Thursday, February 26, 2015

In Memory of Daniel — Reviving Research to Prevent Gun Violence — NEJM

In Memory of Daniel — Reviving Research to Prevent Gun Violence — NEJM

by Chana A. Sacks, M.D.  (Massachusetts General Hospital)

At the moment that Daniel was shot, I had just fallen asleep after a night on call in the cardiac intensive care unit. My attending during that rotation was Robert Gerszten, who offered us insights from the burgeoning field of metabolomics and cardiovascular disease: that alterations in levels of blood metabolites may precede chronic illnesses by decades — knowledge that might someday enable us to identify people at risk for diseases years before the first clinical manifestation. Contemplating the possibilities of this concept, caring for critically sick patents, and studying the vast cardiology literature, I found my mind filled with a complex amalgam of thoughts that often made post-call sleep restless.
Meanwhile, 150 miles away, the day had started like any Friday. My cousin Mark walked his oldest son to the bus stop at the end of the driveway. James always left for school first, and on that December day, it was still dark. At the sound of flip-flops on asphalt, Mark and James turned to see 7-year-old Daniel bounding toward them in his pajamas; he had woken up early and sprinted outside to see his older brother off to school. Then Daniel and Mark snuggled on the couch, played foosball in the basement and then “Jingle Bells” on the piano. At 8:30, it was Daniel's turn to trek down the driveway. Mark remembers holding Daniel's little hand for the whole walk to the yellow school bus that took his youngest son to Sandy Hook Elementary School.
The next week is a blur...

Wednesday, February 25, 2015

The Great Society Speech = Lyndon Johnson - 1964

President Johnson signing the Civil Rights Act
by Matthew Dallek // George Washington University

The Speech That Launched the Great Society

The Speech at University of Michigan, May 22, 1964

President Lyndon B. Johnson declared that the government, working with a citizenry motivated to improve community life, had to make cities more livable, protect the natural environment, and provide education that gave all citizens regardless of race or class the chance to rise in society and find meaning in life.
The speech was a spiritual invocation as much as a political statement to fulfill Jefferson’s promise in the Declaration of Independence to give all the right to “pursuit of happiness.”
“The Great Society,” Johnson declared, “…demands an end to poverty and racial injustice,” but it also had to be “a place where every child can find knowledge to enrich his mind and enlarge his talent…where the city of man serves not only the needs of the body and the demands of commerce but the desire for beauty and the hunger for community.”

The Great Society, he added, meant making the nation’s cities places where “future generations can come together, not only to live, but to live the good life.” It was a place where “America the beautiful” and “our natural splendor” were protected from the pollution that threatened to destroy “the water we drink, the food we eat, the very air we breath.”

While Johnson’s 1964 speech dwelled on the problems of the cities, the environment, and education, the constellation of programs that came to be known as the Great Society addressed a much wider agenda. They included not only Medicare, Medicaid and civil rights legislation but also the creation of a department of Housing and Urban Development and the National Endowment for the Arts and the Humanities, to name just a few.
“The liberal assumption that rising wealth more widely distributed would liberate Americans for the ‘pursuit of happiness’ had proven…inadequate,” [principal drafter Richard]  Goodwin wrote of the genesis of the speech. The address, he argued, represented “the only possible direction for liberating, progressive change”.

Tuesday, February 24, 2015

House Bill Seeks to Amend Illinois' Premises Liability Act | The National Law Review

House Bill Seeks to Amend Illinois' Premises Liability Act | The National Law Review: "llinois Representative Jack D. Franks (D - McHenry County) has introduced a Bill (HB 1441) that would amend the Illinois Premises Liability Act to eliminate a court's ability to decide that a landowner does not owe a duty to protect those coming on his/her premises against conditions that are open and obvious.

The Illinois Premises Liability Act states (in part) that "The duty owed to such entrants is that of reasonable care under the circumstances regarding the state of the premises or acts done or omitted on them." A longstanding exception to this duty under Illinois common law (and in other jurisdictions nationwide) is that "a party who owns or controls land is not required to foresee and protect against an injury if the potentially dangerous condition is open and obvious." Rexroad v. City of Springfield, 207 Ill. 2nd 33, 44 (2003). This is known as the "open and obvious rule."

