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    Scientists who’ve studied the curious chemistry of the opioid tramadol use an array of adjectives to describe it: “unpredictable,” “messy,” “crazy.” Tramadol is unlike most other opioids in that it must pass through the liver to be metabolized into its most potent form. At the same time, it releases another type of drug that acts as an antidepressant because it increases levels of serotonin in the brain, which elevates mood. But how much opioid and how much antidepressant is released is heavily dependent on users' genetics, said Bertha Madras, professor of psychobiology at Harvard Medical School. One person might get a potent dose of opioid, while the next gets nearly none. Research has shown that some ethnic groups are prone to process tramadol as a far more potent opioid, upping the risk of addiction, Madras said. In a cruel twist, those groups are largely clustered in the areas that lack access to other opioid medications, so are dependent on tramadol for pain relief: Africa, the Middle East and parts of Asia. Studies suggest nearly 30% of North Africans metabolize tramadol to the most active opioid potency, she said, compared with about 1 percent of northern Europeans. Grunenthal, the German pharmaceutical company that originally synthesized tramadol, also points to its strange chemistry to defend its claim that the drug is less prone to be abused. As people begin to abuse most opioids, they move to higher doses, then to snorting or shooting up as they build up tolerance and no longer feel the same high from the same dose. But tramadol, one recent survey suggests, might naturally deter that trajectory because as doses increase, nasty side effects become more pronounced. And since it must pass through the liver to reach full effect, users do not transition to snorting or injecting. Tramadol taken at high doses — particularly when combined with other drugs — can cause the respiratory depression that leads to overdose deaths. The United Kingdom, for example, decided to regulate the drug in 2014, after researchers found that as the number of tramadol prescriptions increased, so did the number of times it was mentioned on death certificates. But it has not as routinely caused overdose as more traditional opioids. Users who take too much often first have a side effect different than other opioids: an overload of serotonin that causes seizures. “Tramadol is most likely not as problematic as some of the big gun opioids like oxycodone and fentanyl and heroin,” Madras said. “But it certainly can be in certain populations and it certainly can be if it’s abused by a wider and wider swath of the population.” When people who’ve become dependent try to stop taking tramadol, they have withdrawal symptoms like those of traditional opioids, including pain, sweating, diarrhea and insomnia, according to the World Health Organization. But the serotonin crash adds other problems: hallucinations, panic, paranoia and confusion.
  • Reports rolled in with escalating urgency — pills seized by the truckload, pills swallowed by schoolchildren, pills in the pockets of dead terrorists. These pills, the world has been told, are safer than the OxyContins, the Vicodins, the fentanyls that have wreaked so much devastation. But now they are the root of what the United Nations named “the other opioid crisis” — an epidemic featured in fewer headlines than the American one, as it rages through the planet's most vulnerable countries. Mass abuse of the opioid tramadol spans continents, from India to Africa to the Middle East, creating international havoc some experts blame on a loophole in narcotics regulation and a miscalculation of the drug’s danger. The man-made opioid was touted as a way to relieve pain with little risk of abuse. Unlike other opioids, tramadol flowed freely around the world, unburdened by international controls that track most dangerous drugs. But abuse is now so rampant that some countries are asking international authorities to intervene. ___ This story was produced with support from the Pulitzer Center on Crisis Reporting. ___ Grunenthal, the German company that originally made the drug, is campaigning for the status quo, arguing that it's largely illicit counterfeit pills causing problems. International regulations make narcotics difficult to get in countries with disorganized health systems, the company says, and adding tramadol to the list would deprive suffering patients access to any opioid at all. “This is a huge public health dilemma,” said Dr. Gilles Forte, the secretary of the World Health Organization’s committee that recommends how drugs should be regulated. Tramadol is available in war zones and impoverished nations because it is unregulated. But it is widely abused for the same exact reason. “It’s a really very complicated balance to strike.” Tramadol has not been as deadly as other opioids, and the crisis isn't killing with the ferocity of America's struggle with the drugs. Still, individual governments from the U.S. to Egypt to Ukraine have realized the drug’s dangers are greater than was believed and have worked to rein in the tramadol trade. The north Indian state of Punjab, the center of India’s opioid epidemic, was the latest to crack down. The pills were everywhere, as legitimate medication sold in pharmacies, but also illicit counterfeits hawked by street vendors. This year, authorities seized hundreds of thousands of tablets, banned most pharmacy sales and shut down pill factories, pushing the price from 35 cents for a 10-pack to $14. The government opened a network of treatment centers, fearing those who had become opioid addicted would resort to heroin out of desperation. Hordes of people