World’s First HIV-To-HIV Kidney Transplant With Living Donor Succeeds

The world’s first kidney transplant from a living HIV-positive donor to another HIV-positive person was successfully performed Monday by doctors at a Johns Hopkins University hospital.

By not having to rely solely on organs from the deceased, doctors may now have a larger number of kidneys available for transplant. Access to HIV-positive organs became possible in 2013, and surgeries have been limited to kidneys and livers.

“It’s important to people who aren’t HIV-positive because every time somebody else gets a transplant and gets an organ and gets off the list, your chances get just a little bit better,” said Dr. Sander Florman, director of the Recanati/Miller Transplantation Institute at Mount Sinai in New York.

Nina Martinez, 35, is the living donor. She donated her kidney to an anonymous recipient after the friend she had hoped to give it to died last fall. Martinez acquired HIV when she was 6 weeks old through a blood transfusion and was diagnosed at age 8.

In a news conference Thursday, Martinez said that even after her friend died, she wanted to carry on in honoring him by donating her kidney and making a statement.

“I wanted to show that people living with HIV were just as healthy. Someone needed that kidney, even if it was a kidney with HIV. I very simply wanted to show that I was just like anybody else,” said Martinez.

Johns Hopkins said that Martinez was being discharged Thursday from the hospital. The anonymous recipient is in stable condition and will likely be discharged in the next couple of days.

Since 1988, doctors have transplanted at least 1,788 kidneys and 507 livers — both HIV-positive and HIV-negative organs — to patients with HIV, according to the United Network for Organ Sharing, a private nonprofit that manages the nation’s organ transplant waiting list. All the HIV-positive organs came from recently deceased people.

Johns Hopkins Medicine was the first to perform the initial HIV-to-HIV transplant from a deceased donor in the U.S. in 2016.

Dr. Dorrey Segev, one of the Johns Hopkins surgeons who performed the organ transplant, said the surgery was no different than any other live donor transplant that he has done because Martinez’s HIV was so well-controlled by antiretroviral medication. He said Johns Hopkins has already been receiving calls from people living with HIV who want to be living organ donors.

“This is not only a celebration of transplantation, but also HIV care,” said Segev during the news conference.

People living with HIV have faced challenges participating in organ transplants as recipients and donors. Organ transplant centers initially hesitated to give these patients organs for fear of inadvertently infecting them with the virus or accelerating the onset of AIDS in the recipient. Physicians thought the medicines given to prevent organ rejection — which suppress the immune system — could allow HIV to attack more of the body’s cells, unchecked.

Yet, some centers assumed the risks and performed these procedures. “There were no rules,” Florman said. “That was the wild west.”

Transplants slowly increased as more evidence proved liver and kidney recipients with HIV survived at rates similar to patients without the virus. But by the 2000s, the medical community and advocates wanted more. Prospective donors with HIV could not donate their organs, as Congress had banned the practice.

The push for change resulted in the HIV Organ Policy Equity Act, known as the HOPE Act, in 2013. This federal law allowed organ transplants between people with HIV in clinical trials. The legislation drastically cuts the waiting time for recipients with HIV who are willing to accept an organ from a person with the virus from years to months, Florman said. Only patients with HIV are allowed to accept these organs.

Kidney and liver transplants began under the HOPE Act three years after the legislation passed. As of March 24, 116 HOPE Act kidney and liver transplants have taken place.

UNOS does not track HIV status information for transplant candidates on its waiting list. But, as of March 8, 221 registrants have indicated they would be willing to accept a kidney or liver from a donor who has HIV.

Under the HOPE Act, recipients and living donors must meet requirements like undetectable levels of HIV, a normal CD4 count — an important type of white blood cell — and no opportunistic infections. Deceased donors are highly scrutinized to make sure they do not have a strain of HIV that is difficult to manage or treat, Florman said.

