Tuesday, June 28, 2011

Doctors who were paid $12-16 million pimped for Medtronic's poor quality spinal fusion material / NY Times

Finally, members of my profession are fighting back against corrupt doctors and the companies who pay lavishly for their undeserved testimonials.  Respected university bigwigs are just as susceptible as anyone else to 10 or 20 million dollar payoffs:  and they may feel they have no conflict of interest as a result and their work is pure.  (So claimed Dr. Thomas A. Zdeblick of the University of Wisconsin, who has earned $20 million from Medtronic for his patents, including those used with spinal fusions.)

Nonetheless, "scientific" studies get performed and written up and published that  misrepresent the truth, so that a product appears more effective and safer than it really is.  Medtronic paid big bribes, but earned about 900 million from this one product last year, used in 100,000 spinal fusions in 2010!

What is extraordinary is that finally many members of our profession have come out about the fraud, filling an entire issue of The Spine Journal to tell the other side of the story.  Medtronic is not a small player gone awry.  It is the largest medical device manufacturer in the US.  Below are excerpts from the NY Times:
 In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product. In a series of reports published in a medical journal on Tuesday, the specialists called the research misleading and biased. 
The repudiation, appearing in a full issue of The Spine Journal devoted to the topic, represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices. It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.
Medtronic, the nation’s biggest maker of medical devices, has been facing intensifying scrutiny over its promotion of Infuse, the bone growth product at the center of the controversy. The bioengineered material is used primarily in spinal fusions, a procedure in which spinal vertebrae are joined to reduce back pain.
Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none. 
“It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports. “It harms patients to have unaccountable special interests permeate medical research.”
“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”
“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”
It is too early to predict how the articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year. But the potential consequences seem significant...

Sunday, June 26, 2011

The Epidemic of Mental Illness: Why? / NY Review of Books

This June 23, 2011 article by Marcia Angell, a former NEJM editor and a Harvard professor of medicine, is a must-read.  Actually, this article is only Part 1, and the second half will come out in two weeks.  Angell reviews 3 books on psychiatry, and asks all the right questions:
  • Why are half of American defined as having a mental illness at some time in their lives?
  • Why have the number of children receiving SSI income for a mental disability increased by a factor of 35 over the past 20 years?
  • Why do people believe in the "chemical imbalance" theory of mental disorders when there is no evidence to support it?
  • Why are new-generation antipsychotics the top-selling class of drugs in the US?
  • What is going on here???
  • If the drugs work, shouldn't the prevalence of mental illness be falling, not rising?
  • Why are illnesses that used to be episodic now chronic, never-ending conditions?
  • Are our drugs actually making matters worse?

Memo reveals intelligence chief wrote dossier on Iraqi WMD knowing that "in terms of WMD Iraq is not that exceptional"/ Guardian

From the Guardian, an article provides new information on how Tony Blair's administration lied to make the case for war in Iraq. What do you call this crime?  Is it treasonous to start a war under false pretenses, costing your country hundreds of lives and billions of dollars?  And what was it for, anyway?
The senior intelligence official responsible for Tony Blair's notorious dossier on Iraq's weapons of mass destruction proposed using the document to mislead the public about the significance of Iraq's banned weapons.
Sir John Scarlett, who as head of the Joint Intelligence Committee was placed "in charge" of writing the September 2002 dossier, sent a memo to Blair's foreign affairs adviser referring to "the benefit of obscuring the fact that in terms of WMD Iraq is not that exceptional".
The memo, released under the Freedom of Information Act, has been described as one of the most significant documents on the dossier yet published.
The disclosure supports the evidence of the former intelligence official Michael Laurie, who told the Chilcot inquiry into the Iraq war that it was widely understood that the dossier was intended to make a case for war and misrepresented intelligence to this particular end...

