It is a fairly well accepted theory that under/untreated pain can/may cause elevated blood pressure and also that the 4 or 5 different categories of Pharma produced blood pressure meds will not do little/nothing to lower the pt’s blood pressure, because there is a separate biological pathway that is used to elevate blood pressure that the pharma meds do not address.

Here is the current levels and how they are categorized by the American Heart Assoc https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings

It is a known fact that high blood pressure can cause kidney damage. IF a pt has been told that their pain meds are going to be lowered. Would it be a good idea for the pt to request lab test for these substances that are generated by the kidneys – to establish a base line – and when the pt’s blood pressure goes up – especially to HYPERTENSIVE CRISIS LEVEL to ask that they be run again and if they have changed dramatically and especially if they are outside of the normal range, would it suggest that the pt is/could be experiencing kidney damage because of their under/untreated pain. There is a number of damage to a pt’s body caused by elevated blood pressure, and the higher the blood pressure the more likely the damage will progress at a more rapid rate.  The DEA has always “hung their hat” on the claim that there is no way to document that a pt is dealing with pain and/or the intensity of their pain.  If the pt has had their pain meds reduced and their blood pressure has gone up – especially to  HYPERTENSIVE CRISIS LEVEL and their lab values from substance created by the kidney are now outside of normal values, could we back the DEA down? Would it be a good idea to put the pt back on their pain meds for 30 to 60 days and see if the pt’s blood pressure goes back down.  Then  perhaps it is time for some clinical trials to establish the relationship between under/untreated pain, high blood pressure and the lab values of those specific substances created by the kidneys being out of range.  All practitioners  are  suppose  be healers and allowing a pt to be at risk of all the potential damages of high blood pressure because of the failure to treat the pt’s chronic pain. The same theory should apply to Pharmacist who claim that they are “not comfortable” to fill pain meds for a pt.  Could some clinical trials turn the CDC dosing guidelines UPSIDE DOWN and be justification to have those guidelines and the MME system TOSSED IN THE TRASH?

Are there any substances produced by the kidneys that will affect or control blood pressure

Yes, the kidneys produce several substances that affect and control blood pressure:

1. Renin: This enzyme is produced by special cells in the kidneys and released into the bloodstream when blood pressure drops too low[2]. Renin plays a crucial role in activating the renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure[3].

2. Angiotensin: While not directly produced by the kidneys, angiotensin is part of the RAAS. Renin from the kidneys acts on angiotensinogen (produced by the liver) to form angiotensin I, which is then converted to angiotensin II. Angiotensin II causes blood vessel constriction, increasing blood pressure[6].

3. Urotensin: The kidneys produce urotensin, which causes blood vessels to constrict and helps raise blood pressure[7].

4. Nitric oxide and prostaglandins: These substances, produced by the kidneys, help regulate blood flow and pressure within the kidneys and can influence overall blood pressure[1].

The kidneys also play a crucial role in regulating blood pressure by controlling sodium excretion. When too little sodium is excreted, blood pressure is likely to increase[7]. Additionally, the kidneys’ ability to excrete sodium in response to elevated blood pressure (pressure natriuresis) is a major factor in long-term blood pressure regulation[1][3].

Citations:
[1] https://www.jci.org/articles/view/72274
[2] https://my.clevelandclinic.org/health/body/22506-renin
[3] https://www.clinhypertensionjournal.com/articles/ach-aid1011.php
[4] https://newsroom.uvahealth.com/2022/01/11/blood-pressure-drugs-may-cause-kidney-damage-study-suggests/
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC5515225/
[6] https://my.clevelandclinic.org/health/articles/23359-angiotensin
[7] https://www.merckmanuals.com/home/kidney-and-urinary-tract-disorders/biology-of-the-kidneys-and-urinary-tract/kidneys
[8] https://newsroom.uvahealth.com/2024/11/18/blood-pressure-kidney-damage/

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Is there a way to detect those substances in the patient’s blood

Yes, there are several ways to detect kidney-produced substances that affect blood pressure in a patient’s blood:

## Renin Test

A renin test, often performed alongside an aldosterone test, can measure the levels of renin in the blood[1][5]. This test is particularly useful for:

– Diagnosing the cause of high blood pressure, especially in younger patients
– Determining if high blood pressure is related to salt sensitivity
– Identifying potential adrenal gland issues

The test involves taking a blood sample, typically in the morning when renin levels are highest[1].

## Angiotensin II and Angiotensin (1-7) Test

This test directly measures the levels of Angiotensin II and Angiotensin (1-7) in plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS)[3]. It can be used as:

– An adjunct to plasma renin activity and aldosterone measurements
– A tool for investigating potential associations with outcomes of coronavirus infection

## Urotensin II Test

While less common, urotensin II levels can be measured in blood serum. This test has been used in research settings to study conditions like inflammatory bowel disease and may have implications for blood pressure regulation[4].

## ACE (Angiotensin-Converting Enzyme) Test

The ACE test measures the level of angiotensin-converting enzyme in the blood[7]. This enzyme plays a crucial role in the renin-angiotensin-aldosterone system, which regulates blood pressure.

When conducting these tests, it’s important to consider factors that may affect the results, such as:

– Time of day
– Patient’s body position
– Medications (especially blood pressure medications)
– Salt intake
– Stress levels
– Pregnancy

Healthcare providers may need to adjust a patient’s medications or diet before conducting these tests to ensure accurate results[1][6].

