Illinois Shutting Down Ice Cream Maker For Using Fresh Fruit

August 12th, 2011

KitchenLore.com

By: Dawn Xiana Moon

The State of Illinois is shutting down local, artisan ice cream makers for such terrible offenses as using fresh fruit instead of fruit syrup and fresh cream instead of pre-packaged soft serve mix. What, you say? How can this be? Health officials in this state are known for being overzealous when it comes to making sure that small, independent businesses follow obscure rules – and when I say small and independent, I’m talking about businesses that are often owned and run by 1-2 people renting space in a shared, licensed commercial kitchen. These are not corporations with large amounts of money who have the capital to hire lawyers or contribute significant sums to political campaigns. No, these are real people, individuals who do their best to follow labyrinthine food regulations based on the information that they’re given by governmental agencies who don’t always agree on what the rules should be.

Illinois health regulators seem to hate anything that isn’t incredibly processed. Last year, they destroyed thousands of dollars worth of local fruit that had no health issues. Why? Monica Eng from the Chicago Tribune put it this way: “At best it was a victim of paper work confusion among city bureaucrats who couldn’t agree on a policy.” One woman was put out of business for six months.

Now, the health department is saying that Nice Cream, a local maker (read: primarily one woman, Kris Swanberg) that I’ve followed since reading this 2009 profile from the Chicago Reader, is being forced to shut down because she lacks a dairy permit. Nevermind that she and others in her field have been creating artisan ice creams for years without ever hearing that such a permit existed – or that they needed one. Nevermind that the office that issued their business licenses (the Department of Business Affairs and Consumer Protection) failed to inform any of them that they needed one in order to operate. IDPH has spoken, and now Swanberg and others will need to use sub-par ingredients or cough up around $40,000 for a pasteurizing machine.

Processed ingredients would mean that Nice Cream – which built its reputation by using fresh, organic ingredients that are sourced from local farms – would be allowed operate without needing the dairy license. The problem with the dairy license is that in order to pass inspection, you have to make sure your bacteria levels are so low that using real ingredients simply doesn’t work.

Technically, using fresh strawberries is legal. However, IDPH does not recommend using them, because “when you try and clean a strawberry to make sure it doesn’t have any bacteria, it kind of deteriorates.” Irradiated strawberries apparently look fine but are somewhat lacking in the taste department. So IDPH explicitly suggests “strawberry syrup.” Fresh cream requires the dairy license, so the alternative would be to use premade ice cream mix, the kind of stuff that is full of stabilizers and additives and usually found at places like Dairy Queen. (If you’ve never done it, read the label of your grocery store ice cream sometime – if you’re not buying Häagen-Dazs, Ben and Jerry’s, or Breyers, you’ll probably be reading a long list of ingredients, half of which are near unpronounceable.) Clearly, the results of these changes would turn Nice Cream into a generic brand that’s barely worth mentioning, rather than the wizards who made me realize for the first time that strawberry ice cream could actually taste good. Better than good. Amazing.

Which brings us back to the pasteurizing machine and its $40,000 price tag. That’s a lot of money for a small business to find. But it’s not a lot of money for a large corporation, and that’s the type of organization that the rules were invented for. In fact, the rules about dairy licenses apply to the mega-corporation and the one-man show equally in the eyes of the state. Something’s wrong with that. Something’s wrong with the fact that Cargill can stay in business after having to recall 36 million pounds of salmonella-tainted turkey, but Nice Cream may not be able to stay in business after keeping a clean record. Something’s wrong with the fact that health departments are pushing businesses to produce processed food rather than fresh, locally-sourced food, which is much healthier. Something’s wrong here, and local ice cream may be a casualty of it.

Click here for the full report from KitchenLore.com

Women Hospitalized After Bogus Butt Enhancements

March 8, 2010

FoxNews.com

A black-market butt-enhancement “practitioner” is injecting New Jersey backsides with household caulk and other hazardous materials, according to New Jersey health officials who have alerted New York authorities to the rear and present danger.

Six Newark-area women in the last two months have been hospitalized with infections caused by injections of “a variety of unknown materials,” said New Jersey Health Department epidemiologist Dr. Tina Tan.

Officials said they believe the injected mixture includes silicone, petroleum jelly and hardware-grade caulk.