Researchers are seeking to expand the HOPE Act protocol to other organs. Dr. David Klassen, the chief medical officer for UNOS, said the Johns Hopkins living donor transplant opens up a promising new avenue for both organ recipients and donors living with HIV.

“As we accumulate more safety data, I think it is possible that the HOPE Act could become a standard of care possibly in the next couple of years,” said Klassen. “At some point, I think this will move into the mainstream.”

Some view the legislation not only as an avenue to advance medicine, but also to challenge how people perceive HIV. The ability to donate an organ implies a certain level of health that was once thought impossible in people living with HIV, said Peter Stock, professor of surgery at the University of California-San Francisco and one of the pioneering surgeons in HIV organ transplants.

“It used to be a death sentence,” he said of HIV. “And now we’re transplanting them.”

Dr. Christine Durand, another Johns Hopkins surgeon involved in the organ transplant, encouraged those living with HIV to sign their organ donor cards and contact their local transplant center if they’re interested in living donation.

“I am hoping this leads to a ripple effect,” said Durand. “And many people with HIV will be inspired to sign up as an organ donor as a result.”

[Update: This was story was updated at 3 p.m. ET following a news conference with the kidney donor and Johns Hopkins surgeons.]

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Mozambique to start cholera vaccinations next week after cyclone

BEIRA, Mozambique (Reuters) – Mozambique will start a cholera vaccination campaign next week in areas ravaged by Cyclone Idai, the World Health Organisation (WHO) said on Thursday, after five confirmed cases were detected.

Women braid hair in a tent at a camp for people displaced in the aftermath of Cyclone Idai in Beira, Mozambique, March 28, 2019. REUTERS/Mike Hutchings

Thousands of people were trapped for more than a week in submerged villages without access to clean water after Cyclone Idai smashed into the Mozambican port city of Beira on March 14, causing catastrophic flooding and killing more than 700 people across three countries in southeast Africa.

With tens of thousands of displaced people moved to makeshift camps, relief efforts have increasingly focused on containing outbreaks of waterborne and infectious diseases.

David Wightwick, a senior member of the WHO’s response team in Beira, told reporters that seven clinics had been set up in Mozambique to treat cholera patients and that two more would be ready soon.

“We have 900,000 doses of oral cholera vaccines which are coming in on Monday, and we will start a vaccination campaign as soon as possible next week,” Wightwick said.

Cholera is endemic to Mozambique, which has had regular outbreaks over the past five years. About 2,000 people were infected in the last outbreak, which ended in February 2018, according to the WHO.

But the scale of the damage to Beira’s water and sanitation infrastructure, coupled with its dense population, have raised fears that another epidemic would be difficult to put down.

Wightwick could not confirm whether there had yet been any deaths from cholera in Mozambique.

A Reuters reporter saw the body of a dead child being brought out of an emergency clinic in Beira on Wednesday. The child had suffered acute diarrhea, which can be a symptom of cholera.

In nearby Malawi, which was badly hit by flooding and heavy rains in the leadup to Cyclone Idai, the government said arable and livestock farming had been badly affected and that irrigation infrastructure had been damaged.

Agriculture ministry spokesman Hamilton Chimala said around 420,000 metric tonnes of maize had been lost, representing roughly 12 percent of the country’s forecast output of 3.3 million metric tonnes in the 2018/19 farming season.

Impoverished Malawi is regularly hit by food shortages, so the damage to the country’s staple grain is a cause for concern.

Zimbabwe’s Local Government Minister July Moyo said on Wednesday the government would spend another $18 million to deal with the aftermath of the cyclone.

As of Wednesday, 713 people in Mozambique, Zimbabwe and Malawi had died in the tropical storm and in the heavy rains before it hit.

