Young Todd with a TV

Young Todd in a helmet (to protect his head from potentially fatal trauma)

Todd Robert Smith was my friend and my hero. He was born on May 7, 1962. He passed away peacefully last Thursday, August 9, surrounded by his beloved family, his dog Eiger, and me. I will forever be grateful for every moment I spent with Todd, and these moments are no exceptions.

We met in 1991 at Power Up Software in San Mateo, where Todd was a geeky IT person and QA manager with thick coke-bottle glasses, adorable curly hair, and a penchant for very silly hats. He was initially trapped behind a glass cage in the server room, so we developed a witty banter via what could be called early forms of text and instant messaging. Since he controlled servers, we had him to thank for nerd-humor network communications that always brought a smile to my days. Eventually I would literally fill a book with the long tangential electronic banter that flowed between us, which I preserved and later assembled and presented to him for his 40th birthday. It was my great privilege to work and play well with this brilliant and charming man.

It was at Power Up that I also met his friend and fellow legend David Gerard Powell, who worked in customer support. Both Todd and David were hemophiliacs.

A tall, dark, and dashing figure, Dahveed, as he was called, was always supportive, endlessly helpful, and inherently polite, but often with a vigilante-like swashbuckling edge. He had a wild caterwaul laugh which I can still hear in my head and which smelled like the menthol cigarettes he smoked with abandon. I knocked back several whiskeys with him in his time indeed.

Todd and Moya at a Hemophilia Ball in the early 1990s

Todd and David were wickedly smart readers and researchers, strong fighters, and slightly intimidating to be around. They worked tirelessly to make life better for their fellow blood-brothers. Todd volunteered every year at an outdoor camp for hemophiliacs where they could get out and get dirty and wet in the river and the great outdoors, because he knew the value of keeping active and staying alive despite a potentially fatal blood disorder.

These two men were the first hemophiliacs I had ever known, and they gave me an impression of hemophilia far different from that of a “life of peril” of just a few decades past. But a different matter of blood would end up clouding that picture greatly.

At some point months after meeting Dahveed and Todd I remember connecting hemophilia with risk of contracting HIV and casually asking Todd about this risk.  “It is a concern,” he replied, in typically understated fashion.  It wasn’t until several months later that I learned that he in fact had been HIV- and Hepatitis-C positive for quite some time, and later still till I learned more about the contaminated hemophilia blood products story.

In 1994 I helped David Powell translate his deeply researched and well written missive about the dangers of contaminated blood products, the warnings of inadequate testing of national blood supply, and the need for better regulation, quality control, and accountability.  David delivered this speech before the FDA Blood Products Advisory Committee, and wanted it translated into Japanese, German, and French to mail directly to the chairmen of the pharmaceutical companies associated with the contaminated blood products, Baxter International, Green Cross Corporation, Bayer AG, and Rhone-Poulenc Rorer.  I include the English version below so that we can finally index it and bring it into the Internet world of record.  (I apologize for any funny translations – I’m working from a record that no doubt went from English to German to French and now back to English – but I’m as faithful as possible to David’s original words.)

In 1998, in one of the most courageous acts imaginable, Todd traveled to Germany to Bayer headquarters to deliver a speech directly to chairman Manfried Schneider, in German, at Bayer’s shareholder meeting. You can read it here in English.

“Herr Schneider,” he asks, “Why has Bayer never, to this day, warned its customers that they might have been exposed to the AIDS virus through their products, or that their product was being intentionally manufactured from high-risk donors?”

Riskier products (which were contaminated) were shipped overseas under less regulated atmospheres (see also the great timeline at the end of this article), as Todd continues with Herr Schneider:

In 1985, Bayer had a virally inactivated product available in the USA. But Bayer did not withdraw the older, untreated product from the market. In fact, Bayer told its distributors of the medicine to make sure they sold the old product before the new. Why, after the FDA prohibited the sale of untreated factor medications in the United States, did Bayer transport the remaining untreated, unsafe products to developing countries such as Costa Rica – countries without such strict regulations – only to infect hundreds or thousands more?

Often sick, vulnerable, and impoverished communities of hemophiliacs bounced back and forth between years of liability cases and appeals. The pharmaceutical industry apparently wanted these issues (and the “dramatic” and “hysterical” people associated with them) to quietly just go away, while in classic “too big to fail” rulings, appeals were dismissed since the lawsuits might bankrupt the industry. Early on these same companies were protected by the very organizations deigned to protect us (the FDA): “MAY 1985 — The Food and Drug Administration realizes that companies are still selling unheated concentrate overseas. F.D.A. official wants problem ”quietly solved without alerting the Congress, the medical community and the public,” according to Cutter documents.”

