Once again, it seems to be the Chinese involved in a consumer product recall. This time, it’s Baxter Healthcare’s Heparin, a blood thinner widely used by patients in this country. The FDA has admitted that the plant should have been inspected, in fact, it was scheduled to be inspected, but it was not inspected. The FDA attributes the non-inspection to human error. This past Monday, the company announced it was suspending production of Heparin because of 350 reactions (including 4 deaths) linked to the drug. 40% of the reactions were considered serious by the FDA. Symptoms include stomach pain, vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.
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Yesterday, I filed a lawsuit against a visiting priest from India and the Diocese of Pensacola-Tallahassee. The priest, Fr. Vijay molested a 15 year old girl two years ago. He was adjudicated guilty and kicked out of the country. However, no one knows if Catholics in Inddia know about this molesting priest. He may be molesting other children.
Today, I’m in Jacksonville preparing to file a sex abuse lawsuit against the Diocese of St. Augustine for the abuse one of its priests, Fr. William Weinheimer, perpetrated against a young boy while he attended St. Mary’s Academy in Jacksonville. The boy’s family kept letters from the priest which intimated sexual abuse. The abuse occurred in the 1950’s but the now adult man still can’t come to grips with the effects of the abuse.
While the preliminary report from the FDA on Botox was careful in discussing the potential dangers of Botox, one thing is clear, the benefits from Botox injections are unclear at best. However, the worst side effects appear to be in children with cerebral palsy. The adverse symptoms associated with Botox are similar to those of botulism, including difficulty swallowing, breathing problems and weakness.
I wish I could say that the priest abuse crisis is over. I wish I could say that institutions like the Catholic Church had made enough changes to stop the awful scourge of the sexual abuse of minors. This week, I’ll be filing three new lawsuits in Florida against Catholic priests and the Dioceses that allowed them to prey on children. Until we have transparency in the Catholic Church the potential for abuse continues.
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The crash accident report for the January 9, 2008 chain auto truck pile up was released by the Florida Highway Patrol this week and does not mention the smoke from the fire that Florida state employees let get out of control. The chain reaction collision on the Florida interstate between Lakeland and Tampa caused 5 deaths and 38 injuries. The cause of the chain pile up was a combination of smoke and fog that reduced visibility to zero. However, the newly released 120 page crash report does not even mention to role of the careless and negligent state employees that let a fire get out of control. Perhaps we need an independant investigation. Here we have the state employees of the highway patrol investigating other state employees of the Department of Forestry. However,some comments from Florida Highway Patrol Trooper Coggins are encouraging in that there may be some follow up investigation on the role that the smoke played in this horrific crash.
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FDA Notifies Public of Adverse Reactions Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place
The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
In an early communication based on the FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.
The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these products.
The agency is currently reviewing safety data from clinical studies submitted by the drugs’ manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.
The notification is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
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When Medtronic recalled its Sprint Fidelis defibrillator because of faulty lead wires in October 2007, very little attention was paid to the history of the medical device in the first place. When Medtronic introduced its Sprint Fidelis defibrillator, the company touted the device’s thinner wires as an advance in defibrillator technology. What it didn’t tell the public was that these leads may be prone to fracture because they are thinner than the older defibrillator wires which had been functioning without problems. If the previous model of lead wires functioned without fracture problems, why create a new product that had the potential to cause grave harm and risk the possibility of extraction and further surgery? The answer lies in marketing and company profits rather than good medical science. Medtronic wanted to grow market share and increase company profits. In reality, there was no medical reason to introduce a new device to the market. This is an important issue that raises ethical questions about the behavior and marketing practices of pharmaceutical and medical device companies. A new medical device product or new drug may substantially increase company sales but does it benefit healthcare professionals in determining what is best for the patient? That’s the question that seems to get lost in the race for money and market share.
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Some might dismiss the healdline of this blog post except for the fact that 13 of the 20 most popular drugs taken on the mainland are manufactured in Puerto Rico. According to an Associated Press report, the drug factories have consistently failed in terms of maintaining a sterile environment and have even shipped tainted pills to the US mainland. This in spite of the fact that even the modern facilities are failing. In one incident, an employee started covering exposed pills after noticing the blue specks of the pills matched the paint color of the factory walls! This is not a good sign for a pharmaceutical industry which plans to start manufacturing their drugs overseas where the FDA’s control is severely limited.
The problem is not isolated to pharmaceutical drugs. Medtronic’s recalled Sprint Fidelis defibrillator was manufactured in Puerto Rico and has experienced serious issues with faulty and breaking leads. At this point it appears that the faulty leads with the Sprint Fidelis are attributable to welding.
Yet, these pharmaceutical and medical device companies are always looking to cut costs and increase profits. They are trying to move their operations overseas to capitalize on the cheap labor pool. But this raises a serious consumer safety problem. If we can’t maintain quality standards in the US how do we plan to ensure safety when we’re exporting the drugs and have no regulatory authority?
A new study suggests babies may be exposed to toxic chemicals from such everyday products as baby powder, baby lotions, and shampoo. These potentially harmful chemicals are called phthalates and are found in ordinary pediatric products on the market today. Phthalates are used in plastics such as toys and baby bottles as well as personal hygiene products and medical equipment. The real danger is that parents may be exposing their children to this potentially toxic chemical without even knowing it since the government doesn’t require products to list phthalates as an ingredient.