Monthly Archives: September 2005

Merck Exec Feared Vioxx Sales Drop if Warning Label Was Placed on Vioxx Product

A top Merck executive testified yesterday that the Vioxx manufacturer feared as much as a $500 million drop in sales if regulators had succeeded in placing an unfavorable warning on the Vioxx label three years ago. David Anstice,who headed Merck’s US marketing campaign at the time, admitted an internal Merck memo showed the company feared a huge drop in sales if the FDA won its battle over the Vioxx label.

FDA Says Defibrillator Defects Increasing

The number of defects present in implantable defibrillators is rising at a dangerous pace, according to joint research Harvard Medical School and
the Food and Drug Administration. The study suggests that the recent recalls by defibrillator manufacturers such as Guidant, Medtronic, and St. Jude’s Medical point toward a growth in the number of defibrillator defects. Additionally, they also state that defibrillator replacements due to these defects has decreased, showing that even though the number of defective devices are rising, not enough is being done to assist in the replacement of the devices.

Guidant Issues Pacemaker Alerts

Guidant Corp. warned doctors Thursday of more problems with some of its pacemakers, saying at least 10 people have been hospitalized because of flaws in some essential functions. The alert involves Guidant’s Insignia and Nexus lines of pacemakers. The NY Times reported that Senator Charles Grassley, chairman of the Senate Finance Committee, notified Guidant that his committee is investigating where the company had violated a 2003 agreement that required it to notify the government of product problems. The FDA considers the pacemaker action to be a recall, making it the 5th recall by the company. The latest problems include intermittent or permanent loss of pacing output, loss of telemetry, and the appearance of a warning message when the device is being checked, a spokesman for Guidant said.

Vioxx Deadly Even With Short Term Use, Expert Testifies

An expert witness testified Thursday that even short term use of the painkiller Vioxx can double the risk of heart attach and death, a finding that the drug’s manufacturer Merck & Co. misrepresented. University of Washington biostatistician Richard Kronmal said company sponsored tests showed that patients who took the drug suffered serious side effects to blood vessels amost immediately. After reviewing Merck’s own data, Kronmal stated, “It clearly is a drug that has severe effects on the vascular system.”

Pope Benedict XVI Approves Ban on Gay Seminarians

In a story published in Catholic World News today, Pope Benedict XVI has signed off on a document banning homosexuals from studying for the priesthood. The document is seen as a response to the priest abuse crisis that has dominated the Church, particularly in the West, for the last five years. The new pope has also ordered an investigation into 229 US seminaries which will look for evidence of homosexuality and how celibacy is taught in each institution.
It seems to me that making homosexuals the scapegoats for the sexual abuse crisis doesn’t address the issue at hand. The Catholic bishops are the ones responsible for the crisis. They continued to protect, transfer, hide, and cover up for priest abusers. They were warned, most notably by Rev. Thomas Doyle back in 1985. Rather than listen to the prophetic warnings, the bishops chose to ignore the problem. It’s high time that these men were held accountable for their actions and tragic inaction.
Paul Baier of notes the following:
“The entire text of this guide is important. A few important points that have not been emphasized in the media commentary:
Sexual Abuse Ignored – The sexual abuse crisis, which is the reason for the seminary visitations, is nowhere mentioned in the document.
Homosexuality Scrutinized – The reference to homosexuality (para. B.4.3), which has prompted so much comment, is not the only allusion in the document to this issue (see, for example, the mention of particular friendships in para. B.6.10 and the reference to the Vatican’s Pastoral Care of Homosexual Persons in para. B.7.4).
Elimination of Dissent Emphasized – The issues of proper supervision and dissent (e.g., para. B.2.7) are more prominent than homosexuality in the guide. For example, the Visitors to each seminary are to check that moral instruction is based on certain Vatican texts, including the birth-control encyclical Humanae vitae (see para. B.7.4).
Secrecy Enforced – The seminary Visitors (many of whom appear to be American bishops, some with a bad track record during the crisis) are bound by pontifical secret (para. A.2.9).
Classified Report – No provision is made for reporting the results of the visitation to the laity, who have been so harmed by poorly trained priests, or even for reporting to priests, seminarians, and most bishops. Only the bishop or major superior who is responsible for a seminary will get that seminary’s report.
Seminary History Not Included – Aside from an invitation to recent seminary graduates (para. A.2.7), no provision is made for investigating the sexual abuse history of the seminary. But that history is the reason for the visitation.”

Laveranues Coles’ Revelation of Childhood Abuse Took Courage

I’d imagine that childhood sexual abuse will get a lot of attention this week after Laveranues Coles’ revealed he had been the victim of sexual abuse. The popular receiver for the NY Jets came forward last week so that others won’t be victimized. “If it gets one kide to come out and say, ‘Look, this is happening to me,” Sexual abuse of a child is the most horrific crime that our society has had to endure. When we can’t protect our children from expoloitation and abuse, it’s not a good sign for our society. Hopefully, Laveranues Coles’ courage will spare other children from what he had to endure as a child.

Second Week of Second Vioxx Trial

As the second week of the nation’s second Vioxx trial prepares to open in New Jersey this week, Merck’s lawyers continue their obfuscation and “don’t confuse me with the facts” campaign. Last week, Merck’s lead lawyer was reprimanded by the judge for bashing her fellow colleagues as well as trying to mention that Merck pulled the Vioxx drug off the market. On Thursday, Judge Higbee barred the Merck lawyers from making reference to Vioxx being pulled from the market. The judge noted that such information was irrelevant to the case since the plaintiff had suffered a heart attack prior to Merck’s withdrawal of Vioxx.

Medtronic to Release Malfunction Data Beyond FDA

Medtronic, the nation’s biggest manufacturer of heart devices, has said that it was considering making available to doctors and patients some of the datat concerning product malfunctions that until now only provided to federal regulators. Currently, manufacturers of devices like defibrillators and pacemakers provide the FDA far more details about how and why those devices are malfunctioning than they currently give to doctors. Medtronic already provides more information to doctors than its two leading competitors, Guidant and St. Jude Medical.

Ford Recalls 3.8 million Pickups and SUVs due to engine fire concerns

Ford just announced the recall of 3.8 million of its pickup trucks and SUVs due to concerns over engine fire concerns. Ford Motor Co. on Wednesday recalled 3.8 million pickup trucks and sport utility vehicles for a cruise control switch suspected of causing engine fires. It is the fifth largest auto industry recall in U.S. history.
Ford said the recall of 1994-2002 model-year vehicles includes the company’s hot-selling F-150 pickup truck, Ford Expedition, Lincoln Navigator and Ford Broncos. The company said it would start sending out recall notices to vehicle owners immediately.
The National Highway Traffic Safety Administration and the No. 2 U.S.-based automaker have been investigating complaints of engine fires linked to the switch.
NHTSA has received more than 550 complaints of engine fires from the cruise control switch. There have been allegations of three deaths in cases cited in news reports or lawsuits in Iowa, Georgia and Arkansas.
The affected vehicles include: 1994-2002 model F-150s, 1997-2002 Expeditions, 1998-2002 Navigators and 1994-1996 Broncos equipped with factory-installed speed control.