Thursday, December 31, 2009
Wednesday, December 30, 2009
The state is encouraging more than 80 people to take antibiotics and anthrax vaccine after an environmental sample at the United Campus Ministry in Durham tested positive for anthrax.
The announcement today comes after a young woman remains in critical condition with gastrointestinal anthrax. She attended a drum circle at the ministry building, which the state ordered closed until further notice.
However, many questions remain about the vaccine's efficacy and safety. Whether vaccination is appropriate in the current setting is another question, since anthrax vaccine has not been FDA-approved for this purpose, and provided no additional benefit for persons who took antibiotics after anthrax exposure in 2001. When CDC offered the vaccine for post-exposure prophylaxis in 2001, it failed to make a positive recommendation for the vaccine's use, since no data supported a presumption of benefit from the vaccine then, and none support it now. In fact, the New Hampshire department of health rightly points out that, "The vaccine is not effective in prevention of the disease after someone has been exposed." Although CDC's Advisory Committee on Immunization Practices recently voted in favor of post-exposure anthrax vaccination, the recommendation is provisional and has not been approved by CDC's director or DHHS.
Weeks (or months) after an exposure, one's risk of developing anthrax drops toward zero. The likelihood of another case developing in New Hampshire is extraordinarily low.
If anthrax vaccine was perfectly safe, people who might have been exposed to anthrax would do well to use it as extra insurance against the disease. But there are troubling safety questions. The GAO (the investigative arm of Congress) reported in 2007 that, "Officials from the VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death." I discussed this earlier here.
Below is a table from the largest trial of Biothrax anthrax vaccine conducted in humans, by CDC, published in the October 1, 2008 Journal of the American Medical Association. A total of 1564 people were entered in the study, and 1300 received anthrax vaccine. In the 1564 subjects, 229 serious adverse events occurred during the 43 month trial. A listing of all the adverse events, comparing the vaccine and placebo groups, has yet to be published--but study authors reported that the following 7 serious adverse events (including two people with new breast cancers) were possibly related to the vaccine:
Table 7. Serious Adverse Events Rated as Possibly Associated With the Study Agent (anthrax vaccine) Since Study Initiation
A Latin phrase encapsulates the anthrax vaccination issue, for those civilians in a position to choose whether to take it: Caveat Emptor (or in English, Let the Buyer Beware).
... H5N1 (avian or bird flu virus) would alter government approaches to pandemic planning. But it would also create a new and unprecedented opportunity for the global pharmaceutical industry. It was, as Dr. Ossi recalls, “an obvious commercial opportunity” for the drug companies – one that is reshaping their businesses.
In a matter of a few years, flu shots have gone from being a marginal, money-losing business to a massive profit generator for a small number of global companies, as
governments and the public hasten to protect themselves from getting sick.
Between 2004 and 2007, vaccine sales across the industry soared an average
of 32 per cent each year, with flu vaccine leading the way. That is roughly four
times faster than any other pharmaceutical product.
This is the story of how that happened – how Flu Inc. grew out of nowhere, transforming a once struggling business characterized by lab closures and lawsuits into a high-profit industry in less than a decade, and of the steps the pharmaceutical industry has taken to ensure the dollars keep flowing.
The change is driven by a new way of thinking in government about how to approach future threats of a flu pandemic. Health officials have begun to see merit in pursuing a strategy of stockpiling vaccines, even at a much higher cost per dose than they paid in the past...
The problem with making vaccines
For years, scientists had tried to find a faster way to make vaccines. They chased a variety of theories, including isolating the DNA of a virus, which many researchers believed would unlock new ways to fight infections. But at its main vaccine facility in Rixensart, Belgium, Glaxo had found a way to make vaccines more potent using another kind of technology: adjuvants...
Adjuvants are like superchargers for vaccines. They are mild contaminants that cause the body to respond with a more intense immune response. When paired with antigens, the adjuvant liquid can make the vaccine's impact stronger. This allows for more doses to be produced from less antigen...
Adjuvants allowed companies to pump out more, but it is also a higher-margin business than antigens... “The barriers to enter the market are extremely high,” said Mr. Monteyne in Belgium. “You don't become a vaccine maker over night. That's why we have a few big players, and very few only.” That meant the giants could push hard to increase prices. And they did.
...the cost of a flu shot is flexible depending on whether the buyer can pay more. “We have a tiered pricing strategy,” Mr. Monteyne said. “It is mainly based on the level of income of the country.”
...Switzerland was the first country to jump in. In October, 2006, with fear over H5N1 at fever pitch, the Swiss signed a contract with Glaxo on a stockpiling deal that called for 8 million doses of avian flu vaccine, slightly more than one shot for every citizen. This emerging business – pre-pandemic treatment – was rounding into shape. Glaxo began trade-marking the names of vaccines along those lines, registering its vaccines as Prepandrix.
... There was just one problem: the H5N1 pandemic never happened. The virus stayed mostly with animals. The Swiss were left with one of the world's largest stockpiles of unused H5N1 flu vaccine. Glaxo's sales of avian flu vaccine fell 54 per cent in 2008, as countries realized their stockpiles weren't needed.
... Once a country bought a large supply of adjuvant, it was locked in as a buyer for Glaxo's antigen for years to come. Countries were not just vaccine buyers now; they were subscribers, coming back annually to the company for more and different types of shots... In the past 12 months, the number of countries using such stockpiling methods has grown to 60 from less than 10. (See discussion of how the UK is negotiating with GSK to cancel H1N1 shots and in exchange stockpile GSK's adjuvant, here.)
... Soaring vaccine sales are also pushing companies to chase profit in other types of shots. The race is now on to develop blockbuster vaccines, defined as those that bring in more than $1-billion annually. Two recently developed vaccines – Prevnar for pneumonia and Gardasil for cervical cancer – have become blockbusters, selling close to $2-billion a year.... It's a new marketplace.
Tuesday, December 29, 2009
You read it here first on October 25: bird flu vaccinations may be next.
From the BBC:
Dr Margaret Chan says avian flu is more of a problem than swine flu
The head of the World Health Organisation (WHO) has warned the global swine flu pandemic is not yet over and the virus could still mutate....
