Category: Science/medical

Former Pharmaceutical Exec Pleads Guilty To Bribing Doctors

The former head of sales for an Arizona drug company pleaded guilty Wednesday for his role in a conspiracy to defraud insurance companies by bribing doctors to prescribe a highly addictive fentanyl-based pain drug when it wasn’t needed, according to court documents.

The man, Alec Burlakoff, 44, of West Palm Beach, Florida, is former vice president of sales for Insys Therapeutics Inc. of Chandler, Arizona. Court documents show that Burlakoff agreed to cooperate with prosecutors in their case against Insys at a hearing Wednesday in U.S. District Court in Boston.

Prosecutors said Burlakoff is the highest-level executive to admit wrongdoing in their investigation of the company’s billionaire founder, John Kapoor, and five other co-defendants, all of whom have pleaded not guilty.
Insys agreed to pay $150 million to settle related claims in August.

Burlakoff pleaded guilty to a single count of racketeering conspiracy in exchange for a likely reduction in the maximum sentence of 20 years in prison when he is sentenced next May. He will remain free until then, according to court documents.

An updated indictment filed in September accuses Kapoor and the others of having conspired to bribe doctors to prescribe the drug Subsys to boost sales and defraud insurers from 2012 to 2015.
Subsys, an under-the-tongue spray that manages pain in cancer patients, contains fentanyl, an opioid that the U.S. Drug Enforcement Administration says is 25 to 50 times more powerful than heroin. It is the drug that killed Prince.
ccording to the superseding indictment, Burlakoff and the others ran a sophisticated scheme that used pharmacy data to identify doctors who prescribed a lot of opioids. They then bribed the doctors with offers of cushy speaking engagements to increase their Subsys prescriptions even further and to write a minimum number of prescriptions at a minimum dose to generate as many insured refill orders as possible “without regard to the medical needs of … Subsys patients,” according tot he indictment.

In June 2017, Patty Nixon, an Insys sales representative-turned-whistleblower, told NBC News how the company lured doctors into prescribing the drug for patients who didn’t need it.

“My job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” said Nixon, who said she was fired after she stopped showing up for work because she felt guilty about lying on the job.

A 30-day supply of Subsys can cost as much as $30,000, generating sales of $240 million in 2016.

FDA Finds Avocado Skins Contaminated With Listeria

Earlier this month, the FDA issued a report saying it is now crucial to wash your avocados before eating them, because almost 18% of avocado skins tested over 18 months showed positive results for salmonella and listeria.

0.24 percent of the avocados tested were also found to have listeria within their edible portions. It’s a small percentage, but it was notable enough for the FDA to double down on this warning. Also of note: the FDA’s samplings were of both domestically and internationally grown avocados.

If you’re  wondering why this matters since we don’t actually eat the tough outer skins of avocados, here’s why it does: The knife you’re using to cut through the potentially contaminated skin can carry that bacteria into the pulp of the fruit.

In order to decrease your chances of ingesting the bacteria, recommends you thoroughly wash all hard-shelled produce that comes through your home before eating it. You can do so with “a clean produce brush, and then dry it with a clean cloth towel or paper towel to further reduce bacteria that may be present.”

