A guest blog by Chris Douglas, 8th February 2012
After Judy Mikovits was dismissed by the WPI, I sought clarification from Annette Whittemore regarding the institute’s plans for the UK study so that I could decide whether or not to continue as a participant. It subsequently emerged that both my blood sample and consent form had been lost. Perhaps, predictably, the WPI blamed Dr Mikovits’ housekeeping and tried to ‘move me along’.
Let me state, at this point, that I really do not care whether Judy Mikovits, Annette Whittemore or the Easter Bunny personally lost my blood sample and consent form. What I care about is receiving a sincere apology and a credible explanation from the organisation (not an individual employee) responsible for the study I participated in.
At the risk of doing the work for the WPI, such a communication might go something like this.
Dear xxxx –
We are deeply sorry to have to inform you that we do not have your blood sample or consent form.
We have made inquiries with the phlebotomy company who drew your blood, the couriers who shipped the blood to the US and within the US, and another lab that handled the blood. We also contacted other participants who had their blood drawn on the same day as you.
Based on these findings, we believe that your blood and consent form [select option]:
(a) was not collected by the courier in the UK.
(b) was lost by the courier in international transit.
(c) was mislaid by the other US lab that received your blood.
(d) was lost in transit between the other US lab and the WPI.
(e) was lost at the WPI.
We take this matter most seriously and can assure you that the issue is being addressed with the greatest attention. We will notify you if, and when, further information comes available.
In the meantime, please find attached a blank consent form for you to sign and return. We have added a clause which refers to the lost blood sample and preceding consent form and which allows you to choose how both should be handled in the event that they are discovered (e.g. retained for study, destroyed, etc.).
We thank you for your patience and understanding in this matter and hope that you will continue to support the WPI in its future endeavours.
With kind regards,
Xxxx
Instead, after a four month email correspondence on the matter, the University of Nevada, Reno, Institutional Review Board stated simply:
“We are not at liberty to discuss with you any investigations that may have been undertaken by our office. I can assure you, however, that we take seriously the oversight of any research studies conducted on our campus that include human participants, including those conducted at WPI.
“Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either. We appreciate you contacting our office regarding this issue but we are unable to provide any further information to you.”
As a consequence, I have sent the following email to the US NIAID representatives who manage the R01 grant that funds the UK study (i.e. Dr Christopher Beisel and Dr Catherine Laughlin, Chief of the Virology Branch). I asked Khaly to publish this so that other participants of WPI studies are made aware of the issue. Thanks to her for doing so.
—– Original Message —–
From: xxxxx
Cc: catherine.laughlin@nih.gov
Sent: Tuesday, February 07, 2012 12:00 PM
Subject: R01 Grant Holder Loses Blood Sample and Consent Form
Confidential. Without Prejudice.
Dear Christopher
R01AI078234 Grant Holder Loses Blood Sample and Consent Form
I am a British participant in a research programme funded by NIH grant no. R01AI078234 (New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome). As you will be aware, this, initially, was awarded to the Whittemore Peterson Institute (WPI) at the University of Nevada, Reno (UNR), and its then Principal Investigator (PI), Dr Judy Mikovits.
In 2011, I had cause to consider whether or not to withdraw informed consent to this study and so entered into related correspondence with the WPI and the UNR’s Institutional Review Board (IRB). As a result, I discovered that the WPI had lost both my blood sample and consent form and either cannot, or will not, identify where these might be. Indeed, in the final correspondence from the UNR IRB, I was told that: “Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either.”
That the WPI has lost my blood and consent form is alarming enough but that both they, and the UNR IRB, repeatedly respond with ‘we can not help you’ is simply deplorable.
When I asked the UNR IRB if a formal investigation had taken place that would include, for example, contacting the phlebotomists who drew the blood in the UK, the courier who shipped the blood to the US, any other labs that may have had access to the blood, other participants whose blood was drawn on the same day, etc., I was told that: “We are not at liberty to discuss with you any investigations that may have been undertaken by our office.”
In effect, both the WPI and the UNR IRB have washed their hands of me and are not honouring the ethical and legal commitment of participant protection as stated on the consent form that I signed in good faith.
