European Governments Cancel Vaccine Orders

January 13, 2010

Wall Street Journal

By Jeanna Whalen and David Gauthier-Villars

Just months after rushing to order enough swine-flu vaccine to protect their citizens, European governments are cancelling 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 “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. f

Review of the Flu ‘Pandemic’

January 13, 2010

Reuters

By Jonathan Lynn

The World Health Organization is to examine its handling of the H1N1 pandemic, the group said on Tuesday, after accusations by some politicians that it exaggerated the dangers of the virus under pressure from drug companies.

The United Nations health agency will review the way it dealt with the outbreak of swine flu once the pandemic has subsided, WHO spokeswoman Fadela Chaib told a news briefing.

“Criticism is part of an outbreak cycle. We expect and indeed welcome criticism and the chance to discuss it,” she said, adding the WHO’s review would involve independent outside experts and its results would be made public.

But she said it was too soon to say when the examination would take place or which experts would be involved.

In the latest complaint about the way authorities have dealt with the pandemic, the Council of Europe, a political forum of most European countries, is to determine whether drug companies influenced public health officials to spend money unnecessarily on stockpiles of H1N1 vaccines.

Chaib said the WHO took its work of providing independent advice to its 193 member states seriously, and guarded against the influence of vested interests.

REVIEWING DEMAND

Several countries are cutting back orders for H1N1 vaccines as it becomes clear that the outbreak, declared a global pandemic by the WHO in June, is not as severe as at first feared.

Governments will have an opportunity to question the WHO about H1N1 at a meeting of its 34-member board next week.

The WHO’s top flu expert, Keiji Fukuda, will brief the board on January 18 about the latest developments in the first influenza pandemic in more than 40 years.

Developing countries still lack adequate access to both antivirals and vaccines despite donations from industrialized countries and drug makers, the WHO said.

Some 200 million doses of H1N1 vaccine and funding of some $12 million have been pledged to date, it said in a document prepared for the board.

“Significant progress in international solidarity has been achieved, through donations by developed countries and manufacturers, but overall access to antiviral medicines and vaccines in developing countries remains limited,” it said.

GlaxoSmithKline, Novartis and Sanofi-Aventis are among H1N1 vaccine producers.

The WHO last week delivered donated H1N1 vaccine to Mongolia and Azerbaijan, the first of 95 developing and middle-income countries targeted to receive supplies.

It aims to provide these countries with enough vaccine to cover 10 percent of their populations, with health care workers a top priority.

The WHO said last week that southern hemisphere countries struck by H1N1 last year are now broadly protected against new infections, and sickness levels are declining in much of the northern hemisphere, including North America where it first emerged last April.

According to lab-confirmed cases, swine flu has killed at least 12,799 people, but the real toll is much higher and will take several years to establish, the WHO says.

Click here for the full report.

European Parliament to Investigate WHO and “Pandemic” Scandal

January 4, 2010

Global Research

The Council of Europe member states will launch an inquiry in January 2010 on the influence of the pharmaceutical companies on the global swine flu campaign, focusing especially on extent of the pharma‘s industry’s influence on WHO. The Health Committee of the EU Parliament has unanimously passed a resolution calling for the inquiry. The step is a long-overdue move to public transparency of a “Golden Triangle” of drug corruption between WHO, the pharma industry and academic scientists that has permanently damaged the lives of millions and even caused death.
The parliament motion was introduced by Dr. Wolfgang Wodarg, former SPD Member of the German Bundestag and now chairman of the Health Committee of PACE (Parliamentary Assembly of the Council  of Europe). Wodarg is a medical doctor and epidemiologist, a specialist in lung disease and environmental medicine, who considers the current “pandemic” Swine Flu campaign of the WHO to be “one of the greatest medicine scandals of the Century.”[1]

The text of the resolution just passed by a sufficient number in the Council of Europe Parliament says among other things, “In order to promote their patented drugs and vaccines against flu, pharmaceutical companies influenced scientists and official agencies, responsible for public health standards to alarm governments worldwide and make them squander tight health resources for inefficient vaccine strategies and needlessly expose millions of healthy people to the risk of an unknown amount of side-effects of insufficiently tested vaccines. The “bird-flu”-campaign (2005/06) combined with the “swine-flu”-campaign seem to have caused a great deal of damage not only to some vaccinated patients and to public health-budgets, but to the credibility and accountability of important international health-agencies.”[2]

