Tuesday, April 24, 2012

Emergent plans $108M expansion/ LSJ

From the Lansing State Journal:  The anthrax vaccine manufacturer, with one product and basically one buyer, YOU (your taxes at work) plans to expand.  But sorry, there won't be any new jobs as yet, although Michigan will have to pay its share.   How the state will benefit is unknown.
...Emergent BioSolutions would fund the entire project, Alley said, though it has applied for roughly $6.4 million in local brownfield incentives that would reimburse expenses through 2041. He said the project should generate $3.6 million in new property taxes for local governments. [Over how many years?  And won't EBS require discounts?]

Construction and the scope of the project is contingent upon approval of the brownfield plan, Alley said...
No formal recruiting push is expected as a result of the renovations ...

Study Links Plant Damage to Nanoparticles/NY Times blog

Thanks to Teresa Binstock for this tip--
At left, a radish plant exposed to no copper nanoparticles, and then a range, culminating at 1,000 parts per million at right.
An exposure to nano-scale copper oxide particles stunted the shoots and roots of radishes and two species of rye grass.

Treating sinusitis: Politically incorrect drug resistance due to Pneumococcal vaccine

I have treated so many patients with sinusitis in the last several weeks, I decided to review new guidelines that were issued by the Infectious Diseases Society of America (IDSA) recently on sinusitis.  Wow, the changes were BIG and I had missed them.  Seems the drugs I used to use don't work so well any more.

Everyone has heard about drug resistance.  We had to watch a movie about it in medical school in the 1970s.  It was very important that we not use antibiotics with broader, more powerful antimicrobial effects than necessary.  Else plagues of drug-resistant bacteria would rain down upon us, and we would run out of effective antibiotics.

I got it. Use basic, relatively narrow spectrum antibiotics unless there is a very good reason to use the bigger guns -- like your patient was so sick he might not survive if you picked the wrong drug to start.

Plus, there are very few new antibiotics in the pipeline.

I recently learned that 80% of the antibiotics sold in the US don't treat humans.  These antibiotics are used in animal feed, enabling owners of livestock and poultry farms to crowd the animals together, where they frequently live in their own merdeFDA banned this use of fluoroquinolone antibiotics in 2005, but compliance by industry has been poor.  (Industry can still feed animals other classes of antibiotics.) So FDA will now restrict sales of this class of antibiotic to only those with a veterinarian's prescription, and ask farmers for voluntary compliance in reducing use of other antibiotics, 61 years after first approving this practice. 

Yale's Dr. David Katz notes that the use of antibiotics in farm animals is a bigger problem for drug resistance than doctors choosing the wrong antibiotics.

But back to  sinusitis:  too many of my patients needed a change in antibiotic after 4 days on the first antibiotic.  Good drugs for sinusitis used to include penicillins, cephalosporins, macrolides and sulfa drugs:  four different categories of drugs.  Now they are inadequate, caused by too many resistant Strep. pneumoniae and Hemophilus influenzae, the most common bacteria causing sinusitis.

What now?  IDSA's #1 choice is Augmentin, a very broad spectrum combination of amoxicillin and clavulanic acid.  The clavulanic acid prevents most bacterial resistance to amoxicillin.  This treatment may cause more drug resistance down the road.

But what if you are allergic to penicillin?  Doxycycline or a fluoroquinolone can be used.  Doxy can't be used in children, however.  What else should you use?  Clindamycin plus a cephalosporin, say the guidelines.  But Clostridium difficile infections occur in 1-10% of patients treated with clindamycin.  These can be impossible to treat.  This is not looking good, I realize.

