Posts Tagged Ben Goldacre

Reporting results from clinical trials is vital for science-based medicine

Real medicine is built on high quality data. That’s one lesson I learned through my rehabilitation as a former naturopath. I can assure you that this principle does not apply to naturopathy or any of the other types of alternative medicine, which are mostly based on anachronistic traditions, magical thinking, and poor academic integrity. I now know that real medicine incorporates any therapy scientifically demonstrated to be effective and safe, regardless of origin. Therapies that fail to demonstrate effectiveness remain alternative for good reason.

I made a sharp turn in my career when I realized this, but I was recently surprised to learn that a failure to respect the data can sometimes also characterize medicine. I’m not trying to fool anyone with an appeal to hypocrisy (often used by alternative medicine zealots to argue that their beliefs are somehow valid simply because medicine has problems). But I do want to draw attention to a problem with medical research, which has the potential to undermine science-based medicine and take us down the dark path of misinformed medicine — medicine based on incomplete data.


Most people probably don’t realize that a majority of clinical trials do not report their findings.[1–3] About half of trials conducted before 2007, before it was legally required to register and report clinical trials, have never been published.[4, 5] Even since stronger legal mandates were enacted, most clinical trials still are not registered or reported.[1–3] As a result, there is a huge amount of clinical data unknown to the medical community and not available to clinicians or patients.

This effectively means that medical decisions can be based on incomplete information, not only diminishing the effectiveness of treatments but also eroding the perceived plausibility of medical interventions over time. This is what Sense About Science’s AllTrials campaign is all about: ensuring that all clinical trials register and report results in a publicly-available database. I see it as an obvious and straightforward means to improve medicine. (more…)

Posted in: Clinical Trials, Ethics, Naturopathy, Politics and Regulation, Quality Improvement, Science and Medicine

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How not to report about vaccine safety issues, Toronto Star edition

This is the original headline of the Toronto Star's scientifically incompetent and fear mongering Gardasil story. It was later changed to "Families seek more transparency on HPV vaccine."

This is the original headline of the Toronto Star‘s scientifically incompetent and fear mongering Gardasil story. It was later changed to “Families seek more transparency on HPV vaccine.”

I remember it well, because several of my readers forwarded it to me not long after it appeared on the website of the Toronto Star: An eye-catching headline proclaiming a “wonder drug’s dark side,” that “wonder drug” being Gardasil, one of two vaccines against the human papilloma virus (HPV) designed to prevent cervical cancer by preventing infection with the HPV virus. The story’s caption blared:

Hundreds of thousands of teen girls in Canada have safely taken Gardasil, a vaccine shown to prevent HPV. But a Star investigation has found that since 2008 at least 60 Canadians have experienced debilitating illnesses after inoculation. Patients and parents say the incidents point to the importance of full disclosure of risks.

There was even a video that would have been right at home on a variety of antivaccine websites, such as Age of Autism, SafeMinds, or VaxTruth:

Indeed, the video above reminded me more than anything else, of a segment from the antivaccine “documentary” that functions as antivaccine propaganda, The Greater Good, which portrays as one of its vaccine “victims” Gabi Swank, a girl whose story is not unlike that of Kaitlyn Armstrong, the teen profiled by the Star. Both girls had a deterioration of their health that appears to have happened sometime after receiving Gardasil. Both attribute their health issues to Gardasil. Neither story was examined with even a modicum of skepticism or critical thinking. In fact, part of the reason I recognized immediately how bad the Star story was derives from my previous experience examining similar stories promoted by the particularly vociferous wing of the antivaccine movement that focuses on the perceived “evils” of Gardasil. That’s something we expect from an antivaccine propaganda film like The Greater Good. We expect better from investigative journalists like David Bruser and Jesse McLean. We don’t get it.