The Parliamentary inquiry will look into the issue of „falsified pandemic“ that was declared by WHO in June 2009 on the advice of its group of academic experts, SAGE, many of whose members have been documented to have intense financial ties to the same pharmaceutical giants such as GlaxoSmithKline, Roche, Novartis, who benefit from the production of drugs and untested H1N1 vaccines. They will investigate the influence of the pharma industry in creation of a worldwide campaign against the so-called H5N1 “Avian Flu”  and H1N1 Swine Flu. The inquiry will be given “urgent” priority in the general assembly of the parliament.

In his official statement to the Committee, Wodarg criticized the influence of the pharma industry on scientists and officials of WHO, stating that it has led to the situation where “unnecessarily millions of healthy people are exposed to the risk of poorly tested vaccines,” and that, for a flu strain that is “vastly less harmful” than all previous flu epidemics.

Wodarg says the role of the WHO and its the pandemic emergency declaration in June needs to be the special focus of the European Parliamentary inquiry. For the first time, the WHO criteria for a pandemic was changed in April 2009 as the first Mexico cases were reported, to make not the actual risk of a disease but the number of cases of the disease basis to declare “Pandemic.” By classifying the swine flu as pandemic, nations were compelled to implement pandemic plans and also the purchase swine flu vaccines. Because WHO is not subject to any parliamentary control, Wodarg argues it is necessary for governments to insist on accountability. The inquiry will also to look at the role of the two critical agencies in Germany issuing guidelines on the pandemic, the Paul-Ehrlich and the Robert-Koch Institute.

Bravo!

Click here for the full report.

Novartis Opens First Vaccine Manufacturing Facility in the U.S.

December 10, 2009

Infowars

by Dr. Sherri Tenpenny

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)

The use of human and animal cells for biological and pharmaceutical research is big business, particularly in Europe. For example, the European Collection of Cell Cultures (ECACC), established in 1984, is an international depository of cell culture collections. The ECACC describes itself as having one of the “premier collections of authenticated cell cultures in the world.” It holds more than 40,000 cell lines representing 45 different species and 50 different tissue types. (5) Many of these lines are used in cancer research; some are specifically made for use with vaccines.

To replicate, influenza viruses need to be mixed with living cells and several types of mammalian cells have been used for this purpose since the 1950s. Examples include calf lymph for smallpox vaccines, African green monkey cells (AGMK cells and VERO cells) for polio vaccines, and mouse brain cells for Japanese encephalitis vaccines. In the 1960s, tissues from aborted human fetal tissue, called MRC-5 and WI-38 cells, were developed and are still used for the manufacture of rubella, hepatitis A, chickenpox, and shingles vaccines. Since 2000, new cells under investigation for making flu shots include cells derived from retinas of aborted fetuses (PER.C6), cells from ovaries of Chinese hamsters, and even cells from insects.

Perhaps even the FDA agrees that a vaccine made from infected caterpillar eggs is just a little too weird. On November 19, an FDA panel voted 6 to 11 against the approval of FluBlok, flu shots made from bugs, citing “lack of safety data” as the reason. Made by Protein Sciences Corp. of Meriden, Connecticut, FluBlok would have been the first cell-line influenza vaccine licensed in the U.S. (6) Novartis must have been thrilled that its closest U.S. cell-line competitor was knocked out of the running days before it officially announced the launch of its Holly Springs plant.

Novartis still needs approval of its cell line, MDCK cells originating from dog kidneys, before it can ramp up flu shot production. Novartis has been using MDCK cells for several years to make its European-approved influenza vaccines: Optaflu, for seasonal flu, and Celtura, for swine flu. I find it interesting that the plant has been built, the vats are in place and the opening ceremony has been announced…and yet, flu shots made from dog cells have not been approved by U.S. regulators.

