He’s 16 years old, tall, slim and handsome. A year ago he started running, and now he runs a mile in 6 minutes 30 seconds, competes in races all over the state, has won trophies and awards and in a recent race finished 90^th out of 1,183 runners. His name is Alex and he has autism.

Alex and his twin brother Jamie, who also has autism and runs an 8:30 mile, run in competitive mainstream races throughout the state. They are able to do this with the help and dedication of an amateure, where experienced runners volunteer their time providing one-to-one support to special needs kids in races all over the country.

When they first started, their coaches held their hands while running with them, not sure what to expect as both Alex and Jamie have limited language and self-injurious behavior that can oftentimes be unpredictable. REgardless, it wasn’t long before the coaches were able to let go and run with them side by side.

This simply shows that even kids with special needs can compete and even need to compete.

I’ve been researching terbutaline, when giving off-label to slow pre-term labor, and the possibilities of proving it causes autism in the child. The information I continue to find amazes me! Even though the FDA placed a warning against such use, many medical practices continue to use this drug. Even more amazing is the lack of research proving this medication helps with preterm labor.

There is considerable disagreement in the medical community about the use of terbutaline as a preterm labor drug. Some doctors believe it is an effective treatment for preterm labor. However, other doctors have concerns about whether it is safe and whether it works and either do not prescribe it or prescribe it only for short periods of time.

The American College of Obstetrics and Gynecology (“ACOG”) warns against the use of terbutaline to prevent preterm labor, when they stated in a Technical Bulletin to it’s members that “no studies have convincingly demonstrated an improvement in survival or any index of long-term neonatal outcome with the use of tocolytic (Terbutaline) therapy. On the other hand, the potential damages of tocolytic therapy to the mother and the neonate are well documented.”

How can prescribing this medication be allowed when studies are not conclusive and lack to exist? Better yet, how are doctors given the right to prescribe a drug that has been marketed for asthma without scientific analysis proven? We put our trust in the FDA and fail to question the doctors when in reality we must learn to educate ourselves to protect ourselves.

The definition which was once based upon immigration and the hopes for a new beginning, is now simply having a healthy family with full bellies and a roof over their heads. This dream can be changed within seconds of a wrong decision but what if that decision isn’t made by you? What if the decision of a physician changes your American dream? What if your trust and confidence lies within a doctor and they fail you as a human being by prescribing a medication that causes autism in your unborn child?

Who’s to blame? Where do you start to receive justification for a mistake you didn’t make? This happens on a regular basis but proving your physician’s mistake can feel like a never ending circle of denial and mishaps.

One new study shows the prescribing of terbutaline, an off-label drug used to prevent pre-term labor, may cause autism in the unborn child. Proving this concept is difficult but if sets of fraternal twins diagnosed within the autism spectrum come forward the chances are within reach.

Fraternal twins are two eggs fertilized at the same time from different genetic make-ups. They are no more alike than any other siblings. Therefore, if fraternal twins are both diagnosed within the autism spectrum after the mother was placed on terbutaline this may prove the drug caused the disorder.

Until parents of fraternal twins come forward, doctors will continue to neglect the truth and cause families to lose hope in the American dream. Blame needs to be placed and justice is a must to stop this negligence.

For the better part of a decade, a factory in Puerto Rico produced potentially faulty and contaminated drugs for British drug maker GlaxoSmithKline.

This week, the drug maker said that it has reached a $40.75 million settlement with 37 states and the District of Columbia under their consumer protection laws following a $750 million criminal and civil settlement with the federal government last October.

Both settlements involve manufacture of substandard medicines made from 2001 through 2004 at a factory in Cidra, Puerto Rico. The poorly manufactured drugs include included Paxil CR, a blockbuster antidepressant that has since gotten generic competition, plus anti-infection ointment Bactroban, sterile anti-nausea medication Kytril and Avandamet, a diabetes drug.

