Study 329: Minions No Longer
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.
Review
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.
Press release
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.
The Mario Negri Institute does not bow before GSK
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.
Nice to know some people still have good ethics. Well done to this institute. The Commonwealth Serum Laboratories in Australia, were good too, until somehow they went private…. Fallout fluvax, and one in 100 babies either dying or being seriously ill… Why? they added an extra 4th flu without testing….. money, money, money. Now banned for kids until over year 5….. This fluvax is still killing, and some doctors still using on kids under 5….. If it kills, it kills, just because someone is stronger to fight the toxic damn fluvax, doesnt make it safe.
Well done study329.org
agreed, well done!
Thank You to Dr.David Healy, to the Mario Negri Institute in Milan Italy, for naming and shaming the greedy rootless Pharmaceutical Co., and to the people responding with concerns about the lack of good ethics and morals of Pharmaceutical Industries who are clearly putting their profit first and are willing to play Vaccination Roulette with new born Babies, their Mothers and Grandparents & Families……from birth till death do us part.
As well as abusing children and adults with antidepressants known to also cause people to kill themselves.
Hell on earth is all around us…also in Australia….and the battle between good and evil continues.
The Federal Government Senate Inquiry Commission, invited submissions to the *No Jab No Pay* Amendment to the Social Service Act which wants to tie vaccination to welfare payments to families for children from birth to 20yrs of age.
It is an unconstitutional cruel attempt to *save* dollars, they say, and at the same time inject as many children as possible with and ever increasing number of toxic, infectious, neurologically damaging and sometime killer vaccines.
Why? When credible scientific studies, FREE from vested interest, to prove that vaccination prevents the diseases they say are preventable,and achieve the elusive *herd immunity* … do NOT exist.
There is much credible evidence available to testify to the damage vaccines do
Here are a few informative Australian web sites –
http://www.vaccinationdecisions.net
http://www.avn.org.au
VTS – vaccination information service
VISA – vaccination information serving Australia
and
http://www.sanevax.org.uk (United Kingdom)
and many more also in the United States of America.
If the majority of people would act responsibly, instead of acting in *blind-faith* re. medical and pharmaceutical matters, if they would get off the proverbial fence, stand tall and ask questions also about the ingredients being injected in their bodies, about the simple Home Nursing protocol to follow from the very beginning of illness or infection ( a doctor of medicine said that Home Nursing is now a forgotten art….. replaced by pill popping and lack of sensible hygienic practices in society).
It is also deeply disturbing that when little Babies die after being vaccinated, the Coroner’s report will say that the Baby died of SIDS or SUDS.
What a heartless misnomer for the cause of death of a Baby who has been poisoned by vaccines.
Wow!
You could have bowled me over with a feather!
I am practically faint with the notion that there is an ethical pharmaceutical company on this Earth.
As in the “Blueprints for Change” chapter in Bob Whitaker’s excellent “Anatomy of an Epidemic”, which gives examples of excellent mental health care (involving minimal and judicious, cautious use of psychiatric drugs), this institute points the way for governments – as well as potentially ethical (even thinking about it) pharmaceutical companies- to straighten up and fly right.
No sleight of hand here, just the truth.
Thank you for making me aware of this phenomenon.
Hooray for the folks at the Instituto and the example they are setting! Science doesn’t belong to corporations, hedge funds or shareholders–in fact they may destroy science altogether if we don’t watch out. A case in point: two consulting firms set up by US psychiatrists recently. You could call these guys the Anti-Mario-Negri Institute:
http://www.medavante.com/scientific-risk-reduction-services/
http://www.bracketglobal.com/
Both Medavante and Bracket are in the business of “preventing failed trials.” They can show you how to screen out trial subjects who won’t do well on your new drug (and those who will do well on placebo); pick the rating scales that will show your drug in the best light, etc. In other words, how to rig any trial to get the result the sponsors want to see.
They ought to lose their fancy university jobs for this, maybe even do some jail time. At the least, they ought to be selling their products under the table in some seedy back room. Instead, they do it out in the open, complete with press releases! Are their colleagues just too hypnotized by years of corporate dominance to object? They need to snap out of it. Maybe the Mario Negri team can help.
This and several other posts in the 329 series are reproduced on Mad in America, where this comment has just appeared
There is a new comment to Study 329: Minions no Longer.
Comment Link: http://www.madinamerica.com/2015/10/study-329-minions-no-longer/#comment-75525
Author: BetterLife
Comment:
I found the researchgate link too, and was happy to see that the third author had uploaded it to his account, allowing free access for all. I hope it’s in violation of BMJ’s copyright.
minion
Synonyms: underling, henchman, flunky, lackey, hanger-on, follower, servant, hireling, vassal, stooge, toady, sycophant;
I like “stooges” better than minion and underling.
