What the Tamiflu saga tells us about drug trials and big pharma

We have been subscribers to the All Trials network since founded by physician Ben Goldacre in Jan 2013. The mission statement is simple “All Trials Registered | All Results Reported”. The above-captioned article by Dr. Goldacre will make it clear why this initiative is so important:

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

Tamiflu being made by Roche

 

(…snip…)

This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda, and this may be our only opportunity to fix it in a decade. We cannot make informed decisions about which treatment is best while information about clinical trials is routinely and legally withheld from doctors, researchers, and patients. Anyone who stands in the way of transparency is exposing patients to avoidable harm. We need regulators, legislators, and professional bodies to demand full transparency. We need clear audit on what information is missing, and who is withholding it.

Finally, more than anything – because culture shift will be as powerful as legislation – we need to do something even more difficult. We need to praise, encourage, and support the companies and individuals who are beginning to do the right thing. This now includes Roche. And so, paradoxically, after everything you have read above, with the outrage fresh in your mind, on the day when it feels harder than any other, I hope you will join me in saying: Bravo, Roche. Now let’s do better.

• Ben Goldacre is a doctor and the author of Bad Pharma.

You can help the All Trials mission. Join and sign the petition here. Spread the word, lean on your politicians, get involved.

Kerry Emanuel: An Obligation to Take on ‘Tail Risk’ vs. Alarmism

On the 24 March Econtalk Russ Roberts interviewed John Christy and Kerry Emanuel. Prof. Roberts is very effective at moderating an informal debate like this – he keeps each party focused on reply and rebuttal to the key points. This is far more effective than the usual “debate” where each side essentially repeats prepared talking points, with very little contact with the arguments made by the opposition.

I have been following the writings of MIT prof. Kerry Emanuel for a long time. Besides his climate science expertise, he has been an effective voice for pragmatic carbon policy that includes nuclear power. E.g., on 3 November Dr. Emanuel and three other top climate scientists joined together in an open letter directed to the Baptists in the “Bootleggers and Baptists” coalition that have made it impossible to make any real progress decarbonizing the global economy.

Related posts on Kerry Emanuel’s work are Enviros and climate scientists continue their fight over nuclear power, and Kerry Emanuel: Reddit AMA on climate change and severe weather.

Though I’ve not reviewed the book here, I highly recommend Emanuel’s compact primer What we know about climate change. It is a remarkably short, apolitical and information-dense survey of a complex subject.

In the above-captioned short essay by Emanuel, he takes a similar theme to the Econtalk interview — that to develop effective climate/energy policy we need to focus on the risk management. It won’t be a surprise that I support Kerry Emanuel’s risk framing — because that is how I look at climate policies. I think we need to keep our attention on both mitigation and adaption policy options. Generating more policy options is how we get better results (exactly the opposite of what activists want – which is to limit our options to the activists’ preferred technology/approach).

This is all about risk – and risk appraisal and management are skills that we humans do not manage well at all. 

Jennie Schmidt: The Costs of GMO Labeling

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Jennie Schmidt is the proprietor of TheFoodieFarmer “Blogging about how your food gets from field to fork”. Jennie is very different from your typical Whole Foods customer, who has never set foot on a farm – she knows farming in depth. In particular she understands the supply chain – which is why she is especially qualified to write the captioned essay on what “right to know” really costs. This is the real deal, carefully researched, first-hand explanations of what is involved in establishing traceability of every ingredient that goes into food on your supermarket shelf. Read Jennie for the particulars. She closes with this summary:

Those who say GMO labeling won’t add to the consumer’s grocery bill need to go back to Economics 101 and some basic high school math.

True traceability in our food supply system will be hugely expensive.

Its likely that as a nation, we’d never capitalize all that infrastructure to achieve true traceability.

Which goes to the crux of the matter – this isn’t about labeling, as I cited in my last GMO blog, labeling is a means to an end. As noted by many activist groups, the ulterior motive behind labeling is not about a consumer’s right to know, it is about banning the technology.

Say NO to mandatory GMO labeling. Stand for science.

I liked Jennie’s essay so much that I posted the following comment:

Jennie – thanks heaps for taking the time to document some of the true costs that the “right to know” lobby wants to impose on consumers. I’m happy to see you already have a well-deserved pat on the back from Prof. Kevin Folta.

When we see such a “movement” promoting regulations that don’t make sense – that’s a good time to ask “who benefits?” If we follow the incentives we find there are a number of special-interests who are funding this campaign. David Tribe framed the smelly bedfellows as Big Quacka and Big Organic.

A concept from Public Choice economics that helps us understand how these hidden interests operate is called “Bootleggers and Baptists”. In your GMO labeling case the Bootleggers include Whole Foods and trial lawyers. Back in the CA Prop 37 fight I wrote a few posts on this concept, such as How California’s GMO Labeling Law Could Limit Your Food Choices and Hurt the Poor and Scott Andes: Why California’s GMO Labeling Proposition Should be Defeated.

The key idea is that the Bootleggers have learned that the best media reception is obtained by fronting the Baptists, preferably worried-looking moms holding their beautiful babies.

The Bottom Line: if you want to know about food and farming – talk to farmers, not to Greenpeace.

