Monthly Archives: August 2009

Scranton’s Bishop Martino Resigns

Bishop Joseph Martino, head of the Catholic Diocese of Scranton has resigned abruptly. His resignation has reportedly been accepted by Pope Benedict XVI. Martino, 62, was appointed bishop of Scranton in 2003, and is a full 13 years away from the mandatory retirement age of bishops in this country.
Martino’s tenure as head of the Scranton diocese has been filled with controversy over his staunchly conservative views including his refusal of communion to pro-choice politicians, parish closings, and his handling of the priest abuse scandal.
In the news reports concerning his resignation, media outlets have mentioned his statement that “No USCCB document is relevant in this diocese. The USCCB doesn’t speak for me. The only relevant document,’ he said, was his letter on politics, which he had ordered read at all parishes.”
I wonder if that includes the so-called Dallas Charter approved by the US Bishops as a response to the priest abuse crisis.
Martino’s hard-line stance on issues such as abortion have carried over to his handling of priest sex abuse in his diocese. While we can only speculate about the reasons spurring his resignation, we can hope that the next bishop handles pastoral concerns such as the treatment of sexual abuse survivors in a different fashion.

Florida Docs Paid by Drug Company Lilly

It’s no secret that pharmaceutical companies pay huge sums of money to doctors. The practice has been going on for years. Some of the payments come in the form of gifts such as expensive dinners, parties, vacations, and golf outings. Other forms of payment come as fees for consulting and speaking appointments during which the doctors are paid to promote the companies’ products.
This year alone, drug giant Eli Lilly has paid $22 million to 3,400 healthcare professionals in the first three months. In Florida, the pharmaceutical company has paid $350,000 to a dozen doctors.
How do we know this? As part of settlement with the federal government, Eli Lilly was forced to disclose these payments. Yet, drug makers are willing to continue to make these payments to influence doctors because of the handsome return on investment. Drug companies such as Lilly target doctors and lavish attention on them in order to secure their endorsements as well as their use of their products.
Congress is aware of the problem and has been pushing the companies to disclose such payments. Aware of the potential for a conflict of interest, federal lawmakers want the public and other healthcare providers and institutions to be aware of the tremendous influence such payments have over patient care. Even academic institutions haven’t been immune to the influence peddling.
This behavior isn’t restricted to drug companies either. Major medical device companies pay researchers and doctors huge sums to promote their devices such as artificial hips, knees, and other medical devices. It’s a concern that has warranted the attention and perhaps regulation of Congress.

Justice Ginsberg Denies Diocesan Request to Keep Documents Sealed

The sex abuse scandal in the Catholic Church has always centered on the Church’s paper trail. In the instances where the church documents have been made public by court order, they’ve often revealed the abuser’s history as well as the Church’s efforts to keep that history from the general public. That’s why the documents have been the center of so much litigation.
Yesterday, US Supreme Court Justice Ruth Bader Ginsberg denied a request by the Diocese of Bridgeport to keep their documents sealed. The documents in question number about 12,000 pages of court testimony, depositions, and legal arguments involving 23 priest abuse lawsuits concerning 7 Diocese of Bridgeport priests. Prior to Justice Ginsberg’s ruling, the Connecticut Supreme Court has ruled twice in favor of unsealing the church papers. The Diocese’s only legal option now is to appeal to the full US Supreme Court in order to keep the documents secret.
While the lawsuits against the Diocese of Bridgeport have long since been resolved, newspapers including the Hartford Courant and the NY Times have petitioned the court for access to these church files. The media is interested in reviewing the documents in order to determine Cardinal Edward Egan’s role in the priest abuse scandal while he was bishop of Bridgeport in the 1980’s.

Off-Label Prescription Dangers

In this blog, I’ve often discussed the common practice of doctors prescribing drugs for off-label uses. This is a perfectly acceptable practice since it’s generally assumed that doctors have the knowledge and expertise to make such a decision. In discussing this practice, I’ve distinguished this from the prohibited practice of pharmaceutical companies marketing their drugs for off-label uses. The FDA has maintained that drug companies may only advertise drugs for purposes specifically approved by the federal agency.
However, the NY Times is reporting that a national survey of physicians has found a disturbing trend in the off-label use practice. The study in Pharmacoepidemiology and Drug Safety found that many doctors aren’t aware when they are prescribing drugs for off-label use. According to the study, the average physician’s survey response indicated that they identified the F.D.A. approval status correctly for only about half the drugs on a list provided by the researchers.
The gastrointestinal drug Reglan (generic equivalent Metoclopramide) has been approved for 90 day use by the FDA. Yet, Reglan continues to be prescribed for longer periods than the approved 90 days. Longer term usage has been linked with a serious central nervous system disorder called Tardive Dyskinesia.
Ignorance of a drug’s FDA approval status can be dangerous and cause significant damage to the patient. For instance, the survey found the most physician confusion concerning psychiatric drugs. According to the NY Times article, “Confusion was greatest with psychiatric drugs, the survey of some 600 doctors found. Nearly one in five who prescribed Seroquel (quetiapine) in the previous year thought it was approved for patients with dementia and agitation, even though it was never approved for this use and even carried a “black box” warning that it was dangerous for elderly patients with dementia. And one in three doctors who used lorazepam (often marketed as Ativan) to treat chronic anxiety thought it had been approved for this use; in fact, the F.D.A. warning advises against using it for this purpose.”