After botched efforts to plump their rear ends like naturally well-endowed celebs such as Kim Kardashian, the victim’s derrieres resembled “moonscapes” filled with lumps and craters, said a hospital source.

“What we’ve been hearing from the hospitals is that these women are presented with deep tissue infections and skin infections. Abscesses form in some cases,” said Tan.

According to hospital sources, the six women were all from the Dominican Republic. The injection “treatments” occurred in hotels around the Newark area, the hospital source said.

Click here for the full report.

Swine Flu Vaccine Orders Being Canceled

January 14, 2010

Wall Street Journal

By Jeanne Whalen and David Gauthier-Villars

Just months after rushing to order enough swine-flu vaccine to protect their citizens, European governments are canceling orders and trying to sell or give away extra doses as they sit on a glut of the vaccine.

The main reason: European health officials decided that only one shot per person was needed, instead of the two originally planned. Low demand is also to blame. Many Europeans believe the pandemic has turned out to be fairly mild, and don’t see a reason to get vaccinated. Some are also concerned that they will suffer side effects from the shots, despite assurances otherwise from global health officials.

“The population is not running to get the vaccination,” says Roland Jopp, a spokesman for Germany’s health ministry.

Declining interest in the shots could be bad news for vaccine makers, particularly if countries demand their money back for supplies already delivered.

Companies may be able to sell the shots elsewhere, however. Most vaccine makers, including GlaxoSmithKline PLC, Sanofi-Aventis SA, Novartis AG and Baxter International Inc., have been expecting a large sales bump from H1N1 vaccine.

In October, analysts estimated that Glaxo would ring up an extra £1 billion ($1.62 billion) of fourth-quarter sales thanks to the vaccine. Novartis has forecast H1N1 sales of $400 million to $700 million for that period.

But some countries are now canceling orders. Germany on Tuesday said it canceled 30% of the 50 million doses it had ordered from Glaxo, which it said would save the country €133.3 million ($194 million). Mr. Jopp of the German health ministry said the main reason for the cancellation is that only one shot is needed per person.

France, which had ordered 94 million doses from four companies, is seeking to cancel 50 million of those doses, according to its health ministry. The U.K., Switzerland, the Netherlands and Spain also say they are seeking to trim their orders, or to sell already delivered doses to other countries.

In the U.S., where vaccine supplies are now ample after an earlier shortage, a top health official last week said the country is focused on vaccinating as many people as possible, and has made no decision about canceling vaccine orders or selling supplies.

Mr. Jopp said Germany still aims to vaccinate one-third of its population, which would cover all groups who are at greater risk for suffering bad infections—including pregnant women, young children and people with asthma. So far, though, only about 10% of the population has stepped forward to be vaccinated, he said.

Some health officials say the public’s lack of interest reflects the thought that the outbreak is milder than many people expected.

Last week, the World Health Organization said that rates of “influenza-like illness” have declined substantially in Western Europe in recent weeks, though it added that there was still “intense virus circulation” in parts of Central, Eastern and Southeastern Europe.

When France began vaccinating people in November, the government opened makeshift vaccination centers in basketball arenas and meeting halls.

People at first rushed to get vaccinated, even lining up in the cold. After a few weeks, however, the public’s concern ebbed, leaving most vaccination centers idle and the government facing criticism that it overreacted to the threat.

French President Nicolas Sarkozy on Tuesday defended the government’s planning. “I will always prefer to be too prudent when it comes to people’s health than not enough,” he said in a speech to doctors and nurses.

France initially focused on vaccinating high-risk groups, but has since made vaccine available to the entire population. Still, as of Jan. 10, only about 8% of France’s population of 65 million had been vaccinated, according to health officials.

Swiss authorities have run television and Internet ads to promote vaccination, helping convince about 15% to 20% of the population to get vaccinated— about the same number that would during the regular flu season most years, a spokesman for the Swiss health ministry said.

In an emailed reply to questions, a WHO spokeswoman declined to comment on countries’ attempts to cancel their vaccine orders.

She said: “It is premature to consider the pandemic as completed, and there is still immense value in the H1N1 immunization.”

Glaxo said it is “working closely with governments to respond to their changing needs.” Novartis said it “will evaluate government requests on a case-by-case basis within the framework of the contractual agreements, which are considered binding.”

