Polio and Acute Flaccid Paralysis

In post one of this series on polio, a term was introduced: “Acute Flaccid Paralysis”. [1]

Acute Flaccid Paralysis is a term which applies to the exact clinical symptoms you would expect to see from poliovirus infection, but which are not necessarily caused by polioviruses. Paralytic polio is actually considered a sub-category in the broad umbrella of acute flaccid paralysis. See pages 300-312 [1] for a chart and summary of many other causes of AFP, a few of which are: Guillaine-Barre syndrome, Cytomegalovirus polyradiculomyelopathy, Acute transverse myelitis, Lyme borreliosis, nonpolio enterovirus and Toxic myopathies.

For many years the medical profession assumed that when they saw paralysis with a particular cluster of symptoms, it was poliomyelitis. The 1954 Francis Trials of the Salk vaccine [2] triggered a reconsideration of this assumption, and a major change in the diagnostic criteria.

How were polio cases counted in 1954?

In 1954 most health departments worked with the WHO definition:

“…Signs and symptoms of nonparalytic poliomyelitis with the addition of partial or complete paralysis of one or more muscle groups, detected on two examinations at least 24 hours apart.” [3, p. 88]

How were polio cases counted in 1955?

In 1955 the criteria were changed to conform more closely to the definition used in the 1954 field trials: residual paralysis was determined 10 to 20 days after onset of illness and again 50 to 70 days after onset. [3, p. 88]

Thus, simply by changes in diagnostic criteria, the number of paralytic cases was predetermined to decrease in 1955-1957, whether or not any vaccine was used. At the same time, the number of nonparalytic cases was bound to increase because any case of poliomyelitis-like disease which could not be classified as paralytic poliomyelitis according to the new criteria was classified as nonparalytic poliomyelitis. Many of these cases, although reported as such, were not non-paralytic poliomyelitis. [3, p. 88] (emphasis added)

It was after the SALK vaccine was introduced, when fully vaccinated people continued to get “polio”, that doctors started looking a lot more carefully at the viruses in individuals. Many viruses were found to cause paralysis, for example coxsackie B, enterovirus 71, etc.

Paul Meier, looking back at the problem of misdiagnosis of polio during the Francis Trials.

Next, we said, the diagnosis of polio is tricky, but we need to have the entire country’s physicians participate, because we can’t look over every case where there’s some kind of paralysis. So physicians reported the cases they thought were polio according to the protocol, and we accepted those cases. Now about half those cases were probably not polio at all, but still, we did have total reported cases, compared with paralytic and nonparalytic cases. [4]

By 1960, in order to be defined as “poliomyelitis”, virus tests on stool samples were required.   If polioviruses were not seen, additional tests to find other viruses were run, and sometimes, no virus could be found at all.  Whatever the “cause”, paralysis following sickness was no longer automatically classified as polio. It was now re-classified under many different diagnoses, with “Acute Flaccid Paralysis” as the loose umbrella heading under which paralysis caused by poliomyelitis viruses was a sub-category.

The history of polio in the U.S. is presented with numbers like this:

…in seven years the Salk vaccine reduced the incidence of polio in the United States by more than 96 percent, from 38,476 reported cases in 1954 to 1,312 in 1961. [5]

These statistics are simply not  accurate.   The 1954 “polio” data includes all paralysis.   While some of this may have been from polio, in reality, much of it was from other causes.  With the change of diagnostic criteria in 1955 that reduced case numbers, followed by laboratory testing that excluded vast numbers of other causes, the 1961 data only includes the small subgroup of paralysis caused by poliomyelitis.  This is then compared with the catch-all 1954 definition. Because it was impossible to know what proportion of 1954 data were really caused by poliomyelitis viruses, the 1954 data was left as it was, and nothing of the back story is revealed to  the readers. When people say: “we know the polio vaccine saved us from huge epidemics of this devastating disease” they are basing their knowledge on misinformation.

If polio is wiped out, will that mean the end of “infantile paralysis?”

No.

How was the prevaccine data from developing countries collected, before they implemented vaccination programmes?

