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Wednesday, October 27, 2010


A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: 26 Oct 2010
Source: Deccan Chronicle [edited]

Even as the country celebrated a startling fall in wild polio cases
in 2010 on [24 Oct 2010] -- polio eradication day -- a new, rare
strain of the virus, one of the 3 cases of which was reported in
Tamil Nadu this year [2010], has the medical community worried.

A 9-year-old girl from Tirupattur, in Vellore district, who had taken
the oral polio vaccine (OPV) as an infant, developed paralysis.
Doctors diagnosed her with vaccine-derived polio virus (VDPV),
type-2, which mutates from the weakened live virus found in the OPV.
As many as 21 cases of VDPV were detected last year [2009].

"This child from Tamil Nadu had a weak immune system, and hence
developed VDPV. If OPV is given to a child who is immunodeficient,
the body will not be able to clear the virus for months, and even
years," says Dr Vipin Vashishtha, convener, polio eradication
committee of the Indian Academy of Paediatricians.

The only way to prevent VDPV is to replace the oral polio vaccination
with the inactivated polio vaccine (IPV) that comprises dead viruses.
"Several developed countries in the world have shifted to IPV," he says.

However, there is no reason to press the panic button in Tamil Nadu,
which has a track record for being polio-free since 2005. "Both
children and adults in the girl's village were tested for the
contagion and found to be negative. We followed the case for 3 months
and found no cause for alarm," said an official associated with the
national polio surveillance project.

There is also no rationale to shift to IPV at present, when the
country is yet to eradicate type-1 and type-3 of the wild polio
virus, says Dr P. Ramachandran, director of the institute for child
health in Egmore. The need of the hour was to monitor the stray cases
of VDPV closely, he says.

Communicated by:
HealthMap Alerts via ProMED-mail

[2] cVDPV - WHO data
Date: 12 Oct 2010
Source: Polio eradication initiative website [edited]

Circulating vaccine-derived poliovirus (cVDPV) 2000 - 2010 (as of 12 Oct 2010)

Country: Type: 2000 / 2001 / 2002 / 2003 / 2004 / 2005 / 2006 / 2007
/ 2008 / 2009 / 2010 / 1st case / last case
Nigeria: VDPV 2: - / - / - / - / - / 1 / 21 / 88 / 63 / 153 / 16 / 2
Jul 2005 / 26 Aug 2010
DR Congo: VDPV 2: - / - / - / - / - / - / - / - / 14 / 4 / 8 / 22 Mar
2008 / 13 Aug 2010
Afghanistan: VDPV 2: - / - / - / - / - / - / - / - / - / - / 3 / 10
Jun 2010 / 2 Jul 2010
Niger***: VDPV 2: - / - / - / - / - / - / 2 / - / - / - / 1 / 28 May
2006 / 1 Jun 2010
Ethiopia: VDPV 3: - / - / - / - / - / - / - / - / - / 1 / 5 / 27 Apr
2009 / 17 May 2010
India: VDPV 2: - / - / - / - / - / - / - / - / - / 15 / 1 / 14 Jun
2009 / 18 Jan 2010
Somalia: VDPV 2: - / - / - / - / - / - / - / - / 1 / 4 / - / 29 Jun
2008 / 24 Dec 2009
Guinea***: VDPV 2: - / - / - / - / - / - / - / - / - / 1 / - / [6 May
2009] / 6 May 2009
Ethiopia: VDPV 2: - / - / - / - / - / - / - / - / 3 / 1 / - / 4 Oct
2008 / 16 Feb 2009
Myanmar: VDPV 1: - / - / - / - / - / - / 1 / 4 / - / - / - / 9 Apr
2006 / 6 Dec 2007
Cambodia: VDPV 3: - / - / - / - / - / 1 / 1 / - / - / - / - / 26 Nov
2005 / 15 Jan 2006
Indonesia: VDPV 1: - / - / - / - / - / 46 / - / - / - / - / - / 9 Jun
2005 / 28 Oct 2005
Madagascar**: VDPV 2: - / 1 / 4 / - / - / 3 / - / - / - / - / - / NA
/ 13 Jul 2005
China: VDPV 1: - / - / - / - / 2 / - / - / - / - / - / - / 13 Jun
2004 / 11 Nov 2004
Philippines: VDPV 1: - / 3 / - / - / - / - / - / - / - / - / - / 15
Mar 2001 / 26 Jul 2001
DOR/Haiti: VDPV 1: 12/ 9 / - / - / - / - / - / - / - / - / - / 12 Jul
2000 / 12 Jul 2001