A Baxter spokeswoman said its contracts “have always included provisions allowing the contract holder to adjust its vaccine supply requirements based on its evolving pandemic needs.”

All three companies declined to comment on how cancellations might affect sales.

A Sanofi spokesman said the company doesn’t yet anticipate any significant changes in revenue due to vaccine cancellations.

Click here for the full report

France Cancels Order for Flu Vaccine

January 13, 2010

Reuters

By Anna Willard

France ordered the vaccinations from Sanofi-Pasteur, a unit of Sanofi-Aventis, GlaxoSmithKline, Novartis and Baxter International.

The government estimated 94 million individual shots were needed, thinking that everyone would need two jabs for immunity against the illness.

Doctors now say a single vaccination is sufficient, meaning that France, with a population of some 65 million has a massive oversupply and is already trying to sell on some of the surplus shots it has received.

“I have canceled 50 million doses,” Bachelot said on TF1 television.

“These orders had not been paid for or delivered so they are canceled,” she added.

The Health Ministry said it had originally bought the 94 vaccines at a cost of 869 million euros. Bachelot said the canceled order would save more than 350 million euros.

Opposition politicians have criticized the government, saying it has wasted money and helped drugs companies. Socialist Party spokesman Benoit Hamon said large pharmaceutical firms were “the big winners in this affair.”

A Sanofi-Aventis spokesman said on Monday that the company and the government had started a review of a contract for 28 million vaccine doses before the Christmas holidays.

About half of the doses had been delivered he said but it was premature to comment on the implication of the canceled order for the company. Some five million people in France have so far been vaccinated against H1N1, health officials say.

The flu virus has killed an estimated 198 people on mainland France, according to data released on December 29, but doctors have said new infections have fallen sharply in recent weeks.

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Flu Vaccine Was Safe Despite Recall

December 18, 2009

Mercury News

By Lisa Fernandez

Federal health officials Tuesday recalled 800,000 doses of an H1N1 vaccine geared for young children, affecting 900 doses used by Santa Clara County, and an unknown number used by other valley health care providers such as Kaiser Permanente.

The recall is for the shots used for children ages 6 months to 3 years old, made by Sanofi Pasteur, which did a quality control test and found some of the vaccine doses weren’t strong enough.

Santa Clara County used those particular doses at free clinics held at the county fairgrounds Dec. 6 and 12, and at the California Children’s Services clinic on Empey Way in San Jose. Kaiser also received some of the recalled doses.

Santa Clara County’s top health officer says

 the recall is nothing to be worried about and children don’t need to be revaccinated.

“What we’re hearing is that the doses are just short of the potency they need to be,” Dr. Marty Fenstersheib said. “The children in this age group need to second-dose anyway.”

Kaiser spokesman Karl Sonkin said the health care company on Tuesday was still compiling the exact number of recalled doses it received and which facilities received them. He agreed with Fenstersheib that children who received the recalled batch do not need to be revaccinated.

As of Friday, 435,270 doses of H1N1 vaccine for all age groups have been sent to health care providers in Santa Clara County since October, according to state data. As of Dec. 9, 825 people

countywide have been hospitalized for serious complications related to H1N1, and 15 have died since May 1. That’s 40 more hospitalizations and one more death than in the previous week, according to the county.

Although the antigen level in the recalled batch of vaccines fell slightly short of what’s necessary, Fenstersheib pointed to the joint statement by the Food and Drug Administration and the Centers for Disease and Control and Prevention saying the “small decrease in antigen content is unlikely to result in a significant reduction in immune response.”

Fenstersheib said that if children received a recalled dose and it was their first swine flu vaccine, they should still get a second dose in about a month, as recommended previously. If the recalled dose was their second vaccination, then he said that would be sufficient. He said children do not need a third vaccine, even if they received one of the less-potent doses.

“The CDC is a conservative agency,” he said, “and they tend to err on the side of safety. I’m confident that if they tell us it’s potent enough, then it is.”

Fenstersheib said the recall is geared mostly for health care providers to send back any of the unused, less-potent batches. He said the shots are perfectly safe and parents shouldn’t worry that their children’s health has been harmed.

The county receives vaccines from the federal government, and about 90 percent of the H1N1 doses are made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group.

The company reported the potency findings to the government officials and did a voluntary recall. A Sanofi Pasteur representative could not immediately be reached for comment Tuesday.

