(c) 2014 Jon L Gelman, All Rights Reserved.

Friday, November 21, 2014

Genetic Testing and the Need for a Federal Regulation

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The one dream that will never fade is falling in love, marrying the love of your life and starting a family. Now, imagine John and Jane Doe, a couple who fell in love in high school and got happily married after years of dating. The only thing missing to complete their fairytale romance was a family. After many unsuccessful attempts, the couple soon learned that they were infertile. Seeking help from the medical profession, they learned about the use of assisted reproductive technology (ART) to enhance their chances of becoming parents.
Pursuing the ART method, John and Jane found a donor whose sperm or eggs they wanted to use. They were assured from the sperm or egg bank that they chose a donor that had undergone careful screening and had been tested for health problems as required by law. Based on these assurances, the couple conceived using the donated reproductive tissue (DRT) that they procured from the bank and successfully gave birth to twins. Shortly after birth, both twins were diagnosed with a life threatening genetic disorder. This unfortunate outcome is the sad reality that arises from inadequate federal regulation of DRT in ART fertility treatments.
ART treatments entail surgically removing eggs from a woman's ovaries, combining them with sperm in the laboratory and returning them to the woman's body or implanting them in another woman's body. In the US alone, 20,000-30,000 babies a year are conceived (PDF) using...
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Congress and science: White House threatens to veto bills that would change EPA science advisory boards and limit EPA use of science

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Often unwatched by all but policy-wonks yet key to determining policies put forth by the US Environmental Protection Agency (EPA), are the EPA’s Scientific Advisory Boards. These boards consult with the EPA on the science that influences regulations, particularly on individual chemicals – science that’s used to protect the public from chemical hazards. On Tuesday the House passed a bill, the EPA Science Advisory Board Reform Act of 2013 or H.R. 1422, that would change how the EPA selects Scientific Advisory Board (SAB) members. The White House, in a statement from the Office of Management and Budget (OMB), said that if presented with the bill, the President’s senior advisors will recommend a veto. “H.R. 1422 would negatively affect the appointment of experts and would weaken the scientific independence and integrity of the SAB,” wrote OMB.
The bill was sponsored by Representative Chris Stewart (R-UT), and passed the House on a vote of 229 to 191 – on what amounts to a party-line vote, with one Republican voting against the bill and only 4 Democrats voting in favor. All of the bill’s 21 co-sponsors are also Republican.
If passed, the new law would require that ten percent of SAB members be employed by a state, local or tribal government, regardless of any scientific expertise. It also would prohibit an SAB member from participating in “advisory activities that directly or...
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Talcum Powder Lawsuit: Suit alleges talcum powder use linked to ovarian cancer

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In a suit filed against Johnson & Johnson, Sanofi US and a number of other talcum powder manufacturers, Motley Rice attorneys and co-counsel are asking why a common over-the-counter hygiene product that has been linked to an increased risk in ovarian cancer for more than 30 years has no warning about this risk on its label.
Filed on Nov. 5, 2014, the suit is being brought by the widower of a woman who used talcum powder in her genital area since childhood and later developed ovarian cancer, eventually passing away from the disease in 2012 at the age of 63.
Along with this failure to warn on talcum powder labeling, the suit claims that talcum powder manufacturers represented that the product was safe and encouraged the use of these powders to mask odors. However, talcum powder—also known as baby powder, body powder and talc—has been shown to migrate to the ovaries when used around the exterior genitals, and a 2003 analysis showed “a statistically significant result suggesting a 33% increased risk of ovarian cancer with perineal talc use.”
The suit seeks compensatory and punitive damages for wrongful death, gross negligence, failure to warn and misrepresentation, among other allegations.
In other talcum powder cancer news, a 2014 investigation delved into additional potentially dangerous side effects of  one particular brand of talcum powder, which found “that this product line...
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Takata’s Switch to Cheaper Airbag Propellant Is at Center of Crisis

