An Invitation to Save Our Profession and Improve Working Conditions |
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An Invitation to Save Our Profession and Improve Working Conditions |
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Never submit passwords through Google Forms.
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https://ncpa.org/newsroom/qam/2021/05/26/qam-gi-over-counter-doesnt-mean-always-safe
Rep. Debbie Dingell (D-Mich.) didn’t want to take opioids after painful dental surgery. So she took Motrin. A lot of it. All that Motrin led to emergency surgery last week for a perforated ulcer. According to a story from The Washington Post, “there’s a real education gap” among members of the public about the potentially serious side effects of these medications. “Just because something’s available over the counter doesn’t mean it’s safe to be used by everyone for any amount of time,” the director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital said. Experts explain why Dingell’s experience should serve as a cautionary tale.
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Buying prescription drugs through GoodRx, Amazon and other alternative avenues does not guarantee patients are getting a good deal.
The big picture: More people are purchasing their drugs with cash instead of using their health insurance, in large part because they are getting sizable discounts. But discounted prices often still have no relation to a drug’s actual cost.
How it works: The amount people pay out of pocket for their medication is tied to secretive contracts among pharmacy benefit managers, health insurers, distributors, pharmaceutical companies, pharmacies and other entities.
Yes, but: Generic versions of the HIV pill Truvada have significantly brought down the drug’s price, but not for everyone, according to new research from analysts at drug-pricing firm 46brooklyn.
The bottom line: The existence of so many drug-discount programs is an indictment of both America’s insurance and pharmaceutical systems.
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Alphabet Inc.’s GOOG 1.02% Google and national hospital chain HCA Healthcare Inc. HCA 0.77% have struck a deal to develop healthcare algorithms using patient records, the latest foray by a tech giant into the $3 trillion healthcare sector.
HCA, which operates across about 2,000 locations in 21 states, would consolidate and store with Google data from digital health records and internet-connected medical devices under the multiyear agreement. Google and HCA engineers will work to develop algorithms to help improve operating efficiency, monitor patients and guide doctors’ decisions, according to the companies.
“Data are spun off of every patient in real time,” said Dr. Jonathan Perlin, chief medical officer of HCA, which is based in Nashville, Tenn. “Part of what we’re building is a central nervous system to help interpret the various signals.”
The deal expands Google’s reach in healthcare, where the recent shift to digital records has created an explosion of data and a new market for technology giants and startups. Data crunching offers the opportunity to develop new treatments and improve patient safety, but algorithm-development deals between hospitals and tech companies have also raised privacy alarms.
Google has previously reached deals with other prominent U.S. hospital systems, including St. Louis-based Ascension, that granted access to personal patient information, drawing public scrutiny.
Google and Ascension sought to develop a search tool for patient information. The work, dubbed “Project Nightingale” and described in articles by The Wall Street Journal, prompted an outcry over privacy of patient records shared with Google, which included names, dates of birth and medication information. The companies said the effort complied with federal privacy laws.
Google also reached an ambitious deal with Mayo Clinic that combined storage of voluminous medical, genetic and financial data with algorithm-development efforts. The Google deal with Mayo allows Google access to identifying patient information, when needed.
Other tech giants have struck similar deals with hospitals that grant access to identifying information in technology development, such as an effort by Microsoft Corp. and hospital system Providence to use patient records to develop cancer algorithms.
HCA said Google isn’t permitted to use patient-identifiable information under the agreement. Dr. Perlin said HCA patient records would be stripped of identifying information before being shared with Google data scientists and that the hospital system would control access to the data. Terms of the deal weren’t disclosed by the companies.
Google will access data when needed with consent from HCA, but the tech giant can develop analytic tools without patient records and allow HCA to test the models independently, said Chris Sakalosky, managing director of healthcare and life sciences at Google Cloud. “We want to push the boundaries of what the clinician can do in real time with data,” he said.
Personal patient information is protected under the federal health-privacy law, known as the Health Insurance Portability and Accountability Act. The law allows hospitals and some other healthcare companies, such as health insurers, to share information with contractors, which must also abide by the law’s privacy protections.
