I have to admit that I tend to stay away from writing about Big Pharma and prescription drugs, mainly because, in a US healthcare system that seems to pride itself on being opaque, frustrating, and yet outrageously expensive, the prescription drug industry takes the cake. It’s too much of a mess.
But a “Netflix model” for drug development? Consider me intrigued.
It’s easy to understand why market forces might not do well with rare diseases that need an “orphan drug,” but the “subscription model” approach that the Pasteur Act seeks to address is something that most of us need: antibiotics. Antibiotic resistance has made many of our front-line antibiotics less effective, but discovering new antibiotics is a slow, expensive process, and many pharmaceutical companies are reluctant to take the risk. The Pasteur Act would essentially pay for their development in return for “free” use of subsequently invented drugs.
As recent events in northeastern Syria make clear, the number of displaced people in the world is rising — as are their health needs.
In 2018 I went with a team of other doctors to a Syrian refugee camp in Lebanon. At one stop, a woman offered us homemade bread as we examined her husband, although the couple had very little money and not enough food for themselves. As we ate the bread, she asked if we could leave them extra medications since they didn’t know when the next humanitarian mission would come through their camp.
Her request was reasonable in the situation – indeed, many other refugee families we treated asked us the same thing. Their host countries’ healthcare systems are simply not equipped to handle their needs. Lebanon alone has almost 1.5 million refugees, an increase of 1/4 of their population.
But expecting vulnerable and displaced people to hoard needed medicine is neither sustainable nor humane. Instead, we must make it part of the social contract for healthcare corporations to use some of their massive wealth to help reduce disparities in global access to healthcare. Pharmaceutical companies and the retail industry have already created efficient models healthcare corporations could follow.
Jessica DaMassa interviews Paul Simms, the Chairman of eyeforpharma. Eyeforpharma are the “media moguls” when it comes to the Pharma industry. In order to innovate the industry, they are holding two different conferences this year to bring pharma leaders and health technology startups together to foster relationships and strategic partnerships with one another. Their first conference will be held in Barcelona in March, and the second one will be in Philadelphia in April.
Paul speaks to Jess about how health tech startups are maturing in their ways and realizing that health care is an institutionalized game, causing them to pivot their companies’ directions to fit that model. He also comments on how the pharmaceutical industry is trying to build strong relationships with particular startups to innovate their business practices, whether it be in R&D, drug discovery, or clinical research. Paul argues that the future of Pharma is more akin to a platform model, where pharma companies are not just limited to their internal capacity but are much more reliant on a larger ecosystem of moving parts that will help develop and grow the space. He also mentions that Pharma companies could really benefit from taking a page out of Google’s or Facebook’s business model which allows people to innovate and create their own content on these platforms. He further states that large B2C companies, like Amazon, will change the entire game of how people receive and curate their health insurance plans.
eyeforphrama’s conference theme is “medicine is just the beginning”. Paul and his team believe if they bring together specific groups of people, it will benefit the pharmaceutical industry in the short term as well as the long term. Paul believes that “Pharma companies need to have a wider portfolio of innovation that goes far beyond medicine, whether that is drug+plus a solution or without the pill at all.”Currently, Paul states, that the merging of pharma companies with other pharma companies is like having “s*x with your cousins” and believes that Pharma companies need to bridge out of their own space to keep up with the times. If you are a startup in this space, be sure to check out eyeforpharma’s upcoming conferences.
The best-selling drug in pharmaceutical industry history, Pfizer’s cholesterol-lowering Lipitor, lost its patent protection Thursday. But the huge savings that consumers, insurance companies and the government usually realize when generic versions of a best-selling pill hit the market are still six months away, and, consumer advocates fear, may never come to pass.
The reason is the unprecedented series of side deals that Pfizer has signed in recent months with some insurers and pharmacy benefit managers to offer lower-priced versions of Lipitor, known generically as atorvastatin. They also are offering consumers $4 co-pays – comparable to prices paid at discount outlets like Walmart and Costco – so they’ll continue buying the brand name version of the drug.
