Merck's failed HIV vaccine trial

This has nothing to do with biological warfare, but I feel compelled to make a few points about this trial anyway.

1. The volunteer subjects who received vaccine were apparently harmed. But did they receive sufficient warning that this could happen? Merck/NIAID will no doubt say it could not have been foreseen (though one article suggests the consent form stated that participation might decrease, increase, or have no effect on your risk of AIDS). Does this mean the lawyers knew the vaccine might be harmful but the doctors didn't?

A number of animal vaccines were developed, some even licensed, sold and used on pets and livestock -- when it turned out they increased susceptibility to the illness they were trying to protect against. This potential adverse effect should be well known to vaccine developers.

Not to mention the obvious -- small pilot trials of the vaccine should precede large-scale trials to rule out this dread complication. This was a Phase 3 trial in 3000 people.

2. The vaccine trial that took place in South Africa started at a later date (2007) than trials in the other countries started (2004). Yet it was the South African trial that blew the whistle on the increased rates of HIV in vaccine recipients. At that point, in late October, investigators from the earlier trials claimed they would have to evaluate their data to see if it bore out the South African findings. Now they admit their data confirms what the South African investigators identified: more HIV infections in those who received vaccine compared to placebo.

Guess what? Each trial of this vaccine was required to have a Data Safety Monitoring Board whose job is to monitor interim trial results to end a trial early if things are going wrong, as in this case -- and warn subjects if needed.

Clearly, this board was not doing its job in a timely fashion. Even worse, it is a good possibility that had the South Africans not blown the whistle, the other investigators might have attempted to sweep these data under the rug. Merck may have even tried to sell this vaccine, if it had been able to analyze the data in such a way this negative effect was not identified.

Why did it take the South Africans only months to see what the other centers only acknowledged last week, 3 years into the trial?

Although it sounds far-fetched, many pharmaceutical companies require medical investigators, even those at prestigious medical schools, to agree they will not get access to their own data, as a condition of being hired to conduct a clinical trial. Only the company gets to see the raw data.

The whitewashing has already begun: In Australia, investigator "Kelleher defended the protocol that halted the trial halfway on the advice of the Data Safety Monitoring Board and praised the transparency of the communication to participants."

But look back to the beginning of this fiasco becoming pubic: from the October 25, 2007 Washington Post:

Warning Is Sent to AIDS Vaccine Volunteers

...The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck..."

Think of this article next time you considering volunteering for a scientific experiment

Report: President's Commission on Care for America's Returning Wounded Warriors

The motto of the report is "Serve, Support, Simplify." Further information on the Commission and report can be found at www.pccww.gov

Caution flag raised on mandatory anthrax vaccines

Former Air Force navigator says neurological reaction has left him disabled

By ELLEN GABLER
egabler@journalsentinel.com

Posted: Oct. 28, 2007

With his trim runner's build, tight flattop and thin, muscular arms, Stephen DeGuire does not seem like a man who is unable to empty the dishwasher, mow the lawn or throw baseballs to his young sons.

He forgets the names of neighbors he has known for years and grimaces as he pushes himself into a standing position. His torso tilts forward as he walks stiffly through his Mequon home. A wooden cane hangs on a chair in the living room. It is one of a collection that DeGuire keeps around. He frequently forgets where he puts them.

DeGuire is one of possibly thousands of veterans suffering from what some military and civilian doctors believe is a neurological reaction to the anthrax vaccine. The vaccine is controversial, yet now mandatory for many American troops and civilian contractors. About 1.6 million people have received the vaccine since 1998.

Nearly four years ago, DeGuire was stationed in Kuwait as a navigator for the U.S Air Force. Today, the 43-year-old struggles with migraines, memory problems, chronic pain and fatigue as his body slips further from his control.

DeGuire's Air Force physical evaluation in 2006 listed his ailments and noted that they began to occur after he received the vaccine.