Some consider the federal law outdated, saying the law’s protections haven’t kept pace with the technology sector’s growing demand for patient data, said Michelle Mello, a Stanford University professor of law and medicine who focuses on health-data privacy.
Companies may also use the data under the law in ways to develop products that boost corporate profit, with no visibility or control for patients over how their data is used. “Some people just don’t want their data used in particular ways by particular parties,” said Dr. Mello, who has served as an adviser to Alphabet’s Verily Life Sciences.
Health and technology giants have pushed into healthcare data aggregation and algorithm development with mixed results. International Business Machines Corp. has explored a sale of its IBM Watson Health business, as the company’s healthcare artificial-intelligence unit struggled, The Wall Street Journal reported in February.
Hospitals are uniquely positioned as brokers for data created by patients seeking care and interacting with doctors, laboratories, pharmacies and medical devices. They have increasingly sought to capitalize on that data in deals to aggregate patient records or develop products with pharmaceutical and technology companies. “They aren’t sleeping on this opportunity either,” said Jeffrey Becker, principal analyst for healthcare at CB Insights.
Fourteen hospital systems in February announced a newly formed company, Truveta Inc., to sell access to their anonymized records for patients across 40 states. Other hospitals have invested in health-record analytic companies, such as Health Catalyst Inc., which went public in 2019.
The multiyear HCA-Google agreement will seek to develop algorithms using data from 32 million annual patient visits that could help monitor patients and guide treatment, said Dr. Perlin. During the pandemic, HCA used its own technology to monitor critically ill Covid-19 patients and notify doctors of potentially better treatment options. The company found that survival rates increased by comparing the outcomes for patients before and after rolling out the algorithm.
The companies will also seek to develop algorithms that would help improve operations, Dr. Perlin said, such as by automating how hospital units track inventory of critical supplies.
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https://www.medscape.com/viewarticle/951931
The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the US Food and Drug Administration (FDA) to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.
The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis.
The boxed warning on the label has also been revised to include this information.
For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.
Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA, as reported by Medscape Medical News.
Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.
According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.
PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.
The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.
The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died.
Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.
The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).
Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.
During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.
The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.
Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.
Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.
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in reading this… it may more apply to those folks that get both Medicare disability monies and are also eligible for Medicaid assistance.
https://themighty.com/2021/05/disability-benefits-stimulus-checks-chronic-illness/
When the United States government approved sending stimulus checks to American citizens and residents during the COVID-19 pandemic, many people were relieved. Due to layoffs, cut hours and parents having to leave work to take care of their kids, many people have been struggling.
What was supposed to help Americans is now hurting some members of the disability community. HuffPost reported last week that the stimulus checks have caused some people to lose disability benefits.
Supplemental Security Income recipients are not allowed to have more than $2,000 for one person at a time or $3,000 for a couple. The program also only provides people $794 a month, and it can take years for disabled people to even be approved.
As stimulus checks are counted under tax credits, they should not affect people’s eligibility to receive Supplemental Security Income. “The whole point of stimulus was to help people who were being harmed during COVID, and now there’s going to be people facing a cessation of benefits and they’re going to end up in a worse place,” Michelle Spadafore, senior supervising attorney with the New York Legal Assistance Group, told HuffPost.
The exact number of recipients who lost their disability benefits is unknown. Joseph Morris told HuffPost that he lost his Supplemental Security Income because he had more than $2,000 in his bank account after receiving a stimulus check. HuffPost reported that “starting next month, Social Security will take 10% out of Morris’ monthly benefits until it recoups the several thousand dollars the agency believes it overpaid him last year.” Morris was understandably upset, and he said the following:
You’re going to give me a stimulus check to stimulate the economy, and I can’t go out under doctor’s orders and you’re penalizing me for having this money. Now it’s going to cost me money to have this money.
Grace Kim, an acting assistant deputy commissioner for Social Security, said that the department is looking into this issue, but did not give an estimate of when disabled people who lost their benefits should receive them again.
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There’s a new nontraditional company in town purchasing physician groups: a London-based digital health company.
