After Doctors Cut Their Opioids,

After Doctors Cut Their Opioids, Patients address a Risky Treatment for Back Pain

WASHINGTON — An injectable drug that the manufacturer says is just too dangerous to use along the spine is growing in popularity for back pain as doctors shy away from opioids.

The anti-inflammatory, called Depo-Medrol and made by Pfizer is approved for injection into muscles and joints. Once a drug is approved, however, doctors may legally prescribe it however they see fit.

And doctors have long given Depo-Medrol shots, or the generic equivalent, on the brink of the medulla spinalis for painful backs, necks, and conditions like spinal stenosis.

What few doctors or patients know is that Pfizer, faced with many complaints about injuries and complications associated with the shots, asked the Food and Drug Administration to ban that sort of treatment five years ago.

The corporate cited the danger of blindness, stroke, paralysis, and death — an invitation that neither the agency nor Pfizer made public.

The F.D.A. declined to issue a ban but toughened the label warning. Other countries — among them Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland — heeded Pfizer’s request.

After concerns were raised about the off-label treatments, the use of the injections declined. But the opioid epidemic appears to be spurring their popularity despite risks known to public health officials and doctors.

According to the F.D.A., back problems are the foremost common explanation for disabling, chronic pain.

Weekend classes to coach physicians within the procedure are flourishing.

Critics like Dr. Terri A. Lewis, a rehabilitation specialist, and lecturer at Southern Illinois University, say they're liable for transforming pain clinics into “drill mills.”

And in June, as a part of legislation to tackle the opioid crisis, the House of Representatives approved a rise in Medicare reimbursement for the procedure.

The number of Medicare providers giving steroid injections along the spine, including Depo-Medrol and other drugs had increased by 13 percent in 2016 from 2012.

The amount of Medicare beneficiaries receiving these injections is up 7.5 percent.

The Department of Veterans Affairs reported a 17 percent increase within the injections from 2015 to 2017.

And total sales of brand name name and generic Depo-Medrol grew 35 percent to $185 million from $133 million from 2015 to 2017, consistent with the IQVIA Institute for Human Data Science, a health data firm.

It’s a troubling trend to researchers and experts like Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University.

“The victims of our era of aggressive opioid prescribing are being exploited in some cases by interventional pain doctors, who will continue them on opioids in exchange for allowing them to perform expensive procedures that they don’t need,” said Dr. Kolodny, who is additionally executive of Physicians for Responsible Opioid Prescribing.

“These aren't benign procedures. Patients are often harmed and are harmed.”

Pfizer, in 2013, quietly asked the F.D.A. and regulators in other countries to ban Depo-Medrol for epidural use.

“It must not be employed by the intrathecal, epidural, intravenous, or the other unspecified routes,” the corporate wrote.

It is unusual for a pharmaceutical company to request a contraindication for one among its own products.

During this case, some doctors say Pfizer was worried about liability from off-label use, which doesn't provide a manufacturer an equivalent degree of protection as approved uses.

When the F.D.A. authorized a stronger warning in 2014, it noted that giving steroid shots on the brink of the spine could cause rare but catastrophic injuries or death.

The warning applied to the whole class of epidural steroid injections, estimated at about nine million a year — and to not be confused with the pain blocks, often called epidurals, given to women during childbirth.

Now, interviews with dozens of pain specialists show that the pressure to wean patients off opioids is prompting many doctors to refer patients to pain intervention specialists who promote the shots.

The values per shot varies widely, from $100 up to $800, with a further fee getting to the hospital or clinic where it's administered.

“The truth underlying it's that doing an injection is quicker and leads to higher reimbursements, compared to other ways of managing an equivalent pain,” said Dr. James P. Rathmell, chairman of anesthesiology, perioperative and pain medicine at Brigham and Women’s Hospital.

It was Dr. Rathmell who first brought the difficulty to the F.D.A. and oversaw a panel charged with recommending guidelines on safety.

“The use of injections has increased dramatically, yet the prevalence of back pain has remained relatively unchanged,” Dr. Rathmell said.

Doctors can choose among several sorts of epidural steroid injections. Depo-Medrol features a major share of the market.

Epidural steroid injections within the cervical (neck) area and midback are considered the foremost dangerous.

They work like this: A steroid is injected into the epidural space within the vertebral canal.

Most of the injuries occur if the needle misses its target and directly injures nerves or places the drug into the cerebrospinal fluid or arteries, depriving the medulla spinalis of blood.

A review of F.D.A. records show that there have been 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths.

Pfizer declined to discuss the deaths, pointing to the product’s warning label: “Serious neurologic events, some leading to death, are reported with the injection of corticosteroids.

