CASE CLOSED … what really happened in the 2001 anthrax attacks?

* In a rabbit protocol provided by USAMRIID today, there is familiar discussion of drugs to be administered to the rabbits – for the Sept/Oct 2001 period, is there a contemporaneous log relating to the administration of drugs such as there is in a hospital?

Posted by Lew Weinstein on November 15, 2011

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8 Responses to “* In a rabbit protocol provided by USAMRIID today, there is familiar discussion of drugs to be administered to the rabbits – for the Sept/Oct 2001 period, is there a contemporaneous log relating to the administration of drugs such as there is in a hospital?”

  1. DXer said

    I believe Euthasol is a Schedule III due to pentobarbital/phenytoin mix.

    I believe under the regulations for Controlled Substance Usage Records, the registrant for each registered location must maintain complete, current, and accurate usage and administration records if controlled substances are stored, delivered, or administered at that location.

    I believe Title 21 CFR, Section 1304.22: Records for manufacturers, distributors, dispensers, researchers, importers and exporters is the controlling regulation.

    Usage and administration records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the registrant. The use of the word “shall” is mandatory.

    Usage and administration records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

    All usage and administration records must be maintained for at least 2 years from the date of such records and be readily retrievable for immediate inspection and copying by authorized employees of the DEA. Five years is recommended for record retention.

    Here, however, with Dr. Ivins having the largest repository of Ames in the world, records relating to activities in the B3 at Building 1425 counseled preservation of the records. Indeed, didn’t the FBI obtain those documents during the legal 2 year retention period? The hot suite was used regularly for small animal experiments and so the dispensation of the controlled substance were an excellent source of information on the use of the lab.

    Under the regulation, readily retrievable means that certain records are kept in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

    All usage and administration records must be stored in a secure location at the registered site preferably locked in a cabinet or safe.

    In other words, the registrant should not ever be in the position of arguing that they keep the records but cannot find them.

    Under Usage Records, controlled substances must be tracked from acquisition to administration (to a research subject or usage in an in-vitro or chemical process) or disposal.

    It is recommended to keep all usage and administration records in standard binders (Schedule I and II records separated from Schedule III-V records) and to securely store the binders in a locked cabinet or drawer.

    A separate usage form should be used for each unique vial or container

    The following logs can be utilized to assist in tracking:

    • Multiple Dose Usage Log
    • Combination Solution Usage Log
    • Diluted Drug Solution Log
    • Chemical or Powder Usage Log

    Registrants may develop their own forms or logs to document administration or usage provided a controlled substance can be tracked from acquisition to research subject, experimental endpoint, transfer, or disposal.

    Compounded solutions containing a controlled substance prepared within the laboratory should be labeled with the following:

    • Name of the controlled substance(s)
    • Lot number(s)
    • Date vial opened or prepared
    • Final concentration(s) and amount(s) per container
    • <7 day expiration date, unless product stability data suggests otherwise
    Routine Auditing of Controlled Substances Records

    • Registrants or authorized agents are encouraged to perform weekly to monthly audits of their controlled substance inventory to accurately track inventory and avoid discrepancies.
    • One authorized agent and an authorized agent witness must complete the inventory audit.
    • At the conclusion of the audit, the authorized agent shall document the date, their initials, and a statement indicating the records to be accurate or reason for discrepancy.
    • Registrants must review records that fail to reconcile in an attempt to identify recording errors or missing transactions. Inventory discrepancies are generally due to:
    • Mathematical errors
    • Non-recorded administration or dispensing transactions
    • Errors in receiving and general inventory updates
    • Refer to the Controlled Substances Theft or Loss page for unaccountable inaccuracies.

    • DXer said

      AUSA Lieber in her Amerithrax investigative summary writes:

      “It bears mention that during the first five days of this second phase, Dr. Ivins did make notations regarding the health of some mice involved in a study being conducted by another colleague – thus justifying his presence in the lab for a short time on each of those days (Friday, September 28 through Tuesday, October 2). However, the first three of those days, he was in the hot suites for well over an hour, far longer than necessary to check to see if any mice were dead.”

      She does not cite any authority. Mara Linscott, the lab technician who worked with Dr. Ivins (before leaving USAMRIID), in contrast says it was a one -person job that would take a couple of hours. (DOJ and Mrs. Stevens have agreed to shred Mara’s deposition so her deposition testimony is not available and we only have her statement to the FBI). How long would it take the AUSA to assess whether an animal moribund and if so, administer Euthasol to the affected animals?

      She certainly was racing to tell Dr. Ivins that she wanted to put a needle in his arm.

