Vanity Fair notes in a current piece by writer Tina Nguyen how we all knew that White House Chief of Staff John Kelly, presented in the media as the straight shooter who is bringing order to the Trump Administration, would eventually have to shame himself in order to keep favor with the mercurial Trump and his loose association with anything resembling the truth:
All senior White House staffers duty-bound to serve President Donald Trump have, at one point in their tenure, stood in front of a crowd of reporters and delivered untruths to cover for their boss—a ritualistic torching of their integrity, as it were. Secretary of State Rex Tillerson was forced to dodge accusations that he had called Trump a “moron”; National Security Adviser H.R. McMaster, meanwhile, had to defend Trump after the president shared another spy agency’s intel with Russian officials. It was only a matter of time before Chief of Staff John Kelly’s turn arrived, and arrive it did, with Kelly unexpectedly taking the podium during a press briefing Thursday to exculpate Trump after he was accused of mishandling a phone call to a grieving war widow. Standing before the press, Kelly used his position as a four-star general who has lost a son in battle to take Florida Congresswoman Frederica Wilson to task, saying he was “heartbroken” by her comments criticizing the president, and accusing her of bragging about appropriating money for an F.B.I. building—a claim that was disproved hours later, when video of Wilson’s speech was released.
Plenty of Trump staffers have doubled down on more egregious falsehoods (beleaguered former Press Secretary Sean Spicer comes to mind), but to hear the claims coming from the sterling four-star general was a departure. Kelly, after all, entered the White House as part of a contingent of sober grown-ups, and reportedly felt duty-bound to restrain Trump when he supplanted Reince Priebus as chief of staff. Hopes rose that Kelly’s military discipline and love of country would keep the president in line. “He has a lot of credibility,” presidential historian Douglas Brinkley told The Washington Post at the time. “Trump better not double-cross him . . . The integrity is so high.”
That reputation held after Trump’s Charlottesville press conference and speech at the United Nations, where Kelly was photographed staring dourly at the ground in apparent shame. As my colleague Gabriel Sherman reported last week, Kelly is “miserable” in his job but has remained out of a sense of duty, while carefully eyeing an eventual exit strategy. But after Wilson told reporters that Trump had upset the widow of slain solder La David Johnson, saying of her late husband, “I’m sure he knew what he was signed up for,” Kelly took it upon himself to defend the president. Rather than delivering boilerplate condemnations, he leaned in to his own experience as a father of a slain soldier to attack Wilson, who had heard Trump call Johnson’s family and relayed his comments to the public.
“I just thought the selfless devotion that brings a man or woman to die on the battlefield, I just thought that might still be sacred,” a visibly emotional Kelly said, describing how his first reaction, upon hearing Wilson’s remarks, was to take refuge at Arlington National Cemetery. “I hope, as you write your stories, let’s not let this last thing that is sacred—a young man or woman giving his or her life for country—let’s somehow keep that sacred. It eroded a great deal yesterday by the selfish behavior of a member of Congress.” Kelly then called Wilson’s integrity into question, saying that, during the dedication ceremony for a building honoring two slain F.B.I. agents, she had bragged in a speech about how “she got the money” for the building.
You have probably seen the video evidence, released soon after Kelly’s comments, showing that Rep. Wilson said no such thing. In fact, she said things that would make any right winger proud in praising two murdered FBI agents and her bipartisan efforts to rush through legislation on Capitol Hill naming a new building after them.
(Of course she was taking some credit for what was an honorable thing to do. That is what politicians do. They transmit to the folks who vote for them that they have done something that warrants continued support. But that is nowhere near falsely claiming to have secured funding to get something built. )
In light of all of this, Kelly’s beatification in the press as one of the lone credible people trying to bring order to a chaotic, dissembling White House begs some questions.
Has he been turned to the dark side, willing to say anything to keep his job and puff up Trump’s fragile ego? Or has he always been there and this episode brought it out?
Perhaps Kelly’s love and dedication to country, the main reason he is rumored to have taken the chief of staff job in the first place, has taught him that he needs to go along to get along and keep an easily distracted and offended Trump from veering off course over an incident that, while certainly important to Wilson and La David Johnson’s family, is only another blip in the President’s continued campaign to bamboozle everyone into not paying attention to the real harm he is doing behind the scenes of the chaos he creates and craves.
It says much that is terrible that we live in a time when we have a presidency wherein the ability to tell, and further, easily disprovable lies is a chief job description for even Marine generals with a long history of rectitude.
Controversial drug trial which broke all the rules on patient safety has among its investors Trump supporter — and FDA critic — Peter Thiel.
As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks.
