June 29, 2010

Tainted-blood compensation incomplete as deadline nears

André Picard
Public Health Reporter — From Wednesday's Globe and Mail
Published on Tuesday, Jun. 29, 2010 9:26PM EDT
Last updated on Tuesday, Jun. 29, 2010 9:42PM EDT

Canada Day 2010 is a bittersweet occasion for victims of the tainted blood tragedy: The final deadline to apply for compensation is midnight Wednesday and, despite some $2.7-billion invested in making amends, there are growing fears the money is running out.

“I think there is a moral obligation to make sure everyone is compensated,” said Trevor Breslin, a claimant from Burlington, Ont.

His father, Bob Green, contracted hepatitis C from a blood transfusion he received while undergoing dialysis in 1985 and died in 1992. The family, after a ponderous process, was awarded nearly half a million dollars under the terms of a class-action settlement, but has received only $125,000.

“They told us that the fund is nearly exhausted,” Mr. Breslin said. “This is quite shocking.”

Peter Roy, a lawyer involved in the class action by those infected by hepatitis C prior to 1986 and after 1990, said there was $1-billion in the fund at the outset and there is about $250-million left. To date, more than 11,000 claimants have been paid and some 3,500 claims are outstanding.

The problem of money being held back, he said, is largely a technical one: Monies were set aside to compensate for pain and suffering and for loss of income, and the latter portion is running low. Money cannot be shifted around without an actuarial analysis and the approval of the courts.

“I believe this is going to get fixed; everybody will be compensated,” Mr. Roy said.

The tainted blood tragedy is Canada’s worst-ever public-health disaster. About 2,000 hemophiliacs and transfusion recipients contracted HIV/AIDS, and another 20,000 recipients of blood and blood products contracted hepatitis C.

A high-profile public inquiry revealed that many of those infections were due to bureaucratic bungling and foot-dragging, and the failure to take the threat of contaminated blood seriously.

Over the years, governments, the Red Cross (which used to collect and distribute blood) and insurance companies have created a number of compensation programs and settled class-action lawsuits in a bid to make amends.

But it has been a long, drawn-out and expensive affair.

The largest fund, $1.2-billion, was set aside to compensate those who contracted hepatitis C between 1986 and 1990. (In that period, a test was available to screen blood for the deadly virus but it was not used.)

Harvey Strosberg, one of the lawyers overseeing the fund, said there have been more than 12,600 claimants paid to date, and there are nearly 600 claims outstanding, but “there is no danger of running out of money.”

In fact, he said, “this is one of the great success stories of class actions … it worked out better than anyone every imagined.” One of the unique features is that claimants can apply for more money as they get sicker; this is important for a degenerative illness like hepatitis C.

The first compensation program, created in 1989, was markedly different: It assumed that everyone who contracted HIV/AIDS from tainted blood would be dead within four years. They were given a lump-sum payment of $120,000, a program that Ottawa announced on Christmas Eve to ensure it would get no media attention.

That first compensation plan, called the Extraordinary Assistance Program, cost $150-million. There were just over 1,200 claimants.

A few years later, it was expanded and renamed the Multi-Provincial-Territorial Assistance Plan (MPTAP). Hemophiliacs and transfusion recipients who contracted HIV/AIDS from bad blood were awarded $30,000 a year for life, indexed to inflation. (The current annual payment is nearly $41,000.) Spouses and children who were infected by the recipient of tainted blood were also eligible for smaller payments.

About 1,050 people have benefited from that program, which has cost the provinces and territories close to $260-million.

“These compensation programs allowed people to live their lives with some dignity,” said David Page, executive director of the Canadian Hemophilia Society. “But I don’t think we can ever talk about lives and dollars in the same breath. We can never adequately compensate for tainted blood.”


