President Trump Is Urged to "Make a Deal" to Aid Multiple Sclerosis Patients
Representative Elijah E. Cummings has often displayed an interest in the high prices of drugs in the United States, and has even met with Trump to discuss his concerns in the past. Now, he has launched an investigation into the soaring prices of multiple sclerosis drugs and has recently published a series of tweets demanding that the president take action against the exorbitant prices of Zinbryta.
The tweets
The tweets that were sent out by Cummings a few months back stated, "@realDonaldTrump, Mr. President, you promised lower drug prices, but companies are charging $87k/yr for a drug YOU own. Please act now!"
"US government holds the patent to #Zinbryta (treats #MS) and licenses it to @biogen. You can make a deal to lower the price now!"
"If they refuse, you can revoke their license or license the drug to more companies to lower the price today! Shouldn't cost $87k per year!"
Zinbryta
The drug being referred to is Zinbryta, which was approved by the FDA in 2016 for the treatment of relapsing forms of multiple sclerosis. Unfortunately, approximately 2.3 million people across the world are affected by the autoimmune disease.
With a list price of $86,000 per year, Both Cummings and Representative Peter Welch of Vermont have already requested information from seven producers of drugs in order to begin an investigation into why the prices of medications for MS are so unbelievably high.
These representatives are far from alone in their fight to make Zinbryta more affordable. Knowledge Ecology International is a nonprofit aimed at intellectual property, often in the sphere of public health. They have written to the Department of Health and Human Services in order to formally request that they consider further options that would enable a lower price tag for the drug. What kind of options are available? Knowledge Ecology International stated that by "march-in" rights, the government would be able to revoke Zinbryta's patent and license it to another company. Another thought could be for the government to simply end the license, which would disable the high price. This letter was also referred to by Cummings.
At least one of Zinbryta's cinical trials was also performed by a unit of the National Institutes of Health, further leading to Cummings and Knowledge Ecology International's belief that Trump, as president, would have some power over the price of the drugs. The federal government is funding almost fifty clinical trials to study the drug, resulting in the outcry of many that it must therefore be involved in managing the pricing.
Council at KEI, Andrew Goldman, stated that Zinbryta "is just a really egregious example of excessive pricing. Trump campaigned on promises to lower the cost of drugs, so we want to hold him to that." However, unfortunately, Goldman did state that despite their letter, they had not yet heard back from HHS.
Of course, President Trump does not actually personally own the drug, as one of Cummings’ tweets might suggest, but the National Institutes of Health own the patents to the drug. As President of the United States, Cummings argues that this is akin to ownership, and therefore he has the ability to solidify a lower price of MS patients. This could indeed be the case, as the drug was developed via technology that was licensed from the federal government.
Biogen produces Zinbryta, and they have responded, "Biogen has been in contact with Representative Cummings and his staff in connection with his request for information about the pricing of MS therapies. We are continuing to cooperate with his inquiry."
However, many are bothered by the fact that Zinbryta is significantly more expensive in the United States than it is in other countries. For example, the drug is 2.8 times more expensive than in Norway and Denmark and 3.8 times more expensive than it is in Switzerland. Knowledge Ecology International made sure to include these stats in their recent letter to emphasize the injustice in the high pricing.
Medical trends
Unfortunately, Zinbryta is not the only MS medication that is priced so highly out of reach. In recent years, the prices of medications used to treat MS have been rising in general. The National Multiple Sclerosis Society has stated that the annual cost for medications, on average, was $78,000, which is four times the amount it was in 2004, at $16,000 at the time.
Cummings has also mentioned that there are other Biogen drugs, but also products from Bayer, Novartis, Roche, Sanofi, and Teva that he finds fault with the price of.
How does Trump play into the prices of these drugs? One of his campaign promises was that he would be able to bring down the prices of drugs, which many believed given his former experience with making deals, given his notoriety as a businessman. However, many are beginning to feel that this, among other, campaign promises are not coming to light as they might have wished. The rhetoric regarding the importance of making drugs more affordable that was heard so often in 2015 and 2016 is almost entirely gone now that he is in office. Now, many investors have ignored the claims he formerly made.
This is part of why Knowledge Ecology International may have their work cut out for them. Zinbryta is far from their first experience in trying to bring down the prices of overly expensive drugs. They have previously urged the government to utilize the march-in rights specifically designed for them on drugs including Japan's Astellas Pharma Inc. and Pfizer's Medivation Inc.'s prostate cancer drug by the name of Xtandi. Will the NIH listen to them, however? It might be unlikely, unfortunately. THE NIH previously declined to use march-in rights to drop drug prices, including Xtandi, regardless of KEI's requests.
KEI also has other involvements in taxpayer-funded research and licensing. They were integral parts of the Sanofi Zika vaccine deal with the United States Army, and were crucial in ensuring price assurances, due to the massive public support of the potential product. Of course, Zika's spread stopped being as powerful, and as a result the deal did not appear to be as vital. Therefore, officials announced that it would not be moving forward. However, it still speaks to KEI's commitment to the fairness in pricing and willingness to fight for it.
The positive note is that many lawmakers are now beginning to feel drug prices are worth fighting for. Cummings, Welch, and famously Senator Bernie Sanders have become very active in drug pricing in recent years. Cummings even met with Trump to discuss a Medicare price negotiation. He also contested Marathon's $89,000 launch price for Duchenne muscular dystrophy medicine Emflaza, which then was paused by the company and was offloaded to PTC Therapeutics.
Do you think Americans should have control over how much they pay for drugs they fund the development of? Is there any reason that drugs should be many times as expensive in the United States as they are in other countries? These questions, and many more, are likely to be prominent in upcoming discussions about the federal government's role in pharmaceuticals.
References
http://www.businessinsider.com/elijah-cummings-to-trump-on-ms-drug-prices-2017-9
