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About The Bulletin. (Bend, OR) 1963-current | View Entire Issue (June 8, 2021)
The BulleTin • Tuesday, June 8, 2021 A5 FDA approves Alzheimer’s drug panned by experts BY MATTHEW PERRONE Associated Press WASHINGTON — Government health officials on Monday approved the first new drug for Alzheimer’s dis- ease in nearly 20 years, disregarding warnings from independent advis- ers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. The Food and Drug Administra- tion approved the drug from Biogen based on study results showing it seemed “reasonably likely” to bene- fit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of Americans and their fam- ilies, is certain to spark disagreements among physicians, medical research- ers and patient groups. It also has far-reaching implications for the stan- dards used to evaluate experimental therapies, including those that show only incremental benefits. The new drug, which Biogen de- veloped with Japan’s Eisai Co., did not reverse mental decline, only slow- ing it in one study. The medication, Connections Continued from A1 The program recently received a $137,837 grant from the Central Oregon Health Council. And the program is also using a software system to collect statistics on the number, frequency and duration of phone calls. The informa- tion will then be analyzed by the Oregon Health & Science University Com- munity Research Hub to understand the effect of the weekly calls. LaBuda said the program may soon expand to in-per- son visits as well. “We already have vol- unteers who would like to go see the people,” LaBuda said. “They would like to meet them when it gets safe and build a friendship in person.” Bradley signed up for the program three months ago and was matched with Alli- son. Bradley has experience caring for seniors through her business, The Devoted Daughter, which offers re- sources for professional caregivers and those care- giving for a family member. “This is kind of in my wheelhouse,” Bradley said. “I saw the ad and thought I can do this. It’s not a big deal. I called and said I’d love to help if I can.” Every time Allison an- swers the phone, Bradley can tell she is smiling. “She is very positive. She’s always happy,” Bradley said. “She has lots of interest- ing stories. Although we come from different back- grounds, we always find things to chit chat about. I think it’s good for both of us.” The weekly phone calls often turn into productive conversations. A couple weeks ago, Allison was writ- ing a story for her grandson and needed help giving the characters names. Bradley helped Allison come up with ideas. “It’s just good to be able to help her, and I enjoy it,” Bradley said. After three months, Bradley feels like she knows Allison on a personal level. She would be able to tell if something was wrong with Allison. The weekly calls of- fer comfort for them both. “We spend hours on the phone,” Bradley said. “I would be worried if she was down in the dumps. That’s not her.” e Reporter: 541-617-7820, kspurr@bendbulletin.com “We already have volunteers who would like to go see the people. They would like to meet them when it gets safe and build a friendship in person.” — Denise LaBuda, Council of Aging of Central Oregon What does it do? Aducanumab (add-yoo-CAN’-yoo- mab) helps clear a protein called beta- amyloid from the brain. Other experimental drugs have done that, but they made no difference in pa- tients’ ability to think, care for them- selves or live independently. David A. White/Biogen via AP A researcher works on the development of the medication aducanumab in Massachu- setts. Aducanumab will be the first new drug for Alzheimer’s disease in nearly 20 years. aducanumab, will be marketed as Aduhelm and is to be given as an in- fusion every four weeks. Dr. Caleb Alexander, an FDA ad- viser who recommended against the drug’s approval, said he was “sur- prised and disappointed” by the de- cision. “The FDA gets the respect that it does because it has regulatory stan- dards that are based on firm evi- dence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University. The FDA’s top drug regulator ac- knowledged that “residual uncer- tainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is ex- pected to help slow dementia. “The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said the FDA carefully weighed the input of people living with the “devastating, debilitating and deadly disease.” Under terms of the so-called accel- erated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so. Biogen said the drug would cost ap- proximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that thanks to insurance coverage and other discounts. The company said it aims to complete the FDA-mandated follow-up trial by 2030. Biogen shares jumped 38% in trad- ing Monday on the news, with an- alysts forecasting billions in future sales. The Cambridge, Massachu- setts-based company plans to begin shipping millions of doses within two weeks. The nonprofit Institute for Clinical and Economic Review said that “any price is too high” if the drug’s benefit isn’t confirmed in follow-up studies. Some 6 million people in the U.S. and many more worldwide have Alz- heimer’s, which gradually attacks ar- eas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s. The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies pre- viously shelved by drugmakers. Water: From tribes to farms, claims to rights in the Klamath Basin abound don’t want the bigger community hurt,” he said. Bentz said negotiations are the best way forward. Legal issues can be cleared up in court, but communities have to compromise if they want to live with each other and share water long