Click here for full report

Taxpayer Dollars Used to Build Norvartis Vaccine Plant

December 10, 2009

Huffington Post

by Dr. Sherri Tenpenny

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)

The use of human and animal cells for biological and pharmaceutical research is big business, particularly in Europe. For example, the European Collection of Cell Cultures (ECACC), established in 1984, is an international depository of cell culture collections. The ECACC describes itself as having one of the “premier collections of authenticated cell cultures in the world.” It holds more than 40,000 cell lines representing 45 different species and 50 different tissue types. (5) Many of these lines are used in cancer research; some are specifically made for use with vaccines.

To replicate, influenza viruses need to be mixed with living cells and several types of mammalian cells have been used for this purpose since the 1950s. Examples include calf lymph for smallpox vaccines, African green monkey cells (AGMK cells and VERO cells) for polio vaccines, and mouse brain cells for Japanese encephalitis vaccines. In the 1960s, tissues from aborted human fetal tissue, called MRC-5 and WI-38 cells, were developed and are still used for the manufacture of rubella, hepatitis A, chickenpox, and shingles vaccines. Since 2000, new cells under investigation for making flu shots include cells derived from retinas of aborted fetuses (PER.C6), cells from ovaries of Chinese hamsters, and even cells from insects.

Perhaps even the FDA agrees that a vaccine made from infected caterpillar eggs is just a little too weird. On November 19, an FDA panel voted 6 to 11 against the approval of FluBlok, flu shots made from bugs, citing “lack of safety data” as the reason. Made by Protein Sciences Corp. of Meriden, Connecticut, FluBlok would have been the first cell-line influenza vaccine licensed in the U.S. (6) Novartis must have been thrilled that its closest U.S. cell-line competitor was knocked out of the running days before it officially announced the launch of its Holly Springs plant.

Novartis still needs approval of its cell line, MDCK cells originating from dog kidneys, before it can ramp up flu shot production. Novartis has been using MDCK cells for several years to make its European-approved influenza vaccines: Optaflu, for seasonal flu, and Celtura, for swine flu. I find it interesting that the plant has been built, the vats are in place and the opening ceremony has been announced…and yet, flu shots made from dog cells have not been approved by U.S. regulators.

Concerns about Injected Animal Cells
When viruses are combined with animal and human cells in culture, the new, “immortalized” cells can replicate in perpetuity. By their very design, the cells are neoplastic (i.e. abnormal). If these abnormal clumps cause tumors when injected into experimental animals, the cell line is called tumorigenic. If the tumors are cancerous, the cell line is labeled as oncogenic. (7)

No matter how careful manufacturers try to be, animal cells, animal DNA and culture-contaminating viruses end up in the final vials. While dog kidney cells have reportedly fewer stray viral contaminants than eggs, the injection of animal DNA could have untoward results in humans. The FDA is aware of this and is rightfully concerned. These stray proteins can be incorporated into vaccine recipient’s own DNA, leading to the risk of abnormal genetic transcription. To minimize that possibility, the FDA has set manufacturing guidelines: The final vaccine product should have less than 1 million residual [animal] cells and less than 10 ng of DNA. (8) The FDA trusts that vaccine manufacturers will comply with these standards. I wonder who will be responsible for quality control and batch checking?

I find it disturbing that the FDA has been discussing cell-line concerns since 1998. Couldn’t manufacturers develop something better? Less risky? Less disgusting? An even bigger question is, knowing the potential cancer-causing risks of animal cell lines, why have government regulators allowed this technology to evolve and be used at all?

Concerns about the adjuvant, MF59
An adjuvant is molecule added to a vaccine so that less antigen (virus) is needed to achieve an antibody response. This reduces vaccine production costs and when the amount of virus is in short supply, adding an adjuvant stretches the available vaccine supply. With a few exceptions, adjuvants are foreign to the body and can cause adverse reactions.

Several types of adjuvants are used today. The most common are aluminum hydroxide, aluminum phosphate and calcium phosphate. There are a number of others under investigation: oil-based emulsions, products from bacteria, liposomes, endotoxins, and aliphatic amines. (9) Of these, oil-in-water adjuvants are at the forefront because they have been added to several of the pandemic swine flu vaccines.