It is also well-established case law that the question of whether or not a duty exists is a question of law for the court to decide. Forsythe v. Clark USA, Inc., 224 Ill. 2nd 404, 411 (1991).

There are exceptions to the "open and obvious rule," however, Representative Franks' Bill seeks to limit the application of the rule by excluding it as something a court can consider it determining whether or not a landowner owes an entrant a duty by adding the following language to the Premises Liability Act:

"Whether a condition is open and obvious may be considered by the trier of fact only in assessing the degree of comparative fault, if any, under Section 2-116 if the Code if Civil Procedure and shall not be considered with respect to any other issues of law or fact, including duty." (Emphasis added).

The proposed amendment would expose landowners to additional liability for open and obvious conditions, and make cases with these circumstances more difficult to defend"



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Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease - NYTimes.com

Monica Seles, retired tennis star, now shilling for Shire
The big drug companies are market makers - first they help create a diagnosis, then they sell the cure.   Not that there is no such thing as binge eating.  A recently acquired box of Girl Scout cookies (chocolate thin mints) had a very brief half-life in my hands.  - gwc

Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease - NYTimes.com

by Katie  Thomas

 "As Shire introduces an ambitious campaign to promote Vyvanse but also to raise awareness about the disorder, some are saying the company is going too far to market a drug, a type of amphetamine, that is classified by the federal government as having a high potential for abuse. Shire’s track record is adding to the worry: The company helped put another once-stigmatized condition — attention deficit hyperactivity disorder — on the medical map and made billions of dollars from the sale of drugs, like Vyvanse and Adderall, to treat it. In recent years, federal officials have cited the company for inappropriately marketing Vyvanse and other A.D.H.D. drugs."

***
The retired tennis player Monica Seles spent this month making the rounds of television talk shows, appearing on everything from “Good Morning America” to “The Dr. Oz Show” to share her personal struggle with binge eating.

“It took a while until I felt comfortable talking about it,” she said in a People magazine interview, explaining that she secretly devoured food for years while she was a professional athlete. “That’s one of the reasons I decided to do this campaign: to raise awareness that binge eating is a real medical condition.”

But that is not the only reason. Ms. Seles is a paid spokeswoman for Shire, which late last month won approval to market its top-selling drug, Vyvanse, to treat binge-eating disorder, a condition that once existed in the shadow of better-known disorders like anorexia and bulimia but was officially recognized as its own disorder in 2013 by the American Psychiatric Association.


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Monday, February 23, 2015

J&J to Pay as Much as $420 Million More in ASR Hip Accord - Bloomberg Business

J&J to Pay as Much as $420 Million More in ASR Hip Accord - Bloomberg Business:

by Jef Feeley

(Bloomberg) -- Johnson & Johnson agreed to pay as much as $420 million more to resolve lawsuits over recalled hip implants that were excluded in 2013 from a $2.5 billion settlement of claims that the devices were defective and caused metal poisoning in patients.
J&J’s DePuy unit agreed to push back the deadline for recipients of the company’s ASR implants to file settlement claims to Jan. 31 of this year, according to a filing Friday in federal court in Toledo, Ohio. That will allow as many as 1,400 patients who’ve had ASR hips removed since 2013 to seek about $300,000 each in compensation under the original 2013 accord.
“By extending the benefits of the previously announced U.S. Settlement Program to an additional group of ASR patients, we are again providing fair compensation” to artificial hip recipients “without the delay and uncertainty of protracted litigation,” Mindy Tinsley, a DePuy spokeswoman, said in an e-mail Friday.
“J&J has seen the handwriting on the wall about these hip cases and they’ve figured it out: It’s better to settle all of these suits and get this debacle behind them,” said Erik Gordon, a professor at the University of Michigan’s business and law schools who teaches about class-action settlements.


