Additional Forensic Investigation of 2001 Anthrax Attacks

From the University of Pittsburgh Center for Biosecurity comes this short report, a reiteration that the spores in the anthrax letters could not have come directly from those prepared by Bruce Ivins at Fort Detrick, as they lacked two substances contained in the RMR1029 anthrax spore collection. Thanks to Ross Getman for the citation.

Additional Forensic Investigation of 2001 Anthrax Attacks

By Amesh A. Adalja, MD, FACP, May 25, 2012 

The FBI’s conclusion that USAMRIID scientist Dr. Bruce Ivins perpetrated the anthrax attacks of 2001 is largely built on an extensive microbial forensics investigation. That investigation linked the spores found in recovered letters to material contained in a flask labeled “RMR-1029” that was under Dr. Ivins’ control. According to the FBI’s analysis, RMR-1029 contained anthrax spores of the Ames variety, with specific genetic features consistent with the letter attack materials. The results of research by the Chemical, Biological, Radiological and Nuclear Sciences Unit of the FBI just published in the Journal of Forensic Scientists provide additional data about the attack material.1
Evidence Based on Spore Purification Compounds. 

During the Amerithrax investigation, it was discovered that some laboratories that possessed the Ames strain were purifying the spores using a product that contained meglumine and diatrizoate. From lab records, it was determined that the spores contained in RMR-1029 were similarly purified using these compounds. This information gave rise to the question of whether the attack materials were taken directly from RMR-1029. To answer this question, the FBI developed a detection method that employed liquid chromatography and mass spectrometry to determine the presence of these compounds.1 As expected, the FBI investigators did find that anthrax spores taken directly from RMR-1029 contained both meglumine and diatrizoate. However, no evidence of these compounds was found when the spores from the anthrax letters were analyzed using the same method.1

          Source of Attack Material?

The major implication of this study, as the authors note, is “that the evidentiary spore material was not diverted directly from RMR-1029.” (1)  This fact means that if the anthrax spores used in the attack were taken from RMR-1029, their preparation would have required extra steps prior to mailing. That type of purification would have required specialized machinery and likely would have left traces of the material on machinery. No such material was found, though, and in a recently settled civil case in Florida, the U.S. Department of Justice acknowledged that the specialized machinery was not available at USAMRIID. (2) 

In the 2011 National Academy of Sciences report evaluating the FBI’s scientific conclusions in the Amerithrax case, this finding was cited in support of the report’s conclusion that “it is not possible to reach a definitive conclusion about the origin of the B. anthracis in the mailings based on the available scientific evidence alone.” (3) 

References 

   1.   Swider C, Maguire K, Rickenbach M, et al. Trace detection of meglumine and diatrizoate from Bacillus spore samples using liquid chromatography/mass spectrometry. J Forensic Sci 2012; http://onlinelibrary.wiley.com/doi/10.1111/j.1556-4029.2012.02128.x/abstract. Accessed May 16, 2012.
 
   2.   Justice Dept. takes on itself in probe of 2001 anthrax attacks. Washington Post. January 27, 2012. http://www.washingtonpost.com/politics/justice-dept-takes-on-itself-in-probe-of-2001-anthrax-attacks/2012/01/05/gIQAhGLlVQ_story.html

   3.   National Research Council. Review of the Scientific Approaches Used During the FBI's Investigation of the 2001 Anthrax Letters . Washington, DC: The National Academies Press; 2011.