Click here for full report

FDA Approves Another Flu Vaccine

November 30, 2009

CNN

The U.S. Food and Drug Administration said Friday it has approved a new vaccine to prevent seasonal influenza.

Agriflu, made by Novartis Vaccines and Diagnostics, is not intended to protect against the H1N1 virus, commonly known as swine flu.

The vaccine was approved using an accelerated approval process, the FDA said. Novartis demonstrated that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza, but it still needs to conduct further studies.

Agriflu, for ages 18 and older, is administered as a single injection in the upper arm and is available in single-dose, prefilled syringes, according to the FDA.

Novartis produces another licensed vaccine for seasonal influenza, Fluvirin, approved for ages 4 and older.

Although no vaccine is 100 percent effective in preventing disease, vaccination is the key to flu prevention, according to the FDA.

Novartis spokesman Eric Althoff said Agriflu is made in Siena, Italy, with eggs, and it has been available in Europe under the brand name Aggripal. This approval, he said, will add to future seasonal vaccine supplies.

Click here for the full report.

New Emergency Law Will Require Sick Pay

November 4, 2009

Reuters

By Maggie Fox

U.S. employers who tell workers to stay home when they are sick will have to give them paid time off for up to five days under new federal legislation proposed on Tuesday.

The emergency law would cover pandemic H1N1 flu or any other infectious disease, said California Representative George Miller, a Democrat who chairs the House Education and Labor Committee and who introduced the bill.

“Sick workers advised to stay home by their employers shouldn’t have to choose between their livelihood, and their co-workers’ or customers’ health,” Miller said.

“This will not only protect employees, but it will save employers money by ensuring that sick employees don’t spread infection to co-workers and customers, and will relieve the financial burden on our health system swamped by those suffering from H1N1.”

The U.S. Centers for Disease Control and Prevention advises employers to encourage sick workers to stay home so they do not spread H1N1. “But workers have been reporting that many of them are either afraid or cannot afford to take time off,” Miller told reporters in a telephone briefing.

Paid sick leave is not required by U.S. laws.

Miller said the committee would hold a hearing the week of November 16 and he would press to have a full vote as soon as possible.

Miller said at least 50 million American workers are not paid for time taken off sick, “many in lower-wage jobs that have direct contact with the public such as the food-service and hospitality industry, schools and health care fields.”

MORE VACCINE READY

In a regular briefing, CDC director Dr. Thomas Frieden said 31.8 million doses of flu vaccine have now become available — still far short of the minimum of 80 million to 100 million that had been projected for the first week of November.

This number includes vaccine already administered. Frieden said CDC hoped 10 million new doses will have been made available by the end of the week.

He said the pandemic may be having an unexpected side-effect — increasing demand for the seasonal influenza vaccine. “We think this year will be the highest ever uptake on seasonal flu vaccine,” Frieden said.

“We anticipate there being around 114 million doses of seasonal flu vaccine available through the market by the end of the year. It may be there is even greater demand than that by the end of the season.”

This includes healthcare workers, who are often reluctant to be vaccinated. In recent years, only around 38 to 40 percent of healthcare workers get flu vaccines, but that percentage may be higher this year, Frieden said.

As with the vaccine against H1N1 swine flu, distribution is slow and patchy for seasonal flu vaccine. “We continue to hear that people are unable to get the vaccine,” Frieden said.

The United States buys both seasonal and H1N1 vaccine from five makers — GlaxoSmithKline Plc, AstraZeneca Plc’s MedImmune unit, Novartis, Sanofi-Aventis and CSL Limited.

Some members of Congress and media commentators complained that detainees at Guantanamo Bay — the U.S. base in Cuba — would receive H1N1 vaccines when Americans were still struggling to find them.

But White House spokesman Robert Gibbs denied this on Tuesday. “There is no vaccine in Guantanamo and there’s no vaccine on the way to Guantanamo,” he told reporters.

Click here for the full report.

Gitmo Detainees to Get No H1N1 Vaccine

November 4, 2009

Reuters

By Patricia Zengerle

The White House denied on Tuesday that any H1N1 flu vaccine is now going to terrorism suspects held at the Guantanamo Bay Naval Base in Cuba, heading off controversy over swine flu prevention priorities.

