Glibertarians.com 2019 Archive

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  • Chapter 10 – The Anthrax Vaccine Fails, Is Awarded Zero Points… and you’ll still have to roll up your sleeve!

    The manufacturing process for Anthrax Vaccine is not validated.[i]

    The anthrax vaccine’s manufacturer has had an interesting ownership history, beginning in 1968 as the Michigan Department of Public Health (MDPH), a public entity that manufactured the earliest vaccine through 1997, when it spun off its ‘biologics’ division into a for-profit entity, the Michigan Biologic Products Institute (MBPI), BioPort, Inc. quickly bought MBPI in 1998. While management and ownership structure changed, one thing has remained remarkably consistent: how badly the vaccine has been manufactured from when it first began being inspected. BioPort/MBPI/MDPH has continued to violate the regulations governing the manufacture of the vaccine and current Good Manufacturing Practices (cGMP) for as long as it has records of inspections. The regulations regarding the manufacture of biologic products is fairly tedious, but the underlying philosophy can best be summarized by the first pull-quote above: the manufacturing process for the anthrax vaccine is not validated.

    Because Anthrax Vaccine Adsorbed (AVA) is a biologic product designed for human consumption, it is controlled by very stringent requirements. A GAO report pointed this out and explained the necessity for it:

    The inspection process for ensuring vaccine safety is more stringent and complex than for chemical drug because vaccines have three distinguishing features. First, either they have no clearly chemically defined composition, or chemical analysis is extremely difficult. Second, proper evaluation of vaccines generally requires measuring their effects in animals. Finally, quality cannot be guaranteed from final tests on random samples but only from a combination of in-process tests, end-product tests, and strict controls of the entire manufacturing process.[ii]

    Biologic products are regulated by the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FDCA). 42 U.S. Code §262 describes the regulation of biologic products according to the PHS Act. Chapter 9 of Title 21 of the U.S. Code contains the FDCA.

    The FDCA provides the following definition of an adulterated drug:

    A drug shall be deemed to adulterated (a)(1) (A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.[iii]

    Thus, in sum, a drug is adulterated if it is either (a) made under “insanitary conditions” or, (b) if the manufacturer does not comport with current Good Manufacturing Practices (cGMPs). The Code of Federal Regulations, specifically 21 C.F.R. §600 and following, sets forth the current Good Manufacturing Practices for Biologic products. 21 C.F.R. §601.12 reads, in part:

    (a) General. As provided by this section, an applicant shall inform Food and Drug Administration (FDA) about each change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling, established in the approved license. Before distributing a product made using a change, an applicant shall demonstrate through appropriate validation and/or other clinical and/or non-clinical laboratory studies, the lack of adverse effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.

    (b) Changes requiring supplemental submission and approval prior to distribution of the product made using the change (major changes). (1) A supplement shall be submitted for any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety and effectiveness of the product. (2) These changes include but are not limited to: (i) Changes in the qualitative or quantitative formulation or other specifications as provided in the approved application or in the regulations; (vi) Changes which may affect product sterility assurance, such as changes in product or component sterilization method(s), or an addition, deletion or substitution of steps in a aseptic processing operation.

    Until a 1988 contract with the DoD, the production of Anthrax Vaccine Adsorbed (AVA) was infrequent, a batch being produced every three to four years, with the largest being 7500 doses. MDPH had one production line for AVA that they alternately used for other vaccine products. The 1988 contract with DoD called for a drastic increase in the amount of production of the anthrax vaccine: 300,000 doses over a five-year period. The only possible way to meet the requirements of the DoD contract was to increase the production facility itself. One production line would simply not meet the demands of that new contract.

    The first production line, and only one licensed by the FDA, was built around a 100-liter sintered glass-lined fermenter, where the anthrax bacteria was cultured and grown. In 1990, two new stainless-steel fermenters were added to grow the bacteria. In 1991, the original, licensed glass-lined fermenter was removed and two more new stainless-steel fermenters were added, bringing the number of production lines to four.

    None of the new fermentors were approved by the FDA prior to being installed and beginning to produce the anthrax vaccine. This was not news to anyone; MDPH was aware of the need for prior FDA approval. Documents show that Dr. Robert Myers, the Responsible Head of MDPH, was well-briefed in the FDA requirements for amending the Establishment License Agreement (ELA). Dr. Myers notified the Center for Biologics Evaluation and Research (CBER) in June 1990 that BioPort would replace the approved fermenter and chill tank on or about 15 August 1990 with a new fermenter. A 9 July 1990 Conversation Record by FDA employee Rebecca Devine to Dr. Myers indicates that he was informed that this would be considered a major change and should be submitted in the form of an ELA amendment. An FDA official also communicated to Dr. Myers that the new equipment was considered a “major change” to the facility’s Establishment License Agreement (ELA) in December 1990.[iv]

    MDPH applied for the necessary amendment to the ELA in December 1990 for the first two new fermenters installed in that same year.[v] This ELA amendment request indicates, however, that the renovation had already taken place. Additionally, the two production lines added in 1990 consisted of stainless-steel fermenters, stainless-steel chill tanks, and low-protein-binding nylon membrane filters, while the production line in the original ELA consisted of glass-lined fermenters, a glass-lined chill tank, and sintered-glass filters. The 1990 ELA amendment request, while indicating that stainless-steel equipment was being used, failed to identify this as a change in equipment type for the additional production lines. As a result, the FDA was unaware of the substantial likelihood of the amendment request to have an adverse effect on the “identity, strength, quality, purity, or potency of the product as they may relate to the safety and effectiveness of the product.” Finally, the FDA did not approve these fermenters in 1993.[vi] No amendment was ever sought for the subsequent two stainless steel fermenters, nor was there ever an amendment made to the Product License Amendment for this change in how the cultured bacteria was being grown.

