Why the Pharmaceutical Industry Does Not Support Regenerative Medicine Research for COPD and Other Lung Diseases?

by Dr. Alan Moy, November 10, 2018

According to a report by Allied Market Research the global COPD and asthma inhaler market would reach $34.3 billion by 2020 and grow at 4.5 percent annually. These same inhalers are frequently used for both asthma and COPD. While inhalers are clearly effective for treating asthma, they achieve mixed success in patients with COPD. COPD consists of two types of conditions: (1) chronic bronchitis which is an irreversible airway disorder of chronic airway inflammation, mucous overproduction and altered airway structure that leads to airway obstruction; and (2) emphysema which is a loss of alveoli connective tissue that leads to lung overexpansion and loss of normal alveoli recoil and the normal exchange of oxygen and carbon dioxide. Many COPD patients have a combination chronic bronchitis and emphysema. Inhalers are designed to target airway disorders like chronic bronchitis, while less effective in treating emphysema because the latter is not an airway disorder. While airway disease in COPD leads to significant loss of physical capacity, the ultimate poor prognosis for COPD (as well as all other lung diseases regardless of cause) is irreversible and progressive loss of normal alveolar function. Thus, alveolar disease cannot be treated by inhalers-it requires a regenerative medicine approach that targets alveolar repair and cell replacement.

Unfortunately, the pharmaceutical industry does not make any long-term investments in research in alveolar regeneration. Over the years, I have spoken to countless respiratory research and development leaders from every major pharmaceutical company that manufactures respiratory products. Every company has stated that they have no interest or plans to devote resources in respiratory regenerative medicine. Their explanations are that it’s too early for them; or they do not understand the science; or don’t understand how to integrate the science into a business model. Pharmaceutical companies prefer to commercialize products that will have a 5-year horizon to market. They want to see clinical research that validate proof of concept. However, I believe that there is more to their decision. Here are other reasons:

1. Pharmaceutical companies are already making great revenue from their legacy products-so why upset the apple cart?
2. Most pharmaceutical companies that produce respiratory products are led by non-MD and non-scientist CEOs. They are led by executives with sales and marketing or legal backgrounds.
3. There is no champion executive within these companies to advocate for regenerative medicine.
4. There are very few scientists that have scientific training or expertise in regenerative medicine that work in the pharmaceutical industry.
5. There is frequent turnover of scientists and management at pharmaceutical companies, which prevent continuity and formation of cohesive scientific teams that can focus on long-term research in emerging areas.
6. Pharmaceutical companies are so worried about what Wall Street think- encouraging short-term corporate earnings over long-term growth.

For example, GalaxoSmithKline (GSK), which has the largest portfolio of respiratory inhalers, recently made an announcement that it is considering reducing its research and development in respiratory disease in favor of oncology because the revenue growth of inhalers is modest in their opinion. Thus, there is little evidence that the pharmaceutical industry will ever take a leadership role in regenerative medicine and, consequently, take major leaps to offer novel therapies in treating patients with respiratory disease. Unfortunately, similar problem exists within academia and at government labs. A discussion of this topic is outside the scope of this post.

Thus, one of the Institute's therapeutic priorities is to focus on regenerative medicine in areas of chronic disease that are unperformed by the pharmaceutical industry. For the above reasons, the Institute pursues regenerative medicine research for lung diseases like COPD, pulmonary fibrosis, ARDS and Cystic Fibrosis because they all share a common problem of alveolar failure.

The next series of posts will highlight the past clinical trial failures of stem cell therapies for COPD with emphasis on what has been learned. We will also explain the basic strategies and progress, to date, of the Institute’s research (explained for the layperson) in regenerative medicine for respiratory diseases.

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