Recently in Ethics Category

In the current housing market, a seller's serotonin levels may determine just how likely a buyer's low offer will be accepted. Serotonin depletion and the acceptance of unfair offers were recently explored on a smaller scale by researchers at the University of Cambridge and UCLA by using the so-called Ultimatum Game—a game which uncomfortably resembles today's property transactions.

The investigators examined the responses of 20 healthy volunteers, who underwent a double-blind, placebo-controlled depletion of tryptophan,* the amino-acid precursor of serotonin. After the procedure, participants were offered 1 of 3 ways to split a sum of money with another player: fair (45% of stake); unfair (30%); or most unfair (20%).

The investigators found that respondents were significantly more likely to reject "most unfair" offers after tryptophan depletion than after placebo treatment (F = 7.551; P = .013). However, the rejection rates of fair or unfair offers were not significantly affected by tryptophan depletion. On the basis of related assessments, the researchers concluded that the higher rejection of "most unfair" offers with tryptophan depletion could not be attributed to other factors, like changes in mood.

* Acute (5-hour) tryptophan depletion results from the ingestion of a tryptophan-free amino-acid drink (see Young SN et al. Psychopharmacology (Berl). 1985;87:173-177).

Photo: iStockPhoto

By now, pretty much everyone has seen the June 19 videotape of Esmin Green, 49, dying on the waiting room floor of Brooklyn's Kings County psychiatric facility, aka G Building, while others―including security guards―saw the prostrate woman and did nothing. Until it was too late.

But reports of inhumane psychiatric care at Kings County Hospital (dubbed "Killer County" by online wags) are nothing new. A search of the NYT archives reveals that repeated and gross deficiencies in treatment existed there at least as far back as the 1960s. On a least 2 occasions, the facility lost its accreditation status, according to the paper. The remarkably dubious history of the public facility, culminating in Green's death, suggests that blame could go as high up as possible, arguably to city hall.

Last year, the Mental Hygiene Legal Service (MHLS) and the NY Civil Liberties Union, on behalf of patients, filed suit against the NYC Health and Hospital Corporation (HHC) and others, alleging that the Kings County facility is a "chamber of filth, decay, indifference, and danger where individuals...are subjected to overcrowded and squalid conditions often accompanied by physical abuse and punitive injections of mind-altering drugs." The plaintiffs cite lack of basic sanitation and laundry services, inadequate food, no wheelchair accessibility, vermin infestation, and neglect alternating with verbal or physical abuse from healthcare staff and security personnel.

The HHC, the largest city hospital and healthcare system in the United States, comprises more than a dozen hospitals, including Kings County, in the city's 5 boroughs. The HHC Chairperson, Charlynn Goins, along with HHC President and CEO, Alan D. Aviles, are named defendants in the lawsuit. Goins and Aviles, both lawyers, were appointed to their positions by Mayor Bloomberg in 2004 and 2005, respectively. Yesterday, Aviles provided a written statement to new sources on the death of Green: "We are shocked and distressed by this situation. It is clear that some of our employees failed to act based on our compassionate standards of care."

The suit also names the following defendants, at least 2 of whom are longstanding employees of Kings County:

• Jean G. Leon, RN, Executive Director, Kings County Hospital: Leon, a native of Trinidad, has evidently held her position for at least 13 years (see 2005's "10 years of inspired leadership"). A PR-type video on YouTube featuring Leon was posted April 2008.
• Kathie T. Rones, MD, MPH, Medical Director, Kings County Hospital: Rones, a 1980 graduate of the Brown University School of Medicine and a board-certified internist, has held her position since 1996. She received a tribute for her services from the NY House of Representatives on April 3, 2006.
• David K. Dailey, MD, Chief of Psychiatry, Kings County Hospital: According to the NY State Department of Health, Dailey is a 1981 graduate of the Loyola University Chicago, Stritch School of Medicine and has been licensed in the state since 1998.
• Joseph A. Charlot, MD, Comprehensive Psychiatric Emergency Program, Kings County Hospital: Charlot received his medical degree in 1968 from the State University of Haiti and has had a NY medical license since 1979.
• Ellen B. Tabor, MD, Medical Director, Adult Psychiatric Inpatient Services, Kings County Hospital: Tabor is a 1983 graduate of the Rush University School of Medicine in Chicago. She has held a NY medical license since 1990.
• Jacqueline Purser, Captain, Hospital Police
• Oswald David (or David Oswald), Assistant Director of Nursing/Product Line Manager, Comprehensive Psychiatric Emergency Program, Kings County Hospital
• Elsa P. Bush, Associate Executive Director of Nursing, Kings County Hospital

