|Flu Vaccine Makers Say
Gov't Must Increase Demand
WASHINGTON (Reuters) - 12 February 2004
Vaccine makers can not guarantee enough future supplies of flu vaccines unless the government can help ensure profitability, drug company officials told U.S. Congress on Thursday.
Unless the market is expanded -- either by ensuring that more at- risk people get vaccinations for influenza or simply more people in general, companies have little incentive for innovation, the executives said.
"Raising demand is key to raising supply," Howard Pien, president and chief executive officer of Emeryville, Calif.-based Chiron Corp. said.
"The next flu pandemic could be right around the corner," U.S. Rep. Henry Waxman (D-Calif.) said at the meeting.
But manufacturers said they need steady demand when there isn't a pandemic in order to have the capacity to quickly increase production during an emergency -- otherwise they could loose money on unused equipment and doses.
The three companies that make flu vaccines for the U.S. market -- Aventis SA, Chiron and MedImmune Inc. presented testimony at a meeting of the U.S. House Government Reform Committee.
This year's flu season hit early and was heavily covered by the media, creating vaccine shortages as people rushed to get flu shots.
UPDATE: U.S. officials are worried that tens of thousands of doses of flu vaccine may go to waste, after the press touted a flu vaccine shortage people stood in line for their shot... now demand is dwindling and so are profits. A federal advisory panel recommended the government ease restrictions on the nation's supply and make shots available to everyone 50 and older.
"Anytime a commodity is scarce, and it is a desired item, demand will increase," Dr. Louis Manza, psychology professor at Lebanon Valley College in Pennsylvania...[17 - 18 December 2004 - AP]
New Influence in Congress
Thursday, 21 November, 2002
WASHINGTON, Nov. 20 -- Having spent more than $30 million to help elect their allies to Congress, the major drug companies are devising ways to capitalize on their electoral success by securing favorable new legislation and countering the pressure that lawmakers in both parties feel to lower the cost of prescription drugs, industry officials say.
The industry's hand appears stronger now than at any other time in recent years, a result of its large donations to political parties and candidates and millions of dollars spent on television advertising by industry-financed groups. The money was spent overwhelmingly on behalf of Republicans, who now control both houses of Congress.
Executives of the major drug manufacturers met last week at the Westfield International Conference Center, near Dulles International Airport in Northern Virginia, to plan ways to turn that influence into legislative victories.
The executives included Robert Essner, president of Wyeth; Peter R. Dolan, chairman of Bristol-Myers Squibb; Sidney Taurel, chairman of Eli Lilly; and Raymond V. Gilmartin, chairman of Merck. They discussed specific ways to leverage their investment in this year's elections to advance their agenda on Capitol Hill, participants said.
The meeting was described by an industry lobbyist as a "strategic planning retreat" and "deep philosophical conversations about our message for 2003." A pervasive theme was how to block proposals that could erode profits by limiting drug prices or making it easier for people to buy low-cost generic versions of brand-name medicines.
Drug industry executives who attended the conference, put on by the industry's main lobbying arm, the Pharmaceutical Research and Manufacturers of America, said they were delighted with the election results, yet cautious and apprehensive, given the pressure that Republicans as well as Democrats face from voters demanding lower drug prices.
"Sure, we will have more access," one executive said. "Our hand is stronger because of the election results, but who knows how much stronger it really is."
Already, industry executives have been encouraged by a recent move to insert a provision in the domestic security bill limiting the legal liability of vaccine manufacturers like Eli Lilly. On Tuesday, several senators from both parties said Republican leaders had promised to alter the provision next year, so it would apply only to vaccines made in the future.... and much more
On Live Virus Vaccines
VALHALLA, N.Y., 18 June 2004 -- A New York Medical College microbiologist warns that live virus vaccines to prevent infectious diseases like West Nile virus and yellow fever could have dire consequences. Should one of the vaccine flaviviruses recombine with a wild-type virus, a new microbe with potentially undesirable properties could result, according to Stephen J. Seligman, M.D., research professor of microbiology and immunology.
His paper, "Live flavivirus vaccines: reasons for caution" appears as a rapid review article in the June 19, 2004, issue of the journal Lancet. Co-author is Ernest A. Gould, Ph.D., of CEH-Oxford in the UK.
