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Critics are calling on patient advocacy groups to be more transparent about disclosing their financial ties with drug companies, saying the public has a right to know about potential conflicts of interest organizations may have when lobbying for the approval of new medications.
The Food and Drug Administration’s approval of the costly new Alzheimer’s medication aducanumab has sparked renewed concern about outside influences on the agency’s decision making. The FDA cleared the drug, branded by drugmaker Biogen as Aduhelm, for sales earlier this month under its accelerated approval pathway and required the drug’s maker to conduct a Phase 4 post-market trial.
The Alzheimer’s Association and other patient groups failed to disclose that they had received financial contributions from Biogen when they urged the drug’s approval during public hearings and statements, said Dr. Michael Carome, director of the Health Research Group at the consumer advocacy organization Public Citizen.
“It’s a problem when they lobby Congress, or put out a press release, or publicly endorse products, because there’s the assumption that these organizations are motivated solely by the interests of the patients they purport to represent,” Carome said. “When they are getting significant sponsorships from pharmaceutical companies, that’s an incorrect assumption.”
Biogen gave $275,000 to the Alzheimer’s Association in fiscal year 2020, according to the organization’s financial reports. For the calendar year of 2019, the company gave between $49,000 and $99,999 to the Alzheimer’s Foundation of America and an undisclosed amount to UsAgaisntAlzheimer’s, which was worth at least $1,000.
Patient advocacy groups are not required to mention financial ties they may have with a drug company while they are publicly advocating for approval of a medication. Organizations, however, are required to disclose donations in their financial reports, which are available to the public.
Required or not, patient groups nevertheless should be more open about their financial relationships with drugmakers when they lobby regulators to approve a drug, Carome said. This would enable patients to consider that when deciding whether to use a medicine endorsed by a patient group, he said.
“Transparency is critical when these types of organizations endorse a particular drug made by a company from which the organization is receiving funding,” Carome said. “They need to be transparent about it every time and it should be disclosed every time.”
Financial support from pharmaceutical companies does not influence the Alzheimer’s Association’s advocacy, said Joanne Pike, the group’s chief strategy officer. Contributions from the drug industry amounted to less than 1% of the association’s total contributed revenue in fiscal year 2020, she said.
“We make our decisions based on science and the needs of our constituents,” Pike said.
In comments submitted to the FDA last October, Pike wrote in support of accelerated approval of aducanumab. Patients in need would be denied help if the agency were to extend the timeline by making Biogen conduct another Phase 3 trial, she argued.
“A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease,” Pike wrote. “While the trial data has led to some uncertainty among the scientific community, this must be weighed against the certainty of what this disease will do to millions of Americans absent a treatment.”
Patient groups say their partnerships with pharmaceutical companies are beneficial to patients. Working together, they argue such relationships provide valuable resources to educate the public about new, potentially life-saving medications.
But having money ties to pharmaceutical companies creates bad incentives for patient advocates, Carome said. By relying on drug industry funds, these organizations are more likely to take positions that preserve their relationships with donors rather than be focused entirely on patients’ needs, he said.
Financial links between patient advocates and pharmaceutical companies have gotten more scrutiny in recent years as the number of organizations receiving drug industry sponsorship grows.
A 2017 study published in the New England Journal of Medicine found that 83% of the 104 largest patient advocacy organizations in the U.S. receive financial support from the drug industry. In 2015 alone, patient groups collected at least $116 million from the drug industry, according to a database of contributions compiled by Kaiser Health News in 2018.
Aducanumab is the first new Alzheimer’s medication approved since 2003. The FDA’s decision has proven controversial in part because agency officials disregarded their own outside advisory committee, which recommended against approval last November. The panelists cited a lack of evidence that the drug is efficacious at slowing the progression of Alzheimer’s.
The FDA held two internal meetings in March and April to further review the clinical evidence, which led to the agency clearing the medicine based on indications that it removed brain plaque, according to agency documents released Tuesday. Although unproven, researchers have long suspected that brain plaque causes Alzheimer’s.
With a list price of $56,000, aducanumab has the potential to become Medicare’s most expensive drug. If just one-fourth of the 2 million Medicare Part D enrollees who used an Alzheimer’s drug in 2017 were to take aducanumab for a year, it would cost nearly $29 billion, a recent analysis by the Kaiser Family Foundation shows. By contrast, Medicare Part B’s total drug spending in 2019 was $37 billion.
“The decision to approve aducanumab was one of the worst decisions the agency ever made,” Carome said. “It’s indefensible, irresponsible and it was reckless.”
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