Doctors used “lameness surveys” as a means to look for people with deformed or shrivelled legs, on the presumption that such problems were causes by the polioviruses, and then multiplied that data to cover the surrounding areas which weren’t directly surveyed.

1970 – 1980
Lameness surveys demonstrate that polio is widespread in many developing countries, leading to the introduction of routine immunization with OPV in almost all national immunization programs. [7]

What was the case definition used for these lameness surveys?

The case definition used most frequently consists of (1) flaccid paralysis with atrophy, (2) no decrease in sensation, and (3) a history of acute onset with no subsequent progression of disease. This definition assumes that the sequelae of residual paralytic poliomyelitis are observable and distinctive enough to be reliably attributed to poliomyelitis; however, the sensitivity and specificity of the definition have not been evaluated. [7]

Were the surveys conducted with consistent methodology around the world and throughout the 10 year process?

The percentage of all lame children who are categorized as having paralysis due to poliomyelitis has varied markedly from one survey to another…Some variation is to be expected, but the specificity of the case definition is a reasonable concern. Also, the case definition has not been applied uniformly. [7]

How can we be sure lameness surveys were accurate?

We can’t be. Lameness surveys were essentially a “look and guess” exercise. Even though poliomyelitis researchers knew from the U.S experience that large numbers of polio cases had other causes, lameness surveys were used as factual evidence that poliomyelitis viruses were the sole cause of lameness around the world.

1992 – 1993

The Global Polio Laboratory Network is formally established to facilitate high quality virologic investigation in all countries.  [6]

This process appears to parallel what occurred in the U.S, whereby a  loose definition of polio is used to collect the pre-vaccine incidence of the illness.

As vaccination programs are implemented, a formal process of accurate and consistent diagnosis is put into place. Only at this point, after vaccination is in use, is there any attempt to accurately and consistently separate the non-polio caused cases of acute flaccid paralysis from the polio caused cases.

When polio has been eradicated from an area, how much acute flaccid paralysis is still occurring?

Here is an example from the Americas after the eradication of polio:

In 1993, regional vaccination coverage among children with at least three doses of oral poliovirus vaccine was 87%; 33 of 38 countries had achieved and maintained coverage of more than 80%. Routine vaccination has been supplemented by annual national immunization days *. Since August 21, 1991 (when the last confirmed case was reported), approximately 6000 acute flaccid paralysis cases have been investigated; however, none of these cases were confirmed as paralytic polio resulting from wild poliovirus. In addition, approximately 25,000 stool specimens obtained from these patients and their contacts were negative for wild poliovirus (Figure_1). Finally, key surveillance indicators have been at acceptable levels in all countries during the past 3 years. Based on review of these data, all 26 national or multinational certification commissions recommended that their countries be certified as polio-free. (emphasis added) [8] (4th paragraph)

This World Health Organization database, which goes back to 1996,  provides a lot of information about polio cases and acute flaccid paralysis cases.

How many cases of acute flaccid paralysis (excluding cases due to polio) occurred from 1996 to 2009?

608,832 cases of AFP were reported, worldwide. Looking at the data, year by year, certain countries have ND in the AFP cases reported column. ND means No Data. Which means that the 608,832 cases is incomplete and that there were even more cases of non-polio AFP during this period.

In the same period, there were 39,131 cases of polio identified. [9]

Here is some information on Acute Flaccid Paralysis in India:

In India polio cases had come down from 24,257 in 1988 to 4793 cases in 1994 with the help of routine immunization, well before the ‘eradication programme’ started in India, In those days all cases of acute flaccid paralysis (AFP) with residual paralysis beyond 60 days were diagnosed as polio. [10]

