Friday, October 20, 2006

Black Box Warning —Wulsin’s Claims of Innocence

Posted by The Dean of Cincinnati

A guest article by Dr. Robert Baratz.

(Black Box warnings are text put on drug labels inside a black box to alert clinicians and consumers of serious adverse reactions.)

In response to criticism about her involvement with “Malariotherapy,” Victoria Wells Wulsin, MD has claimed that she was only doing a literature review for Henry Heimlich and the Heimlich Institute.

Wulsin shares any “ethical violations perpetrated by the Heimlich Institute” related to the East African data reviewed in her report because of the U.S. Common Rule at 45 CFR 46, with which Wulsin is no doubt familiar from her employment with the CDC.  Other other widely recognized statements of ethical principles require prior IRB review and approval for the use, collection, or dissemination of *identifiable private information* collected about living human beings in the course of an “interaction” not otherwise exempt. Her activities in reviewing these data do not meet any of the exemptions at 45 CFR 46.101 (b):

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

In particular her activities do not meet the exemption for use of “existing data” because the data are neither public nor de-identified, whether permanently or by a key held by a third party. We can be certain the data were not de-identified because Wulsin does not say they were.

Moreover, Wulsin admits she was unable to ascertain that there was ethical review and approval of this study or that subjects gave informed consent. In fact no IRB would ever approve a trial which delayed treatment of subjects infected with falciparum malaria.  Note here that the identity of the strain of malaria is something Wulsin was “unclear” about. In just the same way as researchers do not use data gathered by Nazi researchers in the course of unethical research, so too Wulsin is constrained from reviewing and causing to be further disseminated the data from East Africa. Put differently, she had an affirmative obligation to refuse to review or otherwise use these data.

Let’s face it, Wulsin made a terrible mistake in judgment, first to get involved with the Heimlich Institute at all, and second, to assist in the attempt to lessen the well-deserved stigma of malariotherapy by lending her skill and reputation to it by compiling the report.

In response to questions and justifiable outrage, instead of honest contrition, Wulsin attempts to minimize her actions and defends herself with the very same inane arguments put forth by Dr Heimlich many years ago when he was criticized severely for these outrageous experiments by the same CDC for which Wulsin previously worked. These arguments were false then and are equally false now.  They severely diminish Wulsin’s reputation as a physician.

If scrutiny and criticism bother her, Wulsin shouldn’t have invited it by running for political office.

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says:
20 Oct 2006  at  06:02 pm | #

Carl Weiser posted the following on today’s web chat with Vic Wulsin:

A local blogger, [The Dean of Cincinnati] submitted this question: At what institution was the recent commercial showing Dr. Wulsin directly helping patients filmed? When was the last time Dr. Wulsin
served in such a medical capacity, directly treating patients?

I think it’s pretty obvious that there are actually two questions above.  I wanted to know where the recent commercial was filmed, and I wanted to know the last time she directly treated patients.

Wulsin’s answer dodges the first question:

[The Dean of Cincinnati]: I’ve been a clinical physician since 1980 when I graduated. I worked at the Cleveland Clinic, I worked in several health centers in Boston and Cincinnati, and then I was the Cincinnati city epidemiologist for 5 years. In that role, I led teams of doctors, nurses, and parents in keeping children and families healthy. My most recent clinical work was at the Health Resource Center in Over-the-Rhine from 1998 to 2001. Since then, my clinical work has been primarily in east Africa where I run a non-profit that delivers primary care.

So was that a real hospital in this commercial?  Does Wulsin has privileges there?  Is that a radiograph she’s examining?  Is she allowed to do that?

Check this exchange, too:

What is malariotherapy? We’ve gotten a few e-mailed questions on it, like this: Why did Dr. Wulsin fail to oppose the malariotherapy experiments (of which she analyzed unredacted human data for the Heimlich Institute), instead writing what reads like a business plan for continued collaboration with East African experimenters?

Her answer:

Carl, I’ve answered the questions regarding malariotherapy many times, and I can do so again. I was hired by the Heimlich Institute to write a literature review about malariotheraphy. The idea behind malariotheraphy was that you can stimulate the immune system by exposing the body to malaria. I read the relevant literature and found that malariotheraphy had no legitimacy and further research was unwarrented. I wrote that in my report and I was fired the next day.