This attitude is particularly contemptuous given that, not only did travel to the blood draw harm my health but, as per many participants in this British study, I donated financially to the cost of the venue hire (a curious anomaly in light of the WPI’s million dollar funding from the US NIH and, perhaps, a breach of IRB ethics in itself).
I would appreciate any advice you can offer on how to progress this matter to a more satisfactory conclusion, viz to identify the precise whereabouts of my blood sample and consent form and/or the point between Devon, UK and UNR, US at which they were lost.
I also would appreciate advice on how to withdraw consent given that the WPI and UNR IRB deny I am, or ever have been, a participant in this study.
Finally, I wish to express concern that, following a recent NIH review, the WPI has been allowed to retain the R01 funds. Having been a previous supporter of the institute, it is with great regret that I now suggest this organisation is neither capable, nor responsible, enough to manage such a large US Government grant.
A responsible organisation would have investigated thoroughly the loss of my blood sample and consent form and presented me with a credible explanation. Instead, all the WPI and UNR IRB have said is that the previous PI may have held the documents and such issues will not occur “in the future”.
This is akin to a manufacturer refusing to investigate a product complaint because the Production Director no longer works for the company. The complaint, however, remains the responsibility of the manufacturer (not its ex-employee), just as the lost blood and consent form remain the responsibility of the research institute (not its ex-PI). If the WPI can not grasp this basic rule of good conduct, how can it be trusted with over $1m of US taxpayers’ research dollars? I find this situation even more worrying given the WPI President’s current involvement in civil embezzlement litigation.
In addition, my own experience should raise concerns about other participants’ blood samples and consent forms, particularly those drawn in the UK during the last two weeks of July 2010. Regardless of assurances about blood draws “in the future”, how many samples already may have been lost or misidentified without the WPI or participants yet knowing it?
Please note that this letter will be placed in the public domain so that other participants of the WPI’s studies are made aware of the issues that I have encountered. I consider it only fair that others should have access to these facts when considering their own continued participation in such research.
Yours sincerely,
xxxxx.
Sequence of Events
26th July 2010
My blood was drawn in Ashburton, Devon, UK, by Phlebotomy Services International (PSI), a US company working on behalf of the WPI. At this time, I signed a consent form of which I have a blank copy (not a signed copy as the venue was a small hotel and did not have copying facilities).
Blood was drawn from two other participants at this venue and from additional participants on the same day at a different venue. It is my understanding that all blood samples and consent forms from these draws were collected from PSI by FedEx (for shipment to the US) later that day.
17th October 2011
I emailed the WPI’s President, Annette Whittemore, to request clarification of the status of this research but received no response other than two acknowledgements from her daughter, Andrea, on 25th October and 1st November.
15th November 2011
In the absence of a response from the WPI, I emailed the UNR IRB to ask who held consent forms for the study and whether the holder has a legal obligation to provide copies to participants.
17th and 30th November 2011
The UNR IRB acknowledged receipt of my inquiry, the latter email stating that the WPI was reviewing my request for a copy of my consent form.
16th and 22nd November 2011
I emailed Kellen Jones-Monick, the WPI’s Office Manager, to request clarification of the study’s status and, also, who holds participants’ consent forms.
22nd November 2011
Kellen confirmed that the WPI holds the consent forms and that she could provide copies upon request.
I requested a copy of my consent form from Kellen (request sent again on 27th November 2011).
5th December 2011
Kellen confirmed that both my blood sample and consent form had been lost.
“After carefully reviewing our study records, I was unable to find a consent for you. I also checked with the lab to determine whether or not we have your blood sample and it appears we never received one. Therefore, according to our records you are not enrolled in the R01.”
6th December 2011
I replied to Kellen with questions concerning the feasibility and ethics of identifying blood samples in the lab and forwarded the correspondence, without prejudice, to Nancy Moody, Director, Office Human Research Protection, at the UNR IRB.
15th December 2011
I prompted Kellen for a reply to my questions and she confirmed that it was not a breach of ethics for her to identify coded blood samples in the lab.
16th December 2011
I requested further clarification of Kellen’s reply and restated that I wanted to know the whereabouts of my blood and consent form.
