Posted - 08/19/2008 : 13:54:49
| With Ed Yazbak's permission I am posting his March 2006 Red Flag's article 'The Birth of a Pandemic':-
The Birth Of A Pandemic
By Red Flags Columnist, F. Edward Yazbak, MD, FAAP
Occasionally a major genetic shift in the influenza virus results in a deadly new virus strain to which the human population does not have immunity, and a global pandemic outbreak occurs…. Public health officials and the scientific community agree that the world is long overdue for a pandemic influenza outbreak.
Sanofi Pasteur, Jan. 7, 2004
In an announcement two years ago, pharmaceutical companies Aventis and Crucell revealed that they had agreed to further develop and commercialize influenza vaccine products based on PER.C6™ cell line technology. (1)
The agreement gave Aventis Pasteur, the vaccine branch of Aventis and a vaccine giant headquartered in Lyon, France, the exclusive license to manufacture and sell influenza vaccines using the unique cell line technology that had been developed by Crucell, a small company of 180 employees headquartered in Leiden, the Netherlands.
Crucell received (US) $38 million in return, as well as “high single-, up to double-digit” royalties on future PER.C6-based influenza vaccine sales. It also retained marketing rights for Japan (15 percent of the global influenza vaccine market), promising to pay Aventis Pasteur royalties on those sales.
Owning 38 percent of the global influenza vaccine market at the time, Aventis Pasteur was already the world leader, with sales of €460 million (US $579 million) in 2002 alone.
The PER.C6 technology promised to allow not only the production, but also the competitive pricing, of literally unlimited quantities of influenza vaccine yearly. It is considered superior to other cell-culture technologies and is faster, safer and cheaper than the old egg-based process.
Now that there was a potential for a limitless supply of influenza vaccine, all that was needed was to create a market with an insatiable appetite. Coming to the rescue were the Centers for Disease Control and Prevention (CDC) and its ever faithful Advisory Committee on Immunization Practices (ACIP). Gradually, large segments of the population were deemed in need of “protection:” Individuals aged 50 to 64 years because “nearly one-third of them had one or more medical conditions that placed them at increased risk for serious flu complications,” and any person in close contact with someone in a high-risk group. In addition, all pregnant women and all small infants aged 6 to 23 months in the United States — but nowhere else — suddenly needed a yearly influenza vaccine.
Vaccine manufacturers have always enjoyed “favored status.” They cannot be sued in the United States and they never have to worry about generic substitutes. The flu vaccine manufacturers are the luckiest of the bunch: Their pediatric product does not have to be thimerosal-free like all other pediatric vaccines and their complete line of products needs only to be effective for one season — if that.
Every year, a bunch of scientists fly into Geneva, Switzerland, to feast over delicious fondues and a variety of Swiss cheeses and chocolates and decide which two strains of influenza A virus and one strain of influenza B virus should be included in the next season’s influenza vaccine cocktail. With great assurance, the chairman of the international committee usually makes the announcement and reminds the world that the committee is only wrong once every 10 years “on average.” Every other year, he calmly repeats the same assurance, when large outbreaks occur because somehow the virus in the community was totally unrelated to the Geneva-predicted three. The CDC immediately comes to his rescue and reminds the good people of the United States that 36,000 citizens die from “Influenza” every year and that, although there was no viral match, at least the vaccine will help “prevent death.”
Because only 10 percent of people have an “influenza-like illness” every year, the perceived threat and the resulting scare have had a limited impact on vaccine sales. If Sanofi Pasteur was to really benefit from its acquisition, a new market or a bigger scare had to be created.
Selling millions of doses of vaccines is obviously a great success story to report at the annual stockholders’ meeting. Selling millions more to prevent a disease that does not exist and may never come, must undoubtedly be the ultimate “Good News.”
This happened in 2003.
In October of that year, the Denmark Ministry of Foreign Affairs in its “Invest in Denmark” feature reported that a small Danish biotech company, Bavarian Nordic, had informed the Copenhagen Stock Exchange that high turnover had been generated in the first nine months of 2003 through sales of smallpox vaccines to the United States, the United Kingdom and Germany. The exuberant report of the ministry, entitled “Bavarian Nordic vaccine sales go through the roof,” went on to reveal that the vaccine company’s third-quarter earnings before tax amounted to (US) $30.5 million, compared with a loss of (US) $10.3 million for the same quarter in 2002.
“Turnover increased from a mere DKK 2.8 million (USD 442,000) to a mighty DKK 414 million (USD 65.4 million),” the report went on. Bavarian Nordic’s share price rose 110 percent between the first of the year and Sept. 30. (2)
The investment was considered worthwhile by the governments that bought the vaccine because they had no cases of smallpox. Obviously, the rest of the world did not either — without investing in the Danish Economy and its vaccine industry.