Specific events reported include, but aren't limited to, medulla spinalis infarction, paraplegia, quadriplegia, cortical blindness, and stroke.”

In West Virginia, the guts of the opioid epidemic, anesthesiologist Dr. Brian Yee said more general practice physicians are referring patients to his clinic for epidural steroid injections and other procedures, like medulla spinalis stimulation, than in past years.

Dr. Yee believes spinal injections are valuable if administered properly.

But he worries that weekend classes aren’t sufficient training.

“With people trying to require away opioids now, we are opening up another doorway for people to overutilize other options which will be helpful with the proper doctors and therefore the right patients,” he said.

Vaginal Laser Treatments Can Cause

Vaginal ‘Rejuvenation’ Treatments could also be Unsafe, the F.D.A. Says

WASHINGTON — The Food and Drug Administration on Monday announced that it had warned several companies to prevent marketing laser devices for procedures billed as “vaginal rejuvenation,” saying they were dangerous and deceptive treatments.

The agency originally permitted the lasers and related energy-based devices onto the marketplace for the treatment of great conditions, like cancer, genital warts, or surgery including hysterectomies.

But in recent years, manufacturers are heavily promoting the lasers for symptoms associated with vaginal atrophy, menopause, enuresis, and sexual function. Cosmetic, spa treatments using laser and other products for vaginal health have also become popular among younger ladies.

Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems associated with dryness or other ailments. The F.D.A. disagrees. But albeit the agency originally approved the devices surely treatments, it's legal for doctors to use them for off-label conditions.

The agency noted in one letter that a manufacturer, BTL Industries were marketing a radiofrequency device, Exilis Ultra 360, as a replacement approach to “women’s intimate health” albeit the merchandise had only been approved by the F.D.A. for uses in dermatology like wrinkle treatment, including the eyelids.

The F.D.A. described the company’s “pelvic-suite” website, where the device was advertised as ready to build collagen and elasticity for “female intimate parts,” and requested that the corporate furnish documentation that it had been cleared to plug the merchandise for such uses.

The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore System, and other devices, telling them to not promote the devices for the rejuvenation procedure.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Dr. Scott Gottlieb, the F.D.A. commissioner.

“We are deeply concerned women are being harmed.”

Dr. Gottlieb also said he was concerned that deceptive marketing of those devices might prevent some patients from getting appropriate therapies for severe medical conditions.

The F.D.A. said the complete extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain following the treatments.

The agency has received 14 reports of adverse events associated with the treatments, including burning sensations and significant pain.

The companies targeted by the F.D.A. were In mode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; Venus Concept and Cynosure.

Some companies didn't immediately answer requests for comment.

Jane G. Mazur, a spokeswoman for Hologic, Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the F.D.A. notice.

“We are evaluating the letter fully and can collaborate with the agency to make sure all product communications adhere to regulatory requirements,” Ms. Mazur said.

Domenic DiSisto, general counsel for Venus Concept, said the Venus Fiore device isn't currently marketed or sold within the us, which the corporate had modified its website.

The F.D.A.’s letters are considered a step in need of a proper warning. The manufacturers are asked to supply details on the merchandise and on what basis they're assuming approval.

The agency has been struggling to hurry up the approval of medical devices.

Critics have said that the F.D.A. device approvals are already going too fast and happening with insufficient oversight.

within the announcement Monday, Dr. Gottlieb said the agency would strengthen its studies of devices after they need to be approved purchasable.

No agency or medical society has figures for the quantity of those procedures are done per annum, but an off-the-cuff search through gynecology practices show they're becoming prevalent — despite opposition from the American College of Obstetricians and Gynecologists.

The medical society has issued several statements noting that the devices, including the MonaLisa Touch, don't have F.D.A. clearance or approval for treatment of menopausal symptoms, as advertised.

“Obstetrician-gynecologists should be cognizant of the evidence regarding innovative practices” and will be wary “of adopting new or innovative approaches on the idea of promotions or marketing,” the school said.

Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and plastic surgery at MedStar Washington Hospital Center said the laser technology held promise, but that more study was needed to know the security also as to which patients the devices might help.

“I think the F.D.A. is trying to be conservative,” she said. “They don't want the marketing to be before the science on this.”

But some doctors already say the devices work well for his or her off-label use.

During a testimonial on its website, Alma Laser featured a video of Dr. Leslie Apgar, a Maryland gynecologist, who said she was pleased with the Femilift, also because of the company’s assistance with marketing.

“With Alma, I used to be ready to get the Femilift system that I wanted, alongside the marketing solution that included a replacement website fully optimized for Google and every one the opposite search engines,” Dr. Apgar said within the video.

“It has figured out extremely well on behalf of me, as I even have gotten new patients weekly directed to my practice.”

