Wednesday, December 28, 2011

Proven Ways to Avoid Influenza Safely and Inexpensively

How well does flu vaccine work?

Two major reviews have come out in the past two months.  Michiels et al from the University of Antwerp found that the vaccine does prevent influenza among those aged 6-65, "however, there is strikingly limited good-quality evidence of the effectiveness of influenza vaccine on complications such as pneumonia, hospitalization and influenza-specific and overall mortality..."  as well as efficacy over 65.  It is less the flu than the complications and deaths from flu that we want to avoid... but these complications are precisely what no one has been able to show are improved by vaccination.  Vaccine 2011. Nov 15; (29) 49: 9159-70.

Michael Osterholm's group (U Minnesota) found effectiveness of standard (killed) flu vaccine for adults aged 18-59.  His authors used as gold standard the presence of influenza virus by PCR or culture.  No trials in adults over 65 or children below 18 met the strict criteria.  For live flu vaccine, efficacy was shown for 9 of 12 seasons in 10 trials, but only for children aged 6 months to 7 years.  
The group concluded, "Influenza vaccines can provide moderate protection against virologically confirmed influenza, but such protection is greatly reduced or absent in some seasons. Evidence for protection in adults aged 65 years or older is lacking.  New vaccines with improved clinical efficacy and effectiveness are needed to further reduce influenza-related morbidity and mortality."

What to do? 

Excerpted from:  A Home Toolkit for Primary Prevention of Influenza by Individuals and Families. Finkelstein et al. DISASTER MEDICINE AND PUBLIC HEALTH PREPAREDNESS 2011; 5: 266-271.  The authors of this review article are members of MIT’s Engineering Systems Division.  They suggest the following proven methods:

Wash your hands thoroughly after leaving a sick person’s room. Scrub with soap and water or an alcohol-based hand sanitizer for 20 to 30 seconds.
Wear a mask. At minimum, the mask prevents a healthy person from transferring a virus to his/her own nose and mouth—the highway to infection.
Install air filters. High-efficiency particulate air (HEPA) filters can remove nearly 98 percent of virus particles; portable air purifiers and pointing a window fan out the window of the sickroom can also help.
Control temperature and humidity. Higher temperatures and humidity levels can kill or disable viruses.
Install an ultraviolet light. UV light is antimicrobial, and portable air purifiers with both UV lamps and HEPA filters can be purchased for $180 to $370.

Tuesday, December 20, 2011

Judge says no to inquest on weapons inspector Dr Kelly/ Mail

And the judge adds insult to injury by asking retired surgeon Halpin to pay Attorney General Grieve's legal costs.  The Mail provides the details:
A retired surgeon lost a major court battle yesterday in his campaign to secure a proper coroner's inquest into the death of weapons inspector Dr David Kelly.
Dr David Halpin was refused permission to challenge Attorney-General Dominic Grieve's refusal to hold an inquest into the Government scientist's mysterious death.
As the decision was announced at the High Court in London yesterday, there were cries from the public gallery of 'Shame' and 'This is not justice'.
A High Court judge refused a plea to open an inquest into the death of government weapons advisor Dr David Kelly
A High Court judge refused a plea to open an inquest into the death of government weapons advisor Dr David Kelly
One woman shouted at the judge, Mr Justice Nicol, 'What about the fingerprint evidence?', a reference to the fact that no fingerprints were found on the knife Dr Kelly allegedly used to kill himself.
Dr Kelly was found dead in an Oxfordshire wood in July 2003 after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war.
His death was the subject of a public inquiry in 2003 chaired by Lord Hutton which found he committed suicide by slashing his wrist and swallowing painkillers.

He is believed to be the only person in modern times to have died in suspicious circumstances in this country whose final hours have never been fully examined by a coroner.
Reviewing the controversial case in June this year Attorney General Dominic Grieve said the evidence of suicide was 'overwhelming'.
But yesterday Dr Halpin, 71, a retired trauma surgeon, claimed Mr Grieve had acted 'unlawfully' and 'irrationally'.
An aerial view of Harrowdown Hill, Oxfordshire where Dr David Kelly's body was found
An aerial view of Harrowdown Hill, Oxfordshire where Dr David Kelly's body was found
Dr Kelly allegedly slashed his wrist and swallowed painkillers after being named as the source of a BBC report accusing Tony Blair¿s government of lying to take Britain into the Iraq war
Dr Kelly allegedly slashed his wrist and swallowed painkillers after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war
Hundreds of Daily Mail readers were among 830 members of the public who contributed around £40,000 to cover Mr Halpin's legal fees.
Rejecting Mr Halpin's application to seek judicial review, the judge told a packed courtroom yesterday it was the Attorney General's role to act as a 'filter' before matters got to court.
Mr Justice Nicol said: 'Parliament considered it necessary for such a filter. In my judgment he [the attorney general] has exercised that discretion and power lawfully.'
After the hearing Mr Halpin, from Newton Abbot, Devon, said: 'Nothing has changed as a result of today's decision.
'Dr Kelly has still not had an inquest, which makes him unique. I still think it is impossible to bleed to death by cutting an ulnar artery. I still don't understand why there must be so much secrecy around this case.
'This case was shackled by the law and the facts were obscured by that. The Hutton Inquiry had more holes in it than a Swiss cheese.'
Mr Justice Nicol ordered Mr Halpin to pay £5,568 towards the Attorney General's legal costs.

