Ireland preserves Democracy, Scraps E-Voting Machines/ The Independent

From the Irish Times:

In a final vote of no confidence, Ireland’s ill-fated e-voting machines are finally headed to the scrap heap.

From the June 29 Independent:

THE Government has sold the infamous €54m e-voting machines for scrap -- for €9.30 each. [Sold as scrap for about 15 cents per ten dollars spent on their purchase.]

A huge fleet of trucks will begin removing the 7,500 machines from 14 locations on Monday.

They will be taken to a Co Offaly recycling company, KMK Metals Recycling Ltd in Tullamore, where they will be stripped down and shredded.

Ironically, the owner of the firm, Kurt Kyck, cast his vote on one of the machines in the 2002 elections. He has now paid €70,000 for the lot.

Scrapping the machines brings to an end the embarrassing e-voting debacle which has cost the taxpayer more than €54m since it emerged the expensive equipment was faulty. 

They could not be guaranteed to be safe from tampering. And they could not produce a printout so that votes/results could be double-checked...

But the voting machines still being used in the USA have identical problems. Even the Voice of America has reported on the ease of hacking our votes.  

"We believe that a very resourceful 12 to 13-year-old would be able to essentially produce these alien electronics that can hijack the machine," said Roger Johnston.  Roger Johnston heads up Argonne National Laboratory’s Vulnerability Assessment Team.

"I think our view of the voting machines we’ve looked at is that there really isn’t much security thought put into these devices," he said.
Johnston says security concerns are not isolated to the way the machines are made. 

"Often the warehouses where these machines are stored have fairly weak security, but almost universally, these machines are transported by third party low bid trucking companies, where there’s no background checks on these individuals," said Johnston. "Often the machines arrive at a polling place and there’s no one to sign for them or to take responsibility for their oversight.  So there’s often quite a period of time when these machines could be tampered with." 

ABC News covered this topic in 2006:

Princeton University researchers using an Accuvote TS -- a touch screen version of the Diebold machine -- showed how easy it would be to deploy a virus that would, in seconds, flip the vote of any election...

"We're taking the vote-counting process and we're handing it over to these companies -- and we don't know what happens inside these machines," said Edward Felten, a professor and a researcher at Princeton's Center for Information Technology Policy, which ran the study...

Machines malfunctioned in Texas, where 100,000 votes were added.
In California, directions for voters with vision problems came out in Vietnamese.

And in Maryland, screens froze and memory cards went missing.
Gov. Robert Ehrlich, a Republican running for reelection, advised residents to vote by absentee ballot because he had no confidence in the machines. 

"I don't care if we paid half a billion dollars or $1 billion," Ehrlich said. "If it's going to put the election at risk, there's no price tag for a phony election or a fraudulent election..."

Anthrax Vaccine Manufacturer, with no expertise and no new products after 14 years in business, gets $220 million grant to develop nuclear, chemical, radiological and biological countermeasures for the US government/ Biz Journals

The Gang who Couldn't Shoot Strait at Emergent BioSolutions gain more largesse from the USG.  Yet this company cannot do anything right except obtain government contracts, kill off the competition, co-opt watchdog nonprofits and set up their own education agencies. See "Anthrax Vaccine:  to the Victor the Spoils"

"This award underscores Emergent’s core competencies not only in product development and manufacturing,  [They have developed no products--Nass] but also our expertise in contracting with the U.S. government and navigating the regulatory process," CEO Daniel J. Abdun-Nabi said in a statement.

From BizJournals:

Rockville-based Emergent BioSolutions Inc has formed a public-private partnership with the Department of Health and Human Services to establish a Center for Innovation in Advanced Development and Manufacturing.

The contract has an initial run of eight years worth $220 million with up to 17 additional one-year options. The partnership, with HHS’s Biomedial Advanced Research and Development Authority [BARDA], will initially develop a new pandemic influenza vaccine and construct facilities to produce it.

It will also develop chemical, biological, radiological and nuclear medical countermeasures.

Emergent (NYSE: EBS) announced the partnership shortly before the markets closed Monday. Its stock gained 77 cents, or 5.6 percent, in late-day trading and closed at $14.41 per share.

