While we are sorry to see Dave leave, COTT wishes him all the best in his future endeavors, and we are pleased that discussions are underway regarding how Dave would continue to bring us the ongoing benefit of his unparalleled knowledge regarding for instance, “The Affordable Care Act” and how its implementation is impacting people with hemophilia and other high cost rare diseases.

We will continue to seek Dave’s input on these important issues where possible. We are excited to announce that Michael Allen will become our new Administrative Assistant working at our Washington D.C. office. Michael is an intelligent and passionate young man and will bring a youthful enthusiasm to COTT and its ongoing work in advocating for blood safety, informed consent and equity of care to people of all backgrounds and cultures, and chronic disease. Michael is a 27-year-old man with sickle-cell disease, in a family with three children over two generations with sickle-cell disease. He is representative of another of the recipient communities dependent on this nation’s blood supply to maintain a relative modicum of health and wellness as well as quality of life.

From our perspective, the new “Canaries In the coal mine” are those disease communities dependent on the blood components side of our nation’s blood supply. Sickle Cell is at the top of the list among others, as components are unable to withstand the very viral inaction technologies which have rendered the plasma derivative side of the blood supply the safest t it has ever been. We are concerned about what we perceive as a lack of the financial and political will necessary to significantly move the equation regarding pathogen reduction technologies for our nation’s blood component users. We have seen a limited number of transmission of serious pathogens such as hepatitis C, “HCV” in our nation. The limited number of transmissions should make us all the more vigilant rather than comfortable in our success. For COTT, it has always been about multiple disease states, and diverse peoples and cultures representing those disease states, that was the future of COTT. We hold that original vision to remain sound in 2013 and central to the mission and work of the Committee of Ten Thousand.

Growing up with the hemophilia community, being the son of COTT Secretary Larry Allen, and having a disease that causes high chronic pain, gives Michael the advantage of bringing a different disease perspective while understanding the most relevant and important period in hemophilia, the 1970′s to the present. Our hope and certainty is that this new diverse infusion will further strengthen our ability to advocate and represent those communities dependent on our nation’s blood supply, including both as always, not limited to, the HIV/AIDS and HCV infected hemophilia community our original and first constituency. 

The entire Board of Directors expresses its heartfelt love and deep respect for Dave Cavanaugh and all he has accomplished for our community and others. We wish him the best and send him off with a fraternal and maternal love and respect. We also wish the best for Michael Allen in his new endeavor with COTT and our ability to collectively attain the original vision articulated by COTT’s founders.

The survival of COTT is imperative if we are to continue to have an independent community voices participating in the regulatory structure as full stakeholders and partners. Your support is critical to our continued ground breaking work in blood safety and in the significant impact of trauma associated psychosocial challenges such as depression and Post Traumatic Stress Disorder, which our community members confront on a daily basis.

What can you do? Plenty. Send COTT a donation, by check in the mail or by clicking on “Donate” on the home page of our website, www.cott1.org. All amounts are welcome. Then talk to friends, neighbors, relatives about blood safety and ask them to donate with you.

Click here to download the latest issue of the COTT Washington Update, volume 14, number 4.

It was then-FDA Commissioner David Kessler who specifically instructed the committee’s staff secretary to declare a consumer seat and place Mr. Dubin in it. His service there — despite much early skepticism by the academic and industry-linked other members — paved the way for all subsequent consumer representation, on BPAC and also on the Advisory Committee on Blood Safety and Availability, in the DHHS Office of the Secretary (on which Corey Dubin has also served).

For the second year in a row, COTT has served on the FDA committee to review nominations for Consumer Representative seats on all FDA Advisory Committees.

I.

R. R. “This is factor eight and it is what infected Loras Goedken with HIV.”

L. G. [seated in an examination room having blood drawn]  ”Every time I get an infusion,   I’m tired  of being a hemophiliac. Every time I have to run for a blood test, I’m tired of having HIV.  But, ya’ gotta’ go on.”

R. R. [narrative] “Goedken is from a large Iowa farm family.”

L. G. [seated next to his mother, Mary at their Iowa home] “Mother had to write all the names down so she wouldn’t forget us.”

R. R. [narrative] “Six of Mary Goedken’s seven sons were born with hemophilia. For much of their  lives, the boys depended on transfusions of whole blood or plasma to stop severe bleeds. In the early ’70s, factor eight changed everything. An infusion only took ten or twenty  minutes, and it could be done at home.”