SuperPACs: faster than a speeding bullet; able to leap tall buildings in a single bound. Is this even politics?/ NY Times

Why are Super PACs different than all other PACs?  [No, we are not discussing Passover tonight.]  See what the NY Times has to say.  But here is a quick summary:

1. Super PACs can accept and spend donations throughout the year, not just during election periods
2. Super PACs have few or maybe only one donor, and therefore no public accountability
3. The donors set the agendas, not the candidates
4. Funding is not limited by campaign spending limits on regular PACs
5. It's fast cause you don't have to get contributions from lots of associates, then bundle them; instead, wealthy donors can just write one fat check for, well, the sky's the limit!
6. The campaigns may be ethically and factually challenged
7. There is unlimited gravy available for political consultants in advertising commissions 

Per the Times:

... Once seasonal affairs, campaigns from the presidential race down to House contests are becoming longer and more intense, driven by deep-pocketed donors eager to see incumbents pummeled throughout the political cycle. Decisions about attack ads and negative campaigning that once weighed on candidates are now made by consultants and donors with little or no accountability to the public.

“It’s not just easier to raise super PAC money — it’s dramatically easier,” Mr. Davis, a prominent Republican advertising strategist, said. “We raised more money than the Huntsman campaign, but we only had 20 or 30 donors.”

... With the primaries winding down, many consultants are turning to “boutique” super PACs, smaller outfits set up on behalf of a few donors — sometimes only one — to influence a few House and Senate races and other lower-profile campaigns. And some of the presidential super PACs are refashioning themselves as platforms for their vanquished candidates or as vehicles for general election spending. Mr. Schuman converted Americans for Rick Perry into the Restoring Prosperity Fund, with some of the same donors. The group will focus on Latino turnout and on efforts to help Mr. Romney in what Mr. Schuman called “second-tier” battleground states like Nevada and Colorado.

Super PACs offer advantages to the donors as well. Because they can give unlimited amounts to outside groups, they can have substantial influence without the hard work of raising money for a candidate, $2,500 check by $2,500 check, from other donors.

And super PACs allow them to spend on specific races or strategies, a development that could leave some candidates less dependent on party committees to decide whether they get the support they feel they need.

“You can’t roll into the National Republican Senatorial Committee and say: ‘Here is my check. I want it to go to these races,’ ” said one consultant who works with outside groups. “And you can with the super PAC.”

Are You Unwittingly Sharing Your Health Information?

The federal government has spent $547 million issuing grants to "independent" "health information exchanges" to collect and share citizens' medical records.  Each state and territory has an agency established for this purpose. 

The federal government has promised up to $27 billion in Medicare/Medicaid incentives for medical practices and hospitals to use electronic medical records, which are necessary to transfer health information electronically.  Many patients are not aware that their personal medical records are being shared and can be widely accessed. (In Maine, 75% of the population already has health information that has been uploaded to the system.) 

The reason given for health information exchanges is to improve healthcare quality.  The reason given for computerizing medical records is to improve the efficiency and cost of healthcare.  However, the electronic medical record systems used in the US tend to reduce physician efficiency, and increase costs, at least in the short-term.  My personal experience is that they increase errors and reduce patient safety, in addition to being inefficient.  But that's another story.

Our medical staff had several meetings about Maine's health information exchange, and our docs were wary of the concept, because we did not feel privacy was assured.  However, we were told that the exchange was an independent, state-based institution whose goal was to improve care through sharing of information from one Maine provider to another.  Information would not be "placed on the internet."  What I learned instead, through online searching, was that Maine's HealthInfoNet had received $6.6 million in federal grants, which was the major funding source and impetus for the program.  A federal agency coordinates all the state programs.

It was implied that information sharing would be limited to within Maine.  However, DHHS's goal is to share information nationwide, through the internet:

"On January 27, 2011, an additional $16 million was made available to states through ONC’s new Challenge Grants program. This program will provide funding to states to encourage breakthrough innovations for health information exchange that can be leveraged widely to support nationwide health information exchange and interoperability..."

We were told the new database would not collect information on HIV status or treatment by mental health professionals. What I learned from the HealthInfoNet website was different:  mental health records will be entered in the database.  HealthInfoNet got a $600,000 federal grant for this purpose inFebruary.  And it appears that local privacy safeguards for these records may erode as well, if one reads between the lines:  "many efforts are underway to integrate the treatment of mental illness into the general medical care structure."

