Rational Vaccine の現状について

大変ご無沙汰しておりますが、とっても忙しくて更新＆リサーチの時間が取れずにおりました…。

色々と、ご心配頂きまして、本当にありがとうございます…。

今回は、ちょっと、とっても残念なお知らせをお伝えすることになります… (*´з`)

これまで、いろいろと Dr Harold の研究について追いかけながら、レポートしてきましたが、どうやら Rational Vaccines 自体が FDA から取り調べの対象となっているらしく、実際に調査が行われているようです。

これまで記事では、Southern Illinois University の先生（Dr. Gershburg）が Dr Harold の研究と事業を引き継いでいくようにお伝えしておりましたが、関係した研究者が全員取り調べの対象となっているらしく、おそらく、同大学を退職している模様です…。

Rational Vaccineにはかなり期待していたのですが…、おそらくこれでこの研究の芽は無くなったと思います。というのも、

1. FDAが承認していない手続きで治験を行った。
2. その治験で症状が悪化した人が複数いるようで、その人たちが大学を相手に訴訟を起こしている

という状況になっているからです…。

治験に参加した人たちが全員完治していれば、こういうことにはならなかったのでしょうが、とっても残念ですが…、Rational Vaccine が承認されるということは、これからよほどのことがない限り、難しいと思われます…。

一応、今回参考にした記事を以下に掲載しておきますので、興味のある方はご一読ください…。

Three who knew about herpes vaccine testing have left SIU, dean says

http://www.sj-r.com/news/20180122/three-who-knew-about-herpes-vaccine-testing-have-left-siu-dean-says

By Dean Olsen 

Staff Writer 

Posted Jan 22, 2018 at 12:55 PM

Updated Jan 22, 2018 at 6:26 PM

 

At least three people at Southern Illinois University School of Medicine knew about but failed to report unethical and potentially illegal testing of genital herpes vaccines on humans by a former SIU researcher, the medical school’s dean said Monday.

Those three unnamed employees — a faculty member, a graduate student and an office worker — no longer work at the Springfield-based institution, SIU dean and provost Dr. Jerry Kruse said.

“They were the only ones we’ve found so far that knew, and we’re still investigating,” Kruse told The State Journal-Register in an interview updating SIU’s internal investigation into the activities of the late William Halford.

The Springfield resident and longtime SIU faculty member died in June at age 48 from a rare form of nasal cancer.

Kruse wouldn’t identify the former employees in question who left, but he acknowledged that Halford’s wife, Melanie, 49, an SIU officer worker, is no longer employed.

She worked for SIU from January 2015 to Nov. 1, 2017, SIU spokeswoman Karen Carlson said. Melanie Halford didn’t return a phone call from the SJ-R.

Edward Gershburg, 49, an SIU faculty member and former research colleague of William Halford’s, left SIU Nov. 30 after 10 years on the faculty, Carlson said.

She said all three resigned. “They left for a variety of reasons,” she said.

Reached Monday afternoon, Gershburg said he is working for Rational Vaccines, the independent company that William Halford helped to start in early 2015. Gershburg wouldn’t comment further.

‘Step-by-step process’

Rational Vaccines, based in Springfield, was formed to seek regulatory approval so Halford’s vaccines — shots to treat herpes symptoms and shots to prevent herpes infection altogether — can be broadly available in the United States and across the world.

Halford committed serious ethical and regulatory violations when, without the knowledge of top SIU officials, he did his own unapproved injections of his vaccines on several people in Springfield, Kruse said.

Most of the injections involved Halford’s therapeutic vaccine Theravax on people with herpes, and a few injections involved the preventive Profavax vaccine, Kruse said.

Halford, a New Orleans native who held a doctorate degree in viral immunology but wasn’t a physician, also injected himself, Kruse said.

It appears that most, if not all, of these injections took place before Rational Vaccines was formed, Kruse said.

“I can’t give you a definite answer on that because we’ve done everything that we can to secure (Halford’s) office, secure his laboratory, his computers, ... and we’re moving through that in a step-by-step process,” Kruse said.

SIU has hired “external legal firms, external auditors and forensic IT organizations, as well, so we’ve gone all-out in this investigation,” Kruse said, adding that he’s not sure when the investigation will be completed this year.