Citations:
[1] https://www.webmd.com/hypertension-high-blood-pressure/renin-test
[2] https://www.columbiadoctors.org/health-library/test/renin-blood-test/
[3] https://www.mayocliniclabs.com/test-notifications/attachment.php?id=64257
[4] https://pmc.ncbi.nlm.nih.gov/articles/PMC8476337/
[5] https://www.labcorp.com/tests/002006/renin-activity-plasma
[6] https://www.uhs.nhs.uk/Media/UHS-website-2019/Patientinformation/Genetics/Renin-and-aldosterone-test-2433-PIL.pdf
[7] https://www.ucsfhealth.org/medical-tests/ace-blood-test
[8] https://www.nature.com/articles/pr2017183
[9] https://medlineplus.gov/lab-tests/renin-test/
[10] https://www.urmc.rochester.edu/encyclopedia/content?contenttypeid=167&contentid=angiotensin_converting_enzyme_blood
[11] https://www.mayocliniclabs.com/test-catalog/overview/8060

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would those substances be higher or lower in the pt’s blood if the pt’s blood pressure in higher

In patients with higher blood pressure, the levels of substances produced by the kidneys that affect blood pressure can vary:

## Renin

Renin levels can be either high or low in patients with high blood pressure, depending on the underlying cause:

– High renin: This may indicate salt sensitivity or kidney problems[3][5].
– Low renin: This could suggest a condition called low renin hypertension (LRH) or primary aldosteronism[7][3].

## Angiotensin II

Angiotensin II levels are typically higher in patients with hypertension:

– Higher than normal angiotensin II levels cause excess fluid retention and high blood pressure[6].
– Elevated angiotensin II can contribute to heart enlargement in hypertensive patients[6].

## Aldosterone

Aldosterone levels can also be elevated in some forms of hypertension:

– High aldosterone with low renin may indicate primary aldosteronism, a cause of high blood pressure[3][5].
– Elevated aldosterone causes the kidneys to retain more water and salt, increasing blood volume and pressure[5].

## Angiotensinogen

Recent research has shown a positive association between angiotensinogen levels and blood pressure:

– Higher angiotensinogen levels are associated with higher odds of prevalent hypertension[2].
– The relationship between angiotensinogen and blood pressure appears to be stronger in males compared to females[2].

It’s important to note that the relationship between these substances and blood pressure is complex and can vary depending on the specific cause of hypertension. Measuring these substances, particularly through tests like the renin activity test and aldosterone levels, can help healthcare providers determine the underlying cause of high blood pressure and guide appropriate treatment.

Citations:
[1] https://www.uclahealth.org/medical-services/surgery/endocrine-surgery/patient-resources/patient-education/endocrine-surgery-encyclopedia/renin-test
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC10352958/
[3] https://www.webmd.com/hypertension-high-blood-pressure/renin-test
[4] https://pmc.ncbi.nlm.nih.gov/articles/PMC1693859/
[5] https://my.clevelandclinic.org/health/body/22506-renin
[6] https://my.clevelandclinic.org/health/articles/23359-angiotensin
[7] https://www.healthline.com/health/high-blood-pressure-hypertension/low-renin-hypertension
[8] https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16514
[9] https://www.healthcentral.com/condition/hypertension/renin-activity-test

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what are the normal lab values for these substances Renin, Angiotensin, Urotensin, renin-angiotensin system activity, Nitric oxide and prostaglandins

Based on the provided search results, here are the normal lab values for some of the substances you inquired about:

## Renin

The normal range for Plasma Renin Activity (PRA) in adults varies slightly depending on the source:

– 0.7 to 3.3 ng/mL/hr (or 0.7 to 3.3 mcg/L/hr in SI units)[1]
– 0.2 to 1.6 ng/mL/hour while lying down and 0.5 to 4.0 ng/mL/hour while standing[4]

## Nitric Oxide

For serum nitric oxide metabolites (NOx):

– Men: 11.5 to 76.4 micromol/L
– Women: 10.1 to 65.6 micromol/L[3]

For exhaled nitric oxide (FeNO):

• Values below 25 parts per billion (ppb) are considered low
• Values above 50 ppb are considered high and consistent with type 2 inflammation

It’s worth noting that nitric oxide levels can vary based on factors such as age, height, gender, and certain medical conditions.

## Prostaglandin D2

For adults:

– 35-115 pg/mL[7]

## Angiotensin, Urotensin, and Renin-Angiotensin System Activity

The search results do not provide specific normal values for angiotensin, urotensin, or direct measurements of renin-angiotensin system activity.

It’s important to note that “normal” values can vary depending on the specific laboratory, testing method, and patient factors such as age, sex, and medical conditions. Additionally, some tests, like the aldosterone-renin ratio (ARR), use combinations of these values for diagnostic purposes. For example, an ARR greater than or equal to 20 with serum aldosterone greater than or equal to 15 ng/dL may indicate probable primary aldosteronism[2].

Citations:
[1] https://www.primaryaldosteronism.org/step-1-aldosterone-renin-ratio-arr/
[2] https://pediatric.testcatalog.org/show/PRA
[3] https://pubmed.ncbi.nlm.nih.gov/19782059/
[4] https://www.ucsfhealth.org/medical-tests/renin-blood-test
[5] https://pubmed.ncbi.nlm.nih.gov/8662293/
[6] https://journals.physiology.org/doi/full/10.1152/ajpregu.1999.276.4.R1125
[7] https://www.mayocliniclabs.com/test-notifications/attachment.php?id=58887

 

Filed under: General Problems | 2 Comments »

The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly

https://www.propublica.org/article/glenmark-pharmaceuticals-recalls-fda-oversight

Reporting Highlights

• Flawed Drugs: Indian drugmaker Glenmark Pharmaceuticals issued a string of recalls for pills that didn’t dissolve properly. In one case, the company said the problem could be deadly.
• Anemic Response: Since the recalls, the FDA still hasn’t visited the factory in India that manufactured the drugs or stopped Glenmark from shipping other drugs made there to the U.S.
• Death Reports: Glenmark got reports of three deaths of patients who took the recalled pills. The cause is unclear. A lawsuit alleges the pills killed a Maine woman. Glenmark denies it.

The drug potassium chloride has been on the market for decades, widely prescribed to help the nerves and muscles — including the heart — function properly in patients with low potassium. Too much of it, however, can kill you.

