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FDA head calls for probe into Alzheimer's drug review

FDA head calls for probe into Alzheimer's drug review

The acting head of the Food and Drug Administration is calling for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drugBy MATTHEW PERRONE AP Health WriterJuly 9, 2021, 6:40 PM• 5 min readShare to FacebookShare to TwitterEmail this articleWASHINGTON — The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.Dr. Janet Woodcock announced the extraordinary step via Twitter. It’s the latest fallout over last month’s approval of Aduhelm, an expensive and unproven therapy that the agency OK’d against the advice of its own outside experts.Woodcock made the request to the Department of Health and Human Services’ inspector general, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous calls for a probe into the approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review.“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock wrote on Twitter. Biogen pledged to cooperate with the inquiry.Last month, the health news site Stat reported on the unusually close collaboration between Aduhelm drugmaker Biogen and FDA staff. In particular, the site reported an “off-the-books” meeting in May 2019 between a top Biogen executive and the FDA’s lead reviewer for Alzheimer’s drugs.The meeting came after Biogen stopped two studies because the drug didn’t seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug’s conditional approval two years later, on the basis that it reduced a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.FDA interactions with drug industry staff are tightly controlled and almost always carefully documented. It’s unclear if the May 2019 meeting violated agency rules.When Biogen and FDA brought the drug before the FDA’s panel of outside advisers in November, the group was nearly unanimous in urging its rejection.The FDA isn’t required to follow the group’s advice. And the FDA lead staff reviewer — who had been working with Biogen for months on the drug’s data — called it “exceptionally persuasive,” “strongly positive” and “robust.”The consumer advocacy group Public Citizen called for an investigation into the collaboration after the November advisory meeting. The group’s health director Dr. Michael Carome welcomed Woodcock’s request for an inquiry.“We’re pleased to see that belatedly she has made this request that should have been made months ago,” Carome said. “The signs of an inappropriate collaboration have been clear to us since November.”The FDA has faced intense backlash since approving the drug, which costs $56,000 a year and requires monthly IVs.Three of the FDA advisers who opposed the drug resigned over the decision. Among other issues, they protested that the agency did not disclose that it was considering approving the drug on a conditional basis, based on its effect on brain plaque, rather than any actual benefit to patients. Aduhelm is the first Alzheimer’s drug approved in that manner.“I think all the different parts of the decision are worthwhile for an independent investigation,” said Harvard University researcher Dr. Aaron Kesselheim, one of the three advisers who resigned. “The trust that we have in FDA’s ability to make independent decisions is very important.”On Thursday, the FDA took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend that it only be given to patients with mild or early-stage Alzheimer’s. That came after many doctors criticized the original label as too broad, because it said the drug could be given to anyone with Alzheimer’s.Aduhelm hasn’t been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. More than two dozen other drugs have previously tried that approach without yielding positive results. Biogen is required to conduct a follow-up study to definitively answer whether it really works. Other Alzheimer’s drugs only temporarily ease symptoms.Woodcock has been serving as the agency’s acting commissioner since January. Previously she spent more than 25 years directing the agency’s drug center. While widely respected among government and drug industry circles, she has also been criticized for often pushing aggressively to approve new therapies, even when their benefits aren’t certain.———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.

