Wednesday, December 27, 2006

Screw-upitis!!!!!!

It seems to me that most bureaucratic organizations or countries have a natural rhythmic cycle that can be defined as follows:

First some make money by screwing-up - screw-upitis or better f***-upitis;
this is followed by income generting activity called inquiryitis;

This is followed by checkeritis - and then they often hire a checker to check that the checker checked that the checker checked if the checker checked that ....... forgetting to hire anybody to do the work that the checkers were going to check!

Wednesday, December 20, 2006

SUPERBUGS, MAD COWS, MAD SCIENCE

SUPERBUGS, MAD COWS, MAD SCIENCE AND
REGULATORY-SCIENTIFIC MISADVENTURES:

IT’S A TIME TO BE HUMBLE; IT’S A TIME TO APOLOGIZE!
<< "Seeing reality is the first step towards changing it." >>

New mission statement for public health agencies:
To play nicely TOGETHER in the sand box and find ways to tolerate and resolve differing minority regulatory science opinions (the approach of the supreme court should be considered);
TO BE HUMBLE by remembering the many regulatory-scientific misadventures in our past, e.g., the blood crises, the Vioxx paradox, SARS farce, the ongoing superbug crisis (add any number of other examples) and to reflect that mad cow disease is perhaps the greatest regulatory-scientific misadventure, amounting to the ultimate doctors’ dilemma and vegetarians’ worst nightmare because of the potential broad impact on foods, drugs, medical devices, cosmetics and other bovine sourced consumer products ......
To work cooperatively and transparently with all fellow Canadian citizens to maximize the health impact of the public health resources being spent;
To resist creating false expectations by making promises we know we can’t keep;
To resist wasting precious public health resources by working in redundancy or reinventing the wheel (mapleleafing) and by fostering progress by adopting or importing innovations that exist elsewhere;
To accept full responsibility for the regulatory-scientific misadventures the same way we celebrate regulatory-scientific successes;
To recognize that spin doctoring and "lience" have no place in public health science;
To admit that we may not have all the answers all of the time and that our answers are not the only possible answers; and to never again pronounce that "The review process is sound, rigorous and based on the best available scientific information and we can be confident in our conclusions." ..... IT’S A TIME TO BE HUMBLE!

NO MORE LEADERSHIT! - The Institute for Leadershit Studies

Tuesday, December 19, 2006

The absurdity of "safe" - foods, drugs etc.