According to today's NYT, the hospital fired the director of psychiatry, the doctor on duty, and the director of security at Kings County on June 20, the day after Green died.  It is not clear if the "director of psychiatry" refers to Dailey, Charlot, Tabor, or someone else. According to Esmin Green's medical records, provided by the NYCLU, a "Dr. Estes" was on duty at the time of her death. Two nurses and one security guard were also "suspended pending union-mandated hearings."

The NY Daily News provides earlier coverage and more background on Esmin Green and Kings County:

June 27 "Shocking death on Kings County Hospital psych ward stirs reform call"

June 22 "Video shows staff ignored patient later found dead"

June 21 "Patient dies waiting for bed at Kings County Hospital"

June 21 "Video shows Brooklyn hospital staff ignore patient later found dead"

May 17 "US Attorney probes claims of patient abuse at Brooklyn psych ward"

In addition to a Federal investigation of civil rights violations at Kings County, the latest reports indicate that criminal charges are being considered in the case of Green's death.

07/03/08 update: The NY Daily News reports that Pierre R. Arty, MD, the head of psychiatry at Kings County, was 1 of 6 people fired after Esmin Green's death. The others included Kenneth Jones, the hospital's director of security, and the 2 security guards (not 1, as previously reported) seen in the waiting-room videotape.

In its recently released Policy Announcements, the ACCME proposed that the commercial support of CME should only be allowed to continue in the setting of several changes. These proposed changes stipulated that educational needs and CME content should be specified by a "bona fide" organization that does not receive commercial support. Some (eg, Daniel Carlat) have suggested that these organizations may include those that draft core competencies (eg, the American Board of Psychiatry and Neurology) or, perhaps, practice guidelines. However, a responding question to that definition is Must the authors of these guidelines have no ties to industry? Which begs the follow-up, What is the extent of commercial ties among authors of practice guidelines?

This question is examined in the latest issue of Neurology, which reports potential conflicts of interest (COIs) among guideline authors for the American Academy of Neurology (AAN), the flagship organization of practicing neurologists.* The authors reported that, among 50 clinical-practice AAN guidelines examined, more than 90% had at least 1 author with a potential COI, and almost half of all authors had 3 or more COIs. The breakdown of the types of potential COIs is provided:

• Any, 77% (n = 272/351)
• Research, 45%
• Clinical practice, 42% (ie, practice of clinical procedure within last year)
• Personal income, 33% (eg, fees for consulting, speakers' bureaus, ad boards)
• Equity/stock options, 7%
• Expert testimony, 6%
• Fiduciary role, 3% (ie, officer, director, partner, or manager in company)
• Advocacy role, 2% (ie, payment for advocacy in nonprofit organization or government)
• Patent rights/royalties, 2%

The AAN's most recent Policy on Conflicts of Interest (June 2008) stipulates that COIs may be resolved or lessened by avoidance, withdrawal (either from the commercial relationship or the AAN responsibility), or disclosure. However, given the high rate of disclosed COIs among drafters of the AAN guidelines, it appears impractical and unrealistic to expect avoidance or withdrawal. To that point, the AAN currently indicates that "[d]isclosure is the appropriate remedy for mitigating most instances of [COI]."

Of note, two authors of the Neurology article (Holloway and Miyasaki) disclosed their own potential COIs with commercial entities.