Is another reason for computerizing and sharing medical records to allow the federal government to gain more personal information on US citizens in an era of increasing domestic surveillance?

According to today's C/NET:

The FBI is asking Internet companies not to oppose a controversial proposal that would require firms, including Microsoft, Facebook, Yahoo, and Google, to build in backdoors for government surveillance...  the White House, U.S. senators and senior FBI officials argue the dramatic shift in communication from the telephone system to the Internet has made it far more difficult for agents to wiretap Americans suspected of illegal activities, CNET has learned.

The FBI general counsel's office has drafted a proposed law that the bureau claims is the best solution: requiring that social-networking Web sites and providers of VoIP, instant messaging, and Web e-mail alter their code to ensure their products are wiretap-friendly...

James Bamford (author of The Puzzle Palace) tells us in WIRED that the feds have continued their Total Information Awareness project, supposedly cancelled by Congress in 2003, when it was run by the infamous John Poindexter, only now it has another name.  And we are the subjects of this federal surveillance:  those of us with credit cards, computers and mobile phones, not the unwashed and unwired terrorists.  The US government is building the largest data collection center in the world to collect info on everyone, and to break into encrypted information:

[The] 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.”

Has your health information been put in an electronic database without your consent?  In my state, the legislature voted for an "opt out" HealthInfoNet system rather than a system where citizens opt in:  Everyone in Maine is enrolled unless you opt out.  They say you can opt out by going to the HealthInfoNet website and unenrolling.  I wonder how well this works?  Since you opt out through the exchange, rather than through your local medical provider, it seems that medical information gets sent to the exchange on everybody, including those who opt out. 

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--

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 merde.  FDA 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.

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...

Published on Deccan Chronicle (http://www.deccanchronicle.com)

---

Rise in paralysis cases after polio vaccine

Cases of non-polio acute flaccid paralysis, better known as AFP, has sharply increased with the increase in the administration of oral polio vaccination (OPV) in the country under the much-acclaimed polio eradication programme. According to a report by Dr. Neetu Vashisht and Dr. Jacob Puliyel, appearing in the April-June issue of the Indian Journal of Medical Ethics, the incidence of non-polio AFP had gone up by 12 times over and above the normal rates with the onset of the administration OPV 10 years ago. The report appeared at a time when Kerala is getting prepared for another round of OPV on April 15. Dr. Jacob, also a member of the national technical advisory group on immunisation and of the working group on food and drug regulation in the 12th Five Year Plan, told DC on Friday that there was a definite co-relation between the increase in the number AFP and the irrational administration of OPV. Normally, he said, the chances of children under the age of 15 getting affected by non-polio AFP are 1-2 per 100,000. But, the rate of non-polio AFP nationally “is now 12 times higher than expected.” In 2011, an additional 47,500 children were newly paralyzed, over and above the standard rate of 2 children per 100,000 non-polio AFP cases, says the paper in the journal. Dr. Jacob said the increase in the occurrence of non-polio AFP could be directly linked to the massive increase in the dosage of OPV in the name of eradication. Although, the increase in the non-polio AFP was known for quite some time, it was for the first time that a co-relation was established by collating the data of the national polio surveillance, he said. “It is sad that, even after meticulous surveillance, this large excess in the incidence of paralysis was not investigated as a possible signal.” , nor was any effort made to try and study the mechanism for this spurt in non-polio AFP.” According to Dr Jacob, the dream of eradicating polio will remain a mirage due to the existence of “residual samples of samples virus stored in laboratories, by vaccine-derived polioviruses or by poliovirus that is chemically synthesized with malignant intent”. The increase in non-polio AFP might have been caused by the increase in OPV, leading to virus strains other than that of causing polio getting active, he said.

---

Source URL: http://www.deccanchronicle.com/channels/cities/thiruvananthapuram/rise-paralysis-cases-after-polio-vaccine-234

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?

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.