At high doses, it is so effective at stopping the heart that some states have used injections of it for executions.

So the danger was obvious in May, when Indian drugmaker Glenmark Pharmaceuticals recalled nearly 47 million capsules for a dire flaw: The extended-release medication wasn’t dissolving properly, a defect that could lead to a perilous spike in potassium. The U.S. Food and Drug Administration deemed it the most serious kind of recall, a defective drug that had the potential to kill people.

At the time of the recall, the FDA, which is charged with protecting Americans from unsafe drugs, was already on notice about troubles at Glenmark.

The Mumbai-based company had four recalls in the previous eight months and would have two more in following months, all for the same dangerous tendency for pills to dissolve improperly. All the faulty medications were made at the same Glenmark factory in central India, government records show.

Yet the FDA hasn’t stopped Glenmark from shipping pills from the factory to American patients. Nor did it send investigators to the Indian facility to figure out what had gone wrong. Its last inspection of the plant was more than four years ago, before the COVID-19 pandemic.

“They should have been camping out there,” said Patrick Stone, a former FDA inspector who now advises pharmaceutical companies.

Since the May recall, Glenmark told regulators it has received reports of three deaths, three hospitalizations and four other serious problems in patients who took the recalled potassium chloride capsules, FDA records show. It’s unclear if the drug was the cause.

A federal lawsuit alleges that the pills were responsible for the death of Mary Louise Cormier, a 91-year-old woman in Maine. A letter informing her of the recall arrived three weeks after she died.

The FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories. The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills and never mentioned that millions of them had been sold to consumers.

From the day of the first recall in October 2023 through the next 12 months, the FDA oversaw 22 recalls for drugs that didn’t dissolve correctly and could cause harm, agency data shows. That single Glenmark factory was responsible for more than 30%, a ProPublica analysis found.

“The FDA is always late to respond,” Stone said. “This should have been dealt with immediately.”

The FDA has long said it polices foreign plants by prioritizing inspections based on risk. For routine inspections, the agency uses a computer model that weighs prior recalls, the date and results of the most recent inspection, and other factors. FDA employees decide when to send investigators for more urgent visits based on signs that something is amiss. But the agency would not explain why Glenmark’s string of recalls didn’t meet that threshold.

What’s more, federal regulators were aware of significant deficiencies at three of Glenmark’s four other factories that have made drugs for the U.S. market, FDA records show. The breakdowns were so grave at one plant that the FDA barred drugs made there from entering the country.

The FDA’s failings date back decades. In her book “Bottle of Lies,” journalist Katherine Eban exposed the agency’s struggles to identify and combat corruption in the global pharmaceutical industry amid a huge demand for cheap generic drugs in the U.S. The book detailed how a whistleblower in 2005 started feeding the FDA insider details about unsafe medications at a different Indian drugmaker, but it took federal officials almost nine years to wrap up a criminal case.

The majority of the factories making drugs for U.S. patients are in other countries, many of which churn out the generics that make up more than 90% of prescriptions filled here. Yet the investigative arm of Congress has repeatedly found that the FDA has too few inspectors to adequately oversee these plants.

The consequences of lax oversight were unmistakable when the U.S. Centers for Disease Control and Prevention reported in 2023 that four people died and others had to have their eyeballs removed after they used contaminated eyedrops made by a different Indian company. The FDA had never inspected that factory before people got sick.

Fed up with what they called “institutional weaknesses and dysfunction” in the oversight of foreign drugmakers, the House Committee on Energy and Commerce in June demanded that the head of the FDA turn over documents about inspections in India and China.

A spokesperson for the FDA declined to answer questions about the Glenmark recalls or inspection history, saying the agency could not publicly discuss potential or ongoing compliance matters. “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,” FDA spokesperson Amanda Hils wrote in an email. A recent reorganization, she added, “will ultimately help the agency be more efficient and cohesive in our inspection and investigation efforts.”

Officials with Glenmark also declined to answer detailed questions. In a court document, the company denied being responsible for the death of Cormier, the woman in Maine.

“Due to the ongoing litigation, we are unable to provide further information at this time but Glenmark is fully committed to maintaining the highest standards of quality and regulatory compliance in all our operations,” a Glenmark spokesperson wrote in an email. “We continue to work closely with the FDA to ensure compliance with manufacturing operations and quality systems.”

Overseas compliance with U.S. manufacturing standards is crucial in a drug market where foreign factories like the ones operated by Glenmark make a wide range of injections and pills that treat some of the most vulnerable patients in the U.S., including those with cancer, heart disease, epilepsy and kidney ailments. What happens in a factory a half a world away can have deadly consequences.

Glenmark’s major troubles with the FDA began in 2019 at a factory far from the one that made the potassium chloride.

That spring, FDA investigators went to the company’s Himachal Pradesh plant in northern India and reviewed more than 100 complaints about products made there: A steroid cream was gritty, a medication was watery, and tubes of medicines were cracked and punctured

The inspectors found so many problems at the facility that the agency sent Glenmark what’s known as a warning letter, a disciplinary tool the FDA uses to lay out significant violations of federal requirements and demand changes. Too often, Glenmark didn’t identify the root causes of problems and failed to come up with plans to prevent the same defects in the future, the director of the FDA’s Office of Manufacturing Quality wrote to Glenmark’s chairman.

“Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” the FDA official wrote.

This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manufacturing processes that prevent defective drugs from winding up in American medicine cabinets.

FDA records show the problems stretched from India to the U.S., where Glenmark has a factory outside of Charlotte, North Carolina. In August 2021, Glenmark recalled every product it made at that plant. The recall notices said they failed to meet manufacturing standards.

In the spring of 2022, FDA investigators spent more than a month in that factory, documenting 17 violations that resulted in a warning letter for that plant as well.