From Scott Lilly, former staff director of the House Appropriations Committee,  who wrote a report on Emergent BioSolutions' financial whiz-bangery in 2010:

... A report I recently completed for the Center for American Progress examines one particular set of contracts involving the purchase of a vaccine for exposure to Anthrax.  Normally it is virtually impossible to estimate the profit margin that a government contractor is making on a particular contract with information available in the public domain.  This contract was different, however, because the contractor was a public corporation which had only one product and only one customer.  Because the Securities and Exchange Commission requires disclosure of revenues and expenditures to stock holders,  it is possible to see how much it cost the company to produce what it was selling to the federal government. 

In the Form 10K released by this contractor in March,  the company disclosed that its revenues for the sale of its vaccine totaled $217 million.  The cost of sales according to the report was only $46 million.  Further research indicated that the company has enjoyed such margins for nearly a decade with sales exceeding $1.3 billion and expenses of less than $0.3 billion.

The company, Emergent BioSolutions,  argues that such margins are justified because it has faced a high level of financial risk in being a provider to the government.  But an examination of the risks it has faced since its founding in 1998 turned up a remarkable lack of risk compared to almost any other type of commercial endeavor.  The vaccine which is now sold under the name of BioThrax was developed by the U.S. Army in the 1960s.  The license to manufacture the vaccine was obtained by the state of Michigan and the state also built the facilities used for manufacture.  Those facilities were bought by Emergent with a down payment of $2.25 million.  They were then upgraded almost entirely at the expense of the U.S. government. 

The price of the vaccine was raised from a little less than $3 a dose which the government was paying to the state of Michigan to $10.60 a dose after Emergent took over. The price was then inexplicably raised again to more than $27 a dose—yielding the enormous profit margins detailed in the company’s annual report.  To protect those hefty margins, Emergent has probably the largest and most expensive lobbying team in Washington when lobby expenditures are compared to company revenues. 

We don’t have any idea how many high profit margin contracts the government has and it is only a result of the rather odd business model of this company that its high margins were uncovered.  Annual reports for companies that have multiple products and sell to customers other than the government ordinarily yield little information that would permit an estimation of the markup they get out of their government sales...  

Clinical Trial Ethical Underpinnings: reflecting on a pediatric anthrax vaccine trial / Sci Am Blogs

In her third excellent Scientific American blog post, Infectious Disease doctor Judy Stone has delved into the ethical and regulatory framework under which clinical research must be conducted.  Dr. Stone provides a succinct historical overview of the important documents, and how they were enshrined in regulations guiding the conduct of research in humans.  For readers unfamiliar with The Declaration of Helsinki, the Belmont Report, and the Nuremberg Code, this is important information.  Did you know that informed consent is a relatively new, post World War II phenomenon?

The addition of children as routine research subjects is even newer, dating back only 10-15 years.

Given this context, Dr. Stone explores how the proposed trial of pediatric anthrax vaccine fails to comply with the existing norms and regulations:

... How does the proposed pediatric vaccine trial fit with the precepts outlined above? 

First, the Belmont principle “respect for persons” is violated, in that this vaccine trial, using the adult anthrax vaccine (AVA) has known serious risks and other potentially unknown risks in kids, and no benefit. We won’t even know if any antibodies formed would be protective.

Belmont principle of benefits to the participant is violated since there are none. Furthermore, U.S. regulations (45 CFR 46, Subpart D) state that children may not be exposed to risk if a medical experiment does not offer them a direct benefit. Even the NBSB report notes “Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration”…There is only the potential future benefit...

And it appears that the Belmont principle of justice will be violated. A vulnerable population will be used without assent. (How many kids would willingly take a painful course of five injections, even without worry of other side effects?) How will the children’s continued participation be ensured? Coercion? Or bribes? Reportedly, the study is to be done in New York City, where there are 9/11 first responders who would be willing to volunteer their children. These parents, traumatized by 9/11, are unlikely to be able to review an informed consent form critically or objectively. Would there be such enthusiastic parents in rural America? I doubt it. I like the biting suggestion by Dr. Anthony Robbins, “How about the children of people who have the national security clearance required for the government to share with them all the evidence that adds up to a “credible threat?” With that information in hand, these parents would be able to make the choice-an informed decision for their children-that the rest of the public surely cannot.” ...