rushed in, seeking help in managing excruciating withdrawal. For some, tramadol had become as essential as food. “Like if you don’t eat, you start to feel hungry. Similar is the case with not taking it,” said auto shop welder Deepak Arora, a gaunt 30-year-old who took 15 tablets day, so much he had to steal from his family to pay for pills. “You are like a dead person.” ___ Jeffery Bawa, an officer with the United Nations Office on Drugs and Crime, realized what was happening in 2016, when he traveled to Mali in western Africa, one of the world’s poorest countries, gripped by civil war and terrorism. They asked people for their most pressing concerns. Most did not say hunger or violence. They said tramadol. One woman said children stumble down the streets, high on the opioid; parents add it to tea to dull the ache of hunger. Nigerian officials said at a United Nations meeting on tramadol trafficking that the number of people there living with addiction is now far higher than the number with AIDS or HIV. Tramadol is so pervasive in Cameroon scientists a few years ago believed they’d discovered a natural version in tree roots. But it was not natural at all: Farmers bought pills and fed them to their cattle to ward off the effects of debilitating heat. Their waste contaminated the soil, and the chemical seeped into the trees. Police began finding pills on terrorists, who traffic it to fund their networks and take it to bolster their capacity for violence, Bawa said. Most of it was coming from India. The country’s sprawling pharmaceutical industry is fueled by cheap generics. Pill factories produce knock-offs and ship them in bulk around the world, in doses far exceeding medical limits. In 2017, law enforcement reported that $75 million worth of tramadol from India was confiscated en route to the Islamic State terror group. Authorities intercepted 600,000 tablets headed for Boko Haram. Another 3 million were found in a pickup truck in Niger, in boxes disguised with U.N. logos. The agency warned that tramadol was playing “a direct role in the destabilization of the region.” “We cannot let the situation get any further out of control,” that alert read. Grunenthal maintains that tramadol has a low risk of abuse; most of the pills causing trouble are knock-offs, not legitimate pharmaceuticals, and American surveys have shown lower levels of abuse than other prescription painkillers. The company submitted a report to the WHO in 2014, saying that the abuse evident in “a limited number of countries,” should be viewed “in the context of the political and social instabilities in the region.” But some wealthy countries worried about increasing abuse also have acted to contain the drug. The United Kingdom and United States both regulated it in 2014. Tramadol was uncontrolled in Denmark until 2017, when journalists asked doctors to review studies submitted to regulators to support the claim that it has a low risk for addiction, said Dr. Karsten Juhl Jorgensen, acting director of the Nordic Cochrane Centre and one of the physicians who analyzed the materials. They all agreed that the documents did not prove it's safer. “We know that opioids are some of the most addictive drugs on the face of the planet, so the claim that you’ve developed one that’s not addictive, that’s an extraordinary claim, and extraordinary claims require evidence. And it just wasn’t there,” said Jorgensen. “We’ve all been cheated, and people are angry about that.' Jorgensen compares claims that tramadol is low risk to those made by American companies now facing thousands of lawsuits alleging misleading campaigns touting the safety of opioids unleashed the U.S. addiction epidemic. Stefano Berterame, a chief at the International Narcotics Control Board, said there is a critical difference: The crisis is not as deadly as the American one, which began with prescription opioids and transitioned to heroin and fentanyl. Tramadol does not as routinely cause the respiratory depression that leads to overdose death. But it is mostly afflicting poor nations, where overdose statistics are erratic, he said, so the true toll of tramadol is unknown. ___ The United Nations established the International Narcotics Control Board in 1961 to spare the world the “serious evil” of addiction. It has since tracked most opioids. Tramadol’s exemption means authorization isn’t required as the drug moves across borders. Its easy availability also leads to confusion about what tramadol even is, experts say. In many countries, it is thought to be a mood enhancer or treatment for depression and post-traumatic stress. Some take it to improve sexual stamina or endure grueling labor. Grunenthal synthesized tramadol in the 1960s, as the company was embroiled in scandal over its marketing of the sedative thalidomide, which caused extreme birth defects in thousands of babies whose mothers took it. Tramadol was initially believed to have a low risk of abuse because initial trials studied injected tramadol, the most potent route for most opioids. But researchers later found that tramadol releases a far more powerful dose taken orally because of how it is metabolized by the liver. Tramadol’s worldwide market quickly expanded in the 1990s. In 2000, the WHO, which assesses medications and recommends scheduling, noted reports of dependence. A committee has reviewed the drug numerous times since, recommended it remain under surveillance but declined to add international regulation. There is no alternative to tramadol, said Forte, the committee’s secretary. It is the only opioid available in some of the world’s most desperate places; relief organizations rely on it in war zones and natural disasters. It is used extensively not because it is a particularly