R. R. [walking by Loras' side in a cemetary]  ”Who was the first to die?”

L. G. “From HIV? My brother Ernie. He was 47.”

R. R. “And then?”

L. G. [standing in front of a long row of tombstones] “And then my nephew, Clayton at four and a half months old. Then Carl died; and Clayton’s father, Denny; and then Jan, my wife, in  April of ’90; and then Clayton’s mother; and then Jay died in August of ’91.”

L. G. [speaking from a residence, presumably his home in Houston]  ”If I had to point a finger, I  would probably blame the factor eight producers.”

R. R. “Because?”

L. G. “Because I think they were forwarned. And I think they were forwarned early enough to prevent a lot of us from getting HIV.”

R. R. [narrative] “Loras Goedken was diagnosed HIV positive just before Christmas, 1985. Then, the doctors tested his wife.”

L. G. “I took her in in January of ’86, and they called me at the office and gave me the results of  her test. And I just… [pausing] I left the office, walked around the block three times, and  I’d never been around the block downtown. [pause] -did a lotta’ cryin’, did a lotta’ kickin’, and had to come home and tell her she was positive.”

R. R. “You told her?”

L. G. “Yep. It was my place to tell her.”

R. R. “Why?”

L. G. “She was my wife. And I gave it to her.”*

II.

“Loras Goedken died at age 52 on August 24, and a singular family nightmare ended.

Altogether, eight Goedkens died. In the two decades of this [AIDS] epidemic, authorities know of no other American family that has suffered so much…

Year after year, the Goedkens died.

As Loras’ wife Jan deteriorated, she spent days in front of the television with a credit card in hand, ordering stuffed animals and dolls from television shopping channels. Dementia set in. She no longer recognized Loras, and when she came home from the hospital before her death on April 18th, 1990, she did not know it was her house…

Loras Goedken was by all accounts a vibrant man, ambitious and energetic-even when hemophilia twisted his knees and elbows into swollen knobs. And he brought passion to his fight against AIDS.

He spoke at schools. He testified before a U.S. Senate committee hearing on HIV. He traveled to Japan last year as a guest speaker at the International Conference on Hemophilia and HIV…

Mary Goedkin is alone now-her husband died of stroke earlier this year. Now, in her little white house, dozens of family photographs line the walls and the shelves. The Goedkin brothers look out of their tinted graduation portraits, young, handsome, their eyes soft.

Half a mile away, there is a row of small pink headstones in the Sacred Heart cemetary in Monticello for the Goedken family.

“I didn’t have to look for heroes outside my family,” said [Loras' sister, Judy]. “I had them right here.”**

III.

Below are two links to other articles written about the Goedken family:

http://www.people.com/people/archive/article/0,,20121879,00.html
http://www.newsweek.com/1994/02/06/an-american-tragedy-in-iowa.html

IV.

It is the intent of the “archive e-newsletters” to present historical hemophila-related material in an accurate and objective manner which is why I generally refrain from personal commentary and rely almost entirely on quoted sources from previously published material.

I would like to add one personal thought to this edition, however.

As I looked through the archive videos and articles re: Loras Goedken, I was truly struck by the monumental sacrifice made by Loras and his family. Even after losing a brother and brother-in-law to HepC and HIV in my own family, I still could not begin to conceive of the staggering tragedy the Goedkin family endured.

Because of the enormous price paid by hemophiliacs and tainted blood transfusion recipients during the AIDS crisis, we all now enjoy a much safer blood supply. Regrettably, I do not ever recall anyone in the general public saying “thank you”.

To this day, there still exists no national memorial, visible to the general public, to honor our dead. There is a sculpture and fountain within NHF headquarters which does not include names, which few will ever see. Some local hemophilia chapters have planted trees or display quilts or photos of our lost, but those are the only efforts I am aware of. Engand, Canada, and Japan are among those countries who have established  national memorials, and I can only wonder why it has never been done in the U.S.

Once more, the hemophilia community must “do for itself”. In that regard, I have included an attachment containing the COTT memorial brochure. Will YOU help us to remember our lost by supporting the Committee of Ten Thousand’s effort to establish a national memorial? Information on how to help can be found in the brochure.

Thank you,

Barry Haarde

The second article, “New Drug to Give Hemophiliacs Aid”, is dated 1969, and heralds the arrival of the new factor concentrates.   I’m also including some biographical information about Dr. Ed Shanbrom and his role in the development of factor concentrates.

