Overdosing in Clinical Trials Prompts FDA Warning

Pfizer has received an FDA warning letter for significant violations concerning its clinical trials of Geodon. Pfizer is trying to expand Geodon’s use to pediatric patients suffering from bipolar disorder. As of yet, the FDA has not approved Geodon for use in children. The FDA warning letter cited “widespread overdosing” in patients involved in the clinical trials. The letter also noted that the problem was not detected or corrected in a timely fashion. The warning letter came as a result of inspections of Pfizer’s clinical trial sites in 2005 and 2006.
While Pfizer officials vowed to correct the problem, the FDA warning letter stated that the violations were repeat violations involving 7 pediatric patients. In spite of the warning letter, Pfizer will continue to pursue FDA approval for Geodon use for children. This is not the first problem with Geodon. Last fall, Pfizer agreed to pay $2.3 billion to settle federal and state civil and criminal charges stemming from charges of improper marketing of four drugs, including Geodon. In addition, to the settlement, Pfizer agreed to pay several states $33 million to settle claims that the company illegally promoted Geodon for use in children and in higher than approved doses.

GlaxoSmithKline in Trouble for Another Misleading Drug Ad

As the huge pharmaceutical company GlaxoSmithKline contends with safety issues concerning its diabetes drug Avandia, it’s also contending with a fresh FDA allegation that it ran false or misleading advertisements about its cancer drug Arzerra. The FDA has cited Glaxo for omitting important information about the drug’s safety and effectiveness. These are basically the same charges Glaxo face in dealing with its diabetes drug Avandia. FDA officials singled out a drug ad which ran in December of last year for failure to reveal any of the drug’s potential side effects including a serious brain infection, pneumonia, fevers and other blood disorders. In response to the FDA concern about Arzerra, a Glaxo spokesperson stated that the ad won’t be used again.

Archbishop Wenski?

Rumors are swirling in Miami that Orlando bishop Thomas Wenski will be named the new archbishop of Miami. If true, the announcement will be made tomorrow in Miami. Wenski, 59, has been the Bishop of Orlando since November 2004. He had previously been an auxiliary bishop in Miami where he was ordained a priest in 1976. While a priest in Miami, Bishop Wenski served the Haitian community.

FDA May Halt Avandia Trials Due to Safety Concerns

An Avandia-Actos comparison safety study may be halted by the FDA due to safety concerns about Avandia. Avandia at one time a best selling diabetes drug for GlaxoSmithKline PLC, has come under increased scrutiny since a 2007 study found that Avandia had been linked to an increased risk of heart attack.
The current FDA study compares Avandia with a leading rival Actos for safety and efficacy but some regulators are calling into question the ethics of testing a drug that’s already questionable for its link to increased heart attack risk.
According to the Wall St. Journal, “Joshua Sharfstein, principal deputy commissioner of the FDA, tells the WSJ that no decision on the trial (called TIDE) has been made yet, and won’t be until after a July meeting about the drug. By then the agency will also have the results of an Institute of Medicine review examining the appropriateness of such head-to-head safety trials.”
In February, the Senate Finance Committee lambasted GlaxoSmithKline for withholding information about the known safety risks concerning Avandia. According to the Senate report, company officials knew for years that Avandia had serious safety issues but did not disclose the safety concerns to the public. The Senate report was also critical of the FDA for allowing the clinical trial to continue in spite of the fact that the FDA itself estimates that 83,000 heart attacks have been caused by Avandia between 1999 and 2007.
At the time of the Senate report in February, GlaxoSmithKline was involved in the study involving its rival Actos and had enrolled 16,000 trial participants. FDA researchers quoted in the Senate report were highly critical of the trial at that time stating that the study was “unethical and exploitative” since trial participants were being subject to the Avandia’s safety issues.
While the debate over the clinical trial continues, there are more than 13,000 Avandia lawsuits pending in courts around the country. The first of two US federal bellwether trials are scheduled for June 1 in Pennsylvania.

Indian Priest Convicted of Sexual Abuse Leaves Italian Parish

An Indian priest, Vijay Vhaskr Godugunuru, has left an Italian parish after the Associated Press reported earlier this week that the priest pleaded no contest to charges that he sexually assaulted a Florida minor. As part of the plea deal, Godugunuru was ordered to return to India, obtain counseling, and refrain from any activities with minors. We represented the minor in the civil suit and followed up with a letter to Cardinal Levada inquiring as to the priest’s whereabouts. Levada has yet to answer our letter. However, as part of a worldwide investigation into priests who’ve sexually abused minors and allowed to transfer to a different country, the Associated Press found Godugunuru working in an Italian parish with no restrictions on his ministry. When questioned by the Associated Press, his superiors responded that they believed he was innocent and allowed him to continue working in a parish. He had been working at the Italian parish since 2008. Presently, his whereabouts are unknown and his future priestly ministry has yet to be determined.

