Results matching “FDA ”

Joe Palazzolo reports for the WSJ (emphasis added):

A Johnson & Johnson company opposes plans by Florida authorities to use one of its drugs in an upcoming execution, marking the first time the world's largest pharmaceutical manufacturer has waded into the death penalty debate.

Earlier this year, Florida amended its lethal injection protocol to include etomidate, an anesthetic agent that has never been used in executions, after exhausting its supply of the sedative midazolam.

Florida authorities are slated to use the updated protocol for the first time on Thursday in the execution of Mark Asay, who was sentenced to death for the 1987 killings of Robert Lee Booker and Robert McDowell in Jacksonville, Fla.

Scientists at Johnson & Johnson's Janssen Pharmaceuticals NV created etomidate in the 1960s. The company no longer distributes the drug, which is still used in hospitals.
Excuse me, J&J, but if you no longer make or distribute this drug, and if the patent expired long ago, how exactly is this any of your damn business?

News Scan

New Hampshire Decriminalizes Pot:  New Hampshire Governor Chris Sununu signed a bill into law which reduces the penalty for possession of 3/4 oz. or less of marijuana or 5 grams of hash and converts it to a civil offense.  The Associated Press reports that a person caught with these amounts of pot or hash would face a fine of up to $100.  New Hampshire joins 20 other states which have decriminalized possession of marijuana.   

More Arrests in NY Gang Killings:  Suffolk County, NY, police officials announced Wednesday that at least four additional MS-13 members had been arrested for the April murders of four young men at a Long Island park.  Liz Robbins of the NY Times reports that with the recent arrests, 15 members of the gang will be facing charges in the quadruple homicide, while a total of 17 members face federal murder charges for at least 12 murders and other crimes.  The crackdown began in March when MS-13 members were arrested for the brutal April 2016 machete/baseball bat murders of two teen-aged girls in Brentwood.  After the bodies of the four Long Island victims were discovered, Attorney General Jeff Sessions said in a statement to MS-13 members, "We are targeting you, we are coming after you."   
Attorney General Jeff Sessions just held a news conference at which he confirmed that his answers about Russia contacts during his confirmation hearings were true answers to the questions as he understood them -- about contacts concerning the campaign or as a spokesman for the campaign and not unrelated contacts in his capacity as Senator.  However, he will recuse himself from any matters involving the Trump campaign.

Now the Senate Judiciary Committee and the full Senate need to get moving on the Deputy Attorney General nomination.  We have already seen what can happen when important decisions are made by Obama holdovers.

The WSJ has a stub of a story here, which says it will be updated as the story develops.

News Scan

Georgia DA Seeks Death for Alleged Cop Killer: In Byron county GA, the district attorney intends to seek the death penalty for the suspected murderer of two Georgia police officers. Fox News reports that District Attorney David Cooke announced Thursday that his office will seek the death penalty against 57-year-old Ralph Stanley Elrod Jr. A grand jury indicted Elrod this week on the charges of aggravated assault and murder of Deputy Daryl Smallwood,39, and Sgt. Patrick Sondron, 41. The officers were reportedly responding to a call about the suspect making threats with a rifle when the officers were shot.

Indiana Murderer May Have Forfeited Review:  The Indiana Supreme Court is set to consider if a murderer's refusal to sign court documents for post-conviction relief will end further review of his case. Dan Carden at the NWI Times reports that Kevin Isom, 51, was convicted of the 2007 murders of his wife and two stepchildren and was given the death penalty for the crimes. After the state Supreme Court upheld his conviction and sentence on direct review, Isom refused to sign the required documents for post conviction (habeas corpus) review until he was given an attorney he likes.  The Superior Court ruled that if Isom would not sign, his right to further review was forfeited.  Isom's attorneys, apparently without his permission, have appealed that holding. The state's brief in the case is here

Parolee Charged With Murder After an Car Accident:  A parolee in Indio, CA. has being charged with murder for gunning down a man who ran into his SUV.  As reported by CBS news James "Chip" Milton Nathaniel, 30, in addition to being charged with murder, he also faces charges of being a felon in possession of a firearm.  Nathaniel was released from prison on parole 2014 for shooting a man in 2005.  Nathaniel is now facing trial for murder for reportedly firing multiple rounds into the 35-year-old victim following a collision between the vehicles of the two men in 2015. 