There was also an unexplained increase in AFP – especially non polio AFP. In 2005 there were 10,055 non polio AFP cases in Uttar Pradesh (UP) where 561 cases were expected. A delegation from the Public Report on Health (PRoH) (Council for Social Welfare, New Delhi) in November 2006 investigated the problem of residual paralysis in ‘non polio AFP’. The PRoH found that most cases of AFP were not being followed up (unless they cultured virus in the stools). Information provided under the Right to Information Act and available from National Polio Surveillance Project (NPSP) is shown in the Table. Of the 10264 cases of AFP, 209 were cases of polio or compatible with polio. Of the remaining 10055, only 2553 were followed up; of these, 898 had residual paralysis (that would qualify them to be diagnosed as polio using the old definition) and 217 died. Projecting these figures on those not followed up, it will appear that approximately 4800 cases had residual paralysis or died in UP after acquiring non polio AFP in the year 2005. This figure must be compared to the all India figures of 4793 polio cases in 1994. It is not surprising the NPSP is not keen on the follow up of these cases. The data from 2006, after 6 doses of mOPV had been administered in 2005, in districts of UP, are worse. [10]

The Acute Flaccid Paralysis cases in India continue to increase, year by year. For the year 2009, using the WHO data, we find 50,416 total cases. Out of this total 752 were polio. [9]

In 2000 WHO announced:

There were 719 cases of wild poliovirus in 2000. This represents a 99% reduction in cases since the programme began in 1988, with 350,000 estimated cases from lameness surveys. [5]

Note the similarity to the announcement of a 96% reduction in the U.S. by 1961, based on enlarged pre-vaccine numbers and selective post-vaccine numbers.

The rest of the story of polio in the year 2000:

There were a total of 2,971 cases of polio in the year 2000. [9]

Of these cases, 719 were identified as cases due to wild poliovirus. [9]

The other 2,252 may have been due to wild poliovirus or they may have been due to the vaccine virus. They were left off of the WHO timeline.

There were 27,654 cases of non-polio acute flaccid paralysis, which were left off of the WHO timeline. [9]

Based on the quotes from the Bernier article [7] (see above) the accuracy of the claimed 350,000 annual cases of polio-caused paralysis based on the lameness surveys, is dubious at best.

Puliyel also questions the validity of these numbers:

WHO claims five million children have been saved from polio paralysis. It is instructive to see how this figure is arrived at. In 1988, there were 32,419 cases of paralytic poliomyelitis. The WHO arbitarily raised this number ten-fold to 350,000 claiming incomplete reporting. In 2004 with the changed definition, only culture positive paralysis was considered polio and there were 2000 such cases. Subtracting 2000 from 350,000, the WHO calculated that 348,000 children were saved from paralysis that year. [9]

To sum up:

The numbers used in the U.S. to claim that the Salk vaccine caused a huge reduction in the number of cases of paralysis due to polio were manipulated by changing the criteria for diagnosing the disease.

The numbers used in the worldwide program to eradicate polio were estimates using very loose standards that hypothesized the number of cases, and extrapolated them across large areas before vaccination campaigns were ignited.  This was followed by much stricter diagnostic standards that weeded out Acute Flaccid Paralysis from other causes.

As the number of cases subjected to laboratory analysis rose, and the number of cases of polio dropped, the number of cases of acute flaccid paralysis rose.

Is there an epidemic of acute flaccid paralysis occurring due to various non-polio causes? Are any steps being taken to deal with this expanding problem?

Over 600,000 people coming down with some degree of paralysis in a period of 13 years seems like cause for concern.

The Global Polio Eradication Initiative (GPEI), spearheaded by national governments, the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF, is the single-largest, internationally-coordinated public health project the world has ever known. Since 1988, more than two billion children around the world have been immunized against polio thanks to the unprecedented cooperation of more than 200 countries and 20 million volunteers, backed by an international investment of more than US$ 5 billion. [6]

$5,000,000,000.00 and 20 million volunteers.

What about the 608,832 cases of AFP worldwide since 1996 (not counting the 26,014 cases of AFP from January 1st through May 21, 2010)?

Further information on the changes in methodology for the diagnosis of polio can be found here. [11]

Coming up next: Polio and Sanitation.

