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Drug Administration | SEONewsWire.net http://www.seonewswire.net Search Engine Optimized News for Business Fri, 06 Jan 2017 20:00:11 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.8 Ecstasy moves closer to getting approved as PTSD treatment http://www.seonewswire.net/2017/01/ecstasy-moves-closer-to-getting-approved-as-ptsd-treatment/ Fri, 06 Jan 2017 20:00:11 +0000 http://www.seonewswire.net/2017/01/ecstasy-moves-closer-to-getting-approved-as-ptsd-treatment/ Veterans struggling with post-traumatic stress disorder (PTSD) may soon have another form of treatment to turn to for relief when traditional therapies fail to work. The Food and Drug Administration on November 29 authorized large-scale phase three clinical trials of

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Veterans struggling with post-traumatic stress disorder (PTSD) may soon have another form of treatment to turn to for relief when traditional therapies fail to work. The Food and Drug Administration on November 29 authorized large-scale phase three clinical trials of MDMA after promising results from earlier studies. The trial could help open doors to more treatment options for PTSD patients who do not respond to traditional methods such as psychotherapy or antidepressants.

MDMA, commonly known as ecstasy, is an euphoria-inducing drug that has long been considered an illicit street substance. Research has shown ecstasy causes the brain to release chemicals that evoke feelings of trust and well-being while reducing anxiety, fear and negative memories that can overwhelm PTSD patients.

If successful, the trials may lead to the approval of ecstasy as a prescription drug for treating PTSD by 2021. Researchers have proposed the drug be used under the guidance of trained psychotherapists as part of a broader course of treatment. However, some scientists are concerned that approval of the feel-good drug could trigger abuse. Prolonged MDMA use and overdosing can lead to conditions such as serious brain damage, panic attacks and seizures.

The Multidisciplinary Association for Psychedelic Studies is funding the research. The nonprofit group advocates for the therapeutic use of marijuana and other banned drugs. Earlier stages of the clinical trials found ecstasy was effective in helping to reduce the severity of symptoms among patients with chronic PTSD. In addition, follow-up tests showed improvements lasted months after the trial.

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” said Dr. Michael C. Mithoefer, a psychiatrist who conducted earlier trials. “We think it [MDMA] works as a catalyst that speeds the natural healing process.”

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Family files wrongful death lawsuit against medical scope manufacturer over deadly superbug infection http://www.seonewswire.net/2015/08/family-files-wrongful-death-lawsuit-against-medical-scope-manufacturer-over-deadly-superbug-infection/ Mon, 31 Aug 2015 11:25:47 +0000 http://www.seonewswire.net/2015/08/family-files-wrongful-death-lawsuit-against-medical-scope-manufacturer-over-deadly-superbug-infection/ A wrongful death lawsuit has been filed by the family of a woman who died, allegedly from a drug-resistant superbug infection after being examined with a medical scope. The lawsuit was filed by the family of Antonia Torres Cerda, 48,

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A wrongful death lawsuit has been filed by the family of a woman who died, allegedly from a drug-resistant superbug infection after being examined with a medical scope.

The lawsuit was filed by the family of Antonia Torres Cerda, 48, who died in November, and was allegedly infected by deadly bacteria following a liver transplant. The lawsuit accuses the maker of the medical scopes of wrongful death, negligence and fraud and demands an unspecified amount of punitive and exemplary damages.

Cerda was given a procedure for endoscopic retrograde cholangiopancreatography (ERCP) prior to the liver transplant, and she underwent a second procedure afterwards. The procedures were carried out with a duodenoscope made by Japan’s Olympus Medical System Corp. and sold and marketed by Olympus Medical System Corp. and Olympus Corp. of the Americas.

According to the Food and Drug Administration, each year approximately 500,000 people undergo procedures with duodenoscopes, which are flexible tubes inserted down the throat and reaching into the small intestines. However, the scopes in question are suspected of playing a role in an outbreak of deadly bacteria that has affected several patients at UCLA Medical Center. Two patient deaths and five other infections are believed to be linked to the scopes, and the hospital informed 179 people that they may have been exposed to the infection, which cannot be treated with antibiotics.

