One step could dramatically improve hospital care and patient safety

Information has many ways of falling through the cracks in hospitals and medical practices.

The wrong test may be mistakenly ordered by the doctor. The ward secretary may order the wrong test. The lab may perform the wrong test, or rarely perform it on the wrong person. The result may not be available until after the patient leaves the hospital, and then gets lost in cyberspace; or it reaches the chart after the doctor has dictated the discharge summary and is never seen.

Usually more than one doctor takes care of each patient, but each may not be aware of everything the other has done, or which tests were ordered and are still pending.

A simple fix would be to require that all electronic medical records systems must be linked to the laboratory and radiology departments, and must be able to generate a list of all tests ordered; their results; and those tests whose results are still pending. At the end of a hospitalization, each doctor would have to sign off on the list, to ensure all tests had been considered.

We currently have a hodge-podge of hundreds of proprietary EMR systems that do not communicate with each other throughout the US, and the system I use does not have this capability.

Electronic medical records are a wonderful idea in theory. In practice, they are fraught with difficulties and potentially may be accessed or "hacked" by unauthorized individuals, making a mockery of patient confidentiality. The problem of confidentiality is central to getting a working EMR system in place throughout the nation, through which doctors and patients can communicate; yet it requires cybersecurity resources beyond the financial resources of hospitals and medical practices in the private sector. This is why the development and maintenance of such a system must be federalized.

MK Shai calls for anthrax vaccine experiment probe

from YNet:

Kadima Knesset Member and former Israeli Defense Force spokesman Nachman Shai on Friday said either a state commission of inquiry or a parliamentary commission of inquiry should be set up to look into the anthrax vaccine experiments conducted on IDF soldiers. MK Shai said, "The fact that the experiment was hidden from the public and the examinees is a moral issue of the highest degree".

More on the Israeli anthrax vaccine experiment on soldiers

From the Jerusalem Post

From the AP

Excerpts from today's Ha'aretz:

Dr. Reuven Porat, who chaired the medical committee, told Haaretz the panel had not been presented with any official documentation that shows the decision to develop, test and produce the vaccine had been authorized by the government. Similarly, there was no authorization presented from the defense minister, who is charged with responsibility for the Institute for Biological Research, and not from the IDF, and there was no proof the chief of staff was consulted about or agreed to the project...

In its report the panel is highly critical of the "secrecy" imposed by the managers of the experiment and ask "whether the secrecy was necessary because the experiment was to be hidden from the Israeli public."

The medical panel noted: "Selecting soldiers as the population for the experiment prevented achieving the declared aim of the experiment, which was to examine its safety and effectiveness in broad use among the general civilian public, the elderly, women, children and sick patients," the committee wrote.

From YNet come these excerpts:

Israel has admitted to developing a vaccine against anthrax, fearing it might be used as a bio-weapon by enemy nations against civilians, and tested it on IDF soldiers. "Once we face a substantial threat, we would be able to vaccinate all citizens, ranging from babies to the elderly, and protect them against the virus," a senior defense source told Ynet. (But the report indicates Israel already had a large enough stock of vaccine for its population prior to beginning this trial--Nass) From PressTV: Some of the soldiers, who say that the experiment has had life-threatening side effects for them are now filing a lawsuit against the Israeli Army, Haaretz reported... Israeli Physicians for Human Rights have also filed a lawsuit against the army over the experiments.

Medical panel: Anthrax experiments on IDF soldiers were unjustified

Another fascinating article on the Israeli anthrax vaccine experiments by Yossi Melman in Haaretz. Excerpts follow. It seems no one in Israel would take any responsibility for the experiment, which is being laid at the feet of (assassinated) former Prime Minister Itzhak Rabin -- but no documentary evidence was given to the Israeli Medical Association committee invesetigating the experiment to support the putative association with Rabin.