* The AAN does not allow industry employees to participate in the guideline process or direct corporate sponsorship of the process; however, the AAN does accept corporate funding generally.

I've deigned to think differently from Daniel Carlat. 

A fervent critic of all industry-supported CME and the host of The Carlat Psychiatry Blog, Dr. Carlat initially expressed cautious optimism last Thursday about the ACCME's newly proposed guidelines ("ACCME Gets Serious With 'New Paradigm'") to monitor industry-supported CME. However, he showed serious disdain for the very same guidelines 48 hours later ("Using ACCME's New Rules for Bias and Profit"), evidently in response to my criticism on Friday of the ACCME's overblown and confusing verbiage in its document and the organization's apparent failure to entertain the consequences of its proposed actions.

What's somewhat perplexing, other than Dr. Carlat's turnaround opinion, is his not-so-subtle castigation—and even analysis—of me. (So what do I owe you, doctor?) Of course, the absolute gorgeousness of having a blog (other than the fact that I can use words like "gorgeousness" without fear of editing) is that I can respond to Dr. Carlat's post right here on my own little cyber-acre. So here I go.

Dr. Carlat began:

In bmartin's pro-industry-CME blog Pathophilia, there is an interesting post about the newly proposed ACCME rules intended to stamp out commercial bias while still allowing commercial support.

I wouldn't characterize my blog as "pro-industry-CME"; however, I'm not against industry-supported CME, particularly given the current guidelines for its production. Nor am I in favor of stifling the flow of information, whatever its source. It's important to remember that industry-supported CME isn't consumed in a vacuum, but that it exists in the context of commercially supported CME from various industry competitors, as well as a wealth of educational information from nonindustry sources. And doctors are a pretty independent bunch. They can and do decide, individually, what to believe and how to apply information in practice on the basis of a piece of information's provenance and a whole host of other factors, like data reproducibility and clinical experience. Moreover, to my knowledge, there are absolutely no controlled studies demonstrating that participation in industry-supported CME leads to suboptimal medical care or poor patient outcomes. 

Bmartin parses out the wording of ACCME's proposal in order to try to divine the organization's actual intentions, and finds much to ridicule. 

I parsed the ACCME's wording to express my opinion that the ACCME is in love with its own bombastic voice at the expense of meaning. 

You can detect a heavy dose of financial anxiety in this post. It's an attempt to read the tea leaves in ACCME's new policy in the hopes that it will not actually mean any significant changes in the current system. But bmartin ends on a decidedly pessimistic note, predicting that the regulations will lead to less industry funding, and ultimately, to the disappearance of ACCME itself.

Well, maybe Dr. Carlat detects financial anxiety. I thought I was just pissed off at the writing style and lack of forethought of yet another bureaucratic organization.

While I wish I could agree with bmartin, unfortunately I see this as very good news for industry support. Anybody who owns a CME company and has undergone accreditation and reaccreditation (as I have) knows that there is really nothing new in this "new" guidance. Any company will be able to demonstrate compliance with each of these and yet still produce promotional and biased CME. Let's take each of these elements point by point and apply it to a recent promotional CME article produced by Medscape (see here for more details, and see Barnard Carroll's excellent investigative journalism on Medscape here and here).

I'm not sure if Dr. Carlat's implying that I don't know what I'm talking about; however, for what it's worth, I have experienced an ACCME reaccreditation process (which, BTW, generated a lot of printed paper). But more to the point, the ACCME's newly proposed guidelines are different from the existing guidelines (other than the general guideline that content should be free of commercial bias). For instance, there is currently no mandate that educational needs must be identified by an organization that does not receive commercial support—which eliminates most (if not all) MECCs, professional organizations, and university-based CME offices. My main beef with the ACCME's newly proposed guidelines is that they're too vague in how they should or can be executed.

1. Needs assessment will have to be identified by a neutral organization. Not a problem! You want to keep the flow of money coming from Janssen to help it promote Invega? Many non-industry funded organizations will report that practitioners have a need to learn more about the appropriate use of antipsychotics. Bingo—you've just done your needs assessment.