This is an open letter:
Dear Senator *******:
I am a retired food microbiologist and would like to make a preliminary comment on your call for a food safety task force. For once we should get real before we start such an undertaking. I recently received my copy of the October/November copy of Food Quality (US). As always I enjoyed reading it. I was however astonished to read the following in the editorial on page 8: "Consumers have the right to take for granted that their food is safe." I have published a number of letters where I make the following observation: I can say with confidence that the food supply has not been safe in the past, is not safe at present and will most likely not be safe in the future. Those who label the food supply as safe must be using a funny definition of safe and it seems to me that they give a false sense of security to consumers. It seems to me they are also giving an implied warranty which could/should make them liable under certain conditions or could be used to question their credibility. The item below elaborates some on this. Also, if we accept that the US has 76 million cases and Canada between 11 to 13 million cases of microbial foodborne disease annually then North America has as many as 89 million cases annually or 243835 cases daily - funny definition of safe!
With reference to contamination of vegetables I recently made the following observation: The authors are clearly out to lunch when they write: "that the (microbial) risks associated with fresh produce have only been recognized in the past decade". Let me provide some evidence: "Melick mentioned a number of instances where vegetables have caused disease" (1917. J. Infect. Dis., 21, 28). "Another outbreak occurred in Philadelphia where 18 out of 19 persons who ate water cress sandwiches became ill with typhoid fever" (1917). There are many other examples in chapter 15, Microbiology of vegetables and vegetable products, The Microbiology of Foods, F.W. Tanner, 1944, Gerrard Press, Champaign, Ill., USA. My motto has always been that one can't discover what is already recorded in text books and having studied Tanner's book while an undergraduate and teaching assistant at the University of Alberta in the late 50's to mid 60's I became distraught in the mid 70's when some of my colleagues talked bull poop about having discovered various food microbiological problems. To make sure that there would be a copy of the Tanner book I advertised with The American Society for Microbiology and got a copy. My first act when a food microbiological problem is "newly discovered" is to look at what, if anything was known before 1944. It may surprise some folks that the possibility of Salmonella being transmitted by chocolate, a current problem that has resulted in chocolate recalls in U.K. and Canada, was studied as long ago as 1915. Just like phage therapy is an old-new-again subject being rediscovered by researchers - so poop has been happening for a long time in barns and public health/regulatory offices as well as academic and industry laboratories when people don't read references more than 10 years old!
Let me further illustrate just how little progress has been made in food safety microbiology in the last 100 years:
Re: Salmonella forces Hershey to recall 25 products, Ottawa Citizen, Nov. 13, 2006, D1
Research reported in 1915 concluded that there was a possibility of disease caused by Salmonella being transmitted by infected chocolate. Thus it is clear that Salmonella in chocolate is not a new topic and is not a subject in search of new research initiatives. Information on the topic is voluminous as can be shown by performing Internet searches with the string, "Salmonella in chocolate." A search using google Scholar gave 2,420 hits - these should be mainly peer reviewed papers and include references written by Health Canada experts such as Dr. JY D'Aoust; a google search of the entire web gave 642,000 hits; while googling pages from Canada only gave 72,600 hits. It is obvious that information on the topic is widely and easily available and spokespersons on the subject should take this into consideration. Cute or evasive communication strategies will not suffice.
It is obvious from the literature that this is not the first case of Salmonella in chocolate and it will not be the last! We must stop telling North Americans that the "food supply is safe" - it is a lie as is obvious when the website of the Canadian Food Inspection Agency also declares that "public health experts estimate that there are 11 to 13 million cases of food borne illness in Canada every year" or as many as 35000 cases daily. There is some risk in almost everything we do and the risk associated with manufacture and consumption of chocolate has long been studied to death. Surely we can expect that the scientific representatives from regulatory agencies, industry and academia will deal with outbreaks, which have and will inevitably occur, honestly, professionally and effectively. In my humble opinion this has not to date been the case with the current Salmonella in chocolate outbreak. Salmonella has demonstrated a tenacious love for chocolate and the two have a long history together. While one can not and should not disregard the problem it is equally important to put the issue into proper perspective. According to my literature collection scientists have been trying to get salmonella out of chocolate for almost 100 years; however, there have been periodic outbreaks.
What I have said about Salmonella in chocolate can be largely applied to the contamination of field grown vegetables; however, getting pathogens out of vegetables is perhaps even more difficult considering that they are grown in fields where they may be subject to contamination from pathogens found in soil, irrigation water and faecal material from wild as well as domestic animals and birds as well as other contamination sources. My point is that: first, we should have an honest foundation of what we have known for a long time; second, we should not make promises that we know we can not keep; and third, we should stop telling consumers that the food supply is safe - it is a lie! .........................

Yours truly, phdkso

Safe foods, safe drugs, safe medical devices - mission impossible;
honesty - mission possible!

Saturday, December 16, 2006

What is leadershit?

Leadershit - trying to provide leadership without credibility.
Credibility is like virginity, you have it until you lose it and you can't get it back.

Usually loss of credibility comes from lack of judgement and loss of respect -
thus loss of respect and/or credibility means the end of leadership.

Never before have so few leaders produced so much leadershit in so little time!

THE INSTITUTE FOR LEADERSHIT STUDIES

Sunday, December 10, 2006

On bureaucarcy

BUREAUCRACY IS ABOUT MAKING INCOME FOR BUREAUCRATS
NOT ABOUT MAKING OUTCOMES FOR CITIZENS!

THE ANSWER OF BUREAUCRACY TO BUREAUCRACY
IS MORE BUREAUCRACY
BECAUSE BUREAUCRACY NEEDS BUREAUCRACY TO BE BUREAUCRACY AND
BUREAUCRACY IS INTERESTED ONLY IN THE GROWTH OF BUREAUCRACY
BECAUSE WITHOUT BUREAUCRACY WHERE WOULD ALL THE BUREAUCRATS MAKE THEIR LIVING!

Saturday, December 09, 2006

Phage Therapy & Superbugs

Death by superbug - the gift of death we keep on giving – too often unnecessarily!