The lead U.S. researcher, William Halford, openly acknowledged he was flouting Food and Drug Administration regulations in the consent forms they signed. He would be injecting them with a live, though weakened, herpes virus without U.S. safety oversight.
Still, many of them felt upbeat when they arrived on St. Kitts and Nevis in the spring of 2016. They had struggled for years with debilitating, painful herpes. Halford, the creator of the vaccine, sounded confident.
Maybe they could be cured.
“It felt like paradise,” one of the participants recalled. “Or therapy combined with vacation.”
A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks.
They also can’t rely on his university, which shares in the vaccine’s patent but says it was unaware of the trial until after it was over. Because the FDA didn’t monitor the research, it can’t provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.
At a time when the Trump administration is pushing to speed drug development, the saga of the St. Kitts trial underscores the troubling risks of ambitious researchers making their own rules without conventional oversight.
“This is exactly the problem with the way the trial was conducted,” said Jonathan Zenilman, an expert on sexually transmitted diseases at Johns Hopkins Bayview Medical Center in Baltimore. “These people are supposed to have rights as human subjects, but now there’s nowhere for them to go. We may never know if this vaccine worked, didn’t work or, even worse, harmed anyone.”
Rational Vaccines, the U.S. company co-founded by Halford, still hopes to market the vaccine. It touted success online and to other researchers, prompting millions of dollars of recent investment, including from a company run by Peter Thiel, a backer of President Donald Trump.
Thiel, a PayPal co-founder who has excoriated the FDA as too bureaucratic, declined to answer questions about his investment, which occurred after the trial had ended.
Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of Halford.
The participants agreed to speak on condition of anonymity because they don’t want to be known as having herpes. Most also said they feared retaliation from Halford’s company but hoped by speaking out some of their concerns might be addressed.
Their accounts, along with documents, a video and emails obtained by KHN from the offshore trial, pointed to what experts said were serious irregularities:
Halford did not rely on an institutional review board, or an “IRB,” which monitors the safety of research trials. The company has said it doesn’t know where Halford manufactured the vaccine, so it isn’t known whether he followed U.S. government guidelines when transporting it. Halford offered booster shots of the unapproved vaccine inside the United States. FDA regulations prohibit such injections.
“The FDA goes after these types of violations,” said Holly Fernandez Lynch, a lawyer and assistant professor who specializes in medical ethics at the University of Pennsylvania’s Perelman School of Medicine. “[Researchers] can be prosecuted.”
SIU, however, did little to discourage Halford. The university, which has a financial interest in the patent, said it learned of “the concerns” only after his death. In August, after KHN asked about the trial, the medical school’s IRB launched an investigation into whether Halford violated U.S. regulations or university rules.
In a statement to KHN, Rational Vaccines acknowledged that Halford “discussed a myriad of concerns … including the potential need for booster shots.”
“Unfortunately, Dr. Halford is no longer with us to address all the ways in which he may have investigated his concerns …,” stated the company. It added, “We nevertheless wholeheartedly intend to continue his line of investigation in a clinical setting to international good clinical practice standards.”
Racing Against Time
Halford first broke with scientific protocols in 2011, shortly after he was diagnosed with nasal cancer and treated with chemotherapy and radiation, according to an account he later posted on his blog.
In 2015, Halford set his sights on launching an offshore clinical trial.
However, his unorthodox approach made some of his peers recoil.
“He sat in my kitchen and tried to convince me to join him,” said Terri Warren, a nurse practitioner in Oregon who was approached by Halford in 2016 to help with the trial. “He believed so firmly in his vaccine. He said, ‘Think of all of the herpes patients who are suffering.’”
Warren had previously worked with Halford on a different, IRB-approved trial studying a new blood test to diagnose herpes. This time, she said, she became concerned about his methods, including how he was selecting his participants.
“I told him absolutely not,” she recalled. “I didn’t want anything to do with it. I felt bad for him because he was dying, but I thought he had lost perspective.”
But Halford did find backers, including Hollywood filmmaker Agustín Fernández III, whose credits include action films and an award-winning documentary.
Fernández recently declined to respond to questions. But in an earlier interview this year with KHN, he said he initially contacted Halford to try to help someone he knew who was battling the disease. He said he didn’t have herpes, or a background in science.
Fernández, however, became such a believer in Halford, he said, he allowed Halford to inject him with the vaccine. In 2015, he co-founded Rational Vaccines with Halford and invested his own money into the company. That same year, the company licensed two patents related to the vaccine from SIU.
“I felt like Bill had the answer, and we had to make sure he got a chance to prove it,” Fernández said.
