Dr. Thomas Kline, MD, PhD: Myth 14: Benzodiazapines will addict and kill you

Valium related drugs, or benzos, are an especially drug for treating seizures, comas, and anxiety. attempts to demonize benzos are underway. the medical text do not support the dangers claimed. We do not recommend tapering unless previous shown genetic addiction of opioids or benzos.

C50 is proudly hosting a Meet & Greet/conference: February 7th from 12-4pm: Olympia, WA

https://www.facebook.com/2011191425805198/posts/2528180017439667/

The C50 is proudly hosting a Meet & Greet/conference in the Columbia room at Washington State Capitol Building. The topic: Effects of Opioid Prescribing Policy on the Opioid Crisis February 7th from 12-4pm  Olympia, WA

https://www.eventbrite.com/e/effects-of-opioid-prescribing-policy-tickets-92395524501

 

How Chaos at Chain Pharmacies Is Putting Patients at Risk

How Chaos at Chain Pharmacies Is Putting Patients at Risk

https://www.msn.com/en-us/money/companies/how-chaos-at-chain-pharmacies-is-putting-patients-at-risk/ar-BBZvMwk?li=BBnbfcL

For Alyssa Watrous, the medication mix-up meant a pounding headache, nausea and dizziness. In September, Ms. Watrous, a 17-year-old from Connecticut, was about to take another asthma pill when she realized CVS had mistakenly given her blood pressure medication intended for someone else.

© Jeremy M. Lange for The New York Times

Edward Walker, 38, landed in an emergency room, his eyes swollen and burning after he put drops in them for five days in November 2018 to treat a mild irritation. A Walgreens in Illinois had accidentally supplied him with ear drops — not eye drops.

For Mary Scheuerman, 85, the error was discovered only when she was dying in a Florida hospital in December 2018. A Publix pharmacy had dispensed a powerful chemotherapy drug instead of the antidepressant her doctor had prescribed. She died about two weeks later.

The people least surprised by such mistakes are pharmacists working in some of the nation’s biggest retail chains.

In letters to state regulatory boards and in interviews with The New York Times, many pharmacists at companies like CVS, Rite Aid and Walgreens described understaffed and chaotic workplaces where they said it had become difficult to perform their jobs safely, putting the public at risk of medication errors.

They struggle to fill prescriptions, give flu shots, tend the drive-through, answer phones, work the register, counsel patients and call doctors and insurance companies, they said — all the while racing to meet corporate performance metrics that they characterized as unreasonable and unsafe in an industry squeezed to do more with less.

“I am a danger to the public working for CVS,” one pharmacist wrote in an anonymous letter to the Texas State Board of Pharmacy in April.

“The amount of busywork we must do while verifying prescriptions is absolutely dangerous,” another wrote to the Pennsylvania board in February. “Mistakes are going to be made and the patients are going to be the ones suffering.”

State boards and associations in at least two dozen states have heard from distraught pharmacists, interviews and records show, while some doctors complain that pharmacies bombard them with requests for refills that patients have not asked for and should not receive. Such refills are closely tracked by pharmacy chains and can factor into employee bonuses.

Michael Jackson, chief executive of the Florida Pharmacy Association, said the number of complaints from members related to staffing cuts and worries about patient safety had become “overwhelming” in the past year.

The American Psychiatric Association is particularly concerned about CVS, America’s eighth-largest company, which it says routinely ignores doctors’ explicit instructions to dispense limited amounts of medication to mental health patients. The pharmacy’s practice of providing three-month supplies may inadvertently lead more patients to attempt suicide by overdosing, the association said.

“Clearly it is financially in their best interest to dispense as many pills as they can get paid for,” said Dr. Bruce Schwartz, a psychiatrist in New York and the group’s president.

A spokesman for CVS said it had created a system to address the issue, but Dr. Schwartz said complaints persisted.

Regulating the chains — five rank among the nation’s 100 largest companies — has proved difficult for state pharmacy boards, which oversee the industry but sometimes allow company representatives to hold seats. Florida’s nine-member board, for instance, includes a lawyer for CVS and a director of pharmacy affairs at Walgreens.

