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Week Ending: August 25th , 2007
Alan Franciscus
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August 18th, 2007
Jail doc’s past in question
http://www.thetimes-tribune.com
Borys Krawczeniuk
Staff Writer The Lackawanna County Prison’s medical director was fired from a similar post at a Pittsburgh-based health care services company in 1999 in an apparent dispute over a new treatment for hepatitis C in state prisons the company served.
Company officials could not be reached to explain his termination, but in a lawsuit later filed against the company, Dr. Edward J. Zaloga claimed he was fired because he disagreed with a plan to begin treating the liver disease with a then-new, unproven drug that ultimately would be a waste of taxpayer money.
The treatment “would waste more than $7 million of the (state) taxpayers’ money on unnecessary and unwarranted medical treatment,” he charged in a suit filed against Wexford Health Sources Inc. in November 1999.
He claimed in his suit that his management practices had created a profit for the company of $4.1 million, and the company — which at the time was trying to get the state to pay for the new treatment — feared it might have to pay for treating inmates if the state found out about its profits. He was fired for raising the concerns, he alleged.
The suit demanded more than $1 million in unpaid wages, expenses, lawyer’s fees and punitive damages.
The company, in its legal responses, denied earning anywhere near $4 million. It denied his other claims as well.
County judges rejected Dr. Zaloga’s suit in separate rulings in 2002 and 2004 with one judge writing that Dr. Zaloga failed to establish “a report of wrongdoing ... or waste.”
Wexford in its legal filings acknowledged firing Dr. Zaloga but did not say why.
Dr. Zaloga is now co-owner of a company, Correctional Care Inc., of Moosic, that provides medical services to county prison inmates, and oversees those services.
A former inmate, Shakira Staten, 22, a federal prisoner who gave birth at the prison July 10 and has since been transferred to Adams County Prison to await sentencing, has sued him, the company and the prison in federal court.
She claims she was a victim of cruel and unusual punishment because her pleas to be taken to the hospital when she went into labor were ignored and she had the baby alone in a cell.
The county Prison Board this week apologized for the way she treated and blamed a Correctional Care nurse for “serious errors of judgment” that included failing to properly monitor her labor and unnecessarily delaying taking her to the hospital. The board barred the nurse from working in the prison.
A secretary in the company’s office said Dr. Zaloga was not available for comment and would only reply to written questions.
A secretary at Wexford Health Sources said no company officials would be available to comment until next week.
Dr. Zaloga was Wexford’s regional medical director for its central Pennsylvania operations from Feb. 1 to Sept. 29, 1999, the day the company’s operations director dismissed him, according to court records.
County Commissioner A.J. Munchak, the Prison Board chairman, said he was unaware of the lawsuit or Wexford’s dismissal of Dr. Zaloga, who is a longtime friend. He referred questions to Dr. Zaloga.
“You’ll have to ask him,” he said.
Asked if anyone conducted a background check when Dr. Zaloga was hired, Mr. Munchak said, “Background check? On the doctor? Please. Oh, here we go again. No comment.”
The commissioner has touted Dr. Zaloga’s credentials in the past, including his work overseeing the central Pennsylvania prisons. He and other Prison Board members have consistently praised Correctional Care’s work at the county prison, and view the treatment of Ms. Staten as an exception.
The increase in diagnoses of hepatitis C in the 1990s caused great concerns in prisons nationwide because it is expensive to treat.
In his suit, Dr. Zaloga said a state task force set up by the Department of Corrections to develop a treatment protocol was seriously looking at boosting the use of Rebetron, which had been approved by the Food and Drug Administration a year earlier, but whose effectiveness had not been established.
The state prison system adoped use of Rebetron in 2001, but reduced its use to select circumstances two years later, according to information from the Department of Corrections.
Contact the writer: bkrawczeniuk@timesshamrock.com
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August 20th, 2007
Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
http://pharmalive.com
WAYNE, N.J., and EMERYVILLE, Calif., August 20, 2007 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, has been accepted for review and granted Priority Review status by the U.S. Food and Drug Administration (FDA). Nexavar is currently approved in more than 50 countries for the treatment of patients with advanced kidney cancer.
Priority Review designation is intended to expedite the regulatory review process for investigational agents or uses that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within six months of the date on which they received the sNDA.
"This Priority Review underscores the potential of Nexavar to be a significant advance in the treatment of liver cancer," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "If approved, Nexavar would be the first FDA-approved therapy for patients battling this devastating disease."
The sNDA submission, completed in June 2007, was based on data from the Phase 3 SHARP trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on this data, the companies also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in June.
"The incidence of liver cancer continues to rise in the United States and around the world, highlighting the significant need for new therapies," said Hank Fuchs, executive vice president and chief medical officer of Onyx. "Our comprehensive development program continues to identify new areas where Nexavar's unique combination of multi-targeted activity, tolerability and oral dosing may meet additional unmet needs in cancer."
HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.(3) Over 600,000 cases of liver cancer are diagnosed globally each year(3) (about 19,000 in the United States(4) and 32,000 in the European Union(5)) and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of liver cancer.(6)
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar in patients with advanced kidney cancer were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar(R), a small molecule drug, with Bayer Pharmaceuticals Corporation. Nexavar is approved for the treatment of advanced kidney cancer in more than 50 countries. For more information about Onyx's pipeline and activities, visit the company's web site at: www.onyx-pharm.com.
About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2006, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.
References
1. World Health Organization. Hepatitis B. Available at:http://www.who.int/csr/disease
/hepatitis/whocdscsrlyo20022/en/. Accessed April 10, 2007
2. Penn State Milton S. Hershey Medical Center College of Medicine. Malignant Hepatoma. Available at: http://www.hmc.psu.edu/healthinfo/m/
malignanthepatoma.htm. Accessed April 10, 2007.
3. International Agency for Cancer Research. GLOBOCAN 2002. Available at: http://www dep.iarc.fr. Accessed April 23, 2007.
4. Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
5. International Agency for Cancer Research. EUCAN 1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm. Accessed April 26, 2007.
6. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed April 10, 2007.
CONTACT:
Mark Bennett of Bayer HealthCare Pharmaceuticals,+1-203-314-5556; or media contact, Alicia Samuels of GCI Group,+1-914-720-4635, for Bayer HealthCare Pharmaceuticals; or Julie Wood ofOnyx Pharmaceuticals, Inc., +1-510-597-6505; or media contact, Hala Mirzaof WeissComm Partners, +1-212-301-7205, for Onyx Pharmaceuticals, Inc.
Web site: http://www.nexavar.com/ http://www.onyx-pharm.com/
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Bloody awful: How money and politics contaminated Arkansas's prison plasma program.
By Mara Leveritt
Arkansas Times
Last April, at the Abbey Garden on Great College Street in London, a British widow vented her frustration over a now-defunct state program in Arkansas that may have killed her husband.
She addressed Lord Archer of Sandwell, a former solicitor general, who is leading an independent inquiry into how 4,500 hemophilia patients in the UK were exposed to lethal viruses in blood products in the 1970s and '80s. Two thousand have since died of either Hepatitis C or HIV, in what has been called the worst disaster in the history of the nation's health service.
The widow, 47-year-old Carol Grayson, spoke calmly of the death of her husband, Peter Longstaff, two years ago. She explained that he was one of the patients who were treated with Factor 8, a blood-clotting product manufactured from human plasma.
Grayson and Longstaff had believed that his medicine was safe; that it had been derived from plasma collected in the U.K. from donors who were not paid.
They learned too late that it had been manufactured, not from plasma collected in their own country, but from persons in other parts of the world and that some of those sellers were, in fact, Arkansas prison inmates.
In the U.K., it is illegal to collect plasma from prisoners. That restriction arose in part from a philosophy that considered plasma from unpaid donors to be safer, and partly because collecting human tissue from prisoners — paid or not — was considered exploitative.
When Grayson was called to testify, she recounted the shock she felt when she and Longstaff learned that plasma collected from groups, such as prisoners, who were considered in the U.K. to be high-risk, had been pooled, fractionated and dispensed as medicine to people like her husband.
Shredded records
She described his difficult death and the further difficulty that she and other activists have had in tracking down records from their own and other governments about how the catastrophe occurred. For instance, she said, they learned that many of the files in the U.K. dealing with the scandal were shredded during the 1990s.
In 2000, the British Department of Health conducted an inquiry into the records' destruction, but never published its findings. This spring, as Lord Archer's inquiry was getting underway, the BBC requested the health department's report, but was told that the document was still being withheld at the request of the prime minister's office.
Grayson and other members of the country's Haemophilia Society are pressing their government for full disclosure. They would also like to see records from this side of the plasma transaction, particularly records pertaining to the inmate plasma center run from 1964 to 1991 by the Arkansas Department of Correction.
Grayson is particularly interested in the Arkansas center. With the help of Little Rock documentary filmmaker Kelly Duda, she said, she has tracked batches of the blood-clotting product her husband received to plasma that was drawn from inmates at Arkansas's Cummins Unit.
Duda has become something of a celebrity among hemophiliac victims and their survivors since his film, Factor 8: The Arkansas Prison Blood Scandal, was released in 2005. A review that year in the trade magazine Variety called the film “a sturdy, concise, no-nonsense documentary that ... would probably win Peabodys if shown on ‘Frontline,’ HBO or any of the several other outlets with social agendas and nerve enough to air the appalling story...”
