Wednesday, August 31, 2011

Is Curing Cancer Bad For Business?

Ten years ago when the first full human genome was sequenced after a mammoth 14-year effort and a $3 billion effort, we were promised a bounty of cures for the diseases that afflict is. But things haven't turned out quite that way and, in many ways, sequencing the first genome was just the first, superficial question in a much more complex set of problems. Nonetheless it was an important milestone and its true applicability - as opposed to fanciful notions - is starting to become apparent. In the field of cancer research, for instance, there is a growing consensus that it makes more sense to classify and treat cancers not by their location in the body but, rather, by their specific genetic mutations. This is allowing for mutation-specific treatments and personalized medicine, such as the breakthrough drugs vemurafenib and Yervoy, hailed as the "biggest breakthrough in 30 years."

But if the approval of drugs like Yervoy, vemurafenib and Provenge (for prostate cancer) are giving new hope, they also reveal some of the political and economic barriers to cancer treatment and broader anti-aging strategies. The first thing that becomes apparent after the glow of hope that these breakthroughs elicit fades is that they are exceedingly expensive - and profitable. And while they extend cancer free survival they rarely lead to complete regression. This suggests the need for continual and evolving treatment, perhaps in the manner of HIV/AIDS, with a drug cocktail. But, as with HIV/AIDS it begs the question of who can afford the treatment?

"If you convert cancer to a chronic disease, and you've got now people living 10, 20, 30 years with cancer but they're on a polypharmacy, there's no way you can have them with three drugs that each cost $80,000 a year," said LaMattina, now senior partner at PureTech Ventures, a healthcare venture capital firm.
The tragedy of people dying because of lack of access to expensive drugs - a commonplace in parts of Africa where rates of HIV/AIDS remain at epidemic levels - becomes comic when we see the industry's attempt to "solve" this problem by creating package deals of multiple drugs with other companies. This may bring down the price somewhat initially but the jockeying for profit in these "strategic partnerships" leads to that other great past-time of capitalism - litigation. The costs of suits and counter-suits end up built into the price of the drug, along with marketing and other costs unrelated to the ability of the drug to cure the disease for which it is prescribed. From the same article quoted above this is put starkly:
"Almost everybody we are working with is either suing us or we are suing them," Glaxo CEO Andrew Witty told the drugmaker's annual meeting in May. "However, if we refused to work with people who sued us, we would not have any friends at all."
Beyond the price of the drug - and the economic incentive to maintain "addiction", as opposed to cure - there are other side effects of a for-profit model for healthcare, which limits not only cures for diseases like cancer but more broadly effects the possibility of longevity treatments. Most obviously, there is no necessary relationship between the profitability of a treatment and its effectiveness. And where a treatment - no matter how powerful - cannot guarantee significant financial returns, it will not receive research support. An example of exactly this dynamic is seen with a new model of immunotherapeutic treatment for cancer called Adoptive Cell Transfer (ACT) wherein a patient's own killer T-cells are extracted, sometimes modified to specifically target tumour cell proteins, multiplied in the lab and then re-introduced to the patient.  The results of a limited study, released in August 2011, on patients suffering from late-stage leukemia suggest that this treatment can have a dramatic effect in eliminating cancer cells.

Two leukemia patients were cancer-free in three weeks after being treated with genetically engineered versions of their own immune cells, an early finding that could lead to a new approach for treating the blood cancer.
The trial of three patients showed that researchers could reprogram enough infection-fighting T-cells to wipe out malignant cells. The procedure also stimulated cells that defend against the cancer’s return, according to papers published today in Science Translational Medicine and the New England Journal of Medicine...
The third patient was in partial remission and has remained there for seven months, the study showed. All of the patients had previously been treated with cancer drugs such as Biogen Idec Inc.’s and Roche Holding AG’s Rituxan, and Sanofi’s Campath.

These preliminary results suggest that this is a promising area of research that deserves the kind of big money reserved for potential blockbuster pharmaceuticals. And, yet, an April 2011 article discussing the exciting possibilities of ACT notes that there has been little interest from pharmaceutical companies in pushing ACT. This is despite the fact that a study on the effectiveness of ACT in late stage melanoma - without the more recent addition of gene therapy as in the leukemia study - led to a total remission of cancer in 21.5% of the patients. The new breakthrough drugs Yervoy and vemurafenib, mentioned above, only had total remission rates of 0.6 and 2.0 percent respectively. With the above quoted leukemia study researchers were only able to study three patients because neither the pharmaceutical industry nor the National Cancer Institute (USA) would fund the research. How could this be?

It might seem perplexing that the private sector has not pushed for an FDA-approved licensing trial. However a clear path to profitability is still missing in the development of ACT-based immunotherapy for use in the medical marketplace. Not a simple injection or a pill, ACT-based treatments are uniquely tailored for each patient. The cost of entry into the field with a licensing trial includes construction of a specialized facility and the acquisition of highly trained medical and laboratory staff. There may also be a perception that ACT-based approaches lack a clearly defined claim to intellectual property (IP), which entices companies and their shareholders to invest in the development of new treatments. After all, it is not easy to own the “drug” used in ACT—the patient’s own T cells.
Thus in two key ways, the cure for cancer remains elusive. Not only are the drugs outrageously expensive - you could literally die from lack of money to pay for them. But the treatments that have the greatest potential to cure could easily not be developed because there is no clear path to make a profit off of them. Surely, we think, the market will snatch these methods up. It may be messy but the best method always succeeds in the end. Sadly, that's not true. Think of the lowly QWERTY keyboard. It's common knowledge that the Dvorak keyboard is much easier and more efficient to use. It was known back in the 19th century that QWERTY wasn't the best keyboard layout - but the inventors of QWERTY had investors with a lot of money. Capitalism isn't about efficiency or quality, it's about profit.

NEXT: Capitalism Is Killing Healthcare
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