(ALTERNET) When a prescription drug causes risky side effects, the word often doesn’t get out for years, allowing Big Pharma to make money anyway.
The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck’s risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because “the drug potentially provided a significant therapeutic advantage over existing approved drugs,” the FDA said.
Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.
Here are some drugs whose risks did not did not keep them from getting their “patent’s worth.”
(VAX TRUTH) When a normal, healthy, vibrant seven year-old child dies suddenly we want to know why. Things like that just don’t happen – at least they didn’t used to happen at the rate they appear to be happening lately.
This report from an Independent News Source in Vermont relates the story of what happened after Kaylynne Matten was taken by her parents for her annual physical on December 2, 2011. During the physical Kaylynne was given a flu vaccine. Four days later she was dead. She wasn’t even sick when she went to the doctor!
The state health commissioner, Dr. Harry Chen, “is not convinced” the girl’s death was from the flu vaccine, citing the “very rare” incidence of serious reactions to the flu shot and the huge numbers of people who receive them each year. Dr. Chen declares that serious reactions to flu vaccines are so “rare” that death by flu shot has never been reported in Vermont.
BINGO! There’s the problem. Every time a healthy child dies or is seriously injured by a vaccine, those who are responsible for determining the cause of death immediately rule out vaccines because they are “so safe” and serious reactions are “so rare” – No. They’re not. They’re just not reported because of people like Dr. Chen, whose job is dependent on the sale of vaccines. That’s what he does. He ensures that all of the people in his state are fully vaccinated. Without vaccines, Dr. Chen would be unemployed; at the very least he’d be looking for another job. But then, without vaccines there would be a LOT of doctors looking for jobs, so there’s a good chance Dr. Chen would be collecting unemployment benefits.
Dr. Chen is worried that people will over-react to this girl’s death. He cautions about “alarmist” reactions to the death of Kaylynne Matten. Excuse me? We are not supposed to be ALARMED? Clearly, Dr. Chen has become complacent when it comes to young children dropping dead for “no apparent reason.” Dr. Chen is worried that if people become “alarmed” their concerns may lead them to avoid getting a flu shot. If they start looking into the dangers of flu shots, it’s a very slippery slope. You know how it goes. Flu shot research is like “the gateway drug” that causes us (parents who are easily influenced) to become fanatics. We research the flu vaccine and the true dangers of the flu and before you know it we start to realize we’ve been lied to. From there it’s all downhill for Dr. Chen and his cronies. As we become “hooked” on research we learn more and more about vaccines and the more we learn the more we realize that vaccines are dangerous and the risks of infectious diseases are small in comparison.
As the article states, Vermont already has one of the most dismal (hear the sarcasm, please) vaccination rates in the nation. If even more people start researching and learning about the children and adults throughout the U.S. and the world who have died or been seriously harmed by vaccines, that dismal number might just fall even farther. Heavens! That would be a real tragedy – for Dr. Chen.
The fox is guarding the henhouse. How in the world can this vaccine-related death even be questioned? It’s like saying “John Smith walked across the 495 beltway and was hit by a semi. Mr. Smith survived the accident and was taken to the hospital where he lapsed into a coma and died 4 days later. Mrs. Smith believes it was the semi that killed her husband. The hospital administrator (who happens to be married to the driver of the semi) is not so sure. Autopsy results are pending…” GIVE ME A FREAKIN’ BREAK!
According to the CDC there are between 3,000 and 49,000 deaths each year in the U.S. due to the flu (influenza). That sure sounds like a lot of people dying from the flu. Before we become “alarmed” by these “huge” numbers, lets see what they mean in terms of the percentage of U.S. citizens. The U.S. Census Data indicates that the population of the U.S. is somewhere around 300,000,000 people: 304,059,700 as of the latest data. That means in a “good” year (fewer deaths from flu) the percentage of U.S. citizens who die from the flu is 0.0000986%. Whoa….. that’s a lot of zeros. In translation, this equates to 9.8 (less than ten) people for every 1 Million citizens in the U.S. Of course, in a very BAD year the numbers are higher. Taking the worst-case scenario (49,000 deaths), the yearly death toll would be 0.0016115% of the U.S. population. This number equates to 1.6 (less than two) deaths per 1,000 people. That’s a little bit scarier. However, we have to consider how many of those deaths occur in 7 year-old children.
Just what is the real risk of death from flu for a seven year old? How do we find out? If we just read the article, we are told “The majority of those severe illnesses and [3,000 to 49,000] deaths occur among infants, young children, pregnant women, seniors and people with chronic medical conditions.” I don’t know about you but when I read this I tend to think this means infants, young children and pregnant women are those who are MOST at risk. It might just be me, but when something falls at the top of the list when someone is talking about relative risk, I associate that with meaning they are the ones we need to be most concerned about. Actually, the opposite is true in this case.
