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By Megan Cooley and Robert G. Bell

Megan CooleyRobert BellAre pharmaceutical companies in the business of simply treating patient’s symptoms rather than curing diseases? In our opinion there is no grave conspiracy theory amidst pharmaceutical companies toward the general public. After all they are a business, and businesses are out to make profits. With that said, it is hard to ignore the slow advancements in new therapeutics for terminal illnesses such as cancer. Previously, Megan published a post in response to an NPR interview with Ayalew Tefferi from the Mayo Clinic. He was voicing concern over the financial conflicts his patients face with their course of treatment for various forms of leukemia. Treatments can cost upwards of $100,000 per round of treatment, which is above the average U.S. household annual income.

An example is Nexavar, a cancer drug used to treat late-stage kidney and liver cancer. In the U.S., treatment cost are approximately $96,000 a patient. “We did not develop this medicine (Nexavar) for Indians,” Bayer CEO Marijn Dekkers said in 2014, “We developed it for Western patients who can afford it.” But Western patients also have a hard time affording it.

These treatments currently buy patients time, not a new lease on life. Where are the investments in research and development? The pharmaceutical industry is the most profitable U.S. industry and they are the top lobbyists in Washington D.C., yet funding for research and development has been cut repeatedly. Research and development is continually cut because it is not lucrative. The “low-hanging fruit” is gone. We have treatments for many common illnesses that were considered deadly, and we can treat and manage pain.

Numerous drugs that were under patent by their original producers have become available to the rest of the industry, via generics and biosimilars. This is where the profits reside for the industry. Generics are compounds that companies have to change minimally before they can be rebranded and released to the market. Currently, there is nothing that regulates drug prices apart from availability on the market. How can prices be better regulated to not drive consumer prices beyond what is affordable?

However, even old standards and generic products are not immune to this practice. Products such as colchicine, a gout remedy that the ancient Greeks were familiar with, which used to cost about 25 cents per pill in the U.S., jumped in price over 2,000% to $5 per pill due to an unintended side effect of the 2006 Food and Drug Administration compliance policy (PDF) to require any unapproved product to undergo safety and efficacy testing, regardless if it has been on the market for decades. These approvals of older known products give the drug sponsor an immediate monopoly on many commonly used drugs used in many routine medical procedures. According to a drug price survey of more than 21,000 generic drugs for Bloomberg News by DRX, more than 3,500 generic drug prices have doubled or more since late 2007, ranging from basic chemotherapy medicines to old antibiotics, with no advances with the products in innovation, safety, or efficacy. So why the big increases? Profit. It appears to be business profit models driving the pricing over our existing social medical needs to provide affordable safe and effective medicines to those in need.

There are a variety of opinions as to how drug prices can be better regulated to make them more affordable:

  1. The FDA should be reformed and revert back to only assessing safety and efficacy. Furthermore, they should not evaluate generics on a case-by-case basis, but instead as belonging to a class of compounds. Toxicity and pharmacokinetic properties have been previously determined for these compounds. Evaluating them again is time consuming and costly. By streamlining the approval process in these ways, individual companies would not be able to capitalize on gaps within the market.
  2. Allow Medicare to establish drug prices. This idea is predicated on the fact that Medicare is the largest consumer of prescription medications. This approach would likely benefit a select few, senior citizens on fixed incomes, but the general public would end up with the offset in prices dictated by the insurance companies.
  3. A “drug abacus,” which would place restrictions on drug prices by breaking drugs down into categories such as novelty, public demand, cost of development, etc. This would prevent increases on prices for generics and would impose limitations on pricing new drugs into the market.
  4. Tax incentives should be taken away for rare disease drugs. This may encourage drug companies to prioritize their efforts in a way that would not benefit the consumer.
  5. Ensure the drugs that are in serious shortage have not only a priority to alleviate the backlog but allow for affordable pricing. Recall the FDA approves drugs but does not dictate the pricing—the companies do.

What is truly unfortunate is that none of the aforementioned ideas will help reduce drug costs for patients with terminal illnesses like cancer. Patients will still choose death if faced with a treatment that will cost them $100k+ per round of treatment and might only buy them six months of life. It will be interesting to see whether the cancer task force established by the Obama administration will have any impact on prices or reinvigorating research and development in the industry.

It appears that profit will always be the key driver in pharmaceutical drug development and that many of the newer life saving therapies will be available only to those that can afford them. This is a true health outcomes inequality that cannot be encouraged, condoned, or tolerated. Equal access to life saving medicines should be afforded to all.

Megan Cooley is not authorized to speak on behalf of MRIGlobal; the opinions expressed are her personal opinions and not those of MRIGlobal.

Megan Cooley, Ph.D., is a Staff Scientist at MRIGlobal. Her work is focused on analytical method development and analysis of biological samples as a part of the Product Development and Repository Management Division.
Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.