However she admitted she had not yet had a vaccine but said she would have it soon.
She said that although countries are now better prepared to cope with a global disease outbreak, people still had to be aware of the dangers of bird flu (H5N1).
She said this was more toxic and deadly than swine flu and that many countries remained ill-prepared for mass outbreaks of this virus.
"The world is not ready for a pandemic to be caused by H5N1," she said.
And old bird flu vaccine trial data were substituted to license European swine flu vaccines (a neat way to distribute swine flu vaccine before there is any data on it).
Might the 97 partnerships and collaborative arrangements with WHO, which supply about 80% of WHO's budget, or simply channeling money have influenced the way WHO weakened the criteria for a pandemic last spring, and/or influenced WHO's support for billions of doses of unnecessary vaccine for swine flu?
Monday, December 28, 2009
Adverse events designated serious were 50% higher (based on doses distributed, not doses used) for swine flu compared to seasonal flu. Monitoring will continue over a longer duration and for more vaccine doses. For 13 deaths reported following vaccination:
"No patterns in age, sex, or type of underlying medical condition were observed that might lead investigators to suspect a causal link with vaccination."
Sunday, December 27, 2009
Egypt's health ministry has confirmed an H5N1 avian influenza infection in a 21-year-old woman, the country's third case since late September, the World Health Organization (WHO) reported today. She received Tamiflu.
An investigation into the source of her infection revealed that the woman had close contact with dead poultry and had helped slaughter sick birds.
Egypt's latest case confirmation raises the global H5N1 tally to 447 cases, of which 263 have been fatal (a 59% fatality rate--Nass).
The country so far has recorded more H5N1 cases in 2009 than any other. Of 52 cases reported internationally, 39 were from Egypt. Of those Egyptians who were infected in 2009, only four died (a 10% fatality rate. This makes you wonder whether cases have been primarily diagnosed posthumously, and that cases who survive are being missed...after all, what country wants to advertise rising numbers of humans with avian flu, since tourism will be affected, and it doesn't help other businesses--Nass )
UPDATE: Science covered the story of asymptomatic individuals who were antibody positive for avian (bird) flu in 2005, suggesting the mortality rate could be considerably less than expected.
December 21, 2009 07:15 CET/ Novartis press release: Basel, Switzerland
All three Novartis A(H1N1) 2009 influenza vaccines prequalified (read that as untested or inadequately tested for third world distribution) by World Health Organization (WHO) for use in developing world
· First prequalification from WHO for multiple influenza A(H1N1) 2009 vaccines from a single company: Celtura® and Focetria®, both with the Novartis adjuvant MF59®, as well as unadjuvanted A(H1N1) vaccine from the Fluvirin® platform
· WHO prequalification of two MF59 adjuvanted vaccines highlights Novartis adjuvant’s antigen sparing potential as means to enhance global supply of pandemic vaccines· More than 80 million doses of Novartis influenza A(H1N1) vaccine shipped to 21 countries around the world
Saturday, December 26, 2009
Vaccine industry is being revived: New technology, greater funding and higher profits are a shot in the arm for advances/ LA Times
Breakthroughs in technology, increased funding and higher profits are spurring a boom in vaccine discovery and development that could save or improve the lives of millions of people by attacking such scourges as cancer and malaria.
Three new vaccines arrived on the market in 2006, the most in a single year. They include vaccines for the human papillomavirus, linked to cervical cancer, and for rotavirus, which causes severe diarrhea and kills 600,000 children globally each year. Another prevents shingles in the elderly.
As early as the end of the decade, scientists say, there may be new immunizationsagainst herpes simplex and rheumatoid arthritis and a better seasonal influenza vaccine.
Researchers also are talking about a potential vaccine within five years to fight malaria -- long one of mankind's deadliest and most elusive adversaries.
Other scientists are making progress with what are known as therapeutic vaccines, which fight already diagnosed diseases or conditions, including cancer and Alzheimer's, or addictions to substances such as nicotine, by "teaching" the body to fight back. They're further down the road but hold the potential to transform medical care, experts say.
"It may turn out we have a perfect storm here of several different things coming together at the right time. This is a tremendous time of opportunity for both the developed and the developing world," said David Fleming, director of the Bill & Melinda Gates Foundation's global health strategies program, which has made vaccine development and access a cornerstone of its mission.
"It's clear there is a renaissance going on around vaccines," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "We have made more progress with some [vaccines] in the past few years than we have in the past 30."
The current immunization boom could rival or even surpass the Golden Age of vaccine development between the late 1940s and early 1960s, experts say, when scientists such as Jonas Salk discovered inoculations for polio, flu, mumps and measles. But relatively few vaccines were found in the decades that followed, partly due to lack of profitability for drug companies and reduced vaccine research funding.
Perhaps the best evidence of a vaccine revival is that the pharmaceutical industry is returning to the market.
... Jean Stephenne, president of GlaxoSmithKline Biologicals, expects his company to have five new vaccines in the next five years and that its vaccine business will grow from 6% of the company's sales this year to 14% by 2010.
Overall, the number of vaccines in development has risen from 285 in 1996 to 450 today.
Drug executives say they can charge considerably more for today's vaccines -- up to several hundred dollars or more -- versus a few dollars for older vaccines.... But Greene said major recent advances in vaccine technology had made finds considered unattainable a decade ago look possible. [Although the term is never used in this article, what is really meant by "recent advances" is the potential use of novel adjuvants, which have been around for awhile but never looked close to widespread usage before the carefully orchestrated pandemic response of 2009.--Nass]
Thursday, December 24, 2009
The article pounds the drum regarding the need to protect manufacturers from liability, repeats the "millions of deaths" mantra, and no doubt helped push along billions in funding for Tamiflu and H5N1 vaccine development and stockpiling.
Can someone please tell me how you can assure adequate safety testing when manufacturer liability is waived? Unless manufacturers have tested enough to know about their products' problems, millions of people will be at risk from using medical products rushed into use. Yet US law says that manufacturers can only be liable for damages if they know about problems and choose to ignore them. Thus manufacturers are incentivized to perform the most minimal testing allowed. Is that why millions of doses of vaccine from 2 manufacturers were recalled for potency problems in the past 2 weeks?
