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How To Avoid China’s Medicine Monopoly

The AHA! Team — Mon, 29 Jul 2024 08:11:31 +0000

Al Sears, MD, CNS – I want to share a shocking statistic with you… Around 80% of all the pharmaceuticals sold in America — both prescription and over-the-counter — are manufactured in China. I’m talking about drugs for Parkinson’s and Alzheimer’s, blood pressure and blood thinners, diuretics, aspirin, antibiotics, and a big chunk of the world’s insulin and diabetes drugs — just to name a few.1 We don’t even make penicillin anymore. The last penicillin plant in the U.S. closed its doors in 2004. Americans who rely on medicine are now almost entirely at the mercy of a country whose relations with the U.S. have become more tense than they were just a few years ago. Yet, there’s no need to panic. And in a moment, I’ll tell you why… First, let me share why we need to be concerned. Around 80% of all the pharmaceuticals sold in America.. are manufactured in China Pharmaceutical companies can’t just pack up their overseas operations and build drug-making plants in America or move them to some other country. It could take years to develop the infrastructure to re-establish manufacturing capacities in the U.S. and get the FDA licenses to replace the loss of the Chinese supply. But there’s an even bigger problem… Drugs imported from China have additional safety risk factors that go beyond the well-known side effects I’ve written to you about before. The FDA insists that pharmaceutical ingredients from China are safe. But I don’t buy it. The FDA has a long history of failing to oversee drug sources in other countries. In 2008, contaminated supplies of the blood-thinning drug Heparin from China led to the deaths of 149 Americans and hundreds more allergic reactions. Though that scandal prompted the FDA to start stationing inspectors in overseas plants, a recent scathing report by the U.S. Government Accountability Office highlighted the FDA’s long history of failing to conduct oversight on foreign drug factories.2 The reason the FDA had little chance to uncover the heparin contamination before Americans started dying: It hadn’t inspected the plant. Even now, the FDA is plagued by a staffing shortage. In China and India, there are just 15 combined inspector positions – and five of those remain unfilled. That’s less than 10 inspectors to oversee 5,000 Chinese drug-making facilities.3 If you’re a regular reader, you’ll know I’ve been warning patients for years about the dangers of Big Pharma’s concoctions. At my clinic, I work to get my patients off prescription drugs. I prescribe pharmaceuticals only when absolutely necessary. Blockbuster drugs like statins, ACE inhibitors, beta-blockers, bisphosphonates, and antidepressants — all made in China — can often create new and dangerous health issues and can make recovery impossible. Mainstream medicine wants to scare you into thinking you need these drugs to keep you alive and healthy. In fact, in many cases, the opposite is true. But here’s the secret Big Pharma and its Chinese partners don’t want you to know: For every disease — and every Big Pharma drug — nature has provided a natural, non-toxic non-pharmaceutical alternative that’s free from side effects. Develop your own medical supply chain I recommend that you become the master of your own “medical” supply chain – so you’ll no longer be at the mercy of Big Pharma, China, and an unreliable FDA. The natural alternatives and therapies I’m going to tell you about are much safer, often more effective, and cost much less than any drug from Big Pharma or its Chinese manufacturers. Here are some alternatives to some of Big Pharma’s biggest blockbuster drugs: Blood thinners. Studies also show that warfarin increases your risk of stroke, atherosclerosis, and osteoporosis. One