New York, Apr 15 (AP/UNB) - A drug that's used to help control blood sugar in people with diabetes has now been shown to help prevent or slow kidney disease, which causes millions of deaths each year and requires hundreds of thousands of people to use dialysis to stay alive.
Doctors say it's hard to overstate the importance of this study, and what it means for curbing this problem, which is growing because of the obesity epidemic.
The study tested Janssen Pharmaceuticals' drug Invokana. Results were discussed Sunday at a medical meeting in Australia and published by the New England Journal of Medicine.
About 30 million Americans and more than 420 million people worldwide have diabetes , and most cases are Type 2, the kind tied to obesity. It occurs when the body can't make enough or properly use insulin, which turns food into energy.
This can damage the kidneys over time, causing disease and ultimately, failure. In the U.S., it's responsible for nearly half a million people needing dialysis, and for thousands of kidney transplants each year.
Some blood pressure drugs lower this risk but they're only partially effective. The new study tested Invokana, a daily pill sold now to help control blood sugar, to see if it also could help prevent kidney disease when added to standard treatments.
For the study, about 13,000 people with Type 2 diabetes and chronic kidney disease from around the world were to be given Invokana or dummy pills. Independent monitors stopped the study early, after 4,400 people had been treated for about 2.5 years on average, when it was clear the drug was helping.
Those on the drug had a 30% lower risk of one of these problems — kidney failure, need for dialysis, need for a kidney transplant, death from kidney- or heart-related causes, or other signs that kidneys were failing.
For every 1,000 people taking the drug for 2.5 years, there would be 47 fewer cases of one of these problems, researchers estimate.
Rates of serious side effects were similar in the drug and placebo groups including leg, foot or toe amputations, a concern raised by a previous study of Invokana. One side effect, when the body can't produce enough insulin, was more frequent among those on Invokana but rare overall.
Janssen, which is part of Johnson & Johnson, sponsored the study and many authors work or consult for the company. The drug costs about $500 a month in the U.S. Out-of-pocket costs for patients may be different, depending on insurance.
The importance of this large and well-done study "cannot be overstated," Drs. Julie Ingelfinger and Clifford Rosen, editors at the medical journal, wrote in an accompanying article.
In recent years, several studies have found that Invokana and some similar drugs can lower heart risks. The new results, showing that Invokana also may stall or prevent kidney failure, expand the potential benefits of the drug.
Salem, Apr 10 (AP/UNB) — Rose Marie Bentley was an avid swimmer, raised five kids, helped her husband run a feed store, and lived to the ripe age of 99. It was only after she died that medical students discovered that all her internal organs — except for her heart — were in the wrong place.
The discovery of the rare condition, which was presented this week to a conference of anatomists, was astounding — especially because Bentley had lived so long. People with the condition known as situs inversus with levocardia often have life-threatening cardiac ailments and other abnormalities, according to Oregon Health & Science University.
Cameron Walker's class at the university in Portland was examining the heart of a cadaver last year when they noticed the blood vessels were different. When they opened the abdominal cavity, they saw that all the other organs were on the wrong side. The unusual blood vessels helped the heart compensate.
In a telephone interview Tuesday, Walker described his reaction to the find as "definitely a mix of curiosity, fascination and a sense of wanting to explore a little bit of a medical mystery — a medical marvel really — that was in front of us."
"And I would say the students felt something very similar," Walker, an assistant professor of anatomy, told The Associated Press.
Bentley's family had not known about the condition, which OHSU says occurs only once in every 22,000 births. Apparently Bentley didn't either.
Bentley, who lived in Molalla, 25 miles (40 kilometers) south of Portland, had led a normal life. Her only recurrent physical complaint was arthritis, her daughter Louise Allee remembered.
But there were signs.
