Monthly Archives: February 2010

Connecticut Latest State to Introduce Sex Abuse Legislation

Lawmakers from the state of Connecticut have introduced legislation that would eliminate statute of limitations on civil cases involving childhood sexual abuse. The legislation comes in the wake of a Connecticut doctor accused of abusing hundreds of victims over a period of several decades. Dr. George Reardon, a deceased endocrinologist, has been accused of the sexual abuse and exploitation of hundreds of victims over decades. State Senator Mary Ann Handley is supporting the bill because she recognizes many abuse victims don’t initially recognize that fact that they have been harmed.
“Children don’t always recognize that what’s happening to them is abuse,” Handley said. “At times, it takes a very long time to acknowledge that.”
Current Connecticut law requires a victim file a lawsuit by the time they turn 48 years old.

Scranton Diocese Gets New Bishop

Monsignor Joseph Bambera, now Bishop-elect Bambera, has been chosen as the new Catholic bishop for Scranton. He replaces retired Bishop Joseph Martino who retired last year in the midst of a storm of controversy over his handling of parish closings and the priest abuse scandal in his diocese.
Bambera had served as a liaison between Cardinal Justin Rigali of Philadelphia and the Diocese of Scranton during the inter regnum period since Bishop Martino’s resignation and the appointment of the new bishop of Scranton.

Doctor Pleads Guilty to Falsifying Drug Research Data

A Massachusetts doctor accused of falsifying scientific research concerning such drugs as Vioxx, Bextra, Celebrex, Effexor, and Lyrica has entered a guilty plea. According to federal prosecutors, Dr. Scott S. Reuben, former chief of acute pain at Bay State Hospital in Springfield, MA, had sought grant money from pharmaceutical companies in order to do research concerning their drug products. Prosecutors discovered that from 1996 to 2008, Reuben published 21 papers concerning his alleged research and in those papers, all or most of the data was falsified or fabricated completely. The fabricated research influenced doctors who, relying on Reuben’s work, prescribed drugs such as Vioxx to patients suffering pain associated with knee, hip, or other joint problems. Even the FDA was influenced by Reuben’s lies. In some instances, the federal agency decided not to restrict certain drugs based on Reuben’s testimony.
As part of his plea agreement, Reuben will repay $361,932 in research grants and forfeit assets worth at least $50,000. He has also agreed not to practice medicine. In addition, Reuben faces up to 10 years in prison, to be followed by three years of supervised release and a $250,000 fine, the Associated Press said. His sentencing is scheduled for May.
It’s unknown how many people have been adversely affected by Dr. Reuben’s lies. This is perhaps one of the worst cases in which so-called scientific research is held hostage by influence peddling and money. It’s time, past time, that any research concerning drugs and medical devices be completely free from financial associations with medical device companies and/or pharmaceutical companies. Doctors have to be able to trust the research provided them concerning a drug or a medical device is objective and accurate. It can’t be tied to money or lobbying from the companies who manufacture the drug or the medical device. It’s disappointing to me that there’s scant mention of this issue on Capitol Hill when legislators discuss healthcare reform.

Delaware Pediatrician Indicted on Sex Abuse Charges

Delaware pediatrician, Earl Bradley, has been indicted on 471 counts of sexual abuse on 103 children. Dr. Bradley was originally arrested in December 2009. Delaware Attorney General Beau Biden noted that all 103 children had been videotaped as the pedophile doctor sexually abused them. The videos were seized from Bradley’s office and home and date as far back as 1998.
Biden, son of Vice President Joe Biden, became emotional as he announced the indictment. “These were crimes committed against the most vulnerable among us — those without voices, . . .I know of no other that has this many victims.”
Bradley faces criminal charges that include rape, sexual exploitation of a child, unlawful sexual contact, continuous sexual abuse of a child, assault and reckless endangering. Bradley’s bail is set at $2.9 million. His medical license in Delaware has been permanently revoked by the state Board of Medical Practice.
While suspicion swirled for years about Bradley’s strange behavior, it was a 2 year old girl who reported to her mother that the doctor had hurt her during an exam in December 2009. That revelation led to the pedophile’s arrest last December.

FDA Wants Avandia Pulled from Market

The Wall St. Journal is reporting that the FDA has recommended to GlaxoSmithKline that it pull its diabetes drug Avandia from the market because of its association with heart attacks.
The studies are part of a report released by the Senate Finance Committee. Initial reports of an FDA market withdrawal were published in Saturday’s edition of the NY Times. Avandia’s difficulties began in 2007 when Cleveland Clinic cardiologist Steve Nissen published a study in the New England Journal of Medicine that found Avandia users were subject to a 43% higher risk of heart attacks than those who used other diabetes drugs. Glaxo added a “black box” warning to Avandia in November 2007.
According to the Wall St. Journal, the conclusions drawn by the Senate Finance Committee were critical of Avandia’s manufacturer.
“The Senate Finance Committee report concludes that Glaxo was aware of the possible cardiac risk years prior to Dr. Nissen’s study. The report says Glaxo had a duty to warn patients and the FDA about its concerns in a timely manner. “Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk,” the report says.