In the US, I have been unable to learn who has been behind approval of the anthrax vaccine for mass use, when there exists no experimental evidence for human efficacy, the safety profile is awful, and the need has never been demonstrated.

Following a three-month legal battle in Israel's High Court of Justice, the report was finally approved for publication Wednesday...

The experiments were carried out in light of what was then defined as the "strategic threat of a surprise biological attack facing Israel. However, the report said that it was not clear who the decision makers were who determined the vaccine's necessity...

The Chairman of the medical committee, Dr. Reuven Porat, told Haaretz that the panel was not presented with any official evidence indicating that either the government, the defense minister of the IDF chief of staff had authorized the development, testing, or production of the vaccine...

The report insinuates that it was improper motivation that prompted the launch of the experiments, but it does not specify what these motivations were, saying that the panel "could not make out the true inspiration behind them..."

The report reveals that even while the experiment was taking place Israel already had a stock of vaccines, a fact which further raised the concern that the experiment wasn't necessary; that it was carried out as a result of external pressure. "An accelerated effort to produce large quantities of the vaccine was underway a year prior to the experiment, and by the time the experiments were launched, Israel had enough vaccines to cover the civilian concerns," the report said...

Israel and the IDF accepted the principles of the Helsinki Accords, declaring many times that they meet their standards. In reality, however, the report states that "the military Helsinki committee failed to fulfill its duties in 'Omer 2' in every one of the points examined by the report."

"No scientific justification was found for the experiment, scientific background was lacking, the experiment's design and execution did not suit its goals, and no result would have justified those goals. Also, conventional guidelines were not followed, risks and possible side effects were not thoroughly investigated, and a follow-up mechanism to keep track of participating soldiers was not set up....."

Preventing Bioterrorism (Op/Ed by Rep. Rush Holt)

Preventing bioterrorism:

Thursday, March 12, 2009
BY RUSH HOLT
Last year, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism -- itself an outgrowth of the 9/11 Commission and its recommendations -- issued its report. It used alarming language to prod our government to act. It affirmed something that was demonstrated with the deadly anthrax attacks: Terrorists will likely use WMD attacks on America that feature biological weapons. The question now is: Have we implemented "lessons learned" from these attacks that took place in the fall of 2001, which caused such havoc here in New Jersey and across the nation?

I agree with the commission's assertion that "only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity." To that end, the commission made a number of recommendations for improving biosecurity here at home, including the more thorough and persistent monitoring of personnel working at high-containment laboratories (i.e., those who work with dangerous pathogens) and the designation of a single federal agency for tracking the number of such labs in the United States.

I support those and other measures, but I do not believe Congress and the incoming administration can craft an effective biosecurity program for our country unless and until we take the time to investigate thoroughly the only major (and still unsolved, according to many) bioterror attack on our country to date.
Last week, I reintroduced the Anthrax Attacks Investigation Act, to examine and to report on how the attacks occurred and how we can best prevent similar episodes in the future.

Readers may wonder why the commission did not address the 2001 anthrax attacks in detail in its report. The answer is that examining those attacks was not an explicit mandate of the WMD Commission. This is in contrast to the 9/11 Commission, which was specifically charged with looking at how the Sept. 11, 2001 attacks happened, why the federal government failed to prevent the attacks, and what remedial measures are necessary to prevent a similar catastrophe in the future.

A thorough investigation into the federal government's response to the first modern bioterror attack on our soil is absolutely essential if we are to ensure that we have learned the right lessons from that episode to implement countermeasures and changes in policy that are directly tied to those "lessons learned" -- something that The Times of Trenton repeatedly has pointed out in its frequent coverage of this tragedy.

While many of the WMD Commission's recommendations for improving biosecurity look sound on the surface, none of their specific action proposals are based on a detailed examination of how the 2001 anthrax attacks occurred. More than seven years after the attacks, many critical questions remain unanswered. Chief among them is why the Federal Bureau of Investigation's (FBI) "Amerithrax" investigation focused for so long on the wrong suspect.

