Two House Democrats Bill Pascrell, Jr. (D-NJ) and Lloyd Doggett (D-TX) have introduced important legislation that would create a national database for medical devices including artitificial hips and knees. The database would allow industry analysts as well as government oversight groups to analyze the medical devices’ effectiveness as well as compaints concerning faulty devices.
There’s been considerable talk and little action for the last decade concerning the establishment of such a registry. The development of a privately-run and industry financed registry has never progressed due in large part to the medical device industry’s unwillingness to finance the project.
The government-run registry will provide the necessary independent oversight as well as play a crucial role in President Obama’s overhaul of healthcare. The “comparative effectiveness” reviews will allow an important analysis of which medical products and procedures are working and most cost effective.
Other countries have oupaced the US in such use of medical device databases where patients receiving artificial medical devices such as hips and knees are registered so that their progress can be determined.
The urgent need for the device database was highlighted last year when Zimmer Holdings, Inc., the country’s most prolific manufacturer of artificial hips and knees, came under scrutiny after doctors had complained to Zimmer that its product, the Zimmer Durom cup was failing at a higher than acceptable rate. In spite of the doctors’ complaints, Zimmer continued to market and sell the Durom cup. While Zimmer was reviewing their data concerning the cup complaints, it’s estimated an additional 1,300 patients received the Durom cup. In response to the NY Times article concerning the device registry, Zimmer officials declined comment on how many patients need revision surgery as a result of the failed Durom cup.
An advocate of the medical device registry, Dr. Henrik Malchau, an orthopedist at Massachusetts General Hospital, told the NY Times that such a device registry could save many patients the pain and suffering of undergoing a revision surgery due to a faulty medical device. Malchau estimated that in countries with no such registry, patients face double the risk of undergoing such risky revision procedures.
In Malchau’s comment’s concerning the Zimmer Durom cup issue, Malchau noted that if the country had had a medical device registry in place at the time doctors were complaining about the Durom cup, the issue could have been resolved far more quickly resulting in fewer patient problems and a decreased number of instances of hip revision surgery.
It’s estimated that the current House proposal would take up to three years to complete and would fall under the control of the Agency for Health Care Research and Control, a division of the Division of Health and Human Services.

I stopped in a health food store in St. Petersburg the other day with an attorney friend of mine. We wanted a quick protein shake after a strenuous workout. While the person behind the counter was preparing our shakes, my friend pointed to a bottle of NOX. He told me that he had heard from friends how this mixture increased the benefits of a workout while simultaneously maximizing energy and concentration throughout the day. The bottle’s ingredients were a veritable plethora of “natural” ingredients including nitrous oxide. The small bottle’s price was $59.99
His enthusiasm for the product and desire to buy it made me think about the many clients I represent who’ve been injured by other “natural” products.
The diet supplement sector is a multi-billion dollar a year industry whose growth potential is infinitely larger than any of the regulated pharmaceuticals manufactured to fight disease, cure illness, or stave off any of a number of ailments that afflict human beings.
The industry’s marketing campaigns are slick and disciplined in honing in on their target audience. Today, one can’t go into a smoothie shop, vitamin store, or health food outlet without noticing the multitude of products promising weight loss, weight gain, increased muscle, better performance, and better health.
Yet, these claims are for the most part untested and completely unregulated by the government. The FDA has no regulatory influence over the industry. It’s literally a “wild west” scenario where any one with entrepreneurial skills and access to “natural” ingredients can produce a product that promises results with very little to no scientific evidence to support the claims.
Recently, the FDA has intervened in cases concerning diet supplements where the ingredients are mixed with a regulated prescription ingredient. That’s clearly illegal and the FDA has rightly stepped in to halt the sale of such products.
However, the majority of these “natural” products remains on the market and enthusiastically purchased by those seeking the results promised in the marketing campaigns.
The products are not only found in health stores and smoothie shops. They can be purchased online. They are advertised in health magazines, muscle and fitness publications, and on television.
It’s not only those who are interested in fitness who are buying these products. Such “natural” products are marketed to those desiring more energy, better concentration, better sexual performance, healthier skin, and stronger bones.
The fact that the industry is unregulated is a boon for those with no scruples and a dearth of scientific evidence. The labeling on such products has been demonstrated to be vague at best. At times, the labeling of ingredients is actually false. Even the stated amount of the ingredients can be inaccurate. Many of these so-called “energy boosters” can contain harmful amounts of caffeine and/or sugar.
Perhaps more importantly, certain combinations of “natural” ingredients can be harmful if not fatal. Take for instance kava kava or hydroxycut. These so-called products haven’t been tested for safety and evaluations of these products have never been performed.
Until the FDA can gain regulatory control over this burgeoning industry, it’s a wild west scenario and “buyer beware” can take on morbid overtones. If you’re taking one of these products, you may be playing a dangerous game with your health.