Of course, those in the CME business know that a 1-sentence rationale from any organization is not a sufficient assessment of educational need. Needs assessments are typically multipage documents that include information from literature searches, clinician interviews, outcomes from prior CME programs, physician surveys, and other sources. 

2. Practice gaps will have to be identified by neutral organizations. Same non-issue as number one. Any reasonable organization will identify adequate treatment of schizophrenia as a "practice gap." For example, the AHRQ produced this document which can be cited to support the need for education about how to use atypical antipsychotics. Medscape will argue that focusing an article on treating a schizophrenic patient with liver disease (which just happens to be the specialty of Invega, its sponsor's medication) fills an identified "practice gap," and ACCME won't argue with them.

This point indicates that there are government sources to guide the treatment of conditions like schizophrenia, and that these sources can be used in an assessment of educational need. However, an educational activity that focuses on antipsychotic use and liver dysfunction could not rest (at least, in my experience) on the one generality—namely, that there is a need for education on the use of atypical antipsychotics. But my question to the ACCME would be Must the authors of these government-dispensed treatment recommendations have no ties to industry?

3. The curriculum must be specified by a bona fide organization. This is a hard one...let me see...okay, how about psychiatry's specialty board, the American Board of Psychiatry and Neurology, Inc., which publishes these "core competencies" in psychiatry. Go to the "Somatic treatment" section and you'll find the following recommended curriculum for psychiatrists:

Again, my question to the ACCME would be Is a specialty board, or more specifically, are the drafters of a board's core competencies sufficiently commercial-free? 

4. It must be verified as "free of commercial bias."

This is a redundancy, since this is already a centerpiece of ACCME Standards for Commercial Support. The organization will never have the resources to monitor the thousands of industry-supported CME activities hatched yearly.

Maybe they will; maybe they won't. In my scenario, I guess it's possible that there could be a point of equilibrium, where the dwindling number of CME providers can be sufficiently managed by a beefed-up ACCME—until the organization collapses from lack of fees.

So don't fret, bmartin—in fact, I would argue that this is a cause for great joy. ACCME is handing you the perfect mechanism for a commercial CME whitewash. Use some of that industry money to celebrate.

Okay, it's my turn for analysis...um, bilious sarcasm?

In an ongoing effort to protect consumers from fraudulent cancer treatments, the FDA sent warning letters to 25 web-based businesses from April 17 to June 9. The warned companies or entities and a list of their 125 "fake cancer 'cure' products" were posted yesterday at the FDA web site. These letters follow a series of warning letters sent by the FTC earlier this year to 112 web sites, which falsely promoted cancer treatments, says the FDA. Consumer complaints and a web search performed by the FDA, FTC, and members of the Mexico-US-Canada Health Fraud Working Group prompted the overdue crackdown.

At least 3 of the targeted entities are already known to the FDA. A search of warning letters at Casewatch indicates that Vitasalus Inc (Nu-Gen Nutrition), Vitapurity, and H&L Worldwide all received earlier letters from the FDA, which claimed that the businesses promoted products for the "cure, mitigation, treatment, or prevention of diseases" in violation of the Federal Food, Drug, and Cosmetic Act. These repeat warnings do not necessarily include the numerous instances in which companies have fraudulently hawked the same products—for example, "Coral Calcium" or "Curcumin"—in rotating fashion as disease treatments.

An FDA warning letter sent to Vitasalus (Nu-Gen Nutrition) in May 2002 cited a single website, cancerchoices.com, and the product Squalamax. However, the most recent FDA letter cites 7 websites and 6 other products, in addition to Squalamax. A Wayback search reveals that 6 of the 7 Vitasalus websites named this year existed in 2002. The 2 other companies, H&L Worldwide (Chang Li) and Vitapurity (Otto Roder), have evidently not moved their cyber or land-based addresses since the time of their FDA warning letters in 2004 and 2005, respectively. Given the number of products promoted by each company and those cited by the FDA this year, business does not seem to have suffered for either company in the interim.