The problems snowballed in the fall of 2022. The FDA sent Glenmark’s chairman yet another warning letter, this time about its factory in Goa, India, which the agency said failed to thoroughly investigate discrepancies among batches of drugs and lacked the procedures necessary to ensure that its products had the strength, quality and purity that Glenmark claimed. And FDA officials were so concerned after a subsequent inspection of Glenmark’s Himachal Pradesh factory that they placed it on the agency’s dreaded import alert list, which allowed federal regulators to prevent drugs made there from entering the U.S.

At that point, three of the five Glenmark factories that had made drugs for American consumers were in trouble with the FDA.

But one plant has escaped scrutiny in the last few years: the Glenmark facility that made the recalled potassium chloride.

The factory, in Madhya Pradesh, India, previously had a mixed record with the FDA. The agency had sent inspectors every year between 2015 and 2020, finding problems in half the visits.

In 2018, the FDA asked Glenmark to voluntarily make improvements after inspectors found evidence that drafts of internal investigations were shredded in the quality department, among other deficiencies.

Subsequent inspections in September 2019 and February 2020, though, went well.

Then the COVID-19 pandemic hit, and the FDA put all but the most urgent inspections on hold. An Associated Press analysis this September found that about 2,000 pharmaceutical plants had not been inspected by the FDA in five years.

The FDA doesn’t have enough experienced investigators to figure out what’s wrong at factories where there are signs of trouble, said Peter Baker, a former FDA inspector who consults on pharmaceutical quality.

“It’s really difficult to be proactive when you don’t have people,” Baker said.

People familiar with FDA enforcement say inspectors are often frustrated because they have little say on which facilities they inspect. That decision is made by another arm of the agency that doesn’t have the same sort of on-the-ground view of what’s going on in factories.

Those who have the most to lose — the patients who could be endangered by defective pills — rarely, if ever, learn about the conditions inside the manufacturing plants. The FDA doesn’t make it easy for people to know where a drug is made, let alone whether it was by a factory with a concerning safety record.

To determine that the recalled Glenmark drugs were all made at the Madhya Pradesh factory, ProPublica matched drug-labeling records from the U.S. National Library of Medicine with details in two FDA databases. Because the FDA doesn’t routinely post its inspection reports online, ProPublica obtained these and other records from Redica Systems, a data analytics company that receives this information from the FDA through public-records requests.

The first in the string of recalls from the plant came in October 2023 for a drug that treats iron overload from blood transfusions. Days later, the company announced a second recall, this time for a medication for chest pain. Then came two more for capsules that treat high blood pressure. The potassium chloride recall was Glenmark’s fifth. Two more came after that, for a cholesterol-lowering drug and a rheumatoid arthritis medicine.

The only one mentioned on the FDA’s recalls website was the potassium chloride. In that case, the agency followed its practice of posting a press release from the drug company rather than writing its own alert for the public.

“Public notification is generally issued when a product poses a serious health hazard or has been widely distributed,” the FDA spokesperson wrote in an email.

Records show the agency determined that potential harm from taking the other pills Glenmark recalled was likely to be temporary or reversible. But it never told the public what that harm might be.

Mary Louise Cormier never knew her potassium chloride pills had been recalled.

On June 27, the 91-year-old was taken to the emergency room from her nursing home in Brunswick, Maine. She was lethargic and could give only soft, monosyllabic answers to questions, according to the lawsuit filed by one of her daughters.

A blood test showed that her potassium level was alarmingly high — so high that an emergency room doctor had the lab run the test a second time to make sure the result wasn’t a mistake, according to the lawsuit. A level above 6 millimoles per liter is considered a medical emergency. The tests showed Cormier’s level was 6.9, the lawsuit says.

Cormier — who had raised five children, cared for babies in the foster care system and once ran a day care out of her home — suffered cardiac arrest and died, the suit says.

The lawsuit, filed in federal court in Newark, New Jersey, accuses Glenmark of a “systematic disregard for drug safety” and alleges the company sold pills “more suitable for an execution” than for the vulnerable patients they were supposed to help. Cormier’s pharmacy confirmed that her pills came from recalled batches, the lawsuit says. The suit is seeking class-action status.

In a court filing, Glenmark denied the allegations. The company’s attorneys listed dozens of defenses, including that the injuries claimed were the result of preexisting or unrelated medical conditions and that the product contained an adequate warning. There can be other reasons for a spike in potassium, and ProPublica was unable to independently verify key details in the suit. Cormier’s daughter referred a reporter to her attorney, Aaron Block, who declined to release Cormier’s medical records, citing the early stage of the litigation.

It’s not clear when Cormier’s pharmacy first learned the pills could be dangerous, but news of recalls can often take time to reach pharmacists — and longer to get to patients. The suit says Cormier’s pharmacy dispensed the pills on June 25. That was the day the FDA posted the recall on its website and three days before Cormier died. Medicines in the U.S. often pass through distributors. The manufacturer is responsible for notifying its distributors, who then have to notify their customers and so on down the supply chain.

News of the recall didn’t reach Cormier’s family until three weeks after her death. As her family was preparing for her memorial, a letter arrived. Cormier’s health insurance company was writing with “important drug recall information” about her potassium chloride: “Our records show that you may have recently filled a prescription for this product.” The letter made it clear that the pills may cause high potassium levels, potentially leading to cardiac arrest and death.

Glenmark knew there was a problem with its potassium chloride at least a month before Cormier died.

On May 29, a Glenmark executive wrote a letter to distributors saying a batch of potassium chloride had failed to dissolve correctly in a test, so the company was issuing a recall. The executive told the distributors that the recall was “being made with the knowledge of the Food and Drug Administration” and used red capital letters to mark the notice “URGENT.” The letter was sent via FedEx overnight. But the company and the FDA didn’t tell the public at the time.

In late June, Glenmark recalled dozens more batches, including the pills that the lawsuit says Cormier took.

On June 25, about four weeks after the Glenmark executive had written to distributors, the FDA finally alerted the public.