Catholic Omertà

A French website has published a 2001 letter written in French from Cardinal Dario Castrillon to a French bishop Pierre Pican. In 2001, Castrillon was Prefect for the Congregation for the Clergy. Pican refused to report a priest accused and later convicted of the rape of a young boy and sexual assaults on 10 other minors.
Castrillon’s Congregation for the Clergy had been one of the Vatican departments in charge of investigating sexual abuse allegations and laicization requests. Castrillon writes that he is proud to have such a confrere as a bishop. Castrillon noted, ““I rejoice to have a colleague in the episcopate who, in the eyes of history and all the others bishops of the world, preferred prison rather than denouncing one of his sons, a priest.” Later in the letter, he compares the bishop to St. Paul who was in “chains for Christ”. Clearly Castrillon believed that it was better to protect the reputation of the accused priest (later convicted) and the institution of the Church than protect innocent, young lives from rapists. In his letter, written on Congregation for the Clergy stationary, Castrillon indicates a strong preference for the Church’s policy of “omerta” or silence and cover-up when it comes to handling priest abuse cases.

St. Louis Post Dispatch Correct on Off Label Marketing Suit

The St. Louis Post Dispatch editorial got it right this morning when it argued that the legalization of off-label marketing would prove to be dangerous for consumers. The newspaper’s editorial concerned Allergan’s lawsuit against the FDA for disallowing off-label marketing practices as a violation of free speech. As a point of clarification, doctors may prescribe any medicine for purposes they deem appropriate. However, drug companies are not allowed to market their drugs for those purposes not specifically approved by the FDA. This seems like a common sense, obvious consumer protection that should continue.
The Post Dispatch writes persuasively: “Rightly or wrongly, doctors rely on pharmaceutical company marketing as an important source of information about drugs.
Letting drug companies stack the deck by providing truthful but incomplete information about off-label uses increases the odds that doctors will write prescriptions for those uses. The case in point: Cox II inhibitors.
The drugs were approved to treat arthritis pain without causing stomach or intestinal problems. Studies conducted a decade ago found that most users of those medicines weren’t at risk for those problems.
You might think it wouldn’t matter. The evidence shows otherwise. Two of the most popular Cox II inhibitors, Vioxx and Bextra, later were taken off the market after testing showed that they increased the risk of fatal heart problems and strokes.”

Boy Scout Abuse Trial Ends in $1.4 Million Verdict for Survivor

A Portland jury ruled in favor of a former boy scout who was sexually abused by assistant Scout Master Timur Dykes in the 1980’s. Dykes, who had admitted to molesting 17 other Boy Scouts to a Mormon Bishop, was convicted and served time in prison for sexual abuse of scouts. The trial marked the second time that a jury has actually seen the so-called Boy Scout “perversion files” which were the Boy Scout secret files kept by the organization. The perversion files documented sexual abuse accusations and other inappropriate acts by Boy Scout leaders. In addition to the $1.4 million verdict for negligence, the Boy Scouts will face additional civil penalties for punitive damages. The Boy Scouts could face up to $25 million in punitive damages.
The Boy Scouts had fought to keep the “perversion files” confidential and away from potential jurors but in February an Oregon court ruled that the documents could be made public. The perversion files contain 1,000 pages of documents kept by the Boy Scouts on alleged pedophiles from 1965 until 1984.

