hospital invoked a law allowing it to deny further care to a Texas woman

Texas woman taken off life support against family’s wishes – then a pro-life group stepped in

https://www.foxnews.com/health/texas-woman-plug-pulled-life-saving-escape

A Texas woman was taken off life support Monday, against her family’s wishes, after the hospital invoked a law allowing it to deny further care.

But a pro-life group stepped in and helped her “escape” to a place that was willing to provide care. She is now in stable condition.

Donald Jones and his daughter, Kina, were preparing their final goodbyes earlier this week as their wife and mom, Carolyn Jones, 61, who suffered a stroke in 2017 and has been transferred between different rehabilitation facilities, was denied life-saving care by the ethics committee at Memorial Hermann Southwest in Houston.

Texas Right to Life and other pro-life groups in the state rallied together after the plug was pulled and the hospital refused to give Jones dialysis. They were able to get her out Wednesday night using a private ambulance.

“It’s kind of crazy that you try to get someone out of a hospital so their life could be saved,” Mark Dickson, director and vice president of Right to LIfe East Texas, who was with Jones, told Fox News.

Carolyn and Donald Jones have been married for 40 years. Donald had to fight to get his wife out of a hospital that refused her life-saving care. (Texas Right to Life)

The lead pastor of SovereignLOVE church in Longview felt God call him to drive the several hours it took to help rescue Jones. He read her Psalm 71, “about people that are trying to take your life” and encouraged her to keep fighting — that God nor they would abandon her.

“We never thought we’d have to arrange an escape from a hospital,” Dickson recalled. “But we did.”

On Thursday, Jones began receiving dialysis at the new hospital.

Her daughter, Kina, said her mom is in stable condition and looks like herself once again.

Few prescription medications MADE IN THE USA

Heart-Drug Suppliers for Millions Faulted Over Data, Bugs and Dirt

https://www.supplychainbrain.com/articles/29738-heart-drug-suppliers-for-millions-faulted-over-data-bugs-dirt

A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues.

Cadila Healthcare Ltd. and Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. market. Neither company made any of the recalled valsartan, but both companies have recently been cited by agency inspectors for quality-control failures that echo problems at other drugmakers — renewing questions about the safety of some of the world’s most widely prescribed medicines.

Workers ignored testing data showing product flaws; destroyed records indicating that drugs were failing key quality measures; and didn’t properly clean equipment, FDA inspection reports stated. Inside one factory, inspectors said they saw swarms of insects.

Millions of Americans take valsartan for high blood pressure and heart failure. Since last year, pharmacies have pulled many formulations of it, as well as other medications in the same class of drugs, after some were found to contain potential cancer-causing contaminants. Some versions of valsartan are now in short supply.

Most of the tainted drugs originated in India and China, which have become popular sources of generic medications and active-drug ingredients as producers and health-care providers try to hold down costs.

Those forces have left regulators scrambling to police an expanding global supply chain. Some of the plants that made the contaminated drugs were flagged by FDA inspectors prior to the valsartan recalls for attempting to cover up manufacturing problems, as reported by Bloomberg News earlier this year.

But the generic drugmakers cleared by the FDA to make versions of valsartan since the recall have many of the same red flags.

No Control

Records obtained through a public-information request show that a year before the FDA cleared Alkem on March 12 to sell generic valsartan in the U.S., agency inspectors noted numerous issues at one of the company’s two main manufacturing plants in India.

At a plant in Daman, India, inspectors found that workers destroyed logbooks or deleted data on quality testing and ignored signs that drugs made there contained impurities. In less than a month, workers deleted 2,000 files that appeared to include failing quality-test results, according to the inspection records. Data issues were so widespread that inspectors wrote that “there is no quality control unit” at the plant.

Inspectors also observed flying insects, including mosquitoes and gnats, that were “too numerous to count,’’ according to the reports.

Despite the array of problems described in the inspection, Alkem’s plant received a clean bill of health. The FDA revisited Daman in January, nine months after its initial, troubling inspection and gave the plant a pass. Two months later, the agency approved Alkem’s valsartan.

Alkem said its version of the drug was made in India but wouldn’t confirm at which plant. The company said the January visit from the FDA didn’t produce a list of any problems at the factory, an indication that the matter is closed.