Maybe You Were Thinking About Eating

Maybe You Were brooding about Eating Raw Centipedes. Don’t.

An Asian red-headed centipede. it's going to look delicious, but scientists report that it's going to carry lungworm which will infect the brain.

Credit...Yasunori Koide Scientists in China now have hard evidence that eating raw centipedes may be a really bad idea.

That might go without saying in most parts of the planet.

But centipedes are a longtime remedy in traditional medicine in China.

As an ancient nostrum for epilepsy, stroke, cancer, tetanus, or atrophic arthritis, the two-inch-long arthropods are alleged to be eaten dried, powdered, or after being steeped in alcohol — not raw.

But a study published on Monday within the American Journal of Medicine and Hygiene describes two hospital patients — a mother and son — who ended up with rat lungworms in their brains after eating wild-caught centipedes the son had purchased at a farmer’s market.

Rat lungworms — named because they were first found in 1934 within the pulmonary arteries of a brown rat in Guangzhou, China — are often life-threatening.

But usually, they infect only people that eat raw snails or slugs.

Those include fans of northern Thai cuisine, children (or sometimes adults) who eat slugs on a dare, and unlucky salad-eaters who accidentally ingest slugs with unwashed lettuce.

In rare cases, lungworms are often picked up from undercooked shrimp or crabs that ate the larvae.

The new study is that the first proving they will be found in centipedes, too.

The patients, a 78-year-old woman, and her 46-year-old son, were admitted to Zhujiang Hospital in Guangzhou in 2012 with headaches and stiff necks, signs of meningitis.

“It took us a while to work out what they were affected by ,” said Dr. Lingli Lu, a neurologist at the hospital and co-author of the study.

After eliminating bacterial and viral causes, she said, the treatment team focused on common parasites like cysticercosis, caused by pork tapeworms, or toxoplasmosis, which comes from cat feces.

Ultimately, she said, a meningitis specialist suggested a test for lungworms.

The previously healthy man had listened to someone who told him raw centipedes would prevent winter colds, Dr. Lu said, and his mother “was old and takes anything the son gives her.”

Both patients recovered after treatment with an anti-parasitic drug and corticosteroids.

To confirm their suspicions, the researchers bought 20 live centipedes at the market that the son had patronized and located seven of them teeming with lungworm larvae.

Asked why anyone would sell live centipedes — which have a venomous bite — Dr. Lu explained that some traditionalists boil them in teas or pickle them in wine to use as home remedies.

“In my opinion, it might be rude to inform the customer, ‘Don’t eat them raw,’” she said. “It would say the customer is stupid.”

Medicare Slashes Star Ratings for Staffing at 1 in 11 Nursing Homes

Medicare has lowered its star ratings for staffing levels in one out of 11 of the nation’s nursing homes — almost 1,400 of them — because they were either inadequately staffed with registered nurses or did not provide payroll data that proved that they had the specified nursing coverage, federal records released in the week show.

Medicare only recently began collecting and publishing payroll data on the staffing of nursing homes as needed by the Affordable Care Act of 2010, instead of relying because it had before on the nursing homes’ own unverified reports.

The payroll records revealed lower overall staffing levels then the homes had disclosed, particularly among registered nurses.

Those are the highest-trained caregivers required to be during a home, and that they supervise other nurses and aides.

Medicare mandates that each facility have a RN performing at least eight hours a day.

“It’s a true positive that they really are taking the payroll-based system seriously, that they’re using it to punish that nursing homes that either isn’t reporting staffing or people who are below the federal limit,” said David Grabowski, a professor of health care policy at Harvard school of medicine. 

“Could they be doing more? Sure, but I feel it’s a very good start.”

The five-star scoring system may be a tool for families checking out nursing homes, and therefore the rankings are published on the government’s home Compare website.

The revised ratings gave a rock bottom rating for staffing to 1,387 of the nation’s 15,616 skilled nursing facilities, consistent with a Kaiser Health News analysis of the newest data released by Medicare.

All of they received one star out of a possible five on July 25, when Medicare updated the ratings.

Nursing home industry officials have acknowledged that some facilities are struggling to satisfy the new payroll reporting requirements.

Katie Smith Sloan, president of LeadingAge, an association of nonprofit providers of aging services including nearly 2,000 nursing homes, said the lowered star ratings were disappointing and attributed them largely to a piece force shortage.

“Our members are battling on multiple fronts to recruit and retain all kinds of qualified staff, and nurses especially,” she said during a statement.

In footnotes on the home Compare website, Medicare said the homes with the one-star staffing rating either lacked an RN for “a high number of days” over three months, provided data the govt couldn’t verify or didn’t supply their payroll data in the least.