See Also:
Woman still fighting for compensation for family after 25 years
Tainted-blood tragedy: Never again

CDC Survey Finds Nine in 10 U.S. Adults Consume Too Much Sodium

For Immediate Release: June 24, 2010
Contact: CDC Division of Media Relations
(404) 639-3286
Majority of sodium comes from most commonly eaten foods
Less than 10 percent of U.S. adults limit their daily sodium intake to recommended levels, according to a new report, "Sodium Intake in Adults – United States, 2005-2006," published today in CDC's Morbidity and Mortality Weekly Report. The report also finds that most sodium in the American diet comes from processed grains such as pizza and cookies, and meats, including poultry and luncheon meats.
According to the report, U.S. adults consume an average of 3,466 milligrams (mg) of sodium per day, more than twice the current recommended limit for most Americans. Grains provide 36.9 percent of this total, followed by dishes containing meat, poultry, and fish (27.9 percent). These two categories combined account for almost two-thirds of the daily sodium intake for Americans.
An estimated 77 percent of dietary sodium comes from processed and restaurant foods. Many of these foods, such as breads and cookies, may not even taste salty. "Sodium has become so pervasive in our food supply that it's difficult for the vast majority of Americans to stay within recommended limits," said Janelle Peralez Gunn, public health analyst with CDC's Division for Heart Disease and Stroke Prevention and lead author of the report. "Public health professionals, together with food manufacturers, retailers and health care providers, must take action now to help support people's efforts to reduce their sodium consumption."
The 2005 Dietary Guidelines for Americans recommends that people consume less than 2,300 mg of sodium per day. Specific groups, including persons with high blood pressure, all middle-aged and older adults and all blacks, should limit intake to 1500 mg per day. These specific groups comprise nearly 70 percent of the U.S. adult population. This study found that only 9.6 percent of all participants met their applicable dietary recommendation, including 5.5 percent of the group limited to 1,500 mg per day and 18.8 percent of the 2,300 mg per day group.
The report examined data for 2005–2006 from the National Health and Nutrition Examination Survey (NHANES), an ongoing study that explores the health and nutritional status of adults and children in the United States. Researchers used information from 24-hour dietary recall and the USDA National Nutrient Database to estimate the daily sodium intake and sources of sodium intake for U.S. adults.
The findings add to a growing body of observational research studies on Americans' excessive sodium consumption. Overconsumption of sodium can have negative health effects, including increasing average levels of blood pressure. One in three U.S. adults has high blood pressure, and an estimated 90 percent of U.S. adults will develop the disease in their lifetime. Blood pressure is a major risk factor for heart disease and stroke, the first and third leading causes of death among adults in the United States.
For more information about sodium and blood pressure, visit www.cdc.gov/salt.



Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health on National HIV Testing Day June 27, 2010

For Immediate Release

Monday, June 28, 2010
Contact: NIAID Office of Communications
Routine HIV testing is central to ending the HIV/AIDS pandemic. In the United States, someone becomes infected with HIV every nine and a half minutes. More than 20 percent of the estimated 1.1 million Americans living with HIV infection do not know they are infected.

On National HIV Testing Day, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, urges everyone between the ages of 13 and 64 years to be tested for HIV at least once in their lifetime in keeping with the recommendation of the Centers for Disease Control and Prevention (CDC). People at high risk for HIV infection — including substance abusers and their sexual partners, gay and bisexual men, female partners of bisexual men, and individuals with multiple sex partners — should get tested at least once a year.

Knowing one’s HIV status is vitally important to the individual and for protecting the broader public health. Testing positive for HIV infection is the critical first step linking a person to counseling, medical care and treatment, which help improve quality of health and stave off HIV-related complications and co-infections. People who know they are infected with HIV also are more likely to reduce behaviors that could transmit the virus to others, which benefits the larger community.

Additionally, a growing body of evidence suggests that people infected with HIV who consistently take antiretroviral therapy to control the virus not only protect their health but may be less infectious to others — a theory NIAID is currently examining through clinical research.

Later this year, in collaboration with CDC and local health departments, NIAID will launch a feasibility study in several U.S. cities, designed to determine whether expanded HIV testing along with better linkages to medical care and treatment can show value as part of a broader campaign to reduce HIV incidence.