“In the late 1960s, a new and more concentrated form of Factor VIII was developed. Drs. Kenneth Brinkhous of the University of North Carolina and Edward Shanbrom of Hyland laboratories produced the Factor VIII concentrate by pooling hundreds-later thousands-of units of plasma. From these pools they made large quantities of cryo[precipitate]. Then they redissolved the cryo, treated it with chemicals, fitered it, and centrifuged it-all to produce a white crystalline powder of pure, highly concentrated Factor VIII. *

“Hemophiliacs and their families greeted the new product with jubilation. Carried in a vial the size of a salt shaker, the concentrate had one hundred times the clotting power of raw plasma-so concentrated that the patient could inject it with a syringe if he wanted, instead of with a blood bag…By injecting ‘early and often,’ as manufacturers suggested, hemophilia patients could quickly control their bleeds, avoid the devastating episodes of joint pain, and gain enough freedom to go on vacations.”*

“After completing his studies [at Chapel Hill], [Murray] Thelin was hired by Hyland, and he brought the Chapel Hill method with him…Shortly after he began to test this substance, he had a brain hemorrhage and decided to risk using the new concentrate on himself. After the first transfusion, his Factor VIII levels ‘soared, and in ten days ‘he walked out of the hospital smiling’…he and medical director of Hyland, Dr. Edward Shanbrom, decided to test whether the concentrate could be used to prevent prolonged bleeding. Shanbrom administered daily and weekly injections to Thelin. ‘The results seemed miraculous: weeks passed without a bleed.’ **

“Soon after they began producing the substance, [Dr. Shanbrom] noticed that the lab workers developed jaundice after breathing the plasma mist in the cold rooms. Suspecting hepatitis, he conducted tests on the liver enzymes of experimental patients, which showed pathological changes. ‘It was obvious there was some kind of virus there’, he said later. He did not consider withdrawing the product; like everyone who had seen its miraculous effects on hemophiliacs, he had no doubt that the benefits exceeded the risk. Yet he felt that, given the product could spread a chronic disease, the company should try to minimize the risk. He notified his superiors to take preventive measures, such as closing its collection centers in hepatitis hot spots. They ignored his suggestion, and he eventually left Hyland.” *

Dr. Shanbrom “tried to persuade the four manufacturers of clotting-factor concentrates to use a detergent process for viral inactivation as early as the mid-to late 1970s. Though some of the companies demonstrated interest in the process, there were no takers because, as Dr. Shanbrom recalls, ‘They said, We don’t have a problem.’ ***

“Dr. Shanbrom approached the [CDC] hoping to interest them in using and studying his detergent process of viral inactivation. The response was a letter from the CDC that he has saved to this day. The CDC expressed interest in Dr. Shanbrom’s process but regretted that it did not have enough chimpanzees to enable researchers to conduct experiments with it. For want of adequate funding to the CDC for chimpanzees, clotting factor remained infectious.” ***

“Once AIDS became an acknowledged reality, the drug firms quickly developed screening tests and virus-killing technologies…If they had heeded the warnings of factor VIII pioneer, Ed Shanbrom and others who issued early warnings about viruses, they would have abandoned the high-risk collection centers sooner and worked more intensively on virus-killing technology.” *

“Shanbrom himself addressed this issue at a 1996 conference of AIDS victims in Japan. He had not taken the podium in order to defend himself; indeed, the moderator had introduced him as the man whose advice the industry should have taken. Nevertheless, Shanbrom lowered his head in a long ceremonial bow. ‘I would like to officially and openly apologize for the pain and suffering to all the hemophiliacs and their families,’ he said. ‘While we attempted to do good we also did harm. For this I apologize.”*

The following testimony was given by Richard Valdez, then president of “HIV Peer Association (California), at the September 12th, 1994 Institute of Medicine hearings:

“Ed Shanbrom, I met with him February of 1992. We talked for an hour just like two fathers because he lost a son too in a tragic traffic accident…He said to me, ‘Dick, [HIV contamination of factor] was an accident waiting to happen.’ Remember, Dr. Shanbrom was one of the co-founders of the process to make factor. His own workers [were] getting sick at Hyland from hepatitis…Ed Shanbrom said to me, ‘Dick, the present and the future is bioengineering. Anytime that you grow a culture you have the potential for a virus.’ “****

Ed Shanbrom was born in West Haven, Connecticut in 1924. He received his B.S. in biology from Alleghany College and his M.D. from the University of Buffalo School of Medicine. He served as physician, specializing in hematology, in addition to his work with Hyland/Baxter. Much more information about Dr. Shanbrom, the develpment of factor concentrates, and information on other key researchers can be found on PBS’s website at the following URL:

http://www.pbs.org/wnet/redgold/innovators/bio_shanbrom.html

Still more information can be found in the following books, from which I have quoted material in this edition of the “e-newsletter”:

Regards,

Barry Haarde

In the story, “Tommy” is confronted with bullying from school mates and conflict with his girlfriend involving his overwhelming desire to keep his hemophilia a secret. Those living with hemophilia are often reluctant to inform others about their condition, a phenomenon that was vastly compounded by the spread of HIV/AIDS among hemophiliacs, which did not occur until ten years after the publication of this cartoon strip.