The FBI's performance in the wake of the attacks has left me and many other Americans wondering whether the Bureau is truly equipped to handle bioterrorism. Deterring such attacks in the future depends in part on at least the expectation of swift and certain detection and punishment.

Neither happened in the case of the 2001 anthrax attacks. We need to know why the first attack succeeded and why the perpetrator or perpetrators escaped justice.

Just as the 9/11 Commission looked not only at the attacks of that morning, but also at recommended changes in the structure of government agencies, screening methods and even congressional oversight, so should an anthrax commission look at the specific crime, but also at measures for prevention, detection and investigation of any future bioterrorism.

An anthrax attack investigation would help address these kinds of policy questions in a level of detail that the WMD Commission could not.

Rep. Rush Holt, D-Hopewell Township, is chairman of the House Select Intelligence Oversight Panel.

FBI Press Release details the meaning of the ASM presentations in Baltimore last week--with comments

For Immediate Release
March 6, 2009

Washington D.C.
FBI National Press Office
(202) 324-3691

FBI Responds to Science Issues in Anthrax Case

FBI Laboratory Director D. Christian Hassell, PhD issued the following statement:

During a recent American Society for Microbiology Biodefense (ASMBD) meeting in Baltimore , Maryland , questions were raised regarding two scientific analyses conducted during the course of the anthrax investigation. While this information is not new, it is important for the FBI to clarify the science since these findings continue to be misinterpreted by various media outlets.

The first item involves the elemental analysis of the anthrax spores that was conducted by Dr. Joseph Michael, a materials scientist at Sandia National Laboratories. At the conference, Dr. Michael presented analyses of three anthrax letters (Leahy, Daschle, and New York Post). He concluded that the anthrax powder in the three letters shared a chemical fingerprint but did not match the chemical fingerprint of spores in Ivins’ flask. Spores from the letters showed a distinct chemical signature that included silicon, oxygen, iron, tin, and other elements. Spores from Ivins’ RMR-1029 flask did not contain those elements in quantities that matched the letter spores. This is not unusual considering that Ivins’ RMR-1029 preparation had been submerged in water and other chemicals since 1997 and was a mixture of 34 different spore preparations. The letter spores were dried spores, produced from two separate growth preparations as indicated by differences in the New York and Washington, D.C. mailings. Although the chemical fingerprint of the spores is interesting, given the variability involved in the growth process, it was not relevant to the investigation.

It is important to note that the genetic profile of the spores from the letters and the spores from Ivins’ RMR-1029 flask was identical. Ivins’ RMR-1029 spore preparation had the same combination of anthrax mutations found in the letters. Only eight of the anthrax samples collected during the course of the investigation matched the genetic profile in the letter material and all were linked back to RMR-1029. This conclusion was the most significant and relevant scientific finding in the case.

By analogy, if one were to grow a corn stalk from a specific corn seed, the trace chemical fingerprint of the stalk might differ from that of the seed due to different compositions—for example iron—in the respective fertilizers used to grow each; however, the genetic profile of the seed and the stalk would be identical.

The second item involves isotopic analysis of the mailed anthrax. Media reports indicated that FBI scientists had concluded in 2004 that out of many domestic and foreign water samples analyzed only water from near Fort Detrick, Maryland, where Dr. Ivins worked, had the same isotopic signature as the water used to grow the mailed anthrax. This statement is incorrect. While water isotopic analysis was researched, the FBI concluded that there were too many confounding variables to precisely match bacteria that were grown using different materials and recipes. This technique was not relevant to the investigation.

While we have full confidence in our scientific approach, an additional independent review will provide further validation and thus benefit the larger scientific community. Consideration of an outside review began before any public disclosure of the scientific aspects of the investigation. This follows our approach throughout the investigation: to bring in external scientists to review and provide advise on our methodologies.

