Sunday, October 04, 2015

The Lancet: WHO Estimates That 50% Of Drugs For Sale Online Are Fake



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It’s a story we’ve covered before (see Study: Substandard & Falsified TB Drugs & Interpol & FDA: Operation Pangea V), but according to experts, it is getting worse:  The rise in fake, or substandard prescription drugs, often sold via online pharmacies.  


Some of these drugs have none of the promised active ingredients, while others may be less potent than advertised, or are laced with potentially dangerous substitutes or fillers. Often more money is spent trying to duplicate the packaging of a legitimate product, than is spent producing the medicine itself.


And the end result can not only be tragic for the user – but also to society – as using substandard medicines is one of the ways that drug resistant bacteria, viruses, and parasites can be created and spread.


A prime example, In 2012, in FDA Warning On Fake Adderall we learned that some of these drugs don’t even come close to containing what they advertise:


FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.


And if you think buying from a `Canadian online pharmacy’ is some kind of guarantee that you won’t get ripped off, know some of those are just web fronts for illegal pharmacies operated around the globe.  

Yesterday The Lancet published a long report on the spectacular growth of fake online prescription drugs in:


Rise in online pharmacies sees counterfeit drugs go global

Fiona Clark 



In high-income countries it might not be at the forefront of every practitioner's mind, but the rise of online pharmacies in Europe and the USA could change that. WHO estimates that 50% of the drugs for sale on the internet are fake and even though the online dispensaries might look legitimate, a survey of 10 000 of them done by America's National Association of Boards of Pharmacy (NABP) found that 9938 did not comply with NABP patient safety and pharmacy practice standards or US state and federal laws. Most said they were based in Canada but were really a front for illegal offshore operations.

. . . .

WHO puts the annual death toll from counterfeit drugs at around 1 million. The largest single group is in Africa where around 200 000 people are said to die each year as a result of fake antimalarial drugs. In the USA, in the late 2000s, 81 people died from using an adulterated heparin imported from China and another 68 lost their lives in other parts of the world.

(Continue . . . )



Unless you are buying your prescription drugs from an unscrupulous online pharmacy, Americans are most likely to encounter these fake or substandard medications while traveling to developing countries.  The CDC’s Traveler’s Health website offers the following advice.

Counterfeit Drugs

Bottle of pills

Counterfeit (or fake) medicines are manufactured using incorrect or harmful ingredients. These medicines are then packaged and labeled to look like real brand-name and generic drugs. Counterfeit medicines are unsafe because they may not be effective or may even harm you.

Counterfeiting occurs throughout the world, but it is most common in countries where there are few or no rules about making drugs. An estimated 10%–30% of medicines sold in developing countries are counterfeit. In the industrialized world (countries such as the United States, Australia, Japan, Canada, New Zealand, and those in the European Union), estimates suggest that less than 1% of medicines sold are counterfeit.

The only way to know if a drug is counterfeit is through chemical analysis done in a laboratory. Counterfeit drugs may look strange or be in poor-quality packaging, but they often seem identical to the real thing. The only way to make sure you have the real thing is to bring all the drugs you will need during your trip with you from the United States, rather than buying them while you are traveling.

Pills being manufactured

If an emergency occurs and you must buy drugs during your trip, you can reduce your chances of buying drugs that are counterfeit:

  • Buy medicines only from licensed pharmacies and get a receipt. Do not buy medicines from open markets.
  • Ask the pharmacist whether the drug has the same active ingredient as the one that you were taking.
  • Make sure that the medicine is in its original packaging.
  • Look closely at the packaging. Sometimes poor-quality printing or otherwise strange-looking packaging will indicate a counterfeit product.
  • If you buy drugs online, visit Buying Prescription Medicines Online: A Consumer Safety Guide to learn how to buy safely.

Media: Shengzhou Reports 1st H7N9 Case Of The Fall


Zhejiang Province – Credit Wikipedia




Although I can find nothing on the Zhejiang Provincial MOH website, we’ve an unusually detailed report in the local state media ( of what is reportedly China’s first H7N9 case of the fall. China’s H7N9 season doesn’t usually get started in earnest until winter, but this is still a rather late date for the first report of the fall.


