"First we will have a general healthcare product offering," Biogen CEO Adu Helm said in an internal presentation detailing the marketing plan for the Alzheimer's drug.
By April 2021, Biogen's AduHelm Health Capital program will be "preclinical, diagnostic and proportional," according to the filing. The company wanted to provide promotional materials focused on black and Latino patients and their health care providers. It also plans to invest millions in media advertising targeting patients of color and multilingual patients.
There was just one problem: AduHelm's clinical trial didn't support the company's marketing playbook or plan to create a public narrative that promoted equity and health access. In the first phase 3 study of the drug, 3.0% of participants were Hispanic, 0.6% were black, and 0.03% were American Indian or Alaska Native.
Released in conjunction with an 18-month congressional investigation into the controversial approval of AduHelm, the secret marketing scheme failed to highlight racial disparities in clinical trials. Many clinical trials do not include certain minority groups, despite the high risk of morbidity and mortality in their population.
The congressional report serves as a warning as the Food and Drug Administration gives fast-track approval to Legembi (lecanumab), a similar amyloid-busting drug made by Biogen and Issay. Patient deployment must lead to clinical trials or the company's FDA-approved label will be limited. The label should encourage business attention.
"Unfortunately, communities of color are considered at the end of the process," said Andrea Richardson, Zeno Group's global head of diversity, equity and inclusion. "We need to move forward with a bit of a shift in organizational behavior that takes communities of color into account sooner rather than later."
Marketing was only one aspect of Aduhelm's launch that opened up to criticism. Concerns include the drug's efficacy, safety, availability, and list price.
Aduhelm received accelerated FDA approval on June 7, 2021. Less than 12 months later, the company went out of business. The move comes after Medicare severely limited reimbursements and Biogen saw lower sales levels compared to expectations for success.
Unsealed documents show how Biogen plans to target communities of color. The plan calls for the company to create a public narrative that promotes health equity and opportunity. He also offered to work behind the scenes to support and advocate for Aduhelm among Alzheimer's advocacy organizations that serve people of color.
As part of the strategy, Biogen will develop promotional materials for Black and Latino patients and their healthcare providers. Among other projects, he plans to buy advertising space from Telemundo and BET. The company said it may spend $3 million on media advertising targeted at patients of color and another $1 million in funding for multilingual patient care and patient transportation.
However, these proposed plans were not sufficiently supported by the clinical trials of Aduhelm, which have not yet been completed. According to the published study, only 0.6% (19 people) of participants identified as black, 3% as Hispanic, 0.03% (1 person) as Native American or Alaska Native, and 0.03% as Hawaiian or Pacific. Island dweller. Information
Black seniors are twice as likely to develop Alzheimer's disease as white seniors, the researchers said. "However, Biogen reported that six black men were randomized to receive the FDA-approved treatment dose."
As the Centers for Medicare and Medicaid Services proposed a national coverage decision that would require CMS-approved studies to be representative of the national population of people with Alzheimer's disease, Biogen lawyers vowed to increase diversity by seeking Chapter 4 approval.
Aduhelm's findings have important implications for how future therapies should improve their clinical research for physicians, patients, taxpayers, and other stakeholders. At the very least, lack of information about people of color can lead to self-doubt.
But there are encouraging signs. One is to be more aware that this is a moral and scientific issue.
The FDA's April draft on Diversity, Equity, and Access to Clinical Trials highlights the link between disease prevalence and trial participation. Participating in a trial that replicates the prevalence of the disease is one way to ensure that clinical outcomes have universal implications.
While Aduhelm's clinical trials did not include non-white participants, Legumbi's was a different story. It was clear that this study was an effort to improve the overall enrollment of multiple participant groups, the researchers said.
In the Legambi study, 20% of the subjects were non-white. Data published in the New England Journal of Medicine showed that 6.1% and 28.1% of 3,638 participants in the United States and 4.5% and 22.5% of randomly assigned participants were black and Hispanic, respectively.
Richardson said these efforts must be strengthened to address racial disparities in clinical trials.
"Every community that will be affected by this treatment or any future treatment should be involved in the process from start to finish, from testing to drug development, so these patients can feel real confidence when the product comes to market." announced