study estimated that nursing home residents alone suffer 34,000 fatal, life-threatening, or serious events related to warfarin every year.4 Natural alternative – curcumin. You know this spice has potent anti-inflammatory, antioxidant, antibacterial, and anti-cancer properties. But recent studies show it’s also a powerful anticoagulant, working to inhibit clotting factors and prevent blood clots from forming. Choose a supplement with at least 90% curcuminoids. And look for one that contains piperine, a black pepper extract that boosts absorption. Take between 500 mg to 1,000 mg each day. Arthritis drugs. NSAIDs increase your risk of heart attack and stroke after just one week of consistent use. And the more you use them, the more your risk goes up.5 Natural alternative – frankincense: Also known as Boswellia serrata, this herb has a long history of treating arthritis without side effects. In a large study, researchers followed 440 arthritis patients for six months. They found that frankincense relieved pain as effectively as painkiller drugs. It also significantly improved arthritic knee function.6 Frankincense contains enzymes that block prostaglandin e2 (PGe2). This hormone-like chemical is produced by the body in response to an injury. It makes blood vessels dilate and expand. This causes the injured area to become swollen and arthritic. By directly attacking PGe2, frankincense stops inflammation before it starts. Look for a Boswellia serrata supplement standardized to at least 65% boswellic acids. I recommend 400 mg three times a day. Blood pressure pills. Diuretics, beta-blockers, ACE inhibitors, and calcium channel blockers have serious side effects. I’m talking about things like edema, dizziness, nose bleeds, rash, and hearing loss. They can lead to cardiac failure, heart attack, depression, colitis, and arthritis pain. Natural alternative – magnesium: This is your body’s own blood vessel relaxer. I’ve used it in my practice with great results. It helps balance potassium, sodium, and calcium, all of which affect blood pressure. In a review of 34 studies covering more than 2,000 patients, researchers found that taking magnesium daily for one month lowered systolic pressure by 2 mmHg and diastolic pressure by 1.8 mmHg.7 I recommend between 600 mg and 1,000 mg a day. Take it with vitamin B6. It will increase the amount of magnesium that accumulates in your cells. To Your Good Health, Al Sears, MD, CNS References: 1. Ewen M, et al. “A perspective on global access to insulin: a descriptive study of the market, trade flows and prices.” Diabet Med. 2019;36(6):726-733. 2. Denigan-Macauley M. Drug Safety: Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections. GOA report December 2019. Accessed March 17, 2023. 3. “Comparing Global Pharmaceutical Markets, the US, UK, and China.” February 2023. https://pharmanewsintel.com/features/comparing-global-pharmaceutical-markets-the-us-uk-and-china#:~:text=Currently%2C%20the%20Chinese%20pharmaceutical%20sector,according%20to%20a%20Forbes%20ranking. Accessed March 17, 2023. 4. Gurwitz JH, et al. “The safety of warfarin therapy in the nursing home setting.” Am J Med. 2007;120:539-544. 5. Harvard Health Publishing. FDA strengthens warning that NSAIDs increase heart attack and stroke risk. https://www.health.harvard.edu/blog/fda-strengthenswarning- that-NSAIDs-increase-heart-attack-and-stroke-risk-201507138138. Updated August 22, 2017. Accessed March 17, 2023. 6. Chopra A, et al. “Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: A randomized, double-blind, controlled equivalence drug trial.” Rheumatology (Oxford). 2013;52(8):1408-1417. 7. Zhang X, et al. “Effects of magnesium supplementation on blood pressure: A meta-analysis of randomized double-blind placebo-controlled trials.” Hypertension. 2016;68(2):324-333. To read the original article click here.