Glenmark and the FDA declined to say why the initial recall in May didn’t include all of the faulty pills or why they didn’t tell the public sooner. Speaking generally, Hils, the FDA spokesperson, said that the agency does not have the authority to mandate recalls of most drugs, with a limited exception for controlled substances. The agency’s role, she said, is “to oversee a company’s recall strategy, assess the adequacy of the company’s action, and classify the recall.”

Since then, Glenmark has told the FDA about reports it received of the deaths, hospitalizations and other serious health problems in patients who took the recalled potassium chloride. Companies are required to file reports to the FDA’s Adverse Event Reporting System so the agency can monitor the safety of drugs. The FDA’s online database includes only bare-bones details, so ProPublica was unable to independently verify what happened in each case. While the FDA would not comment on these complaints, the agency generally warns, “For any given report, there is no certainty that a suspected drug caused the reaction.”

A majority of the reports said the patients suffered from abnormal heart rhythms, while the second-most-common complaint was of muscle problems. Glenmark’s public alert said that the recalled pills could cause irregular heartbeats and severe muscle weakness.

Glenmark’s top executives have told financial analysts on earnings calls that the company has invested in improvements to its factories.

The company’s troubles with U.S. regulators are so well known to investors that its compliance officer notified the National Stock Exchange of India in September that FDA inspectors had found no problems at one of its other factories in India. As the news spread, Glenmark’s stock jumped 9%.

Filed under: General Problems | 2 Comments »

Here is a definition  of extortion:https://legaldictionary.net/extortion/ 

This DOJ action seem very similar to the DOJ recent action against CVS

Biden’s DOJ taking its last swing for the fences

In Settling Fraud Case, N.Y. Medicare Advantage Insurer, CEO Will Pay Up to $100M

https://www.medpagetoday.com/practicemanagement/medicolegal/113546

It’s one of the first to accuse a data mining firm of helping a health plan overcharge

A western New York health insurance provider for seniors and the CEO of its medical analytics arm have agreed to pay a total of up to $100 million to settle Justice Department allegations of fraudulent billing for health conditions that were exaggerated or didn’t exist.

Independent Health Association of Buffalo, which operates two Medicare Advantage plans, will pay up to $98 million. Betsy Gaffney, CEO of medical records review company DxID, will pay $2 million, according to the settlement agreement. Neither admitted wrongdoing.

“Today’s result sends a clear message to the Medicare Advantage community that the United States will take appropriate action against those who knowingly submit inflated claims for reimbursement,” Michael Granston, a Department of Justice (DOJ) deputy assistant attorney general, said in announcing the settlement on December 20.

Frank Sava, a spokesperson for Independent Health, said in a statement: “The assertions by the DOJ are allegations only, and there has been no determination of liability. This settlement is not an admission of any wrongdoing; it instead allows us to avoid the further disruption, expense, and uncertainty of litigation in a matter that has lingered for over a decade.”

Under the settlement, Independent Health will make “guaranteed payments” of $34.5 million in installments from 2024 through 2028. Whether it pays the maximum amount in the settlement will depend on the health plan’s financial performance.

Michael Ronickher, an attorney for whistleblower Teresa Ross, called the settlement “historic,” saying it was the largest payment yet by a health plan based solely on a whistleblower’s fraud allegations. It also was one of the first to accuse a data mining firm of helping a health plan overcharge.

The settlement is the latest in a whirl of whistleblower actions alleging billing fraud by a Medicare Advantage insurer. Medicare Advantage plans are private health plans that cover more than 33 million members, making up over half of all people eligible for Medicare. They are expected to grow further under the incoming Trump administration.

But as Medicare Advantage has gained popularity, regulators at CMS have struggled to prevent health plans from exaggerating how sick patients are to boost their revenues.

Whistleblowers such as Ross, a former medical coding professional, have helped the government claw back hundreds of millions of dollars in overpayments tied to alleged coding abuses. Ross will receive at least $8.2 million, according to the Justice Department.

Ross said that CMS “created a bounty” for health plans that added medical diagnosis codes as they reviewed patients’ charts — and whether those codes were accurate or not “didn’t seem to bother some people.”

“Billions of dollars are being paid out by CMS for diagnoses that don’t exist,” Ross told KFF Health News in an interview.

Data Mining

DOJ’s civil complaint, filed in September 2021, was unusual in targeting a data analytics venture — and its top executive — for allegedly ginning up bogus payments.

DxID specialized in mining electronic medical records to capture new diagnoses for patients — pocketing up to 20% of the money it generated for the health plan, according to the suit, which said Independent Health used the firm from 2010 through 2017. DxID shut down in 2021.

Gaffney pitched its services to Medicare Advantage plans as “too attractive to pass up,” according to the Justice Department complaint.

“There is no upfront fee, we don’t get paid until you get paid and we work on a percentage of the actual proven recoveries,” Gaffney said, according to the complaint. Timothy Hoover, an attorney for Gaffney, said in a statement that the settlement “is not an admission of any liability by Ms. Gaffney. The settlement simply resolves a dispute and provides closure to the parties.”

‘A Ton of Money’

CMS uses a complex formula that pays health plans higher rates for sicker patients and less for people in good health. Health plans must retain medical records that document all diagnoses they highlight for reimbursement.

Independent Health violated those rules by billing Medicare for a range of medical conditions that either were exaggerated or not supported by patient medical files, such as billing for treating chronic depression that had been resolved, according to the complaint. In one case, an 87-year-old man was coded as having “major depressive disorder” even though his medical records indicated the problem was “transient,” according to the complaint.

DxID also cited chronic kidney disease or renal failure “in the absence of any documentation suggesting that a patient suffered from those conditions,” according to the complaint. Past conditions, such as heart attacks, that required no current treatment, also were coded, according to the DOJ.

The suit alleges that Gaffney said renal failure diagnoses were “worth a ton of money to IH [Independent Health] and the majority of people (over) 70 have it at some level.”

