I have been involved in epidemiological research for the past 7 years,
serving as a Research Analyst with a Ph.D. in Computer Science under a
grant sponsored by the Centers for Disease Control and Prevention
provided to the Los Angeles Department of Health Services, Acute
Communicable Disease Control Unit. I discovered a deleterious effect
concerning the varivax (chickenpox) vaccine. All positive results of
my research were published; however, the negative results were
suppressed. Key data was omitted from Annual reports. Technical papers
submitted to supervisors were not reviewed and released for
publication. Are these actions considered Research Fraud and what can
be done to obtain a release of my technical papers that document the
deleterious effect?  The research has already been reviewed by Dr.
Philip Krause--head research scientist of the FDA Biologics Laboratory
and another renown statistical expert. They are of the opinion that
the material merits consideration and publication.  Basically, by
eliminating chickenpox (varicella) by universal vaccination of
children (with Varivax by Merck & Co.) all adults will experince
higher incidence of shingles since exposure to children with
chickenpox was a mechanism by which adult immune systems were
previously boosted to suppress the reactivation of herpes zoster.

The first part of your question, "Are these actions considered
research fraud" can be answered with a definitive "Yes", if willful
omission of data or results is occurring such that the research record
is not represented accurately, as seems to be the case. This behavior
breaches not only accepted norms of scientific responsibility and
professional ethics, but it also violates federal policies and
regulations concerning research supported by government (Public Health
Service in this case) funds. The fact that the findings being
suppressed are actually adverse effects of a treatment (or
vaccination) to be used in human populations is particularly serious
and disturbing.

The U.S. Office of Science Technology Policy issued Proposed Federal
Policy on Research Misconduct To Protect the Integrity of the Research
Record" (see: frwebgate4.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=3520669279+3+0+0&WAISaction=retrieve)
and a Notification of Final Policy on the proposed policy (see:
ori.dhhs.gov/html/policies/fed_research_misconduct.asp) that defined
research misconduct as follows. The acts of suppression that you
describe are referred to as "falsification" in this definition.

The policy states:

"Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results.
Fabrication is making up data or results and recording or reporting
them.
Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
Plagiarism is the appropriation of another person's ideas, processes,
results, or words without giving appropriate credit.
Research misconduct does not include honest error or honest
differences of opinion.

A finding of research misconduct requires that: 
* There be a significant departure from accepted practices of the
scientific community for maintaining the integrity of the research
record;
* The misconduct be committed intentionally, or knowingly, or in
reckless disregard of accepted practices; and
* The allegation be proven by a preponderance of evidence"

Further information about this policy may be obtained from the named
contact:
Holly Gwin, Office of Science and Technology Policy, Executive Office
of the President, Washington, DC 20502. Tel: 202-456-6140; Fax:
202-456-6021;
e-mail: hgwin@ostp.eop.gov

These Public Health Service's scientific misconduct regulations are
found in 42 C.F.R. Part 50, which references enacted legislation
(Section 493 of the PHS Act). See
(http://ori.dhhs.gov/html/misconduct/regulation_subpart_a.asp). These
regulations include the responsibility of awardees and applicant
institutions for dealing with and reporting possible misconduct in
science.

The DHHS Office of Research Integrity (ORI) (www.ori.dhhs.gov)
oversees and directs Public Health Service (PHS) research integrity
activities on behalf of the Secretary of Health and Human Services
with the exception of the regulatory research integrity activities of
the Food and Drug Administration. Since your research was supported by
the CDC, it should be in the ORI's purview, and this Office has a
substantial set of guidelines and resources for dealing with
scientific misconduct. Its Model Procedures for Responding to
Allegations of Scientific Misconduct (see:
ori.dhhs.gov/multimedia/acrobat/mod_proc.pdf) includes the
responsibility to report research misconduct.

The ORI lists a set of guidelines for handling of misconduct inquiries
at: ori.dhhs.gov/html/misconduct/inquiry_issues.asp#(6)%20Ownership%20and%20Retention%20of%20Data

You might also contact the ORI directly to obtain information and
advice about how to proceed with your complaint. See
ori.dhhs.gov/html/about/addresses.asp for contact information.

The following office is listed as the contact to contact for persons
concerned about retaliation against the act of exposing scientific
misconduct. It may be able to lead you to specific advice concerning
filing your complaint.
Office of Research Integrity
Division of Policy and Education
5515 Security Lane, Suite 700
Rockville, MD 20852
Telephone: (301) 443-5300
Fax: (301) 594-0042

Note that according to regulations, the research data belong to the
grantee institution, not the principal investigator, and that
institution has obligations about retaining the data for specific
lengths of time and to provide records on request to support a grant
project. The institution itself (Los Angeles Department of Health
Services in this case) may have also developed specific internal
procedures defining the types of research records that must be kept,
their form, and the length of time they must be retained, and should
also have its own policies and procedures for ensuring against
misconduct in research, as stipulated by 42 C.F.R. Part 50.

