Good for Business, Bad for Patients?

Excerpts from Dr. Jon Abramson's ABC News Op-Ed:

It's perfect. Pfizer buys Wyeth's pipeline, the behemoth marketing power of Pfizer gets leveraged, the work force gets consolidated and the $22 billion borrowed is read as a sign that banks are willing to lend again...

The core problem with American medicine isn't really access or cost. It's that medical knowledge itself has been turned into a commodity, produced and disseminated with the primary goal of optimizing profits rather than health...

What we've got is a good old-fashioned case of market failure. But understanding the magnitude and consequences of the failure of the market to oversee the relevance and integrity of commercially generated medical knowledge is virtually impossible to see unless you're a corporate insider or have a subpoena to gain access to the unspun scientific evidence (closely held as proprietary information by the drug companies) and other corporate documents...

More pictures +/- the complete exosporium

Here (or here, if you are having trouble viewing the first set of images) is a side by side comparison of the Sandia pictures (from Anonymous) with pictures of 2 different batches of anthrax spores from another paper. One picture shows anthrax spores WITH an intact exosporium, the other WITHOUT an intact exosporium. Clearly the Sandia picture most resembles the one WITHOUT an exosporium. This contradicts Sandia's claim that their picture of the mailed spores has an intact exosporium.

More on health financing (NYT Blog): How Do Hospitals Get Paid? A Primer

Wonderful article by economist Uwe Reinhardt clarifying bizarre hospital charges and third-party reimbursements, and how much of the healthcare dollar they waste. Excerpt:

Americans can be forgiven their ignorance on this issue because, as I put it in a recent paper on the subject, the pricing of hospital services is best described as “Chaos Behind a Veil of Secrecy.”

Army releases some e-mails from anthrax suspect/Frederick News-Post

Article by Justin Palk

The U.S. Army released 33 pages of Bruce Ivins' e-mails Thursday from his account at Fort Detrick.

The e-mails, obtained by The Frederick News-Post under the Federal Freedom of Information Act, span the period from September 1998 through January 2002.

The documents contain 16 threads of communication, some including multiple e-mails between Ivins and his correspondents.

The e-mails all address one of three issues: the work of Ivins and other individuals to plan an international meeting of anthrax researchers in Annapolis for the summer of 2001; discussions of lab research; and in two cases, copies of The New York Times articles about the investigation into the 2001 anthrax mailings that Ivins e-mailed to himself.

The news articles both concern the difficulty investigators had early on in tracking the history and origins of the Ames strain of anthrax used in the mailings.

The Army continues to review additional e-mail messages from Ivins.

In August, the Department of Justice announced it considered Ivins, a U.S. Army Medical Research Institute of Infectious Diseases microbiologist, its sole suspect in the 2001 anthrax mailings that killed five and hospitalized 17 others.

Ivins died on July 27 after intentionally overdosing on acetaminophen.

His attorney has maintained Ivins was innocent.

Defense attempting to block report about anthrax trial/Haaretz

Excerpts from the article:

... IDF soldiers were given seven doses of an anti-anthrax vaccine developed by the Nes Tziona biological institute. But there was no extended medical supervision of the vaccinated soldiers.

A year and a half ago, a group of soldiers vaccinated in the experiment asked the IDF and Defense Ministry for all the details of the experiment, saying they suffered from debilitating side effects. The army and Defense Ministry ignored the request and would not recognize the soldiers as disabled veterans - eligible for benefits from the IDF.

Fixing the financial incentives in medicine

Medco (this is the pharmacy benefits company that settled for $155 million over charges of defrauding the federal government and paying kickbacks in 2006) manager Dave Snow has jumped into the healthcare debate. His idea is to force doctors to prescribe pre-selected treatments: if you diagnose A, you treat with B.

Obviously, Mr. Snow doesn't understand why medicine is an art. You have to take into account preexisting illnesses, risk factors, other medications, drugs allergies, drug intolerances, likelihood of compliance, and patient psychological, social and too often, financial factors to come up with a treatment. And then you should negotiate it with the patient to increase compliance and understanding. That is why B is often not the best choice. (Medco may not even offer B on its formulary, which is an additional reason to choose C.)

