By Dr. Tony Magana

EM stain Influenza A H1N1A world wide shortage of antiviral drugs to fight Swine Flu H1N1 exists because of faulty decisions by world health authorities and socialist interference into private industry. Obama and the liberal left are complicit in poor vigilance and not protecting the American pharmaceutical industry which is strategically important to the health and security of the United States.

Every hour we are hearing about more cases of Swine Flu H1N1 infection occurring around the world. The virus has now proven itself to be easily transmissible between people but the question remains about how pathogenic (pathogenicity can be thought of as the potential to cause serious illness or death) the virus will be as it affects large populations. Public health measures such as limiting movement and isolating the affected will help but there is still a potential that 50% of the world’s population could be infected.

The virus might disappear as warmer weather sets in world-wide but since it will only have affected a small percentage of the population there will not be enough immunity in the population to prevent a recurring epidemic when the winter season begins again for the northern hemispheres including the United States. It is possible that an immunization to the virus may be developed by next winter but many say the chances of developing a successful vaccine in less than 8 months without compromising effectiveness or safety is small.

There are two drugs available to treat infection which could potentially save millions of lives. Tamiflu is an oral drug and Relenza is used as an inhalant. As I wrote earlier, the Bush administration had called for increasing the stockpile of Tamiflu, in preparation for a possible avian flu outbreak, to be increased from 50 million doses to 195 million doses in June 2008 when the flu pandemic response plan was created. The same plan that President Barack Obama praised in his 100 Day speech on August 29, 2009.

A few days ago the Obama administration revealed that the stockpile was never increased. Many on the left including the Huffington Post are accusing the “GOP” of “stripping” the flu preparedness initiative in the stimulus compromise legislation. They seem to forget that only two Republicans , Susan Collins and Olympia Snowe, voted for the package that stripped the funding originally proposed by President Bush. They have claimed that they did not intend that initiatives not be funded but that they wanted funding to be approved through other routes of legislation. Senator Arlen Specter who is now Democrat also voted for the measure but all the other Republicans in House and Senate did not approve the compromise. The removal of the funding that would have tripled the stockpile of Tamiflu was a Democratic plan voted in place by a Democratic majority.

The Huffington Post does not mention how they as well as Keith Olbermann, Chris Matthews and many others in the cast of the liberal news media spin group praised Specter, Collins, and Stowe for being “bipartisan” and thanked them for their working with the Democrats on the stimulus package.

If the Swine Flu H1NI virus does develop demonstrated severe pathogenicity then the current supply of Tamiflu according to a recent report in Nature may only be enough to supply 2% of the world’s population. Three factors have contributed to this potential shortage.

Since 2003 the world has been most concerned about the possibility of an avian flu rather than a swine flu epidemic. The development of Tamiflu was initially hailed as great success and many countries began to order it. At the same time there has been an international movement to limit patent protections for pharmaceuticals where countries are now claiming that they have the right to produce generic drugs for domestic consumption. Tamiflu become the poster child of the socialist movement against patents and private drug production.

Hoffman La Roche makes Tamiflu under license from the American developer Gilead. They have claimed that the process to make Tamiflu is long and complex and also depends upon some scarce ingredients. Under pressure from United Nations agencies and the threat that countries like Taiwan and India would produce their own Tamiflu if licensing agreements would not be signed guaranteeing a low price, decisions about production were difficult.

The United States has a strong history of promoting strong pharmaceutical patents but that may end with the Obama administration. Obama has proposed shortening pharmaceutical patents duration and putting patent approval for them up to public criticism and comment. One could easily imagine that private research companies will be dissuaded from developing new drugs if “activists” are demanding very short patent lengths. Conversely, Obama has also proposed a gold plated type of patent specification that will favor large companies over smaller start up companies which often are the main source of new innovations.

A key ingredient to make Tamiflu is shikimic acid. Up until very recently the source of this substance was the star anise plant. A variant of the plant is found in China which had relatively high concentrations of shikimic acid yet it takes many pounds of plant to get enough for one pill.

Along with the patent fight many generic drug companies and others have been looking for ways to supply this ingredient. Recently Hoffman La Roche signed an agreement with the French firm, Sanofi-Aventis to produce shikimic acid using e. coli bacteria. According to Nature, two thirds of Tamiflu production is from star anise and one third from the new process. In March of this year company spokesmen and academicians familiar with the process said that the production could be significantly increased but would take a year to maximize. American researchers are working on other promising sources of shikimic acid.

If only 2% of those infected with Swine flu H1N1 become seriously ill and half of the world becomes infected then the anticipated need for Tamiflu will be at least 30 billion capsules says Jeff Levi of the Trust of America’s Health. Many experts in infectious disease, the drug production process, and public health arena seem to agree that a drug shortage is inevitable if swine flu proves deadly.

Relenza requires an inhaler because the oral form is not well absorbed. There have been many legal fights between its inventors, Biota of Australia, and the licensed producer, pharmaceutical giant Glaxo which have hampered its development. Just as in the case of Tamiflu, Glaxo has been threatened by generic production and licensing from countries if their demands for low prices were not met.

Another contributing factor to the shortage of the antiviral drugs has been a controversy in public health circles as to the effectiveness of these drugs against avian flu. Up until the recent swine flu outbreak, world health officials had seemed to have forgotten about swine flu (the last outbreak occurred in the first Bush administration). Some researchers were reporting resistance developing in avian flu to Tamiflu especially. This prompted some health officials to restrict its distribution for fear of increasing resistance and also questioned the wisdom of stockpiling the drug if there was resistance.

Even if we get over this crisis, there will be more. Viruses will mutate to new forms that will become resistant to current drugs and immunizations. If the Obama plan to destroy the patent process for pharmaceuticals goes forward the mechanism for new drug development will be stopped cold. The protection of the American pharmaceutical industry is a strategic necessity. We need to have capability to not only develop but also produce drugs with readily available materials.

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