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Has Israel Just Found the Cure for Covid?

AHA Publisher — Tue, 09 Feb 2021 08:00:39 +0000

Abigail Klein Leichman via Israel21c – Even with Israel’s world-leading rollout of Covid-19 vaccinations, drugs to treat Covid patients are in desperate need across the world. Two such drugs developed in Israel show great promise in clinical trials: EXO-CD24 and Allocetra. EXO-CD24, an experimental inhaled medication developed at Tel Aviv Sourasky Medical Center, cured all 30 moderate-to-severe cases in a Phase I clinical trial. Developed over the past six months at the hospital, EXOCD24 stops the “cytokine storm” – where the immune system goes out of control and starts attacking healthy cells – that occurs in the lungs of 5-7% of Covid-19 patients. “To date, the preparation has been tried with great success on 30 severe patients, in 29 of whom the medical condition improved within two to three days and most of them were discharged home within three to five days. The 30th patient also recovered but after a longer time,” the hospital reports. “The drug is based on exosomes, [vesicles] that are released from the cell membrane and used for intercellular communication. We enrich the exosomes with 24CD protein. This protein is expressed on the surface of the cell and has a known and important role in regulating the immune system,” explained Dr. Shiran Shapira, director of the laboratory of Prof. Nadir Arber, who has been researching the CD24 protein for over two decades. “The preparation is given by inhalation, once a day, for only a few minutes, for five days,” Shapira said. She said the experimental treatment has two unique characteristics. The first is that it inhibits the over-secretion of cytokines. The second is that it is delivered directly to the lungs and therefore has no systemic side effects that injected or oral drugs can cause. “Even if the vaccines perform their function, and even if no new mutations are produced then still in one way or another the corona will remain with us,” said Arber, director of the medical center’s Integrated Cancer Prevention Center. “To this end, we have developed a unique drug, EXO-CD24.” Arber added that this advanced preparation “can be produced quickly and efficiently and at a very low cost in every pharmaceutical facility in the country, and in a short time globally.” Prof. Ronni Gamzu, CEO of the medical center, said, “Prof. Arber’s results for first-phase research were excellent and gave us all confidence in the method he has been researching [here] for many years. I personally assisted him in further obtaining the approvals from the Ministry of Health for further research.” Allocetra Meanwhile, Enlivex Therapeutics last week reported positive results from a multi-center Phase II clinical trial of its experimental Covid-19 immunotherapy drug Allocetra in severe and critical Covid-19 patients. We reported in October that five Covid-19 intensive care patients were discharged from Hadassah University Medical Center in Jerusalem after treatment with Allocetra. Nine severe and seven critical Covid-19 patients were treated with Allocetra in the Phase II clinical trial. Fourteen of them recovered and were discharged from the hospital after an average of 5.3 days. The Phase II trial originally was expected to enroll 24 patients but was “completed early in support of anticipated accelerated regulatory filings of the trial’s positive safety and efficacy data,” Enlivex reported. Altogether, 19 out of 21 Phase II and Phase Ib Allocetra trial patients recovered and were discharged from the hospital after an average of 5.6 days. Most of the patients in both studies had pre-existing risk factors such as male gender, obesity and hypertension. “The results we have seen from the 12 Covid-19 patients treated to date with Allocetra are exciting,” said Prof. Vernon van Heerden, head of the General Intensive Care Unit at Hadassah and the lead investigator of both clinical trials. “The Phase II patients who have been discharged from the hospital are currently healthy. We believe that these compelling results have demonstrated the safety and efficacy of Allocetra in these complicated patients, highlighting the potential of Enlivex’s product candidate to benefit severe and critical Covid-19 patients as well as others suffering from cytokine storms and organ dysfunctions across various clinical indications.” Allocetra is based on the research of Enlivex chief scientific and medical officer Dr. Dror Mevorach, head of internal medicine and of one of Hadassah’s coronavirus wards. It works by restoring balance to the immune system. Mevorach said Allocetra “may have utility as a safe and efficacious treatment … regardless of the specific coronavirus mutation that afflicted the patients, and across different life-threatening, high mortality clinical indications with high unmet medical needs.” To read the original article click here. For more articles from Israel21c click here.

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One New Drug May Treat Both Covid-19 and Alzheimer’s