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?

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.

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.”

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.

Pennsylvania flu cases drop by 97% over last year/Pennlive.com

Documented flu cases have dropped by 97 percent compared with this time last year.  There have been NO flu-related deaths registered in Pennsylvania this year.

Why are pharmacies still advertising flu shots?

CDC reports only 5 child deaths due to flu, in the entire United States, have occurred this 2011-2012 flu season.

The reason for the extremely low flu rate is obscure.  Some say there is less flu this year than any other year since records started being kept.

Experts continue to recomend yearly flu shots. 

“I always get concerned that people will get complacent,” said Dr. Thomas Weida, a family doctor at Penn State Milton S. Hershey Medical Center.

Medical societies fight CMS efforts to make CME funding more transparent

On February 9, 2012, I wrote about how Merck manages to evade FDA regulations on advertising by funneling money through third party intermediaries: educational institutions and education/PR companies.  These third parties then pay doctors to provide advertising to other professionals in the form of continuing medical education.  Merck can then have the doctors speak about off-label uses of its drugs and vaccines, a discussion which is prohibited by FDA if conducted by (direct) employees of Merck.

Doctors are required to obtain at least 50 hours of continuing medical education yearly in order to maintain their licenses.  A common way to do so is to attend professional meetings, which have individual talks or even whole sessions sponsored by pharmaceutical companies.  This is said to keep the cost of attending down, and additionally funnels money to the professional organizations that put on the meetings. Professional organization can earn huge fees from this type of sponsorship.

The Centers for Mericare and Medicaid Services (CMS) have proposed regulations that would make the process of using third parties to obscure who is funding educational programs for medical professionals more transparent.  Speaking fees and other "transfers of value" from industry would be published on the internet for all medical practitioners.  Using third parties would not exempt the information from publication.

The information provided would come from the pharmaceutical companies.

But the professional societies are balking.

According to Medscape,

CMS proposes requiring drug and device makers to report not only direct transfers of value to physicians but also indirect transfers through a third party when the manufacturer knows whom the ultimate recipients are. An example would be a grant given to CME faculty by an industry-funded CME provider. Organized medicine has cried foul about this, saying that CMS is going beyond the intent of Congress.

In their letter to CMS, the AMA and its allies contended that accredited CME does not need to be policed for influence peddling, as it is structured to prevent industry funders from controlling its content, speakers, or attendees. [Give me a break--Nass]  According to organized medicine, following these dollars would further burden CME providers, manufacturers, and physicians, who would have to track "any activity that could conceivably have any indirect transfer of value." That task contributes greatly to the 80 hours of annual paperwork that the regulation would impose on physicians, stated the medical societies. Accordingly, they urged CMS to exclude CME from the reporting requirements.

The ACC also asked CMS to exempt CME. Otherwise, drug and device makers would be less likely to fund CME events, and physicians would be less likely to attend.
"Better educated physicians furnish higher quality care," the ACC stated. "Reducing available CME activities certainly does not assist in achieving that goal."  [The problem is that our CME are currently so tainted, they can often not be believed.--Nass]

Bradley Manning revealed information of major international import/ Bill Blum

Bradley Manning spent nearly a year in solitary, being tortured with ploys like forced nakedness (perfected in Iraq as a torture method?).  He is unlikely to ever be free.   Julian Assange got the honeypot treatment and is likely to spend much of his remaining life incarcerated.

Yet we were told those leaked cables had little of value, except for their embarrassment potential.  I certainly didn't have the time to read them.  I accepted the received wisdom from the NYT etc.