Is that really what she wrote?

Really?!

formerly f says:
20 Oct 2006  at  09:38 pm | #

So was that a real hospital in this commercial?  Does Wulsin has privileges there?  Is that a radiograph she’s examining?  Is she allowed to do that?

She can legally use a real or a fake hospital on the commercial.  It makes no difference.  She would not have to have privileges in a hospital to film a commerical there. 

Privileges tell you what procedures and services you can perform in the hospital.  So long as she is not actually performing a procedure she isnt privledged to do in the commerical she is well within her rights to show herself as a doctor, look at x-ray films, re enact talking to patients etc.

says:
21 Oct 2006  at  06:36 am | #

The phrase “clinical physician” is vague, and I think purposefully so.  It does not indicate a position where some works in a direct-care capacity, as with, say, your family doctor.  However, that is how Wulsin comes across in her commercial.

I thought radiographs were associated with patient information, which would violate HIPAA standards if Wulsin has no privileges at the institution where she filmed the ad.

So there may be more to this, though—notice that Wulsin will not answer the question.  Why?  It is a simple request?  Why fuel this speculation, if there is nothing to it?

Now, for the other question.  In her report, Wulsin did write:  “The preponderance of evidence indicates that neither malaria nor Immunotherapy will cure HIV/AIDS.” However, in the web chat, Wulsin wrote:  “I read the relevant literature and found that malariotheraphy had no legitimacy and further research was unwarrented. (sic) I wrote that in my report and I was fired the next day.”

There is a difference between saying evidence indicates it will not cure AIDS, versus saying it has no legitimacy and that further research is unwarranted.

But here are some excerpts from the report:

Further field studies of Immunotherapy, including Phase III and IV clinical trials, require the verification of the encouraging results from East Africa, elaboration on discrepancies between them and the results from the Phase II trial in China, and professional dissemination and transparent discussion with scientists, physicians, and other stakeholders.

C’mon komarek—write your defenses till your fingers fall off, that is not a statement that research is unwarranted!

Or this, Wulsin’s ideas for the future of her work with the HI:

Programmatic Next Steps

1. Write a strategic plan for the Heimlich Institute.
2. Rename malariotherapy “Immunotherapy” [“IT”].
3. Verify and elaborate on East Africa Phase II trial. 
4. Explore further collaborating with Michele Ashby, the Denver Gold Group, and/or the CEOs, medical directors, &/or others of appropriate mining companies.
5. Complete and publish review of Immunotherapy.

Financial Next Steps

1. Write a budget for all activities: research, education, outreach, interventions, etc.
2. Secure funding.
3. Work with the Board of Directors to identify individuals, foundations, and corporations to solicit for financial support.
4. Contact Lynn Tilson to explore hosting a Cincinnati-located fundraiser (e.g., “Henry’s Angels”). 
5. Contact Martha Jones regarding the Gates Foundation
6. Explore NIH for relevant RFAs [Requests for Applications] and RFPs [Requests for Proposals].

Institutional Next Steps

1. Negotiate with the Deaconess Associations Incorporated a relationship beneficial to all concerned.
2. Write a business plan that includes development, operations, and logistics.
3. Schedule a “retreat” for the Board of Directors.
4. Write a succession plan for Dr. Heimlich with clear milestones, assignments, and requisite resources.


If further research is unwarranted, why all the plans for the future?

You know, when someone doesn’t answer the question, we say they speak “like a politician.” But Wulsin isn’t even good enough to reach that level of lowness.

komarek says:
21 Oct 2006  at  09:23 am | #

1. US law does not apply to all research outside the US, so there may have been no IRB requirement. Even so, there may well have been patient protections none of us knows about. Dr. Wulsin never even spoke with the researchers in East Africa. She did read data about the patients, but so what? Were there patient names? Apparently not, because the report always refers to the patients by number—see page 9 of the original report. Dr. Wulsin recommended a thorough, professional review of the published results of this clinical trial. Wasn’t this the right thing to do?

