With the 2012 Presidential election upon us, healthcare – both as a social service and essential sector of our economy – is once again a main pillar in the heated political debate.
Mitt Romney’s positions on the future of access to healthcare in this country are well-known. From this angle, we expect to see major changes in tenets the Obama administration outlined if Governor Romney is elected. These changes may have a significant effect on our niche – the corporate development of emerging growth companies in life sciences – in how medicine reaches the consumer public.
Indeed, it will be interesting to see how the temperature of biotech development will fluctuate. In the previous quarter, we covered several judicial and legislative stances that may as well alter the industry.
During his term, President Obama has ushered in sweeping changes to government-sponsored healthcare assistance programs, the insurance-patient-physician complex and universal healthcare for the uninsured. Through the passage of the JOBS Act, President Obama and Congress have created more channels for emerging growth companies to access capital.
Critics of the Obama administration, however, gripe of an egregiously influential executive branch in dictating FDA policy, say, in limiting the use of antibiotics in healthy farm animals. Critics from both sides point to a Supreme Court bench that has at times contradicted itself – in, say, deciding against Prometheus Laboratories’ patent claim and vastly broadening the definition of “natural law”, or in ruling ‘in favor’ of generic drug companies in a series of civil suits, instead finding their non-generic peer companies culpable.
For the Republican Party’s first family, however, the issue of healthcare and the importance of fostering medical advancement is a very personal issue. Mr. Romney’s wife, Ann, was diagnosed with multiple sclerosis in 1998, and credits a combination of mainstream and alternative treatments with sustaining a comfortable lifestyle. In a USA Today article published before the last Presidential election, Mrs. Romney said that her honesty and acceptance has inspired the MS community at all corners of the campaign trail.
The couple has been very open about the toll the disease can take on a family, the fear of diagnosis, and empowering the patient in spite of bleak treatment options. Mrs. Romney is an activist in promoting awareness and the need for new treatments, and is a board member of the New England chapter of the National Multiple Sclerosis Society.
Mrs. Romney credits some pharmaceuticals with stopping the progression of the disease (initially using corticosteroids), however found the side effects of these treatments too debilitating to continue. Fortunately, Mrs. Romney’s MS has not progressed to the secondary progressive form. She relies on non-pharmacological treatments including reflexology, acupuncture, stress management, yoga, and cranial-sacral therapy, which has helped her live mostly without limitations.
Mrs. Romney has supported the development of new therapies, including stem cell research; Mr. Romney has also been regarded as being pragmatic in accepting these advancements, with his stint as Governor of Massachusetts a precedent of his support for the life sciences sector.
During the Democratic National Convention on September 7th, First Lady Michelle Obama spoke candidly of her father’s battle with multiple sclerosis. Fraser Robinson, a pump operator at the City of Chicago water plant, was diagnosed with MS in his 30s, when Mrs. Obama was very young. Mrs. Obama described her father waking every morning with a smile, despite struggling to get out of bed.
“I watched my father…grab his walker, prop himself up against the bathroom sink and slowly shave and button his uniform,” Mrs. Obama said during a powerful speech during the Democratic National Convention last week. “And when he returned home after a long day’s work, my brother and I would stand at the top of the stairs to our little apartment, patiently waiting to greet him…watching as he reached down to lift one leg, and then the other, to slowly climb his way into our arms.”
Mrs. Obama said her father hardly ever missed a day of work, despite being in severe pain. Fraser Robinson died in 1991 at age 66.
The stories of Mrs. Romney and Mr. Robinson are of particular interest to the OneMedPlace community. OneMedPlace has recently announced coverage of Opexa Therapeutics, a biotechnology company developing patient-specific cellular therapies for the treatment of autoimmune diseases including MS. Opexa has developed a proprietary T-cell technology platform that allows for the production of patient-specific T-cells that induce therapeutic immune responses to combat MS. The company’s lead candidate, Tcelna, is in late stage clinical development and Opexa will soon be initiating a Phase IIb clinical trial in Secondary Progressive MS (SPMS).
Secondary Progressive MS is estimated to have a global market of over $5.7 billion by 2015. It is estimated that 50% of cases of earlier relapsing forms of MS progress into SPMS within ten years, and 80 to 90% of cases do so within 25 years. In May 2012, OneMedRadio spoke with Opexa CEO Neil Warma about this unmet market need.