Sanofi Pasteur bills itself as the No. 1 manufacturer of flu vaccines in the world. It makes flu vaccine at sites in France and in Pennsylvania.

The Santa Clara County Public Health Department has held five large-scale vaccination clinics so far, including Saturday and Sunday, where more than 8,100 people were vaccinated.

County health officials have used a telephone alert system to remind parents to get their children dosed twice. But Fenstersheib said that as of Tuesday, the health department hadn’t notified parents of the recall, although he added his team would discuss doing that.

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No More Mandatory Flu Shots For Day Care Children

November 25, 2009

Press of Atlantic City

By Ben Leach

A shortage of seasonal flu vaccine has forced the state’s health department to ease up on mandatory flu shot requirements for young children who want to remain in day care and preschool.

On Tuesday, New Jersey’s Department of Health and Senior Services announced that children between the ages of 6 and 59 months who are in day care or preschool do not need a seasonal flu shot. Normally, they would have to get vaccinated by Dec. 31, 2009.

However, state health officials still want children to get vaccinated if they can get a hold of the vaccine.

“We still strongly encourage parents to get their kids vaccinated,” said DHSS Commissioner Heather Howard. “Our message is still the same.”

The seasonal flu vaccine is one of 11 vaccines that children are required to get as a prerequisite for entering day care or preschool in New Jersey. Children in that age range still need the other vaccinations.

According to Howard, manufacturers have said that more seasonal flu vaccine should be available in December. However, since the state does not know how many doses of the vaccine will be available, the requirements for young children will be waived for this year.

No seasonal flu clinics currently are scheduled for the area. Howard said she does not know how many people have already been vaccinated, but she added that many people did take advantage of earlier flu clinics this year.

“When we knew we were going to be delayed in getting the H1N1 vaccine, we encouraged people at the end of the summer to get their seasonal flu vaccine first,” Howard said.

The health department also reported Tuesday that influenza like activity throughout the state has decreased for the second week in a row. However, flu activity is still considered widespread, and the H1N1 influenza virus has claimed another life.

Howard announced that a 35-year-old Morris County man died from the H1N1 influenza virus on November 16. The state does not know if the man had any underlying medical conditions.

So far, 29 people throughout the state have died from complications related to the H1N1, or “swine flu,” virus.

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Canadian Health Officials See Bad Reactions to Flu Shots

November 25, 2009

ON Deadline

By Michael Winter

Canadian health officials are investigating what caused six severe allergic reactions to the H1N1 vaccine earlier this month, which the World Health Organization calls “an unusual number.”

The report comes amid signs that the worst of the pandemic might be over in Canada.

The vaccine triggered anaphylaxis, which causes breathing problems, low blood pressure and swelling of the throat, tongue, lips and eyes. It can be fatal.

The inoculations came from a batch of 172,000 doses of the Arepanrix vaccine, made by GlaxoSmithKline, that was distributed across Canada. The unused batch was recalled and all six Canadians recovered.

Normally, one adverse reaction per 100,000 doses is expected. In several lots of vaccines, no adverse reactions have been reported.

“An unusual number of severe allergies to the vaccine have been detected in Canada,” World Health Organization spokesman Thomas Abraham told AFP. “The Canadian authorities are conducting the appropriate investigations on the vaccines. … We need to understand what happened.”

Click here for full report

Airports Screening for Swine Flu

October 9, 2009

Wcbstv.com

With the holiday season just a few weeks away, health officials fear the swine flu will pick up right along with air travel.

New government guidelines are on their way, designed to help keep passengers healthy.

This flu season, airport staff across the nation won’t just be screening for security threats. The government says that people traveling internationally may be screened for the H1N1 virus as they leave or enter the U.S.

“It feels a little bit overboard,” Stanford, Conn. resident Derek Ferguson said.

The government warns that some passengers may be asked to pass through a screening device, have their temperatures taken, answer questions about their health, and even be quarantined if someone on the flight shows symptoms of H1N1.

“I’m all for it, I really am,” Mount Vernon resident Rosa Raspaldo said. “Because – guaranteed – if people are coughing on the plane, all of those germs will be spread around.”

But the H1N1 virus isn’t just a danger in the skies. Buses and trains can also be a breeding ground for germs. Millions of riders climb aboard every day, and that has many taking precautions.