H7N9, which spreads silently and asymptomatically in birds, can produce a wide spectrum of illness in humans.  While fewer than 700 human infections have been identified since 2013, this is likely just a subset of the total – the `sickest of the sick’.


Mild or even asymptomatic cases have been detected, and it is assumed that there may have been thousands of such cases that have gone unidentified (see Lancet: Clinical Severity Of Human H7N9 Infection).   Perhaps even tens of thousands.


Worth noting, over the past few weeks Sharon Sanders of FluTrackers, who scours the Chinese and Arabic media every day, has posted a number of media reports of heightened respiratory virus activity in Zhejiang province.  While there is no evidence that any of them have anything to do with H7N9, heavy flu activity may increase the chances that mild H7N9 cases go undetected.


China - 20% growth in pediatric outpatient visits in last 2 weeks at a Hangzhou hospital, Zhejiang province - September 23, 2015

China - Flu, respiratory patients up 3% "more than normal" - Hangzhou, Zhejiang province - September 16, 2015


While we wait for an `official’ confirmation, we have the following media report on the Zhejiang’s first H7N9 case of the fall.


Shaoxing Shengzhou confirmed one case of H7N9 cases has started contingency plans Ningbo, China   2015-10-04 14:32:09 Manuscript Source: Zhejiang News

October 2, Shaoxing Shengzhou confirmed one case of H7N9 cases, this is the first case since the autumn of this year in the city appear.

According to CDC epidemiological investigation, the patient Moumou, female, 62 years old, who lives in the town of Shengzhou three realms. It has purchased two weeks before the onset of breeding, slaughter poultry history. Currently serious condition, is in active treatment.

After the outbreak, Shengzhou people infected with H7N9 government to immediately start working mechanism of joint prevention and control and relevant emergency plans, held a special conference, a clear focus on the prevention and control tasks: First, to strengthen surveillance, diagnosis and treatment of patients with fever specification, unexplained pneumonia patient investigation and Early antiviral treatment work; the second is to do poultry "slaughtering, killing white listing" to regulate the live bird market transaction management; third, to conduct joint special rectification, investigate and punish the illegal trading of live poultry behavior.

Experts advise consumers to ban live poultry trading, the implementation kill white marketed not only the government's requirements, but also to prevent bird flu, pay attention to science healthy lifestyle inevitable choice. We hope that the public changes in consumer attitudes, consumption of chilled poultry products set to kill white listed healthier and more secure scientific ideas.

Meanwhile, the current time when respiratory diseases high season, the public should pay attention to personal hygiene, indoor ground ventilation, fewer trips to places with poor ventilation, do not contact with sick / dead poultry category, careful contact with live poultry, fever, cough, symptoms should go directly to medical institutions fever clinic as soon as possible, and be sure to tell the doctor if there is a history of exposure before the onset of poultry.

(Continue . . . )


A final note:  Official reporting on H7N9 in China degraded significantly last season, with some provinces only reporting aggregate totals in their monthly epidemiological reports.   Recent WHO DON Updates – which are based on information provided by the Chinese MOH – have been disappointingly light on epidemiological data.


While we still continue to see some excellent scientific papers coming out of China on H7N9, our day-to-day feel for what is going on there with the virus is significantly less than what we had during the first two waves.

Saturday, October 03, 2015

9 Killed, 37 Seriously Wounded When MSF Hospital Bombed In Afghanistan


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The pictures and accounts coming out of last night’s bombing of an MSF (Médecins Sans Frontières) hospital in Afghanistan are both tragic and disturbing.   Details on how this happened, or who was responsible, are still emerging. 


CNN reports that the Pentagon is investigating whether a AC-130 gunship operating in the area may have been involved, but the facts of the matter are far from clear.


For now, all we really know is the MSF – which has suffered terrible losses and hardships battling Ebola in West Africa over the past 18 months – has endured yet another tragedy. 

This from their twitter feed.



Philippines: Suspected MERS Case Dies – 12 HCWs In Quarantine



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In what is getting to be a habit in the Philippines, another patient with a suspected novel virus infection has died, but was not tested for the suspected pathogen, leaving the question of their disease status open.  


