Tennessee Legislature Allows Two Anti-Gay Education Bills To Die

Tennessee has been a toxic place on issues of sex and gender recently, with the University of Tennessee recently caving to Fox News’ complaints and cutting funding for students’ “Sex Week” programming. This week there was some good news, however, because two anti-gay pieces of legislation died in committee.

The first was the odious “Don’t Say Gay” bill, which was originally designed to censor school officials and teachers from discussing homosexuality in grades K-8. Versions introduced this year included requirements that school counselors out LGBT students to their families or prevent counselors from providing mental health services whatsoever. The bill did not receive a second when it was moved in the House Education Subcommittee and subsequently died. State Rep. John Ragan (R), who sponsored the bill because “it was about school safety,” has promised to reintroduce it next year.

Another bill targeted institutions of higher education, threatening to cut support for campus police if universities required student groups to abide by “all-comers” nondiscrimination policies. The intention behind such measures, like one recently passed in Virginia, is to allow Christian groups to discriminate against gay students. Tennessee Attorney General Robert Cooper (D) called the bill unconstitutional and Gov. Bill Haslam (R) said he saw no reason to have the bill considered. Last year, he vetoed a similar bill targeting university nondiscrimination statements. The bill’s sponsor, Rep. Mark Pody (R), took the bill “off notice,” killing it, but his apparent vendetta against Vanderbilt University’s “all-comers” policy suggests this isn’t the last of his efforts.

The death of these two bills is a nice reprieve for Tennessee’s LGBT community, but it seems neither of these fights is permanently over.

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UPDATE 1-Chelsea says FDA allows Northera resubmission with existing data

(Adds details, analyst comments; updates share movement)

Feb 20 (Reuters) - Chelsea Therapeutics International Ltd

plans to repitch its once-rejected hypotension drug Northera in the second quarter after a review by U.S. health regulators determined that the company could use its original data for the resubmission.

Shares of Chelsea were up 93 percent at $1.48 in heavy volume trading on Wednesday on the Nasdaq. The stock traded around the $4 levels before the FDA rejection.

"(Wednesday's news) was surprisingly positive given what the FDA reviewers earlier said," Liana Moussatos of Wedbush Securities said.

The FDA's guidance was in response to a formal appeal by the company to the Director of the Office of New Drugs of the FDA, after the Cardiovascular and Renal Products committee denied approval to the drug last March, asking for another study to show long-term benefit.

This means the FDA believes the data Chelsea had submitted last year for approval can serve as the basis for a resubmission of the marketing application of Northera, analyst Moussatos said.

Northera is being tested for symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up that is most often associated with Parkinson's disease. The drug has an orphan drug status, or a seven-year marketing exclusivity from the day of approval.

"We now have a regulatory path forward, including the potential for an approval of Northera later this year," said Chelsea's interim Chief Executive Joseph Oliveto.

However, risks still remain as the Cardiovascular and Renal Products committee of the FDA, which rejected the drug last year, will be the one reviewing it after Chelsea resubmits its application, Moussatos added.

Since the first rejection, Chelsea has cut jobs, reduced officer compensation and abandoned the development of a rheumatoid arthritis drug to cut costs and focus on Northera, its most advanced clinical product.

The Charlotte, North Carolina-based company had cash and cash equivalents of about $28.4 million as of Dec. 31. Chelsea said it expects this money would fund its operations into the third quarter of 2014.

"The company will continue to explore options for new capital, including various partnering and financing options," the company added.

Moussatos said British drugmaker Shire Plc and California-based BioMarin Pharmaceuticals Inc could be among companies potentially interested in partnering Chelsea.

"The disease that they are treating is common in Parkinson's patients, so potential partners could be any big pharma or a company that is interested in orphan drugs," Moussatos said.

In August, Chelsea changed the main goal of its earlier study, codenamed 306B, and re-reported results in December.

Chelsea said on Wednesday the FDA guidance suggests data from its 306B study strongly showed short-term clinical benefit, but the regulator could ask for a post-approval study to verify Northera's long-term clinical benefit.

The company said it plans to start a new clinical trial in the fourth quarter to test for long-term benefits.

However, it added that its current cash reserves would not be sufficient to complete the post-approval study, which is likely to run into 2015.

(Reporting by Zeba Siddiqui and Pallavi Ail in Bangalore; Editing by Roshni Menon)

((zeba.siddiqui@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: zeba.siddiqui.thomsonreuters.com@reuters.net))

Keywords: CHELSEATHERAPEUTICS FDA/

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Supreme Court Allows Assault On Stem Cell Research To Die

Two years ago, Reagan-appointed Chief Judge Royce Lamberth suspended all federal funding for embryonic stem cell research in a sweeping opinion that even invalidated funding permitted under President George W. Bush’s policies. Despite the fact that the Clinton, Bush and Obama Administrations all agreed that Judge Lamberth misinterpreted federal law, Lamberth relied on a federal law forbidding funding of “research in which a human embryo or embryos are destroyed” to hold that federal spending not only cannot fund the destruction of a new embryo, it also cannot fund research that builds on past research that resulted in the destruction of an embryo.