Babylon, which provides virtual care and health monitoring services, purchased Novato, Calif.-based Meritage Medical Network in April and plans to open a new office in Palo Alto, Calif. Meritage has 700 physicians who are now part of Babylon, which aims to continue its U.S. expansion. Click here to read more about the transaction and Babylon’s strategic plans.
Meritage, an independent practice association, cares for a population of more than 500,000 and has relationships with eight hospitals and other healthcare providers.
This acquisition furthers the trend of nontraditional companies, such as insurers or retailers, employing physicians. Optum, a division of UnitedHealth Group, has the largest physician network in the U.S. with 56,000 affiliated, contracted or employed physicians. The company is on track to reach its goal of adding 10,000 more physicians this year after purchasing the 715-person physician group Atrius Health in Newton, Mass., in March.
In April, Humana purchased Kindred at Home, the largest home health provider in the U.S., for $5.7 billion. It also rebranded its healthcare services arm in March as CenterWell, which includes 90 Conviva primary care clinics.
Walmart and CVS both also have telehealth services as well as brick-and-mortar clinics that employ healthcare providers. Amazon announced plans to broaden its telemedicine program to offer services to large U.S. employers. The nontraditional entrants are focused on bringing primary care physicians into their networks, which are often a big referral source for specialty care and ASC physicians.
As insurers, tech companies and retailers see more opportunities in healthcare, ASCs will be attractive targets as efficiently run healthcare businesses. Optum already has a chain of hundreds of ASCs, as part of Surgical Care Affiliates, and Amazon Care’s services include treatment for back, neck and joint pain.
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The following comments will be submitted to the FDA. I will demonstrate why the Morphine Milligram Equivalent (MME) conversion chart, the main pillar of the CDC 2016 Prescribing Guidelines, is deeply flawed. Hence, all opioid policies are based on MMEs are likewise invalid, yet they continue to be accepted as gospel. The gospel needs to be changed.
Nearly three years ago I wrote how the science behind US opioid policies was deeply flawed, in particular, the use of Morphine Milligram Equivalents (MME) to quantify recommendations, policies, or laws. I argued that any use of MME was automatically flawed because it ignored even the most basic tenets of pharmacology, the absence of which made it impossible to rationally determine the relative strength of one drug to another. Unfortunately, it was just this methodology that became the foundation of the CDC’s catastrophic 2016 publication Prescribing Guideline for Prescribing Opioids and its use has metastasized ever since as one state after another has passed laws limiting the prescribing of opioid analgesic, often based on the Guideline’s erroneous conclusions.
It is not surprising that such a baseless document was created. First, the CDC lacks both the authority and expertise to regulate drugs; that is the function of the FDA. Second, the anti-opioid group Physicians for Responsible Opioid Prescribing (PROP), which also lacks expertise in drugs and pharmacology, has undue influence with the CDC – a relationship that remains nebulous to this day.
It was almost a foregone conclusion that the CDC “recommendations” would become law. Indeed, this is now the case in more than 30 states. Sadly, drug abusers, pain patients, and their physicians have paid a very steep price for this ill-conceived document.
Although it is years too late, it is nonetheless encouraging that the FDA is holding a workshop to examine the fundamental pharmacology of opioids. The deficiencies of the 2016 Guide need to be addressed. Here are my comments.
Can Opioid Drugs Be Directly Compared?
Table 1. Opioid conversion factors. Source: CDC
Table 1 forms the basis of the MME approach. Its basic premise is that different opioid drugs can be quantitatively compared and the data used to establish dosing limits for different drugs. For example, if 90 mg of morphine (90 MME) is set as the upper limit for a daily dose, then the maximum allowable doses for oxycodone and oxymorphone would be 30 mg and 45 mg, respectively. But if the assumptions in the table are incorrect then any use of them to form policy must also be incorrect.
The primary reason that the MME conversion table is inadequate is that it fails to take simple pharmacological principles into account. In order to understand this limitation, we need to examine some of the fundamental principles of pharmacokinetics – the effect of the body on the drug. Arguably, the most important parameter is our individual metabolism. It is critical in determining the fate of a drug once it enters the blood and by extension, the proper dose.