Ross filed the whistleblower case in 2012 against Group Health Cooperative in Seattle, one of the nation’s oldest managed-care groups.

Ross, a former medical coding manager there, alleged that DxID submitted more than $30 million in disease claims — many of which were not valid — on behalf of Group Health for 2010 and 2011. For instance, Ross alleged that the plan billed for “major depression” in a patient described by his doctor as having an “amazingly sunny disposition.”

Group Health, now known as the Kaiser Foundation Health Plan of Washington, denied wrongdoing. But it settled the civil case in November 2020 by agreeing to pay $6.3 million. The DOJ filed a second complaint in 2021, against Independent Health, which also used DxID’s services.

Ross said she lost her job after her suit became public in 2019 and was unable to secure another one in the medical coding field.

“It was rough at times, but we got through it,” she said. Ross, 60, said she is now “happily retired.”

False Claims

Whistleblowers sue under the False Claims Act, a federal law dating to the Civil War that allows private citizens to expose fraud against the government and share in any recovery.

At least two dozen such suits, some dating to 2009, have targeted Medicare Advantage plans for overstating the severity of medical conditions, a practice known in the industry as “upcoding.” Previous settlements from such suits have totaled more than $600 million.

The whistleblowers have played a key role in holding health insurers accountable.

While dozens of CMS audits have concluded that health plans overcharged the government, the agency has done little to recoup money for the U.S. Treasury.

In a surprise action in late January 2023, CMS announced that it would settle for a fraction of the estimated tens of millions of dollars in overpayments uncovered through its audits dating to 2011 and not impose major financial penalties on health plans until a round of audits for 2018 payments, which have yet to be done. Exactly how much plans will end up paying back is unclear.

“I think CMS should be doing more,” said Max Voldman, an attorney who represents Ross.

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An insurance CEO was gunned down. Malignant health care system in Kansas explains reaction.

https://coloradonewsline.com/2024/12/23/an-insurance-ceo-was-gunned-down-malignant-health-care-system-in-kansas-explains-reaction/

I remember the room so clearly. It was a small conference space in the Concord Monitor newspaper office in New Hampshire, scarcely big enough for two people. I had ducked into the room to make a phone call to a mail-order pharmacy, one of the “conveniences” required by my health insurance company.

My voice shook, and I could barely contain my emotion.

Do you understand that I need this drug to live? I told the person on the other side. Do you understand that without this medicine I will die?

If you want to understand why so many Americans of disparate political ideologies have cheered on Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, you might look to that moment, one that I’m confident has been shared by countless people in recent decades. The exact medicine I was talking about doesn’t matter in the grand scheme of things — some folks depend on EpiPens, others on asthma inhalers, others on insulin, others on antiretroviral therapy, still others on chemotherapy drugs.

Until you find yourself on that call, begging our nation’s health care cartel to keep you alive, you don’t know what it’s like.

The shame grinds at you.

But at least there’s some sort of coverage underneath it all. You’re not one the approximately 172 Kansans who died this year because of the Legislature’s blinkered refusal to expand Medicaid. Imagine their friends and families, reeling from preventable carnage.

We have numbed ourselves, I think, to the shocking cruelty of it all, to the everyday horror of begging for medicine, for medical care, for someone to listen. Insurers and the dubious shell companies they spawn (take a look into pharmacy benefit managers sometime) enjoy record profits. Meanwhile, everyday folks grit their teeth and persist.

Those a rung or two lower on the social ladder? Forget about it.

Mangione has been apprehended and will face justice. Murder and violence, no matter the motivation, are wrong. Killing Thompson not only wounded his loved ones and friends, but it arguably makes efforts to improve the system more difficult. No CEO wants to appear as though fear has changed their behavior.

Yet when so many feel powerless as a system runs roughshod over them, we should not be surprised that some number (perhaps larger than we imagine) will condone horrifying violence.

Consider that the Kansas Legislature passed Medicaid expansion — yes, passed it — a mere seven years ago. Then-Gov. Sam Brownback vetoed the bill, and lawmakers couldn’t override him. Each year, advocates trek to the Statehouse in Topeka and make their case. Each year, think tanks issue papers showing how many more parents and children would be covered. Each year, the news media points out the clear good that such a move could make.

One year, demonstrators even unfurled banners covered with red handprints, declaring the legislators had blood on their hands. Others have tried mildly disruptive tactics, anything to seize the attention and make the case.

We know the cost — you can calculate it with publicly available numbers. Once 2024 ends in a couple of weeks, some 1,720 Kansans will have died over 10 years.

Yet nothing happens.

Writ large, the same story has played out across the nation. Despite the Affordable Care Act’s success in covering more Americans, the law did not prevent for-profit insurance companies from playing the angles to maximize their take. It has not meaningfully lowered prices. Mangione’s manifesto points out — entirely accurately — that we spend more money on health care in the United States than any other nation yet see poor health outcomes.

Mangione faces first-degree murder charges in New York. If found guilty, he will face punishment from society. We punish those who commit acts of violence against others — as long as they do it one-on-one. The German philosopher Friedrich Engels described a different kind of murder in 1845. He called it “social murder,” described it as occurring when society’s elites created conditions for the poor that inevitable prove fatal.

“When society places hundreds of proletarians in such a position that they inevitably meet a too early and an unnatural death, one which is quite as much a death by violence as that by the sword or bullet; when it deprives thousands of the necessaries of life, places them under conditions in which they cannot live – forces them, through the strong arm of the law, to remain in such conditions until that death ensues which is the inevitable consequence – knows that these thousands of victims must perish, and yet permits these conditions to remain, its deed is murder just as surely as the deed of the single individual,” he wrote.

Engels also helped create communism with Karl Marx, so skepticism might be warranted. Yet he precisely defines the socially excused violence that threatens our state and nation.

