Drug Products

Raytheon Says It Will Take 78 Years to Clean Up Toxic Plume in St. Petersburg

That’s not a typo. Raytheon’s consultant Arcadis estimates that it will take 78 years for the defense contractor to clean up the toxic mess it caused in St. Petersburg’s Azalea neighborhood. 78 years is generational damage. This is simply not acceptable. If Raytheon expects to be regarded as a good corporate citizen it can’t expect the good people of St. Petersburg’s Azalea neighborhood to sit idly by and accept their consultant’s conclusion that it will take 78 years to clean up this mess.
Of course, as Mark Douglas, the Channel 8 reporter who first broke the story points out, the Raytheon mess would still be a secret if the news channel hadn’t uncovered the problem in the first place. This is an outrageous situation in which a large corporation is allowed to operation with impunity while innocent citizens suffer the consequences of their behavior.

Delaware Pediatrician Abuse Case Eerily Familiar

The circumstances surrounding the arrest and subsequent revelations of sexual abuse concerning Delaware pediatrician Dr. Earl Bradley is all too familiar to this writer. What I’ve seen and experienced helping survivors of priest sexual abuse over the years is sadly similar to what I’m reading about the pediatrician. Dr. Bradley was in a position of special trust among parents, colleagues, and law enforcement. That special trust allowed Bradley to continue sexually abusing kids for decades in spite of the fact that there were suspicions about him for years. Bradley, like the Catholic priest abusers, groomed his victims. He was very popular and appeared to be generally good with children. He had a thriving practice. The possibility that he could be a monster abusing the community’s children was unthinkable. Essentially, he was an iconic figure in the town.
And that’s part of the problem. Institutional figures-whether they be teachers, police officers, clergy, doctors, or lawyers-are not above the law. They are human beings who’ve been given a special trust in society. However, that does not mean they should be treated with a blind faith or the sense that they are infallible. Because of their special role in our community, these people should be held to a higher standard of accountability. If this were the case, perhaps Dr. Bradley would have been arrested years ago when the first child complained that the doctor had touched him/her or kissed him/her.

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.