[1] Differential Diagnosis of Acute Flaccid Paralysis and Its Role in Poliomyelitis Surveillance, Arthur Marx, Jonathan D. Glass, and Roland W. Sutter. Epidemiologic Reviews, Vol. 22, No. 2, 2000. http://epirev.oxfordjournals.org/cgi/reprint/22/2/298.pdf

[2] “A calculated risk”: the Salk polio vaccine field trials of 1954, Marcia Meldrum, BMJ 1998, 317: 1233-1236 (31 October) http://www.bmj.com/cgi/content/extract/317/7167/1233

[3] The Present Status of Polio Vaccines (a panel discussion), Illinois Medical Journal, August, 1960.

[4] A Conversation with Paul Meier, Harry M. Marks. Clinical Trials 2004, 1, 131. http://www.hopkinsmedicine.org/histmed/people/faculty/papers/meier.pdf

[5] The Making of the Polio Vaccine, Douglas Hand, Invention and Technology Magazine, Summer 1985, Volume I, Issue 1. http://www.americanheritage.com/articles/magazine/it/1985/1/1985_1_54.shtml

[6] World Health Organization. Global Polio Eradication Initiative, The History. (site visited on May 30, 2010) http://www.polioeradication.org/history.asp

[7] Some Observations on Poliomyelitis Lameness Surveys,  Roger H. Bernier,  Reviews of Infectious Diseases, Vol. 6, Supplement 2. International Symposium on Poliomyelitis Control (May – Jun., 1984), pp. S371-S375
http://www.jstor.org/pss/4453375

[8] MMWR Weekly, October 7, 1994, 43(39); 720-722 http://www.cdc.gov/MMWR/preview/mmwrhtml/00032760.htm

[9] WHO, Immunization Monitoring,  Diseases, Poliomyelitis Case Count, accessed multiple times between May 1 and June 1, 2010. http://apps.who.int/immunization_monitoring/en/diseases/poliomyelitis/case_count.cfm

[10] Polio eradication & the future for other programmes:
Situation analysis for strategic planning in India (Editorial), Jacob S. Puliyel, Manoj Anand Gupta, Joseph L. Mathew, Indian J Med Res 125, January 2007, pp 1-4 http://jacob.puliyel.com/download.php?id=132

[11] Guide to Poliovirus Isolation and Serological Techniques for Poliomyelitis Surveillance, I. Domok and D. I. Magrath, WHO, Geneva, 1979. http://whqlibdoc.who.int/offset/WHO_OFFSET_46.pdf

Comments

19 Comments on Polio and Acute Flaccid Paralysis

  1. MinorityView on Sat, 5th Jun 2010 1:30 pm
  2. http://www.nypost.com/p/news/opinion/opedcolumnists/false_prophets_of_swine_flu_pandemic_6SBIhspASK7NbaOUjE1xSJ?CMP=OTC-rss&FEEDNAME=

    WHO is still twisting the statistics to justify hugely expensive programs against infectious diseases.

    quote: In fact, health agencies have every motive to vastly exaggerate infectious-disease threats, because the scares reliably increase the agencies’ budgets and authority over individual governments. Hence the UN predictions that avian flu would kill 150 million, the WHO’s promotion of the 1993 SARS panic (744 deaths worldwide, zero Americans) — and, before that, the WHO’s 12-fold exaggerating of worldwide HIV infections.
    ———————————————————

    and before that the hugely inflated numbers of polio cases…

  3. cynic on Sat, 5th Jun 2010 2:45 pm
  4. Thank you so much for explaining the problems with polio diagnoses pre-vaccine. I am so sick and tired of hearing vaccine pushers use polio as an example of vaccine success while reminding people of poor little children in iron lungs.

  5. Peter on Wed, 9th Jun 2010 2:05 am
  6. Thank you very much for your work. I would like to see more on the crucial point of this story:

    “By 1960, in order to be defined as “poliomyelitis”, virus tests on stool samples were required. ”

    - Do you have further detals about those tests? What was the time they became available?
    - Do you have any knowledge at what time in Europe those tests started to be required?