good medication, he said. The most effective opioid is morphine, but morphine is strictly controlled and countries in crisis fear abuse. Tramadol became the default precisely because it’s uncontrolled. The WHO is analyzing whether any other drug could take its place but have so far found none. Meanwhile, Forte said, the agency is working with battered nations to ferret out counterfeits. Legitimate tramadol remains a lucrative business: market research estimates the global market amounts to around $1.4 billion, according to Grunenthal. The medication long ago lost its patent protection. It is now manufactured by many companies and sold under some 500 brand names. Grunenthal markets it as Tramal as well as Zaldiar, tramadol combined with paracetamol. In 2018, those products brought in 174 million euros ($191 million), according to the company’s annual report. “Our purpose at Grunenthal is to develop and deliver medicines and solutions which address the unmet needs of patients with the goal of improving their quality of life,' the company wrote in a statement that said it acknowledges opioids pose a risk of abuse and addiction. “”We do so with the highest ethical standards.” Grunenthal also sells other opioids and is expanding around the world. The Associated Press this year revealed executives were swept up in an Italian corruption case alleging they illegally paid a doctor to promote the use of opioids. The company has campaigned to keep tramadol unregulated. It funded surveys that found regulation would impede pain treatment and paid consultants to travel to the WHO to make their case that it’s safer that other opioids. Spokesman Stepan Kracala said regulation would not necessarily curtail illicit trade and could backfire: Some desperate pain patients turn to the black market if no legal options exist. Egypt’s long struggle with tramadol abuse is an example, he said. The country enacted strict regulation in 2012 and a later survey found some suffering from cancer using counterfeit tramadol for relief. Kracala also pointed to regulatory decisions as proof of tramadol’s comparable safety: The U.S. in 2014 added tramadol to its list of controlled substances but included it in a lesser category than opioids like oxycodone or morphine, signaling it is less risky. There are growing calls to change that. The Mayo Clinic hospital in Minnesota worked to reduce opioids prescribed post-surgery as the American epidemic escalated, said surgeon Cornelius Thiels. Doctors there started shifting patients to tramadol because it was billed as safer. But Thiels and his colleagues analyzed prescription data and were surprised to find patients prescribed tramadol were just as likely to move on to long-term use. They published their findings this year to alert authorities, he said: “There is no safe opioid. Tramadol is not a safe alternative. It’s a mistake that we didn’t figure it out sooner. It’s unfortunate that it took us this long. There’s a lot more that we need to learn about it, but I think we know enough that we also can’t wait around to act on this.” ___ Indian regulators knew the massive quantities manufactured in the country were spilling over domestically and countless Indians were addicted. But S.K. Jha, responsible for the northern region of India’s Narcotics Control Bureau, said he was shocked to learn in 2018 that tramadol from India was ravaging African nations. They realized then they needed to act, he said. India regulated tramadol in April 2018. Regulators say exports overseas and abuse at home came down. But they acknowledge that the vastness of the pharmaceutical industry and the ingenuity of traffickers makes curtailing abuse and illegal exports all but impossible. Tramadol is still easy to find. Jyoti Rani stood on her front steps and pointed to house after house where she said tramadol is still sold in her neighborhood of narrow roads and open drains, where school-aged boys sit hunched over the street in the middle of a weekday. Rani’s addiction began with heroin. When her 14-year-old son died, she fell into depression. “I wanted to kill myself, but I ended up becoming an addict,” she cried. A doctor prescribed tramadol to help kick the habit — instead, she formed a new one. She locked herself in her room, not eating or taking care of her two children. Rani used tramadol until she ran out of money and entered treatment. Now her family tells her she’s her old self again. The crackdown on tramadol coincided with the opening of dozens of addiction clinics that administer medicine and counseling to more than 30,000 each day. “We are trying our level best,” Jha said, “but it’s a challenge for all of us.” Countries’ efforts to control tramadol on their own often fail, particularly in places where addiction has taken hold, according to the Center for Strategic and International Studies. India has twice the global average of illicit opiate consumption. Researchers estimate 4 million Indians use heroin or other opioids, and a quarter of them live in the Punjab, India’s agricultural heartland bordering Pakistan, where some of the most vulnerable are driven to drugs out of desperation. Amandeep Kaur was pregnant when her husband died of a heart attack. She turned to the sex trade to make ends meet. She wanted not to feel, and a fellow sex worker suggested tramadol. She had no idea she’d get addicted, but eventually needed three pills to get through the day. “If I didn’t have it I felt lifeless, my body ached as if I was going to die,” she said, and joined the line stretching from the addiction clinic’s doors. ___ The Global Opioids project can be seen here. https://www.apnews.com/GlobalOpioids ___ Associated Press journalist Rishi Lekhi contributed to this report.