These cases would plod slowly to settlement while many died, but with widely differing outcomes. Says Todd to Herr Schneider:

Around the world, Bayer has reached various, widely differing financial settlements with hemophiliacs in many countries. Japan’s government was firm, and forced a reasonable settlement including a large lump sum, annual payments and medical care for life. In my country, Bayer is paying only $100,000 for each life destroyed by its product, and no further payments or benefits of any kind – in a country without socialized medicine.
There are hundreds, like myself, who chose not to accept such a pitiful amount for the egregious actions of this company, and have legal cases pending in US courts.
Why are the human lives in Japan and America worth vastly different amounts, while hemophiliacs in some countries recieve no relief at all? Is Bayer not a multinational corporation?

It’s hard to imagine more poignant David and Goliath stories, and it’s not always easy to piece together the complete picture on behalf of all the Davids and their blood brothers (and some sisters), and all their families and friends and countless more who are touched through their lives. I can still hear David Powell quoting Todd’s questions to Herr Schneider.  Shortly after Todd’s trip to Germany, David Powell died after fighting complications of AIDS.

Todd kept fighting for years on behalf of his fellow hemo families, and it was only later that I learned about many of his efforts. He never went out of his way to talk with me about injustices, he never sat back and lamented, and although he regularly crusaded through a personal myriad of health odysseys, he simply persisted to live, not die, with various blood disorders and infections.

The biggest legacy of these cases and the work of friends like Todd Smith and David Powell is not the financial quality or lack thereof of settlement, but the discourse, education, and lasting change in blood quality control to prevent future tragedies.

I dedicate David’s letter below to the power of friendship, love, and truth in all the moments we are privileged to find them, amongst the exceptional and everyday heroes we get to call friends. These are the things in life that are indeed “too big to fail.”

David Powell and Todd Smith — Sometime in the mid 1990’s

Todd and Moya, in hospice at UCSF, overlooking the foggy San Francisco skyline. August 9, 2012

FROM:

David G. POWELL
321 West 42nd Avenue
San Mateo, California
94403 USA

TO:

Chairman and CEO
Rhone-Poulenc Rorer
25 Quai Paul Doumier
92408 Courbevoie
CEDEX, France

Chairman and CEO R. Vemon Loucks, Jr.
Baxter International
1 Baxter Parkway
Deerfield, IL 60015 USA

Chairman Renzo Matsushita
Green Cross Corporation
1-15-1 Imabashi / Higashi-Ku
Osaka, 541 JAPAN

Chairman Manfred Schneider
Bayer AG
Leverkusen 5090
Bayerwerk, GERMANY

Dear Chairmen and CEOs.

Please consider this document. It contains the speech I make today, December 15, 1994, before the Office of the Food and Drug Administration of USA (Food & Drug Administration. FDA), Center for Biological Evaluation and Research, Blood Products Advisory Committee.

As an American citizen, I deliver this speech before the competent authorities to inform the U.S. president, the National Congress, the Department of Health and Human Resources of the urgency of the creation of better control of quality in the blood products industry.

As businessmen, I hope you will immediately recognize the value of incorporating a complete quality review of blood products.

David G. Powell

On December 15, 1994.

Statement to the Blood Products Advisory Committee, Biological Research Office Food and Drug Administration (FDA) Rockville, Maryland.

In 1805, Dr. John C. Otto writes about families living with hemophilia around New Jersey. Dr. Otto had not yet given a name to this disease, but he was one of the first American doctors to have it recognized and accurately described.

In his last paragraph on hemophilia, he made a personal description of hemophiliacs whom he met. He described the American hemophiliac in 1805 as “remarkably healthy,” “athletic,” “of a florid countenance,” and “irascible.”

Today, before this committee, doctors, industry and the public, I offer my “irascible” commentary on blood quality and safety in the United States as a hemophiliac. I would give my opinion on behalf of my brother and all hemophiliacs I have spoken with since the Creutzfeld-Jacob syndrome (CJD) was discovered a month ago.

I listened to a hemophiliac who helped his company win the Malcolm Baldrige National Award for quality before he retired himself having contracted HIV.

I listened to a hemophiliac in poverty who has access to products from the American Red Cross.  This hemophiliac has been exposed to Creutzfeld-Jacob syndrome through a contaminated batch of blood product which was later withdrawn from circulation without him being notified. This patient, like many others in the U.S., just received a new prescription permitting him to use non-contaminated blood at the center of blood transfusions for hemophiliacs.

No effort was made to prevent patients from using contaminated supply, or to recall contaminated products already distributed. These products are listed according to the U.S. federal code as “minimum reserve to keep in case of emergency or unforeseen circumstances.”

It is so scary to contemplate the number of contaminated products that are being recalled. There are countless reports about products that were withdrawn from the market because of contamination without the users being warned, and even without organizations attempting to recall them.