Earlier this year (see Philippine DOH Statement On Suspected Imported Avian Flu Case) we saw an Overseas Filipino Worker (OFW) recently returned from China who displayed symptoms consistent with bird flu - but the DOH never actually confirmed the diagnosis - opting instead for a quick cremation to `end the threat’.


Today, we’re learning that a Saudi National, recently arrived in the Philippines, fell ill with MERS-like symptoms on Sept 26th and died on the 29th.  During the patient’s brief hospitalization, apparently no one took samples for MERS testing, and the patient’s remains were quickly repatriated to Saudi Arabia for quick burial.


DOH: Saudi national with MERS-CoV symptoms dies

October 3, 2015 11:28am

(Updated 12:20 p.m.) The Department of Health (DOH) on Saturday announced that a Saudi national who arrived in the country last September 17 and showed symptoms of the Middle East Respiratory Syndrome-coronavirus (MERS-CoV) has died.

Health Secretary Janette Garin said in a press conference that the 63-year-old Saudi national died last September 29.

Garin said that the Saudi national started showing MERS-CoV symptoms on September 26. The patient asked to be brought to the hospital on September 28 and died the next day.

DOH spokesperson Lyndon Lee Suy clarified during the briefing that they were not able to test the Saudi national and confirm if his death was caused by MERS-CoV.

(Continue . . . )


As the Philippines DOH website is thus far silent on this case, all we have to go on are media reports. 


Assuming these reports are reasonably accurate, the fact that MERS was not immediately suspected (and tested for) in a traveler recently arrived from Saudi Arabia who presented with `fever, cough, and chills’  is less than reassuring.

Particularly since the Philippines have already seen two other (confirmed) MERS cases already in 2015. 

CDC: Updated RIDT Guidance - When `No’ Doesn’t Always Mean No


Credit CDC


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With flu season soon to be upon us, the CDC has released extensive updated guidance for clinicians on when to use, and how to interpret the results of, RIDTs (Rapid Influenza Diagnostic Tests) – and just as importantly  - when additional laboratory testing might be warranted.  


The full guidance documents are available at:


The above guidance documents are lengthy, technical, and of greatest interest to medical professionals, but an overview can give us a pretty good idea of their importance. 


RIDTs are popular in-office test kits that are designed to detect Influenza A and Influenza B infections in 15 minutes or so. They are quick, convenient and reasonably inexpensive - but their accuracy has come under scrutiny in the past (see MMWR: Evaluating RIDTs).  


In this 2012 study, 11 commercially available Rapid Influenza Diagnostic Tests that were were tested against 23 flu viruses (16 A & 6  B strains) that have circulated in the United States since 2006. Each virus was tested at five different dilution strengths, in order to gauge relative sensitivity of these tests.


All but one managed to correctly return a positive result at the highest tested viral concentration, but at lower titers the results were highly variable.


The two main measures of the accuracy of a diagnostic test are sensitivity and specificity.

  • Sensitivity is defined as the ability of a test to correctly identify individuals who have a given disease or condition.
  • Specificity is defined as the ability of a test to exclude someone from having a disease or illness.


The CDC has this to say about the accuracy of these tests:


Reliability and Interpretation of Rapid Test Results

Proper interpretation of test results is very important for accurate clinical management of patients with suspected influenza. The reliability of rapid diagnostic tests depends largely on the conditions under which they are used. Understanding some basic considerations can minimize being misled by false-positive or false-negative results.

  • Sensitivities of rapid influenza diagnostic tests are approximately 50-70%, and specificities of rapid diagnostic tests for influenza are approximately 90-95%, when compared with viral culture or reverse transcription polymerase chain reaction (RT-PCR)
  • False-positive (and true-negative) results are more likely to occur when disease prevalence in the community is low, which is generally at the beginning and end of the influenza season.
  • False-negative (and true-positive) results are more likely to occur when disease prevalence is high in the community, which is typically at the height of the influenza season.


In simple terms, if you’ve got classic flu symptoms, but your RIDT comes back negative – and it’s the height of the flu season – there’s still a pretty good chance you have the flu. Note: some of these false negatives may be due to the stage of infection which influences viral load or sample collection methods.