into the future. “This situation has reached a point where we need a long-term solution, and everything we do now is going to be brought to bear in trying to get to a long-term solution,” Bentz said. “I think everybody’s worn-out from paying law- yers.” Continued from A1 He argued that the Bureau of Recla- mation, which has allocated no water to farmers in the Klamath Project this year due to unprecedented drought con- ditions and obligations under the En- dangered Species Act, is violating those rights. “Due process has not happened for you guys here in this valley,” Soper said. The Klamath irrigation project has a right to stored water in Upper Klam- ath Lake dating back to the early 1900s, though some individuals and irrigation districts within the project have rights that go back even farther. Soper told the crowd that, based on the state court cases, the water cur- rently held in Upper Klamath Lake is unequivocally the property of project farmers and that the federal govern- ment has unlawfully taken their prop- erty from them. He encouraged them to engage in “peaceful noncompliance” to take what court decisions and contracts say belongs to them. “It’s really cut-and-dried,” he said. “It really is quite that simple. They’re steal- ing your water. They’re stealing your property. So what do you do? You stand up and you take your property back.” But as anyone who has skin in the game in the Klamath Basin can attest, the water issue here is anything but cut- and-dried. There are many varied in- terests that depend on the watershed, many of whom have their own legal claims to the water. “There are a lot of moving parts in the basin,” said Jay Weiner, lawyer for the Klamath Tribes. “If these things were easy the basin would’ve solved them by now.” Don’t forget the treaties The most senior water rights in the Klamath Basin don’t belong to farmers: They belong to the federally recognized tribes that have lived in the region for countless generations. When asked about the fact that tribes in the Klamath Basin also have claims to water in Upper Klamath Lake, Soper seemed to suddenly adopt the language of negotiation. “We need to put our differences aside, and we need to sit down and talk and understand,” Soper said. “Ob- viously there’s differences in opinions in the ownership. How do we rectify that?” In addition to instream rights in trib- utaries to Upper Klamath Lake, the Klamath Tribes possess a right to wa- ter levels in the lake itself to maintain a healthy habitat for fishing, hunting and gather rights. Previous lawsuit Following the 2001 irrigation shut- off, irrigators sued the federal govern- ment. They argued the government had taken stored water reserved for ir- rigators and used it to provide habitat for endangered fish, and that irrigators were not provided just compensation in place of their water. The litigation lasted nearly 20 years before a federal court ruled against irrigators and the Supreme Court denied to hear the case last year, allowing the lower court rul- ing to stand. “The court said that, ‘Irrigators, your property wasn’t taken, because your right is junior to water rights of the tribes, and those tribal water rights must be at least as much water as the ESA, so really you didn’t even have a right to that water,’” saidPaul Simmons, executive director and counsel for Klamath Water Users Association. Simmons doesn’t believe that’s the fi- nal word on the matter, though, because irrigators hope to challenge the tribes’ Alex Schwartz/Herald and News “It’s really cut-and-dried. It really is quite that simple. They’re stealing your water. They’re stealing your property. So what do you do? You stand up and you take your property back,” BJ Soper, of Redmond, told a crowd recently at the encampment in Klamath County. assertions that they need as much water as is reserved in their rights to protect their fisheries. Tribal lawyers still believe the case was a pretty definitive affirmation of the existence of tribal water rights. Sue Noe, a lawyer with the Native Amer- ican Rights Fund who represents the Klamath Tribes, doesn’t think dragging up the same legal argument again will work in irrigators’ favor. “The irrigators had the same idea in 2001, that it was their water. Through- out most of the litigation, they main- tained that same view. I don’t think they could conceptualize that it wasn’t theirs,” she said. “They had their chance to litigate the issue, and the courts ruled on it. They couldn’t prevail because of the senior tribal rights.” Amy Cordalis, Yurok citizen and counsel to the Yurok Tribe, said the Yurok water right also played a role in the outcome of the case, despite the fact that it hasn’t been quantified. She sees that case as an affirmation of her tribe’s water right. “We have to look comprehensively at all of the water rights and be able to ba- sically live within that system,” she said. “All of the people who rely on water in the Klamath Basin are connected and related and somewhat dependent upon one another.” Endangered Species Act questions remain Currently, the Bureau of Reclamation maintains lake levels and flows to keep endangered Lost River and shortnose suckers in Upper Klamath Lake and threatened Coho salmon in the Klam- ath River from going extinct. By-and-large, irrigators believe the federal government is overstepping its bounds when it comes to implementing the Endangered Species Act, and that Reclamation doesn’t have the right to use water stored for irrigation to satisfy lake level requirements or downriver flows. They petitioned the Trump ad- ministration’s Department of Interior to conduct a legal review of Klamath proj- ect contracts and ESA language, and the department released memos in January