Factor 8 was seen by relatively small audiences in Little Rock during two recent film festivals. It is receiving greater attention in countries affected by the tainted blood. The film focuses on how the Arkansas plasma program operated during the 1980s, years when Bill Clinton was governor — and when the emergencee of the AIDS virus was making all trade in blood a deadly serious business.
In her testimony to Lord Archer, Grayson suggested, “As Clinton now travels the world on AIDS prevention, surely he should be willing to assist with investigations into a past prison plasmapheresis program in his own backyard.”
She added, “Perhaps the Inquiry could write to him officially and ask him to help us secure the relevant documentation relating to Cummins Unit Arkansas Prison.”
Why?
Dan Farthing, communications manager for Britain's Haemophilila Society, echoed Grayson's interest in seeking answers from Arkansas. “We know of three UK cases of HIV that can be directly traced back to Arkansas prison blood,” he wrote in an e-mailed response to questions.
Farthing wrote that members of the society wonder why “high-risk groups like prisoners were not excluded from donating blood.” With reference to Arkansas, he wrote, “The state officials should not have approved such practices, and our government certainly should not have licenced the import of products made from prison blood.”
Since the U.S. Food and Drug Administration had banned prison blood from being sold in the U.S. as early as 1984, Farthing said he wondered, “why blood and blood products not thought fit for U.S. consumption was allowed to be exported rather than destroyed.”
In his film, Duda chronicled his mostly fruitless attempts to obtain documents on the plasma program from Arkansas prison officials and officials of the two companies that contracted with the ADC to run the program during the 1980s. This reporter is shown in one part of the film explaining that records from Clinton's terms as governor were also unavailable, since Clinton took possession of them when he left office to run for president.
Today, Clinton's governor's papers — some 2,000 boxes of them — are are stored on the upper two floors of the Central Arkansas Library System's Main Library, a few blocks west of the Clinton Presidential Center. While the presidential papers have been made public, records of Clinton's years as governor have not; nor does Clinton mention prisons in his autobiography.
The library system's director, Bobby Roberts, says the governor's papers eventually will be moved to the Arkansas Studies Institute, now under construction near the main library. But, Roberts added, the papers will only be released to the institute in batches by topic, with Clinton's approval.
A lot of politics
Besides his current role as the archivist of Clinton's papers, Roberts, a former member of Governor Clinton's staff, also served on the Arkansas Board of Correction during some of the most controversial years of the state-run plasma program. Clinton appointed him to the board in 1986.
It was an era when almost everything about the prisons was contentious, if not dangerous. Problems with the prisons' plasma program were almost totally eclipsed by other serious problems — including suspected murders, rapes, bribery, embezzlement, and substandard medical care. Clinton and his aides were also battling to end an entrenched system of bonuses for high-ranking prison employees.
There were schemes and practices in the prisons that many in the state would prefer to forget. Even the ADC's own website, which chronicles the prison system's history from 1838 to the present, omits the entire the span of years covered by this article.
But Roberts was willing to discuss them, perhaps because he opposed so much of what transpired during the administration of ADC Director A.L. “Art” Lockhart. Roberts went even further than discussing the prisons, the plasma program, and some of the politics that shaped them. He also volunteered that he had placed his own records from his years on the prison board in the library's Butler Center for Arkansas Studies and that they were available for examination.
The papers tell an ugly story of a prison system that was often described in newspapers at the time as a fiefdom controlled by three men: state Sen. Knox Nelson of Pine Bluff, state Rep. William F. “Bill” Foster of England and ADC Director Lockhart. There were allegations — some proven — that some in “the cartel,” as it was also called, used the prisons to enrich themselves, along with a cadre of local businessmen.
Roberts recalled it as a time when Nelson held the upper hand over Clinton with regard to the prison system, which was headquartered in his district. Roberts said Nelson made it clear to Clinton that, as chairman of the Senate Rules Committee, he would prevent legislation the governor wanted in other areas, such as schools, roads, and economic development, from ever reaching a vote if Clinton pressed for changes in the prisons.
“Knox and I got into it about everything under the sun,” Roberts said. “I don't think any governor was going to cross him — and a handful of other senators down there — and think he was going to get anything done.”
“There was a lot of politics that went on in those things. You could not do anything with the ADC if you ran afoul of Bill Foster and Knox Nelson. That's just the reality of it.”
Even so, Roberts bridles at the suggestion, made in Duda's film and elsewhere, that responsibility for the problem-riddled plasma program rests with the former governor. He admits that “the management down there was flawed,” that “some inmates were using their position to gain leverage,” and that, “certainly, that bunch that was running it was inept at best.”
But, he insists, “Those mistakes rest with me and the board, not the governor. I think that's what irritates me.”
Roberts said he was a member of the minority on the board that tried to tackle Lockhart, Nelson, Foster, and many of their prison programs. Because there were so many concerns, he says, “We weren't focused on plasma.”
A hateful way
Arkansas is one of the few states that does not pay inmates even minimal amounts for work. Yet most correction experts agree that inmates need money. For years, the justification offered for running a plasma program at all was that it offered inmates a way to make money that was acceptable to the citizens of Arkansas.
Roberts was acutely aware, as he put it, that people in prison “need a source of money.” Some tried to send a bit home to relatives. Others used it to purchase small commissary items such as paper and stamps. “Some of them,” he said, “would only get two apples for Christmas. It was an unfortunate set of circumstances.”
At the same time, Roberts understood public resistance here to allowing inmates to earn even minimal funds. “If we tried to do that in the General Assembly,” he said, “we wouldn't have gotten five votes for it. The only way for inmates in this state to get money — and it's a hateful way — was to sell plasma.”
Throughout most of the years the program endured, inmates who donated plasma were paid $7 a unit. They could participate twice a week.
As a board member, Roberts said he figured: “If we quit this project, who gets hurt? The inmates get hurt. I think I was willing to go along for that reason.”
In addition, it was understood that the ADC made some profit from its contract with the plasma wholesaler. Most news reports from the 1980s that mentioned the contract at all said the ADC took half the proceeds from the plasma operation.
But, as records in Roberts' files reveal, there was more to the plasma deal than consideration of inmates' needs — or even money to help run the state's prisons.
A time bomb
In the early '80s, the ADC contracted with Health Management Associates both to provide medical services in the prisons and to run the plasma program. HMA's president was Leonard Dunn, a Pine Bluff banker, whom Clinton later appointed to the Arkansas Industrial Development Commission. Dunn would eventually chair the finance committee for Clinton's final gubernatorial campaign.
But HMA ran into serious problems, both in delivering the prisons' overall medical services and in running the plasma program. It did not help, in Roberts' view, that Clinton had appointed HMA's attorney, Don Smith, to serve on the seven-member Board of Correction.
In January 1984, Roberts, who was not yet on the prison board, advised Clinton in a letter that he considered it improper for Smith “to be serving on a board that controls a five-million-dollar contract with a firm he represents.” In the same letter, Roberts warned Clinton that HMA was “a time bomb waiting to blow up in somebody's face.”
In fact, by the time Roberts wrote that letter, the time bomb had already exploded. Months earlier, in the summer of 1983, the FDA had learned that HMA had sold 38 units of plasma drawn from inmates who were known to have tested positive for hepatitis. The products were recalled, but not quickly enough.
Almost four thousand vials of product made from the unsafe plasma were sent around the world, many for use by hemophiliacs.
The following year, in 1985, Peter Longstaff in the U.K. tested positive for HIV.
In the wake of that disaster, four U.S. companies that fractionated plasma into blood products stopped accepting prison plasma. Centers such as Arkansas's had to begin looking for new buyers. They contracted with brokers who sold the plasma abroad.
But though state officials were willing to keep pumping inmate plasma onto the global market, problems in its operation were so severe that federal authorities blocked those plans — at least for a few months.
The FDA revoked Arkansas's plasma license in February 1984. The agency cited a litany of problems, including drawing plasma from disqualified donors, altering records and improperly storing plasma. At the same time, the agency issued a warning that prisoners were more likely than the general population to be infected with the AIDS virus.
The National Correctional Association responded to the alert. In 1984, it sent an “information bulletin” to its members, warning about plasma centers. In a section titled “Ethical and Moral Issues,” the bulletin noted that research showed that a higher percentage of prisoners were “illicit drug abusers before their incarceration,” and that, “because of the close living conditions of large groups of inmates, a high incidence of homosexual activity is found.”
The bulletin noted that the consumers of blood products were already concerned about the level of “quality control” in prison centers. Most U.S. prisons stopped operating plasma programs entirely at this time.
In Arkansas, however, plans were being made to restart the plasma program. And they continued, even when HMA's insurer dropped the company's coverage, in the summer of 1986. At that point, the prison board, which now included Roberts, hired an outside body, the Institute for Law and Policy Planning of Berkeley, Calif., to review HMA's performance. The ILPP returned a scathing report.
Though the ILPP report did not focus on the plasma program, it concluded with this note: “HMA originally may have diverted the ADC's payments to support acquiring plasma centers, or to other purposes that may well warrant further inquiry. In any event, it was early in the five-year contract period that HMA established a pattern of contract shortfalls, and ADC accepted them. For HMA, all this must be viewed as profit-motivated business decision making, at best. At worst, it calls for further inquiry.”