News Scan

OH Plans January Execution Using 3-Drug Combo:  Representatives for Ohio announced Monday of the state's plans to resume executions in January with a new three-drug combination, following a three-year moratorium brought on by drug shortages and legal challenges.  Andrew Welsh-Huggins of the AP reports that the drugs intended for use by the state are midazolam, which renders sleep, recuronium bromide, which causes paralysis, and potassium chloride, which stops the heart.  The drugs have been approved by the FDA and are not compounded, says Thomas Madden of the Ohio attorney general's office.  The last time Ohio carried out a death sentence was January 2014, when Dennis McGuire was put to death in a procedure that took 26 minutes using a two-drug combo that had never been tried.  It was McGuire's execution which led to several complicating legal problems and changes to the state's death penalty system.  There are over two dozen inmates on Ohio's death row with firm execution dates, some of which are scheduled as far out as October 2019.  The next inmate in line to be executed is Ronald Phillips, who raped and murdered his girlfriend's three-year-old daughter in 1993. 

Video Shows Mob Attacking CHP Patrol Car with Officer Inside:  A newly released video taken on Sept. 25 in Fresno, Calif., shows a police officer who responded to several calls about illegal street racing and reckless driving become surrounded by a mob of people yelling at him and kicking his vehicle while he sat inside.  Kristine Guerra of the WaPo reports that the crowd of 30 to 40 people shouted, "F the police, we run the streets," as they violently kicked the sides of the officer's SUV and recorded the incident on their phones.  The officer, whose name has not been released, drove away unharmed, while his patrol car sustained $12,000 worth of damage.  Police have arrested three men in connection with the incident, two of whom are members of the Bulldog gang, and more suspects are being sought.  Fresno Police Chief Jerry Dyer said during a Friday news conference that he believes this incident is a symptom of the current environment of riots and targeted attacks on police officers across the nation.

NY Community Reeling from Violent Impact of Immigration Policies: 
A violence-plagued Long Island, N.Y., community is pointing a critical finger at federal and local immigration policies that have allowed illegal immigrants to flood Suffolk County and gangs to thrive.  Joseph J. Kolb of Fox News reports that over the past four years, 225,725 unaccompanied Central American children entered the U.S., 3,500 of them placed in Suffolk County between October 2013 and July 2016.  A federal policy allowing Central American children apprehended at the border to be placed with illegal immigrant sponsors has enticed thousands of unaccompanied minors to journey to the U.S., where they are often placed in homes with little supervision and government monitoring.  The HHS website indicates that in FY 2015, only 1,895 home visits were conducted out of 33,726 referrals made by DHS.  This means that young migrants are even easier to target for gang recruitment by the MS-13, a notorious El Salvadorian gang that is thriving under Suffolk County's sanctuary city policies.  Last month, two 15-year-old girls were brutally murdered and the skeletal remains of two teenage boys were discovered, all allegedly connected to MS-13. 
One of the ploys that opponents of the death penalty use to try to block it -- given that the American people are solidly against their real position -- is to drag out the appeals process for decades and then claim that it is cruel to keep people on death row for decades.

This is called the Lackey claim for Justice Stevens's solo opinion in Lackey v. Texas, 514 U.S. 1045 (1995).  After Justice Stevens retired, Justice Breyer took up the cause.  He reiterated his position last night in the last minute appeal of Georgia murderer John Wayne Conner.  But he is still alone.  No other justice joined his dissent.

Conner was executed at 12:29 a.m. Friday with the single-drug method using pentobarbital, Rhonda Cook reports for the Atlanta Journal-Constitution.  Georgia can apparently still get pentobarbital, the preferred drug for this purpose, though most states cannot.

The lethal injection drug shortage is entirely artificial and due in large part to the misinterpretation of the Food, Drug, and Cosmetic Act by the D.C. Circuit in Cook v. FDA, 733 F.3d 1 (2013).  Congress can and should correct that misinterpretation with a simple fix.

5 Reasons Marijuana Is Not Medicine

Bertha Madras, professor of psychobiology at McLean Hospital and Harvard Medical School, has this article in the WaPo with the above title.