Flaviviruses, which can recombine within species and may recombine between species, also include dengue, Japanese encephalitis and tick-borne encephalitis. They cause substantial sickness and death each year. Although live-virus vaccines offer great promise in terms of cost and efficacy, their use should be approved by an international authority due to safety concerns, the authors write.
The article lists five main lessons learned from other live virus vaccines:
* reversion of vaccine strains to increased virulence;
* development of disease in individuals with compromised immune systems;
* birth defects, particularly if the vaccine is given in the first trimester;
* spread of vaccine strains to unvaccinated persons and;
* the discovery of new, previously undetermined complications.
A European-produced flu vaccine widely used in other countries will be tested at four locations in the United States, the government announced.
NIAID said Thursday it hopes to enroll 1,000 healthy adults in the new tests by Dec. 23, 2004 in Rochester, N.Y., Cincinnati, Baltimore and Houston.
While more than 126 million doses of the test vaccine, Fluarix, have been distributed in more than 70 countries worldwide, Fluarix has never been tested or licensed for use in the United States. It is made by GlaxoSmithKline Biologicals of Rixensart, Belgium.
Health and Human Services Secretary Tommy G. Thompson has announced a plan to import 4 million doses of Fluarix as an investigational new drug.
The trial will be conducted at the University of Rochester Medical Center, Cincinnati Childrens Hospital, University of Maryland School of Medicine and Baylor College of Medicine.
National Institute of Allergy and Infectious Disease: http://www.niaid.nih.gov[10 December 2004 - AP]
The European Union warned on Monday that an influenza pandemic was waiting to happen and said nations were still struggling to prepare for it. "It is now a certainty that at some point in the future we will have a pandemic and therefore we need to prepare as much as possible," said EU Health Commissioner Markos Kyprianou after a meeting of the bloc's 25 health ministers.
The 1918-1919 Spanish Flu outbreak killed up to 40 million people around the world, much more than the Great War that preceded it. There also were major outbreaks in 1957-58 and 1968-1969 that killed more than a million each. The most virulent strains hit about every 30 years.
"Some say it is overdue, some say the near future. What is important is that it is coming and we have to prepare for it," Kyprianou said.
If a pandemic breaks out, EU nations will face two main challenges, said Dutch Health Minister Hans Hoogervorst, who chaired the meeting. The virus will most likely be totally new and it will likely take about a year to have an efficient antidote on the market ready for use. [6 December 2004 - AP]
For Future Use?
Deadly genes from the influenza virus which caused the 1918 pandemic have been resurrected by scientists.
The Spanish flu, which killed up to 50 milion worldwide, has been revived in an attempt to understand what made it so virulent, reports New Scientist.
Researchers have tested reconstructed viruses and warn that it might one day return. If it does, anyone born after 1918 will have virtually no immunity.
Yoshihiro Kawaoka of the University of Wisconsin in Madison, US, and colleagues reconstructed five of the eight genes of the 1918 virus from fragments in victims buried in permafrost.
Experiments with the more virulent strains were conducted at the highest possible level of containment, at Canada's National Microbiology Laboratory in Winnipeg.
Kawaoka's team found that, while people who experienced the 1918 flu have antibodies that neutralise the reconstructed 1918 H, people immune to current flu viruses have almost no protection. [11 Oct 2004 - ananova.com
U.S. Health and Human Services Secretary Tommy Thompson said Thursday at an international conference on biological threats. Thompson, joined by health ministers from the other Group of Seven nations and Mexico, said any one of their countries could be targeted by bioterrorists.
"You have to assume that sometime in the future one of our countries ... is going to be hit by a bioterrorism attack," he said during a news conference with France's health minister, Philippe Douste-Blazy. "The better prepared we are, we will be able to minimize the injuries, death and suffering for citizens in the country that is hit."
He did not specify the threats.
Thompson's remarks came less than a week after his stark warning about the vulnerability of the U.S. food supply to terror attack.
"For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do," Thompson said last week in announcing his departure from the Bush Cabinet. "We are importing a lot of food from the Middle East, and it would be easy to tamper with that."
President Bush played down Thompson's warning a day later. [9 December 2004 - AP]
Medical products maker Baxter International Inc. said Thursday it suspended flu vaccine testing being conducted in Europe after more participants than expected came down with mild fevers.