Roberts observed, “I don't have a particular problem with contracting, but those guys didn't know what they were doing. I think it was an insider, Pine Bluff deal. Those were companies set up specifically for doing business with the ADC.”
Not surprisingly, further inquiry was not forthcoming. Instead, the ADC negotiated to revive the plasma program, this time with a newly formed company, Pine Bluff Biological Products.
It was clearly a “profit-motivated business.”
The deal
At the time, a unit of plasma could be sold to an international blood broker for at least $50 per liter.
According to Roberts' records, PBBP reported collecting an average of 960 units of plasma a week in fiscal year 1986. Calculated at a conservative selling rate of $50 per unit, that volume of plasma grossed approximately $2.5 million that year.
According to PBBP's contract, the ADC was to receive $5 for every unit of plasma collected. So here's how the numbers looked in a year when the median income in Arkansas was half what it is today — and when the scourge of contaminated blood products was beginning to be felt around the world:
Of PBBP's $2.5 million in annual gross sales, $350,000 went to pay inmates their $7-per-unit fees.
The state of Arkansas collected $249,600 for prison operations.
PBBP had gross revenues of $1,896,969.
What the company netted is proprietary information. However, Arkansas's contract allowed PBBP to use the ADC's plasmapheresis center at the Cummins unit without charge, while the ADC provided all utilities and janitorial services, as well as “access” to inmates at approved units ”desiring to participate in the program.” That included busing some inmates to the center.
For its part, PBBP agreed to “assume responsibility/liability for all plasma product(s) produced.” The company was also required to maintain appropriate licensure and provide necessary professional staff, though the ADC also contributed inmates to work in the operation.
“I think the inmates were looked on sort of as little cows,” Roberts said.
That said, Roberts rejects critics' charges that Arkansas should have abandoned its plasma program as unsafe in the mid-1980s, when most other states did — and that it certainly should not have revived it, handing the contract to PBBP, after the FDA pulled HMA's license.
“At first, there was not much concern about the quality of the blood supply,” Roberts says. “Then the FDA came out with that study that said prison plasma was more likely to be tainted.
“I deny the premise. I disagree that prison plasma blood was more dangerous than what was coming out of the for-profit places in the free world. Out there, anybody could bleed anybody.”
Roberts bases his confidence in the state's plasma program on the fact that, unlike downtown plasma centers, the ADC had medical records on every inmate who participated. It knew who was safe to bleed, he says, and who wasn't.
Yet that defense suffers, even as Roberts offers it. He admits, “We always had problems with medical care. We had particular problems because of our history, because of having been more of a torture chamber, at times, than a prison.”
So, even as Roberts says he disagrees “with the whole damn premise” that prison plasma was riskier than its paid-for free-world counterpart, he acknowledges that, “That does not absolve us from what went on in actual implementation of the program.”
“We did not monitor it well,” he said, “and that's terrible.”
A dying program
PBBP made millions in the late 1980s on its contract with the ADC. But, by 1990, as the scale of the global Hepatitis C and HIV disaster began to be understood, PBBP found it increasingly difficult to find buyers. As a result, prices were plummeting.
An ADC official secretly amended the plasma contract, cutting the share of money the PBBP would pay to inmates and the state. Even so, the plasma center operated at a loss. When the renegotiated contract came to light, officials with the ADC and PBBP begged the board of correction to keep the program going – allegedly for the sake of the inmates.
PBBP's president, Jimmy Lord, told the board, “I think that it's a dying program, but I also think we will be in it as long as anyone else in the country.”
He was right. Arkansas was the last state in the United States to close its prison plasma operation. In March 1991, the board voted not to renew PBBP's contract.
By then, Roberts had been forced off the board. In 1988, he headed the library at the University of Arkansas at Little Rock, and Knox Nelson had found a law forbidding state employees from serving on state boards.
In Roberts' resignation letter to Clinton, he wrote: “There have been days when I was truly proud of the changes that we were able to make, and there were other times when the sadness of not being able to correct the problem was almost overwhelming.”
The “problem” he referred to was Lockhart. As Roberts put it in the letter, “I have only one regret about the whole experience and that is that when I had to leap over the cliff, I did not have Art by the nuts when I went down.”
In 1992, the year after the plasma program closed, Peter Longstaff tested positive for Hepatitis C. In March of that same year, as Clinton was running for president, his former chief of staff, Betsey Wright, sent a memo titled “prison positives.” That memo, a copy of which is in Roberts' files, mentioned four points, including, “education into prison by bc.” But the first point Wright listed was: “Run cheapest system in country.”
In 1994, Longstaff and Grayson began their campaign to expose how tainted blood had been able to make its way into their country.
In a recent interview by email, Grayson wrote, “My husband was so disgusted at the blood-for-money trade he began a very public treatment strike in 2000, refusing human plasma products from paid donors. He believed that paying people for their blood was immoral and exploited impoverished people around the world.”
“The most recent example of this is Henan province in China, where many villagers that sold their blood are now infected with HIV, as the blood-heads that collected the plasma re-used equipment. The safety [warnings] echoed those in U.S. prisons 20 years before, showing that lessons still needed to be learnt.”
Noting Clinton's recent efforts to lower the price of AIDS drugs for people in the developing world, Grayson added that she would soon be writing to the former president “to request that he addresses what happened in Arkansas” and to ask that he “calls for a global ban on the use of paid plasma donors.”
http://www.arktimes.com/articles/
articleviewer.aspx?ArticleID=3038e9e5-b309
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My Letter to the Editor - Arkansas Times
Friday, August 17, 2006
Mara Leveritt's August 16th article ("Bloody Awful") on the Arkansas Prison Blood Scandal is well written and insightful. We should all thank her for bringing more attention to this shameful period in Arkansas history, as well as the current attempts around the globe to receive justice for the victims.
I have appreciated Ms Leveritt's support on this subject. As someone who has investigated this subject for several years, I would nevertheless like to point out some important facts not covered.
The prison plasma program did not end in 1991 as the article states. Alpha Therapeutics ended its contract with Pine Bluff Biologics in 1990 and another company, PFE, Inc. out of California discontinued its contract with PBBP the following year, but CTM Industries out of New York took over the plasma harvesting operation at the Arkansas Department of Correction in 1991 for the next three years until the doors shut for good in the spring of 1994.
Also, it’s important to note that despite all its problems, Health Management Associates (HMA) was allowed to restart the program after the shutdown in 1984 prior to Pine Bluff Biologics being "awarded" the state contract.
Bobby Roberts asserts in the article that prison plasma was as safe as plasma from the outside world. It’s an absurd notion. Not only does it fly in the face of common sense, but several studies, prior to Roberts’ placement on the board, demonstrated that blood from prisoners was not safe.
In fact, twenty years before the advent of AIDS, the dangers of prison blood were well known due to the threat of viral hepatitis.
In the 1960s the CDC recognized that prisoners were a "high-risk group of plasma donors" for spreading hepatitis and other diseases. In 1970, Baxter-Hyland, a major drug company that used prison plasma in its products, conducted studies showing that prisoners had elevated liver enzymes levels for viral hepatitis. In 1974, a Cutter Labs memo from its Senior Vice President for Scientific Operations stated that, “Prison centers would not be suitable because of the high incidence of hepatitis in prisons.” A year later, the Stanford University Medical Center wrote to the FDA stating that blood and plasma products from inmate donors should not be administered to patients. In 1977, the American Medical Association demonstrated that 30 percent of inmates studied in a program to improve health care in jails had abnormal liver function tests. Then in 1982, as studies were beginning to show that prisoners were ten times more likely to be infected with HIV than the general population, the FDA warned against the further use of prison plasma in blood products in the U.S.
No matter how Mr. Roberts would like to spin it, the Arkansas Department of Correction’s plasma program with all its known problems, should never have been allowed to be re-open after the severe FDA violations, failed international recalls of tainted blood, and the revocation of the center’s license. Yet, it did reopen, under Gov. Clinton, for another decade.
Dying victims say that the Department of Correction, the former members of the Board of Correction and ex-Gov. Bill Clinton all have blood on their hands. I’d love to see all the players get together in the same room in an open forum and have to defend their positions. Then they’d be forced to face each other and the public…. Perhaps the Times woulld like to sponsor such an event.
Kelly Duda
Director of Factor 8: The Arkansas Prison Blood Scandal
Little Rock
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Researchers find hepatitis B clues in old northern blood
http://www.cbc.ca
CBC News
Samples collected 2 decades ago frozen in Alberta lab get high-tech analysis
A Canadian research scientist is using frozen blood samples, taken two decades ago from thousands of people across the North, in hopes of revealing new clues about hepatitis B.
The 14,000 samples, collected about 20 years ago from people in communities across the Northwest Territories and modern-day Nunavut, have since been kept frozen in an Alberta laboratory.
Now, as part of an International Polar Year research project, scientists are putting the samples through current research technology to learn more about various strains of the blood-borne virus.
"This is a tremendous resource, really, for Canada and particularly for the Arctic region, because I can say that there really is no other sample set like this in the world," said Dr. Carla Osiowy, a research scientist with the Public Health Agency of Canada's National Microbiology Lab in Winnipeg.