It’s almost unheard-of for the agency to sign off so quickly on fixes by a plant with extensive problems, according to Massoud Motamed, a former FDA inspector who conducted inspections in China and India and now works in the drug industry.

“That’s not realistic to fix that in nine months,” said Motamed, who left the agency in 2017 and had no role in the Alkem inspection. “Working for industry, I can tell you it’s impossible.’’

An FDA spokesman, Jeremy Kahn, said in an email that the agency can inspect a facility at any time and does so based on risk factors including when the last inspection took place and the prior inspection history. The FDA also considers the need to maintain sufficient supply of a particular drug, he said.

“The agency followed an appropriate timeline given the factors relevant to this firm,” he said. “Generally, FDA can expedite inspection of facilities and assessment of drug applications for drugmakers that want to produce drugs in short supply so they can become operational as soon as possible.”

Quality Concerns

Cadila received approval from the FDA on March 16 to sell valsartan combined with another blood-pressure drug, hydrochlorothiazide. About a month later, records show, FDA inspectors tallied a lengthy list of quality concerns at a plant in Ahmedabad, India, that is making that drug combination.

Inspectors found in April and May that equipment at Cadila’s facility wasn’t cleaned appropriately to prevent contamination and that workers ignored signs of impurities.

A representative for Cadila didn’t respond to a request for comment.

Those issues are similar to problems FDA inspectors flagged at the company in China that’s at the center of the recall. Zhejiang Huahai Pharmaceutical Co. Ltd. was found to have ignored impurity indications in its valsartan. In a November warning letter, the FDA said that if the company had investigated further, it might have been alerted to the presence of the carcinogen NDMA sooner than the original recall, in July 2018.

The NDMA may have been in the valsartan as long as four years, the FDA said at the start of the recall. The agency is looking into whether the manufacturing process may have led to the contamination.

The FDA has estimated that for every 8,000 people who took the highest dose of valsartan, there would be one additional case of cancer.

China Echoes

In 2017, Motamed, the former inspector, discovered that Zhejiang Huahai workers omitted from official records quality-test failures, including ones that flagged impurities in unnamed drugs the company didn’t attempt to identify.

Motamed wanted to impose strict penalties on Zhejiang Huahai but was overruled by senior FDA officials, who allowed the company to attempt to address the problems. A year later, another generic drugmaker that bought valsartan from the manufacturer found an impurity that was determined to be potential carcinogen NDMA — kicking off the wave of recalls, which continues to expand.

The recall has heightened scrutiny of the safety of generic drugs, which are used to fill nine of every 10 prescriptions in the U.S., according to the FDA. Competition from generics has been a key part of the Trump administration’s push to lower drug costs.

Last month, the FDA posted a list of 43 versions of valsartan and similar drugs that don’t contain carcinogens. The FDA hasn’t updated the list, which names another 386 drugs that still need to be evaluated.

Alkem’s valsartan and Cadila’s combination pill aren’t listed in either category. The list will be updated on a periodic basis, said Kahn, the FDA spokesman.

Purdue cannot control how individual patients use and respond to its products

North Dakota to Appeal Ruling in Suit Against Opioid Maker

www.nytimes.com/aponline/2019/05/15/us/ap-us-opioids-lawsuit-north-dakota.html

BISMARCK, N.D. — North Dakota Attorney General Wayne Stenehjem said the state will appeal the dismissal of the state’s lawsuit against the maker of OxyContin over opioid abuse.

South Central District Judge James Hill on Friday threw out the state’s claim that Connecticut-based Purdue Pharma minimized risks and overstated benefits of long-term use of narcotic opioids including OxyContin.

North Dakota sought unspecified damages and attempted to hold the company liable for opioid overused and addiction in the state.

The Bismarck-based judge ruled the drug maker doesn’t control its product after it enters the market.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products, regardless of any warning or instruction Purdue may give,” the judge wrote.

North Dakota and five other states filed lawsuits a year ago accusing the pharmaceutical company of using deceptive marketing to boost drugs sales that fueled opioid overdose deaths.

The North Dakota ruling is the first in which a court has tossed a state’s claim in its entirety, though a Connecticut judge dismissed lawsuits earlier this year that were brought by several municipalities, saying the local governments didn’t have standing to sue.

Purdue spokesman Bob Josephson said in an email that the company was pleased with the North Dakota ruling.

“As the judge stated in his decision, one company cannot be held accountable for a complex public health issue such as the opioid crisis,” he wrote.