Nass comments: Even if everything stated above is accurate, the FBI has yet to prove that Ivins himself, not just his flask, provided the parent spores for the anthrax letters.

-- How did the FBI "rule out" as perpetrators over 100 other people who had access to spores from Ivins' flask?

-- How did the FBI ascertain that all of the secondary spore collections, derived from the flask, were 100% secure and could not have been surreptitiously obtained by others?

-- How was the FBI sure that no one else received spores from Fort Detrick, given that Fort Detrick's inventory problems were serious enough for there to have been a temporary "stand-down" of research just last month? Also consider that Ivins' flask was in a separate building from his lab, to which others had access, for over a year.

Since a thorough, complete accounting of its six year long, resource-intensive investigation has yet to be provided by the FBI, the following questions (raised by Representative Rush Holt on October 16, 2008) are additionally relevant:

"Are any of the FBI’s scientific findings inconsistent with the FBI’s conclusions?

Are there any scientific tests that the FBI has not done that might refute their conclusions?

Did the FBI follow all accepted evidence-gathering, chain of possession, and scientific analytical methods? Is it possible that any failure to do so could have affected the FBI’s conclusions?

Is it scientifically possible to exclude multiple actors or accessories?"

It is now 7 months since FBI announced the case was closed. During that time, FBI has released many pieces of (selected) evidence. The latest release, at a special ASM meeting convened for the purpose, was designed to make the scientific case.

The FBI charade has failed. The most basic questions remain unanswered.

Israeli Ministries take 'full responsibility' for anthrax vaccine trials

Article in THE JERUSALEM POST
Mar. 4, 2009
Yaakov Lappin

The Defense Ministry, Health Ministry and IDF said they took "full responsibility" for all side effects suffered by participants in a test of an anthrax vaccine, in a joint statement issued Wednesday.

The statement will be submitted to the High Court next week as a reply to petitions submitted by two IDF soldiers who took part in the trial and suffered negative aftereffects.

The petitioners raised questions about the way the vaccine trial was conducted, and are claiming the monitoring of volunteers and subsequent care provided to them was inadequate.

The vaccine trial, code-named Omer 2, took place between 1998 and 2006, and sought volunteers from elite IDF units. Following the test, a number of participants complained of breathing problems and skin conditions.

A quarter of participants were given an American version of the vaccine, while 75 percent were injected with the Israeli vaccine, which had not been previously tested. Members of both groups suffered side effects.

According to the statement, which was released by the Defense Ministry, 716 soldiers took part in the trial, and 11 later required medical treatment.

"Volunteers were given a detailed explanation about the vaccination, the study, and potential side effects. They were given a sheet to study and sign," the statement said.

"All of the soldiers who requested medical care received it," it added.

The Defense Ministry went on to describe Omer 2 as a project with "strategic importance for the State of Israel," adding, "Thanks to Omer 2, Israel has a medical response for the general public against a most severe threat. We thank the volunteers and appreciate their willingness to take part in this important trial, and their contribution to the general security of residents of Israel."

The vaccine is as safe as the anti-anthrax vaccine developed by the US, the Defense Ministry said.

Academic experts and oversight committees within the IDF closely monitored the vaccine trial, the statement added.

Remembering the anthrax attack

Glenn Greenwald's March 4, 2009 Salon article on Representative Rush Holt's bill and the ramifications of the anthrax attack is a must-read. Great links. Here is an excerpt:

The ultimate establishment organ, The Washington Post Editorial Page, issued numerous editorials expressing serious doubts about the FBI's case against Ivins and called for an independent investigation. The New York Times Editorial Page echoed those views. Even The Wall St. Journal Editorial Page, citing the FBI's "so long and so many missteps," argued that "independent parties need to review all the evidence, especially the scientific forensics" and concluded that "this is an opportunity for Congress to conduct legitimate oversight."
In the wake of the FBI's accusations against Ivins, the science journal Nature flatly declared in its editorial headline -- "Case Not Closed" -- and demanded an independent investigation into the FBI's case. After the FBI publicly disclosed some of its evidence against Ivins, The New York Times reported "growing doubts from scientists about the strength of the government's case." The Baltimore Sun detailed that "scientists and legal experts criticized the strength of the case and cast doubt on whether it could have succeeded." Dr. Alan Pearson, Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation -- representative of numerous experts in the field -- expressed many of those scientific doubts and demanded a full investigation.
There may be legitimate grounds for doubting whether an independent, 9/11-type Commission of the type Holt proposes is the ideal tribunal to conduct a real investigation, but it is clearly the best of all the realistic options. The only other plausible alternative -- an investigation by Congress itself -- is far inferior, as anyone who has observed any so-called "Congressional investigation" over the last decade should immediately recognize (here, as but one example, is the account I wrote about a House hearing last September attempting -- with cringe-inducing ineptitude and total futility -- to "grill" FBI Director Robert Mueller about the FBI's case against Ivins). How effective an independent investigative Commission like this will be will depend on the details of its structure -- its subpoena powers, punishments for defiance, and the independence of its members. That Rush Holt will play a key role, if not the key role, in overseeing its creation is a reassuring feature that the bill he introduced can be actually productive.

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

For Immediate Release Contact: Zach Goldberg March 3, 2009
202-225-5801

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

Bill Would Create 9/11 Commission-Style Panel to Investigate Anthrax Attacks and Government Response

(Washington, D.C.) – Rep. Rush Holt (NJ-12) today introduced the Anthrax Attacks Investigation Act of 2009 (HR 1248), legislation that would establish a Congressional commission to investigate the 2001 anthrax attacks and the federal government’s response to and investigation of the attacks. The bipartisan commission would make recommendations to the President and Congress on how the country can best prevent and respond to any future bioterrorism attack. The attacks evidently originated from a postal box in Holt’s Central New Jersey congressional district, disrupting the lives and livelihoods of many of his constituents. Holt has consistently raised questions about the federal investigation into the attacks.

“All of us – but especially the families of the victims of the anthrax attacks – deserve credible answers about how the attacks happened and whether the case really is closed,” Holt said. “The Commission, like the 9/11 Commission, would do that, and it would help American families know that the government is better prepared to protect them and their children from future bioterrorism attacks.”

Under Holt’s legislation, the commission would be comprised of no more than six members from the same political party. The commission would hold public hearings, except in situations where classified information would be discussed. The commission would have to consult the National Academies of Sciences for recommendations on scientific staff to serve on the Commission. The Commission’s final report would be due 18 months after the Commission begins operations.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said. “One of the most effective oversight mechanisms we can employ to get answers to those questions is a 9/11 style Commission.”

Examining Other Healthcare Models

Healthcare is highly valued by our society, yet it seems that many of our pundits and politicians are willing to create a new healthcare system from whole cloth. In other words, let's consider this or that experiment, and the winner will be the compromise melange that gets passed by Congress. (Definition of melange: a collection containing a variety of miscellaneous things.)

Well, we already experimented with the theory that government was the problem, tossing strict regulation (of banks, mortgage providers, stockbrokers, the food and drug industries, and military procurement, to name a few) in the wastebin, and where did it get us? Do we really want our healthcare system to be crafted by a bunch of horse-traders, and laden with pork?

I, for one, don't think we have the time or money for another major social experiment. I think it is time to put the available information to work to craft a system that we know will meet our needs, before we put it into place.

So far, there has been deafening silence on the subject of healthcare systems in the rest of the world, and what is wrong and right with them. Yet these models can tell us so much about how different programs are likely to work. We should be examining the other systems under a microscope right now, as the administration and Congress begin taking positions.

Thankfully, blogger Tim Foley at Change.org has begun this conversation, describing how a low-cost, high tech, high drug use system has led to enviable life expectancy and infant mortality rates in Japan. Enjoy his enlightening piece.