"It's providing us with a snapshot in time of what has occurred with hepatitis B virus."
Osiowy said she has found a new sub-genotype — a strain within a strain — of hepatitis B among people in Nunavut, related to a strain found in Japan. She said this particular strain produces a milder form of the disease in which those infected carry the virus but are otherwise healthy.
"Therefore, we're very interested in knowing whether this particular new sub-genotype is highly prevalent in the North," Osiowy said.
"It may allow us to possibly predict what we may expect as a future clinical outcome in this particular population, based on what we know from a very small sample subset."
During the mid-1980s, Dr. Bryce Larke — now the Yukon's chief medical health officer — and nurse Glory Froese travelled to arenas, bingo halls, schools and even a liquor store in 51 communities, taking blood samples from Inuit, aboriginal, Metis and non-aboriginal individuals.
Their work was part of an effort to pinpoint which communities had higher infection rates of hepatitis B to determine which communities most needed an expensive new vaccine to fight the virus. They found Inuit and aboriginal peoples had higher infection rates than other Canadians.
The original study searched for an antibody, or viral protein, in the blood samples. Osiowy said she can now use modern technology on the 20-year-old samples to find out more about what's in the blood.
"Now we have the means to do a molecular detection. With these techniques, I'm able to do a more thorough analysis of the virus that was found in those individuals that were infected."
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Intercell AG / other / Intercell´s therapeutic Hepatitis C vaccine meets primary endpoints in Phase II interim analysis
http://www.n-tv.de
First data from 25 patients reveals statistically significant viral load reduction and very good safety profile
Data opens door for therapeutic vaccination in the arena of existing and future treatment options - but not yet a breakthrough for vaccination as monotherapy
Data still has to be interpreted with caution given the small sample size - full study data expected for Q1 2008
Vienna, Austria, 20 August 2007. Today, Intercell AG (ICLL) announced the analysis of Phase II interim data for its peptide-based therapeutic Hepatitis C vaccine (IC41) in an exploratory clinical study targeting treatment-naïve Hepatitis C patients. The vaccine comprises eight T-cell antigens and Intercell´s first-generation poly-arginine adjuvant (IC30). It is designed to stimulate T-cell responses against viral protein structures conserved throughout the major HCV genotypes, in order to reduce viral load in the blood of chronically infected patients.
The current study comprises 50 patients chronically infected with Genotype 1 of the Hepatitis C virus, which is known to be very difficult to treat with Interferon/Ribavirin standard therapy. The patients enrolled in the study have not received any other therapy and were given 8 intradermal injections of the IC41 vaccine in bi-weekly intervals for 14 weeks. This intensified vaccination schedule was derived from a recent optimization study aimed at improving the vaccine´s T-cell immune response. The desired outcome of the ongoing study is the demonstration of a constant and sustaineddecline in HCV viral load that is increased by reiterative vaccinations during the treatment period.
In the current interim analysis, 25 patients have been evaluated in the "per protocol" population. The data obtained shows that the primary endpoint set for this study, namely a statistically significant sustained HCV- RNA decline, has been met. In the second week after the final vaccination, a 40 % reduction of viral load (0.2log) was observed in comparison to the baseline prior to vaccination.
The therapeutic effect of the vaccine on the viral load is small, but found to be significant when data was submitted for rigorous statistical analysis (p=0.0178).
The results are especially significant in the light of the observation that viral load reduction is increasing with the number of vaccinations and is most pronounced two weeks after the vaccination schedule has been concluded. The study included patients with various levels of viral loads. In the subset of patients (N=12) with high viral load (> 2 million copies/ml) before treatment, a statistically significant (p=0.0168) average decline of 60 % (0.4 log) was achieved. Thus, it seems that the therapeutic effect is morepronounced when the patients´ immune system is unable to keep the viral load in check.
Final results of the study with the full set of patients and an analysis of HCV-RNA and T-cell responses until 24 weeks after the last vaccination are expected in early 2008. Furthermore, an extendedanalysis of how the therapeutic effect relates to the induction of T-cell responses has to be awaited until the final outcome of the trial.
Although the interim analysis is restricted by the limited number of subjects evaluated at this stage, the present findings - if confirmedby the final data - would indicate for the first time that a therapeutic vaccination schedule is able to reduce HCV viral load and has thereby potentially opened a new door for HCV treatment.
Although options for the treatment of chronic Hepatitis C with Interferon/Ribavirin have improved, treatment will remain very difficult and a significant unmet medical need, especially in the case of Genotype 1. Immunotherapies, and possibly therapeutic vaccines, might become an option in the arena of existing and future HCV combination treatments. Thus, Intercell and its co-development partner for therapeutic Hepatitis C vaccines, Novartis, will define afurther development strategy that might also take advantage of an enlarged antigen portfolio and of IC31®, Intercell´s second-generation adjuvant that has recently demonstrated the generation of T-cell responses, in human vaccine trials, to a level not yet seen for other known adjuvants.
"The new data obtained encourages us very much to further strengthen our HCV franchise and to accelerate our efforts towards obtaining an HCV therapeutic vaccine", states Gerd Zettlmeissl, CEO of Intercell.
About Hepatitis C
HCV is a major cause of chronic liver disease, including cirrhosis and liver cancer. According to the World Health Organization (WHO), approximately 170 million people worldwide are chronic HCV carriers (3% of the world´s population), including about 10 million Europeans, 3.9 million Americans and 2 million Japanese. 35,000 new infections occur in the United States alone each year. The Substantial unmet medical need is underscored by the fact that each year 8,000 to 10,000 deaths and 1,000 liver transplants in the United States are due to HCV. Currently, there is no vaccine against Hepatitis C and the infection can only be treated with a combination of Interferon and Ribavirin - a long-term therapy with limited efficacy and substantial side effects. It also gives rise to high treatment costs for patients. In 2002, worldwide sales of HCV drugs totalled around EUR 2.8bn, and demand has since grown significantly.
The market has been seen to expand to about EUR 3.5bn by 2006.
Further inquiry note:
Contact Intercell AG:
Gerd Zettlmeissl, CEO
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-121
Mail to: gzettlmeissl@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market
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Six Diseases of the Liver, Six Different Viruses, One Name: Hepatitis
http://www.voanews.com
Millions of people get hepatitis. Some become very sick. Others never even know they are infected.
Transcript of radio broadcast:
20 August 2007
VOICE ONE:
This is SCIENCE IN THE NEWS in VOA Special English. I’m Barbara Klein.
VOICE TWO:
And I’m Steve Ember. This week, we will tell about six diseases of the liver. The six diseases come from six different viruses. Doctors have one name for all of them: hepatitis.
VOICE ONE:
The liver is in the upper right part of the stomach area. This dark red organ is big -- it weighs more than one kilogram. And it has a big job. The liver helps clean the blood and fight infection. It also helps break down food and store energy until the body needs it.
Hepatitis destroys liver cells. Some kinds of hepatitis are much more serious than others. Scientists have identified the six kinds of hepatitis with the letters A, B, C, D, E and G. Which kind a person has can only be known from tests for antibodies in the blood.
Antibodies are special proteins that the body's natural defense system produces in answer to a threat. Identify the antibody and you identify the threat.
VOICE TWO:
Hundreds of people waited for hepatitis vaccinations at a hospital in Massachusetts in 2004 after an employee at a local restaurant developed hepatitis A.
Hepatitis A is usually spread through human waste in water or food. It is in the same group of viruses as those that cause the disease polio.
The hepatitis A virus causes high body temperature, weakness and pain. It causes problems with the stomach and intestines, making it difficult to eat or break down food. Also, the skin of a person with hepatitis may become yellow. This is a sign that the liver is not operating normally.
To help prevent the spread of hepatitis A, people should wash their hands after they use the restroom or change a baby's diaper. People should also wash their hands before they eat or prepare food.
VOICE ONE:
Hand washing can prevent the spread of hepatitis A
Hepatitis A can spread quickly to hundreds or thousands of people. But the virus is deadly in less than one percent of cases. Many people infected with the virus never even get sick. But those who do generally recover within two months.
The World Health Organization says hepatitis A is often found in Africa, Asia and Central and South America. People who have had hepatitis A cannot get it again. There is a vaccine to prevent hepatitis A. America's Centers for Disease Control says the vaccine is the best way to protect against the disease.
VOICE TWO:
The World Health Organization says hepatitis B is one of the major diseases of mankind. W.H.O. officials say two billion people are infected with the hepatitis B virus. More than three hundred fifty million of those infected have lifelong infections. The highest rates are in developing countries.
This virus is in the same group as the herpes and smallpox viruses. Hepatitis B vaccines have been given since the early nineteen eighties. The W-H-O says the vaccine is ninety five percent effective in preventing the development of infection in both children and adults.
VOICE ONE:
Hepatitis B spreads when blood from an infected person enters the body of another person. An infected mother can infect her baby. The virus can also spread through sex, and if people share injection devices.
Blood products from an infected person can spread hepatitis B. People also can get infected if they share personal-care products that might have blood on them. Examples include toothbrushes and hair-cutting equipment like razors.
VOICE TWO:
Worldwide, most hepatitis B infections are found in children. Young children are the ones most likely to develop a lifelong, or chronic, infection. The risk of such an infection is small for children older than four years.