** Madagascar 2 different outbreaks (2001/2002 and 2005)
*** Niger 2006, Niger 2010 and Guinea 2009 cVDPVs are linked to the
Nigeria outbreak

[A map with the locations of the VDPV cases confirmed during the last
6 months can be found at the above given URL link. - Mod.MPP]

Communicated by:

[The above newswire serves as a reminder of the challenges associated
with the use of the oral polio vaccine (OPV) in areas where there has
been interruption of WPV transmission. If the newswire is providing
adequate, correct information, the involved case is an immune
deficient child who has had a known chronic infection with the
vaccine virus following receipt of the OPV in early childhood. If
this is the case, at the time of infection, this child was living in
an area with WPV circulation and the child's risk of infection with a
WPV far outweighed the child's risk from the OPV. During the
following 8-9 years, this situation has changed, and Tamil Nadu has
been polio free. Historically, there have been concerns about these
chronically infected individuals serving as sources for cVDPV in
areas where vaccination coverages are suboptimal. It awaits to be
seen whether there will be more cases associated with this particular
virus or whether it will remain an isolated case in an !
immunodeficient individual.

Unfortunately, cVDPVs have been associated with outbreaks of
paralytic disease in Egypt, Niger, DR Congo, Nigeria, Hispanola, the
Philippines, Indonesia, Romania, China, Jamaica and Madagascar (see
references below and the table presented in [2] above). Note that in
the situation where disease eradication is the target, the definition
of an outbreak is a single case. With respect to polio, we know that
for each paralytic case, there are between 50 and 1000 others who are
infected but do not have paralytic disease. This figure is the figure
cited routinely for WPV, but we do not have an estimate of the ration
of paralytic to non-paralytic infections with respect to cVDPV. In a
recent article in NEJM, Jenkins et al (see ref. 13 below) concluded
that "the attack rate and severity of disease associated with the
recent cVDPV identified in Nigeria are similar to those associated
with WPV." (The authors estimated average annual clinical attack
rates associated with infections with WP!
V-1 (6.8 with 95 percent [confidence intervals] CI 5.9 to 7.7), cVDPV
2 (2.7 with 95 percent CI 1.9 to 3.6), WPV 3 ( 4.0 with 95 percent CI
3.4 to 4.7).

As the end game of polio eradication draws near and there are fewer
cases of polio caused by wild poliovirus (WPV), there is a shift in
the proportion of paralytic cases identified that are associated with
vaccine derived polioviruses (VDPVs), and more countries have been
identifying outbreaks associated with the circulation of these VDPVs.
In the 2005 WHO document giving a framework for national policy
makers in OPV-using countries for cessation of OPV use after polio
eradication is declared, there is a quote from the Geneva 21-22 Sep
2004 meeting of the Advisory Committee on Poliomyelitis Eradication
(ACPE) that is relevant here: "After eradication of wild poliovirus,
continued use of oral polio vaccine (OPV) would compromise the goal
of a polio-free world." See

Unfortunately, many countries have seen decreases in their polio
vaccination coverages as they get further and further away from
having identified circulating WPV in their country, and the National
Immunization Days (NIDs), where extensive social mobilization efforts
were conducted leading to high vaccination coverages at the time,
become events of historical significance. This seems to be the
fertile background for the occurrence of outbreaks of paralytic polio
associated with cVDPV's, where there are significant pockets of
inadequately immunized individuals into which these reverted viruses
find environments for significant transmission (see refs 3, 8,10, 11).