Lamberth’s decision was eventually reversed by a conservative panel of the United States Court of Appeals for the District of Columbia Circuit. The appeals court held, correctly, that even though Lamberth might have proposed a plausible reading of federal law, longstanding Supreme Court precedent generally requires courts to defer to an agency’s reading of a statute. As the appeals court explained, “the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an [embryonic stem cell] will be used.” Yesterday, the Supreme Court announced it would not hear this case, effectively killing this challenge to stem cell research.

This is an important victory for science, and it is just as much a victory for judicial restraint. As the near-success of the Affordable Care Act lawsuits demonstrate, conservative judges and justices are increasingly willing to substitute their policy preferences for the law, even when they must rely on legal theories that, in the words of one of the nation’s most conservative judges, have no basis “in either the text of the Constitution or Supreme Court precedent.” The requirement that judges defer to agencies in interpreting ambiguous statutes is an important check on the judiciary’s ability to impose their policy views on the nation. Agency leaders change with each presidential election; judges do not. And so the power to interpret a genuinely ambiguous statute should rest with officials whose legitimacy flows more closely from the will of the people.

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Supreme Court Allows States to Opt out of Medicaid Expansion

States are already struggling to pay their Medicaid bills. Why put taxpayers on the hook to pay even more?

Medicaid is the single biggest item in state budgets today. It consumes, on average, 23 percent of state dollars spent, pinching funds for other high-priority functions such as education, transportation and emergency services.

Yet expanding Medicaid was a central tenet of the Patient Protection and Affordable Care Act. It required states to open their program to all individuals earning less than 138 percent of the federal poverty level. The goal was to reduce the number of uninsured - by dumping 17 million Americans onto the Medicaid rolls.

Such a huge expansion wouldn't come cheap, and cash-strapped states grumbled that they couldn't possibly afford it. So the architects of Obamacare decided to take a carrot-and-stick approach to get the states to play ball.

The carrot: We, the feds, will pick up 100 percent of your expansion costs for three years, and lesser percentages thereafter. The stick: If you don't expand your program, we'll cut off all your federal Medicaid funds.

The fact that the authors of Obamacare felt the need to threaten states with total defunding tells you that they knew many states would resist expanding their programs - even with 100 percent federal funding.

Why? For starters, many state officials are leery of federal promises to pay program costs in perpetuity.

Such skepticism is warranted. Washington has rung up a $16 trillion debt and is running more than $1 trillion in the red annually, even without any of the costs associated with the health-care law.

Where will it get the money to make good on this promise? And will future administrations honor this promise, no matter what? State officials also worry about how such a massive expansion of their Medicaid programs will affect the quality of care available to their poorest citizens.

States are already having difficulty finding enough physicians willing to accept Medicaid patients, largely because of the program's low reimbursement rates. Expanding patient rolls by a third will only exacerbate this problem.

Here too, Obamacare tries to hoodwink the states. The states are required to increase pay to Medicare levels for primary care physicians. The federal government picks up the tab, but only temporarily.

In 2015, states will either have to find the money to replace the federal dollars or let primary care payments drop back down again. And if a state decides to keep the primary care doctor rates up, guess what? Without doubt a flood of non-primary care doctors and other health care providers will argue - wait, what about us?

To persuade doctors to start accepting Medicaid patients or increase their already swollen caseloads, states will have to sweeten the pot considerably. Cha-ching! And states unable to sweeten the pot sufficiently will see wait lists get longer and longer, and the quality of care declines.

"If a deal sounds too good to be true, it probably is." That adage certainly applies to Obamacare's promise of "free" expansion of Medicaid for the states. Thankfully, the Supreme Court struck down the law's "stick," ruling that threatening to yank all federal funding to states that refused to expand their programs was unconstitutionally coercive.

Now, states don't have to walk the plank on Medicaid expansion. And they shouldn't.

Medicaid is a troubled program than can't be sustained in its current form, much less on the grander scale envisioned by Obamacare advocates. What's needed is not expansion, but reform - a complete makeover of the program that gives the working poor access to private health insurance like the vast majority of Americans enjoy today and restores Medicaid to a true safety net to meet the needs of the most vulnerable in society.

ABOUT THE WRITER

Nina Owcharenko is director of the Center for Health Policy Studies at The Heritage Foundation. Readers may write to the author in care of The Heritage Foundation, 214 Massachusetts Avenue NE, Washington, D.C. 20002; Web site: www.heritage.org.

First moved by McClatchy-Tribune News Service.

Nina Owcharenko Director, Center for Health Policy Studies and Preston A. Wells, Jr. Fellow

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