  • The country's most populous state could become the first to require a portion of new truck sales be electric or “zero emission” vehicles as California grapples with how to clean up its worst-in-the nation air quality. Home to the two largest ports in the country in Los Angeles and Long Beach, California has roughly 1.5 million medium and heavy duty trucks on the road that spew harmful pollutants as they haul freight to warehouses. The state's transportation sector accounts for 41% of all greenhouse gas emissions, a cause of climate change, and is a major source of ozone and particulate matter pollution that can cause respiratory problems. Regulators estimate the new rules would result in roughly 74,000 zero emission trucks on the road in California by 2030, or about 4% of all trucks. California already has a rule requiring car makers to offer for sale specific numbers of clean cars. But Mary Nichols, chairwoman of the California Air Resources Board, said the truck rule would be the first of its kind in the world. The board considered the new rule in a public hearing on Thursday that drew more than 100 public comments. The board won't vote on the proposal until next year. But Thursday was the last chance for advocates and opponents to weigh-in. “Trucks are increasingly a major contributor to air pollution nationwide, but especially in our cities where they are among the largest sources of toxic emissions in vulnerable neighborhoods,” Nichols said. If adopted, at least 15% of sales of heavy duty pickup trucks like the Ford F-250 and full size vans like the Chevrolet Express must be zero emission vehicles by 2030. That standard also applies to the heaviest trucks, including tractor trailers. The standard is tougher for box trucks and delivery trucks, mandating at least half of all new sales be zero-emission vehicles by 2030. The rules are part of the state's plan to have 100% zero emission truck sales by 2040. By then, state regulators say the phased-in limits could prevent more than 600 premature deaths due to poor air quality in California. Sales requirements for the heaviest trucks would begin in 2024 and gradually increase until 2030. Sales requirements for pickup trucks would not begin until 2027. The proposed rules continue California’s aggressive push on environmental regulations, which already include tougher emission standards on cars and trucks than the federal government imposes and a first-in-the-nation cap-and-trade system that requires big polluters to purchase credits to let them pollute. Most environmental groups support the rule, but they say it is not strong enough. Trucks last longer than passenger vehicles, which is why companies are slower to replace their fleets. While the rules would impact up to 50% of some new truck sales by 2030, it would only result in about 4% of trucks on the road being zero emission vehicles. Andrea Vidaurre, policy analyst for the Center for Community Action and Environmental Justice, said these types of trucks historically are clustered in poorer communities. That includes communities in the Inland Empire, an area next to Los Angeles where warehouses store freight from ports. The group says low-income communities can be most impacted environmental health hazards. “We have so much traffic going in right now just in this area, and the rule currently, it would barely cover it,” she said. Jed Mandel, president of the Truck and Engine Manufacturers Association, said he supports efforts to get more zero-emission trucks on the road. But he said making rules “on a naked sales mandate is fundamentally flawed.” “Trucks are not cars. Our customers invest capital to purchase vehicles that must return a profit,” Mandel said. “We all know today that (zero emission vehicles) are more expensive than traditionally fueled vehicles.' Mandel said California regulators should narrow the rule to apply to trucking segments that are “more readily suited to that technology,” including school buses and municipal fleet step vans.
  • More than 130,000 people have purchased health insurance through California's state-run marketplace for the first time, a 16% increase from last year now that the state is offering more money to help people pay their monthly premiums and will begin taxing people next year who refuse to buy insurance. Covered California released the numbers on Thursday ahead of a Sunday deadline for people to purchase insurance and have their plans effective Jan. 1. Plans purchased after Sunday would take effect Feb. 1. California's open enrollment period closes Jan. 31. In addition to the new enrollments, more than 1.13 million people in California have renewed their plans for next year. Former President Barack Obama's health care law created marketplaces where people who don't get insurance through their employer can shop and compare prices. Most states let the federal government operate their marketplaces. California is one of 13 states that operates its own marketplace. The federal government helps some people who purchase their health insurance on these marketplaces pay their monthly premiums. To be eligible, people must earn less than 400% of the federal poverty level, or $25,750 for a family of four. California offers additional help. For people who earn up to 400% of the federal poverty level, the state will chip in an extra $21 per month for payment of monthly premiums. So far, that's about 460,000 people. And this year, California became the first state in the country to give premium assistance to households earning up to 600% of the federal poverty level. That means families of four with an annual household income of up to $154,500 per year would be eligible. Covered California Executive Director Peter V. Lee announced about 44% of people in that income range who have purchased insurance on the state marketplace have qualified for assistance. That's about 23,000 people. But Lee said he expects the number to grow considerably in coming weeks. California pays for those subsidies mostly by taxing people who refuse to purchase insurance, with some exceptions. The tax would be at least $2,000 for a family of four. The federal government once imposed a similar tax until the Republican-controlled Congress repealed it as part of a 2017 overhaul to the tax code. Lee estimated the tax will generate between $300 million and $400 million for California. That will not cover all of the state's subsidies, but the state will pay for the rest from its general fund. “The goal is to have no one pay that penalty. We’d rather have everyone with insurance,” Lee said. California's numbers come while the federal marketplace that covers 38 states has experienced a 3.5% drop in new enrollments compared to last year. But the enrollment period for the federal marketplace is one day shorter this year. The federal marketplace also no longer includes Nevada, which now operates its own exchange. Plus, Maine and Virginia have since expanded their Medicaid programs, meaning fewer people in those states will need to purchase insurance. When factoring in those things, new enrollments for the federal marketplace are close to last year's numbers — which would break a multi-year trend of decline, according to Joshua Peck, co-founder of the nonprofit Get America Covered and former chief marketing officer for the Centers for Medicare & Medicaid Services under President Obama. 'The fact California is up 16% is really something they should be proud of,' Peck said.