The political process, if working correctly, should reform the mechanisms that create such suffering. Successive generations of reformers, from Teddy Roosevelt to Franklin Roosevelt to Lyndon Johnson, created a web of safety nets. Untold numbers of lives were saved.

Yet that process has solved fewer and fewer problems of late. Americans feel in their bones that something is amiss, that something has gone wrong and needs fixing. Conservatives blame liberals, while liberals blame conservatives. Neither want to blame actual culprits, the wealthy, because they underwrite each party’s existence.

Extremism flourishes when officials close off everyday avenues of social and government change.

I fear it, from any party or ideology. Once lit, certain fires can be difficult to extinguish. We have witnessed the results of popular uprisings over the past 150 years, and they do not fill one with confidence. Revolution often ends poorly. Dictators and strongmen rise, while the ultra-wealthy flee to stable fortresses elsewhere.

We know what we need to do. Create a responsive government at the state and national levels. Lower health care costs without sacrificing coverage or quality. Reorient society from a win-at-all-costs mindset to the neighborliness of an earlier age. Show others the caring we would hope they show us.

Yet how can we plausibly achieve these goals? Ideological chasms yawn. Many have abandoned hope, drawn into black holes of nihilism. Those of us who dare to imagine better outcomes wonder if we lead others astray by doing so.

We are all locked in that room together now, still on that phone call, begging for our lives.

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From this interaction between this pt and this pharmacist – which is really the MOST UNCOMFORTABLE? I am going to share – again- the graphic that explains the potential comorbidity complication – or cause additional comorbidity issues – from under/untreated pain. One of the very basic functions of the practice is the starting, changing or stopping a pt’s therapy. Does this pharmacist’s action – and many other Pharmacists that “we” never hear about – are potentially practicing medicine without a license?

Here is something – are these Pharmacists violating the oath that we all took – JUST LOOK AT THE FIRST LINE (PROMISE) of the Pharmacist’s Oath!

Should pts and prescribers start filing complaints with respective state Boards of Pharmacy with this Pharmacist Oath enclosed/attached?  If the pharmacy boards gets enough complaints – will some of them become UNCOMFORTABLE?

 

 

In case someone takes issue with the fact that the Pharmacist Oath was recently revised. I found a version where the revisions are in COLOR

Oath of a Pharmacist: Final revised draft

I will consider the welfare of humanity and relief of suffering my primary concerns.

I will apply my knowledge and experience to advance health equity to assure optimal outcomes for all patients.

I will respect and protect all personal and health information entrusted to me.

I will accept the responsibility to improve my professional knowledge, expertise, and self-awareness.

I will champion diversity and inclusion, respect the perspectives of others, and mitigate my personal biases.

I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

I will embrace and advocate changes that improve patient care.

I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Edits to existing statement

New statement

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As Drugstores Close, Older People Are Left in ‘Pharmacy Deserts’

https://www.nytimes.com/2024/12/21/health/drugstore-closures-seniors.html

Shuttered drugstores pose a particular threat to older adults, who take more medications than younger people and often rely on pharmacies for advice.

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In this day and age, most healthcare professionals are just employees of a large corporation. They have little/no say over staffing levels. Patients that are in charge of caring for can get possible good or bad care .. depending on the staffing levels. Generally, these attorneys/bureaucrats go after “deep pockets”.  The got after the pharmas, the drug wholesalers, the physicians – they all have deep pockets.

I had never really thought about it until now, but when it comes to hospitals and nursing homes. The attorneys/bureaucrats seem to go after the employees of those entities. Could it be that “they” believe that going after the employees of those corporations will be perceived as a “warning” to the corporation to straighten up in staffing levels and/or the quality/training of the staff so that pts are more properly cared for?

I am not an attorney, but I counted 38 different counts stated in the video and I presume that each one of the 18 staff of the nursing home had 38 charges against each of them. for a GRAND TOTAL OF 684 charges collectively.

It was stated within those 18 staff members, there was the administrator and a nurse, so that state of Virginia is going to after least financially bankrupt the administrator and the nurse and the balance of those charged will need the state to provide them with legal counsel (Public Defender). Will this cause the Nursing Home Industry in Virginia to get their act together?

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This video was done on Dec 3, 2024 and as typical of me, I was little late to the party, since I just watched it today. You would not believe all the links to some video that can be a ONE HOUR+ that are shared with me.  Unfortunately, I have to pick and chose which ones that I have to carve out the time to watch.

One of the most poignant info was from Attorney Kate Nicholson, who stated that just trying to make change only at the state or federal level, success will be fairly limited. Her statement is toward the end of the video.

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I talked to a practitioner a few days ago, this practitioner had a high intensity, intractable chronic pain pt who had been filling a opiate Rx at a local grocery store pharmacy for some time.  All of a sudden, the pt was informed by a Pharmacist at the pharmacy that he “was not comfortable” to continuing filling the pt’s C-2 and this was just a few days before the pt was get a new C-2 filled. In fact, the practitioner had already electronically sent the C-2 Rx to the pharmacy.

The pt had been taking 135 MME/day for some time. I have often stated that one of the basics of the practice of medicine, the starting, changing, stopping a pt’s therapy. In reality, “I’m not comfortable” is not a valid clinical reason for stopping a pt’s therapy and it would suggest that this Pharmacist is totally indifferent to intentionally throwing this pt into a cold turkey withdrawal and within days of Christmas.

I don’t know if this pt was intending to travel to be with family or the pt was planning on having family at their house for Christmas?

IMO, this Pharmacist should be taken before the state pharmacy board for unprofessional conduct and lack of empathy for the cold turkey withdrawal and torturous level of pain the Pharmacist’s action was intentionally causing for this patient.

I wonder what a State Board Pharmacy actions would  take – if any- against a Pharmacist, if a pt would file a formal complaint?