Now Bill Blum says we got it wrong.  There was big stuff in those cables, and they helped bring on the Arab spring and with it the Occupiers.  Hmmm.  What was revealed?  "Here is a sample of some of the other Wikileaks revelations that make the people of the world wiser:

• In 2009 Japanese diplomat Yukiya Amano became the new head of the International Atomic Energy Agency, which plays the leading role in the investigation of whether Iran is developing nuclear weapons or is working only on peaceful civilian nuclear energy projects. A US embassy cable of October 2009 said Amano "took pains to emphasize his support for U.S. strategic objectives for the Agency. Amano reminded the [American] ambassador on several occasions that ... he was solidly in the U.S. court on every key strategic decision, from high-level personnel appointments to the handling of Iran's alleged nuclear weapons program."
• Russia refuted US claims that Iran has missiles that could target Europe.
• The British government's official inquiry into how it got involved in the Iraq War was deeply compromised by the government's pledge to protect the Bush administration in the course of the inquiry.
• A discussion between Yemeni President Ali Abdullah Saleh and American Gen. David H. Petraeus in which Saleh indicated he would cover up the US role in missile strikes against al-Qaeda's affiliate in Yemen. "We'll continue saying the bombs are ours, not yours," Saleh told Petraeus."

There is plenty more.  Read Blum's piece.

Before making generalizations about vaccines, learn some facts

One particularly obnoxious quality of mine is that I do not suffer fools gladly.  I get mad;  I get contemptuous;  and I want to get even.  So when I read this uneducated paean to VACCINES I was forced to respond.  When the newspaper would not publish my response and instead sent a little box that said "Oops" I got madder.  Here is the result:

A vaccine is something designed to stimulate the immune system.  (Actually some drugs do that too.)  Most vaccines get injected, but some get swallowed.  Most drugs get swallowed, but some get injected.  When medical practitioners have to know that every drug does not have a positive benefit/risk ratio for every patient, how can some medical practitioners believe that every vaccine's benefits overwhelmingly outweigh its risks?

The authors of this article lump all vaccines together.  For example: 

1. "Vaccines have been saving our children, our pets and us from the ravages of countless bacteria and viruses. 
2. The science of vaccines has come a long way, over the 200 years since Edward Jenner coined the term vaccination...
3. Vaccines are the seat belts against many infections..."

Yet the authors wouldn't think of lumping all drugs together and claiming uniform effectiveness.  Nor would they claim for drugs (as a class) as they do for vaccines: "The risks of any side effects are far outweighed by the benefits of vaccines..."

In fact, each vaccine is different from every other, and each has its unique benefits and risks.  Many vaccines (for both humans and animals) have been taken off the market because they increased susceptibility to the disease they were intended to prevent, or caused severe adverse reactions. (I have blogged on this issue previously, with examples.)

Vaccines that recently caused more problems than they solved (and were taken off the market) include Rotashield and Lymerix.  Pandemrix use has been stopped for certain demographic groups.  Pandemrix was estimated to have saved 6 lives in Sweden, but caused 170 cases of narcolepsy in Swedish children.

If anything, the effect of Pandemrix was "public health in reverse" -- at least in Scandinavia and Finland, where most of the studies have been done.

Vaccines have been made from the pus of calves' bellies (smallpox), monkey kidneys (polio), fetal cells (Hepatitis A, Rabies, Varicella and Zostavax (shingles) vaccines), insect proteins (Cervarix), mouse proteins (Japanese Encephalitis vaccine) -- need I say more? -- and have included many known and unknown extraneous viruses and other unwanted material.  Vaccines commonly contain heavy metals and potentially dangerous adjuvants that were deliberately added as immune boosters or to suppress microbial growth (we are speaking of unwanted microbes that should not even be in the vaccines and are not mentioned in the label, but require growth suppression nonetheless:  thus the addition of mercury).

There is no reason to glorify every product that comes under the rubric 'vaccine'.   To a great extent, the value of a vaccine is a function of the reliability of its manufacture and its testing.   Testing before licensure is entirely paid for by the manufacturer, and all data are owned by the manufacturer.  FDA approves every vaccine (or drug) and crafts a label (along with the manufacturer) describing the safety and efficacy of every vaccine (or drug), based only on these data. 

