5 ms·

The biggest takeaway here: surround yourself with the right people. I find it hard to believe Holmes wanted to outright commit fraud with Theranos. Instead, so

by amb23 8y ago

The biggest takeaway here: surround yourself with the right people. I find it hard to believe Holmes wanted to outright commit fraud with Theranos. Instead, some combination of startup “disruption” tactics and a crew of unqualified yes men led to a toxic company culture that cultivated lying and, eventually, criminal fraud. On the first point: There’s a very real culture in Silicon Valley where it’s expected that everyone lies, at least a little bit. Startups will massage their numbers in VC pitch decks, or launch “Wizard of Oz” products that aren’t based on new tech. If you’re on a client-facing team, you’re expected to learn which white lies to tell. Most startups get away with this without a problem, and Theranos probably expected to as well when they came out of stealth mode and debuted their testing equipment. But this process doesn’t work in biotech when it affects real consumer health outcomes; there is a reason behind much FDA bureaucracy, and it’s to protect people’s health. The tech industry could use a better ethical backbone overall. On surrounding yourself with the right people: The anecdote about the manager who lied about results, was given promotions and accolades, and then promptly quit when it became time to become accountable, was telling to me. First, there was a lack of checks and balances in place to prevent these lies—how was Holmes supposed to know the manager was lying? The board had little technical or scientific background, and it’s not clear that the company set up processes to ensure research was sound. And the most likely reason why? They probably just trusted people and didn’t expect that these problems could happen. The only way to ensure you’re not blindsided by issues like these is to make sure those around you are capable, experienced, and have been through this before. Company culture is everything. As bad as Theranos is, the tech industry is rife with fraudulent practices and bad apples. I’d hope Holmes’ criminal charges make executives pause and think about setting up processes to allow for honesty and accountability. Unfortunately, though, the mainstream narrative has been to paint Holmes as an unsophisticated crook instead of looking at the systematic problems of the company as a whole, and that means people will keep on keeping on with the practices that led to Theranos’ downfall.

lykr0n 8y ago
> there is a reason behind much FDA bureaucracy, and it’s to protect people’s health. This is what people don't realize when they try and say the FDA is a bureaucratic nightmare. Every process in place is designed to make sure that the drugs that hit the US market work. Look at what happened with Thalidomide. The FDA didn't allow it to hit the US market due to strict requirements about what tests and processes the drug companies were required to follow. Europe had a massive problem, while the US didn't. What most people don't realize or know, is that the FDA will readily expedite promising drugs and/or products if results are promising and the data is valid. Companies, if they have strong data from Phase I or II trials, can be bumped to the top of the review queue or be granted interim permission to sell their drugs before Phase III trials are complete. I personally think the FDA is a great example of a well designed bureaucracy. The value it adds to the public is insurmountable, while not being unreasonable.
- beagle3 8y ago
  Are there examples other than thalidomide? Because e.g. the FDA was just as bad with Vioxx and worse with OxyContin.
  - lykr0n 8y ago
    I, personally, don't consider Vioxx a failing of the FDA. I might be wrong, but reading the Wikipedia article makes it sound like more of issues surrounding the drug's promotion and marketing- not the drug itself (considering the US and Canada both voted to allow it back on the market). And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
    - beagle3 8y ago
      > I, personally, don't consider Vioxx a failing of the FDA. I was following the case in real time, and it certainly looked like a failing of the FDA and being way way too cozy with Merck about it; compared to how it looked then, the wikipedia article looks incredibly white washed. I'm not sure we read the same Wikipedia article - the one I read said that Merck withheld information from the FDA, and makes no mention of any resulting sanctions or penalties (which is exactly how I remember it). Does this sound like a working regulatory agency to you? > And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. Not at all. Perdue made false claims about how long acting OxyContin is, and as a result of the recommended prescription, many people both suffered and got hooked, see e.g. [0], which was the first result for "oxycontin perdue abuse", but by no means the only one. > I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working. ... to me, the fact that Thalidomide is basically the only example that everyone brings up, it means that the European system is essentially equally effective, despite your implied claim ("Europe had a massive problem, while the US didn't.") that the US one is superior. [0] https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxy...
mmt 8y ago
> a toxic company culture that cultivated lying and, eventually, criminal fraud. FTA: > The scientists worked 12-16 hour days. I have to wonder if it's really as simple as exhaustion/overwork causing a breakdown in reasoning to the point of removing ethical inhibition. I would hope that scientists would know better than to allow themselves to be worked like that, but, well, I know better.

by amb23 8y ago

lykr0n 8y ago

> there is a reason behind much FDA bureaucracy, and it’s to protect people’s health. This is what people don't realize when they try and say the FDA is a bureaucratic nightmare. Every process in place is designed to make sure that the drugs that hit the US market work. Look at what happened with Thalidomide. The FDA didn't allow it to hit the US market due to strict requirements about what tests and processes the drug companies were required to follow. Europe had a massive problem, while the US didn't. What most people don't realize or know, is that the FDA will readily expedite promising drugs and/or products if results are promising and the data is valid. Companies, if they have strong data from Phase I or II trials, can be bumped to the top of the review queue or be granted interim permission to sell their drugs before Phase III trials are complete. I personally think the FDA is a great example of a well designed bureaucracy. The value it adds to the public is insurmountable, while not being unreasonable.

beagle3 8y ago
Are there examples other than thalidomide? Because e.g. the FDA was just as bad with Vioxx and worse with OxyContin.
- lykr0n 8y ago
  I, personally, don't consider Vioxx a failing of the FDA. I might be wrong, but reading the Wikipedia article makes it sound like more of issues surrounding the drug's promotion and marketing- not the drug itself (considering the US and Canada both voted to allow it back on the market). And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
  - beagle3 8y ago
    > I, personally, don't consider Vioxx a failing of the FDA. I was following the case in real time, and it certainly looked like a failing of the FDA and being way way too cozy with Merck about it; compared to how it looked then, the wikipedia article looks incredibly white washed. I'm not sure we read the same Wikipedia article - the one I read said that Merck withheld information from the FDA, and makes no mention of any resulting sanctions or penalties (which is exactly how I remember it). Does this sound like a working regulatory agency to you? > And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. Not at all. Perdue made false claims about how long acting OxyContin is, and as a result of the recommended prescription, many people both suffered and got hooked, see e.g. [0], which was the first result for "oxycontin perdue abuse", but by no means the only one. > I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working. ... to me, the fact that Thalidomide is basically the only example that everyone brings up, it means that the European system is essentially equally effective, despite your implied claim ("Europe had a massive problem, while the US didn't.") that the US one is superior. [0] https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxy...

mmt 8y ago

> a toxic company culture that cultivated lying and, eventually, criminal fraud. FTA: > The scientists worked 12-16 hour days. I have to wonder if it's really as simple as exhaustion/overwork causing a breakdown in reasoning to the point of removing ethical inhibition. I would hope that scientists would know better than to allow themselves to be worked like that, but, well, I know better.