Monthly Archives: October 2008

Vatican Decrees Use of Psychological Test to Weed Out Homosexuals

In an unprecedented move, the Vatican has decreed that priest candidates (seminarians) who show signs or tendencies of homosexuality will have to undergo a battery of psychological tests prior to ordination to the priesthood. While psychological testing is not new to the priesthood-most seminaries require some sort of psychological report prior to accepting a candidate for a course of priestly study. However, the public manner in which the Vatican is making this move is somewhat new.
Of course, while many will question the Vatican’s attempt to link homosexuality with the sexual abuse of minors. The Vatican is clearly linking the two and is taking a public step to do something about the abuse scandal.
It’s quite interesting to note the words the Vatican officials are using to describe what they’d be looking for in a dubious candidate. Here are sampling of the terms: “strong affective dependencies; notable lack of freedom in relations; excessive rigidity of character; lack of loyalty; uncertain sexual identity; deep-seated homosexual tendencies, etc.” These are words we’ve seen on numerous occasions when investigating the background of a sexually abusive priests. They often come up in the church’s internal documents and are terms to describe sexually abusive behavior of minors.
It seems to me that if the Church were truly serious about eradicating this sex abuse problem it would develop a program for wayward bishops who transfer and cover up for these sick priests. Therein lies the real problem and the real scandal.

FDA on Drug Pre-Emption Lawsuits-Not What You Might Think

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
Officially, the FDA supports federal drug-approval and warning-label standards trumping stricter state laws in the Supreme Court case, Wyeth v. Levine that will be heard this coming Monday. However, internal memoranda support the opposite. In internal FDA memos, two FDA officials state that it’s wrong to assume FDA drug labels are completely reliable or that they contain full disclosure of the drug’s risks.
According to a story in today’s Wall St. Journal, “‘[M]uch of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis,’ wrote John Jenkins, the top official in the drug approval section, in 2003.”
When the FDA was confronted with the apparent contradiction, an FDA spokesperson noted that any large orgnization is bound to have differing views. However, the contradictory notions coming from the FDA are bound to give anti-preemption legislators fodder for overturning the Bush preemption policies.
The injustice of the Levine case is the unwarranted extension of the preemption doctrine. The basic law is this: Congress can preempt state laws in areas of national concern by expressly providing in the language of a bill that state regulations are preempted or superseded by the federal law. That is called express preemption. Until the Bush administration the FDA had always taken the position that state consumer tort suits were a consumer protection that complemented the federal FDA regulation. The Levine case is a prescription drug labeling case. The FDA approves labeling including warnings for prescription drugs. In most drug lawsuits the consumer claims that the manufacturer did not warn of a danger of which it knew. Most of the time these dangers are not disclosed or are concealed from the FDA like with Fen Phen or Vioxx. The drug company argument in Levine is that consumer tort suits for failure to warn on the labeling should be preempted under implied preemption because the FDA reviewed and approved the label.
This preemption question is one that can be solved by legislation that has already been proposed that expressly states that the the FDA regulatory process is not intended by Congress to preempt state consumer lawsuits.

FDA Warns Bayer on Marketing Practices

The FDA has sent two warning letters to Bayer regarding two aspirins, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage. According to the FDA, Bayer’s marketing campaigns make health claims that have not been proven by the federal agency. The Bayer aspirins are marketed as successfully battling osteoporosis and heart disease. The claims have been made with out substantiation or at the very least such substantiation has not been submitted to the FDA.

Thoratec Heart Pump Recalled after Deaths Reported

A small mechanical heart pump manufactured by Thoratec Corporation has been recalled after 5 deaths were reported. The affected catalog numbers are 1355 and 102139. The heart pumps have been distributed to 153 hospitals throughout the country since the beginning of clinical studies in 2003.
The HeartMateII pump was approved in April for the temporary treatment of patients awaiting heart transplants. The recall was prompted by a failed electrical wire in the heart pump. The failure occurred in 27 of the 1,972 people who were using the heart pump device. In June 2007, Thoratec began using a stronger, more durable wire that has shown a lower failure rate.
Thoratec has recommended that patients using the heart pump device consult with their physician to determine the condition of the electrical wire.

Rev. Donald McGuire Guilty on Both Counts

Rev. Donald McGuire, the Chicago Jesuit priest who had served as spiritual director to Mother Teresa and her Daughters of Charity religious order has been found guilty on both counts in federal court in Chicago. His sentencing will be in December. McGuire has been dismissed from the priesthood.
McGuire’s victims were taken on trips out of state and witnessed the lavish lifestyle of a Jesuit priest. The sexual abuse consisted of massages (fondling), intercourse, and other vile acts. Well, the rooster has finally come home to roost.