20th December 2011
Kellen confirmed that “It is not a breach for me to access the master code and verify it against coded samples in the lab” and that “We have a meeting scheduled with an IRB representative at the end of the month regarding this matter.”
I replied to ask whether ‘this matter’ referred specifically to my case and, also, to clarify the identity of an unknown email recipient who had been copied on our correspondence without my permission.
Kellen’s response to the first query was a non-committal: “We communicate with the IRB regularly in regards to every matter concerning human subjects.” To the second query: “…Carli, our VP and legal representative.”
22nd December 2011
I asked Kellen why the WPI’s legal representative had been copied on the correspondence and without my permission.
23rd December 2011
Kellen confirmed that “Carli is in charge of compliance issues and is in continuous communication with the IRB.”
27th January 2012
I emailed Nancy Moody at the UNR IRB to ask if there had been any progress regarding my lost blood sample and consent form.
Nancy confirmed that Michelle Johnson of the UNR IRB completed a review and: “There is no blood specimen or informed consent document found in the study documentation regarding your enrollment in the study. The previous Investigator is no longer with WPI. It is unknown what the Investigator did with documentation if she was in receipt of it. Carli West Kinne of WPI has informed you of no record of your participation in this study, also. IRB has concluded our review of the study team and documents. Administrative procedures are in place to mitigate from such poor study record keeping in the future.”
I replied that I had not been contacted by Carli or anyone else at the WPI since 23rd December. I stated that I did not accept the WPI attributing the loss of my blood sample and consent form solely to the previous PI and so absolving itself of all responsibility. I asked if a formal investigation had included the phlebotomists, international courier, any other lab involved, other participants, etc.
Michelle Johnson replied that:
“We are not at liberty to discuss with you any investigations that may have been undertaken by our office. I can assure you, however, that we take seriously the oversight of any research studies conducted on our campus that include human participants, including those conducted at WPI.
“Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either. We appreciate you contacting our office regarding this issue but we are unable to provide any further information to you.”
CFS Untied
It is clear from WPI’s cavalier attitude and lack of concern about the ethics involved in this incident that they have no business receiving our tax money.
Patricia Carter
I’m puzzled that you don’t seem to allow the fault to be with the Phlebotomy service. Is it definitively the case that PSI was directly contracted by WPI ? Or was the PSI contract with IiME ? I know this has been discussed previously on this blog http://cfsuntied.com/blog2/2011/11/30/and-the-real-funder-of-the-wpis-uk-study-is/ but is it not the case that IiME paid for the Phlebotomy part of the study – and this is what is referred to in the IiME annual financial statement: “In discussions with WPI Invest in ME agreed to help fund this research.” ? and the sum of £2,168 listed as donations out of restricted funds (funds which are collected for a specified purpose) is the amount paid toward blood collection and shipping ?
The answers to these questions don’t absolve the WPI of responsibility, but it does open up the possibility that the explanation is one of poor communication between partner groups, rather than simple negligence. There should have been a clear failsafe protocol in place, that ensured the WPI laboratory confirmed in writing the receipt of samples to each donor, and that this protocol was made clear to donors before or at the time of donation.
The shipping of samples across national boundaries entails a numer of difficulties – not least that different advisory and legal regimes will apply in the donor country from that of the recipient country – very particular care should have been taken where this applied. It would be good to hear IiME’s take on this issue.
IVI
Phlebotomy Services International was engaged directly by the WPI, as per the terms of the UNR IRB study approval. With respect to IiME, previous posts on this blog indicate that they contributed to the cost of blood draws for the first 50 participants only. This happened in March 2010 whereas the case above refers to blood drawn in July 2010.
As IVI wrote: Anybody involved at that chain could be at fault.
What I wonder: If the fault lies at the WPI, shouldn’t the head of research not be the first person who’d have to answer questions?
And more interesting would be these questions: Was only this blood sample and consent form lost? Or more? Did actually any samples and consent forms from the UK for that study end up at WPI? Could Kellen produce these consent forms, if others asked for theirs?
Your not on your own, my husband is still waiting for a reply to emails asking where his blood is, he was second draw. Disgusting really.
Surely WPI would have had to sign the mail receipt for these samples; could, or have you asked that company to produce the signed receipt?