FDA Meeting to Review 510 (k) Medical Device Approvals

According to Reuters, the Food and Drug Administration will meet today to discuss changes to a program that oversees the way medical devices are approved for use in this country. Industry insiders consider this an important meeting since the FDA receives more than 3,000 medical device applications each year and the process has been controversial in the past.
The 510 (k) approval process has been dogged by allegations of fraud, safety problems, corruption, and conflicts of interest. Even the head of the committee, Dr. Daniel Schultz, prior to his resignation, admitted to problems with the process. Schultz admitted that the committee was often pressured to approve medical devices against the committee’s better judgment.
The meeting will be divided as follows: 1)issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence; 2)issues related to new technologies and scientific evidence; 3)issues related to practices the FDA adopted in response to a high volume of submissions; and 4)issues related to post-market surveillance and new information about marketed devices.

Toyota Considering Recall of Corolla

This has to be unprecedented for any auto company, no, any business. Incredibly, Toyota officials are contemplating another recall-this time concerning its highly popular Toyota Corolla due to power steering defects.
So far, there are fewer than 100 complaints in the US concerning the Corolla and its power steering mechanism.
In the past four months, Toyota has recalled a total of 8.5 million vehicles due to sticking accelerators, faulty floor mats, and faulty brakes. The auto company is facing Congressional inquiries as well as an investigation from the National Highway Transportation Safety Board.
The recalls and defects involve some of Toyota’s most popular name brands including the Prius hybrid, the Corolla, and the Camry. Some on Capitol Hill have criticized the manner in which it has dealt with past safety concerns including allegations by some that Japanese company officials didn’t fully disclose the nature of safety concerns in order to avoid a slump in sales.

Irish Bishops Conclude Uneventful Meeting with Pope

If you didn’t have a calendar readily available, you could’ve easily thought the US bishops were meeitng with Benedict XVI’s predecessor in 2002. “Frank” words were exchanged. The bishops spoke of scandal and sorrow. The pope called the sexual abuse a sin. So, what’s different now? Absolutely nothing. Perhaps the media hyped the significance of the papal meeting with the Irish bishops. This meeting marked the first time Pope Benedict could have drawn a sharp distinction between his papacy and his predecessors in terms of how he would deal with priest sexual abuse. So the expectations were high. Neither side impressed anyone or showed any real effort at breaking new ground. Old words were spoken, tired cliches were utilized, and the Irish bishops left Rome with job security. Nothing changed and it appears nothing will change. Irish children are no safer after the two day papal visit. Survivors were not addressed or consoled. The public was not given any reason to regard the institution as anything but corrupt and incapable of real change. If the church’s bishops continue on this path, they risk irrelevancy and scorn. Their influence will continue to wane in other areas in which the church holds sway.

New Study Links Hydroxycut with Liver Damage

A new study has linked the once popular diet drug Hydroxycut to liver damage. The study, published in the latest publication of the American Journal of Gastroenterology, followed 17 cases of Hydroxycut users whose livers had been damaged by use of the diet supplement. Nine of the cases had been reported to the FDA while the other 8 were discovered in the study.
The eight cases led researchers to conclude there was a greater than 95 percent likelihood that the weight-loss aid was to blame. In five cases, the researchers concluded that Hydroxycut was “highly likely” the cause (a 75 to 95 percent chance), while it was probably to blame in two cases (a 50 to 74 percent chance). The last two cases were considered to be possibly linked to Hydroxycut use.
This is the first such scientific study that shows a strong link between the diet drug and actual liver damage. Prior to the publication of this study, no causal link between the drug and liver damage had been established.
Hydroxycut was removed from the market in the spring of 2009 after the FDA received 23 reports of adverse effects associated with Hydroxycut.

Irish Bishops Meet with Pope Benedict

In a scene eerily reminiscent of his predecessor’s meeting with US cardinals in 2002, Pope Benedict XVI has begun a two day meeting with 24 Irish prelates, each of whom were scheduled to speak about the Irish sex abuse scandal for seven minutes. The Irish bishops were summoned to the Vatican after an independent report detailed the shocking details of 325 sex abuse claims in Irish dioceses from 1975-2004.
The Irish Catholic Church has been rocked by the sex scandals with episcopal resignations and accusations between government officials and church clergy flying. The real issue is threefold: 1)the prevention of the future abuse of children, 2)real reform characterized by actions rather than words, 3)collaboration between the church and secular authorities in order to make the church transparent
While chatter about the summit meeting appeared to be taken from public relations’ cue cards, any real success will be determined by the Church’s actions toward those who’ve been abused. Once again, it’s a case of wait and see.

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