Skewed Results? Failure to Account for Clinical Trial Drop-Outs Can Lead to Erroneous Findings in Top Medical Journals / BMJ

Unmanned satellite-aircraft devices can now stay in orbit more than a year, then return to earth and make a soft landing at a military base!  Just imagine the accuracy and precision of the measurements and analysis needed to achieve this.  This accomplishment deserves more than a hat-tip to the scientific method.

Yet when it comes to medical research, arguably as important to the well-being of citizens, accuracy and precision are nowhere in sight.  Results of studies are all over the map.  Some researchers best distinguish themselves by the clever ways they can transform any set of results into support for whatever drug, device or vaccine their sponsor wants to sell.  Imagine if they were rocket scientists!

I have previously discussed about ten methods that have been used to squeeze an ill-fitting conclusion from a clinical dataset.  One such method:  the handling of subjects "Lost to Followup" has now been shown to skew the results of as many as one third of clinical trials published in top medical journals, according to an open-access article in the May 18, 2012 BMJ by Akl EA et al.  Akl's group examined 235 papers in 5 top medical journals for whether losses to followup were mentioned, and how the losses were handled.  Over half the authors of the 235 papers (54%) did not respond to questions from Akl's group regarding details of the research, which is troubling.

Nineteen per cent of the trials did not mention how losses to followup were being handled.  Of those papers that did mention losses to followup, generally 2-15% of total subjects were lost.

When reasonable assumptions about these losses were made, it was found that the conclusions of the trials could become nonsignificant in about 1/3 of cases.  In other words, the positive result would be lost.

From the SUNY Buffalo press release:

“We found that in up to a third of trials, the results that were reported as positive – in other words, statistically significant – would become negative – not statistically significant, if the investigators had appropriately taken into consideration those participants who were lost to follow-up,” says Elie A. Akl, MD, MPH, PhD, lead author, and associate professor of medicine, family medicine and social and preventive medicine at the University at Buffalo School of Medicine and Biomedical Sciences and School of Public Health and Health Professions. He also has an appointment at McMaster University

“In other words, one of three claims of effectiveness of interventions made in top general medical journals might be wrong,” he says.

In one example, a study that compared two surgical techniques for treating stress urinary incontinence found that one was superior. But in the analysis published this month, it was found that 21 percent of participants were lost to follow-up. “When we reanalyzed that study by taking into account those drop-outs, we found that the trial might have overestimated the superiority of one procedure over the other,” Akl says.

According to Akl, it has always been suspected, but never proven, that loss to follow-up introduces bias into the results of clinical trials. “The methodology we developed allowed us to provide that proof,” he says.

The methodology that he and his coauthors developed consists of sensitivity analyses, a statistical approach to test the robustness of the results of an analysis in the face of specific assumptions, in this case, assumptions about the outcomes of patients lost to follow-up.

Narcolepsy traced to specific vaccine batches/ The Local

Very interesting:  the Narcolepsy Association discovered that specific lots were involved, after the Swedish Medical Products Agency denied it.  Bad lots may mean that the regulators were not doing their job.  If this devastating narcolepsy epidemic was caused by bad lots, liability for the injuries might land on the manufacturer, in this case GSK.  From Sweden's The Local:

A new Swedish study shows that all Swedes who developed narcolepsy from the swine flu vaccine Pandemrix received the vaccine from 12 of the 35 batches, despite the Swedish Medical Products Agency’s (Läkemedelsverket) previous claim that no such connection exists.

“We will have to think again,” said Maria Szirmai of the Swedish Medical Products Agency to newspaper Göteborgsposten (GP).

Over 220 Swedes, most of them children, developed narcolepsy as a side effect from the Swine flu vaccine Pandemrix, according to the reports filed with insurance company Läkemedelsförsäkringen.

All these had received the vaccine from some 12 of the 35 batches of vaccine delivered to Sweden.

From 23 of the 35 shipments there is no recorded case of anyone developing the condition, according to the study, which was carried out by the Swedish Narcolepsy Association (Narkolepsiföreningen).

The association traced the vaccine through the batch number on the side of the boxes.

Their findings will now be investigated by the agency, which has previously denied any connection between different vaccine shipments and the onset of narcolepsy.

In some parts of Sweden, namely in counties Skåne, Västra Götaland, Dalarna and Uppland, there are more children affected by narcolepsy than anywhere else in the country, which has so far flummoxed researchers.

Over half a million Swedes were vaccinated against swine flu with Pandemrix between autumn 2009 and spring 2010.