Leaders of the Energy and Commerce committee, John Dingell (D-MI) and Bart Stupak (D-MI), requested that 4 drug companies adhere to rules for direct-to-consumer (DTC) ads that are mostly already in place. The letters were sent May 20 to leaders at JNJ, Pfizer, Merck, and Schering-Plough following a May 8 congressional hearing, "Direct-to-Consumer Advertising: Marketing, Education, or Deception?" Responses to the representatives' letters were posted yesterday at the committee's website.

Today's media coverage largely focuses on the representatives' request for a voluntary, 2-year moratorium on DTC advertising of new drug products, which was declined by the companies. However, Dingell and Stupak made other requests, as described in sequence here:

1. That the companies follow the AMA's guidelines for the use of actors and health professionals in DTC ads.

The AMA's policy H-105.988 states that "product-specific DTC advertisements should not use an actor to portray a health care professional...because this portrayal may be misleading and deceptive. If actors portray health care professionals in DTC advertisements, a disclaimer should be prominently displayed." Also "[t]he use of actual health care professionals, either practicing or retired, in DTC to endorse a specific drug or implantable medical device product is discouraged but if utilized, the advertisement must include a clearly visible disclaimer that the health care professional is compensated for endorsement."

The representatives' request is, no doubt, a response to Pfizer's semi-controversial use of artificial-heart inventor Robert Jarvik to promote Lipitor in its now-pulled DTC ads. Pfizer replied to the committee that it is "currently working internally to ensure that the recent AMA guidelines...are fully incorporated into our DTC advertising when applicable." Merck responded that none of its current DTC ads use physicians or actors who play physicians. All companies, including JNJ and Schering-Plough, agreed to comply with the AMA policy in cases where it might be relevant.

2. That DTC ads not market products until a "valid outcomes study" is completed, and the results are released.

The representatives' definition of valid outcomes is not entirely clear; although they may be referring to longer-term clinical outcomes—for example, cardiac events instead of surrogate cholesterol levels in the case of cholesterol-lowering medications (ie, statins). Certainly DTC ads can only promote the use of FDA-approved pharmaceuticals, which must show at least clinically meaningful efficacy and safety to be approved. JNJ wrote that it has concerns about categorically prohibiting DTC ads "before completion of studies of an undetermined time and nature." Merck indicated that it would defer to the FDA on this point. Pfizer and Schering-Plough (which market Lipitor and Vytorin, respectively) indicated that waiting for long-term clinical outcomes would compromise consumer education and, therefore, consumer health.

3. As recommended by the Institute of Medicine, that there be a 2-year (instead of the conventional 6-month) moratorium on DTC ads for new prescription drug products.

In 2006, the IOM recommended that the FDA require a special product label to identify a new drug or new drug combination, and that DTC advertising should be restricted during 2 years. The FDA has not implemented the IOM's recommendation. All companies contacted by the representatives indicated that they abide by a general, internal 6-month moratorium on DTC advertising and would continue to do so. The companies cite PhRMA guidelines, which state that "companies should spend an appropriate amount of time to educate health professionals...before commencing the first DTC advertising campaign...[C]ompanies should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and health care professionals' knowledge of the condition being treated."

4. That DTC drug ads should not market off-label uses.

Probably the most blatant example of grandstanding by the congressmen. Of course, DTC advertising must comply with FDA-approved labeling, and all companies indicated their compliance.

5. That DTC ads include the FDA's toll-free MedWatch phone number for reporting adverse events.

Current law mandates the listing of the MedWatch number in DTC print ads, and a toll-free information number in televised ads. JNJ indicated that it would include the MedWatch number in its TV ads. The other companies stated that they would defer to the FDA, pending the agency's ongoing investigation of this particular matter.

6. That so-called black-box warnings be included in DTC ads.

Merck and Schering-Plough indicated that they did not have any DTC ads for products with black-box warnings, and all companies replied that they have deferred (ie, Pfizer) or would defer to the FDA about how to incorporate such safety information into DTC ads.

