Tag: drug manufacturers

First Fentanyl Execution Carried Out In Nebraska

Fentanyl was one of four drugs used to kill Carey Dean Moore.

Nebraska has become the first state to execute an inmate using the powerful synthetic opioid fentanyl.

On Tuesday, Aug. 15, the state used a lethal injection of fentanyl to execute Carey Dean Moore, a 60-year-old who was given the death penalty for killing two cab drivers, Reuel Van Ness and Maynard Helgeland, in 1979.

Fentanyl was one of four drugs used to kill Moore. According to the New York Times, the four-drug cocktail included “diazepam, a tranquilizer; fentanyl citrate, a powerful synthetic opioid that can block breathing and knock out consciousness; cisatracurium besylate, a muscle relaxant; and potassium chloride, which stops the heart.”

The first drug was injected at 10:24 a.m., and Moore was pronounced dead at 10:27 a.m..

As drug manufacturers increasingly refuse to allow states to use their products for lethal injections, states are looking for alternative execution means. Some people say that this is why states are using fentanyl, a painkiller that has become better known as a dangerous street drug and blamed for a spike in overdose deaths around the nation.

“There’s no particular reason why one would use fentanyl,” Robert Dunham, executive director of the Death Penalty Information Center, a Washington nonprofit group, told The Washington Post. “No one has used it before, and we’ve had hundreds and hundreds of executions by injection. That suggests that the state is using fentanyl because it can get its hands on it.”

Scott R. Frakes, director of Nebraska’s Department of Correctional Services, said in a federal affidavit that states were very limited in the drugs they could use for executions.

“Lethal substances used in a lethal injection execution are difficult, if nearly impossible, to obtain,” he wrote.

In July, Nevada was slated to become the first state to use fentanyl as part of a lethal injection. However, the execution was stopped because Alvogen, maker of the sedative midazolam, objected to the drug’s use as part of a lethal injection.

After a judge blocked the execution, the company said that it “does not condone the use of any of its drug products, including midazolam, for use in state-sponsored executions.”

After the court hearing the Nevada execution was put on hold indefinitely.

In a handwritten statement distributed Tuesday, Moore said that he did not wish to delay his execution after spending 38 years on death row. However, he urged people who are against the death penalty to turn their attention to the four individuals on death row in Nebraska who claim to be innocent.

“How might you feel if your loved one were innocent and on death row or if you were the innocent on death row,” he wrote.

View the original article at thefix.com

16 August 2018
Man Sets Out On Legal Mission After Seeing Opioids Destroy His Hometown

A West Virginia lawyer is working to hold major opioid manufacturers legally responsible for their role in the epidemic that has ravaged his home state.

With record-high rates of overdose deaths and babies born with opioid dependence, Huntington, West Virginia is at the heart of the nation’s overdose crisis.

It’s also home to Paul Farrell, a lawyer working to sue major opioid manufacturers, who doesn’t want his town to be grouped into the usual picture of downtrodden rural America.

“People have been underestimating me for a very long time,” Farrell told MSN. “I’m accustomed to being stereotyped as the Appalachia, redneck hillbilly.”

Farrell is leading the lawsuits for many West Virginia towns, who are suing big names like Purdue Pharma, Johnson & Johnson, Endo Pharmaceuticals, Teva, and drug distributors.

He says that he has personally seen the toll that opioids have taken on the region. “I have people my age that I know that are addicted to opioids,” Farrell said. “I know people that have children in their early 20s that they have lost.”

And yet Farrell isn’t overly sentimental about the crisis—he’s out for revenge. “We eat what we kill,” Farrell said. “I’m stalking. I’m stalking the herd.”

Many of Farrell’s lawsuits hang on public nuisance laws, with his argument essentially being that drug manufacturers and distributors created a massive and costly public nuisance throughout the state.

“If you drop a nuclear bomb right there—boom!—this is the fallout,” Farrell said of the region.