In absolute contrast to this encouraging story, I thought I had seen the worst that pharmaceutical companies can do until along came Valeant. Its owner, J Michael Person has become a billionaire by buying older drugs and increasing the price exponentially. For example, one gentleman in the US, aged 68, has been taking a drug Cupramine, for 55 years for the effective treatment of Wilson Disease and, without it, he will die. Valeant quadrupled the price of the drug overnight and Medicare will have to pay (if it agrees) $35,000 for a month’s supply, while the patient will have to come up with $1800 a month himself instead of the $366 he used to pay. His wife has had to take on a second part-time job to pay for the drug.
This year alone, Valeant raised prices on its brand-name drugs an average of 66 percent, according to a Deutsche Bank analysis, about five times as much as its closest industry peers.
Valeant said that it “prices its treatments based on a range of factors, including clinical benefits and the value they bring to patients, physicians, payers and society.” It says patients are largely shielded from price increases by insurance and financial assistance programs the company offers, so that virtually no one is denied a drug they need. Sure, and there’s a bridge in Brooklyn I’d like to interest you in.
CEO Pearson, a former McKinsey & Company consultant, has said that he has a duty to shareholders to wring the maximum profit out of each drug. If “products are sort of mispriced and there’s an opportunity, we will act appropriately in terms of doing what I assume our shareholders would like us to do,” he told analysts in April.
It raised the price of the diabetes pill Glumetza, about 800 percent, in two steps going from about $520 a month to $4,643.
Valeant is known for buying one company after another, and laying off their employees to achieve savings, and pays extremely low taxes because it is officially based in Canada, although Mr. Pearson operates from New Jersey. As a Canadian, I am even more enraged!
Dr. Irl B. Hirsch, a diabetes specialist at the University of Washington School of Medicine in Seattle, said insulin prices had risen so much in recent years that some patients were scrimping on groceries to pay for it. The price of a package of five Lantus injectable pens from Sanofi has gone from about $179 in 2010 to $372 last year, he said, and insurance will often cover only one package at a time.
Anyone looking for a definition of evil?
Johanna – I see that ‘Bracket’ offer “Unobtrusive analysis identifying potential sources of anomalous data patterns”. What’s your interpretation of ‘unobtrusive’ ? (!!).
Um… “Rater #32B from Chattanooga needs to get with the program — tell her to start seeing some improvement, or start looking for a new job.”
Or: “Subject #522, the one who just got that weird rash? I think he lied on his registration form, he drinks 7 pints a week not 3. Why don’t we remove him for a Protocol Violation.”
But then, I’m way too cynical.
Found this week’s post such an uplifting read but the stories that followed, I found so depressing – how anyone can equate such behaviours with ‘success’ completely baffles me. Shame it doesn’t baffle a few shareholders here and there too.
23h
Cochrane @cochranecollab
.@bengoldacre: “If you torture the data hard enough it will confess to anything” #cochranevienna #AllTrials http://ow.ly/i/dtK3K
Retweeted by michelev
Lost in translation..
If you torture the patients hard enough it will confess to anything…
#Study329.org #Paroxetine #Seroxat #Paxil #GSK #$$$
FT The Big Read..
http://www.ft.com/cms/s/2/3a7f8df0-f7b7-11e4-9beb-00144feab7de.html#axzz3nltUmo00
Investors in shares don’t think quite the way that we do……as can be seen on The Wish List (as in Titanic) on Rxisk.org
How Ben Goldacre can declare himself a patient advocate baffles me.
I think the ‘minions’ should stay in the title.
I wonder how it remains possible for people like Ben Goldacre to speak of “evidence based medicine” while simultaneously revealing that we don’t actually have any evidence these days. My own feelings about the approach from early days of working with epidemiologists at McMaster University have been, and remain, that it’s an approach that has led to the near death of medicine. I recently watched two TED talks, one after the other. The first was Dr Goldacre denouncing the fraud in drug testing and in research in general. The second was Dr Abraham Verghese speaking of the demise of touch and the physical examination with the patient as the centre of the process. It would be hard to find two more opposite positions and personalities but very easy to decide which one you would want taking care of you.
Irene – You speak of the “demise of touch, as referenced by Dr. Abraham Verghese. Just yesterday, I said farewell to my primary care physician of six years. She is so very human, always takes “way too long”, regularly turns down patient requests for medications (the example she gave was anti-depressants) that she does not feel they need, and declared that I was her healthiest patient – along with a 90-year-old. She has respected my wish to take no medication unless she makes a compelling case for it and I can back it up with my own research. So I take nothing but a thyroid medication.
She has endeared herself to me and we exchanged private email addresses. I believe that we will be friends in the future, now that we are no longer in a doctor-patient relationship.
My physician was born in Ethiopia and did some her training outside of the U.S. which, I believe, gives her a broad perspective on the practice of medicine.
We have had long talks about the death of my family member due to Zyprexa, and she has encouraged me to live a full life despite my sorrow, which I am doing.
My physician lamented not having enough time to do the research that she would like to do, and hopes to be able to reduce her hours in the future, not only to do research, but to have a more well rounded life.
We gave each other a hug goodbye….in the past, she always gave me a pat on the shoulder or held my hand, gently, with kindness and compassion. I will miss her.