2. Dean, you can repeat and repeat what you want. But I answered this completely in

comment1

comment2

comment3

as well as responded to your comment at

dean’s comment with

point-by-point comment.

Your charges go beyond what even Dr. Baratz claims. Read his comments. He has always focused on Dr. Heimlich’s actions and steps taken before Dr. Wulsin wrote her negative report. He certainly does not dispute Dr. Wulsin’s main point, which is that there should be no further human trials until there is scientific review and agreement that the procedure makes sense.

--pk---

says:
21 Oct 2006  at  04:37 pm | #

Wulsin wrote a report.  She recommended against the therapy.

anon says:
21 Oct 2006  at  07:30 pm | #

komarek: 1. US law does not apply to all research outside the US, so there may have been no IRB requirement.

Wrong. The Heimlich Institute is wholly owned by Deaconess Associations. Deaconess funded the China and Africa experiments. Pull the 990s. You know how to do that, don’t you? If not, start here: http://www.circare.org/malariotherapy2.htm

Deaconess gets federal dollars and therefore must meet HHS guidelines including IRB oversight. Wulsin says she was paid by the Heimlich Institute, wholly owned by Deaconess. Ouch.

If you’d really like to exonerate your lame candidate, why not ask her to demand that Deaconess issue a statement? She won’t because Deaconess won’t and none of them want any attention brought to bear because they’re all dirty. Same reason she doesn’t report them - she’d go down with the ship. Not that the outcome of this mess depends on Wulsin’s integrity, thank goodness, given the short supply of that characteristic in her nature.

Ever ask yourself why Wulsin wanted to get involved with Heimlich? Ever consider that she’s a failure in her profession and needed to scrape the bottom of the barrel for some of the ready green? 

Questions, komarek. Are you or any of your family members affiliated with the Wuslin campaign? Do you have a professional or personal relationship with her or any of her family? What’s your dog in this hunt?

says:
22 Oct 2006  at  07:03 am | #

John in Cincinnati:

She wrote a report.  She recommended changing the name to Immunotherapy, continuing research, and reestablishing contact with gold mines (perhaps for more slaves to test?).

says:
22 Oct 2006  at  07:04 am | #

komarek,

Dr. Baratz wrote this before Wulsin made on the record statements during her web chat.

Coma Wreck says:
22 Oct 2006  at  07:28 am | #

Paper: The Cincinnati Post
Title: Ohio court suspends three local attorneys
Date: November 26, 1998

The Ohio Supreme Court suspended three Cincinnati lawyers from the practice of law Wednesday for professional misconduct....Lawyer Paul Komarek was indefinitely suspended from the practice of law for misappropriating client funds and neglecting legal matters after the court found he had committed at least 40 violations.

Lawsuits against Komarek’s clients were dismissed and default judgments entered against them due to his inaction and he kept legal fees he had not earned, the court found. Komarek was ordered to pay a $155,000 malpractice judgment and provide restitution before applying for reinstatement.

Copyright 1998 The Cincinnati Post
Author: Post Ohio Bureau
Section: News
Page: 19A

D'OH Y'All says:
22 Oct 2006  at  07:29 am | #

Just who is Vicki married to? Want to guess where that commercial was filmed? Do your research boys.

komarek says:
22 Oct 2006  at  08:00 am | #

Anon,

The Heimlich Institute was not the American sponsor of the research in question. Dr. Baratz seeks to find out the name of the sponsor. Dr. Wulsin does not know who it was.

Dean,

Dr. Baratz did start as a Dr. Heimlich critic. He may well be right about Dr. Heimlich. But why do we continue to have this dogged pursuit of Dr. Wulsin in the face of a report that harmed no one?

I can understand the interest in finding out what was in the report. Once you obtained the report I urged you to publish it. Ever since you published it I’ve been quoting chapter and verse on how these attacks don’t bear up when you compare the accusations to what is actually in the report.

The question for me now, after all of this, is why these attacks persist when simply reading the report shows that Dr. Wulsin did nothing to anyone!

After repeatedly disproving all these baseless claims, it’s only fair to examine the motivations of the accusers.