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Jury Awards $218.5 Million Against PLO and Palestiinan Authority

A Manhattan jury has awarded $218.5 million damages to the families of civilians killed and injured by attacks by Palestinians inside Israel, the New York Times reports.  The action was brought under the Anti-Terrorism act which creates a cause of action even for acts occurring outside the United States. The act provides for treble damages plus costs of suit to be awarded to victims who suffer "by reason of an act of international terrorism".  The causal language is so broad that the Palestinian Authority and PLO were held responsible for acts which they politically opposed. The Times reports that
The defense had argued that their clients had nothing to do with the attacks. Mark J. Rochon, a defense lawyer, told the jury on Thursday that he did not want “the bad guys, the killers, the people who did this, to get away while the Palestinian Authority or the P.L.O. pay for something they did not do.”
Hanan Ashrawi, a member of the P.L.O.’s executive committee who testified for the defense, told the jury, “We tried to prevent violence from all sides.”
But citing testimony, payroll records and other documents, the plaintiffs showed that many of those involved in the planning and carrying out of the attacks had been employees of the Palestinian Authority, and that the authority had paid salaries to terrorists imprisoned in Israel and made martyr payments to the families of suicide bombers.
Such a verdict presents a policy dilemma for the U.S. and European countries which fund and support the moderate leaders of the Palestinian Authority.  The Palestinian Authority is formally a governmental partner of Hamas and the PLO includes groups who have relied on attacks on civilian though the leadership of the Authority and the Organization generally opposes such measures and is barely on speaking terms with Hamas which governs Gaza. - gwc

Friday, February 20, 2015

#BlackLivesMatter — A Challenge to the Medical and Public Health Communities — NEJM

#BlackLivesMatter — A Challenge to the Medical and Public Health Communities — NEJM

by Mary T. Bassett, M.D., M.P.H.

Commissoner, New York City Department of Health and Mental Hygiene

As New York City's health commissioner, I feel a strong moral and professional obligation to encourage critical dialogue and action on issues of racism and health. Ongoing exclusion of and discrimination against people of African descent throughout their life course, along with the legacy of bad past policies, continue to shape patterns of disease distribution and mortality.1 

There is great injustice in the daily violence experienced by young black men. But the tragedy of lives cut short is not accounted for entirely, or even mostly, by violence. In New York City, the rate of premature death is 50% higher among black men than among white men, according to my department's vital statistics data, and this gap reflects dramatic disparities in many health outcomes, including cardiovascular disease, cancer, and HIV. 

These common medical conditions take lives slowly and quietly — but just as unfairly. True, the black–white gap in life expectancy has been decreasing,2 and the gap is smaller among women than among men. But black women in New York City are still more than 10 times as likely as white women to die in childbirth, according to our 2012 data.



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Judge rejects BP challenge to penalty regulations

Judge Carl Barbier Orders BP May Face Clean Water Act Maximum Penalty of $4,300 per Gallon

Rejecting a BP challenge to the rule-making authority of the Environmental Protection Agency District Judge Carl Barbier yesterday ruled the BP may be penalized $4,300/gallon for the 2010 Gulf of Mexico oil spill.  In the matter of Deepwater Horizon [Case 2:10-md-02179-CJB-SS ED LA.] "the Court finds that the EPA’s regulation, 40 C.F.R. § 19.4 (2010),
adjusting the civil penalty in 33 U.S.C. § 1321(b)(7)(D) is valid and that the maximum CWA civil
penalty that may be imposed against BPXP is $4,300 per barrel of oil discharged.

"For similar
reasons, the Court finds that the highest maximum civil penalty that may be imposed against
Anadarko Petroleum Corporation under 33 U.S.C. § 1321(b)(7)(A) is $1,100 per barrel.4
In light
of these conclusions and the fact that the parties agree that the Coast Guard incorrectly adjusted the
CWA civil penalty, the Court does not address whether the penalties in subsection (b)(7) were also
within the Coast Guard’s jurisdiction for purposes of the Inflation Adjustment Act."



The judge has not yet ruled how much BP will be penalized.  The company has argued that its clean-up efforts, responsiveness, and falling oil prices should mitigate the penalties to be assessed. - gwc







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In Regulating E-Cigarettes, No Easy Fix For The FDA – Health Affairs Blog