Among persons aged <19 years, an estimated annual average of 97 (range: 41 in 1981–82 to 234 in 1977–78) influenza-associated deaths with underlying pneumonia and influenza causes occurred . The average annual rate of influenza-associated deaths for this age group was 0.1 deaths per 100,000 persons (range: 0.1–0.3). Among adults aged 19–64 years, an estimated annual average of 666 (range: 173 in 1981–82 to 1,459 in 2004–05) influenza-associated deaths with underlying pneumonia and influenza causes occurred. The average annual rate of influenza-associated deaths for this age group was 0.4 deaths per 100,000 persons (range: 0.1–0.8). Among adults aged ≥65 years, an estimated annual average of 5,546 (range: 673 in 1978–79 to 13,245 in 2003–04) influenza-associated deaths with underlying pneumonia and influenza causes occurred. The average annual rate of influenza-associated deaths for this age group was 17.0 deaths per 100,000 (range: 2.4–36.7). Deaths among persons aged ≥65 years accounted for 87.9% of the overall estimated average annual influenza-associated deaths with underlying pneumonia and influenza causes.
So…. how do we figure out the risk for a seven year-old? One way would be to divide 97 by 19, which would give us the average number of deaths per year of age. We can estimate this as FIVE, since 97 is very close to 100 and 19 is very close to 20. According to this calculation, there are approximately FIVE seven year-olds in the U.S. who die from the flu each year. Clearly the risk of death from the flu was astronomically small for 7 year-old Kaylynne.
Dr. Chen can talk all he wants about the risks of flu. His fear mongering won’t save his job. People are too smart to fall for the trickery anymore. Parents in the United States and around the world are tired of being lied to. We are tired of doing as we are told and watching our children die as a result.
Dr Chen: I suggest you update your resume. I think you’re going to need it.
Kaylynne Matten: Cause of Death “Undetermined.” Parents Believe Flu Vaccine Killed Their 7 Year-Old Daughter.
(NY TIMES) Virus surveillance systems are ill-equipped to detect mutations arising in flu viruses. So, work on the viruses is unlikely to offer significant, immediate public-health benefits, some say.
Why would scientists deliberately create a form of the H5N1 avian influenza virus that is probably highly transmissible in humans? In the growing debate about research that has done precisely that, a key question is whether the public-health benefits of the work outweigh the risks of a potential pandemic if the virus escaped from the lab.
For the scientists who have created the mutated strains of the H5N1 virus, the justifications are clear. Surveillance of flu viruses could, they argue, allow health organizations to monitor birds and other animals for the mutations that would provide an early warning of a pandemic and enable authorities to act quickly to contain the virus.
That claim is meeting with skepticism, however. More than a dozen flu experts contacted by Nature say they believe that the work opens up important vistas in basic research, and that it sends a valuable warning about the potential for the virus to spark a human pandemic. But they caution that virus surveillance systems are ill-equipped to detect such mutations arising in flu viruses. As such, work on the viruses is unlikely to offer significant, immediate public-health benefits, they say.
That tips the balance of risk-benefit assessment in favor of a cautious approach, says Michael Osterholm, who heads the University of Minnesota’s Center for Infectious Disease Research and Policy in Minneapolis, and who is a member of the US National Science Advisory Board for Bio-security (NSABB).
In a paper submitted to Science, Ron Fouchier’s team at Erasmus Medical Center in Rotterdam, the Netherlands, found that just five mutations allowed avian H5N1 to spread easily among ferrets, which are a good proxy for how flu behaves in other mammals, including humans. All five mutations have been spotted individually–although not together–in wild viruses. Yoshihiro Kawaoka of the University of Wisconsin-Madison and his colleagues have submitted similar work to Nature, which is partially described in an online Comment published this week.
Acting on advice from the NSABB, the U.S. government last month asked Science and Nature to publish only the broad conclusions of the two studies, and not to reveal the scientific details, in order to limit the risk that uncontrolled proliferation of such research might lead to accidental or intentional release of similar mutant viruses. The journals and the authors have agreed to this redaction, provided that a mechanism is established to disseminate the data to flu researchers and public-health officials on a need-to-know basis. The US government, the World Health Organization (WHO) and other bodies are now trying to put this mechanism together, along with a framework for international oversight of such research.
