FEIBA drug safe and effective for patients with hemophilia A

November 3rd, 2011

An international research team led by Dr. Cindy Leissinger of Tulane University School of Medicine, along with Dr. Alessandro Gringeri from the University of Milan, has found that a drug commonly used to treat bleeding events in people with a type of severe hemophilia can also be used to prevent such events from happening in the first place. The study, the first to confirm the efficacy and safety of the drug FEIBA™ in bleed prevention is published in the November 3, 2011 issue of The New England Journal of Medicine.

The study examined the ability of FEIBA to prevent bleeds in people with severe hemophilia A with inhibitors. People with this condition produce antibodies known as inhibitors. These inhibitors render ineffective the usual treatment for hemophilia, which involves replacement of the blood clotting factor (Factor VIII) that is absent in hemophilia patients. Approximately 30 percent of patients with severe hemophilia A develop such “inhibitor” antibodies. Hemophilia A patients with inhibitors require treatments with alternate forms of clotting factor concentrates, known as bypassing agents, and until recently primarily had to be infused with clotting factors “on demand” as bleeding episodes occur. Treatment of bleeding events in these patients is not always effective, leading to significant problems for patients, who typically experience repeated joint bleeding and progressive joint disease.

The Tulane-led study tested if preventive treatment with the bypassing agent FEIBA is safe and effective in preventing joint and other bleeds in hemophilia A patients with inhibitors. Thirty-four patients were enrolled for the 15-month-long study.

The study showed that, compared to on-demand therapy, FEIBA infused three times per week resulted in an overall reduction of 62 percent in all bleeding events and a 72 percent reduction in target joint bleeding (“target joints” are joints that experience repetitive bleeding). Nearly two-thirds of patients showed a very good response to preventive FEIBA treatment, experiencing a reduction in bleeding events of 82 percent.

Source: The New England Journal of Medicine

For more information follow attached link, here.

FDA approves Bayer’s new room temp storage option for Kogenate FS

Room Temperature Storage Up to 77 degrees F for One Year Provides Added Convenience

WAYNE, N.J., April 25, 2011 /PRNewswire/Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved a new storage option for Kogenate® FS, antihemophilic factor (recombinant), now allowing the product to be stored at room temperature (up to 77 degrees F) for up to one year.  Compared with the previous three-month room temperature option, this new storage option for Kogenate FS offers added convenience for patients with hemophilia A and is immediately available to customers.

Factor VIII products are typically stored in the refrigerator and are stable at room temperature for a limited time.  With this new storage option, people who use Kogenate FS may have more flexibility for storing their medication whether they’re at home or at school, at work or at play or when traveling. For some, the approval of this new storage option may free up refrigerator space or possibly eliminate the need for a separate “factor fridge.”  

“As convenience with medication is important to people with hemophilia A, we’re pleased to offer a new storage temperature option, which complements other convenience features, including Grab and Go packaging with BIO-SET®, a compact and complete reconstitution system for Kogenate FS,” said Paul Bedard, Vice President/General Manager, Hematology, Bayer HealthCare Pharmaceuticals.  ”This new option demonstrates Bayer’s ongoing commitment to the hemophilia A community.”

The starting date of room temperature storage for Kogenate FS should be clearly recorded on the unopened product carton.  Once stored at room temperature, the product must not be returned to the refrigerator.  The shelf-life then expires after the storage at room temperature (up to 12 months) or the expiration date on the product vial, whichever is earlier.

SOURCE Bayer HealthCare Pharmaceuticals Inc.

Factor 8 Movie

Film Synopsis:

For more than two decades, the Arkansas prison system profited from selling blood plasma from inmates infected with viral hepatitis and AIDS.

Thousands of unwitting victims who received transfusions of a product called Factor 8 made from this blood died as a result.

Follow along as filmmaker Kelly Duda uncovers the tragedy that many consider a crime. Through exclusive interviews and key documents as well as never-before-seen footage, he builds a formidable case that cries out to be heard. See in-depth interviews with a wide variety of players including: victims in Canada who contracted the diseases, state prison officials, former employees, high-ranking Arkansas politicians, and inmate donors, all of which paint a horrifying portrait of what happened.

Why did the state of Arkansas and its prison system risk selling inmates’ blood for so long and how was it able to continue?