The case was brought after a company whistleblower reported on conditions in the factory to the Food and Drug Administration. The whistle-blower had already reported many other violations to her bosses, including a contaminated water system and an air system that allowed for cross-contamination between different products being made there. She said she was fired in 2003 after repeatedly reporting the problems to the company.

GlaxoSmithKline admitted no wrongdoing.

Products made at the Puerto Rico plant have all been recalled or are past their expiration dates.

Source: the Associated Press

Manufacturing problems dogging Johnson & Johnson since 2009 still have not been solved. The company announced yet another drug recall because of musty odors — this time involving branded and generic forms of risperidone, the antipsychotic drug.

MedPage Today is reporting that the company’s Ortho-McNeil-Janssen subsidiary voluntarily recalled certain lost of the drug. The recall is for one lot of 3 mg Risperdal in 60-tablet bottles, lot number 0GG904, expiration May 2012, and of one lot of generic risperidone in a 2 mg dosage, lot number OIG175, sold by Patriot Pharmaceuticals.

As with several previous recalls — including the Tylenol brand of acetaminophen, Benadryl allergy medications, and topiramate (Topamax) — the company said in a statement that it had received reports from patients that the risperidone products emitted “an uncharacteristic odor.”

The two affected lots total about 40,000 bottles of risperidone.

The company advised patients with medications from these lots not to stop taking the medication. However, if they notice unusual odors, they should return the tablets to their pharmacist.

The odor in all these recalls appears to stem from a chemical preservative, 2,4,6-tribromoanisole (TBA), in wooden pallets used in shipment and storage.

No serious adverse events have been reported with the affected risperidone lots. However, according to Ortho-McNeil-Janssen, “a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.”

Source: John Gever, MedPage Today

The Food and Drug Administration doesn’t try to find out whether or not medical-device recalls are successful.

Referring to a report by the Government Accountability Office,  The Hill reports that the FDA doesn’t have clear policies in place to determine whether a recall worked and doesn’t analyze individual recalls in search of more fundamental problems, the GAO said.

According to the GAO report, the FDA doesn’t have criteria for measuring whether manufacturers actually pull every defective device during recalls. Agency officials sometimes disagree about whether similar recalls have worked, the report says.

The agency also does not document its reasons for determining that recalls are complete.

By Lucia Graves, The Huffington Post

According to a new report, industry regulators have known for years that Roundup causes birth defects.

Roundup, produced by U.S. company Monsanto, is the world’s best-selling herbicide.

The report, “Roundup and birth defects: Is the public being kept in the dark?” found regulators knew as long ago as 1980 that glyphosate, the chemical on which Roundup is based, can cause birth defects in laboratory animals.

But despite such warnings, and although the European Commission has known that glyphosate causes malformations since at least 2002, the information was not made public.

Instead European regulators misled the public about glyphosate’s safety, according to the report, and as recently as last year, the German Federal Office for Consumer Protection and Food Safety, the German government body dealing with the glyphosate review, told the European Commission that there was no evidence glyphosate causes birth defects.

The report comes months after researchers found that genetically-modified crops used in conjunction Roundup contain a pathogen that may cause animal miscarriages. After observing the newly discovered organism back in February, Don Huber, a emeritus professor at Purdue University, wrote an open letter to Secretary of Agriculture Tom Vilsack requesting a moratorium on deregulating crops genetically altered to be immune to Roundup, which are commonly called Roundup Ready crops.

Although glyphosate was originally due to be reviewed in 2012, the Commission decided late last year not to bring the review forward, instead delaying it until 2015. The chemical will not be reviewed under more stringent, up-to-date standards until 2030.

Johnson & Johnson’s troubles just get more and more stinky.

According to CNN, the pharmaceutical giant announced on Thursday a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.

The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.

The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled. However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.

J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The drug is already under fire because it has been linked to oral birth defects in infants who were exposed when their mothers took it.

Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.