If, by ‘that company’, you mean the courier, participants do not have a contract with this firm and so have no legal right to request signed receipts from them. Either the WPI and/or PSI would be in a position to request such receipts and the former seems unwilling to do this themselves or to ask the latter about it. The UNR IRB’s reply to this line of questioning was: “We are not at liberty to discuss with you any investigations that may have been undertaken by our office.” Note, also, that a signed receipt would be for a box of samples rather than individual ones.
Is it coincidence, just after posting on this blog I get an email?
———————–
Dear Helen,
Thank you for your email. It has recently been brought to my attention that you have never received a response, and I sincerely apologize for the delay.
According to our Institutional Review Board protocol, we are not permitted to provide results for the research tests performed on a participant’s sample.
Best Regards,
Kellen Jones-Monick
Study Coordinator
The Whittemore Peterson Institute
University of Nevada Reno ▪ MS 0552
1664 North Virginia Street ▪ Reno, Nevada 89557
Phone (775) 682-8250 ▪ Fax (775) 682-8258
http://www.wpinstitute.org
Perhaps not a coincidence given that the Reno ISP was one of the first to access the blog.
The WPI’s reply indicates that the IRB has changed the protocol so that participants, now, will not be given the results of research tests. With respect to the UK study, participants were told at the start that they would receive results (indeed, the first 50 already have theirs). This raises two questions. Firstly, is it legally and/or ethically acceptable to change the terms of participation retrospectively and for only a proportion of participants? Secondly, what other changes have been made to the scope of the UK study without participants being notified (e.g. the purpose, type and duration of research) and do the original consent forms cover such amendments?
The original consent form states: “If the researchers change the study design or use of the data, you will be told about the changes and asked to give your assent again. You will be told of any new important information that may change your mind about staying in the study.”
This commitment has not been honoured by the WPI and, as such, I would suggest that it is in breach of the original assent document.
Is it a coincidence that the first 50 to have received their results were those whose cost was met by IiME Chris? Could there have been a separate arrangement for them do you think?
Although it is evident that the first 50 samples were handled differently to those drawn in July, it is difficult to judge the degree to which IiME’s involvement in the former may have played a role. The charity’s withdrawal of funding after the first 50 samples may have contributed to financial issues for the remainder of the draws but it is questionable whether this would have had any bearing on the communication of results to patients.
The IRB protocol applied (should still apply) to all participants, regardless of when their blood was drawn, and it would be highly irregular for this to allow a minor, third party funder to stipulate study conditions in return for its small donation.
It is more likely that ‘something(s)’ went wrong after the first 50 samples were drawn and tested (which may have led to IiME getting cold feet) and that this underpins the various issues experienced by UK study participants. Enough information continues to be released into the public domain to be able to guess at what that ‘something(s)’ might be.
It therefore begs the questions
just how many UK blood samples were actually received by the WPI? (surely that information is available and can be correlated to the number drawn in July)
can we be sure that any subsequent individual results are accurate for that person?
Can we be certain that our own actual sample is correctly removed if we request it to be?
Was there ever any intention to provide us with individual results?
All good questions although (2), now, is made irrelevant by the WPI’s statement to Helen that participants will not receive individual results. With respect to (4), a precedent was set in providing the first 50 UK study participants with their results and, so, one would assume that there was an intention, at some time, to do the same for the remainder. With respect to (3), this would depend upon the WPI’s ability to identify a participant’s sample correctly and also the controls they and the UNR IRB have in place for removal and destruction. I am sure that many participants would be interested to see such a protocol. With respect to (1), this would involve the WPI co-operating with both Dr Mikovits and PSI, an action which seems unlikely given the recent breakdown in relationship between the parties.
Chris,
Thank you for clarifying those points. Very helpful.
Whatever their past failures the WPI should now conduct a full audit of samples recieved via the PSI contract and match that to the PSI rendered account. It should be entirely clear that if PSI have billed for x number of bloods, and WPI has received less than that – then PSI has failed. If the WPI signed in the right number, then either they have the right number in store, or they don’t. If they have the right number then there’s been a screw up in processing (i.e PSI didn’t account for all samples but still provided the contracted number), and if WPI don’t have the right number, they’ve lost samples. This really shouldn’t take more than few hours to resolve and should be an essential action given that security of samples has been questioned.
