The FDA has issued a warning to Merck & Co. for its 80mg dosage of Zocor. The warning was issued because of Zocor’s association with an increased risk of muscle injury. Zocor, also known as simvastin, is a cholesterol lowering drug. While statins in general tend be associated with a higher incidence of muscle injury, Zocor may leave patients susceptible to an even higher risk of muscle injury including rhabdomyolysis. Rhabdomyolysis is a critical form of muscle injury, which has the potential to cause serious kidney damage, kidney failure, and even fatality.
In the midst of a sexual abuse crisis that has now crept dangerously close to the 82 year old pope himself, Benedict XVI issued a letter to Irish Catholics apologizing for the abuse and criticizing the country’s bishops for “grave errors of judgment and failures of leadership.” The letter doesn’t address Benedict’s own involvement in the crisis nor this past week’s revelation that as the Archbishop of Munich Benedict himself shared in those “grave errors of judgment and failures of leadership”.
The most astute analysis of the situation comes from Terry McKiernan, founder and president of bishopaccountability.org McKiernan correctly stated, “There’s a strong tendency to approach this as a problem of faith, when it is a problem of church management and a lack of accountability,”
McKiernan’s comments underlie the real issue at hand. Neither the bishops nor the pope appear ready or willing to come to terms with it. Stories of clergy sexual abuse of minors are not an attack on faith or the church, for that matter. Rather, these stories highlight the colossal mismanagement of bad priests and bishops as well as a total lack of accountability to the society at large. Until this is recognized by the church officials, true reform remains a distant hope.
The Holy See’s Promoter of Justice at the Congregation of the Doctrine of the Faith, Msgr. Charles J. Scicluna has admitted that the Catholic Church’s statute of limitations on clergy sex abuse of minors should be permanently revoked. Scicluna noted that “the limit of ten years is not enough in this kind of case, in which it would be better to return to the earlier system of delicta graviora [more serious offenses] not being subject to the statute of limitations.”
As a member of the Pope’s former dicastery, Scicluna seems to acknowledge the severity of the abuse issue. This is an important revelation in that this priest holds an important position in the church and his remarks were not a mere “slip of the tongue”.
If the Catholic Church (at least some top offiicals) are willing to capitulate and say the statute of limitations should be abolished, why can’t we get Catholic bishops to do the same with civil and criminal statute of limitations? If it’s a matter of delicta graviora, then why aren’t the Catholic bishops standing with survivors of Catholic priest abuse?
Soon after Avandia was linked with an increased risk of heart attacks, a team of researchers at the Mayo Clinic reviewed more than 200 scientific studies that were favorable to Avandia and found that 94% of those authors had financial ties to the drug companies, including GlaxoSmithKline. Nearly half of those had monetary arrangements with pharmaceutical companies that posed a serious conflict of interest.
According to Reuters, “It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication,” Dr Victor Montori of the Mayo Clinic, whose study appears in the British Medical Journal, said in a telephone interview.”
This is precisely why the manner in which these scientific studies are done has to be reformed. If the author of a so-called scientific study is being remunerated by a drug company, the author has a financial interest in writing favorably on behalf of his client. That’s not objective science.
What is perhaps more troubling in the Reuters article is that 25% of those who did have financial ties with the drug companies failed to disclose such a relationship.
The FDA plans to hold a meeting sometime in July to discuss the risks and benefits of the drug Avandia. The meeting will take place after two US senators released a report from FDA safety officials who recommended removing Avandia from the marketplace.
The other shoe just dropped. After a week of harsh denunciations and howls of protest, a German psychiatrist has come forward to state that senior officials in the Archdiocese of Munich ignored repeated warnings about a sexually abusive priest in the Archdiocese of Munich. Dr. Werner Huth gave explicit warnings in oral and written form, so it’s going to be difficult for the Pontiff to deny his most senior officials weren’t warned.
“I said, ‘For God’s sake, he desperately has to be kept away from working with children,’ ” the psychiatrist, Dr. Werner Huth, said in a telephone interview from Munich. “I was very unhappy about the entire story.”
This is bad, very bad for the 82 year old German Pope. It amounts to the cover-up of the cover-up. I find it hard to imagine how those Vatican insiders could’ve made such a full throated defense of the Pope as Archbishop of Munich while at the same time knowing full well the German psychiatrist was lurking in the shadows waiting to tell the truth about the sexually abusive priest. The Vatican’s defensive posture all but assured the psychiatrist would eventually come forward to tell his side of the story. While the psychiatrist stated he hadn’t had any direct communication with Ratzinger, the priest was allowed to begin parish work almost immediately after commencing therapy in Munich, in spite of the psychiatrist’s warnings. According to the NY Times, “In 1980, after abuse complaints from parents in Essen that the priest did not deny, Archbishop Ratzinger approved a decision to move the priest to Munich for therapy.
Despite the psychiatrist’s warnings, Father Hullermann was allowed to return to parish work almost immediately after his therapy began, interacting with children as well as adults. Less than five years later, he was accused of molesting other boys, and in 1986 he was convicted of sexual abuse in Bavaria.”
In his telephone interview, Dr. Huth noted that he set three conditions upon which the priest could work in ministry: “that he stay away from young people and alcohol and be supervised by another priest at all times.”
Unlike last week when news first broke about the Pope’s involvement with a sexually abusive priest, there has been no Vatican comment, no comment from the former Vicar General, and no reaction from the Pope himself. After all, there’s not much to say this time.