When Bentley was in her 50s, she underwent a hysterectomy, and the doctor also wanted to remove the appendix but couldn't find it, Allee said in a phone interview. She said it was removed later. Oregon Health & Science University noted that Bentley had three organs removed during her life, but only the surgeon who removed her appendix recorded its unusual location.
When Bentley had her gallbladder removed, it was on the opposite side of where it should have been, Allee said.
"No one said a thing," Allee said. "I was surprised. This was before they did it with a scope, and she had a good-sized incision. You'd think they would have said something, but they didn't."
Walker expressed his gratitude for Bentley agreeing to donate her body to OHSU, Oregon's only academic health center.
"This is an important case that really gave us an opportunity to talk about the importance of future clinicians paying attention to subtle anatomic variations, not just large anatomic variations, in terms of addressing their future patients as individuals," Walker said. "Don't judge a book by its cover, and always check and see what you've got before you talk about care."
He has researched how long people with the condition have lived, and he found no documented cases in which a person lived beyond age 73. Bentley surpassed that by 26 years.
Allee said her mother would have been delighted that the donation of her body led to a learning experience.
"She would have been tickled to know she could educate with something unusual," Allee said. "Dad would have loved to know about it so he could tease her."
Her husband, James, died about 15 years ago.
Washington, Apr 4(AP/UNB) — Doctors can safely transplant hepatitis C-infected lungs and hearts into people desperate for a new organ, say researchers who may have found a way to protect those patients from getting the risky virus.
The experiment, reported Wednesday, is the latest attempt to put a dent in the nation's long transplant waiting list by using organs that otherwise would be wasted, often ones from victims of the opioid epidemic.
The new twist: Instead of trying to cure hepatitis C after it took hold in transplant recipients, researchers at Boston's Brigham and Women's Hospital say a faster, cheaper treatment seems to prevent infection in the first place.
"This is about not discarding organs that are medically suitable," said Dr. Ann Woolley, a Brigham infectious disease specialist who co-authored the study in the New England Journal of Medicine.
Transplanting organs that could infect someone with a liver-damaging virus sounds drastic, but the organ shortage has more hospitals giving it a try. More than 113,000 people are on the national waiting list for a transplant; just 36,529 people got one last year. For heart or lung transplants, about 1,000 people a year die waiting.
"I knew that time was getting shorter for me," said Rexford Kelley, 71, of Searsport, Maine. So he sought out the Brigham study in hopes that accepting a lung infected with hepatitis C would mean a speedier transplant. "I'm thankful I got the lung," said the retired state trooper, who now breathes easy enough to get back on the golf course.
Until recently, doctors tended to transplant hepatitis C-infected organs only into patients who already had that virus.
But in 2016, spurred by powerful new drugs that promised to cure hepatitis C, surgeons began experimenting with so-called mismatched transplants — giving infected kidneys to hepatitis-free recipients. If those patients showed signs of infection, they got three months of medicine to beat it back. Last year, small studies at the University of Pennsylvania and Johns Hopkins University showed not only were patients cured of their hepatitis, the new kidney worked fine.
It was time to test more scarce transplants of lungs or hearts. Among the questions: Would hepatitis C make it harder to transplant those more fragile organs? And because the hepatitis medicine costs tens of thousands of dollars, could patients fare as well with a shorter — and cheaper — course of treatment?
In February, Penn researchers reported the standard three-month treatment cured 10 recipients of a hepatitis C-infected heart. One eventually died of organ rejection but the others were faring well.
Brigham researchers took a different approach. Within hours of either a heart or lung transplant, participants started taking medicine for a month in hopes of blocking hepatitis C infection rather than having to treat it.
The study detailed how about half of the 69 transplant recipients so far are faring. Six months after transplant, none showed signs of hepatitis C and their organs were functioning well. One died eight months after transplant from a bacterial infection unrelated to the hepatitis but 15 are doing well a year later.
Woolley said researchers might test even shorter treatment, noting the virus was undetectable at two weeks.
