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Monday, August 3, 2009

Swine Flu Vaccine Trial And Error

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Dear Reader,

Trial data has yet to prove the safety and effectiveness of H1N1 (swine flu) vaccines. In fact, only one of the five companies seeking approval has even STARTED human trials.

But—surprise, surprise—that's probably not going to stop the FDA from approving them.

Data will start coming in next month, and will continue through the early part of next year. But the World Health Organization wants to start vaccinating people in October, so they don't have time for pesky details like whether or not the vaccines are safe.

In fact, the whole thing will take on a scary trial-and- error approach. FDA officials say they'll update the immunization program as the trials shed more light— including whether or not two doses are better than one, or if a vaccine turns out to be ineffective.

In that case, emergency authorization for an oil-in-water adjuvant may be needed. The adjuvant sparks a stronger immune reaction, but causes more side effects.

What's perhaps most alarming is that, according to FDA officials, approving a vaccine without safety data is actually not uncommon (though this situation is new and exciting in that they don't usually approve them when major clinical trials of safety are ongoing)!

Seasonal flu vaccines are actually approved using the FDA's "strain change" process, in which manufacturers actually don't even have to provide information on whether the vaccines are safe—or if they even work!

That's right—put it out there, see if it works and how many people are hurt in the process, and clean up the aftermath later.

Look. Swine flu could end up being a very real problem in the coming months. But we can't let our panic get the best of us—shooting people up with unproven (and possibly unsafe) drugs could have disastrous consequences.

You know, I don't know what it's like to be a guinea pig. And I have absolutely no interest in finding out.

Yours in good health,

Christine O'Brien

Thursday, July 30, 2009

Walmart Swine Flu Vaccine

WalMart and swine flu vaccine: a perfect match?
Tom Barlow
Jul 30th 2009 at 7:56PMText
More

At least once a month, the typical American shopper trudges to the local WalMart (NYSE:WMT) to stock up on groceries, dry goods, entertainment, and ... vaccines? The company is in talks with the U.S. Centers for Disease Control and Prevention about what role it can play in the CDC's ambitious immunization process for the H1N1 (swine) influenza outbreak.

According to Dr. John Agwunobi, WalMart's president of health and wellness, as reported by MSNBC, the chain is offering to help with the CDC's plan to immunize the portion of the nation's population most vulnerable to the disease. 302 people in the U.S. have died of Swine Flu so far. The CDC recently estimated that hundreds of thousands of Americans could die of the disease in the next two years if the vaccine and other countermeasures fail.

WallMart's help could take the form of inoculation sites within some of its 4,000 U.S. stores, or by using its legendary logistics system to distribute the 160 million doses of the vaccine that will be available before flu season begins.

The offer certainly makes business sense for WalMart, which would experience a boost in foot traffic beyond its usual 140 million customers per month. Using its economy of scale and up-sell opportunities, the chain could set a price that would drive out any for-profit distributors. The company is already planning to offer the standard annual flu vaccines at its stores, administered by a third party.

The losers here stand to be the doctor's offices, clinics, and other health care outlets that use flu vaccinations to build good will and maintain contact with their customers. The winners? The American public, who would gain greater access to the vaccine.

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TO: Members of the Faculty, Hoover Institution Fellows,
Academic Staff, and Library Directors

FROM: Condoleezza Rice, Provost

RE: Copyright Reminder

October 30, 1998

This memorandum provides a general description of the applicability of the copyright law and the so-called "fair use" exemptions to the copyright law's general prohibition on copying. It also describes "safe harbor" guidelines applicable to classroom copying.

The federal copyright statute governs the reproduction of works of authorship. In general, works governed by copyright law include such traditional works of authorship as books, photographs, music, drama, video and sculpture, and also software, multimedia, and databases. Copyrighted works are protected regardless of the medium in which they are created or reproduced; thus, copyright extends to digital works and works transformed into a digital format. Copyrighted works are not limited to those that bear a copyright notice. As a result of changes in copyright law, works published since March 1, 1989 need not bear a copyright notice to be protected under the statute.

Two provisions of the copyright statute are of particular importance to teachers and researchers:

* a provision that codifies the doctrine of "fair use," under which limited copying of copyrighted works without the permission of the owner is allowed for certain teaching and research purposes; and

* a provision that establishes special limitations and exemptions for the reproduction of copyrighted works by libraries and archives.

The concept of fair use is necessarily somewhat vague when discussed in the abstract. Its application depends critically on the particular facts of the individual situation. Neither the case law nor the statutory law provides bright lines concerning which uses are fair and which are not. However, you may find it helpful to refer to certain third party source materials. Guidelines for classroom copying by not-for-profit educational institutions have been prepared by a group consisting of the Authors League of America, the Association of American Publishers, and an ad hoc committee of educational institutions and organizations. In addition, fair use guidelines for educational multimedia have been prepared by a group coordinated by the consortium of College and University Multimedia Centers (CCUMC). These guidelines describe safe harbor conditions, but do not purport to define the full extent of "fair use."