Thursday, June 23, 2011

Use of Psychological Profile to Infer Ivins's Guilt Is Problematic/ Clinical Psychiatry News

Dr. Annette Hanson penned the following piece on the ethically impaired "Expert Behavioral Analysis Panel" paid for by FBI:

In March, a panel chaired by Dr. Gregory Saathoff, commonly known as the expert behavioral analysis panel (EBAP), released a report containing a summary and analysis of the investigation of Dr. Bruce Ivins, the suspected anthrax mailer. (1) The panel was convened at the request of the Chief Judge of the U.S. District Court, Royce C. Lamberth. The full report containing Dr. Ivins’s previously confidential and sealed medical information is being sold online by the Research Strategies Network, a non-profit organization that consults to the Department of Defense and whose president is Dr. Saathoff.(2) After reading the redacted executive summary, I felt compelled to review the work of the panel in light of standards set forth in the American Academy of Psychiatry and Law’s Ethical Guidelines for the Practice of Forensic Psychiatry.(3)

Although the panel undertook the investigation with “no predispositions with regard to [Dr. Ivins’s] guilt or innocence and in fact without a focus on that issue,” it nevertheless concluded that Dr. Ivins was the anthrax mailer. Dr. Ivins’s guilt has never been established in a court of law since he committed suicide in August 2008 and was never charged with the deaths of the five anthrax victims. This pronouncement of guilt is not consistent with the ethics and traditional practice of forensic psychiatry. Ethical guidelines state that forensic psychiatrists should: “...communicate the honesty of their work...by distinguishing, to the extent possible, between verified and unverified information as well as among clinical ‘facts,’ ‘inferences, and ‘impressions.’ ” The panel report concluded guilt based upon “considerable circumstantial evidence” found in the medical records without acknowledging that this conclusion was based on psychodynamic inference. Specifically, the report found that Ivins had the “psychological disposition,” motive, means and the “behavioral history” to carry out the attacks. The use of a psychological profile to infer guilt is particularly problematic, since this evidence is not admissible in most jurisdictions. Bioterrorist profiles are likely more unreliable than most given the paucity of subjects upon which to base a profile.

From an ethical standpoint, the sale of the panel report is particularly problematic. Forensic reports are generated at the request of the retaining agency or individual, and the information in the report is usually not distributed beyond the parties immediately involved in the proceedings. The forensic evaluator himself does not typically distribute a report to non-involved individuals, nor does the evaluator sell the report to the public. While Dr. Ivins signed several releases of information during the course of his career, it is unlikely that he could have foreseen or given knowing consent to worldwide sale of his medical information. The panel report details Dr. Ivins’s social awkwardness and eccentricities, romantic rebuffs, and early childhood abuse while making careful note that his early abuse did not “exonerate” him for the criminal acts of which he is presumed guilty.

Although the investigation was requested by the court, the panel’s work product was intended to benefit national security investigators. According to the website of the Research Strategies Network, which organized the panel, the RSN has previously collaborated with the F.B.I. and the Department of Defense. This creates an appearance of conflict of interest and bias, a common problem among mental health professionals who consult with law enforcement agencies. Psychologists who consult with law enforcement have ethical guidelines that caution against these dual agency roles due to the risk of unintended bias and the danger of distortion when forming an opinion.
Although the majority of the expert behavioral analysts on the panel are not board-certified forensic psychiatrists, standard practices and ethical guidelines still apply. Many people who read the report will be struck by Dr. Ivins’s distasteful traits and behaviors, and some may be convinced of his guilt. This should not detract from the larger issue of the proper role and duties of psychiatrists in such investigations.

1. Executive summary of the expert behavioral analysis panel. Accessed at https://www.researchstrategiesnetwork.org/pages/view/Amerithrax/ on June 5, 2011
2. The Amerithrax case: report of the expert behavioral analysis panel. Accessed at
www.lulu.com/product/paperback/the-amerithrax-case-report-of-the-expert-behavioral-analysis-panel-%28redacted-version%29/15208937 on June 14, 2011

3. American Academy of Psychiatry and Law. Ethics guidelines for the practice of forensic psychiatry. Accessed at www.aapl.org/ethics.htm on June 17, 2011

FDA Anger over Australian flu vaccine investigation/SMH

From the Sydney Morning Herald comes this piece that says our FDA found CSL's "investigation" of why so many children had seizures post-vaccination to be entirely inadequate.  If you don't find the problem then you don't have to make any expensive changes to your manufacturing facility.  And you are not liable for willful misconduct, which would be the case were you to find the problem yet continue to sell products whose mode of manufacture had not been upgraded.