While DeGuire's main concern is to keep his body from further deteriorating, he worries about his family's financial future. He said he makes one-third of what he made as a civilian and will likely never work full-time again because of his condition.

Disability linked to reaction from the anthrax vaccine is deemed non-combat-related, meaning veterans like DeGuire are taxed on their disability payments. The anthrax vaccine is also not part of the National Vaccine Injury Compensation Program, which allows people who suffered vaccine reactions to collect money for their disability. DeGuire worries about soldiers who will be required to receive the anthrax vaccine in the future. He says the program was "well-intentioned," but that officials in the government did not stop the vaccine when problems arose.

"They've had enough data to know there is something wrong with the vaccine," DeGuire said.

The Department of Defense made the anthrax vaccine mandatory in 1998 out of concern that enemies would use anthrax as biological warfare. If inhaled, the substance is usually fatal. Mandatory vaccines were halted in October 2004, when a judge questioned the Food and Drug Administration's approval procedures. In December 2005, the FDA gave final approval for the vaccine, and the Department of Defense made it mandatory again for soldiers and contractors serving in the Middle East, Central Asia and parts of Korea.

The Department of Defense maintains that the vaccine is "safe and effective." In a media conference call last fall, assistant defense secretary William Winkenwerder said that the vaccine had not led to increased deaths or hospitalizations.

Critics of the vaccine disagree. Physician Meryl Nass said her patients usually have 10 or 15 different diagnosis that she attributes to the anthrax vaccine - sleep disorders, fatigue, cognitive disability and higher rates of neurological disorders such as multiple sclerosis. A doctor in Maine, Nass testified about the vaccine in July before the House Veterans Affairs Health Subcommittee.

Nass also points to records collected by the Vaccine Adverse Reporting System, which catalogs vaccine complications. The system has received about 5,359 adverse event reports for anthrax vaccine. About 670 of the reports were considered "serious" and about 44 of the reports recorded deaths. In the reports, some soldiers or their families pleaded with the military to stop the vaccines.

Most vaccines are linked with side effects, ranging from simple soreness to death. But that's not much comfort to people like DeGuire, or other veterans he met while at Walter Reed Army Medical Center who also think they were affected by the anthrax vaccine.

Unlike many of those other veterans, DeGuire's case was recently accepted by the Mayo Clinic, so in early August, he lugged his three-inch-thick medical file to Rochester, Minn. While doctors are working on his physical problems, DeGuire and his family are pushing legislators to do something about veteran benefits and mandatory vaccines.

DeGuire said he has tried to no avail to have legislators introduce an amendment to the defense appropriations bill that would stop mandatory anthrax vaccines until more research is done.

Congress is considering changes on the benefits issue. The Disabled Veterans Tax Termination Act would give disabled veterans the same benefits as retired veterans with 20 years of service. The act is pending in the House subcommittee on disability assistance and memorial affairs. But no efforts are under way to reclassify ailments associated with the anthrax vaccine as combat related.

Two HIgh Court petitions in Israel over anthrax vaccine tests on soldiers

Group wants end to Israeli anthrax tests

Published: Nov. 1, 2007 at 9:36 AM

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JERUSALEM, Nov. 1 (UPI) -- A rights group petitioned Israel's High Court on Thursday to stop the military from performing anthrax vaccine experiments on soldiers.

Physicians for Human Rights filed one petition, while a second was filed by a group of soldiers seeking to be recognized as casualties of the experiments, Ynetnews.com reported.

From 1999 to 2006, some 800 soldiers underwent vaccinations of a vaccine developed in the United States and the rights group claimed in their petition scientific errors were made. They included tracking the soldiers' conditions consistently during and after the experiments, the report said.

The group also alleged the troops were misinformed of potential consequences of the tests and were given no opportunity to consult with non-military specialists for advice.

Attorney Michael Spharad, who filed the petition on behalf of the Physicians for Human Rights said the military had too much medical freedom.

"These days it is more difficult to experiment on animals than on humans," Spharad said.