The downgraded homes reported seven or more days with none registered nurses, the analysis found.

For roughly half the homes, the downgrades lowered their overall star ratings, which are the measures displayed most prominently on the location.

But a number of the homes saw their overall ratings stay an equivalent or maybe rise, buoyed by their scores on other quality measures. Seventy-nine are still rated with a coveted five stars.

While the Kaiser Health News analysis found substantially lower average staffing of nurses and aides at for-profit facilities than at nonprofits and government-owned homes, the number of downgraded nursing homes was roughly proportionally divided among the three categories, indicating the industry-wide issue with staffing by registered nurses especially.

Medicare concedes that because the payroll system is geared toward reporting hourly work, salaried staff might not always be reflected correctly, especially if they were working overtime.

But Medicare had warned the nursing homes in April that the downgrades would be coming if facilities continued to point out no registered nurses on duty.

The agency noted it's been preparing nursing homes since 2015 for the new payroll system.

“We’ve just begun to leverage this new information to strengthen transparency and enforcement with the goals of improved patient safety and health outcomes,” the Centers for Medicare & Medicaid Services said during a statement.

The payroll data, analyzed by Kaiser Health News, showed that for-profit nursing homes averaged 16 percent fewer staff than did nonprofits, even after accounting for differences within the needs of residents.

The most important difference was within the number of registered nurses:

At the typical nonprofit, there was one RN for every 28 residents, but at the typical forprofit, there was just one RN for every 43 residents.

Researchers have repeatedly found lower staffing in for-profit facilities, which structure 70 percent of the industry.

The data also revealed that nursing homes have large fluctuations in staffing. the typical home had one licensed nurse caring for as few as 17 residents or as many as 33, counting on the day.

On the best-staffed days, each certified nursing assistant or other aide cared for nine residents, but on the worst-staffed days, each aide was liable for 16 residents.

Weekend staffing was particularly sparse. On weekends on average, there have been 11 percent fewer nurses providing direct care and eight percent fewer aides.

Meet the Rebate, the New Villain of High Drug

Meet the Rebate, the New Villain of High Drug Prices

An increasingly popular culprit within the debate over high drug prices are that the pharmaceutical rebate, the after-the-fact discounts that form the guts of the nation’s arcane — many would say broken — marketplace for prescribed drugs.

Now, a growing chorus wants to urge obviate them, or a minimum of change the way they're applied after drug companies have already set their prices.

Rebates, critics say, have pushed up the asking price of brand-name drugs, which consumers are increasingly liable for paying.

Insurers generally get to stay the rebates without passing them along to their members.

Last week, the drug industry’s largest trade group, the Pharmaceutical Research and makers of America, took aim at the rebate system, proposing a change to the way middlemen handle rebates, and the way those companies are paid.

And the Trump administration has taken the primary step toward eliminating a “safe-harbor” provision that permits rebates to be paid in Medicare’s Part D drug program without violating federal anti-kickback laws.

The details, though sparse, briefly caused the autumn of the stocks of major pharmacy benefit managers like Express Scripts and CVS Health as investors worried that company profits would be hurt by the rebate’s demise.

Here’s a rundown on everything you would like to understand about rebates.

What is a rebate?

Pharmaceutical rebates are almost like the sort that you simply get once you buy a toaster — discounts that are redeemed after the transaction has taken place.

Except with the toaster, you get to stay the cash. With drug rebates, it’s the insurer or employers who usually reap the benefit.

Under the present system, drugmakers set an inventory price for his or her products, then negotiate with pharmacy benefit managers like Express Scripts or CVS over what proportion of a reduction they're going to provide off that asking price.

The size of the rebate depends on a variety of things, including what percentage of drugs are employed by the insurers’ members, and the way generously the merchandise is going to be covered on a formulary, or list of covered medicines.

Companies that provide bigger rebates are often rewarded with better access like smaller co-payments.

Most of the rebate — and sometimes, all of it — goes to those that are paying the bill for the drugs, mainly insurers or large employers who cover their workers’ health care.

Pharmacy benefit managers usually, keep a percentage of the rebate as payment.

Insurers and employers get their rebates in lump sums that they assert are often wont to offset general health care costs and to carry down premiums.

What’s all the fuss about?

Although rebates are wont to negotiate drug prices for years, they didn’t catch much attention until 2011, when CVS, which operates one among the country’s largest pharmacy benefit managers announced it had been excluding 34 drugs from its national formulary.

The rebate then became a potent negotiating tool, pitting drug companies against one another in an attempt to secure an area on the formulary. Other benefit managers, like Express Scripts, soon followed suit.

But that has led to an escalating game, where drug companies raise their list prices to take care of their profits and to supply bigger rebates.