Metabolism
The purpose of metabolism, which occurs almost exclusively in the liver, is to break down and eliminate drugs and other chemicals from the blood – the body’s “detox” system. Metabolism can be subdivided into two distinct phases, based on the type of chemical transformation and the enzymes that are responsible for this transformation.
Phase 1 enzymes are members of the Cytochrome P450 enzymes (CYP family). The function of CYP enzymes is to break down drugs. In contrast, Phase 2 enzymes are not members of the CYP family; they have unique names, such as UGT and SULT, abbreviations for the enzyme carrying out a specific reaction. Phase 2 enzymes don’t break down molecules; they add to them. Although they act in different ways, the primary function of both classes is to facilitate the elimination of drugs.
Phase 1 vs Phase 2 Metabolism
The difference between the first and second phases can be illustrated by examining the metabolic fate of two simple, naturally occurring chemicals. Anisole, (aka methoxybenzene) is one of the essential oils that give licorice its flavor and scent. Phenol (aka hydroxybenzene) has antiseptic and anesthetic properties. Although they are similar in structure – differing only by one carbon atom – the two chemicals are metabolized very differently.
Figure 1. Phase 1 enzymes such as CYP2D6 and CYP3A4 catalyze the oxidation of anisole to phenol. As is common in Phase 1 reactions, a hydroxyl group (green oval) is formed.
Upon consumption, anisole is converted by Cytochrome P450 (CYP) enzymes to phenol (3) as shown in Figure 1. Note the loss of the methyl group, leaving a hydroxyl group (green oval) in its place. As is the case with anisole, Phase 1 metabolism is (normally) an oxidation reaction, in which lipophilic (fat-loving, poorly water-soluble) molecules, are broken into smaller fragments that are more hydrophilic (water-loving and water-soluble). Phase 1 metabolites often contain hydroxyl (OH) or amino (NH2) groups.
Phase 2 metabolism is fundamentally different. Phase 2 enzymes conjugate or add water-solubilizing groups to a drug or its metabolite to facilitate the elimination of the drug in the urine. One example is the sulfation of phenol shown in Figure 2.
Figure 2. Phase 2 metabolism – The PST enzyme catalyzes the conversion of phenol to phenyl sulfate (aka phenol hydrogen sulfate), which is then excreted in the urine.
The hydroxyl group in phenol acts as a chemical “handle” that allows the attachment of a water-solubilizing group, such as sulfate, that plays a critical role in conjugation and elimination. (The abbreviated name of the enzyme that promotes this reaction is PST, short for Phenol SulfoTransferase.)
What Does This Have To Do With Opioid Dosing?
Plenty. This can be seen by examining the structures of oxycodone (Figure 3, Left) and oxymorphone (Right). and their similarity in structure to anisole and phenol, respectively.
Figure 3. Anisole and oxycodone both contain methoxy groups, which makes them substrates for Phase 1 enzymes. Phenol and oxymorphone both contain hydroxyl groups, which makes them substrates for Phase 2 enzymes.
As shown in Figure 3, anisole and oxycodone are structurally similar in that they both contain a benzene ring bearing a methoxy group (shaded blue). This makes them substrates for Phase 1 CYP enzymes (oxidation). In contrast, phenol and oxymorphone are similar in that they both belong to the phenol class – a benzene ring bearing a hydroxyl group (shaded green). The phenyl hydroxyl (phenol) group makes both of these chemicals substrates for Phase 2 enzymes (conjugation/elimination). The second row in Table 2 shows the primary metabolic enzyme(s) for each drug.
Table 2. Three pharmacokinetic parameters of oxymorphone (right) and oxycodone (left). Source: Ref. (a). Ref. (b).
Direct Comparison of Opioid Drugs – the Essence of MME – is Scientifically Unsound
The two opioid drugs at the bottom of Table 1 are metabolized by a different family of enzymes and at a different rate, yet all the CDC table tells us is that one is twice as strong as the other. It’s quite tidy to state that oxycodone is 1.5-times stronger than morphine and that oxymorphone is twice that, but what does this mean? Perhaps this is true in a binding assay or even clinically in some people but the statement is, at best, oversimplified. But the metabolism of each drug is radically different, which affects the amount of drug present in the blood and brain.