At this point, you may be wondering how doctors are supposed to interpret results from a test that may, or may not, correctly show when a patient has the flu.


It gets pretty complicated, but the CDC provides guidance on not only how to interpret the results, but also under what circumstances they recommend using these diagnostic kits at:


Guidance for Clinicians on the Use of Rapid Influenza Diagnostic Tests


You’ll find several decision tree charts on this page, including the following one which advises whether Rapid Influenza Testing is appropriate during periods when influenza viruses are circulating in the community.




Given only a 50%-70% sensitivity with seasonal A & B flu strains, you might be wondering how well these test kits perform when encountering a non-seasonal (aka novel, swine, or avian) strain or subtype of the flu.  


The results – at least on the swine variant viruses – have been mixed.

In the  Influenza and Other Respiratory Viruses journal  a 2102 paper called Analytical detection of influenza A(H3N2)v and other A variant viruses from the USA by rapid influenza diagnostic tests found:


All RIDTs evaluated in this study detected the seasonal influenza A(H3N2) virus, although detection limits varied among assays. All but one examined RIDT identified the influenza A(H1N1)pdm09 virus. However, only four of seven RIDTs detected all influenza A(H3N2)v, A(H1N2)v, and A(H1N1)v viruses. Reduced sensitivity of RIDTs to variant influenza viruses may be due to amino acid differences between the NP proteins of seasonal viruses and the NP proteins from viruses circulating in pigs.


This year we’ve seen 5 swine variant human infections identified, although given the sparse surveillance and testing, it is very likely this under represents the true number of cases in the United States.  


This winter we’ve potentially a new wrinkle, in that HPAI H5 is expected to return via migratory birds, perhaps in greater volume than we saw last year.


While human infection has not been reported with the strains circulating in North America, that could conceivably change over time (or other subtypes could be imported, such as we’ve seen over the past two years with  H7N9 and H5N1 in Canada).


The CDC advises clinicians to consider additional laboratory testing  (viral culture or RT-PCR) when:

  • A patient tests negative by RIDT when community influenza activity is high and laboratory confirmation of influenza is desired.
  • A patient tests positive by RIDT and the community prevalence of influenza is low, and a false positive result is a consideration.
  • A patient has had recent close exposure to pigs or poultry or other animals and novel influenza A virus infection is possible (e.g., influenza A viruses circulate widely among swine and birds, including poultry, and also can infect other animals such as horses and dogs)


Obviously, better rapid tests are needed.  Not just for common seasonal strains, but ideally for all flu strains.


But until they become available, doctors must carefully weigh RIDT results along with the patient’s clinical signs and symptoms - and level of flu in the community - in order to come up with the best diagnosis.

Friday, October 02, 2015

When H2N2 Predictions Go Viral


Credit ECDC – 125 years of  Pandemic  History


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Over the past 48 hours the Russian (and Eastern European) media have gone a bit wild over a story that quotes Russian virologist Vladimir Blinov as predicting the return of pandemic H2N2 in 2017.  While an eye-catching story, I would be remiss if I didn’t mention that this isn’t the first `aggressive’ pandemic prediction coming out of Russia in recent years.

  • In 2006 Dimitri Lvov predicted 1 billion deaths from an expected H5N1 pandemic (see From Russia, With Lvov (Again)).
  • While Russia’s Chief Health Officer Gennady Onishchenko, all but  predicted a Bird Flu pandemic would hit Russia later that same summer.

The return of H2N2 – the virus that sparked the 1957 pandemic – is a scenario we’ve looked at previously (see Nature: A Preemptive H2N2 Vaccine Strike?), and would not be totally unexpected.


However, when it comes to predicting when and from where, that’s another matter entirely.


Still, the story has gone viral, and I suspect it may show up eventually in English language media, so it is probably worth reviewing the history and our concerns over the H2N2 virus, aka the `Asian Flu’ of 1957.


First though, a couple of links to the avalanche of H2N2 prediction stories.  While the translations are often syntax challenged, the gist is pretty clear.