Alli, Xenical (orlistat) Diet Drugs Investigated for Liver Injury

After receiving 2 dozen reports of liver injury, the FDA is investigating over-the-counter Alli and its prescription counterpart Xenical. Alli is an over-the-counter weight loss aid manufactured by GlaxoSmithKline. Xenical is made by Roche.
According to the FDA news release, “Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.”
A few months ago, the weight loss supplement Hydroxycut, was removed from the market over similar liver concerns.
Anyone whose taken these drugs and is experiencing weakness, fever, jaundice or brownish colored urine should consult their physician immediately.

Reglan Has a Marketing Problem

Reglan and its generic equivalent Metoclopramide are safe drugs-if they are prescribed and taken in the approved fashion. Reglan and Metoclopramide were approved for short term use only. The problem with the drug arises when doctors continue to prescribe the drug for more than 90 days (approved usage period). The FDA approved Reglan in June 1985 to treat certain gastrointestinal problems such as gastroesophageal reflux disease (GERD) , nausea and vomiting, reflux, heartburn, Gastroparesis and diabetic gastroparesis. The treatment was only supposed to be proffered as a last resort when other treatment options were not viable or had proven to be ineffective.
What is clear is that neither Reglan nor Metoclopramide are safe when ingested for a longer period than the approved 90 days. Reglan use beyond this 90 day period has been linked to Tardive Dyskinesia, a central nervous disorder which has no known cure and is permanent. Tardive Dyskinesia is characterized by involuntary muscle movements or twitches.
Reglan and Metoclopramide are dangerous because they’ve been used for periods of time that are clearly prohibited by the FDA. Doctors have a duty to know that the drug may only be used safely for a 90 day period. The drug manufacturers need to stop pushing this drug for use beyond the period for which it is approved.

Medical Ghostwriting-Great Marketing Tool for Big Pharma

For years now, pharmaceutical companies and medical device manufacturers have hired professional writers to “ghost” articles about their products and placing the names of prominent doctors and professors on the “scientific” articles. It’s been a great marketing tool for the drug companies and medical device firms since they get to tout their wares in established, reputable journals. It’s also been good for the doctors who get published without having to do any of the work. It’s not so good for the general public and other doctors who thought they could rely on such journal articles to treat their patients.
Senator Charles Grassley understands the grave ethical and health consequences and has apparently decided to do something about it. In a letter written last week to the National Institute of Health, Grassley called on the organization to curb the practice of ghostwriting. As the NY Times noted this morning, this is a significant move since NIH funds most of the country’s medical research. So far, the NIH has been reluctant to intervene. However, with pressure from Senator Grassley, it may have no choice but to act.
Recent issues concerning the issue of ghostwriting make one believe the problem is widespread. The NY Times interviewed one doctor who isn’t comfortable with the practice.
“Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug,” Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, said this month. “This happens all the time.” He declined to attach his name to the paper.
The medical ghostwriting issue gained prominence with the infamous fen-phen diet drug taken off the market in 1997. Yet, the same company remains under scrutiny for hiring a professional writing company to write 60 favorable articles concerning one of its menopause drugs. The company, Design Write, had as its stated goal to downplay the risk of breast cancer linked to hormone drugs while promoting the Wyeth products as beneficial.
The problem with the ghostwriting projects is that they are not truly independent. The companies hired to ghostwrite the articles are paid handsome sums of money to act as marketing tools for the drug companies and medical device manufacturers. This puts doctors at risk and consumers in harm’s way.

Pasco Youth Pastor Sentenced for Sex Abuse

A Pasco County youth minister has been sentenced to four years in prison for the sexual abuse of a minor. Scott Dewayne Wright, 35 pleaded guilty to two counts of unlawful sexual activity with a 16 year old girl in her home. Wright met the teen when he was youth pastor at Calvary Chapel Worship Center in New Port Richey. Pastor Wright, a married father of four children, will also have to complete sex offender registration as well as probation. He will be barred from living near any school.
As is typical in church sex abuse cases, the youth pastor had ingratiated himself into the community and used his influence as a pastor to lure the child into the sexually abusive situation. Worshipers trusted the pastor and believed their children were safe in his company.

Fentanyl Patch Recalled

One lot of fentanyl patches manufactured by Watson Pharmaceuticals Inc. has been recalled because of leaks. The lot is number 145287A, and the patches were shipped to customers between April 2 and May 20. Their expiration date is February 2011. Watson officials stated that some of the gel patches leak and may directly expose patients and healthcare workers to the gel.
The Fentanyl Transdermal System patches are supposed to release the narcotic painkiller at a rate of 100 mg per hour. The leaks could cause an overdose, respiratory depression, and death. The fentanyl pain patch is a generic version of the Duragesic patch used to treat severe, chronic pain. There have been six other fentanyl pain patch recalls due to manufacturing defects since the product was first introduced in 1994. Fentanyl lawsuits regarding manufacturing defects such as leaks and overdoses have been filed.

Irish Priest Abuse Has US Connections

Those of us who’ve been active in the Catholic Church priest abuse scandal are aware of the ramifications of the Irish abuse report due to be made public in the next few weeks. Undoubtedly, some of the priests involved in the abuse of children in Ireland also abused minors here in the United States. The connection between Irish priest abusers and so-called “mission” dioceses is particularly troubling. In the 1960’s and 1970’s, many Irish clergy came to places like Florida to serve the burgeoning Catholic population. Some of these Irish clergy had a history of abuse in Ireland and continued their criminal behavior in Florida.
Presently, victim advocacy groups like Bishop Accountability are actively researching the connection. Bishop Accountability is seeking the names of those priests. As they’ve done so well, the organization is compiling a database on these priests. It’s a tremendous public service that is certain to shed light on this tragedy.