Episode 85: AllTrials and Vanessa’s Law

In this episode of Life, the Universe & Everything Else, Gem Newman and Richelle McCullough discuss Bill C-17 (“Vanessa’s Law”) and are joined by Ian Bushfield of Sense About Science’s AllTrials project to discuss the problem of publication bias.

Life, the Universe & Everything Else is a program promoting secular humanism and scientific skepticism presented by the Winnipeg Skeptics and the Humanists, Atheists & Agnostics of Manitoba.

For those curious what we were talking about near the end of the episode when we joked about white college students being the “perfect generalizable group”, we were referencing the fact that much of the research purporting to show great insight into human psychology is done on young people from western, educated, industrialized, rich, democratic societies. Psychologists are increasingly skeptical of the generalizability of these results, as these traits are hardly representative of humanity as a whole. See the links to Salon and Behavioral and Brain Sciences below for more information.

Links: The AllTrials Project | Sense About Science on Twitter | Bad Science Watch on Twitter | “Vanessa’s Law” Bill C-17 (Bad Science Watch) | Cochrane Collaboration (Wikipedia) | LUEE Episode 81: Book Reviews (with Greta Christina!) | Discrepancies between Meta-Analyses and Subsequent Large Randomized, Controlled Trials (NEJM) | I Never Meta Analysis I Really Like (Science-Based Medicine) | Cochrane Reviews: The Food Babe of Medicine? (Science-Based Medicine) | Daryl Bem’s “Feeling the Future” Controversy (Wikipedia) | Psychology Is WEIRD (Slate) | The weirdest people in the world? (Behavioral and Brain Sciences)

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Episode 81: Book Reviews (with Greta Christina!)

In this episode of Life, the Universe & Everything Else, Gem Newman, Ashlyn Noble, and Kristina Anderson review some popular science books, and are joined by Greta Christina, who tells them all about her newest book, Coming Out Atheist.

Life, the Universe & Everything Else is a program promoting secular humanism and scientific skepticism presented by the Winnipeg Skeptics and the Humanists, Atheists & Agnostics of Manitoba.

Books Reviewed: Coming Out Atheist: How to Do It, How to Help Each Other, and Why, by Greta Christina | Soundings: The Story of the Remarkable Woman Who Mapped the Ocean Floor, by Hali Felt | Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, by Ben Goldacre | Bad Pharma: What Happened Next (Free Follow-up Chapter) | The Hungry Scientist Handbook, by Patrick Buckley and Lili Binks

Other Recommendations: The Ebony Exodus Project, by Candace R.M. Gorham | Why Are You Atheists So Angry?, by Greta Christina | Bad Science: Quacks, Hacks, and Big Pharma Flacks, by Ben Goldacre | The Rocks Don’t Lie, by David R. Montgomery | The Map That Changed the World, by Simon Winchester | The Rithmatist, by Brandon Sanderson | The Runelords, by David Farland | The Demon-Haunted World, by Carl Sagan | Last Chance to See, by Douglas Adams and Mark Carwardine | The Day of the Triffids, by John Wyndham | The Lathe Of Heaven, by Ursula K. Le Guin | I Am Legend, by Richard Matheson | Little Brother, by Cory Doctorow

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Write Canadian MPs to bring Clinical Trial Transparency to Canada

The fine folks at AllTrials have an important reminder for you. Act now! (Stay tuned to the next episode of Life, the Universe & Everything Else, when we discuss some of these issues in a bit more depth.)

We have just heard that we have a chance to improve clinical trial transparency in Canada. Bill C-17 or “Vanessa’s Law” is being considered this Tuesday and there’s a chance to get clinical trial transparency measures added to it.

We urgently need you to write to the MPs on the Standing Committee on Health to tell them how important clinical trial transparency is. A template letter is below, followed by the emails for the MPs on the committee. We’ll keep you posted about the Bill’s progress, but please send your emails today.

They have a sample letter that you can send on their website. Because I’m also concerned about Vanessa’s Law ignoring potentially-dangerous natural health products, I sent a slightly modified version, below:

Ben Lobb, Chair ben.lobb@parl.gc.ca
Libby Davies, Vice-Chair libby.davies@parl.gc.ca
Hedy Fry, Vice-Chair hedy.fry@parl.gc.ca
Eve Adams eve.adams@parl.gc.ca
Claude Gravelle <laude.gravelle@parl.gc.ca
Wladyslaw Lizon wladyslaw.lizon@parl.gc.ca
James Lunney james.lunney@parl.gc.ca
Dany Morin dany.morin@parl.gc.ca
David Wilks david.wilks@parl.gc.ca
Terence Young terence.young@parl.gc.ca

Dear members of the House of Commons Standing Committee on Health:

I'm writing to you regarding Bill C-17, known as "Vanessa's Law". I am pleased that Parliament is considering a number of new measures such as the power to recall drugs that will significantly improve patient safety; however, I strongly believe the Bill needs key amendments to fully protect patient safety.