The company said it is no longer recruiting participants for its current tests involving its PreFluCel vaccine and is putting on hold the additional clinical studies that were scheduled for 2005
Some Not Getting Flu Shots
Of the Americans who most need a flu shot, fewer than half actually get one, federal health officials warned Thursday as they called for special attention to babies, toddlers and the elderly as vaccinations begin next month.
A record 100 million doses of flu vaccine will be available this year, the vast majority of it shipped to doctors' offices by the end of October, said Dr. Keiji Fukuda of the CDC.
That assurance comes several months after one major supplier, Chiron Corp., delayed its shipments because the vaccine was contaminated with Serratia bacteria.
Serratia has been secretly used by the military on U.S. Citizens during bio-warfare studies.
During the 1950 - "Operation Sea-Spray" - U.S. Navy visited the San Francisco coast unleashing huge amounts of the experimental bio-warefare bacterium Serratia into the air over the city. Hospitals in the area were then covertly monitored for an increase in pneumonia.
Aventis has partnered with a company in the Netherlands, Crucell, to research using transgenic cells - - human and animal cells in place of eggs. The genetic material might interact with the flu viruses, creating dangerous hybrids. These so-called cell cultures could be maintained indefinitely and ramped up on demand whenever vaccine is needed.
For Refusing Vaccine?
There is "talk" ... would your legislators agree to tie forced vaccine shots to things such as your driver's license, employment, welfare, medicare, health insurance, the ability to travel anywhere by any means? Would they go so far in order to keep their pay checks? If the world's elite get their way the answer is yes.
It could begin like this... at first, people who refuse will be made into "social outcasts" ... much like the government's demonization of smokers. People who were never particularly bothered by tobacco smoke became utterly hysterical over the issue after the government pointed out the "ill effects" of tobacco smoke. Some things are easily manipulated into being socially acceptable or unacceptable with a cleverly run psy-ops campaign. Non-vaccinated people will be high on the social agenda at some point in time. Hysteria against non-vaccinated people may easily be generated by those with financial, political and social interests to do so. If you are not vaccinated, if you do not have your "shot records" your social and economic life may become very limited. Will you be bothered by working in the same office with non-vaccinated people? Shot records may soon become a condition of employment by large corporations, especially international corporations. How would you feel about being forced to show your health records before you enter a sports stadium, a movie theater, a grocery store, or a restaurant? A chip would make all this much easier.
One may also consider the huge financial profits pharmaceutical corporations will generate by "creating criminals" out of healthy people refusing to go along with mandated vaccine shots... law enforcement "holding facilities" will be bursting at the seams. In order to create demand for vaccine would "test" viruses be unleashed? Would the mainline press run a psy-ops campaign to frighten the public into demanding vaccine? Again, the answer is yes. If there were no financial profit involved would the politicians and their corporate co-horts care about your health? Not likely. The point is... there is no financial profit to be made off of a healthy and sane population.
FDA Reviews When Bayer Revealed Drug Risks
If this week's allegations prove true that the company knew but was slow to inform the government that its drug was riskier than comparable drugs, the Food and Drug Administration could begin a criminal investigation, one official said this week.
Bayer internal company records now in the public domain indicated that by May 28, 1998, three months after the drug went on the market, people who took the drug with gemfibrozil, another cholesterol-lowering drug, had elevated levels of an enzyme that accompanies muscle injury or had developed a rare muscle-wasting disorder. Bayer did not warn doctors and patients not to take the two drugs together until December 1999, four scientists wrote in a Journal of the American Medical Association paper released this week.
In addition Bayer scientists knew in late 1999 and early 2000 that using Baycol alone "substantially increased the risk" of people getting a rare muscle-wasting condition, compared with a rival drug, but they did not immediately alert physicians or patients. FDA rules require speedy notification of serious side effects linked to drugs.
The JAMA article alleged that "before the agency was aware of the data, the company knew that the drug was more dangerous than others. If this allegation is correct, the FDA takes it extremely seriously and we're going to have our criminal investigators look into this," Dr. Steven Galson said during a C-SPAN appearance. Galson is acting director of the FDA's Center for Drug Evaluation and Research.
"Right now, we don't really know whether that's true or not," said Galson. "We read about it in this level of detail for the first time" in the JAMA papers, he said.