National centers for the treatment of hemophilia, pharmacies and private hospitals are saying they must first be contacted by the producers, or they do not have sufficient information. We are not experts in extracting plasma, yet we know that albumin, prolastin and various blood products result from the same process.

When the decision to withdraw a product from distribution is made, a group of consumer organizations starts by calling for the defense of local hemophiliacs, drug users and blood. The National Hemophilia Foundation, under new management, with little silver does its best to warn officials at the grassroots of our movement. Then our leaders must use their own funds to try to prevent harm to patients and families. Moreover, these funds are normally intended for the prevention of AIDS.

We will never have as much contact with hemophilia in the past or future as we did in 1982. Few users of the blood supply are now living, or they use a low quality product that was very widespread here for several years. Hemophiliacs today are physically disabled, mentally shattered, tired of this shameful charade. Hemophiliacs now think that plasma collection, processing and distribution will never change. Hemophiliacs, without anyone to protect them and with little ability to protect themselves, have lost all hope of the role of the Office of the Food and Drug Administration (FDA).

Again and again I see the widespread devastation caused by a pharmaceutical industry that refuses to consider its most destitute consumers. Unfortunately, the social and financial status of different patients does not influence the prevention or destruction of contaminated blood products. We are all equal in the biological warfare trenches. By this, I do not lack respect for the medical profession, or for experts who examine the blood products and who fight every day with us for better quality products. They all want the best services we can offer. But the actual prevention of distribution and recovery of contaminated products is still very random, and cannot under any circumstances be considered reliable.

Today, I question the quality of services and support received by American hemophiliacs who buy and administer products that are even more expensive than the pharmaceutical industry has to offer. This industry was greatly surprised at the discontent of hemophiliacs when it only publicly announced the existence of Creutzfeld-Jacob syndrome in blood products currently on sale several weeks after its discovery. It is true that a few years earlier, a regular blood donor dying from a debilitating illness would not have attracted the attention of the FDA. It is also common to hear a representative of the FDA declaring that “no one currently uses the products of the Red Cross, and only a limited number – if that – of Dutch hemophiliacs and French were exposed to the virus.” It’s not just that hemophiliacs are calling into question the competence of our authorities in prevention and how quickly they act to remove contaminated products from the market. It is partly also what hemophiliacs in the United States have learned in recent weeks that the pharmaceutical industry itself has not manifested.

I have read and heard comments from hemophiliacs across the nation about the threat this new virus brings to our community. Hemophiliacs all send me a clear message: “A virus that can destroy our nervous system by attacking the brain is not desirable. We already have our share of disasters in our medical community and the idea of this new virus is a great threat, especially when Creutzfeld-Jacob syndrome frightens even pathologists themselves.”

I speak today as one hemophiliac unrelated and unaffiliated with industry and organizations that produce blood products. I speak today as an individual gravely concerned for his community and his nation.

American hemophiliacs today are not remarkably healthy, as Dr. Otto liked to describe them in 1805. No, the American hemophiliacs today as elsewhere in the world have suffered and still suffer the decisions made by the pharmaceutical industry. As we all know now, the AIDS virus, viral hepatitis and many other blood diseases are relatively recent due to the modern miracle of vaccination, blood transfusion, blood banks and plasma fractionation.

The number of hemophiliacs infected with the AIDS virus between 1982 and 1986 is a recent example of irresponsibility on the part of our officials and pharmaceutical industries. In fact, the general rule was that the doctors’ oath of “do no evil” has been violated. Today, in 1994, it is impossible to count the number of hemophiliacs who have died of the fatal injury of the AIDS virus in the United States.

Statistics show 3500 dead. We also know that between 1983 and 1989 the longevity of life of hemophiliacs fell twenty years. Modern medicine has never taken such a step backwards. We have learned that 90% of hemophiliacs using coagulants (Factor VIII) have contracted the AIDS virus.

The tragedy of American hemophiliacs is fairly well described by thousands of notes prepared by the Institute of Medicine, the National Science Academy, after an investigation on the transmission of the AIDS virus. A complete file from the Institute of Medicine is due in 1995.

A bill will be proposed next year before the United States Senate on workers compensation management of American hemophiliacs. A trial will also be launched in Chicago against the pharmaceutical industry. Compensation and legal penalties are now estimated at over 2 million French francs.

The director of a blood transfusion center of a large American city announced at a council with representatives from the Department of Health that “600 million francs reserved for testing blood for hepatitis B proved too expensive.” The pharmaceutical industry supported his opinion, and as yet to test for the AIDS virus, to be thrifty, no money was spent.

Today, 600 million francs seems like a joke compared with the price of blood reserves of an entire nation.

