The Health News US March 28 2018

  • A U.S. jury on Monday ordered AbbVie Inc to pay more than $3 million to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack, though the jury did not find AbbVie strictly liable. The verdict in federal court in Chicago came down in the second trial over claims by Oregon resident Jesse Mitchell after U.S. District Judge Matthew Kennelly in December tossed a previous $150 million jury verdict for being “logically incompatible.”
  • According to a congressional report released Monday, the prices of the 20 most commonly prescribed brand-name drugs for seniors have risen nearly 10 times more than the annual rate of inflation over the past 5 years. By law, Medicare is not allowed to directly negotiate drug prices, which critics say results in the government spending tens of billions of dollars unnecessarily. Democrats have long pushed for Medicare to be able to negotiate on pricing, while Republicans have opposed such measures.
  • The FDA is taking another look at premium cigars in a move that anti-tobacco groups fear could weaken regulations. The agency is seeking guidance on how it should regulate premium cigars. It expanded the definition of tobacco products in 2016 and in doing so, brought premium cigars within its oversight. Commissioner Scott Gottlieb said in a statement that the FDA also wants to understand whether premium cigars pose different risks or are used in different patterns compared with other combustible tobacco products.

https://www.reuters.com/article/us-abbvie-lawsuit-androgel/u-s-jury-orders-abbvie-to-pay-3-million-in-androgel-retrial-idUSKBN1H22UD

 

A U.S. jury on Monday ordered AbbVie Inc to pay more than three million dollars to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack, though the jury did not find AbbVie strictly liable. The verdict in federal court in Chicago came down in the second trial over claims by Oregon resident Jesse Mitchell after U.S. District Judge Matthew Kennelly in December tossed a previous one hundred fifty million dollar jury verdict for being “logically incompatible.”

It is the second verdict against AbbVie in the consolidated litigation over testosterone replacement products by the Chicago-based company and other drugmakers. More than six thousand similar lawsuits have been filed, the bulk of them against AbbVie. In a separate trial, a federal jury in January found AbbVie not liable in a lawsuit by an Arizona man who claimed he had suffered a pulmonary embolism as a result of using AndroGel.

According to court filings, the jury on Monday concluded that AbbVie had not falsely marketed the drug and was not strictly liable, but found that the company acted negligently. It awarded Mitchell two hundred thousand dollars in compensatory damages and three million dollars in punitive damages.
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According to his lawsuit, Mitchell suffered a heart attack in two thousand twelve after almost five years of treatment with AndroGel but recovered after several months.
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https://edition.cnn.com/2018/03/26/health/report-medicare-drug-prices-soaring/index.html

 

According to a congressional report released Monday, the prices of the twenty most commonly prescribed brand-name drugs for seniors have risen nearly ten times more than the annual rate of inflation over the past five years.
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Senator Claire McCaskill, Democratic from Missouri has released the report as part of a years-long investigation into escalating drug prices. McCaskill has long taken aim at soaring drug prices, raising questions about why the costs continue to skyrocket even amid congressional investigations. The new report, called “Manufactured Crisis: How devastating drug price increases are harming America’s seniors,” said the extreme price hikes show the need for further investigation to determine the “impact on healthcare system costs and financial burdens for the growing U.S. senior population.”

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The report examined the costs of the twenty most-prescribed drugs under the Medicare Part D program from two thousand twelve to two thousand seventeen. It found that the drug Nitrostat, used to relieve chest pain, had increased the most: a percentage change of four hundred seventy seven percent.

Zostavax, prescribed for shingles among seniors, had the lowest percentage increase but was still high: thirty one percent over five years. The report found that twelve of the twenty drugs saw their prices increase by more than  fifty percent over the five-year period and six had price increases of over one hundred.

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By law, Medicare is not allowed to directly negotiate drug prices, which critics say results in the government spending tens of billions of dollars unnecessarily. Democrats have long pushed for Medicare to be able to negotiate on pricing, while Republicans have opposed such measures.
….

https://www.cnbc.com/2018/03/23/fda-seeks-guidance-on-regulating-premium-cigars.html

 

The Food and Drug Administration is taking another look at premium cigars in a move that anti-tobacco groups fear could weaken regulations. The agency is seeking guidance on how it should regulate premium cigars. It expanded the definition of tobacco products in two thousand sixteen and in doing so, brought premium cigars within its oversight.

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In its advance notice of proposed rulemaking published Friday, the FDA says it’s seeking feedback on how to define premium cigars, how these products are used and any public health considerations. It wants data and research results that weren’t previously submitted. Commissioner Scott Gottlieb said in a statement that the FDA also wants to understand whether premium cigars pose different risks or are used in different patterns compared with other combustible tobacco products.
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Campaign for Tobacco-Free Kids President Matthew Myers urged the FDA not to revise the rule that allowed the agency to regulate premium cigars and other tobacco products.
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The FDA announced its comprehensive plan last summer. The agency has adopted the idea that nicotine products live on a continuum of risk, with conventional cigarettes being the most harmful and alternatives like e-cigarettes possibly being less risky. Last week, the FDA took the first step in lowering the amount of nicotine in cigarettes. Earlier this week, the agency said it would examine the role flavors, including menthol, play in attracting young people to tobacco products and adult smokers in switching to products that are potentially less harmful than cigarettes.

 

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