FDA spokeswoman Kathleen Quinn said, "Bottom line: We have to go back and look at all the data (to) see what we have and compare and make sure we had all we could have - which we think we did."
Bayer said in a statement that the JAMA articles "contain no new information regarding Baycol and Bayer's timely reporting of data. Bayer kept the FDA fully informed about all pertinent safety information, including adverse event reports. Indeed, an FDA audit of Bayer's postmarketing practices during the time Baycol was on the market demonstrated no deficiencies."
Its pharmaceutical division withdrew Baycol from the market on Aug. 8, 2001, after it was linked to a sometimes fatal muscle-wasting condition, rhabdomyolysis. By then, the FDA had received reports that 31 Americans died from severe rhabdomyolysis after using Baycol. Twelve of those people used Baycol in combination with gemfibrozil.
The company reported it paid $1.1 billion, without admitting liability, in out-of-court settlements of 2,895 cases related to Baycol side effects. The suits were filed after Baycol was withdrawn from the market. Some 7,169 cases are still pending.
Besides published scientific reports and FDA data, the authors of the JAMA paper reviewed internal Bayer documents that entered the public record due to lawsuits filed against the company.
In long-term clinical trials, cholesterol-busting statins atorvastatin, lovastatin, pravastatin and simvastatin were associated with lower risks of causing patients to develop the muscle-wasting condition, the JAMA paper said. Baycol represented only 2 percent of market share - 9.8 million of 484 million statin prescriptions written. Yet Baycol was linked to 57 percent of the muscle-wasting side effects reported by statin users between January 1990 and March 2002.
In an accompanying paper in JAMA, however, an attorney defended the company's actions and noted that at least two of the authors of the JAMA article had been paid experts in plaintiffs' lawsuits against Bayer.
"It always is possible to second guess decision-making after the fact," wrote Joseph D. Piorkowski Jr., outside counsel in Baycol litigation for Bayer Corp., the German drug maker's U.S. subsidiary. "However, when judged fairly by all the facts in their proper context, Bayer's conduct in the marketing of (Baycol) from 1997 to its voluntary withdrawal from the market in August 2001 was responsible, appropriate, and consistently motivated by concern about the safety and welfare of patients." [AP - 27 November 2004]
Cause Strokes, Heart Attacks
Aleve (manufactured by, Bayer AG a German company) An Alzheimer's disease prevention trial was suspended after researchers said there were more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve
Celebrex,(manufactured by Pfizer Inc.) a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class - COX2 enzyme inhibitors - as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke.
Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study. [21 December 2004 - AP]
Asian gene linked to outbreak
Washington, 3 October 2003
A genetic susceptibility may explain why SARS raged earlier this year in South-East Asia and nowhere else outside of Toronto, according to Taiwanese researchers.
They found that a variant in an immune system gene called human leukocyte antigen, or HLA, made patients in Taiwan much more likely to develop the life-threatening symptoms of severe acute respiratory syndrome.
The gene variant is common in people of southern Chinese descent, the team at Mackay Memorial Hospital in Taipei reported.
Their finding, published in the online journal BMC Medical Genetics, must be confirmed by independent researchers.
But the Taiwanese team said the genetics could explain the puzzling distribution of SARS.
"After the outbreak of SARS coronavirus infection in the Guangdong Province of China, it was surprising to observe that the spreading of the disease was mostly confined among southern Asian populations (the Hong Kong people, Vietnamese, Singaporeans and Taiwanese)," they wrote.
The head of infectious diseases at the US Centres for Disease Control and Prevention, James Hughes, said genetic susceptibility was an area his agency was investigating.
"It is conceivable that people of a certain genetic disposition have a susceptibility to or risk of complications," Dr Hughes said.
SARS first arose in Guangdong last November. It spread to Hong Kong, Taiwan, Vietnam, Beijing and Singapore, carried by infected airline passengers.
SARS was suspected of affecting 8098 people and killing 774, according to the World Health Organisation's latest figures.
The flu-like disease is caused by a virus from a family known as coronaviruses.
They cause diseases in livestock and some cases of the common cold in people.