Data from 2015 indicate that 30 percent of current cannabis users harbor a use disorder -- more Americans are dependent on cannabis than on any other illicit drug. Yet marijuana advocates have relentlessly pressured the federal government to shift marijuana from Schedule I -- the most restrictive category of drug -- to another schedule or to de-schedule it completely. Their rationale? "States have already approved medical marijuana"; "rescheduling will open the floodgates for research"; and "many people claim that marijuana alone alleviates their symptoms."

Yet unlike drugs approved by the Food and Drug Administration, "dispensary marijuana" has no quality control, no standardized composition or dosage for specific medical conditions. It has no prescribing information or no high-quality studies of effectiveness or long-term safety. While the FDA is not averse to approving cannabinoids as medicines and has approved two cannabinoid medications, the decision to keep marijuana in Schedule I was reaffirmed in a 2015 federal court ruling. That ruling was correct.
The President, the Attorney General, and a great deal of the political establishment in Washington vocally back legislation to provide mass, and retroactive, sentencing reduction for federal felons.  Drug traffickers lead the list of intended beneficiaries. The establishment politicians call their proposed reductions sentencing "reform," in a somewhat half-hearted attempt to disguise what they're actually up to.  

It's simply beyond sensible argument that such "reform" would mean more crime faster, the federal recidivism rate being at about 50%.  "Reformers" like to fuzz over this fact, but the numbers don't lie.  "Reformers" think that paying the price in increased crime (which they either deny, minimize or garble) is worth it because America has just gone overboard with incarceration, or should adopt a medical model of crime, or is a racist pigsty, or some mix of the three.  Some also believe, or say they believe, that prison costs too much, although none has yet taken my bet the the DOJ budget will increase whether this legislation passes or not.  At some level, they know that "reform" will not save the taxpayers a single dime; the money will just get spent on different DOJ projects.

Career Assistant US Attorneys  --  the non-political, line prosecutors who have to deal with reality rather than indulge Al Sharpton's ideological fantasies  --  are sounding the alarm.  It take guts to do so.  No one wants to be on the outs with the boss, particularly when the boss is the Attorney General.

No AUSA has been more outspoken, or more courageous, than the head of the National Association of Assistant US Attorneys, Steve Cook.  Although I have never met Steve, I am proud to have corresponded with him and to have benefited often from his knowledge.

Congressional Quarterly (link regrettably unavailable) has taken grudging note of Steve's courage and impact.  I reproduce its April 4 article about him after the break.
Astrid Galvan and Justin Pitchard report for Association Press:

Compounding the nation's severe shortage of execution drugs, federal authorities have confiscated shipments of a lethal-injection chemical that Arizona and Texas tried to bring in from abroad, saying such imports are illegal.

The Food and Drug Administration said Friday that it impounded orders of sodium thiopental, an anesthetic that has been used in past executions in combination with drugs that paralyze the muscles and stop the heart. It currently has no legal uses in the U.S.
Multiple errors in the story here. Thiopental has also been used alone.  When Ohio pioneered the single-drug method, it used thiopental.  The drug was used in medical treatment for decades, and there is no prohibition against using it.  No company ever went through the FDA approval process for it, probably because it has been around since before such approvals were required. 

"Courts have concluded that sodium thiopental for the injection in humans is an unapproved drug and may not be imported into the country," FDA spokesman Jeff Ventura said in a statement.
Actually there is only one case.  The "courts," plural, are the District Court and Court of Appeals in that one case, Cook v. FDA

That case was wrongly decided, in my opinion.  The Supreme Court 30 years ago decided in Heckler v. Chaney that the FDA has discretion to not enforce the restrictions of the Food, Drug, and Cosmetic Act in a context where it was never meant to apply and where its requirements make no sense.  What is "safe and effective" for an execution drug?  Effective for this purpose is necessarily the ultimate unsafe.  However, the Cook court (the same court the Supreme Court reversed in Heckler) thought the importation law was distinguishable from the domestic use law at issue in Heckler.

The state have partly themselves to blame for not fighting that decision.  Now they need to vigorously take this up to the Supreme Court to have Cook overruled or get Congress to abrogate it by statute.  Prohibiting the importation of the drug that is clearly superior to the midazolam approved in Glossip is just crazy.