Paul Greenberg is a Chicago work accidents and wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

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New Hepatitis C Cure Could Strain VA Finances http://www.seonewswire.net/2015/02/new-hepatitis-c-cure-could-strain-va-finances/ Mon, 23 Feb 2015 11:31:57 +0000 http://www.seonewswire.net/2015/02/new-hepatitis-c-cure-could-strain-va-finances/ The high cost of Sovaldi, a new drug that cures Hepatitis C, could cost the Veterans Administration (VA) $1.3 billion in the next two years. The high cost of the drug could force the agency to make budget cuts in

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The high cost of Sovaldi, a new drug that cures Hepatitis C, could cost the Veterans Administration (VA) $1.3 billion in the next two years. The high cost of the drug could force the agency to make budget cuts in other areas.

Chronic Hepatitis C infections can destroy the liver. Eventually, sufferers will require a liver transplant or will die from the disease. The VA is the nation’s single largest care provider for Hepatitis C, with 174,000 veterans currently documented as having the virus and as many as 42,000 undocumented cases.

In July, the VA gave the Senate Veterans Affairs Committee a $17.6 billion wishlist of resources. At that time, VA officials stated that the high cost of Sovaldi was cutting into their resources. Congress approved the new funding, but none of the funding was specifically earmarked for Sovaldi.

Sovaldi was developed by Gilead Sciences and approved by the Food and Drug Administration last year.

The drug cures 90 percent of Hepatitis C cases. Patients who are cured of the disease no longer carry the virus or show symptoms, making it by far the most effective treatment available.

But the cure comes at a high cost. Each pill costs $1,000, with a full 12-week course clocking in at $84,000. If all 3.2 million Americans with Hepatitis C were treated, the total cost of treatment would exceed the amount that the United States currently spends on all drugs.

Sovaldi may be at the frontline of a new trend of specialty drugs that provide dramatic results for specific illnesses but come with huge, perhaps uncarryable, costs. Experts worry that Sovaldi and other drugs could eventually strain Medicaid, Medicare and the prison system, as well as the VA.

In the fiscal year that ended on September 30, the VA spent $220 million on Sovaldi. The agency was able to negotiate the price of one tablet down to $543 from $1,000.

Gilead recently came under investigation by the Senate Finance Committee, which inquired as to how Gilead came to set the high price of the drug. Gilead blamed the high price on the amount it spent developing the drug.

Legal Help for Veterans, PLLC fights for veterans rights. We fight to make sure you get the benefits you deserve from the Department of Veterans Affairs. To learn more or contact a veterans lawyer, visit http://www.legalhelpforveterans.com/ or call 800.693.4800

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Pradaxa Bleeding Lawsuits Progress in Federal Multidistrict Litigation http://www.seonewswire.net/2014/01/pradaxa-bleeding-lawsuits-progress-in-federal-multidistrict-litigation/ Mon, 06 Jan 2014 01:43:04 +0000 http://www.seonewswire.net/2014/01/pradaxa-bleeding-lawsuits-progress-in-federal-multidistrict-litigation/ More than 1,700 personal injury lawsuits are pending against pharmaceutical company Boehringer Ingelheim in Illinois. Plaintiffs filing in the in federal multidistrict litigation allege that the company’s blood-thinning medication Pradaxa caused internal bleeding. These lawsuits are part of multidistrict litigation

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More than 1,700 personal injury lawsuits are pending against pharmaceutical company Boehringer Ingelheim in Illinois. Plaintiffs filing in the in federal multidistrict litigation allege that the company’s blood-thinning medication Pradaxa caused internal bleeding.

These lawsuits are part of multidistrict litigation in U.S. District Court, Southern District of Illinois. On November 4, the court established a protocol for selecting bellwether cases, directing both sides to select up to three lawsuits as possible candidates. In January 2014, the court will select four of those cases for the first bellwether trials, which are scheduled to commence in August 2014.

According to court records, at least 1,767 lawsuits are pending in the litigation. The complaints allege that Boehringer Ingelheim failed to adequately warn doctors and patients about internal bleeding as a side effect of Pradaxa and about the lack of an available antidote.

The Food and Drug Administration recorded more than 582 deaths and 3,292 reports of other adverse events involving Pradaxa in 2012, according to the Institute for Safe Medicine Practices. The figure exceeds the adverse reports of any other drug tracked in 2012.

According to news reports, regulators in several countries have issued warnings regarding the side effects of the drug, especially concerning internal bleeding.

Pradaxa has been sold as an alternative to warfarin, an established blood-thinning medication. Blood-thinning medications are prescribed to prevent strokes caused by blood clots. Some research has found Pradaxa to be more effective than warfarin at preventing such strokes. However, internal hemorrhaging caused by warfarin can be treated with vitamin K; there is no such effective treatment for stopping internal bleeding caused by Pradaxa.

