The Cincinnati Beacon - Wulsin Pressured Into Press Statement by The Cincinnati Beacon? (Ethically Challenged, Part Three)

Sunday, September 17, 2006

Wulsin Pressured Into Press Statement by The Cincinnati Beacon? (Ethically Challenged, Part Three)

Yesterday, Dr. Vic Wulsin issued a press release concerning her position on some bits of “medical research.” In the release, she cites her work on malariotherapy for the Heimlich Institute, and she even uses the occasion to make public her report on malariotherapy. It is noteworthy how long she waited to release this report. After telling The Cincinnati Beacon for months that the report would be forthcoming, she only made it available after we acquired a copy and started analyzing her apparent condition of being ethically challenged. Now, the Wulsin spin doctors are trying to downplay her role in advocating more human experiments.

Here is the Wulsin campaign’s full press release:

WULSIN ON THE IMPORTANCE OF MEDICAL RESEARCH

Cincinnati, OH – “Every day I thank God for modern medicine and I thank God for the ability to keep our loved ones healthy so that they may live long, full lives,” said Dr. Victoria Wulsin today, after having participated in the 5 K Race for the Cure in Mason, OH on Sunday with her supporters.

Dr. Wulsin, the Democratic nominee for Congress in Ohio’s 2nd Congressional District, has dedicated her career to public health. She was Cincinnati’s chief epidemiologist between 1989 and 1995, responsible for the prevention and treatment of disease throughout the city. In 1994 she led the team of doctors, nurses, parents and teachers that successfully minimized and controlled the spread of Whooping Cough.

Dr. Wulsin received her AB from Harvard University after earning a merit scholarship. She received her MD from Case Western Reserve University in 1980, and then went back to Harvard to earn her Doctorate in Public Health with a specialization in disease prevention in 1985.

“Medical research holds the wondrous potential to cure disease and improve the lives of billions of Americans and people around the world,” said Wulsin. Last month, Rep. Jean Schmidt voted against public funding for stem cell research, which many scientists believe will help us uncover cures for Alzheimer’s, Parkinson’s and other diseases that afflict millions of Americans.

“As researchers, there are times when we conclude that potential medical techniques are unworthy of further pursuit. Immunotherapy for AIDS is one such example.” In a 2004 paper entitled “Immunotherapy and Beyond” that she wrote for the Heimlich Institute, Dr. Wulsin reviewed the relevant literature on a proposed medical technique and concluded that “The preponderance of evidence indicates that neither malaria nor Immunotherapy will cure HIV/AIDS.” That paper is available on the Wulsin for Congress campaign website at

http://www.wulsinforcongress.com/downloads/heim_inst_report.pdf

Victoria’s mother is a breast cancer survivor. “We can prevent cancer and if we catch it early, we can beat it,” Wulsin said. “I enjoyed the run on Sunday and applaud the Komen Foundation for its work on breast cancer prevention, treatment, and awareness.”

Dr. Wulsin has been an Epidemic Intelligence Service Officer at the Centers for Disease Control (CDC), where she was assigned to the National Institute for Occupation Safety and Health (NIOSH); she has been a primary care physician at the Health Resource Center, the free clinic in Cincinnati; and she was the regional advisor for HIV/AIDS for the United States Agency for International Aid (USAID) for East Africa, stationed in Nairobi.

At first, the fifth paragraph seems quite conclusive; however, we have already addressed the report’s inconsistencies (see ”Ethically Challenged, Part Two: Looking for Wulsin’s Silver Lining” ). As an experiment, consider the following version of that paragraph, which is just as legitimate as the one she wrote, given the details of the whole report:

“As researchers, there are times when we conclude that potential medical techniques are unworthy of further pursuit. But sometimes we decide to continue researching them anyway, looking for abused mining workers in the third world for our experiments.” In a 2004 paper entitled “Immunotherapy and Beyond” that she wrote for the Heimlich Institute, Dr. Wulsin reviewed the relevant literature on a proposed medical technique and concluded that the HI should “[e]xplore further collaborating with Michele Ashby, the Denver Gold Group, and/or the CEOs, medical directors, &/or others of appropriate mining companies.” That paper is available on the Wulsin for Congress campaign website at

http://www.wulsinforcongress.com/downloads/heim_inst_report.pdf

If things had turned out differently—and Wulsin was still working for the Heimlich Institute instead of running for Congress—what did Wulsin predict she would be doing right now? Answer: working on malariotherapy experiments.