Reporting by Stephen Eisenhammer in Beira, Frank Phiri in Blantyre, MacDonald Dzirutwe in Harare and Stephanie Ulmer-Nebehay in Geneva; Writing by Alexander Winning; Editing by Gareth Jones

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Bayer shares sag after U.S. jury verdict in Roundup cancer trial

FRANKFURT (Reuters) – Bayer AG shares sank to their lowest in almost seven years on Thursday after a U.S. jury awarded $80 million to a man who claimed use of the group’s weed killer Roundup caused his cancer, with thousands of similar lawsuits looming.

The jury in San Francisco federal court on Wednesday found Bayer liable because its Monsanto unit did not warn plaintiff Edwin Hardeman of the herbicide’s alleged cancer risks.

German chemicals giant Bayer, which bought Roundup maker Monsanto last year for $63 billion, said it would appeal the verdict.

Its shares were down 1.3 percent at 55.59 euros at 1023 GMT. That added to last week’s 9.6 percent plunge after the jury concluded part-way into the trial that there was a causal link between the weedkiller and Hardeman’s disease.

The steep, steady slide since the first adverse verdict in a Roundup lawsuit in August 2018 has pushed Bayer’s value down to about 52 billion euros ($58 billion), which is several billion dollars less than what the drugs and crop chemicals group paid to acquire Monsanto in 2016.

On Wednesday, the jury awarded Hardeman $5 million in compensatory and $75 million in punitive damages. Under a 2003 U.S. Supreme Court ruling, punitive damages are generally limited to less than 10 times the compensatory damages award, meaning the current verdict will likely be reduced, said Adam Zimmerman, a law professor at Los Angeles-based Loyola Law School.

The trial is only the second of more than 11,200 Roundup lawsuits set to go to trial in the United States.

In the first trial, a California man was awarded damages by a jury in state court in August, which were later reduced to $78 million from an original $289 million that Monsanto sought to throw out. The case is on appeal.

FILE PHOTO: Monsanto’s Roundup weedkiller atomizers are displayed for sale at a garden shop near Brussels, Belgium November 27, 2017. REUTERS/Yves Herman/File Photo

A third Roundup trial, handled by the same plaintiff lawyers who won the August verdict, is scheduled to start in California’s Superior Court in Oakland on Thursday.

It was brought by California couple Alva and Alberta Pilliod who were diagnosed with non-Hodgkin’s lymphoma in 2011 and 2015 respectively. They allege their decades-long use of Roundup caused their cancers.

Analysts at JP Morgan and Liberum said Bayer’s stock price shows the market expects an eventual settlement of up to 20 billion euros or 40 billion euros. They said that was overly pessimistic and they expected the final amount to be “substantially lower” than that.

“Even if Monsanto/Bayer may win some cases, there is great uncertainty about the number of victories and defeats. That is why we expect Bayer to try to settle the remaining cases,” said Bryan Garnier analyst Jean-Jacques Le Fur.

Peter Verdult, an analyst at Citigroup, said more focus should be paid to trials later in the year outside of California to better determine settlement estimates. At least two trials are scheduled to take place in St. Louis, Missouri state court this fall.

Hardeman’s case was considered a bellwether trial to help determine the range of damages and define settlement options for the more than 760 other federal cases pending in the same court before U.S. District Judge Vince Chhabria. Other cases will be heard in state courts.

“This verdict does not change the weight of over four decades of extensive science and the conclusions of regulators worldwide that support the safety of our glyphosate-based herbicides and that they are not carcinogenic,” Bayer said.

Monsanto’s Roundup was the first to contain glyphosate, the world’s most widely used weed killer. But it is no longer patent-protected and many other versions are available.

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Bayer does not provide sales figures for the product and analysts no longer deem it a major profit driver.

Genetically modified crops that resist glyphosate’s plant-killing effect, however, contribute heavily to earnings at Bayer’s agricultural division.

The U.S. Environmental Protection Agency, the European Chemicals Agency and other regulators have found that glyphosate is not likely carcinogenic to humans. The World Health Organization’s cancer arm in 2015 reached a different conclusion, classifying glyphosate as “probably carcinogenic to humans.”