FDA head calls for inquiry into Alzheimer's drug review

FDA head calls for inquiry into Alzheimer's drug review

The acting head of the Food and Drug Administration is calling for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drugBy MATTHEW PERRONE AP Health WriterJuly 9, 2021, 6:39 PM• 5 min readShare to FacebookShare to TwitterEmail this articleWASHINGTON — The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.Dr. Janet Woodcock announced the extraordinary step via Twitter. It’s the latest fallout over last month’s approval of Aduhelm, an expensive and unproven therapy that the agency OK’d against the advice of its own outside experts.Woodcock made the request to the Department of Health and Human Services’ inspector general, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous calls for a probe into the approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review.“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock wrote on Twitter. Biogen pledged to cooperate with the inquiry.Last month, the health news site Stat reported on the unusually close collaboration between Aduhelm drugmaker Biogen and FDA staff. In particular, the site reported an “off-the-books” meeting in May 2019 between a top Biogen executive and the FDA’s lead reviewer for Alzheimer’s drugs.The meeting came after Biogen stopped two studies because the drug didn’t seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug’s conditional approval two years later, on the basis that it reduced a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.FDA interactions with drug industry staff are tightly controlled and almost always carefully documented. It’s unclear if the May 2019 meeting violated agency rules.When Biogen and FDA brought the drug before the FDA’s panel of outside advisers in November, the group was nearly unanimous in urging its rejection.The FDA isn’t required to follow the group’s advice. And the FDA lead staff reviewer — who had been working with Biogen for months on the drug’s data — called it “exceptionally persuasive,” “strongly positive” and “robust.”The consumer advocacy group Public Citizen called for an investigation into the collaboration after the November advisory meeting. The group’s health director Dr. Michael Carome welcomed Woodcock’s request for an inquiry.“We’re pleased to see that belatedly she has made this request that should have been made months ago,” Carome said. “The signs of an inappropriate collaboration have been clear to us since November.”The FDA has faced intense backlash since approving the drug, which costs $56,000 a year and requires monthly IVs.Three of the FDA advisers who opposed the drug resigned over the decision. Among other issues, they protested that the agency did not disclose that it was considering approving the drug on a conditional basis, based on its effect on brain plaque, rather than any actual benefit to patients. Aduhelm is the first Alzheimer’s drug approved in that manner.“I think all the different parts of the decision are worthwhile for an independent investigation,” said Harvard University researcher Dr. Aaron Kesselheim, one of the three advisers who resigned. “The trust that we have in FDA’s ability to make independent decisions is very important.”On Thursday, the FDA took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend that it only be given to patients with mild or early-stage Alzheimer’s. That came after many doctors criticized the original label as too broad, because it said the drug could be given to anyone with Alzheimer’s.Aduhelm hasn’t been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. More than two dozen other drugs have previously tried that approach without yielding positive results. Biogen is required to conduct a follow-up study to definitively answer whether it really works. Other Alzheimer’s drugs only temporarily ease symptoms.Woodcock has been serving as the agency’s acting commissioner since January. Previously she spent more than 25 years directing the agency’s drug center. While widely respected among government and drug industry circles, she has also been criticized for often pushing aggressively to approve new therapies, even when their benefits aren’t certain.———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.

FDA trims use of contentious Alzheimer's drug amid backlash

FDA trims use of contentious Alzheimer's drug amid backlash

The Food and Drug Administration has approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drugBy MATTHEW PERRONE AP Health WriterJuly 8, 2021, 8:44 PM• 4 min readShare to FacebookShare to TwitterEmail this articleWASHINGTON — A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use.The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month.The new drug label emphasizes that the drug, Aduhelm, is appropriate for patients with mild symptoms or early-stage Alzheimer’s but has not been studied in patients with more advanced disease. That’s a big change from the original FDA instructions, which said simply that the drug was approved for Alzheimer’s disease in general.Drugmaker Biogen announced the change in a release Thursday, stating that the update is intended to “clarify” the patient group studied in the company trials that led to approval. The FDA first approached the company about narrowing the label and OK’d the language.“Hearing these concerns, FDA determined that clarifications could be made to the prescribing information to address this confusion,” the agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.When the drug was first approved, a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”The FDA’s OK last month quickly sparked controversy over Aduhelm’s $56,000-a-year price-tag and questionable benefits. Three of FDA’s outside advisers resigned over the decision with Harvard researcher Dr. Aaron Kesselheim calling it the “worst drug approval decision in recent U.S. history.”On Thursday, Kesselheim tweeted that the change was “a welcome step” but added that the FDA and Biogen should do much more to combat “misperceptions about this drug.”Sweeping changes to drug labels are rare, particularly only a few weeks after approval.“It’s a responsible move by both the FDA and Biogen to maximize the safety while giving the drug the best chance to work,” said Dr. Ronald Petersen of the Mayo Clinic, who has consulted for Biogen and other drugmakers. The drug’s side effects include brain swelling and bleeding.Aduhelm hasn’t been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say there is little evidence to support that claim.Biogen is required to conduct a follow-up study to definitively answer whether the drug slows mental decline. Other Alzheimer’s drugs only temporarily ease symptoms.Because of its price and broad approval some analysts have worried that Aduhelm could add tens of billions in new expenses to the U.S. health care system, particularly the federal government’s Medicare program. Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare.Two congressional committees in the House have launched an investigation into the FDA’s review of the drug. And lawmakers in the Senate have called for hearings into the drug’s cost and impact on federal spending.The narrower label may ease some of those concerns by shrinking the number of patients likely to get the drug, which requires monthly IVs. Many hospitals have already stated that they plan to limit the drug’s use to patients with earlier stage disease. Doctors could still prescribe the drug for more advanced patients, though insurers might refuse to pay for it, citing the FDA label.“It was pretty troubling that the previous label was so broad and included groups of patients in whom the drug had never been tested,” said Dr. Suzanne Schindler of Washington University in St. Louis. “I think this is a positive change because it better reflects the patients in whom the drug was actually studied.”Wall Street analysts said the change wouldn’t significantly impact projected sales for Biogen. Michael Yee of Jefferies said in a research note that the company already planned to target the drug for the 1 million to 2 million Americans with mild Alzheimer’s.———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.