In 2004 10 Tamiflu pills cost $10 wholesale. The retail price in my neighborhood this year was $100. Pandemic mongering is great for business. And as the BMJ pointed out 3 weeks ago, there is no reliable evidence it works. Excerpts from this piece follow; reading it will help you understand how the response to this year's swine flu epidemic was decided years ago, and had almost nothing to do with the characteristics of this year's virus.
... If Asia's potent H5N1 bird flu assumes a form transmitted between humans, this drug, oseltamivir, would be the world's only initial defense against a pandemic that could kill millions of people. But oseltamivir, sold as Tamiflu, is made by only one company, Roche, at a single plant in Switzerland. "We are living in a brave new world where we only have one drug," says flu expert Arnold Monto of the University of Michigan, Ann Arbor, who spoke before the working group meeting of the G7+ Global Health Security Action Group.
That grim assessment is one indicator of the world's vulnerability to pandemic influenza. Most virologists say a pandemic is a virtual certainty within the next few decades, if not from H5N1 then from another avian flu strain (see p. 392). When that happens, public health officials will have two tools to battle the disease: antiviral drugs and vaccines. But although research has produced effective new antivirals, they are expensive, and global supply falls far short of need. And a promising genetically engineered vaccine against H5N1 is still an experimental product only just now being tested in people.After years of warning from flu experts, governments are finally beginning to respond. Some countries are starting to stockpile antivirals.
... However the vaccine is made, countries would need to pass legislation to shield companies from liability should the vaccine cause serious side effects, as did the swine flu vaccine. Some believe these problems will quickly be solved if a pandemic arrives. "What happens in a crisis is, a lot of the roadblocks get moved," says virologist Maria Zambon of the U.K.'s Health Protection Agency.
... fellow scientists have accused Osterhaus of fear-mongering. Luc Bonneux, an epidemiologist at the Netherlands Interdisciplinary Demographic Institute, says Osterhaus is part of a "flu mafia" and that he's hyping the threats of both avian and swine flu. Miquel Ekkelenkamp, a microbiologist at University Medical Center Utrecht, called Osterhaus a "panic virologist" in a recent op-ed, adding that he "should be banned from television permanently."And last July, it was pointed out that the UK's appointee (Sir Roy Anderson) to the WHO Strategic Group of Experts (that helps make decisions about the approach to pandemics) received 116,000 pounds from GlaxoSmithKline as a director last year. That is $185,000 US dollars. Glaxo sells Relenza for swine flu treatment. Sir Roy took over as Rector of Imperial College, London last year, where he earns up to £400,000 a year in additional compensation.
... Bonneux has also taken aim at the European Scientific Working Group on Influenza (ESWI), an industry-supported group that Osterhaus has chaired since 2000. ESWI organizes meetings, promotes awareness about flu, and tries to raise vaccination levels. Bonneux says the group—which receives a 40,000 contribution from each of 10 companies annually—is little more than a lobby club that gives "trumped-up, sensational stories a scientific seal of approval."
Wednesday, December 23, 2009
... armed with the firm conviction that he was about to do good in the world, and coincidentally sell a ton of drugs for Merck, Jeremy Allen set out to completely rework the way that bone was measured in America.
Now, to do this, he figured, the first thing he needed was an institution, an entity whose mission was not to sell drugs, but to serve the public good. So he decided to create one. In 1995, Allen convinced Merck to establish a nonprofit called the Bone Measurement Institute. On its board were six of the most respected osteoporosis researchers in the country. But the institute itself had a rather slim staff: Allen, you see, was its only employee.
Mr. ALLEN: There was no payroll, there was no building, there was no office with the name Bone Measurement Institute...
... Jeremy Allen says that to encourage other companies to take seriously Merck's goal of dropping the price of measuring machines, Merck actually purchased a bone measurement business.
Mr. ALLEN: We bought one of the companies and showed how low the price could become purely to get everybody's attention. And we got everybody's attention. And subsequently, when everybody else moved, we let it go, and the company closed. And we cheered its demise...
From 3/2008 CIDRAP:
Until now, the Centers for Disease Control and Prevention (CDC), which is advised by the ACIP, recommended flu vaccination for children from 6 through 59 months old. The new ACIP recommendation expands the target groups to include children from ages 5 through 18 years. That adds about 30 million children to the groups targeted for flu shots, the CDC estimates.
[Dr.] Wexler [executive director of the Immunization Action Coalition, an industry-sponsored vaccine advocacy group--Nass] observed that the ACIP recommendation pushes the country closer to embracing universal flu vaccination. Previously, flu immunization recommendations covered groups constituting about 74% of the US population, she said. Now, "it's probably up to 90%, or at least up to 85%."
In light of those numbers, she said, "I think it would be better to recommend vaccination for everyone. It's much simpler. . . . It's going to save clinicians a lot of time, instead of having to wade through and figure out who's supposed to be vaccinated. It'll be much easier for [insurance] coverage to be ascertained. . . . And I think it'll reduce influenza in circulation."[Why bother making an informed vaccination risk-benefit determination for each patient when it's so much easier to ignore their underlying conditions and recommend that every American get a flu shot, every year--Nass]
Feb 27 CIDRAP News story "ACIP recommends flu shots for all school children"
... [Gerberding] came to the CDC in 1998, and was credited with smoothly handling the media after the mysterious anthrax attacks that followed the World Trade Center attack.
Merck is one of the largest vaccine makers in the world; Gerberding will be overseeing a $5-billion-a-year business starting in late January...
Gerberding, a long-time advocate for vaccines, has some potholes ahead of her. Merck has caught flack for aggressively pushing its new and expensive Gardasil vaccine... Sales of the vaccine have slipped recently--falling 22 percent to $311 million during the third quarter.
And from the Atlanta Journal-Constitution on Gerberding:
Earlier this year she was attacked for encouraging people to get vaccinated against the new H1N1 virus at the same time she was a consultant for Edelman, a public relations firm with lots of Big Pharma clients, including Merck. [No wonder she ignored illegal conflicts of interest in CDC's vaccine experts--Nass] And Merck itself has come under criticism from within the public health community for pushing its expensive new HPV vaccine for children...As head of the agency from 2002 to 2009, Gerberding oversaw a not-so-popular reorganization of CDC management, and led the agency through some high-profile crises, including SARS and several food-borne outbreaks.