Sanofi Pasteur also needed serious returns for its investment in the new PER.C6™ cell line technology, so the Perfect Scare had to be created: “Occasionally a major genetic shift in the influenza virus results in a deadly new virus strain to which the human population does not have immunity, and a global pandemic outbreak occurs. The most severe pandemic recorded, the Spanish influenza pandemic, occurred from 1918 to 1920 and caused an estimated 50 million deaths worldwide. Public health officials and the scientific community agree that the world is long overdue for a pandemic influenza outbreak.” (1)
Again, this statement was made not in January 2006, but on Jan. 7, 2004.
* * * *
The avian or bird flu
Avian influenza occurs worldwide. It is caused by type A strains of the influenza virus and affects all birds.
The mild form of the disease is quite common; it causes decreased egg production, mild respiratory symptoms and ruffled feathers. The “outbreaks” can be so mild as to actually go unnoticed — unless the birds are routinely tested.
The severe form of the disease, first identified in Italy in 1878, is far less common. It is very contagious, has a sudden and dramatic onset and is almost always rapidly fatal with multiple-organ invasion and internal hemorrhaging. (3)
All subtypes of influenza viruses infect wild waterfowl, often without causing clinical illness. In these birds, the virus is identified only by testing.
Outbreaks of virulent avian influenza have only been caused by certain H5 and H7 subtypes possessing a genetic and distinctive “signature” that is associated with exceptional virulence.
Though not all virus strains of the H5 and H7 subtypes are highly pathogenic, they all have the potential to mutate and become virulent after circulation in poultry. It is believed that recently some species of migratory waterfowl have been carrying aggressive strains of H5N1 virus in its highly pathogenic form and introducing it to new geographical areas along their migration routes.
Avian influenza viruses are easily transmitted from poultry farm to poultry farm and can survive for extended periods of time. Best control measures are rapid culling of infected and exposed birds, careful disposal of carcasses and strict quarantine.
Vaccination of poultry in high-risk areas is useful only if quality-assured and type-specific vaccines are used. Less than optimal vaccines compound the risk to exposed humans by allowing the shedding of viruses by birds appearing healthy.
The first documented outbreak of human infections with H5N1 occurred in Hong Kong in 1997. Eighteen individuals were affected and all had direct contact with sick birds. The outbreak stopped after the entire Hong Kong poultry population was destroyed.
In December 2003, outbreaks of bird flu occurred in the Far East and later in other countries. With great diligence, the press and the 24-hour television news channels have described each and everyone of them “in depth.”
Again, a few human cases of H5N1 influenza virus infection occurred mostly following direct and close contact with infected poultry. A few rare cases of supposed “human-to-human” spread of H5N1 virus were also reported but diligent investigation and follow-up could not document any further spread.
Nevertheless, “experts” have maintained that it is not a question of if but of when the pandemic of bird flu will start — by the spread of disease from person to person.
By January 2006, Sanofi Pasteur, still the world’s No. 1 producer of influenza vaccines, had quietly increased its share of the global market from 38 to 50 percent. (4)
On Dec. 15, 2005, it had announced “promising results” from early clinical trials involving 300 people in France who were given the new Aventis Pasteur H5N1 vaccine. The vaccine was found to be safe and effective when given in two doses and “combined with a chemical that stimulates the immune system.” Of course, the criteria for safety and efficacy and the identity of the immune system booster were not disclosed.
Although second-stage trials were slated to be completed by the end of 2006, Sanofi has already signed contracts with the U.S., Australian and French governments to produce more than five million doses of the vaccine “to be stockpiled in case of emergency.”
The $100 million deal with the U.S. Health & Human Services Department was signed in September 2005. The 1.4 million doses purchased by France's health ministry were to be delivered before Dec. 31, 2005.
Vaccine manufacturers do not usually mass-produce expensive vaccines before they are tested and approved. Sanofi is not only proceeding with production but actually stepping it up. According to the company’s vice-president for research and development, "This isn't business as usual. There's a sense of urgency about this pandemic."
Now that is positive thinking!
Meanwhile, seasonal flu vaccines will remain Sanofi’s money-makers as demands increase steadily in the U.S. — thanks to the ACIP and its yearly brain storms. Sanofi's flu vaccine sales rose 33 percent, to $627 million last year. Sanofi Pasteur/Merck posted an additional $132 million in flu vaccine sales in Europe, up 10.2 percent over 2003.
Avian flu vaccine production, by contrast, "isn't an important commercial activity," said a French financial analyst. "I wouldn't buy Sanofi [shares] for this reason...The H5N1 vaccine is not intended to make Sanofi and its stockholders rich, but if health authorities' worst fears about avian flu come to pass, it could help save millions of lives.”
This statement was not echoed elsewhere. If antigenic shift of the influenza A strain does occur and if it trigers a pandemic — high person-to-person transmitability and high case fatality — the World Bank puts the cost at an estimated (US) $550 billion.