Some say the system has created a series of perverse incentives, where the middlemen have an interest keep the asking price high.

Additionally, to pharmacy benefit managers, wholesalers and pharmacies also are paid supported a percentage of the asking price.

Drugmakers — on the defensive after weathering attacks by President Trump, other elected officials, and therefore the public — have pointed fingers at the pharmacy benefit managers, saying they're struggling to boost list prices to stay all of those players happy.

But pharmacy benefit managers and insurers disagree, arguing that refunds are a diversion which their negotiating tactics have kept total drug costs in restraint.

As proof, they point to data that shows that in 2017, net spending on brand-name drugs grew only 1.9 percent, consistent with IQVIA, a drug research firm, while list prices grew 6.9 percent.

In a twist, the pharmaceutical companies cite equivalent research to point out that drug prices aren't as steep as they appear.

How are consumers affected?

Even as insurers’ drug spending has grown slowly, critics say the rebate game has served to inflate the asking price of medicine, which consumers are increasingly liable for paying.

This is often very true for expensive specialty drugs, which treat serious conditions like cancer and MS — and whose prices are skyrocketing?

As the cost of those products has gone up, insurers have raised deductibles and out-of-pocket contributions in order that many of the sickest Americans must now pay thousands of dollars a year to hide their drug costs.

These out-of-pocket costs are calculated using something on the brink of the asking price of a product, not internet price.

What’s being proposed?

Alex M. Azar II, the secretary of health and human services, has singled out rebates as a primary way that patients’ costs could fall.

“Right now, everybody within the system makes their money off a percentage of list prices,” Mr. Azar testified in June before a Senate committee.

“We may have to maneuver toward a system without rebates.”

Last week, the Trump administration signaled that it'd attempt to end the “safe harbor” exemption that protects rebates from falling under anti-kickback laws.

That might affect government programs like Medicare’s Part D drug plans, but it wouldn’t affect rebates privately plans — like those offered by employers.

Changes to large programs like Medicare often have a rippling effect across the industry.

Pharmacy benefit managers and insurers warn that eliminating rebates could face legal hurdles and said that the move could finish up raising consumers’ premiums because insurers and employers use their rebate payments to plug other holes.

“Plan costs within the short run would go up, that’s just the truth of things,” said David Dross, the statesman of the managed pharmacy practice at Mercer, which negotiates with pharmacy benefit managers on behalf of employers.

Getting Real About Periods, Breast

Getting Real About Periods, Childbirth, Menopause and More

My friend’s question was simple: Are there any foods that help ease the intensity of hot flashes?

She went online hoping to seek out a community of girls who could help her navigate a transition — menopause — that half the population will experience.

What she found instead were recommendations for drugstore supplements like ginseng and tofu. I was surprised, but I shouldn’t are.

Women’s health issues and biological processes have long been shrouded in secrecy and shame.

Who among us hasn’t hidden our pad or tampon wrappers under a wad of loo paper, lest we appear unattractive or messy? The result: We feel alone, often at a young age, once we are anything but.

Worse yet, data suggests that bias can lead doctors to dismiss women’s health problems.

(Even Serena Williams felt her concerns after childbirth was snubbed by hospital personnel.)

And for women and ladies round the world, these taboos can have tragic consequences: during a corner of Nepal, girls have died after being banished from their homes while menstruating; in Kenya, poorer girls may trade sex to afford pads.

But there’s a growing wave of girls who are speaking openly and unabashedly about their health issues, giving the center finger to modesty and bringing these once-private struggles into the general public sphere.

This week, The NY Times published a piece of writing about advocates and activists who are pushing for recognition of a woman’s right to manage her period “with dignity,” urging states to exempt menstrual hygiene products from nuisance tax and bringing into the talk the concept of “menstrual equity,”

which involves equal access to hygiene products and education about reproductive health.

“Why are tampons taxed when Viagra is not?” the piece asks, echoing a standard refrain.

In Harper’s Bazaar, the photographer Frances F. Denny recently opened about the vaginal tearing she experienced during childbirth, an injury that affects many American mothers.

In May, the supermodel and cookbook author Chrissy Teigen, a very candid presence on social media, shared that she too had experienced severe vaginal tearing together with her firstborn.

Harper’s Bazaar also published a piece of writing last week about the hurdles new mothers face while trying to pump breast milk while working.

And Buzzfeed has published demystifying articles like “Is Your Period Too Heavy? We’ve

Got Answers” and “17 fresh Period Jokes just in case You’re uninterested in Laughing At The Old Ones.”

This surge of frank discourse comes among growing concern about reproductive-health issues within the Trump era.

This month, we stunned global health officials by upending deliberations on a resolution supporting breastfeeding to guard the interests of infant-formula manufacturers.