Gerberding’s six years leading one of the nation’s most trusted institutions were marked by numerous controversies, from allegations that she allowed politics to interfere with science to concerns that her strategic decisions incapacitated the agency’s ability to respond in a public health crisis.
... for much of her tenure, many CDC employees lacked confidence in her vision for the agency. Just 48 percent of CDC staff said they had a high level of respect for the agency’s senior leaders, according to results released last year of a federal survey of government employees.
Last year, congressional investigators concluded the CDC failed “in almost every respect” to protect Hurricane Katrina’s victims from dangerous formaldehyde fumes in government-provided trailers. And Gerberding was accused of playing politics by refusing to reappoint the director of the agency’s worker safety division —- a man widely respected by business leaders, labor unions and lawmakers.
Gerberding drew fire from Democratic lawmakers in 2007 when she delivered testimony to Congress about the health effects of climate change that had been censored by the White House.
In 2003, Gerberding launched a massive reorganization of the CDC that many employees say plunged the nation’s 911 system for public health into turmoil and caused an exodus of key scientific staff.
In December 2005, five former CDC directors sent Gerberding a highly unusual joint letter warning that the agency was in trouble in the wake of her reorganization. They were alarmed by the departures of critical staff...
photo of Julie Gerberding, Reuters
From Reuters' Maggie Fox, we learn that the swine flu "pandemic" has opened avenues for increasing vaccine uptake in the US... by grabbing children in schools, which might reduce the impact of seasonal influenza. (Let's experiment on tens of millions of American children to find out.)
The vaccine spin doctors know how to take every bit of news and turn it into an opportunity to increase Pharma profits. Let's spend a billion bucks and vaccinate 75 million children (yearly) to prevent 75 pediatric deaths (most of which occur in children with severe chronic illnesses)--and that is a best case scenario, occuring only if the vaccine strains are perfect matches to the flu viruses, and if efficacy is 100%.
The swine flu pandemic may have changed the U.S. approach to handling influenza forever, and for the better, U.S. officials said on Thursday.
While they said years of work were needed before vaccine production was up to the desired standard, some experiments such as vaccinating children in schools might work to help control seasonal influenza.
Yet in a 2006 New England Journal article on school-based vaccine programs, researchers found the results of the study were paradoxical: in families of children who attended schools that had vaccine programs, there were more adults and children who were hospitalized than in families of children from control schools that did not vaccinate. And vaccinated children had no fewer hospitalizations than unvaccinated children. So what do our public health policymakers suggest? Expand the experiment to all our children. Hello!?
As long as we continue to fail to perform active side effect surveillance for a meaningful duration, we'll never know how many cases of Bell's Palsy, Guillain Barre Syndrome, Crohn's Disease, Asthma, Diabetes, Lupus, Developmental Disorders, etc. are due to the vaccines. Instead, we can posit air pollution as the cause of autism (for example), as some "expert" did last week, or suggest that any other byproduct of modern society is the reason so many Americans are developing neurologic and autoimmune disorders, compared to years past.
Ever wonder why Julie Gerberding, former CDC director, moved the vaccine safety group into the Office of the Director at CDC? Could it be to maintain control over how aggressively they looked for side effects? She starts work next month as president of Merck Vaccines. A fitting reward for her success at keeeping the lid on vaccine injuries. Here's one method she used:
According to the NY Times' Gardiner Harris,
A new report finds that the Centers for Disease Control and Prevention did a poor job of screening medical experts for financial conflicts when it hired them to advise the agency on vaccine safety, officials said Thursday... the inspector general of the Department of Health and Human Services, found that the centers failed nearly every time to ensure that the experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions.Thanks, Julie. I'm sure you'll do a great job promoting school-based vaccine programs for many Merck vaccines, including blockbuster Gardasil. After all, you wouldn't want a 9 year old boy to get a case of genital warts, would you? (Yes, believe it or not, genital warts is the indication for boys aged nine and up to get this vaccine.)
The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers.
... little attention has been paid to the potential conflicts of advisers to the C.D.C., even though that agency’s committees have significant influence over what vaccines are sold in the United States.
Tuesday, December 22, 2009
And I saw a new case of Bell's palsy this week in someone a week after receiving both seasonal and swine vaccines. Is it coincidence or causation? Likely we will never know. But there were many cases of Bell's palsy reported after anthrax vaccinations, which led me to ask about vaccinations.
Flu activity is only "widespread" in 11 states per CDC. But how widespread could it be when less than 2% of tests for flu are now coming up positive?
This report points up the difficulty linking an injury to a vaccine. Taiwan's CDC Director-General said, "There is also no evidence at present to link the boy’s death to the vaccine.” Apparently all reported deaths were determined by the Department of Health to be unrelated to the vaccine, even though the doctor's son appeared to die from an autoimmune reaction:
After preliminary discussions, the experts concluded that the boy’s death
was unrelated to the vaccination, Kuo said, adding that an immune system problem was a possible cause of death.“The boy’s parents are welcome to request an investigation into the case to allow experts to make a more comprehensive, independent judgment,” Kuo said.
Problems and side effects that have been reported so far from the vaccine
include deaths among elderly recipients and dizziness among
students. These have dissuaded some from getting vaccinated.Health officials
said the reports of dizziness caused some parents, to withdraw their permission
for their children to receive the shots.“A total of 331 cases of side effects
from the vaccines has been reported, but all the symptoms were
temporary,” Kuo said. “These cases will not affect our vaccination
"... The Geneva-based WHO is coordinating efforts to encourage rich countries to
share vaccines with poorer nations who had little or no access to supplies.
Fukuda said six manufacturers and 12 countries had so far pledged some 180
million doses of vaccines to be distributed to around 95 countries.
Officials at the drug companies had no immediate comments on the German and Spanish government moves."