Anthrax vaccine – To the victor, the spoils / Scientific American blogs

From infectious disease MD Judith Stone at Scientific American comes this comprehensive look at what is behind the push to keep buying anthrax vaccine and even give it to children:

In my last post, we began to play “Follow the Money” to better understand the history of the anthrax vaccine and the current proposal to test the vaccine on children. 

Conflicts of Interest-Case Study 

Major issues with the anthrax vaccine include safety, conflicts of interest and the lobbying power of the drug developer. I don’t have all the answers, but will outline some of the concerns. Some of these are voiced by ardent vaccine opponents, such as NVIC; others sound more akin to “conspiracy theorists.”  

A list of safety concerns is presented by two ex-officers in the National Guard. Counterarguments as to safety issues are given by the Institute of Medicine and were outlined in the first part of this series. 

Earlier, Steve Salzberg pointed out the conflicts of interest with advisory committee members who receive their funding from government biodefense contracts. But let’s look at the sole manufacturer of the country’s vaccine. 

The anthrax vaccine was initially developed by the state of Michigan’s Biologic Products Institute (MBPI). In 1998, the MBPI plant was closed for “renovations” coincidentally following an FDA “notice of intent to revoke licenses”. MBPI was sold in 1998 to for-profit BioPort corporation, which became a subsidiary of Emergent BioSolutions. 

According to the Department of Defense’s anthrax vaccination website, Emergent is headed by Fuad El-Hibri and Admiral William Crowe, Jr., a former Chairman of the Joint Chiefs of Staff (appointed by President Reagan) and the U.S. ambassador to Britain (1994-1997, appointed by President Clinton). El-Hibri was “CEO of the British company Porton International, which had made a fortune selling anthrax vaccine to countries like Saudi Arabia during the Gulf War.” El-Hibri was not a U.S. citizen at the time and there was reluctance in some quarters to have the government’s sole anthrax vaccine supply controlled by foreign nationals. So Crowe was brought in as director in exchange for about 10% of the company’s stock. 

The Corporate Research Project details the bailouts to BioPort to keep the company, the sole manufacturer of anthrax vaccine, viable following considerable regulatory and financial problems. 

“BioPort had originally been awarded a $29.4 million DoD contract to supply 8.7 million doses of anthrax vaccine at the price of $4.36 each. But in 1999, the company got a $24.1 million bailout from the DoD. This included an increase in the price per dose from $4.36 to $10.64 and a reduction in the number of doses by about 30 percent. The Pentagon also agreed to advance BioPort $18.7 million to help it cover its debts. The new agreement increased the cost of the contract for the Pentagon to $49.8 million over the following five years. The government has reportedly spent more than $120 million of taxpayers’ money to keep the company afloat.” 

Reporter Bob Evans further details BioPort’s financial mismanagement, quoting Congressman Walter Jones, R-N.C., “The message seems clear: If a company wants to make millions without providing a product or service, enter into a sole-source contract with the Department of Defense to produce vaccines…BioPort appears to have the government over a barrel.” 

In addition to the financial subsidies, outlined above, concerns have been raised about irregularities in the manufacturing process. Reportedly, on the eve of the Gulf War, the Department of Defense “accelerated and altered the vaccine’s manufacturing process, but without proper regulatory approvals.” “The Government Accountability Office (GAO) reported that the manufacturer “did not notify FDA of a number of changes made in the manufacturing process in the early 1990s and no specific studies were undertaken to confirm that vaccine quality was not affected.” GAO added that the “ingredients used to make vaccine were changed from the original vaccine,” and that “prior to the time of licensing, no human efficacy testing of the … vaccine was performed.” A 2000 Congressional report stated, “use of the current anthrax vaccine for force protection against biological warfare should be considered experimental and undertaken only pursuant to FDA regulations governing investigational testing for a new indication.” 

After September 11, 2001, Bioport quickly got its license back, although the FDA had previously found a number of quality control issues in the manufacturing process.
Since then, Emergent BioSolutions has had a lucrative government monopoly and has been aggressive in protecting it. According to the Center for Responsive Politics, Emergent spent more than $3.2 million on lobbying in 2011 alone. 

