From the pandemic, a roadmap for lowering the costs of medicine

‘To speed Covid-19 treatments, federal officials adopted a new, nimbler regulatory posture. The change was long overdue...

‘In recent decades, for example, the FDA — scarred by episodes like the Vioxx debacle and buoyed by scientists’ increased understanding of the body — has pressed drug makers to demonstrate increasingly rigorous understanding of the mechanisms by which their medicines work. Yet, one might argue that these guidelines reflect either hubris or naivete: The vast majority of safe and effective drugs were approved despite uncertainty about their mechanisms of action. Even today, scientists do not completely understand how acetaminophen works, yet the world is a far healthier place for having this drug...

‘In some high-profile cases during the pandemic, the FDA leaned less on mechanistic proof of effectiveness and more on empirical indicators, such as patient survival rates. For instance, when objective data revealed that the steroid dexamethasone helped severely ill patients survive what might otherwise have been deadly coronavirus infections, the FDA was quick to support the drug’s use, despite scientists having only a speculative understanding of how the steroid works against the disease. To be sure, the FDA must continue to prioritize its mandate to protect patients and clinical trial volunteers. But the pandemic has shown that safety and speed need not be an either-or proposition.’

Read here (Undark, Mar 25, 2021)

Intellectual property cause of death, genocide

‘Refusal to temporarily suspend several World Trade Organization (WTO) intellectual property (IP) provisions to enable much faster and broader progress in addressing the COVID-19 pandemic should be grounds for International Criminal Court prosecution for genocide. 

‘Making life-saving vaccines, medicines and equipment available, freely or affordably, has been crucial for containing the spread of many infectious diseases such as tuberculosis, HIV-AIDS, polio and smallpox. 

‘Jonas Salk, who developed the polio vaccine, insisted that it remain patent free. Asked who owned the patent 65 years ago, he replied, “The people I would say. There is no patent. You might as well ask, could you patent the sun?”

Read here (ksjomo.org, Feb 8, 2020)

Vulnerable: The law, policy and ethics of Covid-19

The contents of this 649-page book ‘confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. Covid-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, and recovery include all individuals, not just some.’

Most of its contents are focussed on Canada, however, there are articles about other places. The last 100 pages e.g. is on “Global health and governance”. Even while being Canada-centric, many of the issues are relevant to other countries albeit developed ones.

Download here (uO Research, University of Ottawa, 2020)

Politics, profits undermine public interest in Covid-19 vaccine race

‘Some pharmaceutical giants, e.g., Glaxo-Smith-Kline and Sanofi, claim they do not expect to profit from the Covid-19 vaccine. But such recent industry promises not to profiteer from making the vaccine globally available are hard to reconcile with the record that drug research and development has long been driven by the prospect of massive profits.

‘Such firms have been urged to make the Open Covid pledge to voluntarily relinquish their IP rights (IPRs), at least until the Covid-19 pandemic is over... Governments can also use ‘compulsory licencing’, permitted by World Trade Organization rules, to enable companies that do not have the IPRs, to make, manufacture and sell generic versions of patented medicines...’

Read here (IPS News, May 26, 2020)

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

‘Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”

‘Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.’

Read here (The Washington Post, May 1, 2020)

Dr Anthony Fauci says Gilead’s remdesivir will set a new ‘standard of care’ for coronavirus treatment

• White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news” and sets a new standard of care for Covid-19 patients.
• Fauci said the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group. 
• The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released later Wednesday.

Read here (CNBC, April 29, 2020)