Experts agree there is a strong likelihood of a vaccine coming to market in the next six to 12 months, and an even stronger indication that an effective COVID-19 vaccine can create outsize value for global citizens, economies, and healthcare systems. With all that in mind, there are six actions that stakeholders in the vaccine ecosystem can take as they continue with development, manufacturing, policy making, implementation, and other efforts. Key COVID-19-vaccine stakeholders will need to continue to monitor and adapt to the new SARS-CoV-2 variants emerging across the globe to respond effectively.
At the same time, the firm has been allegedly advising numerous major corporate pharmaceutical clients, including helping opioid makers fend off and water down FDA regulations, multiple news outlets have reported. On April 13, the House Committee on Oversight and Reform released an interim staff report that contained preliminary findings from the Committee’s investigation into McKinsey’s consulting work during the opioid epidemic. The investigation confirmed that McKinsey consultants frequently worked on FDA contracts while also working for opioid manufacturers and did not disclose conflicts of interest to the FDA. Additionally, the company was found to have used its government consulting work, connections and influence to solicit more business from opioid manufacturers and allegedly attempted to influence government officials to advance the interests of opioid clients.
The opioid manufacturer Purdue Pharma, beleaguered and in financial trouble, wanted to revamp its business, and an executive there sought out Dr. Smith. The news of McKinsey’s opioid work apparently did little to dampen the FDA’s enthusiasm for the consultancy. In March 2019, just after the news broke, the agency signed a new contract with McKinsey — extending the firm’s multiyear effort to help the FDA “modernize” the process by which it regulates new drugs. At a separate Senate hearing Tuesday, the head of FDA’s drug center director told lawmakers McKinsey’s work was about “organizational design and did not entail involvement in product regulation.” The agency currently has no contracts with McKinsey, she noted.
I don’t think you’re wrong, but, as part of their contract that requires them to divulge potential conflicts of interest, why didn’t they just notify the FDA that they have separate teams that are working with Purdue and J&J? That would have satisfied the contract, and everyone already knows they have their fingers in everything everywhere, so there would have been no issue. No, they were hoping that this information would never come to light, and they wouldn’t have to say anything about it. “We are steadfastly committed to protecting our clients’ confidential information and guarding against conflicts of interest,” the company said in a recent statement.
Moreover, McKinsey trumpeted its government access to solicit more business from opioid makers, as well as to influence key health officials. A preliminary report from the committee found 22 McKinsey consultants who worked for both the FDA and an opioid manufacturer over the span of a decade. The overlapping work included McKinsey staffers advising the FDA trolls disney car toys on overhauling its approach to drug safety, according to the committee’s review of thousands of company documents. As noted, a variety of scenarios can emerge that will affect the demand for a potential vaccine. Governments, distributors, manufacturers, regulators, and other stakeholders should build contingency plans to react and adapt successfully.
“Gavi launches innovative financing mechanism for access to COVID-19 vaccines,” Gavi, June 4, 2029, gavi.org. At the other end of the spectrum, in a scenario in which COVID-19 transmission wanes and breakthrough therapeutics against the disease emerge, a vaccine has a somewhat limited role, serving as more of an insurance policy for society. There would likely be more focused demand for a vaccine in this scenario (for example, for use in high-risk populations), but the investment made to develop and scale the COVID-19 vaccine would be considered protection from a more severe outbreak. In a more moderate scenario, vaccines have a focused role, with the demand still significant, albeit lower. For example, if transmission rates remain stable, the duration of immunity from a vaccine is about three to five years, and the availability of therapeutics and testing improve, the broad-scale need for vaccines is less acute. However, a COVID-19 vaccine could still be used to protect vulnerable populations and to address hot spots that could emerge in future waves.
Last year the consulting powerhouse agreed to pay $600 million to settle lawsuits over its work advising opioid makers , though it admitted no wrongdoing. Device makers can apply to have their products designated “breakthrough,” granting them more direct lines of communication with FDA officials, coordination on faster clinical trials, and generally a quicker pathway to market. McKinsey even stressed its relationships with regulators, saying they had “developed insights into the perspectives of the regulators themselves” in a 2009 presentation to a pharmaceutical industry group. Consultants even sought to hide email exchanges between the firm and Purdue amidst their growing number of lawsuits, minimizing their role in advising the pharma company. McKinsey employees working with Purdue also influenced written materials sent from the company to government officials and agencies, including the new secretary of Health and Human Services in 2018, Alex Azar, downplaying how serious the opioid crisis was. One senior partner complained that a colleague working with Purdue “waters down everything I say.”
As such, the report is “absolutely a wakeup call,” the consultant said, both for marketers working on governmental contracts or simply competing pharma brands. McKinsey has faced scrutiny in recent years for allegedly accepting work from U.S. government agencies without disclosing potential conflicts of interest from the private sector or foreign governments. “We know that McKinsey worked with Purdue Pharma to ‘turbocharge’ sales of OxyContin, and it is deeply troubling that McKinsey was getting paid by opioid manufacturers such as Purdue Pharma at the same time it was working for the FDA,” Hassan wrote. “We must get to the bottom of these reports and understand the full scope of McKinsey’s involvement in fueling this crisis, as well as discover what more the FDA needs to do to avoid future conflicts of interest.” McKinsey’s failure to disclose its industry engagements deprived the FDA of the opportunity to consider whether, for example, the overlap between McKinsey’s government and pharmaceutical industry projects and the potential financial incentives at play constituted a conflict, experts said. During that same decade-plus span, as emerged in 2019, McKinsey counted among its clients many of the country’s biggest drug companies — not least those responsible for making, distributing and selling the opioids that have ravaged communities across the United States, such as Purdue…