About ninety percent of babies infected with hepatitis B during the first year develop chronic infections. Such persons are at high risk of death from liver disease or liver cancer. The hepatitis B vaccine is considered to be the first medicine that can protect people against liver cancer.
VOICE ONE:
Hepatitis C is even more dangerous. Like hepatitis B, it spreads when blood from an infected person enters someone who is not infected. The hepatitis C virus belongs to the same group of viruses as yellow fever and West Nile virus.
Most people infected with hepatitis C develop chronic infections, often without any signs. They are at high risk for liver disease and liver cancer.
The World Health Organization says about one hundred eighty million people are infected with hepatitis C. The W.H.O. reports that as many as four million more become infected each year. And it says that one hundred thirty million of those with the disease may develop diseases of the liver, including liver cancer. The W.H.O. says the highest rates of infection are in Africa, Latin America and Asia.
VOICE TWO:
Scientists have been working to develop a vaccine against hepatitis C. The virus was first observed in nineteen seventy-four. But it was not officially recognized as a new kind of hepatitis until nineteen eighty-nine.
The Centers for Disease Control says about four million Americans have been infected with hepatitis C. It says that those especially at risk include persons who inject themselves with drugs and those who received blood or blood products before nineteen ninety.
VOICE ONE:
Hepatitis D is also spread through blood, but only infects people who already have hepatitis B. The virus greatly increases the chance of severe liver damage. Experts say hepatitis D infects about fifteen million people around the world.
Doctors say the best way to prevent hepatitis D is to get vaccine that protects against Hepatitis B. Doctors can treat some cases of hepatitis B, C and D. The drugs used are very costly, however. But they are less costly than another treatment possibility: getting a new liver.
VOICE TWO:
The fifth virus is hepatitis E. Experts say it spreads the same way as hepatitis A -- through infectious waste. Cases often result from polluted supplies of drinking water. Medical science recognized hepatitis E as a separate disease in nineteen eighty.
Hepatitis E is also found in animal waste. Studies have shown that the virus can infect many kinds of animals, including cows, monkeys and pigs.
VOICE ONE:
The W.H.O. says many hepatitis E cases have been reported in Central and Southeast Asia, North and West Africa and Mexico.
No vaccines or medicines are effective against hepatitis E. Most people recover, usually in several weeks or months. But the disease can cause liver damage. And, in some cases, hepatitis E can be deadly.
The virus is especially dangerous to pregnant women. Twenty percent of women with hepatitis E die in the last three months of pregnancy.
VOICE TWO:
Scientists discovered yet another kind of hepatitis in the nineteen nineties. It has been named hepatitis G. The hepatitis G virus is totally different from any of the other hepatitis viruses.
Donald Poretz is an infectious disease specialist and professor at the Georgetown University School of Medicine in Washington, D.C. He says the hepatitis G virus is spread through blood and blood products. But he says the virus has not yet been found to cause any real disease.
VOICE ONE:
There are no cures for any kind of hepatitis. The only way to protect against infection is to receive vaccines against hepatitis A and B, and avoid contact with the other viruses. And that may be very difficult.
Remember that some kinds of hepatitis spread through sex or sharing needles. Blood products should be carefully tested for hepatitis. People in high-risk groups and those who have had hepatitis should not give blood. They also should not agree to provide their organs to others after they die. Donated organs can also spread hepatitis.
VOICE TWO:
Health experts say people can take other steps people to protect themselves. These include always washing your hands with soap and water after using the restroom. Also, wash your hands after changing a baby's diaper and before preparing or eating food.
Experts also say travelers should not drink water of unknown quality when visiting foreign or unknown areas. Visitors to such areas also should avoid eating uncooked fruits and vegetables. And, again, do not forget to wash your hands!
VOICE ONE:
This SCIENCE IN THE NEWS was written by Nancy Steinbach. Our producer was Brianna Blake. I’m Barbara Klein.
VOICE TWO:
And I’m Steve Ember. You can download transcripts and audio of our programs, at voaspecialenglish.com. Listen again next week for more news about science in Special English on the Voice of America.
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An Adaptor By Any Other Name
http://www.the-scientist.com
Volume 21 | Issue 8 | Page 65
By Kerry Grens
Four groups simultaneously identify the same adaptor in the viral RNA immune-response pathway.
Cells have evolved numerous ways to detect viral infection and set off the immune system's alarms. Extracellularly, Toll-like receptors spot double-stranded viral RNA, while inside the cell retinoic acid-inducible gene I ( RIG-I ) and melanoma differentiation-associated gene 5 ( Mda-5 ) are responsible for detecting viral RNA. Ultimately, through a sequence of activating events - with the complete set of steps yet to be characterized - all roads lead to interferon production, but some viruses are able to evade the system by exploiting weak links.
Inside four weeks, in 2005, four independent groups identified a missing link in the chain from the initial detection of viral RNA to the activation of downstream kinases. Two of the resulting publications are Hot Papers. Lead by Zhijian (James) Chen at the University of Texas Southwestern Medical Center, the first group to publish christened the adaptor MAVS, for mitochondrial antiviral signaling.1 The following week Hong-Bing Shu at Wuhan University in China and his colleagues called the same protein a virus-induced signaling adaptor, or VISA.2 Shizuo Akira's group at Osaka University called it interferon-beta promoter stimulator 1 (IPS-1),3 and Jürg Tschopp at the University of Lausanne in Switzerland and his colleagues named the adaptor Cardif.4 (The teams all found the adaptor by searching for proteins with a CARD domain that would link it to RIG-I.)
These papers established the importance of the RIG-I pathway and "opened up this field of research into sensing and responding to viral infection," says John Hiscott at McGill University's Jewish General Hospital. Though there's no agreement on a name, for the most part the findings are the same: Overexpression of the adaptor leads to activation of two transcription factors, interferon regulatory factor 3 and NF- κ B, which drive antiviral gene expression. Moreover, depleting the adaptor wiped out RIG-I-mediated antiviral immune response. Following up with in vivo knockout studies in mice, Chen's and Akira's groups in 2006 confirmed the findings.
Idiosyncrasies
In 2004 two groups identified the initial detection elements that signal the presence of intracellular viral RNA. Immediately investigators around the globe began searching for downstream proteins in the pathway. Chen says he had "no idea" his group was racing neck and neck with several others to identify RIG-I's adaptor.
Each paper makes slightly different observations about the adaptor. For example, Tschopp's group found that Cardif binds to a certain kinase complex called IKK, whereas Chen's group found no direct interaction between the two. Shu's team found the adaptor required the signaling protein TRAF6 to activate a transcription factor, while Akira's group found the opposite. There are numerous disparities, but Akira says that overexpression experiments can cause inconsistencies. Several groups are working to resolve precisely the proteins with which the adaptor associates. Recently, investigators found that the signaling protein TRAF3 associates with the adaptor and is essential for antiviral immune responses on the RIG-I pathway,5 while Hiscott's group identified another adaptor in the pathway that operates on a kinase complex downstream of the first adaptor.6
Exploitations
Perhaps the most significant distinction among the papers was the observation by Chen's team that the adaptor has a mitochondrial transmembrane segment, which is necessary to signal the immune response (see "Mitochondrial immunity," The Scientist , 21(1):58, 2007). "Before, we never knew mitochondria were involved in the immune response," Chen says. "It was something of an enigmatic observation at the time," says Hiscott.
It turns out that the adaptor's association with mitochondria is the Achilles' heel of the viral RNA detection pathway. Tschopp's group showed that a serine protease from hepatitis C cleaves the adaptor, leaving only an impotent segment in the mitochondrial membrane and thereby blocking the cell's antiviral response. "It's one of the reasons why hepatitis C establishes chronic infection in human," Chen says.
Hiscott's group followed up in 2006 and proposed that the hepatitis C protease disrupts an association between the adaptor and one of the cell's kinase complexes, IKK epsilon.7 "How important this is for innate immune signaling remains to be resolved," Hiscott says. It is still unclear why the adaptor has to be on the mitochondrial membrane to work, says Chen.
Researchers are also trying to identify which of the other viruses short circuit the immune response system and succeed with infection. Chen says he is working on herpes and respiratory syncytial virus, while others this year have found that hepatitis A operates similarly to hepatitis C by proteolyzing the adaptor, chopping it off the mitochondria, and disrupting the immune response.8
These Hot Paper findings also have implications for neurodegenerative disease research. Yue Huang, a researcher in Glenda Halliday's laboratory at New South Wales University in Randwick, Australia, says the findings support a hypothesis of sporadic Parkinson disease that involves viral infection and mitochondrial dysfunction. However, Huang writes in an e-mail, "the signaling cascade mediated by MAVS/VISA in PD remains unknown."