THE US drugs watchdog has slammed Melbourne-based drug manufacturer CSL for mounting an ''inadequate'' investigation of convulsions suffered by children who had used its flu vaccine.
CSL withdrew the vaccine, sold as Fluvax in Australia and Afluria in the US, for use on children under five in June last year after it was linked to convulsions and fevers.

But the company has yet to discover why the dangerous side effects were far more common in young children vaccinated with Fluvax than those who used other brands.
In a letter sent to CSL, the Food and Drug Administration lists 15 ''significant deviations'' from drug manufacturing standards uncovered during an inspection of CSL's Parkville facility in March.
''You failed to thoroughly investigate any unexplained discrepancy, or the failure of a batch [of vaccine] or any of its components to meet any of its specifications,'' the FDA's head of compliance, Mary Malarkey, said in the letter, dated June 15.
Ms Malarkey told CSL that their response so far had failed to take a ''more global approach'', including closer scrutiny of raw materials used during drug making.
CSL spokeswoman Sharon McHale said that the company had 15 days to submit a detailed response.
''We're working on our response now and will meet that deadline,'' she said.
The company will then meet with the FDA, probably in the first half of next month.
''If they say our response is adequate we'll continue to implement our action plan,'' Ms McHale said.
''If they feel as though we haven't complied, then they can take regulatory action.''
Ms McHale said that if the FDA was not comforted by CSL's response, ''it can impact our ability to provide vaccine into the US market''. Flu vaccine forms a relatively small part of CSL's $4.6 billion a year in revenue, with worldwide sales last financial year totalling $124 million, of which $53 million was sold in the US.
Convulsions hit between five in 1000 and seven in 1000 children under three vaccinated with Fluvax last year, according to a study by Australian drug regulator the Therapeutic Goods Administration. The baseline rate, observed in a five-year US study, is less than one in 1000.
A TGA survey of hospital data also found children under five vaccinated with Fluvax were between three and 6.5 times more likely to have a fever than users of competing products.
The TGA said that as a working hypothesis a higher concentration of the enzyme neuraminidase due to the inclusion of a swine flu vaccine might have caused the additional convulsions.
''However, despite extensive analyses the biological basis for the excess cases of fever and febrile convulsions remains unclear,'' the TGA said in its report, issued in October.
CSL no longer sells Fluvax for use on children under five and its use on children aged between five and 10 is now only recommended if no other vaccine is available.

Wednesday, June 22, 2011

What DHHS proposes to tell parents about giving anthrax vaccine to their children

In order to meet the requirements of 45 CFR 46.407, a federal advisory panel must review the proposed pediatric research, agree that it will provide important generalizable knowledge, and that children participating in the research will be protected from taking dangerous risks.  DHHS has convened the necessary panel, which will meet to discuss details of the proposed research on July 7, 2011.  The research is only legally approvable if it meets accepted ethical standards and children are protected from potential serious harm.  In order to appear to meet this requirements, the vaccine is being billed as perfectly safe.  The whitewash is being carefully prepared.  The fun begins at the Washington Plaza Hotel, 10 Thomas Circle, Northwest
Washington, DC between 9 and 4:30 pm.  Note the colored text below, where parents are not being told the whole truth about what their children may experience.  Such inadequate disclosure might be seen as willful misconduct on the part of those conducting the study, since they have failed to fairly review the prior body of literature on anthrax vaccine side effects.--Meryl Nass, M.D.

Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers
The population has been told by public health authorities that they were in an area deemed to be exposed to anthrax spores. Public health officials have antibiotics and anthrax vaccine available.
Dialogue of parent to provider:
1. Q - Is my child at risk for developing anthrax?
A - Yes. If your child was exposed to anthrax spores, your child is at risk. 2. Q - What treatments are available?
A - Your child will need to take an antibiotic for two months. A vaccine is also available. 3. Q - Should I get my child vaccinated?
A- Based on what we know about the use of the vaccine in adults, public health officials believe it will provide benefit to your child, however, this has not been previously examined. Your child would still need to take the antibiotics. The vaccine should prevent the disease from occurring after the antibiotics have been stopped. 4. Q - What is the anthrax vaccine?
A - The vaccine is a preparation of proteins from the anthrax bacteria. Vaccination
results in an immune response (the body develops antibodies to ready to fight an infection). The immune response kills and clears the anthrax bacteria. 5. Q - Has this product ever been given to children before?
A- No, the product has never been given-to or evaluated-in children before. 6. Q - How do you know this vaccine is safe for my child?
A - Public health and other experts have reviewed all the available safety data collected
as this vaccine is used in adults and from that believe that the vaccine should be safe in children. Like other vaccines, anthrax vaccine is expected to produce local discomfort, pain, and swelling at the injection site that usually goes away. 7. Q - Do you know if the anthrax vaccine will work in children?
A - Based on the data used to support FDA licensure, public health officials and other
experts, believe it will work, however, there are no data on effectiveness in children or in adults for that matter. 8. Q - How do you know how much vaccine to use for children?
A - The pediatric dose is based on the dose given to adults. We expect this dose will
result in the same protective response. We simply will not know unless we study the immune response in children of different ages. 9. Q - Why does my child need both an antibiotic and a vaccine? What are the risks if my
child does NOT receive the anthrax vaccine? A - If your child was exposed to anthrax spores, your child will need to complete a
2-month course of antibiotics. Antibiotics do not kill anthrax spores. The antibiotics work directly against the active anthrax bacteria. The bacteria were delivered as


Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers – continued
spores, which are very hardy and when they germinate, or “hatch” the resulting bacteria cause the disease. These spores can last several months in the body before hatching. The anthrax vaccine prepares the immune system to directly attack the anthrax bacteria and gives protection beyond the 60-days of antibiotics. As with other bacteria, anthrax bacteria may develop resistance to antibiotics. Also, we do not know enough yet about long-term exposure risks from living in an area that has been contaminated with spores from an attack. 10. Q - Does the anthrax vaccine cause anthrax disease?
A - No. The vaccine cannot cause anthrax. 11. Q - What are the risks if my child does get vaccinated – will the vaccine harm my child?
A - The vaccine causes a local reaction that can be mild or severe, with local pain,
swelling and difficulty moving the arm. This reaction can last for days or even longer before going away. As with other vaccines, your child may experience muscle aches, fatigue, and headache. These will go away. Rarely, your child may have a serious allergic reaction within minutes after vaccination and require medication to treat. We will watch for this after your child has been given the vaccine. 12. Q - Will my child be protected against anthrax for life?
A - No. The three doses of vaccine your child will receive are for this particular event.
Based on the data we have at this time, it will not protect your child for life.
13. Q - If your child were exposed to anthrax, would you want them to get the vaccine?
14. Q - Since we do not know the exact dose of vaccine to give your child and its protective
ability, except for the adult dose and data, would you want the US government to collect data on pediatric dosing and protective ability ahead of time, that is, before an exposure? A study done prior to an exposure would help us decide whether the dose that we would use after an exposure is the preferred dose for protecting your child while likely minimizing any side effects.
15. Q - Since we do not know the exact dose of vaccine to give your child and its protective
ability, except for the adult dose and data, would you want the US government to collect data on pediatric dosing and protective ability during an event, that is, after an exposure? A study done only after an exposure would need to start with the adult dose that we believe will be effective, as a lower dose may not be effective. We will not know if this is necessary, since a lower dose may be as protective, but with fewer side effects. Enrolling your child in a study will help us figure this out for future children (or future doses for your child).