Sunday, December 20, 2009
Wolfgang Wodarg , former SPD member of parliament, and chairman of the European parliament’s health committee, initiated the inquiry. The motion was passed unanimously by his colleagues in the European parliament‘s health committee.
Wodarg has criticised the measures taken against the swine flu as "one of the biggest medical scandals of the century.“
He said the influence of the the pharmaceutical industry on scientists and government officials has resulted in "millions of healthy people being exposed unnecessarily to the risks of an inadequately tested vaccine.“ That even though the swine flu virus is "much less harmful“ than last year’s seasonal flu, causing "not even a tenth of the usual deaths associated with flu.“
Wodarg has also criticised the way pharmaceutical companies have made gigantic profits at the expense of taxpayers.
He accused vaccine manufacturers of being willing even to inflict bodily harm in their pursuit of profits, noting that the adjuvants in the swine flu jab have hardly been tested. In addtion,the vaccine‘s side effects including dangerous paralysis have not been adequately recorded.
Wodarg has said that the role of the WHO and its pandemic emergency declaration in June needs to be the special focus of a European parliamentary inquiry. For the first time the criteria for a pandemic was made not the actual risk of a disease, but the number of cases of the disease.
By classifying the swine flu as pandemic, nations were compelled to implement pandemic plans and also to purchase swine flu vaccines.
Because WHO is not subject to any parliamentary control, Wodarg argued it is necessary for governments to insist on accountability.
Friday, December 18, 2009
... In the U.K., under two percent of the population has stepped up, and only 17 percent of those at special risk of flu complications, according to Bloomberg News...
Ah, but look at the Scandinavians. They are Europe's model citizens when it comes to doing what public health officials want. According to Andrea Gerlin of Bloomberg, Norway has managed to vaccinate all 1.2 million people in high-risk groups. At least a third of Swedes have gotten swine flu shots.
Thursday, December 17, 2009
Public health officials are misleading Canadians by continuing to
characterize the H1N1 virus as a threat in the hopes of unloading millions of
doses of unused vaccine, charges Ontario's former chief medical officer of
They are trying to save face because of an expensive overreaction, Dr.
Richard Schabas said Thursday as lineups for the vaccine continued to
He made his comments the day after the Public Health Agency of Canada
unveiled a new advertising campaign aimed at encouraging Canadians to get
Tuesday, December 15, 2009
"while no safety concerns have been identified to date, a project will be initiated this fall to focus on the safety of the pandemic (H1N1) influenza vaccine and of antiviral medicines for pregnant women and their newborns..." [a.k.a. the 'Shoot first, answer questions later' principle--Nass] "FDA is collaborating with CDC, HHS, private partners and other government agencies to enhance adverse event safety monitoring during and after the Influenza A (H1N1) 2009 vaccination program in all populations, including pregnant women."
"Influenza vaccines, both seasonal and the recently licensed Influenza A (H1N1) 2009 monovalent vaccines, are not contraindicated for use in pregnancy. [Beware the use of a double negative--Nass] As with many other vaccine products, the manufacturers did not conduct clinical studies specifically to evaluate the influenza vaccines in pregnant women prior to approval of these vaccines."
Treatment of Influenza During Pregnancy
The Centers for Disease Control and Prevention (CDC) recommends women in any trimester of their pregnancy who have a suspected or confirmed influenza infection receive prompt antiviral therapy with Tamiflu (oseltamavir) or Relenza (zanamivir).
Are Tamiflu and Relenza safe to use in pregnancy?
Relenza and Tamiflu are both FDA approved for treatment of influenza. Both drugs have been carefully looked at to understand their safety profile in pregnancy and we are continuing to monitor them closely. For a pregnant woman and her developing baby, the benefit of any drug needs to be considered in light of the risks from the drug and the risks from not treating the disease or condition.
Both drugs are designated "Pregnancy Category C," which means that they have not been studied in pregnant women. However, Pregnancy Category C does NOT mean the drug cannot be used in pregnant women. Pregnant women can and should receive a category C drug when the possible benefits of using the drug are more likely than the possible risk of harm to the woman or her baby.
The Sanofi vaccine is a killed vaccine. Live vaccines may be killed by adverse environmental conditions, and protein in a killed vaccine may be denatured by heating or freezing. But the vaccine was only just manufactured, and should not have lost potency naturally in the short time since it left the plant. Likely it never met potency requirements. Why would vaccine be retested weeks after passing a potency test? Perhaps the potency tests weren't conducted before the 4 lots were released, given the hurry for vaccine.
The recall is for about 800,000 pre-filled syringes intended for young children, ages 6 months to nearly 3 years. The shots, made by Sanofi Pasteur, were distributed across the country last month and most have already been used, according to the Centers for Disease Control and Prevention.
Doctors were notified of the voluntary recall on Tuesday. Dr. Anne Schuchat, a CDC flu expert, stressed that parents don't need to do anything or to worry. The vaccine is still safe, she said.
The issue is the vaccine's strength. Tests done before the shots were shipped showed that the vaccines were strong enough. But tests done weeks later indicated the strength had fallen slightly below required levels. Why the potency dropped isn't clear.
Yet the FDA says, "In addition, before they can be used, all Influenza A (H1N1) 2009 monovalent vaccines must undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines." And the FDA Commissioner repeated this in a November 10 letter to health professionals:
We are not cutting any corners. Just as for seasonal influenza vaccine, no lot of the 2009 H1N1 vaccine can be used until it has been carefully evaluated and released as sterile and potent by both the manufacturer and by the FDA.So it's unclear what the facts are.
Children who already received most of this lot are probably not protected, although some officials are saying otherwise. They are still susceptible to adverse reactions from the vaccine components, whether or not the vaccine was effective.
Monday, December 14, 2009
Vaccine Makers Struggle to Speed Output: Cell-Culture Technology Hastens the Process, but Slow-Growing Virus Remains a Problem
Nor will the plant's cutting-edge technology do much to solve one of the biggest problems vaccine makers have faced in churning out this year's swine-flu vaccine: a slow-growing virus. High-speed techniques that bypass the lengthy and onerous process of incubating viruses to make vaccine are years away... It isn't clear how many benefits cell-culture technology will offer. A spokeswoman for Illinois-based Baxter International Inc. said the company's cell-culture plant in the Czech Republic—one of the first large-scale cell-culture facilities—initially experienced the same difficulty growing the H1N1 virus that egg-based plants did.