In general, vaccine manufacturers are protected against product liability lawsuits.  That protection is absolute in the US for some vaccines, like US swine flu vaccine in 2009 only, and anthrax and smallpox through 2015,  and it was granted overseas for the 2009 Pandemrix and other swine flu vaccines.

I can assure the article's authors that no evidence exists that anthrax vaccine is effective for inhaled anthrax in humans.  Anthrax has never been used against soldiers, and therefore has not protected any soldiers from anthrax, despite the authors' claims.  But it has led to serious illnesses in 1-2% of recipients, according to the CDC and General Accounting Office. See pages 3-4.

For vaccines, as much else in life, the devil is in the details.  And public access to those details (especially regarding safety) remains constrained.  Why the data are hidden should concern you.

Early diphtheria-tetanus-pertussis vaccination associated with higher female mortality and no difference in male mortality/ Arch Disease Childhood

Peter Aaby's group from Statens Serum Institute, Denmark, has been studying the effects of many vaccines in African children for many years.  The group has found some similar results in the past.  The fact that they continue to see the same effect (huge increases in death rates in young vaccinated female infants, increases not seen in unvaccinated females) is extremely troubling, and calls into question the rationale for early female DPT vaccinations in countries with already high mortality rates.

From the original article:  Early diphtheria-tetanus-pertussis vaccination associated with higher female mortality and no difference in male mortality in a cohort of low birthweight children: an observational study within a randomised trial:

What is already known on this topic

• ▶ Live vaccines such as measles vaccine and Bacille Calmette-Guerin have non-specific beneficial effects in areas with high mortality.
• ▶ Previous studies from several low-income African countries have suggested that inactivated vaccines, including diphtheria-tetanus-pertussis (DTP), may have non-specific negative effects for survival of girls.
• ▶ WHO sponsored studies which have found a beneficial effect of DTP have major methodological problems.

What this study adds

• ▶ Adjusted for nutritional status, DTP vaccinated children, particularly girls, had threefold higher mortality between 2 and 6 months of age.

• ▶ Nutritional status was a strong predictor of mortality among boys but not girls.

• ▶ There is a continuing contradiction between studies of DTP from low-income countries and current policy.

  
  "Adjusting for mid upper arm circumference (a surrogate measure of nutritional status), the overall effect for DTP vaccinated children was 2.62 (95% CI 1.34 to 5.09); the death rate ratio was 5.68 (95% CI 1.83 to 17.7) for girls and 1.29 (95% CI 0.56 to 2.97) for boys (p=0.023, homogeneity test). While anthropometric indices were a strong predictor of mortality among boys, there was little or no association for girls."
  
  [If these adjustments are accurate, it seems both girls and boys died at higher than expected rates.--Nass]

Common toxic exposures can affect future generations/PLOS

This story was reported today in Science News, and the scientific publication from which the story was derived also came out today in PLOS. The concept is troubling:  toxic materials we encounter in everyday life may seriously scar our progeny generations later.  Although this research was performed for the Army, using toxics encountered by military personnel, the toxic exposures were also those faced by civilians.  Exposures to incinerator fumes (dioxins), the linings of tin cans (bis-phenol-A) and insect repellents all affected rat offspring.

Back in 2009, I wrote about birth defect rates after anthrax vaccine, and noted that the rate of major birth defects was about 3.0% in the US population overall.  But the rate is higher in the military:  in  offspring of military women who did not receive anthrax vaccine prior to pregnancy, the birth defect rate is 3.85--4.0%.  In female military servicemembers  who received anthrax vaccine before or during their pregnancies, the birth defect rate rises to 4.5--4.7%.

Why is the birth defect rate higher for offspring of military mothers who did not receive anthrax vaccine than for civlian moms?  This report hints at an answer.  Exposure to toxic materials is widespread in the military and almost impossible to avoid, although less than in years past.