Halford’s alleged injections should have been but weren’t approved ahead of time and supervised by SIU’s “institutional review board” or a similar board to ensure the safety of patients was protected, Kruse said.

SIU first learned of the alleged injections on July 31, slightly more than a month after Halford died, from Rational Vaccines chief executive officer Agustin Fernandez, who lives in Los Angeles and New York and traveled to Springfield to “raise concerns” with SIU’s institutional review board, according to Kruse.

Rational Vaccines spokesman Troy Petenbrink said in an email Monday that Fernandez formed the company “after he was made aware of and met individuals who experienced positive outcomes from the vaccine. ... This was the same information that he shared with SIU. He had no specific knowledge of the circumstances by which those individuals received the vaccine from Dr. Halford.”

Petenbrink didn’t say why Fernandez chose to raise “concerns” and why Fernandez chose to speak with SIU officials a few weeks after Halford’s death rather than before.

Petenbrink has refused to speak by phone or make Fernandez available for an interview since information about the unsupervised vaccine injections came to light last year.

‘Willing to help’ patients

Kruse said he doesn’t know where the vaccine used for the injections was made — whether in Halford’s lab at SIU, at Rational Vaccines’ office in Springfield or somewhere else.

Several patients who received injections from Halford have contacted SIU since July 31, Kruse said.

“We have had discussions with them, and we are always willing to help,” he said without elaborating.

Kaiser Health News has reported that several patients who claimed to receive injections from Halford in 2013 at two Springfield hotels later experienced what they feared were complications from the vaccine.

Theravax and Profavax were created by Halford based on his research at SIU.

Though Halford didn’t have herpes, he said before his death that he was passionate about fighting genital herpes, a disease that affects about one in seven people in the United States and more than 400 million people worldwide.

SIU owns the patent for the technology that Halford developed and has licensed the technology to Rational Vaccines.

SIU has sent reports, and regularly reported on the progress of its investigation, to the U.S. Food and Drug Administration and the U.S. Department of Health and Human Service’s office for human research protections, Kruse said.

The federal agencies haven’t made any final determinations but could decide to rescind millions of dollars in federal research dollars to the medical school.

SIU responded Thursday to questions posed by U.S. Sen. Charles Grassley of Iowa about SIU’s investigation, saying SIU will use the probe to make changes to its policies and procedures.

Kruse noted, though, that researchers already receive extensive training, as Halford did as recently as 2014, regarding ethical practices.

“When things are irregular, there is duty on the part of people at every level at the SIU School of Medicine to report those things appropriately, whether that be the staff members, the faculty members, the students, the learners (and) anybody else,” Kruse said.

SIU’s response says Halford’s case was one of three cases since 2013 in which allegations of unapproved research were reviewed at the medical school.

A 2014 allegation was determined to be unfounded, according to the response, while a 2013 complaint, apparently not involving Halford, determined that unapproved research had occurred.

The researcher in the 2013 case, who isn’t named, saw his or her research privileges terminated, the response says without detailing the research.

SIU’s internal investigation isn’t focusing on a 2016 clinical trial of Theravax in the Caribbean island nation of St. Kitts and Nevis, though that early stage trial has come under fire by American scientists and in St. Kitts because the trial didn’t have oversight by an “institutional review board” to look out for patients’ safety.

Kruse said SIU didn’t know about that trial until after it happened. And he said SIU wasn’t responsible or liable for the lack of IRB oversight.

SIU didn’t have jurisdiction over the St. Kitts trial because the trial was conducted by Rational Vaccines with RV’s own funds, he said.

Shocked and disappointed

Kruse said he and other SIU officials who previously commended Halford’s work before and shortly after his death have been shocked when they learned about the allegations of research irregularities.

Many people felt embarrassed that they were duped by what apparently was Halford’s “double life,” Kruse said.

“He was an exemplary faculty member,” Kruse said. “He won teaching awards. There was just nothing that would make anyone think he was anything but an exemplary faculty member.

“We, I and the institution really deeply regret the actions that Dr. Halford took here,” Kruse said. “There’s no doubt that he violated our policies and procedures and federal regulations, and he did it willfully and knowingly and misled us. At first we were astonished by that, disappointed, then upset that he misled the institution, the scientific community, his fellow colleagues, even the people involved in these studies.”

Contact Dean Olsen: dean.olsen@sj-r.com, 788-1543, twitter.com/DeanOlsenSJR.