Factor 8: The Arkansas Prison Blood Scandal is an unsettling look at the complex issues surrounding prison corruption, blood safety and government oversight. This feature length documentary takes the viewer into the underbelly of the good ole boy South, and, like a Grisham novel, delivers disturbing subplots, amazing coincidences and a possible conspiracy.

At the heart of the documentary is one reporter’s dogged search for the truth. He discovers that his home state knew it was dealing a dangerous product, yet put profits over public safety while federal regulators looked the other way. Charges of cronyism and cover-up reach all the way to the administration of then-Gov. Bill Clinton. And, years before he would assume higher office, the question of “what did he know and when did he know it” comes into play.

Add death threats, burglary, and a murder to the story and a suspected campaign of fear and intimidation surfaces lending explanation to how this story was kept quiet for so long.

Even now, families are still grieving. People are still dying. Around the world major classaction lawsuits have been filed and criminal investigations are underway. While the rest of the globe looks to America for answers, the story remains largely untold and no one has ever been held accountable.

Factor 8 is one citizen’s attempt to set that right.

For more information look here.

Conflicts in medical management of hemophilia

entire Article can be found here: Conflicts in medical management of hemophilia.

 By Everett Winslow Lovrien, M. D  (Author of “Doctor Guilt?“)
WordPress blog

Hemophilia is a medical disorder that is part of our genetic load as humans. It will never disappear. Therefore, the only way to live with it is to receive adequate medical management. Its effects on those males who have inherited the disorder that affects their blood clotting without treatment includes recurrent hemorrhages (bleeds) into joints as well as internal bleeding. The bleeds are painful, resulting in disuse, disability and crippling. The first signs usually appear in early childhood. A child who suffers a mouth bleed can slowly lose enough blood to result in death.

Prior to 1960, the expected life of a child born with severe hemophilia in the USA was less than 11 years. A common cause of death in childhood was bleeding into the brain, an intracerebral hemorrhage. This agonizing threat could be overcome with the discovery of Cryoprecipitate in 1964 by Dr. Judith Pool at Stanford University. The missing precursor to deficient clotting factor, antihemophilia factor VIII (AHF VIII) was obtained from the blood plasma of normal donors. A further step led to the production of AHF in the form of a lyophilized powder (Concentrates) that could be re-constituted and infused at home to treat bleeding. The introduction of concentrates was a marvelous innovative form of treatment that considerably improved the lives of those born with hemophilia by eliminating agonizing suffering.

Constraint in hemophilia treatment by HIV and hepatitis viruses

Despite the great success of Concentrate therapy for replacement of missing AHF in persons who have hemophilia, two conflicts have clouded the brightness of its use. The first major hazard of replacement therapy was the discovery that the magic medicine was contaminated with hepatitis viruses and HIV, the virus that cause AIDS. The drug companies that manufactured AHF Concentrates derived from plasma sacrificed safety bypassing purification in their drive for profitability. Thousands of boys and men who had hemophilia died all over the world from liver failure and AIDS as a result of the polluted medicine they infused to treat their bleeding episodes. More than 10,000 persons with hemophilia became HIV infected in the USA, which could have been prevented.

High costs limit availability of hemophilia treatment

The second conflict in AHF replacement is the cost of the medicine. AHF infusions to treat or prevent bleeds in hemophilia are not infused just once; instead infusions are required every few days in childhood. A person with severe hemophilia often exceeds 1,000 infusions by adulthood. The cost of treatment depends on the amount of AHF infused. A child requires less than an adult. A single treatment costs $1,000 to $2,000 for an adult. In the USA, estimates reveal that 12,000 persons with severe Type A hemophilia infuse an average of 171,760 units of AHF each year totaling 2,060,000,000 AHF units, including surgery. The average maintenance per person without surgery is less. However, recent recommendations for the prevention of bleeding in hemophilia include scheduled prophylactic infusions of Factor VIII, three times each week. A person who receives 150 infusions each year at 750 units per infusion will receive 112,500 AHF units; if the amount is 1,000 units three times each week, the yearly infusions total 150,000 units. The pharmaceutical manufacturing of AHF concentrates, as plasma derivatives and by genetic recombinant methods, world-wide is a multi-billion dollar industry. Production of AHF in 1995 equaled $2.4 billion, and amounted to $6 billion by 2011. AHF concentrates are sold primarily in countries with high incomes (RE: J.S. Stonebraker et al, Hemophilia (2010), 16, 33-46).