Then it gets worse.  What has happened?  IDSA let the cat out of the bag on page e16:
... both the prevalence of H. influenzae (40%– 45%) and proportion of b-lactamase–producing H. influenzae (37%–50%) (extrapolated from middle ear fluid cultures of children with acute otitis media) have markedly increased among other upper respiratory tract infections since the widespread use of conjugated pneumococcal vaccines...
Whereas S. pneumoniae was more common than H. influenzae prior to 2000, the prevalence of H. influenzae has clearly increased while that of S. pneumoniae has decreased in the post–pneumococcal vaccine era, such that currently they are approximately equal...  (* See IDSA citation below)
Now 30% of Strep pneumoniae are resistant to macrolides, while 30-40% are resistant to sulfa drugs (page e3).  What IDSA didn't delve into was the fact that non-vaccine Strep serotype 19A, which is multidrug resistant, spread throughout the world as the result of the niche created by vaccination with the 7-serotype vaccine.  Recently a replacement pneumococcal conjugate vaccine was licensed that includes 13 serotypes in the US, and varied numbers of serotypes in other countries.  Any unintended consequences have yet to be identified.

The strains of Strep pneumoniae circulating among us have changed as a result of the Prevnar 7 vaccine, and the new strains are decidedly more drug resistant.  I'd rate this vaccine's net value a big negative.

WHO and NIAID list the causes of antibiotic resistance:  agricultural use is last on both lists, and vaccines fail to be mentioned. 

Yet the consequences of this change in resistance patterns are profound.   Now routine cases of sinusitis, earaches, strep throats and pneumonias have become significantly harder and more expensive to treat.  I can't tell you the relative contributions that Prevnar 7 vaccine, prescribing errors and antibiotic feeding make to this mess.  But the serious unintended consequence of Prevnar 7 (the 19A proliferation) needs to be fully grasped, and the lesson absorbed, in order to avoid making a similar mess with other vaccines.

* Casey JR, Adlowitz DG, Pichichero ME. New patterns in the otopathogens causing acute otitis media six to eight years after introduction of pneumococcal conjugate vaccine. Pediatr Infect
Dis J 2010; 29:304–9.

Monday, April 23, 2012

Another request for inquest for David Kelly

From Dr. Stephen Frost, one of the doctors making this request of the Attorney General:
I am one of the doctors who have been fighting for an inquest into the suspicious death of Dr David Kelly in July 2003, pointing out that due process of the law has been subverted by four successive UK governments, including the present, by their not allowing, using a variety of highly dubious tactics, the legally required inquest to take place.  
Because of the increasingly obvious anxiety, even desperation, of successive governments to block a formal inquest and the disingenuous reasons given for not holding an inquest, many fear that there has been a cover-up of epic proportions and many others have wondered what it is that is so important to hide that precludes an inquest taking place.
There are some who suspect that Dr Kelly was murdered and of course without an inquest that possibility has not been excluded.  If he was murdered by the state, or with the knowledge of the state, and the murder has been covered up, that would constitute criminalization of the state and would fatally undermine trust, and the notion of democracy, and the delicate relationship of those who govern and those who allow themselves to be governed.
In normal circumstances, in England and Wales, a coroner holds an inquest into a suspicious death.  There appears to be no intention to hold an inquest into the death of Dr David Kelly.  This is a unique and unacceptable state of affairs.  At medical school we were taught that without coroners and inquests nobody is safe.  The Coroner speaks for the dead to protect the living...

Saturday, April 21, 2012

Rise in paralysis cases after polio vaccine

Thursday, April 19, 2012

Ireland: Narcolepsy rate 13 fold higher after Pandemrix/Irish Times etc.

All the Irish papers report on the government's announcement that Pandemrix swine flu vaccine is associated with many cases of narcolepsy.  

The Irish Times reported:
An official report has concluded that an increase in the sleep disorder narcolepsy among young people since 2009 is associated with the swine flu vaccine Pandemrix.
The report, commissioned by the Department of Health, found there was 13-fold higher risk of narcolepsy among children and adolescents who received the vaccine compared with unvaccinated young people.
The results are very similar to those seen in similar studies in Sweden and Finland...
Dr Holohan emphasised that vaccination was very safe. "It is important that the current vaccination programmes continue to protect children and adults against the serious consequences caused by these preventable diseases," he said. 
Yet according to the Irish Examiner
The condition is most prevalent among 13 to 19-year-olds in Ireland. In 2009 it is understood to have affected five in every 100,000.
That means that one in every 20,000 vaccinated Irish children developed a (usually severe) case of narcolepsy.  Yet it is uncertain if the swine flu shots saved any lives.  
The United States has about 80 million children.  During 2009-10, when swine flu was active for nearly the entire year (rather than a brief flu season) 282 children are reported to have died from flu (all strains of influenza).  IN 2010-11 122 US children are reported to have died from flu (all forms).   In 2011-12 a total of 13 (thirteen) children are reported to have died from flu.