To further complicate the situation, we have arrived at a time where
we truly live in a global village, and microbial organisms can (and
do) travel from one part of the world, where there may be high
vaccination coverages, to another part of the world, where there are
significant pockets of inadequately immunized individuals, in hours
rather than weeks as in the past (See ref. 2 - the VDPV involved in
this community was found to be older than the infected infant,
suggesting it had come from another country. MMWR Dispatch.
Poliovirus Infections in Four Unvaccinated Children -- Minnesota,
August-October 2005. 14 Oct 2005; 54
.). So, while these
immune compromised hosts who are chronic shedders of VDPVs may live
for many years, the viruses they are shedding may enter healthy hosts
who are en route back to areas where vaccination coverages are suboptimal.

1: Jackson ST, Mullings AM, Booth TF, MacDonald L, Henry SO, Khan CA,
McLaughlin PD. Molecular analysis and implications of neurovirulent
circulating vaccine-derived poliovirus in Jamaica. A case report and
review of literature. West Indian Med J. 2008 Nov;57(5):511-4.

2: Alexander JP, Ehresmann K, Seward J, Wax G, Harriman K, Fuller S,
Cebelinski EA, Chen Q, Jorba J, Kew OM, Pallansch MA, Oberste MS,
Schleiss M, Davis JP, Warshawsky B, Squires S, Hull HF;
Vaccine-Derived Poliovirus Investigations Group. Transmission of
imported vaccine-derived poliovirus in an undervaccinated community
in Minnesota. J Infect Dis. 2009 Feb 1;199(3):391-7.

3: Rakoto-Andrianarivelo M, Gumede N, Jegouic S, Balanant J,
Andriamamonjy SN, Rabemanantsoa S, Birmingham M, Randriamanalina B,
Nkolomoni L, Venter M, Schoub BD, Delpeyroux F, Reynes JM.
Reemergence of recombinant vaccine-derived poliovirus outbreak in
Madagascar. J Infect Dis. 2008 May 15;197(10):1427-35.

4: Estivariz CF, Watkins MA, Handoko D, Rusipah R, Deshpande J, Rana
BJ, Irawan E, Widhiastuti D, Pallansch MA, Thapa A, Imari S. A large
vaccine-derived poliovirus outbreak on Madura Island--Indonesia,
2005. J Infect Dis. 2008 Feb 1;197(3):347-54.

5: Vaccine-derived poliomyelitis in Nigeria. Lancet. 2007 Oct

6: Combiescu M, Guillot S, Persu A, Baicus A, Pitigoi D, Balanant J,
Oprisan G, Crainic R, Delpeyroux F, Aubert-Combiescu A. Circulation
of a type 1 recombinant vaccine-derived poliovirus strain in a
limited area in Romania. Arch Virol. 2007;152(4):727-38. Epub 2007 Jan 3.

7: Liang X, Zhang Y, Xu W, Wen N, Zuo S, Lee LA, Yu J. An outbreak of
poliomyelitis caused by type 1 vaccine-derived poliovirus in China. J
Infect Dis. 2006 Sep 1;194(5):545-51. Epub 2006 Jul 26.

8: Shimizu H, Thorley B, Paladin FJ, Brussen KA, Stambos V, Yuen L,
Utama A, Tano Y, Arita M, Yoshida H, Yoneyama T, Benegas A, Roesel S,
Pallansch M, Kew O, Miyamura T. Circulation of type 1 vaccine-derived
poliovirus in the Philippines in 2001. J Virol. 2004 Dec;78(24):13512-21.

9: Rousset D, Rakoto-Andrianarivelo M, Razafindratsimandresy R,
Randriamanalina B, Guillot S, Balanant J, Mauclere P, Delpeyroux F.
Recombinant vaccine-derived poliovirus in Madagascar. Emerg Infect
Dis. 2003 Jul;9(7):885-7.