Metabolism Isn’t the Only Difference: Bioavailability and half-life
Table 2 shows two other pharmacological parameters, bioavailability, and half-life, which are just as important in determining the properties of drugs.
Bioavailability measures how efficiently an orally administered dose of a drug gets absorbed into the blood. The higher the number the higher the absorption and resulting blood concentrations. Table 2, row 3 shows that the bioavailability of oxycodone (60-87%) is significantly better than oxymorphone (10%).
Half-life (Table 3, row 4) is the amount of time that it takes for the concentration of the drug to decrease by 50%, a function of our metabolism. The half-life of oxycodone is 3-4 times that of oxymorphone, so it stays in the blood much longer.
So, which is a better pill?
The CDC chart says that oxymorphone is three times as strong as morphine, but much less of it gets into the blood and when it does it is metabolized and excreted quickly. Oxycodone is supposed twice the strength of morphine, but is well absorbed and remains in the blood for considerably longer.
The answer is: who knows? But it sure isn’t as simple as what the CDC guideline state – that 300 mg of morphine is equivalent to 100 mg of oxymorphone counts and 150 mg of oxycodone. Convenient? Yes. Accurate? Absolutely not.
Bottom Line
It is incomprehensible that the CDC would put out a series of guidelines without bothering to consider even the most fundamental tenets of pharmacology. But this is what happens when a woefully uninformed group like PROP feeds advice to an equally clueless CDC and lawmakers pick up the baton – a shameful and disastrous chapter in American medical history.
The failure to consider even these simple metabolic differences is a primary reason why the CDC table fails as a useful guide and why the concept of morphine milligram equivalents is scientifically faulty.
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https://ankylosingspondylitis.net/infographic/chronic-pain-impact
In September of 2019, Health Union (the parent company of ankylosingspondylitis.net) partnered with the US Pain Foundation for our first ever Chronic Pain in America survey to ask members of our communities about their experiences with chronic pain and what they wish others knew about their pain. 4,725 people living with chronic pain completed the survey and shared how pain impacts their life, from their work and employment status to changed relationships with family and friends. However, everyone can improve the quality of life most specially if you have enough sleep everyday. But that is only possible if you have these hospital beds of highest quality which are available at SonderCare!
More than 8 in 10 respondents shared that their life has changed significantly as a result of their pain. These life changes have a large impact on quality of life and affect both physical and mental health.
Chronic pain is a constant companion. The levels of pain may vary day to day, but for most, at least some pain is experienced on a daily basis. Back or neck pain was the most common diagnosis, with over 2/3 of respondents having been diagnosed with this. Additionally, 78% of respondents shared that they have experienced pain for at least 5 years.
The short answer is yes. Over 8 in 10 people shared that their life has changed significantly as a result of pain. Chronic pain impacts both physical and mental health and only 24% of respondents stated that they feel control of their life despite their pain.
Unfortunately, for many, a “normal” day is still really painful. Respondents shared that the pain they experience on a normal day makes it difficult to get out of bed in the morning or to do whatever they want to accomplish that day. But for many, they don’t have a choice. They push themselves through the pain daily leaving them exhausted, only to do it all again the next day.
Pain has affected work and career for over 2/3 of people who participated in the survey. On top of that, many reported changed relationships with family or friends and limitations when it comes to new places or spending time with others. All of this has a large impact on quality of life and what they are able to do day to day.
Many respondents shared what they wish they had done sooner or advice that they would give to their former selves about pain. Responses ranged from sharing that they should have asked for help sooner or taken better care of their bodies to wishing that they had better advocated for themselves. When it comes to treatment, some expressed being more assertive about early treatment whereas others wish they had been more patient in finding the right treatment.
The Chronic Pain in America 2019 survey was conducted online from mid-September through mid-October of 2019. 4,725 respondents were recruited from Health Union’s Community channels, as well as the US Pain Foundation’s member touchpoints.
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