  • The death toll in the vaping illness outbreak has topped 50, U.S. health officials said Thursday. The 52 deaths in 26 states are among the 2,409 hospitalized cases that have been reported across the nation this year, the Centers for Disease Control and Prevention said. Hospitalized cases have been most common in the Midwest, with some of the highest rates in Illinois, Indiana, and Wisconsin. The median age of the people who died is 52, but most people who suffered lung damage have been much younger, with half in their teens or early 20s. The outbreak appears to have started in March. The bulk of the cases occurred in August and September, but new cases are still being reported, including 118 in the past week, the CDC said. Some of the newly reported illnesses happened more than a month ago but were only recently reported. However, 43 percent of the latest batch of cases were people hospitalized since Nov. 17, the agency said. Most patients have said they vaped products containing THC, the ingredient that produces a high in marijuana. CDC officials have gradually come to focus their investigation on black-market THC cartridges. Last month, CDC officials said they had narrowed in on a culprit — a chemical compound called vitamin E acetate that has been commonly found in the lungs of sick patients and in the products they vaped. It's a thickening agent that's been added to illicit THC vaping liquids. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
  • The Senate on Thursday confirmed Dr. Stephen Hahn to lead the Food and Drug Administration despite concerns about how he will confront the growing problem of underage vaping. Hahn, a cancer specialist and hospital executive, won confirmation to the role of FDA commissioner with a vote of 72-18. The move comes as key decisions about regulating electronic cigarettes, including how to keep them away from teenagers, remain unresolved. More than three months ago President Donald Trump and his top health officials said they would soon sweep virtually all flavored e-cigarettes from the market because of their appeal to children and teens. But that effort has stalled after vaping lobbyists pushed back and White House advisers told Trump the ban could cost him votes with adults who vape. In his confirmation hearing last month, Hahn repeatedly sidestepped questions about the fate of the flavor ban. When lawmakers tried to pin down his preferred approach to regulating vaping, Hahn said only that he would follow the “science and evidence.” Still, he won the backing of several key vaping critics in the Senate, including Illinois Democrat Dick Durbin, who said he hoped Hahn would use his influence to push the Trump administration to crack down on the industry. “Dr. Hahn said to me he doesn't want to be known in history as the head of the FDA who saw this epidemic grow dramatically,' said Durbin, speaking on the Senate floor Wednesday. Durbin, the No. 2 Democrat in the Senate, supports legislation that would place new taxes on e-cigarettes and restrict flavors with the aim of discouraging underage use. Anti-vaping groups and health experts argue that flavors like fruit, mint, menthol and others attract underage teens. But vaping proponents say flavors can help adult smokers switch to vaping from cigarettes, which cause cancer, lung disease, stroke and other deadly diseases. Underage vaping has reached what health officials call epidemic levels. In the latest government survey, 1 in 4 high school students reported using e-cigarettes in the previous month, despite federal law banning sales to those under 18. More than a third of U.S. states have already raised their sales age for e-cigarettes and other tobacco products to 21. E-cigarettes typically heat a solution that contains nicotine, which makes cigarettes and e-cigarettes addictive. They are generally considered less harmful than paper-and-tobacco cigarettes, though there is little research on their long-term health effects. Hahn, 59, will succeed Dr. Scott Gottlieb, who left the federal agency in April. Gottlieb bucked expectations early in his tenure by announcing an unprecedented effort to curb smoking. Under the plan outlined in July 2017, the FDA would use its authority to cut nicotine in cigarettes to non-addictive levels, encouraging smokers to quit or switch to less harmful products, such as e-cigarettes. The proposal for cutting nicotine was targeted for release in October this year, according to the agency's regulatory agenda. But it didn't appear and was dropped last month from the FDA's updated list of regulatory priorities. An FDA spokeswoman said the agency is continuing to review the policy. But anti-tobacco advocates worry the Trump administration is backing away from its earlier commitment to making cigarettes less addictive. The FDA regulates a broad array of consumer goods and medicine — everything from new drugs and medical devices to packaged food, nutrition labeling, tobacco and cosmetics. As FDA commissioner, Hahn will face a raft of other pressing health issues, including dealing with the prescription opioid epidemic, safety problems with imported drugs and the regulation of CBD, a marijuana derivative that has become a trendy food additive. Hahn, who specializes in treating lung cancer, most recently worked as the top medical executive at MD Anderson Cancer Center in Houston. ___ Follow Matthew Perrone on Twitter: @AP_FDAwriter ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
  • A German doctor has been convicted for the second time of violating a ban on advertising abortions in a case that has become a rallying point for opponents of the law. News agency dpa reported Thursday that Kristina Haenel was fined 2,500 euros ($2,775) by the state court in the central city of Giessen. Alongside the fine, it made clear that it wasn't convinced the law is in line with Germany's constitution. In 2017, Haenel was fined 6,000 euros after stating on her website that she carried out abortions. That violated a German law that bans 'advertising' the procedure, and which carries a fine or a prison sentence of up to two years. In July, a Frankfurt court overturned that conviction and ordered a retrial after the government loosened the rules on the issue. Under a compromise reached earlier this year, Chancellor Angela Merkel's governing coalition left the ban on advertising abortions formally in place but allowed doctors and hospitals for the first time to say on their websites that they perform abortions. They were not, however, allowed to give more detailed information. Haenel, who has argued that the change doesn't go far enough and still amounts to 'state censorship,' plans to appeal the latest ruling. The change in the law on advertising didn't affect Germany's law on abortion itself. The procedure is allowed in the first 12 weeks of pregnancy on condition that a woman undergoes counselling at least three days beforehand.