For the full background and a legislative proposal, see this paper.

California's New Death Row -- Virginia

The title of this post is taken from Debra Saunders' spot-on and mind-bendingly ironic column in today's SF Gate. As Ms. Saunders notes:

California has a new Death Row -- it's called Virginia. Death penalty opponents, federal judges and defense attorneys have been so successful at blocking capital punishment in California that a San Quentin Death Row inmate has more to fear from being extradited for a capital murder to another state than seeing his sentence carried out here. There has been no execution in California since a federal judge effectively halted the practice in 2006.

There is undoubtedly someone more deserving of execution than the killer facing his imminent punishment in Virginia, but it's hard to think of one off-hand:

Take serial killer Alfredo Prieto. In 2005, Prieto was on San Quentin's Death Row for the 1990 rape and murder of 15-year-old Yvette Woodruff in Riverside County, when DNA evidence linked him to three 1988 murders in Virginia. Under Gov. Arnold Schwarzenegger, California sent Prieto to Virginia, where killers sentenced to death actually face the likelihood of execution. (Authorities say evidence links Prieto to nine murders.) In 2010, a Virginia jury sentenced Prieto to death for the murder of Rachel Raver and Warren Fulton, both 22. Prieto is scheduled for lethal injection at the Greensville Correctional Center in Virginia Thursday night. Just 13 inmates have been executed in California since the death penalty resumed in 1978. Prieto will become the second√ California Death Row prisoner to be executed in another state.

We will probably never know how many innocent people are dead because Prieto wasn't executed before now.

Euthanasia in Europe

Charles Lane has this opinion article in the WaPo, headlined, "Europe's sinister expansion of euthanasia."  CJLF takes no position on the issue, and I won't volunteer my personal opinion, at least not today, but I thought I would note this paragraph:

Frank van den Bleeken, imprisoned for 30 years for rape and murder, sought euthanasia from Distelmans, citing his incurable violent impulses and the misery of life behind bars. Belgian officials and Distelmans initially agreed; a lethal injection the murderer might have gotten as punishment in the United States would be supplied as therapy in anti-death penalty Europe.
And what do Belgian doctors prescribe for a painless death?  Sodium thiopental, the drug we are blocked from importing by the D.C. Circuit's dubious decision in Cook v. FDA.

How Dylann Roof Got the Murder Weapon

Scott Johnson reports:

After Dylann Roof murdered nine pastors and churchgoers in the course of Bible study in Charleston, President Obama couldn't wait to use the occasion for his narrow political purposes. "Let's be clear," he said with urgency in his voice. "At some point we as a country will have to reckon with the fact that this type of mass violence ... doesn't happen in other places with this kind of frequency. And it is in our power to do something about it." The implication, of course, was that additional gun control legislation was required but that his political opponents refused to see the light.

Now we learn in whose power it was to do something about it, and it wasn't anyone Obama was talking about. The Washington Post reports: "Dylann Roof, who is accused of killing nine people at a church in South Carolina three weeks ago, was only able to purchase the gun used in the attack because of breakdowns in the FBI's background-check system, FBI Director James B. Comey said Friday." The White House, of course, declines to comment.

I said at the time of his nomination that Jim Comey was a man of integrity.  I feel vindicated today.  As to his boss, I have as much comment as the White House.

Sanctuary Cities and Blood

Miriam Jordan and Zusha Elinson report for the WSJ:

The fatal shooting of a woman in San Francisco last week, allegedly by an illegal immigrant man convicted of seven felonies and previously deported to Mexico, has sparked a debate about the extent to which local law enforcement and federal immigration authorities should cooperate.

At issue is the Department of Homeland Security's practice of seeking to identify potentially deportable individuals in jails or prisons nationwide by issuing a "detainer," a request rather than an order to extend the individual's detention.

Kathryn Steinle, 32 years old, was walking with her father along Pier 14 on the evening of July 1 when she was shot in her upper torso, police said. She later died at a hospital.

*                               *                             *

On March 26, [the suspect, Francisco] Sanchez was booked into the San Francisco County Jail on a local drug-related warrant after serving a federal prison term, the city's sheriff's office said. The next day, Mr. Sanchez appeared in San Francisco Superior Court and the drug charges were dismissed.

