The Affordable Care Act has catapulted the US Preventive Services Task Force from an obscure agency which produced unenforceable guidelines about screening and preventive services into one whose recommendations directly impact reimbursement.

The health reform law requires insurers to pay in full for services receiving an A or B recommendation from the Task Force. The flip-side is that insurers may not have to pay at all for services that are not recommended by the Task Force. As a result, the Task Force’ new best friends include lobbyists and disease advocates who want their priorities – things like screening for Alzheimer’s disease, HIV and diabetes or HIV – to get covered.

The American Diabetes Association, for example, is advocating that insurers be required to cover a broader population than current Task Force recommendations suggest. Current recommendations are that only patients with high blood pressure should be screened.

The HIV Medicine Association has made a similar argument to the Task Force. It claims that a key reason why 20% of people infected with HIV are unaware of that fact is because most insurers don’t cover the costs of testing.

“If you want to be evidence-based, lobbying doesn’t fit,” Ned Calonge, the chairman of the Task Force told the Washington Post. “My charge to members would be to stay true to the methods and the evidence.”

The Task Force, by the way, is the same one that caused a stir before the 2008 presidential election when it recommended that women should start receiving screening mammograms at the age of 50, rather than 40. That move was eventually trumped by an amendment to the Affordable Care Act which required insurers to cover mammograms for women in their 40s.

A Presidential commission tasked to explore ethical issues associated with man-made life has held initial meetings to better understand the matter and begin figuring out whether additional regulations are needed for the burgeoning new field.

In May, J. Craig Venter and colleagues reported creating a self-replicating synthetic bacterial cell, a landmark achievement that many believe represents the dawn of an era in which man can create brand-new organisms that produce drugs and fuels, and perhaps gobble up oil spills on the cheap.

The report prompted President Obama to organize the commission. He has asked it to produce recommendations within 6 months.

Venter attended the opening meetings himself. He suggested that researchers in the field could, perhaps, produce seed stock for a flu vaccine in just 12 hours. “With rapid DNA sequencing, we can predict, we think, well in advance what the changes will be for next year’s flu before the WHO even makes the decision as to the vaccine stocks,” he told  BurrillReport.

Venter added that synthetic biologists could also potentially cause harm—as by producing new, highly lethal viruses. Venter insisted however that such behavior could “be readily prevented by some straightforward regulations.”

Kristala Prather, a Chemical Engineering professor at MIT concurred that, that although the potential benefits are large, so too are the risks. “Because there is this information gap between what we understand about biology and what our capabilities are, it is impossible to predict what’s going to happen in every experiment,” she told GenomeWeb News.

The commission will hold more meetings in September and November.

Last week, the American Board of Internal Medicine sanctioned 139 physicians for sharing test questions and answers from the board’s certification test.

The move came a few months after the ABIM sued New Jersey-based Arora Board Review for theft of trade secrets and copyright infringement. The sanctioned physicians had disclosed actual board questions to Arora while participating in one of its exam prep courses.

ABIM and Arora reached a settlement in the case in which Arora’s manager agreed not to offer a live board review course. Terms of the agreement did not require Arora to admit wrongdoing.

ABIM CEO Christine Cassel told AMedNews that her organization became aware of the issue after stumbling upon copyrighted exam questions on Arora’s website.

“At the Arora Board Review courses, [the manager] was not only bragging that he had ABIM questions but soliciting people who remembered questions to report them back to him,” Cassel said.

Physicians must sign a “pledge of honesty” 3 separate times during the exam. The pledge warns test-takers not to disclose, copy or reproduce test-related material, and threatens penalties for those who do.

Camille Miller, the lawyer who represented Arora in the suit, said that Arora disagreed with ABIM’s actions. “Physicians routinely discuss examination content with others,” she said. “ABIM has not apparently enforced this consistently against other physicians.”

Penalties levied by ABIM against the physicians may include revocation of board certification or suspension of certification for up to 5 years depending on the particular offense. Noncertified physicians would need to wait for a year or more before retaking the test.

The physicians have 2 months to appeal the ABIM’s decision. After that, the board will start notifying state medical licensing boards of its actions.

The National Institutes of Health has announced it intends to revise its policies governing financial conflicts of interest. The changes will increase disclosure responsibilities on institutions that receive funding from the agency,  increase transparency and accountability, and toughen-up rules it first promulgated in 1995.