Pollutants long gone, but disease carries on

Certain chemicals cause epigenetic changes that foster illness in rats’ offspring

By Janet Raloff

Exposure to certain pollutants early in a rat’s pregnancy can foster disease in her offspring during their adulthood as well as in subsequent generations, a new study shows. A wide range of pollutants elicited such lasting effects, despite future generations never encountering the triggering pollutant.
Some chemicals tested led to premature puberty among great-granddaughters, with an increased risk of disease in reproductive tissues. In some tests, the chemicals disrupted ovarian function, something that in humans could lead to infertility or premature menopause. And another chemical exposure caused premature death of sperm-forming cells in the great-grandsons, researchers report online February 28 in PLoS ONE.
Rather than altering genes, the tested pollutants altered chemical switches that regulate genes, reports Michael Skinner and his colleagues at Washington State University in Pullman. These epigenetic switches can lock a gene on or off...

In the new work, Skinner worked with the Army, which funded the study, to identify pollutants to which troops would probably be exposed. They settled on dioxins (spewed by burning materials or the defoliant Agent Orange); the insect deterrents DEET and permethrin; the plastic ingredients bisphenol A and phthalates; and jet fuel (often sprayed onto dirt for dust control). “I tried to pick classes of compounds that were across the whole [pollutant] spectrum — everything from hydrocarbons down to an endocrine disruptor like bisphenol A,” Skinner says.

The exposures used were relatively high, but not high enough to cause fetal deaths or signs of toxicity in either exposed rat moms or their pups. Yet “all promoted epigenetic transgenerational changes,” Skinner says. This suggests that epigenetic changes that get passed down through the generations are not some unique quirk of any one chemical, he says; he now suspects most pollutants have the potential to do this...

Metal on Metal Hips release two probable carcinogens and fail at rates 300% plus higher than other hip materials/ BMJ

One million Americans have received faulty hips, which continue to be promoted by manufacturers according to the British Medical Journal. The cobalt and chromium they release into local and distant tissues destroy muscle and bone and cause so-called genotoxicity, which may translate into cancer.  Definitely worth a read of the whole article, but excerpts are posted below:

Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices, a BMJ/ BBC Newsnight investigation reveals this week. Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment. 

This isn’t the unlucky failure to spot the misdemeanours of one rogue company or the occasional unforeseen breakdown of a small number of devices. It is the inability to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally—a class of implant that the usually reticent National Joint Registry of England and Wales described recently as a “cause for concern.”1 2 The implants concerned are “metal on metal”—the head at the top and the lining of the cup it fits into are made of cobalt-chromium alloy rather than ceramic or polyethylene—and there are models for both total hip replacement and hip resurfacing...

Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices, a BMJ/ BBC Newsnight investigation reveals this week. Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment. 

The manufacturers were aware of the potential for genotoxicity. The BMJ and Newsnight have seen a DePuy internal memo from July 2005, that says: “In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic. The mechanism is not known and only 24 local malignancies have been reported in patients with joint replacements. Also worrying is the possibility of distant effects. One study suggested a threefold risk of lymphoma and leukaemia 10 years after joint replacement. The metal to metal total hip appears to be quite promising and in the laboratory the data is (sic) definitely in its favour. However, the ultimate test is the long term human experience...” 

Linking side effects that develop many years after an exposure to the exposure

Over the past two weeks, several people asked me about illnesses they developed a number of years after exposures to the Gulf War, to anthrax vaccine, and to other toxic products.  Because this is an extremely complex subject, and a recurring issue, I thought I should address it in the blog, rather than try to discuss it separately with each person who approached me.

Here are the big questions embodied by the issues raised, imho:

1. Did the exposure cause (or perhaps contribute to) the illness?
2. Is there is a convincing way to link the original exposure to an illness that only became known many years later?
3. What kinds of compensation might the person be eligible for?