  7. Peter on Wed, 9th Jun 2010 4:38 am
  8. follow-up:

    In Poland authorities claim that poliomyelithis was also managed only by vaccination. Here the graph they use: http://img714.imageshack.us/img714/3589/poliomyelitis19502005.jpg

    That is why I am interested in the availability/correctness of tests that were performed in the 60′s.

    Interestinlgy in my country just after introduction of Salk vaccine in Oktober 1957 polio cases increased 5 times in 1958 compared to 1957 (starting vaccination in Oktober could not have that big impact on cases counted that year.) Considering the fact that in 1957 compared to 1951 number of cases decreased by 70% without vaccination until Oktober 1957.

    - Have you noticed the same increase after SALK vaccination in other countries?

    Right after introduction of OPV in 1968 again we saw increase of “polio” by 75 times in 1968 as compared to 1967. Authorities acknowledge that 75% of cases in 1968 was due to polio type 3.

    - Have you noticed the same increase vaccination in other countries?

  9. admin on Mon, 14th Jun 2010 3:30 pm
  10. Regarding data for USA, we can’t answer your questions with regard to America, because the American Medical Association removed all the United States Polio Surveillance Units statistics bulletins from all libraries from the years 1955 – 1964, and they were withdrawn from all libraries world wide. they were also removed from NZ libraries. There is only one copy available now, at the central library (which used to be on the top floor of the AMA building). They are classified, and only available on application from approved researchers. Written permission is given, and has to be presented at arrival, and from what I heard from the last person who tried to look at them you are supervised, and no copying is allowed.

    One of our insidevaccines team got to know some of the data from Dr Herbert Ratner – and they most certainly showed higher rates of both paralytic and non-paralytic polio in the vaccinated, compared to the unvaccinated right through to 1964. Remember that only 38% of Americans had had the three shots by 1958.

    I’ll research the tests you asked about and get back to you.

  11. cynic on Tue, 22nd Jun 2010 6:40 pm
  12. because the American Medical Association removed all the United States Polio Surveillance Units statistics bulletins from all libraries from the years 1955 – 1964, and they were withdrawn from all libraries world wide.

    Huh? I would like some elaboration on this assertion, if that’s possible. People will say this data was unreliable, or there were other reasons for making it unavailable.

  13. admin on Wed, 23rd Jun 2010 10:16 am
  14. Hi Cynic,
    Please, prove us wrong! Put in a request through your local public library for a copy of the United States Polio Surveillance Units statistics bulletin for any of those years. The library will try and track them down. If they can’t find them and there is no explanation for their disappearance, then I think we’ve made our case. If there is an explanation we can see if it makes sense. If they can find them, great! We’ll finally be able to see the wonderful success of the Salk vaccine during those years (sarcasm). Cheers!

  15. Peter on Wed, 7th Jul 2010 1:01 pm
  16. Thank you for giving me the inspiration. After some research I discovered that polish authorities started checking AFP cases for polio virus in 1959/1960. Therefore all their data prior to that date shows all possible AFP cases.

  17. admin on Wed, 7th Jul 2010 5:08 pm
  18. That is excellent work, congratulations on tracking down the information. Thanks for sharing it with us, too.

  19. Peter on Sat, 11th Sep 2010 6:04 am
  20. I think there is one missing piece of this puzzle. Considering the fact that diagnosis criteria for virus-related paralisis (real poliomyelitis) was changed, what happened with cases not related with polio virus? How were they reported back in the first years after the definition/diagnosis changed? How many were reported?

    Once this data is available we could maybe see how many paralisis cases were really saved by vaccination back in 60′s. I see in your comments that this data is not available any more.

    In some articles related to US I could find that the cases of asymptomatic meningitis increased and that this is the missing piece.

  21. Mike on Mon, 11th Oct 2010 2:24 pm
  22. To Peter -

    I checked the Israeli statitstics of Polio mortality.
    1954 – 89 cases
    1955 – 51 cases
    1956 – 45 cases
    1957 – 6 cases (Salk vaccine introduced this year)
    1958 – 49 cases
    1959 – 3 case
    1960 – 4 cases
    1961 – 12 cases (Sabin vaccine introduced this year)
    1962 – 1 case
    1963 – 1 case

    Seems quite similar to the pattern you observed in Poland.