On average, in each of the last three years in the US, 1.7 children per million died from influenza (swine flu and other types).

In Ireland, 50 children per million who received Pandemrix vaccine developed narcolepsy.  Would you call that "very safe"?  I'd like to see Dr. Holohan's risk-benefit analysis.  And how would he comment on preventable vaccine injuries from untested vaccines?

Thursday, April 12, 2012

Drug Data Shouldn’t Be Secret/ NY Times

Having dissected the false claims made for Tamiflu, which the US government stockpiled to the tune of $1.5 Billion dollars, Peter Doshi and Tom Jefferson draw some important conclusions about drug data and regulation in this NY Times Op-ED of April 10:
IN the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu — data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission — were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin.
After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica. Independent verification of the data seemed imminent. But more than two years later, and despite repeated requests, we have yet to receive even a single full trial report. Instead, the manufacturer released portions of the reports, most likely a very small percentage of the total pages. (One of us, Tom Jefferson, has been retained as an expert witness in a lawsuit relating to some of these issues.)
This is entirely within Roche’s rights. After all, regulators have never required drug or medical device manufacturers to share their data with independent researchers or academics. They are required to show the information only to the regulators themselves, who treat the data as secret.
Some may argue that, because the Food and Drug Administration approves drugs for the United States market based on these data, this is not a major cause for concern. But the actual use of drugs is often driven by assumptions about drug safety and effectiveness put forth by articles in peer-reviewed journals (sometimes written by doctors affiliated with the drug manufacturers) and clinical practice guidelines that can be entirely inconsistent with the F.D.A.’s assessments.
In the case of Tamiflu, some of these assumed properties led to stockpiling at great taxpayer expense — more than $1.5 billion. The F.D.A. approved Tamiflu for the treatment of influenza (on the basis that it could reduce the duration of flu symptoms by about a day); not for the prevention of transmission. But other agencies are far more enthusiastic about Tamiflu’s benefits. The Centers for Disease Control and Prevention has argued that it reduces the duration of hospitalizations and serious complications like pneumonia, citing Roche-authored papers. The Department of Health and Human Services, also citing Roche, assumed in its national influenza pandemic plan that Tamiflu would cut complications. And the World Health Organization’s pandemic planning assumed that the drug would cut transmission of the virus. But here’s the rub: none of these organizations have vetted the original trial data.
The only agency in the United States that seems to have independently reviewed the original trial data never made these claims. The F.D.A.’s conclusion — which it required Roche to print on Tamiflu’s product labeling — is that “Tamiflu has not been shown to prevent” complications like serious bacterial infections (for instance, pneumonia). It seems that federal agencies like the C.D.C. and H.H.S., instead of conducting an independent evaluation of Tamiflu, advocated stockpiling by referencing claims in journal publications written by the drug’s manufacturer, ignoring the F.D.A.’s assessment that those very claims were unproven.
Why would they do this? Unwarranted trust in the peer-review process of medical journals probably has something to do with it. So, too, does wishful thinking; lacking good alternatives, it’s tempting to hope that the drug we have works wonders. And it’s important to remember that correcting the statements of medical journals or public health agencies falls outside the F.D.A.’s jurisdiction — when it comes to drugs, the F.D.A. is responsible for regulating industry, not other government agencies.
But this is no way for supposedly evidence-based decision making to work, and the F.D.A. could do much more. As a result of new freedom of information policies in Europe, the Continent’s version of the F.D.A., the European Medicines Agency, has released 22,000 more pages of Roche’s Tamiflu trial reports. But even this represents an incomplete picture, as the most detailed portions of the reports are not in the European drug regulator’s files.
Nevertheless, the data point to a drug of minimal benefit. In accordance with the F.D.A.’s findings, it appears to shave a day off the duration of influenza symptoms, butMore worrisome, we found suggestive evidence that Tamiflu interfered with the body’s ability to produce antibodies against influenza we found no decrease in risk of hospitalization and no evidence that it could stop the spread of the virus — which could affect the body’s response to influenza vaccine and its ability to fight off future influenza infections. But to do a complete analysis, including evaluating Tamiflu’s potential harms, we need the remainder of the data — the full “clinical study report” — promised by Roche, but never delivered.
In response to our conclusions, which we published in January, the C.D.C. defended its stance by once again pointing to Roche’s analyses. This is not the way medical science should progress. Data secrecy is a disservice to those who volunteer their bodies for clinical trials, and is dangerous to those being asked to swallow approved medicines. Governments need to become better stewards of the scientific process. The European regulator’s announced intention to release clinical study reports after it finishes reviewing a manufacturer’s application is an important precedent. But the F.D.A. — guardian of arguably more trial data than any other entity in the world — appears stuck in the era of data secrecy.
We should not have to wait for patients to be hurt by the medications they take, as recently happened with the diabetes drug Avandia, before reviewing this wealth of data.