largely supporting their viewpoints. However, Interior Secretary Deb Haaland, appointed by President Joe Biden, withdrew those memos shortly after assuming her position in mid- March. At a meeting with farmers and ranch- ers Thursday, U.S. Rep. Cliff Bentz, R-Ontario, said he’s not sure whether still having the memos in place would have resulted in a different outcome for irrigators this year. But after reviewing the legal opinion and speaking to Haa- land about it “at length,” he said he be- lieved she wasn’t breaking any rules by pulling those memos out of play. “When the new administration took over, there were certainly grounds in the law to reverse the position,” Bentz said. Instead, Reclamation’s authority un- der the Endangered Species Act will likely have to be litigated through a lawsuit brought by the Yurok Tribe in the U.S. District Court of Northern California against the agency several years ago. It’s currently on hold in court. The Klamath Water Users Association hopes it will provide more clarity on how Reclamation can operate under the ESA. “There’s good arguments going both ways,” Bentz said. While Bentz agreed that Oregon courts have found that irrigators have a right to use stored water in Up- per Klamath Lake, he said the ESA “primes” that right. Treaties and federal law trump state laws in most cases. Funding in jeopardy Bentz acknowledged the people at the head gates who intend to take matters into their own hands and take water they believe is rightfully theirs. He said that complicates things and that illegal activity won’t bode well for his efforts to acquire more disaster relief from Con- gress for communities throughout the basin — roughly $40 million of which would go to irrigators. “I would counsel against that for two reasons: One, I think you’ll end up in jail. And two, It’s going to hurt my abil- ity to get money for this basin,” Bentz said. Bentz said the efforts of Oregon Sens. Jeff Merkley and Ron Wyden, both Democrats, to acquire $10 million for drought relief in the basin several years ago required approval from all 100 sen- ators. If there’s violence at the A Canal head gates, Bentz said the state’s con- gressional delegation would be hard- pressed to get every senator’s name on the dotted line again. “In politics, you never really know what’s going to affect people, but the general thought was that (direct action) would not help,” Bentz said. “I think the patience for anybody right now step- ping over the line in a protest situation, given what happened at the Capitol on January 6, is probably pretty limited.” Bentz emphasized that he’s all for peaceful protest, but he does not sup- port trespassing on government prop- erty or engaging in violent behavior. “I want them to understand that there’ll be consequences and they’re far beyond just themselves going to jail. I ‘Writing us out of the whole story’ In an interview with Talking Points Memo, Ammon Bundy dismissed the legitimacy of other claims to water in the Klamath Basin, referring to them as “liberal talking points that are there, designed to literally strip the people of their rights and to put the power in the government’s hands.” For Cordalis, the erasure of tribal rights to water in the Klamath Basin is not only short-sighted — it’s a remnant of colonialism and leads people to be- lieve that the basin’s original inhabitants no longer live here. “You’re writing us out of the whole story, and that is unacceptable,” Corda- lis said. “I should not have to say that I am still here and I have water rights.” Weiner, the Klamath Tribes’ lawyer, said the federal government has prom- ised too much water to too many peo- ple, and that tribes know all too well what it’s like for the United States to walk back its promises. “The promises that the federal gov- ernment made to the Klamath Tribes were made first and disregarded for longer,” Weiner said. “At this point the balance seems to be changing.” Some tribal members feel there’s a double standard associated with some groups that assert the Constitution as the arbiter of what’s moral and legal in the United States, while conveniently leaving out the fact that the same doc- ument also obligates the U.S. to uphold its treaty obligations to sovereign tribes. “Treaties are the supreme law of the land, and our rights flow from that. They are property rights,” said Klamath Tribal Chairman Don Gentry. “They are what we reserved. We were never given those rights — we reserved those rights through treaty. Just to dismiss those as liberal talking points that just kind of stand in the way...is really puz- zling to me when I think about these folks that want to stick up for the rights of individuals.” Frankie Myers, vice chairman of the Yurok Tribe, said he’s all for upholding the Constitution — but that the folks at the A Canal head gates would be in for a rude awakening if the United States actually upheld the part of the docu- ment that concerns tribes. “First in time, first in right is a sound principle. I think the federal govern- ment should uphold senior water rights,” he said. “So besides their racist twist to it, I would say I support the ba- sic logic of what they’re saying.” Myers said he thinks those on all sides who have been involved in civil negotiations over water in the Klamath Basin know where each other is coming from, and that they’re not interested in disregarding anyone’s rights or histories. “No one is fighting in the basin for the complete destruction of each other’s communities. And I think people like Ammon Bundy don’t understand that concept, and they are choosing which pieces of history to acknowledge and what truths to really uphold,” he said. “That type of rhetoric really leads to atrocities.”