    More troubling is that a July 1990 Trip Report to the Michigan facility by a member of the U.S. Army Medical Research and Development Command (USAMRD) indicates that at least one 100-liter fermenter had been added to the AVA production line and that a recently delivered 100-liter fermenter could be diverted from production of another vaccine to the AVA production line. A September 1990 Trip Report to the Michigan facility discusses the necessity and the ability to put the recently acquired additional fermenter into AVA production. Also discussed is the total number of fermenters that the facility could hold, i.e. three additional fermenters for a total of four fermenters producing AVA. This Trip Report also indicates that FDA must approve the change in fermenter types from glass-lined to stainless steel and that FDA approval will require developing the definitive data that the product from the stainless steel fermenters is the same as the glass-lined fermenters.

    It also bears noting that each of the production lines did not produce individual lots of the vaccine. After 1990, while the old (licensed) line was running, alongside the  two new stainless-steel lines, each production line’s output was stored as a sublot and then combined for shipment to form what was labeled as the “final anthrax vaccine” lot (FAV-001, FAV-002, etc.). The stainless steel sublots supposedly produced a more potent vaccine. As a result, MDPH delivered a least one dose of AVA to DoD that was produced after the major manufacturing change had occurred and before the ELA amendment was approved.

    As if all of the above-listed, unapproved changes were not enough, MDPH changed the type of filter used in the manufacturing process. This filter is the only part of the manufacturing process that purifies the vaccine. There were no amendments sought to either the ELA or the PLA. This means that all of the anthrax vaccine produced from these lines was and is, by definition, adulterated. Every dose delivered since the 1990 manufacturing change has occurred without an ELA amendment for the change in filter type. Lest this appear to be scientific or legal quibbling, when the FDA conducted inspections through 1995, this specific filter would fail inspection.

    The FDA inspectors conducted numerous inspections of the anthrax production facility over some 7 or 8 years. During this time, the inspectors would cite repeated and serious problems with the manufacturing process. Below is a bulleted list of some of the major findings.

    1988.[vii]

    • “There is no written procedure for assessing stability characteristics of final biological products.”
    • “No direct physical accountability for packaged undated anthrax vaccine which was stored alongside of packaged and dated vaccine with the same lot number. Nine hundred and six vials of unfinished vaccine were distributed freely in 3 cardboard boxes with unknown number of vials in each carton. Removal of vials as needed was not indicated.”

    1990.[viii]

    • “Anthrax prod. fac. was observed to be in a state of general disrepair in that there was: (A) Paint peeling from the walls (B) Exposed light fixtures (C) Cracked ceiling (D) Exposed raceways (E) Dirt & filth & dust on overhead pipes (F) Cluttered work space.”
    • “Anthrax prod. records are inconsistent in that procedures used to formulate Lot #21 are different from those used to formulate Lots #25, 26 & 27 in that media is autoclaved for sterilization for Lot #21 and filtered for sterilization for Lots #25, 26 & 27.”

    1992.[ix]

    • “Changes in the manufacturing methods for…were not submitted as amendments to the product license application prior to releasing the material for distribution…”
    • “No SOP [standard operating procedure] exists to describe procedures for handling potentially infectious material…”

    1993.[x]

    • “There are insufficient personnel to assure compliance with current GMP regulations, e.g., failure to report changes in manufacturing, failure to maintain calibration records adequately, failure to adequately validate equipment used in the formulation or testing of product.”

    1994.[xi]

    • “There are insufficient personnel to assure compliance with current GMP regulations, e.g., failure to maintain calibration records adequately, failure to maintain environmental controls adequately in that production area temperatures were above 80°F, and failure to submit changes to CBER.”
    • “There is no annual review of production batch records [anthrax].”
    • “Raw material [anthrax vaccine materials] stored in an unapproved warehouse, building (redacted) i.e., no ELA [establishment license application] supplement has been submitted for this area.”

    1995.[xii]

    • “the company did not inform FDA of the procedural and equipment change during the production of…”
    • “facilities and equipment were not adequate.”
    • “SOP’s did not exist for many procedures.”
    • “SOP’s were incomplete or incorrect.”
    • “SOP’s were not adhered to.”
    • “Frequent contamination during vaccine manufacturing was documented but not investigated.”

    Finally, on June 22, 1995, the CBER Inspection Task Force recommended the issuance of a Warning Letter to MDPH. Another Warning Letter was issued to MDPH on 31 August 1995. Subsequent inspections found that the warning had no effect on the quality of the product being produced.

    1996.[xiii]

    • “The firm had not completed cleaning validation studies for routine cleaning procedures on multi-use equipment.”
    • “Validation studies to demonstrate microbial retention and compatibility have not been conducted for sterilizing filters…”
    • “There was condensate dripping onto open (redacted) tanks…”
    • “There was no procedure for clean-up of live rabies virus spills…”
    • The anthrax production facility was not inspected because “it comes under military inspection.”[xiv]

    In 1997, after some ten years of continuous violations of CGMPs, CBER issued a “Notice of Intent to Revoke” the license of MBPI.[xv] The Army responded by sending in a team to assist the manufacturer develop a “strategic compliance plan.” In January 1998, anticipating another inspection by the FDA, MBPI decided to “voluntarily” shut down its production.[xvi] An FDA inspection in February returned a report which concluded:

    “The manufacturing process for Anthrax Vaccine is not validated.”