The ORI's guidelines include "Tips for Sequestration of Physical
Evidence in Scientific Misconduct Cases, which might help the
institution to help you. (See:
ori.dhhs.gov/html/programs/tipsforsequestration.asp)

You were correct to employ the Freedom of Information Act, which
includes public access to research data, although open access is
controversial even in the scientific community out of concerns for
protecting research interests and privacy. Nevertheless, the response
that you received is puzzling. I would pursue the reasons for denial
of access and advice about how to appeal can be found at:
www.tncrimlaw.com/foia_indx.html


ADDITONAL REFERENCES AND RESOURCES

FEDERAL REGULATIONS (links can be found at: 
ori.dhhs.gov/html/policies/regulations.asp)
They are:
Scientific Misconduct Regulations - 42 CFR Part 50, Subpart A
Objectivity in Research - 42 CFR Part 50, Subpart F
Freedom of Information Regulation - 45 CFR Part 5
HHS Debarment Regulations - 45 CFR Part 76
Notice of Proposed Rulemaking Regarding the  Protection of Research
Misconduct Whistleblowers - 65 Fed. Reg. 70830

WHISTLEBLOWER RESOURCES

You did not ask about the aspect of potential retaliation, but it
receives enough attention that it seems worth providing some
information about.

The importance of enforcing policies against research misconduct is
serious enough to merit specific legislation (Federal Whistleblower
Protection Act) and regulations that have been designed to protect the
position and reputation of informants (known as whistleblower
protection, see ori.dhhs.gov/html/misconduct/whistleblowers.asp) from
retaliation. A number of collections of resources for informants are
also readily available, and communities have formed to support their
roles.

ORI's "Guidelines for Institutions and Whistleblowers Responding to
Possible Retaliation Against Whistleblowers in Extramural Research" is
found at: ori.dhhs.gov/html/programs/guidelin.asp

The procedure and address for filing complaints about retaliation
actions are listed as follows:

"A whistleblower who wishes to receive the procedural protections
described by these Guidelines shall file his or her retaliation
complaint with the responsible official at the appropriate institution
within 180 days (2) from the date the whistleblower became aware or
should have become aware of the alleged adverse action. Covered
institutions shall review and resolve all whistleblower retaliation
complaints and should do so within 180 days after receipt of the
complaint. If the whistleblower fails to receive an institutional
response to the complaint in accordance with these Guidelines within
ten (10) working days
(3), the whistleblower may file the retaliation complaint directly
with ORI at the following address:
Office of Research Integrity
Division of Policy and Education
5515 Security Lane, Suite 700
Rockville, MD 20852
Telephone: (301) 443-5300
Fax: (301) 594-0042

Government Accountability Project's site with significant resources
and contacts
www.whistleblower.org 

It lists "Twelve Survival Strategies:
1. Before taking any irreversible steps, talk to your family of close
friends about your decision to blow the whistle.
2. Be alert and discreetly attempt to learn of any other witnesses who
are upset about the wrongdoing.
3. Before formally breaking ranks consider whether there is any
reasonable way to work within the system by going to the first level
of authority. If you do decide to break ranks, think carefully about
whether you want to "go public" with your concerns or remain an
anonymous source. Each strategy has implications: the decision depends
on the quantity and quality of your evidence, your ability to
camouflage your knowledge of key facts, the risks you are willing to
assume and your willingness to endure intense public scrutiny.
4. Develop a plan-such as stategically-timed release of information to
government agencies-so that your employer is reacting to you, instead
of vice-versa.
5. Maintain good relations with administration and support staff. 
6. Before and after you blow the whistle, keep a careful record of
events as they unfold. Try to construct a straightforward, factual log
of the relevant activities and events on the job, keeping in mind that
your employer will have access to your diary if there is a lawsuit.
7. Identify and copy all necessary supporting records before drawing
any suspicion to your concerns.
8. Break the cycle of isolation research and identify and seek a
support network of potential allies, such as elected officials,
journalists and activists. The solidarity of key constituencies can be
more powerful than the bureaucracy you are challenging.
9. Invest the funds to obtain a legal opinion from a competent lawyer.
10. Always be on guard not to embellish your charges. 
11. Engage in whistleblowing initiatives on your own time and with
your own resources, not your employer's.
12. Don't wear your cynicism on your sleeve when working with the
authorities.
Bruce Martin, of Australia provides very much information suppression
of research data and whistleblowing on his web site (see below). He
also notes about the Government Accountability Project:

Government Accountability Project (GAP) provides advocacy and legal
assistance to whistleblowers. With a 16-person staff, it can provide
advice and referrals. However, direct legal representation by GAP
attorneys is only possible in a fraction of cases. GAP has developed
special expertise in dealing with whistleblower rights, nuclear
weapons facility clean-ups, food safety, laws on environmental
protection, and national security abuses.
Address: 1612 K St., NW, Suite 400, Washington DC, 20006
Phone: (202) 408 0034
Fax: (202) 408 9855
Email: gap1@erols.com

West coast office:
1402 Third Avenue, Suite 1215, Seattle, WA 98118
Phone/fax: (206) 292 2850
Email: gap@whistleblower.org

University of California, San Diego resources:
http://cmrg.ucsd.edu/courses/ethics/whistle.html
Federal Policy on Research Misconduct:
www.ostp.gov/html/001207_3.html

INTEGRITY IN SCIENTIFIC RESEARCH

On Being a Scientist Responsible Conduct In Research 
www.nap.edu/readingroom/books/obas/

Bibliography at: www.aaas.org/spp/video/articles.htm

The Online Ethics Center for Engineering and Science at Case Western
University honlineethics.org/keywords/miscon.html

http://depts.washington.edu/hssexec/newsletter/1997/nelkin.html 
Science, Technology and Public Policy - by Dorothy Nelkin in History
of Science Society Newsletter, Volume 16, No. 2 (April 1987)

An American Association for the Advancement of Science paper, Secrecy
in Science www.aaas.org/spp/yearbook/2000/Part7.pdf
Resources: Guidelines for Scientific Integrity, from University of
California, San Diego
ethics.ucsd.edu/courses/survival/resources/guidelines.htm

LEGAL ASPECTS

Issue of journal "LAW AND CONTEMPORARY PROBLEMS" focusing on the
subject, Court-Ordered Disclosure of Academic Research: A Clash of
Values of Science and Law
www.law.duke.edu/journals/lcp/lcptoc59dsummer1996.htm


ACCESS TO RESEARCH DATA

Current federal activity in the Office of Management and Budget
regarding public access to research data
(http://www.whitehouse.gov/omb/fedreg/2ndnotice-a110.html)
OMB Circular A-110, "Uniform Administrative Requirements for Grants
and Agreements with Institutions of Higher Education, Hospitals, and
Other Non-Profit Organizations"

Book "Access to Research Data in the 21st Century" 
books.nap.edu/books/030908329X/html/index.html


BRIAN MARTIN'S RESOURCES AND ADVICE

Specific pages on Brian Martin's site that may be worth browsing are:

www.uow.edu.au/arts/sts/bmartin/pubs/99air/ (An Australian paper about
suppression of research data)

www.uow.edu.au/arts/sts/bmartin/pubs/98jse.html Strategies for
dissenting scientists

Brian Martin's site recommends:
"US whistleblowers should obtain the book The Whistleblower's Survival
Guide: Courage Without Martyrdom by Tom Devine, available from the
Government Accountability Project (see first entry below) for $13.95
plus $2.00 postage and packing. This is an extremely valuable analysis
of whistleblowing, and includes details on US official channels."

"Official channels Hotlines to receive reports of fraud, waste or
mismanagement are available in nearly every federal government
department and agency. However, GAP says "hotlines are in most cases
worthless at best": few reports are investigated and in many cases the
whistleblower's confidentiality is violated. In the private sector,
the equivalent of government hotlines are corporate voluntary
disclosure programmes. They appear to work no better than hotlines. In
the armed forces, service suggestion programmes provide rewards for
employees who make suggestions that save money. However, the rewards
are small and making suggestions can lead to reprisals. Most
government agencies have an internal office responsible for
investigating misconduct, usually called an inspector general (IG).
Whistleblowers should be wary of IGs: often they cover up problems,
doing damage control for management; sometimes they are corrupt
themselves; and they may act to discredit and attack whistleblowers.
The Office of the Special Counsel (OSC) is a formal channel for
government whistleblowers to make disclosures. The OSC can refer
charges to the agency in question to answer, but does this only
rarely. GAP concludes that "an OSC whistleblowing disclosure is likely
to be unproductive or even counterproductive--unless it is part of a
larger strategy involving other institutions." One of the most
promising avenues for redress is to sue under the False Claims Act.
However, this can be highly expensive, open the whistleblower up to
blacklisting and prevent speaking out for the duration of the case,
often years."

