Gilead's battle with Médecins Sans Frontières (MSF) and plans for limited access to #Lenacapavir raise disturbing questions about #ResearchEthics and who a corporation is responsible to. My latest:
www.forbes.com/sites/judyst...
#ClinicalResearch #AccessToMedicines #Bioethics
@gregggonsalves.bsky.social: "The policy by Gilead is delay and deflect—it’s disingenuous, manipulative and will cost lives..In the end Gilead sees one audience for what it is doing, its shareholders, & maximizing share prices is more important to them than the lives of people around the world.” 4/4
@gregggonsalves.bsky.social: “This drip-drop, slow-walking approach to LEN access is again evident in Gilead’s refusal to sell LEN to Doctors Without Borders, telling them to go ask the Global Fund, when the supply availability through the Fund is limited and way below need in LMICs." 3/4
Forbes: "If corporations’ sole responsibility is to shareholders, that leads us to the question Ugandan researcher Peter Mugyenyi asked at the 2000 AIDS Conference, “Where are the drugs? The drugs are where the disease is not. And where is the disease? The disease is where the drugs are not.”2/4
As a pharma company, you know your position is morally indefensible when even business publications like Forbes are scathing about your refusal to supply HIV drugs to MSF and much of the world, while charging the few you do sell to exorbitant prices. 1/4
www.forbes.com/sites/judyst...
Do I know anyone who has recently done a MSc Politics and International Relations at SOAS? Asking for a friend who is looking into the program and has some questions.
thank you!
I'll be speaking on goods in transit issues at the Fordham University School of Law IP and Policy Conference this week.
Glad to connect with others working on all things pharmaceutical - feel free to reach out.
"Companies sought...to reduce budgets for scientific & policy activities carried out by WHO, to pit other UN agencies against WHO, to convince developing countries that WHO’s tobacco control program was a “First World” agenda...to distort the results of important scientific studies on tobacco." 5/5
Some excerpts:
"In their campaign against WHO, the documents show that tobacco companies hid behind a variety of ostensibly independent quasi-academic, public policy, and business organizations whose tobacco industry funding was not disclosed." 4/5
www.publichealthlawcenter.org/sites/defaul...
Also recommend a banger of a report - "Tobacco Company Strategies to Undermine Tobacco Control Activities at WHO."
There are multiple chapters on scientific misdeeds alone, not to mention surveillance. 3/5
www.publichealthlawcenter.org/sites/defaul...
"Efforts to deny & distort the scientific evidence of smoking's harms are demonstrated by not only decades of press releases, reports...& scientific symposia & publications, but also by evidence of their concerted efforts to attack & undermine the studies in mainstream scientific publications." 2/5
Is the Philip Morris currently on an advertising blitz to 'free the science' the same one that DOJ described as having "suppressed research, destroyed documents... distorted the truth, and abused the legal system"?
🤔❓😠
See DOJ summary of U.S. v. Philip Morris www.justice.gov/osg/brief/ph... 1/5
This is concerning but the impact is hard to gauge without detailed guidance defining how 'ingredients' and 'onshore' will be implemented in practice.
www.whitehouse.gov/fact-sheets/...
Gilead spends millions on PR to make 2 million doses sound like something other than the pittance it is. 2 million will have virtually no impact, see the green line below >>
20 million people need PrEP, and of those many would prefer lenacapavir to oral options. Unless Gilead makes more doses available, access will just remain cruel hype.
Already in Eswatini, where HIV prevalence is 25%, clinics are stocked out of lenacapavir because demand is so great >>
In 2027! But the drug is needed today.
Doctors Without Borders calls Gilead ‘unconscionable’ for refusing to sell HIV prevention drug to organization.. statnews.com/pharmalot/20... #pharma #HIV #AIDS #pharma #Gilead
I've walked thru the economic logic here, but Gilead obviously does not say this out loud. They don't really have a good reason not to sell to MSF, which is why they landed on negotiating supply contracts is "a lot of work" (actual thing they said). 13/
www.doctorswithoutborders.org/latest/preve...
I've walked thru the economic logic here, but Gilead obviously does not say this out loud. They don't really have a good reason not to sell to MSF, which is why they landed on negotiating supply contracts is "a lot of work" (actual thing they said). 13/
www.doctorswithoutborders.org/latest/preve...
Theoretically yes, there are a few pathways. But they require nat'l authorities (not MSF) actioning CLs, which takes time (as well as time to develop the drug). In territories where Gilead has granted a VL, generics are preparing to launch, but this isn't expected until at least next year.
Even if Gilead would likely make at least a 100% profit selling to a LIC for $80, it becomes politically incredibly difficult to justify your $28,000 price tag in the US.
Here's a clip of the BIO lobby saying just this in a USITC hearing. 12/
You also have to think about price pressure: HIV is Gilead's core business, and despite the HIV burden not being heaviest in the US, 81% of Gilead's revenue comes from the US alone (bc prices are so high, even if volumes are low.) 11/
But you have to think abt a potential sale in terms of their portfolio: a 10,000% markup sounds good, unless your other drugs that are vying for time and space on production lines yield you a 70,000% markup. This is why drug companies outsource manufacturing, engage in licensing deals, etc. 10/
To understand this, you have to think about opportunity costs. Gilead told us in meetings that they expect prices to fall below the $40/year price generics have offered - this isn't an expensive drug to manufacture. 9/
At this point, I'm taking of my MSF hat and putting on my academic economist hat to step back and try to make sense of this for folks. (Again, to be clear - this is speculation about markets and I do not speak for MSF).
Why would a pharma company like Gilead forego a profitable sale? 🤔8/
The focus of critiques about pharmaceutical monopolies is generally on PRICE. But this case is a compelling example for problems of SUPPLY: it's not a great world when one company controls global supply of a drug and can just refuse to sell it to people who need it. 7/
This situation is extra bad because it's not that Gilead isn't interested in markets in the rest of the world - they have filed for patents and signed licenses blocking dozens of countries from accessing future generic supply. 6/
I expect at this point you are muttering to yourself, "there must be some rational explanation."
We thought so too. Which is why we tried & tried again before going public, in the hope that shame still exists and Gilead can be persuaded to do what pharma companies are supposed to do: sell drugs. 5/
Here's where things get weird: Gilead is refusing to sell lenacapavir to MSF.
In a series of meetings, Gilead communicated that they're just not really interested in selling lenacapavir in most of the world beyond the cap. Depending on estimates, this cap = between 0.5% and 10% of global demand. 4/
Here's where MSF comes in. We have a long history of offering HIV treatment and prevention services. We have a long history of buying drugs from Gilead.
We were not expecting this to be complicated: they have a drug, we want to buy it, thanks to our donors we have money to pay, etc etc. 3/