  • Sharpening their 2020 election message, House Democrats on Thursday pushed through legislation that would empower Medicare to negotiate prescription drug prices and offer new benefits for seniors. The vote along party lines was 230-192. Speaker Nancy Pelosi's bill would cap Medicare recipients'out-of-pocket costs for medicines at $2,000 a year. It would use about $360 billion of its projected 10-year savings from lower drug costs to establish Medicare coverage for dental care, hearing, and vision, filling major gaps for seniors. But the legislation has no chance of passing the Republican-controlled Senate, and the White House has issued a veto threat. Still, Democrats saw a victory in the message their bill sends to voters. “I think that it is going to be too hot to handle for the Republicans,” said Pelosi, D-Calif. She is claiming bragging rights because her bill would deliver on the promise that Donald Trump made as a candidate in 2016, when he said he would “negotiate like crazy” to lower prescription drug prices for Medicare recipients. It's a pledge that Trump has backed away from as president. For months, Pelosi's office and the White House had talked privately about Medicare negotiations. But the sides went their own ways partly because administration officials concluded her approach could never win support among congressional Republicans. Trump now favors a bipartisan compromise in the Senate that would limit drug price increases and cap what seniors pay out-of-pocket, but would not authorize Medicare negotiations. Negotiations are “the heart of the matter,” Pelosi insisted. High prescription drug prices consistently register as the public's top health care concern. But it's unclear in a capital divided over Trump's impeachment that any major legislation will pass before next year's elections. Pelosi's bill 'is a serious proposal but everyone knows that the Senate isn't going to go for it,” said John Rother, CEO of the National Coalition on Health. “It is about legislating, but even more it's about establishing a platform that Democrats can run on going into the next election cycle and lays the groundwork for legislative activity in 2021,' Rother said. His organization is an umbrella group that represents health care industry groups and consumers. The pharmaceutical industry is strongly opposed to the bill. Among the groups backing it is AARP. Medicare's popular prescription drug benefit is delivered through private insurers. Republicans say the government has no business setting prices for medicines. They argue that the hit on the pharmaceutical industry's bottom line will stifle innovation, discouraging investment in the hunt for cures for Alzheimer's and other intractable illnesses. “Drugs that save lives will not be around,” said Rep. Greg Walden, R-Ore. “Innovation goes on the rocks; lives will be lost.” House Republican leader Kevin McCarthy of California accused Democrats of putting politics over solutions, 'catering to their progressive base by opening the door to a government takeover of our prescription drug market.” Republicans point to a major concern about the legislation: that it would result in fewer drugs coming to market. But there's debate about the extent of the expected impact. The nonpartisan Congressional Budget Office estimates about 3% to 10% fewer new drugs. The White House Council of Economic Advisers says it could be much higher, up to one-third of new medications. Rep. Bobby Scott, D-Va., who helped write the Pelosi bill, said Republicans predicting the drug pipeline will dry up are using scare tactics. “Any drug that’s out there, we’re going to have access to,” he said. “The U.S. would still be the biggest market.” The bipartisan Senate bill the White House is now backing steers clear of negotiations. It would cap seniors' out-of-pocket costs, at $3,100 a year, and require drugmakers to pay Medicare rebates if companies raise prices above inflation. Senate Majority Leader Mitch McConnell, R-Ky., hasn't said if or when he'll bring it to the floor. Inflation rebates are included in Pelosi's bill as well, so there's considerable overlap. But Pelosi's measure goes further with several unique features, including: — Medicare would be authorized to negotiate prices for costly medications, using a formula based on lower prices paid in other economically advanced countries. — Drugmakers that refuse to negotiate would be hit with steep sales taxes for the medication at issue. Republicans say proposed taxes as high as 95% are unconstitutional. The budget office projects that most pharmaceutical companies would opt to accept lower prices from Medicare. — Private health insurance plans would be able to receive Medicare's discounted prices. Congressional budget experts estimate the price negotiations provisions of Pelosi's bill would save $456 billion over 10 years. After subtracting for new Medicare benefits, that still leaves money for medical research, community health centers, and countering the opioid epidemic. Democrats have named the drug legislation after the late Rep. Elijah Cummings, D-Md., who early on sought a dialogue with Trump on drug prices. Cummings, as chairman of the House Oversight and Reform Committee, was a target of Trump outbursts on Twitter.
