To The Editor:
It is time that the full weight of the federal government be brought to bear in fighting Alzheimer’s.
An estimated 5.8 million Americans are currently living with Alzheimer’s. By 2050 that number is expected to grow to 14 million. The current cost to the country is $2.9 billion and that is estimated to grow to $1.1 trillion. Since 2010, the number of persons dying from Alzheimer’s or dementia rose 123 percent.
The news has been equally disheartening in Alzheimer’s drug development. The Pharmaceutical Research and Manufacturers of America report that from 1998 to 2017 there were 146 unsuccessful attempts to develop medicines to treat and potentially prevent Alzheimer’s. In that same time frame, only four new medicines were approved to treat the disease. Between 2002 and 2012, the success rate for Alzheimer’s drug trials was 0.4 percent and two major pharmaceutical companies abandoned the Alzheimer’s drug development market.
There is hope for the future. As researchers have been able to better isolate the effects of Alzheimer’s on brain function and to map its onset and development, drug companies are responding. There are now over 100 Alzheimer’s drugs in the final two phases of FDA testing.
While this is good news, FDA drug testing is a long process, averaging 10-12 years to bring a drug through testing, approval and market. This provides little comfort to Alzheimer’s patients and their loved ones presently.
Right to Try laws do not provide Alzheimer’s patients early access to experimental drugs (excepting Texas). However, there is a little-known FDA expanded access program that could work, but it will take public pressure on the FDA, the Trump administration and Congress to make it happen for Alzheimer’s patients.
In response to the HIV/AIDS epidemic of the 1980s, the FDA created “Parallel Track” authority that made promising investigational agents available to people with AIDS and other HIV-related disorders who could not participate in controlled clinical trials and who had no therapeutic alternatives. It was only through the advocacy of ACT UP and other groups and individuals that the FDA granted this expanded access. Parallel Track has not been utilized since.
Given the toll that Alzheimer’s takes nationally, it dwarfs the HIV/AIDS crisis in its effects. It is time for the Alzheimer’s Association and Alzheimer’s advocates across the country to act now and bring the Parallel Track program to the Alzheimer’s crisis. The patients and their families deserve no less.