From a projected timeline in her report:

2006—East African Phase II Clinical trial is published and/or presented and received with enlightened enthusiasm. East African investigator/s and the Heimlich Institute attain IRB approvals. East African Phase II Clinical trial is published and presented and received with guarded interest.

2007—East African investigator/s and the Heimlich Institute [H.I.] enroll initial 75 patients. East African investigator/s and the H.I. attempt to attain IRB approvals.

What is Wulsin talking about? Why would there be collaboration with East African investigators and the enrollment of 75 initial patients, if this idea does not work and has no scientific validity?

By the way, if you are wondering what she means by “Phase II,” read this:

Issues specific to individual phases of Immunotherapy trials are:

· Phase I: safety of Plasmodium falciparum as a therapeutic agent.
· Phase II: logistics of infecting, treating, and following-up study subjects.

Once again, Dr. Vic Wulsin has shown the kind of equivocation we expect from a mediocre politician and not a steadfast doctor. Should we elect ethically challenged people to public office?

UPDATE: (4:45pm) The “Executive Summary” which constitutes the first page of the report as provided by Wulsin is new. It was not included in the original report.

-----
Read ”Ethically Challenged Part Two, Looking for Wulsin’s Silver Lining”
Read ”Dr. Vic Wulsin, Ethically Challenged? Part 1”

• Share This Article!
Listen to this article

Help The Cincinnati Beacon Grow! Participate in Social Networking!

Socializer!

Members

Tell us what you think!

Anonymous comments are allowed, but you can create an account above to stamp your name and to avoid typing the anti-spam code.

If you are not familiar with our rules for leaving comments, click here! The Cincinnati Beacon is not responsible for the contents of any comments. Comments do not represent the views of the moderators of The Cincinnati Beacon.

Real Dem says:
17 Sep 2006 at 05:46 am | #

Dean, there are Democrats out there who are not blind, supporting everyone with a (D) behind their name. We’ve been following this Wulsin situation, and we are eager to see how it plays out! Thanks for the work.

Freedom Fighter says:
17 Sep 2006 at 07:32 am | #

[Editor’s Note: Freedom Fighter, I told you that you need to stay on topic. This comment was just a really long insult. But don’t worry. I have not censored you; instead, I have placed a copy of your comment in the special forum designed just for you. Click here.]

anon says:
17 Sep 2006 at 08:37 am | #

I have placed a copy of your comment in the special forum designed just for you.

Good solution, Dean. Thanks for helping to keep the discussion on point.

Freedom Fighter says:
17 Sep 2006 at 08:50 am | #

[Editor’s Note: This is a thread to discuss Wulsin’s report, or her actions. Cite from the report, or my argument, and provide logical discourse. Otherwise, visit the special strand I made for you—which is where I posted the comment you tried to insert here.]

says:
17 Sep 2006 at 10:06 am | #

Why does everyone want to avoid the obvious—the flip-flopping of the Wulsin report? Is a questionable ethic acceptable when one runs as a Democrat?

says:
17 Sep 2006 at 10:17 am | #

The last thing we need to have in our government is another flip flopping politician. We have plenty of those. and we probably shouldn’t be even considering electing someone with the ethic problems of this Doctor.

anon says:
17 Sep 2006 at 10:27 am | #

From “Heimlich Manuevers” by Linda Vaccariello, Cincinnati Magazine, 12/05

“Hank is a scientist and his research is subject to scrutiny,” says Dr. Victoria Wells Wulsin, referring to Henry Heimlich by his nickname. “That’s what the scientific method is all about.”

Wulsin is probably better known to Cincinnatians as a candidate in last spring’s Democratic primary for the Ohio Second Congressional District seat. But she’s also a 52-year-old epidemiologist from Indian Hill who has worked for the Centers for Disease Control and Prevention. Three years ago, after working on a public health project in Kenya, she started a nonprofit organization called Soteni that works with women and orphans in Kenya who are affected by AIDS. In 2004, she was approached by Heimlich and the board about becoming the director of the institute. Wulsin felt it would be a good fit for her. “I was very interested in AIDS in Africa, and that was one of the areas that the Heimlich Institute is interested in,” she says. But the salary she was offered ($75,000) was low, even for someone accustomed to working in public health. Moreover, she felt the salary suggested that she wouldn’t really be given the reins. “I’m interested in being a decision-maker, not just an adjunct to Hank,” she says. “So I declined the offer.”