The guidelines, as well as other source material, are available through a variety of resources, including through the world wide web site http://fairuse.stanford.edu. Stanford University Libraries & Academic Information Resources, in collaboration with the Council on Library Resources and FindLaw Internet Legal Resources, are sponsors of this web site. The site assembles a wide range of materials related to the use of copyrighted material by individuals, libraries, and educational institutions.

I hope that the discussion below helps to clarify further the nature of "fair use."

I. Fair Use for Teaching and Research

The "fair use" doctrine allows limited reproduction of copyrighted works for educational and research purposes. The relevant portion of the copyright statue provides that the "fair use" of a copyrighted work, including reproduction "for purposes such as criticism, news reporting, teaching (including multiple copies for classroom use), scholarship, or research" is not an infringement of copyright. The law lists the following factors as the ones to be evaluated in determining whether a particular use of a copyrighted work is a permitted "fair use," rather than an infringement of the copyright:

* the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;

* the nature of the copyrighted work;

* the amount and substantiality of the portion used in relation to the copyrighted work as a whole, and

* the effect of the use upon the potential market for or value of the copyrighted work.

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A federal appeals court recently decided an important copyright fair use case involving coursepacks. In Princeton University Press, et.al. v. Michigan Document Services, the U.S. Court of Appeals for the Sixth Circuit concluded that the copying of excerpts from books and other publications by a commercial copy service without the payment of fees to the copyright holders to create coursepacks for university students was not fair use. The size of the offending excerpts varied from 30 percent to as little as 5 percent of the original publications. Although the opinion in this case is not binding in California, it is consistent with prior cases from other courts, and there is a reasonable likelihood that the California federal courts would reach a similar conclusion on similar facts.

Where questions arise, we suggest that you consult the guidelines for classroom copying and other available source material available on the fair use web site, cited above. Please note that the guidelines are intended to state the minimum, not the maximum, extent of the fair use doctrine. Thus, just because your use is not within the guidelines, it is it not necessarily outside the scope of fair use. In the absence of a definitive conclusion, however, if the proposed use deviates from the guidelines, you should consider obtaining permission to use the work from the copyright owner. In instances where the fair use question is important and permission would be difficult or expensive to obtain, a member of the Fair Use Advisory Group (described below) or the Legal Office can assist in analyzing whether a particular proposed use would constitute "fair use."

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* Number of copies to be made

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II. Course Reserves

Some libraries at Stanford will refuse to accept multiple photocopies or to make photocopies of copyrighted materials needed for course reserves without first having permission from the copyright holder. Other libraries on campus will accept a limited number of photocopies for course reserves. Consult individual libraries for clarification of their policies.

While the libraries have blanket permission from dozens of journals, obtaining permission sometimes takes a good deal of time. Experience in obtaining permission has shown that an inquiry addressed to a journal publisher frequently produces information that the copyright is actually held by the author, and four weeks is often inadequate to obtain such permission. Four to six weeks is considered the norm.

Permission may be obtained in a number of ways:

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* Written permission may be obtained by the academic department.

* Oral permission may be obtained by faculty members, departmental secretaries, or library staff, in which case a written record is needed of that action.

Note that filling course reserve requirements may require two to three months before the quarter begins if the library does not already have a copy of the publication, if the publication is out of print, or if the copyright holder is not readily available.

III. Resources

Additional information on copyright issues may be found on the world wide web site http://fairuse.stanford.edu.

Questions about the copyright law as it affects faculty and staff in their University capacities should be directed to a member of the Fair Use Advisory Group (see attachment) or to Linda Woodward in the Legal Office (3-9751), who can put you in touch with the appropriate lawyer to respond to your specific question. Questions about library policy and course reserves should be addressed to Assunta Pisani, Associate Director, University Libraries (apisani@sulmail or 3-5553). Information concerning the application of copyright law to computer software can be found in the memorandum "Copying of Computer Software" distributed by the Library and Information Resources and in Administrative Guide Memorandum 62.

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3 More Die From Swine Flu

3 more Massachusetts residents die from swine flu

By Stephen Smith, Globe Staff

Three more Massachusetts adults, all who had serious underlying health problems, have died from swine flu, state public health authorities said this afternoon.
Since the virus was first detected in the state in April, 10 people have contracted fatal infections. Nationally, 302 people had died from the virus as of last week, not including the most recent Massachusetts deaths.
The latest Massachusetts victims include a 53-year-old Essex County resident who died Saturday; a 20-year-old Norfolk County resident who died Friday; and a 21-year-old Hampden County resident whose date of death was not immediately available.
The identities and genders of the victims were not disclosed because of patient confidentiality rules.
The virus has proven especially dangerous to people already coping with respiratory ailments such as asthma, heart disease, diabetes, and conditions that impair the body's ability to fight invading germs. And as the deaths of the 20- and 21-year-olds demonstrate, the germ known by the scientific name H1N1 has also proven to be a particular threat to young adults, as well as children.
A federal advisory panel yesterday recommended that children and young adults be among the groups that are at the top of the list to receive a vaccine against swine flu, which could be available as early as October.