Specifically, it is clear that the bill needs to be amended (1) to require that all clinical trials and observational studies are publicly registered before they begin; (2) to mandate that all trials have their full methods and results reported after completion (preferably within one year); and (3) to include provisions for natural health products (NHPs) to be recalled in the same fashion as pharmaceuticals.

Results from around half of clinical trials have never been published and many have never been registered. New laws in the United States and Europe require the registration and reporting of future clinical trials but in Canada there is no legal requirement to register or disclose the results. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated (at great cost). Further, the regulator's interpretation of the evidence must be publicly available when it approves, refuses or recalls a drug from the market.

Further, it's very important to ensure that information about clinical trials and observational studies is not considered confidential. This information is generated because people participate in trials in the hope of advancing knowledge. If we treat this information as private property, it ignores the contribution that clinical trial participants make.

Finally, it is my understanding that the law currently exempts natural health products (NHPs) from the same level of scrutiny that it applies to pharmaceuticals. To be clear, NHPs are drugs. They are pharmacologically active, they can be dangerous in certain circumstances, and they can have negative drug-drug interactions with pharmaceuticals. For this reason, it is vital that we not exclude NHPs from close scrutiny and potential recall simply because they are "natural".

I understand that Bill C-17, in its current form, lacks these important measures. For this reason, I'm writing to you, in your capacity as a member of the Standing Committee, to urge you to consider amending Bill C-17 to make sure Canada's drug regulatory system is transparent and to ensure that Canadians are protected from all drugs, whether they're "natural" or not. These critical amendments would ensure that the evidence base behind all drugs are open to scrutiny, physicians and other health care providers are adequately informed about the risks and benefits, and patients are better protected from harm.

Gem Newman

Hat tip to Ian Bushfield from Sense About Science.

Thrills, Spills and Big Pharma Shills

Cross-posted from Subspecies

“Big Pharma shill” has been bandied around so much that it has really started to lose all meaning. Your family doctor is a dealer, the hospital doctors promote drug dependency, scientists have blinders on to all but positive data about drugs, and anyone who says otherwise is brain washed. However, sometimes, there are actual shills for “Big Pharma.” Take, for instance, Ronald C. Petersen, M.D., Ph.D. He recently wrote a Clinical Practice article for the New England Journal of Medicine, detailing what’s currently known about the etiology, diagnosis, progression and treatment of mild cognitive impairment, and makes recommendations for clinicians seeing someone with mild cognitive impairment in their practice. He’s a director for the Mayo Clinic’s research centre on Alzheimer’s. He’s also a (cue ominous music) Big Pharma Shill.

Dr. Petersen reports receiving consulting fees from Elan Pharmaceuticals and GE Healthcare, receiving royalties from Oxford University Press, and serving as chair of data monitoring committees for Pfizer and Janssen Alzheimer Immunotherapy.

With odious credits like working for both GE and a pharmaceutical company, being paid to write books, and playing watchdog for Pfizer, surely the recommendations were to drug them up, use expensive equipment to poke and prod patients, and admit them to a care facility immediately to start billing the insurance company!

…Or not. (Emphasis added)

Depression should be ruled out. Referral for neuropsychological testing may be appropriate, particularly if the concern is the degree of impairment relative to the cognitive changes of aging…  An MRI scan is suggested to rule out other conditions that might explain her memory loss (e.g., vascular disease, tumor, or hydrocephalus); the results might also show changes (e.g., hippocampal atrophy) suggesting that she is at increased risk for rapid progression to Alzheimer’s disease, although more data would be needed to justify the use of MRI for this purpose.

…  At this time, I would not routinely recommend tests to predict the risk of progression (e.g., 18FDG-PET or measurement of biomarkers in cerebrospinal fluid) but would encourage the patient to consider participation in research evaluating these tools. I would explain that at present there are no FDA-approved medications for this condition; I would also review the negative results of medication trials thus far and explain the costs and potential side effects of pharmacotherapy. I would recommend engagement in aerobic exercise, involvement in intellectually stimulating activities and participation in social activities, given that these might be beneficial and pose little risk, although more data are needed to inform their efficacy in reducing the risk of progression to the dementia stage of Alzheimer’s disease.

It’s true! The “Big Pharma shill” is saying, you know what, don’t waste your time and money on fancy tests because we’re not sure they’ll work. He’s explaining to his patient that medication is not a good option due to all the failed trials out there, and explaining why the drugs would be expensive and harmful. What should his patient do instead? Exercise her body, and exercise her brain. Why? The evidence is unclear on all current therapies for halting Alzheimer’s progression, the cause of mild cognitive impairment is probably multi-factoral, and until we know why it happens, we can’t stop it from happening.The drugs available to treat it are cost-prohibitive and detrimental to the patient’s quality of life in other ways. Many people who develop mild cognitive impairment will not progress to dementia, and our tests are just not good enough to distinguish between the stable individuals and the ones who need intervention. There is some demonstrated benefit to physical and intellectual stimulation, and there’s no downside to it.

When it comes right down to it, he’s saying it because the evidence is unclear, and this is how a good doctor and scientist deals with muddy evidence, no matter who is paying his salary.