Reporting by Ludwig Burger; Additional reporting by Tina Bellon in New York; Editing by Keith Weir and David Gregorio

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Only Spoken Words Processed in Newly Discovered Brain Region

News Picture: Only Spoken Words Processed in Newly Discovered Brain Region

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WEDNESDAY, March 27, 2019 (HealthDay News) — A dementia study has led researchers to a brain region that processes spoken, not written, words.

Northwestern University researchers worked with four patients who had a rare type of dementia called primary progressive aphasia (PPA), which destroys language.

Although able to hear and speak, they could not understand what was said out loud. However, they could still process written words. For example, if they read the word “hippopotamus,” they could identify a picture of a hippo. But if someone said the word “hippopotamus,” they couldn’t point to its picture.

Through their tests with these patients, the researchers were able to identify an area in the left brain that appears specialized to process spoken words.

“We always think of these degenerative diseases as causing widespread impairment, but in early stages, we’re learning that neurodegenerative disease can be selective with which areas of the brain it attacks,” said senior author Sandra Weintraub. She’s a professor of psychiatry and behavioral sciences and neurology at Northwestern’s Feinberg School of Medicine in Chicago.

“The fact that only the auditory words were impaired in these patients and their visual words were untouched leads us to believe we’ve identified a new area of the brain where raw sound information is transformed into auditory word images,” Weintraub explained in a university news release.

Because the study included only four patients, the findings are preliminary. But the study authors said further research could improve understanding of this type of dementia and lead to therapies for it that focus on written, rather than spoken, communication.

“It’s typically very frustrating for patients with PPA and their families,” said Weintraub. “The person looks fine, they’re not limping and yet they’re a different person. It means having to readjust to this person and learning new ways to communicate.”

The study was published March 21 in the journal Cognitive and Behavioral Neurology.

— Robert Preidt

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SOURCE: Northwestern University, news release, March 21, 2019

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Using opioids safely

Doctors may prescribe opioids, a class of drugs used to treat pain, after surgery or an injury. Although opioids can be an important part of treatment, they have serious risks like addiction, abuse, and overdose, especially if used continuously.

That’s why Medicare is working with doctors and pharmacists to perform safety checks to help you use opioids safely. Medicare is also using new drug management programs to look for potentially high-risk opioid use.

These checks and programs generally won’t apply to you if you have cancer, are in hospice, get palliative or end-of-life care, or if you live in a long-term care facility.

Safety checks at the pharmacy

When a prescription is filled at the pharmacy, your Medicare drug plan performs additional safety checks and may send your pharmacy an alert to monitor the safe use of opioids and certain other medications.

These safety checks may cover situations like possible unsafe amounts of opioids, first prescription fills for opioids, or use of opioids at the same time with benzodiazepines (commonly used for anxiety and sleep). If your pharmacy can’t fill your prescription as written, the pharmacist will give you a notice explaining how you or your doctor can call or write to your plan to ask for a coverage decision. Visit the Medicare drug plan coverage rules page for more information about safety checks.

Drug management programs

As of January 1, 2019, some Medicare drug plans have a drug management program in place to help you use opioids safely. If you get opioids from multiple doctors or pharmacies, your drug plan may talk with your doctors to make sure you need these medications and are using them safely and appropriately.

Safety checks and drug management programs are just some of the ways that Medicare, Medicare drug plans, and pharmacies are working together to make sure you’re getting the pain relief treatment you need while keeping you safe. Read your Medicare drug plan’s materials for more information on their specific drug coverage rules.

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Device-Safety Experts To FDA: Make Data Public

Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices.

A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices.

One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public.

While the FDA pledged quickly to review the safety of one such device — the surgical stapler — researchers say the agency needs to open the data on scores of other devices, which have included mechanical ventilators and pacemaker electrodes.

“The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety.

During a recent interview, FDA Commissioner Scott Gottlieb said that he had no immediate plans to release the device-safety reports, but that the matter is under review. In an updated statement Tuesday, he added that “we are looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible.”