Monday, June 13, 2011

Fukushima lesson: You can't rely on govt or industry when a real crisis comes along/ NY Times

Most detailed look yet at the flawed decision-making and terrible information sharing between TEPCO, government bureaucrats, political leaders and outsiders during Japan's nuclear crisis by the NY Times:

The Fukushima Daiichi nuclear plant, damaged by a tsunami on March 11, became the site of the worst nuclear disaster since Chernobyl, as workers successfully warded off a complete meltdown, but could not prevent the release of considerable amounts of radioactive material.

In nuclear crisis, crippling mistrust

TOKYO — On the evening of March 12, the Fukushima Daiichi nuclear plant’s oldest reactor had suffered a hydrogen explosion and risked a complete meltdown. Prime Minister Naoto Kan asked aides to weigh the risks of injecting seawater into the reactor to cool it down.

MASAO YOSHIDA The manager of the power plant, he ignored orders to stop pumping seawater into a reactor to cool it, an act of defiance that may have prevented many deaths.

At this crucial moment, it became clear that a prime minister who had built his career on suspicion of the collusive ties between Japan’s industry and bureaucracy was acting nearly in the dark. He had received a confusing risk analysis from the chief nuclear regulator, a fervently pro-nuclear academic whom aides said Mr. Kan did not trust. He was also wary of the company that operated the plant, given its history of trying to cover up troubles.
Mr. Kan did not know that the plant manager had already begun using seawater. Based on a guess of the mood at the prime minister’s office, the company ordered the plant manager to stop.
But the manager did something unthinkable in corporate Japan: he disobeyed the order and secretly continued using seawater, a decision that experts say almost certainly prevented a more serious meltdown and has made him an unlikely hero.
The convoluted drama has exposed the underlying rifts behind Japan’s handling of the worst nuclear disaster since Chernobyl, which eventually resulted in explosions at four of the plant’s six reactors. Mutually suspicious relations between the prime minister’s aides, government bureaucrats and company officials obstructed smooth decision-making...

F.B.I. Agents Get Leeway to Push Privacy Bounds/NYT

More on America's widening surveillance state from the NY Times:

The Federal Bureau of Investigation is giving significant new powers to its roughly 14,000 agents, allowing them more leeway to search databases, go through household trash or use surveillance teams to scrutinize the lives of people who have attracted their attention.
Valerie E. Caproni, the F.B.I. general counsel, said the bureau had carefully considered each change to its operations manual.

The F.B.I. soon plans to issue a new edition of its manual, called the Domestic Investigations and Operations Guide, according to an official who has worked on the draft document and several others who have been briefed on its contents. The new rules add to several measures taken over the past decade to give agents more latitude as they search for signs of criminal or terrorist activity.

The F.B.I. recently briefed several privacy advocates about the coming changes. Among them, Michael German, a former F.B.I. agent who is now a lawyer for the American Civil Liberties Union, argued that it was unwise to further ease restrictions on agents’ power to use potentially intrusive techniques, especially if they lacked a firm reason to suspect someone of wrongdoing...

Sunday, June 12, 2011

Attorney General Dominic Grieve refuses to order an inquest on death of David Kelly