It might work "because maybe the virus hasn't had the chance to establish itself," said Dr. Peter Reese, a Penn kidney specialist who helped pioneer hepatitis C mismatch transplants but wasn't involved in the latest research. But, "if the short course doesn't work, it's incumbent to be up front with patients about what they would do."
Larger and longer studies are key for all hepatitis C-infected transplants, Reese added.
Many hospitals aren't waiting for more evidence. Last year, there were 1,274 hepatitis C-infected transplants in people without the virus compared to several hundred the year before, according to the United Network for Organ Sharing, which oversees the nation's transplant system.
"It's not established that cure rates are 100 percent," cautioned UNOS chief medical officer Dr. David Klassen. "To believe they would be, would be a little naive."
But one Penn heart recipient said patients should know this option could cut their waiting time. Tom Giangiulio Jr., 59, of Waterford Township, New Jersey, was steadily deteriorating after two years awaiting a transplant when doctors asked if he'd be their study's first volunteer. He was transplanted in June 2017.
"My first thought was saving my life," he recalled. "My next thought was, 'I'm the front-runner here. What I'm doing could open up a tremendous number of hearts to other recipients.'"
Dakar, Mar 28 (AP/UNB) — One out of four people interviewed in eastern Congo last year believed Ebola wasn't real, according to a new study released Wednesday, underscoring the enormous challenges health care workers are now facing.
The survey found that a deep mistrust of the Ebola response resulted in those people being 15 times less likely to seek medical treatment at an Ebola health center, according to the study published in The Lancet Infectious Diseases journal.
The study was based on interviews conducted last September, about a month after the outbreak began. It comes as the number of probable and confirmed cases has exceeded 1,000. At least 639 people have died from Ebola since August in what is now the second deadliest outbreak in history, according to the World Health Organization.
The outbreak's response has been hampered by a series of deadly attacks on Ebola health centers since the study was completed. As a result, Doctors Without Borders has stopped staffing two health centers at the outbreak's epicenter after violent attacks.
Researchers said their study published Wednesday showed more precisely how individual people's misinformed views about Ebola were undermining the response and helping to spread the deadly virus.
"It really helps us understand how central and fundamental community trust should be as part of the response," said Patrick Vinck of Harvard University, who led the research.
Eva Erlach, the community engagement and accountability delegate for the International Federation of Red Cross and Red Crescent Societies, called the findings "absolutely interesting" and said they show how the level of trust correlates with preventative behaviors.
The organization has had more than 800 trained volunteers working to get out prevention messages amid the region's security challenges.
"There is still a part of the community who do not believe that Ebola is real and we definitely still need to continue focusing on community engagement," said Erlach, who was not part of the study. "And this is why this report is so helpful even if it's from September."
WHO Director-General Tedros Adhanom Ghebreyesus said earlier this month he was encouraged "to see the communities accepting the response more and more."
Wednesday's study highlights just how pervasive misinformation has been in places in eastern Congo like Beni and Butembo, where in-person interviews were conducted with 961 people.
Some 25.5 percent of those interviewed did not believe Ebola was real. In addition, nearly 45.9 percent of people thought the Ebola outbreak was being fabricated to destabilize the region or for financial gain. Additionally 18.2 percent believed all three of those statements, the study found.
Those who didn't believe Ebola was real were far less likely to agree to agree to the Ebola vaccine or to go to a treatment center. Ebola is spread through the bodily fluids of the sick, and isolation of those infected is key to stopping transmission.
This outbreak has been uniquely challenging because of the volatile security situation in the region. Eastern Congo is home to numerous armed groups and the Ebola epidemic has deepened the political and economic grievances of many in the area. The fact that people in Ebola affected areas were excluded from the December presidential election has only heightened conspiracy theories.
Tariq Riebl, of the International Rescue Committee, who is currently working in eastern Congo, said the findings released Wednesday mirror what he and his colleagues are seeing on the ground. Concern remains about how Ebola prevention efforts are going because new cases are still emerging.