--pk---

says:
22 Oct 2006  at  08:15 am | #

It is strange, because anon comment 9 and komarek’s comment 11 were both waiting to be approved at the same time.  So neither saw the other’s post before writing.

I find it at least somewhat noteworthy that komarek is now saying we should examine motives, when it looks like he was suspended from the practice of law.

Is that the same komarek?  What are your motives?  Can you be trusted?

Looks like that may be a fair question to ask…

komarek says:
22 Oct 2006  at  08:33 am | #

Anon,

The only thing I have ever received from the Wulsin campaign was a yard sign. I’ve never even met her.

Sure that’s me. Email me if you’d like to have a conversation about trying to do some good in this world 10+ years after recovering from a serious bout of mental illness.

I’ve never claimed a bit of authority on this matter, apart from the text of Dr. Wulsin’s report. But with respect to this issue I have consistently demanded one thing only. Read Dr. Wulsin’s report. The answers to all these baseless claims is in the report.

--pk---

says:
22 Oct 2006  at  08:51 am | #

Komarek, I have reviewed the comments to which you have linked.  Our claims are not baseless based on your inadequate responses.

Fact:  Wulsin did more than a simple literature review.  She presented a marketing strategy for the future of the Heimlich Institute.  In fact, she hoped to take over the HI one day.

Fact:  Wulsin analyzed raw and unredacted human data from East Africa, which seems an ethical violation.

Fact:  Wulsin said that the preponderance of evidence suggests malariotherapy will not cure AIDS.  She did not, however, say that the entire project should cease.

Fact:  Wulsin wanted to continue work on the project, renaming malariotherapy “immunotherapy” because of bad press it had received.

Fact:  Wulsin wanted to explore further collaboration—and whatever the agenda she might have in these “explorations,” the bottom line is that such collaboration does not match her claims that she recommended that the research stop.

You continuously try to make the argument that she was trying to strengthen the ethics of the HI.  But that is not the point.  The actuality of her report does not match her current claims.  If you are right, then why won’t she just tell the whole truth?

With Friends Like Komarek.... says:
22 Oct 2006  at  08:54 am | #

For more on Paul Komarek, check out the county clerk’s page. There’s a long list of actions against him, many of them from court reporting companies whom he apparently stiffed for fees: http://www.courtclerk.org/comp_name_search.asp

KOMAREK PAUL 00CJ27870
KOMAREK PAUL 94CV20473
KOMAREK PAUL 95CV23237
KOMAREK PAUL A 9605595
KOMAREK PAUL CJ05008522
KOMAREK PAUL CJ06004759
KOMAREK PAUL CJ95000484
KOMAREK PAUL CJ95010114
KOMAREK PAUL M 9801098
KOMAREK PAUL A 92CV17263
KOMAREK PAUL A 95CV12185
KOMAREK PAUL A A 9405518
KOMAREK PAUL A CJ92006354
KOMAREK PAUL A AKA PAUL ANTHONY KOMAREK 9500906
KOMAREK PAUL A ESQ A 9105428
KOMAREK PAUL ESQ 90CV38063
KOMAREK PAUL ESQ 91CV35356

says:
22 Oct 2006  at  09:07 am | #

Anon 15, perhaps you should contact komarek.  He seems interested in talking about it!

komarek says:
22 Oct 2006  at  09:33 am | #

Pardon me but your “facts” are wrong.

Claim: “In fact, she hoped to take over the HI one day.” Not based upon the text of the report. And again, so what?

Claim: “Wulsin analyzed raw and unredacted human data.” Not based on the text of the report. Nowhere does it imply that the data was “unredacted” especially as all patient info was based on “patient numbers.”

Claim: “She did not, however, say that the entire project should cease.” She said it could continue if further analysis of the esisting studies was found by the scientific community, after publication and verification, to have merit. She said the data currently did not justify further trials. What is wrong with saying that? Doesn’t that mean the same thing as “stop doing more trials unless you can prove that this works”?

Claim: “Wulsin wanted to continue work on the project, renaming malariotherapy “immunotherapy” because of bad press it had received.” So what? If the procedure was shown to work, the name does not matter.