HT for story: Pharmalot. 

Mainstream media outlets

and blogs are chattering about the news that Harvard psychiatrists Joseph Biederman, Timothy Wilens, and Thomas Spencer did not fully disclose their pharma consulting fees to the university, possibly in violation of academic and federal conflict-of-interest rules. According to the online Congressional record, Senator Chuck Grassley (Iowa-R) began an investigation last fall, which sought to determine the full extent of industry fees paid to the psychiatrists. The doctors also received NIH grants for clinical studies of commercial pharmaceuticals.

Persistent investigation by Grassley revealed that, from 2000 to 2007, Biederman and Wilens each earned more than $1.6 million from commercial sources, and that Spencer earned more than $1 million, according to the record. The majority of these fees (for services that are not specified) had not been reported to the university. The propriety, or even legality, of the physicians' reporting behavior is the subject of much online speculation. However, it remains unclear what led Grassley to investigate these physicians in the first place—among any number of possible targets.

Grassley may have been alerted to Biederman (and thereby, his Harvard colleagues) through the death of 4-year-old Rebecca Riley. As reported by "60 Minutes" in September of last year, Rebecca Riley died on December 13, 2006, at her home in Hull, Massachusetts, due to an overdose of psychiatric drugs. The drugs—Depakote (divalproex; Abbott), Seroquel (quetiapine; AstraZeneca), and clonazepam—were prescribed by Tufts psychiatrist Kayoko Kifuji for the child's bipolar disorder, which was diagnosed at the age of 2 years. Before her death, Rebecca had also been given an over-the-counter cold medication and at least one additional, unprescribed dose of clonazapam by her mother (and possibly more for a period of time before the child's death).

According to "60 Minutes," Dr. Kifuji's prescribing practices were heavily influenced by the research and views of Biederman, who was interviewed for the news show. Biederman has evidently been instrumental in the trend to apply the diagnosis of bipolar disorder, in broader terms, to very young children. And with the diagnosis goes pharmaceutical treatment in the form of some drugs that have not been systematically tested in children.

In a Boston Globe story, Kifuji's lawyer stated that the Harvard psychiatrists were "by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar." The paper also wrote of the extensive financial ties between pharma and Biederman, who had "received research funding from 15 drug companies and serves as a paid speaker or adviser to seven of them," including Eli Lilly (Zyprexa [olanzapine]) and Janssen (Risperdal [risperidone]). The Congressional record also reports financial ties between Biederman and BMS (Abilify [aripiprazole]), Cephalon (Vivitrol [naltraxone]), GSK, JNJ, and Pfizer.

Right or wrong, Biederman and his colleagues Wilens and Spencer have evidently influenced the diagnosis and treatment of bipolar disorder, as well as those of ADHD, through the medical literature (for example: Frazier JA et al. J Child Adolesc Psychopharmacol. 2001;11:239-250; Wilens TA et al. J Child Adolesc Psychopharmacol. 2003;13:495-505) and through pharma-supported CME programs (for example: "The Evolving Face of ADHD" and "Focus on ADHD"). The question is whether commercial funding influenced Biederman et al to promote the relatively aggressive, unapproved use of pharmaceuticals in children with psychiatric problems. The chief of psychiatry at MGH, Jerrold Rosenbaum, wrote in an e-mail to the Boston Globe, "I think a pharma person would not dare to tell Joe [Biederman] what to say...For Joe, it is his ideas and mission that drive him, not the fees."

As far as the aftermath of Rebecca Riley's death is concerned, the child's parents, Carolyn and Michael, were charged with first-degree murder and await trial. Dr. Kifuji agreed to suspend her medical practice pending an investigation by the Massachusetts medical board.

Photo: iStockPhoto. 

Mercury-containing dental fillings may harm pregnant women and young children.

