avian influenza strain H5N1 appears in gold
people or profits?
As the presence of the H5N1 avian influenza ("bird flu") virus, once limited to Southeast Asia, is confirmed in Russia, Britain, Romania, Greece, and Turkey, and as the world's people and governments begin to realize that the only thing standing between them and a potentially catastrophic global flu pandemic are stockpiles of the anti-viral drug Tamiflu®, a wave of correspondingly-global public and governmental activism is arising to make sure that one company's commitment to maximizing its profits does not endanger the future of humanity.
early warning
Etopia Media News Networks first sounded the alarm on the threat of a 1918-style global influenza pandemic in an October 4, 2004, article entitled
"Could the bird flu virus H5N1 cause a 1918-class global influenza pandemic?".
This was followed up on November 3, 2004, with an exclusive, 53-minute audio interview entitled
"Dr. Dominick Iacuzio, Medical Director at Roche Pharmaceuticals, explains how anti-virals such as Tamiflu® work and how they can provide a more reliable defense against a possible avian influenza pandemic than a strategy relying on vaccination".
This, in turn, was followed by the publication, on March 25, 2005, of an exclusive written Q & A with Roche Pharmaceuticals about Tamiflu® entitled
"Roche Pharmaceuticals answers some questions about Tamiflu®".
U.S. media and politician arrive late to the party
early on (nine days ago), Roche's rights were sacrosanct
On October 14, 2005, the Etopia Media's newly-created
Tamiflu® World published an article entitled
"Original developers of Tamiflu and Relenza seek reversion of ownership rights; WHO won't pressure Roche on generics; Montanan urges consideration of equity issues in the comparative availability of Tamiflu," in which it was reported that
Lee Jong-wook, Director-General of the United Nation's World Health Organization (WHO) "told the 56th WHO committee meeting of the Western Pacific Region in Noumea, New Caledonia, on Monday, September 19, 2005, that WHO would not push Roche to relinquish its (still currently-held) patent rights in Tamiflu to allow the production of generic versions of the drug by other, additional manufacturers."
a breach in the wall
followed by calls for "consumer rights" and the defense of private profit
On that same day, in this same article,
Tamiflu® World referred to an article in the
Herald Times Daily entitled
"U.S. should OK generic bird flu drug imports-group," in which James Love, director of the
Consumer Project on Technology called upon the U.S. Government to "allow imports of generic versions of patented medicines such as Roche AG‘s Tamiflu to help the country prepare for a possible bird flu pandemic," and
Billy Tauzen, former Democrat, former Republican Chairman of the House Energy and Commerce Committee and currently President and CEO of the
Pharmaceutical Research and Manufacturers of America (PhRMA) (a job he started on January 3, 2005, the same day he left Congress), said that allowing the generic production of Tamiflu® at this time "would take away incentives for other companies to undertake the difficult and costly work of searching for new antivirals and vaccines for this possible health crisis. The work being done by America‘s pharmaceutical research companies is the greatest hope of finding additional treatments and a vaccine for avian flu, and policy measures should be developed to encourage these efforts, not discourage them."
New York's Senator Schumer forces Roche to bite the bullet and agree to talks with generic manufacturers
As reported on October 21, 2005, in a
Tamiflu® World article entitled
"Ownership of Tamiflu® in doubt as Senator Schumer forces Roche to license rights to four generic manufacturers, three of which are already at each others' throats," United States Senator from New York Charles Schumer, no doubt under severe pressure from constituent groups interested in having enough Tamiflu® produced to protect both themselves and those they care about elsewhere, met with George Abercrombie, CEO of
Roche Pharmaceuticals, based in Nutley, New Jersey, and then announced that he had:
"provided the names of four companies to Mr. George Abercrombie, the CEO of Roche in the United States. These companies – Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories, and Ranbaxy Laboratories – each believe they can produce more Tamiflu if given the chance, and want to step up to serve the global public health need by working in cooperation with Roche.
"Roche has agreed to meet with each of these companies as soon as possible – and indeed will begin meeting with additional companies immediately, also in cooperation with HHS, which may have additional companies in mind as well.
"Roche has agreed to sub-license the production of Tamiflu to any of these companies that can produce it in quantities large enough to help meet the anticipated demand in case of a flu outbreak, and the determination as to who gets licensed will be made in cooperation with the U.S. Government and other governments around the world."