FDA trims use of contentious Alzheimer's drug amid backlash

FDA trims use of contentious Alzheimer's drug amid backlash

The Food and Drug Administration has approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drugBy MATTHEW PERRONE AP Health WriterJuly 8, 2021, 8:44 PM• 4 min readShare to FacebookShare to TwitterEmail this articleWASHINGTON — A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use.The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month.The new drug label emphasizes that the drug, Aduhelm, is appropriate for patients with mild symptoms or early-stage Alzheimer’s but has not been studied in patients with more advanced disease. That’s a big change from the original FDA instructions, which said simply that the drug was approved for Alzheimer’s disease in general.Drugmaker Biogen announced the change in a release Thursday, stating that the update is intended to “clarify” the patient group studied in the company trials that led to approval. The FDA first approached the company about narrowing the label and OK’d the language.“Hearing these concerns, FDA determined that clarifications could be made to the prescribing information to address this confusion,” the agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.When the drug was first approved, a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”The FDA’s OK last month quickly sparked controversy over Aduhelm’s $56,000-a-year price-tag and questionable benefits. Three of FDA’s outside advisers resigned over the decision with Harvard researcher Dr. Aaron Kesselheim calling it the “worst drug approval decision in recent U.S. history.”On Thursday, Kesselheim tweeted that the change was “a welcome step” but added that the FDA and Biogen should do much more to combat “misperceptions about this drug.”Sweeping changes to drug labels are rare, particularly only a few weeks after approval.“It’s a responsible move by both the FDA and Biogen to maximize the safety while giving the drug the best chance to work,” said Dr. Ronald Petersen of the Mayo Clinic, who has consulted for Biogen and other drugmakers. The drug’s side effects include brain swelling and bleeding.Aduhelm hasn’t been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say there is little evidence to support that claim.Biogen is required to conduct a follow-up study to definitively answer whether the drug slows mental decline. Other Alzheimer’s drugs only temporarily ease symptoms.Because of its price and broad approval some analysts have worried that Aduhelm could add tens of billions in new expenses to the U.S. health care system, particularly the federal government’s Medicare program. Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare.Two congressional committees in the House have launched an investigation into the FDA’s review of the drug. And lawmakers in the Senate have called for hearings into the drug’s cost and impact on federal spending.The narrower label may ease some of those concerns by shrinking the number of patients likely to get the drug, which requires monthly IVs. Many hospitals have already stated that they plan to limit the drug’s use to patients with earlier stage disease. Doctors could still prescribe the drug for more advanced patients, though insurers might refuse to pay for it, citing the FDA label.“It was pretty troubling that the previous label was so broad and included groups of patients in whom the drug had never been tested,” said Dr. Suzanne Schindler of Washington University in St. Louis. “I think this is a positive change because it better reflects the patients in whom the drug was actually studied.”Wall Street analysts said the change wouldn’t significantly impact projected sales for Biogen. Michael Yee of Jefferies said in a research note that the company already planned to target the drug for the 1 million to 2 million Americans with mild Alzheimer’s.———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.

