As Novartis gears up for an important court case in India that can be traced to the pricing and accessibility of its Gleevec cancer med, the drugmaker is now facing a grassroots challenge in the US over the same issue. A petition was recently created on Change.org to demand that Novartis lower the price and that Congress should intervene if the drugmaker fails to do so voluntarily.
"Novartis developed this drug in the 1990s. In the years since then, the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost of Gleevec," the petition states. As of today, more than 300 people have signed (see here).
The petition is "notable as a reflection of the growing economic desperation here," writes Joana Ramos, an independent health policy consultant in Seattle. "The already-high, formerly global price has climbed sharply upward in recent years, and coincides with privately insured patients being now forced to shoulder much more of the cost themselves, increasingly impossible for so many. (An) informal survey shows the retail price of an average monthly (supply) of 400mg tablets seems to now be in the $6,000 to $7,500 range" (look here for one example).
Debate over Gleevec pricing has long plagued Novartis, which initially charged about $2,400 a month when the medication was launched in 2001. Five years ago, Brian Druker, who was the key researcher behind the discovery of the drug and who heads the Knight Cancer Institute at Oregon Health and Science University, caused a stir when he publicly chastised Novartis for pricing that caused him "considerable discomfort" (see here).
"Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible," he wrote in an essay at the time.
The issue has been most prominently on display in India, where the Supreme Court will hear arguments this summer over whether the government had the right to deny a patent to Novartis for the cancer med. The drugmaker wants a patent based on a new form of its drug, which would offer a 20-year extension. A previous government ruling denied its request after deciding the new form did not meet a standard for enhanced efficacy. Patient advocates argue that a Novartis victory would amount to evergreening, a reference to patent extensions based on minor changes, and inhibit access since generic drugmakers would be prevented from making lower-cost versions (see this).
We asked Novartis about the petition and received this reply from a spokesman: "Novartis seeks to provide treatment options at prices which reflect the value they bring to patients and society, the scientific innovation they represent and the necessary investment in clinical studies to support development of innovative medicines." He added that the drugmaker runs patient assistance program that provided $144 million of free Gleevec to 4,000 people in the US last year.
The Gleevec patent, by the way, will expire in 2015 in the US.