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Japanese company Eisai has not rejected the possibility that its Alzheimer’s drug had a hand in the brain bleeds of two patients. The patients died during the trials but the company insists that the drug was not the cause of the deaths. According to Eisai, the deaths could not possibly be directly credited to lecanemab, which is a drug used to decelerate cognitive decline in patients with early-stage Alzheimer’s by 27%. Lecanemab is being developed in collaboration with Biogen. Both the patients who passed had taken blood-thinning medication and were elderly, one in his 80s and the other in her 60s. Knowing this Eisai told doctors to hold the risk-benefit dialogue with the caregivers before a prescription for patients taking anticoagulation medication. Eisai stood by its monoclonal antibody therapy’s safety, which is the very first to reduce the rate of the condition’s progression in a big trial. It has raised expectations of a new treatment for the disease which is affecting over 50M people globally. Ivan Cheung, the CEO of Eisai US said, “Our assessment is that these deaths cannot be attributed to lecanemab. Of course, we cannot rule out the possibility that lecanemab might have increased the susceptibility of bleeding risk in the brain.” The results of the trial showed that 13 out of about 1,800 participants (Below 1%) died in the first year and a half of the trial. However, none of the fatalities were credited to lecanemab. 7 of the 13 deaths were of people in the placebo group. Two deaths that were alarming for the investors took place during an extension period after the first 18 months. During this period lecanemab was administered in placebo group patients as well. Doctors have long been worried about the chance of swelling and bleeding in the brain due to monoclonal antibodies. According to Eisai, one of the deaths was due to a brain hemorrhage, while the other cause of death was concluded as cardiopulmonary after autopsy. Vice-President of clinical research at Eisai, Michael Irizarry said that there were complicating aspects in both cases and lecanemab does not seem to be directly responsible for the deaths. However, he said that the possibility of its involvement cannot be ruled out. Michael Irizarry also mentioned the need of discussing the benefit-risk concerning lecanemab use for people who are consuming or intend to start consuming anticoagulative medicine. Hostile events befell 14% of the participants in the active drug group while 11.3% of the placebo group participants faced similar problems. Nearly one in six participants (16.7%) who were given the drug went through micro-bleeds in the brain compared to below one in ten (

Alzheimer’s drug did not lead to trial patients’ deaths according to Eisai

Editorial Team

December 6, 2022
3 min read

The audit report shows million in Medicare overcharges federal audit reports disclosed recently show excessive charges in terms of pending payments charged to Medicare Advantage health plans for senior citizens. These included plans overcharged to the government by over $1,000 per patient annually. The government's audits revealed around $12 million in net overpayments for the care of over 18,000 patients who were sampled, however, the actual costs to taxpayers are likely substantially more significant. Medicare Advantage is considered an expanding alternative to traditional Medicare, which is mostly managed by large insurance firms. CMS officials have stated that they will cover the payment rate mistakes for the entire membership. They anticipate collecting over $650 million in compensation. CMS had scheduled to implement the mentioned rule in November but delayed it until February of next year. According to CMS, most of the audited plans were of high sensitivity. They were among the most active in pursuing additional compensation for patients they said were sicker than others. The government pays healthcare providers using a mechanism known as a "risk score," which is expected to result in higher charges for sicker patients and lower prices for healthy ones. Over the past ten years, CMS has completed 90 audits, During that time, enrollment in Medicare plans increased nearly four times to twenty-eight million dollars as of 2022, increasing the cost to the government to over $420 billion. According to government statistics, audits have shown overpayments of $1,000 per patient. Additionally, Humana, one of the top Medicare Advantage sponsors, had overpayments above the $1,000 average in 10 audits. Auditors characterize overpayments as when patient records do not justify the payment made by the government for their health condition, or when doctors are unable to identify the intensity of sickness. Over the three years, this occurred for little over 20% of the medical disorders evaluated; rates of unconfirmed illnesses were greater in other plans. Three groups, including KHN, have filed a lawsuit against CMS to get information regarding the overpayment audits, known as Risk Adjustment Data Validation. As per legal reports, CMS had charged a legal firm a search cost worth $120,000, leading to giving nothing in return. The law firm filed a suit in federal court in Washington, D.C. last year, and the case is still pending. In September 2019, KHN filed a lawsuit against CMS after the agency failed to reply to the audit request. CMS agreed to turn up the audit summaries and other records in exchange for $63,000 in legal costs to Davis Wright Tremaine, the law firm that represented KHN. CMS has made no admission of wrongdoing in withholding the documents. Mary Beth, President of Medicare Alliance stated: "While this data is more than a decade old, more current research shows Medicare Advantage's affordability and good management of Medicare resources, the sector provides superior service and outcomes for patients.