‘Finally … Someone Who Cared’
As soon as news began spreading in the tight-knit herpes online community that Halford may have a cure, he began hearing from the most desperate who asked to be included in any future research.
For many, herpes is a mild disease that can be controlled by antiviral medicines. However, for some, it becomes a life-altering disease that destroys any hope of intimate relationships.
To several of the participants, Halford was an empathetic scientist who refused to give up on finding a cure.
“After dealing with doctors who had no answers, it felt like you were finally talking to someone who cared and could help,” said a participant in his 30s from the South who had described the trial as “paradise.”
There were other perks as well.
Rational Vaccines told some participants they would be reimbursed for their flight and hotel expenses. If they got through the entire trial, they would be given an extra $500.
As Halford organized two groups of 10 participants, he instructed them on drawing their own blood for the trial, according to a video filmed in a medical lab.
He proceeded with the trial from April to August 2016, giving participants three shots over three months.
Once in St. Kitts, many of them quickly bonded with one another and Halford. Even though they ranged in age from their 20s to 40s and came from different regions, they had the disease in common. They commiserated about how herpes had wreaked havoc on their lives.
“It was a relief to meet people who understood what we were talking about,” the Southerner said.
But other participants now say they noticed some troubling signs.
They received the injection in a house in St. Kitts, not a medical clinic.
Halford, whose gaunt frame made his cancer apparent by then, at times appeared disoriented.
Fernández, a constant presence, was introduced to them by name and made some of them uncomfortable when they socialized over drinks and dinner.
Some patients became anxious about their participation soon after receiving the vaccine.
One, a web developer in his 20s, felt ill after receiving just one dose.
“I experienced tiredness and ringing in my ears,” said the web developer, who reported the feelings along with “disequilibrium and slurred speech” continue to this day.
He said he decided not to return to St. Kitts for follow-up shots after Halford dismissed his symptoms as arising from a common cold.
Another participant, a Colorado woman in her 40s, said she told Halford she experienced flu-like aches and pains and tingling and numbness soon after the second shot. The symptoms were followed by an “excruciating” 30-day outbreak of herpes.
“I have new symptoms every day,” that woman later wrote Halford in an email exchange provided to KHN. “This is terrifying.”
Halford initially dismissed her symptoms, speculating they were caused by a mosquito-borne virus, she said.
She returned for the third shot but had her doubts. Halford and Fernández met her at a café to talk about her concerns, she recalled.
“[Fernández] kept saying, ‘You signed the consent form. You knew the risks,’” said the Colorado woman, who said Halford then removed her from the trial.
Another participant, a Californian in his 30s, said he went through with all three shots despite feeling a “terrible pain in my stomach.”
Halford then told him he had noticed in his research of mice that another version of the virus entered the gut of the mice and killed them, the participant said.
“I then thought maybe this is dangerous,” said the Californian, whose pain went away but his outbreaks did not.
Warren, the nurse practitioner in Oregon, said two participants tracked her down as a herpes expert. She said that they described possible side effects from the vaccine.
Halford had told participants he would follow up on their reactions to the vaccine for a year, according to the consent form. But he stopped sending questionnaires to the two participants who said they had been dropped from the trial.
Warren said that even when researchers stop administering a vaccine because of possible side effects, known as adverse events, they have a duty to track the subjects’ reactions.
“There is no doubt that these were adverse events that should have been reported,” Warren said.
Rational Vaccines did not respond to questions about the complaints. In previous public statements, it acknowledged that one of the 20 participants was concerned about possible side effects.
Some participants also wonder where Halford made the vaccine and how he transported it to St. Kitts.
Halford told his business partner he had made it outside of the United States, without disclosing where.
After the trial ended, some participants began complaining that the vaccine hadn’t worked. Halford and Fernández offered booster shots, according to four participants.
One participant, a man in his 40s who was also from California, declined to get the booster. He said he decided to go back to antiviral drugs when his outbreaks returned.
The Southerner said he agreed to allow Halford to give him booster shots at an office in Springfield, Ill., where Halford worked.
“It was between me and him,” said the participant. “He was doing me a favor.”
“I don’t know if it was a different strain or what, but he gave me a set of double boosters at the same time, one in each leg,” recalled the Southerner, who said he didn’t have records of the injections. He said he received them as Halford continued to collect data for the trial.
Months later, he said, he returned a second time for another set of boosters.
Courting Support Without Results
Halford, meanwhile, tried to persuade a U.S. scientific journal to publish a lengthy manuscript detailing the results of both his experiments on himself and his offshore trial. Halford put the cover letter on SIU letterhead.
In December 2016, only months after the trial had ended, Halford’s paper was rejected by the journal.