Tuesday, April 10, 2012

Sid Wolfe/Public Citizen Warned about YAZ contraceptive 10 years before FDA added warning: for this he was disqualified from serving on his FDA advisory committee

Today FDA said that YAZ, Yazmine, Beyaz and Safyral  (oral contraceptives made by Bayer) cause a higher than usual increase in blood clots in users.  Blood clots are increased by all contraceptives and other drugs utilizing female hormones.  It is estimated that in the US, 200,000 people die yearly from blood clots that travel to the lungs and obstruct the flow of blood.  In young women, this may be one of the most common causes of death.
Anyway, Public Citizen listed YAZ as one of its "Do Not Use Pills" in 2002.  Sid Wolfe, MD is director of Public Citizen's Health Research Group, which makes up this list.
In December, FDA prohibited him from fully participating in its advisory committee discussion of YAZ, due to an "intellectual conflict of interest."  This was a new spin on the concept of conflict of interest, which is generally accepted to mean a financial conflict of interest.  Wolfe simply had some prior knowledge about YAZ, which led his group to form an opinion about the drug, and other drugs.
In banning Wolfe from participating fully on the committee of which he was a member, FDA made clear that it only wanted people who were uneducated about the drug as to serve as "experts" advising FDA -- in other words, it wanted people who would not see beyond the data FDA presented to them, when offering advice on the drug.
It's about time FDA announced it was adding a warning to the label of these four contraceptives, which share the same progestin, admitting they caused even more blood clots than is usual for oral contraceptives.  This is 10 years after YAZ made PCHRG's list of bad drugs.  What took so long?  And has FDA apologized to Sid?  Or to the young women of America?

Friday, April 6, 2012

Emergent and its 44.75 million dose sale of Biothrax for civilians

With respect to the 44.75 million doses of anthrax vaccine that Emergent BioSolutions (EBS) has announced it is selling to DHHS for the civilian stockpile (for the past several years), comes this curious notice from the Maryland Gazette.  Perhaps not all federal bureaucrats are happy about paying a king's ransom for an unsafe and unproven vaccine.  Or perhaps EBS must continue to tithe before collecting all its bounty.
Emergent BioDefense Operations Lansing, a wholly owned subsidiary of Emergent BioSolutions of Rockville, reported an award from the Centers for Disease Control and Prevention for as many as 44.75 million doses of its BioThrax vaccine worth as much as $1.25 billion during the next five years.
The contract was effective last Sept. 30, but was just recently reported by Emergent to the Securities and Exchange Commission. The first doses were delivered in December. BioThrax is the only federally approved anthrax vaccine.
So far, $225 million has been committed under the CDC contract, according to the SEC filing. The rest of the award is subject to available federal funding.

