Tuesday, September 20, 2016

We don't know if it works or is safe--but don't let that stop you, Doctor. Push Gardasil

WebMD Professional
Developed under the direction and sponsorship of Merck.
Helpful information when talking to parents about HPV vaccination

Prescribing Information     Patient Information
When talking to parents about the HPV vaccine…
Focus clearly on cancer prevention
The CDC suggests:
Consider telling parents that HPV vaccination is about cancer prevention: cervical, vaginal, vulvar, and anal1
Example:
"HPV can cause certain cancers, and the vaccine helps prevent HPV-related cancers and diseases caused by 9 types. I want to help protect your child from these cancers."
CDC=Centers for Disease Control and Prevention.
Indication
GARDASIL 9 is a vaccine indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 26 years of age for the prevention of anal cancer caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
(Indication continued below)

Select Safety Information
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
(Select Safety Information continued below)
Learn more about how to clearly recommend
HPV vaccination in your office ▶

Saturday, July 30, 2016

The case of the vanishing pandemic: Deadly bird flu flies the coop in the US/ Ars Technica

Remember when we kept on hearing that the next big disaster was going to be avian (bird) flu?  Well, bird flu petered out and instead of jumping to humans jumped into a black hole.  The lack of flu vaccinations for farmed chickens and ducks in North America may be key.  The following excerpts come from Ars Technica :
  • The case of the vanishing pandemic: Deadly bird flu flies the coop in the US
  • Scientists puzzled by disappearance, but think lack of vaccination may be key. 
In November of 2014, a highly pathogenic strain of bird flu derived from Eurasia called H5N2 popped up in North America—in a Canadian turkey farm east of Vancouver, to be exact. From there, the virus quickly spread and mutated into new varieties, including H5N1, fanning fears it would vault to humans and cause a deadly pandemic. By March of 2015, it and its kin had swooped into 15 US states, causing 248 outbreaks in domestic birds and $5 billion worth of damages to poultry operations.Then, it vanished. 
…In a controversial twist, it may mean that bird vaccines, which aren't used in the US, are boosting potential pandemic flu viruses in other places of the world.

Webster and his team didn’t find any of the high-pathogenic H5N2 viruses in the wild US birds, nor any of the virus’ hybrid offspring… wild water fowl in the US had not tested positive for a highly pathogenic H5N-something virus once in the 43 years prior to the outbreak.

Webster hypothesizes that the garden-variety flu viruses essentially elbow out the highly pathogenic ones. So, when those nasty varieties move into wild bird populations, they don’t stay long. 
But, if Webster is right, it raises more questions about why and how some places, particularly in Asia, continually see the spread and maintenance of those highly pathogenic flu viruses in wild birds. And this is where vaccines come in to Webster’s hypothesis. 
Flu vaccines for domestic birds don’t always completely block the virus. In a small number of vaccinated birds, highly pathogenic flu viruses can still get a foot in the door and cause an infection. But those infections are mild, more like seasonal flus—unnoticeable to poultry farmers and perhaps even the bird. However, those domestic birds will still poop and shed massive amounts of highly pathogenic viruses. And those viruses can then continually be picked up by wild birds. 
In many places in Asia, poultry farmers clamor for vaccinations. But, in the US and Europe, which don’t see the same levels of highly pathogenic viruses, vaccines aren’t regularly used.

Instead, the US Department of Agriculture adopted a system of monitoring, quarantining, and culling.  It’s expensive, Webster noted, but it may be the best way to squash a potential pandemic.

Leaks Show DNC Asked White House to Reward Donors With Slots on Boards and Commissions

Political Corruption comes in many forms.  Here is just one of them--Meryl
by Alec Goodwin, Center for Responsive Politics