References
1. R.B. Seth et al., "Identification and characterization of MAVS, a mitochondrial antiviral signaling protein that activates NF- κ B and IRF 3," Cell , 122:669-82, 2005. (cited 127 papers) [PUBMED]
2. L.G. Xu et al., "VISA is an adapter protein required for virus-triggered IFN- β signaling," Mol Cell , 19:727-40, 2005. (cited in 108 papers) [PUBMED]
3. T. Kawai et al., "IPS-1, an adaptor triggering RIG-I and Mda5-mediated type I interferon induction," Nat Immunol , 6:981-8, 2005. (cited in 127 papers) [PUBMED]
4. E. Meylan et al., "Cardif is an adaptor protein in the RIG-I antiviral pathway and is targeted by hepatitis C virus," Nature , 437:1167-72, 2005. (Cited in 135 papers) [PUBMED]
5. S.K. Saha et al., "Regulation of antiviral responses by a direct and specific interaction between TRAF3 and Cardif," EMBO J , 25:3257-63, 2006. [PUBMED]
6. T. Zhao et al, "The NEMO adaptor bridges the nuclear factor- κ B and interferon regulatory factor signaling pathways," Nat Immunol , 8:592-600, 2007. [PUBMED]
7. R. Lin et al., "Dissociation of a MAVS/IPS-1/VISA/Cardif-IKKepsilon molecular complex from the mitochondrial outer membrane by hepatitis C virus NS3-4A proteolytic cleavage," J Virol , 80:6072-83, 2006. [PUBMED]
8. Y. Yang et al., "Disruption of innate immunity due to mitochondrial targeting of a picornaviral protease precursor," Proc Natl Acad Sci , 104:7253-8, 2007. [PUBMED]
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Texas To Establish State's First Needle-Exchange Program
http://www.emaxhealth.com
The Commissioners Court in Bexar County, Texas, on Wednesday unanimously voted to move forward with a pilot initiative that will establish the state's first needle-exchange program, the San Antonio Express-News reports (Finley, San Antonio Express-News, 8/15).
The Texas House in May voted 71-60 to approve a provision in a Medicaid bill (SB 10) that would establish the state's first needle-exchange program in Bexar County, which includes San Antonio. Rep. Ruth McClendon (D), who sponsored the provision, initially tried to add an amendment that would have created a statewide program. However, the program was limited to the San Antonio area after the broader program failed to gain support in the House.
According to McClendon, needle-exchange programs help to curb the spread of bloodborne diseases, including HIV and hepatitis C, among injection drug users. Rep. Dianne White Delisi (R), who sponsored the Medicaid bill, did not dispute the potential public health benefits of an exchange program but said that Texas residents are concerned about whether "promoting the free exchange of needles for the illegal use of intravenous drugs is something the state should be doing." Texas is the only state that does not have a needle-exchange program (Kaiser Daily HIV/AIDS Report, 5/24).
The court voted to approve spending $60,000 for a staff position and planning costs for the program beginning in October. The program likely will cost more when it begins operations, and organizers plan to seek funding from private groups to offset costs. A working group of health and government officials is designing the program and plans to launch it Jan. 1, 2008, the Express-News reports. Advocates of the program hope that if it is successful, it will be easier to pass a statewide program during the next legislative session. According to Fernando Guerra, director of the health district, about 200 new HIV cases were reported in Bexar County last year, 10% of which were among IDUs. One can "appreciate the burden of disease and the high cost" when those cases are added to the several thousand cases of hepatitis C in recent years, Guerra said.
According to the Express-News, District Attorney Susan Reed recently said that the law authorizing the exchange program is faulty. The court when approving the program expressed hope that any legal issues could be resolved, the Express-News reports (San Antonio Express-News, 8/15).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.
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Can-Fite Successfully Completes Preclinical Trials With Its Second Drug Candidate CF102
http://www.pharmalive.com
PETACH TIKVA, Israel--(BUSINESS WIRE)--Aug 20, 2007 - Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced today the successful completion of preclinical trials with CF102, the second molecule in the Company's development pipeline, which is the basis for a drug indicated for the treatment of liver cancer and hepatitis. Success of the preclinical trials will enable Can-Fite to submit to the US Food and Drug Administration (FDA) an application for phase I human clinical trials. The Company estimates that the clinical phase of the trials will begin in the up-coming months.
Can-Fite VP Drug Development Dr. William Kerns: "CF102 has been evaluated in an IND enabling pharmacokinetic, metabolism, toxicology and safety pharmacology program in the US and Europe. Theses preclinical studies progressed smoothly and no issues that could adversely affect the clinical development program were identified. In particular, CF102 has been shown in these pre-clinical studies to be safe. CF102 is thus positioned to move forward to Phase 1 clinical trials. The company plans to file an IND and commence Phase 1 during the next couple of months," stated Dr William Kerns, VP Development for Can-Fite.
With the initiation of the CF102 clinical trial, Can-Fite will have two pipeline drugs in humans for diverse indications including cancer, autoimmune inflammatory disease and viral diseases.
CF102 binds with high selectivity and specificity to the A3 Adenosine Receptor, which is over-expressed on the cell surface of liver cancer cells. Laboratory studies have shown that CF102 induces apoptosis of liver cancer cells. Liver cancer affects about 450,000 new patients each year and is highly prevalent in people infected with hepatitis virus and in alcohol abusers. This type of cancer is particularly common in Eastern countries, due to the high proportion of people infected with the hepatitis virus. The current market share for liver cancer is estimated at about USD 0.5 billion due to lack of appropriate treatment.
CF102 belongs to a chemical class of substances called nucleosides, known to act as antiviral agents. Laboratory studies conducted by the Company in collaboration with a leading laboratory at Temple University in Philadelphia show that CF102 is also active against the hepatitis virus. The number of individuals infected with hepatitis B and C worldwide is 350 million and 170 million, respectively, and these numbers are rapidly increasing in recent years. The market share is currently about USD 3 billion annually due to lack of appropriate treatments.
Prof. Pnina Fishman, CEO of Can-Fite, said today: "We are very pleased with the rapid progress in the development of CF102 and with the impressive results obtained in preclinical studies which will enable the Company to proceed into human clinical trials within several months. This drug is added to CF101, which is being developed for three indications: rheumatoid arthritis, psoriasis and dry eye syndrome."
Can-Fite recently reported the results of a phase IIb trial with CF101 for the treatment of rheumatoid arthritis. Following these results, the company decided to further pursue the development of this indication. A decision will be made in the near future about the nature of further development and type of trials required.
CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, a Rabin Medical Center investigator, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Fishman and focuses on the development of molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development.
Can-Fite currently has two drugs in development, CF101 and CF102. The company is simultaneously conducting several clinical and preclinical trials with the two drugs for various indications. CF101 is being studied for the treatment of rheumatoid arthritis, dry eye syndrome and psoriasis. Can-Fite has also begun the development of CF102 for the treatment of liver cancer and hepatitis is also underway.
Contact
Can-Fite BioPharma
Pnina Fishman, Ph.D., +972-3-9241114
Chief Executive Officer
Fax: +972-3-9249378
pnina@canfite.co.il
http://www.canfite.com/
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Age Is Found No Barrier to Liver Transplants
http://www.medpagetoday.com
By Michael Smith,
Senior Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD;
Associate Clinical Professor of Medicine,
University of California, San Francisco
LOS ANGELES, Aug. 20 -- Being 70 or older is no barrier to a liver transplant, researchers here said.
In an 18-year review of more than 900 orthotopic liver transplants, there was no survival difference between patients who were 70 or older and those who were ages 50 through 59, according to Ronald Busuttil, M.D., Ph.D., of the UCLA, and colleagues.
On the other hand, four other biological or physiological variables (of 26 considered) were found to be significant or near-significant predictors of death, Dr. Busuttil and colleagues reported in the August issue of Archives of Surgery.
The four were:
- Cirrhosis caused by hepatitis C and alcohol, which carried a relative risk of death of 2.52, with a 95% confidence interval from 1.32 to 4.54, and was significant at P=0.006.
- Preoperative hospitalization, which carried a relative risk of death of 1.54, with a 95% confidence interval from 1.05 to 2.28, and was significant at P=0.03.
- An increasing Model for End-stage Liver Disease (MELD) score, which carried a relative risk of death of 1.014 per point, with a 95% confidence interval from 1.002 to 1.029, and was significant at P=0.04.
- A prolonged period of cold storage between liver removal and transplantation, which carried a relative risk of death of 1.03 per hour, with a 95% confidence interval from 0.99 to 1.08, and was borderline significant at P=0.08.
But when the researchers compared survival outcomes -- between the 62 patients who were 70 or older at the time of transplant and the 864 who were in the younger group -- there was no significant difference.
Specifically, one-year, three-year, five-year and 10-year survival among the older group was 73.3%, 65.8%, 47.1%, and 39.7%, respectively. The comparable figures for the younger group were 79.4%, 71.5%, 65.3%, and 45.2%.
There was also no significant difference in overall survival, the researchers found -- although the relative risk of death was 1.28 in the older patients compared with the younger group, the P-value was 0.27
Indeed, the longest surviving patient was 88 at 15 years after transplantation, Dr. Busuttil and colleagues said.
The researchers said the study was limited by the small number of patients 70 or older, but added that it confirms previous work showing the importance of pre-transplant hospitalization and cold storage time.
The study implied that "biological and physiological variables may play a more important role than advanced age in predicting poor survival after liver transplantation," the researchers concluded.
When physicians evaluate older transplant patients, the process should include measures of physiological age and risk of complications, they added, noting that "chronological age by itself is not a sole predictor of outcome."
Action Points
- Explain to interested patients that an increasing number of patients 70 or older need liver transplants for various reasons.
- Note that this study suggests that age alone has little effect on survival, while other factors, including cirrhosis caused by Hepatitis C and alcohol, play a major role.