Stenehjem said in a statement that he believes the case will reach a different result in the state Supreme Court.

“I am confident that the state has strong claims against these defendants, whose unconscionable actions demand they be held accountable, and there are well-reasoned arguments that support our position,” Stenehjem said.

At least 39 states have filed lawsuits seeking to have Purdue, the Connecticut-based maker of OxyContin, held accountable for an opioid addiction and overdose crisis. The most recent, filed this month in Pennsylvania, was announced on Tuesday. In March, Purdue and the family that owns the company settled a lawsuit with Oklahoma for $270 million before trial; the company also settled with Kentucky for $24 million in 2015.

In all, about 2,000 state, local and tribal governments have sued players in the drug industry over the toll of opioids. About 1,500 of those claims have been consolidated under one judge in Cleveland. The judge is pushing for a settlement but has scheduled the first trial for October.

Opioids, including prescription painkillers, heroin and fentanyl, were factors in nearly 48,000 deaths in the U.S. in 2017, according to the U.S. Center for Disease Control and Prevention. That’s more deaths than car crashes were responsible for that year.

Is it time to change more of the nomenclature ?

They have already in the process of changing from using the term opiate EPIDEMIC to opiate crisis – because  the term  epidemic suggests that we are dealing with a contagious disease and neither pain nor substance abuse is contagious.

They have also seemed to be in the process of getting rid of the term dependency and addiction and anyone taking/using a opiate (legally/illegally)  > 90 days is now claimed to  have a opiate use disorder.  Does this give the DEA a bigger “body count” ?

They are now also seeming to no longer using the term “accidental opiate death”… now anyone having a opiate showing up in their toxicology one of their causes of death will be “opiate related death” and this could also add to the “body count” for the DEA

Who believes that there is ‘over prescribing of opiates” ?  Especially since the number of opiate Rxs have been declining since 2012.  Maybe the term should really be “careless opiate prescribing”…  some of it being fueled by greed others where the prescribers gives out 2-3 times the days supply that the pt dealing with acute pain really needs and/or abruptly cutting off pts that have been given too many doses and/or too many refills and they are thrown into cold turkey withdrawal and they and their family come to the conclusion that they are “addicted”…  when in reality if they were properly weaned… there really was no real addiction being dealt with.

Retired Navy Chief Chris Fowler funeral fund

https://www.gofundme.com/f/retired-navy-chief-chris-fowler-funeral-fund

From Valorie Hawk:

I am in a state of shock. Chris Fowler was a good man, and no one should have to raise money to do this. His wife Nicole Howe Fowler was one of my first ‘mom friends’ in Hawaii, as we were in a baby hui together. Nicole was/is (we haven’t seen each other in over a decade, but keep in touch) a very good friend, and an enormous support to Jack and I during some very difficult times, as was was Chris. Please share this, especially to any military groups you might be in, as it’s wrong to have this kind of stress on top of grief and shock. The military will pay for the funeral, but they must get his body cremated and get to where the funeral/burial site is. RIP Chris

 

The future of getting the right medication to the right pt

www.dnamedmatch.com/

AARP accused of fighting Trump proposal that could help seniors with more affordable prescriptions

AARP accused of fighting Trump proposal that could help seniors with more affordable prescriptions

www.bizpacreview.com/2019/05/14/aarp-accused-of-fighting-trump-proposal-that-could-help-seniors-with-more-affordable-prescriptions-754466

AARP is reportedly opposing a proposal by the Trump administration that could help seniors better afford their prescription drugs.

Practicing Physicians of America co-founder Dr. Marion Mass told The Daily Caller that AARP has aligned itself with “being for kickbacks that are costing the American patient money at the pharmacy counter.”

Critics of the current drug payment system in the U.S. say that middlemen, called pharmacy benefit managers (PBMs), are adding significant cost to drug prices. AARP is closely tied in to one of those PBMs and, according to Mass, that is why the non-profit group that boasts 38 million members and says its mission is to “empower people to choose how they live as they age” is fighting the plan that would help seniors.

Drug manufacturers pay rebates to PBMs, Medicare Part D plans, and Medicaid managed-care organizations to get their pharmaceuticals on health plans’ formularies–lists of drugs that payors cover. Health and Human Services (HHS) Secretary Alex Azar rightfully calls them “kickbacks.”

