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 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.