UPDATE Interview with Dr. Halpin.
Dr Halpin said he was going to 'take stock and reflect on what to do next' as a result of the decision.

Monday, December 19, 2011

Judge to hear campaigner's plea for inquest into Dr Kelly's controversial death/ Mail

From the Daily Mail:
A retired surgeon campaigning for a full coroner’s inquest into the death of Dr David Kelly will have his case heard by a High Court judge  on Monday (December 20).

David Halpin, 71, is seeking permission to challenge the Government’s decision in June not to order a coroner’s inquest into the controversial death...

Mr Halpin, a former trauma surgeon from Newton Abbot in Devon, said: ‘More than 800 members of the public worldwide, hundreds of them Daily Mail readers, have given about £40,000 to cover legal fees associated with this case. I am enormously grateful...

Saturday, December 10, 2011

SIGA's sweetheart deal for smallpox drug questioned by Anderson Cooper/ CNN

This story, detailed by David Willman in the LA Times (and blogged by me 4 weeks ago) has now been re-reported (in great detail for television) by CNN.  It certainly deserves plenty of scrutiny, especially after SIGA's stock rose 32% yesterday, supposedly due to board member Fran Townsend's denying company interference with the contract.  DHHS (what a surprise!) even had the temerity to tell CNN that replacing the government's chief negotiator saved the taxpayer lots of money!

In case you forgot, the issues are these:

SIGA is selling the govt (for $433 million to 2.8 billion) a drug developed with government money to treat smallpox. No one knows if it works.  SIGA's controlling shareholder is Ron Perelman, a billionaire Democratic donor.  Contracting requirements were changed several times to ensure SIGA got the contract, and at a very high price.

Former administrations made sweetheart deals for 2 smallpox vaccines, for a total cost over a billion dollars, during the Clinton and Bush administrations.  There is enough vaccine for every American in a stockpile.  The vaccine works up to 4 days after an exposure.  There is no real need for a drug too.

The Obama administration, it appears, did not want to miss out on the opportunity (which generating fear of bioterrorism has provided) to spend huge amounts of taxpayer funds on useless products.  At least now a light is shining into the fetid swamp of bioterrorism procurements.  SIGA's is only one of many questionable deals.

UPDATE:  SIGA stock down 85% in 2011.

Tuesday, December 6, 2011

FDA disqualifies advisory committee member due to "intellectual conflict of interest"/

Sidney Wolfe, MD, is a well-known drug safety advocate and founder/ director of the organization Public Citizen's Health Research Group.  FDA finally blessed the quality of his work and reputation by inviting him to join its Drug Safety and Risk Management Advisory Committee in 2008.

But suddenly FDA has disqualified him from full voting membership at the committee meeting on the drug YAZ due to a claimed intellectual conflict of interest.  Let's look first at the basis of FDA's claim, and then look into what is generally considered a conflict of interest.

According to the Newark Star-Ledger, Public Citizen gave a "Worst Pills" rating to Yasmin, the predecessor to YAZ oral contraceptive, now the leading contraceptive pill by sales in the US:
The FDA said it disqualified Wolfe, the director of Public Citizen’s Health Research Group, from the meeting on the contraceptives for his "intellectual conflict of interest.’’
The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of "Do Not Use Pills’’ in 2002.
"He did not volunteer this information,’’ said agency spokeswoman Erica Jefferson. "It was brought to our attention.’’
The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.
Wolfe declined both options.
Advisory committee members, she said, are asked by the agency to disclose such information. "We do value Dr. Wolfe’s contributions,’’ Jefferson said, "but we are committed to preserving the integrity of the committee process.’’
 The Public Citizen website appears to give YAZ a balanced report.

What precisely is the meaning of "conflict of interest"?  According to the Columbia University course "Responsible Conduct of Research" syllabus:
There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a "wide range of behaviors and circumstances," they all involve the use of a person's authority for personal and/or financial gain.2

2.  Bradley SG. Managing Conflicting Interests, p. 136. In: Magrina FL, editor. Scientific Integrity: An Introductory Text with Cases. Washington, DC: American Society for Microbiology; 2000, pp. 131-157.

