#PoliticalSpeak: the not so BigPharma Alternative - sorry we have let you down

We do not have enough hours, or energy, to reignite our BigPharma Alternative. #PoliticalSpeak #MSBlog

Impact when you don't expect, or deserve, to have one. I received the following email from a PhD researcher earlier this week:

Dear Prof. Giovannoni,

Your article about repurposing in ‘Multiple Sclerosis and Related Disorders’ has caught my attention.

I am a ..... researcher at the ....... and I am doing research about drug repurposing in oncology. More specifically, I am focusing on the regulation, the intellectual property right strategies, and the economic implications of drug repurposing.

I am working in close collaboration with the Anticancer Fund, a Belgian non-profit organization that is currently funding several clinical trials investigating off-patent repurposed drugs in cancer patients.

Similar as to what is described in your article, we have encountered several hurdles in getting the repurposed drugs to the patients. Please find attached our policy brief listing these hurdles and proposed action items for regulators and policy makers.
I think the proposed movement to support the “Big Pharma Alternative” as described in your article is inspiring and I was wondering whether there is any progress in the field of multiple sclerosis with regard to drug repurposing?

Thank you for your time, I look forward to hearing from you....

Sadly, I have to respond to him that the BigPharma Alternative has floundered. We have only so many hours in a day and when the repurposing, or off-patent, drug bill was filibustered out of the house of commons and we we received a stern response from George Freeman, the then Parliamentary Undersecretary of State for Life Sciences, stating that there were no hurdles for prescribing off-label we lost steam. What George Freeman was saying that Pharma, in particular Big Pharma, is such a big part of or knowledge economy that we don't want to kill the goose that lays the golden eggs. In other words let Pharma innovate and make money, we will pay them, tax them and we will all live happily ever after. What this attitude doesn't address is the difficulty people have when they live in resource-poor environments, or are part of healthcare systems that require individuals to co-pay. Two thirds of personal bankruptcies in the US are triggered by ill-health. The article below from an American lawyer highlights the other side of the story, or the underbelly of Big Pharma; i.e. their predatory behaviour to milk the system. This is something we can't ignore and it is very prevalent in the MS space. 

Can we revive our BigPharma Alternative? I am not so sure. We will continue to promote our Barts-MS Essential Off-Label DMT list for use in resource-poor environments and will provide our off-label treatment protocols to anybody who wants to use them. However, we don't have the energy or resources to take these big issue on by ourselves; the sad thing is the politicians and lobbyists seem to have won. Just may be if the health policy unit at our University had supported us we would have had a chance of building some momentum, but Professor Allyson Pollock, who has now left our University, was adamant that she thought what we were doing was wrong. The good news is that the MS International Federation, or MSIF, has agreed to carry the baton when it comes to promoting off-label DMTs in resource poor environments; at least we have some help on this front. This is the battle we are prepared to fight, with a little, or a lot of, help from our friends. 

Giovannoni et al. The problem with repurposing: Is there really an alternative to Big Pharma for developing new drugs for multiple sclerosis? Mult Scler Relat Disord. 2015 Jan;4(1):3-5.

If it is not feasible to develop licensed drugs to the stage that they can actually be prescribed for a new indication, can we justify, either ethically or economically, the undertaking of proof-of-concept studies using off-patent medications? Without a financial incentive it is very difficult to repurpose off patent drugs for a new indication. Therefore, we need a political solution to allow the repurposing of off-patent drugs by other stakeholders or Big Pharma.

Levy MS. Big Pharma Monopoly: Why Consumers Keep Landing on "Park Place" and How the Game is Rigged. Am Univ Law Rev. 2016;66(1):247-303.

Now, more than ever before, pharmacologists are contributing medical advances to confront ravaging disease. They are developing drugs to mitigate the effects of Alzheimer’s, HIV, multiple sclerosis, and various forms of cancer. To capitalize on the opportunity, brand-name pharmaceutical firms are patenting these drugs, consequently guarding formulas and, with it, profits. Patents grant brand-name firms market exclusivity, which essentially allows them to set their own prices. Even though brand-name firms are investing some of their capital to cultivate new drugs, they also are enjoying gigantic revenue streams, absurd profit margins, and seemingly unfettered control of their respective markets. Consequently, sick patients are unable to afford their medication; high prices are bankrupting consumers in the absence of reasonably-priced generic alternatives. Despite the fact that generic drugs contain identical ingredients, cure the same symptoms, and cost 70% less, brand-name drugs persistently dominate their generic counterparts. Indeed, brand-name firms are improperly preventing generic market entry. Without generic competition, no watchdog exists to curb big pharma’s prohibitive prices. Despite the Supreme Court’s fleeting fix in FTC v. Actavis, which condemned reverse payment settlements that precluded competition, brand-name firms are employing other tactics predatorily to extend their market exclusivity and charge consumers unaffordable prices. To prevent brand-name abuse and help infirm patients afford their medication, this Comment proposes that courts apply federal antitrust law to brand-name firms that attempt to monopolize a pharmaceutical market through anticompetitive means, particularly by abusing Risk Evaluation & Mitigation Strategies (REMS) and by "product hopping." To combat exclusionary conduct, courts should mirror the “rule of reason” framework set forth in Actavis and apply an "enhanced" version specifically tailored to the pharmaceutical industry, giving stronger credence to generic challengers. In addition to finding brand-name tactics exclusionary, this Comment also proposes that courts adopt a bright-line rule prohibiting brand-name firms from exploiting the "legitimate business" defense to immunize their destructive conduct. The current framework perpetuates abuse and grants brand-name firms ostensibly indefinite monopolies. Analyzing brand-name defensive tactics under federal antitrust law would facilitate generic market entry and consequently moderate drug prices. Even after sacrificing their entire financial portfolios, patients are still unable to afford their medication. This Comment interprets Actavis as prohibiting the “legitimate business” defense and provides a remedy to deserving consumers by preventing REMS abuse and product hopping, fostering generic competition, and tempering excessive drug prices.

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