No wonder Republicans hate them! Planning and responsibility — who has time for that crap? Especially when it costs money.
Who needs review and ethical approval of drug trials, after all? These are just things we put in our mouths or inject into our veins, so sure, let’s just go crazy and shoot up whatever. It can’t hurt. If a rich tech vampire endorses it, that should be good enough for everyone. Especially if they are testing it, just not on Americans — those brown guinea pigs on Caribbean islands are good enough.
Heavyweight tech investor and FDA-critic Peter Thiel is among conservative funders and American researchers backing an offshore herpes vaccine trial that blatantly flouts US safety regulations, according to a Monday report by Kaiser Health News.
The vaccine—a live but weakened herpes virus—was first tested in a 17-person trial on the Caribbean Island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and slammed the poor quality of the data collected, which has been rejected from scientific publication. However, investors and those running the trial say it is a direct challenge to what they see as innovation-stifling regulations by the Food and Drug Administration.
Yeah, that’s their motive: skip the whole structure of regulatory fol-de-rol and fast-track testing by throwing it on a non-American population. The work was done to benefit a pharmaceutical company, which was plugged in the manuscript that the author attempted to publish (conflict of interest much?) and was done on a tiny population. What work was done put subjects at risk and also had negligible statistical power, but hey, the PI, Halford, and Thiel were stickin’ it to the Man and bypassing those onerous regulations, so it ought to get extra brownie points for that.
Other researchers and experts strongly disagreed with Halford’s stance and handling of a live, attenuated virus vaccine, which can cause infections in the uninfected or severe side-effects in those already infected. “What they’re doing is patently unethical,” Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division, told KHN. “There’s a reason why researchers rely on these protections. People can die.”
Robert Califf, who served as FDA commissioner during the Obama era, agreed. “There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” he said. “It may be legal to be doing it without oversight, but it’s wrong.”
You can read the reviewer’s comments on the paper for yourself. They are polite, professional and scathing. A sample:
4. The author presents results of 2 experiments on humans, the first one a safety study that he conducted on himself. While self-experiments are generally permitted, these still require IRB review. Please provide assurance that this protocol was IRB reviewed and that the participant signed an informed consent. Unfortunately, data on 1 person does not prove safety of a product.
5. The subsequent Phase 1 study was conducted on a Caribbean island nation. Again, no information about IRB for this study is provided, and the trial does not seem to be listed on clinicaltrials.gov. The data for efficacy are based on self‐report on participants who were questioned by the author and other staff before and after. As the author states “self‐reported cessation of genital herpes… should be viewed with skepticism.” Agreed.
6. On Figure 8, there is an impressively small p value. However, how it was derived is not shown. Given that there were only 17 persons in this study, it is unlikely that an appropriate statistical test for performed to obtain this result.
Someone also saw right through the whole game.
6. Flying U.S. trial subjects to St. Kitt for the immunizations and then flying them back to the US is ethically questionable. Who is giving the immunizations in St. Kitt and who is following them medically when they return to the US? Where is the clinical protocol based? Is this an end run around the FDA?
It is true that IRBs are a pain in the butt, and sometimes you just want to scream that they are unnecessary — that you know how best to care for your subjects, you have years of experience, why do you need to document basic stuff that everyone in the field knows you have to do? Well, just imagine that a Peter Thiel gets hired by your university. That’s why we have to go through the nitpicky rigamorole, because there are bad guys looking for excuses to do stuff you would never imagine doing.
For another example of disastrous lack of planning and oversight, look south to Houston. Texans are notoriously defiant about regulations and little things like zoning, so Houston grew willy-nilly, with industry flourishing for the short term with the relative lack of demands for safety and disaster planning, and factories and chemical plants sprouting little clouds of residential housing around their dangerous facilities. I’m sure it made commuting convenient, and also helped pay for desirable amenites like schools, but still…would you want to live next door to a bomb?
In Crosby, Texas, there is a place called the Arkema chemical plant where they work with something called organic peroxides. This plant is located amid a residential and business district where, remarkably, human beings live and work. If the cooling systems in the plant fail, as they apparently have, these organic peroxides can explode. A 1.5 mile radius around the plant has been evacuated.
The state and plant owners have been lying lately about the hazards
“[The Harris County fire marshall] said that they don’t expect like a shock wave kind of explosion,” Matt Dempsey, a data reporter for the Houston Chronicle, told Maddow. “That’s in contradiction to the expert said who said we’re sitting on a powder keg type of situation here.”
