Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

[sharon sanders]

Today Hoffman-La Roche, the maker of the anti-viral Tamiflu, and the Department of Health and Human Services (HHS), the lead health agency of the United States, announced a program to promote the stockpiling and distribution of Tamiflu as part of a pandemic preparedness program for corporations.

This program called Roche Antiviral Protection Program (RAPP) will allow corporations to more easily afford and stockpile Tamiflu for use by their employees. For the price of $6.00 USD per course (10 tablets), per annum, each corporation can have a private stockpile of Tamiflu that is maintained and delivered by Roche within 24 - 48 hours of request. The final price of the order will be set according to the wholesale price of Tamiflu at the time of requested delivery. One benefit of this program is that corporations do not have to worry about drug expiration dates since delivery will not be made until requested.

Each corporation can order courses of Tamiflu for prophylactic and/or treatment for each employee and a doctor's prescription is required for each order. Employees of U.S. corporations who are physically located outside of the U.S. are not covered by this program yet.

The promotion of this kind of program from a private pharmaceutical company by a major U.S. health agency is unprecedented but the potential threat of a pandemic warrants such action. At this time the minimum order is 2500 courses but this may be lowered later. The question of legal liability for corporations who elect to distribute Tamiflu to their employees is not addressed by this program. HHS is promoting this program as part of the philosophy of "shared responsibility" of pandemic preparedness. Each individual, family, and community must share the responsibility of mitigating any disaster, including pandemic.

In attendance at the announcement conference were: George Abercrombie, president and CEO, Hoffmann-La Roche Inc.<o></o>, Mike McGuire, vice president of anti-infectives, Hoffmann-La Roche Inc.<o></o>, Tevi D. Troy, deputy secretary, U.S. Department of Health and Human Services (HHS)<o></o>, [FONT=&quot]Bruce Gellin, M.D., director, National Vaccine Program Office; chair, Task Force on Influenza Preparedness, HHS, and Robin Robinson, HHS.<o></o>[/FONT]



by Sharon Sanders
FluTrackers.com

 

[sharon sanders]

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Hat-tip Lili61!

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Reserving Tamiflu for workers in case of pandemic
<hr style="color: rgb(204, 204, 204);" size="1"> <!-- / icon and title --> <!-- message --> Reserving Tamiflu for workers in case of pandemic

By LAURAN NEERGAARD, AP Medical Writer 23 minutes ago

WASHINGTON - Fears of bird flu are slumping and so have sales of the anti-flu drug Tamiflu. Now its maker is offering a deal to U.S. employers: Pay an annual fee and reserve enough to protect every worker if a new super-flu strikes.
ADVERTISEMENT
click here

The plan announced Thursday comes as the federal government also begins a new effort to encourage many businesses to stockpile anti-flu drugs in case of a pandemic. Those private stockpiles would supplement a national stockpile that contains enough doses to treat only part of the population.

But stockpiling is a big upfront investment for a threat that may never arrive ? and requires rotating in new supplies whenever drug doses expire. Roche Holding AG says its plan would remove some of those barriers for companies otherwise interested in Tamiflu.

http://news.yahoo.com/s/ap/20080626/...piling_tamiflu
</td></tr></tbody></table>

 

[mixin]

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

From an update from Reuters:

http://www.reuters.com/article/mark...6?rpc=401&&pageNumber=3&virtualBrandChannel=0

The company currently can make 400 million courses of therapy a year.

"To date, Roche U.S. has received inquiries from more than 800 U.S.-based companies, large and small in a variety of industries, with Tamiflu orders from more than 300 companies, in quantities ranging from a few hundred to hundreds of thousands of treatment courses," Roche said in a statement.

 

[sharon sanders]

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

I would like to make clear that FluTrackers does not endorse Tamiflu or any other pharmaceutical for any of the diseases that we cover here.

We report the news and developments then viewers can decide for themselves.

 

[Sally Furniss]

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Roche Offers Option to Pre-Order Tamiflu for Outbreak (Update1)

By Tom Randall
June 26 (Bloomberg) -- Roche Holding AG will sell companies the option to buy doses of Tamiflu as part of a plan to boost demand for the flu-fighting medicine and increase preparedness for a global outbreak.
Roche will store Tamiflu pills for companies that pay a fee of $6 a treatment, the Basel, Switzerland, company said in a statement today. In a flu outbreak, companies will have the option to buy the stockpile at the wholesale price and have it delivered within two days. Participating companies must pay to secure enough Tamiflu to treat at least 2,500 people.


Tamiflu sales fell last quarter because some countries have bought enough supplies for a potential outbreak and because emerging resistance to the medicine, also known as oseltamivir, has led doctors to consider GlaxoSmithKline Plc's Relenza and other treatments. The disease kills about 250,000 to 500,000 people a year, the World Health Organization says. A pandemic would increase that number.