According to this definition, because Sid Wolfe did not stand to gain from either the presence of YAZ and Yasmine on a Public Citizen website, nor from his presence on the committee as a voting member,
he had no conflict of interest and therefore had no obligation to disclose to FDA what was on the Public Citizen website (or anything else).

FDA is plagued by many members of its advisory committees having financial conflicts of interest, which are not always disclosed.  Sometimes 50% of members have such conflicts, for which waivers are routinely granted.

Yet here comes physician Sid Wolfe, whose clear, career-long interest is in making the US pharmacopiea safer, and who may have preexisting knowledge about the drug in question.  Shouldn't FDA encourage members with more knowledge of a specific drug to participate in discussions about that drug?

Yet FDA finds this an intellectual conflict of interest.  I recall the CDC advisory committee that voted to expand the indications for anthrax vaccine.  None of them were experts on the vaccine... and this meant they were easily led by factual omissions and spin in the way information was presented to the committee by CDC staffers.  No one had the knowledge to detect the spin.

I just discovered that Ed Silverman at Pharmalot is blogging about this subject, so please go to his site for more information, including a pending inquiry to FDA.  Note also that Janet Woodcock of CDER is the person who pulled the plug on Wolfe in this case... and she is someone not known for her integrity in the relicensure of Lotronex.  Public Citizen also discusses Lotronex and Woodcock on its website.

Friday, December 2, 2011

Eliot Spitzer: A Secret Scandal/ Slate

Half the US GDP was loaned to banks with no collateral.  Recall that (former NY Attorney General and Governor) Eliot Spitzer was investigating the Wall Street banks at the time his indiscretions with call girls led to his resignation, ending any hopes of seeking the presidency.  Not only American, but many foreign banks were bailed out in the program Spitzer discusses.  An excerpt follows:
... During the deepest, darkest period of the financial cataclysm, the CEOs of major banks maintained in statements to the public, to the market at large, and to their own shareholders that the banks were in good financial shape, didn’t want to take TARP funds, and that the regulatory framework governing our banking system should not be altered. Trust us, they said. Yet, unknown to the public and the Congress, these same banks had been borrowing massive amounts from the government to remain afloat. The total numbers are staggering: $7.7 trillion of credit—one-half of the GDP of the entire nation. $460 billion was lent to J.P. Morgan, Bank of America, Citibank, Wells Fargo, Goldman Sachs, and Morgan Stanley alone—without anybody other than a few select officials at the Fed and the Treasury knowing. This was perhaps the single most massive allocation of capital from public to private hands in our history, and nobody was told. This was not TARP: This was secret Fed lending. And although it has since been repaid, it is clear why the banks didn’t want us to know about it: They didn’t want to admit the magnitude of their financial distress.

The banks’ claims of financial stability and solvency appear at a minimum to have been misleading—and may have been worse. Misleading statements and deception of this sort would ordinarily put a small-market player or borrower on the wrong end of a criminal investigation.

So where are the inquiries into the false statements made by the bank CEOs? And where are the inquiries about the Fed and Treasury officials who stood by silently as bank representatives made claims that were false, misleading, or worse?

Only now, because of superb analysis done by Bloomberg reporters—who litigated against the Fed and the banks for years to get the information—are we getting a full picture of the Fed and Treasury lending. The reporters also calculated that recipient banks and other borrowers benefited by approximately $13 billion simply by taking advantage of the “spread” between their cost of capital in these almost interest-free loans and their ability to lend the capital.

In addition to the secrecy, what is appalling is that these loans were made with no strings attached, no conditions, and no negotiation to achieve any broader public purpose....

Thursday, December 1, 2011

Fukushima nuclear catastrophe closer than thought/ The Australian

The Japanese government and TEPCO have released new information (based on simulations, however) on the extent of damage to the Fukushima nuclear reactors.  The Australian reports on the catastrophe:
MOLTEN nuclear fuel in one reactor at Japan's stricken Fukushima Daiichi plant burned through the steel pressure vessel and three-quarters of the surrounding concrete containment vessel that formed the reactor's last substantial internal barrier...

... In the case of the No 1 reactor, any fuel that escaped the secondary concrete vessel would have landed on a protective steel plate. Had it burned through that, it would then have confronted a 10m thick steel foundation beyond which lays ordinary soil.

The TEPCO and government analyses - which may not be the final word on the extent of the meltdown - showed that the fuel burned through a total of about 2m of the 2.6m thick secondary containment vessel.

The operator and the government agencies in charge of regulating the nuclear industry have consistently underestimated the severity of events at the plant...

More than 80,000 people have been forced out their homes as a result of the disaster, which ranks second only to the 1986 Chernobyl incident in terms of severity. Japan has also been forced to endure a run of food scares thanks to radioactive cesium deposited across wide areas around the plant.

The Japanese government has conceded that it may take 30 years to fully decommission the plant and that some areas around it may be uninhabitable for decades...