Earlier in the year, Helen Thomas of Wall Street Journal wrote on the “Heard on the Street” column about the large and highly concentrated investments that the biopharmaceutical industry is making in oncology research. Citing data from a Barclays analysis, Thomas voiced the following concern.
“A question arises over where R&D dollars are being allocated. Barclays says that one-third of spending is going into oncology and inflammation, despite these areas accounting for less than 17% of projected revenue. New drugs don’t necessarily cannibalize sales of existing treatments. But if R&D spending is becoming more concentrated, firms may be swapping development risk for commercial and marketing risk.”
John Carroll of FierceBiotech was even more blunt in his criticism of this “gold rush mentality”.
“You’d have to be deaf, dumb and blind to overlook the way pharma has crowded into the cancer arena looking for the next big immunotherapy or the next big targeted oncology drug – or both……….It’s worth noting, though, that the first time someone does something solid in Phase III, the rest of the industry will plow back in right behind it.”
First of all, Carroll’s comment of companies plowing in after a competitor reports promising Phase 3 results is really not valid. If a company waits until that point to begin an R&D program to chase a competitor’s experimental medicine, it is doomed to failure. It will take at least 10 years – and a lot of luck – to get a similar drug on the market which then would have to compete with an entrenched drug whose patent is near expiration. That is a flawed strategy that few, if any, follow.
However, Thomas and Carroll make a fair point. There are probably 1,000 experimental drugs in development at this point. Is this overkill? Not really. These drugs seek to test a wide range of ideas and hypotheses concerning tumor growth and metastases. Some are “targeted” agents that are specific to a certain growth pathway for tumors. Others block steps key to a tumor’s survival, such as preventing the tumor from growing blood vessels needed to source nutrients. In addition, there is an explosion of research in exciting immunotherapeutic approaches designed to help one’s own immune system fight off the cancer. This is just a sampling of the exciting, cutting-edge research ongoing in cancer R&D.
This pipeline of promising drugs has not recently arisen. It is the result of decades of work that has focused on how cancers grow and spread. In fact, if one had done an analysis in the 1990s about the Return On Investment (ROI) for cancer R&D in the biopharmaceutical industry, the data would have been very discouraging. Nixon’s “War on Cancer” began in 1972, but it was more than 25 years before tangible results began to be realized and in the last decade a number of viable experimental drugs have been put into development.
The concern of Thomas and Carroll rests in the fear that there will be too many new cancer drugs to compete for too few dollars; the scientific risk may be lessening, but that just mean the commercial/marketing hurdles will be large. It must be noted that, while there are 1,000 cancer compounds in development, we all will be fortunate if as many of 200 make it due to the normal attrition that any drug experiences such as toxicity, lack of specificity, or insufficient efficacy. People also need to realize that cancer is not a single disease. There will not be a magic bullet cure. Even within certain types of cancers, there are numerous subgroups. Finally, in all likelihood, cancer patients will need to be treated with multiple drugs used in combination. Actually, 200 new anti-cancer drugs may not be enough to meet the needs of all cancer patients.
Pfizer’s lung cancer drug, Xalkori, is an excellent example of this. It is the first of a class of compounds called ALK inhibitors designed to benefit lung cancer patients who have never smoked. Non-smokers make up about 10% of the lung cancer population. While Xalkori is an important drug, it doesn’t work in 30% of those who take it. Hopefully, other ALK inhibitors will make it to the market, so that patients who are resistant to Xalkori will have other options. But, if others were not also working in this field, there would be no potential alternatives.
It also should be noted that this high investment in cancer R&D is temporal in nature. As these new areas of research get explored and played out, resources will be shifted to other areas. In the 1980s and 1990s, a tremendous amount of research went into new treatments to reduce blood pressure – a leading cause of heart disease and strokes. These efforts led to multiple classes of important drugs, such as ACE inhibitors, calcium channel blockers, and angiotensin 2 receptor blockers. These drugs proved to be great treatments for reducing blood pressure, but once they successfully reached the marketplace, the medical need for new hypertension drugs evaporated and R&D resources were shifted to other areas – like cancer.
The biopharmaceutical industry’s focus on cancer R&D should be applauded. Sure, the large investment comes with downstream risks – but no R&D area is risk free. The ultimate payoff of this large investment should be measured not just in financial returns but in the saving and lengthening of lives of millions around the world.