Hospitals & Providers

Audit report shows million in Medicare overcharges

Editorial Team

December 3, 2022
3 min read

mRNA Technology Successfully Tested for Universal Flue Vaccine researchers may be one step closer to creating the long-desired universal flu vaccine as a result of mRNA technologies. In a study published online in Science on November 24, researchers from the University of Pennsylvania's Perelman School of Medicine stated that they had created an mRNA-based vaccine that is effective against all 20 known variations of the A and B flu viruses. For the production of a successful seasonal flu vaccine, some foresight is required. There are numerous influenza viruses, but each vaccine can only target up to four of them. If scientists fail to correctly make predictions about different strains each season, that typically leads to a waste of a lot of time and money. Moreover, it puts the public at risk, as they stay unprotected from the flu. This is why the mRNA technologies at work here are in such high demand. Each year, experts forecast which four influenza viruses will cause the most damage during the coming season. On the basis of those strains, they create a "split virion protein vaccine," which involves growing the viruses in chicken eggs before cutting them up to render them inactive. These inactive fragments are then injected into the body, prompting the immune system to generate antibodies against the four different strains. The issue with this method is that it necessitates the development of new vaccines every year, some of which may prove inadequate against the season's main flu strains if initial predictions are inaccurate. The split virion protein vaccine can't protect against a wide range of strains because it can only handle up to four of them. Hence, scientists have tried developing universal vaccines targeting common parts of the flu virus, albeit without much success. In the Penn study, mRNA was used to generate an antibody response to Hemaglutinin (HA) proteins that protrude from the surface of the virus and enable it to infect host cells. The 20 subtypes of A and B influenza viruses that infect humans have their own unique HA proteins. Scientists tested the vaccine's efficacy by administering it to mice and ferrets and then exposing them to flu viruses representing 20 different lineages 28 days later. They discovered that while not all of the animals were completely immune to infection, they were protected from death or serious illness. Four months after receiving the vaccine, their antibody levels were still quite high. Additionally, the vaccine was effective in rodents that had already contracted the flu prior to vaccination. The vaccinated rodents developed antibodies against all 20 lineages, protecting them from lethal doses of influenza A, B, and C viruses. Scott Hensley, Ph.D., and senior author said in a press release, “The idea here is to have a vaccine that will give people a baseline of immune memory to diverse flu strains so that there will be far less disease and death when the next flu pandemic occurs.” The researchers are currently planning clinical trials in humans. They also want to include young children in the trials because they think the vaccine has the potential to create a long-lasting immune memory against all 20 flu variations.

Technology & AI

mRNA Technology Successfully Tested for Universal Flue Vaccine

Editorial Team

December 3, 2022
3 min read

Technology & AI

Study shows more accurate way for Aortic Dissections through AI

Editorial Team

November 30, 2022
3 min read

91 more deaths were reported due to the Phillips respirator recall, the total death toll reaches 260 between April 2021 and November 2022, and Phillips received over 90,000 complaints regarding its sleep apnea devices and ventilators. Nearly a year and a half ago, Phillips began recalling its respiratory devices after receiving complaints about how the polyester-based polyurethane foam used for soundproofing the vibrations of its devices was breaking down over time causing chemicals and debris to float into the airways. The potential health risks of the disintegrating PE-PUR foam used for muffling sound include headache, difficulty breathing, dizziness, chest pain, cancer, pneumonia, asthma, infection, and more. Approximately 5.5 million of the company’s CPAP and BiPAP machines and other affected devices have been called back in a recall that began in June 2021. Despite this, the FDA has still been receiving complaints. Between 2011 and April 2021, Phillips passed on only 30 medical device reports (MDRs) to the FDA in a bid to detect potential device-related safety issues. Of these, nine were related to death or injuries resulting from the respiratory recall. 19 months later, over 90,000 complaints have piled up of which more than half or 48,000 complaints, were received between May 1 and July 31 of this year. 21,00 MDRs were received between Aug. 1 and Oct. 31. These complaints were filed by healthcare providers, consumers, and patients. While most of the complaints received at this point were of non-fatal injuries, 91 complaints reported patient death. Adding this number to the existing number of complaints that link the faulty ventilators to potential fatalities, the death toll has now been raised to 260. Over 120 of these complaints were submitted between April 2021 and April 2022, and the remaining patient death reports came in between May 1 and July 31. Despite the large numbers of MDRs submitted in the wake of the class 1 ventilator recall, the FDA has clarified that not all death reports and injuries can be linked to it. “The incidence, prevalence or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about details such as frequency of device use,” the agency stated. Presently, the agency is putting its efforts towards determining why reports are continuing to increase, given that the latest wave of patient death reports is more than double the size of the previous one. This can possibly be attributed to Philips’ inadequate notification efforts. The rate at which the company is notifying users of affected devices and is beginning to repair and replace them is considered to be too slow by the FDA. The FDA and the U.S. Department of Justice are both making efforts to mitigate these concerns. While FDA has proposed another order on Phillips's replacement and repair program the DOJ is in talks about a consent decree with the device maker. In the most extreme circumstances, it is also possible that production at certain manufacturing sites will be shut down till all recall-related issues are resolved.

Medical Devices

91 more deaths were reported due to the Phillips respirator recall, total death toll reaches 260

Editorial Team

November 30, 2022
3 min read

J&J Returns Failed Eye Issue Gene Therapy

April 21, 2026
4 min read

Oscar Health Announces Lucie, Its Go-To Platform

April 20, 2026
4 min read

According to a study by Lilly, the

April 18, 2026
4 min read

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