The proposed rule would end an exception currently in place that protects PBMs from certain parts of the Anti-Kickback Statute being enforced against them. The rule would still permit rebates “for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs,” according to a January Health and Human Services news release.

AARP believes drug manufacturers, not PBMs, are to blame for high drug costs, a spokesman for the organization told The Daily Caller. “We strongly agree with President Trump on the need to address soaring drug prices, but on the rebate rule, (the Congressional Budget Office) has said it would raise all seniors’ Part D premiums, cost Medicare nearly $200 billion, and have little impact on drug prices.”

Mass countered that AARP’s stance is tied directly to its partnership with UnitedHealth Group (UHG), which runs PBM Optum Rx. “AARP, in your relationship with mega PBM Optum, you’ve defined yourself as being for kickbacks that are costing the American patient money at the pharmacy counter and in hospitals, Mass charged. “You don’t stand for America, you stand for yourselves.”

According to AARP’s financial statement, in 2017, the group derived $627 million in royalties from UHG, well over twice the amount it collected in membership dues.

“The two of those together are an absolute powerhouse in the Medicare industry. We believe that it’s almost criminal what the two companies do. They coordinate to make additional profits when AARP plays itself out to be an organization to benefit and help seniors save money, so it’s a big farce,” said Paul Cornell, CEO of AARP competitor American Seniors Association, in a phone interview with The Daily Caller News Foundation.

The new HHS rule does not go far enough, according to Mass. “No manufacturing, no development, no distribution even,” she said. “(The PBMs and group purchasing organizations) just simply decide who’s going on the formularies and what products are used in hospitals and nursing homes. Why should anyone have legalized kickbacks? There’s three giant PBMs, there’s four giant group purchasing organizations, and these companies are pretty much running the American pharmaceutical supply.” For senior citizens there are 24/7 Assisted Care that can help them during their tough times.

AARP has been a controversial group for decades, with many claiming that it has no business being a non-profit. In the 1990s, the U.S. Senate investigated AARP’s non-profit status, but uncovered insufficient evidence to strip the group of that status. Just a few years ago, in an interview with the Des Moines Register, former Senator Alan Simpson indicated that he was still “troubled by AARP’s practices.” He called AARP “the biggest marketing operation in America and money-maker” and an organization with market practices that are “the greatest abuse of American generosity I witnessed in my time in the U.S. Senate.”

Just have to follow the money trail.. is AARP really about helping seniors and fighting legislation that best for seniors or more interested in helping put money in their own coffers ?

Does this demonstrates the War on drugs – a lot of wasted actions/movements… little/no OUTCOMES ?

The chronic pain community is SPEAKING are the bureaucrats LISTENING ?

Reporting Medicare/Medicaid fraudulent billing

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Fraud-Abuse-MLN4649244.pdf

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Fraud-Abuse-MLN4649244-Print-Friendly.pdf

What Is Medicare Fraud?

Knowingly ordering medically unnecessary items or services for patients

What Is Medicare Abuse?

Abuse describes practices that may directly or indirectly result in unnecessary costs to the Medicare Program. Abuse includes any practice that does not provide patients with medically necessary services or meet professionally recognized standards of care.

We know that both the FDA and Pfizer does not approve – or discourages – the use of Methylprednisolone and similar cortisteroids to be administered as epidural spinal injections (ESI).

How many pts have been told that they must get ESI in order to get oral opiates… even if previous ESI’s have provided little/no pain relief.

How many pts have been given additional ESI because the insurance will “pay for it again”.. after the pt has been told that the procedure will provide some pain relief for months, but in reality the pt is lucky to get some pain relief for days or weeks.

It has become rather routine for the DEA to charge prescriber’s offices that they have raided with “Medicare/Medicaid fraud” because the DEA has determined that the prescriber provided oral opiates that were not medically necessary.

It is estimated that 10 million ESI are provided to chronic pain pts EVERY YEAR and abt 5% will contract adhesive Arachnoiditis https://www.practicalpainmanagement.com/pain/spine/arachnoiditis-part-1-clinical-description

Pts can call 800-MEDICARE to file a complaint but I doubt if they will take a complaint seriously… I doubt if those employees of CMS are interested in anything that would cause a downsizing of their agency.  More action and attention may be achieved by contacting the pt’s Federal  Senators and Representative.