Aside from creating potential conflicts of interest, the industry presence can stifle complaints. “We are afraid to speak up and lose our jobs,” one pharmacist wrote anonymously last year in response to a survey by the Missouri Board of Pharmacy. “PLEASE HELP.”

Officials from several state boards told The Times they had limited authority to dictate how companies ran their businesses. Efforts by legislatures in California and elsewhere have been unsuccessful in substantially changing how pharmacies operate.

A majority of state boards do not require pharmacies to report errors, let alone conduct thorough investigations when they occur. Most investigations focus on pharmacists, not the conditions in their workplaces.

In public meetings, boards in at least two states have instructed pharmacists to quit or speak up if they believe conditions are unsafe. But pharmacists said they feared retaliation, knowing they could easily be replaced.

The industry has been squeezed amid declining drug reimbursement rates and cost pressures from administrators of prescription drug plans. Consolidation, meanwhile, has left only a few major players. About 70 percent of prescriptions nationwide are dispensed by chain drugstores, supermarkets or retailers like Walmart, according to a 2019 Drug Channels Institute report.

CVS garners a quarter of the country’s total prescription revenue and dispenses more than a billion prescriptions a year. Walgreens captures almost 20 percent. Walmart, Kroger and Rite Aid fall next in line among brick-and-mortar stores.

In statements, the pharmacy chains said patient safety was of utmost concern, with staffing carefully set to ensure accurate dispensing. Investment in technology such as e-prescribing has increased safety and efficiency, the companies said. They denied that pharmacists were under extreme pressure or faced reprisals.

a close up of a bottle: Trexall, a brand name for the drug methotrexate, can be used to treat cancer.© Provided by The New York Times Trexall, a brand name for the drug methotrexate, can be used to treat cancer.

“When a pharmacist has a legitimate concern about working conditions, we make every effort to address that concern in good faith,” CVS said in a statement. Walgreens cited its confidential employee hotline and said it made “clear to all pharmacists that they should never work beyond what they believe is advisable.”

Errors, the companies said, were regrettable but rare; they declined to provide data about mistakes.

The National Association of Chain Drug Stores, a trade group, said that “pharmacies consider even one prescription error to be one too many” and “seek continuous improvement.” The organization said it was wrong to “assume cause-effect relationships” between errors and pharmacists’ workload.

The specifics and severity of errors are nearly impossible to tally. Aside from lax reporting requirements, many mistakes never become public because companies settle with victims or their families, often requiring a confidentiality agreement. A CVS form for staff members to report errors asks whether the patient is a “media threat,” according to a photo provided to The Times. CVS said in a statement it would not provide details on what it called its “escalation process.”

a hand holding a bottle: For Mrs. Sullivan’s infant to safely wean off the high-dose steroid he was given by mistake, he had to keep taking it for two weeks after the error was discovered.© Nina Robinson for The New York Times For Mrs. Sullivan’s infant to safely wean off the high-dose steroid he was given by mistake, he had to keep taking it for two weeks after the error was discovered.

The last comprehensive study of medication errors was over a decade ago: The Institute of Medicine estimated in 2006 that such mistakes harmed at least 1.5 million Americans each year.

Jonathan Lewis said he waited on hold with CVS for 40 minutes last summer, after discovering his antidepressant prescription had been refilled with another drug.

Mr. Lewis, 47, suspected something was wrong when he felt short of breath and extremely dizzy. Looking closely at the medication — and turning to Google — he figured out it was estrogen, not an antidepressant, which patients should not abruptly quit.

“It was very apparent they were very understaffed,” Mr. Lewis said, recalling long lines inside the Las Vegas store and at the drive-through when he picked up the prescription.

Too Much, Too Fast

The day before Wesley Hickman quit his job as a pharmacist at CVS, he worked a 13-hour shift with no breaks for lunch or dinner, he said.

