Search This Blog

Saturday, November 30, 2019

China to use drug bulk-buy program to close price gap

China will use its national drug bulk-buy scheme to lower the price of drugs currently sold at higher prices compared with other markets, it said in an official statement.

The move could force international drugmakers to further cut prices and enable copycat medicines to replace imported off-patent brands at faster pace.
Many branded versions of drugs are currently more expensive in China than in other major markets. They could now be subjected to a centralised procurement program where manufacturers will have to go through a bidding process to get the right to supply drugs to public hospitals, the National Health Commission said in a document published on late Friday.
The bulk-buy program, which currently covers 25 types of medicines, allows no more than three successful bidders access to China’s public hospitals, where most Chinese people buy their drugs.
The program caused the price of some drugs to plunge more than 90% when it was introduced last year in some cities, state news agency Xinhua said.
Multinational drugmakers usually cut the price of drugs when they go off-patent and face competition from generic versions, but such price drops were slow to happen in China, partially because many local drugmakers were unable to develop high-quality generic drugs to compete with off-patent branded drugs.
In the first round of nationwide implement of the program, in September, multinationals including Sanofi and Eli Lilly managed to cut some prices low enough to levels close to those offered by local generic makers.
Beijing will strengthen its monitoring of overseas drug market and collect global prices for imported medicines, Friday’s guideline said.
The government is leveraging its large patient population to push non-domestic drugs companies to cut prices to their lowest level globally.
Most foreign drugmakers offered Beijing the lowest prices globally in a recent round of negotiations in order to get some of their new products included in national insurance program, a move that will help them gain access to more patients in less-affluent cities, officials said on Thursday.
Posted by at No comments:

Telemedicine growth follows ‘Anywhere to Anywhere’ rule at VA

The Veterans Affairs Department reported significant telemedicine growth for fiscal 2019, the first full year since implementing a policy that lifted state licensing requirements for VA providers practicing virtual care.
State licensing restrictions have posed a challenge for telemedicine adoption nationwide, and some have suggested the VA’s policy could be a first step toward thinking about a national medical practice licensing concept.
More than 900,000 veterans used VA telemedicine services in fiscal 2019, up 17% from the previous year, the VA said Friday.
“VA is committed to offering veterans the healthcare they deserve, whenever and wherever they need it,” VA Secretary Robert Wilkie said in a statement.
Growing use of telemedicine among veterans is reflective of the U.S. population at large.
The VA has offered telemedicine services for years, said Dr. Ron Moody, chief medical officer at consulting firm Accenture’s federal services division, though that historically involved connecting clinicians and patients in one facility to clinicians in another facility. Most of the VA’s recent growth has come from its push to serve patients at home, outside of a hospital or clinic, he said.
That’s in part as a result of recent policy changes at the VA, which have allowed the agency to cut across some of the regulatory barriers hindering increased telemedicine adoption in the private sector.
State licensing requirements have posed a major hurdle for many healthcare organizations, according to a 2017 survey conducted by law firm Foley & Lardner. State-by-state licensing often means that a physician practicing in one state can’t conduct a video visit with a patient located in another state.
Those licensing restrictions have made it “very complicated” for national and regional health systems to roll out telemedicine programs, since not all of the system’s providers will be eligible to provide care for each of the system’s patients, said Dr. Kevin Vigilante, executive vice president at consulting firm Booz Allen Hamilton.
That’s something the VA has been able to bypass through a federal rule finalized in May 2018, which overruled requirements for state licensing—allowing VA physicians and nurses to administer care to veterans via telemedicine across state borders.
The rule’s helped the agency to make telehealth as “effective as possible,” said Alex Lennox-Miller, a senior analyst with market research firm Chilmark Research.
That not only alleviates barriers for patients seeking input from specialists out-of-state, but also helps the VA to “balance resources,” Vigilante said, focusing on having an appropriate amount of providers who can use telemedicine to serve the VA’s patient population, without regard for their location.
The VA plans to make all primary-care and mental-healthcare providers available to deliver care to patients in person and via telemedicine by the end of fiscal 2020.
The 2018 rule was part of an initiative the VA calls “Anywhere to Anywhere,” which the agency unveiled in 2017 during Dr. David Shulkin’s tenure as VA secretary. The rule, which the VA proposed in late 2017, was finalized in May 2018 after Wilkie assumed the VA secretary role in an acting capacity.
“This new rule is critical to VA’s ‘Anywhere to Anywhere’ initiative,” Wilkie said at the time. “Now that the rule has been finalized, VA providers and patients can start enjoying the full benefits of VA’s telehealth services.”
The “Anywhere to Anywhere” program applies to any telemedicine services that veterans access, whether at a VA facility, online through a website or through VA Video Connect, a telemedicine app the VA began rolling out in 2017. Through the app, veterans can schedule video appointments and message their providers.
More than 99,000 veterans used the VA Video Connect app in fiscal 2019 to complete roughly 294,000 video sessions, more than two-thirds of which were for mental healthcare, the VA said.
The VA did not share the top specialty or use case for its telemedicine services overall and didn’t respond to a request for comment on its telemedicine services.
With private-sector hurdles like state regulation accounted for, ensuring that veterans are in areas with the broadband infrastructure needed to complete high-quality telemedicine visits is the main challenge that remains for the VA to tackle, Lennox-Miller said.
Nearly one-quarter of veterans live in rural regions, according to findings that the U.S. Census Bureau released in 2017. And roughly 31% of rural residents lack access to wired broadband that meets the Federal Communications Commission’s speed benchmark, according to a 2018 FCC report.
That’s something the FCC is working to address through the Connected Care Pilot, a $100 million pilot program the agency has proposed to promote telemedicine services. The program would support a limited number of projects to help “defray” the broadband costs of bringing telemedicine to low-income Americans and veterans.
“That’s the single biggest barrier,” Lennox-Miller said of the dearth of high-speed internet in rural areas.
Posted by at No comments:

Antiarrhythmic Drug Response My Be Affected by Obesity

New research suggests that obesity may reduce response to sodium channel blocker antiarrhythmic drugs for atrial fibrillation (AFib).
The researchers, publishing in JAMA Cardiology, explained that “the association between obesity, an established risk factor for AFib, and response to antiarrhythmic drugs remains unclear,” and sought to determine whether obesity mediated response to antiarrhythmic drugs in those with symptomatic AFib, and in mice with diet-induced obesity and pacing-induced AFib.
The observational study included 311 patients enrolled in a clinical registry, as well as mice fed a high-fat diet for 1- weeks. The researchers defined  a symptomatic response as the continuation of the same antiarrhythmic drug for at least three months, with nonresponse defined as the discontinuation of the drug therapy withing three months of initiation due to poor symptomatic control of AFib that necessitates alternative rhythm control therapy. They defined outcomes measure in the mice as pacing-induced AFib and suppression of AFib after two weeks of treatment with flecaninide acetate or sotalol hydrochloride.
According to the study results, nonresponse to class I antiarrhythmic drugs in obese patients was less than those without obesity (30% vs. 6%, respectively; difference= 0.24; 95% CI, 0.11 to 0.37; P=0.001). The researchers reported that both groups showed similar symptomatic response to potassium channel blocker antiarrhythmic drugs. After multivariate analysis, obesity, arrhythmic drug (class I vs. III, P=0.001), female vs. male sex (P=0.03), and hyperthyroidism (P=0.02) were significant indicators of likelihood of nonresponse to antiarrhythmic drugs. In the mouse arm, pacing-induced AFib occurred in 100% of the mice with diet-induced obesity vs. controls (P<0.001), and there was a greater reduction in AFib burden within the group treated with sotalol compared with flecaninide (P<0.01).
“This is the first time anyone has shown that there is a differential response to antiarrhythmic drugs for AFib,” senior author Dr. Dawood Darbar, professor and head of cardiology at the University of Chicago College of Medicine, said in a press release. “As 50% of the patients in our AFib Registry are obese, this provided us with a unique opportunity to determine whether obesity affected response to drug treatment for AFib. Our study provides new information that physicians can use to guide their decisions for obese patients with AFib.”
Posted by at No comments:

Some brain-boost supplements contain unapproved drug that could harm users

Promising to lift brain fog or improve memory, brain-boosting supplements have joined sexual-enhancement and weight-loss remedies in the lightly regulated world of dietary supplements. These products may be sold legally with broad-brush come-ons like these, as long as they don’t make specific claims about treating a disease — or contain actual drugs.
New research led by Dr. Pieter Cohen of Harvard Medical School documents five supplement brands for sale in the U.S. that contain various amounts of piracetam, a drug prescribed in European countries for cognitive impairment in dementia but not approved in the U.S.
The Food and Drug Administration doesn’t allow piracetam to be sold as a dietary supplement and has issued warning letters in the past to other companies marketing supplements that contain it. Though the drug is approved in Europe, evidence for using piracetam to improve cognition was “inadequate,” a Cochrane Review analyzing 24 studies that enrolled more than 11,000 patients concluded in 2012.
Cohen and his colleagues reported in JAMA Internal Medicine on Monday that piracetam is listed as an ingredient on the labels of five supplements for sale online. Relentless Improvement, Nootropics, and Specialty Pharmacy sold their products as piracetam. BPS named its supplement Compel, and Cognitive Nutrition called its NeuroPill but included piracetam on the label.
“It seems kind of bold to put a non-approved substance on the label,” said Dr. David Seres, associate professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center, who was not involved in the study. “It’s horrifying but not terribly surprising.”
Side effects of piracetam include agitation, anxiety, and depression, but that’s when prescribed at a standard dose of the drug, whose mechanism of action was described in one research paper as “an enigma.” In Europe, older patients tend to be prescribed lower doses, Cohen said, to account for reduced kidney function that comes with age. That could be a concern for an older person seeking help with memory problems.
Cohen, who also practices internal medicine at Cambridge Health Alliance, worries that consumers could be taking a drug under no medical supervision at a dangerous dosage. In the study, Cohen’s team found wide variation in how much piracetam a person could be ingesting. “You just do not know from day to day if you’re getting zero of a drug or if you’re getting an amount that is more than a prescription.”
“It seems like this is a case where the FDA knows that something’s not permitted,” Cohen said. “They know it’s still on sale and they haven’t used their full enforcement power, nor have they informed the public that this is out there and should be avoided.”
Companies can start selling dietary supplements without notifying the FDA. But under the Dietary Supplement Health and Education Act, the FDA can take action if products are unsafe or misbranded. Marketing messages can’t claim the supplements treat Alzheimer’s disease, for example, nor can they contain unsafe ingredients. If they purport to treat, diagnose, prevent, or cure disease, the FDA can send warning letters or remove the products from the market.
These actions can seem like a game of whack-a-mole in the $46 billion arena of supplements, which has ballooned from 4,000 products in 1994 to as many as 80,000 products in the 25 years since Congress passed the dietary supplement law. In general, the FDA does not comment on individual studies like Cohen’s, spokeswoman Lindsay Haake told STAT, but it does step in for certain cases.
“The FDA prioritizes its actions based on available resources and the level of safety concern identified,” she said in a statement. “The agency faces the challenge of having limited resources to monitor the marketplace for potentially harmful, or otherwise unlawful, dietary supplements.”
The Council for Responsible Nutrition, an industry group that represents makers of dietary supplements, took a dim view of the small sample size in Cohen’s paper — “out of the entire internet, he was only able to find five products” — but agreed with him on the need for more enforcement of current law.
“We think there is more the FDA can be doing,” said Steve Mister, president of the trade group. “There are tools the agency has that it is simply not using as aggressively as it should.”
Change may be coming. In its 2020 budget, the FDA has proposed requiring supplement makers and distributors to list with the FDA all products marketed as dietary supplements. The FDA would then know when new products are introduced and take action against dangerous or otherwise illegal ones, Haake said.
Until then, Seres of Columbia has some advice.
“Eat a well-balanced diet,” he said. “And unless a health care professional suggests to you that you are deficient in any substance, perhaps consider that these may not be of benefit to you.”
Posted by at No comments:

TB could be conquered by common painkillers

Aspirin could be used to treat the world’s deadliest infectious disease, according to new research conducted by Dr. Elinor Hortle at the Centenary Institute in Sydney.
Tuberculosis—which affects a third of the global population—currently kills two million people every year. The spread of multi-drug resistant strains mean antibiotics are becoming less effective.
To find new treatment options, Elinor infected zebrafish with a close relative of tuberculosis to determine how the deadly bacterium survives within its host.
Her research showed that platelets—the cells which form blood clots—interact with the bacteria, helping them evade the host’s .
“What this means is that we can use cheap, safe anti-platelet drugs like Aspirin to block this interaction, and to stop the bacteria from growing,” she says.
Her research showed that zebrafish treated with aspirin or other anti-platelet drugs had half the bacterial growth of untreated fish. This is the first time that platelets have been linked to a direct effect on bacterial growth in an .
“What’s exciting is that this finding has prompted other researchers to look back into hospital records of people who had TB,” Elinor says.
“They show that patients who took  while they were infected had better outcomes that those who didn’t. That’s a really good sign that what we’ve found in the fish might also be true in people.”
She adds that further research is needed to determine whether the same outcomes will be seen in humans.
Explore further
Posted by at No comments:

High-fat diet fuels prostate cancer progression, apes key cancer alteration

What molecular event happens for prostate cancer to progress faster and to be deadlier when patients eat a high-fat diet? This is the question Dr. David P. Labbé, a scientist at the Research Institute of the McGill University Health Centre (RI-MUHC), and his colleagues recently elucidated. In a study published in Nature Communications, they showed that saturated fat intake induces a cellular reprogramming that is associated with prostate cancer progression and lethality. These findings could have a clinical utility in identifying patients at higher risk of a more aggressive, lethal disease. In addition, they suggest that dietary intervention involving the reduction of animal fat, and specifically saturated fat consumption in men with early-stage prostate cancer, could possibly diminish or delay the risk of disease progression.
Some genes—called oncogenes—play a role in cancer initiation and progression. MYC is one of those.
“In this paper, we showed that by mimicking a MYC overexpression, saturated fat intake makes prostate cancer worse,” says Dr. Labbé, who started this study at the Dana-Farber Cancer Institute in the United States, under the supervision of Dr. Myles A. Brown, Director of the Center for Functional Cancer Epigenetics and Emil Frei III Professor of Medicine at Harvard Medical School.
“MYC overexpression profoundly rewires cellular programs and bolsters a distinctive transcriptional signature. MYC is a key factor in tumorigenesis, i.e. it induces malignant properties in  and fuels the growth of cancer cells,” adds Dr. Labbé, who is also assistant professor in the Department of Surgery, Division of Urology at McGill University.
Based on answers to validated food frequency questionnaires obtained from the Health Professionals Follow-Up Study and the Physician Health Study cohorts, researchers were able to stratify prostate cancer patients based on their fat intake— vs. low-fat diet—and the type of fat they were eating—either saturated, monounsaturated or polyunsaturated fat. By integrating dietary and  from 319 patients, researchers discovered that animal fat and specifically saturated fat consumption mimicked a MYC overexpression. They validated their findings in vivo using a murine prostate cancer model.
Strikingly, patients who had the highest level of the saturated fat intake (SFI) MYC signature were four times more likely to die from prostate cancer, compared to patients with the lowest level, independently of the patient’s age or year at diagnosis. Even after adjusting the results for cancer Gleason grade—an indicator of the aggressiveness of the disease—this association remained significative.
Since fat consumption could be linked to an increase in body fat and obesity, and since obesity is also a risk factor associated with prostate cancer, Dr. Labbé used the Body Mass Index (BMI) to make sure that it was only saturated fat intake—and not obesity—that promoted the progression to a metastatic and lethal disease.
“Even after removing obesity from the equation, patients with high levels of the SFI-MYC signature are still three times more likely to die of prostate cancer,” says Dr. Labbé. “Epidemiological studies have previously reported that saturated fat intake is associated with . Our study provides a mechanistic underpinning to this link and a basis to develop clinical tools aimed at reducing the consumption of saturated fat and increasing the odds of surviving.”
The study also showed that for saturated fat to induce MYC reprogramming, the tissue needs to be transformed.
“In a prostate cancer patient, the  contains both tumour and normal tissue,” explains Dr. Labbé. “We showed that saturated fat intake only affects the transcriptional program in the tumour tissue.”
“Altogether, our findings suggest that a substantial subset of  patients, including some without MYC amplification, may benefit from epigenetic therapies targeting MYC transcriptional activity or from dietary interventions targeting metabolic addictions regulated by MYC.”
Knowing the dietary pattern of a patient or his level of physical activity, clinicians could eventually suggest some specific intervention to decrease the likelihood of progression to a lethal disease. But in order to do that, more research is needed.
“The impact of diet on cancer development has been first established more than 100 years ago. However, lifestyle-related data is only sparsely collected among patients, thereby limiting our capacity to define the molecular link between lifestyle factors and cancer initiation, progression and lethality,” says Dr. Labbé. “We will start soon here at the RI-MUHC to gather dietary and physical activity and assess body fatness information from patients undergoing screening tests for different cancers. And with that data, combined with research in the laboratory, we hope to be able to build personalized interventions for patients who are more at risk of having their  progress rapidly, and to ultimately improve outcomes.”
Explore further
More information: David P. Labbé et al. High-fat diet fuels prostate cancer progression by rewiring the metabolome and amplifying the MYC program, Nature Communications (2019). DOI: 10.1038/s41467-019-12298-z
Posted by at No comments:

High-Protein Diet Could Be Harmful, Even for Healthy Kidneys

A high-protein diet, often recommended as a way to lose weight and stay healthy, appears to be harmful to the kidneys in individuals with apparently normal kidney function, two separate new studies indicate.
The two studies, from the Netherlands and Korea, were published online in Nephrology Dialysis Transplantation.
Many previous studies have shown that a high-protein diet may harm kidney function, and this is why nephrologists recommend patients with known early stage chronic kidney disease (CKD) stick to a low-protein diet.
But people who have mild CKD of which they are unaware or those at high risk may follow the trend of eating a protein-rich diet because they believe it is healthy, say Kamyar Kalantar-Zadeh, MD, PhD, and colleagues in an accompanying editorial.
“The high-protein culture has emerged as the preferred, healthy, and safe way of eating at the dawn of the 21st century,” they write.
Dietary regimens such as the Atkins, Zone, South Beach, and Ketogenic diets have emerged “in which daily protein intake increased to 20% to 25% or more of the total daily energy intake. We are being told that getting plenty of protein is the revival of our hunter–gatherer ancestral spirit and it will help maintain our lean muscle and reduce fat mass,” the editorialists note.
But given these two new studies, “and other data, it is time to unleash the taboo and make it loud and clear that a high-protein diet is not as safe as claimed, as it may compromise kidney health and result in a more rapid kidney function decline in individuals or populations at high risk of CKD,” they underscore.
“It is prudent to avoid recommending high-protein intake for weight loss in obese or diabetic patients, or those with prior cardiovascular events, or a solitary kidney if kidney health cannot be adequately protected,” they summarize.
“It is essential that people know there is another side to high-protein diets and that incipient kidney disease should always be excluded before one changes one’s eating habits and adopts a high-protein diet,” added the senior author of the editorial, Denis Fouque, MD, PhD, of Centre Hospitalier Lyon-Sud, France, in a press release issued by the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA).