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Vaccines Far More Deadly Than The Swine Flu

July 28, 2009

Institute of Science in Society

The vaccines far more deadly than the swine flu; mass vaccinations a recipe for disaster Dr. Mae-Wan Ho and Prof. Joe Cummins

This report has been submitted to Sir Liam Donaldson, Chief Medical Officer of the UK, and to the US Food and Drugs Administration

Please circulate widely, with all the hyperlinks included, to your elected representatives, wherever you are

A swine flu outbreak occurred in Mexico and the United States in April 2009 and spread rapidly around the world by human-to human transmission. The new type A H1N1 influenza virus is unlike any that had been previously isolated [1, 2], judging from the first data released in May. It is a messy combination of sequences from bird, human and swine flu virus lineages from North America and Eurasia. A senior virologist based in Canberra, Australia, told the press he thought that the virus could have been created in the laboratory and released by accident [3]. Some even suggest it was made intentionally as a bioweapon [4], while others blame the intensive livestock industry and extensive trafficking of love animals over long distances, which provide plenty of opportunity for generating exotic recombinants [5]. But what worries the public most is the mass vaccination programmes governments are putting in place to combat the emerging pandemic, which could well be worse than the pandemic itself.

Watchdog opposes fast-track vaccine for school children

The US government is intending to vaccinate all children in September when school re-opens, and the country’s vaccine watchdog National Vaccine Information Center (NVIC)  has called on the Obama Administration and all state Governors to provide evidence that the move is [6] “necessary and safe”, demanding “strong mechanisms for vaccine safety screening, recording, monitoring, reporting and vaccine injury compensation.”

The US Departments of Health and Homeland Security had declared a national public health emergency in April soon after the swine flu outbreak. As a result, some schools were closed, people quarantined, and drug companies were given contracts worth $7billon to make vaccines that are being fast tracked by the Food and Drugs Administration [7]. That means they will only be tested for a few weeks on several hundred children and adult volunteers before being given to all school children this fall.

Furthermore, under federal legislation passed by Congress since 2001, an Emergency Use Authorization allows drug companies, health officials and anyone administering experimental vaccines to Americans during a declared public health emergency to be protected from liability if people get injured. US Secretary of Health and Human Services Kathleen Sebelius has granted vaccine makers total legal immunity from any lawsuits that may result from any new swine flu vaccine. And some states may make the vaccination mandatory by law.

The NVIC is asking whether the states are prepared to obey vaccine safety provisions in the 1986 National Childhood Vaccine Injury Act, which include: 1. Giving parents written information about vaccine benefits and risks before children are vaccinated; 2. Keeping a record of which vaccines the children get, including the manufacturer’s name and lot number; 3. Recording which vaccines were given in the child’s medical record; and 4. Recording serious health problems that develop after vaccination in the child’s medical record and immediately making a report to the federal Vaccine Adverse Event Reporting System.

NVIC also wants to know if the states are prepared to provide financial compensation to children injured by the swine flu vaccines, whether parents will be given “complete, truthful information about swine flu vaccine risks”, and have the right to say “no” to vaccination.

Co-founder and president of NVIC Barbara Loe Fisher said [6]: “Parents and legislators should be asking themselves right now: Why are children the first to get experimental swine flu vaccines? Are schools equipped to get signed informed consent from parents before vaccination, keep accurate vaccination records and screen out children biologically at high risk for suffering vaccine reactions? Will people giving these vaccines know how to monitor children afterwards and immediately record, report and treat serious health problems that develop? And will states have the financial resources to compensate children who are injured?”

WHO and mass vaccination fever

The mass vaccination order has come from the World Health Organization (WHO) [8].  In early July 2009, a group of vaccination experts concluded that the pandemic is unstoppable, and Marie-Paul Kieny, WHO director on vaccine research said all nations will need access to vaccines, and that a vaccine should be available as early as September.

Critics point out that the ‘vaccination experts’ are dominated by the vaccine makers standing to gain from the enormously lucrative vaccine and antiviral contracts awarded by governments. But the decisive argument against mass vaccinations is that flu shots simply don’t work and are dangerous [9].