  • When Clara Massons was in labor with her son, a midwife climbed onto her bed and pushed down on Massons’ belly, explaining that she was helping to deliver her baby. For the next few hours, the midwife and a doctor took turns pressing down during contractions, using an old, now controversial technique for troubled deliveries. Masson said her pleas to stop were ignored at the Barcelona hospital where she delivered two years ago, and she later complained to authorities. The hospital said doctors took “appropriate measures” during her delivery. “I thought I was going to die,” she said. “For one month after, my belly was blue and purple.” The technique is known as the Kristeller maneuver and was first described in an 1867 German textbook. It is sometimes used during the second stage of labor to assist delivery and avoid a cesarean section when complications arise. But many doctors in developed countries say they have stopped using it because of the potential for broken bones, organ damage, and other complications. The World Health Organization does not recommend the technique. Yet the procedure is still commonly performed in many European countries, highlighting how once-accepted practices can persist even long after they’re considered to be unnecessary or even dangerous. Europe has some of the world’s lowest maternal and infant death rates, and assertions of mistreatment during childbirth are more common in Africa, Asia and Latin America. But the Kristeller maneuver and some other medical practices related to childbirth have come under increasing scrutiny in Europe, including complaints about inadequate anesthesia, surgical incisions during vaginal births and failure to seek patient consent for certain procedures. “Depending on the act, these practices rise to the level of a human rights violation,” said Mindy Roseman, director of a global justice and women’s rights program at Yale Law School. “Not obtaining consent from women for medical procedures, not providing pain relief or doing something that’s not scientifically justified, that is simply not the standard of care and it’s troubling wherever that occurs.” Last year, Croatian lawmaker Ivana Nincevic Lesandric drew attention to the anesthesia issue when she complained to Parliament she did not receive any for an emergency procedure after a miscarriage. “I don’t think I’ve ever been in (a) much more painful situation in my life,” Lesandric said. In response, the Speaker of the House chastised Lesandric for speaking over her allotted time and for publicly sharing such intimate details, saying it put him in an awkward position. The Ministry of Health, while not directly commenting on her case, said doctors typically use a local anesthetic for such procedures. Officials suggested there may have been a “misunderstanding” on Lesandric’s part regarding the type of anesthesia she received. Dr. Frederick Mercier, chair of obstetrics for the European Society of Anesthesiology, said general anesthesia is “most often used” in procedures like the one Lesandric had. He said local anesthesia isn’t used because “it is less effective.” In the days following her speech to Parliament, a childbirth advocacy group asked for and received hundreds of complaints about medical care from Croatian women. Three U.N. human rights experts, including two from Croatia, later said the responses “showed a pattern of abuse and violence against women undertaking medical procedures.” “I see it as another #MeToo campaign where certain issues were not being seen as human rights violations and were being tolerated,” said Ivana Radacic, a Croatian who sits on a panel for the U.N.’s Human Rights Council. In submissions for a U.N. report presented in October, several European countries or government-appointed experts acknowledged lapses in how informed consent from women during childbirth was obtained. The Czech Republic wrote that women were sometimes given documents to sign “without any explanation or information on the nature or reason for the procedure.” Dr. Ozge Tuncalp, a maternal and reproductive health care expert at WHO, said the U.N. health agency has noted increasing reports of mistreatment by women seeking health care in Europe. “Some of these things have become common practice and people think this is what they’re supposed to do, so it is very difficult to undo,” she said. The WHO says a once common procedure — a surgical incision to enlarge the vagina during childbirth and prevent tears — should not be used in more than about 10% of women and that consent should be mandatory. Yet government figures show rates range from 30% to more than 90% in countries including the Netherlands, Portugal, Spain and Romania. In France, a 2018 government report estimated that half of women who had the incision weren’t told beforehand. In Italy, one survey estimated 61% of women did not consent. Marta Busquets, a Spanish lawyer, said she asked the two midwives handling her delivery not to make the incision, but that they cut her anyway. “I felt really humiliated, but it’s my word against theirs,” she said. The hospital would not comment on her case, but said the procedure should not be performed routinely and that it obtains verbal consent when it is performed. In October, the Council of Europe passed a resolution on “obstetrical and gynecological violence.” Among other recommendations, it called on European member countries to implement laws on informed consent and to create specific reporting and complaint mechanisms, including sanctions for mistreatment. How often the Kristeller maneuver is used isn’t clear since it often isn’t included in medical records. Doctors, nurses and midwives in countries including Bulgaria, Croatia, Hungary, Italy, Portugal, Romania and Spain told The Associated Press they see it used on a weekly, if not daily, basis. A French government report last year estimated it was used in about 22% of births. In Italy, researchers