Email exchanges involving top officials at the Democratic National Committee released along with private documents by WikiLeaks show that DNC officials hoped to reward top donors and insiders with appointments to federal boards and commissions in coordination with the White House.
The revelations give an inside look into how the Democratic Party attempted to leverage its access and influence with the White House to bring in cash.
In an April 20, 2016 email, DNC National Finance Director Jordan Kaplan canvassed what appears to be the committee's finance department -- its fundraising office -- for names of people (mainly donors) to reward with federal appointments on boards and commissions.
That email exchange yielded a list compiled by DNC Finance Chief of Staff Scott Comer and emailed to Kaplan on April 26 titled "Boards and Commissions Names_Final," which listed the names of twenty-three DNC donors and insiders.
Kaplan emailed the list to Amanda Moose, special assistant to the president for presidential personnel, later that day. In an email without a subject line, Kaplan wrote just one line: "For your review," seemingly referring to a previous conversation or exchange.
Then on April 28, Kaplan missed a call with Moose. He emailed Comer asking for Moose's number that afternoon, presumably to call her back. Comer sent Kaplan the number. It's unclear if Kaplan and Moose spoke.
But the two may have spoken several days later; a May 3 email from Comer to Kaplan shows that Moose wanted to set up a "20 minute conversation" with Kaplan.
None of the individuals on the list have been appointed to boards or commissions since the email exchanges took place almost three months ago. A few were named to slots in previous years.
The White House strongly denied any link between financial support for the party and appointments.
"Being a donor does not get you a role in this administration," said White House spokesman Eric Schultz in an email to OpenSecrets Blog, "nor does it preclude you from getting one. We've said this for many years now and there's nothing in the emails that have been released that contradicts that."
The people on the list weren't just hefty donors to the DNC; many also gave big money to Obama.
The practice of rewarding big donors with federal positions dates back to the times of the founding fathers.
Bob Biersack, who spent 30 years at the Federal Election Commission and is a senior fellow at the Center for Responsive Politics, said that "Big donors have always risen to the top of lists for appointment to plum ambassadorships and other boards and commissions around the federal landscape. This example shows that party fundraisers continue to see these appointments as an important tool in the donor maintenance process."
Most of the people on the list gave huge sums to the Democratic National Committee, as well as the party's primary fundraising arms for its congressional candidates: the Democratic Congressional Campaign Committee (DCCC) and the Democratic Senatorial Campaign Committee.
As the table shows, the people whose names were on the list for possible federal appointments are big donors to the DNC, hold important positions there, and/or are big donors to Obama.
Many on the list bundled for the Obama campaign and are bundlers for Democratic nominee Hillary Clinton. Notably, the individuals on the list gave significant sums to Clinton and none to Bernie Sanders.
Wade Randlett, also who formed the Democratic PAC, was appointed to the Advisory Committee on Trade Policy and Negotiations in 2014. Another on the list -- Shekar Narasimhan -- was appointed to Obama's Advisory Commission on Asian Americans and Pacific Islanders in 2014. David Shapira, CEO of supermarket company Giant Eagle, was nominated to be on the board of governors of USPS by Obama in 2014, but the nomination was blocked by Congress.
In the emails leaked by WikiLeaks, Kaplan wrote "this is the last call for boards and commissions; if you have someone, send to Comer -- full name, city, state, email and phone number."
"Send as many as you want, just don't know how many people will get to," Kaplan wrote in an email sent April 20 to what appears to be the DNC's finance department.
Comer clarified in a later email, "Any folks who you'd like to be considered to be on the board of (for example) USPS, NEA, NEH. Basically anyone who has a niche interest and might like to serve on the board of one of these orgs."
These emails appear to show that DNC finance staffers -- the DNC's fundraising staff, in other words -- could suggest people they felt should be rewarded with federal appointments.
Responding to another question, Comer wrote "I should say, though, that the likelihood of landing a spot on ones as prestigious as NEA/USPS is unlikely. It's much more likely they'll get something like 'President's Commission on the Celebration of Women in American History.' (no shade to women)." In that same email, sent on April 21, Comer also said "when you submit your names, we don't need specific designations."
Comer's statements imply that the DNC could neither guarantee any specific position nor ensure that a person suggested would receive an appointment at all from the Obama administration.
Reached at her office in the White House, Moose said she was not authorized to comment. OpenSecrets Blog did manage to contact Kaplan, but he hung up after realizing it was a reporter. Comer directed our request for comment to a political consultant, who forwarded it to the DNC, which did not respond by press time.
The list was first reported on by the Daily Caller, a conservative news organization. The Caller article implied that the documents and emails showed Clinton traded appointments for donations. But the publication did not note the direct coordination with the Obama administration shown in the emails. 