Hemophilia appears in males from all of the world’s races. With a world population of 7,000,000,000 (CIA, 2010) and an average birth rate of 20 per thousand individuals, there are 140,000,000 births each year in the world. One half are males, (70,000,000). One in 5,000 newborn males has hemophilia, equaling 14,000 new cases of hemophilia that are born in the world each year.

Within the U.S., with a population of 310,000,000, a birth rate of 14 per thousand equates to 4,340,000 births each year. In the U.S. 2,170,000 males are born annually. Experience has revealed that one in 5,000 will have hemophilia, equaling 434 new cases of hemophilia in the USA each year. Approximately 20,000 persons living in the USA have hemophilia ( RE: J.S. Stonebraker et al Hemophilia (2010), 16, 20-32). Of these, 12,000 are males who have severe type A hemophilia requiring Factor VIII replacement infusions.

Thanks to the federal government’s establishment of Hemophilia Treatment Centers, whose goal is to identify all of the persons who have hemophilia within the center’s health region, most cases of hemophilia in the USA, as well as in other high income countries are identified. Recognition is a necessary step that leads to treatment and relief from suffering.

But, that’s not the case in the major parts of the world. It is estimated that one–half, or even three-fourths of the children born in the world who suffer from hemophilia receive inadequate or no treatment (World Federation of Hemophilia, WFH). Often, they are not identified. The lack of treatment in economically poor counties of the world is the result of the high cost of the replacement AHF medicine, made in America without cost controls, that is not affordable in many countries.

Information provided by Mr. Patrick Robert of Marketing Research Bureau, Orange, Connecticut, for 2009 revealed the following:

Factor VIII sales in the USA (2009)
Plasma derived AHF Factor VIII	360,000,000 units
Recombinant AHF Factor VIII	1,700,000,000 units
	Total 2,060,000,000 units

 

Factor VIII worldwide sales (2008)
Plasma derived AHF Factor VIII	2,900,000,000 units
Recombinant AHF Factor VIII	4,000,000,000 units
	Total 6,900,000,000 units

 

Price of Factor VIII
Recombinant Factor VIII	$.90 -$.99 / unit
Plasma derived AHF Factor VIII	$.60/ unit within the USA
	$.50/ unit outside the USA

The USA includes only 4.7% of the world’s population but it uses 30% of the Factor VIII concentrates produced in the world. 12,000 males (Type A hemophilia) using 2.06 billion units of AHF annually average 171,670 units for each person. This amount of AHF appears to be excessive but considering the large amounts of AHF utilized during surgery, prophylactic infusion therapy three times each week, and induction of immune tolerance to overcome inhibitors the amount may be even higher. Mr. Mark Skinner, president of WFH, believes the utilization of AHF will increase as children in the USA, who have been maintained on prophylaxis become adults. An adult male weighing 175 lbs who infuses 2,000 units of Factor VIII prophylactically three times each week uses 312,000 units each year, at a cost of $187,200 to $308,880 depending on whether recombinant or plasma-derived Factor VIII is infused.

Donations of AHF from pharmaceutical manufacturers to underserved person have been welcome. Pfizer has provided 10 million units of its ReFacto AHF to persons suffering from hemophilia in underserved countries, valued at $13 million (Medical.net/news 2010-02-03). Medical insurance providers may question the high prices of AHF Factor VIII they pay to pharmaceutical manufacturers for the benefits of their subscribers while they give away medicine to others without a cost. There remains a dilemma – a marvelous treatment exists but it is not affordable for most persons in the world. AHF treatment is available for persons who live in rich countries—so, a societal issue arises. If medicine exists to provide treatment, relieve pain and suffering, prevent disability and prolong life expectancy, is it a basic human right that the medicine should be available to everyone who needs it?