Hiroshima Syndrome on Arnie Gundersen’s latest fabrications

Leslie Corrice at Hiroshima Syndrome just posted a must-read takedown of Arnie Gundersen's latest psuedoscience video. I used to think Gundersend was just dim-witted. But such obvious propaganda could only be produced by someone who is deliberately crafting lies to be consumed by gullible viewers (and journalists). You must read the whole piece. Leslie closes with this paragraph:

Now, here’s the part that really sets me off. Gundersen ends the video by saying, “It is solid scientific material like this that you will not see or hear via traditional news stories, TEPCO, or the IAEA. Fairewinds has long said that there will be significant increases in cancer in Japan as a result of the Fukushima Daiichi accident, and this video describing just one hot particle confirms our worst fears.” (Emphasis added) First, the video as evidence is about as solid as overly-cooked noodles…if that. Second, the reason you don’t find this anywhere else is because it is absolute balderdash. The Press around the world might have a strong antinuclear agenda, but they draw the line at pure nonsense. And, finally, Kaltofen’s folly in no way confirms Gundersen’s worse fears for a major cancer increase in Japan’s future. But, it does confirm that Gundersen will grasp even the most flimsy straw to try and keep his fantastic Fukushima forecasts alive.

Fairewinds has long said” is one of Gundersen's tricks. As though Fairewinds was something real, like a research institute – instead of Arnie's bedroom.

Norman Borlaug: A Man For All Seasons

Norman Borlaug was a friend and mentor of molecular biologist Henry Miller, hence this moving salute to Borlaug's 100th:

In his professional life, Norman struggled against prodigious obstacles, including what he called the “constant pessimism and scare-mongering” of critics and skeptics who predicted that in spite of his efforts, mass starvation was inevitable and hundreds of millions would perish in Africa and Asia. His work resulted not only in the construction of high-yielding varieties of wheat but also in new agronomic and management practices that transformed the ability of Mexico, India, Pakistan, China, and parts of South America to feed their populations.

How successful were Norman’s efforts? From 1950 to 1992, the world’s grain output rose from 692 million tons produced on 1.70 billion acres of cropland to 1.9 billion tons on 1.73 billion acres of cropland — an extraordinary increase in yield per acre of more than 150 percent. India is an excellent case in point. In pre-Borlaug 1963, wheat grew there in sparse, irregular strands, was harvested by hand, and was susceptible to rust disease. The maximum yield was 800 lb per acre. By 1968, thanks to Norman’s varieties, the wheat grew densely packed, was resistant to rust, and the maximum yield had risen to 6000 lb per acre.

Without high-yield agriculture, either millions would have starved or increases in food output would have been realized only through drastic expansion of land under cultivation — with losses of pristine wilderness far greater than all the losses to urban, suburban and commercial expansion.

Norman recalled afterwards without rancor the maddening obstacles to the development and introduction of high-yield plant varieties: “bureaucratic chaos, resistance from local seed breeders, and centuries of farmers’ customs, habits, and superstitions.” About his experience in India (in the early 1960′s), he said:

When I asked about the need to modernize agriculture, both scientists and administrators typically replied, “Poverty is the farmers’ lot; they are used to it.”

I was informed that the farmers were proud of their lowly status, and was assured that they wanted no change. After my own experiences in Iowa and Mexico, I didn’t believe a word of it.

In Pakistan and Egypt, government research directors actually sabotaged trials of Norman’s seeds in order to discredit his work. As a result, people starved.

(snip)

Please read Dr. Miller's essay – you'll be glad you did.

 

32 planned German power plants are not viable

The German energy industry association, BDEW, says that 43 per cent or 32 of the power plants planned for construction in Germany may never come to fruition, due to lack of economic viability.

The association’s managing director said: “Unless there is clarity very soon about the future structure of the market and a relevant capacity market model, the situation for power stations will result in a serious problem for as an industrial location.”

The association says a combination of a lack of clarity about the future structure of energy markets and the lack of profitability for coal- and gas-fired power stations because of competing energy supplies from subsidised renewable power had severely undermined investor confidence.

BDEW said that a year ago, it had only questioned the economic viability of 22 long-term projects and warned that the situation had regressed to the point that unless action was taken to encourage the construction of more power stations to ensure stable supply, energy security issues were inevitable.

The report from BDEW was issued on the first day of the Hanover Trade Fair, when the body traditionally prescribes its solutions for a more effective German energy policy.

It warned that if current plant closure plans were added up with cancellations of new construction, some 13,600 MW of so-called secure load, that runs 24 hours, would be shut by 2022.

(…snip…) 

Source Power Engineering 4 April 2014 by Diarmaid Williams.

How crowdsourcing helps robots substitute for humans

MIT'S Erik Brynjolfsson said “We’re at a real inflection point in terms of artificial intelligence and machine learning. Things are speeding up.”

How crowdsourcing helps robots:

White-collar jobs were once deemed mostly immune to such automation, but that is no longer true, either. Carl Benedikt Frey, an economist, and Michael Osborne, a professor of machine learning, at Oxford University estimate that about half of American jobs — sailors, paralegals, you name it — are susceptible to automation. “Software substitution, whether it’s for drivers or waiters or nurses” is coming, Bill Gates said recently at the American Enterprise Institute in Washington. “Twenty years from now, labor demand for lots of skill sets will be substantially lower. I don’t think people have that in their mental model.”