    The report also noted that “[t]here are no written procedures, including specifications, for the examination, rejection, and disposition of Anthrax and Rabies.”  And, finally, what should have been reported seven years earlier: “Prior to August 1997, the (redacted) filters used for harvest of Anthrax vaccine were neither validated nor integrity tested. This filter is the only sterile filtration step in the Anthrax manufacturing process.” An inspector “questioned W. White, D. Slabbekoorn, and T. Wilsey regarding the filters used prior to this validation. Each reported that the filters used prior to the introduction of the [redacted] filters had not been integrity validated nor were they routinely integrity tested.” The filters were approved in August 1997, however, a February 1998 inspection revealed that the validation process used to gain the approval was not valid. Incredibly, the validation for the filters was not done using the anthrax vaccine. “Validation of microbial retention by the (redacted) filters used for harvest of Anthrax vaccine was performed only with (redacted) media, which is used in tetanus production. Studies were not performed using Anthrax product or media.” This means that there had been no test done to determine if the filters would even work to filter out the necessary impurities in the anthrax vaccine, but instead had been done on the tetanus vaccine.

    Another finding was that “[t]he firm does not trend multiple contaminations with microorganisms in sublots.” As a result of this February inspection, MBPI “voluntarily” quarantined 11 lots of AVA. The failure of FDA to recall the quarantined vaccine and order it destroyed resulted in some of it being shipped to the Canadian military and being used on their servicemembers.[xvii] The list of violations, unfortunately, does not end here.  Another inspection took place in October 1998, finding:[xviii]

    • “Stability testing has not always been performed in accordance with stability protocols, for example…”
    • “CBER has not been notified in accordance with Error and Accident reporting of the following…
    • “On 6/30/98, the firm installed a new reaction tank mixer on Tank (redacted). There is no data documenting that the new mixer is equivalent to the old mixer, including mixing profiles. In addition, CBER has not been notified of this change.”

    Yet again, in 1999, the FDA found that “[t]he manufacturing process for Anthrax Vaccine Adsorbed is not validated.”[xix]

    Thirty observations were noted. The inspection report ends with this comment. “The observations noted in this FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the GMP regulation.” What is unique about these findings is not that they are out of the past trend-line of the manufacturer, but these were found at the new facility! The old facility had been razed in 1998 and a new one built in an extraordinary windfall from the U.S. taxpayers approved by the DoD, which will be discussed in some detail later. Despite all of this, in 2000:[xx]

    • “The design and construction…do not assure sterility of products filled…”
    • “The following product lots failed initial sterility testing for release or for stability testing…Investigations into these initial sterility failures are incomplete…”
    • “Investigations are incomplete, inaccurate, or not conducted.”
    • “There is no assurance equipment is operating as designed.”

    In addition to these violations in manufacture, there were also significant problems in what happened to the vaccine after it was made. A product can be adulterated even after it is manufactured correctly (which didn’t happen in this case) if it is “prepared, packed, or held under insanitary conditions”. The regulations regarding processing also apply to packing and holding. Thus, “[t]he failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.”[xxi]

    Biologic products also have expiration dates as described in Part 600 of 21 C.F.R. Modifications to the expiration dates “shall be made only upon written approval, in the form of a supplement [amendment] of the product license, issued by the Director of the Center for Biologics Evaluation and Research.” Expiration dates are also regulated under the current good manufacturing practices. The reason for this is that biologic products by their very nature may break down chemically over time. In order to “assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in §211.166.” 21 C.F.R. § 211.166 states in part:

    There shall be a written stability testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expirations dates.

    In 1997, MBPI relabeled 1.5 million doses of AVA. That is, MBPI took vials of AVA that were already labeled with an expiration date and soaked the labels off. They then relabeled the vials with new expiration dates. These 1.5 million doses of AVA are adulterated for that reason alone. Also, at the time of the relabeling, MBPI had no approved stability testing program, as observed in the February 1998 FDA inspection.  They also had no approved procedures for removing and relabeling filled vials of vaccine. In other words, there was no certified process to guarantee that the originally labeled vials were the same ones when relabeled. In other words, MBPI could not assure that the vials would be re-identified correctly, i.e. FAV008, or FAV009, etc. Hopefully, whoever soaked the labels off, got the right number back on the right bottle.

    MBPI also “re-dated” bulk vaccine that had expired without justification or approved procedures. These doses, too are legally & scientifically “adulterated.” Both of these practices, relabeling and re-dating, require a supplement to the product license IAW 21 C.F.R. § 610.53(d). No supplement was sought or approved at the time of these events. Current good manufacturing practice regulations require compliance with these parts of the C.F.R. Non-compliance renders the drug adulterated.

    There is no other way to express the violations of FDA regulations by the manufacturer of the anthrax vaccine as anything other than laughably abhorrent. Two things make it worse: First, the FDA’s failure to police a manufacturer who is wantonly violating regulations designed to protect the health of U.S. citizens, and second, the DoD’s actions in light of these continued violations, of which it had full knowledge. The public actions of both of these agencies are almost too incredible to believe in light of what both knew was going on at the production facility, but they happened. Now that we’ve considered the manufactures actions, I turn first to the DoD’s actions and then to the FDA’s.

    Endnotes

    [i] FDA Form 483 Inspectional Observations Feb. 4-20, 1998.

    [ii] GAO Report T-NSIAD-00-48 (Oct. 12, 1999).

    [iii] 21 U.S.C. § 351 (2000)(emphasis added)

    [iv] Conversation record memo from Rebecca Devine to Dr. Myers, 9 July 1990.

    [v] MDPH letter to CBER seeking to amend establishment license for new equipment, 6 December 1990.

    [vi] CBER letter to MDPH granting approval of new equipment, 27 July 1993.

    [vii] FDA Form 483 Inspectional Observations, 26-27 April 1988.

    [viii] MDPH letter to CBER responding to FDA inspectional observations made on 12-13 September 1990, 10 October 1990.

    [ix] FDA Form 483 Inspectional Observations, 29-31 July 1992.

    [x] FDA Form 483 Inspectional Observations, 4-7 May 1993.

    [xi] FDA Form 483 Inspectional Observations, 31 May – 3 June 1994.

    [xii] FDA Form 483 Inspectional Observations, 23 April 1995 – 5 May 1995,

    [xiii] FDA Form 483 Inspectional Observations, 18-27 November 1996.

