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Court documents filed in a Pfizer Neurontin lawsuit allege that the pharmaceutical company tried to suppress data from a study showing that Neurontin was ineffective in alleviating nerve pain. The documents reveal Pfizer executives strategizing about how to silence a British researcher whose study found the negative Neurontin results. At the same time these inner dealings were going on inside the corporate world of Pfizer, the company's marketing machine was engaged in an aggressive campaign to market the drug. The marketing campaign touted a smaller Neurontin study showing positive effects of the drug Neurontin.

The documents filed in court in anticipation of a potential class action lawsuit provide consumers and the courts with an insider's view of how the large drug companies influence and manipulate the flow of data and information presented to doctors and their patients.

According to the Boston Globe, "a dozen researchers and physicians reviewed thousands of documents for the plaintiffs' attorneys; their conclusions included that Pfizer controlled the information available to doctors and consumers by suppressing or delaying negative studies about Neurontin's effectiveness for certain types of pain, migraine headaches, and bipolar illness, and by manipulating other studies before they were published to make the results look more positive.

"They created the illusion of Neurontin's efficacy in the scientific literature," said lead plaintiff attorney Thomas Greene of Boston. "Pfizer's scientific misconduct and unethical behavior caused physicians to write tens of millions of ineffective prescriptions for serious and debilitating conditions resulting in billions of dollars in profit for Pfizer at the expense of patients and insurance companies."

Once again, we see the importance of transparency with the documents of large corporations. Just like that other large corporation immersed in scandal because of its internal documents, the Catholic Church, drug companies like Pfizer have had a disturbing history of covering up information that is not beneficial to them or their bottom line. A new and urgent call for transparency is the way out of this public relations morass but neither the Catholic Church nor the large pharmaceutical companies want to come out of the shadows and be transparent.

It's too bad for that's the only way to restore public confidence.

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This past weekend, Bishop Martino waded deep into the political maelstrom by ordering that his pastoral letter on abortion be read at all the masses in the Diocese of Scranton. As everyone knows, Scranton is a blue collar city in the swing state Pennsylvania. Joe Biden's from there and Barack Obama is starting to show some real traction in the Keystone state.

In his letter Bishop Martino states emphatically, “Being ‘right’ on taxes, education, health care, immigration and the economy fails to make up for the error of disregarding the value of a human life. It is a tragic irony that ‘pro-choice’ candidates have come to support homicide — the gravest injustice a society can tolerate — in the name of ‘social justice.’ ”

Now, that's a real whopper of a statement! Martino is linking elected officials and those who vote for them with homicide if they are considered "pro-choice". Besides the glaring logical fallacies Martino makes by trying to make such a connection, his hypocrisy is beyond belief.

If he's so concerned with pro-life issues where has he been when it comes to ministering to sexual abuse victims? I represent a dozen or so Catholics and former Catholics who were abused by Scranton priests. I'm talking about known abusers, the notorious ones, such as Robert Capparelli, Peter Crynes, Albert Liberatore, and Carlos Urrutigoity. Martino hasn't lifted a finger to help sexual abuse victims in the Diocese of Scranton.

His recent letter on "abortion" is nothing more than a cheap political trick to keep a Republican in the White House. By the way, none of our previous Republican presidents have been successful in getting Roe v. Wade overturned.

If Bishop Martino wants to involve himself and his Diocese in presidential politics, he is certainly free to do so. However, he can't have it both ways. If he's going to continue to make political statements and tell Catholics for whom they can vote without risking going to hell, he shouldn't keep his tax exempt status. Perhaps the IRS should look into this and revoke their status as a tax exempt organization.

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Initially, the FDA issued a safety alert regarding Medtronic's implantable drug pump but now the federal agency has classifed it as a Class I recall. The Class I status means that there is a reasonable probability that use of the product will cause serious adverse health consequences including death. Thus far one death has been attributed to the implantable drug pump with 83 adverse reaction cases reported. The problem concerns improper connections between the pump and the catheter which can lead to an overdose of pain medication, withdrawal symptoms or a recurrence of symptoms if the drug isn't administered properly due to the catheter connection problem.