Paul Hanly, a lawyer who has sued Big Tobacco and is working with Farrell on his suits, said that Farrell is tenacious in defending his region.

“He’s a gladiator,” Hanly said. “He feels he’s on a mission to correct some wrongs that have adversely affected his state worse than any other state in the nation.”

Farrell is also unapologetic about the potential money that he could make from the lawsuits. The firms filing the suits stand to make up to 25% of their client’s portions of any settlement. With settlements that could reach $50 billion, the payout for lawyers could be significant.

“Sometimes it’s a feast. Sometimes it’s a famine,” Farrell said.

Farrell started his career in family law, before moving on to the more lucrative role of a plaintiff’s attorney, representing people who had been harmed. “I was writing very large checks to dumbass lawyers, and I thought to myself, ‘I’d like to be one of those dumbasses that gets one of these checks,’” Farrell said.

This time, he’s aiming for a significant payout for the communities that have been impacted. Farrell believes that past settlements between West Virginia and opioid manufacturers have been too small.

“It pissed me off that we got handled like that,” he said.

View the original article at thefix.com

25 July 2018
News Groups Demand Opioid Distribution Data Be Made Public

Media outlets want access to the info to support their coverage of the opioid epidemic and increase public accountability by manufacturers.

Some of the nation’s top news organizations, including the Washington Post, are demanding that the federal government release information about the sale and distribution of controlled substances by pharmaceutical distributors and manufacturers.

The information, which is part of the Drug Enforcement Administration’s (DEA) federal opioid distribution database, was turned over as potential evidence in the hundreds of lawsuits filed against pharmaceutical companies for their alleged role in the national opioid crisis.

The media outlets want access to the information to support their coverage of the opioid epidemic and increase public accountability by manufacturers.

As the Associated Press reported, the government consented to submit opioid distribution data culled from 2006 to 2014 from its registry to these lawsuits, but with the requirement that it only be used for legal and law enforcement purposes.

But on July 9, 2018, lawyers for the Washington Post and HD Media, which owns West Virginia’s Charleston Gazette-Mail, filed a request in a Cleveland federal court for release of the records. The Associate Press, along with other news groups, has also requested access to the information.

“Where releasing records would merely bring embarrassment or adverse publicity to a corporation or a government agency, the records must be disclosed,” wrote Post lawyer Karen Lofton in a court filing on July 9. “In this case, disclosure of the distribution data would cause no conceivable harm to patients or other innocent individuals. If anything, their interests would be advanced by the public accountability that would be demanded in the wake of such disclosures.”

Pharmaceutical manufacturers and distributors are opposed to a public release of the information, as is the government, which argued in a court filing in June that making public the database information would have a negative impact on not only the companies’ distribution methods, but also criminal investigations and state public record laws.

But lawyers countered by pointing to a 2016 article by the Gazette-Mail that revealed that drug companies made available more than 700 million pills to West Virginia residents between 2007 and 2012, a period in which more than 1,700 individuals in the state died from opioid overdoses.

The Gazette-Mail obtained the information from drug shipping sales records sent by the DEA to West Virginia Attorney General Patrick Morrissey’s office and made public by a West Virginia district judge.

The lawyers presented the decision to release the information and the story that resulted as a prime example of why the national distribution data should be made public.

View the original article at thefix.com

16 July 2018
Opioid Makers Cut Back On Marketing Payouts To Doctors

In 2016, Big Pharma shelled out more than $15 million to doctors for opioid-related marketing—33% less than the year prior.

Drugmakers are cutting back on opioid-related marketing payouts to doctors, according to a data analysis by ProPublica.

The newly released figures come as the latest update to the nonprofit news site’s Dollars for Docs online tool that tracks payments to physicians from drug companies and other medical companies.

In 2016, the latest numbers show, Big Pharma shelled out more than $15 million to doctors in exchange for opioid-related speaking and consulting work. That was 33% less than the 2015 figure and 21% less than the 2014 figure. Repeatedly, research has drawn a link between marketing and prescribing practices.