Flu shots ineffective and increase risks of asthma

There are widely acknowledged reasons why flu vaccines won’t work, as already pointed out with regard to the much touted vaccines against the ‘pandemic bird flu’ that has yet to materialize [10] (How to Stop Bird Flu Instead, SiS 35). The flu virus changes quickly – even without the help of genetic engineering in the laboratory, and especially with the help of the intensive livestock industry – whereas the vaccines target specific strains. Furthermore, flu vaccination does not give permanent protection, and must be repeated annually; the vaccines are difficult to mass-produce, and some strains won’t grow at all under laboratory conditions.

Numerous studies have documented that flu shots give little or no protection against infection and illness, and there is no reason to believe that swine flu vaccines will be different.

A review of 51 separate studies in 2006 concluded that flu vaccines worked no better than a placebo in 260 000 children ranging in age from six months to 23 months [11]. A report published in 2008 found flu vaccines in young children made no difference in the number of flu-related doctor and hospital visits [12].

On the other hand, a study of 800 children with asthma found that those receiving a flu vaccine had a significantly increased risk of asthma-related doctor and emergency room visits [13]; the odds ratios were 3.4 and 1.9 respectively. This was confirmed in a report published in 2009, which showed children with asthma who received FluMist had a 3-fold increased risk of hospitalization [14]

Flu vaccines are equally useless for adults, including the elderly, giving little or no protection against infection or illnesses including pneumonia (see [9]).

Toxic adjuvants in flu vaccines

Vaccines themselves can be dangerous, especially live, attenuated viral vaccines or the new recombinant nucleic acid vaccines [10], they have the potential to generate virulent viruses by recombination and the recombinant nucleic acids could cause autoimmune diseases.

A further major source of toxicity in the case of the flu vaccines are the adjuvants, substances added in order to boost the immunogenicity of the vaccines. There is a large literature on the toxicities of adjuvants.  Most flu vaccines contain dangerous levels of mercury in the form of thimerosal, a deadly preservative 50 times more toxic than mercury itself [9]. At high enough doses, it can cause long-term immune, sensory, neurological, motor, and behavioural dysfunctions. Also associated with mercury poisoning are autism, attention deficit disorder, multiple sclerosis, and speech and language deficiencies. The Institute of Medicine has warned that infants, children, and pregnant women should not be injected with thimerosal, yet the majority of flu shots contain 25 micrograms of it.

Another common adjuvant is alum or aluminium hydroxide, which can cause vaccine allergy, anaphylaxis, and macrophage myofascitis, a chronic inflammation syndrome, In cats, alum also gives rise to fibrosarcomas at the site of injection [15]. Numerous new adjuvants are no better, and could be worse. According to a recent review in a science and business pharmaceutical publication [15], most newer adjuvants including MF59, ISCOMS, QS21, AS02, and AS04 have “substantially higher local reactogenicity and systemic toxicity than alum.”

Current status of swine flu vaccines

Five different companies have been contracted to produce vaccines worldwide: Baxter International, GlaxoSmithKline, Novartis and Sanofi-Aventis and AstroZeneca [16]. Already stretched beyond capacity, there is every intention to make smaller vaccine doses go further with a range of new adjuvants [17], with the blessing of the WHO (see later).

Flu vaccines are traditionally produced from non-virulent (attenuated or weakened) influenza viruses (see Box for a description of the viruses). To be effective, the genes of the non- virulent virus used must match those of the viral strain spreading in the population. Activation of the immune system by exposure to the non pathogenic form of the circulating pathogenic strain leads to the production of antibodies that will confer protection against the pathogenic strain. Producing the non-virulent virus involves first identifying and then recreating the subtypes of two of the virus’s surface proteins, haemagglutinin (H) and neuraminidase (N), which determine the strain’s virulence and ability to spread, and are also the target proteins for vaccine production.

Seed viruses are first made to provide the starting material for large scale production of live non-virulent flu viruses. The seed viruses are approved by the WHO or the United States Food and Drug Administration (USFDA). The usual method of seed virus production is reassortment (see Box). Fertilized chicken eggs are injected with both a standard non-pathogenic influenza strain known to grow well in eggs and the strain that carries the genes expressing the desired vaccine H and N protein subtypes. The two viruses multiply, and their eight genome segments reassort with 256 possible combinations. The resulting recombinant viruses are then screened for the desired virus with the six genome segments that allow the standard strain to grow so well in eggs and the H and N genes from the circulating strain. The seed virus is then injected into millions of eggs for mass production of vaccine. This conventional method of seed stock production takes about one to two months to complete [20].

