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Researchers find little evidence Tamiflu reduces flu complications in otherwise healthy people

December 9th, 2009

From The Associated Press:

British researchers say there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths.

Researchers at the Cochrane Review, an international nonprofit that reviews health information, looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The papers were published online Tuesday in the British journal, BMJ.

The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.

Fiona Godlee, BMJ’s editor, said the papers cast doubt not only on how safe and effective Tamiflu is, but on the drug regulatory system that approved it. “Governments around the world have spent billions of pounds (dollars) on a drug that the scientific community now finds itself unable to judge,” she said in a statement.

But the World Health Organization disagreed. They said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications, like pregnant women, the elderly, children, and those with underlying medical problems.

“This will not change our (Tamiflu) guidelines,” said Charles Penn, a WHO antivirals expert. Penn said that while past studies show Tamiflu only has a modest benefit, when patients with severe illness or at risk of complications are treated early, there are fewer hospitalizations and deaths.

And Roche, the maker of Tamiflu, defended the drug, saying in a statement that they “firmly believe in the robustness of the data.”

Both the British researchers and WHO said there is little evidence to support the widespread use of Tamiflu in otherwise healthy people — precisely the policy Britain has adopted to fight swine flu.

In addition to recommending Tamiflu be saved for at-risk groups, WHO recommends Tamiflu only be used on a doctor’s recommendation.

In Britain, however, Tamiflu is regularly dispensed to healthy people who catch the flu. The drug is given out via a national swine flu hotline by call center workers with no medical training.

First Evidence Of Virus In Malignant Prostate Cells: XMRV Retrovirus Linked To More Aggressive Tumors

December 9th, 2009

From ScienceDaily.com:

In a finding with potentially major implications for identifying a viral cause of prostate cancer, researchers at the University of Utah and Columbia University medical schools have reported that a type of virus known to cause leukemia and sarcomas in animals has been found for the first time in malignant human prostate cancer cells.

If further investigation proves the virus, XMRV (Xenotropic murine leukemia virus-related virus), causes prostate cancer in people, it would open opportunities for developing diagnostic tests, vaccines, and therapies for treating the cancer, according to the study published Sept. 7 online in the Proceedings of the National Academy of Sciences. Prostate cancer is expected to strike nearly 200,000 U.S. males this year, making it the second most common form of cancer, outside of skin cancers, among men.
“We found that XMRV was present in 27 percent of prostate cancers we examined and that it was associated with more aggressive tumors,” said Ila R. Singh, M.D., Ph.D., associate professor of pathology at University of Utah and the study’s senior author. “We still don’t know that this virus causes cancer in people, but that is an important question we’re going to investigate.”
Singh, also a member of the U of U’s Huntsman Cancer Institute and associate medical director at ARUP Laboratories, moved to Utah from Columbia University Medical Center in 2008, where she began this research. She remains an adjunct faculty member at Columbia.
Along with providing the first proof that XMRV is present in malignant cells, the study also confirmed that XMRV is a gammaretrovirus, a simple retrovirus first isolated from prostate cancers in 2006 by researchers at the University of California, San Francisco (UCSF), and the Cleveland Clinic. Gammaretroviruses are known to cause cancer in animals, but have not been shown to do so in humans. The UCSF study did not examine benign (non-malignant) prostate tissues, so could not link XMRV to prostate cancer. They also did not find the virus in malignant cells.
Singh and her fellow researchers examined more than 200 human prostate cancers, and compared them to more than 100 non-cancerous prostate tissues. They found 27 percent of the cancers contained XMRV, compared to only 6 percent of the benign tissues. The viral proteins were found almost exclusively in malignant prostatic cells, suggesting that XMRV infection may be directly linked to the formation of tumors.
Retroviruses insert a DNA copy of their genome into the chromosomes of the cells they infect. Such an insertion sometimes occurs adjacent to a gene that regulates cell growth, disrupting normal cell growth, resulting in more rapid proliferation of such a cell, which eventually develops into a cancer. This mechanism of carcinogenesis is followed by gammaretroviruses in general. Singh is currently examining if a similar mechanism might be involved with XMRV and prostate cancer.
In another important finding of the study, Singh and her colleagues also showed that susceptibility to XMRV infection is not enhanced by a genetic mutation, as was previously reported. If XMRV were caused by the mutation, only the 10 percent of the population who carry the mutated gene would be at risk for infection with virus. But Singh found no connection between XMRV and the mutation, meaning the risk for infection may extend to the population at large.
While the study answers important questions about XMRV, it also raises a number of other questions, such as whether the virus infects women, is sexually transmitted, how prevalent it is in the general population, and whether it causes cancers in tissues other than the prostate.
“We have many questions right now,” Singh said, “and we believe this merits further investigation.”
Viruses have been shown to cause cancer of the cervix, connective tissues (sarcomas), immune system (lymphoma), and other organs. If the retrovirus is shown to cause prostate cancer, this could have important implications for preventing viral transmission and for developing vaccines to prevent XMRV infection in people.