VA Decides to Continue Lethal Canine Experiments

The US government has decided to continue controversial experiments on dogs, despite critics in congress and elsewhere attacking the experiments as cruel and unnecessary.
The department for veterans affairs (VA) has approved the continuation of the testing, which it says will help doctors find new ways to treat wounded soldiers, according to USA Today
Researchers running the experiments will remove sections of the dogs’ brains that control breathing, sever spinal cords to test cough reflexes and implant pacemakers before triggering abnormal heart rhythms. All the dogs involved will ultimately be euthanized. 
But controversy is brewing over how exactly the vivisections were approved. When the testing was first exposed by an anti-animal testing group last year – White Coat Waste Project – congress passed a law prohibiting the VA department from conducting them without its secretary’s direct approval.
VA spokesman Curt Cashour said that the former VA secretary David Shulkin signed off on continuing the experiments on the day he was fired by Donald Trump in March. 
But Shulkin, who lost his job amid allegations he had misspent taxpayer funds on a trip to Europe his wife took in 2017, told the newspaper he had never been asked to restart the dog tests. 
Documents are currently showing the VA is currently carrying out nine experiments on dogs at various facilities.  In Cleveland, tests involve using electrodes on dogs’ spinal cords to measure cough reflexes before and after severing the cords.
In Richmond, Virginia, experiments include implanting pacemakers in dogs, then inducing abnormal heart rhythms and running the animals on treadmills to test cardiac function before euthanizing them by injection or draining their blood.
Veterans Affairs Secretary Robert Wilkie is publicly backing the value of canine medical testing at his department, saying the practice could provide potential breakthroughs in treatments for spinal cord injuries and other challenges facing veterans.
“We have an opportunity to change the lives of men and women who have been terribly hurt,” Wilkie said in comments at the National Press Club last week. “And until somebody tells me that research does not help in that outcome, then I will continue it.”
One of the lawmakers who is trying to pass a bill which would ban the testing, Democrat Dina Titus, said: “It’s not economically sound, they could be looking at new technologies, and morally people just don’t support testing on puppies.”
But a review launched by Shulkin before he was fired – on the medical necessity for using canines – has found that dogs are “the only viable model” for the specific experiments, the VA spokesman said. 
Nevertheless, the department has also commissioned the National Academy of Sciences to spend $1.3 million to run another study investigating if dogs are really needed for this research.
Justin Goodman, the vice president of advocacy and public policy for the White Coat Waste Project, said it was disconcerting that “disconcerting that Secretary Wilkie was brought in to clean up the VA, and yet he is doubling down on a program that has continued to fail veterans, taxpayers and dogs”
Veterans’ groups are divided on whether the experiments should continue. The founder of Iraq and Afghanistan Veterans of America organisation said that as long as the research was done “ethically” it could lead to medical breakthroughs.
But Paralyzed Veterans of America, which was initially in favor of the VA dog testing, has now changed its mind and said it did not oppose efforts to stop the experiments.
The VA, which said that more than 99 per cent of its animal testing involved rats or mice, insisted that dogs remained a necessary part of its research.
But when asked what medical progress had come about because of dog testing, the agency’s spokesman could only point to breakthroughs which date back to the 1960s.

Scientists Discover New Bacteria That Eliminates Carbon Dioxide

Scientists who were studying the ecosystems in the Clarion-Clipperton Fracture Zone (CCFZ), a trench that extends 2.5 miles beneath the surface of the ocean recently discovered Bacteria that absorbs carbon dioxide (CO2) and potentially turns itself into a food source for other sea creatures. The area is currently being explored for its deep sea mining potential—contractors from nations including Korea, Germany and the U.K. believe the site to be a promising source of polymetallic nodules, which contain metals like nickel, copper and cobalt. Teams of researchers are now conducting surveys to assess the biodiversity of the CCFZ to understand what the impact deep sea mining might have.

Andrew Sweetman, from the Heriot-Watt University in Edinburgh, U.K., and his colleagues carried out a series of experiments of the sediments located in the CCFZ and discovered something unexpected—bacteria that was consuming huge amounts of CO2.

“We … discovered that benthic bacteria are taking up large amounts of carbon dioxide and assimilating it into their biomass through an unknown process,” Sweetman said in a statement. “Their biomass then potentially becomes a food source for other animals in the deep sea, so actually what we’ve discovered is a potential alternative food source in the deepest parts of the ocean, where we thought there was none.” Sweetman went on to publish his findings in the journal Limnology and Oceanography.

Before this study, researchers thought the biggest source of biomass on the seafloor was organic matter—like dead fish and plankton—that floated down.