"Once you reach a wider outbreak zone, especially urban zones, the community engagement and prevention side of things is almost more important than the treatment side," Riebl said.
"If you can't have those messages out successfully, it doesn't matter if you have all the treatment options available because no one is ever arriving to take advantage of that," he said.
Silver Spring, Mar 26 (AP/UNB) — Government medical advisers said Monday it's too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem.
The Food and Drug Administration panel didn't recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks of the devices, which have been subject to safety concerns for decades.
The FDA has been grappling with how to manage emerging science that shows the implants can trigger a rare form of lymphoma that grows in the scar tissue surrounding the breasts. The agency identified about 450 cases of the cancer worldwide, including 12 deaths. Almost all of the cases involve a type of textured implant that is designed to stop implants from slipping and to minimize scar tissue.
But the majority of the 19 panelists — including plastic surgeons and cancer experts — said it was too soon to remove the products from the market.
"Do we want to get into the situation where we pull one sweetener and the replacement is even worse?" said Karla Ballman, a biostatistician at New York's Weill Cornell School of Medicine. "I think a knee jerk reaction of just pulling something without knowing what the replacement will be might get us into more trouble."
Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000. It grows slowly and can usually be successfully treated by removing the implants. The FDA said it has also received reports of the disease in smooth implants — which account for most of the U.S. market.
Another panelist said a ban on textured implants would be an "extraordinary overreaction."
But that opinion wasn't unanimous. The panel's consumer representative stressed the risk to women who get implants for reconstructive purposes after breast cancer surgery and could face a second cancer.
"I think that's so much of a risk that they need to be taken off the market," said Roberta Brummert. Her comments set off cheers from dozens of women who attended the hearing.
In the U.S., roughly 400,000 women get breast implants each year; 100,000 women get them after cancer surgery.
On Tuesday, the same FDA panel will make recommendations on studying and defining the risks of long-term chronic conditions with breast implants. Thousands of women have blamed their implants for a host of other chronic ailments, including rheumatoid arthritis, chronic fatigue and muscle pain.
Patients and advocates have used the recent scrutiny to call for new warnings and restrictions on implants.
"Don't ignore us. We are real," said Holly Davis, of Charleston, South Carolina.
Davis, 60, said she experienced chronic pain, hair loss, rashes and memory loss after receiving silicone gel-filled implants following a double mastectomy in 2002. Davis said she learned her implants had ruptured when they were removed in 2017; her symptoms have since resolved.
She and other patients want the FDA to require manufacturers to give standardized risk disclosure information to all women considering implants.
"We need to know what we're signing up for — it can't be a surprise down the road," Davis said.
In the U.S., most women choose silicone implants, which are considered more natural looking than saline implants. Both types have a silicone outer shell.
The panelists also heard from researchers who theorize, based in part on animal studies, that silicone that leaks from implants can trigger or exacerbate immune system disorders in certain patients.
In 1992, the FDA temporarily pulled silicone gel implants from the market because of fears they might cause breast cancer, lupus and other disorders. But when studies seemed to rule out most of the disease concern, regulators returned them to the market in 2006.
But critics of that research noted its shortcomings at Monday's meeting.
"The studies at that time were not very good and did not have the statistical power to determine rare diseases," said Diana Zuckerman, president of the nonprofit, National Center for Health Research, which published an analysis of more than 20 breast implant studies last year. The group concluded that virtually all were too small or too short or didn't focus on patients who had their implants long enough to develop problems.
The FDA says on its website there is no "apparent association" between breast implants and chronic, debilitating diseases, such as connective tissue disease.
However, earlier this month, the FDA appeared to signal a shift in its thinking. The agency said it would begin studying whether certain materials used in breast implants, metal hips and other devices can trigger health problems in patients.
"We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune-inflammatory reaction when exposed to select materials," the agency said in a statement.