The FDA has issued a warning that some long-acting asthma drugs actually increase the asthma risks they are designed to lessen. The group includes GlaxoSmithKline PLC’s Serevent and Advair, Novartis AG’s and Schering-Plough Corp.’s Foradil and AstraZeneca PLC’s Symbicort. The group of drugs known as long-acting beta-agonists or LBA’s have been under FDA safety review for quite some time because they may increase asthma related death, hospitilization, and intubation. These risks may actually be higher in children. The class of drugs already carry a black box warning but the FDA is considering a stronger move against them if it turns out their analysis of the drugs warrants such action.
The FDA study included 110 trials and 60,954 patients. Serevent studies alone involved 43,000 trials. According to the Wall St. Journal, “Overall, the agency said its analysis showed “that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation and asthma-related hospitalizations.”

Bishop Blase Cupich, head of the Diocese of Rapid City South Dakota, is the new chair of the bishops’ Committee on the Protection of Children and Young People. As the new chair, Cupich has stated the bishops priority must be reaching out to victims. Pope Benedict XVI said the same thing eight months ago and nothing has changed. Bishops are still filing appeals in order to withhold documents and settlement awards. They are still transferring priests and making all sorts of excuses about how they didn’t know, how they couldn’t have known, etc, etc. Words are hollow unless they are supported by clear, transparent action. Since we haven’t witnessed any of the latter, a lot of people have chosen to ignore the former.
Have you noticed that the bishops’ authority in this country seems to be waning? They make individual or collective statements about this or that and the general public yawns. Could it be that the bishops have lost their influence and power among the people because they’ve lost their moral compass? That moral compass was lost during the priest abuse scandal. As a group of religious leaders, they couldn’t have acted worse or fumbled so many things including reaching out to victims.
If Bishop Cupich is serious he has a lot of work to do. Before he tries to reach out to the sex abuse survivors he might want to try and reach out and poke his brother bishops. They need to wake up and treat survivors in a way that befits their Gospel values.

In the electronic age more companies are hawking their products over the Internet, using Google and YouTube as venues to sell their products. Now, the medical device industry is joining in. At least three medical device manufacturers including Abbott Laboratories, Medtronic Inc. and Stryker Corp. have placed direct to consumer ads on YouTube. While the marketing plan may be innovative it may not be legal.
According to Prescription Project, a consumer advocacy group, the ads don’t contain the proper disclosures or the warnings that are required in the conventional marketing media such as print, radio, and television. Prescription Project has petitioned the FDA to investigate the ads as well as update their marketing regulations to conform to the electronic medium.
Federal rules require drug companies and medical device manufacturers to clearly provide the consumer with information about potential risks and side effects. In its letter to the FDA, the Prescription Project cited ads for Abbott’s Xience V, a drug-coated stent; Medtronic’s Prestige Cervical Disc, a spinal implant; and Stryker’s Cormet hip-resurfacing system.
According to a Wall St. Journal report, “Stryker said it wouldn’t comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down.
An Abbott spokesman said the company posted a link to Adderall XR’s safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.”

It has been more than six months since Pope Benedict visited the US. During his visit, he made a number of statements about his expectations concerning the treatment of sexual abuse survivors and the responsibility the bishops have as pastors to root out the evil affecting the Catholic Church.
When Benedict left, I wrote in this blog that I was cautiously optimistic about the potential change. In the ensuing months, that optimism has been eroded by bishops who continue to obfuscate, hide behind church lawyers, and deny any wrongdoing. Furthermore, their statements and more importantly, their actions underscore the fact that nothing has changed. They still remain concerned about their reputations, the reputations of those priests accused, and the general perception of the institutional Catholic Church. I’ve found precious little evidence of any concrete efforts to reach out to the survivors, remove abusive priests, and open up their files in order to show a good faith effort at transparency.
So, the court battles continue. As lawyers for survivors, we have to go to court and fight the Church in order to determine what happened and why survivors were shunned while priest abusers were shuffled off to other unsuspecting parishes. It’s obvious to me the majority of the bishops have no intention of real reform or change.

I’m about to start a press conference in downtown Chicago about the filing of another priest abuse lawsuit against Fr. Richard Emerson and Bishop Melczek of the Diocese of Gary. I’ve sued both of them before (twice) in Florida. Those cases are still pending. This new case involves recent abuse by Fr. Emerson dating to 2003-04 when the perp priest was stationed at St. Thomas More in Munster, Indiana. We now know that Bishop Melczek knew about Fr. Emerson’s issues with children back in 1992. He told then Cardinal Ratzinger that he (Melczek) had known about inappropriate behavior with children since Melczek cam to Gary in 1992. Furthermore, we have a letter from the former Bishop of Orlando to the Bishop of Gary in which the Orlando Bishop told the Bishop of Gary that Emerson must return to Orlando because of Emerson’s inappropriate attention to young boys.

The family of a California woman who died after neck surgery has sued Medtronic and blamed the company for the woman’s death. At the center of the lawsuit, Medtronic’s Infuse Bone Graft, is already under federal investigation for Medtronic’s possible illegal marketing of the product. Federal officials are investigating to determine if Medtronic was promoting the protein product for uses which the FDA did not approve.
According to the Wall St. Journal, “Use of Infuse in the neck is one of these so-called off-label uses. The only type of spine surgery for which Infuse has been approved is a frontal approach to the lower backbone, known as the lumbar spine.”

Controversy is swirling about Johnson & Johnson’s attempts to bankroll a health institute focusing on treating children with the controversial drug Risperdal. While doctors can prescribe drugs for uses not approved by the FDA, pharmaceutical companies are prohibited from marketing such drugs for non-approved uses. That’s the controversy surrounding J&J and the antipsychotic drug Risperdal.
Internal company emails circulating in J&J’s Janssen unit dating from 2001-02 raise issues about the pharmaceutical company’s behavior, especially since Risperdal was not officially approved by the FDA since 2007.
Risperdal has been a controversial antipsychotic drug since its approval. It has been at the center of a debate concerning the use or overuse of such drugs among young children.

The FDA has found trace amount of melamine in baby formula. This marks the first time that melamine has been found in baby formula in the United States. Earlier this year, tens of thousands of Chinese babies were sickened when much higher levels of melamine were found in their formula. At least four babies died as a result of the melamine contamination. The problem in China concerned someone adding melamine to the baby formula in order to artificially increase protein levels in the product. As a result, many babies suffered kidney stones or kidney failure.
The FDA said melamine was found in Mead Johnson’s Infant Formula Powder, Enfamil LIPIL with Iron, and a byproduct, cyanuric acid, was found in Nestlé’s Good Start Supreme Infant Formula with Iron. The companies were first identified by the Associated Press.
Melamine is a chemical used in the production of housewares and other durable products.and has no business being added to any food stuff. It is made of nitrogen, carbon and hydrogen. When ingested into the body, melamine can cause kidney stones as well as renal failure.