WFH and the National Hemophilia Foundation (NHF) continue their advocacy for all persons born with hemophilia. The Hemophilia Treatment Centers (HTC) in the USA have improved the management of hemophilia resulting in an improved quality of life and increased life expectancy within the USA. Other countries that have a high average income have also experienced the improvement of hemophilia care as the result of the pharmaceutical manufacturers’ entrepreneurship. The innovative production of AHF for the treatment of hemophilia as a safe plasma derivative and by genetic recombinant methods by industry has been remarkable. The challenge ahead for treating hemophilia has shifted from production of medicine to distribution.

Aquired Hemophilia – Clinical Trial Phase III

Ipsen’s Partner Inspiration Biopharmaceuticals Announces The Treatment Of The First Patient In Phase III Pivotal

From MedicalNewsToday – Article Date: 20 Nov 2010

Ipsen (Euronext: IPN, ADR: IPSEY) announced that its partner Inspiration Biopharmaceuticals, Inc. (Inspiration) has initiated treatment of patients in the first of two phase III pivotal clinical studies of OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, for the treatment of acquired hemophilia A, a rare, though potentially life-threatening bleeding disorder. Under the terms of their partnership agreement signed in January 2010, Inspiration in-licensed OBI-1 from Ipsen, and is responsible for the clinical development, regulatory process and commercialization of the product. In the context of this first phase III clinical study initiation, Ipsen has subscribed to a US$50 million newly issued convertible note by Inspiration, bringing its fully diluted share ownership position in Inspiration to about 34.0%.

About the study (acquired hemophilia A)

The pivotal phase III study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes in individuals with acquired hemophilia caused by development of autoimmune inhibitory antibodies to human FVIII. Serious bleeding episodes include those that are a threat to a patient’s life or vital organs or limbs, or which require a blood transfusion. In addition, the study will obtain data about the pharmacokinetic behavior of OBI-1.

About Hemophilia and Acquired Hemophilia

Hemophilia is a group of bleeding disorders caused by low levels or absence of proteins called a coagulation factors, essential for blood clotting. The two most common forms of hemophilia are types A and B. Hemophilia A is caused by a factor VIII deficiency and the congenital form occurs in ~1 out of every 5,000 male births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births. Approximately 60% of individuals with hemophilia have a severe condition, which results in frequent spontaneous 2/3 bleeding episodes, in addition to serious bleeding after injuries. The annual market for hemophilia treatments is c. $7.5 billion worldwide.

Acquired hemophilia is a rare, though potentially life-threatening, bleeding disorder caused by the development of autoantibodies (inhibitors) against coagulation factors. Unlike congenital hemophilia, acquired hemophilia is typically a disorder of older adults, and occurs in both males and females. Also, the pattern of bleeding seen in acquired hemophilia is different from that observed in the more common congenital form. In acquired hemophilia, individuals typically bleed into the skin, muscles and soft tissues, as opposed to bleeding into joints, which is more typical in congenital hemophilia.

About OBI-1

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII (hFVIII) and can no longer respond to treatment with the coagulation factor. Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway and forcing coagulation with much higher levels of FVIIa than normal. In contrast, OBI-1, a recombinant form of porcine FVIII that typically possesses low cross reactivity to anti-hFVIII antibodies, is a replacement therapy, activating the natural hemostatic pathway. This should allow clinicians to correlate activity and efficacy with a biomarker, and therefore guide dosing to better predict treatment outcomes. OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to hFVIII and is highly desired by the medical community.

OBI-1 has been evaluated in a Phase 2 study in patients with congenital hemophilia A who have developed inhibitors to hFVIII, and who presented with a non-life/non-limb threatening bleed. The Phase 2 study demonstrated OBI-1 was well-tolerated and can be given over a short infusion time. In addition to the recently initiated pivotal trial of OBI-1 in individuals with acquired hemophilia A, Inspiration expects to initiate a separate pivotal trial in individuals with congenital hemophilia A who have developed inhibitors against hFVIII.

About Ipsen

Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros in 2009. The Group has total worldwide staff of more than 4,400 employees, of which nearly 900 contribute to the discovery and development of innovative drugs for patient care. Ipsen’s development strategy is based on fast growing specialty care drugs in oncology, endocrinology, neurology and hematology, and on primary care drugs. This strategy is supported by an active policy of partnerships. Ipsen’s research & development (R&D) centers and its peptide & protein engineering platform give the Group a strong competitive edge. In 2009, R&D expenditure totaled close to €200 million, representing nearly 20% of Group sales. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY.

