Currently more than 55 million people live with dementia worldwide, and there are nearly 10 million new cases every year. Alzheimer’s Disease (AD), as the most prevalent form of dementia, was shown to be the only cause of death in America’s top 10 causes of death that cannot be prevented or cured. Typically occurring in the older population, AD is terrible news for many of our grandparents. This led to numerous scientists and researchers devoting thousands of hours attempting to develop the drug that can meet the needs of the patients. Nevertheless, these drugs were only able to relieve, or ameliorate, the symptoms of AD, but not cure them of the pathologic conditions. These drugs, approved by the FDA, include AChEIs donepezil, galantamine, rivastigmine, and the NMDA antagonist memantine.
Then in 2021, a latest drug for AD was approved by the FDA to be used as clinical medication. Primarily known as the Aduhelm, or aducanumab, this drug was the first ever drug to actually treat the AD, rather than just lessening the symptoms. With the release of this drug, the AD patients and their loved ones finally seemed to have some hope. However, much to their dismay, there are currently too many concerns and unanswered questions that serve as barriers for these patients. One of the largest issues on the surface is obviously implications for clinical research. There were countless ethical concerns about the efficacy of the drugs, and despite the conclusion by an FDA statistician and an advisory committee it was still approved, using the “accelerated approval” option. Biogen, a biotechnology company that develops and specializes on drugs/therapies for neurological disease, has indicated that the study will be completed by 2030, which is an unacceptably long time to wait and has a potential to fail at identifying true clinical benefit. Additionally, evidence from aducanumab’s trials shows an unclear relationship between beta-amyloid (known to be a contributing factor in AD) reductions and cognitive improvements. Several of the tests have failed and even showed clinical worsening in some cases, which shows that the researchers have “cherry-picked” their data to fit the significance level and the clinical efficacy.
As one can expect, this is beyond unacceptable for patients who are waiting for the drugs. Ethics of neuroscience is clearly violated in several aspects. Firstly, there has not been a precedent for this, so the researchers fail to draw on any historical analogies to this problem and cannot consider past understandings of resolutions. The novelty of this ethical concern makes it especially controversial, since aducanumab was only approved based on select data that the researchers handpicked, with some data unvalidated. Thus, having the drug out in the open for patients to use is extremely dangerous. Would one provide the drugs that were never proven as effective to his or her grandparents? The answer is a hard no for most. Another category of the 6 P’s that was violated was the prediction. The future impacts of this resolution on who might be affected by the drug was not seriously considered. Not only does the resolution fail to properly address the problem, but also fails to provide certainty for the people who are taking risks to use the drugs. As was mentioned earlier, the patients are the primary stakeholders who make up the frontline of the risks associated with the aducanumab. These are the people that are first exposed to any side effects, and there is already public information as to what can possibly occur for the patients who take this drug, including areas of brain swelling, brain bleeding, and headache. Therefore, the patients can potentially face these unwanted side effects with their lives on the line, since most AD patients are seniors who are more vulnerable to pathological conditions.
There is also another perspective to consider when it comes to clinical drugs: the insurers. Whether it is private companies or nationwide public health insurance like Medicaid/Medicare, the complexity is that these groups are on the verge of facing potential bankruptcies as a result of this novel drug. The question of if aducanumab is a reasonable and necessary treatment for their beneficiaries and how to ascertain whether they are benefiting is not clearly defined. This makes a transition to the expense problem of the drug. The drug’s annual price per patient is at $56,000, which is certainly not cheap. Taking this into effect, national coverage can become extremely hard to obtain, since the public health insurance can only provide so many bills for all the patients. The healthcare system is simply unprepared for the reimbursement and access challenges. There are a couple suggested methods of preparation such as providing a performance warranty, which will help apportion risk associated with initial therapy value estimates between drug manufactures and payers, and adopting a “subscription” payment agreements to address system affordability issues. However, these are currently unrealistic due to the fact that the drug’s effectiveness is still not guaranteed and the price is still unreachable by most citizens of the U.S. With the issue already so difficult for the insured, one can only imagine how difficult it would be for the uninsured. The uninsured patients face the problem of having to pay out-of-pocket money, with the copayment going as much as 20% of the total cost. Thus, monetary risk for the patients is extremely high as of right now. What clinicians and researchers must seriously consider is the aspect of persistence. Considering this as a fractious problem that requires time and persistence in understanding the problem, the experts can come to a more definitive and comprehensive conclusion for the patients. With some time, the price will definitely come down to an affordable level, but what is not definite is when this will be.
The ethical concerns do not end with just ethics of neuroscience. There is also a neuroscience of ethics aspect, concerning the use of this drug. Numerous scientists have been arguing how one might not feel so safe as to what treatment/therapy to receive due to the invasive features they can have. Neurotechnology such as Deep Brain Stimulation and Direct Current Stimulation have been pioneered as a treatment for tremors in patients with Parkinson’s disease, yet they have been somewhat controversial due to its invasiveness of the therapies. The aducanumab is in a similar situation, where the therapy consists of inserting a type of human monoclonal antibody that can selectively interact with Aβ aggregates, including soluble oligomers and insoluble fibrils, followed by clearing of Aβ. Aducanumab is the first therapy to prove that removing Aβ leads to better clinical outcomes, but before any of this, patients’ rights must be protected and upheld. Because the therapy involves having the antibody placed manually in the patient’s body system, there are definite risk factors associated that the patients must be aware of before signing up to use the drug.
Clearly, there are a lot of perspectives surrounding the issue of the drug, and numerous people are at risk. Then, one must consider who actually benefits from all this. The answer is Biogen and associated biotech companies that are about to rake up millions, even billions, of dollars. According to the New York Times article by Rebecca Robbins and Pam Belluck, the drug is all but certain to unleash a gusher of profits for Biogen because the drug is “expected to become one of the best-selling pharmaceutical products in the world within a few years - as well as for the hundreds of clinics.” This is all anticipated to be shouldered primarily by Medicare and secondarily by out-of-pocket money from the patients. Thus, companies like Biogen are pushing for sales and within no time, there will be commercials everywhere advertising the latest installment of this drug. Unfortunately, not everyone will know the truth to this story and be quick to obtain this drug for their loved ones, since it is the only option available right now. Hopefully, the right-minded clinicians and researchers can take a proactive action and stand up for the truth. Before establishing any measures to make this drug a nationwide product, we must see what is right versus wrong so that no one is harmed from the usage.