Monthly Archives: June 2008

Archbishop Burke’s Transfer to the Vatican

While many are decrying Pope Benedict’s decision to move Archbishop Raymond Burke of St. Louis to head the Apostolic Signatura in Rome, it may be too early to judge the move. Admittedly, Burke has had a deplorable history of dealing with sexually abusive priests during his 5 year tenure in St. Louis. He’s not only been completely unwilling to act against such priests, he’s actually welcomed a few into the Archdiocese of St. Louis from other dioceses!
Yet, let me play devil’s advocate for a moment. As head of the Apostolic Signatura (the church’s highest court), Burke will no longer be able to wreck havoc in parishes and dioceses. Rather, he’ll be mediating disputes between lower church tribunals (courts) over matters of canon law. In other words, he’ll be in an ivory tower removed from dealing with pastoral issues. We all know that’s not the way most of us would deal with someone like Burke, but it’s very typical in the often shadowy world of the Vatican. Perhaps, the people of St. Louis will receive a caring, compassionate shepherd willing to deal with the problem of abusive priests as well as their survivors. Perhaps, this is a good move for the church in America, just a thought.

Heart Contrast Agents Continue to Draw Safety Concerns

Contrast agents used in echocardiograms continue to raise serious safety concerns even after the FDA decided earlier this year to relax some of its earlier warnings. The products — which include Optison, made by General Electric Co’s GE Healthcare, and Definity, made by privately-held Lantheus Medical Imaging — have already been linked to serious heart problems and deaths in some patients. In October 2007, the FDA stepped up its warnings for the imaging agents after the federal agency had received 200 complaints and reports of 7 deaths.
The contrast agents help radiologists view the heart more clearly yet these contrast agents have been linked to cardiopulmonary problems as well as breathing difficulty and seizures.

British Neurologist’s Neurontin Warnings Ignored

A British neurologist has testified under oath that he had warned Neurontin’s manufacturer, Pfizer, of its potential link to aggresion and depression. The testimony has been taken in order for the court to determine if Neurontin lawsuits will be allowed to continue. Plaintiffs have alleged that more than 100 suicides are linked to the drug Neurontin.
According to a Wall St. Journal report, “Dr. Trimble said that in 1995 and 1996, he was hired to write two confidential reports for Parke-Davis — now a unit of Pfizer — because the company “was concerned about psychosis in relation to their drug.” Dr. Trimble said he was unable to find a link to psychosis, but noted effects of depression and aggression.”

Diocese of Fairbanks Looking for Priest Abuse Victims

Already in Chapter 11 bankruptcy, the Diocese of Fairbanks is actively seeking anyone who may have been sexually abused by Catholic priests, nuns, religious brothers, or any person affiliated with the Diocese of Fairbanks from the 1950’s until the 1980’s. As part of the bankruptcy, victims will have until December 2, 2008 to come forward to have their abuse claims evaluated and processed.
The Diocese of Fairbanks follows in the footsteps of Portland (Oregon), Tucson, and Davenport.

Salmonella Tainted Tomatoes Spreads

The last food contamination scare has now spread to five more states and the District of Columbia. Salmonella tainted tomatoes has spread to 28 states thus far. 277 people have fell ill because of the salmonella contamination.
The FDA has yet to determine the source of the salmonella but the agency is looking closely at farms in Mexico and central Florida as the culprit.
Food contamination has been a growing concern for consumers as well as the FDA. The FDA is already overburdened in attempting to deal with dangerous drugs as well as the growing food contamination problem.

Drug Companies and Marketing Practices

The large pharmaceutical companies agreed to hold off any direct to consumer marketing of their drugs after coming under heavy fire from Congress and the FDA regarding the controversial marketing practice. The Congressmen behind the investigation, Michigan Democrats Bart Stupak and John Dingell had wanted a two year moratorium on such advertising. In the end, the drug companies agreed to something that allows them to continue their deceptive marketing practices.
The companies still can pitch their products directly to consumers. They’ll still use hired guns, actors, and celebrities who have no relation to the efficacy of the drug whatsoever. Finally, they didn’t agree to advertise products only when studies have shown they improve clinical outcomes. Drugs are often approved (and advertised) solely based on surrogate markers.
In the end, this isn’t good news for consumers and patients who rely on science rather than marketing practices to ensure their own health and welfare.

Thoughts on Tim Russert’s Passing

The unexpected and untimely death of NBC’s Tim Russert is a blow to the nation that’s come to expect honesty, integrity, and professionalism from Russert. Respect for Russert knew no partisan, religious, ideological, or professional boundaries. He was the consummate journalist who knew how to ask just the right question at the precise moment. He was a gentleman who never succumbed to the tempation of hyperbole or headline grabbing soundbites. He represents the best of his profession and the best of our country. Tim Russert will be sorely missed.

FDA Wants Stricter Eye Contact Lens Solution Controls

Two years after Bausch & Lomb’s Renu eye contact lens solution was linked to serious eye infections, the FDA is recommending new labeling instructions including rubbing the contact lens in order to remove dirt and bacteria in spite of some products marketed as “no rub” solutions.
Of course, this is too little, too late for those who’ve suffered terrible eye injuries because of contaminated lens solutions that actually caused the eye infections in the first place.
According to an article in Forbes, “Advanced Medical Optics’ withdrew its solution last year after government scientists linked it to a rare eye-infecting parasite called Acanthamoeba keratitis. It is not among the bacteria and fungi FDA currently requires products be tested against.
Panelists overwhelmingly said FDA should require companies test their solutions against the parasite before gaining market approval.”

Drug Researchers’ Pay Raises Questions

An investigation by Senator Chuck Grassley has revealed what many have suspected for quite some time, researchers who are funded by pharmaceutical companies often under report or don’t report at all income derived from their work for these very same pharmaceutical companies. The potential for conflicts of interest are obvious when scientists are paid by those who have real pecuniary interests in the outcome of the research. This was not the case two or three decades ago when the federal government financed most of the drug and medical device research. Now that the pharmaceutical companies and medical device manufacturers are the main sources of such financing the reliability of such research is rightly called into question.
This coupled with the fact that FDA warning letters to medical device makers and drug manufacturers have declined by 50% in the last five years makes one wonder about consumer safety.
In another piece of disturbing news, seven doctors have been disqualified by the FDA from doing research. Their disqualifications stem from misconduct such as fraud and disregard for patient safety. The FDA relies on these doctors as they approve drugs and medical devices. The FDA has come under heavy criticism for taking so long to discipline these wayward doctors. In some instances, it tood a decade for them to be removed from their posts!

Tomato Salmonella Risk too High for McDonald’s

If you’re hankering for a Quarter Pounder or a Big Mac, don’t expect to find a tomato as part of your fast food indulgence. McDonald’s and other restaurants have decided to no longer offer sliced tomatoes after fresh tomatoes have been linked to salmonella. Nearly 150 cases of a type of salmonella have been reported around the country since April, including at least 23 hospitalizations, according to the Food and Drug Administration.
The source of the tomatoes has yet to be determined.