Recently the pharmaceutical giant Pfizer has come under tremendous criticism for it’s decision to discontinue further research into discovering treatments for Alzheimer’s and Parkinson’s diseases. They have even been accused of profiteering off the recent tax cuts to the detriment of patients suffering from these diseases.
Nothing could be farther from the truth.
Pharmaceutical companies around the world invest billions every year into research and development. The top ten companies (of which Pfizer is number four) alone invested $72.84 billion dollars in R&D in fiscal year 2015 to 2016. By comparison, the entire budget of the U.S. government for research and development in 2016 was just $32.2 billion dollars. But unlike the pharmaceutical companies, the National Institutes of Health don’t have to worry if there is any return on their investments. They can just go back to Congress for additional funding.
In their Pipeline Update dated January 30th, Pfizer announced they were discontinuing further research into 8 potential neurological drugs in Phase I and Phase II clinical trials. Allow me to clarify – Phase I clinical trials test the Safety of a potential new drug. Phase II clinical trials test the Efficacy of new drugs, in other words, do they actually work. These compounds were not limited to just Alzheimer’s and Parkinson’s research, but also included epilepsy and schizophrenia. Six of the compounds were still in Phase I, while only two (one for Epilepsy and one for Parkinson’s) had reached Phase II trials.
In a letter from Mikael Dolsten, M.D., Ph.D., President of Pfizer Worldwide Research and Development dated January 11, 2018 he explained Pfizer’s decision and their plans to continue to support R&D in these therapeutic areas via other means. He said
“…after our internal programs faced continual setbacks, we had to come to terms with the fact that our research efforts were simply not making the progress necessary to translate into truly transformational therapies for patients.”
In other words, the Phase I and Phase II clinical trials showed that these potential drugs just were not working. Now if Pfizer were the only pharmaceutical company investing into research for Alzheimer’s and Parkinson’s, this would be devastating news. Fortunately, they are not and Dr. Dolsten goes on to explain
“While our efforts were not successful, we have full faith in the broader scientific community that meaningful therapies can and will be discovered in the long term. That is why Pfizer plans to create a venture fund, with the specific goal of investing in biotech companies conducting promising neuroscience research, particularly in the area of unmet needs.”
Therefore, while Pfizer will no longer be conducting their own research and development into Alzheimer’s and Parkinson’s, they are still allocating funds to support research by other biotech companies in their R&D efforts.
In the meantime, they plan to continue investing R&D dollars into promising, and much needed new drugs, such as a vaccines against Clostridium difficile and Staphylococcus aureus. CDiff, as it is commonly known, is a devastating infection causing uncontrolled and debilitating diarrhea and is largely immune to nearly every known antibiotic. I know, as my mother had it, and it eventually led to her death. Staph infections are equally deadly.
Based on a report by the Centers for Disease Control, in 2011 there were 453,000 cases of Clostridium difficile that resulted in 29,000 deaths. This report, published in the New England Journal of Medicine also found that approximately two-thirds of the cases resulted from hospital or nursing home stays.
In regard to Staphylococcus aureus, it may be more familiar to you by the acronym MRSA (which represented methicillin-resistant Stapylococcus aureus) another infection commonly found in hospitals and also highly resistant to antibiotics.
Pfizer is now conducting Phase II clinical trials on its vaccine against SA, while the vaccine against Clostridum difficile is now in the much larger, and more expensive Phase III clinical trials. The FDA requires results from two Phase III trials (large and well-controlled – usually involving 2,000 plus patients at multiple facilities) before it will even consider reviewing a drug for possible approval. Phase III trials are also double-blind studies in that neither the physician administering the drug nor the patient receiving knows if the patient is receiving the actual drug or a placebo. The cost of the trials usually run into the millions of dollars.
So the next time you see or hear somebody criticizing Pfizer for its decision to cease R&D into Alzheimer’s and Parkinson’s remember these facts. And put yourself in their shoes. Would you want them to continue spending money on drugs that aren’t going to work, or would you rather they spend money on other drugs that could potentially save thousands of lives each year?
[Editor’s note: The author of this article had 15 years experience in the pharmaceutical industry, of which 8 years were in Medical Affairs which oversaw clinical trials.]