A first of its kind revolutionary cancer treatment was approved by the FDA this week which boasts cure rates for childhood leukemia upwards of 70-80 percent. The innovative nature of the treatment lies in how it genetically re-engineers a patient's own immune system to find and destroy tumors.
While this is certainly noteworthy news, a major controversy is being overlooked by the mainstream media. As Novartis announced their $450,000 price tag, the media failed to report on who actually paid for the development of this breakthrough treatment. The answer, according to a patient advocacy group, is—you.
As MIT's Technology Review notes, the therapy, which will be marketed as Kymriah, is a customized treatment that uses a patient’s own T cells, a type of immune cell. A patient’s T cells are extracted and cryogenically frozen so that they can be transported to Novartis’s manufacturing center in New Jersey. There, the cells are genetically altered to have a new gene that codes for a protein—called a chimeric antigen receptor, or CAR. This protein directs the T cells to target and kill leukemia cells with a specific antigen on their surface. The genetically modified cells are then infused back into the patient.
In clinical trials, involving 63 children with a type of acute lymphoblastic leukemia, 83 percent of patients that received the CAR-T therapy had their cancers go into remission within three months. At six months, 89 percent of patients who received the therapy were still living, and at 12 months, 79 percent had survived, according to MIT.
These results are nothing short of staggering. Given the fact that thousands of children and young adults are diagnosed every year in the US—making it the most common childhood cancer—the opportunity to save lives is overwhelming.
However, like all opportunity, Kymriah comes with a price.
Novartis announced the price this week of $475,000 per treatment. This was sold to the public as an ostensible win since the drug was predicted to be priced at $600,000 to $750,000 per treatment. If Novartis had solely financed and conducted their own research, of course, they could certainly charge whatever they wanted to charge. But this is not the case, according to the advocacy group Patients for Affordable Drugs.
According to David Mitchell, the founder of the group, $475,000 per treatment is excessive because the federal government threw more than $200 million of your tax dollars into researching CAR-T therapy. According to Mitchell, Novartis simply purchased the rights to the treatment and failed to disclose what amount, if any, they invested in the research.
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On Thursday, Mitchell released the following statement praising the FDA's decision to approve the drug, but decrying the monopoly granted to Novartis.
"As a cancer patient, the potential of CAR-T is exciting and I applaud FDA’s approval. It means hope for hundreds of children and their families, and we’re all excited at the potential for cancer patients.
“But let’s remember, American taxpayers invested over $200 million in CAR-T’s discovery. To date, Novartis has not acknowledged the significance of taxpayers’ investment, and the company declined to detail its own investment.
“While Novartis’ decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive. Novartis should not get credit for bringing a $475,000 drug to market and claiming they could have charged people a lot more.
“The drug pricing system in America is completely broken. Until policy in this country changes, the vicious cycle of patients struggling under high drug prices will continue.”
Patients for Affordable Drugs isn't pulling this number out of anywhere either. They conducted an extensive review of CAR-T funding and completed a report on it last month.
A whopping $204,288,340.00 in taxpayer dollars was given to various universities and research groups who contributed to the findings related to chimeric antigen receptor research.
To those paying attention, this should come as no surprise. As TFTP reported last year, the Journal of the American Medical Association officially recognized why drug prices skyrocket in America. Big pharma is granted a monopoly by the state which effectively eliminates their competition and allows them to charge any price they want — so they do.
The paper, published on August 23, 2016, The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform, set out to "review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs."
What the paper's authors, Harvard Medical School doctors Aaron Kesselheim and Jerry Avorn, and jurist Ameet Sarpatwari, found and subsequently admitted, shattered the very assertion that government regulation in the market is needed to keep medical care costs low. In fact, their findings were quite to the contrary.
According to the paper:
The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents.
This time, however, not only did the government grant Novartis a monopoly on the treatment but they also used your money to fund it.