other hand, patient safety requires exacting scientific standards that are often at odds with the marketing and business plans of the large pharmaceutical and medical device companies. Of course, it would be tremendously helpful to the FDA if all pharmaceutical and medical device companies considered safety issues as vital to their own bottom line as the profits made from the sale of these products. There exists an inherent tension and at times, a conflict of interest within these companies. That tension and/or conflict exists between the scientific research divisions and the marketing divisions. Unfortunately, in some instances the marketing division influences and dominates the research. In these cases, it falls to the FDA to step in and ensure patient safety. Perhaps the best and most recent example of such tension can be found in the marketing and sale of the metal-on-metal hip replacements, some of which have failed-the DePuy ASR XL and DePuy Pinnacle hips are the most obvious instances of this. In light of this, the FDA has intervened and called for a thorough review of these metal-on-metal hip replacement devices. For some patients who’ve already suffered through revision surgeries, FDA action has come too late.

A federal panel is urging the FDA to take a more detailed look at the approval process for medical devices. The recommendation comes in the wake of a spate of medical device recalls and failures in the past two years. The FDA has already taken some action regarding hip replacement medical devices after a rash of hip replacement failures and recalls that involved the DePuy ASR XL and DePux Pinnacle metal-on-metal hip devices.
The 12 member panel at the Institute of Medicine, a part of the National Academy of Sciences, is expected to carry significant weight and influence the FDA’s ultimate decision. The panel has recommended that the FDA review and revise its 510(k) review process under which the FDA approves medical devices without human studies if the device is “substantially equivalent” to others already on the market. That simpler approval process, known as a 510(k) approval, generally doesn’t evaluate the safety and effectiveness of a product in the way that is required for most drugs. This quicker approval process has led to criticism and resulted in device failures and recalls in the last few years.

On Friday Common Pleas Court Judge Lillian Ransom ruled that Monsignor William Lynn will stand trial on a charge of conspiracy to endanger the welfare of children. Lynn had been a top official in the Archdiocese of Philadelphia under Cardinal Anthony Bevilacqua. Prosecutors contend that Lynn knowingly assigned priests who’d been accused of sexually abusing minors to parish assignments within the Archdiocese where they would have the opportunity to continue to molest children.
The Lynn case is significant because it marks the first time in the United States a Catholic priest who is not accused of physically molesting a child stands charged with a crime of covering up and allowing the sexual abuse to continue. Philadelphia prosecutors had been frustrated for years that they had not been able to prosecute top-ranking Archdiocesan officials.
While the latest grand jury report recommended criminal charges against Monsignor Lynn, the conspiracy charge was later added by the prosecution. According to the Philadelphia Inquirer,
“In the criminal case, for the child-endangerment charges to rise to the level of felony, prosecutors must show that Lynn colluded with others over a long time to put children, even unintentionally, in harm’s way. As evidence, they introduced on July 22 thousands of pages of grand-jury testimony that Lynn, two bishops, several accused priests, and Bevilacqua gave between 2002 and 2004.:

We’ve seen this time and time again. On more than one occasion, we’ve been directly involved in it. I’m talking about Catholic Church documents related to the abuse of minors by priests. The Church’s lawyers do everything in their power to keep them secret and we fight to get them released to the general public. After all, the real issue is child safety. That same fight has taken place in Philadelphia where state prosecutors had to fight to release the grand jury testimony of retired Cardinal Anthony Bevilacqua. They were posted online for the very first time by the Philadelphia Inquirer. They make for an interesting read. However, they are filled with the same kind of denials, half-truths, excuses, and obfuscations as we’ve seen before in Boston and Los Angeles. It’s also worth noting the reaction of Bevilacqua’s lawyers to the grand jury interrogation. The lawyers claimed the prosecutors were “anti-Catholic” and said they were disrespectful to the Cardinal during his testimony. These types of comments are instructive and give the reader an insight into how the Church and her lawyers think about the abuse crisis in general. In their world, church leaders, especially cardinals, are not to be questioned. They are especially not to be dragged before civil grand juries and asked questions about their own judgment.
It took courage and integrity to release the documents. Let’s hope as a result fewer children will be harmed because society is armed with knowledge about the issue and the scandal.