Although expanded HIV testing initiatives and prevention efforts appear to be having some positive impact, far too many people still are getting infected with HIV. Nearly three decades into the HIV/AIDS epidemic, more than 56,000 new HIV infections occur each year, an unacceptably high rate that has remained relatively stable since the late 1990s.

HIV infection may not grab the headlines as it did during the darkest days in the 1980s, but it is still a serious, incurable medical issue that can lead to AIDS — a disease that claimed nearly 18,000 American lives in 2007. Too many people are diagnosed with HIV late in the course of infection, missing the window of opportunity when antiretroviral therapy can provide the best health outcomes.

Sadly, the stigma and fear associated with HIV testing are still very real concerns for many. On this National HIV Testing Day, we all must do our part to eliminate these obstacles and emphasize the important, lifesaving value of getting tested. To find an HIV testing site near you or for more information about HIV testing, visit AIDSinfo and AIDS.gov.

Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Md.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

The White House
Office of the Press Secretary
For Immediate Release June 25, 2010
Statement by the President on National HIV Testing Day
This Sunday is National HIV Testing Day, an occasion to raise awareness of the steps each of us can take as individuals to fight HIV/AIDS. As we mark this day, I would like to renew my call for all Americans to help reduce the risk of infection by getting tested for HIV and learning their HIV status. One in five Americans who are currently living with HIV-- more than 230,000 people -- do not know their status. The majority of HIV infections are spread by those who are unaware that they have the disease. And research shows that people who know their status take better care of themselves and take steps to reduce the risk of transmitting HIV to others. That is why it is so important that people get tested.
In recent years, we have made huge advances in HIV research, prevention and care. Still, HIV and AIDS remains an epidemic in this country. That is why my Administration is launching in the coming days a comprehensive National HIV/AIDS Strategy focused on reducing new HIV infections, increasing access to care, and reducing HIV-related health disparities. But government cannot address this important issue alone. We need the commitment of businesses, churches and faith groups, philanthropic organizations, the scientific and medical communities, educational institutions and others. And all of us have a responsibility to reduce our risk and know our status, to continue to support those already affected by this disease, and to fight the stigma and discrimination people still face. So on this National HIV Testing Day, let us all recommit to do our part to help stop the spread of HIV and AIDS.


90% of HCV patients to be treated with triple therapy regimens, finds Decision Resources

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical profiles provided to them, surveyed clinicians estimate that one year after the launch of Vertex Pharmaceuticals/Johnson & Johnson/Mitsubishi Tanabe Pharma's telaprevir and Merck's boceprevir, at least 90 percent of hepatitis C virus (HCV) patients will be treated with triple therapy regimens.

The new Physician & Payer Forum report entitled Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers finds that surveyed physicians expect to treat 71 percent of treatment-naive and 78 percent of nonresponder patients with telaprevir/peg-IFN/ribavirin and 19 percent of treatment-naive and nonresponders with boceprevir/peg-IFN/ribavirin. Similar to clinicians, managed care organizations' (MCO) pharmacy directors are open to reimbursing telaprevir and boceprevir. However, surveyed pharmacy directors do not indicate a clear preference for either one of these protease inhibitors.

"Only 10 percent of the pharmacy directors we surveyed do not expect to add telaprevir or boceprevir to their drug formularies," said Decision Resources Analyst Alexandra Makarova, M.D. Ph.D. "The remaining surveyed pharmacy directors are split regarding the choice of the protease inhibitor for addition to their formularies. Twenty-five percent expect to add both telaprevir and boceprevir, while 15 percent will add only telaprevir and 5 percent will add only boceprevir. Forty percent of pharmacy directors will make their choice based on the relative cost of each agent."