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without 3/3 taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned.

The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results.

The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

Source: Ipsen

Octapharma Clinical Trial Begins in the US and Germany Treating Hemophilia A Patients with First Recombinant Factor VIII Derived from a Human Cell-Line

LACHEN, Switzerland, Thursday, October 28th 2010 [ME NewsWire]:

(BUSINESS WIRE)– Octapharma, one of the largest human protein products manufacturers in the world, today announced that patients diagnosed with severe hemophilia A have started treatment with the first recombinant Factor VIII derived from a human cell line (Human-cl rhFVIII). Researchers are investigating pharmacokinetics, efficacy, safety and immunogenicity of Human-cl rhFVIII for previously treated patients with severe hemophilia A.

The prospective, randomized, actively controlled, open label, multicenter Phase 2 trial is being conducted at research centers in the US and Germany under the title “Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients with Severe Hemophilia A.” The study started in spring 2010 and patient enrollment is well underway. Please visit www.clinicaltrials.gov for details.

Human-cl rhFVIII is a fourth-generation recombinant factor VIII (rFVIII) concentrate developed by Octapharma for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A. Human-cl rhFVIII is produced in genetically modified Human Embryonic Kidney (HEK) 293F cells. Human-cl rhFVIII is currently the only rFVIII, which has a human glycosylation pattern. Today, the development of antibodies against infused FVIII represents the most devastating complication in modern Hemophilia A replacement therapy. The human glycosylation pattern in Human-cl rhFVIII should make it possible to avoid potentially immunogenic epitopes as expressed by hamster cells. This may result in improved safety and long-term reduced immunogenicity of Human-cl rhFVIII. During a previous first single-center clinical study, Human-cl rhFVIII demonstrated its safety and efficacy in 22 PTPs without causing any inhibitors or non-inhibitory antibodies against Human-cl rhFVIII.

Human-cl rhFVIII is concentrated and purified for virus inactivation/removal by solvent detergent and nanofiltration although the cell bank and end of production cells have been extensively tested to ensure they are free of any endogenous or infectious viruses. The process ensures that any theoretical virus contamination is safely inactivated and/or removed. The manufacturing of Human-cl rhFVIII is completely free of animal or human derived added materials. The clinical development plan for Human-cl rhFVIII follows the requirements of the U.S. Food and Drug Administration and European guidelines.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is one of the largest plasma products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell lines. Octapharma is currently developing the first commercial recombinant coagulation FVIII from a human cell line (Human-cl rhFVIII), which is designed to reduce the overall immunogenic challenge (and resulting inhibitor formation) to the haemophilia A patient.

At the present time, Octapharma has 37 subsidiaries and representative offices. The company employs over 4,000 people and is making sales in 80 countries worldwide. For more information, please visit www.octapharma.com.

© Octapharma AG, 2010

For media enquiries, please contact:

Octapharma AG
Corporate Communications
Corinne Landolt
Tel.: +41 (55) 451 21 36
Corinne.Landolt@octapharma.com

Book Review: Dying in Vein

Name:  Dying in Vein: Blood, Deception … Justice

Description:

Photographer Kathy Seward MacKay and writer Stacy Milbouer bring to light one of the worst preventable medical disasters in United States history – the spread of the AIDS and hepatitis
viruses through the nation’s blood supply and its devastating effects on the world’s population of hemophiliacs and their families. Approximately 100,000 hemophiliacs were infected with the viruses.

The documentation of this tragedy is provided in a 1995 independent study by the Institute of Medicine – part of the National Academy of Sciences. In the report, medical experts estimated that up to 70 percent of the HIV infections in hemophiliacs may have been prevented had the FDA and the pharmaceutical companies acted when the warnings signs were evident in the early 1980s.

A timeline in “Dying in Vein” gives an overview of the blood supply problems, beginning with the first known outbreak of hepatitis in the 1940s. It is easy to see that decades later the deaths of thousands of people with bleeding disorders were largely a result of corporate greed by four pharmaceutical companies and FDA regulatory failure.