    [xiv] Summary of Findings Report, 14 January 1997.

    [xv] CBER NOIR letter to MBPI, 11 March 1997.

    [xvi] FDA Form 483 Inspectional Observations, 4-20 February 1998.

    [xvii] Ann Rees, “Their Dangerous Dose”, The Province [Vancouver, Canada], 25 Jun 2000

    [xviii] FDA Form 483 Inspectional Observations, 19-23 October 1998

    [xix] FDA Form 483 Inspectional Observations, 25-23 November 1999.

    [xx] FDA Form 483 Inspectional Observations, 10-26 October 2000.

    [xxi] 21 C.F.R. 210(b)

  • The Big Things

    If you read my previous post, you will know that I shared some of my favorite little things: fresh coffee, good whiskey and hot shaves.  I truly believe that the small things in life are what make us happy, but unless the big things are properly managed, we won’t be able to enjoy them.  The big things may not be exciting, but they are important.  Here are some of my big things.

    Three years ago my wife insisted I go to the doctor.   The fact that I work in healthcare pretty much guaranteed that I would not see a doctor unless a loved one forced me to go.  Because I value a happy wife, I acquiesced and made the appointment.  As I am sitting in an assess gown on the exam table that is covered with butcher paper I am reminded why I don’t like to go.  The assistant enters the room and asks me to step on the scale, which I assume has not been properly calibrated because the number is far too high.  She then takes my blood pressure, which I assume she is not practiced in, because yet again, the number is way too high.  Thankfully, the incompetent assistant leaves and I can finally speak to the ARNP.  

    “You are too fat Mr. Man and I want to run labs,” says the ARNP dryly?  

    I think to myself, “Run labs?  I am in my early thirties, why would I need labs?”

    I assume they are likely running up the bill, but what do I care, I have insurance.  Thanks Obamacare! I get a call a week later informing me that I need to come in to discuss my lab work as soon as possible.  The primary care provider explains that my good cholesterol is low, my bad cholesterol is high, and my very bad cholesterol is immeasurable because my triglycerides are dangerously high.  The PCP recommends several medications and lifestyle changes. I respond completely rationally and tell the PCP, “NO DEAL!”.

    I make a bargain for a three month reprieve and promise to make lifestyle changes. I will retest and if I am still high, I’ll concede to the medications.  The PCP reluctantly agrees, sharing that when TGs are as high as mine, he has never seen diet alone correct the problem and it is most likely genetic. I decline to share with my wife the seriousness of my visit, because I don’t want her to worry, and make no mention of the risk for pancreatitis with which I was cajoled.  

    I confess, to enjoying the finer things in life, especially rich food, wine, beer, cocktails, whiskey and lazy days lounging by the pool.  The day I left the doctor’s office, I cut all calories out of my drinks. No more booze, sodas or sugary coffee drinks. I greatly restricted my carb consumption and drastically reduced my portion sizes.  I fasted one day per week for 24 hours to shock my system.  In three months I had lost over twenty pounds and cut my TGs to one third of the original, which were still above normal, but good enough to avoid medication.  My PCP asked to see me in six months and if I had not reached normal levels, still wanted to start me on a much smaller dose of medication. I agreed to the terms and decided to redouble my efforts.  I joined a gym, started doing circuit machines and rowing, and then strong lifts 5×5.  Next came Mad Cow and now a strength program that Leap at the Wheel helped me design and some mixed cardio of biking and boxing.  I am proud to say I am in better shape at 38 than I was as a teenager.  I’ve keep the weight off and normalized my labs without medication.  

    Another key to a healthy life is reducing stress.  A major source of stress for many Americans is debt, which brings me to my next story.  In July of 2010, I got married and significantly increased my debt.  I graduated from the University of North Florida the year before with six figures of college loans.  My wife had graduated not long before the wedding with nearly six figures in debt as well. On the bright side, I was able to pay for the ring and honeymoon in cash and her parents helped pay for the wedding, so at least we had no matrimonial debt.  I purchased a Tacoma after graduation, due to having crashed my RX-8, but luckily my wife was still driving her paid-in-full Jetta.  We shared an inexpensive apartment while my wife looked for work and I worked long hours at the trauma hospital.  

    Then we got robbed.  Cash, computers, televisions, and several firearms were stolen.  Most heartbreakingly, my wife’s camera, with our honeymoon pictures, was gone.  Needless to say, we no longer felt safe in our current lodgings, so we sought new accommodations.  It was the end of 2010 and the housing market had mostly finished collapsing, so we decided to buy a bank-owned home.  We found a home that needed some TLC and made the purchase in January 2011. I had just turned 30 and now had a mortgage, car payment, two grad schools worth of loans and a home depot credit card maxed out to pay for flooring and a new AC unit for our home.  

    Looking back, I have no idea how we made those payments, especially in the summer when my wife was not earning a paycheck.  In 2012, we added a new RAV4 to the family as we felt life was too easy with only stifling debt, instead of crushing debt.  I wish I could tell you when or why my interest sparked in finance, but I can’t remember. I do know it started with Benjamin Graham’s The Intelligent Investor and more books than I can remember going forward.  The wife and myself decided to get debt free and paid the Home Depot card and closed the account.  Then I paid the Tacoma off and focused on the student loans. Luckily I had avoided conventional wisdom and had not consolidated my debt nor my wife’s, so we could pay the fourteen loans off smallest to largest.  With each reduction in minimum monthly payments we could save to tackle the largest loans.  

    In 2015, I refinanced our mortgage to a 15 year loan with a 3.5 percent rate. In 2016, we made the final payment on my wife’s car, leaving only the mortgage.  It took a lot of sacrifice to get out from under our debt and years later our home is still mostly empty as we chose not to use credit to fill the house with furniture or pay for the remodel.  We may not drive the latest cars or wear the fanciest clothes, but we do not fight over bills we can’t pay either, and not fighting with a wife is priceless.  