“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said during the interview last week. “I think these databases by and large should be searchable to the public.”

An agency spokeswoman said the FDA revoked most of the “alternative summary reporting” exemptions in mid-2017 and asked device makers who kept their exemptions to file a public report summarizing what information they’d send in a spreadsheet directly to the agency. That new approach doesn’t affect the hidden reports dating to 2000.

Agency data show that more than 2 million alternative summary reports have been filed since the start of 2014.

In a February guidance statement for device makers, the FDA said summary reporting can streamline reporting for the industry and simplify the agency’s review process “while maintaining or enhancing the quality, utility, and clarity of MDRs [device reports] through a more holistic view of reportable event trends.”

Makers of about 100 devices filed reports that way over the years, and the FDA has not disclosed the reports’ content beyond responding to KHN’s questions about specific devices. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA.

Asked for more detail on staplers and other devices with exemptions, the agency referred to the Freedom of Information Act process, which can take nearly two years.

That’s not soon enough for organizations like the ECRI Institute. Chief policy officer Ronni Solomon said the nonprofit does device-safety analyses for the government and evidence-based reports for hospitals and performs device-related accident investigations.

Having thorough data on device-related harm is key on all fronts, she said, noting that the organization is exploring ways to get access to more FDA data.

Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency’s public device-safety database, called MAUDE, in his research, said paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation.

He noted that an important safety tenet in hospitals is: the more eyes on the patient the better. He said there’s a clear parallel to the work researchers do with agency data to identify device-safety lapses.

“The FDA isn’t so capable that they can afford to hide data,” he said.

Hani Elias, chief executive of Lumere, said his consulting company uses the open FDA device data to advise health systems across the nation on device safety for purchasing decisions. He co-founded the company after seeing hospitals make device-buying decisions based on the effectiveness of the sales force rather than on quality and safety.

“There’s a lot of benefit in opening up this data,” Elias said.

Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.

“You don’t want to be the people known for the products known for hurting people,” said Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine.

In 2018, the FDA approved a new pathway for makers of 5,600 device types to file malfunction reports in summary format. That program relieves the device makers of seeking a special exemption. It requires one public report detailing a novel or unique type of malfunction. Information about subsequent, similar malfunctions can be sent straight to the FDA in a spreadsheet.

The agency has also quietly granted device makers other summary-reporting exemptions for injury information gleaned from litigation and from device-specific registries used for research. Device makers filing such reports also have to file a public report summarizing the data that is sent directly to the FDA and isn’t readily available to the public.

Agency records show that some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.

Prior to the KHN investigation, Zuckerman said she was aware the FDA granted reporting exemptions but the sheer number of reports “takes my breath away.”

In the interview, Gottlieb said he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.” Gottlieb has announced his resignation; his last day will be April 5.

Card also said the KHN report was a surprise, but now that it’s out, it’s time for the FDA to open the records to help doctors and patients make the safest choices. “There are a lot of people out there who are trying to make reasonable decisions on data that isn’t what it was purported to be,” he said.

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Hospital pharmacists face dozens of drug shortages yearly

(Reuters Health) – More than two-thirds of pharmacists in U.S. hospitals deal with at least 50 drug shortages every year, according to a new study that suggests hospital staff are often forced to ration life-saving medicines as a result.

FILE PHOTO: A technician stocks the shelves of the pharmacy at White House Clinic in Berea, Kentucky, U.S., February 7, 2018. REUTERS/Bryan Woolston/File Photo

Researchers surveyed 719 pharmacists at large and small hospitals across the country in 2018. Every one of them reported experiencing at least one drug shortage in the past year, and 69 percent had dealt with at least 50 shortages in that time.

Most often, pharmacists said they had less than a month of warning about dwindling supplies before they had to manage an active drug shortage, the study team reports in JAMA Internal Medicine.