U.S. District Judge David Herndon recently ruled that Boehringer Ingelheim must pay a fine of almost $1,000,000 for withholding or failing to preserve “countless” files sought by the plaintiffs. Judge Herndon said that the company acted in bad faith and that its efforts to safeguard the documents were grossly inadequate.

The documents in question concerned the drug maker’s development and marketing of Pradaxa. Judge Herndon said that the failure to preserve them was “egregious.”

Boehringer Ingelheim said that there were unintentional and unexpected discovery problems in the litigation, and that the plaintiffs were not prevented from obtaining access to the central documents in the case.

A key allegation in the lawsuits is that Boehringer executives were aware of the risk of death from internal bleeding when they brought the drug to market in 2010. Pradaxa has generated sales of more than $1,000,000,000 for the German, family-owned firm.

Bob Briskman is a injury lawyer and attorney in Chicago with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

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Wrongful Death Lawsuit Involving Dimethylamylamine (DMAA or Jack3d) Moves to El Paso, Texas http://www.seonewswire.net/2013/12/wrongful-death-lawsuit-involving-dimethylamylamine-dmaa-or-jack3d-moves-to-el-paso-texas/ Tue, 17 Dec 2013 19:47:03 +0000 http://www.seonewswire.net/2013/12/wrongful-death-lawsuit-involving-dimethylamylamine-dmaa-or-jack3d-moves-to-el-paso-texas/ The wrongful death trial for a 22-year-old solider has been moved from California to Texas, closer to the lab that produces a supplement at the center of a storm of controversy. The producers and distributors of a non-prescription supplement known

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The wrongful death trial for a 22-year-old solider has been moved from California to Texas, closer to the lab that produces a supplement at the center of a storm of controversy.
The producers and distributors of a non-prescription supplement known as “Jack3d” (also referred to as DMAA or dimethylamylamine) have been implicated in a wrongful death suit.

Michael Sparling was training at Fort Bliss in 2011. He collapsed during a training exercise and died of a cardiac arrest. At the time, he was taking DMAA as part of his personal routine. His parents filed a wrongful death lawsuit stating that the USPlabs supplement was the cause of his sudden, unexpected death. The case was transferred to a jurisdiction in which the applicable state law would apply. In this instance, the case has been moved to Texas, even though Sparling started taking the supplement while he was in Sacramento, California. He died in Texas while still consuming the questionable product.

It is expected the defendants will argue that the young soldier’s death was the result of a training exercise or previously unknown or undiagnosed medical condition, or that Sparling died due to his own reckless, careless behavior by taking the supplement negligently and without fully vetting the product.

USPlabs LLC (the producer of the supplement) and GNC Corporations (the distributor of the supplement) are named defendants in the lawsuit, as are both operating officers of the laboratory being sued and Natural Alternatives International Inc. (Natural Alternatives granted their patent rights to another company for the component CarnoSyn (or beta-alanine), which is found in Jack3d). USPlabs has stated that the plaintiff’s contention — that the company negligently ignored the dangers of the supplement outlined in two published studies — does not make sense, since neither study was published until after Sparling’s death (they were released in 2011 and 2012, respectively).

However, if the results of those studies show that the supplement is dangerous, their date of publication will not matter in court. DMAA is rated as a stimulant with links to more than 100 illnesses and at least six deaths. However, the U.S. Food and Drug Administration has not yet concluded whether or not Jack3d contributed to the fatalities, although it has issued a warning that the supplement could dangerously elevate blood pressure and even cause a heart attack.

Prior to this lawsuit, four other servicemen’s deaths have been attributed to the use of Jack3d, at least initially. In all four cases, the supplement was ruled out by a U.S. Army and Department of Defense (DOD) safety review panel. The panel did state, however, that it was of the opinion that some personnel may be predisposed to serious consequences while using this supplement.

So, does this case have a chance at success? Providing that the jury attaches probative value and significance to the studies that indicate it to be dangerous, and to the observations on possible adverse effects made by the DOD, yes: the young soldier’s parents may well succeed in court. Trials like this one are often long and complex affairs, but it is the attorney’s job to meet the challenge and to fight for an equitable verdict.

Perlmutter & Schuelke, LLP is one of the premier trial firms in Austin Texas. Contact a wrongful death attorney by calling 512-476-4944 or learn more at http://www.civtrial.com/.

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