Even when the new Novartis plant is up and running, flu viruses that grow slowly in eggs, as does the current H1N1 virus, may also grow slowly in cells, meaning production may not be much faster, scientists warn.
Cell-culture technology "is not the end game for us," said Anthony Fauci, director of the U.S. government's National Institute of Allergy and Infectious Diseases. His institute is spending $262 million this year on influenza research, including research on a new generation of vaccines that can be made without having to grow a virus...
The government began investing heavily in flu vaccine after the outbreak of avian flu in 2003, and then a shortage of seasonal-flu vaccine in 2004 when a large manufacturer [later bought by Novartis--Nass] suffered a contamination problem. HHS has put $1.56 billion into cell-based projects like the new Novartis plant...An oversupply of flu vaccine on the U.S. market in the past three years has pushed prices down 30% to 40%, "creating a strong disincentive for manufacturers to maximize or even maintain current production capacity for the U.S. market," Vas Narasimhan, president of Novartis Vaccines USA, said in written testimony submitted for a congressional hearing last week. [Is this what is driving vaccine mandates?--Nass]
... Other companies have had mixed results with cells. GlaxoSmithKline PLC of the U.K. received a $274 million HHS contract in 2007 to develop cell-culture vaccine and to build manufacturing capacity for it, but in an interview in September, the head of the company's vaccine business said the technology is about a decade away from being "mature" enough for use. "GSK will be in cell-culture technology perhaps in ten years, but not today," Jean Stephenne, the Glaxo official, said.
France's Sanofi-Aventis, the world's largest flu-vaccine maker, has also cast doubt on the immediate usefulness of cell-culture technology. In an interview in April, Sanofi's chief executive said the sticking point was designing the right kind of cells. "We just haven't actually found the right cell lines that do what we need them to do," he said."We're still several years away from cell-based flu vaccines," he said.
It will be interesting to see how those with vested interests in vaccination try to push vaccine mandates in future, now that swine flu is petering out.
The rate of seasonal influenza vaccination among American adults this year is only slightly higher than last year, according to results of a nationwide survey. These results were somewhat surprising to many infectious disease experts because earlier data indicated that seasonal influenza vaccination rates would be significantly higher this year because of increased public awareness.
...“It does not appear that the increased public discussion of the role of influenza vaccines has had a significant impact on the public’s behavior,” said Katherine Harris, senior economist at RAND, a nonprofit research organization, and one of the researchers who conducted the survey. “Most of the results from our latest survey look much like those from last year.” ...overall vaccine uptake through mid-November this year was comparable to uptake during the same period last year. In addition, about half of health care workers had been vaccinated by the middle of November this year; this rate is similar to the rate from last year.
Swine-flu shots are going begging in Germany, and the government is selling some of its vaccine on the foreign market, NPR’s Shots blog notes. Only 5% of the overall population and 15% of doctors have gone to the trouble of getting vaccinated.
from the UMinn's CIDRAP:
"... It will be several more years before we are able to wean ourselves away from egg-based vaccine, but we are committed to moving ahead with 21st century vaccine development," Health and Human Services (HHS) Secretary Kathleen Sebelius said in a taped opening statement.
Federal investments made since 2005 should improve that picture, the officials said, but they cautioned that the timeline for developing new methods of producing vaccines can stretch to 15 years before licensing begins...
New technologies will also require a revamp in the regulatory framework for approving them, said Dr. Jesse Goodman, the FDA's chief scientist and acting deputy commissioner for science and public health.
Some of the technologies now being considered for flu vaccine manufacture, such as cell-culture and virus-like particles, are already used to produce vaccines against other diseases and have received regulatory approval in the United States. But others rely not only on new manufacturing methods but also on different ways of provoking immunity to the flu virus, compared with the current vaccine. Traditional regulatory tests for flu vaccine include measuring immune response using agreed-upon correlates of immunity—but since some of the new vaccines would not provoke an immune response in the same manner, they would not pass evaluations conducted by current standards.
Alternate proofs of efficacy may require large clinical studies conducted during flu season, Goodman said: "A whole new science is going to need to develop around these vaccines that tells us what is protective."
Saturday, December 12, 2009
Friday, December 11, 2009
"H1N1 has come at a bad time for the public health system," said Thomas Frieden, director of the Centers for Disease Control and Prevention. "State and local health departments are doing a terrific job overall in responding," he said in an interview. But they are suffering from years of underinvestment, layoffs and hiring freezes, he said...
In Maine, which is still experiencing a surge of swine-flu cases, state health officials are reserving home visits by public health nurses only for major threats such as tuberculosis or child-abuse cases, said Dora Anne Mills, director of the Maine Center for Disease Control and Prevention. About three-quarters of the department's staff has been diverted to H1N1. Some chronic-disease programs have "taken a back seat" for the time being, she said.
Thursday, December 10, 2009
The Telegraph explains that no inquest was ever held regarding Kelly's death. Several medical experts have remarked on the unconvincing evidence for suicide during the past few years.
The Daily Mail adds more detail to the story, discussing the incestuous Hutton Inquiry (which supported Kelly's death as a suicide) methods and findings.
In the US, approximately 2,000 lab-confirmed deaths have occurred from swine flu, with a CDC-estimated 20,000,000 swine flu cases. This translates to 0.01% mortality. My guess is that there were somewhat more deaths in the elderly, but also many more cases--or the epidemic would not now be dying out. So 0.005% to 0.01% seems a reasonable mortality estimate. Furthermore, now that we understand how to treat the serious cases better, mortality rates should drop over time.
UPDATE: Just-released modelling estimates from CDC suggest 50 million Americans have been infected, and 10,000 have died from swine flu. This yields an estimate of mortality congruent with the UK estimate of 0.02%.
Wednesday, December 9, 2009
[Go here for the rest of the article.]
Lance Cpl. Josef Lopez still suffers from injuries he began experiencing in Iraq three years ago — injuries caused not by bombs or guns but by a military-administered smallpox vaccine he got before he left the United States.