    July 2020 will be the tenth year spent with my wonderful wife.  We have decided that a vow renewal is in order and we will be inviting friends and family to celebrate what is increasingly becoming a rare event.  I attribute our longevity to similarity in personality, compromise and luck. My wife and I have different politics, religious beliefs and ethnic backgrounds. Our mutual respect for each other’s differences, while focusing on shared values is crucial.  I am an atheist, my wife a catholic, but she doesn’t try to convert me and I accompany her to mass whenever she likes.  Politics is the third rail in our family and is best left untouched, however on occasion we remind ourselves why we don’t discuss the topic.  Regarding our ethnic differences, with her being a first generation American with South and Central American parents and me a white redneck/southerner, we still have common values.  Thrift, work ethic, honesty, politeness, and kindness are shared values that are much more important than skin tone or nationality. 

    It was blind luck that after we married we discovered we have similar spending habits and agreed where we should live.  We have learned to compromise, communicate and give each other space to be individuals within our marriage.  She meets friends for movies and book clubs, while I do poker nights with the boys and Halloween Horror Nights.  We still have our fights about house chores and little annoyances that are unavoidable when you live with someone, but we are fortunate that we have no big problems in our marriage.  That part didn’t just happen through blind luck. It came with hard work and understanding that no one person can be your everything and no one is perfect. We are all humans with insecurities and imperfections.  You have to be able to forgive and move on or ill feelings fester. I am no relationship expert and am probably the last person you want to listen to, because without my wife it is very likely I would be a hermit due to my social anxiety.  I do know if you are unhappy with a relationship, whether it be family, friend or lover, you must make an honest effort to improve the relationship or chose to lose the connection.  Doing otherwise just leads to heartache.

    Do I like working out and restricting my diet?  Do I enjoy paying off debts instead of vacationing in Vale?  Do I enjoy the hard conversations with my wife and reflecting on my own flaws?  Absolutely not. But if I don’t make the effort, I will be broke, fat, alone and all the coffee, whiskey and hot shaves in the world wouldn’t make me happy.  I would love to hear about your big things (phrasing). Please share in the comments.

     

  • Tuesday (only?!) Afternoon Links

    My youngest has been coughing the last couple of nights like a seal barking. Now, rationally, I know there’s nothing dangerous about it — there’s no fluid or labored breathing — still I was up several times to check on him, give him cough medicine, and just generally lay awake in state of helpless alert. Stupid monkey brain.

    “This Syria withdrawal is almost as haphazard as our Iraq exit” — paraphrase of the money quote.

    PG&E: Hey, you wanted us to be responsible for fires — suck it!

    So yesterday, I posited that the $730B in “propsed gains” from “taxing the rich” wouldn’t even cover the deficit. But Holee Fuch.

    Man, intersectionality is a bitch.

    Space is BIIIG.

  • The Face of Battle – A Book Review

    On a long drive to an undisclosed location recently, I listened for the second time to British military historian John Keegan’s The Face of Battle, his first book for the more-or-less general public.  I first listened to it probably 15 years ago, so my recollection was pretty fuzzy.  I’ve listened over the years to many of his books, and never been disappointed.  I expect I will revisit all of them in time.

    One of the things I enjoy about John Keegan is the quality of his prose.  It is just wonderful –clear, nuanced, with a dry wit underneath it all.  Very Brit, the kind of writing that reminds you they invented the language.

    The book falls into five parts.  The first is easily skipped, as it is the most academic by far – an extended discussion of the history of battle literature, the various academic fads and literary approaches, etc.  The approach he adopts is to focus (to the extent he can) on what the soldier’s experience of the soldiering and the battle would have been.

    He then examines three battles:  Agincourt, Waterloo, and the Somme (really, the first day of the Somme).  His Brit-centricity shows in his selection of battles that Britain not only fought, but ultimately won (although the first day of the Somme was an archetypal defeat that struck very deeply into British society).

    The accounts of Agincourt and Waterloo are very illuminating, with the account of the Somme being something of a letdown.  In part, I suspect, because the fighting on the first day of the Somme was essentially decided, and not in the Brits’ favor, within the first half hour, although nobody had any idea what was actually happening until the day was over.  Also, the very simplistic tactics of the Brits (an artillery barrage that was both enormous and almost completely ineffective, and then men walk in line across no-man’s land) are quickly comprehended and just don’t carry the interest of the back-and-forth at both Agincourt and Waterloo.  Overall, though, he strikes a nice balance between giving a tactical overview of the fighting and a look at the experience of the common soldier and their officers.

    The final section  is a review of what we have seen and learned and an attempt to generalize.  He addresses two issues.

    The first is why men will actually fight in a battle, going beyond the usual “because their buddies are”.  Historically, desertion and abandonment were always very present (providing a counterpoint to the standard narrative), with harsh penalties and soldiers posted specifically to keep men facing the front (such as Wellington’s positioning of cavalry behind some units of foot soldiers).  At Agincourt and Waterloo, whole units left the battle by the simple expedient of hiding in nearby woods.  In a modern-day battlefield, he concludes, men fight because the battlefield is so huge and deadly that front-line soldiers can’t escape it, except by fighting their way through.

    The second question is whether modern warfare has made “traditional” pitched battles between large opposing armies a thing of the past.  This is where I would have really like to see a post-script, as his answer here bounded by the Cold War face-off in Europe (recall, the book was written in the mid-70s).  Between the insupportable demands on the fighting men of a battle between NATO and the Soviets, and of course the risk of nuclear war, he leans toward the conclusion that large scale battles may be a thing of the past.