As to the regular flu vaccine, 14 companies now provide 90 percent of the global vaccine supply. Because the current trivalent inactivated influenza vaccines production of around 300 million doses can only cover 14 percent of the global population, the demand for more doses will continue and influenza vaccines sales that accounted for approximately 14 percent of total 2004 vaccine sales, or $1.3 billion were predicted to rise to $3.7 billion by 2010. (5)
But Sanofi's human vaccines business seems to have beaten those expectations already in 2005: It jumped 50 percent to $776 million in the fourth quarter alone and increased 27 percent to $2.49 billion for 2005. "The US flu season was the most successful in its history as it sold 64 million doses of vaccine. Flu-vaccine revenue represented about one-third of total vaccine sales last year," the company said in explaining these results. (6)
When increased demands will be made, the vaccine industry and particlularly Sanofi Pasteur with its PER.C6™ cell line technology will be there, waiting and ready.
The pandemic: an update
March 23, 2006: Voice of America (7)
“The World Health Organization says the deaths of five people in Azerbaijan have pushed the world total human deaths from H5N1 bird flu past 100. Experts say it is only a matter of time before the virus spreads to the United States. Federal, state and local officials, companies, schools and individuals are trying to prepare for it….
“The United States Congress allocated $3.3 billion this year to protect Americans against bird flu. Half of that money is for vaccines, starting with the one that fights the Vietnamese version of bird flu.”
"No one in the world is well prepared for a pandemic. We are better prepared now than before and we will be better prepared in the future than we are now. But it is a continuation of preparation.
— U.S. Health and Human Services Secretary Michael Leavitt
* * * *
March 25, 2006: The Gazette, Colorado (8)
“If a pandemic hits, people will be on their own, at least for a while, government officials said…. If the virus evolves into a bug that spreads between humans, it could fan out across the globe, killing millions, including 26,276 in Colorado, if it mimics the deadly strain that wiped out 50 million in 1918….
“At the first statewide public meeting to address pandemic planning, (Colorado) Gov. Bill Owens and Mike Leavitt, U.S. Department of Housing and Human Services secretary, emphasized preparedness begins at home.”
“A flu pandemic is not something the government alone can handle…. It’s going to be everybody’s responsibility to deal with it…. That means families should stock food to last a month or more, keep bleach on hand to disinfect their homes and be prepared to care for a family member who becomes sick…. They also should be ready to work from home, not go to public events and to attend open-air rather than indoor funerals…”
— Colorado Governor Bill Owens
“A pandemic doesn’t happen at once, it happens over an extended period of time, a year, one and a half years…. It’s hard to talk about because anything you say before a pandemic happens sounds alarmist…. But anything we have done after it starts will seem inadequate, so the best thing we can do is talk about it openly, talk about it in ways that will inform, not inflame, to do our best to inspire a sense of preparation, not panic.”
— U.S. Health and Human Services Secretary Michael Leavitt
March 31, 2006: The Week (9)
“Any community that fails to prepare, with the expectation that the federal government will at the last moment come to the rescue, will be tragically wrong…. At this point, if you are a bird, it is a pandemic. If you are a human being, it’s not.”
— U.S. Health and Human Services Secretary Michael Leavitt
* * * *
And so it goes.
I do not know if the H5N1 virus will undergo genetic changes that will suddenly allow it to easily infect humans, causing pandemic disease. I certainly hope not.
I do know that vaccination against the swine flu, and more recently anthrax and smallpox, have resulted in disastrous complications and sometimes death.
I also know that we already have some other serious health problems that are not receiving the attention that they deserve because we are being distracted by dead chickens in faraway places.
“Aventis and Crucell Announce Strategic Agreement to Develop and Commercialize Novel Influenza Vaccines.” Available at http://tinyurl.com/mppws
“Bavarian Nordic vaccine sales go through the roof.” Invest in Denmark. Ministry of Foreign Affairs of Denmark. Available at http://tinyurl.com/g39sc
World Health Organization, Avian Influenza Fact Sheet. Available at http://tinyurl.com/6
“Preventing the Pandemic.” BusinessWeek/OnLine http://tinyurl.com/zlyq2
M.J. Belsey, B. DeLima, A.K. Pavlou, J.W. Savopoulos. “From the Analyst’s Couch: Influenza Vaccines.” Nature Reviews Drug Discovery 5, 183-184 (March 2006). Available at http://www.nature.com/nrd/journal/v5/n3/full/nrd1988.html
Wai Lang Chu. “Sanofi 4Q overshadowed by impending legislation.” Jan. 31, 2006. Available at http://tinyurl.com/bolv4
Mohamed Elshinnawi. “Americans get ready for Bird Flu.” Voice of America. March 23, 2006. Available at http://www.voanews.com/english/2006-03-23-voa34.cfm
Pam Zubeck. “Officials: All must gear for pandemic.” The Gazette. March 26, 2006. Available at http://www.gazette.com/display.php?id=1315927&secid=1
“New Warnings on Bird Flu. The main stories and how they are covered.”
The Week. Volume 6. Issue 252: 7. March 31, 2006.