Mission Statement:

After the death of my 33-year-old husband, a hemophiliac infected by tainted blood products, I wanted to use my skills as a photographer to show the pain and suffering of the victims and the families of the blood-supply crisis within the hemophilia community. I wanted to tell the story with candid, real-life moments. It was also important for me to capture the fervent activism in this community, the everyday life of infected hemophiliacs and the strength of the human spirit. I wanted the people responsible for this travesty to see the toll their actions and decisions had on the lives of their victims. And I wanted to inspire those who saw these photographs to think, feel, maybe even act in response to it.

For my husband, David, living with the cloud of HIV over his head, was not an easy task, yet he lived a full life. As a special education teacher, he touched many lives and sent his students on the path to productivity, rather than ruin. The ripple effects of his contributions are still seen today. Yet, he died too young and his two sons have suffered from the absence of a father since the ages of 4 and 8.

While David was alive, he often suggested that I document the plight of an HIV-positive hemophiliac. He knew there was a whole generation of people with bleeding disorders who faced extinction. For me however, this was a topic I just did not want to cover – it was too close to home. I didn’t want to draw attention to the issue. I wanted to try to live a “normal” life. We believed he would remain one of the long-term survivors of HIV. Then, after he very suddenly died of liver failure from hepatitis C in 1997, I was thrown into the world of hemophilia, injustice and activism. I quickly learned that this horrific tragedy could have been prevented if it weren’t for corporate greed and the immoral decisions within our federal Public Health Service.

As a photographer, I could no longer ignore such an important story. I felt obligated to do my part for the cause. My main goal was to educate the public and to do my small part in preventing another tragedy of this nature. I soon realized how important it was to provide a voice to those who felt the government and the press ignored their stories.

“Dying in Vein” is for those victims of the blood supply crisis: Those who have perished. Those who are suffering. And those who have survived the death of their loved ones.

Dying in Vein is also for all healthcare consumers: Those who rely on drug companies to make the right decisions for us. Those who rely on the FDA to make the right decisions for us. And those who rely on doctors to make the right decisions for us.

Link to FaceBook page, here.

New Book – Hemophila History

Doctor Guilt?
by Everett Winslow Lovrien

Editorial Reviews

Product Description

Brent admired the chimpanzee he sketched at the zoo. He regarded the animal as contemplative. He was unaware that similar animals in the wilds of Africa were the source of a virus that would lead to his death from AIDS. Brent became infected with HIV from the medicine he infused to treat his hemophilia. At six months of age, his parents were alarmed when they discovered bruises on his chest which led to the discovery of hemophilia. From that moment forward, he received frequent intravenous infusions of concentrate to treat recurrent bleeding episodes. Infusions of the medicine relieved pain and suffering from bleeding. His life seemed normal. Unexpectedly, Brent’s life changed after the discovery of HIV contamination of the medicine. The medicine was manufactured from the plasma of paid blood donors. Unbeknownst to Brent, the plasma was polluted with HIV. The SIV in chimpanzees changed to become HIV in humans. But the chimpanzees were not the cause of the transfer of SIV in animals to HIV in humans. The change from SIV in animals to HIV in humans was the result of human activity. The change came about with the production of the hepatitis B vaccine. Who was responsible for the pollution of the hemophilia medicine with HIV and hepatitis viruses? Was Brent’s death preventable?

Product Details

• Hardcover: 500 pages
• Publisher: iUniverse.com (August 23, 2010)
• Language: English
• ISBN-10: 1450216846
• ISBN-13: 978-1450216845

Excerpt from the book….

This is the story of a boy who had hemophilia, a bleeding disorder that resulted in pain, disability and death before adulthood. A new medicine was developed which brought an end to suffering and increased longevity in persons with hemophilia.  The effect of the new medicine was like magic. It was a remarkable revolutionary advancement in the treatment of hemophilia, a medical disorder that had caused suffering for many previous centuries.

The medicine was manufactured from the plasma of paid blood donors.  Unexpectedly, a dark cloud descended when persons infusing the medicine became ill. It was discovered that the new medicine was polluted with hepatitis viruses and HIV.  By the time of discovery it was too late to prevent infection. The boy and 10,000 others in the USA became infected with HIV the virus that causes AIDS. He died from AIDS at age seventeen rather than have a prolonged life that was intended with the new medicine.  The medicine was sold to other countries resulting in thousands of deaths from AIDS all over the world.