The SARS coronavirus is unique genetically but similar versions have been found in animals sold in Chinese food markets. Marie Lin, Chun-Hsiung Huang and colleagues examined the HLA gene in 37 cases of probable SARS, 28 fever patients later excluded as probable SARS, and 101 non-infected health-care workers who were exposed or possibly exposed to SARS coronavirus.
"An additional control set of 190 normal, healthy unrelated Taiwanese was also used in the analysis," they wrote in their report.
They found that patients with severe cases of SARS were likely to have a version of the HLA gene called HLA-B 4601. They noted that no indigenous Taiwanese, who make up about 1.5 per cent of the population, ever developed SARS.
HLA-B 4601 is not seen among indigenous Taiwanese, they said.
"Interestingly, (HLA-B 4601) is also seldom seen in European populations," they added.
Dr Frederick Hayden, an expert on influenza and SARS at the University of Virginia, said it would take a large, carefully designed study to confirm the findings. - Reuters
To Be Used As Fertilizer
Despite Cancer Risks
Government Agencies Are Killing People
By JOHN HEILPRIN
17 October 2003
WASHINGTON (AP) - The Environmental Protection Agency will let farmers and others use sewage sludge as fertilizer without concern for the amount of dioxins, a class of organic chemicals that the agency's studies have shown pose a possible cancer risk in humans.
"We're deciding not to regulate dioxin in land-applied sludge that farmers use," EPA spokeswoman Lisa Harrison said Friday, adding that the agency will instead "encourage proper management" of the chemicals.
About 5.6 million tons of sewage sludge is used or disposed of each year in the United States, including more than 3 million tons used as fertilizer on farms, forests, parks, golf courses, lawns and home gardens.
A National Research Council panel said last year the government was using outdated science to assess the health risks of the sewage sludge used as fertilizer.
However, Geoffrey Grubbs, who heads the EPA Office of Water's science and technology program, said the decision to not regulate dioxins in land-applied sludge came after five years of peer-reviewed analysis and study.
"The risk of new cancer cases from this source is small, is substantially smaller than other chemicals we regulate," Grubbs said. EPA also looked at the potential risks to wildlife and didn't find "any significant impacts," he said.
According to EPA's analysis, only 0.003 new cases of cancer could be expected each year - a statistic that means roughly one case every 300 years - from exposure to dioxins in sludge used on farms to fertilize crops and animal feed.
But he said the agency has worked hard to reduce people's exposures to dioxins through stricter technology requirements for incinerators and cement kilns in the past 15 years.
EPA was due to issue a final rule Friday to regulate the amount of dioxins in sludge spread as sewage on land as part of a settlement agreement with the Natural Resources Defense Council, the environmental group said.
NRDC calls dioxins "among the most toxic substances on earth, and land-applied sewage sludge is the largest source of dioxin exposure in the United States after backyard barrel burning."
Nancy Stoner, director of NRDC's clean water project, said the problems extend well beyond farms.
"This is not about a farm product. This is about sewage sludge that comes out of large urban environments," she said, adding that the group would now review EPA's decision to see if more legal action is warranted.
The group said the settlement was meant to conclude lawsuits filed by NRDC and environmentalists in Oregon more than a decade ago in an attempt to force the agency to limit toxic pollutants in sludge.
NRDC said the Clean Water Act required the agency to limit toxic pollutants such as dioxins that may harm human health or the environment.
An EPA scientific advisory committee in 2001 reported that dioxins cause cancer in laboratory animals, and possibly in people - conclusions that had potential effects for everything from milk, beef and fish to medical, chemical and paper products.
But that committee had split over whether to change wording in a draft report from a year earlier that had said dioxins should be classified as a known human carcinogen.
Dioxins, or dioxin-like compounds, are pollutants found in air, soil and water, which can be released when industrial waste is burned. They build up in fatty tissues of animals, and scientists believe that humans are exposed to them when they eat animal fats. Breast-feeding infants and unborn children are at risk of suffering harmful effects like behavioral disorders and cancer if they are exposed to high levels.
The contaminant used in Agent Orange, a defoliant sprayed during the Vietnam War, included the most toxic form of dioxins.
By JULIE HALENAR
BALTIMORE (AP) - University of Maryland researchers are testing radioactive material from Russian military nuclear stockpiles to see if it can be used to fight cancer.
The researchers hope to use the uranium extract to attack the blood vessels that feed tumors.