The team has said it is imperative more research into the seafloor biology is carried out before any mining activities begin. If the findings from the study are scaled up to the oceans globally, it could mean 200 million tonnes of CO2 is being turned into biomass every year. “This equates to approximately 10 percent of the CO2 that the oceans remove each year, so it’s possibly an important part of the deep-sea carbon cycle,” he said. “We found the same activity at multiple study sites separated by hundreds of kilometers, so we can reasonably assume this is happening on the seabed in the eastern CCFZ and possibly across the entire CCFZ.”

“We … discovered that benthic bacteria are taking up large amounts of carbon dioxide and assimilating it into their biomass through an unknown process,” Sweetman said in a statement. “Their biomass then potentially becomes a food source for other animals in the deep sea, so actually what we’ve discovered is a potential alternative food source in the deepest parts of the ocean, where we thought there was none.”

The findings follow another study carried out last year where scientists discovered bacteria in a lake located deep beneath the West Antarctic ice sheet was consuming methane—an extremely potent greenhouse gas. Researchers found the bacteria was digesting methane and preventing it from entering the water and eventually escaping into the atmosphere.

Aetna Forced to Pay 25 Million After Refusing Treatment for Cancer Patient

An Oklahoma jury has awarded $25.5 million to the family of a cancer patient denied coverage by Aetna, with jurors saying that the insurer acted “recklessly” and Aetna doctors didn’t spend enough time reviewing Orrana Cunningham’s case, The Oklahoman reported.

The jury ruled that Aetna recklessly disregarded its duty to deal fairly and in good faith with Cunningham, who had nasopharyngeal cancer. The award is believed to be the largest verdict in an individual “bad faith” insurance case in Oklahoma history, one court observer said, and could have major ramifications across the country for a form of cancer treatment called proton beam therapy.

The case revolved around the 2014 denial of coverage for Orrana Cunningham, who had stage 4 nasopharyngeal cancer near her brain stem. Her doctors wanted her to receive proton beam therapy, a targeted form of radiation that could pinpoint her tumor without the potential for blindness or other side effects of standard radiation, but an Aetna doctor denied coverage deeming the treatment to be too experimental.

Aetna is considering whether to appeal. Company attorney John Shely said the insurer tries to do the right thing.

“If it’s in our control to change, that’s what we’re going to do,” Shely said. “Aetna has learned something here.”

An Aetna doctor denied Cunningham coverage for proton beam therapy in 2014, deeming it experimental, and two other in-house doctors reviewed and upheld the decision.

Aetna attorney John Shely said in closing arguments that the insurance giant was proud of the three medical directors who denied coverage, even turning to thank them as they sat in the front row of the courtroom.
Ron Cunningham, Orrana’s husband, said this week’s verdict was vindication for the suffering his wife went through. She had filed the initial paperwork to sue Aetna, saying that if her case helped save the life of one person, it would be worth it.

“My wife started the case, and I’m just finishing the fight,” he said. “We did her proud. My wife wanted to make sure that it got out. Her comment was ‘if we could just save one person.’

Cunningham said he had another encounter in court. He said John Shely, Aetna’s lead attorney, walked up to him and congratulated him after the verdict before telling him he’d lose on appeal.

Surgeon admits to lasering his initials into patients’ organs during surgery

A surgeon has admitted burning his initials into the livers of two transplant patients with a laser beam.

Consultant Simon Bramhall, 53, branded “SB” on the organs of a man and a woman undergoing transplant operations.

On Wednesday, he admitted two counts of assault by beating at Birmingham Crown Court but pleaded not guilty to alternative charges of assault occasioning actual bodily harm.

Liver surgeons use an argon beam to stop livers bleeding, but can also use the beam to burn the surface of the liver to sketch out the area of an operation.

It is usually not harmful and the marks would normally disappear.

But the female patient’s liver did not heal itself in the normal way and the initials were found in a follow-up operation.

Bramhall was a liver, spleen and pancreatic surgeon who worked at the liver unit within the Queen Elizabeth Hospital in Birmingham, West Midlands, for 12 years.