Claim: “Wulsin wanted to explore further collaboration—and whatever the agenda she might have in these “explorations,” the bottom line is that such collaboration does not match her claims that she recommended that the research stop.” In her report she says further research could take place only after the current research is published and verified and proven out. If Heimlich wanted more studies now, isn’t what Dr. Wulsin said that the same as saying that research should stop?  And what’s wrong with making contingency plans, especially if those plans included the right patient protections for a procedure that did prove worthwhile?

--pk---

says:
22 Oct 2006  at  09:59 am | #

Claim: “In fact, she hoped to take over the HI one day.” Not based upon the text of the report. And again, so what?

I never said the report included the claim.  But it is a fact.

See:  http://www.youtube.com/watch?v=w8l9aK-zlKg

Wulsin:  “I was asked to lead the Institute, but due to some disagreements with Hank I never got that chance.”

Claim: “Wulsin analyzed raw and unredacted human data.” Not based on the text of the report. Nowhere does it imply that the data was “unredacted” especially as all patient info was based on “patient numbers.”

I base my use of the word “unredacted” on previous context established by a medical doctor (Dr. Baratz):  “You claimed in your later added Executive Summary that you were only doing a literature review.  How is it then that you actually analyzed data in your report?  These were raw, unredacted, human patient data.  Your analysis was not a literature review, it was a participation in the studies.” (source)

On the recent chat, Wulsin did not dispute my use of the word.  So for right now, it’s your word, versus that of a doctor. 

Claim: “Wulsin wanted to continue work on the project, renaming malariotherapy “immunotherapy” because of bad press it had received.” So what? If the procedure was shown to work, the name does not matter.

This is where you become logically fallible, komarek.  I am not talking about malariotherapy, but instead Dr. Wulsin.  Wulsin said in the chat-transcript copied above, “I read the relevant literature and found that malariotheraphy had no legitimacy and further research was unwarrented.” (sic)

Whether the name matters has no bearing on whether Wulsin is telling the truth.

Claim: “Wulsin wanted to explore further collaboration—and whatever the agenda she might have in these “explorations,” the bottom line is that such collaboration does not match her claims that she recommended that the research stop.” In her report she says further research could take place only after the current research is published and verified and proven out. If Heimlich wanted more studies now, isn’t what Dr. Wulsin said that the same as saying that research should stop?  And what’s wrong with making contingency plans, especially if those plans included the right patient protections for a procedure that did prove worthwhile?

Within the past few days, Wulsin said further research was unwarranted.  Now, let’s assume your reading is totally correct.  “In her report she says further research could take place only after the current research is published and verified and proven out.” Well, that’s not what she is saying on the campaign trail.  “If Heimlich wanted more studies now, isn’t what Dr. Wulsin said that the same as saying that research should stop?” No, it is not the same thing, and I can’t believe you cannot discern the difference.  “And what’s wrong with making contingency plans, especially if those plans included the right patient protections for a procedure that did prove worthwhile?” What’s wrong?  Again, you are changing the subject.  Wulsin says further research is unwarranted, but that’s not what she wrote in her report.  That’s the issue here:  her story changes when beneficial to her.

komarek says:
22 Oct 2006  at  10:30 am | #

Okay, I’m not infallible.

But you can certainly admit this much: Dr. Wulsin’s actions resulted in no harm to anyone.

--pk---

says:
22 Oct 2006  at  10:33 am | #

So you admit that Wulsin is not being truthful in regards to her role in malariotherapy?

says:
22 Oct 2006  at  10:34 am | #

I will admit this:  Wulsin could have taken action to prevent human experimentation, and it does not appear that she took any action whatsoever.

komarek says:
22 Oct 2006  at  10:42 am | #

She experimented on no one. The report she wrote was effective in preventing further human experimentation. That is consistent with what Dr. Wulsin has said.

--pk---

anon says:
22 Oct 2006  at  11:42 am | #

Email me if you’d like to have a conversation about trying to do some good in this world 10+ years after recovering from a serious bout of mental illness.

...and losing your license to practice because you defrauded clients and being a deadbeat on thousands of dollars worth of debt. Now we’re supposed to take you seriously as Mr. Medical Ethics defending Wuslin, whose has been playing dodge the questions every step of the way?