U.S. Unprepared For Swine Flu

U.S. unprepared for second wave of swine flu, report finds
By CARRIE WELLS

McClatchy Newspapers
The federal government isn't prepared for a potential outbreak of swine flu this fall, a Government Accountability Office report released to Congress concluded Wednesday.
Furthermore, said the GAO, Congress' nonpartisan investigative arm, federal agencies haven't addressed nearly half of the 24 recommendations it made last month.
William Coor, the deputy secretary of health and human services, disputed the findings.
"Given the speed at which the virus has spread we felt our work and coordination has been outstanding," he said. However, Jane Holl Lute, the deputy secretary of homeland security, acknowledged that, "We still have work to do."
The GAO agreed, saying that if a severe outbreak struck:
-Federal, state and local governments would have trouble coordinating with one another.
-The number of beds and medical supplies would be insufficient.
-Plans to protect federal workers aren't adequate.
Health officials worldwide acknowledge that the virus has reached pandemic proportions and could strike more severely in the fall. In the U.S., more than 43,000 people have contracted the virus, and so far, 302 have died.
Rep. Bill Pascrell, D-N.J., called the report "startling" after it was presented to the House Homeland Security Committee Wednesday.
The committee voted unanimously to urge the federal departments to respond to the GAO's recommendations within three months.
"Based on our survey, progress seems to be limited," said Bernice Steinhardt, the GAO's director of strategic issues. The rosy outlook of the agencies could be because they still haven't tested what they'd do in a severe outbreak, she added.
Lute listed the steps that her agency has taken to prepare, including reaching out to Native American tribal governments and drafting a response plan.
Coor also defended his department's actions.
Coor added that HHS and the Federal Emergency Management Agency in the next few weeks will give directions to state and local governments on how to deal with a big outbreak.
Swine flu, or H1N1, emerged in April in the U.S., and by June, the World Health Organization said it had grown to pandemic proportions. The WHO said it has killed at least 816 people worldwide. The Southern Hemisphere is now in its regular flu season, and swine flu there has been particularly deadly.
Coor said a vaccine won't be ready for several more months, after trials are finished. He also said federal and state governments have stockpiled 75 million to 100 million antiviral treatments, a number he called "sufficient."
National Treasury Employees Union President Colleen Kelley told the committee the federal government communicated poorly with federal workers earlier this year.
For example, federal employees were forbidden from wearing face masks to avoid getting the virus unless they were within six feet of a person who seemed likely to have swine flu.
The committee's chairman, Rep. Bennie Thompson, D-Miss., wasn't happy with the report.
"Given this country's recent experience with disasters, it is hard to believe that there are those who underestimate the importance of plans and drills," he said. "Our children are taught in school what to do in a fire drill. They are not taught to wait until a fire starts, yell instructions and hope everyone makes it to the exit."
Posted on Wed, Jul. 29, 2009 05:04 PM

H1N1 Swine Flu Vaccine

AstraZeneca Sets Sights On Swine Flu VaccineJavier Espinoza, 07.30.09, 03:00 PM EDT
Anglo-Swedish drugmaker rushes to produce 200 million doses for next year.
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LONDON -- Astrazeneca is in a hurry. The Anglo-Swedish drugmaker said it is rushing to produce as many as 200 million doses of swine flu vaccine next year, as it posted a 5.6% raise in second-quarter profit and increased its guidance for the year.
Chief Executive David Brennan told Forbes he estimates his company can deliver 40 million doses in sprayers by March 2010 -- but he hopes to "step up" the number of doses to 200 million.
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"This is not business as usual. We have a public health crisis and we don't know how bad it is going to get. But there are only five companies that can produce the swine flu vaccines and we are doing everything we can to make them available as soon as possible," Brennan said.
Astrazeneca will have to solve a shortage on sprayers to be able to deliver the vaccine. Unlike traditional flu injections, the vaccine is sprayed into the nose, the common entry route for the virus.
"We have been very successful at getting 40 million sprayers over the course of several months but we need to find an alternative way of delivering the vaccine," Brennan said, adding that relaying the vaccine in drops could be an option.
So far AstraZeneca only has a license to develop flu vaccines in the U.S., but it has applied for one in Europe, Canada, Hong Kong, among others.
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The drug company said U.S. government orders for the vaccine would total $151 million of sales in the second half of 2009. Trials of the vaccine begin mid-August and it could be available by September, AstraZeneca said.
Astrazeneca is one of the smaller producers of the H1N1 vaccines. GlaxoSmithKline, Sanofi-Aventis and Novartis have higher capacity; Novartis has already received 690 million orders.
Yet analysts are hopeful about Astrazeneca's abilities. "Astrazeneca has shown that it can participate in the market of swine flu vaccines. Nobody would have thought that it would be capable of doing so at such as scale but it would depend on whether it can reach the 200 million orders," said Ami Roy, an analyst with Nomura International in London. Roy said the drugmaker has already included the swine flu vaccine sales in its guidance for the year.

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