Tuesday, April 3, 2012

The NSA Is Building the Country’s Biggest Spy Center (Watch What You Say)/ Wired

Total information awareness, we can know all about those over here who are plugged in. 

But those people over there who aren't, well, they aren't so easy to know about.  So let's ignore them, and watch the ones we can.  Hey, some of us plugged in ones may be financing some of the unplugged and unwashed terrorists, so while we watch those we can watch with electrons, we are sure to come up with a bit of info on those designated as our enemies, right?  So what if electronic snooping missed every major terrorist attack?  Didn't it stop the others?  (No, we can't tell you about the ones we stopped.  Classified.)

James Bamford, author of The Puzzle Palace, updates us on the NSA's newest projects and building in Wired:
... Under construction by contractors with top-secret clearances, the blandly named Utah Data Center is being built for the National Security Agency. A project of immense secrecy, it is the final piece in a complex puzzle assembled over the past decade. Its purpose: to intercept, decipher, analyze, and store vast swaths of the world’s communications as they zap down from satellites and zip through the underground and undersea cables of international, foreign, and domestic networks. The heavily fortified $2 billion center should be up and running in September 2013. Flowing through its servers and routers and stored in near-bottomless databases will be all forms of communication, including the complete contents of private emails, cell phone calls, and Google searches, as well as all sorts of personal data trails—parking receipts, travel itineraries, bookstore purchases, and other digital “pocket litter.” It is, in some measure, the realization of the “total information awareness” program created during the first term of the Bush administration—an effort that was killed by Congress in 2003 after it caused an outcry over its potential for invading Americans’ privacy.
But “this is more than just a data center,” says one senior intelligence official who until recently was involved with the program. The mammoth Bluffdale center will have another important and far more secret role that until now has gone unrevealed. It is also critical, he says, for breaking codes. And code-breaking is crucial, because much of the data that the center will handle—financial information, stock transactions, business deals, foreign military and diplomatic secrets, legal documents, confidential personal communications—will be heavily encrypted. According to another top official also involved with the program, the NSA made an enormous breakthrough several years ago in its ability to cryptanalyze, or break, unfathomably complex encryption systems employed by not only governments around the world but also many average computer users in the US. The upshot, according to this official: “Everybody’s a target; everybody with communication is a target.”

Monday, April 2, 2012

Bye Bye Bill of Rights/ NY Times

Welcome to the 2012 US Homeland.   Where'd we mislay that old Constitution?

Ours is now the land of extrajudicial killings performed by drones; strip searches for speeding, or for bicycling without an audible bell or having a too-audible muffler; widespread extralegal cell phone surveillance by police, mobile phone companies (for whom it is a new revenue stream), and apparently anyone who can afford the equipment.

I tried hard to avoid blogging about these issues, but they finally got the better of me.   The following three NYT articles are full of dismaying details about our disappearing civil rights. The first article is entitled, "Secret US Memo Made Legal Case to Kill a Citizen."  Some DOJ flunky, following on the heels of the Bush torture/'Geneva Conventions are quaint' memo, came up with an argument that it was perfectly legal to murder a US citizen without any charges or trial.  Smarter than John Yoo, this DOJ flunky's memo is classified.  So we cannot read it or challenge it in the courts.  The ACLU has just asked for clarification:  exactly what is the process for determining who to assassinate, when and how?  Who makes these decisions?  And Nass wonders how is this behavior different from the KGB?

According to the Times:
... The secret document provided the justification for acting despite an executive order banning assassinations, a federal law against murder, protections in the Bill of Rights and various strictures of the international laws of war, according to people familiar with the analysis...

The Obama administration has refused to acknowledge or discuss its role in the drone strike that killed Mr. Awlaki last month and that technically remains a covert operation. The government has also resisted growing calls that it provide a detailed public explanation of why officials deemed it lawful to kill an American citizen, setting a precedent that scholars, rights activists and others say has raised concerns about the rule of law and civil liberties.
Granted the US government is unlikely to kill anyone reading this with a drone.   But 13 milion Americans are arrested each year.  Several of my readers might be arrested.  If you are, you are now subject to exposing your private parts for law enforcement.