I suggest, 1) Invest in a mirror; 2) Seek further therapy.

says:
22 Oct 2006  at  11:49 am | #

komarek, why do you sidestep the issue?  What she said is not what she wrote.  She either cannot remember simple details, or she is a liar.

Neither bodes well for a leader.

komarek says:
22 Oct 2006  at  12:48 pm | #

Dean,

You can’t expect people to mimic what you want them to say, to reject everyone you reject, or to use the same words every time they mention an issue. Her report harmed no one, and her present characterizations of her work ring true.

--pk---

says:
22 Oct 2006  at  12:53 pm | #

For a second (comment #19), it looked like you had come to your senses.

Bottom line:  what she says is not true.

Why can’t you accept this simple fact?

anon says:
22 Oct 2006  at  01:27 pm | #

komarek: Her report harmed no one

False. At the least, Wulsin’s report helped Heimlich pursue his private fundraising for the ongoing Africa project which may now be hurting people.

She could also be reporting Heimlich and Deaconess to oversight authorities in order to perhaps save lives of those being abused in Africa. Her failure to do so speaks volumes about her guilt.

Dr. Baratz and other experts have compared the Heimlich experiments to Nazi concentration camp experiments. Excuses for Wulsin from komarek and others who have posted on the Beacon fit neatly into the pattern of Nazi apologists and holocaust denial. Endless excuses are provided for Wulsin, who is held blameless despite overwhelming facts to the contrary.

Wulsin’s supporters don’t want to face the fact that their candidate is a failure. Successful epidemioloigists would have a strong university affiliation and publishing history. Wulsin has neither.

Wulsin drifted into politics, perhaps a last refuge. If nothing else, it’s an occupation (or pre-occupation in her case since elected office will likely elude her) which provides a reliable supply of gullible, desperate know-nothings who are willing to endlessly defend their candidate, even if her mediocre and ethically-challenged career falls many rungs short of a hastily constructed public image which puts Wulsin on the same shelf Albert Schweitzer, even if inconvenient facts put her below Dr. Phil.

komarek says:
22 Oct 2006  at  01:48 pm | #

Dean,

I really do not think I am sidestepping anything. A fair reading of the material on this blog - and a quick review of the youtube video—is that she has been telling the truth throughout this affair.

I know you do not agree with me.

You apparently would rather have her be more strident and critical of Dr. Heimlich. She’s not, but so what?

You say: “Wulsin could have taken action to prevent human experimentation, and it does not appear that she took any action whatsoever.” But she did take action - through her negative report.

I understand very clearly that we are having a persistent, stubborn disagreement over the interpretation of Dr. Wulsin’s remarks. But for me what is key about the whole controversy is that Dr. Wulsin did nothing that harmed a single patient. She wrote a report that was as critical as it needed to be, and which harmed no one. That’s the truth here.

--pk---

anon says:
22 Oct 2006  at  02:59 pm | #

komarak continues to dodge the questions he doesn’t want to answer, such as why Wulsin hasn’t reported the Heimlich Institute or Deaconess. Not suprising that one doesn’t register with komarek, who stiffed his clients and his vendors out of thousands of bucks, who then and now pleads mental illness as his all-purpose excuse.

The Ohio Supreme Court and Cincinnati Bar were unimpressed with his bullshit and kicked his ass out of the profession. He’s been banned from arguing the law where it counts, so now he spends his time bickering on the Beacon.

komarek also didn’t answer this one above:

Do you have a professional or personal relationship with her or any of her family?

Ever been a patient of Dr. Lawson Wulsin, Vic’s hubby the shrink?

komarek says:
22 Oct 2006  at  04:28 pm | #

Anon:

Do you have a professional or personal relationship with her or any of her family?

No.

--pk---

anonny says:
22 Oct 2006  at  06:46 pm | #

anon: Do you have a professional or personal relationship with her or any of her family?

komarek: No

Then go make an appointment with Wulsin’s husband.

Monica says:
30 Oct 2006  at  12:18 pm | #

I have a question? Why is this important? Dean, should we not vote for Dr. Wulsin? If that is the case then we also should not vote for Pepper? Please clarify!

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