Four in five pharmacists said they hoarded scarce medicines. One in three said the hospital had to ration drugs and deny medicines to at least some patients who needed them.

“Patients are not commonly told when this occurs,” said lead author Dr. Andrew Hantel of the University of Chicago.

“These are issues that directly impact patients and they should be aware that they exist and occur throughout the United States,” Hantel said by email.

One in three pharmacists said their hospital had no valid administrative mechanism to help them respond to a shortage.

Roughly half the time, individual doctors or treatment teams made decisions on their own about how to allocate drugs being rationed, the study also found.

While most of the rest of the rationing decisions were made by committees, only 5 percent of committees included medical ethicists to help guide the use of scarce medicines.

Rationing was more common at academic hospitals and their affiliates than at community hospitals.

Many drugs involved in hospital shortages are injected or infused medicines for pain relief, treating common health problems like cancer and heart conditions, and fighting infections.

Presently, 226 medicines are in short supply, according to a running list kept by the American Society for Hospital Pharmacists. Current shortages include cancer drugs, vaccines and heart medicines.

The study wasn’t designed to look at whether shortages directly impact patient outcomes. It’s also possible that shortages in hospitals might differ from supply problems for drugs people commonly take at home, the study authors note. Researchers also didn’t examine the causes of drug shortages.

“Shortages can happen for many reasons, including disruptions in the supply chain, manufacturers leaving the market and even natural disasters,” said Dr. Aaron Kesselheim, a researcher at Brigham and Women’s Hospital and Harvard Medical School in Boston who wasn’t involved in the study.

“When Hurricane Maria, for example, tragically struck Puerto Rico, much of the U.S. supply of normal saline was affected because much of it was manufactured there,” Kesselheim said by email.

“Policymakers should take up the question of whether a back-up system is needed to ensure that basic staples of inpatient healthcare delivery remain available,” Kesselheim added. “Substitutes may not be available in all cases, and we conducted a study showing that in the case of a shortage of one product, we found that manufacturers of substitutes responded by apparently raising their prices.”

Patients are often in the dark, said Stacie Dusetzina, a health policy researcher at Vanderbilt University School of Medicine in Nashville, Tennessee, who wasn’t involved in the study.

“In cases where there is a clear substitute, then there may be no impact on patients,” Dusetzina said by email. “However, knowing that you cannot obtain a drug that your doctor wants you to take and that there are no substitutes available could be highly distressing and could impact patient health.”

SOURCE: bit.ly/2CDGPq4 JAMA Internal Medicine, online March 25, 2019.

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Diabetes in pregnancy tied to future heart disease risk

(Reuters Health) – Women with pregnancy-related diabetes are at higher risk for developing cardiovascular disease in the decade after childbirth, a research review suggests.

While so-called gestational diabetes has long been linked to an increased risk of heart disease later in life, some previous research suggests this risk may depend on whether the condition evolves into type 2 diabetes that persists after delivery.

Researchers examined data from nine previous studies with almost 5.4 million mothers. Overall, about 8,000 women with a history of gestational diabetes experienced cardiovascular events like heart attacks and strokes, as did more than 93,000 women without this pregnancy complication.

“This study demonstrates that women with gestational diabetes have a 2-fold higher risk of major cardiovascular events than their peers,” said senior study author Dr. Ravi Retnakaran of the University of Toronto.

“This increased risk is not dependent upon (type 2 diabetes),” Retnakaran said by email. “The risk differential between women with gestational diabetes and their peers emerges within the first decade after pregnancy.”

Compared to women who didn’t have gestational diabetes, those who did had a 2.3-fold greater risk of events like heart attacks and strokes within the first decade after giving birth.

Even when researchers looked only at women who didn’t have type 2 diabetes after pregnancy, they still found gestational diabetes associated with a 56 percent higher risk of serious cardiac events.

Type 2 diabetes is associated with obesity and aging and has long been linked to an increased risk of cardiovascular problems like heart attacks and strokes.