I had meant to blog about this incident because the Star story was such a horrendously bad story from a scientific perspective, but, blogging being what it is, other topics intruded and for some reason I never got back to this topic. Over the last 11 days, however, the criticism and inept responses kept percolating along, as you will see, involving a clueless editor who lashed out at critics, a public editor who just didn’t “get it,” and a newspaper that took far too long to admit that it had screwed up epically and only then after sliming its critics. Fortunately, an excellent analysis in the Los Angeles Times by Michael Hiltzik provided me with an “in” to do the post I had wanted to do before. How the Toronto Star wrote the story is an object lesson in how not to do a vaccine safety story, and how it responded to reasonable criticism was an even more pointed lesson in how not to deal with scientific critics.


Posted in: Science and the Media, Vaccines

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Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry

“There is no medicine without medicines” write Ben Goldacre in his new book Bad Pharma. To Goldacre, an author, journalist and physician, this cause is personal. The title, a reference to both his first book, Bad Science, as well as the pharmaceutical industry’s nickname Big Pharma, is a bit of a misnomer. While the focus is pharmaceutical companies and their actions, there are a number of enablers in the health care system – medical journals, regulators, and even medical professionals, all of whom have put the industry’s needs ahead of good medicine. According to Goldacre, the damage is pervasive and deep, right to the roots of modern medicine. These problems know no borders, and affect us all. Despite the different health care systems that exist worldwide, we all depend on for-profit pharmaceutical companies to develop and market new medicines. These companies collectively wield enormous clout, due in part to the remarkable success of medicines over the past several decades. The global pharmaceutical market will probably top $1 trillion (yes, 12 zeros) this year. And Goldacre argues the industry is not only compromised, it is broken. And over 400 pages, he defends the following paragraph:

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most party they have failed; so all of these programs persist, but worse than ever, because now people can pretend that everything is fine after all.

We all have our own biases, and I should disclose mine. I’m a pharmacist who has seen HIV go from a death sentence to a chronic disease, thanks to newly developed drugs. I’ve watched cancers like leukemias be effectively cured, thanks to medication. And I’m amazed that surgeries like double-lung transplants, impossible in the past, are now a reality, thanks in part to drug treatments. Yet I’ve also spent more than a decade reviewing the efficacy and safety of prescriptions drugs. Regrettably few are truly innovative. Many are approved with lingering questions about long-term safety and effectiveness. The value some offer can be questionable. I’ve also seen tremendous harms caused by drugs – from individual patients who have suffered horrible adverse drug reactions to population-level disasters like the Vioxx (COX-2) debacle. And I haven’t ignored the countless fines levied on pharmaceutical companies for bad, and sometimes even criminal, behavior. With its repeated capacity for self-sabotage, the pharmaceutical industry is its own worst enemy. My colleagues who work in the pharmaceutical industry agree. They’re smart, honest people that genuinely want to help get good treatments to patients. They’re embarrassed by what they see. So while I have no doubts about the astonishing track record of innovative new drugs that have transformed medicine, I also have no illusions that drug companies always behave in ways that support science-based medicine. And I think there is the potential for the industry to do much better. So how do we get this? (more…)

Posted in: Book & movie reviews

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The 2010 Lorne Trottier Public Science Symposium

I really have to give those guys at McGill University’s Office for Science and Society credit. They’re fast. Remember how I pointed out that I’ve been away at the Lorne Trottier Public Science Symposium? This year, the theme was Confronting Pseudoscience: A Call to Action, and I got to share the stage with Michael Shermer, Ben Goldacre, and, of course, our host, “Dr. Joe” Schwarcz. Sadly, I couldn’t stay to see The Amazing Randi do his thing yesterday evening, but at least I did get to have breakfast with him before I left.

In any case, the reason I have to hand it to Dr. Joe and his team at McGill is because they’ve already uploaded all the videos for symposium events. Here’s the main page with the videos (the 2010 Trottier Symposium occurred on October 17, 18, and 19), and here are the individual links:

And, because I can’t resist, here are some photos taken with various people’s cell phone cameras. First, we have a lovely poster of woo that I saw at the restaurant where we had lunch on Sunday and just had to snap a quick picture of:

Posted in: Announcements, Science and Medicine, Science and the Media

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