Dutch Study: Protein Intake, CKD Risk Highest in Those With Diabetes

In the Dutch study, Kevin Esmeijer, MD, of Leiden University Medical Center, the Netherlands, and colleagues collected dietary data using a food frequency questionnaire from 4837 patients 60-80 years of age with a history of myocardial infarction involved in the Alpha Omega Trial.
“At baseline and 41 months follow-up, serum cystatin C (cysC) and serum creatinine were measured from stored blood samples,” the investigators explain.
The mean age of the cohort was 69 years and mean estimated glomerular filtration rate (eGFR) was 82 mL/min/1.73m2. As the authors point out, compared with the general population, patients with a history of myocardial infarction have double the rate of annual decline in kidney function and thus are at higher risk for CKD.
For the entire cohort, mean total protein intake was 71 g/day, of which approximately two thirds was from animal protein and the remaining third from plants.
Analyses indicated that the total amount of protein intake per day was inversely associated with the annual rate of kidney function decline. The annual change in eGFRcysC was doubled in patients with a total daily protein intake in excess of 1.20 g/kg ideal body weight, compared with an intake less than 0.80 g/kg.
Specifically, the annual change in eGFRcysC in those with the highest total daily protein intake was –1.60 mL/min/1.73m2 compared with –0.84 mL/min/1.73m2 for those with the lowest total daily protein intake, the investigators report.
And for each extra daily intake of animal protein of 0.1 g/kg ideal body weight, there was an additional decline in eGFRcysC of –0.12 mL/min/1.73m2 per year, they point out.
Subgroup analyses also indicated that the association between protein intake and decline in eGFR was threefold stronger in patients with diabetes compared to those without diabetes.
“Despite the fact that our patients received state-of-the-art drug treatment, we observed a beneficial effect of a low-protein intake on kidney function,” the authors conclude.

Higher Protein Intake and Independent Risk for Renal Hyperfiltration

In the Korean study, Jong Hyun Jhee, MD, of the Institute of Kidney Disease Research, Yonsei University, Seoul, and colleagues analyzed the effect that a high-protein diet had on renal hyperfiltration and declining kidney function in 9226 participants from the Korean Genome and Epidemiology Study.
Patients were classified into quartiles of daily protein intake as assessed by a food frequency questionnaire. The mean age of study participants was 52 years and the mean follow-up was 11.5 years.
Among the four quartiles of daily protein intake, the prevalence of renal hyperfiltration (defined as an eGFR with residuals > 95th percentile after adjustment for confounders) was significantly higher among those in the highest quartile of protein intake, at 6%, compared with 5.2% among those in the lowest protein intake quartile (P = .02), the investigators report.
And the annual mean decline in eGFR was again highest, at –2.34 mL/min/1.73m2, among those in the highest quartile of daily protein intake, compared with –2.01 mL/min/1.73m2 among those in the lowest quartile of protein intake (P = .02).
The researchers also looked at whether a higher protein intake was associated with a greater risk for a rapid decline in kidney function, defined as a decrease in eGFR of > 3 mL/min/1.73m2 per year.
They found that those in the highest quartile of protein intake had a 32% greater risk of experiencing a rapid decline of eGFR per year compared with those in the lowest quartile (P = .03).
Jhee and colleagues then took further steps to substantiate their findings. First, they divided the cohort into those with and without renal hyperfiltration and observed that the mean daily protein intake was higher in participants who had renal hyperfiltration compared with those who did not (P = .02).
They then found that the faster drop in renal function happened only among those with preexisting hyperfiltration.
“These findings lead us to infer that a higher intake of protein may be an independent risk factor for renal hyperfiltration that can accelerate deterioration of kidney function,” they conclude.

Western Societies Consume Too Much Protein

In their editorial, Kalantar-Zadeh and colleagues caution that the new studies “should be qualified for their epidemiologic nature, given that the association does not equate to causality.” And the use of a food frequency questionnaire in both studies “is another limitation,” they observe. Furthermore, “glomerular hyperfiltration cannot be reliably detected by eGFR values.”
Notwithstanding these limitations, the studies suggest that high daily protein intake may have deleterious effects on kidney health in the general population, they state.
The recommended dietary allowance for protein intake is only 0.8 g/kg/day and the requirement for protein is likely even lower, at only about 0.6 g/kg/day, provided adequate essential amino acids are consumed, they explain.
“However, most adults in Western societies eat 1.0 to 1.4 g/kg/day of protein,” the editorialists note, “[and] protein intake may be as high as 20% to 25% or more of the total energy source,” they add — considerably higher than the 10% to 15% recommended by most guidelines.
“Emerging data across individuals and populations suggest that glomerular hyperfiltration associated with a high-protein diet may lead to a higher risk of de novo CKD or may accelerate progression of preexisting CKD,” the editorialists conclude.
Nephrol Dial Transplant. 2019. Study 1, Study 2, Editorial
Posted by at No comments:
Subscribe to: Posts (Atom)