``This option will present something of a tipping point for some companies,'' Mike McGuire, vice president of anti-infective medicine for Roche, said in an e-mailed statement. ``This program addresses questions we've heard from executives, who are interested in securing Tamiflu for their employees, but desire more flexible planning options.''
Bird Flu


Tamiflu and Relenza are being stored by the Geneva-based World Health Organization and governments around the world for use in the event of an avian influenza pandemic in humans. The medicines offer a defense against the H5N1 strain of bird flu, which has spread to more than 60 countries and has killed 243 people in 12 countries as of June 19.


``We're facing an unprecedented threat,'' said Tevi Troy, deputy secretary of the U.S. Health and Human Services Department, in a conference call. ``If a pandemic would break out, we would need help from all aspects of society, not just the federal government but states doing their role and private corporations doing their role. This plan will help with that.''


Revenue from Tamiflu, one of only two medicines that may help prevent an avian flu pandemic, fell 64 percent to 278 million Swiss francs ($270 million) last quarter, Roche reported in April.
To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net.
Last Updated: June 26, 2008 15:42 EDT

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ag1Uzk3NkyVo

 

[gsgs]

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

Re: Hoffman-Roche and HHS Announce Tamiflu Program for Corporations

hmm, isn't flutrackers.com a company ?
Aren't we somehow "employees" ? Maybe a flu-forum does qualify
for the program.
What about organizations, founded for the purpose to
participate in the program, collecting the money from their members ?

 

[Sally Furniss]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

Roche unveils plan to boost employer antiviral stockpiling

Lisa Schnirring

Staff Writer

Jun 26, 2008 (CIDRAP News) – With an endorsement from US health officials, Roche, maker of the antiviral drug oseltamivir (Tamiflu), today unveiled a program to encourage more businesses to stockpile the drug to protect employees in case of an influenza pandemic.

Roche officials, speaking at a press conference, said the program is designed to remove some of the obstacles that have made many businesses hesitate to stockpile the drug, which is recommended as first-line treatment in a pandemic. For an annual fee, companies can secure a supply of Tamiflu, which will be stored, secured, rotated, and kept current by Roche. If and when the company requests its supply, Roche will guarantee delivery within 48 hours in most instances.

George Abercrombie, chief executive officer and president of Hoffman-La Roche, Inc., told reporters that more than 300 US businesses have already stockpiled Tamiflu, but hundreds more have made inquiries and are seeking more flexible options. "This is a solution to address uncertainties in corporate planning and maximize the return on their planning investment," he said.
The cost of storage and the risk that the drug will expire before it's needed are factors that put the cost of stockpiling programs beyond the reach of many companies, Abercrombie said.
On Jun 3, the US Department of Health and Human Services (HHS) released draft guidance on employer antiviral stockpiling. It urges businesses to consider stockpiling antivirals to protect their workers and maintain business operations, especially for those that provide critical goods and services.

At today's press conference, HHS officials were on hand to praise Roche's new program. Deputy Secretary Tevi Troy said the program is an example of a good partnership with the federal government.

"Preparation is a shared responsibility, and businesses and private industry can contribute greatly to community resiliency," he said.
Roche and HHS officials emphasized that the federal government is not subsidizing or contributing in any way to the new business stockpiling program, except to voice support.
Last year, Roche said it had to scale back production of Tamiflu because demand was waning, according to a previous report. Today the company said the business stockpiling initiative is expected to increase demand for the drug and better prepare the world for an influenza pandemic.

Abercrombie said the company has the capacity to produce 400 million courses per year, but governments have purchased only 215 million "We can't have plants and supply lines sitting idle indefinitely," he said.

How the program works

The annual fee for the program is $6 per 10-tablet treatment course, or roughly one-sixth the purchase cost. The minimum order is 2,500 courses. Abercrombie said the company had to set a threshold that can cover the cost and effort required to handle the dedicated Tamiflu supplies. However, he said Roche will monitor the feedback it receives on the minimum-order policy.
Roche reserves and stores each company's requested stockpile amount, officials said. It also rotates stock to ensure that each firm's supply is within its 5-year expiration date. If a business opts to receive its supply, Roche said it guarantees delivery, in most cases, within 48 hour of a request.

The company sets aside each businesses' entire amount, Roche spokesman Terrence Hurley confirmed in an e-mail to CIDRAP News today. "That's the value of the program. Companies have their stockpile of Tamiflu available and ready to ship when they want it," he wrote. Once companies request their order, they pay the wholesale cost for it.
Companies can renew their order each year or discontinue their participation.