    Of course, in the decades since there have been a series of battles, mostly in the Middle East.  I would have liked to read Keegan’s take on these.  Just because they tend to be mostly one-sided probably doesn’t mean they aren’t battles, but much of the fighting I think would not qualify as a battle (which is an interesting question of its own).  The Iraqi wars would have given him a chance to test his thesis that a modern battle could exceed the capacity of men to fight, given the intensity and the doctrine of continuous engagement over long periods of time.

  • Tuesday Morning Links

    I guess actions have consequences. And sometimes it takes a couple years for those consequences to be fully realized.  But I doubt Baker Mayfield understands that. Dude needs to get his head out of his ass or he’s gonna be Johnny Football 2.0. And I don’t really have a dog in this fight. But he really needs to sharpen shit up, and so does the rest of his team.

    Its winner-take-all now!

    Meanwhile, the Yankees swept their way into the ALCS. Hopefully the Astros will join them today, after getting shelled by the Rays yesterday to extend the series.  Meanwhile, both NLDS’s will go to a win-or-go-home game 5 tomorrow. That will be a lot more fun to watch if the Astros take care of business today. Meanwhile, the Blue Jackets topped the Sabres in OT and the Blues made Toronto sad in the Scotiabank Center.

    Apparently this was based on a book.

    My mom turns 70 today. Love you, mom!  She shares it with: “Ace of aces” Eddie Rickenbacker, leftist strongman Juan Peron, the guy who wrote the book they based the “Dune” movie on Frank Herbert, legendary Aussie actor Paul Hogan, race-baiter Jesse Jackson, comedic genius Chevy Chase, punk legend Johnny Ramone, dwarf-person Dennis Kucinich, the lovely Sigourney Weaver, Awesome Bill From Dawsonville, other punk rock legend C.J. Ramone, MATT DAMON, and Bella Thorne.

    That was a decent list. Mostly because it was headlined by my mom.  Love you, mom! Now on to…the links!

    An artist’s depiction of the incident.

    I guess all of those warnings about people causing problems at the Joker movie were right after all. I hope those people affected will be ok.

    Trump is threatening Turkey now to lay off the Kurds after basically giving them the green light to attack Syria. OK, fine. Now bring the troops back home that are scattered all over that shitty region.

    I remember being a kid and having someone say “just walk it off” or “rub some dirt in it” when I got hurt.  Those people are qualified to be doctors in Venezuela now. Way to go, socialism. Way to go.

    An NBA owner said the stupidest fucking thing I’ll hear all day. How hard is it to support individual liberty, people?  I mean…come on.

    “Cocaine’s a hell of a drug.”

    Sorry, sweetie. But I’m not sure there’s a “doing cocaine with the devil” defense in Virginia. Well, unless your name’s Hunter Biden.

    California has gas prices twice the national average. And now their regressive energy policies are about to cause even more ridiculous shit to happen to her residents. I only hope Tractor Supply has enough pitchforks available to keep up with demand. You get what you pay for, people. You get what you pay for.

    And a pair of eagerly-awaited free association cases are headed to the Supreme Court today. Expect a lot of protesting and hand-wringing. And calls for impeachment, obviously.

    Man, I’m not a huge fan of the pretentious bastard. But this is an absolutely wonderful song.

    That’s all I got today, friends.  Except to say “love you, mom!”  Now go have a great day!

  • The end of the road

    I wanted to wait for a resolution, but I can’t wait around. It seems my Company bailed on me due to a dubious, unethical series of events, so I’m in limbo right now, maybe go back to Walmart.

    We did make it to AZ, broke as fuck but not hungry, yet, so I decided to build a 1/144th scale Wargaming table. There are 2 million Wargamers out there, and while they love to play, they hate to build, that’s where I come in….

    How it’s done

    First question, what are you going to do? Dioramas? WG tables? Scatter pieces?

     

    Some nomenclature:

    WG: Wargaming tables with fixed scenery and terrain, very tough and take players abuse well, not cheap, if done well.

    Dioramas: very expensive due to the level of detail required, and very fragile when finished.

    Scatter pieces: these are cool, basically rocks, trees and terrain features that can be moved around to create new scenarios, usually with a battle mat.

    Battle mats: I forgot those, imagine a tarp with caulking covering it, a bit of paint and Voila! War gaming!

     

    In this episode I will show you How I do it. I hope you enjoy, let’s begin.

    First is materials. I get slab foam from Home Depot, but it’s widely available, and some drywall mud, this is essential to making foam look like life, then I figure out what to do….

    After deciding I glue my foam slabs together and cut/sand it all down, layer it all together, then make a trench for my water courses, this is critical, the material I use wants to level, so you need to contain it somewhat. By this time we have the bluffs, hills and river mostly in place, now we need roads. 

    The Megalith:

    I have a plethora of small stones in the front yard so I went wacky with a Stoned Henge monument, take my psycho mind and some rocks and behold! StonedHenge! 

    I went with the Roman roads theme after watching a YT on the subject, very east/west, with some north/south to follow the river, this is difficult. Try to make sure a straight road looks natural after 2 millennia? Let’s see…

     

    As usual, I had no thought of doing this until I sat with a beer and just looked, and it came to me…..

     

    How it’s done pt2

    Good materials, and an imagination are all it takes, fun or money, it matters not. Build or die is my motto.

    Do your elevation layout first, then paint a base coat of your landscape, brown, green and blue, keep the glue away!

    How do I do landscape, Yusef?

    Foam, a cheap knife from Dollar Tree, some sandpaper and you’re done. It’s important to notice that nothing in nature is static, even with patterns, chaos rules, deal with it and you will make nice scenery! Find primary colors for your rock features, then tint dark, overbrush, then tint light and dry brush.

    I’m out till next week, see ya! 

    Gallery, so far.

    Cheers!

  • Monday Afternoon Dear God I’m Management Links

    So I realized, after I spent all day telling other people what I wanted them to do, that even though I still have plenty of actual do-the-work responsibilities, I’ve basically become management. Not sure whether this is going to end with a bender, and whether that bender is going to end with Drano, but… I’m definitely trying not to turn into a pointy-head. I really don’t love spending all day talking.