“There is no vaccine in Guantanamo and there’s no vaccine on the way to Guantanamo,” White House spokesman Robert Gibbs said at his daily briefing, although a Pentagon spokesman said detainees at the base could receive it late this month.

After Gibbs’ comment, Pentagon spokesman Bryan Whitman said detainees at Guantanamo would receive the vaccine only after active duty troops, deployed U.S. contractors and civilians and civilians working for the Department of Defense.

Americans have been lining up for the vaccine to protect against the H1N1 swine flu virus, which has killed at least 1,000 Americans and infected an estimated 5 million.

Given a shortage of the vaccine, clinics have restricted its distribution to those in high-risk groups, but even many of those have been unable to receive it.

A Department of Defense spokesman had said the vaccine would be offered to about 200 Guantanamo detainees, prompting criticism from some conservative politicians and commentators.

“Gitmo doesn’t have any vaccine and is not expected to receive any vaccine for some time, probably late November at the earliest,” Whitman said.

“Because there are limitations on supplies of H1N1 vaccine, we’ve established priorities… But we do have an obligation to provide appropriate medical care to everyone in our custody.”

Whitman said receiving H1N1 vaccine is voluntary for detainees, in other words, many may opt not to receive the vaccine.

The United States has ordered up to 250 million doses of H1N1 vaccine from five companies — MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia’s CSL, GlaxoSmithKline and Novartis.

Click here for the full report.

Drug Companies and Doctors Make Billions on Swine Flu

October 14, 2009

ABC News

By Dalia Fahmy

Americans are still debating whether to roll up their sleeves for a swine flu shot, but companies have already figured it out: vaccines are good for business.

Drug companies have sold $1.5 billion worth of swine flu shots, in addition to the $1 billion for seasonal flu they booked earlier this year. These inoculations are part of a much wider and rapidly growing $20 billion global vaccine market.

“The vaccine market is booming,” says Bruce Carlson, spokesperson at market research firm Kalorama, which publishes an annual survey of the vaccine industry. “It’s an enormous growth area for pharmaceuticals at a time when other areas are not doing so well,” he says, noting that the pipeline for more traditional blockbuster drugs such as Lipitor and Nexium has thinned.

As always with pandemic flus, taxpayers are footing the $1.5 billion check for the 250 million swine flu vaccines that the government has ordered so far and will be distributing free to doctors, pharmacies and schools. In addition, Congress has set aside more than $10 billion this year to research flu viruses, monitor H1N1′s progress and educate the public about prevention.

Drugmakers pocket most of the revenues from flu sales, with Sanofi-Pasteur, Glaxo Smith Kline and Novartis cornering most of the market.

But some say it’s not just drugmakers who stand to benefit. Doctors collect copayments for special office visits to inject shots, and there have been assertions that these doctors actually profit handsomely from these vaccinations.

It is a notion that Dr. Lori Heim, president of the American Academy of Family Practitioners, says is simply not true.

“According to most of the physicians I have talked to, the administration of these vaccines is done for the community’s benefit as opposed to anything that helps profit,” she says. Heim adds that even though doctors will not have to shell out for the H1N1 vaccine, they will bear the usual costs associated with storage and administering the shots.

“There is an administration fee, for the costs that you can’t get reimbursed through Medicare or Medicaid,” she says. “This is usually less than, or right at the break-even point.”

Still, pharmacies also charge co-payments or full price of about $25 to those without insurance and often make more money if patients end up shopping for other goods.

“Flu shots present a good opportunity to bring new customers into our stores,” says Cassie Richardson, spokesperson for SUPERVALU, one of the country’s largest supermarket chains. Drawing customers to the back of a store, where pharmacies are often located, offers retailers a chance to pitch products that might otherwise go unnoticed.

Even companies outside of the medical industry are benefiting: the UPS division that delivers vaccines in specially designed containers, for example, has seen a bump in business.

New Entrants in Flu Shot Business

The intensifying competition has irked some doctors.