Roche officials said companies must decide whether to base their stockpile amount on treatment, prophylaxis, or a combination of the two. The general recommendation for treatment is one dose twice a day for 4 or 5 days. For prophylaxis, the recommendation is one dose each day an individual is exposed to the virus.
In its draft recommendations, HHS says businesses may want to buy antivirals:

• To provide prophylaxis for frontline healthcare and emergency workers
• To protect workers who are needed to maintain essential community services
• To provide early treatment for workers who fall ill
• To protect overseas employees and operations in areas where federal pandemic response activities will not reach

Reactions from the business sector
Karen Dye, director of global business continuity for Sun Microsystems, told CIDRAP News that one potential drawback of Roche's program is that it is only available to US employers. For example, she said Sun Microsystems, based in Santa Clara, Calif., operates in more than 100 countries, with 60% of its workforce living outside the United States.
However, she said the program would probably encourage US-based businesses to stockpile antivirals and added that her company would probably be interested in learning more about the program if it had more global coverage.

Abercrombie said Roche is rolling out the program first in the United States and will later make it available to businesses in other countries. "Our intent is to replicate it throughout the world," he told reporters.

Ann Beauchesne, executive director of the US Chamber of Commerce's homeland security policy division, said the program will likely motivate more companies to stockpile antivirals. "I think this actually might get those companies that were on the fence or considering stockpiling to do it," she told CIDRAP News. "I think the Roche announcement does take some of our concerns off the table, especially the shelf-life issue and potential seizure [of antivirals during a pandemic emergency] by the states."


http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/jun2608tamiflu.html

 

[mixin]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

I think this might make doctors more willing to write prescriptions before they are actually needed.

 

[gsgs]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

the companies will "bribe" the doctors .

Now, will there be lists, which companies provide
Tamiflu-service for their employees and which not ?
They may use this in advertisements to attract new employees.
Although it will usually be only a minor issue for the decision,
compare the $6 yearly with the salary.

But it's politically problematic to prefer employees this way
and refuse the same right for non-employees.

From the doctor's point of view : how does employment suddenly
change the medical status, so the person qualifies for a
Tamiflu-prescription ?

 

[Giuseppe]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

I think the entire situation is paradoxical.

Firstly, Roche Tamiflu is far from be a evidence-based ''drug of choice'' for treatment of influenza (in special for treatment of H5N1-related infections).

Secondly, Roche suffered by a significant slump in its drug demand and revenue.

Thirdly, it is astounding that a government (or many govts around the world) directly finance a single corporation instead to produce themselves the drugs as it would be advisable for emergency events.

Finally, other drugs may be useful to both treatment and prophylaxis of influenza (seasonal or pandemic) but continue to remain in a limbo, dangerously I think for the public health perspective.

The move of govt(s), businesses, international organization(s) aims to support a single company is a dangerous move.

There is probably an impending conflict of interests, in US and elsewhere.

 

[gsgs]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

even if we suppose that USA prefers Tamiflu for some political reason,
I can't believe there is an international conspiracy between governments
to do the same

 

[Commonground]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

I think the entire situation is paradoxical.

Firstly, Roche Tamiflu is far from be a evidence-based ''drug of choice'' for treatment of influenza (in special for treatment of H5N1-related infections).

Secondly, Roche suffered by a significant slump in its drug demand and revenue.

Thirdly, it is astounding that a government (or many govts around the world) directly finance a single corporation instead to produce themselves the drugs as it would be advisable for emergency events.

Finally, other drugs may be useful to both treatment and prophylaxis of influenza (seasonal or pandemic) but continue to remain in a limbo, dangerously I think for the public health perspective.

The move of govt(s), businesses, international organization(s) aims to support a single company is a dangerous move.

There is probably an impending conflict of interests, in US and elsewhere.

Post #7:

Roche and HHS officials emphasized that the federal government is not subsidizing or contributing in any way to the new business stockpiling program, except to voice support.

 

[Commonground]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

IOH wrote:

Firstly, Roche Tamiflu is far from be a evidence-based ''drug of choice'' for treatment of influenza (in special for treatment of H5N1-related infections).

I found this in the NEJM:
http://content.nejm.org/cgi/content/full/358/3/261
Update on Avian Influenza A (H5N1) Virus Infection in Humans
January 17, 2008
-snip-

Treatment

Antiviral Agents

Susceptibility to current antiviral agents varies among circulating strains of influenza A (H5N1) viruses. Clade 1 viruses and most clade 2 viruses from Indonesia are fully resistant to M2 inhibitors, whereas clade 2 viruses from the lineages in other parts of Eurasia and Africa are usually susceptible (Klimov A: personal communication). As compared with influenza A (H5N1) viruses from 1997 or influenza A (H1N1) viruses in vitro,55 clade 1 viruses generally show enhanced susceptibility to oseltamivir carboxylate, but the high-level replication of some oseltamivir-susceptible strains requires higher doses or more prolonged administration, or both, in animal models.55,56 Clade 1 viruses appear to be 15 to 30 times more sensitive to oseltamivir than clade 2 isolates from Indonesia and Turkey,56,57 although the possible clinical relevance of such differences in oseltamivir susceptibility remains to be determined. During oseltamivir therapy, the emergence of highly resistant variants with an H274Y neuraminidase mutation may be associated with a fatal outcome.58 Infection by influenza A (H5N1) viruses containing an N294S mutation that causes a reduction in oseltamivir susceptibility by a factor of 12 to 15 times was reported to be present in two Egyptian patients with fatal disease before therapy,59 and avian influenza A (H5N1) viruses with reduced susceptibility to neuraminidase inhibitors are occasionally detected.60