    To my view, this (and Swissy’s link from earlier today) are just lesser forms of the same millenialist ideology that led the Taliban to blow up the giant stone carvings of Buddha. Lesser degree, because these toads lack imagination and ability compared to the Taliban, but it comes from the same place.

    At Heroic Mulatto’s request, I pass along this link for your adolescent snickering.

    Cool, now do ULA.

    I smell a H&H Extended Universe episode.

     

  • Profiles in Toxic Masculinity VI: Roy Benavidez

    The young Raul Perez Benavidez.

    Profiles in Toxic Masculinity, Part 6

    Appearances Can Be Deceiving

    The young fellow to the right looks like nothing more than a young man from some time ago, a rash, devil-may-care young guy of a sort we’ve all encountered.  Probably a good kid to share a cold beer with; a young guy with little more on his mind than finding a job, buying a car, maybe finding a girl.

    What this young fellow became, though, is much more than that.  This is one of the few photos from the youth of Roy Benavidez, a great hero, a Medal of Honor awardee, and one of the Vietnam War’s most outstanding soldiers.  Say what you will about the Vietnam conflict, but any such scrap yields both villains and heroes; Roy Benavidez is absolutely one of the latter.

    His Maculate Origin

    Raul Perez “Roy” Benavidez was born on August 5th, 1935, near Cuero, Texas.  He was the son of Salvador Benavidez, a farmer, and Teresa Perez, a Yaqui Indian.  Young Roy’s life was not an easy one, as his father Salvador died when young Ro was only two; his mother remarried but also died five years later.  Benavidez lost both of his parents to a disease not often seen today:  Tuberculosis.  On the death of his mother, Benavidez and his younger brother moved to El Campo, Texas, to live with his grandfather and an aunt and uncle.

    The young Benavidez wasn’t one to shy away from work.  He did shy away from schooling, dropping out at age 15, but he was a worker; he shined shoes at the EL Campo bus station, worked on farms on the West Coast, and eventually returned to El Campo to work in a tire shop.  In 1952, he joined the Texas National Guard; in 1955, he joined the active Army as a medic.  It was this change that finally have the young man a career – and considerably more than that.

    His Adventurous Career

    PFC Benavidez.

    Not one to shy away from a challenge, the new soldier from El Campo volunteered for Airborne training and, on completing that, was assigned to the 82nd Airborne at Ft. Bragg, North Carolina.

    In 1965, Sergeant Benavidez was sent to South Vietnam.  There he was assigned, as many Special Forces types were in those days, as an adviser to the Army of the Republic of Vietnam – working with, as U.S. Forces called them, “Marvin the ARVN.”  His luck was not good; one day on a patrol, SGT Benavidez stepped on a mine.

    His injuries were severe.  Benavidez was evacuated to the Army’s Brooke Army Medical Center at Ft. Sam Houston, Texas, where doctors assured him he would never walk again, and began processing his discharge papers.  Sergeant Benavidez decided “f**k that” and decided, in typically tough Special Forces fashion, that he would not only walk again but would resume his Army career; through sheer force of will, he did so.

    Against doctor’s orders, the determined NCO would crawl out of bed after lights out each night.  Dragging himself with his elbows and chin to a wall, he would leverage himself upright, a little further each night, pushing through pain that he admitted left him in tears but was preferable to not walking.  He eventually stood, then walked.  In July 1966, he walked out of the hospital and, despite continual pain from his barely healed wounds, volunteered to return to Vietnam.  Pain from old wounds notwithstanding, Sergeant Benavidez took his career to the next level and volunteered for Special Forces training, which he completed successfully; on his assignment to the 5th Special Operations Group, he sought and was granted assignment to the elite Studies and Observations Group.  In January 1968, his long sought-after orders came through, and he was back in-country.

    Roy Benavidez has already shown himself to have great big balls of solid titanium.  But his biggest test was yet to come.  On May 2, 1968, six hours of action would present (then) Staff Sergeant Benavidez with the necessity of putting his training and courage to the test.

    His One-Man War

    Benavidez in Action.

    On the day in question, a patrol of twelve soldiers, consisting of three U.S. Special Forces advisors and nine Montagnard tribesmen, stumbled into an entire battalion of North Vietnamese infantry, numbering around a thousand men.

    The patrol called for help.  The first attempt at rescue was not successful; several helicopters returned from the first effort with wounded crewmembers and severe damage.  Another effort was quickly assembled.  Among those at the Forward Operating Base at Loc Ninh who hurried to react was Staff Sergeant Roy Benavidez, who scrambled onto a helicopter with his medic’s aid bag and a combat knife – no other weapon, not even so much as a pistol.  He did have his dedication and his adamantine courage, which would prove to be enough.

    On arrival in the middle of a firefight, SSG Benavidez soon realized that all of the Special Forces team members were either KIA or too badly wounded to move to the extraction point.  Benavidez directed the pilot of the helicopter he was in to drop him in a small clearing; he then ran 75 meters under heavy fire to the besieged team’s positions.

    During the 75-meter run, Benavidez was hit three times, in the face, the head and in the right leg.  But that wasn’t about to stop him.  He took charge of the team, directing those still capable of firing to cover the landing of the dustoff helicopter.  He threw smoke grenades to cover the withdrawal and, under intense fire, dragged half of the team members to the helicopter.  When it proved impossible to move the remaining team members, Benavidez picked up a rifle and, shouting to the helicopter’s crew to move to the remaining team members, ran alongside the bird and directed suppressive fire at the North Vietnamese troops.