Baxter Sent Bird Flu Virus to European Labs by Error

November 5th, 2009

From Bloomberg.com:

Baxter International Inc. in Austria unintentionally contaminated samples with the bird flu virus that were used in laboratories in three neighboring countries, raising concern about the potential spread of the deadly disease.

The contamination was discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview.

“This was infected with a bird flu virus,” Rosenberger said. “There were some people from the company who handled it.”

The material was intended for use in laboratories, and none of the lab workers have fallen ill. The incident is drawing scrutiny over the safety of research using the H5N1 bird flu strain that’s killed more than three-fifths of the people known to have caught the bug worldwide. Some scientists say the 1977 Russian flu, the most recent global outbreak, began when a virus escaped from a laboratory.

The virus material was supposed to contain a seasonal flu virus and was contaminated after “human error,” said Christopher Bona, a spokesman for Baxter, in a telephone interview.

‘Sanitized’

Baxter “moved very quickly to sanitize and protect employees,” Bona said. “Labs have been sanitized, potentially contaminated materials have been destroyed and employees were tested and considered not to be at risk.”

Baxter gained 93 cents, or 1.6 percent, to $58.27 at 4 p.m. in New York Stock Exchange composite trading, and has lost 2.3 percent over the last 12 months.

The Austrian health ministry reported the incident to the European Union and is conducting its own audit, Rosenberger said. In response, Baxter said it has put in place “preventive and corrective” measures that the ministry found satisfactory. The vaccine has been destroyed, according to Rosenberger.

The World Health Organization “is aware of the situation and is consulting with the ministers of health of the countries involved to ensure that all public risks arising from this event have been identified and managed appropriately,” said Gregory Hartl, a spokesman in Geneva.

European Agencies

The European Medicines Agency has no immediate comment, said Monika Benstetter, an agency spokeswoman. The U.S. Centers for Disease Control and Prevention, which distributes seasonal flu viruses to companies for vaccine manufacturing, isn’t investigating or providing consultation, said Tom Skinner, a spokesman for the Atlanta-based agency. The CDC is staying in touch with the European Centre for Disease Prevention and Control regarding the incident, Skinner said.

The H5N1 strain of avian flu has been monitored by health officials around the world for more than a decade for signs it could mutate into a form that is easily spread among humans. Currently, it passes mainly among infected poultry.

A flu pandemic of avian or other origin could kill more than 70 million people worldwide and lead to a “major global recession” costing more than $3 trillion, according to a worst- case scenario outlined by the World Bank in October.

H5N1 has infected at least 408 people in 15 countries since 2003, killing 63 percent of them, according to the Web site of the Geneva-based WHO.

Flu Pandemic

BioTest s.r.o, a Czech biotechnology company, was conducting research for a company called AVIR Green Hills Biotechnology using materials supplied by Baxter. The company was “supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus,” BioTest said in a statement last week.

AVIR Green Hills monitored its lab workers for signs of illness and got access to Roche Holding AG’s Tamiflu antiviral in case of infections, said Birgit Kofler-Bettschart, a spokeswoman for the closely held, Vienna-based company. AVIR Green Hills sanitized its laboratories, destroyed potentially contaminated samples, and told health officials, she said in an e-mail today.

Three influenza pandemics, including the 1918 Spanish flu that killed more than 50 million people, have occurred since 1900.

Threats

Another three pandemic threats — situations where a global epidemic is close to occurring — have occurred. One was the Russian flu of 1977.

The H5N1 virus, “even if it were let out of the lab, would be only lethal for birds in its present state,” said Ilaria Capua, a veterinary virologist, whose laboratory in Padova, Italy, handles some of the avian-flu screening for the World Organization for Animal Health. Capua said she has no knowledge of the situation. “In Europe, we can react fast” to outbreaks of the disease in animals, she said.

Baxter, the world’s largest maker of blood-disease treatments, is one of the companies working on a vaccine to be used in case of a flu pandemic. The European Medicines Agency recommended approval of Baxter’s Celvapan, the first cell culture-based vaccine for bird flu in Europe, in December.

To contact the reporters on this story: Michelle Fay Cortez in London at mcortez@bloomberg.netJason Gale in Singapore at j.gale@bloomber

Virus Associated With Chronic Fatigue Syndrome

October 15th, 2009

From WashingtonPost.com:

Scientists have found evidence that a virus may play a role in chronic fatigue syndrome.

Vincent C. Lombardi of the Whittemore Peterson Institute in Reno, Nev., and scientists elsewhere studied 101 patients with chronic fatigue syndrome, a baffling, debilitating and controversial condition that affects an estimated 17 million people worldwide. They discovered that 68 of the patients — 67 percent — had a virus in their blood known as the xenotropic murine leukemia virus-related virus or XMRV. Only eight of 218 similar subjects who did not have chronic fatigue syndrome — 3.7 percent — had the virus in their blood, the researchers report in a paper published online Thursday by the journal Science.