Today's NYT tells us the Supreme Court Ruling Allows Strip-Searches for Any Offense.  The Supremes voted 5-4 to make you spread those cheeks, as was required of the litigant in this case, when he was mistakenly jailed for not having paid a ticket (which had in fact been paid), after his wife was pulled over for speeding and he was a passenger in the vehicle.  Yes, you heard me right.
... The majority and dissenting opinions on Monday agreed that the search procedures the decision allowed — close visual inspection by a guard while naked — were more intrusive than being observed while showering, but did not involve bodily contact.

Justice Stephen G. Breyer, writing for the four dissenters, said the strip-searches the majority allowed were “a serious affront to human dignity and to individual privacy” and should be used only when there was good reason to do so.

Justice Breyer said that the Fourth Amendment should be understood to bar strip-searches of people arrested for minor offenses not involving drugs or violence, unless officials had a reasonable suspicion that they were carrying contraband.

Monday’s decision endorsed a recent trend, from appeals courts in Atlanta, San Francisco and Philadelphia, allowing strip-searches of everyone admitted to a jail’s general population. At least seven other appeals courts, on the other hand, had ruled that such searches were proper only if there was a reasonable suspicion that the arrested person had contraband.

According to opinions in the lower courts, people may be strip-searched after arrests for violating a leash law, driving without a license and failing to pay child support. Citing examples from briefs submitted to the Supreme Court, Justice Breyer wrote that people have been subjected to “the humiliation of a visual strip-search” after being arrested for driving with a noisy muffler, failing to use a turn signal and riding a bicycle without an audible bell.

A nun was strip-searched, he wrote, after an arrest for trespassing during an antiwar demonstration. So were victims of sexual assaults and women who were menstruating...
I think the word privacy will soon be omitted from our lexicon.  The Facebook generation, according to those near and dear to me, chooses to be as transparent as possible.  What is the big deal if Big Brother (make that governments and businesses) can see your every move using your GPS, hear your thoughts via your cell phone, email and tweets, and observe all your purchases via your charge card?  Surely you didn't think you had anything to hide in 2012?

The final NYT article is titled "Police Are Using Phone Tracking as a Routine Tool."  Excerpts follow:
WASHINGTON — Law enforcement tracking of cellphones, once the province mainly of federal agents, has become a powerful and widely used surveillance tool for local police officials, with hundreds of departments, large and small, often using it aggressively with little or no court oversight, documents show.

The practice has become big business for cellphone companies, too, with a handful of carriers marketing a catalog of “surveillance fees” to police departments to determine a suspect’s location, trace phone calls and texts or provide other services...
The internal documents, which were provided to The New York Times, open a window into a cloak-and-dagger practice that police officials are wary about discussing publicly. While cell tracking by local police departments has received some limited public attention in the last few years, the A.C.L.U. documents show that the practice is in much wider use — with far looser safeguards — than officials have previously acknowledged.

... in Arizona, even small police departments found cell surveillance so valuable that they acquired their own tracking equipment to avoid the time and expense of having the phone companies carry out the operations for them. The police in the town of Gilbert, for one, spent $244,000 on such equipment. 

... Another training manual prepared by California prosecutors in 2010 advises police officials on “how to get the good stuff” using cell technology.  The presentation said that since the Supreme Court first ruled on wiretapping law in 1928 in a Prohibition-era case involving a bootlegger, “subtler and more far-reaching means of invading privacy have become available to the government.”  Technological breakthroughs, it continued, have made it possible for the government “to obtain disclosure in court of what is whispered in the closet...”
How 'bout Google?  Isn't their motto "Don't be Evil"  and don't they have a new privacy policy?

Well, according to JDSupra, Google's new "privacy" policy:
"will aggregate data it collects on users across its products (with the exception of Google Wallet and Google Books) and develop a “mega-profile” on each user. That data collection includes a user’s Google searches, Gmail messages content, YouTube favorites, and contacts. It also includes location tracking."
Welcome to the brave new world.