"One of the ways that most solid tumors grow is to induce the body to feed it," said Dr. Bruce Line, the University of Maryland Medical Center's director of nuclear medicine.
"If we can stop that process by cutting off the blood supply to tumors then we can keep the tumor from growing and also help to reduce its size and keep it from eventually taking the patient's life."
Line said the project is in its early stages and researchers are just now understanding the potential of the extract actinium, a powerful source of alpha waves. Animal trials using the material have not yet been conducted and human trials are not expected to begin for at least three to four years, university officials said.
Dr. Nikolay Marchenkov of the Russian Nuclear Research Center's Kurchatov Institute said the material was previously used for military purposes in Russia. Speaking through a translator, Marchenkov said Russian scientists are developing a way to provide enough of the material for future medical use.
The Fox Chase Cancer Center in Philadelphia is also studying the radioactive isotopes, University of Maryland officials said.
The researchers will use polymers to hold an actinium derivative and inject it directly into tumors. The challenge is to do the least harm to normal cells, while damaging cancer cells.
"Although these powerful particles can be stopped by a single sheet of plain paper, in the body they are extremely effective in killing cancer cells," Line said.
The university will get six to eight shipments of the radioactive isotopes in next few months.
U.S. Rep. Steny Hoyer, D-Md., has gotten $800,000 in funds for the partnership known as the American Russian Cancer Alliance. The "atoms for peace" initiative began two years ago.
"The Alliance has sponsored international symposia and workshops in both Russia and the United States - providing a unique venue for these brilliant minds in both countries to work together and learn from each other," Hoyer said.
Dr. Stephen Schimpff, director of the University of Maryland Greenebaum Cancer Center, said the results of preliminary research over the next six months may lead to additional funding from various organizations.
"The word 'cancer' still strikes fear in all our hearts," Schimpff said. "As the population is aging, we're going to see more and more cancer."
How many people take it upon themselves to investigate what vaccine(s) are made of and the pharmaceutical companies who make them? Why would any "sane" human being allow a substance they know absolutely nothing about to be injected into their body or the body of their child? Does this make any sense to you?
December 17, 2004
By ALEXANDRA ZAVIS - AP
JOHANNESBURG, South Africa (AP) - President Thabo Mbeki's ruling party published a stinging attack Friday on top U.S. health officials, accusing them of treating Africans like "guinea pigs" and lying to promote a key AIDS drug.
The criticism reinforces fears of doctors and activists that new questions about the testing of nevirapine could halt use of the drug that's credited with protecting thousands of African babies from catching HIV from their mothers.
The article, published in the online journal ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld criticism of a nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa.
Documents obtained by AP show Dr. Edmund C. Tramont, chief of the National Institutes of Health's AIDS division, rewrote an NIH report to omit negative conclusions about the way a U.S.-funded drug trial was conducted in Uganda, and later ordered the research to continue over the objections of his staff. Tramont's staff worried about record-keeping problems, violations of federal patient safeguards and other issues at the Uganda research site.
"Dr. Tramont was happy that the peoples of Africa should be used as guinea pigs, given a drug he knew very well should not be prescribed," the article said. "In other words, they entered into a conspiracy with a pharmaceutical company to tell lies to promote the sales of nevirapine in Africa, with absolutely no consideration of the health impact of those lies on the lives of millions of Africans."
Smuts Ngonyama, an African National Congress spokesman and editor of the journal, said the article was an opinion piece by a member and didn't reflect official party policy. He wouldn't identify the author.
In the United States, the Rev. Jesse Jackson called for a U.S. congressional investigation and demanded nevirapine no longer be distributed in Africa.
"This was not a thoughtful and reasonable decision, but a crime against humanity," Jackson said Thursday in Chicago. "Research standards and drug quality that are unacceptable in the U.S. and other Western countries must never be pushed onto Africa."
Dr. H. Clifford Lane, the NIH's No. 2 infectious disease specialist and one of Tramont's bosses, has said an internal review cleared Tramont of scientific misconduct.
He said Tramont changed the report because he was more experienced than his safety experts and had an "honest difference of opinion." Tramont has also argued that Africans in the midst of an AIDS crisis deserved some leniency in meeting tough U.S. safety standards.