Does new Alzheimer's drug work? Answers may miss 2030 target

Does new Alzheimer's drug work? Answers may miss 2030 target

WASHINGTON — When a controversial Alzheimer’s drug won U.S. approval, surprise over the decision quickly turned to shock at how long it might take to find out if it really works — nine years.Drugmaker Biogen has until 2030 to complete a study confirming whether its new drug Aduhelm truly slows the brain-destroying disease. That’s under the terms of the Food and Drug Administration’s conditional approva l of the drug, a decision that has been praised by patients as overdue and condemned by the agency’s own outside experts.But both camps agree: 2030 is far too long to wait for answers on the $56,000-a-year drug.“We think nine years is unacceptable and our expectation is that it will happen in a much shorter time frame,” said Maria Carrillo of the Alzheimer’s Association, an advocacy group that pushed for approval but now wants the FDA to set a quicker deadline.Other experts warn that the 2030 timeline could slip if patients balk at enrolling in a new study for a drug that’s already available. And the focus on Aduhelm — the first new Alzheimer’s drug in 18 years — could steer volunteers away from testing of other promising treatments.“If someone can go to their physician and get the FDA-approved drug, why would they go into a trial where they risk getting a placebo?” said Donna Wilcock, an Alzheimer’s researcher at the University of Kentucky.To establish a new drug’s safety and effectiveness, researchers compare results in people who get the treatment to a similar group of people who don’t. That generally means half of the volunteers are randomly assigned to get a fake treatment instead of the real thing.Biogen already conducted two such large studies of its drug, which requires monthly IVs. The studies took about four years to run and followed participants for about 1 1/2 years. Both were stopped early when it seemed the drug wasn’t working, and the results were so mired by flaws and inconsistencies that the FDA deemed them too weak to support approval on the basis of slowing the disease.Instead, the agency took another approach and gave the drug conditional approval based on a promising sign: its success in getting rid of a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.Under its so-called accelerated approval program, the FDA is requiring Biogen to conduct a new study definitively answering whether Aduhelm’s effect on plaque truly slows mental decline in patients. Other Alzheimer’s drugs on the market only temporarily ease symptoms.The FDA has not detailed how the 2030 target came about, or why such a distant deadline was granted for a drug that could be given to millions of patients in the coming years, adding billions to the nation’s health care bill.“Alzheimer’s trials take time to complete,” the FDA said in a statement responding to questions about the study. The agency added that it might be possible to answer key questions about Aduhelm before the study’s completion and that Biogen is expected to submit results “as soon as feasible.”But the agency’s critics point out that nine years is among the longest follow-up periods the agency grants drugmakers. Drugs approved under similar circumstances typically get six years. And, if anything, those studies tend to run behind schedule, not finish early. If follow-up studies don’t have positive results, the FDA can withdraw approval, though it rarely does so.“Just because it says nine years doesn’t mean the evidence will be available in nine years,” said Joshua Wallach, a medical researcher at Yale’s School of Public Health. “There’s all of this back and forth discussion that can happen with FDA that can delay completion.”Biogen isn’t scheduled to submit its initial proposal for the study to FDA until October. The Massachusetts-based company said in a statement that large Alzheimer’s trials often take six or seven years and that FDA-mandated studies can take even longer.”We are working with urgency and putting resources and plans in place,” to complete the trial ahead of schedule, the company stated.Meanwhile, Alzheimer’s specialists like Dr. Samuel Gandy are seeing patients in other drug studies ask about dropping out so they can get Aduhelm.“They’ve all said, ‘You know, I can’t stand the idea of being on placebo,’” said Gandy, who has heard from more than 20 families interested in the drug at New York’s Mount Sinai hospital.After he explained the drug’s unknown benefits and potential side effects — including brain swelling and bleeding — several decided against it. But other patients remain interested.Post-approval studies have become an increasingly common FDA requirement since the 1990s, as regulators have accelerated their reviews of drugs for HIV, cancer and other deadly diseases. But the agency’s mixed record of tracking those requirements and penalizing companies that don’t meet them has been chronicled in government and academic studies.The case of a widely debated drug for muscular dystrophy illustrates how the system can go awry.In 2016, the FDA approved the first-of-a-kind drug from Sarepta Therapeutics based on preliminary results that it might help treat the degenerative disease by boosting a muscle-building protein.As with Aduhelm, the approval was opposed by FDA’s outside advisers who said there was scant evidence the drug actually improved patient health or quality of life. But the FDA granted approval on the condition that Sarepta complete a confirmatory study by May 2021.The trial, though, is still getting underway after “multiple challenges in the overall planning and startup,” according to the FDA’s website. The new target date is 2026, a decade after the drug was allowed on the market.A Sarepta spokeswoman said the company spent years negotiating study details with the FDA, which required testing a higher dose.In the meantime, Sarepta has won approval for two other dystrophy drugs based on similar results that also require follow-up trials, which the company says are already well underway.“The FDA took a risk with Sarepta and I think they’re being burned by it now,” said Dr. Joseph Ross of Yale.Ross and his colleagues have shown that at least a quarter of follow-up results never get published, leaving questions for physicians and patients.The results from Biogen’s two Aduhelm studies have yet to appear in a medical journal. The company says it is “working diligently to publish our data.”——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.