Friday, July 29, 2016

The Bizarre US Pharmaceutical Market




I wrote an Op-Ed for the Portland, Maine Sunday Telegram about my bizarre journey trying to get a prescription filled.  It was published August 7, 2016. Here it is.

http://www.pressherald.com/2016/08/07/maine-voices-drug-costs-should-make-you-blink/


ELLSWORTH — Pricing of and access to medication are handled in an insane manner in the United States. It has been said that between 20 and 30 percent of prescriptions are never filled, presumably because of cost or access issues.

Comparing plans is nearly impossible, because drug tiers, co-pays, deductibles and coinsurance vary from plan to plan and drug to drug. Those with high drug costs on Medicare are likely to fall into the dreaded “doughnut hole,” in which all pharmacy benefits go away, until you have reached an out-of-pocket limit of thousands of dollars.

The complexity almost seems designed to trap the unwary into paying more. Why must things be so complicated, and seemingly, so arbitrary?

My own recent experience is instructive.

I went to Walgreens to refill a prescription for zolpidem. The prescription was valid, but my insurer, Humana, refused to pay for it. I was informed by Walgreens that I could alternatively pay about $200 cash to fill the prescription. Instead, I purchased seven tablets for $17 cash, buying me a week to sort out the problem.

TAKE THAT, WALGREENS!

After 90 minutes on the phone with six Humana staff (who provided me several incorrect explanations for their refusal to pay for the prescription), I was finally able to learn that my private Humana Medicare part D policy limits me to only 90 tablets a year of zolpidem. However, they might allow more with a prior approval. No guarantees.

It was suggested that I ask my doctor to fill in their form and wait to see if it was approved. Since my doctor was away, and it was not apparent whether the process would be successful anyway, I asked Humana to send me the form but kept searching for another solution. (P.S.  Two weeks later, I am still waiting for the form to arrive.)

I was aware of several startup companies that are taking advantage of the huge profits to be made in pharmaceutical sales. Their business model relies on negotiating low prices with pharmacy chains because the startups can provide patient volume. Even though the prices paid are very low, both the pharmacy chain and the startup make a profit.

So I went to Blink Health online to see what they offer. For the grand total of $8 I could fill the prescription that Humana refused to fill and that Walgreens was going to charge me $200 to fill (in the absence of a Humana approval).

Blink charged my credit card $8 and allowed me to print a page (or bring a picture of the page on my phone) to Walgreens, or any one of 19 other pharmacy chains, to collect my prescription.

Wow! I could hardly believe this would work, but I was excited to try it. I gave Walgreens the $8 piece of paper and easily collected my three-month prescription without paying a penny more.

This cost me less than the Humana co-pay would have been.

In my view, it is unacceptable that Humana has given itself the right (with government approval) to decide that some physician prescriptions for its insured patients should be covered for only three months each year. Clearly, this sets up patients to be price gouged, because in my case, anyway, the prescription would still need to be filled for the other nine months.

PRICE GOUGING ENABLED

It is also unacceptable that a medication on which Walgreens and Blink presumably make a profit at $8 is nonchalantly sold for $200 cash to those patients not savvy in the ways of the system.

Why do we Americans accept this treatment? Why has our government created systems that encourage it? I am a Medicare patient, and all of the above has been Medicare-approved.

No wonder health care costs over $10,000 per patient per year in the United States.
If I weren’t a doctor, used to searching the internet, and had not kept looking for ways around this conundrum, most likely I would be without my medication this week. How many of my patients are without theirs?

Thursday, June 2, 2016

Why did the DOE's Lawrence Livermore National Lab produce a 2015 study suggesting that anthrax was NOT used as a bioweapon in Rhodesia's civil war?


Rhodesia is no more, having been renamed Zimbabwe after it became a majority-ruled black nation in 1980. Rhodesia was a British territory before 1965, when the 5% white minority seized control to preclude Britain granting majority rule.  A civil war ensued, with the two sides divided by race.  By the war's end in 1980, the black "guerrilla" "terrorist" "communist" side had been attacked with chemical and biological weapons including organophosphate "nerve gas," rat poison, cholera, anthrax and arguably other chem-bio agents.