“Retailers and other non-medical professionals have siphoned off the passive income that once helped to cover medical overhead,” says Dr. Caroline Abruzese, an internist in Atlanta. “The larger retail chains can invest up front in large volumes of vaccine at low prices, and market to customers already in their stores.”

The promise of profits has attracted new players into the business. Some of the world’s largest drugmakers, who in the past avoided the vaccine market because of its limited scope — its not easy to convince healthy adults to get a shot for measles — are now jumping into the fray.

Last month alone saw three large vaccine deals. Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm that makes and develops flu vaccines. Merck, which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL.

Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry.

Large and small drugmakers are drawn to the business largely because of scientific advances that promise to radically expand the range of health problems that vaccines can address. In addition to preventing childhood diseases such as measles and polio, vaccines can now also ward off cervical cancer, and researchers are working on vaccines for HIV and tuberculosis.

Scientists believe they can create therapeutic vaccines than treat diseases such as Alzheimers and diabetes after they have set in. (At least one company is betting on a vaccine that helps cigarette smokers quit.)

“These innovations broaden the market potential for vaccine makers and partly explained the renewed interest by drugmakers,” says Anthony Cox, a professor at Indiana University’s Kelley School of Business who specializes in the marketing of medical products.

But Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents the country’s leading pharmaceutical research and biotechnology companies, says that drugmakers are also compelled by the government to join efforts to ensure that there is enough vaccine to go around.

“Because of national security implications, the government felt that they needed to encourage and ask [vaccine manufacturers] to move much quicker,” he says. Grayson adds that vaccine manufacturers also face significant costs; aside from the expense of fitting a new vaccine into a tight production schedule, drugmakers GlaxoSmithKline and Sanofi Pasteur were forced to acquire new vaccine production facilities in recent years to keep up with demand.

Alternatives to Vaccines Are Few

While this promise of new treatments for painful diseases brings hope to many, vaccines continue to attract critics. The National Vaccine Information Center, a non-profit advocacy group, is at the forefront of a movement demanding that vaccines be tested more thoroughly before hitting the market. Although there has been little evidence to support their claim, detractors — including the comedian Jim Carrey — believe that vaccines are at least partly to blame for the sharp rise in autism in recent decades.

The swine flu vaccine has also attracted its share of critics. Frank Lipman, a New York-based doctor who specializes in a mix of Western and alternative medicine, points out that the swine flu is rarely fatal and that it’s too early to tell if it’s safe because it hasn’t been widely tested.

Others argue that Americans have little choice. The cost of a widespread pandemic, similar to Spanish Flu outbreak in 1918, which killed 675,000 Americans (and 50 million worldwide), would be devastating. The Trust for America’s Health, a Washington-based non-profit organization, estimates that a severe pandemic could push down GDP by more than 5 percent and cost Americans $683 billion.

“We’re not seeing a pandemic that’s this severe,” says Jeff Levi, director of Trust for Americas Health. “We’ve dodged a lot of bullets.”

Click here for the full report

Microchip Implant Tracking Health, Socials, and Credit

October 13, 2009

BNET

By Jim Edwards

Novartis and Proteus Biomedical are not the only companies hoping to implant microchips into patients so that their pill-popping habits can be monitored. VeriChip of Delray Beach, Fl., has an even bolder idea: an implanted chip that links to an online database containing all your medical records, credit history and your social security ID.

As this presentation to investors makes clear, the chip and its database could form the basis of a new national identity database lined to Social Security and NationalCreditReport.com. The VeriMed Health Link homepage describes the chip:

… a tiny, passive microchip (the nation’s first and only microchip cleared for patient identification by the U.S. Food & Drug Administration) and a secure, private online database that links you to your personal health record. Your Health Link is always with you and cannot be lost or stolen.

That database can be accessed by doctors and nurses:

About the size of a grain of rice, the microchip is inserted just under the skin and contains only a unique, 16-digit identifier. The microchip itself does not contain any other data other than this unique electronic ID, nor does it contain any Global Positioning System (GPS) tracking capabilities. And unlike conventional forms of identification, the Health Link cannot be lost, stolen, misplaced, or counterfeited. It is safe, secure, reversible, and always with you.

Click here for full report

« Previous Page — Next Page »