The pump is used in patients suffering from spasticity related to cystic fybrosis. The affected pumps are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. According to Medtronic, approximately 25, 000 pumps have been sold since 2007.

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Glaxo Smith-Kline has settled a lawsuit concerning Paxil and the manner in which it was marketed as safe and effective to minors. The class action lawsuit was settled for $40 million and the money will be used to reimburse health plans that paid for children's Paxil use. While Glaxo Smith-Kline denies any liability in settling the lawsuit in which the company was charged with promoting the drug to children while at the same time withholding dangerous side effects, the settlement is a victory for consumer advocates who've been alleging that pharmaceutical companies regularly overpromote their drugs to consumers. Hopefully, this will curb pharmaceutical companies from illegally marketing their drugs for purposes which the drugs have not been approved. The drug companies market their drugs in this fashion because in their cost-benefit analysis it is worth it. If they continue to get penalized with lawsuits and federal fines they may re-think their cost-benefit analysis.

In the end, this is a good thing for consumers and children who don't deserve to be victimized by big pharma trying to make huge profits.

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An Emory University psychiatrist failed to disclose fees he received as a result of his consulting work for Glaxo Smith-Kline regarding their controversial drug Paxil. The payments were not a forgettable amount either-$500,000. Charles Nemeroff, chair of Emory University's psychiatry department, was compensated handsomely for making Paxil presentations to doctors on behalf of Glaxo Smith-Kline.

According to a federal inquiry, Emory University was unaware of the conflict or the payments. In fact, according to Emory University officials, Nemeroff was specifically instructed not to take more than $10,000 for the work.

Any federally funded research is supposed to be free of these types of conflicts of interest as well as the egregious behavior of tenured faculty members. Their behavior and greed put the reputation of the entire university on the line when they behave in such a fashion. This isn't the first scandal that clouds Dr. Nemeroff. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn't disclose he was a paid consultant to its maker, Cyberonics Inc.

This is bad for the university, the integrity of research projects in general, and most importantly the health and welfare of the public who receive treatment from doctors who've been bamboozled by people like Nemeroff. Good for Chuck Grassley, keep up the good work in the Senate!

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The federal government is scrutinizing Medtronic's relationship with Infuse Bone Graft physicians who are being paid for their consultative services by Medtronic. Further complicating the situation is the fact that Infuse Bone Graft is linked to potentially life-threatening complications when the graft is used in off-label, unapproved instances. The complications involve dangerous swelling in the neck area. The graft is a manufactured version of a naturally-occurring protein that promotes bone growth. It is approved by the U.S. Food and Drug Administration for use in the lower back, but surgeons say it is used widely off-label in other parts of the spine.

According to a Wall St. Journal report, "Doctors with financial ties to Medtronic have been among those promoting the off-label use of Infuse. Former employees have alleged the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties, and handing out lucrative consulting contracts that required little work."

In their letters, Sen. Kohl said the allegations by former employees are "highly disturbing." Sen. Grassley called them "troubling."

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Florida has now joined eight other states in filing a lawsuit against the pharmaceutical giant Merck for its deceptive and aggressive marketing practices concerning the drug Vioxx. The lawsuit, filed by conservative Republican State Attorney General Bill McCollum, is seeking restititution for all monies spent by state health programs regarding Vioxx. McCollum stated in filing the lawsuit, "Merck's costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment," McCollum also alleged that Merck tried to intimidate and coerce physicians and researchers who questioned the efficacy of Vioxx.