“Experts on one side are saying it’s a huge thing, and I have the government officials and the company saying it might not be that big,” Dempsey continued. “It’s hard to tell for sure.”
Dempsey went on to detail a back-and-forth he’d had with Arkema’s CEO, who refused to make the plant’s inventory public and who hasn’t answered questions about whether the plant has industry standard fail-safes that deplete the stock in case of disasters like Hurricane Harvey.
Oh, no, they say, it’s safe — that big container of highly reactive peroxides isn’t going to explode if neglected and without power. It’s fine. You can trust the CEO who’s not saying anything about their safety measures or even what’s stockpiled there.
Guess what? This morning, it exploded. Twice. And there are concerns that multiple storage sites means that more explosions will occur. But don’t worry, while tons of toxic chemicals are now pouring into the flood waters, we can all hope they’ll catch fire and burn.
Still, the company said Wednesday, “the most likely outcome is that, anytime between now and the next few days, the low-temperature peroxide in unrefrigerated trailers will degrade and catch fire. There is a small possibility that the organic peroxide will release into the flood waters but will not ignite and burn. … In the alternate, there could be a combination event involving fire and environmental release. Any fire will probably resemble a large gasoline fire. The fire will be explosive and intense. Smoke will be released into the atmosphere and dissipate. People should remain clear of the area.”
The Associated Press reported that Arkema was previously required “to develop and submit a risk management plan to the Environmental Protection Agency, because it has large amounts of sulfur dioxide, a toxic chemical, and methylpropene, a flammable gas.”
Good luck, Texans. Your water is poisoned, your neighborhoods have been washed away, and what’s left is on fire, with clouds of sulfurous black clouds in the air. Yeee-hah!
These are human beings suffering from the consequences of generations of irresponsible neglect — where business has flourished at the expense of people’s long term health and happiness. We can blame all of this on the Republican party, which has built its popularity on this kind of contempt for government and regulation.
This is probably going to end up being the costliest disaster in American history. Who do you think is going to pay for it? Not the shareholders in the Arkema chemical plant. Not the legislators who shirked their responsibility. Not the rich capitalists who took advantage of the lax regulatory environment in Texas. It’s going to come out of the pockets of the victims.
Hurricane Harvey could be the costliest natural disaster in U.S. history with a potential price tag of $160 billion, according to a preliminary estimate from private weather firm AccuWeather.
This is equal to the combined cost of Hurricanes Katrina and Sandy, and represents a 0.8% economic hit to the gross national product, AccuWeather said.
“Parts of Houston, the United States’ fourth largest city, will be uninhabitable for weeks and possibly months due to water damage, mold, disease-ridden water and all that will follow this 1,000-year flood,” said AccuWeather president Joel Myers.
The Federal Reserve, major banks, insurance companies and other business leaders should begin to factor in the negative impact this catastrophe will have on business, corporate earnings and employment, Myers said.
That last paragraph says what is wrong with this country. Oh, gosh, the bankers, insurance companies, and CEOs are going to suffer so much! Screw ’em. They’ve been exploiting the people who are now actually suffering for decades.
PZ
are you telling me
the party of personal responsibility
will refuse to take responsibility?
I never
Several years ago, there was an explosion at a chemical factory located in al town in Texas. It caught the plant on fire which burned for quite a while, sending clouds of toxic smoke into the air. I seem to recall the plant owners being somewhat reticent in revealing just what chemicals were on site and what their emergency plans for them were. Well, It turned out that an elementary school and a senior living facility were both within a quarter mile of the plant. Now, to be fair, the plant was there first but what kind of building commission is irresponsible enough for allowing a school and the senior facility to be built that close or allow a plant like that to operate without establishing safety rules and evacuation procedures? Turns out Texas has no restrictions against that sort of arrangement. Still don’t, AFAIK.
For fuck’s sake PZ! Don’t you know that including externalities in the business model would make a lot of businesses insolvent? I mean if we expected coal fired plants to cover the cost of the damage they do (not just CO2, but all that other shit that get pumped into the air), or chemical companies to cover the safety requirements and indeminfy victims of accidents, well, how would one become a rent seeker? I mean, if a mining company actually had to return the open-cut to previous state instead of selling it off to a shell-company just at the end of production so a government picked up that tab, or a power plant had to pay for the CO2 generated, well. Well. how would parasitic businesses make money? How would parasites get ahead? Huh? You haven’t thought this through, have you? And how would lawmakers ensure they become Oligarchs if they didn’t pass laws to ensure this state of affairs continued? I mean, they need to become Oligarchs, after all, we’re sort of plebs….