The researchers made no declaration of conflicts and did not report any outside support for the study.
Primary source: Archives of Surgery
Source reference:
Lipshutz GS et al. "Outcome of Liver Transplantation in Septuagenarians: A Single-Center Experience." Arch Surg. 2007;142(8):775-784.
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August 21st, 2007
EMEA Recommends Orphan Drug Designation for PI-88
http://www.therapeuticsdaily.com
PR Newswire Europe (inc. UK Disclose)
SYDNEY, Aug. 15 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited today announced that the Committee for Orphan Medical Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has adopted a positive opinion recommending the granting of orphan medicinal product designation for PI-88 for the treatment of hepatocellular carcinoma, or primary liver cancer.
The Committee's orphan medicinal products opinions are submitted to the European Commission for orphan designation determination. The orphan drug designation will become effective upon adoption of this recommendation by the European Commission. This is expected to occur before the end of the third quarter of 2007.
The EMEA's orphan drug program is designed to promote the development of drugs to treat rare life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union (EU). The designation provides EU market exclusivity for up to ten years in the given indication. Other potential benefits include: a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval, and EMEA guidance in preparing protocols concerning studies relevant for approval.
PI-88 is part of a new class of multi-targeted cancer therapeutics inhibiting both angiogenesis (or tumour promoting) factors such as Vascular Endothelial Growth Factor (FEGF), Fibroblast Growth Factors (FGF) 1 and 2, and heparanase, a degrading enzyme implicated in metastasis (tumour spread). Progen will this year launch a multi-national two-armed, double-blinded placebo controlled Phase 3 trial using PI-88, with the primary endpoint of disease free survival, in patients with post-operative primary liver cancer. The goals of PI-88 treatment in this population are to reduce disease recurrence, prolong the time to recurrence (known as disease-free survival time) and improve the overall survival time of patients after tumour resection. Additionally, the Company is currently conducting a Phase 2 trial in patients with melanoma, the other indication in which we have received U.S. FDA orphan drug designation, with results from this trial expected during the second half of 2008.
Mr. Justus Homburg, Chief Executive Officer of Progen commented: "While the incidence of primary liver cancer in the European Union is relatively low, with over half a million new cases elsewhere in the world, it is a disease of significant global relevance. We are honored by the Committee's decision and support in our efforts to develop PI-88 for liver cancer."
About Progen: Progen Pharmaceuticals Limited is an Australian-based globally focused biotechnology company committed to the discovery, development and commercialisation of small molecule therapeutics primarily for the treatment of cancer.
Progen Information:
Justus Homburg
Progen Pharmaceuticals Limited
T: +61 7 3842 3333
E: justush@progen-pharma.com
Noreen Dillane
Progen Pharmaceuticals Limited
T: +61 7 3842 3333
E: noreend@progen-pharma.com
Media and Investor Relations Australia:
Rebecca Piercy
Buchan Consulting
T: +61 2 9237 2800 / +61 422 916 422
E: rpiercy@bcg.com.au
Rebecca Wilson
Buchan Consulting
T: +61 417 382 391
E: rwilson@bcg.com.au
Media Relations USA:
Robert D. Stanislaro
FD
T: +1 212-850-5657
E: robert.stanislaro@fd.com
Investor Relations USA:
Evan Smith
FD
T: +1 212-850-5606
E: evan.smith@fd.com
This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for clinical testing, patient recruitment, delays in the conduct of clinical trials, market acceptance of PI-88, PI-166 and other drugs, future capitals needs, general economic conditions, and other risks and uncertainties detailed from time to time in the Company's filings with the Australian Stock Exchange and the United States Securities and Exchange Commission. Moreover, there can be no assurance that others will not independently develop similar products or processes or design around patents owned or licensed by the Company, or that patents owned or licensed by the Company will provide meaningful protection or competitive advantages.
Progen Pharmaceuticals Limited
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August 22nd, 2007
Health officials: Exchange program lowers hepatitis B infection rates
http://times-standard.com
Jessie Faulkner/The Times-Standard
In the more than six years since Humboldt County's needle exchange programs began handing out clean needles there has been a marked reduction in hepatitis B rates on the North Coast, the county's top health official said Tuesday.
In her report to the board, Dr. Ann Lindsay said that historically, a relatively high percentage of hepatitis B cases in Humboldt County were caused by intravenous drug use. The reduction comes not only from the ability to exchange dirty syringes for clean ones -- the heart of the six programs -- but the ongoing effort to vaccinate those who test positive for the disease.
Until 2006, the board had to declare a state of emergency every two weeks to continue the programs. That is no longer required after Assemblywoman Patty Berg's successful legislation authorizing local governments to operate clean needle programs, in consultation with the state Department of Health Services.
”Humboldt County was one of the first counties to enact a needle exchange program when it became legal to do so,” Lindsay said.
That program runs without public funds, relying greatly on the sponsoring clinics, Lindsay said.
Documenting the program's success in reducing HIV and hepatitis C infection rates takes longer to determine. However, Lindsay said, a recent study concluded that while it costs a needle exchange program $27,000 to prevent one case of AIDS, it costs $270,000 to treat one case of AIDS.
In a review of 102 cities nationwide with needle exchange programs since 2002, there's been an 18 percent decrease in HIV infection, Lindsay said. Conversely, in cities without needle exchange programs, the infection rate has increased 8 percent.
The program is not without complications -- part of those being financial. Lindsay said she'd like to be able to use state dollars to purchase syringes, a practice that is currently illegal. That would change under Assemblyman John Laird's proposed legislation, Assembly Bill 110. The bill would allow local agencies to purchase syringes for needle exchange programs with state HIV prevention and education funds, according to Laird's Web site.
The board voted unanimously to accept Lindsay's report and bring information about Laird's proposed legislation and a support letter for related grant applications back in the future.
Jessie Faulkner can be reached at 441-0517 or jfaulkner@times-standard.com.
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August 23rd, 2007
IBM and University Scientists Launch Global Computing Effort to Find Cures for Dengue, West Nile, and Hepatitis C Diseases
http://biz.yahoo.com
Researchers Say the 50,000 Years of Computer Time Needed to Discover Cures May Be Achieved in One Year Using World Community Grid
HOUSTON, TX--(MARKET WIRE)--Aug 23, 2007 -- In an effort to halt the spread of deadly infectious diseases now threatening to reach epidemic proportions around the world, an unprecedented research effort was launched today by IBM (NYSE:IBM - News), The University of Texas Medical Branch (UTMB), and the University of Chicago to discover drugs to treat and cure dengue fever, West Nile encephalitis, hepatitis C, and a host of related diseases including yellow fever.
Dengue fever, found throughout the world's tropical and subtropical regions, and West Nile virus, which affects Africa, Asia, Europe, and most recently, the United States, have no known drug treatments. These diseases are primarily passed to adults and children by infected mosquitoes, and are responsible for millions of illnesses, as well as thousands of deaths each year. With no available cures, these infections severely burden strained medical resources in developed and developing countries.
The project, "Discovering Dengue Drugs - Together," will use the vast computational power of World Community Grid, a virtual supercomputer comprised of hundreds of thousands of individuals who donate their unused computer time, making it as powerful as one of the world's top five supercomputers. Calculations will be run on World Community Grid to find drugs that will stop the replication of the viruses that cause dengue fever, West Nile encephalitis, hepatitis C, and yellow fever. Once the compounds are identified through exhaustive computational analysis, researchers can begin testing these drugs in laboratories and clinics to determine their effectiveness.
"Infectious diseases create not only illness, but also poverty," according to Dr. Ayo Oduola of the World Health Organization's Special Programme for Research and Training in Tropical Diseases. "For example, dengue fever is a serious and growing public health problem affecting millions of people and there are no drugs to treat it. Continued research is needed to better understand the four dengue viruses and to develop drugs that could help reduce the burden of disease and to save lives."
Researchers estimate that about 50,000 years of computational time is needed to complete the calculations necessary to discover effective antiviral drugs. Running on World Community Grid, this project may be completed in less than one year. The more computer power volunteered, the faster the research will be conducted.
Dr. Stan Watowich, lead researcher and Associate Professor of Biochemistry at UTMB, says, "Without World Community Grid, we would have to make inexact, simplifying assumptions that have proven to be obstacles to previous drug development efforts. World Community Grid enables us to perform comprehensive calculations that yield accurate biochemical results, and therefore give us the best chance to discover cures for these serious worldwide diseases."
The first phase of the project will target one of the primary proteins that enables viruses to replicate, and will match this protein against a database of more than six million drug molecules that might inhibit virus replication. The second phase, which is more difficult, will predict which drug molecules bind tightest to the viral proteins, and thus have the best chance of inhibiting virus replication. From these unprecedented calculations, researchers will walk away with several dozen molecules that they can begin testing in the laboratory and clinic, which is the next phase in developing drugs for the marketplace.
"Anyone with a computer and Internet access can be a part of the solution to address this very critical health concern," said Stanley Litow, Vice President of Corporate Citizenship and Corporate Affairs and President of the IBM International Foundation. "Simply by donating our unused computer cycle time, we can all have a profound effect on how quickly this team can move to the next phase of drug discovery. For example, if 100,000 volunteers sign up within the first week for this project, it could reduce the time required to complete calculations by 50 percent."