Can the AG Take Pot Off Schedule I?

The question whether the Attorney General can, strictly on his own initiative, take pot off Schedule I of the federal schedule of controlled substances has been kicking around for some time now.

As with everything inside the Beltway, it's hard to get a straight answer.  The Washington Post at least gives it a good college try today.  The key part of its piece is here (emphasis added):

Under federal law, the attorney general can move to add, reschedule or remove drugs on his own, at the request of the health and human services secretary or in response to a public petition. But the law also requires the attorney general to gather data and scientific and medical evaluation from the HHS secretary before doing so.

Congress can pass laws to change the scheduling of drugs. Even if the attorney general does decide to move toward rescheduling, Congress can overturn his decision, experts say.

The Drug Enforcement Administration already has denied a petition to reschedule the drug, based on findings by HHS. HHS determined that marijuana has a "high potential for abuse" and "no currently accepted medical use in treatment in the United States," leading the DEA to reject the petition in 2011. The petition was filed nearly a decade earlier, in 2002.

I would add four observations.  First, pot is already de facto legal, as you can find out by going to any of a zillion frat parties this weekend.  Second, the incoming AG, Loretta Lynch, has said firmly that she opposes pot legalization  --  a quite direct answer, given the entirety of her testimony.  Third, it was several years into the present Administration that the federal government refused a request to take pot off Schedule I.  Fourth, a Congress vastly more liberal than this one (2006-2010) made absolutely no move to remove pot from Schedule I.

The facts being what they are, this is not that hard to figure out, unless you're stoned.



Terror Around the Globe

It's a grim day in the news today.  Here are several articles from the WSJ:

Qasim Nauman, Safdar Dawar, and Saeed Shah report on the horrifying story of the Taliban in Pakistan taking over a school and methodically shooting schoolchildren in the head, killing 141 people.  That anyone with any political or religious cause, however fanatical, could deliberately and specifically target children for mass murder staggers the imagination.

Rebecca Thurlow and Lucy Cramer report from Sydney on the rememberance of the deceased hostages Katrina Dawson and Tori Johnson.  Mr. Johnson, the cafe manager, grabbed the perpetrator's gun when he saw an opportunity, beginning the termination of the siege and the freeing of all but himself and Ms. Dawson.  There is also a report that "Ms. Dawson was shielding her pregnant friend from gunfire."

Sony Pictures has received threats of terrorist attacks on showings of its comedy film "The Interview," which paints an unflattering portrait of North Korea's leader (who does such a good job of self-parody, he really doesn't need any help from Sony).  Ben Fritz, Danny Yadron, and Erich Schwartzel have this story.  Although the threats are "viewed as far-fetched by U.S. officials," they can't be taken lightly given the Aurora massacre.

Ineffective Assistance of Thomas Jefferson

Most claims of ineffective assistance of counsel are baloney.  They're simply a way to deflect attention from the client's behavior to that of his supposedly all-important lawyer.  What gets lost in the hubbub is that what wins and loses cases is seldom the lawyer.  It's the evidence.

Still, there are exceptions.

Drug Expiration Dates

Willie Trottie is scheduled for execution in Texas today for killing his wife and her brother. David Ingram reports for KTRK:

"I shot my brother-in-law in self-defense and I shot my wife by accident," he told The Associated Press in a recent interview. "There's no doubt I committed this crime. The dispute is the sequence of how it happened."
Actually, not too much of a dispute.  That "accidental" shooting involved 11 bullets.  The gun was a semiautomatic, not a full automatic, so that requires pulling the trigger "accidentally" 11 times.  And there were multiple witnesses.  Trottie told his wife as he was killing her, "Bitch, I told you I was going to kill you."

So when you are stone cold guilty of a crime for which the death penalty is clearly appropriate, what do your lawyers argue about at the last minute?  Drug expiration dates.  Really.