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The Pennsylvania statute of limitations is in their favor and they know it. They are dismissive of priest abuse victims who come forward knowing that as the law stands they will not be held accountable for hiding and transferring their abusive priests. I'm talking about the Diocese of Scranton in Pennsylvania but the same holds true for the Archdiocese of Philadelphia and the other Catholic dioceses in Pennsylvania-Pittsburgh, Erie, Altoona-Johnstown, Harrisburg, Alltentown, and Greensburg. The Archdiocese of Philadelphia has remained unchanged even after the scathing Philadelphia Grand Jury Report condemned their criminal behavior.

And now the Diocese of Scranton releases information about a sexually abusive priest, Rev. Robert Gibson who abused a young man in the early 1970's. The victim, now a grown man, reported the abuse in 2007 but didn't know that his was not the first report against this priest. The Diocese of Scranton had received at least one earlier report and had actually sent the sexual offender priest to a treatment facility a decade earlier. Yet now the Diocese of Scranton decides to release information about Rev. Gibson. According to the article in the Scranton Times-Tribune, here's what the church knew and when they knew it:

"In 2007, Michael Baumann, who now lives in Chesapeake, Va., told the diocese that the Rev. Gibson had sexually abused him in 1973 and 1974, when the Rev. Gibson was his eighth-grade religion teacher at Notre Dame Junior/Senior High School in East Stroudsburg.

Mr. Baumann describes the experience as “nine months of pure hell,” during which he was repeatedly abused in a church rectory and while on a trip with the Rev. Gibson to Disney World.

He never spoke of the experience, but neither did he forget about it. Now, he said, “I’m tired of being embarrassed and ashamed of it. It took me a long time, but it finally dawned on me that I’m not the one to blame for this.”

When Mr. Baumann made his report, he found he was not the first person to come forward about the priest’s actions. The Rev. Gibson had been transferred a decade before to a monitored Missouri treatment facility for troubled Catholic priests, including pedophiles and other sex offenders.

In a statement to The Times-Tribune, William Genello, a diocese spokesman, recounted that past:

On Jan. 5, 1995, the diocese was approached by an attorney for a man who claimed he had been sexually abused by the Rev. Gibson 20 years earlier.

The priest admitted the abuse and four days later resigned as the pastor of St. Bernadette Church in Canadensis, where he was stationed at the time.

The diocese sent the priest for treatment at the Villa St. John Vianney

Hospital in Downington, a behavioral health center for members of the clergy. After the Rev. Gibson was released, the diocese instructed him to continue therapy and assigned him to live under supervision, and without a pastoral role, at the St. Ignatius Rectory in Kingston.

In the spring of 1997, a mother reported that the Rev. Gibson was paying a troubling amount of attention to her son. After an internal investigation, the diocese found the priest was “likely ‘grooming’ the boy for improper activity.” In September, the diocese’s Clergy Review Board, a group of clerics and lay people that reviewed such allegations, determined that the Rev. Gibson “could not be trusted to have any public ministry or reside in any Diocesan facility.”

On Feb. 1, 1998, the Rev. Gibson was placed at the St. John Vianney Renewal Center in Dittmer, Mo., the residential treatment facility run by a religious order that ministers to troubled priests. Bishop James C. Timlin, the head of the diocese at the time, barred the Rev. Gibson from wearing clerical clothes outside the center and stripped him of his priestly faculties. For the last 10 years, he has had no public ministry or contact with young people and has been monitored 24 hours a day.

In all, four people have reported to the diocese that they were abused by the Rev. Gibson, a number Mr. Baumann suspects is “very low.”

What troubles him about the diocese’s response is that the accusations against the Rev. Gibson have never been publicly investigated, despite the fact that the church considers the priest a threat."

As history and experience has shown, the Catholic Church won't move on such an issue unless and until it is forced to by the civil authorities. This isn't a case dating back to the 1950's where the Church claims it didn't know how to deal with such an issue. They heard reports about this priest a decade ago and never did anything. He was never reported to law enforcement. Some things never change until society demands a change.