In closing, let me recommend that you maintain your confidence in this
cause, knowing that both professional scientific ethics and federal
law support your position, and keep your focus on the fact that the
information you want to have released is highly important for the
protection of  public health. Furthermore, what you are doing is in
the interest of pharmaceutical companies as well, who also have a
stake in avoiding the distribution of products that will only have to
be recalled because of adverse effects. Ultimately, very few people,
if any, can be expected to have a real interest in suppressing the
information, whereas the scientific research community as a whole
backs you in principle. Note the people who are sympathetic to your
cause at the Los Angeles Department of Human Services, the federal
agencies, and the scientific community, and follow the procedures that
people can say from experience are effective. I wish you success.

I hope that you find this information useful and that it is what you
were seeking. I trust you will let me know if anything else could be
helpful.

Previously, I had come accross some of the information provided in the
answer, but the answer nicely summarized the main highlights, provided
numerous links, and above all, presented realistic assessment of the
options.

Are you in the position to write a letter to the editor in the journal
in which the original article was published. You could support it with
the additional data that you have. Or, are you being discouraged from
doing so? Do you have copies of your papers?

I have resigned from my employment as Research Analyst. I did write a
note to the editor, but that note was not authorized to be sent. It
contained "proprietary data and information" that would have needed
clearance. I was promised that instead, the paper would be reviewed
and submitted for publication--after waiting in excess of 10 months
with no review I resigned.
Results I obtained that were included in two other papers were also
suppressed.
One of these papers was published word-for-word as a wrote it with the
information concerning HZ (herpes zoster) removed. Another paper on
Capture-Recapture methods used to assess incidence of Varicella
disease was also not published. I have copies of these papers. The
paper concerning high incidence of HZ among children <10 years old
with prior wild-type varicella should now be updated with the third
year of data collection. I have attempted to use the Freedom of
Information Act to obtain "CDC unpublished data" concerning several
studies on HZ.  Instead of using the data from active surveillance of
a desert community of 230,000 individuals, the CDC stated they had
insufficient information from the surveillance site and instead used a
telephone survey concerning 13,000 individuals, which when
age-stratified, yielded no significant change in HZ incidence rates.
Since their sample size was so small, actually no valid conclusions
could be drawn for such a study with no power.

I wonder how many other reports with similar adverse findings have
been supressed world-wide?

I understand chicken pox and shingles are caused by the same virus
i.e. shingles is just the reactivation in adults of the childhood
disease.
If we wipe out chickenpox, we will wipe out shingles.

I think it is pretty selfish to consider not immunizing children just
so that a few adults can have a reduced chance of their shingles
flaring up again.

Smartalec-ga suggests that it is selfish in withholding a vaccine that
eliminates chickenpox and that shingles is simply the reactivation of
shingles.
The issue is this:  In the analysis of the varivax vaccine, it was
assumed (despite evidence contrary)  that there was no interaction
between the closely related epidemiology of varicella and herpes
zoster. In this scenario $80 million in medical costs would be saved
annually by eliminating chickenpox through universal vaccination. 
When we consider that eliminating chickenpox, eliminates the boosting
to suppress reactivation of shingles, a conservative model shows that
instead of a $80 million dollar savings, there is an average  $90
million expense (after taking into account the $80 million dollar
savings considering that varivax is 100% effective) annually over the
next 30 years.

Furthermore, the assumption was that the immunity of varivax was
conferred for life.  However, vaccinated children were boosted by
exposure to children with wild-type varicella, that is why in Japan,
the titre levels of vaccinated children were more elevated after 20
years than when they initially recieved the vaccine.  Only 1 in 5
children in Japan received the vaccine.  Thus, a second booster dose
will likely soon be required. Furthermore, "mass epidemic of herpes
zoster"--which is more expensive to treat in the elderly and results
in more hospitalizations and deaths than varicella were predicted by
two renown researchers in England (Brisson et al, etc.).  Also, in the
U.S. Dr. Charles Grose indicates that the OKA virus (used in Varivax)
is only one variety of VZV (Varicella Zoster Virus) and that another
different strain exists--suggesting the possibility of multiple cases
of varicella as well as the possibility of many breakthrough cases.

The point is this: while in 30 years, there may be a net advantage to
the vaccine, or other interventions, such as varivax vaccination of
all adults (currently under study with Dr. Oxman with the Veterans
Administration project),
the cost to eliminate varicella is far more than anyone previously
imagined. The question is why save 100 lives per year by eliminating
varicella when for the same cost, medical science could provide better
nutrition that would save the lives of 10,000 children.

Interestingly, Merck, which manufactures varivax, also produces
Acyclovir or Zovarax--the antiviral used to treat shingles. Thus, they
have a win-win situation.