In addition to the boy, others like him that received medical care at the same clinic he attended also became infected with HIV and hepatitis viruses. One hundred persons at the treatment center where he received his care died from AIDS or liver failure. A dozen other families who lost a son or father or husband were contacted or interviewed in their homes and asked if they blamed the doctors who prescribed the medicine that resulted in death. Doctors are supposed to provide treatment without causing harm to their patients. The doctors didn’t know that HIV, a new virus that causes AIDS, existed. But could they have known or should they have known?  Do the families view the doctors as guilty of causing harm and death?

The families believe the doctors were incorrect when they told the families to take the medicine and their loved one would live to become an old man and have a near normal life. But they do not believe the doctors are guilty.  They were using the best knowledge available at the time.

However, the families do believe the pharmaceutical manufacturers of the medicine are accountable for the deaths from AIDS in persons who infused their medicine to treat hemophilia. If there was suspicion that the medicine was polluted, why didn’t the producers of the medicine purify it by removing the viruses from the donor plasma?  The manufacturers replied that they didn’t know how to purify the medicine or that the methods of viral depletion were too expensive. But since then, reviews have revealed that although the drug companies didn’t know how to remove the hepatitis viruses and HIV, it was known but not by them. It has been known since World War II that heating plasma inactivates hepatitis viruses. If Hepatitis would have been destroyed in plasma by heating, HIV would have also been eliminated even though its existence was not known. AIDS could have been prevented in hemophilia.

In the USA the system of free marketing and capitalism leads to entrepreneurship resulting in the development of new beneficial medicines by pharmaceutical manufacturers. Remarkable and beneficial new medicines have been developed in the USA using genetic engineering methods with recombinant techniques as a result of capitalism.   The force that drives new development is profitability. But when safety is sacrificed for profitability, in a society without cost controls, greed prevails. The manufacture of medicine to treat hemophilia is a multi-billion dollar industry with intense competition.  Because of human nature regulations are necessary to prevent greed.  The families who lost a loved one from AIDS or liver failure from hepatitis regard the drug companies that made the new medicine for hemophilia as bringing great advancement but guilty of greed.

AIDS is not a mysterious disease. It is the result of HIV infection in humans when the natural occurring virus in simians in Africa, SIV, jumped a species to become HIV in humans.  This came about as the result of the production of the human hepatitis B vaccine. As the result of human behavior, the HIV virus infected intravenous drug users who sold their plasma to pharmaceutical manufacturers of the medicine to treat hemophilia.

The use of a medical treatment requires judgment by the prescribing doctor and the patient recipient.  The benefits of treatment must be compared with the hazards, a trade off. The impact of an activity, a medical treatment or a pharmaceutical innovation, may not be apparent at the time of an action. The risk of harm from a possible but unknown substance in the medicine was judged to be a less threat than the threat of death from bleeding into the brain if medicine was withheld. That turned out to be incorrect.

Sometimes good intentions result in bad things happening.  The intent to prevent hepatitis infection in Africa was a good intention. But the process led to the jumping of a species when SIV of monkeys and chimpanzees mutated to become HIV in humans.

For a balanced society, critical thinking is necessary.  Doctors are closest to their patients and should make treatment decisions, with input from their patients, without influence from pharmaceutical manufacturers and commercial and publicity organizations.

We should not forget the great tragedy that happened in hemophilia when thousands of persons all over the world died from AIDS and liver failure.  AIDS is a man-made disease and could have been avoided. Their families want their story to be told. They should be remembered so that this tragedy does not recur.   They are part of our society and all of us should care what happened to them.

Everett Winslow Lovrien is medical director of Hemophilia Center at the Oregon Health Sciences University and the author of Doctor Guilt?

Bad Blood Documentary Trailer

Bad Blood: A Cautionary Tale
A Film by Marilyn Ness

Order your copy here.

BBC – “Haemophiliacs used in trials”

Here is a video from the BBC.  It’s in three parts.

BBC Newsnight – April 17th 2007 – Blood trials

Evidence has been uncovered, that doctors effectively used Haemophiliacs as guinea pigs for new blood products.

This original 3-part Newsnight report is from April 2007

Susan Watts reports

Part 1

Part 2

Part 3

External link : http://news.bbc.co.uk/1/hi/programmes…