Cell culture systems may eventually replace chicken eggs. Baxter International applied for a patent on a process using cell culture to produce quantities of infecting virus, which are harvested, inactivated with formaldehyde and ultraviolet light, and then detergent [21].  Baxter has produced H5N1 whole virus vaccines in a Vero cell line derived from the kidney of an African green monkey, and conducted phase 1 and 2 clinical trials with and without aluminium hydroxide as adjuvant [22, 23]. The main finding was that the toxic adjuvant did not increase neutralising antibodies against the vaccine strain. Baxter has agreed to ship H1N1 vaccine by the end of July or early August 2009 but details of the production of that vaccine have not yet been released to the public [16].
In December, a Baxter facility in Austria sent a human flu vaccine contaminated with the deadly H5N1 live avian flu virus to 18 countries, including the Czech Republic, where testing showed it killed the ferrets inoculated [24]. Czech newspapers questioned whether Baxter was involved in a deliberate attempt to start a pandemic.

Norvatis, another big pharma, announced on 13 June that it, too, has produced a swine flu vaccine using cell-based technology and the proprietary adjuvant MF59®. The MF59® adjuvant is oil based and contains Tween80, Span85, and squalene [25]. In studies of oil-based adjuvants in rats, the animals were rendered crippled and paralyzed. Squalene brought on severe arthritis symptoms in rats, and studies in humans given from 10 to 20 ppb (parts per billion) of squalene showed severe immune system impact and development of autoimmune disorders [26].

Novartis was in the news in 2008 for a clinical trial of a H5N1 vaccine in Poland. The trial was administered by local nurses and doctors who gave the vaccine to 350 homeless people, leaving 21 died; and were prosecuted by the Polish police [27, 28]. Novartis claimed the deaths were unrelated to the H5N1 vaccine [29], which had been “tested on 3500 other people without any deaths.”

GlaxoSmithKline’s vaccine will be made up of antigens of the recently isolated influenza strain, and also contains its own proprietary adjuvant system AS03 that has been approved in the EU along with its H5N1 bird flu vaccine in 2008. According to the European Public Assessment Report [30], AS03 adjuvant is composed of squalene (10.68 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams). The H5N1 vaccine also contains 5 micrograms thiomersal, as well as Polysorbate 80, Octoxynol 10, and various inorganic salts. The company is aggressively promoting various adjuvant systems as its ‘adjuvant advantage’ that reduces the dose of vaccines [31].

A recent WHO survey of primary vaccine producers concluded that the potential output of 4.9 Billion doses of H1N1 vaccine per year is a best-case scenario, assuming among other factors that the most dose-sparing formulation (that will include toxic adjuvants) be selected by each manufacturer and that production will take place at full capacity. WHO Director-General, Dr .Margaret Chan,  and the United Nations Secretary-General, Mr Ban Ki-moon, met with senior officials of vaccine manufacturers on 19 May and asked  them to reserve part of their production capacity for poor countries that would otherwise have no or little access to vaccine in the case of a pandemic [32].

The last mass-vaccination in the US was a disaster. In 1976, cases of swine flu were found in soldiers at Fort Dix, New Jersey, and one of them died, most likely of physical overexertion rather than from the infection [7]. This led to the launch of a mass vaccination of 40 million against a pandemic that never materialized. Thousands filed claims for injury. At least 25 died and 500 developed paralyzing Guillain-Barre syndrome [33, 34].

Swine flu syndromes mostly mild

As of 22 July 2009, the CDC listed a total of 40 617 cases in the US, with 319 fatalities, giving a fatalites/case ratio of 0.8 percent [35]; though the real death rate – among all cases of infection including the mild ones that go unreported – is probably much lower. Experts estimate that only 1 out of 20 cases are reported [36].

The UK is the worst affected European country, and the pandemic is in the headlines everyday in July. A new telephone helpline was set up on 23 July to let people get advice and tamiflu without seeing a doctor. In that week, there has been a record rise in cases to 100 000 and a total of 30 deaths so far [37], giving a fatalities/case ratio of 0.03 percent, a more accurate reflection of the actual death rate.

UK’s chief medical officer Sir Liam Donaldson has ordered the NHS to plan for as many as 65 000 deaths, with 350 a day at the peak [38]. There has been no plan as yet for mass vaccination; but the UK government has advance orders for 195 million doses of vaccine with GlaxoSmithKline (GSK).