“This manuscript is partly a vision, partly science, and partly wishful thinking …,” said one reviewer for the journal. “Neither safety nor efficacy has been demonstrated by the data presented.”
Halford asked his former doctoral adviser, Daniel Carr, to attend a Rational Vaccines advisory board meeting. Carr, a University of Oklahoma Health Services Center professor, said he and other invitees heard glowing reports about the trial.
Carr agreed in May to present the trial data at a conference of herpes experts in Colorado.
A published summary of the event listed Carr as a lead author, though he said he wasn’t involved in the research.
“I just did it to help him out,” said Carr, who asked for his university’s permission to be on Rational Vaccines’ advisory board and is waiting for word on federal funding to study another version of Halford’s vaccine. “I also presented it because I thought that the scientific community would find it interesting.”
Despite its patent agreement reached in 2015, SIU said it was in the dark about Halford’s offshore activities until October 2016 — months after the trial had ended.
Halford, meanwhile, promoted his work at events attended by university officials.
Then, in April 2017, Halford and Rational Vaccines held a press conference to trumpet an investment pledge by Thiel’s company, according to materials handed out at the event. University officials, including SIU’s medical school dean, were invited speakers.
The university’s IRB is continuing its investigation, which includes scrutinizing whether Halford used university resources.
“If there are areas of concern, SIU will report those findings promptly to Department of Health and Human Services,” said SIU spokeswoman Karen Carlson. “We will also communicate our findings with the scientific community and the public.”
FDA spokeswoman Lauren Smith Dyer declined to comment on the trial except to say the FDA does not have jurisdiction over offshore trials that don’t seek agency approval.
Dyer, however, added that the export from the United States of an unapproved vaccine for research use and the injection of it on U.S. soil would be within the agency’s jurisdiction.
Even so, some participants don’t regret taking part in the trial.
“When you feel like a disease has ruined your life, you become desperate,” said the Southerner, who believes the boosters have lessened his outbreaks. “Some people contemplate suicide. You’re willing to do almost anything.”
Other participants still hope for some sort of accountability.
“I feel like without a doubt that my symptoms were vaccine-related,” said the Colorado woman. “I feel like it triggered something that I’ll have for the rest of my life.”
No matter what, experts said, the university has a responsibility to conduct an in-depth investigation. So far, the university has not reached out to participants who spoke to KHN.
“This researcher went rogue,” said Fernandez Lynch, the lawyer who specializes in medical ethics. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again.”
Interacting with everyday people here in Chicago, during which politics comes up as a topic often, has taught me a few lessons.
Not everyone who voted for Trump is an idiot.
Some of those people had what they thought were very good non-racist reasons for doing so.
The people you often expect to be Clinton, Trump or Sanders supporters from just looking at them will often surprise you.
Many people took Trump at his word because he has been so masterful at painting himself as a guy who does what he says and they thought his bad traits were just for show.
That last one is most important, IMHO.
If you voted for Trump because of #4, then honestly ask yourself: How many promises has he broken? At what point do you have to admit (if you are being honest with yourself) that he is just not the person he said he is, and that he conned you just as he has conned so many other people?
When do you just get mad at what he did to you and so many of his non-rich followers? Or do you just keep up the charade because admitting you were fooled is just too painful?
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Please, please, puh-LEEZE let the people who are fleecing…er, enticing folks with this AMAZING OFFER — the BEST OFFER! — covertly be black lesbian abortionists.
Because, if there are going to be grifters attached to this shady administration, I’d just as soon they be our grifters.
In a related thought: I really should start a right-wing pro-GOP church which preaches the Prosperity Gospel and then secretly give all the proceeds to Planned Parenthood.
President Trump admitted he was floored by how “complicated” the health care system is when speaking Monday at the National Governor’s Association meeting at the White House. “It’s an unbelievably complex subject,” Trump said, while outlining the plans his administration has come up with to repeal and replace ObamaCare. “Nobody knew that health care could be so complicated.”
Trump explained that his team has come up with a solution that gives states “the flexibility they need to make the end result really, really good for them.” But “statutorily” and because they “have to know what the health care is going to cost,” Trump explained, health care has to get sorted out before he can go ahead with his tax cut plan — though he promised that will be “major, it’s going to be simple, and the whole tax plan is wonderful.” “It’s actually, tax cutting has never been that easy, but it’s a tiny little ant compared to what we’re talking about with ObamaCare,” Trump said, deeming the Affordable Care Act a “failed disaster” that’s “no longer affordable.”
Who could have guessed that a $3.2 trillion expenditure that makes up over 17% of GDP could be so complicated? I mean, who’da thunk?