He was also involved in tutoring and examining medical students and supervising postgraduate students in higher degrees, management and research.

Bramhall pleaded guilty to assaulting a patient whose name is protected by a court order during an operation in August 2013. He also entered a guilty plea relating to an operation performed on an unknown patient in February of the same year and will be sentenced on January 12th.

Addressing the court after the pleas, the prosecutor, Tony Badenoch said: “This has been a highly unusual and complex case, both within the expert medical testimony served by both sides and in law.

“It is factually, so far as we have been able to establish, without legal precedent in criminal law.”

Florida insurance companies drop coverage of OxyContin 

FORT MYERS, Fla. — OxyContin has become one of the most recognizable brand names in the nation’s deadly opioid epidemic. Starting Jan. 1, the state’s largest health insurer will cease coverage of the drug in favor of a painkiller less easy to abuse.

Florida Blue’s alternate, Xtampza ER, is similar to OxyContin in that it is an extended-release, oxycodone-based product. 

The big difference, the company said Tuesday, is that Xtampza is more chemically suited to prevent users from crushing, snorting or injecting it — all means of getting a quicker, and potentially more lethal, high.

Florida Blue’s new policy will not apply to generic oxycodone, which is sold as an immediate-release drug at lower doses and is less likely to be so abused, said Scott McClelland, the company’s vice president of commercial and specialty pharmacy.

Florida Blue is taking the action because the abundance of opioids prescribed to its more than 5 million members represents a risk for abuse and provides evidence that doctors are doling out more than patients need of the powerful but addictive drug, said Scott McClelland, vice president of commercial and specialty pharmacy.

Opioids were the direct cause of 2,664 Florida overdose deaths in 2016 and showed up in the toxicology reports of 4,515 Floridians that year, according to an interim reportfrom the Florida Medical Examiners Commission.

“Imagine if you could take an 80-milligram extended-release (OxyContin) tablet and crush it and inject it and get it all at once, as opposed to a five-milligram oxycodone tablet,” McClelland said. “So, that’s the big reason there’s such huge concerns about these extended-release formulations. It’s a really big dose.”

The OxyContin ban applies to all Florida Blue individual and group plans. Medicare Advantage plans are excluded.

Xtampza ER is manufactured by Canton, Mass.-based Collegium Pharmaceutical Inc. Though it touts the drug’s “abuse-deterrent technology” it does not guarantee that the drug cannot be abused.

The company also notes: “Although Xtampza ER is formulated to make manipulation more difficult, it cannot entirely prevent abuse; abuse of Xtampza ER by injection and via the oral and nasal routes is still possible.”

The company’s decision to drop OxyContin follows a federal declaration earlier this year that the nation is in the grips of an opioid overdose epidemic. Shortly thereafter, Florida Gov. Rick Scott signed an executive order declaring the opioid epidemic a statewide public health emergency.

Fentanyl, morphine, and heroin were the top three causes of lethal opioid overdoses. Oxycodone was fourth.
Florida Blue typically pays for 1.5 million opioid prescriptions every year, according to the company. About 8% of that business is for prescriptions lasting longer than 30 days, a group at a higher risk for addiction and overdose.

Florida Blue already has quantity limits on long- and short-acting painkillers. It has also required prior approval for prescriptions of extended-release opioid painkillers, such as OxyContin and fentanyl.

The policy was updated Oct. 1 to include prior approval for short-acting painkillers needed for more than seven days, McClelland said.

“We want to prevent as much abuse and addiction and deaths related to these overdoses as possible,” he said. “We’re just trying to take an active role and prevent these deaths that are occurring on a daily basis.”

Cigna also announced it will continue covering the same OxyContin alternative,Xtampza ER, as   part of its efforts to cut opioid use by its customers 25% by 2019, CNBC reported.

“Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse,” Cigna Chief Pharmacy Officer Jon Maesner said in a statement Wednesday.

