The FDA Should Only Approve Drugs Backed By Science

Here’s some Inauguration Day reading for you:

For half a century, the FDA has regulated drugs on the premise that science should show that they’re safe and effective before drug companies get to sell them. Before modern drug laws, companies filled the market with ineffective products, backed by no evidence that they worked.

As I write this week in Pacific Standard, a couple of candidates for Trump’s FDA seem to think that we should go back to that era before modern drug laws. Jim O’Neill, a venture capitalist who invests in biotech argues that as long as companies can show a drug is safe, the FDA should let patients take it “at their own risk,” regardless of whether that drug is useless.

And biomedical engineer/biotech executive Balaji Srinivasan thinks that, rather than testing drugs with clinical trials, people should just rate them the way they rate their Uber drivers. Given that people believe all sorts of insane things about what makes them healthier, this is not likely to be a way to rigorously learn whether a drug actually does something for the patients who buy – and whether its not just the drug company ripping people off.

In my piece, I explain exactly why these ideas would be bad for you. But the overarching theme is this: the problem with the two candidates, and their associate Peter Thiel (who is advising Trump on the FDA) is that they see drugs and biotech from the view of investors and startup executives. These are people who hear promising, brilliant medical ideas all the time from scientists and entrepreneurs, people who want to take fledgling ideas and turn them into therapies. That’s great, but in the end, most of these promising, brilliant ideas will in fact be wrong – and that’s why we need the FDA to protect us by weeding out the failures.


Filed under: Uncategorized Tagged: drugs, FDA, Science in Society

The FDA is not holding back effective drugs

It’s going unnoticed amidst the news of the rolling disaster that is the incoming Trump administration, but our lame duck Congress has just passed a major piece of legislation called the 21st century cures act. Scientists are happy about the extra $5 billion this bill gives to the NIH – sort of. That money has to go to specific programs, like the Precision Medicine Initiative and Biden’s Moonshot program, rather than being put into the general funds of the NIH, meaning that Congress, and not the NIH, is deciding what specific research to fund. That’s generally not a good idea, but more money toward broad research and translational initiatives like cancer and precision medicine is still a net win.

More controversial are the FDA provisions of this bill. The bill pushes the FDA to take into account other, often less rigorous types of clinical studies when it decides whether or not to approve a new drug. Some worry that this means drug companies will have more leeway to push unsafe or ineffective drugs on the market. I’m more ambivalent – there are cases (drugs for rare diseases) when double blind randomized clinical trials may not be right, and the FDA should have the flexibility to demand the best evidence appropriate to each case. If – and this is a big if as we look ahead – we trust that the FDA can stand up to industry pressure, than giving them more flexibility to follow best scientific practices is the way to go.

My bigger problem with the FDA provisions are that the premise is flawed. As I write in Pacific Standard this week, the bill’s sponsors argue that, by cutting regulations and red tape at the FDA, we’ll free new cures that are just waiting to be put into the hands of patients. That’s wrong – the FDA is not the rate limiting step here. There is no backlog of effective new drugs just waiting to be approved.

Go check out my piece for the details. The rate limiting step is the science. Medical science is hard, and diseases are understood imperfectly. If you want more effective drugs faster, we need to invest more in research.


Filed under: Follies of the Human Condition, This Mortal Coil, Uncategorized Tagged: drugs, FDA, science funding

National drug overdose epidemic

Drug overdose epidemic

Nadja Popovich for the Guardian delves into America’s drug overdose epidemic, starting with an animated map that shows changes from 1999 to 2014.

On initial look, the map looks like your standard county map, but there’s a small wrinkle in the design that makes the geographic spread over time much easier to see. The switch in the top right corner, to toggle between 1999 and 2014, looks like any other. But instead of just a quick flip between 1999 and 2014, the map shifts with annual data, so you can see a smooth transition instead of an abrupt contrast.

Other options, like small multiples or a scroll bar might have worked as an overview, but this route brings focus and eliminates much of the guesswork.

Very nice.

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White deaths increase: drugs, alcohol, suicide, but in US only. Why?

cemetary1-512x320 (1)There’s a big puzzle growing out of that startling new research showing that the death rate among white Americans age 45-54, especially the less-educated, has been rising since 1999. This even though the death rate

Exciting new drugs for Alzheimer’s disease? Nah.

So, exciting new drugs for treating Alzheimer’s disease, right? Wrong. Or, rather, let’s allow for semi-miraculous outcomes and say instead that this recent news is unlikely to be right. Most of the news concerned research results on two monoclonal antibody … Continue reading »

The post Exciting new drugs for Alzheimer’s disease? Nah. appeared first on PLOS Blogs Network.

Science for the People: High Price [Rerun]

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This week, Science for the People is revisiting our look at the science and policy of treating drug addiction. We were joined by psychology professor and researcher Carl Hart to talk about his book “High Price: A Neuroscientist’s Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society.” We also spoke to Donald MacPherson, Director of the Canadian Drug Policy Coalition, about harm reduction strategies to reduce the negative consequences of drug use.

*Josh provides research help to Science for the People and is, therefore, a completely biased and cooperative member of the team.


Filed under: Follies of the Human Condition, This Mortal Coil Tagged: Canadian Drug Policy Coalition, Carl Hart, Donald MacPherson, drug addiction, drugs, High Price, Neuroscience, Podcast, science for the people

Watch: Journalists Get Health Canada License Number for Fake Remedy

If you have ever bought a natural health product approved by Health Canada, you must watch this 22-minute episode of CBC’s Marketplace.

Do you have any idea how easy it is to get approval from Health Canada to manufacture and sell a natural health product?

You will hear from me on this topic in a couple of weeks. In the meantime, watch this incredible report:

http://www.cbc.ca/marketplace/episodes/2014-2015/drugstore-remedies-licence-to-deceive

CBC Marketplace show


Chances that a drug treatment helps

Treatment odds

It's a common belief that if someone has a medical condition, a patient can take a treatment and the condition gets better or goes away. That is, improvement is directly related to intake. However, as it turns out, there's often a good chance the patient would have gotten better without the treatment. There's also a chance a treatment does nothing.

Austin Frakt and Aaron E. Carroll for the Upshot describe these chances through a metric called number needed to treat, or N.N.T. The simple animations throughout the article provide a great dose of perspective to the odds.

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Listen / Watch: The Cost of Cancer Drugs

The only good drug is the one the patient can afford.

WNYC radio show and podcast extraordinaire RadioLab most recently did an episode entitled “Worth” in which the show’s hosts and producer investigated the worth of an extra year of human life. They stumbled upon a very interesting story centred on the cost of cancer drugs in the U.S.

Dr. Christopher Labos brought to my attention a recent report from 60 Minutes which discussed the same controversy (using much of the same interviewees, actually).

If you prefer to listen to a top-of-the-line aural production, check out “Worth” from RadioLab.

If you love the sound of a ticking stopwatch and like your journalism the old fashioned way, check out “The Cost of Cancer Drugs” on 60 Minutes.

Both are excellent.

And if you like getting your news from different sources, enjoy them both!


Cracked Science Video 4: Irreproducible

We often hear the science corrects itself in the long run, but how efficient is this mechanism? Jonathan Jarry reports that reproducibility in the scientific literature is not always a given.

(Des sous-titres en français seront bientôt disponibles!)

Just so you are not too demoralized, the landscape may be changing:
http://www.nature.com/news/journals-u…
http://www.nature.com/news/metascienc…