concluded in a 2018 study that the Kristeller technique was documented in medical records only in about 10% of cases. “The evidence says it’s not helpful, it’s actually harmful,” said the WHO’s Tuncalp. “The fact that so many women are getting an intervention that both national and international guidance recommend against, is very worrying.” The technique is prohibited in the U.K., according to Dr. Patrick O’Brien, of Britain’s Royal College of Obstetricians & Gynaecologists. In the United States, the American College of Obstetricians and Gynecologists said they had no guidelines on the Kristeller maneuver because it is not recommended. “I can’t think of any reason you would resort to this,” said O’Brien. Dr. Ligita Jokubkiene of Sweden said she thinks it is still used because many doctors and midwives aren’t aware of the dangers. She learned it in medical school but no longer performs it herself. “If the woman was having bad contractions or if we wanted the delivery to go a bit quicker, it was easier to press on the woman and try to get the baby out fast,” she said. Spain’s Ministry of Health instructed health professionals to stop using it in its 2007 guidelines. But in a 2016 evaluation, government officials found it was still being done in about a quarter of women having vaginal births. Massons and her husband, Toni, remain troubled by the birth of their son Jaume, now 2. Massons was told the technique was needed because her labor had slowed, and because the baby was in a worrying position. In a letter to Massons that she shared with the AP, Dr. Miquel Gomez, medical director of the private Barcelona hospital where Massons gave birth, wrote that doctors took “appropriate measures.” The ombudsman for the Catalonia region noted the Kristeller technique was “discouraged” but not legally banned. WHO’s Tuncalp said that transforming medical care — and not just guidelines — is very difficult. “It can take generations of doctors to actually change practices in the labor ward,” she said.
  • A group of doctors on Wednesday ended a three-day protest against the U.S. government's refusal to allow the flu vaccine be administered to migrants, following the arrests of six demonstrators outside a Border Patrol regional headquarters in San Diego. Dr. Bonnie Arzuaga said Customs and Border Patrol officials met briefly with her and other protest leaders and vowed to pass her organization's request to start a pilot program to inoculate migrants in detention facilities in San Diego up their chain of command. In the past year, three migrant children have died from influenza after being detained by U.S. Border Patrol agents. They include a 16-year-old Guatemalan boy seen on security footage writhing in agony before he died of influenza in a Border Patrol holding cell. Customs and Border Protection has said they are not equipped to run a vaccination program. “It has never been a CBP practice to administer vaccines,' the agency said in a statement. It added that other agencies are in place to offer such vaccines to people in its custody when appropriate. Arzuaga, a pediatrician from Boston, said the Centers for Disease Control recommends all children above the age of six months be vaccinated against the flu. She said doctors showed up ready to administer vaccines to migrants at a San Diego-area detention facility for free but were kept locked out. So they held an hours-long protest Monday. “We are using our voices as public health physicians to sound the alarm,' said Arzuaga, the founder of Doctors for Camp Closure, representing about 2,000 medical professionals and students. “All we're trying to do is prevent more deaths.' On Tuesday, about 70 doctors and others demonstrated outside the San Diego Sector Border Patrol headquarters, where four doctors and two others were arrested after laying down on a driveway, preventing employees from leaving. Officials met briefly with the group after the arrests were made, Arzuaga said. On Wednesday, about 40 people held a vigil for those who have died while in detention facilities, gathering at the San Ysidro port of entry, one of the world's busiest pedestrian crossings. Then she and other demonstration leaders met again with Customs and Border Protection officials. The Department of Homeland Security's press secretary defended the decision to not let in the doctors, saying on Twitter: “Of course Border Patrol isn't going to let a random group of radical political activists show up and start injecting people with drugs.' Arzuaga said she was saddened the administration was attacking her and others for addressing a public health issue. “We're very much in middle of flu season now,' she said. “We're sort of missing the window of opportunity to keep people protected, not only people in detention facilities, but also in our communities.' Medical professionals repeatedly asked to be able to vaccinate migrants in letters sent months ago to the Trump administration, including the secretaries of health and human services and homeland security, but got no response. Arzuaga said Wednesday they were told Dr. David Tarantino, the senior medical adviser to Customs and Border Protection, would get back to them. The agency said in a statement that “the men and women of the U.S. Customs and Border Protection also share the concern about the welfare of those who come into our custody, and we stand by our process.' It noted that it has recently increased its medical staff to more than 250 health care employees working along the border, and migrants sent to longer-term facilities usually receive such vaccinations. But doctors say many migrants are sent from the short-term holding facilities back to Mexico to wait out their asylum requests under a Trump administration policy. There they often live in crowded shelters and unsanitary conditions. ___ This story has been corrected to show the protest was held at Border Patrol headquarters, not at a detention facility.