After David Cameron recently said a full inquest into David Kelly's death was unnecessary, it was no surprise that his Attorney General soon afterward echoed his statement.  Excerpts from the BBC:
On the day Dr Kelly's body was discovered, then Prime Minister Tony Blair asked Lord Hutton to conduct an urgent investigation into the circumstances surrounding the death.
Unusually, the inquest opened into Dr Kelly's death was never completed.
Lord Hutton released his findings in January 2004, reporting that the scientist had committed suicide by slashing his wrist with a blunt gardening knife.
Lord Hutton requested that the details of the post-mortem examination and toxicology tests be classified for 70 years - to protect the privacy of the Kelly family.
Why have there been calls for an inquest?
A group of doctors have mounted a long-running campaign for the inquest into Dr Kelly's death to be re-opened, arguing that Lord Hutton's suicide verdict was unsafe.
"No coroner in the land would have reached a suicide verdict on the evidence which Lord Hutton heard," they say.
They believe Dr Kelly's wrist wounds were not likely to be life-threatening, making the official cause of death - a haemorrhage - "extremely unlikely".
They say unanswered questions surrounding the death remain, including:
    * why no fingerprints were found on the knife apparently used to slit his wrist
    * how Dr Kelly obtained a packet of coproxamol painkillers
    * why his blood and stomach contained only a non-toxic dose of the drug
    * why he was not spotted by a police helicopter with thermal imaging cameras which    
       flew over the wood where his body was later found
    * whether he intended to kill himself
In September last year they petitioned Attorney General Dominic Grieve for the re-opening of inquiries.
It "may represent one of the gravest miscarriages of justice to occur in this country", the doctors said in a letter in March appealing to Prime Minister David Cameron to intervene on their behalf.
But, in June 2011, Mr Grieve rejected the doctors' petition. He said his department had thoroughly investigated their complaints and could not find any legal basis for referring the case to the High Court, which has the legal authority to order an inquest.
Following the government's decision, the doctors who had petitioned Mr Grieve called for his resignation.
Campaign leader Dr Stephen Frost said: "The continuing cover-up of the truth of what happened is a national disgrace and should be of concern to all British citizens."
The group will now seek to take the decision to judicial review.
From the Daily Mail, more on the story, including a piece by Sue Reid titled, "Questions that Still Demand an Answer."

Monday, June 6, 2011

Why we are still in Afghanistan: One trillion $ in minerals/NPR

Mines, like this one in Badakhshan, could help lift Afghanistan out of poverty.
 Mines, like this one in  Badahkshan, could lift Afghanistan out of poverty (NPR)

From National Public Radio, information on how the Pentagon is working to develop business opportunities in Afghanistan for US corporations:
There's close to a $1 trillion waiting to be unearthed beneath the rocky soil of Afghanistan. The massive deposits of iron, copper, gold and lithium could potentially turn the troubled nation's economy around.
"Afghanistan, with certainty I can say, in 20 years is going to be a mining country," Paul Brinkley, head of a Pentagon group called the Task Force for Business Stability Operations, tells NPR's Rachel Martin. "That is going to happen."...

As part of his efforts, Brinkley brings in corporate executives on trips to Afghanistan to try to get them to invest. An array of executives, including from Citibank, IBM and even Kate Spade, have accompanied Brinkley on these types of trips. When he's making his pitch, he wants to make it clear this is not a charity opportunity. It's strictly business.
"I want them to come in and see that they can make actually make money, that there's a market," Brinkley says, "that there's talent that can be brought to bare for their particular business interests."
High-Risk Investments
But these possible business opportunities are still located in a volatile, dangerous environment. With the task force moving to the civilian-run U.S. State Department, the risk is greater.
State Department personnel are "not trained to be in combat zones," notes Nathan Hodge, author of Armed Humanitarians, "they're not trained to be in combat zones, and very often you're talking about doing this kind of armed development work while being shot at."
Those are the same concerns some lawmakers have on Capitol Hill, saying Brinkley's task force blurs the line between military and civilian missions. They think taking CEOs around Afghanistan is not something the Pentagon should be doing.
Brinkley has had his own close calls. In January 2010, a bomb went off in a Baghdad hotel where he was holding a meeting. Even after that close shave, Brinkley and his team only had one thought.
"Our immediate reaction was we're going right back in," he recalls.
Having A Stake
Once the minerals are extracted from the ground, Brinkley is faced with the reality of possible corruption — his greatest concern. He doesn't want minerals to become the blood diamonds of Afghanistan. To combat this worry, the task force makes sure Afghans have access to mining industry experts.
The overall key, according to Brinkley, is engagement. By staying involved, he says, the U.S. has the ability to better shape the outcome. He also notes, the U.S. does have a strategic interest in seeing Afghanistan develop...

More on the bureaucratic challenges of injecting children " with no clear benefit" with anthrax vaccine/DHHS

See here for a detailed discussion of the expanding anthrax vaccine stockpile, vaccine maker Emergent Biosolutions, and the illegality of shooting up children with an anthrax vaccine potion that is too dangerous for adults.