AHA Publisher — Sat, 27 Jun 2020 07:00:05 +0000

Abigail Klein Leichman via Israel21c – Israeli-born Harvard professor’s investigational therapy suppresses immune system’s overproduction of proteins that trigger inflammation. “By the age of 80, one in three people develops Alzheimer’s. I’m trying to move the curve to 85 or 90 or maybe beyond.” A novel Alzheimer’s disease treatment now in advanced Phase 3 clinical trials could also prove effective in treating lung inflammation caused by Covid-19. The investigational therapy, ALZT-OP1, suppresses the immune system’s production of cytokines — proteins that trigger inflammation in a natural response to infection. A “cytokine storm” caused by an overzealous immune response plays a role in neuroinflammatory diseases such as Alzheimer’s, and in infectious diseases such as Covid-19 and influenza. “When we have too much virus in our lungs, our immune system starts reacting by activating cytokines to bombard the virus,” explains Israeli-born Harvard Medical School associate professor and serial medical entrepreneur David Elmaleh, scientific founder and CEO of AZTherapies. “But the number of cytokinesis is so high it causes inflammation of the lung and that can be dangerous. Our drug would slow the cytokine release and allow other treatments to work,” he tells ISRAEL21c. AZTherapies was founded in 2011 with $2 million from some of Elmaleh’s previous Israeli investors. The startup has now raised over $100 million and is building collaborations with Israeli institutions to commercialize the treatment after its expected FDA approval next year. Learning from Mistakes Elmaleh began by examining why previous Alzheimer’s drug candidates failed. Most of them attempted to prevent or dissolve the amyloid-beta plaques long thought to be the primary cause of disease. He saw three main problems plaguing the failed trials: too wide an age range of patients; too narrow a focus on one mechanism of treatment; and toxicity from prolonged drug exposure. Elmaleh’s approach is limited to people in the first stages of the disease and utilizes four treatment mechanisms. ALZT-OP1 is a proprietary mixture of a bit of ibuprofen (to treat inflammation) and cromolyn, originally an asthma drug. “Cromolyn doesn’t work the way it was approved because in asthma treatment it goes only into the upper lung,” Elmaleh explains. “I reengineered it to go into the deeper lung.” AZTherapies has more than 100 patents and patent applications on the formulation and the delivery method to get the drug across the blood-brain barrier. “Although it uses two existing drugs, it’s like a new drug and needs its own approval,” says Elmaleh. Phase 3 Clinical Trials For its advanced randomized clinical trials, AZTherapies identified participants based on cognition, function tests and brain pathology assessed by Alzheimer’s biomarkers in spinal fluid. “We screened 1,753 people in North America and Europe, and from that we got 620 subjects with the biomarkers that indicate early Alzheimer’s,” Elmaleh says. Of those 620, 589 completed 24 weeks of treatment, 492 completed 48 weeks of treatment, and 380 completed the whole 72-week study cycle. “We wanted to see if we are really modifying the path of the disease. We will unblind the study at the end of this year and then we’ll know how successful we are,” says Elmaleh. “We already know that giving our drug for a year and half is safe. That’s a very important issue because in the brain you have to treat disease for several years, unlike cancer.” He stresses that ALZT-OP1 is not a cure. Its goal is to keep early-stage patients disease-free for a longer period by slowing cytokine release. “By the age of 80, one in three people develops Alzheimer’s. I’m trying to move the curve to 85 or 90 or maybe beyond,” says Elmaleh. Covid-19 Trials Meanwhile, the novel coronavirus pandemic hit the world and Elmaleh believed ALZT-OP1 could help patients with associated breathing distress caused by a cytokine storm. AZTherapies prepared a clinical trial protocol for the FDA and has approached several European countries and Israeli hospitals about trying its drug candidate on Covid-19 patients. Elmaleh has an impressive track record: several previous startups (among them Molecular Insight and Puretech Health) led to treatments representing more than a billion dollars in shareholder value. One of his inventions is FDG, the radionuclide used in PET scans. He was named one of “Biotech’s Most Enterprising Entrepreneurs” in Genetic Engineering & Biotechnology News in 2014. Elmaleh was raised in the 1960s in Musrara (Morasha), then a neglected neighborhood of North African immigrants on the then-dangerous seam between the east and west sides of Jerusalem. In 1971, the same year Elmaleh received his PhD in organic chemistry from the Hebrew University of Jerusalem, many of his childhood peers established the Israeli Black Panthers, one of Israel’s first effective movements for social and economic justice. Elmaleh made a different kind of history by becoming the first Musrara resident to do post-doc studies at Harvard. He remained there, raising his family in Boston and finding success in academia and entrepreneurship. Thanks to Elmaleh’s affiliations with Harvard and Massachusetts General Hospital, AZTherapies has an all-star lineup of scientific and business advisers from these institutions. He tells ISRAEL21c that AZTherapies’ approach to neuroinflammation is also being studied by other pharma companies. “Others are now looking at the same things as us, but we are ahead of everyone else and we’ll be the first to market,” he predicts. To read the original article click here. For more articles from Israel21c click here.