As the only pharmacist on duty that day at the Leland, N.C., store, Dr. Hickman filled 552 prescriptions — about one every minute and 25 seconds — while counseling patients, giving shots, making calls and staffing the drive-through, he said. Partway through his shift the next day, in December 2018, he called his manager.

“I said, ‘I am not going to work in a situation that is unsafe.’ I shut the door and left,” said Dr. Hickman, who now runs an independent pharmacy.

Dr. Hickman felt that the multitude of required tasks distracted from his most important jobs: filling prescriptions accurately and counseling patients. He had begged his district manager to schedule more pharmacists, but the request was denied, he said.

CVS said it could not comment on the “individual concerns” of a former employee.

With nearly 10,000 pharmacies across the country, CVS is the largest chain and among the most aggressive in imposing performance metrics, pharmacists said. Both CVS and Walgreens tie bonuses to achieving them, according to company documents.

Nearly everything is tracked and scrutinized: phone calls to patients, the time it takes to fill a prescription, the number of immunizations given, the number of customers signing up for 90-day supplies of medication, to name a few.

The fact that tasks are being tracked is not the problem, pharmacists say, as customers can benefit from services like reminders for flu shots and refills. The issue is that employees are heavily evaluated on hitting targets, they say, including in areas they cannot control.

In Missouri, dozens of pharmacists said in a recent survey by the state board that the focus on metrics was a threat to patient safety and their own job security.

“Metrics put unnecessary pressure on pharmacy staff to fill prescriptions as fast as possible, resulting in errors,” one pharmacist wrote.

Of the nearly 1,000 pharmacists who took the survey, 60 percent said they “agree” or “strongly agree” that they “feel pressured or intimidated to meet standards or metrics that may interfere with safe patient care.” About 60 percent of respondents worked for retail chains, as opposed to hospitals or independent pharmacies.

Surveys in Maryland and Tennessee revealed similar concerns.

The specific goals are not made public, and can vary by store, but internal CVS documents reviewed by The Times show what was expected in some locations last year.

Staff members were supposed to persuade 65 percent of patients picking up prescriptions to sign up for automatic refills, 55 percent to switch to 90-day supplies from 30-day, and 75 percent to have the pharmacy contact their doctor with a “proactive refill request” if a prescription was expiring or had no refills, the documents show.

Pharmacy staff members are also expected to call dozens of patients each day, based on a computer-generated list. They are assessed on the number of patients they reach, and the number who agree to their requests.

Representatives from CVS and Walgreens said metrics were meant to provide better patient care, not penalize pharmacists. Some are related to reimbursements to pharmacies by insurance companies and the government. CVS said it had halved its number of metrics over the past 18 months.

But dozens of pharmacists described the emphasis on metrics as burdensome, and said they faced backlash for failing to meet the goals or suggesting they were unrealistic or unsafe.

“Any dissent perceived by corporate is met with a target placed on one’s back,” an unnamed pharmacist wrote to the South Carolina board last year.

In comments to state boards and interviews with The Times, pharmacists explained how staffing cuts had led to longer shifts, often with no break to use the restroom or eat.

“I certainly make more mistakes,” another South Carolina pharmacist wrote to the board. “I had two misfills in three years with the previous staffing and now I make 10-12 per year (that are caught).”

Much of the blame for understaffing has been directed at pressure from companies that manage drug plans for health insurers and Medicare.

Acting as middlemen between drug manufacturers, insurers and pharmacies, the companies — known as pharmacy benefit managers, or P.B.M.s — negotiate prices and channel to pharmacies the more than $300 billion spent on outpatient prescription drugs in the United States annually.

The benefit managers charge fees to pharmacies, and have been widely criticized for a lack of transparency and applying fees inconsistently. In a letter to the Department of Health and Human Services in September, a bipartisan group of senators noted an “extraordinary 45,000 percent increase” in fees paid by pharmacies from 2010 to 2017.

While benefit managers have caused economic upheaval in the industry, some pharmacy chains are players in that market too: CVS Health owns CVS Caremark, the largest benefit manager; Walgreens Boots Alliance has a partnership with Prime Therapeutics; Rite Aid owns a P.B.M., too.