Woman sentenced to jail for refusing to vaccinate son 

A Michigan judge sentenced Rebecca Bredow to seven days in jail after she violated a court order to have her 9-year-old son vaccinated. Bredow’s case first made headlines last week after her ex-husband took her to court over her refusal to vaccinate their son, despite agreeing to do so in Nov. 2016, Fox 2 Detroit reported.

Bredow told Oakland County Judge Karen McDonald that she takes “full responsibility” for her actions, and that vaccinations go against her beliefs. Last week, McDonald had given Bredow seven days to get the boy vaccinated, but she told news outlets that she “would rather sit behind bars for standing up for what I believe in, than giving in to something I strongly don’t believe in.”

Bredow was found in contempt of court, and McDonald said the boy would be vaccinated today based on the Nov. 2016 agreement made between the woman and her ex-husband.

The mother-of-two was handcuffed in court and escorted out of the room by deputies. 

GOP scraps Obamacare repeal plan; can’t gather enough votes

WASHINGTON, D.C.-  Unable to come with enough votes in a limited amount of time, Senate Majority Leader Mitch McConnell has decided to move away from the health care repeal- for now.

Republican senators decided during their weekly conference lunch on Tuesday that it as best not to not take a vote on the measure to repeal the ACA. This move comes after the GOP considered  a lack of votes, since three senators have explicitly  stated they would vote “no” on the measure, while other law makers have expressed doubts about the bill.

“The decision was a joint one between Lindsey and Bill and the other two sponsors and also the leader that if the votes are not there, not to have the vote, but not to give up,” said Sen. Pat Roberts of Kansas, after leaving the lunch, referring to the latest health care bill’s co-sponsors, Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana.

With no Democrats supporting the repeal of Obamacare, Senate Republicans could afford to lose the support of only two of their 52 members and still pass the bill. On Monday evening, Sen. Susan Collins of Maine became the third GOP senator to publicly oppose the measure, delivering a fatal blow to what was already a last-ditch effort. Sens. Rand Paul of Kentucky and John McCain of Arizona had previously said that they were against the measure.

The Graham-Cassidy legislation was the latest version of a series of efforts to partially repeal and replace the Affordable Care Act, but none were able to find the 50 votes needed to pass.

The timing is critical for the GOP since the Senate only has until September 30 before reconciliation expires. Under reconciliation, a simple majority of 50 votes is needed to pass legislation instead of the usual 60.

House Republicans, who did pass a version of Obamacare repeal in May, were disappointed with their congressional colleagues.

Scientists use spinach To grow heart tissue

A team of researchers just demonstrated that spinach leaves may  be able to grow a heart.

In a paper published Wednesday, researchers from Worcester Polytechnic Institute (WPI), the University of Wisconsin-Madison, and Arkansas State University-Jonesboro detail how they used spinach leaves to grow heart tissue.

Since spinach leaves have a vascular system similar to the human vascular system, researchers pushed a detergent solution through the spinach’s veins, stripping it of its plant cells and leaving behind the structure that keeps those cells in place. They also filled the spinach veins with human cells that line blood vessels.

When human cardiomyocytes—heart muscle cells derived from pluripotent stem cells—were implanted onto the spinach leaf, capillaries carried all the necessary blood and nutrients to the cardiomyocytes. After five days on the leaf, the cardiomyocytes had received enough nutrients and grown strong enough to contract like a muscle, and continued to contract for 21 days.

“Adapting abundant plants that farmers have been cultivating for thousands of years for use in tissue engineering could solve a host of problems limiting the field,” Glenn Gaudette, a professor of biomedical engineering at WPI and corresponding author of the paper, says in a statement.

So far, researchers have achieved similar results in parsley, Artemesia annua (sweet wormwood), and peanut hairy roots, and even found that some plants have better networks than others.

For now, the WPI team is still working to create a vascular network for the outflow of blood and fluids from human tissue, and studying how human cells grow while they are attached to and nourished by plant-based scaffolds.

“We have a lot more work to do,” Gaudette says in the statement, “but so far this is very promising.”