Two leading diabetes drugs, Avandia manufactured by GlaxoSmithKline PLC and Actos made by Takeda Pharmaceutical, are under closer scrutiny after a clinical study of more than 144,000 patients found the drugs cause bone fractures. The drugs, classified as TZDs, have already been linked to an increased risk of cardiac problems including heart failure. The new connection to bone fractures appears more problematic than the cardiac connection.
According to the Wall St. Journal, “I think the fracture issue, perhaps more than concerns about cardiovascular events, could impact how doctors use TZDs in the future,” said Steven Kahn, author of the first study that found fracture risk in late 2006 with Avandia.
Diabetes patients taking Avandia or Actos were found to be 43% more likely to experience a fracture than non-users of the drugs.
According to health officials, TZD drugs diminish bone density by diminishing osteoblast activity which is the body’s bone-building process.

In a move that caught both sides of the debate off guard, Rep. Margaret Markey has announced that she’ll amend the Child Victim Act to include public institutions as well as private organizations in the bill designed to protect children and punish sexual predators and the institutions that protect them.
A spokesperson for the NY State Catholic Conference seemed dumbfounded when confronted with the news. Dennis Poust, quoted in the NY Times, stated, “This is not what we expected; this is something new.”
An interesting quote from the representative of the NY Catholic dioceses. They wanted to kill the bill entirely by calling it unjust and unfair. Now that the amendment has been offered removing the inequity they are caught in a difficult situation. They have no excuse to keep fighting the bill. That is, of course, if they’re interested in protecting children.
The Catholic Church is in a public relations jam with this new revelation. They can’t appear to oppose the bill now that their main objection has been removed. On the other hand, if the bill passes and becomes law, their secrets and the manner in which they shuffled offending priests around will be exposed.
While anything can happen in politics, this should be a no brainer. The NY legislators should overwhelmingly support this legislation. We’ll see what happens.

When Bishop Nicholas DiMarzio went off on a tirade about the pending Child Victim Act legislation in the state of New York, he didn’t stop to think his threats may draw scrutiny from the IRS over the church’s tax exempt status.
Margaret Markey, sponsor of the Child Victim Act, has called into question the bishop’s actions after he threatened NY state lawmakers with the closure of Catholic churches in their districts if the legislators support the child abuse prevention bill.
Markey stated, “He’s on the borderline of jeopardizing his not-for-profit status” by openly politicking, she said. “If I were the bishop, I would walk very cautiously.”
The Bishop’s responded through a priest saying she’s lying.
Lying about what? DiMarzio admitted he made the threats and has been active in efforts to kill the bill. So, what is Rep. Markey lying about?

Until now, not too many folks would compare the popular TV gangster Tony Soprano with Brooklyn Bishop Nicholas DiMarzio. After what happened at his Clinton NY residence last October, perhaps a few NY state legislators will make a connection between the two.
According to the legislators in attendance at the Bishop’s residence last fall, DiMarzio brought up the subject of Rep. Margaret Markey’s bill the Child Victim’s Act. According to the legislators, DiMarzio became so incensed he threatened to close local parishes in the legislative districts of those supporting the bill. According to one anonymous legislator, DiMarzio ranted, “He said, ‘If it passes, we will close a parish in each of your districts and we will tell your constituents that it was your fault,’ ”
Under normal circumstances, legislators don’t take kindly to threats of blackmail. However, this is the Catholic Church in New York, a powerful institution with deep pockets and long institutional tentacles that can influence, cajole, even threaten the highest ranking officials.
DiMarzio’s feeling the heat and will stop at nothing to defeat the Child Victim’s Act, even if it means blackmailing and threatening state legislators. It’s amazing to me that the bishop only spoke to the legislators about the money his diocese would stand to lose in lawsuits if the bill passes and becomes law. There no mention of any concern for the thousand of kids molested and ruined by sexually abusive priests and nuns. It’s all about the money and protecting the institution.
When DiMarzio’s in public he knows the bon mot and speaks about his concern for victims. In private, he’s the don of an institution that doesn’t give a wit about children. It’s all about the money.