The Pharmaceutical Care Management Association, the trade group representing benefit managers, contends that they make prescriptions more affordable, and pushes back against the notion that P.B.M.s are responsible for pressures on pharmacies, instead of a competitive market.

Falling Through the Cracks

Dr. Mark Lopatin, a rheumatologist in Pennsylvania, says he is inundated with refill requests for almost every prescription he writes. At times Dr. Lopatin prescribes drugs intended only for a brief treatment — a steroid to treat a flare-up of arthritis, for instance.

But within days or weeks, he said, the pharmacy sends a refill request even though the prescription did not call for one. Each time, his office looks at the patient’s chart to confirm the request is warranted. About half are not, he said.

Aside from creating unnecessary work, Dr. Lopatin believes, the flood of requests poses a safety issue. “When you are bombarded with refill after refill, it’s easy for things to fall through the cracks, despite your best efforts,” he said.

Pharmacists told The Times that many unwanted refill requests were generated by automated systems designed in part to increase sales. Others were the result of phone calls from pharmacists, who said they faced pressure to reach quotas.

In February, a CVS pharmacist wrote to the South Carolina board that cold calls to doctors should stop, explaining that a call was considered “successful” only if the doctor agreed to the refill.

“What this means is that we are overwhelming doctor’s office staff with constant calls, and patients are often kept on medication that is unneeded for extended periods of time,” the pharmacist wrote.

CVS says outreach to patients and doctors can help patients stay up-to-date on their medications, and lead to lower costs and better health.

Dr. Rachel Poliquin, a psychiatrist in North Carolina who says she constantly gets refill requests, estimates that about 90 percent of her patients say they never asked their pharmacy to contact her.

While Dr. Poliquin has a policy that patients must contact her directly for more medication, she worries about clinics where prescriptions may get rubber-stamped in a flurry of requests. Then patients — especially those who are elderly or mentally ill — may continue taking medication unnecessarily, she said.

The American Psychiatric Association has been trying to tackle a related problem after hearing from members that CVS was giving patients larger supplies of medication than doctors had directed.

While it is common for pharmacies to dispense 90 days’ worth of maintenance medications — to treat chronic conditions like high blood pressure or diabetes — doctors say it is inappropriate for other drugs.

For example, patients with bipolar disorder are often prescribed lithium, a potentially lethal drug if taken in excess. It is common for psychiatrists to start a patient on a low dose or to limit the number of pills dispensed at once, especially if the person is considered a suicide risk.

But increasingly, the psychiatric association has heard from members that smaller quantities specified on prescriptions are being ignored, particularly by CVS, according to Dr. Schwartz, the group’s president.

CVS has created a system where doctors can register and request that 90-day supplies not be dispensed to their patients. But doctors report that the registry has not solved the problem, Dr. Schwartz said. In a statement, CVS said it continued to “refine and enhance” the program.

Dr. Charles Denby, a psychiatrist in Rhode Island, became so concerned by the practice that he started stamping prescriptions, “AT MONTHLY INTERVALS ONLY.” Despite those explicit instructions, Dr. Denby said, he received faxes from CVS saying his patients had asked for — and been given — 90-day supplies.

Dr. Denby, who retired in December, said it was a “baldfaced lie” that the patients had asked for the medication, providing statements from patients saying as much.

“I am disgusted with this,” said Dr. Denby, who worries that patients may attempt suicide with excess medication. “There are going to be people dead only because they have enough medication to do the deed with.”

‘We Already Have Systems in Place’

Alton James never learned how the mistake came about that he says killed his 85-year-old mother, Mary Scheuerman, in 2018.

He knows he picked up her prescription at the pharmacy in a Publix supermarket in Lakeland, Fla. He knows he gave her a pill each morning. He knows that after six days, she turned pale, her blood pressure dropped and she was rushed to the hospital.