In 2017 the world could once again face a pandemic of influenza H2N2

October 2, 2015 8:54 flu Author: Evgeny Kovalev

Virologists believe that in 2 years the world can once again visit the pandemic influenza H2N2.

Forecasts of experts, including the head of the department of bio-information «PanaGene Ltd» Vladimir Blinov associated with cyclical virus. H2N2, which first appeared in 1957, returns every 60 years. In 2017 just expected to start a new cycle.

Now scientists are preparing for the development of a new pandemic, developing measures that can minimize potential victim.

(Continue . . . )


In return the deadly 2017 flu caused two million deaths last century

Publicado: 2 oct 2015 09:22 GMT

The next pandemic strain of influenza A H2N2, which caused two million dead in the middle of the last century, could occur in 2017, says virologist Russian Vladimir Blinov.

Blinov believes that the H2N2 strain has already accumulated many mutations and that these continue to appear periodically. "The bearer should be a pig, and the pig will be the H2N2 strain of the virus will appear," Blinov told Interfax  in the context of a scientific conference held near Novosibirsk.

Chances are that the spread of H2N2, as in the case of other influenza viruses, begins in China, because in this country are the largest populations of poultry and pigs, says Blinov.

(Continue . . . )


While these media reports tend to lack much in the way of specifics, this prediction seems to be based on the idea that influenza pandemics (at least over the past 130 years) have cycled through a series of H1, H2, and H3 viruses, with each returning every 60 to 70 years.


The progression has been H2, H3, H1, H2, H3, H1, H1.


H2N2 sparked two pandemics (1898 and 1957) roughly 69 years apart.  H3 viruses unleashed two pandemics (1900 and 1968) roughly 68 years apart, while H1N1 causing the great 1918 pandemic only to return in the pseudo-pandemic of 1977, 59 years later.


This pattern has led some to question whether a non-H1, H2, or H3 virus has the `right stuff’ to spark a pandemic (see Are Influenza Pandemic Viruses Members Of An Exclusive Club?).  An interesting theory, but 130 years is but a brief glimpse of influenza’s history, making any firm conclusions impossible at this time.


Past performance is often a spectacularly poor predictor of the future, particularly when the data set is so limited.  So a heavy dose of Caveat Predictor is probably in order here.


Still, H2N2 is on our radar screen, because it still circulates in the wild, and as the decades go by the number of people born after its last appearance (1967-68) – and therefore lacking antibodies to this virus – increases.

In 2012, in  in H2N2: What Went Around, Could Come Around Again, we looked at the results of a study conducted by scientists working at St. Jude Children's Research Hospital published in the Journal of Virology, that takes the most detailed look at H2N2 viruses in the wild to date, and concludes that this virus could well pose a threat to humanity again.


A press release on this research warned:


1950s pandemic influenza virus remains a health threat, particularly to those under 50

St. Jude Children's Research Hospital scientists report that avian H2N2 influenza A viruses related to 1957-1958 pandemic infect human cells and spread among ferrets; may aid identification of emerging threats

(MEMPHIS, TENN. – December 3, 2013) St. Jude Children's Research Hospital scientists have evidence that descendants of the H2N2 avian influenza A virus that killed millions worldwide in the 1950s still pose a threat to human health, particularly to those under 50. The research has been published in an advance online edition of the Journal of Virology.

The study included 22 H2N2 avian viruses collected from domestic poultry and wild aquatic birds between 1961 and 2008, making it the most comprehensive analysis yet of avian H2N2 viruses.

Researchers reported the viruses could infect human respiratory cells. Several strains also infected and spread among ferrets, which are susceptible to the same flu viruses as humans. Based on those and other indicators, one virus was classified as posing a high risk for triggering a pandemic.

(Continue . . . )

Pandemic predictions make good news stories, I suppose. But since we can’t even seem to predict how the upcoming flu season is likely to play out,  I’m not inclined to give them much weight.  There simply way too many variables, of which we know far too little. 


I personally prefer to operate under the assumption that whatever happens with influenza six months or a year down the road, we’re going to be surprised.   


Still, H2N2 is considered viable pandemic concern, and given we’ve seen it twice over the past 125 years, it wouldn’t be all that unusual if we see it again . . . perhaps even relatively soon.