That's the general, and not particularly useful, lede provided by most media outlets last week, while reporting on a settlement in the case of Moms Against Mercury et al v. Leavitt et al. As part of the settlement, the FDA will reopen a comment period, beginning July 28, 2008, to potentially reclassify dental amalgam and will issue a final ruling 1 year later. And that's really all that's news, if you call that news.

Essential background on the issue can be found from the American Dental Association, which states in a press release that the "FDA has different classifications for encapsulated amalgam and its component parts, dental mercury and amalgam alloy. The FDA's proposed reclassification, which the ADA has supported since 2002, would place encapsulated amalgam and its components under one classification." The organization also writes, "As far as the ADA is aware, the FDA has in no way changed its approach to, or position on, dental amalgam."

However, last week the media latched onto the following statements made at the FDA web site, in response to the settlement:

Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA’s rulemaking...will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.

Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.

This information is best couched in the FDA's statements indicating that there is not enough information to know whether dental amalgam—which is approximately 50% mercury and has been widely used for more than a century—is harmful to pregnant women or young children. Other countries (Canada, France, Sweden), follow a "precautionary principle" in these populations, given the lack of data. During the comment period, the FDA requests "empirical data and scientific evidence concerning this classification and special controls for dental amalgam."

The original cause of the brouhaha, the "Petition to Order Mercury Amalgam Withdrawn From Interstate Commerce," is, itself, a curious document. For one, the diverse group of petitioners (listed) shows how the ultra-right and ultra-left often come together in their own Bizarro World. They are the following:

• Moms Against Mercury, a nonprofit organization located in North Carolina and founded by Amy Carson, who believes that the ethylmercury-containing vaccine preservative Thimerosal causes autism—despite a wealth of medical data to the contrary.
• The Connecticut Coalition for Environmental Justice, an organization dedicated to eliminating environmental toxins in the state and their effects, particularly on low-income or minority populations. The coalition is led by president Mark A. Mitchell, MD. 
• Oregonians for Life, a pro-life/anti-abortion organization.
• California Citizens for Health Freedom, one of the more "out-there" health-related nonprofits. The CCHF is dedicated to a "toxic-free environment" and the right to access alternative medical treatments for cancer. The organization also opposes the fluoridation of public drinking water.
• Kevin J. Biggers, a candidate for the California state senate and a public member of the Dental Board of California.
• Karen Johnson, an Arizona state senator whose "issues of concern" include the "precious right to life of the unborn," "eradicating pornography," and "standing resolutely against the homosexual agenda."
• Linda Brocato, an Illinoisan who believes that mercury-containing dental fillings caused her multiple sclerosis, and that her symptoms improved substantially after the removal of these fillings.
• R. Andrew Landerman, DDS, a California dentist whose advertised "services" include acupuncture, ayurveda, homeopathy, and the use of the Cavitat device.
• Anita Vasquez Tibau, the California organizer of the Consumers for Dental Choice. Tibau believes that mercury in dental fillings caused her asthma.

The hapless respondents demonstrate, once again, that a visible government job is a gift that keeps on giving: Mike Leavitt, DHHS Secretary; Andrew von Eschenbach, MD, FDA Commissioner; and Dan Schultz, MD, and Mary S. Runner, DDS, both of the FDA's CDRH.

Generally the petitioners allege that the FDA has been negligent in its duty to classify dental amalgam and specifically imply that the FDA has taken a deliberate, passive stance to maintain a profitable status quo for the subversive, pro-amalgam ADA and amalgam manufacturers.

Among the more intriguing allegations in the petition is the following:

It should come as no surprise that all government literature reviews on amalgam's toxicity have been managed by groups composed mainly of dentists. For example, a multimillion dollar grant to study amalgam was given to a dentist sitting on the ADA's Council of Scientific Affairs; that person chose a defenseless group—institutionalized Portuguese orphans—on which to experiment with mercury, without disclosures of health risks. The study is now under investigation by the Secretary's Office of Human Research Protections, the watchdog charged with stopping unethical medical experimentation.

