While scientists from around the world gather in Vienna to discuss how to fight AIDS at the 18th International AIDS Conference, there are a lot of AIDS skeptics doubt that official medicine will be able to find a solution. Robert Scott Bell says that the scientists at the conference are wrong because there is no need for drugs to cure this syndrome.

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By Lee Howard
TheDay.com
04/01/2010

Hartford — Becky McClain, a Deep River scientist who claims to have been infected by an experimental virus while working at Pfizer Inc.’s Groton laboratories, was awarded $1.37 million today by a U.S. District Court jury.

Workers’ rights organizations immediately hailed the verdict, in which Pfizer also was ordered to pay McClain’s attorneys’ fees. They said the outcome of the federal civil suit was a major milestone for biotech and nanotech workers everywhere.

“If this could happen at the biggest drug company in the world, it could happen in other plants,” said Steve Zeltzer, chair of the California Coalition For Workers Memorial Day, a group that advocates for employees hurt on the job. “It’s a vindication of the courage shown by Becky to confront the need to do a proper oversight of the biotech industry.”

The suit, argued during a three-week trial before Judge Vanessa Bryant, has been closely followed by labor organizations, attorneys and members of the medical and research community because it is the first federal case involving a biotech worker who claims to have been harmed by a novel virus on the job.

Workers’ rights groups have criticized Judge Bryant, however, for throwing out McClain’s major claim shortly before the trial began. The claim was that Pfizer engaged in willful and wanton misconduct in exposing her to a dangerous work environment that led to health problems that included bouts of temporary paralysis.

McClain, a molecular biologist who filed her suit about three years ago in New London Superior Court, had claimed that Pfizer violated whistleblower laws. A former member of the company’s safety committee, McClain also charged that Pfizer violated her freedom of speech by terminating her after she pressed complaints with the U.S. Occupational Safety and Health Administration.

McClain’s attorney, Bruce E. Newman of Bristol, previously called the case precedent-setting because there are few government standards regulating the bioengineering field. Backers of McClain said they hoped the scientist’s victory in court would send a notice to companies everywhere that a safe working environment is paramount to those who work in biotech specialties that deal with potentially lethal organisms.

Pfizer continues to deny all of the suit’s charges and said today that the company is considering its options for appeal.

“We are disappointed with the verdict and do not believe the facts of this case warrant the conclusion reached by the jury,” Pfizer said in an e-mailed statement.

“Pfizer is committed to protecting the health and safety of our colleagues and the communities in which we operate,” the statement continued. “In addition to our commitment to full compliance with environmental, health, and safety laws and regulations, we have company-wide policies, standards, and programs combined with site-level management systems and initiatives tailored to the particular safety issues and needs at each location.”

Pfizer previously said it had thoroughly investigated McClain’s health and safety claims and found them to be untrue.

McClain, who worked at Pfizer for nearly a decade before being terminated in 2005, was employed in Groton’s embryonic stem cells program when she said she became ill after being subjected to repeated noxious fumes coming from the hood of a device at Lab B313, according to her suit. She said her supervisor also became ill, but later conspired to cover up the incident, warning her that she “would lose her job if she made too big an issue out of lab safety,” the suit said.

McClain said she asked for a transfer out of Lab B313 because of ongoing health concerns. Later, she developed chronic fatigue symptoms, according to the suit, and discovered that a co-worker had been working next to her with a “dangerous lentivirus material (similar to the AIDS virus) and embryonic stem cells on an open lab bench without biological containment.”

McClain later went on medical leave, according to testimony, but continued to raise safety concerns until she received a termination notice during her absence.

Backers of McClain said OSHA denied her workplace complaints largely because federal worker-safety laws have not kept pace with the rising hazards in U.S. laboratories. They have called for OSHA to reopen its investigation of the McClain case, a cause that may have received a boost from the six jurors whose verdict was read in court today.