Mr. James remembers a doctor telling him his mother’s blood had a toxic level of methotrexate, a drug often used to treat cancer. But Mrs. Scheuerman didn’t have cancer. She was supposed to be taking an antidepressant. Mr. James said a pharmacy employee later confirmed that someone had mistakenly dispensed methotrexate.

Five days after entering the hospital, Mrs. Scheuerman died, with organ failure listed as the lead cause, according to medical records cited by Mr. James.

The Institute for Safe Medication Practices has warned about methotrexate, listing it as a “high-alert medication” that can be deadly when taken incorrectly. Mr. James reported the pharmacy’s error to the group, writing that he wanted to raise awareness about the drug and push Publix, one of the country’s largest supermarket chains, to “clean up” its pharmacy division, according to a copy of his report provided to The Times.

The company acknowledged the mistake and offered a settlement, Mr. James wrote, but would not discuss how to avoid future errors, saying, “We already have systems in place.”

Last September, Mr. James told The Times that Publix wanted him to sign a settlement agreement that would prevent him from speaking further about his mother’s death. Mr. James has since declined to comment, saying that the matter was “amicably resolved.”

A spokeswoman for Publix said privacy laws prevented the company from commenting on specific patients.

It can be difficult for patients and their families to decide whether to accept a settlement.

Last summer, CVS offered to compensate Kelsey and Donavan Sullivan after a pediatrician discovered the reflux medication they had been giving their 4-month-old for two months was actually a steroid. To be safely weaned, the baby had to keep taking it for two weeks after the error was discovered.

“It was like he was coming out of a fog,” Mrs. Sullivan recalled.

The couple, from Minnesota, are still considering a settlement but haven’t agreed to anything because they don’t know what long-term consequences their son might face.

The kinds of errors and how they occur vary considerably.

The paper stapled to a CVS bag containing medication for Ms. Watrous, the Connecticut teenager with asthma, listed her correct name and medication, but the bottle inside had someone else’s name.

Directions on the prescription for Mr. Walker, the Illinois man who got ear drops instead of eye drops from Walgreens, were clear: “Instill 1 drop in both eyes every 6 hours.” He later saw the box: “For use in ears only.”

In September, Stefanie Davis, 31, got the right medicine, Adderall, but the wrong dose. She pulled over on the interstate after feeling short of breath and dizzy with blurred vision. The pills, dispensed by a Walgreens in Sun City Center, Fla., were each 30 milligrams instead of her usual 20. She is fighting with Walgreens to cover a $900 bill for her visit to an emergency room.

Fixes That Fall Short

State boards and legislatures have wrestled with how to regulate the industry. Some states have adopted laws, for instance introducing mandatory lunch breaks or limiting the number of technicians a pharmacist can supervise.

But the laws aren’t always followed, can be difficult to enforce or can fail to address broader problems.

The National Association of Chain Drug Stores says some state boards are blocking meaningful change. The group, for instance, wants to free up pharmacists from some tasks by allowing technicians, who have less training, to do more.

It also supports efforts to change the insurance reimbursement model for pharmacies. Health care services provided by pharmacists to patients, such as prescribing birth control, are not consistently covered by insurers or allowed in all states. But it has been difficult to find consensus to change federal and state regulations.

While those debates continue, some state boards are trying to hold companies more accountable.

Often when an error is reported to a board, action is taken against the pharmacist, an obvious target. It is less common for a company to be scrutinized.

The South Carolina board discussed in November how to more thoroughly investigate conditions after a mistake. It also published a statement discouraging quotas and encouraging “employers to value patient safety over operational efficiency and financial targets.”

California passed a law saying no pharmacist could be required to work alone, but it has been largely ignored since taking effect last year, according to leaders of a pharmacists’ union. The state board is trying to clarify the law’s requirements.

In Illinois, a new law requires breaks for pharmacists and potential penalties for companies that do not provide a safe working environment. The law was in response to a 2016 Chicago Tribune investigation revealing that pharmacies failed to warn patients about dangerous drug combinations.

Some states are trying to make changes behind closed doors. After seeing results of its survey last year, the Missouri board invited companies to private meetings early this year to answer questions about errors, staffing and patient safety.