The shot, which the military strongly encourages troops to get, triggered a rare bad reaction in the Marine from Missouri — leaving the then-20-year-old Lopez in a coma, paralyzed for several weeks and unable to breathe, McClatchy Newspapers reported.
Lopez hasn't been the same since. He's regained the ability to walk, but he limps. His loss of bladder control means he has to wear a urine bag. He takes about 15 pills a day to treat leg spasms and other conditions.
Now, Lopez and his family are upset because the government says he isn't eligible for a special benefit of up to $100,000 for members of the military who have suffered traumatic injuries.
The Department of Veterans
Affairs, which has covered the cost of his regular medical expenses, says that because his health problems were caused by the vaccine, he can't collect the additional benefits that would provide funds to build him a wheelchair lift or help defray money lost while his mother has stopped working to tend for him.
"It's for traumatic injury, not disease; not illness; not preventive medicine," Stephen Wurtz, the deputy assistant director for insurance at the VA, told McClatchy Newspapers. "It has nothing to do with not believing these people deserve some compensation for their losses."
Lopez and his mother, Barbara Lopez — who flew to her son's aid in 2006 when the mysterious illness took over and the chance of recovery seemed grim — have appealed to Sen. Claire
McCaskillof Missouri for help.
McCaskill has drafted a bill that would extend benefits to include those adversely affected by vaccines, KOMU.com reported.
"It would give him the same coverage, and frankly, I really think we need to take care of this young man and his family," McCaskill said in an interview with KOMU TV. "He was willing to take care of us."
Lopez said he feels as though the government has let him and others in a similar situation down by "twisting the rules around to deny people who actually deserve the money."
On November 24, 2009, Novartis officially opened its first, large-scale vaccine manufacturing facility in the U.S. Located in Holly Springs, North Carolina. The project is a collaborative effort between Novartis and the U.S. Department of Health and Human Services, which contributed $457M for the design, construction, and licensing of the facility.
For its part in the deal, Novartis is required to provide two commercial-scale lots of "pre-pandemic" vaccine annually for a minimum of three years. In addition, the government has the right to exercise options to purchase influenza vaccine over the next 17 years. (1) Currently, 191 employees work at the plant but that will increase to 350 persons when fully operational, anticipated to be sometime in 2011. The Holly Springs facility will be able to roll out 150 million flu shots per year.
Even though its use has not been approved by U.S. regulators, the plant will be producing MF59 as early as December 2009.(2) MF59 is Novartis' proprietary and controversial adjuvant composed of squalene and a surfactant called Tween80, also known as polysorbate 80. Back in July, 2009, the department of HHS purchased over $343.8M of "oil-in-water" adjuvant from Norvartis.(3) It looks like the government may want to take delivery on its purchase some time soon.
All flu shots used in the U.S. are made from eggs, a time- and labor-intensive process. But the new plant will provide something different. Vaccines will be brewed from animal cells mixed with viruses in six 1,320 gallon fermenters which are owned by the U.S. government and the Department of HHS, as identified by a bright yellow, plastic plaque on the sides of the giant vats. (4)...
[Go here for the rest of the story.]
However, the University of Minnesota informs us that HHS has actually invested $767 million in Novartis' development of the technology and building costs.
Daniel Vasella, chairman and chief executive of Novartis, gives Health and Human Services Secretary Kathleen Sebelius, left, and North Carolina Gov. Beverly Perdue (D) a tour of the drugmaker's new facility in Holly Springs, N.C. (Photos By Jim R. Bounds/bloomberg)
Progress has been made, Sibelius said. A new facility that can make flu vaccine using cells instead of eggs opened last week in Holly Springs, N.C., after Novartis received more than $400 million in federal funding. But that factory would still be able to produce perhaps only half the vaccine the nation would need in a pandemic, and that process is still prone to delays, she said.
"There are gaps at every stage in the process, from the laboratory to the factory floor, that are slowing or stalling the development of key countermeasures," Sebelius said, referring to the nation's reliance on research conducted at the National Institutes of Health and the Defense Department, which is often not focused on government priorities, as well as the lack of incentive for companies to invest in making new products for public health emergencies.
"In this age of growing public health threats against which countermeasures are often our best defense, that's dangerous," she said.
Novartis has kept a very close hold on the clinical data generated by its MF59 (squalene-containing) adjuvant, both in terms of effectiveness and safety. A French review in Prescrire that I cited months ago found increased side effects but no increased efficacy when MF59-containing flu vaccines were used in the elderly, the only group for which it is approved. I previously cited a statement from FDA indicating concern with the presence of extraneous DNA in vaccine made from the canine kidney cell line to be used by Novartis at the new factory.
The plant has been built and can start making MF59 this month, even though its vaccine production method has not received FDA approval yet, nor has the use of MF59 in US vaccines ever been approved.
"Novartis is one of five companies that were awarded large HHS contracts in 2006 to develop cell-culture technology for making flu vaccines. One of the other four contracts was terminated earlier this year, and a second company has put its efforts on hold. Also, Sanofi Pasteur, which makes the largest share of seasonal flu vaccine in the United States and which received an HHS contract for cell-based vaccine development in 2005, says it is sticking with the traditional egg-based production."
But with nearly $800 million of US government money already invested in the Novartis facility, and a roughly equivalent amount invested in 4 other firms' cell-based vaccine development, is there any doubt FDA approval will be forthcoming?
According to the Novartis press release, "If licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011." Clearly Novartis knows how the game works, and may be counting on an emergency to get their products out to the public.
The post above, by Dr. Sherri Tenpenny, discusses this issue in more depth.
UMinn's CIDRAP dug deep to provide very useful information. For example:
MedImmune, which makes nasal-spray seasonal and pandemic H1N1 flu vaccines, has put its cell-based development efforts on hold, Dr. George Kemble, the company's vice president for research and development, said today.
Kemble said the company has a disagreement with the Food and Drug Administration (FDA) over the direction of clinical trials for its cell-based flu vaccine. MedImmune officials were aiming to conduct trials to determine if cell-based and egg-based versions of the same vaccine were equally immunogenic, he said.