  23. Peter on Wed, 13th Oct 2010 5:50 am
  24. To Mike:

    thanks for this info. Indeed the numbers (relatively) and chronology are very similar. I cant wait to see next parts of Polio Provoked. Once different factors are identified by IV it will make sense to look for common patterns accross countries.

  25. gattarian on Sun, 2nd Jan 2011 3:09 pm
  26. At the request of the face book fan page, I am re posting this comment. Thank you for your attention.

    Referring to this quote from an American Heritage article “The Making of the Polio Vaccine”.

    “…in seven years the Salk vaccine …reduced the incidence of polio in the United States by more than 96 percent, from 38,476 reported cases in 1954 to 1,312 in 1961″

    “The 1954 “polio” data includes all paralysis. While some of this may have been from polio, in reality, much of it was from other causes. With the change of diagnostic criteria in 1955 that reduced case numbers, followed by laboratory testing that excluded vast numbers of other causes, the 1961 data only includes the small subgroup of paralysis caused by poliomyelitis”

    1) we can’t know the number of pre 1954 true polio vs other paralysis cases, yet the blog post continues to suggest that indeed the true polio cases are small in comparison.

    2) The overall suggestion that the polio vaccine was not effective fails to take into account the huge drop in polio numbers even given the pre 1955 diagnostic changes (which were not nearly as drastic as the article suggested. For instance, the only number given in the article suggested that perhaps 50% of the reported cases (in the 1954 trial) were not “true” polio. Given that that trial noticed a massive decrease in cases using the same diagnostic criteria (up to 80% depending on the historical reading). Specifically, of the 863 cases identified as polio 113 occurred in vaccinated children. That is a success rate of between 50 and 75%. Again, this is based on unchanged diagnostic criteria.

    Its little self inconsistencies that make some of the articles here difficult to read.

    Here is a brief article about the 1954 trial which includes some numbers. http://www.stat.luc.edu/StatisticsfortheSciences/MeierPolio.htm

  27. admin on Sun, 2nd Jan 2011 6:06 pm
  28. Thanks for posting your questions here. They are good ones and will take a little time to work through, but I promise a thoughtful response within a few days.

  29. Peter on Sat, 22nd Jan 2011 3:58 pm
  30. To make the picture less incomplete this paper should also be considered (however I have no access to full article):

    The 1955, Journal of American Statistical Assn 50: 1005- 1013, stated of the Francis report:

    “59% of the trial was worthless because of lack of adequate controls. The remaining 41% may have been alright, but contains internal evidence of bias in favour of the vaccinated.”

  31. admin on Sat, 22nd Jan 2011 6:21 pm
  32. Hi Peter, thanks for the quote! I’ll see if I can get hold of the article in question.

  33. deepa on Wed, 20th Jul 2011 3:33 am
  34. Very interesting post i liked it a lot. Great work.

  35. augustine on Wed, 16th Nov 2011 7:44 pm
  36. Paul Meir says that the polio trials had to be the most elaborate because polio was scarce. What does he mean? I thought polio caused children to run out of school buildings like it was the last day of school. Or maybe those black and white films about polio were filmed on the last day of school.

    Anyway, he says that half of the cases were probably not polio at all but it didn’t matter because the total cases of paralysis were less in the vaccine group compared to the control. How does a scientist explain the discrepancy. Meaning how does a polio vaccine cause non-polio paralysis to decrease? Do scientist not care about these types of questions?

  37. Joyce on Tue, 2nd Oct 2012 10:13 am
  38. Around the late 1960′s or early 1970′ the news reprted that after the swine flu vaccine, quite a few people experienced paralissis from the neck down that lasted anywhere from 48 hours to 6 months. these people 10 to 15 years later experienced polio synptoms. This news story was quickly squashed and nothing more was heard about it so……was this a hoax or government cover-up????

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