With the encouragement of his parents and his doctor, “Tommy” eventually discloses his hemophilia to the public after meeting Mark Trail following an untimely hunting accident, and the story ends happily.

I’ve included eight panels excerpted from the catoon series, all of which will be posted on our website in the future. More information about the Mark Trail cartoon strip and its creator, Ed Dodd, can be found on the link below.

http://en.wikipedia.org/wiki/Mark_Trail

The distribution list for the “archive” mailings now exceeds 100 and, as always, anyone wishing to subscribe or unsubscribe, can do so by contacting me by email. All mailings are sent by BCC for privacy.

Regards,

Barry Haarde

This installment of the “archive e-newsletter”  focuses on a very painful, controversial, and divisive era in hemophilia history. The attached scanned image is of a publication, dated February 1992, named “Action Now”, published by Michael Rosenberg and the American H/HIV Peer Association. I’ve also included excerpts from several books, also in the “archive” which provide additional context on the era, as well as Rosenberg himself.

“The Emergence of Hemophilia Activism”

“In the early 1990s, a sudden and dramatic change was to occur in the hemophilia community. Buffeted by knowledge of extraordinary levels of HIV infection among those with the most severe form of the disorder, the difficulties of seeking redress through the courts, the acts of discrimination that had so injured children seeking entry to school- the August 1987 burning of the home of the Ray family in Arcadia, Florida, because their sons had attempted to enroll in school was but the most egregious event- hemophiliacs began to embrace a new militancy. It was a militancy that borrowed from the AIDS activism that emerged within the gay community, but that at the same time carried with it a perspective that was to set apart those who became infected through blood products. Finally, it was a militancy that would shake the relationship between hemophiliacs and their families on the one hand and the National Hemophilia Foundation on the other and would raise troubling questions about the extent to which physicians who had cared for hemophiliacs had betrayed their fiduciary responsibilities.”*  ”At roughly the same moment, organizations reflecting the sense of disaffection emerged on both coasts. In Massachusetts, Jonathan Wadleigh began to organize the Committee of Ten Thousand (COTT) as a support group for hemophiliacs who believed their needs had not been met by the National Hemophilia Foundation. On the west coast, Michael Rosenberg took a more aggresive stance as he organized the Hemophilia/HIV Peer Association. It was Rosenberg’s vision that would ultimately inform and shape the fury of those who had come to see their plight as the consequence of profound institutional failure, although it was COTT that would take on the more enduring organizational form.”*

Rosenberg’s “Causes and Effects of the Hemophilia/AIDS Epidemic”, (also contained in the “archive”), “can be read as a manifesto of the new militancy. In it, Rosenberg laid bare his claims against those who had  failed American hemophiliacs. A ‘genocide’ was occurring because of the ‘commercially driven practices of certain large pharmaceutical corporations.’ The ‘reckless disregard’ of the manufacturers of processed plasma and the failure of the FDA to alter ‘unsafe medical industry practices’ were responsible for the HIV epidemic among hemophiliacs”*   “The voice of protest was also a call to action, and in November 1992, in what they described as a turning point, dissident hemophilacs brought their protest to the annual conference of the Hemophilia Foundation. At a sidewalk demonstration, protesters carried red stained pickets declaiming ‘AIDS, the Avoidable Tragedy.’ Inside the conference center, protesters wearing death masks confronted ‘the corporate mass murderers’ in the commercial exhibit space. A ‘shame list’ of physicians who had betrayed their patients by testifying on behalf of phamaceutical companies in litigation on corporate liability for AIDS was presented. It was a list that was indistinguishable from the medical leadership of hemophilia treatment. Demonstrations like this would be repeated in the next years at NHF conferences. The hemophilia community had become a house divided.”*