Further studies showed that the virus is indeed infectious, and can “provoke” the immune system to respond.

The researchers cautioned that the findings far from prove that the virus causes chronic fatigue. It may be just part of the picture. But they suggest that the virus may at least contribute to the development of the disorder. This isn’t the first time a virus has been associated with the condition. Previous research has suggested that some herpes viruses and other viruses may also play a role.

In an article accompanying the research, John Coffin of Tufts University in Boston and Jonathan Stoye of the National Institute for Medical Research in London agreed. They noted that there are many unanswered questions about the virus, including how it is transmitted. But if the findings are representative of what’s going on in the general public, perhaps 10 million Americans and hundreds of millions of people worldwide might be infected with the virus, which could turn out to be playing a role in a variety of diseases. The virus previously was found in some patients with prostate cancer.

Swine Flu and Choices

October 12th, 2009

To vaccinate or not to vaccinate? This controversy is a significant dilemma that has people on both sides saying that their way — their approach — is right for every person.

In his overview article, “The Big Question: Could Tamiflu® be the wrong way to treat children with swine flu?”, Paul Vallely presents many points from both sides. He concludes with the question: Should I give my child Tamiflu®? And he answers with a summary of both the “yes camp” and the “no camp” answers. Yes, it shortens the time the disease lasts and it also reduces the rate of transmission to other people. Yes, the studies suggesting it does more harm than good are based on normal flu not swine flu. Yes, if symptoms are severe or there is any sign of complications the safety-first option is to take Tamiflu® as soon as possible.

No, rest, fluids and over-the-counter medicine should be sufficient for normal kids with mild symptoms. No, the side-effects of Tamiflu® could outweigh the benefit of it shortening the illness by one day. No, the more people who take anti-virals unnecessarily, the greater the risk the virus will mutate into a more resistant strain (1).

In the “yes camp”, the web site for the Centers for Disease Control and Prevention web states: “Much of the information in this document is based on studies and past experience with seasonal (human) influenza. CDC believes the information applies to 2009 H1N1 (swine) viruses as well, but studies on this virus are ongoing to learn more about its characteristics. This document will be updated as new information becomes available.”(2)

At you’ll find a map of the 50 states. Click on your state to get the latest information on where to get either the seasonal or H1N1 (Swine) Flu vaccines. You’ll also find other valuable flu resources in your state. Then at you can track cases of flu by state.
And at you’ll find a map of the world with flu cases in each country.

Paul Vallely omitted another “no camp” reason: the growing research connecting autism and autism spectrum disorders with vaccinations. For more information from the Medical Voices Vaccine Information Center check out reference 3. And for information on the Defeat Autism Now conference see reference 4.

If you choose not to get vaccinated, what can you do to keep yourself healthy? First, sleep more especially when you feel fatigued. A busy immune system makes you tired, so you’ll sleep and allow the immune system to focus on handling the invaders. Second, drink more water. How much? Take your body weight in pounds and divide that number by two. That’s the number of ounces of water to drink daily. For example, if you weigh 150 pounds, drink at least 75 ounces of water or a bit more than two quarts.

Next, eat foods that strengthen the immune system — citrus fruits for their vitamin C content, garlic, all types of brightly colored fruits and vegetables. Consider herbs like astragalus, echinacea, elderberry, and boneset. Research the homeopathic remedy Oscillococcinum. Take supplements including vitamin C, zinc, selenium, and vitamin D. Check out reference 5 where John Jacob Cannell, MD, Executive Director of the Vitamin D Council, answers questions about vitamin D and the swine flu virus. He recommends taking high levels of vitamin D and being vaccinated.
Naturopathic Physician Karen Peters suggests ventilating airtight houses even during the winter because indoor air is often more polluted than outdoor air. “If, despite her patients’ best efforts, they’re felled by the flu, Peters encourages a light, broth-based diet. We want to shift our body’s energy from digestion to fighting the virus and regaining health,” she says. She suggests herbal cold and flu remedies adjusted to personal needs; and she cautions against trying too hard to lower fevers. “Spiking a fever can be a good thing, it is part of our body’s natural defense system,” she says. While all fevers need to be monitored – very high temperatures can be dangerous – taking heavy doses of medicine to reduce fevers may work against the body’s virus fighting power.”(6)
People must make this choice about themselves and their loved ones. Talk with your physician. Perhaps blend both approaches. Take very good care of yourself. Stay away from crowds. Wash your hands often. AND sleep, drink, eat, and supplement in a way that will truly support your immune system.

References:
1. Vallely, P., “The Big Question: Could Tamiflu® be the wrong way to treat children with swine flu?”, The Independent, August 12, 2009

2. Centers for Disease Control and Prevention. “Questions & Answers: 2009 H1N1 Flu (Swine Flu) and You”

3. Medical Voices Vaccine Information Center; 34 webinars some presented and available; others to happen in Oct-Nov 2009;

6. Robbins, N. “Naturopath bridges gap in treatment, prevention” The San Francisco Chronicle, September 21, 2009