In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?
Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.
No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play. Read More
While I was aghast earlier this week that the White House struggled over whether to fly the flag at half-mast or full for the death of John McCain, and relieved that it was still the American flag, I distracted myself from the drama in Washington with other news:
Item: In Europe, there were 5,000 cases of the measles in all of 2016, 24,000 in 2017, and already 41,000 halfway through 2018, including 37 deaths, according to the World Health Organization. Globally, measles remains a leading cause of death among young children even though a safe and cost-effective vaccine is available.
Bioethicists, policymakers, and clinicians tend not to lump brain death, gene therapy and the anti-vaccine movement together. And why should they? Though fate management is central to each, they are perplexing enough to the public (i.e. me) when considered separately.
The Second Appellate District’s Court of Appeal upheld the California law that removed California’s Personal Belief Exemption (PBE) from school immunization requirements earlier this month.
The decision is a strong endorsement of immunization mandates and is binding on all state courts until another appellate decision is handed down, or the Supreme Court of California addresses the question.
New York’s Court of Appeals reversed an Appellate Division decision and reinstated New York City’s influenza mandate for city daycares in Garcia v. New York City Department of Health and Mental Hygiene in June. Applying the same criteria the court used in 2014 to overturn the city’s controversial Soda Cap, the court found that the rules are well within the Board’s authority.
We can suspect that the recent influenza season influenced the decision, but it was also based on a more explicit delegation of authority, and a history of vaccination programs by the Board.
Also, it’s likely good news for at least some of New York’s youngest, who will be better protected from a dangerous disease, and for the public.
My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).
To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso. Read More
Yesterday, the European Court of Justice has issued an important ruling on vaccine manufacturers liability. N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. This ruling triggered a hailstorm of criticism from different media outlets, including CNN. These outlets, however, have largely misreported the ruling and its underlying reasons, partly because of this misleading Press Release issued on behalf of the Court itself. In this post, I analyze the Court’s actual decision and briefly compare it with the American law.
The case at bar was about an adult patient who developed multiple sclerosis shortly after being vaccinated against Hepatitis B. The vaccination he received was manufactured by Sanofi Pasteur. Following the patient’s death from multiple sclerosis, his family filed a products liability suit against the company. The suit was filed in a French court, whose decision on evidentiary matters triggered a series of appeals that brought the case before the European Court of Justice. The Court was asked to determine whether the French evidentiary rule which allows plaintiffs to prove the vaccine’s defect and causation by “serious, specific and consistent evidence” in the absence of medical research in either direction aligns with the European law of products liability. The Court ruled that it does while making a number of clarifications and setting up conditions for such rules being valid under Article 4 of the European Council Directive 85/374/EEC of 25 July 1985. Read More
It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:
Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.
Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)
On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”
Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.” In particular, the Complaint alleges that Arrowhead:
made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.
According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”