There have also been public relations and “educational” endeavors sponsored by Bioport, though not always advertised as such. The Partnership for Anthrax Vaccination Education, or P.A.V.E., had a website in support of the vaccine, operated by Muhiuddm Haider, a professor at George Washington University. One of PAVE’s regular speakers was Jerome Hauer, former assistant secretary of health and human services for emergency preparedness; there was no disclosure that he was being paid by BioPort. 

Revolving Door Lobbying 

However, in 2003, while still a government employee HHS, Hauer stated that a “new vaccine was “a better long-range option than investing in expanding manufacturing capacity” for BioThrax…” and that “the scientific basis” for a genetically engineered vaccine was “very sound and will result in an improved product.” Yet as soon as he left, and became a member of BioPort’s board, as well as a lobbyist for them, his assessment changed radically as he changed masters. 

Other lobbyists included: 

Louis Sullivan, secretary of health and human services under President George H.W. Bush
McKenna Long & Aldridge (MLA), which helped BioPort win a $122.7 million Project Bioshield contract. “MLA had supplied several lawyers, including one who’d helped write the Homeland Security Act of 2002 and two who’d been tapped by Congress for help in creating the BioShield law.” 

John Hishta, former executive director of the National Republican Congressional Campaign Committee and former campaign manager for Sen. John Warner (R-Va), influential in Pentagon politics. 

A more complete list of lobbyists and spending levels are available from the terrific Center for Responsive Politics here and here. They have a handy list of former Congressmen and a wonderful “revolving door profile.” 

These lobbyists have not only helped Emergent BioSolutions secure these seemingly exorbitant government contracts, but have helped ensure that they maintain a monopoly. Their main rival was VaxGen, who had won an $877.5 million federal contract to develop a safer, genetically engineered vaccine. According to an Los Angeles Times investigation, “Fear Inc.,” “Emergent responded by mobilizing more than 50 lobbyists, including former aides to Vice President Dick Cheney, to make the case that relying on the new vaccine was a gamble and that the nation’s safety depended on buying more of Emergent’s product. 

The company and its allies in Congress ridiculed VaxGen and impugned the competence or motives of officials who supported the new vaccine. The lobbying effort damaged VaxGen’s credibility with members of Congress and the Bush administration.” 

Between 2004-2007, Emergent spent $5.29 million on its cadre of lobbyists, while VaxGen spent only $720,000 on six lobbyists. After VaxGen’s contract was cancelled, Emergent had the audacity to claim that their aggressive lobbying was in the country’s interest. Executive Robert G. Kramer admonished the House Government Oversight and Reform Committee, “HHS has staked the nation’s protection against the No. 1 biologic threat on an experimental product.” He further threatened the committee that, should they fund VaxGen, Emergent would have to reconsider its decision to produce the vaccine. 

Adding insult to mortal injury, in 2008, Emergent purchased Vaxgen’s recombinant anthrax vaccine technology for a bargain $2 million, given that “more than $250 million was spent to develop it.” And now Emergent has lucrative government contracts for a vaccine with the recombinant protein antigen and a third generation vaccine. 

PharmAthene is another Emergent rival and has also had a rocky road, with it’s hopes for a 2008 contract dashed when Biomedical Advanced Research and Development Authority (BARDA) cancelled plans; and Emergent again vastly outspent its rival on lobbying. 

Emergent had another reason to aggressively protect its contract. According to the Center for American Progress’ must read report, Getting Rich on Uncle Sucker, Emergent’s cost of production in 2009 was $46 million and profit $217 million—a markup of about 300%.
Also, since the vaccine only has a four year shelf life, Emergent is guaranteed a steady income stream—on the order of $100 million/year—just to replenish the stock. 

While Emergent won a grant worth up to $1.25 billion in late 2011—and which was a sole-source contract—its future monopoly is not entirely guaranteed. BARDA is supporting development of next generation recombinant protein antigen (rPA)-based vaccines that will require fewer doses and hopefully have less side effects. 

In 2004, President Bush signed Project Bioshield, which earmarked $5.6 billion for new drugs and vaccines to counter bioterrorism. At this point, we seem to have a multi-billion dollar vaccine which has never been shown to be efficacious against inhalational anthrax and was adopted by circumventing usual FDA procedures and despite numerous manufacturing quality issues and safety issues. 

And that brings us to the proposed plan for testing the anthrax vaccine in children… Coming up next. 

About the Author: Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone. 

The views expressed are those of the author and are not necessarily those of Scientific American. 

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)

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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.

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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?