“Although Rosenberg spoke of ‘constructive dialogue’, he depicted the situation as a great wave of alienation within the hemophilia community between persons with hemophilia and their families, on one hand, and on the other hand, the hemophilia institutional structure- including the National Hemophilia Foundation, the chapters, the other grant-based or publicly funded organizations presumably providing services to persons with hemophilia, and the personnel of the hemophilia treatment centers.”**   Rosenberg asserted that “the hemophilia organizations are still in denial about the extent of the phenomenon before us.” He used the term ‘we the alienated’, saying that ‘we do not identify with the hemophilia institutions’ and do not need ‘an organization that cozies up to the corporate factor-makers…’ He called for seeking financial relief in the form of a ‘serious class action suit against the pharmaceutical giants for guaranteed comprehensive health coverage, or government subsidies like those granted to hemophilia families in Canada and in more than twenty other countries, or some combination’.” **

The new militancy was on display at the National Hemophilia Foundation in Indianapolis in 1993.   “Meetings like this used to have an atmosphere of genial comraderie-almost like extended-family reunions-among the foundation, its chapters, the patients, and the doctors. Even the drug companies would attend, setting up ‘infusion suites’ in which patients could treat themselves if they needed some clotting factor, or parents could inject it into their children. At this meeting, however, the atmosphere was different, poisoned by the rising toll of illness and suspicion. The drug companies were nowhere to be seen; or for that matter, were some of the prominent doctors.”***   ” ‘It pains me to say this, because my father was the vice-president of the NHF’, shouted Rosenberg [at the meeting]. ‘But the foundation has become the handmaiden to the industry!’ He then announced that the class action suit the rebels had filed would name the foundation as one of the defendants.”***   “Later a group of activists staged a demonstration outside the convention center, which TV crews had rushed over to cover. Some of the demonstrators wore black cloaks and death masks. Others, like Rosenberg, had no need to do so: Everyone could tell, merely by looking at him, that he only had a couple of months to live. At this point in his life, only anger sustained him. They waved placards: ‘HEMOPHILIA HOLOCAUST’. They chanted: ‘My loss, their profit!’ and ‘Shame! Shame! Shame! Shame!”***  ”Rosenberg hobbled between the marchers and the media, a participant and a commentator at once. ‘This is the et tu Brute,’ he proclaimed. ‘This is the history of shame and betrayal. These were the people that were supposed to protect us’.”***

Interestingly, page three of the “Action Now” newsletter featured in this email contains an anonymous letter from a community member stating that “I would like to see a monument in memory of all in the hemophilia community we have lost to HIV.”****   The goal of the “archive e-newsletter” is to preserve our past history for those who are not aware of it. Along those lines, I’d like to acknowlege and personally thank the Committee of Ten Thousand (COTT) for its effort to establish a national memorial for the thousands of hemophiliacs who have lost their lives to HIV/AIDS and hepatitis C. For information on the memorial project and how to contribute to this effort, please contact:

Terry MacNeill
112 Lexington Rd., Dracut, MA 01826
978- 937-9857

Mary Lou Murphy
71 Winfield St., Needham, MA 02492
781- 444-8672

The content of these pamphlets will be displayed on our webpage in their entirety when the page is developed. Meanwhile, there are a few noteworthy items that I’ll include in this email.   The “Facts About Hemophilia” brochure contains, among other things, the following statements:

“…the hemophilic child is a normal boy with a normal boy’s aptitudes and desires. But his activities must be circumscribed. Repeated hospitalization and inadequate schooling are the lot of many… Handicapped as he is, his choice of career is limited…As in all instances where a child is ‘different’, there are psychological differences to be overcome and important adjustments to be made…”

“Having a hemophilic child is an emotional and financial strain for families…The child must be watched day and night and is a source of constant anxiety…Hospitalization and ambulance services are costly; so are doctor bills, transfusions and such frequently needed requisites as braces, crutches, and wheel chairs.”

“Local measures such as pressure, application of cold and the use of various hemostatics, can at times control bleeding, but the keystone for therapy in hemophilia remains fresh whole blood, fresh plasma, or its derivatives.”

“During the past few years the active ingredient which is lacking in hemophilia has been isolated and has been made available in relatively purified form (italics are mine). Early administration of such products does much to prevent the crippling effects of joint hemorrhages that have plagued hemophiliacs in the past.”

The state medical assistance brochure for residents of Pennsylvania includes infromation on the program as it existed in 1969. Needless to say, the financial eligibility requirements were quite different from what they look like today!

I hope these mailings will continue to prove interesting to members of the hemophilia community and that they will serve to enlighten younger members of our community on our history.   I’ve added quite a few names to the email list recently, so anyone who’d like to receive the initial mailings can contact me and I’ll send them out.

Barry