So as a hemophiliac and a businessman, I try to comprehend the quality control strategy of the pharmaceutical industry. Is it really necessary to bring the industry to court for considerable sums to obtain a better quality of blood products? Is more money for compensation the right solution? Does the pharmaceutical industry not realize that to ignore its consumers and not to improve its products will eventually cost it much more in the long term? A company earns the trust of its shareholders and its customers with the quality of its products and services.

There are obviously synthesized products, the products obtained by cloning of blood cells for those who can afford the expense. But it is the company that will inject the idea of quality from the first donation of blood. A company that will rise to worldwide ranks for its quality products. A company that actually works with governments, institutions, people and medical clients on an international level, which will collect blood, and transform the distribution of quality products.

A company that can win the Malcolm Baldrige National Quality Award.

I speak neither of laws or regulations by which the industry has been governed since 1902, nor for any changing or adding text. I do not speak either of the regulation of quality standards, which is partly insurance for good quality products. I’m talking about comprehensive quality control, which you have perhaps heard referred to as “the global organization for quality assurance” (Worldwide Organization of Quality Assurance), or as “comprehensive quality control” (Total Quality Management. TQM). The pharmaceutical industry has not taken into account the threat to hemophiliacs and did not act according to overall quality control standards. Only recently has the industry, under pressure from the FDA and experts, finally found the need to push for a better quality assurance in blood transfusion centers. It is certainly not yet overall total quality control, but it’s a beginning, 90 years after the first law on organic products was passed.

Quality of blood is the order of the day in 1955, 1969, 1974, 1982, 1983 and now 1994 with Creutzfeldt-Jakob syndrome. During all these years, even before the first tests were performed with the human liver in 1955, the quality of blood was still on the agenda.

At the conference today, we learn that the Creutzfeld-Jacob syndrome transmits through cellular tissue, not by blood transfusion. This is new to our general knowledge: the prion. We hear that no patient has contracted the syndrome by blood transfusion, it is a rare disease and only 250 cases were reported annually in the United States. We’ll hear variations on models not including any risks and other theories from medical experts about a prion protein. We hear the debate on the efficiency of alternative tests and the various scenarios that result, and the new plans in force to study donors and users. We will certainly hear about frightened and confused donors who then refuse to give blood. We hear talk about maybe how much it will cost the industry if it were to fund medical research in the private sector, donor education, breeding programs and alternative tests for blood.

The real problems today are the decisions for quality and, on a larger scale, the choices that our society must take. It’s a choice we all make as citizens, and you can help as the Blood Products Advisory Committee to the FDA. The right choice today is to request a full commitment to quality from industry, medicine and government.

This is the choice that I offer today. We need national guidelines and the will to improve the quality of blood so that all Americans can benefit. This committee should advise Mr. Kessler, the FDA commissioner, to propose to the President of the United States and the United States Congress rapid deployment teams for quality in our nation. We must incite national attention on new guidelines for quality, for donation centers, for all users of blood products.

Blood is a topic of conversation for millions of Americans every day. We need a national agenda to educate Americans of the benefits of blood and the important role it plays in everyday life. There are other elements in the blood besides cholesterol, and the public needs more information so that everyone can enjoy the best system ever imagined for blood collection, donors, and users. We must lift the veil that covers the industry since it began marketing the plasma separation in 1974, a veil that separated us from the social contract for quality and in favor of profit.

I ask this committee to show Mr. Kessler, the FDA commissioner, the urgent need to establish new national guidelines and the commitment necessary to enable the implementation of these guidelines. What consumers want is the mandate given to the FDA, and this is once again what consumers intend to recover. It is the inalienable right of every American, and requires the participation of each of them, in every way possible to succeed.

I also suggest to this committee that you involve the users of blood products in your arsenal for regulatory inspections and audits. Work across the nation with local representatives of the American Society for Quality Control (ASQC) that offer courses certified by the state on regulations to comply with the FDA. I personally know many hemophiliacs and their families infected and affected who are interested in participating in these courses. They themselves could play their role as approved representatives of the FDA, as indicated by the code of federal regulations. In these days of fiscal responsibility and great risks, it is necessary that FDA officials organize unannounced inspections in blood transfusion centers nationally.

I ask that this committee be established to prevent a system for users of blood products. A free telephone line would be open in time to inform users of expired products and recall. I also request that an investigation be conducted immediately by representatives of the FDA on methods of procedure to recover the products contaminated with the Creutzfeldt-Jakob syndrome.

Members of the Blood Products Advisory Committee are also the watchdogs of the national blood supply; you share this in common with hemophiliacs. Thank you for listening to my irascible speech, and for the benefit of the entire nation, I hope you act quickly and accordingly in the interest of all Americans.