Activists in South Africa accused the Health Department and ruling party officials of putting out misleading statements that could frighten patients off their treatment, and worried that governments may now halt use of single-dose nevirapine before alternatives are available.
"NIH may be guilty of a cover up of bad (research) protocols, in which case we would be the first to want them held accountable," said Zackie Achmat, head of the Treatment Action Campaign. "But there is no doubt in my mind about the safety of nevirapine."
Some 70 percent of the 45 million people worldwide infected with HIV live in sub-Saharan Africa.
Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn can reduce the chances of HIV transmission by up to 50 percent. Nevirapine is also used in combination with other drugs to prolong the lives of AIDS patients.
Subsequent research has confirmed the safety and efficacy of nevirapine in protecting newborns, the World Health Organization says. But there's evidence pregnant women who receive a single dose can develop resistance to the drug that can compromise their future AIDS treatment.
A study in Uganda found that 20 percent of pregnant women and 46 percent of their babies developed resistance to nevirapine after taking one dose, a health official said. Scientists don't know the possible long-term effects on the women, said Dr. Philippa Musoke.
"Resistance does occur, but it fades after one year," Musoke said, adding that Uganda will continue distributing the drug "for the time being until we get an alternative."
WHO recommends nevirapine be used in combination with other drugs where possible - a strategy that has reduced transmission to less than 1 percent in wealthier countries. But it says resistance concerns must be weighed against the practicality of administering a single dose of nevirapine in impoverished African countries.
In July, South Africa's Medicines Control Council recommended that nevirapine only be used in combination with other drugs because of the resistance concerns.
The Health Department this week welcomed U.S. concerns about the quality of nevirapine research in Uganda, saying it supported its cautious attitude to the drug.
Until this year, Mbeki's government refused to provide anti-retroviral drugs through the public health system, citing safety and cost concerns. A coalition of doctors and AIDS activists won a 2002 Constitutional Court order requiring the government to immediately expand a pilot nevirapine program to all infected pregnant women.
|The Pharmaceutical Cartel's Survival Insurance - Diseased Populations
you will have deaths in all the continents
AP Report: November 18th 2003 - Experimental Ebola Vaccine is administered to a volunteer on Tuesday at the NIH clinical center in Bethesda. Experimental vaccine used on monkeys is now being assessed for safety in human volunteers, the NIAID (National Institute of Allergy and Infectious Diseases) announced. Ebola vaccine is DNA based and is similar to other trial vaccines that may be used to control AIDS, malaria and hepatitis. Experts fear that, for reasons unknown, outbreaks of Ebola will occur with increasing frequency. AP Report: 17 December 2003 - Ebola virus outbreak in a remote area of central Africa has so far killed 29 people, says the U.N. health agency. Animals are also dying in the area. Since 2001 there have been five outbreaks of Ebola in Republic of Congo and neighboring Gabon.
Korean born, 58 year old, Dr. Jong-Wook Lee, the newly elected (May 2003) director general of the World Health Organization said there is an urgent need for strong surveillance at local, national and global levels and that he is committed to building a staff devoted to that effort. Concerning SARS he also stated, "This will not be the last such problem we will be facing in the coming years."
Dr. David Heymann, head of WHO's communicable diseases unit, intimated outbreaks of deadly viruses are inevitable. He said, "The biggest threat would be an outbreak of a deadly strain of influenza. The big concern is influenza."
The ministers of the Asia Pacific Economic Cooperation (APEC) organization held a conference in Kuala Lumpur, Malaysia. They discussed setting up a network to monitor emerging diseases. High on their priority list was overcoming the economic damage caused by SARS. Thai Prime Minister, Thaksin Shinawatra told the ministers that SARS had caused more economic damage than the 1997-98 Asian financial crisis and warned that "there is no telling when it will re-emerge." David Heymann, the WHO's executive director for communicable diseases stated, "(SARS) certainly won't be over for another year" because the next phase is "intense surveillance for the next year to see whether the virus is still present or whether it's gone." It was at this conference in conjunction with the WHO that SARS was declared "dead in its tracks." [Notice - the focus of concern is economics and not the victims of the disease.] (LasVegasSun.com - June 2003)
Pay attention to the little clues buried in news stories. The little clues abound, at least for those with eyes to see and ears to hear. Disclosures and warnings usually precede action.