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A Tufts University professor has drawn the ire and critique of US Senator Charles Grassley for simultaneously working for the federal government, Tufts University Medical Center, and a heart device company. According to a Boston Globe report, "The specialist, Dr. Marvin Konstam, was hired in January as a senior adviser to the director of the National Heart, Lung, and Blood Institute, wrote Senator Charles Grassley, an Iowa Republican, in a letter sent yesterday to Dr. Elias Zerhouni, director of the National Institutes of Health.

But just last week, Grassley noted, Orqis, the private California company where Konstam is medical director, sent out a press release in which Konstam praised one of its products, a minimally invasive device for helping heart-failure patients. The press release identified Konstam as a professor of medicine at Tufts."

The question the public needs to ask, who's the doctor working for? It seems quite clear he shouldn't be the medical director for a private medical device company as well as drawing compensation from the government and an educational institution both of which are either supposed to be watchdogs for the public or committed to unbiased medical research. This is an example of how doctors can become entangled and conflicted when they are compensated as pitchmen for a medical device or drug while at the same time responsible for research and an unbiased judgment on the efficacy and safety of the same medical device or drug.

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While it sounds like it's a burden for the former Life Teen founder, it's actually going to work in his favor. An Arizona court has ruled that Monsignor Dale Fushek will be tried separately for molesting 5 boys back in the 1980's. However, the county attorney is rightfully upset with the ruling since the separate trials denies the prosecution the ability to explain to a jury what was Fushek's pattern and practice of abuse. This is a central point in the criminal proceedings just as it is always important in priest abuse civil lawsuits. If the jury doesn't hear about a priest abuser's pattern and practice and doesn't hear about how the bishops covered it up by moving the offending priest, the jury never gets the full picture of what happened. The same is true when victims are not allowed access to the internal church files documenting the abuse and the bishop's modus operandi of covering it up by transferring the priest. Church documents can show that the diocese knew that the particular priest was an abuser and that the diocese chose to ignore such information. In New Hampshire, a review of internal church documents revealed that the bishop had promised the offending priest that he (the bishop) would destroy psychological records that showed the priest was a danger to the community. This is the stuff we find in the internal documents of the church when we actually are allowed by the courts to review the documents.

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In Pinellas, Polk, Pasco, and HIllsborough Counties there have been 52 motorcycle accidents resulting in 40 deaths just this year. That's an alarming statistic and the number of motorcycle accidents appears to be growing at a rapid rate this year.

This in spite of the fact that the Florida Legislature passed mandatory motorcycle safety training prior to obtaining a motorcycle endorsement or motorcycle only license in Florida. The training courses spans 15 hours of safety programs. However, the course can't take into account other drivers' inattention to motorcycles.

With fuel prices continuing to rise, especially after Hurrican Ike, there will undoubtedly be more motorcycles on the roads. This coupled with heavy traffic in the Bay area has resulted in these tragic statistics.

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This fall, the US Supreme Court will hear cases involving medical devices that have caused injuries in spite of the fact that they were approved by the FDA. The Court already ruled in favor of pre-emption on February 29, 2008 in Riegel v. Medtronic. In that case, the court stated that if the FDA approves a medical device that later turns out to injure a person that person is barred or "pre-empted" from bringing a lawsuit in state court. This is obviously a huge victory for businesses, especially huge medical device companies. On the other hand, it is very unfair for those with valid claims whose pursuit of justice is now short-circuited by the Supreme Court's decision.

One of the more interesting cases on the Supreme Court docket this fall is Wyeth v. Levine. Drug manufacturer Wyeth (the same company that produced the harmful diet drug Fen-Phen) will argue that it can't be sued for mislabeling its drug Phenergan in spite of the fact that this mislabeling directly resulted in Ms. Levine's loss of her right arm. Wyeth's argument rests solely on the fact that the drug Phergan had been previously approved by the FDA and is therefore immune from any lawsuit brought in state court.

Aware of the injustice and inequity of the Supreme Court's Riegel decision, Congress is working on legislation to fix it. The proposed legislation is called the Medical Device Safety Act of 2008.