The nomination of Judge Brett Kavanaugh to the Supreme Court has renewed specialize in Roe v.

Wade, the 1973 case that guaranteed women access to abortion, and led Massachusetts to last week passed a law — called the NASTY (Negating Archaic Statutes Targeting Young) Women Act — which will ultimately repeal the state’s 173-year-old legislation banning abortions.

Lawmakers called it “an emergency law, necessary for the immediate preservation of the general public health.”

New Alzheimer’s Drug Shows Big Promise

New Alzheimer’s Drug Slows amnesia in Early Trial Results

The long, discouraging go after medicine that works to treat Alzheimer’s reached a potentially promising milestone on Wednesday.

For the primary time during a large clinical test, a drug was ready to both reduce the plaques within the brains of patients and slow the progression of dementia.

More extensive trials are going to be needed to understand if the new drug is actually effective, but if the results, presented Wednesday at the Alzheimer’s Association International Conference in Chicago, are borne out, the drug could also be the primary to successfully attack both the brain changes and therefore the symptoms of Alzheimer’s.

“This trial shows you'll both clear plaque and alter cognition,” said Dr. Reisa

Sperling, director of the middle for Alzheimer Research and Treatment at Brigham and Women’s Hospital in Boston, who wasn't involved in the study.

“I don’t know that we’ve hit a home run yet. It’s important to not over-conclude the info. But as a symbol of concept, I desire this is often very encouraging.”

Aside from a couple of medicines that will slow memory decline for a few months, there's no effective treatment for Alzheimer’s, which affects about 44 million people worldwide, including 5.5 million Americans.

It's estimated that those numbers will triple by 2050.

The trial involved 856 patients from us, Europe and Japan with early symptoms of cognitive decline. 

They were diagnosed with either mild cognitive impairment or mild Alzheimer’s dementia, and everyone had significant accumulations of the amyloid protein that clumps into plaques in people with the disease, said Dr. Lynn Kramer, chief medic of Eisai, A Japan-based company that developed the drug, referred to as BAN2401, alongside Biogen, based in Cambridge, Mass.

Many other drugs have managed to scale back amyloid levels but they didn't ease memory decline or other cognitive difficulties.

Within the data presented Wednesday, the very best of the five doses of the new drug — an injection every fortnight of 10 milligrams per kilogram of a patient’s weight — both reduced amyloid levels and slowed cognitive decline in comparison to patients who received a placebo.

Of the 161 patients within the group taking the very best dose, 81 percent showed such significant drops in amyloid levels that they “converted from amyloid positive to amyloid negative,” Dr. Kramer said in an interview, meaning that the patients’ amyloid levels dropped from being considered high enough to correlate to dementia to A level below that dementia threshold.

And on A battery of cognitive and functional tests measuring memory and skills like planning and reasoning, the performance of the high-dose group declined at a rate that was 30 percent slower than the speed of decline within the placebo group.

Dr. Sperling, who briefly advised Eisai last year on the special drug called the reductions in amyloid “dramatic,” but said the cognitive results were less momentous.

Still, she said, “If you'll really slow the decline by 30 percent for people that are still normal or very mildly impaired, that might be clinically important.”

Dr. Samuel Gandy, associate director of the Sinai Alzheimer’s Disease research facility said that for the drug to actually be effective, it might need to allow patients to function longer independently without having caregivers to assist them with basic daily activities.

That sort of the application wasn't reflected within the data presented Wednesday.

“I wouldn’t say this is often a quantum jump,” he said. “It maybe a convincing moving of the needle.

But it’s not clear that the needle has moved far enough to form a difference in people’s lives.”

Dr. Kramer said the results were statistically significant 18 months after patients began taking the drug, but improvement began to be noticed after about six months.

The 253 patients within the group receiving the second-highest dose also had amyloid and cognitive results that followed an identical trend.

In December 2017, the businesses reported that a statistical analysis of the trial at the 12-month mark projected that the drug wouldn't end in a statistically significant slowing of dementia.

That meant that the trial didn't meet its primary benchmark, which caused some experts and investors to voice skepticism about the drug.

The 18month results allayed a number of that skepticism, although the Alzheimer’s Association issued a press release expressing caution and saying the results were “not large enough to definitely demonstrate cognitive efficacy.”

The results came from a Phase 2 trial, which measures both the security and therefore the efficacy of a drug, but is usually considered an intermediate step to larger and more extensive Phase 3 trials.

Other drugs have shown promise in Phase 2, only to disappoint in Phase 3.

In this trial, patients were randomized into six groups, with 247 patients receiving placebo injections while the opposite five groups received varying doses of the drug.

One unusual aspect of the trial raised questions for a few experts.