Apropos of perhaps nothing much, France24 claims French chemical group Arkema SA owns the plant.
Nerd & myself have been back-and-forth a bit on the depth of Arkema’s planning / actions, and concur (this is Nerd’s summary), “What was needed to shut down production long before landfall and either move all the CHP to safe sites out of the hurricane/flood area, or to neutralize the chemicals prior to the arrival of the storm. The company blew the call.”
@blf #4. Would it have cost them money to do those needs? I mean, if the environment is polluted by their negligence, but cost them nothing much (at least by their estimate beforehand, who knows if there will be a stink kicked up enought for politicians to sacrifice them so that they can keep on, keeping on) how have they lost out?
Larry@2, That was the West Fertilizer Company plant (West, Texas) in April-2013. The problem of schools being located near such facilities with inadequate safeguards is not limited to Texas and the other usual suspects, but is nation-wide, 12,000 U.S. schools are within a mile of a hazardous chemical facility. What should we do about that?
#Harvey was the EVENT not the “Natural Disaster”. #Harvey simply triggered the “man made time bomb” that was lying in wait in Houston. The Disaster is our own creation, not nature’s. #harvey “himself” is also not entirely “natural”, being the result of massive AGW, from human exploitation of stored carbon deposits.
I’ll be the first (maybe) to drop the “natural” from “natural disaster” and stick with the solo latter half of that diptych.
Brian E@5 (I realise you are being ironic), if they are trying to avoid spending money, they didn’t do a very good job of it. First off, they stopped production and moved the stuff into refrigerated storage, which had two (apparently) on-site backup power sources. The stopping production and redundant emergency power clearly costs money (so does the storage but I’ll presume it’s needed for other production-related purposes, or at least for holding / hiding the corpses). And now the facility is blowing up / burning down, besides being flooded, all of which also costs money (albeit the water was supplied for free).
On the other hand, it’s abandoned, so at least they don’t have to pay the employees anything — and can lay them off, saving additional money, as the facility is rebuilt to the cheapest standard they can bribe the local officials to pass. The bribes will just be rolled into the (re-)construction costs, and are presumably eligible for both disaster relief funding and tax breaks.
@6 blf
Eat the fucking rich already.
@Siobhan
That is conservative code phrase for “If things run well, it is all my responsibility for being so able. If things run afoul, it is someone else’s responsibility to clean the mess”, is it not?
If Texas is out, what is Alberta going to do with all that oilsand sludge?
“The author presents results of 2 experiments on humans, the first one a safety study that he conducted on himself. While self-experiments are generally permitted, these still require IRB review. Please provide assurance that this protocol was IRB reviewed and that the participant signed an informed consent. ”
Did that strike anyone else as odd?
That is, it would seem that the one person on whom you should be able to conduct experiments without IRB review is yourself. And, presumably, informed consent would seem not to really apply (or rather be satisfied by definition) where you are both the experimenter and the experimented.
Slight correction PZ,
The test subjects for the Herpes vaccination trials funded by Thiel were not Caribbean natives or nationals but were mostly Americans that were repeatedly flown offshore to dodge the IRB requirements. This doesn’t make it less unethical, just sorta changes the flavor of the crap.
Source: www(dot)pbs(dot)org/newshour/rundown/peter-thiel-sponsors-offshore-testing-herpes-vaccine-sidestepping-u-s-safety-rules/
Keep pumping / shipping it to Texas. The stuff that actually makes it, instead of, say, leaking into the local drinking water en route, will just be piled up in convenient places — schoolyards are cheap — until it’s needed for the reconstruction efforts (or for that stupid fecking wall).
What, you say, you cannot build anything out of oilsand?
AmericanTexas innovation, rah rah rah! Entrepreneurs!! Conartists!!!Just don’t expect to get paid for the stuff Alberta is disposing of in Texas. That would be very unTrump. In fact, like Mexico & that stupid fecking wall, Alberta will pay for it — both the shipping and reconstruction. Obviously.
This is in theory only.
Chances are high that people will go back to their homes and soon even if there is “water damage, mold, disease-ridden water and all that.” (Left off the list is sewage and industrial chemical pollution in the flood waters.)
