Why did Italian media insist that monoclonal antibodies for COVID-19 should have been authorized months ago?
Dear Editor
The story referred in your feature article resembles the slanted media coverage in Italy on monoclonal antibodies in COVID-19 patients, insisting in this circumstance on the effectiveness of these products and on the faulty delay of their emergency approval by the Italian Medicines Agency (AIFA).
Specifically, Italian newspaper articles and political talk shows extensively reported of a meeting held on October 29, where the drug firm Eli Lilly would have offered for free 10,000 doses of bamlanivimab to AIFA for starting a clinical trial in Italy. This trial was reported to be initially proposed to the CEO of Lilly by an Italian immunologist working in Atlanta, acknowledged to be a friend of his. This immunologist and several other opinion leaders raised their protests against AIFA that, as insistently referred by media and Lilly, would have refused both the trial offer and to proceed for emergency approval of such “effective” monoclonal antibodies for COVID patients. [1] In a press release AIFA specified to have never received any proposal for a free-of-charge sale, compassionate use or supply within a clinical trial setting of bamlanivimab, and to have received only a sale approval request based on limited data and derogating from European approval. [2]
On January 21 results from a randomised controlled trial testing bamlanivimab and its combination with etesivimab (n=421) vs placebo (n=156) on COVID patients with early symptoms were eventually published, showing no or limited impact on viral load and a non statistically significant reduction (-4.8%) of the combined outcome hospitalization + emergency department visit, whereas impact on mortality was not measured. [3] These results gained very little coverage by Italian media and opinion leaders, at best shown as relative rather than absolute risk reductions and without specifying lack of statistical significance. Media kept insisting on the “puzzling” refusal by AIFA of the free offer from Lilly. Nobody highlighted the lack of robust results, the challenges of using these drugs in clinical practice on the “right” patients [4] and the implausibility of the alleged offer of 10,000 doses (worth more than 10 million euros) for a trial in Italy of a drug difficult to produce, after testing it on just 421 COVID patients in a multicentre trial in the US.
After receiving a request from the Ministry of Health and following these initial results, since no effective therapies are currently available for high risk patients with early symptoms, on February 4 AIFA released its opinion on the possibility to offer these products as therapeutic option for such patients and released an emergency use authorization, although against a continuous reassessment on the basis of new available evidence and on decisions from EMA, that has not authorized them yet. [5]
Like in the German example, the role of media in this affair has been far from the ideal of providing transparent and evidence-based information, fueling expert opinion [6] and gossip-based controversies unsustained by data, which may be targeted at pursuing vested interests rather than the public's health. It is time to seriously address the potential impact of industry/experts-media relationships on health policy and public health [7] and to discuss about codes of conduct [8] and other possible ways to limit practices which are disruptive of public understanding about health care issues. This effort should be led by scientific journals and truly independent media: who's up for it?
Rapid Response:
Why did Italian media insist that monoclonal antibodies for COVID-19 should have been authorized months ago?
Dear Editor
The story referred in your feature article resembles the slanted media coverage in Italy on monoclonal antibodies in COVID-19 patients, insisting in this circumstance on the effectiveness of these products and on the faulty delay of their emergency approval by the Italian Medicines Agency (AIFA).
Specifically, Italian newspaper articles and political talk shows extensively reported of a meeting held on October 29, where the drug firm Eli Lilly would have offered for free 10,000 doses of bamlanivimab to AIFA for starting a clinical trial in Italy. This trial was reported to be initially proposed to the CEO of Lilly by an Italian immunologist working in Atlanta, acknowledged to be a friend of his. This immunologist and several other opinion leaders raised their protests against AIFA that, as insistently referred by media and Lilly, would have refused both the trial offer and to proceed for emergency approval of such “effective” monoclonal antibodies for COVID patients. [1] In a press release AIFA specified to have never received any proposal for a free-of-charge sale, compassionate use or supply within a clinical trial setting of bamlanivimab, and to have received only a sale approval request based on limited data and derogating from European approval. [2]
On January 21 results from a randomised controlled trial testing bamlanivimab and its combination with etesivimab (n=421) vs placebo (n=156) on COVID patients with early symptoms were eventually published, showing no or limited impact on viral load and a non statistically significant reduction (-4.8%) of the combined outcome hospitalization + emergency department visit, whereas impact on mortality was not measured. [3] These results gained very little coverage by Italian media and opinion leaders, at best shown as relative rather than absolute risk reductions and without specifying lack of statistical significance. Media kept insisting on the “puzzling” refusal by AIFA of the free offer from Lilly. Nobody highlighted the lack of robust results, the challenges of using these drugs in clinical practice on the “right” patients [4] and the implausibility of the alleged offer of 10,000 doses (worth more than 10 million euros) for a trial in Italy of a drug difficult to produce, after testing it on just 421 COVID patients in a multicentre trial in the US.
After receiving a request from the Ministry of Health and following these initial results, since no effective therapies are currently available for high risk patients with early symptoms, on February 4 AIFA released its opinion on the possibility to offer these products as therapeutic option for such patients and released an emergency use authorization, although against a continuous reassessment on the basis of new available evidence and on decisions from EMA, that has not authorized them yet. [5]
Like in the German example, the role of media in this affair has been far from the ideal of providing transparent and evidence-based information, fueling expert opinion [6] and gossip-based controversies unsustained by data, which may be targeted at pursuing vested interests rather than the public's health. It is time to seriously address the potential impact of industry/experts-media relationships on health policy and public health [7] and to discuss about codes of conduct [8] and other possible ways to limit practices which are disruptive of public understanding about health care issues. This effort should be led by scientific journals and truly independent media: who's up for it?
1. https://www.italy24news.com/en/2021/02/monoclonal-it-is-a-clash-between-...
2. https://www.aifa.gov.it/en/-/impiego-in-italia-dell-anticorpo-monoclonal...
3. https://jamanetwork.com/journals/jama/fullarticle/2775647
4. https://www.jwatch.org/fw117232/2020/11/15/paul-sax-bamlanivimab-covid-1...
5. https://www.aifa.gov.it/en/web/guest/-/aifa-pubblica-parere-cts-su-antic...
6. Cochrane Consumer Network. Eminence vs. Evidence. Alan Cassels.
7. https://jme.bmj.com/content/38/8/492.long
8. https://pubmed.ncbi.nlm.nih.gov/16192184/
Competing interests: No competing interests