Government officials fear the full cost of the drugs might then be passed along to insurers and Medicare, although the companies involved say that won’t happen.
The goal of the maneuvers is to keep as many of the estimated 8 to 10 million Americans who take Lipitor ($7.2 billion in U.S. sales in 2010; $10.7 billion worldwide) on either the branded product or on an “official” generic, which in Lipitor’s case will be marketed by Watson Pharmaceuticals. They will sell for about half the price of the branded product for about six months, when a number of generic makers are expected to hit the market. Their versions of atorvastatin could sell for as low as $50 a month, which is less than a tenth its current price and comparable to other generic statin drugs already on the market.
It’s easy to muster a cynical response to Tuesday’s announcement that the world’s largest health products company, J&J, is replacing their current CEO William Weldon (athletic white male and former sales rep who rose through the commercial organization) with Alex Gorsky (athletic white male and former sales rep who rose through the commercial organization). After all, he will be in good company, joining Novartis’s Joe Jimenez (athletic white male – see here — with a background in marketing) and AZ’s David Brennan (athletic while male and former sales rep), among others. Indeed, of the major pharma companies, only Lilly’s John Lechleiter is a scientist (no word on whether he’s athletic; I’m told by Stephen Colbert that he is white).
Even the world of biotechs have fewer medical scientist leaders than you might think (and more white male athletes); true, Gilead, Vertex, and Seattle Genetics are led by scientists, as was Genentech prior to its acquisition by Roche. Yet, many other distinguished large biotechs don’t have medical scientists at the helm – consider Amgen (Kevin Sharer, and his designated successor, Robert Bradway); Celgene (Robert Hugin), Biomarin (Jean-Jacques Bienaime), and Genzyme, prior to their acquisition (Henri Termeer), to name a few. As detailed by Monica Higgins in “Career Imprints,” the development of the biotechnology industry owes much to “the Baxter Boys” – a group of mid-level Baxter-trained managers like Termeer who went off in search of new challenges.
As the pharmaceutical industry seems headed along the lines anticipated in 2010 by Morgan Stanley analyst Andrew Baum (now at Citi) and gradually moves from a “research and development” model towards a “search and development” model, it’s easy to attribute this change to senior leadership teams that never fundamentally understood research, and lacked appreciation for its unique challenges and culture. In simple terms, it’s easy to see why someone more comfortable with the more traditional business processes of making and selling things would look for reasons to remove discovery — the most uncertain and difficult to manage part of the enterprise (even if it’s where, however inconveniently, value is initially created).
I cannot resist writing one more time about the entire market access discussion currently ongoing everywhere, as I believe many of those numerous articles and reports are missing the point.
It is amusing, at least to me, to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches, etc. all over the place, basically suggesting how the industry just needs to throw a few more people with fancy titles here and there, coupled with slight organizational changes, onto the problem and involve stakeholders and—guess what?!—actually talk to patients and perhaps even payers and all of a sudden, like Alice in Wonderland, everything will be good, after all.
The uncomfortable truth is, it won’t be. All this “noise” is only good for one thing, paying the bills of the consultants, which is fine, too, as I have been one myself so I can understand. But it will not address the problem the research-based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry’s survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.
Today the Supreme Court will hear oral arguments in IMS Health v. Sorrell. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain “physician-identified” medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients’ Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont’s restrictions. But I think it is easy to “miss the forest for the trees” in this complex case, and want to make some points below about its stakes.**
Privacy Promotes Freedom of Expression
Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment.
There is an old tension between privacy and the First Amendment, best crystallized in Eugene Volokh’s effort to characterize privacy protections as the troubling right to stop others from speaking about you. Neil Richards has dissected the flaws in Volokh’s Lochneresque effort to reduce the complex societal dynamics of fair data practices to Hohfeldian trump cards held by individuals and corporations. Societies reasonably conclude that certain types of data shouldn’t influence certain types of decisions all the time. And courts have acquiesced, allowing much “of the vast universe of speech [to] remain untouched (and thus unprotected) by the First Amendment.”Continue reading…