Last week, in a statement jointly published in Nature and Science, 39 flu researchers declared a 60-day pause in the creation of lab mutant strains of the H5N1 avian flu virus. The hiatus, they hope, should give scientists and policy-makers time to debate how such research might best proceed, and what safety measures should be required of labs that handle the virus. The signatories to the statement, including the key authors behind the controversial research, plan to bring together some 50 experts at a WHO-hosted meeting in Geneva, Switzerland, next month to discuss these thorny issues.
Scientists contacted by Nature say that basic research on such mutated strains may eventually yield insight relevant to developing pandemic countermeasures such as drugs and vaccines. And they all agree that the new research has done the world a service by showing that H5N1 seems capable of evolving the ability to spread rapidly among humans, in contrast to what some scientists have claimed.
Fouchier’s study “raises a red flag”, says Ilaria Capua, an animal-flu expert at the Experimental Animal Health Care Institute of Venice in Legnaro, Italy. “That is the real, and most important message, of this whole exercise.” It should prompt donors and international organizations to ramp up their funding of efforts to control outbreaks of the H5N1 virus in poultry, and so give the virus fewer opportunities to evolve into a human pathogen, she says. Other scientists add that it should force governments to rethink existing vaccine technologies, which are only capable of supplying vaccine six months after a pandemic starts, and of producing enough vaccine for a small fraction of the world population.
But the notion that the research offers a guide to dangerous variants that could be stamped out before they spread is unrealistic, say Osterholm and other researchers. “In order to even consider the possibility of reducing the animal reservoir of an emerging pandemic virus, one would need rapid and complete detection of virus in all geographical areas,” Osterholm says. Yet surveillance of H5N1 in poultry worldwide is patchy, particularly in poorer countries, where the virus is prevalent. It is also largely geared towards simply detecting and monitoring outbreaks, and few of the viral samples collected are ever sequenced.
Last year, global surveillance resulted in partial sequences from just 160 H5N1 isolates being submitted to GenBank, the main repository of such data (see “Sequence shortfall”). And virus isolates are often sequenced months or years after they are collected–hardly the swift turnaround of a pandemic alert system. “Could we pick up a mutation in real time and stop a pandemic?” asks Capua. “Not with the surveillance we have now.”
Moreover, if H5N1 surveillance in poultry is poor, the situation is far worse in pigs, where there is almost no systematic surveillance, even in richer countries. H5N1 infections in pigs are uncommon and cause only mild illness, creating little economic incentive to monitor them. GenBank contains partial sequences from just 24 pig H5N1 isolates. Yet pigs are a likely source of a human pandemic H5N1 virus because they are susceptible to both human and avian viruses, creating opportunities for genetic re-assortment in co-infected animals.
Fouchier argues that many countries collect more, and more timely, sequence data than those deposited in GenBank. “That some outbreak countries are not yet fully capable of making optimal use of such data should not lead to the fatalistic conclusion not to generate and share the data as they emerge,” he says. “Warnings weeks after dangerous viruses have emerged in poultry, or mammals, may be better than no warnings at all.”
But even if a candidate pandemic H5N1 virus was detected in poultry, culling flocks to eliminate it would be no mean feat. H5N1 has become endemic in many countries, including China, Vietnam, Indonesia, Bangladesh, India and Egypt, and the United Nations’ Food and Agriculture Organization estimates that, with current resources, it would take at least a decade to stamp out the virus in such countries.
The relative ease of making H5N1 transmissible between mammals in the lab should now prompt the world to address these glaring inadequacies in surveillance, says Jeremy Farrar, director of the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Molecular technologies need to be made more easily available and affordable to countries at risk, and genetic surveillance more comprehensive and timely. But building such systems would require sustained political will, financial resources, and overcoming major logistical hurdles in the field.
Even if such a revolution occurred, looking only for the mutations reported by Fouchier and Kawaoka would be short-sighted, says Marc Lipsitch, an epidemiologist at the Harvard School of Public Health in Boston, Massachusetts. “There are many, many, other ways that the virus could become transmissible,” he says. “It would be very unfortunate if people say that if we don’t see these mutations, we don’t need to worry,” he adds. Moreover, says Farrar, H5N1 is far from being the only flu virus that poses a pandemic threat. But he believes that more extensive genetic surveillance could eventually pay off. “The research points us to where we need to go, rather than where we are today,” he says. “Before this research, we were all guessing what changes might be needed. This work pushes that forward.”
Asked whether there were any areas in which the mutant flu research could provide immediate public-health benefits, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, replies: “I would say that, in a perfect world, the immediate benefit would be in surveillance. But from a logistics standpoint, in the world we live in, that will be difficult to do.”
Because the value of these studies is more likely to emerge in the longer term, it makes sense to take time to consider how such research can proceed safely, he says. “What’s the rush?” he asks. “I am very much in favor of having a pause in the research.”