The petitioners are presumably referring to a 2006 study in JAMA by DeRouen et al from the University of Washington and the University of Lisbon. The prospective study was funded by the Cooperative Agreement U01 DE11894 for the National Institute of Dental and Craniofacial Research (NIDCR) of the NIH. According to a 2005 Business Wire story, the University of Washington School of Dentistry did receive $22 million from the NIDCR; however, it is highly unlikely that this chunk of change was consumed by the JAMA study. The story indicated that DeRouen was the designated principal investigator and chair of a research network among his institution, the Washington Dental Service, and the School of Dentistry at Oregon Health Sciences University.

In the JAMA study, more than 500 Portuguese children (aged 8-10 years) received either randomly assigned posterior dental amalgam or resin-based composite as required dental work. The children enrolled were students within the Casa Pia system. According to Wikipedia, Casa Pia is Portugal's largest educational institution for children at risk of "social exclusion or without parental support." Casa Pia has been described as an orphanage in the mainstream press and, parenthetically, is at the center of an ongoing sex-abuse scandal and trial—which should be neither here nor there as far as the DeRouen study is concerned.

It is noted within the JAMA article that the study protocol was approved by the institutional review boards at the University of Washington and the University of Lisbon, and that written, informed consent was obtained from parents or guardians. DeRouen et al reported no significant differences in urinary mercury levels or neurologic function between the 2 treatment groups over the course of 7 years. However, after 5 years, "the need for additional restorative treatment was approximately 50% higher in the composite group."

Regarding implied ethical violations by the study investigators (and presumably the petitioners are referring to the DHHS Office for Human Research Protections), a 2006 AP news report indicated that the counsel for Consumers for Dental Choice, Charlie Brown (who, by george, is one of the petition drafters) found the Casa Pia study unethical because "guardians were never told of the potential risks of the mercury fillings."

DeRouen shot back in the AP story, "We weren't doing anything experimental. We were giving standard dental treatment." A University of Washington review board evidently found the allegations to be unfounded; however, a spokesperson for the OHRP said that the DeRouen study was "under investigation."

According to letters at the OHRP web site, the office did find that the University of Washington's informed consent document "failed to adequately describe the reasonably foreseeable risks of amalgams and composite materials used in dental procedures," as required by DHHS regulations. In response, UW developed a new policy and guidance for its institutional review board concerning the risks of standard-of-care procedures and revised its informed-consent templates to reference this policy. These changes, which appear to be general changes regarding the risks of standard of care and not mercury-related risks specifically, satisfied the OHRP as of April 2007.

Photo: iStockPhoto.

If you're at a loss to understand the slogan of yesterday's anti-vaccination march on Washington, DC—led by Jenny McCarthy and Jim Carrey—you're not alone. The costar of Witless Protection* and the star of Horton Hears a Who! evidently want to promote "cleaner" vaccines (whatever that means—more bacteriocidal Thimerosal?). But what they really want to do is alter the current CDC-recommended schedule for vaccinating children...to God only knows what.

Orac dives into the mess and provides commentary.

*You know, the vehicle for Larry the Cable Guy.

Photo: Jenny McCarthy playing with garden hose in kiddie pool.

Harvard physician Tom Stossel and psychiatrist Daniel Carlat recently debated the Massachusetts Senate ban on pharma gifts to physicians. Unfortunately, the 7-minute discussion (hosted by New England Cable News) was given the typical short shrift by TV-based media and did not include input from informed economic or legal perspectives.

However, in the brief time provided, Stossel did attempt to consider the unintended and uninvestigated consequences of banning low-ticket pharma gifts (eg, pens, notepads, sandwiches), such as the loss of state business and jobs. It is important to note that there is little-to-no evidence indicating that such gifts negatively affect physician behavior or health care outcomes. Stossel also indicated that the ban may limit pharma funding to state institutions for research.

On the other hand, Daniel Carlat—a proponent of banning all pharma gifts and pharma-funded CME—would have you believe that physicians are incapable of autonomous judgment and should, therefore, be subject to his non-evidence-based gut morality.

Photo: iStockPhoto.