A cursory search of the web for articles or news stories this past week has uncovered some strange stories about the FDA’s issuance of a black box warning for the drug. It’s odd because that occurred over a year ago. This isn’t new news. Reglan was issued a black box warning for its association with tardive dyskinesia, a serious and permanent neurological disorder. Reglan is to be used for no more than three months. Longer use of the drug increases the risk of acquiring tardive dyskinesia.
Besides the odd stories about the black box warning, there are other stories about Reglan use in the infant population. Babies may have underdeveloped gastrointestinal tracts and may experience symptoms similar to gastroesophageal reflux disease. Babies experiencing such symptoms are often treated with Reglan even though the drug is not approved for infant use and studies have not determined if babies are being subjected to the risk of developing tardive dyskinesia. It’s not known how Reglan may affect infants. What we do know is that the neurological disorder linked to prolonged use of Reglan in adults is serious and permanent. If the risk is similar for infants, Reglan is simply to dangerous to use with infants.
The FDA is considering halting medical device companies from allowing third parties to review their medical devices rather than the FDA. Initially, allowing third party review of medical devices was thought to quicken the process by which medical devices could be approved for market use. Third party medical device reviews were intended to save taxpayer money. However, the FDA is questioning the quality of the reviews as well as the expense of such processes.
Not all medical devices are eligible for a third party review. The FDA allows such reviews if the medical device in question is similar to a medical device already approved as well as those that pose low to moderate risk to the patient.
The FDA decision to re-consider this process is part of the federal agency’s re-evaluation of how it approves medical devices. Minutes from the December 2009 FDA meeting reveal critiques of the third party process that include a lack of proper expertise as well as a general lack of data analysis. The minutes note that the third party review submissions often regurgitate the content of the submission rather than a critical analysis of that data.
The FDA is expected to make a final determination sometime later this year.
Boston Scientific has suspended sales and recalled two of its most popular cardiac defibrillators because changes to manufacturing processes weren’t approved by the FDA. The suspension and recall affects seven Boston Scientific implantable defibrillators. Products affected by the move were the Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality brands. The action did not affect Boston Scientific’s pacemakers and other medical devices.
While they wouldn’t comment publicly on the issue, Boston Scientific officials will work with the FDA to resolve the problem in an expeditious manner. There is no evidence at this point that the Boston Scientific defibrillators pose any health risk to patients unlike the Sprint Fidelis defibrillator leads manufactured by Medtronic. These leads were recalled in late 2007 after they were found to break causing inconsistent electrical impulses to the heart muscle.
The FDA has ordered a black box warning for Plavix intended to advise healthcare practitioners of Plavix dangers in those patients who fail to metabolize the clot busting drug. This failure to metabolize may increase the risk of heart attacks and strokes in patients.
The warning is a blow to Bristol-Myers Squibb Co. and Sanofi-Aventis whose sales have topped $8 billion. The Plavix safety issue may affect 2 to 14% of Plavix users.
This is the second and more serious drug label change for Plavix. In November 2009, the FDA warned that those taking Plavix in combination with heartburn drugs such as Nexium, Prevacid, Prilosec OTC, and Protonix were 50% more likely to have a heart attack.
I’ve been representing survivors of priest sexual abuse for the better part of this decade now. I thought I had heard and seen just about everything concerning this tragedy but I was wrong. I’m witnessing a Pope being dragged into the middle of the Catholic priest abuse crisis. I’m not talking about his failure to discipline bishops or advocate for reform. I am talking about this Pope’s own personal involvement in sexual abuse. As the Archbishop of Munich in the early 1980’s, a priest working in the Archdiocese had been accused of the sexual abuse of at least one boy. This same priest was later allowed to return to pastoral ministry where he was later convicted of more sexual abuse crimes. As the sexual abuse scandals hits the Catholic Church in Germany, the Pope’s former archdiocese has been forced to deal with this scandal and the fact that a priest abuser had been re-assigned under Cardinal Ratzinger’s (now Pope Benedict) authority. Spokesmen for the Archdiocese of Munich moved quickly to squelch the news that the Pope himself was involved in allowing an abusive priest to continue in ministry. They even paraded Munich’s vicar general out in order that he could claim “full responsibility” for the ill advised transfer. Anyone familiar with the inner workings of the Catholic Church knows full well that the Archbishop had knowledge of this situation even if his name isn’t on any official document (see Cardinal Bernard Law’s depositions in Boston). Archbishops don’t cede authority over personnel decisions to lower ranking clerics. It is simply isn’t credible that the present pope didn’t know about this case.
If the Munich case wasn’t bad enough, Pope Benedict still has to deal with the letter he authored in 2001 as the Cardinal Secretary of the Doctrine for the Congregation of the Faith in which he instructed all Catholic bishops to refer all priest abuse cases to his office. In the letter, Ratzinger sternly warned the bishops that these matters were subject to the “pontifical secret”. The pontifical secret is a serious matter for Catholics in that it binds those who are subjected to it to complete and total secrecy. In essence, Ratzinger was telling the bishops that they couldn’t tell anyone (including civil authorities) about anything involving the particular sex abuse case. Isn’t that what we call in this country obstruction of justice?
This week hasn’t been a good one for Pope Benedict. He’s got a growing credibility problem. His past actions may be coming back to haunt him. We haven’t witnessed this before. We could say his predecessor John Paul II was inept in handling the issue or that he turned a blind eye. What we couldn’t say about John Paul was that he was personally implicated in the scandal.