Image result for e-cigarettes

In Regulating E-Cigarettes, No Easy Fix For The FDA – Health Affairs Blog:



by Prof. Wendy Parmet //Northeastern University School of Law



Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.
By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.
It is a victory that was made possible, in large measure, by a constellation of state and federal regulatory interventions: laws regulating the marketing and sale of cigarettes, barring sales to youth, banning indoor smoking, and taxing cigarette sales have all played a role in reducing rates of smoking.
Nevertheless, smoking remains stubbornly common, especially among teens. According to the Centers for Disease Control, in 2012 an estimated 18.1 percent of the U.S. adults were smokers as were 14 percent of high school students. Each year over 480,000 Americans die of smoking-related diseases.
It is in this environment that the market for e-cigarettes has developed since they were first introduced in the U.S. less than ten years ago. By 2013, over 47 percent of smokers had tried e-cigarettes; and 4 percent were regular users. In 2013 more than 250,000 minors who had never smoked had used an e-cigarette.
Although they take many forms, e-cigarettes, also known as electronic nicotine delivery systems (ENDS), or more colloquially as vapes, use battery power to heat and vaporize liquid nicotine that users inhale. In contrast to traditional cigarettes, pipes, and cigars, there is no combustion.
Supporters contend that e-cigarettes can serve as a form of harm reduction, akin to the needle exchange programs that have been used to stop the spread of HIV by intravenous drug use. Less dangerous than cigarettes, e-cigarettes deliver nicotine without exposing users and bystanders to the byproducts of combustion. Therefore they may allow users to get their nicotine “fix” and the sensory pleasures of smoking without being exposed to, or exposing others to, cigarette smoke.
Critics, in contrast, argue that e-cigarettes are not as harmless as they seem. For a start, they expose users to nicotine, a highly addictive drug, which has been associated with numerous health effects. Moreover, studies have shown that the vapor produced by e-cigarettes sometimes contain heavy metals and other toxins.
For example a recent letter to the editor of the New England Journal of Medicine reported on research finding that high voltage vaping may expose users to more than 4 times the amount of formaldehyde presented by traditional cigarettes. And because there are over 400 brands on the market, and most of them are imported, the risk of adulteration is high, as a recent New York Times article pointed out.
Critics also worry that the growth of vaping will lead to more smoking. In particular, they point to the common practice of adding sweet flavors to e-cigarettes and argue that this attracts young people, who may become addicted to nicotine and then “graduate” to conventional cigarettes. There is also concern that the advertising and use of e-cigarettes in public places will renormalize smoking, thereby reversing the change in social norms that has helped support reductions in rates of cigarette usage.

Regulatory Challenges

The challenge for regulators is that the science is not yet settled. In its notice of proposed rulemaking,the FDA admitted that it did “not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health.”
Although the weight of the evidence establishes that e-cigarettes are less harmful than cigarettes, it is simply too early to know the long-term dangers for users or bystanders. Moreover, we don’t know if the proliferation of e-cigarettes will increase or reduce overall rates of smoking. In other words, we just don’t know whether e-cigarettes will prove to be an effective form of harm reduction or a gateway drug.
Adding to the regulatory challenge are the limitations imposed by the federal statutory scheme. In 2010 a federal appeals court ruled that the FDA could not act against adulterated e-cigarettes under the Food, Drug and Cosmetic Act; rather its authority was limited to that provided by the 2009 Tobacco Control Act(“TCA”). That Act imposes regulations on specified tobacco products, such as cigarettes and smokeless tobacco, and all other tobacco products that the FDA “deems” to be subject to the Act. It is this provision that the FDA will invoke if it promulgates the deeming regulations.
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Monday, February 16, 2015

NCAA files opposition to attorneys fee motion in O'Bannon anti-trust case

Plaintiffs counsel Michael Hausfeld
The NCAA has filed its opposition to the class plaintiffs lawyers motion for $50 million in counsel fees in O'Bannon v. NCAA.  The NCAA argues that plaintiffs should recover only $9 million in counsel fees and proposes steep reductions in cost recovery.  
In August 2014 U.S. District Judge Claudia Wilkens ruled that the NCAA violated antitrust law by preventing student-athletes from being compensated for their name, image and likeness rights.
Wilkens' ruling allows schools to pay athletes licensing money into a trust fund starting in 2016. Financial damages were not part of the trial, but Wilkens said the plaintiffs "shall recover their costs from the NCAA."
The NCAA argues that plaintiffs lawyers application is flawed in that it they may not recover fees for work done on the case prior to September 1, 2012 when their theory of the case changed; they  may not recover fees for work done solely to advance claims upon which they did not prevail in substantial part, or for claims that were essentially abandoned; nor may they recover for "work that was unnecessary, redundant and inefficient, unsupported by plaintiffs’ billing records, or that did not reflect sound billing judgment".  Finally the NCAA argues that much of plaintiffs's claims of costs are "unsupported by their submission or the law".