The recent news that the Vatican actually discouraged a full and accurate reporting of the Catholic priest abuse scandal in Ireland has drawn the condemnation of the Irish government and led to the Irish papal representative to be recalled to Rome. This is unprecedented in a country where Catholicism is a fixture of Irish culture and heritage.
This news really isn’t new. In 1997, the bishops of Ireland were told not to move forward with their implementation of an abuse reporting system by the Vatican. Now, the Vatican’s behavior threatens the very foundation of Catholicism on the small European island nation.
According to NCR, “The Cloyne Report, which examined how the Diocese of Cloyne handled accusations of clerical sexual abuse, said the bishop paid “little or no attention” to child safeguarding as recently as 2008 and that he falsely told the government his diocese was reporting all allegations of abuse to the civil authorities.
The report also accused the Vatican of being “entirely unhelpful” to Irish bishops who wanted to implement stronger norms for dealing with accusations and protecting children.
Addressing parliament July 20, Irish Prime Minister Enda Kenny said the Cloyne Report “exposes an attempt by the Holy See to frustrate an inquiry in a sovereign, democratic republic as little as three years ago.”
“And in doing so, the Cloyne Report excavates the dysfunction, disconnection, elitism and the narcissism that dominate the culture of the Vatican to this day,” the prime minister said.

Health Canada is updating its Reglan warnings concerning tardive dyskinesia, a neuro-muscular disorder whose symptoms include involuntary limb movements, Restless Leg Syndrome, lip smacking, facial contortions, and rapid eye movement. There is no known cure for tardive dyskinesia and the contraction of the disorder increases the longer a patient is taking Reglan. The drug has been available to patients by prescription since 1975 and is used to treat digestive disorders.
In February 2009, the US FDA added a black box warning to Reglan. The black box warning is the most serious warning available in the FDA drug warning system. The FDA black box warning was related to Reglan’s association with tardive dyskinesia.

The Cloyne Report, named after the tiny Irish diocese that covers most of County Cork, is perhaps the most damning sexual abuse report ever compiled. If you think that’s hyperbole, look at what Rocco Palmo, himself a devout Catholic, says about the Report. Palmo writes, “But Cloyne has proved to be of a different order.
Because for the first time in Ireland, a report into child sexual-abuse exposes an attempt by the Holy See, to frustrate an Inquiry in a sovereign, democratic republic…as little as three years ago, not three decades ago.
And in doing so, the Cloyne Report excavates the dysfunction, disconnection, elitism….the narcissism …….that dominate the culture of the Vatican to this day.
The rape and torture of children were downplayed or ‘managed’ to uphold instead, the primacy of the institution, its power, standing and ‘reputation’.
Far from listening to evidence of humiliation and betrayal with St Benedict’s “ear of the heart”……the Vatican’s reaction was to parse and analyse it with the gimlet eye of a canon lawyer.”
Palmo’s assessment is sadly accurate and will be hard for the Church to claim it’s just more of the same Catholic bashing. Remember, Palmo doesn’t belong to the cadre of media the Church usually points to when it cries foul. This is coming from a “faithful son of the Church”.
The Cloyne Report is so bad, it’s hard to imagine the Catholic Church in Ireland recovering from this anytime soon.

First, it was an increase in bone fractures, now it’s a potential link to esophageal cancer. The osteoporosis drugs known as bisphosphonates but more popularly known as Boniva, Fosamax, and Actonel may be linked to a certain rare form of throat cancer. No data provides a definitive conclusion at this point, but the potential has led the FDA to move forward with a further investigation of the class of drugs.
According to NPR, “Some research has suggested that regular use of the pills could increase that risk. A paper published in BMJ, the British Medical Journal, last year suggested the medicines could double the risk of such cancers. But the cancers are rare, and the doubling would lead to about 2 cases per 1,000 people over five years instead of 1 case per 1,000 people (among people aged 60 to 79).”

Citing the effects of its subsidiary DePuy Orthopaedics Inc. recall of its DePUY ASR XL hip replacement as well as its continuing woes in the pharmaceutical industry, J&J earnings are off nearly 20% in the second quarter. Despite the drop, Johnson & Johnson still reported net income of $2.8 billion.
DePuy’s ASR XL hip is not the only one facing mounting lawsuits and FDA scrutiny. DePuy’s Pinnacle hip, also a metal-on-metal hip device is also facing lawsuits and an FDA review. The metal-on-metal hips, originally designed to last longer and provide more flexibility, have higher than acceptable failure rates as well as the potential for causing metallosis, a serious medical condition where the hip patient suffers from metal poisoning.

Well, it looks like I was wrong. The National Catholic Reporter is writing that it has confirmation that Archbishop Charles Chaput of Denver will be the next archbishop of Philadelphia. According to NCR, the popular choice, or at least the name submitted to Pope Benedict, was Archbishop Kurtz, the Pope chose Chaput. Chaput, of course, is well known for fighting legislation in Colorado that would have given an opportunity to abuse survivors to file claims against their abusers and the institutions that protected them. We’ll have to wait and see how he handles the inherited abuse situation in Philadelphia.