I was first to publicly identify this anthrax epidemic, which killed at least 182 people and affected 10,000, to be an act of biological warfare, in 1992.  Subsequently much literature (scientific, historical and memoir, originating from Zimbabwe, South Africa, the UK and US) has amplified the evidence base and added details, though much remains hidden. Of interest, this confirmatory literature includes a report from the US Naval War College and US Air War College, and a book and related episode of BBC TV's Panorama.  The history of anthrax biowarfare in Rhodesia seemed incontrovertible.

US DOE's Lawrence Livermore National Laboratory takes aim at this history, misses widely

I was forwarded a report produced in 2015 by a scientist at Lawrence Livermore National Laboratory (LLNL), disputing that the Rhodesian anthrax epidemic was due to biological warfare. The study was published by LLNL, rather than in a peer-reviewed journal, yet it required considerable resources to produce. The report ran to 43 pages and 56 footnotes.

To make the case the epidemic occurred naturally, the report's author, Stephan P Velsko, employed a method he termed "opinion calculus," by which he transmuted the actual facts of the epidemic into opinions and (often incorrect) assertions. He then assigned weights to the opinions and assertions (the weights being his opinions) and used a mathematical construct, Dempster-Shafer theory, to impart a scientific veneer to the gobbledygook calculations.

Unable to marshall any evidence to support his conclusion that biological warfare did not occur, Velsko jettisoned all the existing evidence to instead favor the absence of evidence, claiming,  "Many items of evidence that have been proffered over the years are shown to be nearly irrelevant to the final conclusion, while the absence of certain expected types of evidence plays a critical role in the assessment." 

Here are three examples of Velsko/LLNL's arguments:

1.  Although anthrax cases were required to be reported in Rhodesia, Velsko disputes the meaning of the huge size of the epidemic, suggesting it was inflated by poor quality reporting.  While reporting rates for any rare disease always increase as doctors become more familiar with it, Velsko never mentions the fact that the Rhodesian event remains, by far, the largest anthrax epidemic in world history.

2.  Velsko denies that the epidemic jumped from district to district in a geographic and temporal pattern unknown to other anthrax epidemics, twisting the history. He claims instead that the epidemic was localized to one epicenter, with nearby peripheral cases caused by transport of meat.  In order to make this claim, he omits the considerable evidence of when and where cases occurred.

However, I previously recorded the dates and locations of cases using Zimbabwe's public health records and other sources.  Below is a new photo of the map I annotated in 1992 with multicolored stars for reported anthrax case locations, and numbers of cases, where known.  Some of the stars have gone missing, but it should be obvious that cases were identified widely within Zimbabwe's borders (marked in yellow).  Visible, but more difficult to see, are the case numbers which, despite Velsko's claims, were considerable from east of Harare to northwest of Bulawayo. Additionally, the star colors indicate the temporal movement of the epidemic to new areas over a 2 year period, a feature unique to this epidemic.



3.  Velsko challenges the validity of an ex-Rhodesian intelligence officer's report, simply because anthrax spores were referred to as "spoor." Velsko writes, "the mistaken use of the term “spoor” instead of “spore” leads one to suspect that the author of the letter did not have direct experience with B. anthracis, and was at best quoting others."  However, "spoor" is the correct term in the Afrikaans language (spoken by the white Afrikaaners of South Africa) for spore, and in common use to denote anthrax.  While I don't expect Velsko to know Afrikaans, his argument encapsulates the confluence of ignorance and flawed reasoning that characterize the entire report.

Although I could go on about the misleading claims and suppositions in this "study," the real question of interest is why did the DOE's Lawrence Livermore National Laboratory, a storied federal center for studies of nuclear, chemical and biological weapons, including anthrax, choose to dispute that anthrax biowarfare took place in Rhodesia?  Why now, 37 years after the event, and 23 years after my paper was first published?

Velsko is a math and microbial forensic guy who has written on techniques for establishing the forensic origin of disease.  He has also written on the anthrax letters, and on scientific validation in microbial forensics.  I don't think he is a fool.  Is he a knave?