All the documentation to allow the audit should be onfile, and if it is not, that is in itself a serious failing. The WPI has a serious credibility gap and it should be doing everything it can to address that, if that means owning up to administrative failures, that is better done now than leaving lingering doubt. The newly confirmed principle investigator at WPI should be leading on this.
This blog’s entry for 24th October 2011 states: “It soon transpired, however, that PSI was not charging for its team’s services and that many of the associated expenses were being supported financially by patients.”
http://cfsuntied.com/blog2/2011/10/24/the-wpi-and-iime-uk-study-will-the-real-funders-please-stand-up-guest-blog-by-deckkhardt/
This raises the question: what type of contract did PSI have with the WPI and would it allow the matching exercise you suggest?
This blog’s entry for 30th November 2011 states:
“…the WPI decided to continue the blood draws, even in the absence of funding from either IiME or the NIAID. Instead, the cost was covered by UK and US donors and by Phlebotomy Services International performing the blood draws without charge.
“It is still unknown, however, who funded the drawing and shipment of 50 control samples provided by Jonathan Kerr.”
http://cfsuntied.com/blog2/2011/11/30/and-the-real-funder-of-the-wpis-uk-study-is/
This raises the question: why were patients financially supporting the UK study when the WPI was receiving ~$300k pa from NIAID to fund such research? And was this not a breach of IRB protocol?
so we are not even going to get our results now either . All the while im getting sicker and sicker , I needed my result , my gp wanted to know my result despite all the controversy surrounding xmrv . He also wanted to know what else showed up in my blood seeing as my blood results are all over the place . All the money I have sent to WPI tbh I feel totally conned and violated now . No doubt if I enquired about mine mine will have miraculously vanished too . Im too sick to persue this right now and end up on a merry go round of emails with WPI but I hope they read this . This is also one of the resons folk have stopped donating WPI beacause of the way you keep handling things and the way you have treated patients since everything blew up in September . you cannot treat people like this and still expect us to donate money !!!!
“According to our Institutional Review Board protocol, we are not permitted to provide results for the research tests performed on a participant’s sample.”
Does that sound like bullshit or what? How about the “policy” being published? And exactly who are the “policy” makers?
I do not recall that being part of the deal, the deal was, I recall, that the patients had the option of knowing. So they can’t find it, now they can’t talk about it, as if they now “found” the sample? “Lucy, you got some ‘splainin’ to do!”
IMHO.
From the UNR IRB [9th Feb 2012]: “The IRB process and Investigator protocols as well as grant information is confidential.”
Chris wrote “This raises the question: what type of contract did PSI have with the WPI and would it allow the matching exercise you suggest?
I had previously read these details about the chaotic sample collection process, and to be honest I thought what was being described was a number of isolated incidents being confused in a number different reports. I’m not impugning anyone, I just couldn’t believe the process was that mad, and that’s against my already profound scepticism about the WPI.
If there was no consistent contractual arrangement – i.e if WPI didn’t actually know what samples it was to receive, then indeed the audit that I suggested would not be possible, there would be no master list to back check from. And why there should be any payment problems for WPI in 2010 is inexplicable – they had income of several million dollars passing through their accounts 2009 – 2011 and a hundred or so bloods should have been a minor budgetary issue. I can see why it might have been a fundraising focus, but the availability of funds should not have been an issue.
If the bloods collection was as described, with the Kerr samples being a further complication (what was the collection contract arrangement there ?) then I would see little hope of the IRB being of any assistance. My suggestion would be for UK residents concerned about the process of collecting the UK bloods, to contact the UK Human Tissue Authority http://www.hta.gov.uk/ and ask their advice. I believe that PSI would be required to have a licence from the HTA in respect of the export of human tissue, it maybe therefore that the HTA would be ablet o fully establish PSI’s precise role, and also perhaps given the obvious failures involved, explore with the Nevada IRB, further possiblities of establishing what actually happened. Also the HTA would definitely be able to investigate any question regarding the Kerr samples if they were taken via Kerr’s then University.
