Court: Off-Label Drug Marketing Is 'Free Speech'

By John Fauber, Reporter
Milwaukee Journal Sentinel/MedPage Today
Originally Published: December 04, 2012


A decision by a federal appeals court this week could have a dramatic impact on the marketing of prescription drugs in America, potentially affecting patient care and everything from TV advertising to future government prosecutions which, in the past, had yielded billions of dollars in settlements, doctors and attorneys said Tuesday.

"This risks taking us back to an era when people could promote snake oil without restrictions – a situation I would hate to see," said Richard Deyo, MD, a professor of family medicine at Oregon Health and Science University.

Citizens United Redux

However, others say the ruling by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan is a victory for free speech, one that could become the drug industry equivalent of Citizens United, the 2010 U.S. Supreme Court decision that gave corporations and unions the right to spend unlimited sums on political ads.

Like the Citizens United case, the ruling Tuesday by the prestigious U.S. Court of Appeals for the Second Circuit in New York, involved the right of commercial free speech, applying it to the complicated world of pharmaceutical industry promotion of prescription drugs.

How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.

Once the Food and Drug Administration approves a drug, physicians are free to prescribe that drug as they wish -- but the drug makers can only market the drug for the FDA-approved marketing indication.

The case involves Alfred Caronia, a sales representative with Orphan Medical who was criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy. Cataplexy involves weak or paralyzed muscles.

The FDA required a black box warning on the drug stating that its safety and effectiveness had not been established in people under the age of 16. The active ingredient in Xyrem is GHB, is a powerful medication that acts on the central nervous system and also is known as the "date rape" drug.

The entire story is here.

Gay Conversion Therapy Law Temporarily Blocked By Federal Judge

By LISA LEFF
The Huffington Post
Originally published December 4, 2012


A federal judge on Monday temporarily blocked California from enforcing a first-of-its-kind law that bars licensed psychotherapists from working to change the sexual orientations of gay minors, but he limited the scope of his order to just the three providers who have appealed to him to overturn the measure.

U.S. District Court Judge William Shubb made a decision just hours after a hearing on the issue, ruling that the First Amendment rights of psychiatrists, psychologists and other mental health professionals who engage in "reparative" or "conversion" therapy outweigh concern that the practice poses a danger to young people.

"Even if SB 1172 is characterized as primarily aimed at regulating conduct, it also extends to forms of (conversion therapy) that utilize speech and, at a minimum, regulates conduct that has an incidental effect on speech," Shubb wrote.

The judge also disputed the California Legislature's finding that trying to change young people's sexual orientation puts them at risk for suicide or depression, saying it was based on "questionable and scientifically incomplete studies."

The law, which was passed by the Legislature and signed by Gov. Jerry Brown in October, states that therapists and counselors who use "sexual orientation change efforts" on clients under 18 would be engaging in unprofessional conduct and subject to discipline by state licensing boards. It is set to take effect on Jan. 1.

The entire story is here.

Georgia Court Overturns Assisted Suicide Restrictions

Court Finds that Law Banning People from Advertisng Suicide Violated Free Speech Rights

By Greg Bluestein

Associated Press

Georgia's top court struck down a state law that restricted assisted suicides, siding on Monday with four members of a suicide group who said the law violated their free speech rights.

The Georgia Supreme Court's unanimous ruling found that the law violates the free speech clauses of the U.S. and Georgia constitution. It means that four members of the Final Exit Network who were charged in February 2009 with helping a 58-year-old cancer-stricken man die won't have to stand trial, defense attorneys said.

Georgia law doesn't expressly forbid assisted suicide. But lawmakers in 1994 adopted a law that bans people from publicly advertising suicide, hoping to prevent assisted suicide from the likes of Dr. Jack Kevorkian, the late physician who sparked the national right-to-die debate.

The law makes it a felony for anyone who "publicly advertises, offers or holds himself out as offering that he or she will intentionally and actively assist another person in the commission of suicide and commits any overt act to further that purpose."

The court's opinion, written by Justice Hugh Thompson, found that lawmakers could have imposed a ban on all assisted suicides with no restriction of free speech, or sought to prohibit all offers to assist in suicide that were followed by the act. But lawmakers decided to do neither, he said.

"The State has failed to provide any explanation or evidence as to why a public advertisement or offer to assist in an otherwise legal activity is sufficiently problematic to justify an intrusion on protected speech rights," the ruling said.

State attorneys said they were reviewing the order. The network's members said they were thrilled with the decision.

'Turned out to be a boondoggle'

"This was politically motivated and ideologically driven as opposed to being, in any way, motivated by sound legal practice," said Ted Goodwin, the group's former president and one of the four defendants. "I'm just sorry that as many people have been put through what they've been put through in what turned out to be a boondoggle."

The challenge was brought by four members of the network who were arrested in February 2009 after John Celmer's death at his north Georgia home. They were arrested after an eight-month investigation by state authorities, in which an undercover agent posing as someone seeking to commit suicide infiltrated the group. Prosecutors say group members helped Celmer use an "exit hood" connected to a helium tank to kill himself.

The entire story is here.

NJ school district moves to fire teacher who made anti-gay Facebook comments

By Star Ledger Staff

 

It was three months ago when anti-gay comments posted on Facebook by a Union High School teacher caused a nationwide controversy. Now, those comments may cost the instructor her job.

The Union Township school board announced today it has filed tenure charges against Viki Knox, the longtime teacher and faculty adviser to the high school’s Bible study group.

Board president Francis R. Perkins said the charges were formally filed in late December after a three-month investigation of Knox’s conduct, the first step in what could be a lengthy and costly process to fire her.

"Every student, no matter what race, creed color or sexual orientation ought to be able to come to school and feel comfortable in a learning environment that’s welcoming and nurturing," Perkins said.

Knox, 50, who has been on paid administrative leave, could not be reached. Sandy Oxfeld, Knox’s attorney, said he would have no comment on the case while it is in litigation.

The move by the Union school board has rekindled a broader issue of free-speech rights of teachers in the growing age of social media.

The entire story is here.