Valproate, the epilepsy drug manufactured by Abbott, has been found to significantly lower a child’s IQ, according to a new study published in the New England Journal of Medicine. Valproate (Depakote) was found to lower a 3 year old’s IQ by 9 points in comparison to children whose mothers took other epilepsy drugs during pregnancy.
“We’ve known this drug is a bad actor for a long time,” said Dr. Lewis Holmes, director of the North American Antiepileptic Disease Pregnancy Registry, based at Massachusetts General Hospital in Boston.
Epilepsy is a brain disorder that can cause continual seizures.
The new study found that the higher the dosage of valproate taken during pregnancy the lower the child’s IQ. While the connection between epilepsy drugs and birth defects has been well documented the significant relationship between valproate and birth defects had not been determined prior to the latest study. Valproate use during pregnancy has been found to have a 2-4 times higher ratio of birth defects. Researchers still do not know the reason for the lower IQ in children who’ve been exposed to the epilepsy drug. The study did recommend that pregnant mothers avoid valproate as their first choice for epilepsy treatment.
If you are pregnant or may be pregnant and are epileptic, consult your physician for treatment options.

Bayer AG has settled approximately 40 of the 241 lawsuits concerning its gadolinium contrast dye product Magnevist. The lawsuits contend that the contrast dye has caused Nephrogenic Systemic Fibrosis (NSF) in those with pre-existing kidney disease. NSF can be a fatal disease marked by a hardening of the skin which can replicate in any organ but has been linked to gadolinium in those with kidney disease. Symptoms include hardening of the skin, high blood pressure, burning, and itching.
Bayer is not the only gadolinium contrast dye manufacturer. Other products include Omniscan by GE Healthcare, OptiMARK by Mallinckrodt/Tyco Healthcare, ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.
Gadolinium’s link to NSF led the FDA to ask the manufacturers of the gadoliniums contrast dye to add a black box warning to its label in September 2007.

When confronted with church documents dating back to the 1950’s, two priests vehemently disagree as to why the numerous warnings contained in the documents were ignored.
On the one hand, Monsignor Stephen Rossetti, president and CEO of St. Luke Institute, believes the bishops ignored Rev. Patrick Fitzgerald’s dire warnings about priest sex abusers, because they were coming from only one source and the pleas were emotional rather than scientific.
On the other hand, Rev. Thomas Doyle, OP, who had worked with the bishops in the 1970’s and 1980’s, saw it another way. Doyle believes the bishops ignored the warnings because they simply didn’t want to deal with it. Doyle issued a document to all the US bishops in 1985 warning them again about the growing problem of sexually abusive priests.
Msgr. Rossetti claims to have no knowlege of Fr. Fitzgerald in spite of the fact that Fitzgerald’s order, the Servant of the Paracletes was the primary institution bishops would send priests with problems of sexual abuse, alcoholism, and pedophilia. Since Rossetti is engaged in the same line of work that Fitzgerald had performed decades earlier, it’s hard to believe that he had never heard of Fitzgerald. It’s also similarly difficult to dismiss Fitzgerald as “emotional” since most bishops were indeed sending their sexual abuse priest problems to him for counseling.
The situation became so dire in the 1960’s that Fitzgerald told many bishops and even the Pope about the situation. He even spent $5,000 as a downpayment for an isolated island where he could send these priests.
Since the bishops have been saying that they never knew about the depth and extent of the priest abuse problem until recently, these recently released letters from Fr. Fitzgerald are extremely important. They do a great deal of damage to the credibility of bishops who still continue to pat themselves on the back for all they’ve done to protect children in spite of their past ignorance of the situation.
Facts and documents don’t lie. It’s hard to sidestep such proof in spite of all the slick public relations efforts of the Catholic Church. The Church has a credibility issue when its own bishops dismiss someone like Fr. Fitzgerald. It gets even worse when someone like Msgr. Rossetti attempts to diminish Fitzgerald’s work and his dire warnings.
That’s why courts are ordering dioceses to make such documents public. The public needs to know what happened and why if this crisis will ever come to an end.

Coast IRB, LLC is supposed to supervise and approve safety methods for clients in clinical trials involving human subjects. However, the Colorado based company was caught in a Congressional sting and ordered to cease work in the clinical trials. An FDA spokesperson cited the federal agency’s serious concern that Coast IRB was not doing enough to protect human subjects.
According to a report in the Wall St. Journal, the work stoppage could affect 300 clinical trials and over 3,000 researchers in such fields as pharmaceutical, biotech, and medical devices.
Coast IRB’s deficient practices were uncovered during a Congressional sting operation begun last year. The GAO and congressional staff created a phantom medical study of a phantom product. It was during this phantom study that Coast’s deficient measures to protect humans was discovered.