Certain proton pump inhibitor drugs designed to treat acid reflux have been linked to an increase in pneumonia. Some of those associated with the higher risk included Nexium, Prilosec, and Prevacid.
Dr. Shoshana J. Herzig, chief medical resident at Beth Israel Deaconess Medical Center in Boston, is referenced in the NY Times’ article about acid reflux drugs and pneumonia. According to Herzig, the acid reflux drug suppress stomach acid but may promote the growth of another bacteria in the upper gastrointestinal and upper respiratory tracts. This may be the source of the increased in pneumonia for those taking the acid reflux drugs.
Other acid reflux drugs, notaby Pepcid and Zantac aren’t associated with the increased pneumonia risk because they are histamine-2 receptor antagonists.

It’s been more than a decade long court fight but finally the Diocese of Bridgeport will be forced to hand over more than 12,000 pages of documents concerning priest abuse. The Diocese, which had been headed by none other than Cardinal Edward Egan prior to his departure for NY, had fought for years to keep the documents out of the public eye.
Even in the the midst of defeat, a diocesan spokesperson struck a defiant tone. “”From the anti-church rhetoric of the first trial judge who proceeded to ‘invent’ an entirely new procedure to accommodate the press, to the lack of an impartial trial judge to reconsider the case on remand from the Connecticut Supreme Court, the history of this case raises issues that should be of concern to all. We are, therefore, currently reviewing our options in response to this decision.”
The Hartford Courant is among 3 other newspapers fighting to obtain the internal church documents. Just as they did in Los Angeles, the Connecticut documents will very likely reveal a complicit cardinal in the midst of a priest sexual abuse coverup. Egan may very well join Los Angeles’ Mahony and Boston’s Law in terms of infamy and notoriety.

As he prepared to retire, 76 year old Syracuse bishop James Moynihan agreed to an exit interview of sorts with the local newspaper, the Post-Standard. During the interview, Moynihan was asked about the priest abuse scandal and his refusal to publicly reveal the names of priests in the Diocese of Syracuse who were accused of sexual abuse of minors.
Moynihan scoffed at the idea and took his brother bishops to task for revealing the names of priest abusers in other dioceses. The Post-Standard quotes Moynihan as saying, “We’re not supposed to,” he said. “It’s against the Eighth Commandment.”
Going a bit further, Moynihan chided his fellow bishops. “They shouldn’t,” he said. “They should remember their Baltimore Catechism.”
Well. . .I’m at a loss for words. The Eighth Commandment states, “You shall not bear false witness against your neighbor.” Last time I checked the commandment concerns lying or spreading lies about another person. It doesn’t have anything to do with the socially and morally responsible action of publicizing known child predators who remain a danger to the welfare of children! I’m flabbergasted that a Catholic bishop would use one of the 10 Commandments to defend keeping secret the names of pedophiles and child abusers.
It’s just this sort of commentary that demonstrates why the NY State Legislature needs to pass the Child Victim Act. The Church isn’t going to voluntarily reveal the names of those who’ve abused children. We need legislation to allow survivors access to the civil justice system. The Catholic Church in Ireland is facing a similar credibility issue. The Irish government revealed its report concerning the shocking abuse of thousands of children who were in the control of Catholic orphanages and boarding schools. Yet the report never revealed the names of the abusers. This is half-baked justice.

In what some see as a precursor to the passage of the 2009 Medical Device Safety Act, President Obama issued a memorandum to federal agencies rescinding the pre-emptive policies of the previous Administration. In the memorandum, Obama seeks to roll back aggressive federal regulations to override state laws concerning the environment, health, and public safety. The Bush Administration’s preemption policy protected large corporations, often making them immune from civil lawsuits designed to protect the health and welfare of consumers.
Ironically, it’s usually the Republicans advocating for state’s rights. However, in this strange new political world, it’s a Democratic president who is restoring the rights of states in order to protect consumers.