Roche may have agreed to talk to the generic manufacturers, but still hasn't agreed to license Tamiflu® manufacturing rights to anyone
As this article is posted at 7:30 pm, Pacific Daylight Time, on Sunday, October 23, 2005, Roche has not yet announced its specific agreement with any of the companies listed above, or any other company, to sub-license to them the right to make generic Tamiflu®.
apparently, Indian government and generic drugmakers won't be waiting around for that
On the other hand, in an article posted just after midnight, New Delhi, India, time, on Monday, October 24, 2005, entitled
"Drug firms may get to make Roche’s Tamiflu--Compulsory licensing provision in Patents Act likely to be invoked," it's reported that:
"The [Indian] government is likely to invoke the compulsory licensing (CL) provision in the Patents Act to allow domestic drug firms produce and stockpile Swiss drugmaker Roche’s patented drug Tamiflu, the lead pre-emptive medicine in fighting the dreadful avian flu virus.
"The move is intended to cope with any public health emergency that might arise in case the pandemic hits India. The Cabinet is understood to have taken an in-principle decision in this regard last week and ascertained the willingness of local firms to produce it as a pre-emptive measure.
"Once the CL is issued, India’s generic drugmakers would be able to manufacture the drug not only for supply in the domestic market, but
also for export [bolding added]. According to official sources, the government’s plan is to invoke Section 92 of the Act which obviates the requirement of issuing a notice to the patent holder before initiating CL proceedings.
"At least three firms,
Ranbaxy,
Cipla and
HeteroDrugs, are equipped and are willing to manufacture the drug, and would not mind the risk of pre-emptive stockpiling, given the export opportunity, an industry source said.
Roche now the target of blame and criticism
Now today, October 23, 2005, a number of reports are being published that call into question both the good faith and competence of Roche as sole provider of Tamiflu® to a world possibly on the brink of mass disaster from rampant avian influenza.
In
"Roche accused of serious failings in Tamiflu production by Gilead – report," published by
Forbes, it says:
"Roche Holding AG has been accused of serious failings in the manufacture of Tamiflu by US biotech firm Gilead Sciences Inc, the owner of the patent on the highly sought after bird flu drug, UK Sunday paper The Observer reported citing court papers filed with the US Securities and Exchanges Commission.
"Gilead, which is
demanding termination of its license agreement with Roche because it says that the Swiss drugmaker has failed to market the drug properly, has identified a number of incidents over the past three years which required Roche to issue product recalls, the paper said."
Forbes reports that Roche is denying these charges, quoting them as saying:
"''We are discussing issues with them. We don't agree with the allegations. Legal action is initiated ... the allegations are all without merit and we remain fully committed to ensure that we carry on [producing] the treatments.''"
You can read a complete copy of the report from
The Observer cited in the
Forbes article, on the
Guardian Unlimited web site under the title
"Roche makes a killing--As panic spreads over avian flu, the Swiss pharmaceutical giant is accused of putting profits before people.".
For a related article about this from
The Observer, click on the title of
"Roche accused over flu vaccine.".
Gilead seeks reversion of under-siege patent rights held by Roche
Not only is Roche now subject to all manner of efforts to undermine its patent rights in Tamiflu®, but the company that licensed these rights to it originally, Gilead Sciences, Inc., of Foster City, California, has filed legal papers designed to terminate its licensing agreement with Roche and to return to Gilead ownership of the intellectual property rights the subversion of which is now the subject of concerted efforts worldwide by governments and generic drug companies eager to ramp up production of the potentially life-saving drug.
You can read detailed accounts of this process by clicking on the title of
"Gilead Sciences, Inc., inventor of Tamiflu®, is seeking to terminate its 1996 agreement with Roche, which would result in the rights to Tamiflu held by Roche reverting to Gilead" and you can read the latest statement about the relationship between Gilead Sciences and Roche Pharmaceuticals in terms of the sub-licensing of the right to manufacture Tamiflu® by clicking on the title of
"Gilead Sciences' Director of Public Affairs says that "any potential sub-license is the responsibility of Roche as it pertains to contract manufacturing" of Tamiflu®.".
in the end, it may be "people over profits"
Apparently, while the general rule is that drug innovation and manufacture should be left in private hands, when it appears that the only thing standing between humanity and its destruction is the abrogation of one company's patent rights, almost everyone is going to come down on the side of reduced profits and the continued existence of the human species, rather than the other way around.
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