While the study wasn’t designed to prove whether or how gestational diabetes might directly cause cardiovascular events, it’s possible that risk factors like obesity might contribute to both diabetes in pregnancy and heart problems down the line, researchers write in Diabetologia.

“Although it is not entirely clear, most people believe that pregnancy is like a stress test for future diabetes and heart disease,” said Dr. Jacinda Mawson Nicklas, a researcher at the University of Colorado School of Medicine in Aurora who wasn’t involved in the study.

“So it is not that gestational diabetes causes increased risk, but that when a woman gets gestational diabetes she is revealing an increased risk that was already there,” Nicklas said by email.

Women who do develop gestational diabetes may need regular heart health checkups even while they’re still relatively young, the study authors conclude.

There’s a lot women can do to lower their risk of cardiovascular disease before they conceive, Nicklas said. This includes starting pregnancy at a healthy weight and exercising and eating well during pregnancy.

“However gestational diabetes is common and can happen even in normal weight women,” Nicklas said. “If a woman gets gestational diabetes it is important to work closely with her doctor to control her blood sugars”

After pregnancy, women who have had gestational diabetes should maintain a heart healthy diet and lifestyle and see their doctor for screening, said Dr. Jennifer Stuart of Brigham and Women’s Hospital and Harvard Medical School in Boston.

“Adopting a healthy lifestyle after pregnancy – eating a healthy diet, being physically active, not smoking, and not being overweight or obese – may reduce the risk of heart disease and stroke in women with a history of gestational diabetes,” Stuart, who wasn’t involved in the study, said by email.

SOURCE: bit.ly/2U0VF4p Diabetologia, online March 7, 2019.

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Male contraceptive pill crosses the human clinical trial hurdle

Birth control pills have been around for the past six decades but have been for use of women only. A team of researchers this week have announced the success of the first male birth control pill that could safely prevent pregnancy.

Image Credit: Areeya Ann / Shutterstock

Image Credit: Areeya Ann / Shutterstock

The findings of the study were presented on the 24th of March at ENDO 2019, the Endocrine Society’s annual conference. The results of the study are published in The Journal of Clinical Endocrinology & Metabolism, Volume 104, Issue 3, March 2019.

The team announced that the new drug called 11-beta-MNTDC, has passed a 28-day trial with the volunteers experiencing no major side effects and there have been no drop-outs from the study. The new pill contains two hormones – the male testosterone and the female progestin. Dr. Christina Wang, the Associate director of the Clinical and Translational Science Institute at Los Angeles Biomed Research Institute (LA BioMed) explained that till date the pills that have been devised for men have caused an imbalance between these hormones in the body. This had led to effective contraception but in turn had caused lowering of libido. The pills had thus been unacceptable to the users. This new pill balances both hormones and thus the risk of lowered libido is not a possibility. Wang was part of the team from the University Of Washington School Of Medicine in Seattle that worked on developing this pill.

According to the researchers, once taken the two hormones separately work within the body. Progestin helps prevent production of the sperm and reduces the natural levels of testosterone or the male hormone. Lowering of testosterone normally can lead to lowered libido, depression, risk of blood clots and other side effects. This is balanced by the additional testosterone in the pill. Wang said in a statement, “We want [the hormones] to come on and decrease roughly together.” Professor of medicine at the University of Washington School of Medicine, Stephanie Page, in a statement said, “11-beta-MNTDC mimics testosterone through the rest of the body but is not concentrated enough in the testes to support sperm production.”

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For this trial 40 participants were given pills of 200 (14 volunteers) or 400 milligrams (16 volunteers) of the active ingredient or a placebo pill (10 volunteers) for 28 days. The team was looking at the safety and tolerability of the drug rather than its efficacy is reducing the sperm count. Sperm count reduction takes 60 to 90 days of constant hormonal suppression, they explain. This study was thus designed to test the safety of the drug.