Instead, the board hired her as a consultant. She says that she was asked to do two things: First, to review the literature on malariotherapy as a treatment for AIDS; second, to suggest alternatives to malariotherapy in terms of how the institute could address the AIDS epidemic.

Heimlich and Spletzer provided Wulsin with articles and research reports, and she gathered material on her own. She says that she went through hundreds of articles on HIV treatment, malaria, and HIV itself, “most of which didn’t even address the question of the relationship between malaria and HIV.” But a few articles did, and she developed a quantification system for these: If they suggested that having malaria combated HIV, they were a positive; if not, they were a minus. She met with Heimlich each week to keep him up-to-date. “I had pluses and minuses and I would show them to Hank and he would agree or disagree,” she says. Time and again, he would refer her to a study published in 1986 - “which in medicine, particularly in HIV/AIDS research, is outdated,” she says. Nevertheless, she studied it.

At the end of three months, Wulsin submitted her report, concluding that “the preponderance of evidence indicates that neither malaria nor Immunotherapy [i.e. malariotherapy] will cure HIV/AIDS.”

“I wanted to present (the report) to the board; I thought it was important that they know,” she says. She didn’t get the chance. Wulsin says that the day after she turned in her report, “Hank left me a phone message and said `We won’t be needing your services.’ I called back and asked if we could at least talk. He said, ‘You can come in and clear out your things.’ “

“His passion is malariotherapy,” Wulsin says. “I have spoken with him since, and it still is.” Admittedly, she went into the assignment skeptical about malariotherapy for HIV/AIDS. But, she says, “I tried for three months to have what in my mind was scientific interaction. I was very open-minded to what he said, not only reading but studying the articles that he led me to. And I didn’t feel that was reciprocated.”

During her work, Wulsin was given data from a recent research project in East Africa. While Heimlich and Spletzer received data from the project, Wulsin does not believe that money from the Heimlich Institute was used to fund it. She isn’t comfortable discussing who sponsored the project, but according to her report, “an American sponsor” initiated a discussion with the institute about malariotherapy for East Africans, and in 2003 began working with “12-13 HIV-positive patients.”

Wulsin was shown follow-up data on eight of these patients, and the report notes that “clinically, the patients continue to do well.” But, Wulsin says, she was never shown written research protocols for the project. Without seeing the protocols, she says, she “couldn’t be impressed” with the data that Spletzer and Heimlich showed her. “And I said that in my report.”

She’s still frustrated with the way that data was handled. “I have been a PhD level scientist for 20 years, and I’ve never experienced that level of difficulty in getting information,” she says.

In her report, Wulsin outlines the ethical standards for studies of immunology: patients must he informed and understand the risks and benefits; protocols must be approved by local and donor institutional review boards; the public should have access to the information; research protocols should be designed in advance. “‘Fishing expeditions’ for possible benefits are no longer warranted,” the report chides. It would seem to be a rebuke of the East Africa project - Third World research on human subjects wrapped in a cloak of secrecy.

one advocate says:
17 Sep 2006 at 10:41 am | #

i’m sorry forhavingthis opinion -but ,i don’t think wulsin did naything but what she could under such a contract. whe wastheir employee,was fired fornot promoting the propaganda and forbidden from doing anindependent critical analysis of the issue via that contract. or subsequently beauseshe wasprovided “insider” info that she isnot allowed to use in further works.
i don’t think you guys get the legal parameters associated with this type of contract - she got out of it best she could whene she found the problems. and thata is evident by her being fired and her refusal to do what she obviously found to b e a continued ethical problem given her own review.
that would belikehiring that lee guy to represent your client and then himtestifying that he did it. his job and contract specify otherwise. he would be subject to suit.
she did only what she could do given these legal and professional constraints.

Freedom Fighter says:
17 Sep 2006 at 10:51 am | #

Why does everyone want to avoid the obvious�the flip-flopping of the Wulsin report? Is a questionable ethic acceptable when one runs as a Democrat?

No one is avoiding the flip-flopping because it does not exist.

That fact is: Nobody supports your claims, period !