Eisai and Biogen used a cognitive assessment they devised.

Called the Alzheimer’s Disease Composite Score (Adcoms), it draws on elements from three other, skilled cognitive tests.

Dr. Kramer said Adcoms was developed to compile the measures from those three tests that were sensitive enough to live change at such an early stage of dementia.

The info presented on Wednesday indicated that the patients also showed positive results on two of the three established tests when those were checked out separately.

Some potential Alzheimer’s treatments have resulted in serious side effects which will cause dangerous swelling or bleeding within the brain.

Fewer than 10 percent of the patients taking the new drug experienced such effects, the businesses reported, making it relatively safe.

Grain-Free Dog Foods and heart condition TLDR

The Food and Drug Administration (FDA) has recently announced that it's investigating a potential link between grain-free dog foods and a standard sort of canine heart condition (called dilated cardiomyopathy or DCM).

The health issues were detected in dogs not typically susceptible to this particular sort of heart disease (these breeds included Golden Retrievers, Labs, Whippets, Shih Tzus, and Bulldogs).

The FDA has not yet issued any recalls but is investigating.

What’s Causing This?

The potential risk in grain-free foods comes from high amounts of grain replacements such as peas, lentils, legumes, chickpeas, and potatoes.

These carbs were also found high on the ingredient lists, meaning there's tons of them within the foods.

While there's a possible link between grain-free foods and a heart condition, there have been no recalls yet and therefore the cases documented thus far are limited.

FDA experts and other researchers don't yet know why grain-free diets could also, be causing this health issue.

It’s possible that it might be caused by the overall lack of grains within the diet or the addition of substitute carbs.

The FDA released a press release saying:

“Diets in cases reported to the FDA frequently list potatoes or multiple legumes like peas, lentils, other “pulses” (seeds of legumes), and their protein, starch, and fiber derivatives early in the ingredient list, indicating that they're main ingredients.

Early reports from the veterinary cardiology community indicate that the dogs consistently ate these foods as their primary source of nutrition for time periods starting from months to years.

High levels of legumes or potatoes appear to be more common in diets labeled as “grain-free,” but it's not yet known how these ingredients are linked to cases of DCM.

Changes in diet, especially for dogs with DCM, should be made in consultation with a licensed veterinarian.

Grain-Free Foods 101

Grain-free canine dog foods became popular in recent years after massive safety recalls in 2007 for pet foods contaminated with melamine sources from China.

However, the health benefits of grain-free diets for dogs haven't been proven and this new potential link to health conditions is one more reason to be skeptical of the trend diet.

The NY Times quotes Lisa Freeman, a veterinary nutritionist and researcher with the Cummings School of medicine at Tufts University as saying:

“Contrary to advertising and popular belief, there's no research to demonstrate that grain-free diets offer any health benefits over diets that contain grains.”

“Grains haven't been linked to many health problems except within the very rare situation when a pet has an allergy to a selected grain.”

The American Kennel club quotes Dr. Jerry Klein, the Chief Veterinary Officer of the AKC: “The FDA is investigating a possible dietary link between canine dilated cardiomyopathy (DCM) and dogs eating certain grain-free pet foods.

The foods of concern are those containing legumes like peas or lentils, other legume seeds, or potatoes listed as primary ingredients.

The FDA began investigating this matter after it received a variety of reports of DCM in dogs that had been eating these diets for a period of months to years.

DCM itself isn't considered rare in dogs, but these reports are unusual because of the disease occurred in breeds of dogs not typically susceptible to the disease.”

What Should I Do Now?

It’s too early to understand what exactly is causing the canine heart condition.

Until the FDA releases its final report it’s an honest idea to remain well informed and consult your vet. Dr.

Klein is quoted by the AKC as saying:

“At this point, there's no proof that these ingredients are the explanation for DCM during a broader range of dogs, but dog owners should remember this alert from the FDA.

The FDA continues to figure with veterinary cardiologists and veterinary nutritionists to raised understand the effect, if any, of grain-free diets on dogs.”

Concerned dog owners can switch faraway from grain-free dog foods to more traditional diets.

If you favor trying that, search for products not marked as grain-free and products that don't contain peas, lentils, other legume seeds, or potatoes as main ingredients.

Ebola Outbreak in Congo Has Ended, W.H.O. Says

The Ebola outbreak that began within the Democratic Republic of Congo in April was declared officially over on Tuesday in what seemed to be twin triumphs for a replacement vaccine and rapid response.

Just 33 people died, albeit the outbreak reached Mbandaka, a river the port city of over a million people.

At one point, experts had feared the virus might spread throughout the Central African Republic.

Three years ago, an Ebola outbreak in West Africa cost quite 11,000 lives. Health agencies were slow to reply, and no vaccine was available until it had been nearly over.