Granted, there are numerous problems with our medical system, and there are many possible solutions. In contrast to Mr. Snow, let's look a little deeper at why we have so many problems:

1. The financial incentives are all wrong.

a) You don't get paid more for getting things right: you get paid more for ordering more tests, increasing the number of visits, and spending the shortest possible time with the patient. Four fifteen minute visits pay almost twice as much as one hour-long visit. Spend an hour performing a detailed evaluation of a complex patient, get the diagnosis right and bingo! you have just forfeited reimbursements for additional visits, as well as earning considerably less for the hour you just spent than if you had seen patients with 4 sore throats.

b) You don't get paid for keeping people well, in general.

c) Outcome measures are rudimentary. Doctors are currently graded on whether a sufficient proportion of patients have regular mammograms, PAP tests and vaccinations, and whether their patients with chest pain receive appropriate emergency medications. But these measures indicate nothing about the proportion of correct diagnoses, or patient satisfaction. And they may incentivize bad behaviors. For example, the reasonable requirement to give all patients with pneumonia an antibiotic within 4 hours of ER arrival led to excessive antibiotic prescribing in every patient who "might" have had pneumonia.

d) Primary care docs are paid very little relative to docs who perform procedures. Procedures rule medicine. High profit procedures like cardiac catheterizations, neurosurgery, orthopedic surgery, and endoscopy subsidize ordinary patient care in hospitals and clinics. Hospitals pay hospitalists considerably more than they can bring in (in reimbursements from third party payers), in part because hospitals cannot function without them, but also because these primary care doctors order more lucrative tests and procedures on their patients.

e) Due to concerns about malpractice and meeting patient expectations (most patients expect that everything that can be done for them, will be done) doctors order more tests and procedures than are justified by existing guidelines.

f) The medical literature is contradictory on an enormous number of medical issues, so doctors are hard-pressed to trust the literature to give them the best or most accurate answers...leading to increased testing and procedures, since our culture punishes sins of omission much harder than sins of comission, or "doing too much."

g) The negative results of "doing too much" fail to be acknowledged or quantified. How many cancers are caused by unnecessary CT scans? I have no idea. How many patients die after undergoing cardiac catheterizations, when a medication adjustment might have been as effective? Studies of such questions fail to be published in major journals and do not appear to have affected clinical practice.

h) Professionalism currently demands from doctors that they meet the "standard of care" provided by other local practitioners. In part because the medical system is so complex, and there are so many medical tests, procedures and specialties, our expectation of ourselves as practitioners is more about ordering the right test and referring to the right specialist, rather than correctly diagnosing the patient. We expect that the test or the specialist will provide the answers if we do not have them. Cognitive skills have been devalued.

There is little financial or professional incentive to keep studying and struggling to find answers for the most challenging patients. And no financial or other reward if you succeed.

More later...

Coated and uncoated spores may look alike

Pictures of coated and uncoated spores are here, courtesy of Anonymous.

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Global Security Newswire article
National Journal Group

Friday, Jan. 16, 2009
By Elaine M. Grossman

WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).

(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).

The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to compel inoculations for an unapproved use of the vaccine.

Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.

The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).

A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.

The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).

However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.

The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.

U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."

Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.

"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation," Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."

The 1946 federal law controls how government agencies draft and issue regulations.

A Defense Department spokesman praised the federal judge's decision.

"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.

If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).

In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.

"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory," according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.

The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.

"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."

Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology," according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable."

An FDA spokeswoman today declined to offer comment on the court case.

Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.

Critique of the "chemical signature" assertion and other points by Barry Kissin

Barry Kissin, an attorney in Frederick, Maryland, analyzes several assertions in Scott Shane's January 4 article, by reviewing media and other reports published since 2001. These include the unsupported claim that the "chemical signature" of the water used to grow the letter anthrax could only come from Frederick, Maryland, and that other US government and quasi-governmental biodefense laboratories have been ruled out as sources.

Frederick Police Report out

The Frederick Post has made available a pdf of the Frederick Police Department report regarding its investigation of Ivins' last days.

I have several questions after reading this material. First, I would assume that Ivins made two trips to the Giant Eagle pharmacy an hour apart in order to drop off prescriptions then pick up the medications. The police report claims he purchased one bottle of 70 tylenol pills. Scott Shane said he purchased two bottles of tylenol PM, which includes benadryl, one during each visit to the pharmacy. Prior reports (and one mention in this police report) indicated he ingested tylenol with codeine, which would have required a prescription, and does not appear to have been purchased on July 24.