But the FDA said it wanted the company to proceed with an efficacy trial to determine if the cell-based vaccine actually protects people from seasonal flu. "That added years and hundreds of millions of dollars to the program," he said. [Imagine that! The company was being held to an honest efficacy standard by FDA, instead of being allowed to squeak through licensure using cherry-picked surrogate markers--and has the temerity to complain about it!--Nass]
In view of the FDA's position, Kemble said MedImmune decided to "take a step back," reevaluate the program, and discuss it with HHS officials before deciding what to do next. [Does this mean they will try to go around FDA to get the go-ahead from its parent agency?--Nass]
Meanwhile, Sanofi Pasteur has experimented with cell-based flu vaccines and concluded they offer little advantage, company spokeswoman Donna Cary said today.
In the current pandemic response, egg-based and cell-based facilities produced clinical lots of vaccine and achieved regular production in about the same amounts of time, Cary added.
Tuesday, December 8, 2009
However, 5 children did die soon after vaccinations; the deaths are being investigated.
As the BMJ (a.k.a. British Medical Journal) put it in 2005: "From a bit of a dud to the world's most sought after drug in the space of six months, surely Roche cannot believe its luck with oseltamivir (Tamiflu)."
Then last month, the BMJ reported on researchers from Oxford, noting, "Children should not be given the anti-viral drug Tamiflu to combat swine flu, Oxford University researchers said today.
They urged the British Department of Health to urgently rethink its policy on giving the drugs to youngsters affected by the current flu pandemic."
Can someone develop a short seminar for politicians and public health decision-makers that teaches them that sometimes it's really okay (even best) to do nothing? Explain that the country won't collapse if they leave it to those in the trenches to decide when and how to administer drugs to patients (the way we always have done). They probably won't be voted out of office, either. Maybe support groups can be established for "Decision-Addicted" public servants.
In other words, just because they work inside the Beltway, they don't always have to "decide" everything for the rest of us, and they needn't always spend our money to "help" us.
Tamiflu is a prime example. When the drug was licensed, as I've noted previously, the best that could be said about it was that it reduced the duration of flu symptoms by about one day. At $10/tablet or $100/ten-day course it was an expensive marginal benefit. The drug may also cause a range of unpleasant side effects, include suicidality. Yet it might make a big difference in some cases of severe viral illnesses.
The reason people go to doctors is to receive an individual assessment that provides them a diagnosis, a determination of illness severity, and in the context of their overall medical condition, including the other medications they are using, a personalized therapy.
As one could have predicted, when Tamiflu was given out after a brief phone consultation (and the patient's medical provider was NOT the person on the other end of the phone) the results included nasty side effects in those who turned out not to have swine flu, and Tamiflu prescriptions for people with other serious conditions (including cases of life-threatening meningitis), delaying appropriate diagnosis and treatment, even causing reported deaths in the UK.
Tamiflu was given a PREP Act liability waiver in October 2008 for pandemic influenza use. It is very likely that this allowed the US government to purchase it at a reduced price for the 2009 swine flu pandemic... and also likely that those suffering from serious side effects are therefore barred from seeking damages from the manufacturer.
UPDATE Dec. 29: Letter from FDA to CDC permits outdated Tamiflu to be used under emergency use authorization. Was the fact that some Tamiflu in the Strategic National Stockpile was expired or expiring a factor in CDC recommendations to use stockpiled drug widely for swine flu, without testing patients to see if they had the virus?
It is unclear why this happened, nor whether BARDA is moving away from next-generation anthrax vaccines (characterized by a series of product failures) into other anthrax therapeutics. The markets responded, with Pharmathene shares dropping 52% and EBS shares falling 8%.
My suggestion to BARDA is to consider an emergency stockpile of live, attenuated anthrax vaccine. The advantages of a safe, live vaccine could include: more rapid and cheaper production, more rapid development of immunity with only 1 or 2 inoculations, and broader immune protection.
Friday, November 20, 2009
A future post will discuss the pivotal role of the swine flu pandemic in large-scale acceptance of new vaccine adjuvants, and how this has dramatically improved prospects for the vaccine industry. Here is a taste of the larger story, from the Associated Press:
Vaccines are no longer a sleepy, low-profit niche in a booming drug industry. Today, they're starting to give ailing pharmaceutical makers a shot in the arm.
The lure of big profits, advances in technology and growing government support has been drawing in new companies, from nascent biotechs to Johnson & Johnson. That means recent remarkable strides in overcoming dreaded diseases and annoying afflictions likely will continue.
"Even if a small portion of everything that's going on now is successful in the next 10 years, you put that together with the last 10 years (and) it's going to be characterized as a golden era," says Emilio Emini, Pfizer Inc.'s head of vaccine research.
Vaccines now are viewed as a crucial path to growth, as drugmakers look for ways to bolster slowing prescription medicine sales amid intensifying generic competition and government pressure to cut down prices under the federal health overhaul.
Thursday, November 19, 2009
The laws require multiple consultations in order to prevent our leaders from frivolously invoking emergency powers.
However, in the present instance, the use of "Emergency Use Authorizations" did not conform with US law, in my opinion.
What does the law require in order to allow the use of unlicensed and potentially untested drugs, vaccines, masks and medical tests? Here is the actual language:
§ 360bbb–3. Authorization for medical products for use in emergencies(b) Declaration of emergency
The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of—
(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents;
(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(C) a determination by the Secretary of a public health emergency under section 247d of title 42 that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
Almost everyone would agree at this point that the Swine Flu lacks "a significant potential to affect national security." Shouldn't that result in an acknowledgment that invoking a law requiring a national security threat is wrong, and we either need a new law for using untested products in purely medical emergencies, or we need to revoke the new Emergency Use Authorizations and rethink our preparedness strategies?
In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research.
And half of universities do not ask their faculty members to disclose the amount of money or stock they make from drug and device makers, so the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the report concluded.
Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.
“Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling,” the senator wrote.
“Students are disciplined for not acknowledging that a paper they turned in was written by somebody else,” Mr. Grassley wrote. “But what happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else?”
Note: Plagiarism by a research scientist constitutes scientific misconduct, and is defined as a federal crime in 65 Fed. Reg. 76260.