10: Yang CF, Naguib T, Yang SJ, Nasr E, Jorba J, Ahmed N, Campagnoli
R, van der Avoort H, Shimizu H, Yoneyama T, Miyamura T, Pallansch M,
Kew O. Circulation of endemic type 2 vaccine-derived poliovirus in
Egypt from 1983 to 1993. J Virol. 2003 Aug;77(15):8366-77.

11: Kew O, Morris-Glasgow V, Landaverde M, Burns C, Shaw J, Garib Z,
Andre J, Blackman E, Freeman CJ, Jorba J, Sutter R, Tambini G,
Venczel L, Pedreira C, Laender F, Shimizu H, Yoneyama T, Miyamura T,
van Der Avoort H, Oberste MS, Kilpatrick D, Cochi S, Pallansch M, de
Quadros C. Outbreak of poliomyelitis in Hispaniola associated with
circulating type 1 vaccine-derived poliovirus. Science. 2002 Apr
12;296(5566):356-9. Epub 2002 Mar 14.

12: Yan D, Li L, Zhu S, Zhang Y, An J, Wang D, Wen N, Jorba J, Liu W,
Zhong G, Huang L, Kew O, Liang X, Xu W. Emergence and localized
circulation of a vaccine-derived poliovirus in an isolated mountain
community in Guangxi, China. J Clin Microbiol. 2010
Sep;48(9):3274-80. Epub 2010 Jul 14.

13. Jenkins HE, Aylward RB, Gasasira A, Donnelly CA, Mwanza M,
Corander J, Garnier S, Chauvin C, Abanida E, Pate MA, Adu F, Baba M,
Grassly NC. Implications of a circulating vaccine-derived poliovirus
in Nigeria. N Engl J Med. 2010 Jun 24;362(25):2360-9. Erratum in: N
Engl J Med. 2010 Sep 23;363(13):1290. (Full article available at:
). - Mod.MPP]

[see also:
Polioviruses, vaccine-derived - Finland 20100514.1567
Polioviruses, vaccine-derived - worldwide: 2008-2009 20090922.3333
Poliomyelitis, vaccine-derived strains - worldwide 20071012.3350
Poliomyelitis, vaccine associated - Taiwan: susp 20060808.2226
Poliomyelitis, vaccine associated, 2005 - USA ex Costa Rica 20060202.0334
Poliovirus isolation, vaccine strain - USA (02) 20051015.3003
Poliovirus isolation, vaccine strain - USA 20051014.2996
Poliovirus isolation, vaccine strain - USA (MN): RFI 20051002.2884
Poliomyelitis, vaccine derived - Madagascar: RFI 20050717.2043
Poliomyelitis, vaccine-derived - Madagascar 20020719.4809
Poliomyelitis - Dominican Republic & Haiti 20020331.3848
Poliovirus, inventory of stocks - USA 20021228.6146
Poliovirus, silent carrier - Europe 20020725.4858
Poliovirus, chemical synthesis 20020713.4749
Poliomyelitis, vaccine-derived - Philippines: 2001 20011013.2506
Poliomyelitis - Dominican Republic & Haiti 20011005.2415
Polio, circulation of vaccine-derived virus 20010129.0205
Poliomyelitis - Dominican Rep.: control measures 20001218.2212
Poliomyelitis - Dominican Republic & Haiti: update 20001208.2149
Poliomyelitis - Dominican Republic & Haiti: ALERT 20001202.2098
Latent poliovirus (10) 19950314.0129
Latent poliovirus in AIDS patient 19950307.0110
Latent poliovirus in AIDS patient 19950306.0105]

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Tuesday, October 5, 2010

A Win for Whistle Blowers

by Ralph Nader

Why would Pfizer, the world’s largest drug company, so mistreat and silence one of their top molecular biologists that a federal jury in Connecticut awarded her $1.37 million in damages last week?The unraveling answer promises to tear open the curtain covering hazards confronting tens of thousands of scientists and assistants in corporate and university labs doing genetic engineering work with viruses and bacteria.