Thus it still remains unclear what he purchased, what he had available at home, and how much tylenol (and other substances?) he may have ingested. There should have been investigations of the contents of the orange soda and red liquid found in Ivins' bathroom and bedroom, respectively, but the police report fails to indicate whether these materials were collected and studied.

Second, Ivins' disclosure to the Red Cross of his medical history provides support for the hypothesis that Ivins suffered from chronic medical problems that are commonly found in patients who become ill following receipt of anthrax vaccinations. He reported chronic pain issues ("back/joint/bone problems" for which he took neurontin, lidocaine patches, aleve and diazepam); psychiatric issues ("anxiety/PTSD/Bipolar Disorder" and "depression"); and sleep apnea.

All 3 are among the most common symptoms that occur as sequellae of anthrax vaccine, as noted by me but also by the Vaccine Healthcare Centers Network, which screens many patients for sleep apnea. This diagnosis is relatively rare in thin males, but has occurred in 80% of those disabled males I have evaluated in the past 3 years for the sequellae of anthrax vaccine. All those patients had chronic widespread pain disorders and psychiatric sequellae as well.

Third, Ivins had rhabdomyolysis and (probably secondary) renal failure when he arrived at the ER, in addition to the subacute sequellae of liver failure (presumably from a tylenol ingestion). It is not clear what led to his developing this, which seems to have significantly added to the severity of his final illness. Release of more medical information would help clarify whether the known facts fully explain the medical consequences Ivins experienced.

NYT: Portrait Emerges of Anthrax Suspect’s Troubled Life

Scott Shane's newest, detailed exploration of Bruce Ivins can be summarized in Shane's statement, "unless new evidence were to surface, the enormous public investment in the case would appear to have yielded nothing more persuasive than a strong hunch, based on a pattern of damning circumstances, that Dr. Ivins was the perpetrator."

Let me make a few comments on this very detailed story.

...anthrax specialists who have not spoken out previously said that, contrary to some skeptics’ claims, Dr. Ivins had the equipment and expertise to make the powder in his laboratory.

He may well have--but this begs the bigger question of how long it would have taken and whether he could have done so without being detected.


And most importantly:

The science alone could not close the case. “We could get to a lab, to a refrigerator, to a flask,” said Dwight E. Adams, the F.B.I. laboratory director until 2006. “But that didn’t put the letters in anyone’s hand.”

As the bureau’s undercover informant, Dr. Haigwood struck up a breezy e-mail correspondence about scientific grants, pets and travel. Dr. Ivins complained about psychological screening and other “rather obnoxious and invasive measures” imposed at Fort Detrick since the anthrax attacks.

Dr. Nancy Haigwood believed Ivins was the culprit and had additionally, "damaged my property, he impersonated me and he stalked me.” She was afraid he would send her an anthrax letter. Her goal in renewing their friendship was to get him to incriminate himself. So any evidence resulting from their correspondence would need to be viewed from this perspective and in its entirety.

Dr. Ivins still carried resentment from four decades earlier at Lebanon High School in Ohio, where he had been a nerdy, awkward teenager devoted to photography and, even then, to the study of bacteria.

What percent of Ph.D. scientists did not feel nerdy, awkward and excluded as teens, I wonder? (I do not mean to target scientists. The teen years are awkward for most people.)

Though a public debate had raged for years over whether the mailed anthrax had been “weaponized” with sophisticated chemical additives, the F.B.I. had concluded early on that it was not.

The jury is still out on this issue, but many believe otherwise.

By 2004, secret scientific testing established that the mailed anthrax had been grown somewhere near Fort Detrick.

Presumably this comment refers to properties of the water used to grow anthrax; whether such analysis can reliably pinpoint the Frederick, Maryland area remains open to question.

Rockefeller vows fight on Gulf War syndrome

Excerpted from an article in the December 29 Charleston, W.V. Daily Mail:

.... The senator said it was shameful that neither the Department of Defense nor the Department of Veterans Affairs acknowledge Gulf War syndrome as a real illness.

"We were stonewalled by the DOD in hearing after hearing after hearing," Rockefeller said of several meetings on the issue since the early 1990s. "They thought we were wrong, crazy, and came up with some kind of cockamamie theory. No matter what we produced, they'd send it back and call it nonsense..."

"My attitude is that we should never stop fighting until they get the money and benefits they need," Rockefeller said. ... he'd continue to push for those veterans as a member of the Senate Veterans Committee. He also is set to begin his tenure as chairman of the Senate Commerce Committee."