AP Report: 17 December 2003 - Ebola virus outbreak in a remote area of central Africa has so far killed 29 people, says the U.N. health agency. Animals are also dying in the area. Since 2001 there have been five outbreaks of Ebola in Republic of Congo and neighboring Gabon.
| Notice: It is said, "they have to tell you before they do it." Cohen's statements offer not only disclosure but insight into the game plan... resulting in the "Patriot Act" and all events used manipulating it into fruition. There will be more, count on it. Are you ready?
Army Times Staff Wire Reports
27 October 1998
US Defense Secretary Predicts the Army Will Patrol US Streets "Terrorism is escalating to the point that Americans soon may have to choose between civil liberties and more intrusive means of protection," says Defense Secretary William S. Cohen. The nation's defense chief told the Army Times he once considered the chilling specter of armored vehicles surrounding civilian hotels or government buildings to block out terrorists as strictly an overseas phenomenon.
But no longer.
"It could happen here," Cohen said he concluded after 8 months of studying threats under the Pentagon microscope. Free-lance terrorists with access to deadly chemical and biological bombs are "going to change the way in which the American people view security in our own country," he predicted in a Sept 10 interview.
Cohen is calling for the government to step up its efforts to penetrate wildcard terrorist organizations. "It's going to require greater intelligence on our part - much greater emphasis on intelligence gathering capability - more human intelligence, and it's going to take more technical intelligence," he said.
But using the U.S. military in a domestic law enforcement role would require revisions to laws in force for more than a century, cautions Shreveport attorney John Odom, Jr. "You can't do it from the Defense Department side unless Congress dramatically revises the Posse Comitatus laws," said Odom, a colonel in the U.S. Air Force Reserve and a reserve Judge Advocate.
"The 1878 law specifically prohibits the use of the military in domestic law enforcement unless authorized by Congress or the Constitution and does not allow for military intervention through action by the Secretary of Defense of even an Executive Order from the President," Odom said. We're trained from the first day of Judge Advocate school to think of Posse Comitatus, said Odom. "If Secretary Cohen is suggesting that the Department of Defense be involved, it may be part of a legislative package, but it will not happen unilaterally without a lot of folks thinking long and hard about it."
Cohen said terrorism would be a top priority in 5 new areas he plans to focus on now that he has wrapped up his first defense budget, the quadrennial review of the military and a new 4-year defense strategy. Other goals include modernizing the military, improving troops housing and other benefits, streamlining the defense bureaucracy and shaping new military relationships and contracts across the globe.
Tracking device manufacturer:
Yes, In Your Lifetime...
Consider, everything has a saturation point. Corruption, greed, deceit, immorality, insanity, stupidity, apathy, hedonism, suffering -- all have a saturation point. As above so below. Imagine what happens when the cyclic saturation point is reached on the spiritual level, as well as, the physical. It is a dimensional zero point.
Comprehend the chaos that lies ahead. No, the world will not end per-se, but the face of the planet will change and the form of the world will change with it. Large areas of the United States will be made un-inhabitable and literally millions of human beings and animals will die from starvation, injury, fear, displacement and catastrophic diseases - - this is not to mention the world wide death count.
This is the same game that was played out thousands of years ago. Game? yes, it is a game and everyone on the planet can play. First humanity cooperates in their own demise in one way or another. Human beings have had thousands of years of experience in cooperating in their own demise and are expert in such horrendous matters, after all they are only human.
Second, an elite (el.ite = little fake gods) group with access to special information know in advance a global catastrophe is imminent - - they know because the event is cyclic. It is important for the little fake gods to keep information sequestered from the masses - - aside from the corrupted genetics of the elite and their habit of trafficking in demonic spirits, it's a form of channeled knowledge that keeps them in power. It's called satanism.
Third, the elite group have provided for themselves off-planet refuge during the global catastrophe (at tax payers expense) just as their ancestors had done. They observe from afar (parked in orbit high above the earth) as hundreds of millions of people and animals are destroyed. They think of it as "species cleansing, SACRIFICE." The people being snuffed out think of it as "the wrath of God." It is all a matter of one's point of view at the time.
Wella! the elite return as hero-gods to rebuild a new world with the aid of the few devastated survivors, not un-like Noah and his family after the flood. More later...