Although the UK sample donors seem to have a clear contractual arrangement with WPI, as there is no way to force compliance without going to Court (and even then perhaps no means to ensure that named samples are destroyed) having the HTA investigate may actually be the only non costly way of of gaining influence with the Nevada IRB, and possibly actually getting donor rights exercised.
IVI
This is outside of the HTA’s remit. The Authority only covers storage of research materials on licensed premises within the UK. In fact, there seems to be very little (if any) cross boundary oversight in such matters. Caveat donator.
http://www.change.org/petitions/investigate-possible-wpiunr-misuse-of-taxpayer-funds
Petition to Investigate Possible WPI/UNR Misuse of Taxpayer Funds
This Petition is sponsored by the International M.E. Association.
Petition to Investigate Possible Misuse of Taxpayer Funds by the Whittemore Peterson Insitute/University of Nevada, Reno
WHEREAS, taxpayer funds have been awarded to the Whittemore Peterson Institute/
University of Nevada, Reno (WPI/UNR); and
WHEREAS, the Founder and CEO of theWPI/UNR, Annette Whittemore, is being investigated
by the Federal Bureau of Investigation (FBI) for financial misdeeds; and
WHEREAS, many people who suffer from Myalgic Encephalomyelitis (M.E.) and other US taxpayers and other interested individuals are concerned that their taxpayer funds may be misused by this Institute; and
WHEREAS, WPI/UNR has already received taxpayer funds since firing their scientist competent to serve as Principle Investigator for a grant, for which funds no public accounting has been given; and
WHEREAS, Founder and CEO Annette Whittemore and all other employees of the WPI/UNR have refused to answer any taxpayer questions as to the whereabouts and uses to which said taxpayer funds have been and are being spent
WE, United States taxpayers and other concerned individuals, hereby request the
National Institute of Allergy and Infectious Diseases and
Matthew J Fenton, Ph.D.; Acting Director; Asthma, Allergy and Inflammation Branch, NIAID;
and
the United States Congress to
INVESTIGATE THE POSSIBLE MISUSE OF UNITED STATES TAXPAYER FUNDS
by Annette Whittemore, Founder and CEO of the WPI/UNR, including all taxpayer funds received by the WPI /UNR after the firing of its only scientist competent to serve as a Principle Investigator, Dr. Judy Mikovits, on Sept. 29, 2011, for attempting to prevent misappropriation of funds under NIH/NIAID grant project number 5R01AI078234-03: “New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome.”
.
This investigation must include those funds allocated to NIH/NIAID grant project number 5R01AI078234-03: “New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome” .
This investigation must include, but is not limited to, all funds received from the U.S. government which were used by WPI and/or the University of Nevada, Reno, for the purchase of scientific equipment.
FURTHER, WE, United States taxpayers and other concerned individuals, hereby request the
National Institute of Allergy and Infectious Diseases and
Matthew J Fenton, Ph.D.; Acting Director; Asthma, Allergy and Inflammation Branch, NIAID; and
the United States Congress to
THOROUGHLY INVESTIGATE THE APPOINTMENT OF VINCE LOMBARDI AS PRINCIPLE INVESTIGATOR (PI) OF THIS GRANT
including but not limited to Dr. Lombardi’s education, experience and skill in biomedical research. and Dr. Lombardi’s conflict of interest as a co-owner of VIP Dx commercial laboratory. In addition, we ask that every instance of Dr. Lombardi’s contribution to to NIH/NIAID grant project number 5R01AI078234-03: “New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome” be investigated and proof of such contribution be given to us in public including any notes from each and every experiment in which he participated, in addition to every page of any notebooks of Dr. Lombardi which refer to any experiments performed pursuant to the referenced grant.
AND
WE THE UNDERSIGNED US taxpayers and other interested individuals, hereby request
National Institute of Allergy and Infectious Diseases and
Matthew J Fenton, Ph.D.; Acting Director; Asthma, Allergy and Inflammation Branch, NIAID; and
the United States Congress to
DELAY THE DISBURSEMENT OF ANY FURTHER TAXPAYER FUNDS to WPI/UNR UNTIL THE REQUESTED INVESTIGATIONS ARE COMPLETED AND THE RESULTS OF SUCH INVESTIGATIONS MADE PUBLIC.