CVS and Walgreens said they would attend.

Research was contributed by Susan C. Beachy, Jack Begg, Alain Delaquérière and Sheelagh McNeill.

Research was contributed by Susan C. Beachy, Jack Begg, Alain Delaquérière and Sheelagh McNeill.

Tina Petrova film : PAIN WARRIORS

I reserve the right of editorial censorship

It looks like the political “mud slinging” has already started – IMO – worse than the national election two years ago… I am taking a stand – in particular – against “slanderous name calling”  directed toward specific politicians, particular political parties and/or specific people.  I don’t mind political debate – based on FACTS… when the debate drifts off the road based on FACTOIDS, FAKE NEWS, opinions stated as FACTS.. is where I am going to draw the “line in the sand” and delete comments that go down that path.

While personally, I am not a big fan of our political/bureaucratic system.. IMO.. it is too self serving… Admittedly, politically I tend to lean to the POLITICAL RIGHT but that is because the Libertarian party is seemingly always kept in their place by our dominating “two party system”.

I have belonged to a national pharmacy association for 35 yrs… that promotes the saying “get into politics … or get out of pharmacy ..” If you don’t attempt to influence politicians… someone else will…. and IMO this saying applies to those in the chronic pain community and/or pts who are dealing with subjective diseases.  Legislatures, bureaucrats are doing things that are adversely effecting the quality of life of those pts.  As long as those being affected continue to lack unity and/or a large segment chooses to stand on the sidelines, whoever is successfully “bending the ear” of these politicians … they will continue to do so because they have  little/no concern about the consequences and/or collateral damage that they cause to those suffering and dealing with subjective diseases.

I am sure that the vast majority of my readers will understand and cooperate…those who try to challenge this policy…  It is THREE STRIKES and you are out/banned… and WORDPRESS gives me your IP ADDRESS attached to your comment(s)… Once banned, just posting under a different name – WILL NOT WORK !  Everyone needs to “play nice “

Lastly, please do not post anything promoting a particular vendor or any entity or person selling a product/particular service. Because some may perceive/believe that they have my endorsement which may or may not be the case. Anyone posting a link to a professional selling a product/service will be edited out

Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products – available by mid-April

Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products

https://www.drugtopics.com/diabetes/eli-lilly-introduces-new-lower-priced-versions-humalog-insulin-products

Insulin manufacturers are continuing efforts to provide more cost-savings options to patients with diabetes.

Today, Eli Lilly announced new plans that include 50% lower list prices for certain insulin products that will be available by mid-April

according to a company press release. This will include lower-priced versions of insulin lispro protamine and insulin lispro injectable suspension 100 units/mL (Humalog Mix 75/25 KwikPen) and insulin lispro injection 100 units/mL (Humalog Junior KwikPen).

Lilly initially introduced its first lower-priced insulin, insulin lispro injection 100 units/mL, in May 2019 at a 50% lower list price than the branded version.

Combined, these 3 insulin products comprise of more than 90% of prescriptions written for a mealtime insulin manufactured by Lilly, according to the release. Insulin lispro injectable suspension 100 units/mL, in particular, is one of Lilly’s most prescribed insulin, with approximately 600,000 prescriptions filled in the last 12 months, Lilly said. 

The announcements comes after Novo Nordisk also recently introduced its new insulin cost-savings options for patients experiencing difficulties affording their medications. These plans include short-term free, immediate supply for patients in urgent need with a prescription and a $99 purchase program. Novo Nordisk also offers authorized generic versions of their NovoLog and Novolog Mix.

According to Lilly, the lower-priced version of Humalog Mix75/25 will be known as Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (100 units/mL). The lower-priced version of insulin lispro injection 100 units/mL will be known as Insulin Lispro Injection Junior KwikPen (100 units/mL). Both prices will have a list price of $265.20 for a package of 5 KwikPens.