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Dozens of Potential Anti-Cancer Drugs Netted in Massive Screening Study

AHA Publisher — Sun, 02 Feb 2020 08:00:16 +0000

Dana-Farber Cancer Institute via Newswise – A variety of existing drugs for treating conditions such as diabetes, inflammation, alcohol abuse, and arthritis in dogs can also kill cancer cells in the lab, according to a study by scientists at Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard. Newswise — BOSTON – Nearly 50 existing non-cancer drugs were found to kill some cancer cell lines in the lab and researchers were surprised at the high yield of compounds active against cancer cells. Some of the compounds might in due course be tested in clinical trials, while others could help jump-start new drug development. Scientists reported their findings in the new journal Nature Cancer, saying they found an “unexpectedly high rate of anti-cancer activity” among 4,518 drugs that were tested against 578 laboratory cancer cell lines spanning 24 tumor types. Most of the drugs tested were not originally developed or used in oncology (cancer treatment). Using a massive search strategy designed to identify drugs that could be repurposed as cancer treatments or as candidates for cancer drug development, the scientists identified 49 non-cancer drugs that selectively killed cancer cells and whose activity against cancer could be predicted using molecular biomarkers. They reported that another 103 compounds with less selectivity against the cancer cell lines were also identified. “It is conceivable that some non-oncology drugs could be brought directly to clinical trials for testing in cancer patients,” said the authors, led by Steven Corsello, MD, of Dana-Farber, the study’s first author and the founder of the Broad’s Drug Repurposing Hub. However, they said, it is likely that the potential drug candidates will require further study and modification before being introduced into clinical studies. “We thought we’d be lucky if we found even a single compound with anti-cancer properties, but we were surprised to find so many,” said Todd Golub, MD, chief scientific officer and director of the Cancer Program at the Broad, Charles A. Dana Investigator in Human Cancer Genetics at Dana-Farber, and professor of pediatrics at Harvard Medical School. The new work is the largest study yet to employ the Broad’s Drug Repurposing Hub, a collection that currently comprises more than 6,000 existing drugs and compounds that are either FDA-approved or have been proven safe in clinical trials (at the time of the study, the Hub contained 4,518 drugs). The study also marks the first-time researchers screened the entire collection of mostly non-cancer drugs for their anti-cancer capabilities. Some of the compounds killed cancer cells in unexpected ways. “Most existing cancer drugs work by blocking proteins, but we’re finding that compounds can act through other mechanisms,” said Corsello. Some of the four-dozen drugs he and his colleagues identified appear to act not by inhibiting a protein but by activating a protein or stabilizing a protein-protein interaction. For example, the team found that nearly a dozen non-oncology drugs killed cancer cells that express a protein called PDE3A by stabilizing the interaction between PDE3A and another protein called SLFN12 — a previously unknown mechanism for some of these drugs. Most of the non-oncology drugs that killed cancer cells in the study did so by interacting with a previously unrecognized molecular target. For example, the anti-inflammatory drug tepoxalin, originally developed for use in people but approved for treating osteoarthritis in dogs, killed cancer cells by hitting an unknown target in cells that overexpress the protein MDR1, which commonly drives resistance to chemotherapy drugs. The researchers were also able to predict whether certain drugs could kill each cell line by looking at the cell line’s genomic features, such as mutations and methylation levels, which were included in the CCLE database. This suggests that these features could one day be used as biomarkers to identify patients who will most likely benefit from certain drugs. For example, the alcohol dependence drug disulfiram (Antabuse) killed cell lines carrying mutations that cause depletion of metallothionein proteins. Compounds containing vanadium, originally developed to treat diabetes, killed cancer cells that expressed the sulfate transporter SLC26A2. The observations in the study may represent starting points for new drug development. “The genomic features gave us some initial hypotheses about how the drugs could be acting, which we can then take back to study in the lab,” said Corsello. “Our understanding of how these drugs kill cancer cells gives us a starting point for developing new therapies.” This collaboration involved the Broad’s Center for the Development of Therapeutics, the PRISM team, the Cancer Data Sciences team, and the labs of Todd Golub and Matthew Meyerson, MD, PhD, of Dana-Farber and the Broad. The work was funded in part by SIGMA (Carlos Slim Foundation, Slim Initiative in Genomic Medicine for the Americas), the National Institutes of Health, the Conquer Cancer Foundation (Conquer Cancer Foundation of the American Society of Clinical Oncology), and the Next Generation Fund at the Broad Institute of MIT and Harvard. To read the original article click here.