    Finally, the entire team was loaded aboard the slicks.  Benavidez wasn’t done; he completed one last sweep of the area, retrieving classified papers from the dead team leader’s body even as the enemy fire intensified.  At one point a North Vietnamese soldier rushed him, striking Benavidez with his bayonet; Benavidez killed the NV with his combat knife and continued the mission.

    Finally, suffering from thirty-seven wounds and severe blood loss, Staff Sergeant Benavidez allowed himself to be dragged into the last helicopter, finally allowing the extraction team to un-ass the area, still under heavy fire.  Sergeant Benavidez’s wounds included seven “major” gunshot wounds, twenty-eight fragment wounds, and slashes to both arms from the bayonet attack.  The fragment wounds were in his head, scalp, shoulder, buttocks, feel and legs; his right lung was collapsed, he had been struck in the back of the head with a rifle butt and a 7.62 round had hit him in the back and exited just under his heart.  His actions on that day were credited with saving the lives of eight members of the twelve-man Special Forces team.

    Back at Loc Ninh, a doctor, believing Benavidez dead, ordered him placed in a pile of body-bagged corpses, until Benavidez mustered the strength to spit in the doctor’s face.  Since dead men don’t spit, Sergeant Benavidez was once again evacuated to the States, where he spent a year recovering from his wounds.

    During his recovery, General William Westmoreland visited Sergeant Benavidez, presenting him with the Distinguished Service Cross.  The commander of the 5th, Special Forces, LTC Ralph Drake, had put Benavidez in for the Medal of Honor, but one of the requirements for that award is an eyewitness; all the eyewitnesses for many of Sergeant Benavidez’s heroism were dead.

    Years later, however, an eyewitness surfaced.  One Brian O’Connor, who had been a radioman on the Special Forces team, had been evacuated to the States and since moved to Fiji.  Benavidez had thought O’Connor killed in action, but after reading an account of Benavidez, O’Connor wrote a ten-page account of the events of May 2nd, 1968.

    Finally, on February 24th, 1981, Master Sergeant Roy Benavidez was awarded the Congressional Medal of Honor, placed on him by President Ronald Reagan, who commented that “…if the story of his heroism was a move script, you would not believe it.”  You can read the full citation here.

    His Golden Years

    Roy Benavidez retired from the Army in 1976 and returned home to El Campo.  He spent his retirement wisely, traveling the country speaking to young people about the importance of staying in school and completing their education.  He was in wide demand as a speaker, but favored military audiences, where the example of his Medal of Honor was particularly inspiring; meeting an NCO whom generals salute first isn’t something that happens every day.

    Master Sergeant Benavidez, as I remember him.

    Side note:  This profile has some additional meaning to me, as I had the distinct honor of shaking Roy Benavidez’s hand once.  When I was attending Advance Individual Training at the old 91A school at Ft. Sam Houston, Texas, Master Sergeant (Retired) Benavidez had come to the post to speak to some of the classes.  He later toured the training area where my company was doing some hands-on training.  He spoke to every soldier and shook a lot of hands.  We had heard he would be on post, who he was and what he had done, so we were pretty excited; I remember shaking his hand, he looked at me very seriously and said, “Keep it up, we need medics.”

    It was a considerable thrill and a hell of an honor.  Men like MSG Benavidez don’t come around every day.

    Master Sergeant (Retired) Raul Perez Benavidez died on November 29, 1998, at Brooke Army Medical Center in San Antonio, and was buried with (well-deserved) full military honors at the Ft. Sam Houston National Cemetery.  I had just left my third stint on active duty in the Army not quite two years earlier and was saddened to learn of MSG Benavidez’s passing at the untimely age of 63.  The Army, like any other large institution, has many examples that young people can learn from, both good and bad; Roy Benavidez was certainly a good one.

  • Swiss Last Minute Substitution Morning Links

    OK, maybe not that urgent.

     

    Sloopy had something come up this morning, so you get my rather terse style of linkings this morning. I am not sure exactly what was going on, perhaps the kids were executing a plot to take over the house. They do have sloopy and Banjos outnumbered…

    Sports – not one team I have an interest in has won anything the past week. So sports can go hang. (Ohio State did win, and the Astros are going for a sweep – so sloopy has that going for him)

    Birthdays – large numbers of humans have this particular day as their day of birth! …fine. Yo-Yo Ma and Vlad Putin were born today. Happy?!

    Links!

    • Despite left leaning media being desperate for a theater shooting…this is the best anyone could scratch up. Sorry, no pile of bodies to climb on to denounce whitecishetpatriacrchynationalisms. Oh, and call for gun confiscation.
    • Well then – everyone should be safe now! Oh…what? We will have to keep an eye on this. I would laugh if Erdogan got handed the whole mess by Orange Man Bad.
    • Winning friends and influencing people…to hate you. You want to live like a forest elf? Go ahead. But you aren’t taking civilization away from the rest of us. OK, maybe in the UK or Germany they will.
    • BONUS HOBBYHORSE LINK. Catalans try to use EU as monkey wrench.

     

  • Things to Come – Week of October 7th.

    I tried to get STEVE SMITH to fill in for me tonight…but he just promised HIM FILL SOMETHING IN! So, I sort of ran from having him substitute.

    Here is the week to come:

    Monday – Animal tells us of another Shitlord of Renown. Yusef writes from the road.

    Tuesday – An RC Dean book review, Florida Man changes tack and moves to The Big Things. Later night, prepare to simmer at the further telling of the tale of the DoD Anthrax case.

    Wednesday – Hat and Hair…’nuff said. A cross word for your evening.

    Thursday – SNP! Mojeaux waltzes into a minefield…er, gives us Christianity 101. Football ranking savaging, late night.

    Friday – We hear of the the making of a Libertarian. Cryptid(s) late on.

    Weekend – Sir Digby, Mexican Sharpshooter, Not Adahn, OMWC, Spudalicious, et al keep us informed and entertained.

    Weekday Links – Sloopy and Brett keep us in the know!