Where there is demand, supply must answer.
This logic extends beyond typical consumer products, to drugs developed for treating serious diseases. But when vast riches are on the line for pharmaceutical companies, scientists can become wary about which demand is being met: the revenue, or the victims of a disease. And one new drug is making waves as a potentially gray area.
The Food and Drug Administration just approved the first new treatment for Alzheimer's Disease in nearly 20 years, in a major decision hotly anticipated by millions of U.S. citizens suffering from the condition, according to a recent press release from the agency.
And, the drug's effectiveness will likely see controversy from scientists regarding its effectiveness in the coming months and years.
Some people may experience mild side effects to the new drug
Many other drugs capable of treating Alzheimer's exist, but this new one is reportedly the first to treat what may be the underlying cause of the condition, in addition to the trademark symptom of slow cognitive decline. But the results are only marginal, so far. The new drug, called Aduhelm, works by annihilating clumps of a toxic protein scientists think destroys neurons, leading to dementia. In other words, it's not a cure, and it doesn't restore brain function lost, but it can slow the progression of the disease.
Incredibly, a drug that was summarily declared a total failure two years ago, is about to rack in billions of dollars in revenue for its pharmaceutical developer, Biogen. "This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer's disease," said Michel Vounatsos, Biogen CEO, in a statement, according to Stat News. "We believe this first-in-class medicine will transform the treatment of people living with Alzheimer's disease and spark continuous innovation in the years to come."
However, his move will likely become a controversial one, since the FDA approved marketing clearance in the face of strong opposition from an independent panel of experts. Prescribing information for Aduhelm comes with a warning for amyloid-related imaging abnormalities (ARIA), which can be linked to short-term swelling in regions of the brain without noticeable symptoms, except for a handful who do experience headaches, dizziness, confusion, nausea, and changes in their vision. A second warning on Aduhelm points to a risk of hypersensitivity reactions, like angioedema and urticaria. Most common side effects include diarrhea, headaches, falling, confusion, delirium, the presentation of altered mental states, and general disorientation, according to the FDA release.
Alzheimer's could affect 13 million Americans by 2050
"We are well-aware of the attention surrounding this approval," said Director of the FDA's Center for Drug Evaluation and Research Patrizia Cavazzoni, in the release. "We understand Aduhelm has garnered the attention of the press, the Alzheimer's patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review," added Cavazzoni.
Consequently, the FDA will continue to monitor the drug as it spreads through the U.S. market, while Biogen conducts another clinical trial. The potential benefits are intriguing, but caution is mandatory for a progressive neurodegenerative disorder that gradually annihilates human memory and thinking skills. As of writing, more than 6 million people in the U.S. are suffering from the condition, according to Alzheimer's Association estimates. This estimate is due to rise to nearly 13 million by 2050. While some doctors have declared they won't prescribe the new drug, we're inevitably going to see how the drug fares in real-world victims of the disease, and medical experts will be watching very closely.