To donate their unused computer time to this project, individuals register on www.worldcommunitygrid.org and install a free, small software program onto their computers. When computers are idle, for example when people are at lunch, their computers request data from World Community Grid's server. These computers then perform drug discovery computations using this data, and send the results back to the server, prompting it for a new piece of work. A screen saver will tell individuals when their computers are being used.
For this project, Dr. Watowich worked with Lanier Middle School in Houston, Texas, to develop a special screen saver based on writings of its eighth grade students. The student's writings focus on how to make the world a better place, complementing the humanitarian focus of the research project and World Community Grid. Dr. Watowich said he wanted students to understand the impact of modern biomedical research, give students the feeling of empowerment, and show them they can make a difference through their ideas and actions.
World Community Grid, the largest public humanitarian grid in existence, has an impressive 315,000-plus members and links more than 700,000 computers. However, it's estimated that there will be one billion computers worldwide by 2008, underscoring the potential for World Community Grid's computational power to significantly expand and make an even greater humanitarian impact. Seven projects have been run on World Community Grid to date, including FightAIDS@Home, which completed five years of HIV/AIDS research in just six months. Additional projects are in the pipeline.
For more information about IBM, please visit www.ibm.com.
Contact:
Sandra Dressel
IBM
914-499-6609
sdressel@us.ibm.com
Michelle Rainford
University of Texas Medical Branch
Phone: 409-772-8756
mdrainfo@utmb.edu
Source: IBM
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HIV/HCV coinfected patients who develop severe allergy to nevirapine have significantly increased risk of death
www.aidsmap.com
Adam Legge
People with hepatitis C and HIV coinfection who develop a hypersensitivity reaction to nevirapine (Viramune) have a seven-fold increase in their risk of death when compared to people without HCV, according to Canadian researchers writing in the July 31st edition of AIDS. Their findings add weight to current recommendations that nevirapine should not be used in people with HCV/HIV coinfection.
Nevirapine (Viramune) is a generally well-tolerated non-nucleoside reverse transcriptase inhibitor (NNRTI) but a number of side-effects are seen with this drug. Around 16% of patients will develop a mild to moderate rash while around 6.5% will suffer a more serious rash – usually within six weeks of taking it. But around one in ten patients have elevated liver enzymes while around five per cent will suffer symptomatic liver toxicity.
However, a potentially life-threatening hypersensitivity reaction can occur alongside rash and hepatitis. Women and patients with higher CD4 cell counts are at increased risk of hypersensitivity accompanied by liver toxicity, and because of this women with a CD4 cell count above 250 cells/mm3 and men with a CD4 cell count above 400 cells/mm3 should not start treatment with nevirapine.
People with hepatitis B or C coinfection, and individuals with raised liver enzymes (specifically ALT) are known to be at higher risk of developing a hypersensitivity reaction to nevirapine too. Instead, the risk of death appears to be elevated as a result of treatment interruption after the hypersensitivity reaction.
Researchers from the British Columbia Centre for Excellence in HIV/AIDS in Canada examined all cases of hypersensitivity in the province's patients who had started antiretroviral therapy with nevirapine between 1997 and 2003.
They identified 66 individuals out of 685 treatment-naïve patients starting a nevirapine-containing regimen between 1997 and 2003. Of these 66 people, 26 (53%) had a HCV co-infection and the researchers compared the risk of death between different groups. HIV-infected patients who developed a HSR to nevirapine and were coinfected with HCV were seven times more likely to die than those without the HSR or HCV coinfection (p <0 .01).
The causes of death were similar for both nevirapine-tolerant and hypersensitive patients and were mainly due to HIV disease progression. The authors say the influence of the nevirapine HSR on HCV infection and mortality was “unexpected” but shows it plays some sort of role in modifying the association between the virus and the risk of death. HIV-infected people who developed the HSR but were not HCV-infected had a small but not statistically significant increase in risk of death.
Hypersensitivity or liver failure caused by nevirapine was not the direct cause of death in any patient who experienced hypersensitivity reaction. The risk of death appeared to be elevated in patients with HCV coinfection and hypersensitivity due to treatment interruptions, with nine deaths in 13 patients who did not resume therapy dying during the follow-up period, compared to only one death among 22 patients who resumed therapy within six months of experiencing a hypersensitivity reaction.
A fourfold increase in the risk of death (due to non-AIDS-defining causes) in HIV/HCV coinfected patients was seen among those with HCV who interrupted their antiretroviral treatment in the SMART study, according to findings presented last month at the International AIDS Society conference in Sydney.
Several factors have been associated with increased risk of developing nevirapine HSR including CD4 cell counts of 250 cells/mm3 or above, being female, prolonged exposure to any antiretroviral drug and raised liver enzymes at start of treatment. No such risk factors could be identified in this study, possibly because the numbers studied were too small to reveal them.
However the authors say the results support the recommendation that nevirapine should not be used in people who are infected with both HIV and HCV.
Reference
Phillips E et al. Determinants of nevirapine hypersensitivity and its effect on the association between hepatitis C status and mortality in antiretroviral drug-naïve HIV-positive patients. AIDS 21: 1561-1568, 2007.
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Billboard Campaign Calls Attention To Hepatitis C
http://www.emaxhealth.com
Hepatitis C
A billboard campaign that Maryland state officials hope will raise awareness of the hepatitis C virus (HCV) began appearing this week in the Baltimore area.
"There are ways to protect your liver and avoid transmitting HCV,” said Dr. Michelle A. Gourdine, DHMH deputy secretary for Public Health Services. “If you are at risk, a simple blood test is a good way to learn your status.”
And that is the message the billboards are designed to impart.Six faces jump out of a bright yellow background, all thinking, “Me?” The balance of the text reads “Hep C. Find Out” HepCMaryland.org, a site sponsored by DHMH.
DHMH officials estimate that nearly two-thirds of approximate 100,000 Maryland residents infected with HCV do not know they have the disease.
"Complications of HCV infection are a serious health burden in our state," Dr. Gourdine said. "That’s why it is so important to help all Marylanders be aware of this important public health problem.”
The 16 billboards are posted for a one-month period.Fifteen are located in Baltimore City and one is in Baltimore County. The display is a public service by Clear Channel Outdoors. Production of the print material is through a donation from Maryland Partnership for Prevention, with grant funding from GlaxoSmithKlein.
The Baltimore City locations are:
* North side of Baltimore Street east of Mt. Olivet Lane
* South side of Cherry Bill Road east of Cherryland Road
* South side of Frankfurt Avenue east of Hanover Street
* East side of Haven Street north of O’Donnell Street
* East side of Huntingdon Avenue south of 26th Street
* South side of Lafayette Avenue, east of Charles Street
* South side of O’Donnell Street east of Angelsea Street
* North side of Patapsco Avenue east of 9th Street
* East side of Remington Avenue south of 29th Street
* East side of Shell Road south of Patapsco Avenue
* West side of Warwick Avenue south of Franking Street
* North side of Waterview Avenue west of Cherry Hill Road
* South side of Wilkens Avenue east of Dukeland Street
* South side of Wilkens Avenue east of Cole Street
* North side of 27th Street west of Remington Avenue
* The Baltimore County billboard is east of North Point Boulevard south of Old North Point Road.
HCV infection is four times more prevalent than HIV infection and the most common blood-borne infection in the United States. It's the leading cause of liver disease and the number one indication for liver transplants.
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August 24th, 2007
Drug in New Hepatitis C Clinical Trial
http://biz.yahoo.com/
BRISBANE, Australia, Aug. 24 /PRNewswire/ -- Physicians at Southern Health have started a phase IIa clinical trial designed to test the efficacy of a new strategy for defeating hepatitis C viral infection, one of the toughest infectious diseases in the modern world.
Implicit Bioscience's drug, oglufanide disodium, which works as a regulator of the body's immune response, is being given by intranasal administration to patients with chronic hepatitis C viral infection.
"The drugs currently in use fail to control this disease in about one half of all patients," said Dr Ian Frazer, Implicit's Chief Scientific Officer. "So there is a compelling need for new and better therapies, and we hope that oglufanide disodium may control or reverse the suppression of the immune system which the hepatitis virus uses to defeat our normally healthy defenses."
Dr Frazer is well known as the co-inventor of the recently approved vaccine for papillomavirus, which is designed to prevent cervical cancer.
Dr William Sievert, who is the Principal Investigator for the trial, welcomed the opportunity to study the action of oglufanide disodium in his busy liver diseases clinic at the Monash Medical Centre, which is part of the Southern Health network. "It is an important opportunity for patients to be involved in a new trial such as this, in which new treatment prospects are explored."
Oglufanide disodium was originally developed to treat severe infectious disease in Russia (where it is a registered pharmaceutical), and was extensively studied in cancer clinical trials in the United States before being acquired by the privately-owned Brisbane biotech company Implicit Bioscience Pty Ltd in 2005.
The phase IIa trial of intranasal oglufanide disodium will complement the ongoing phase Ib study of subcutaneously administered drug at the Princess Alexandra Hospital in Brisbane.
Oglufanide disodium regulates the body's innate immune response to defeat invading germs and cancer cells. The drug is also under development by Implicit as a biodefense therapy and for ovarian cancer.
Source: Implicit Bioscience, Inc.
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