Did Velsko/LLNL simply choose to experiment with a new technique, and picked the Rhodesian anthrax epidemic to study, randomly?  If so, why choose a technique that heaps guesswork on guesswork, while ignoring the available data?  That ain't science and I'd wager Velsko knows it.

Why was this report written?

The report's conclusion, that Rhodesia's anthrax epidemic was probably a natural occurrence, may be the first volley of an effort intended to alter history.  Why would a US government lab want to do this, unless the US government had some involvement in that history?

Here's another scary possibility:  the US government finds itself stymied by the existence of a method that can distinguish whether an epidemic is deliberately caused, or a natural occurrence.  A major reason to use a biological weapon is that the resulting epidemic will be assumed to be natural, and go undetected as an offensive act.  A further reason to use a biological weapon is that it is almost impossible to detect who did it.  [Consider the anthrax letters attack and that we still lack proof of their perpetrator.] Velsko and LLNL know this:  this is their field, after all.

Might Velsko and his employer LLNL/DOE/USG be trying to weaken the scientific underpinning of biowarfare epidemic analysis, an analysis that could be used outside US Government-approved channels, to make the investigative techniques appear much softer and less reliable than they really are? Might this be an effort to prevent their future use to detect a biological weapon attack?

Wednesday, May 18, 2016

CDC: Inept. Stupid. Deadly.

Want to learn the newest on screening and managing Ebola?  Screening for Ebola is not an easy task, since many other diseases can look very much like Ebola. But CDC is here to help doctors and other medical professionals with this very challenging, subtle differentiation.
CDC has offered up a video featuring Dr. Knust to give us this important information.  But wait--Dr. Knust is a veterinarian. Huh?  Ebola is not an animal disease.  And Dr. Knust has never (legally) treated a human. Is this the best CDC can do?  Is this a joke or what?  
If you listen to the video, you will find that it acknowledges, but remarkably minimizes, the problem of persisting Ebola virus in patients after recovery.  Dr. Knust mentions there were only "two" documented patients in whom recrudescence of Ebola occurred.  She fails to mention that these "two" were among only a handful of Ebola patients treated in the West: a British nurse (whose recurrence presented as meningitis) and a US-Zimbabwean doctor (whose recurrence presented as an eye infection).  Many African survivors had persisting infections, as evidenced by Ebola virus in semen up to nine months after apparent recovery. We have no reliable data on recrudescence in Africa.  It could have affected hundreds or thousands there.  

Infections have been sexually transmitted following Ebola recovery in Africa.  Minimizing persistent and recurring infections, and failing to screen for them, are shortsighted and make the appearance of a repeat African Ebola epidemic more likely.  
CDC is either criminally misleading or criminally incompetent, giving dangerous, incorrect guidance that doctors are intended to rely on to assess and treat possible Ebola cases.  And, consistent with its horrible record on safety and general incompetence, CDC issues its Ebola guidance through a veterinarian, a profession that cannot legally provide medical advice to humans.
The best thing that could happen to public health in the US would be to shut CDC down and tell its band of merry pranksters to go get a real job.

UPDATE: From USAToday on May 11, after years of CDC keeping it hidden, we learn that CDC has one of the worst regulatory histories in the US, receiving secret sanctions 6 times for safety violations:
"The CDC's own labs also have been referred for additional secret federal enforcement actions six times because of serious or repeated violations in how they've handled certain viruses, bacteria and toxins that are heavily regulated because of their potential use as bioweapons, the CDC admitted for the first time on Tuesday. Before USA TODAY won access to records of the lab suspension, the CDC had repeatedly refused to answer questions about its own labs' enforcement histories.
The revelations show the CDC's facilities are among a small group of biolab operators that have the worst regulatory histories in the country, receiving repeated sanctions under federal regulations..."

Barbara Knust, DVM, MPH
Hello. I am Dr Barbara Knust from the Centers for Disease Control and Prevention's (CDC's) Viral Special Pathogens Branch. I am here today to talk to US clinicians about screening patients with possible Ebola virus disease (EVD) and clinical care for patients who have recovered from EVD (also known as EVD survivors)...

Then she fails to tell us anything about how to do this.  What a sick joke.