McClain’s lawsuit claimed her continued exposure to genetically engineered viruses had led to a condition that leads to periodic paralysis, joint pain and fatigue. The attacks, which were particularly severe before the 52-year-old McClain started taking massive amounts of potassium, have dissipated in recent months, according to Mark McClain, the plaintiff’s husband.

But McClain has said there is no known cure for the condition, and claims that Pfizer has refused to hand over exposure records that might help her identify the virus that infected her. She said Pfizer has claimed exemption from laws requiring health records to be handed over based on other laws that protect patent information.

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Part 1

Part 2

Part 3

Part 4

Part 5

Part 6

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Elias Mbao
AllAfrica.com
12 January 2010

Lusaka — A failed clinical trial HIV vaccine that left 46 Zambian women infected with the virus has sparked controversy.

The Microbicides Development Programme (MDP) 301 trial, which was testing if the gel PRO2000 would prevent HIV infection took place between September 2005 and 2009.

It was conducted at six research centres in South Africa, Tanzania, Uganda and Zambia and 9,385 participated.

From the Zambian site in Mazabuka district – about 160 kilometres South West of the capital Lusaka – 1, 332

HIV negative women were recruited but the results, which the Ministry of Health does not wish to comment on, revealed that between 46 and 50 of women that participated in the clinical trial contracted HIV despite using PRO2000 gel before sex.

“Some participants did become HIV positive because the study was conducted in the normal environment,” confirmed Dr Maureen Chisembele, principal investigator for Microbicides Development Programme Zambia – a subsidiary of the UK based research entity.

“Women who became infected during the study were given further counselling and referred to local health services for ART (antiretroviral therapy).”

The National Aids Council of Zambia (NAC), a government unit mandated to oversee HIV/Aids programme, confirmed that 50 out of the 1, 332 women that participated in the clinical trials contracted HIV.

Due to the sensitivity and repercussions of the issue, the Ministry of Health has remained tight-lipped on the outcome of the trials.

A vaginal microbicide is a product intended for use before sexual intercourse to reduce HIV infection and they are supposed to be used with condoms and complement other prevention strategies such as behaviour change, abstinence and other preventive methods.

It should be noted that vaginal microbicide should not be used alone or replace correct and consistent use of condoms in the fight against HIV and Aids, said Dr Swebby Macha – a gynaecologist at Zambia’s University Teaching Hospital (UTH) in Lusaka, the largest hospital in the country.

The participants in the clinical trial were either assigned the PRO2000 gel or placebo gel (with inactive ingredient) and were instructed to apply gel about one hour before sexual intercourse.

The gel contains molecules that are intended to cluster around the virus before it can penetrate the vaginal wall.

To be effective, the women were counselled on safe sexual behaviour and encouraged to use condoms, which were provided free of charge.

According to Dr Macha, this clinical trial found that the risk of HIV infection in women that were supplied with PRO2000 gel was not significantly different than women supplied with placebo gel.

“The largest international clinical trial to date into a preventive HIV gel has found no evidence that the vaginal microbicide, PRO2000, reduces the risk of HIV infection in women,” said Dr Macha, the former president of Zambia Medical Association (ZMA).

Dr Macha said to date no microbicide had been proved to be effective against HIV infection.

A local traditional ruler has demanded compensation for the infected women and prosecution of architects of the clinical trial.

Chief Mwanachingwala of the Tonga people in Mazabuka district where the clinical trials took place said the women that took part in the trials were “poor and uneducated” and did not know the consequences of the research, which has left some of them infected.

But Ministry of Health officials, speaking on anonymity basis, argued that MDP followed the laid down legal and clinical procedures, therefore, were not liable to prosecution over the outcome of clinical trials.

In an explanatory statement, Dr Chisembele said that during the clinical trial, a lot of emphasis was put on the fact that it was unknown whether PRO2000 gel would work to prevent HIV.

The infection of the 46 women has drawn outrage from many Zambians who are accusing MDP of using some African women as “guinea pig” because they are poor and ignorant.

Zambia is among African countries hardest hit by Hiv infections with prevalence rate of 14.3 per cent of its population estimated at about 13 million people.