The vaccine that GSK is developing will be tested on a limited number of people as the UK drug company reportedly [39] “weighs the pandemic danger against the risks of an unsafe shot.” This was criticized as “risky” by Prof. Hugh Pennington, a retired microbiologist at the University of Aberdeen, Scotland. “By limiting clinical trials, Glaxo raises the danger that the vaccine dose isn’t properly calibrated, and could lead to shots that don’t protect people from the virus or at worse are unsafe,” Pennington said.

Pennington added that the shot’s ability to trigger the body’s defences is crucial and requires tests to determine the best dose and whether an adjuvant is needed to bolster the immunity. (As we know, GSK is definitely promoting its new range of toxic adjuvants.) He also referred to the Fort Dix incident in 1976 (see earlier).

France has ordered vaccines from Sanofi, GSK and Novartis, but sees no reason to ask vaccine makers to shorten or skip clinical trials [16]. Sanofi-Aventis, the French drug maker developing its own swine flu vaccine will begin testing the product in early August, and estimates it will need as much as two and a half months of tests before having a shot that’s “both safe and protective”, according to Albert Garcia, speaking for the company’s vaccine unit, “the vaccine will be ready in November or December, he said.

Baxter, however, will produce a vaccine by early August for clinical tests.

Glaxo also said it is developing a face mask coated with antivirals to prevent infection and boosting production of its Relenza drug for patients already suffering from swine flu.

There are obviously safer and more effective ways to combat the pandemic than mass vaccinations: washing hands often, sneezing into a tissue that can be safely disposed of, avoiding unnecessary gatherings, and delay opening schools – all advised by governments – and we would add, eating healthily, exercise, and getting enough vitamin D to boost your natural immunity [10].

Click here for the full report and links from the Institute of Science in Society.

Soda Tax Could Combat Obesity

July 27, 2009

CBS News

by Stephanie Condon

While Democrats await the results of bipartisan negotiations over health care reform in the Senate Finance Committee, one of the proposals put before the committee received a nod of approval from health officials today: taxing soda.

The committee — the last congressional panel expected to produce its own recommendations for health care reform — listened to arguments earlier this year both for and against imposing a three-cent tax on sodas as well as other sugary drinks, including energy and sports drinks like Gatorade.

The Congressional Budget Office estimates that a three-cent tax would generate $24 billion over the next four years, and proponents of the tax argued before the committee that it would lower consumption of sugary drinks and improve Americans’ overall health.

At the Centers for Disease Control and Prevention’s “Weight of the Nation” conference today, CDC chief Dr. Thomas Freiden said increasing the price of unhealthy foods “would be effective” at combating the nation’s obesity problem, reports CBS News chief political consultant Marc Ambinder.

Freiden said he was not endorsing the tax as a member of the administration but was “just presenting the science,” according to Ambinder. He also said policies that would reduce the cost of healthy foods would effectively bring down obesity rates.

Obesity-related health spending reaches $147 billion a year, double what it was nearly a decade ago, according to a study published Monday by the journal Health Affairs.

Given that evidence, the argument goes, a soda tax could plausibly pay for health care reform both by raising revenues and bringing down the medical expenses associated with obesity.

“It is extremely difficult in reality to make such a snapshot estimate of something so complicated as obesity,” Ambinder notes. “This is one reason why researchers in the field tend to focus on suffering and disparities within populations, rather than aggregate cost.”

Even though the growth rates of American obesity are leveling off overall, he points out, the rate is not slowing among African American women, Hispanics, Native Americans, or among poorer Americans.

Those opposed to the soda tax, however, are also emphasizing the impact it could have on poor Americans. The American Beverage Association, which strongly opposes the tax, told the Wall Street Journal the tax would hit poor Americans the hardest.

The association announced this month it has formed a coalition called Americans Against Food Taxes to oppose the soda tax, the Hill newspaper reported. Made up of 110 organizations opposed to raising taxes on food and beverages to pay for health reform, the group is running an advertisement that shows a family enjoying soda on a camping trip.

Given the current state of the economy, the ad says, “this is no time for Congress to be adding taxes on the simple pleasures we all enjoy.”

Click here for the full report from CBS News.

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