Never before has the superbug crisis been described so eloquently in so few words than in a recent article entited, "Hospital scourge: Millions of patients are infected by bacteria, and may die", which appeared in the Globe and Mail, Sept. 30, 2006; but now that the problem has been described we need solutions!
The absurdity of the superbug crisis consists of the fact that it can be demonstrated that we had technology, namely bacteriophage therapy, long before we created the antibiotic-resistance superbug crisis through massive abuse of antibiotics and other antimicrobials. Additionally many politicians, bureaucrats, scientists and members of the public health community are or should be well informed about phage therapy which can cure many superbug infections. In spite of a voluminous literature attesting to the scientific validity and medical effectiveness of phage therapy (see http://www.phage.org and find phage therapy references), there are still phage therapy deniers who would resist the careful deployment of these weapons of mass-destruction for specific pathogens in the war with superbugs. Superbugs are winning most battles with an estimated 17 million human casualties due to microbial infections worldwide annually ( 17 million is roughly half the population of Canada or California; the total casualties of WW II are estimated to have been 55 million in about 6 years - superbugs kill more people every 4 years) . Many of these infections are acquired by patients after entering hospitals for unrelated illnesses, making hospitals significant killing fields in the war with superbugs. In Canada as many as 30 patients are dying of such infections daily and we have known the magnitude of the problem at least since the early 1970's when Ottawa bacteriologist Dr. J.C. N. Westwood was on the conference and media circuit with essentially the same message that is reflected in current papers and news reports ( J.C.N. Westwood, Current National Patterns - Canada, Proceedings of the International Conference on Nosocomial Infections, Center for Disease Control, Aug. 3-6, 1970, 17). Nothing has significantly changed unless we consider the worsening of the problem as success!
What is Phage Therapy? Prior to the discovery and widespread use of antibiotics, bacterial infections were treated worldwide by the administration of bacteriophages. Bacteriophages or phages are highly specific viruses that invade bacterial cells and, in the case of lytic phages, disrupt bacterial metabolism and cause the bacterium to die. Interestingly it was the French-Canadian microbiologist, Felix d'Herelle, while working at the Institute Pasteur in Paris in 1917 who is credited with discovering and promoting phage therapy. While the use of phage therapy was discontinued in the West soon after the discovery of antibiotics they continued to be utilized in Eastern Europe and today many infections untreatable with antibiotics can be treated in clinics in Georgia (Europe) and Poland. Once one accepts the fact that it requires microscopes to see the world of bacteria and bacteriophages, phage therapy may be compared to any biological control methodology and can conceptually be described as: What a cat is to a mouse the right bacteriophage is to a specific bacterium or superbug. Phage therapy has been going on in nature as a balancing force in the evolution of microbes for a long time. Medical phage therapy is simply the intervention of humans to ensure that the balance is in favour of bacteriophages over susceptible bacterial pathogens! While there is considerable expertise on phage therapy in Canada at the research level as can be substantiated by googling phage therapy ("pages from Canada" only), medical phage therapy is not currently approved or practised in Canada; however, according to a letter signed by the former federal health minister phage therapy can be made available legally to Canadian patients under the Special Access Program of our Food & Drugs Act! A discussion of phage therapy is currently very timely, not only because too many Canadians are dying of superbug infections; but also because of the recent release of the Canadian film: Killer Cure: The Amazing Adventures of Bacteriophage and the June 2006 release of the English book by Thomas Haeusler entitled Viruses vs. Superbugs, a solution to the antibiotics crisis? ( see http://www.bacteriophagetherapy.info ) - both are available at Ottawa libraries. Additionally, the record of an excellent question-and-answer session with Dr. Roger Johnson of the Public Health Agency of Canada can be found at http://meristem.com/topstories/ts06_08.html . Further, the phage therapy file has dramatically changed during the last few weeks because the US Food and Drug Administration (FDA) has amended the US food additive regulations to provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes (see http://www.fda.gov/OHRMS/DOCKETS/98fr/02f-0316-nfr0001.pdf ). This excellent submission evaluation changes the scientific validity of phage therapy from Eastern European science, which sadly too many of us Westerners dismiss with hubris and bias as not credible, to approved and supported by the all-knowing and all-seeing FDA at least for ready-to-eat meats. Otherwise the US situation is similar to the Canadian situation - much expertise at the research level but no human treatment, which is a pity.
Superbugs are everybody’s business because superbugs make everybody their business and every North Americans should study the above references because sooner or later everybody will be faced with an infection or know a relative or friend who will be suffering or dying with one. Withholding such treatment from patients when antibiotics are failing ought to be a crime; however, those who have the money and time to travel when faced with an infection where antibiotics are failing may be able to get phage therapy treatment in Georgia ( http://www.phagetherapycenter.com ) or Poland - http://www.aite.wroclaw.pl/phages/phages.html .