Early treatment with oseltamivir is recommended,61,62 and data from uncontrolled clinical trials suggest that it improves survival (Table 4), although the optimal dose and duration of therapy are uncertain. Mortality remains high despite administration of oseltamivir; late initiation of therapy appears to be a major factor. Uncontrolled viral replication, as reflected in the detection of persistent pharyngeal RNA after completion of standard therapy, is associated with a poor prognosis.58 Higher levels of viral replication and slower clearance of infection probably occur in the lower respiratory tract.3 The oral bioavailability of oseltamivir in patients with severe diarrhea or gastrointestinal dysfunction related to influenza A (H5N1) virus infection or those in whom the drug has been administered extemporaneously (e.g., by means of a nasogastric tube) is uncertain.

 

[gsgs]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

clades:
1:Vietnam/04
2.1:Indonesia/03
2.2:Qinghai/05
2.3:Fujian/05
2.4:Yunnan/03
2.5:Korea/03


susceptability of clades to Oseltamivir:

http://www.cdc.gov/eid/content/13/9/1354.htm
http://www.cdc.gov/eid/content/13/9/1354-G.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=17296744

 

[Giuseppe]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

Obviously, every citizen is in right to trust his government.

It isn't a ''conspiracy'-related obsession mine.

It is a interference in the making of public health policies by powerful corporate executive managers.

I would like to note that some corporations executive councils detain more power in terms of interference and policy-making than most of world national governments.

The link exists between national governments and corporate interests in various sectors of the industrial area: chemicals, oil refinery, stockpiling, energy development and differentiation of resources, technological sectors, communications and transportation, health care (products, drugs, equipments, insurances, welfare state policy, tobacco policy...), heavy industrial equipment, and more other.

Thus, the argument of ''conspiracy'' when one think that govt(s) and corporate managers agreements are wrong, seems to me a bit naif.

It is also to note that my opinion doens't involve Hofman-La Roche / US govt(s) members anyway.

 

[gsgs]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

why should all governments in harmony support one particular company
when there is so much dissent on other issue ?

 

[Giuseppe]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

why should all governments in harmony support one particular company
when there is so much dissent on other issue ?

It is a corporation that supports government(s) policy not the contrary.

I repeat: if a government decide to trust in a company is in full right to do.

Also, if the citizens of the nation the govt is expression trust in the wisdom of their politicians, are in full right to do.

No problems, for me.

I think only that it would be better an independent, proof-based, policy-making in community related issues.

Corporations haven't duties, their CEO(s) aim is gaining power, influence, and finally - why not? - more profits.

 

[Oracle]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

This appears to be the response to demand from corporate America to safeguard their workforce (and profits, while reducing the severity of the medical costs aftermath of a pandemic).

As long as it's not wasted as a broad blanket protective for mild (seasonal) influenza, there is still some hope that it will serve it's pharmaceutical purpose.

The problem is largescale application of poultry and human vaccines that carry antiviral escape polymorphisms are used en masse, repeatedly.

Therefore, it might be a wise for governments to report, and WHO and OIE Z(or their contractors) to record and map (molecular/geographical) the sequences, of vaccines used to combat H5N1.

This information should be posted to an international website and updated regularly.

On a related topic: WHO should push for a rapid dengue fever assay, needed to diagnose viral illness (dengue from H5N1) in Asia. This would allow use of nonsteroidal anti-inflammatory agents conjunctive to antivirals. This pharmaceutical strategy has been recently demonstrated in animal models to boost the efficacy of Tamiflu where treatment is initiated late. NSAIDs are contraindicated for dengue fever (hemorrhagic).

 

[tropical]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

The question:
"The move of govt(s), businesses, international organization(s) aims to support a single company is a dangerous move." -
- can be easily bypassed - if with Roche are other companies enabled to produce the same quality antiviral product in the same scheduled time, they can be concurents on the free market of antiviral supply.

More doubtfully is if the assertion:
"If and when the company requests its supply, Roche will guarantee delivery within 48 hours in most instances."
can be achieved in pandemic times, and if the word "most" means that some of the qualified requesters would remain out of the in-time delivery.

 

[gsgs]

Re: Hoffman-La Roche and HHS Announce Tamiflu Program for Corporations

they may maintain and update a webpage with their current expected
delivery-times