“The cost of insulin at the pharmacy varies dramatically depending on a person’s insurance coverage,” Mike Mason, president, Lilly Diabetes, said in a statement. “These lower-priced insulins may reduce out-of-pocket costs, especially for people in the coverage of Medicare Part D, the uninsured or those with high-deductible insurance plans.”

The Kwikpen contains 3 ml of U-100 insulin so the “5-pak” will be equivalent of 1.5 vials of insulin  and resulting an equivalent cost of $176.8/ 10 ml vial.

 When this was initially announced a few months back… Lilly stated that NO REBATE/DISCOUNT/KICKBACK to PBM would be made and many/most/all PBM’s responded that this generic insulin would be a “non covered item”…  Discounts/Rebates/Kickbacks to the PBM have been reported to be upwards of 75% of the wholesale price of a particular med.

These price reductions by Lilly and Novo Nordisk suggests that they were being forced to “share” around 50% of their insulin revenue to various PBM’s in order to keep their insulin products on the PBM’s approved formulary.

If I was a diabetic and the pharmacy was told that a Rx for these products were “non-covered”.. I would investigate how the pt could submit a claim for reimbursement, they just might reimburse for the medication. If the pt is not reimbursed, it might be advisable to contact the pt’s members of Congress. It would seem unlikely that Lilly’s generic insulin is INFERIOR to Lilly’s brand name insulin.

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines

FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

https://www.news-line.com/PH_news30087_enews

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte, as well as dietary supplements Mello-Tonin and Body Mass Reset and device Energy FX among others. Basic Reset and Biogenyx issued recall notices by email to their customers on Sept. 23 and Oct. 18, requesting disposal or return to the place of purchase for products sold, purchased or distributed after Nov. 7, 2017. Given these products do not comply with appropriate FDA standards, they have the potential to be unsafe or ineffective for their particular uses, and could lead to adverse health impacts. The FDA is reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products as they do not meet FDA regulations.

“The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs and medical devices are safe and effective for their intended uses and that dietary supplements are manufactured and distributed appropriately,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. “All companies must follow the appropriate standards and are given the opportunity to ensure their actions are in accordance with these laws. We will continue to prevent the distribution of products that do not comply with applicable FDA requirements and ultimately place the public health at risk.”

Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded.

This action follows multiple FDA inspections conducted at Basic Reset and Biogenyx between 2012 and 2017 and a 2016 warning letter. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the companies failed to make the necessary corrections. Basic Reset, Biogenyx and the other defendants cannot receive, label, hold or distribute dietary supplements, drugs or devices until they take certain steps to ensure that all of these products comply with the law. Operations can only resume after receiving written permission from the FDA.

The FDA has not received any adverse event reports related to these products. The FDA encourages patients and health care professionals to report any adverse events to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Dr. Thomas Kline, MD, PhD: Myth 13: Everyone should go to a pain clinic

https://youtu.be/pIsiSltSYPk

I suppose every one should go to a sore throat clinic, The most frequent reason for a doctor’s visit is pain. If doctors can’t treat pain, they need a new line of work. 80% of docs in the US are too timid to prescript pain medicine, so they send them to pain clinic, where only 1/3 are treating with pain medicine. Most are under treated, or not treated. Only 13% said good treatment, and 25% with little treatment. CDC gave licence to steal by prescription unneeded urine drug tests and dubious injection mills. 90% have said pain medicine are more effect than injects. 44% said care was worse at pain clinic than doc’s office. 92% of patients wouldn’t Recommend pain clinics.

Dr. Thomas Kline, MD, PhD: Myth 12: Alternatives to pain medicine are safe and effective

The center for disease control, aka the CDC,published guidelines, march 15 2016, attempting to override FDA prescription doses. Without proper authorization, CDC attempted to declassification opioids pain medicine as the drug of choice, as it has been for 50 centuries. They admitted this was based on no or low scientific research, and was based on consults from PROP, an anti-opioid pain medicines group. They recommended alternatives that do not work, and have greater cost and side-affects. One of their prime alternatives, Gabapentin, a seizure medicine, now reporting to cause overdose deaths, just recently.