The Food and Drug Administration is asking several medical device makers, including Zimmer Holdings, Inc. and Medtronic to justify their devices’ safety and effectiveness. This comes in spite of the fact that many of the medical devices are already on the market. Zimmer’s Durom Cup hip implant has faced major scrutiny for defective design.
Of course, the medical device companies are trying to avoid further clinical trials of their products by persuading the federal agency to re-classify them as less risky medical devices.
The controversy stems from a 1990 Congressional order that demanded the FDA to collect sound scientific evidence that the medical devices classified as Class III (most risky) were indeed safe. The problem is that the law was never fully implemented by the FDA. Instead, many medical devices that should have been bound by the Congressional order, received what is known as a 510(k) classification. This “exemption” allowed hundreds of Class III medical devices to be sold in spite of the lack of clinical testing required by law.
In the meantime, consumers remain at risk from these medical devices that have been allowed to slip through the bureaucratic cracks of the FDA. Medical device manufacturers win since they’re can continue to sell products that may in fact be dangerous to consumers and have not been bound to the rigorous and extensive clinical testing required by a Class III categorization.

This is not what any of the Big 3 US automakers need right now, another auto recall due to the potential for fires. In the midst of a declining US auto industry that has caught the attention and scrutiny of the federal government, bad press is not what the industry needs.
Yet, General Motors has issued a large recall of some vehicles that aren’t even in production. The recall includes the 1998-1999 Oldsmobile Intrigue, the 1997-2003 Pontiac Grand Prix, 1997-2003 Buick Regal, and the 1998-2003 Chevrolet Lumina, Monte Carlo and Impala.
All of the vehicles in question have a 3.8 liter V-6 engine and the danger concerns oil that can spill into the exhaust potentially igniting sparks or a fire. In spite of the recall, GM says there have been no reported injuries or fires with any of the vehicles.

With reports of its psoriasis drug linked to progressive multifocal leukoencephalopathy (PML), a serious, progressive neurologic disease caused by a virus that attacks the central nervous system, Genentech has ordered the recall of Raptiva. The drug became available to treat psoriasis in 2003. Since that time, reports of brain infection caused by the suppression of the immune system have dogged the psoriasis drug. In October 2008, the FDA issued a black box warning for Raptiva because it had been linked to serious, life-threatening brain infections.
Raptiva is designed to suppress the immune system in order to treat the psoriasis. However, the suppression of T-cells increases susceptibility to brain infections such as PML.
Since the Raptiva recall just occurred, there remain many questions as to why the drug was approved for use. Did Genentech know about these life-threatening effects and when did they know them? Once again, it’s tragic that psoriasis patients didn’t know about the severity of the Raptiva side effects. As is often the case, healthcare professionals were also unaware and were not able to protect their patients from these brain infections caused by Raptiva.

IF YOU HAVE BEEN INVOLVED IN AN ACCIDENT, SIGNED A RELEASE AND DIDN’T FULLY UNDERSTAND WHAT YOU WERE SIGNING, YOU MAY STILL HAVE RIGHTS. PLEASE CONTACT ME, RICK KRISEMAN, TO DISCUSS YOUR CASE.
Betty, age 56, was coming home from a trip to the mall when she was rear ended while stopped at a traffic signal. The police came to the scene of the accident and issued a ticket to the other driver. Even though Betty was very sore, and the Police offered to call an ambulance for Betty to take her to the hospital to be checked for injuries, she declined and went home to rest.
A few hours later, there was a knock on the door of her home. At her door was Mike Cheatem, an adjuster for Auto Wreck Insurance, the insurance company for the driver who rear ended her earlier that day. Mr. Cheatem asked Betty how she was feeling, and acknowledged that his insured was at fault for the accident. Mr. Cheatem then told Betty that Auto Wreck Insurance wanted to make sure that all of her medical bills were taken care of if she went to the doctor, so he offered to give her a check for $500.00 – which he proceeded to fill out and hand to her on the spot. He told Betty that she would have to sign a form acknowledging that he had given her money for her bills.
Betty, who had not yet been to see a doctor even though she was feeling kind of sore, thought this sounded great, so she took the money and signed the form.
The next morning when Betty woke up, her neck and back were hurting her very badly, and the fingers on her right hand felt like they were asleep. She called her son, who lived in another state, and told him about the accident and how she was feeling. Her son suggested she go to her doctor, just to be safe.
Five days later, Betty was able to get in to see her doctor. After examining Betty and listening to her complaints, her doctor ordered an MRI of her neck. When the results came in, Betty was informed that she was suffering from a herniated disc in her cervical spine. Her doctor told her that’s why her right hand still felt like it was asleep.
When Betty told a friend about the accident and her injuries, her friend suggested she contact an attorney to learn about her rights. So, seven (7) days after the accident occurred, Betty contacted an attorney to discuss her situation. Unfortunately for Betty, after the attorney learned about her accepting the check from Auto Wreck Insurance, and after obtaining a copy of the form Betty signed, the attorney had to advise Betty that under the facts of her case, he could not help her. Because Betty had signed the release, she could not pursue a claim against the other driver or his insurance company. Despite the severity of Betty’s injuries, Betty had unwittingly settled her claim for $500.00.
Betty’s story is not unusual. In the State of Florida, it happens every day. While an attorney is not permitted to contact a person involved in an accident for 30 days, there is no similar restrictions on insurance companies.
Many insurance companies routinely go to the scene of an accident or to the accident victim’s home shortly thereafter in an attempt to limit their liability and exposure by making a minimal offer to the accident victim and then obtaining full and final release from those persons.
In an effort to prevent this story from continually repeating, I filled HB 1281. This bill would prevent an insurance company which provides bodily injury coverage, uninsured motorist coverage, personal injury protection coverage, medical payments coverage or general liability coverage, from fully and finally settling a claim for at least 30 days after the date the injury occurred. Any settlement or release entered in violation of this section would be unenforceable.
The bill would not prevent an insurance company settling a claim in full IF it was tendering its policy limits nor would the bill prevent an insurance company from advancing funds to an injured person. Additionally, if the person injured has consulted with an attorney and WANTS to settle his/her claim before the 30 days have passed, he/she may do so under the provisions of this bill.
When I filed this bill, my goal was to make sure that Betty, and Floridians like Betty all around this state had the time necessary to make an informed decision about their case. Within a few weeks of the bill being filed, I was visited in my office by a lobbyist representing several liability insurance companies. Not surprisingly, he informed me that his clients would not be able to support my bill, stating that it could cost his clients money because they might have to pay more to settle a claim if the person had a chance to think about their claim, and that many of the cases his clients were able to settle quickly could go into litigation down the road. Too Bad.
Aside from the fact that this bill would provide needed protection to persons injured through no fault of their own, the bill also saves money for you and me, the taxpayers of this state, because once a case is settled, if the injured person goes to a hospital for treatment and has no settlement money to pay the medical bills, who do you think pays them? You and me.
I wish I could report that this bill has moved through all committees and is ready for a vote on the floor of the house. But I can’t. This bill, which was assigned to four committees/councils, has not been scheduled for a hearing in even ONE committee. Guess the insurance lobby is stronger than the consumer lobby.