Source: CNN Money

Hip implants aren’t the only defective medical devices giving patients problems.

An Illinois man has filed a product liability lawsuit alleging that he experienced problems with the Zimmer NexGen CR-Flex Porous knee replacement system as a result of a defective design. According to the lawsuit, the design caused the artificial knee to loosen inside the patient’s body and led to the need for additional surgery.

The complaint revolves around the same Zimmer NexGen knee replacement that was the focus of concern at the annual conference of the American Academy of Orthopaedic Surgeons last year. In March 2010, data was presented by several prominent surgeons, including Dr. Richard A. Berger, a former Zimmer knee implant consultant, that suggested Zimmer NexGen CR-Flex knee replacement problems resulted in revision surgery in nearly 9 percent of cases examined and resulted in knee replacement loosening in more than a third of the cases.

Although Zimmer previously paid Dr. Berger millions of dollars to work as an orthopaedic consultant, they reportedly dismissed the surgeon’s concerns and canceled their relationship with him. The medical device manufacturer suggested that the problems identified by Dr. Berger were caused by his surgical skills or technique, not the design of the device.

In August 2010, Senator Charles E. Grassley wrote a letter to the Zimmer CEO and President requesting additional information on what the company was doing to respond to complaints about failures with some Zimmer products and whether there were more consultants who had raised concerns about the company’s implants.

In September 2010, a Zimmer NexGen knee recall was issued for other components, including the NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. The recall was issued after the company received at least 114 reports of Zimmer NexGen knee loosenings and other complications involving those products.

A growing number of Zimmer NexGen lawsuits are being pursued by individuals throughout the United States who have experienced loosening or failure of their knee replacement.

If you have had hip or knee replacement surgery and suffer from defective implants, please call us for professional insight.

2004 Tests Found Chemical Nationwide

Some water utility representatives have protested Environmental Working Group’s report of laboratory tests that found worrisome levels of chromium-6, a suspected carcinogen, in the drinking water of 31 cities across the country.

Yet the tap water industry was worried enough about the contaminant to conduct its own extensive survey in 2004 that found clear evidence of widespread chromium-6 pollution in untreated source water. The survey, conducted by the Awwa Research Foundation (since renamed the Water Research Foundation), an offshoot of the American Water Works Association, obtained data on 341 source water samples from 189 utilities in 41 states. The conclusion: chromium-6 is common in American groundwater.

Tap water industry representatives made no mention of their study when they testified alongside EWG at a Feb. 2 Senate environment committee hearing on chromium-6 pollution. There is no indication that customers of the 189 participating utilities were advised of the chemical’s presence in source waters in their communities.

Chromium-6, also known as “hexavalent chromium,” is often called the “Erin Brockovich” chemical, after the crusading legal assistant who helped residents of tiny Hinkley, Calif, win a $333 million settlement from Pacific Gas & Electric Co, accused of dumping the chemical in local ground water. Actress Julia Roberts won an Oscar for her portrayal of Erin Brockovich in the 2000 film of the same name.

The 2004 industry study, which EWG obtained from a source and cited in its December 2010 report, “Cancer-causing Chromium-6 Pollution in U.S. Tapwater,” demonstrates that chromium-6 pollution was not confined to California.

“The tap water industry’s 2004 study is unmistakable proof that it has known about extensive chromium-6 contamination for at least seven years,” said Jane Houlihan, EWG senior vice president for research. “Water utilities should tell their customers any time they know that a suspected carcinogen has polluted local waters. People have a right to know what they and their families may be drinking.”

Pollution levels in untreated and treated water are not directly comparable. Even so, the two studies, read together, paint a picture of coast-to-coast chromium-6 pollution.

The industry research group provides its report Occurrence Survey of Boron and Hexavalent Chromium to water utilities and their consultants, who pay four or five-figure subscription fees and a document fee of about $300. (The report can now be bought online for $200 or more.)

EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.