“Given the deluge of media attention with the opioid epidemic, I think we’ve seen the pendulum swing in the opposite direction,” Michael Barnett, an assistant professor of health policy and management at Harvard, told ProPublica. “If this is actually a result of manufacturers actually saying, ‘Holy crap, people actually care about opioids being used responsibly’ and they’re aware that their advocacy and payments to physicians could be seen as pushing these medications in a way that is ethically dubious, then that’s a beneficial development and something I’d like to see more of.”

The shift comes amid a growing number of lawsuits against drug companies accused of downplaying the risks of painkillers in aggressive marketing campaigns over a yearslong uptick in opioid use.

It’s not clear exactly what’s driving the changing numbers, though, experts said.

“It’s possible that the pharmaceutical companies voluntarily reduced their marketing, realizing that they may have been contributing to overprescribing,” Dr. Scott Hadland of Boston University School of Medicine told ProPublica.

At the same time the marketing dollars decreased, the number of opioid prescriptions started on the downswing as well. But, so far, the fall in marketing funds has outpaced the reduction in prescriptions.

OxyContin maker Purdue Pharma cut off its speaker program for the drug in 2016, and this year the company halted all physician-targeted promotional efforts of its addictive painkillers and laid off sales reps.

“While the development of important new medicines will be the company’s priority going forward,” the company said last month, “we will continue to support our opioid analgesic product portfolio while continuing our commitment to take meaningful steps to reduce opioid abuse and addiction.”

The FDA greenlit OxyContin in 1995 and since then it’s been Purdue’s biggest financial success, even amid the rise of generic alternatives and the growing popularity of other opioid painkillers.

View the original article at thefix.com

9 July 2018
Drug Shortages Affect Hospitals Across US

The national drug shortage has been severe enough for the FDA to allow Pfizer to sell products that normally would have been recalled.

Emergency departments across the United States are feeling the strain of drug shortages that are affecting physicians’ ability to treat pain and other ailments.

According to the New York Times, some hospitals, like Norwegian American Hospital in Chicago, have been “struggling for months” lacking crucial drugs like morphine, epinephrine (adrenaline) and diltiazem, a heart medication. Norwegian has not had morphine since March of this year, the Times reported.

According to a May 2018 survey of 247 emergency doctors, conducted by the American College of Emergency Physicians, 9 in 10 said they did not have access to important medicines, which they said negatively affected nearly 4 in 10 patients.

While the Times notes that while the reason behind the drug shortage is complex—including the fact that drug companies have little incentive to manufacture drugs that are difficult to make but “cheaply priced”—much of it has to do with manufacturing issues at Pfizer, which produces the majority of generic injectable drugs in the U.S.

“Most of the time, the problem is some type of quality issue related to machine or raw materials,” said Erin Fox, senior director of the University of Utah’s drug information and support services, according to CBS News. “It could be contaminated particles, bacteria, metal shavings, glass particles—all kinds of things. There’s a real quality control problem.”

Pfizer has received multiple warning letters from the Food and Drug Administration regarding issues of quality control, forcing it to slow down production while it addresses these issues. The company estimated that many of its drugs, like morphine, will not be available until 2019, according to the Times.

Incredibly, the drug shortage has been severe enough for the FDA to allow “Pfizer to sell products that normally would have been recalled: In May, Pfizer released morphine and other drugs in cracked syringes, with instructions to health care providers to filter the drugs before injecting them,” the Times reported.

Being the largest pharmaceutical company in the nation, Pfizer’s shortage issues have carried over to competitors who have struggled to fill the void.

The lack of pain medications has been a “huge issue,” according to one emergency room doctor at Norwegian American Hospital. “[Patients] are often disappointed and frustrated that the system is not functioning at the level it should be.”

Fox, who studies drug shortages, explained that the shortage of pain medications not only has to do with manufacturing issues, but opioid restrictions put in place by the government in response to the drug abuse epidemic.

View the original article at thefix.com

6 July 2018