In the Levine case, the issue boils down to this: Do the FDA and other federal regulatory agencies set minimal standards which states are free to strengthen or do federal agencies make judgments about safety standards that states are required to follow?

This will be a very important case for advocates of consumer justice. Will the Supreme Court bar injured victims, who, through no fault of their own, are severely injured by bad medical devices or will the Court side with the consumer recognizing that the courts are their only avenue to pursue justice?

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The Catholic Church has figured out how to spin the priest abuse scandal so that it has minimal damage to its reputation. Initially, the Church played the "blame the liberal media" card. When that got old, it moved to "blame the lawyers". Now, they moved to another phase which can best be described as a public relations two step. Church officials, namely bishops will proclaim from the rooftops that they have established best practices when it comes to ensuring the safety of children and vulnerable populations. Their lawyers then fight behind the scenes to keep their internal documents from public view. Take for example what's happening in the Archdiocese of Los Angeles and the Diocese of San Diego. Both defendant dioceses settled their lawsuits over a year ago. Part of the settlement agreement, arguably the most important part of the agreement, was the dissemination of the church's internal documents concerning their conspiracy of secrecy and coverup in dealing with sexually abusive priests. To date, both Los Angeles and San Diego are fighting to keep those documents from the public! It's clear they don't want their secrets and their practices out in the public arena. The fact that these documents remain hidden constitutes a clear and serious danger to the safety and welfare of all children. The abuse doesn't stop until the secrets reach the light of day. Bad priests, even when removed from the priesthood, will continue to prey upon young victims if the truth about them is not known. The documents must be given to the public. It's time to stop this ecclesiastical two step.

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The American College of Cardiology recently signed a 5 year partnership with the non-profit Cardiovascular Research Foundation. On the surface, this seems a natural mix-a group of cardiologists collaborating with an academic not for profit research foundation. Yet, a US Senator has opened an investigation for potential conflicts of interest regarding the ties between them and the medical device community. It's an ongoing saga of financial entanglements between doctors and either pharmaceutical companies and medical device manufacturers that's drawing Congressional attention. This time, Wisconsin Democratic Senator Herb Kohl is looking into the relationship, especially the financial aspects of the partnership.

According to the Minneapolis Star Tribune, the relationship may underscore a potential conflict. The Star Tribune reports, "Noting that the foundation receives funding from a variety of medical device manufacturers, 'the potential for this partnership to influence clinical practice raises questions concerning the continued impartiality of your organization,' Kohl wrote ACC President Dr. Douglas Weaver in a July 22 letter. A conference organized by CRF annually counts Fridley-based Medtronic Inc. and Boston Scientific Corp. as sponsors."

Last year, Kohl co-sponsored legislation requiring pharmaceutical and medical device companies to list any financial contributions, payments, or gifts made to physicians.

Congressional oversight and regulation of these relationships is a good thing for consumer safety. The public has a right to know the relationships doctors have with drug companies and/or medical device manufacturers. Transparency can only protect consumers from undo influence as well as keep the medical community focused on patient safety rather than the corporate bottom line.

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The FDA has posted on its website reports of a woman's death from a brain infection a year after taking the arthritis and cancer drug Rituxan and warned doctors to cease using the drug if any symptoms of the brain infection appear. The drug, co-marketed in this country by Genentech and Biogen, has been very popular for the treatment of arthritis and certyain forms of cancer.

While the FDA posted the information on its website, the link between the drug and brain infection is still tenuous. The infection is known as progressive multifocal leukoencephalopathy, or PML and has no known cure. The infection is caused by a reactivation of a common virus in the central nervous system of those with weakened immune systems. Symptoms include weakness or paralysis, vision loss, impaired speech, and cognitive deterioration.

Cases of PML had been reported in patients who were using it for which the drug wasn't approved such as Lupus. According to the FDA, this is the first report for a patient taking Rituxan for arthritis.

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