      For starters, let’s obtain a copy of the passive mouse protocol and obtain the DEA Controlled Substances log so as to see whether his “BI” initials confirm the administration of the Category III narcotic.

  2. DXer said

    The multi-tasking Ms. Rogers at USAMRIID FOIA is also inquiring as to whether there is a log that records the date and time of the use of drugs used to make the moribund and animals comfortable and to euthanize them. Nowadays in hospitals they even have scanners that indicate both the date and time (and the person). The time of administration of the drugs could provide further confirmation when Dr. Ivins was pushing the syringe into the rabbit — especially given that the cards attached to the cages were thrown out. (According to Dr. Ivins in an email, they were thrown out by the animal technician). The drugs are named in the protocol for the rabbit formaldehyde study attached to the July 16, 2001 email.

  3. DXer said

    This protocol (from 2000, I think) only contemplated 2X’s check.

  4. DXer said

    Among those as unfamiliar with the documents as Ed, there is huge confusion understanding charting of hours.

    There was a shfft to subcutaneous challenges — and those could be done in Building 1425 B3 instead of in 1412. And that is on what investigator Montooh and prosecution Lieber rely.

    And Ivins colleagues went from 2Xs checks to 3Xs — resulting in what we’ll call the night shift. See protocols.

    Relatedly, the issue of decontamination debacle and implementation of the 2 person rule at USAMRIID prevented them altogether.

    It is breathtaking that no matter how many documents explain — or people tell Ed the blogger — that the animal studies were done in B3, he is still in denial. He is what he calls a True Believer.

    One need only realize lay out the actual animal studies and read the protocols to understand why Dr. Ivins would be where and when.

    If he had half a brain, he would say that his time was explained, but that seized the opportunity to multi-task and use the scheduled B3 time as “cover.”

    Moreover, he would have realized that Dr. Ivins did not need to grow any anthrax because a large amount of Ames made by Dr. Ivins’ assistants is missing.

    Isn’t that why the depositions are being sealed?

    Bruce gave it to the DARPA researchers. see email expressing alarm to superior that his records wouldn’t square up – with him being told to shut up … that everything was ‘under control”.

    GAO: who told Dr. Ivins that everything was “under control”.

    • DXer said

      Lew is in transit and so there may be a delay but you’ll see in the original version of the rabbit protocol involving formaldehyde and 52 rabbits — produced today by USAMRIID — that it contemplated the standard 2Xs daily check.

      The unredacted version explains that it was done in Biolevel-3 conditions.

      • DXer said

        Under the protocol, Dr. Ivins was to observe the rabbits daily for illness or debilitation for 7 days after challenge. That is exactly what the B3 access records reflect he did.

        The original protocol — as do later protocols — provides” “while the animals are housed in biocontainment suite and replaced with clean cages when they can no longer be satisfactorily sanitized or when deemed necessary by the animal caretaker…”

        The protocol explains: “Dr. Bruce Ivins, PhD, has had 28 years of experience in biomedical research, including 18 years of research on anthrax. Dr. Ivins has had research experience with several animal species, including mice, rats, guinea pigs, hamster and rabbits. Dr. Ivins willl help immunize and challenging and euthanizing the rabbits, with which he has had over 6 years of experience. He has been specifically trained by Veterinary Medicine Division personnel in delivering injections to rabbits. Dr. Ivins will also help monitor the animals after challenge.”

        Under biohazard, it states “Animals will be challenged by the s.c. route under conditions of ____ level biocontainment. All procedures involving the infectious Ames strain will be accomplished by personnel immunized with AVA.”

        As I mentioned, the first protocol to be uploaded contemplated only 2X’s daily checks with Dr. Ivins checking in the afternoon — the revised protocol contemplated 3Xs.and required that he work at night.

        Now compare what is provided under the rabbit protocol and ask yourself: Why did the word “rabbits” never even pass Ed Montooth’s or Rachel Lieber’s lips?

        Why did they falsely claim that he had no reason to be in the lab on those nights? GAO and maybe a Special Prosecutor need to investigate.

        The revised protocol — which will be forthcoming — switched to 3X’s daily checks which resulted in the spike of night hours.

        • Anonymous said

          “Why did they falsely claim that he had no reason to be in the lab on those nights? GAO and maybe a Special Prosecutor need to investigate.

          The revised protocol — which will be forthcoming — switched to 3X’s daily checks which resulted in the spike of night hours.”

          Excellent observation. This change to 3X daily is very, very important. The false accusations border on being criminal. Now the cover up is worse than the crime.

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