I went out to www.perplexity.ai and asked the following question:

what could be the consequences to a pharmacist that intentionally cut a legit chronic pain patient off their pain meds and intentionally throws the patient into cold turkey withdrawal. Could the pharmacist be charged with practicing medicine without a license

If a pharmacist intentionally cuts a legitimate chronic pain patient off their pain medications, leading to cold turkey withdrawal, the consequences can be severe and multifaceted. Here are some potential outcomes:

## Professional and Legal Consequences
– The pharmacist could face disciplinary action from their professional licensing board, including the suspension or revocation of their license. This is because such actions would violate the standards of professional practice and potentially harm the patient[1][6][8].

## Criminal Charges
– While the pharmacist would not be charged with practicing medicine without a license, as pharmacists are licensed to dispense medications, they could face other charges. For example, they might be charged with negligence, reckless endangerment, or other crimes related to the harm caused to the patient[5].

## Civil Liability
– The pharmacist and the pharmacy could be held liable in a civil lawsuit for any harm or suffering caused to the patient. This could include damages for physical and emotional distress, medical expenses, and other related costs[5].

## Health Consequences to the Patient
– Abruptly stopping opioid pain medications can lead to serious withdrawal symptoms, uncontrolled pain, psychological distress, and even thoughts of suicide. Patients may also seek other sources of opioids, including illicit substances, which can further exacerbate the situation[1][4][6].

## Ethical and Regulatory Violations
– Such actions would violate FDA guidelines and other regulatory standards that emphasize the importance of gradual tapering of opioid doses to avoid serious harm to patients. This could result in regulatory penalties and further disciplinary action[1][6].

In summary, while the pharmacist would not be charged with practicing medicine without a license, they could face severe professional, legal, and civil consequences for their actions. The primary issue would be the violation of professional standards and the potential harm caused to the patient.

Citations:
[1] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[2] https://www.davidrankinlaw.com/former-pharmacist-arrested-for-practicing-health-care-without-a-license/
[3] https://www.govinfo.gov/content/pkg/FR-2018-04-30/html/2018-09020.htm
[4] https://www.nbcnews.com/health/health-news/cdcs-new-opioid-guidelines-little-late-chronic-pain-patients-rcna74248
[5] https://www.criminaldefenselawyer.com/resources/practicing-medicine-without-a-license.htm
[6] https://www.npr.org/sections/health-shots/2019/10/10/768914092/dont-force-patients-off-opioids-abruptly-new-guidelines-say-warning-of-severe-ri
[7] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[8] https://en.wikipedia.org/wiki/Practicing_without_a_license

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Walgreens’ Woes: Retail Pharmacy Giant Reportedly Weighing Private Equity Sale to Sycamore Partners

https://www.doximity.com/collections/890523eb-6a52-412a-8533-fb6bbf3abd1b

After a tumultuous run which included making major investments into healthcare delivery assets (most notably VillageMD), Sycamore Partners is reportedly taking Walgreens private as scooped by the Wall Street Journal.

In November, Walgreens parted ways with VillageMD CEO Tim Barry.

It has been a tough few years for the beleaguered retail pharmacy player, and Walgreens has been brought to its knees in 2024. The knockout punch was coming. How did we get here?

Walgreens has been hit hard by uncontrollable secular shifts in consumer behavior. Amazon and others are eating Walgreens’ retail lunch.

The retail side of Walgreens’ business is stagnant and oversaturated with stores, as more consumers shift to online shopping. This challenge is two-pronged. The pharmacy business traditionally operated like a “gas station” model—drawing foot traffic that would lead to retail sales. But as patients increasingly choose online prescription refill services for convenience, fewer people are visiting physical pharmacy stores, resulting in decreased retail shopping at these locations.

So when retail sales sagged, Walgreens needed to make a move in a big way. The big plan involved embarking on an ambitious business transformation journey into healthcare delivery .

This journey jump-started in 2021 with VillageMD as Walgreens cobbled together the below healthcare footprint to sell a healthcare transformation story, including diving into value-based care headfirst.

Execution, however, didn’t go as planned. As Hospitalogists reading this breakdown know, healthcare is hard. Primary care is hard. Value-based care is hard. This dynamic isn’t unique to Walgreens and VillageMD, either.

Unfortunately this assemblage of assets no longer seems to be industry leading.

Plain and simple, Walgreens was desperate and overpaid for what it got in a low-interest rate environment. In its 2024 full year earnings release Walgreens incurred an $8.6B net loss on $12.7B in goodwill impairment charges (meaning they overpaid for these companies and the current earnings/economics could not support the acquired valuation, more or less). VillageMD performance weighed down the healthcare story given acute pressures in Medicare Advantage and changes to risk adjustment, along with significant capital and timeline required to build out an appropriate risk-bearing primary care player.

Unfortunately, unlike CVS, Walgreens lacks some of the most important assets to execute on the strategy (at least so far) to make the flywheel…fly – the PBM and the health insurance plan (side note that CVS isn’t doing particularly well either but for its own reasons).

Despite its own struggles, CVS holds a believable narrative to tell investors. From Q3:

But I digress. This is Walgreens’ share performance since acquiring a majority stake in VillageMD for $5.2B in late 2021, then proceeding to attach Summit Health for $9B in late 2022. At its peak, Walgreens held a $100B+ market cap in 2015.

Today it sits at $8B:

In Walgreens, Sycamore is acquiring a struggling giant, but with a vast revenue base and operating footprint – $147.7B in revenue. While not being an accountant, the impairment charges are largely addressed in 2024, so Sycamore probably thinks there’s significant value to unlock over time as a private company – and tax savings to boot. I’m inclined to agree. Walgreens holds some bright spots. Without being under the gun of quarterly investors Walgreens will have more freedom to reduce its debt load and continue billions of dollars in cost-cutting initiatives (1,200+ store closures in the coming years, capex reductions, working capital reductions). Expect to see Walgreens continue this trajectory but also focus on growing service lines like specialty pharmacy – probably its best acquisition to date.

 

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