The report also finds that almost half of surveyed clinicians indicate that they will use Roche's Pegasys and Merck's PegIntron interchangeably in combination with an HCV-specific antiviral agent even if this agent was evaluated in clinical trials involving only one of these peg-IFNs. However, one-third of doctors expect to combine a novel HCV-specific antiviral agent only with the peg-IFN that was used with the antiviral agent in clinical trials. These physicians indicate that they will likely use Pegasys in triple therapy regimens as the majority of HCV-specific antiviral agents are being evaluated with Pegasys rather than PegIntron.

Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers is based on a U.S. survey of 74 gastroenterologists, 26 hepatologists and 20 MCO pharmacy directors. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic and scientific factors.

SOURCE Decision Resources


Bioartificial Human Liver Therapy Trial Progressing

Article Date: 09 Jun 2010 - 2:00 PDT

Vital Therapies, Inc., (VTI) is pleased to announce that the first two subjects have been enrolled at King's College Hospital in London in the expansion of its SILVER (Stabilization In LiVER failure) clinical trial in Europe. The trial is evaluating whether VTI's biological cellular therapy product, ELAD®, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure (ACLF).

The SILVER trial is an open label, multi center, controlled, randomized trial. To date, 29 subjects have been enrolled at 11 U.S. sites and one U.K. site at King's College Hospital, a major European centre for the treatment of complex liver disease. Several other sites will soon be open for enrollment in the U.K., Denmark and Saudi Arabia. More than 20 sites should eventually enroll a total of 80 or more patients in a 1:1 treated-to-control ratio. If successful, the resulting data will provide the basis for a Biological License Application (BLA) in the U.S., a Marketing Approval Application (MAA) in Europe, and a marketing approval application in Saudi Arabia.

The SILVER protocol enrolls subjects with chronic liver disease who have been hospitalized as a result of an event, such as an infection or an episode of bleeding, which has caused deterioration of their liver function (acute-on-chronic liver failure, ACLF). The trial is designed to explore whether the use of ELAD in this setting can prevent continued deterioration of liver function, called progression, and thus improve survival. The trial design uses a well-established measure of liver function called the MELD score to define the status of liver function. Treatment with ELAD, along with standard of care, is compared with standard of care alone. The time to either death or deterioration of liver function by a prespecified amount is measured. It is postulated that the use of ELAD may extend the time to progression and improve survival in this rapidly progressing patient population.

ELAD is a biologic liver support system using a proprietary line of allogeneic human liver cells originally derived from a human liver tumor and refined by several leading cell experts. The cells are stable, immortal, can be grown in unlimited quantities and retain their hepatocyte (liver cell) characteristics. About one pound of cells is used for each treatment. The cells are grown in specially designed cartridges at VTI's plant in San Diego, transported to the hospital and used to treat the patient's plasma outside the body for up to ten days.

At the recent European Association for the Study of the Liver (EASL) meeting in Vienna a symposium sponsored in part by Vital Therapies addressed the use of liver support systems in ACLF. Michael Millis, M.D., Head of Liver Transplantation at the University of Chicago presented results of earlier clinical trials with ELAD including Phase I/II data in patients with acute liver failure. He also presented results of a randomized, controlled trial of ELAD carried out in China in 69 patients with ACLF. The China data confirmed previously reported preliminary data in 60 patients, which showed that ELAD significantly improved transplant free survival in subjects with ACLF compared with standard of care alone, without unforeseen safety issues.

About Vital Therapies, Inc.

Vital Therapies, Inc. (VTI) is based in San Diego, California, with a wholly owned subsidiary in Beijing, China. VTI is developing the first human liver cell-based ELAD Extracorporeal Liver Assist System. ELAD could provide support for patients with severe liver failure by processing toxins and synthesizing proteins and metabolites that are key products of normal human liver function. ELAD is in investigational clinical trials and VTI completed a pivotal trial and filed for market approval in China in September 2007.

About King's College Hospital, Liver Unit

King's College Hospital is home to one of the largest liver units in Europe, performing over 200 liver transplants every year. It is also a major centre for the treatment of complex acute and chronic liver disease, as well as viral hepatitis and pancreato-biliary

Source: Vital Therapies, Inc