Monday, December 14, 2009

Tamiflu Resistance and The Fall of H1N1 Drug Companies

We track all H1N1 companies live here. These companies had been up hundreds of percent earlier this year and have taken a beating recently, as we expected (and wrote about). This was the situation in October:

And this is the status today:

(CHIP was sold.) Note the declines since October.

You may receive technical analysis and alerts of these companies sent automatically to you, by entering the symbols in the Technical Trend Analysis Tool. Here is the current ROI:

Coincidentally with the drop of these H1N1 companies has been the news of Tamiflu resistance. Ilene, from Phil's Stock World, has an update on H1N1, again speaking to Dr. Henry Niman (Harvard/Massachusetts General Hospital and Research Associate at the Shriner’s Burn Center). She discusses several timely topics which directly affect a couple of the companies above:

"The Emergence of Tamiflu Resistance"

The swine flu virus has been increasing showing changes leading to greater incidences of Tamiflu resistance, but this being downplayed by the CDC and WHO. The CDC recently issued this CDC report:

A total of 29 cases of oseltamivir resistant 2009 influenza A (H1N1)
viruses have been identified in the United States since April 2009. In specimens
collected since September 1, 2009, 19 cases have been identified in the United
States, including three newly identified cases since last week. The proportion
of oseltamivir-resistant 2009 H1N1 viruses does not represent the prevalence of
oseltamivir-resistant 2009 H1N1 in the U.S. Most cases were tested because drug
resistance was suspected. All tested viruses retain their sensitivity to the
neuraminidase inhibitor zanamivir. Of the 29 total cases identified, 19 patients
had documented exposure to oseltamivir through either treatment or
chemoprophylaxis, eight patients are under investigation to determine exposure
to oseltamivir, and two patients had no documented oseltamivir exposure.
Occasional development of oseltamivir resistance during treatment or prophylaxis
is not unexpected. Enhanced surveillance and increased availability of testing
performed at CDC are expected to detect additional cases of oseltamivir
resistant 2009 influenza A (H1N1) viruses, and such cases will be investigated
to assess the spread of resistant strains in the community.

According to Dr. Niman, the CDC and WHO typically use these types of announcements for propaganda. The information is factually correct, but extremely misleading. Most patients give a sample prior to treatment and in most cases CDC or WHO can determine if the H274Y marker was present prior to treatment. However, they don't even have a category for those who are initially H274Y positive and then get treated, like the Vietnam cluster.

When there is a small population of drug-resistant viruses co-existing with the wild-type, drug-sensitive viruses, exposure to the drug kills off the sensitive population while allowing the resistant viruses to flourish. In cases testing positive for the H274Y marker, the vast majority of patients has been infected with H1N1 virus with the H274Y marker before treatment, or develops H274Y within a few days. This suggests a pre-existing sub-population is being selected. Data withheld by the CDC and WHO would likely reveal this, destroying the "spontaneous generation" theory, which the CDC, WHO and Roche promote. These propaganda pieces are not only designed to hide the true level of H274Y in the absence of Tamiflu treatment, but also hide the fact that "spontaneous" H274Y mutation is a pure fantasy. The emergence of Tamiflu resistance is NOT due to random mutation.

For a more detailed account, read Dr. Niman’s article Tamiflu Resistance Spike in US Raises Transparency Concerns, Recombinomics, December 14, 2009:
[The CDC report (week 48, above)]
announces three more cases of Tamiflu resistance in the US. This number
matches the increases for each of the past 3 weeks and brings the total for the
past 4 weeks to 16, which is much higher than previous weeks, which usually had
0 or 1 new cases. This recent spike in cases has also been reported by WHO
and raises concerns that H274Y is efficiently transmitting. Moreover,
recent deaths of patients with H274Y in the US (four of ten) and
the Netherlands (four of eleven) have raised concerns that patients with H274Y also have D225G, which has been associated with fatal cases in the US, Ukraine, Norway, Brazil, and France. Moreover, patients with D225G coupled with H274Y have been reported in France and the United States.However, the CDC report does address those concerns because critical data has been withheld. In week 48 the number of
samples tested for H274Y spiked higher, but there is no indication of these are
recent samples or an update of surveillance done on samples collected in the
spring or summer. Similarly, the location of these cases or outcomes are
not given, and there is no indication that patients who developed resistance
during treatment are distinguished from patients who were resistant prior to
treatment, but fell into the "suspect" category because they failed to respond
to Tamiflu.The Vietnam cluster described in this week's New England Journal
of Medicine that would represent such cases. Seven passengers on a train
developed H1N1 infections that had H274Y. However, like most patients worldwide,
the resistance was not discovered until long after treatment and
discharge. The infections were in July, but the first lab confirmations
were in September. Although Tamiflu treatment is not effective against
H1N1 with H274Y, all patients recovered, but clearly represented infections of a
fit and readily transmissible H1N1 with h274Y.
However, using the CDC classification system, these patients would have "documented exposure to Tamiflu" but would not be examples of resistance that developed due to treatment. Although this is the CDC's largest category, they have yet to show a single example of a case that developed resistance after prolong
treatment with Tamiflu. They have described two immuno-compromised patients in Seattle who initially tested as wild type and became H274Y positive during treatment, but one developed resistance between day 4 and 11 of treatment, while the second became positive between days 1 and 18. Results on samples collected on days 3 and 6 were not disclosed, leaving open the possibility that resistance was present on day 2 of treatment, supporting the transmission of a significant sub-population, which is easily detected after a few days of Tamiflu treatment...The failure of the CDC to report any patients who developed H274Y after prolonged treatment, and the efficient transmission of H274Y in Vietnam in July, raise concerns that the weekly reports by the CDC are carefully designed to withhold key information such as the H274Y status prior to treatment, the dates and locations of samples, as well as outcomes of patients who are H274Y positive.This lack of transparency continues to be hazardous to the world's health.

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neroden@gmail said...

Clarification on evolution and natural selection.

Drug resistance appearing in one person is *always* due to a random mutation. The *spread* of resistant strains is due to the drug wiping out the *nonresistant* strains. Without the drug doing this, the resistant strain would generally be outcompeted by the nonresistant strain and would not spread far.

This is basic natural selection.

ilene said...

Dear Neroden, the current popular theory is that tamiflu resistance is developing as (multiple times, in multiple places) as a random mutation. Dr. Niman argues that this is incorrect, that the genetic change conferring tamiflu resistance is present in low levels in the circulating viral pool and by a process of recombination, it quickly spreads - much quicker than would be expected if relying on sporadic mutations randomly occurring. Read the full article and more at Dr. Niman's site for a deeper explanation and evidence presented to support his argument in favor of recombination as a mechanism for change.

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