Results showed that none of the men showed side effects commonly seen due to very low levels of testosterone including depression and high blood pressure. Some side effects were however reported. This included acne in 22 patients, headaches, mild erectile dysfunction, tiredness, lowered sex drive and a weight gain of an average 2.8 or 4.2 pounds. Three taking placebo pills also exhibited these symptoms.

Wang added that long term effects of the pill are yet to be studied. At present lab animals have been administered these pills for three months or more and health effects on them are being studied before the pills can be given to humans for a longer period, the team explained. Wang said most men do not want to take a pill every day and ultimately the researchers aim to convert the pill into an injection that can be taken at regular intervals.

Dr Page said, “The goal is to find the compound that has the fewest side effects and is the most effective. We are developing two oral drugs in parallel in an attempt to move the (contraceptive medicine) field forward.”

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https://www.endocrine.org/news-room/2019/endo-2019—second-potential-male-birth-control-pill-passes-human-safety-tests and https://academic.oup.com/jcem/article/104/3/629/5105936

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Male contraceptive pill shown to be safe and tolerable in phase I trial

A potential new male birth control pill has been declared safe for use after a phase-one trial showed that the once-daily capsule seemed to work without causing any significant side effects.

The male contraceptive pill has been shown to be safe - picture shows man taking pillsMonika Gruszewicz | Shutterstock

The trial investigators say the pill may be available to use within a decade. The drug aims to suppress the hormones that drive sperm production, whilst preserving libido and enabling reversal of the effect once men stop taking the treatment.

The goal is to expand contraceptive options and create a menu of choices for men like we have for women. We are neglecting a major potential user population with the limited options currently available to men.”

Stephanie Page, Co-senior Investigator

For the study, Page and colleagues invited forty healthy men to participate in a trial at the University of Washington and Los Angeles Biomed Research Institute, where the drug is being developed.

Ten participants were given a placebo and the remaining 30 received a 200mg or 400mg dose of the drug, 11-beta-MNTDC. The formulation contains a type of progesterone that blocks the hormone LH, which is needed for testosterone production in the testes and the hormone FSH, which works together with testosterone to make sperm.

It also contains an androgen hormone that counteracts the resulting drop in testosterone: “Since testosterone production is shut down in the testes, the androgen action in the rest of the body maintains ‘maleness’ elsewhere, supporting things like male pattern hair, deep voice, sex drive and function, and lean body mass,” explains Page.

Capsules were taken once a day with food over a 28-day period, at which point the experiment was stopped so that safety and tolerability could be assessed.

As reported in the Journal of Clinical Endocrinology and Metabolism, Page and team found that LH and FSH levels were significantly reduced among those who took the drug, compared with those who took a placebo, suggesting that the drug had stopped sperm production. Furthermore, lead researcher, Christina Wang, says the effects exerted by the drug were reversible once treatment was stopped.

None of the participants dropped out or found they had less sex during the trial, but some did report mild side-effects including headaches, acne, tiredness, and a slightly decreased libido. Two men also reported having mild erectile dysfunction, although they did not report any decrease in sexual activity.

The Family Planning Association has called the development as a step in the right direction, welcoming any new method of contraception that allows men to take greater responsibility for male contraception: “We believe lots of men would be interested in trying new methods of contraception that will allow them to ease the burden of responsibility for their partners.”

Wang says the next step is to measure the fall in sperm production directly to confirm the decrease and determine whether it is sufficient:

This study is very short and we need three months if not more to stop sperm production. All we have shown so far is that it shuts down the hormones that control the function of the testes.”

Stephanie Wang, Lead Researcher

The researchers say it could be a decade before a male pill becomes available on the market, but that they believe there is strong demand from couples: “When we ask men about hormonal compounds, about 50% are willing to try this new method. And when you ask their partners, the percentage is even higher,” says Wang.

Source:

This research was presented at ENDO 2019: Second potential male birth control pill passes human safety tests.

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