During the health care debate, many believed that America was far behind other countries in the quality and effectiveness of our health care system. Others, believed that relationships with industry and physicians can harm the health care system. Despite these narrow views, the largest annual cancer meeting held recently by the American Society of Clinical Oncology in Chicago, “underscores how good we have become at turning new scientific principles into superior medicines.”
According to a recent op-ed in the Wall Street Journal written by Scott Gottlieb, MD a physician and fellow at the American Enterprise Institute, who was deputy commissioner of the Food and Drug Administration from 2005 to 2007, “those who gripe that progress from our huge investments in cancer research are too little or too slow, are ignoring stunning results from two experimental drugs that tell a different story.”
First, “Bristol Myers's drug Ipilimumab, the first treatment to extend the lives of patients with advanced melanoma skin cancer, is based on science that is 30 years in the making.” Second, “Pfizer's drug Crizotinib, which shrank some of the most resistant and fatal forms of lung cancer, was developed as a result of science done over the last decade.”
For those who have knowledge of developing drugs, it should come as no surprise that the process is “lengthy and iterative,” and most likely, this process won’t change significantly since it is necessary to maintain the safety and effectiveness of our drugs. To address this process, private industry has adapted to the lengthy process by using what is developed in academic labs, and turning them into medicines years later.
Evidence of the impact industry has had on cancer treatment and drugs are overwhelming. For example, “private industry used a modern understanding of how our immunity works that was first developed in academic labs in the 1980s, by making copies of antibodies — immune molecules that our bodies produce to fight disease — and turn them into medicines.” Biotech companies were then able to develop an effective antibody drug, known as ReoPro, for the treatment of heart attacks in 1995.
Eventually scientists, working with industry, “figured out how to make drugs using the structures of human antibodies.” From this discovery, the cancer drug Rituxan was launched in 1997, and since then, “has transformed how we treat lymphoma by improving survival while reducing treatment side effects.”
Other examples of the success and progress the pharmaceutical industry has had in collaborating with academic and institutional collaboration include the breast cancer drug Herceptin in 1998, and the approval of the colon cancer drug Vectibix in 2006, which were the first "fully human" cancer antibody medicines. Accordingly, Bristol Myers's Ipilimumab is part of this new wave of "fully human" antibodies, “developed using technology that industry perfected in the late 1990s.”
While Ipilimumab was the product of “30 years of painstaking science,” the breakthrough seen in Pfizer’s Crizotinib, which “blocks an aberrant protein called ALK that's critical for the spread of cancer cells,” is the “product of discoveries made just in the last decade.” The gene it targets, which was fully discovered in December 2007, was shown in a “study of 82 advanced lung-cancer patients with the protein abnormality to shrink or arrest tumors in more than 90% of them.”
These advances in cancer treatment have also flowed “from the mapping of the human genome, which has enabled the drug's rapid development.” The technology and work with industry that has led to the mapping of the human genome is of great “value to patients because it has harnessed our ability to read the genes in each person's tumor and see if a patient is susceptible to the medicine.”
Yet advances such as these have recently faced significant challenges, such as “policies that shrink the incentives that drive the capital investment needed to underwrite these long and risky endeavors, or growing regulation by the FDA that makes it harder to get treatments to market.” What is most troublesome about these obstacles is the growing suspicion of “activists' and regulators' of the collaboration between the academic researchers who uncover basic science and the drug industry that is able to design and manufacture medicines.”
This suspicion is unwarranted and is harmful to patients, physicians, and the field of medicine because without the “hand-off from researcher to manufacturer” there would be no treatments for cancer drugs such as Ipilimumab, Crizotinib and many of our best cancer treatments.” Accordingly, the attacks that groups are making reveal that “too many policy makers don't fully grasp how dissimilar and specialized these fields really are.” And the fact that “Congress is now endeavoring to investigate scientists who get National Institutes of Health research grants and also collaborate with industry,” will only chill research and turn the world’s most prominent and experienced scientists away from such work.
Policymakers and activists must realize that in working with industry “the future promises much shorter periods between the uncovering of vital scientific principals and their conversion into useful medicines.” Such discoveries created in collaboration with industry prove “that the time between basic science and its translation into new drugs has been increasingly shortened as our tools for developing drugs become more sophisticated.”
As a result, Dr. Gottlieb correctly asserts that “severing the links between the academic researchers that firm up basic science and the industries that craft medicines is the surest way will reverse this trend.”
Instead, policymakers and activists should be seeking ways to enhance these relationships, encourage them and preserve the valuable services industry provides to academic research so that patients can continue to have breakthrough treatments in cancer and other deadly diseases.