Since 2007, at least five people have died as a result of defective Sprint Fidelis defibrillator leads implanted in order to correct irregular heart rhythms. Since that time, thousands of patients and doctors have agonized over how to correct the problem. With certain medical devices, the simple solution of removing the offending device is the best option. However, with the Sprint Fidelis defibrillator leads, it’s not that simple, according to cardiology experts. The removal of such leads can cause death if not done properly and some health experts are complaining that the procedures are being performed by those who are not qualified to perform the extraction.
The anxiety for the patient who relies on the cardiac defibrillator is overwhelming. Imagine for a moment you or a loved one had one of these defibrillator leads implanted in order for your heart to function properly. Now you find out the leads are defective and may not work when your heart needs it most. This is a terrible situation for poor patients and a difficult dilemna for healthcare professionals.

Rep. Rick Kriseman (D-53) is an attorney with Saunders & Walker PA
Mikey, age 14, and his friend decided they wanted to go buy a Slurpee at the local convenience store. After telling his mom where he’s going, Mikey and his friend grabbed their bikes and headed off down the street to the local convenience store. When they got back home, Mikey’s mom was waiting at the front door for him. She was not happy. Mikey looked confused, unsure of why his mother was mad at him.
Then, Mikey’s mom reminded him of the law in the State of Florida, specifically Florida Statute 316.2065 3(d), which states that
“A bicycle rider or passenger who is under 16 years of age must wear a bicycle helmet that is properly fitted and is fastened securely upon the passenger’s head by a strap, and that meets the standards of the American National Standards Institute (ANSI Z 90.4 Bicycle Helmet Standards), the standards of the Snell Memorial Foundation (1984 Standard for Protective Headgear for Use in Bicycling), or any other nationally recognized standards for bicycle helmets adopted by the department. As used in this subsection, the term “passenger” includes a child who is riding in a trailer or semitrailer attached to a bicycle.”
Mikey’s mom was mad at him because neither he nor his friend wore their helmets when they rode their bikes to the store.
If HB169/SB68 passes the legislature this year, Mikey will also have to wear a helmet if he goes horseback riding. Under HB 169, any person under the age of 16 must wear a helmet when riding a horse on public lands unless they are competing or performing during a show or an event, or they are riding the horse on private property or engaged in an agricultural related activity. This bill further states that anyone renting a horse to be ridden by a person under the age of 16 must either provide the underage person with a helmet or verify that the underage person has their own helmet.
Therefore, if this bill passes and Mikey and his mom ever go horseback riding, he will have to wear a helmet before he is allowed out of the stables on the horse.
It is the hope of the sponsor that passage of this bill will prevent future head injuries from occurring.
Unfortunately, in the State of Florida, the concern over head injuries seems to cease when a person turns 21, as Florida law DOES NOT require a person over the age of 21 to wear a helmet which complies with Federal Motorcycle Vehicle Safety Standard 218 promulgated by the United States Department of Transportation, provided they carry an insurance policy providing for at least $10,000 in medical benefits for injuries which might be incurred as a result of a crash while operating or riding on a motorcycle. So when Mikey turns 21, the state no longer seems to care about him.
Not a very good example for Mikey, is it? Sure hope he learns of the importance of wearing it now.