What other choice do they have?
Can’t we just do the herpes experiments on chemical plant workers?
I mean, they’re expendable anyway!
Which are imaginary unless you are a Loonytarian.
Lots of drugs and innovative therapies get approved every year.
The system is set up to make sure medical treatments are both safe and effective.
FWIW, the Institutional Review Boards (IRB’s) aren’t much of an obstacle. A lot of them are mostly just rubber stamps.
According to this December-2016 Science piece, Do it yourself? When the researcher becomes the subject, it’s a grey area:
The piece then goes on to give an example where IRB approval could have been a good idea.
As mentioned in the OP, the Arkema organic peroxide tanks, two of them so far, have already exploded. More explosions are expected to occur.
I’m not going to second guess this plant simply because there is a huge lack of details so far.
But it looks a lot like the Japanese nuclear reactor meltdowns at Fukushima after the very large earthquake/tidal wave. They did have backup systems to cool the cores. Backups that were themselves knocked out by the tidal wave.
Same thing happened at Crosby Arkema.
Their backup cooling systems for their organic peroxide tanks also failed due to catastrophic flooding. With the same result. BANG!!!
Did Arkema drop the ball here? Hard to say, but at this point, they need to hire Kellyanne Conway or Sean Spicer to explain things.
Arkema SA?
“I do not like this word bomb. It is not a bomb. It is a chemical factory which is exploding.”
Superficially, perhaps. But not really. You cannot move a reactor, and you have no alternative to keeping it cool. And there was little warning. (In Japan there were also relevant design problems, but whether or not there were any which mattered in Texas is unknown.)
In the on-going Texas situation, there were advance warnings for massive rainfall and extreme flooding, at least some of the stuff could have been moved off-site (which they know how to do since that facility makes it), and there is an alternative to cooling: Neutralization (also called quenching), again a known process. Removing and/or neutralizating would require action in response to properly-understood warnings, and this is where it (currently) seems something went wrong — within a possible background of loose standards / oversight.
@2
Yes, a few years ago there was an explosion in the town of West, Texas that left a 90 foot crater. Prior to that event the public could request a company list what chemicals were on site and in what quantities in order to assess the danger a site presented. Following the explosion, what did the Texas government do to address the problem? Well, they passed a law that such sites did NOT have to respond to such requests and could keep the contents of their site secret, even from fire departments and other organizations which would respond to any disaster at the site. It is this law that Arkema is citing to keep their products unlisted to the public.
This is a disgrace, and can be laid directly at the feet of Republicans.
It’s a 1000-year flood now? Last I heard it was a 500-year flood. All I know is that they’re going to keep repeating those numbers so that people don’t link any of this to climate change.
And they’ll keep doing it for the all the 500- and 1000-year weather events that we’re going to keep getting.
Hold onto your hats – this’ll be a shock…
“Texas Republicans Helped Chemical Plant That Exploded Lobby Against Safety Rules”:
#2 and #22 – I posted links to Rachel Maddow’s reports on it in 2014 and last night here.
@1 Shiv
Personal responsibility, not corporate responsibility. People have to take responsibility for choosing to live near unregulated chemical plants, or in a country with negligible disaster infrastructure.
@6 blf
Nothing. It’s their own fault for being there. If you don’t send your children to an elite private school in a nice place, that’s your own bad parenting.
@ 13 Whoever
This was also apparent from the comments of reviewer 2, quoted in the post.
Flying U.S. trial subjects to St. Kitts for the immunizations and then flying them back to the US is ethically questionable.
One wonders how many St. Kitts‘ laws were broken?
If I were the St. Kitts Gov´t, I’d be a bit annoyed by a bunch of arrogant American yahoos using my country to dodge US laws. It does not help the image of a tropical paradise with outstanding medical schools.
well they might have dodged it this time maybe but with the study being what it is it is that’s a crap shoot at best. What will they do when the predictable catastrophic failure happens? What will they say then?
uncle frogy
Meanwhile Trump hectors supports from a fire truck about the need to reduce taxes. I’m sick of this timeline, when are we sending the robot back to fix it?
Re: unclefrogy (#28):
Perhaps something among the lines of how much better things would have gone if they hadn’t been ‘hamstrung’ by overzealous FDA-regulations and unreasonable review boards holding back progress.
Napoleon had a good approach to the problem of explosives factories, well, exploding…
The Code Napoleon simply required that the managers live on site with their families.