Does new Alzheimer's drug work? Answers may miss 2030 target

Does new Alzheimer's drug work? Answers may miss 2030 target

WASHINGTON — When a controversial Alzheimer’s drug won U.S. approval, surprise over the decision quickly turned to shock at how long it might take to find out if it really works — nine years.Drugmaker Biogen has until 2030 to complete a study confirming whether its new drug Aduhelm truly slows the brain-destroying disease. That’s under the terms of the Food and Drug Administration’s conditional approva l of the drug, a decision that has been praised by patients as overdue and condemned by the agency’s own outside experts.But both camps agree: 2030 is far too long to wait for answers on the $56,000-a-year drug.“We think nine years is unacceptable and our expectation is that it will happen in a much shorter time frame,” said Maria Carrillo of the Alzheimer’s Association, an advocacy group that pushed for approval but now wants the FDA to set a quicker deadline.Other experts warn that the 2030 timeline could slip if patients balk at enrolling in a new study for a drug that’s already available. And the focus on Aduhelm — the first new Alzheimer’s drug in 18 years — could steer volunteers away from testing of other promising treatments.“If someone can go to their physician and get the FDA-approved drug, why would they go into a trial where they risk getting a placebo?” said Donna Wilcock, an Alzheimer’s researcher at the University of Kentucky.To establish a new drug’s safety and effectiveness, researchers compare results in people who get the treatment to a similar group of people who don’t. That generally means half of the volunteers are randomly assigned to get a fake treatment instead of the real thing.Biogen already conducted two such large studies of its drug, which requires monthly IVs. The studies took about four years to run and followed participants for about 1 1/2 years. Both were stopped early when it seemed the drug wasn’t working, and the results were so mired by flaws and inconsistencies that the FDA deemed them too weak to support approval on the basis of slowing the disease.Instead, the agency took another approach and gave the drug conditional approval based on a promising sign: its success in getting rid of a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.Under its so-called accelerated approval program, the FDA is requiring Biogen to conduct a new study definitively answering whether Aduhelm’s effect on plaque truly slows mental decline in patients. Other Alzheimer’s drugs on the market only temporarily ease symptoms.The FDA has not detailed how the 2030 target came about, or why such a distant deadline was granted for a drug that could be given to millions of patients in the coming years, adding billions to the nation’s health care bill.“Alzheimer’s trials take time to complete,” the FDA said in a statement responding to questions about the study. The agency added that it might be possible to answer key questions about Aduhelm before the study’s completion and that Biogen is expected to submit results “as soon as feasible.”But the agency’s critics point out that nine years is among the longest follow-up periods the agency grants drugmakers. Drugs approved under similar circumstances typically get six years. And, if anything, those studies tend to run behind schedule, not finish early. If follow-up studies don’t have positive results, the FDA can withdraw approval, though it rarely does so.“Just because it says nine years doesn’t mean the evidence will be available in nine years,” said Joshua Wallach, a medical researcher at Yale’s School of Public Health. “There’s all of this back and forth discussion that can happen with FDA that can delay completion.”Biogen isn’t scheduled to submit its initial proposal for the study to FDA until October. The Massachusetts-based company said in a statement that large Alzheimer’s trials often take six or seven years and that FDA-mandated studies can take even longer.”We are working with urgency and putting resources and plans in place,” to complete the trial ahead of schedule, the company stated.Meanwhile, Alzheimer’s specialists like Dr. Samuel Gandy are seeing patients in other drug studies ask about dropping out so they can get Aduhelm.“They’ve all said, ‘You know, I can’t stand the idea of being on placebo,’” said Gandy, who has heard from more than 20 families interested in the drug at New York’s Mount Sinai hospital.After he explained the drug’s unknown benefits and potential side effects — including brain swelling and bleeding — several decided against it. But other patients remain interested.Post-approval studies have become an increasingly common FDA requirement since the 1990s, as regulators have accelerated their reviews of drugs for HIV, cancer and other deadly diseases. But the agency’s mixed record of tracking those requirements and penalizing companies that don’t meet them has been chronicled in government and academic studies.The case of a widely debated drug for muscular dystrophy illustrates how the system can go awry.In 2016, the FDA approved the first-of-a-kind drug from Sarepta Therapeutics based on preliminary results that it might help treat the degenerative disease by boosting a muscle-building protein.As with Aduhelm, the approval was opposed by FDA’s outside advisers who said there was scant evidence the drug actually improved patient health or quality of life. But the FDA granted approval on the condition that Sarepta complete a confirmatory study by May 2021.The trial, though, is still getting underway after “multiple challenges in the overall planning and startup,” according to the FDA’s website. The new target date is 2026, a decade after the drug was allowed on the market.A Sarepta spokeswoman said the company spent years negotiating study details with the FDA, which required testing a higher dose.In the meantime, Sarepta has won approval for two other dystrophy drugs based on similar results that also require follow-up trials, which the company says are already well underway.“The FDA took a risk with Sarepta and I think they’re being burned by it now,” said Dr. Joseph Ross of Yale.Ross and his colleagues have shown that at least a quarter of follow-up results never get published, leaving questions for physicians and patients.The results from Biogen’s two Aduhelm studies have yet to appear in a medical journal. The company says it is “working diligently to publish our data.”——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.