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The new airbag propellant was supposed to be the next big thing for Takata in 1998. An engineer for the company, Paresh Khandhadia, declared it “the new technological edge” in an interview with a trade magazine then.
Based on a compound called tetrazole, it was seen as a reliable and effective compound for inflating airbags. Yet despite the fanfare, by 2001 Takata had switched to an alternative formula, ammonium nitrate, and started sending the airbags to automakers, including Honda.
That compound, according to experts, is highly sensitive to temperature changes and moisture, and it breaks down over time. And when it breaks down, it can combust violently, experts say.
“It shouldn’t be used in airbags,” said Paul Worsey, an expert in explosives engineering at the Missouri University of Science and Technology. The compound, he said, is more suitable for large demolitions in mining and construction. “But it’s cheap, unbelievably cheap,” he added.
More than a decade later, that compound is at the center of a safety crisis involving Takata and its airbags. More than 14 million vehicles with the Takata-made airbags have been recalled worldwide over concern that they can explode violently when they deploy in an accident, sending metal debris flying into the cabin. At least five deaths have been linked to the defective airbags.

On Thursday, Takata’s decision to change the propellant is expected to be among the lines of questioning...
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Govt wants more clinical trial results made public

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WASHINGTON (AP) -- Doctors and patients may soon find it easier to learn if clinical trials of treatments worked or not, as the government proposed new rules Wednesday expanding what researchers are required to publicly report.
Thousands of Americans participate in clinical trials every year, to test new treatments or diagnostics, compare which older therapies work best, or help uncover general knowledge about health.
Many of the studies are reported in scientific journals or trumpeted in the news. But researchers don't always publicly reveal their results, especially when the findings show a treatment doesn't work as initially hoped, said Dr. Francis Collins, director of the National Institutes of Health.
Collins cited one recent analysis that found less than half of studies had been published in a peer-reviewed scientific journal within 30 months of completion.
"This is simply not acceptable," Collins said. "This dissemination of trial results is the way in which medical progress occurs."
Wednesday's proposals aim to change that by increasing information available on a public database - - that already is a major source for patients and doctors seeking to find the latest studies that need volunteers.
That site lists basic registration information - what's being studied, in whom - about more than 178,000 clinical trials here and abroad. Some are enrolling participants; some already are completed. By NIH's count, just 15,000 of...
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New safety measures aimed at off-road vehicles

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Similar to all-terrain vehicles (ATVs), recreational off-road vehicles are facing new safety requirements from the Consumer Product Safety Commission, the agency said Tuesday.
The CPSC is proposing new rules for these off-road vehicles to make sure they don't rollover on drivers and passengers while in motion. The safety requirements will include lateral stability measures, vehicle handling requirements, and speed controls.
These recreational vehicles, better known as ROVs, are popular for going off-road on dirt trails and in the woods. But the CPSC says they present an "unreasonable risk of injury and death" that must be addressed with stricter safety measures.
"ROVs and All-Terrain Vehicles (ATVs) are similar in that both are motorized vehicles designed for off-highway use, and both are used for utility and recreational purposes," the agency wrote in the Federal Register. "However, ROVs differ significantly from ATVs in vehicle design. ROVs have a steering wheel instead of a handle bar for steering; foot pedals instead of hand levers for throttle and brake control; and bench or bucket seats rather than straddle seating for the occupants."
The public has 75 days to comment.
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Defective Takata Airbag Grows Into Global Problem for Manufacturer

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SIBU, Malaysia — Law Suk Leh, late in her pregnancy, was driving in the industrial outskirts of this steamy riverside city when her 2003 Honda City collided with a turning car.
Her airbag’s inflater ruptured on the July evening, spraying metal shrapnel into her neck. Ms. Law, 43, bled to death before reaching the hospital, according to the local police.
Doctors performed an emergency operation to deliver Ms. Law’s baby, a girl. But she died two days later.
Honda publicly linked the July death to the inflater last Thursday, making it the first fatality outside of the United States tied to faulty airbags made by Takata, a Japanese auto supplier.
“The cause of death for this incident is rupture of the inflater,” said a Honda spokesman in Malaysia. Ms. Law’s identity was confirmed by the police.
What began as a largely American problem for Takata is taking on ever-wider proportions, confronting drivers and regulators in multiple countries with differing legal systems and attitudes toward automobile safety.
Until the report of Ms. Law’s death, the previous four fatalities were in the United States. But faulty inflaters, made at North American plants, also ended up in overseas cars. Ms. Law’s Honda was manufactured in Thailand.
The spokesman for Honda Malaysia, Jordhatt Johan, said the car was part of a recall in June, although it was limited to passenger airbags. Honda announced a recall last week covering driver airbags.
In the United...
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