Becky McClain’s lawsuit against Pfizer claimed that the company’s sloppiness in 2002-03 exposed her to an engineered form of the lentivirus, a virus related to one that could lead to immune deficiencies. Pfizer denied any connection between its lab practices and Ms. McClain’s recurring paralysis and other illnesses.Back and forth over three years came the scientist’s claims and Pfizer’s denials during which she had to leave her job amidst the increasing retaliatory behavior of her ten-year employer.

Pfizer is known for playing hardball and violating laws. Last year it had to pay the Justice Department one of the largest fines – half civil, half criminal – for illegal promotion of its drugs for unapproved uses. The fine — $2.4 billion – avoided criminal charges and prosecution, either of the company or officials, and became just another cost of doing business.

Just last week, soon after buying Wyeth Labs for $68 billion, Pfizer’s CEO, Jeffrey B. Kindler, told a reporter for The New York Times that his company has “invented too few drugs and left its reputation in disrepair after two criminal cases.”

That record does not diminish Pfizer’s advantage over its imperiled lab workers, which is built on the absence of any available risk assessments, the very nature of possible latent, silent violence, and the cruel refusal to give afflicted employees their own exposure records on the grounds that they are company trade secrets.

Pfizer offered Ms. McClain a paltry sum with a gag order, which she promptly refused. She wanted her freedom of speech and her whistle-blowing rights under federal law. Her lawsuit was filed in 2006 in Hartford.

By dismissing the third count, which might be appealed, in her complaint alleging Pfizer’s wanton misconduct, U.S. District Judge Vanessa L. Bryant ruled that the plaintiff did not have available the evidence of causality and it was a worker’s compensation matter anyway. Herein started the chicken-egg problem. How could Ms. McClain obtain the evidence in order to prove her case when Pfizer said it was proprietary and secret?

The Council for Responsible Genetics (CRG), started by Harvard and MIT scientists, does not believe laboratory exposure records of workers should be trade secrets. Life, health and remedial rights should trump any such alleged, bizarre property right.

Becky McClain has already exhausted any remedies or assistance from the woeful Occupational Safety and Health Administration (OSHA). This agency has been without any regulations or disclosure requirements about biohazards in laboratories. This inertness might change with the appointment of David Michaels to head OSHA, which should bring the agency closer to its mission of preventing or diminishing tens of thousands of fatalities and injuries each year.

Mr. Michaels told the Times that “new biological materials, nanomaterials, there are many things where we don’t have adequate information, and we think workers need to have protection.” He indicated that OSHA will take another look at the McClain case.

Both Jeremy Gruber, president of CRG, and Steve Zeltzer, chair of the California Coalition for Workers Memorial Day, believe the McClain case will lead to broader scrutiny of biologic laboratories, where research is expanding rapidly with heavy federal funding.

It is well known that workers in these labs are inhibited from speaking out, either inside or outside their workplace, for fear of losing their jobs. OSHA has long known that companies in old and new industries often do not come close to fully reporting cases of their injuries and sickness either to their insurers or to state or federal job safety agencies. Some have been found to keep two sets of books.

The Bureau of Labor Statistics data are not at all comprehensive. Under-reporting can hide half or three-fourths of the actual traumatic injuries.

Mr. Zeltzer has denounced what he calls “the failure of top company officials to even report to OSHA and other government agencies that many workers were getting sick numerous times in their laboratories although this is required by the law.” He called on the US Attorney in Hartford to begin a criminal investigation. (see workersmemorialday.org)

As for Becky McClain, this is just the end of the beginning. She says she has lost her career, her health and her health insurance. But she recognizes her case is in the vanguard of many other cases and worker protests to come before enforceable and openly accessible standards and practices become the way of doing business for these labs.

For when it comes to developing materials that are inherently latent, subvisible forms of silent violence, business as usual can become cruel and unusual punishment for innocent, defenseless scientists, lab technicians and other workers.

Such is the weighty responsibility of David Michaels and the new managers of the long moribund, underfunded OSHA in the coming months.