The last known case in Congo occurred in early June, and therefore the World Health Organization declared the outbreak “largely contained” three weeks later.

Declaring it officially over, however, required waiting 42 days — the length of two viral incubation periods.

Tedros Adhanom Ghebreyesus, the W.H.O.’s director-general, joined Dr. Oly Ilunga, Congo’s health minister, in making the announcement within the capital, Kinshasa.

Dr. Tedros thanked “the tireless efforts of local teams, the support of partners, the generosity of donors, and therefore the effective leadership of the Ministry of Health” in Congo.

The W.H.O., which was harshly criticized for failing to react in 2015, rushed in early May as soon as a couple of hemorrhagic fever deaths in Congo was confirmed to have been caused by Ebola.

The organization released $2 million from its emergency fund and sent its first support to the team from Geneva.

As of Tuesday, the agency had asked donors for $57 million to fight the outbreak and donations to all or any entities involved in containing the outbreak amounted to $63 million, according to the United Nations Office for the Coordination of Humanitarian Affairs.

By contrast, stopping the 2014-2015 outbreak in West Africa cost donors quite $3.6 billion, consistent with the Centers for Disease Control and Prevention.

Additionally, the World Bank calculated that the three countries involved — Guinea, Sierra Leone and Liberia — lost a complete of quite $2.2 billion in gross domestic product.

Even though Congo is conversant in Ebola — this was the country’s ninth outbreak since the disease first appeared in 1976 — quite 350 support personnel were deployed there.

They included vaccinators from Guinea, where a completely unique Ebola vaccine was first field-tested.

The Congo outbreak marked the primary during which an Ebola vaccine was readily available.

In addition to giving injections to all or any front-line health care workers, experts used “ring vaccination” to guard all contacts of every person with the disease. quite 3,300 people were vaccinated.

The vaccine, made by Merck and referred to as rVSV-ZEBOV, must be kept at 80 degrees below 0 Celsius (-112 degrees Fahrenheit), so advanced freezers and storage containers had to be deployed to Mbandaka and to Bikoro, a town closer to the outbreak’s epicenter.

The outbreak began in villages within the Ikoko-Impenge area, the number of which was reachable only by motorbike or foot.

Four experimental treatments consisting of antiviral drugs or cloned antibodies were also made available, but the outbreak was contained before they might be used.

The rapid success against Ebola “should make the govt and partners confident that other major outbreaks affecting the country, like cholera and polio also can be tackled,” Dr. Tedros said.

Foods to Eat and Avoid if you've got Malaria

 

Malaria is one of the foremost common vector-borne diseases.

When a mosquito infected with a malarial parasite bites you, it injects the parasite in your body.

Symptoms of malaria usually appear 10-15 days after the sting.

These symptoms may include high-grade fever with chills, headache, body aches, cough, and diarrhea. Severe complications are common, especially with Plasmodium falciparum malarial parasite.

Malaria if not treated timely can cause many complications mainly in children,

pregnant women, and older adults. Almost any system of the body is often suffering from the malarial parasites.

Diet to be taken during malaria treatment:

Water – Always drink boiled water.

Hydrate yourself – Drink many fluids like water, juices, coconut milk, and milkshakes.

It helps the parasites move out of the body quickly.

Work on your carbs- High carbohydrate diet should be taken which will digest quickly and can release energy.

Eat combinations – Always eat a combination of fruits and vegetables in different colors. they assist detox the body.

Have a high protein diet – This helps to guard the body and helps within the synthesis of immune bodies that can fight against parasites.

The need for protein is increased as there's a huge tissue loss. A high protein with a high carbohydrate diet is useful in protein utilization for anabolic and tissue building purposes.

Intake of high biological value protein like milk, curd, lassi, buttermilk, fish (stew), chicken (soup/stew), egg, etc is useful to satisfy the requirement.

Add Omega-3 fats to your diet – It helps to scale back inflammation within the body.

Always take multivitamins- choose B-complex and minerals. vitamin A and Vitamin C rich foods like carrot, beetroots, papaya, fruits especially citrus fruits (e.g. orange, pineapple, grapes, berries, lemon, etc), with B-complex vitamin complex are very useful to spice up immunity.

they assist to rejuvenate your body.

Diet to be avoided during malaria treatment:

• Stay away from fats. Excessive use of fat in cooking or eating fry foods aggravate nausea, impaired digestion which results in diarrhea.
• they ought to be faraway from your meals as they create meals heavy, and is difficult to digest.
• Spicy, fried, and refined food should be avoided Cake, pastries, maida should be avoided. Sauces and pickles shouldn't be taken.
• Avoid hot tea and occasional.