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Study Shows How Sewage Plants Can Remove Pharmaceuticals from Wastewater

AHA Publisher — Tue, 14 Jan 2020 08:00:22 +0000

University at Buffalo via News-Medical Net – A study of seven wastewater treatment plants in the Eastern United States reveals a mixed record when it comes to removing medicines such as antibiotics and antidepressants. The research points to two treatment methods — granular activated carbon and ozonation — as being particularly promising. Each technique reduced the concentration of a number of pharmaceuticals, including certain antidepressants and antibiotics, in water by more than 95%, the scientists’ analysis found. Activated sludge, a common treatment process that uses microorganisms to break down organic contaminants, serves an important purpose in wastewater treatment but was much less effective at destroying persistent drugs such as antidepressants and antibiotics. “The take-home message here is that we could actually remove most of the pharmaceuticals we studied. That’s the good news. If you really want clean water, there are multiple ways to do it.” Diana Aga, PhD, Henry M. Woodburn Professor of Chemistry, University at Buffalo College of Arts and Sciences “However, for plants that rely on activated sludge only, more advanced treatment like granular activated carbon and/or ozonation may be needed,” Aga adds. “Some cities are already doing this, but it can be expensive.” The findings are important because any drugs discharged from treatment plants can enter the environment, where they may contribute to phenomena such as antibiotic resistance, or be consumed by wildlife. “Our research adds to a growing body of work showing that advanced treatment methods, including ozonation and activated carbon, can be very effective at removing persistent pharmaceuticals from wastewater,” says Anne McElroy, PhD, Professor and Associate Dean for Research in the Stony Brook University School of Marine and Atmospheric Sciences. The study — funded by New York Sea Grant — was published in November in the journal Environmental Science: Water Research & Technology. Aga and McElroy led the project, with UB chemistry PhD student Luisa Angeles as first author. The paper was a partnership between researchers at UB, Stony Brook University, the Hampton Roads Sanitation District and Hazen and Sawyer, a national water engineering firm that designs advanced wastewater treatment systems, including some of the systems studied. The research analyzed a variety of technologies in use at seven wastewater treatment plants in the Eastern U.S., including six full-scale plants and one large pilot-scale plant. According to the paper, “more precise locations are not provided in order to protect the identity” of the facilities. Angeles says the study’s findings could guide future decision-making, especially in areas where water is scarce and in cities that may want to recycle wastewater, converting it into drinking water. The research is also important for environmental conservation. It demonstrated that larval zebrafish did not change their behavior when they were exposed to wastewater discharged from treatment plants. However, much more work is needed to understand how longer-term exposures may impact wildlife, Aga says. In a separate study in 2017, Aga’s team found high concentrations of antidepressants or the metabolized remnants of those drugs in the brains of numerous fish in the Niagara River, part of the Great Lakes region. Scientists still don’t fully understand the behavioral and ecological impacts that may occur when chemicals from human medicines build up in wild animals over time, Aga says. Though wastewater treatment plants were historically designed and operated for purposes such as removing organic matter and nitrogen from used water, the new research and other prior studies demonstrate that these facilities could also be harnessed to remove different classes of medicines. To read the original article click here.

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