The Next Church Scandal

The last few months have seen wave after wave of fresh news reports about the Pope’s handling of the sexual abuse scandal in addition to the emerging scandal in Europe. Yet, one might argue the worst is yet to come. Sometime near the end of April, Pope Benedict XVI will receive a report summarizing the findings from a 7 month long investigation into the life and scandal of Fr. Marcial Maciel Degollado, founder and head of the Legion of Christ. The investigation will undoubtedly note that Maciel fathered at least two children and abused scores of Legion seminarians. However, according to journalist Jason Berry, the new scandal will involve money and influence peddling in the Vatican. Berry, who has done extensive reporting and research on the Legion and Maciel himself, has spoken to numerous Vatican insiders and former Legion members. What he discovered is astounding. Berry discovered the following:
Maciel was a morphine addict who abused Legion seminarians from the 1940’s until at least the 1960’s. He was a prodigious fundraiser who distributed his wealth to various high ranking Vatican officials in order to curry favor and protect him and the Legion against the inevitable rumors of his sexual activities. According to Berry, Maciel traveled frequently to Rome in order to dole out large sums of cash to Vatican officials such as Cardinal Angelo Sodano, Pope John Paul’s Secretary of State and Archbishop Stanislaw Dziwisz, who served as Pope John Paul’s private secretary. Maciel directed his financial gifts to those inside the Vatican who could benefit the Legion and Maciel himself. For example, Maciel paid for the renovation of a cardinal’s residence in Rome. The cardinal happened to be Eduardo Francisco Pironio, the prefect for religious from 1976 until 1983. Pironio was the one who had ultimate authority to approve the Legion of Christ’s Constitution which included “Private Vows”. The private vows included a solemn promise to never speak ill of Maciel and to report anyone suspected of uttering criticism of Maciel or any other Legion superior. Initially, Pironio balked at signing off on the Constitution. So Maciel appealed to Pope John Paul himself. Two weeks later, Pironio gave his approval for the new Legion constitution.
Maciel recognized that Dziwisz was the former Pope’s gatekeeper. According to former Legion members whom Berry interviewed, money flowed generously to Dziwisz in order to maintain Legion influence within the papal household. One former Legion member reported that Dziwisz was given $50,000 by a Mexican family after attending a private papal mass.
Maciel’s fundraising prowess and his ability to spread the wealth to high-ranking Vatican officials allowed him to continue to lead a lavish lifestyle, support a drug habit, and continue his sexually deviant behavior around the world. There was no accountability for Maciel because he had bought the silence of high ranking church officials. It wasn’t until 2006, that Maciel was stopped. By that time, he was frail and advanced in age. All this in spite of the fact that Bishop John McGann of Rockville Centre, N.Y., sent a letter by a former Legion priest with detailed allegations to the Vatican in 1976, 1978 and 1989 through official channels. Nothing happened to Maciel for three decades.

Priest Abuse Case Shows Mind of Church

As the Associated Press broke the news yesterday that in 1985 Cardinal Ratzinger (now Pope Benedict) stalled in removing an Oakland priest from the priesthood after he’d been convicted in 1978 of tying up and molesting male children, the Vatican spokesman Rev. Federico Lombardi, SJ tried to defend the Pope’s actions. Lombardi protested that the document produced in order to impugn the Pope was taken out of context. Let’s put the letter in context.
First, there was no single Vatican Congregation responsible for dealing with priests charged with the sexual abuse of minors until 2001 when Cardinal Ratzinger was given that task. Up until 2001, the Congregation for the Doctrine of the Faith (Ratzinger’s congregation from 1981 until 2005) was responsible for doctrinal matters including priests who solicited sexual favors in the confessional. Laicizations (leaving the priesthood) were handled by the Congregation for the Clergy. In the case of Fr. Kiesle, his bishop had recommended he seek voluntary leave (laicization) of the priesthood. Under the papacy of John Paul II, it was customary practice that those priests seeking to leave the priesthood wait until they reached the age of at least 40 (Kiesle was 38 at the time). It seems from all accounts that John Paul II sought to stem the tide of priests leaving their ministry as many had done under Pope Paul VI in the 1960’s and 1970’s. So far, all of this is understandable. However, what’s disturbing about this particular case is that at this point in the early 1980’s there was no set policy or procedure to deal with sexually abusive priests. At that time, it was left up to the individual bishop to deal with a pedophile or ephebophile priest. As we now know, too many bishops sought to ignore the issue or transfer the offending priest to another parish or another diocese where the offending priest would strike again. Furthermore, it’s disturbing to note in Cardinal Ratzinger’s letter (typed in Latin), that there is no demonstrated concern for the boys who were molested by the priest. Ratzinger mentions the “good of the church” and asks the bishop to administer “paternal care” for the offending priest. The absence of any concern for the minor victims is striking and bothersome. How is it that a shepherd of souls doesn’t express any concern for those who’ve been harmed by this bad priest? As has been the case throughout this priest abuse scandal, church authorities rarely if ever show any concern for those victimized by sexual predators. That’s the real problem and the real scandal in this case. Pope Benedict may be able to dance around “who knew what when” but he can’t skirt the issue that he appeared oblivious to the real harm done to innocent children. That’s scandalous and appalling.