Mesh Linked to Problems in Incontinence Surgery

The FDA has received more than 1,000 complaints of problems associated with a vaginal mesh used in surgeries to treat severe incontinence and a prolapsed uterus in women. The problems include erosion of the mesh through vaginal tissue, infection, pain and urinary problems. There has also been a recurrence of the original problem in the mesh surgeries. According to the FDA, it has received complaints from 9 separate manufacturers of the mesh.
According to the FDA, a pelvic organ prolapse occurs when a pelvic organ such as the bladder pushes against the vaginal wall. Other organs that can be involved in such a prolapse include the uterus, bowel, and the rectum. Symptoms of such a prolapse include pain or difficulties with the bladder or bladder. Problems with sexual activity may also by symptomatic.
The FDA lists sample questions one should ask their physicial before having such mesh surgery:
What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
What’s been your experience in dealing with the complications that might occur?
What can I expect to feel after surgery and for how long?
Are there any specific side effects I should let you know about after the surgery?
What if the mesh doesn’t correct my problem?
If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Volusia County Teacher Arrested for Sex with Student

A 45 year old teacher and mother of four has been arrested for having sex with a 17 year old student. Warner Christian Academy teacher Cynthia Horvath has been charged with unlawful sexual activity with a minor, a second-degree felony. Neither of the agencies’ investigations are complete. The sexual trysts occurred at least 25 times in seedy motels, under bridges, and in the teacher’s car.
You don’t even have to be a parent of a teenager to find this extremely disturbing and alarming. The private school was founded in 1971 and its mission is to help students develop “spiritually, academically, socially, and physically.” The school is affiliated with the White Chapel Church of God and serves the Halifax community in Volusia County.
The scourge of sexual abuse of minors is not something that is a bygone phenomenon. It’s happening right now and it’s taking place in our schools, youth groups, churches, and at times, our hospitals. If we’re going to protect our children from the horrors of sexual abuse we have to start with vigilance and education about the dangers of sexual abuse.

Eli Lilly’s Illegal Marketing of Zyprexa Will Cost Company $1 Billion Plus

Eli Lilly took a calculated gamble when it decided to market its blockbuster drug Zyprexa for dementia and mild bipolar disorder. It hadn’t been approved for such purposes and the drug company was prohibited from marketing the drug for unapproved uses. Yet, Lilly decided to do it anyway. The cost of such a gamble: $1.4 billion. However, keep in mind that US sales of Zyprexa are over $2 billion so it was a calculated risk that made the company money, albeit illegally. The $1.4 billion will be charged off against company earnings and Eli Lilly will go on relatively unscathed.
That’s the problem with these huge pharmaceutical companies. They can afford to break the law because it’s still a lucrative thing to do. These practices won’t change in the pharmaceutical industry until the government and the court system decides to play hardball with them and hit them where it hurts-their pocketbook. As long as the consequences are minor, these companies can continue to act with impugnity. The situation will only deteriorate if they get what they want with potential federal pre-emption. This isn’t a good situation for the consumer who relies on the safety of these drugs. Ordinary people have to be able to trust these companies and believe that they are manufacturing safe and effective drugs. If not, our healthcare system is in real peril.

Congress Investigating Drug, Medical Device Company Ties to Doctors. . .Again

This time a letter was sent to the Cardiovascular Research Foundation about its financial ties to researchers. Congress, particularly Sen. Charles Grassley, is investigating the nonprofit group’s ties to drug manufacturers and medical device makers. The letter coincided with the Foundation’s annual conference. The conference, known as Transcatheter Cardiovascular Therapeutics, attracts doctors from around the world. At the conference medical device companies display their products in an exhibition hall.
Congress continues to press drug companies and medical device manufacturers for financial transparency so that the federal government as well as the general public know the relationship between such companies and the researchers who are paid by them. Senators Herbert Kohl and Charles Grassley authored the letter and are pushing for legislation to make the industry more transparent. In the letter, the Senators wrote, “As you are no doubt aware, there are divergent scientific opinions concerning such products, the safety and efficacy of which are a matter of dispute among cardiologists.”
According to a NY Times article, “At the same conference on Thursday, researchers released results of a new study indicating that a drug-coated stent called Endeavor, made by Medtronic, was linked to more heart attacks and deadly blood clots than the Cypher stent made by Johnson & Johnson. ”
This information along with greater financial transparency is urgently needed for an industry that often places profits before public safety.

Pfizer To Settle Bextra and Celebrex Lawsuits

Drug manufacturer Pfizer has announced its intention to settle lawsuits against the pharmaceutical company for its drugs Bextra and Celebrex. The amount of the settlement is $894 million with $745 million set aside to settle the personal injury lawsuits claiming that Bextra and Celebrex users suffered heart attacks or strokes as a result of using the painkiller drugs.
According to the Wall St. Journal, “Attorneys General in 33 states and the District of Columbia, who have filed suits relating to Pfizer’s promotion of Bextra, will receive $60 million of the settlement; the remainder, $89 million, will resolve class actions alleging fraud in connection with the promotion of Celebrex and Bextra.”
The settlement annoucement comes a year after Merck agreed to settle its Vioxx lawsuits. All three drugs are considered Cox-2 inhibitors which became popular for their painkilling ability as well as their gentleness on the stomach. However, the drugs have been linked to an increase in heart attacks and strokes and controversy remains concerning their overall painkilling effectiveness.