The Zombie Defense

Park Dietz & Associates, forensic psychology experts, have an email newsletter.  The current issue has an article on Ambien:

The "Ambien Defense" has been getting a lot of press in 2014.  Sometimes called the "Zombie Defense," it's the argument that someone charged with a crime--and the crimes have ranged from DWI to child sexual abuse to murder-- took Ambien (or generic zolpidem) beforehand and had no memory of the crime.
 •  August 19:  A Montana man was sentenced to 100 years for murdering two sisters in their early 20s.  He stabbed one victim over 130 times, including 34 times in the face, and beat, gagged, strangled, and stabbed the other.  A judge called the killings "ritualistic" and "systematic."  The man said he took Ambien before the killings and had no memory of them, but pleaded no contest to avoid a trial.
A few similar examples follow. 

Vietnam Lethal Injection

Ha An reports for Thanh Nien News:

The Hai Phong man who outraged the nation by killing and dismembering an ex-girlfriend was executed by lethal injection on Tuesday night, despite his pleas for mercy.
*                                    *                                  *
Nghia was watching his new girlfriend's apartment while she was out of town when he called Linh, his one-year college lover, to come over.

After they made love, he stabbed Linh to death, wrapped her torso in a blanket and stashed it on the building's rooftop.

He pawned her motorbike, laptop and mobile phone for VND5 million (US$240).

He was arrested on May 22, 2010 while hiding out in Thai Nguyen Province, one day after police discovered Linh's naked, rotting body.
*                                    *                                  *
Starting in late 2011, Vietnam officially switched from dispatching convicts with firing squads to lethal injections. An EU ban on exports of the lethal cocktail to Vietnam caused a lengthy backlog and drove many convicts to insanity and suicide--until Vietnam began manufacturing its own lethal serum.
So there is a source of supply.  We need the House of Representatives to slip a provision exempting lethal injection drugs from FDA importation requirements into a bill that the Senate politically cannot refuse to pass and the President politically cannot veto.  See prior post.

News Scan

Stalker Released From Jail to Kill ex-Girlfriend: A Northern California woman was shot and killed Monday by an ex-boyfriend who had been stalking her. 32-year-old Renne Pinkston was shot and killed as she sat in her vehicle in downtown Winters on Monday morning.  Pinkston leaves a young daughter.  Lauren Keene of the Daily Republic reports that the suspect, 30-year-old William Carl Gardner III, was allowed to repeatedly post bail and be released back into the community despite a lengthy history of failing to appear in court and repeatedly violating the terms of his probation related to a separate domestic-violence involving another woman.  Pinkston had gotten a restraining order to prevent his continued and sometimes violent harassment. Gardner had been released from jail on a no bail warrant last Friday.  An alert sent out Friday to warn Pinkston of Gardner's release was not received until Monday, at about the time she was killed.  Gardner is still at large. 

Jury in Cop Killing Case Recommends Death Sentence: A Florida man convicted of killing two Tampa police officers in 2010 must now wait for a judge's final penalty decision after the jury presiding over his case unanimously recommended a death sentence.  Beau Zimmer of CBS Tampa Bay reports that the defendant, 28-year-old Dontae Morris, an habitual criminal,  was convicted earlier this year for a murder he committed just 30 days before killing the two Tampa officers.  In Florida, a judge has the final say when it comes to sentencing an individual to death, but is required to give great consideration of the jury's recommendation.

Mandatory Testing for Drug Felons on Welfare:  Residents of St. Louis County, Minnesota who receive state welfare benefits and who have been previously convicted of a felony drug crime are now required to take a mandatory drug test in order to receive benefits.  John Myers of the Duluth News Tribune reports that those drug felons receiving benefits will be subject to a random urinalysis prior to their eligibility reviews every 6-12 months. A positive test will result in a sanction under the state Department of Health and Human Services policy.  A second failure requires disqualification from receiving benefits. About 4 percent of the 4,616 individuals in St. Louis County receiving welfare benefits have been identified as convicted drug felons.

Serial Killer Executed in Missouri: Convicted serial killer Joseph Paul Franklin was put to death Wednesday morning after the U.S. Supreme Court lifted two stays that were granted Tuesday evening seeking to delay his execution.  Karen Brooks of Reuters reports that Franklin was the first Missouri inmate to be executed under the state's new execution protocol which allows the Department of Corrections to use pentobarbital created in a compounding pharmacy rather than in an FDA approved pharmaceutical factory.  Franklin was the 35th death row inmate in the U.S. to be executed this year.
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