A few weeks ago I was asked to review Good Pharma by Don Light and Antonio Maturo. The published review appears in TES – here. It makes a great foil to the Data Wars post earlier this week. The problem was deciding if the title for this post should read Minions no Longer or Underlings no Longer – let me know your thoughts.
Whatever you think of his politics, there was a certain magnificence to Yannis Varoufakis in the recent Greek crisis. Imagine if he had won. It would have been a victory straight from the pages of Asterix the Gaul.
Well Good Pharma is straight from the pages of Asterix, except in this case the little guys facing off against the Imperial Forces are Italian, standing up initially to the Franco-German pharmaceutical industry and latterly an American industry. The irony here is that, Ho Chi Minh-like, the little guys took their inspiration from the American way of doing transparent and egalitarian research in the 1950s only to find themselves now pitted against those they once admired.
Good Pharma is the story of the Mario Negri Institute which is based in a working class suburb of Milan. Mario Negri was a wealthy patron who on his death in 1960 bequeathed a large sum of money to support independent pharmaceutical research to an upcoming researcher Silvio Garattini. At the time new drugs were spilling out of the pharmaceutical industry in abundance – psychopharmacology had just come into being and Garattini had played a part in its birth. New techniques to detect ever smaller amounts of drugs or neurotransmitters or toxins were also emerging and this played straight into Garattini’s strengths. Garattini and Alfredo Leonardi set about building an Institute centred on the new drugs and new techniques.
Trying to make their way in the world they were met with bemusement at their presumption that anyone stood anything to gain from linking to them. Five decades later having faced down the Italian government, the European regulator, GlaxoSmithKline and endless pharmaceutical companies, no-one even thinks about dismissing them.
Major discoveries in cardiology have come from their organization of the some of the first mega-trials in medicine; major discoveries in chemotherapy have come from pioneering research on new compounds; major discoveries in environmental toxicology from their abilities to detect toxins and more recently drug residues in the environment. There are probably very few families anywhere whose health has not benefited from Mario Negri discoveries or Mario Negri resistance to industry or to political efforts to cut corners or fudge data.
They continue to grow without ever having patented any of their many discoveries or concealing any of the data from experiments that didn’t work out or accommodating any of their trials to industry’s wishes. Reading this history, it feels that if there is a sign saying the conventional wisdom points left, Mario Negri have gone right, until you realize that in fact what has happened is what they’ve done was widely supported in the 1960s and it’s the field that has gone the opposite direction not Mario Negri.
Almost everyone has heard of the Cochrane Collaboration, but Mario Negri were pioneering these paths 30 years earlier and doing so across the full range of medical disciplines rather than just clinical trials. Hard-bitten ex-Army type insiders like Tom Jefferson who took on Roche over its claims about Tamiflu and won view the Mario Negri operation with awe but it’s more than it’s worth for industry to let anyone know that there is another way of doing things. If this caught on in medicine, who knows the example might spread to the wider economy.
Work began on Restoring Study 329 in September 2013. Almost the week it started the BMJ carried an editorial outlining a bitter dispute between Mario Negri and GSK. As now, GSK were then trumpeting their embrace of transparency. But it was transparency on their terms it seems. See below and link to the BMJ.
Milan, September 2013 – An editorial in the authoritative BMJ (http://www.bmj.com/highwire/section-pdf/660725/4/1) refers to news that has caused a sensation in the scientific community. The Mario Negri Institute for Pharmacological Research, a non-profit independent foundation, has withdrawn its involvement in an Innovative Medicines Initiative (IMI) project that was funded 50% by the European Union and involved the clinical research and development of a product owned by GlaxoSmith&Kline (GSK).
The Mario Negri Institute withdrew because GSK wanted to control to whom the data could be disclosed and why, as well as what could be published and when. GSK aims to keep control of the study with regard not only to the scientific community but even to the clinical investigators involved.
“Secrecy on clinical data”, comments Silvio Garattini, the Director of the Mario Negri, “implies undue exploitation of the rights of physicians and patients involved in the studies: in the end the data belong to them.”
The Mario Negri Institute did not want ownership of the data. “We never do that”, continues Garattini “since it is against our ethical principles”. It is known that the Mario Negri Institute does not patent its discoveries and publishes all information for the benefit of the scientific community, patients, and the public.
GSK’s demands are even more inappropriate in the context of an IMI project. “The Innovative Medicines Initiative”, points out Vittorio Bertele’ who participated in the negotiation with GSK,
“supports collaborative research projects with EU funds in order to boost pharmaceutical innovation in Europe. The pharmaceutical companies make the raw products available, but it is up to patients and clinical investigators to develop them, in this case with public funds.”
The Mario Negri Institute researchers only asked that the clinical investigators involved in the study were allowed to look at the overall raw data before publication of the final report. It would have been paradoxical for the authors to have had no chance to look at all the data.
“Instead”, emphasizes Guido Bertolini, coordinator of the clinical network that should have been involved in the study,
“we had to discuss with GSK lawyers specious details of a draft agreement that was aimed at leaving GSK in full control of the conduction of the study, data analysis and publication of results.”
This was not acceptable to the Mario Negri researchers and GiViTI, the network of intensive care centres that would have taken part in the study.
Because of the failure to come to an agreement with GSK the Mario Negri no longer has access to the IMI funds.
“This is a substantial sacrifice considering the hard times we are facing”, Garattini concludes. “However, we could not renounce our principles and betray the trust of people who support our research.”
The issue raised by the Mario Negri Institute echoes a problem well known to the scientific community: the need to avoid that commercial interests, however legitimate, prevail over patients’ rights which can only be ensured by the independent planning, conduct and evaluation of clinical research studies.
BMJ. 2013 Sep 4;347:f5354. doi: 10.1136/bmj.f5354.
A failed attempt at collaboration.
Garattini S, Bertele’ V, Bertolini G.
IRCCS-Mario Negri Institute for Pharmacological Research, Milan, Italy.