Some illnesses are known to only be caused by specific exposures, but they are a small minority of illnesses.  An example:  eosinophilia myalgia syndrome, caused by a contaminant in the supplement L-Tryptophan, manufactured by the Showa Denko company of Japan.  This happened to be an early product made from genetically engineered bacteria.  It was a new illness caused by a new toxicant.  This is a very rare occurrence.

Some illnesses are related to a toxic exposures, but not everyone with the illness is known to have been exposed.  Parkinson's disease is much more common in farmers and others exposed to pesticides, but also occurs in the absence of a pesticide exposure.   This probably reflects the general idea that illnesses are due to an interaction between exposures, genetic predispositions, and other factors, such as nutritional state.

Both the VA and wikipedia list the illnesses that have been assigned, over time, as due to Agent Orange (contaminated with the dioxin TCDD) for purposes of a VA disability rating and medical treatment.  Congress granted veterans the "presumption" of disability if they served in Vietnam and developed a designated illness. 

This VA benefit is distinct from an initial settlement of $180 million made by the manufacturers of Agent Orange and attorneys for a Vietnam Veteran class action in 1984. 

Per wikipedia:

In 1991, the US Congress enacted the Agent Orange Act, giving the Department of Veterans Affairs the authority to declare certain conditions 'presumptive' to exposure to Agent Orange/dioxin, making these veterans who served in Vietnam eligible to receive treatment and compensation for these conditions.^[63] The same law required the National Academy of Sciences to periodically review the science on dioxin and herbicides used in Vietnam to inform the Secretary of Veterans Affairs about the strength of the scientific evidence showing association between exposure to Agent Orange/dioxin and certain conditions.^[64]
Through this process, the list of 'presumptive' conditions has grown since 1991, and currently the U.S. Department of Veterans Affairs has listed prostate cancer, respiratory cancers, multiple myeloma, type II diabetes, Hodgkin's disease, non-Hodgkin's lymphoma, soft tissue sarcoma, chloracne, porphyria cutanea tarda, peripheral neuropathy, chronic lymphocytic leukemia, and spina bifida in children of veterans exposed to Agent Orange as conditions associated with exposure to the herbicide. This list now includes B cell leukemias, such as hairy cell leukemia, Parkinson's disease and ischemic heart disease, these last three having been added on August 31, 2010.

Note that diseases were still being added to this list as recently as 18 months ago, for exposures that occurred 40-50 years earlier!

My point is that it can take a long time to identify a statistical relationship and make a causality assessment between an exposure and an illness.  And it can take a long time to develop a related illness after exposure.  In the case of Agent Orange (and probably related herbicides) the connections were only made because of federal legislation that asked the National Academy of Sciences to keep looking into possible connections.

Similar legislation does not exist for most other exposures.  So potential connections are not being made.  And the scientific research that might be used to make them may be sponsored by the manufacturer of the putative toxic substance, with the goal of obscuring a relationship.  For example, despite overwhelming evidence to the contrary, Showa Denko tried to blame overuse of L-tryptophan, rather than a contaminant, for cases of eosinophilia myalgia syndrome.

So it all comes down to politics.  Did Congress face enough pressure to investigate the potential linkage?  Was legislation passed to provide some type of compensation?  Was a viable mechanism set up to review the medical literature in order to identify any linkage?

In the case of illnesses meeting the definition of Gulf War syndrome, if you were physically in the Gulf, and later developed the condition, veterans are eligible for disability benefits and care.

In the case of anthrax vaccine, Congress has provided no remedy for vaccine-related injuries.  There as yet exist no standards for what constitutes an anthrax vaccine injury.  It is difficult or impossible to perform the necessary studies in an unbiased manner, as the Defense Department will not share its data.  And since only soldiers currently receive anthrax vaccine, there is no other modern data.  The Gulf War studies maybe confounded by multiple other exposures, and suffer from the long time that elapsed between the exposures and the self-reports of vaccinations and injuries.

Unless and until the US public demands access to the scientific data it paid for, I see no remedy for this state of affairs.