Quit being a protectionist of your own illusions and just “Move On” .org.

says:
17 Sep 2006 at 02:30 pm | #

one advocate,

Are you telling me Wulsin was contractually obligated to reach certain conclusions before conducting her consultancy? If so, shame on her for taking the gig! If not, shame on her for advocating human experiments for an idea she admits won’t work! If she behaved like this because she wanted to take over the Heimlich Institute, imagine the deals she will make once in office!

says:
17 Sep 2006 at 02:42 pm | #

I support Deans claim FF

anon says:
17 Sep 2006 at 03:26 pm | #

one advocate and others: Dr. Wulsin’s responsibility didn’t end when she left the job. That important point was made in this comment from BuckeyeStateBlog. I’d welcome hearing opinions from others on this subject.

# # #

In her press statement and “Executive Summary”, Dr. Wulsin condemns the Heimlich trials. However, she did not do so in her report which contradicts her own previous public statements. Further, Dr, Wulsin has failed to report the Heimlich Institute to any oversight agency, thereby leaving Afircan patients vulnerable to further abuse.

Elections come and go. Dr. Wulsin has the obligation to report the Heimlich Institute and its parent company, Deaconess Associations, to the proper authorties. Her failure to do so only raises additional concerns about her ethics as a medical professional.

anon says:
17 Sep 2006 at 03:32 pm | #

I also support Dean’s claim, FF, and I support further reporting of this story.

anon says:
17 Sep 2006 at 04:30 pm | #

I support Deans claim FF

Vested interest.

The sock-puppet is talking again !

Give me a Break says:
17 Sep 2006 at 08:38 pm | #

Wulsin Pressured Into Press Statement by The Cincinnati Beacon?

Hardly, she ignored you for months and rightfully so !

Nothing really happens in politics until after labor day. The timing of the press release, coupled with her run for charity regarding cancer is:

Brilliant !

komarek says:
17 Sep 2006 at 11:35 pm | #

Dean,

I just read the report, and there is no news damaging to Wulsin in it.

My previous comments stand. Regarding the East African research—these were not studies where white-coated researchers injected hapless victims with malaria. These were 8 individual cases where people acquired their malaria cases “naturally,” that is, through mosquito bites. The eight patients, facing an AIDS death sentence, were being treated for their malaria. They did consent to delaying the start of antimalarial treatment “for at least two weeks.” See page 9 of the original report (page 11 of the pdf file).

Of course these infections and the delays in treatment all happened before Wulsin became involved in reporting on this subject.

Wulsin’s report says that further work can’t continue until these original 8 cases are followed longer, and until the case studies are published, verified and elaborated. Contrary to your claims, Wulsin does not suggest, condone or sanction further malarial infections or delays in treating malarial infections. See her timeline on page 16 of the report (page 18 on the pdf file I downloaded):

“2005 - 18-24 month follow-up on pilot series of 8 patients concludes with extremely positive results.

“2006 - East African Phase II Clinical trial is published and/or presented and received with enlightened enthusiasm.

“2006 - East African investigator/s and the Heimlich Institute attain IRB approvals.

“2006 - East African Phase II Clinical trial is published and presented and received with guarded interest.”

Wulsin’s report is, of course, dated December 2004, well in advance of any of this anticipated activity.

Note that Wulsin also recommends that any further clinical trials obtain approval of institutional review boards not just in Africa, but also from those in “donor nations.”

Here is what she says:

“Research in Third World countries, notably in Africa, has notoriously neglected sanctions from operational (usually local) and supporting/donor (often First World) institutions through IRB approval. Given the discrepancy in standard of care between the First and Third Worlds, clinical trials should be conducted only with approval from both local and donor IRBs.” This is from page 13 of the pdf file, page 11 of the original report.

You can see that Wulsin is expressing the same concern you and others have about the ethics of conducting medical research in third-world nations.

Dean, your criticisms of Wulsin with respect to this matter are just wrong.

--pk---

says:
18 Sep 2006 at 04:51 am | #

komarek:

What was she doing with a suggestion to collaborate with Michele Ashby of the Denver Gold Group?

komarek says:
18 Sep 2006 at 08:49 am | #

Dean,

“Collaborate” is pretty vague to me.

However, it’s clear from Wulsin’s report that Wulsin did not recommend further clinical trials.

That’s enough for me.

--pk---

brewer says:
19 Oct 2006 at 05:11 pm | #

I haven’t found a single negative thing in the factual record against Wulsin.
A good independent report from nearly a year ago outlines her role quite well:
http://www.radaronline.com/web-only/radar-investigates/2005/11/outmaneuvered-part-ii.php

Frankly, I just see a grand smear campaign by the Schmidt forces.

Hot News!

Contact Us

Events

Sunday, September 17, 2006