“We cannot afford to take chances with the integrity of the research process,” NIH Director Francis Collins remarked at a press conference introducing the proposed changes. “We believe it is essential to tighten up this situation in order to be sure that we are obtaining and maintaining the public trust in the integrity of the scientific enterprise.”

Among the revisions, the NIH proposes to reduce the reporting threshold for conflicts from $10,000 to $5,000. In addition, the NIH wants to shift responsibility for deciding whether a particular relationship is in fact a conflict from the investigator to his or her institution. This would require institutions to establish review processes for potential conflicts and report such matters to the NIH.

The NIH is also proposing that for the first time, Phase 1 Small Business Innovation Research grants and the Small Business Technology Transfer Program would be covered under these policies.

The new rules do exclude income from teaching, lectures, seminars, or service on review or advisory committees review panels for institutions of higher learning or government agencies.

A further change would require grant receiving bodies to disclose on publicly accessible websites any significant financial interests involving their faculty or others related to the entities.

“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,” wrote Collins in a commentary in JAMA. “Americans do not want financial conflicts of interest to influence the federally funded research.”

This post originally appeared on EHRbloggers.com.

These days it’s a given that anyone you meet, from prospective employers to next Friday night’s date is probably Googling you. But how would you feel if you knew that practice extended to your psychiatrist?

If anecdotal observations by Brian Clinton, Benjamin Silverman and David Brendel are generalizable, the behavior is common.

Writing the Harvard Review of Psychiatry, the psychiatrists say they have not carried out research on the practice, but they admit having carried out such searches themselves. They claim to have witnessed other physicians conducting patient searches and to have spoken with many colleagues who had done likewise.

“Most patients would probably be shocked that their doctor had the time or the interest to conduct a search,” Brendel told the Wall Street Journal Health Blog. “A good number of people would feel like their privacy had been breached, although a number might be happy the doctor was thinking about them outside of the 15-30 minutes they were spending together.”

In some instances, the practice can save a life, such as when a patient blogs about suicide, but in other cases, doctors appear to be motivated by “curiosity, voyeurism and habit.”

In the absence of ethical guidelines on the matter, the psychiatrists recommend that physicians think through why they are conducting a search beforehand, and consider whether the result will interfere with their relationship with that patient. They should consider asking the patient for consent.

“Some people say absolutely it should never be done; it’s a breach of privacy,” Brendel said. “But many say it should be done as a matter of routine. It’s information that is in the public domain, and it may be information that is clinically relevant.”

Physicians must follow certain protocols should they wish to dismiss a patient in their practice.

Physicians can ask chronically disruptive or drug-seeking patients to leave their practice. They can do the same for patients who miss appointments or fail to pay bills, but generally they can’t fire patients for simple failure to follow their advice.

Recently, some pediatricians began refusing to care for the children of parents who don’t let them be vaccinated based on fears of a link between vaccines and autism.

The American Academy of Pediatrics frowns on this, Douglas Diekema, a former chairman of its bio-ethics committee told the Wall Street Journal, “because it gives you the opportunity to continue the discussion. Two years later, if the child gets whooping cough, the parents may change their mind.”

State laws on the subject are variable, but in general they require that doctors document the reason for withdrawing care, inform the patient about the problem, give him or her time to find a new physician and then send a certified letter ending the relationship.

The right of doctors to refuse to treat patients was reaffirmed by the Fifth Circuit Court of Appeals, in a case involving John Bower, the director of a kidney dialysis program in Jackson, Mississippi.

Bowers’ patient frequently missed appointments for dialysis, drank excessively and ended up needing emergency care all the time.

Bower eventually told the patient he was ending the relationship, but an advocacy group sued. Bower argued that forcing physicians to treat patients violated the 13th amendment, which outlawed slavery.

He won the case, but ended up treating the patient anyway because his hospital received funds under provisions requiring its physicians to treat anyone that needed care.

The patient died in a car accident 4 years later.

Two weeks ago, the prestigious medical journal Lancet retracted a 1998 article that purported to show a link between childhood vaccines and autism. The article stimulated a decade-long debate about vaccine safety, and the Lancet’s retraction effectively ended reasonable scientific discourse on the subject: the vaccines are safe.

Ten of 13 authors of the paper had issued a partial retraction 6 years ago, but the first author, Andrew Wakefield, did not. 

Wakefield’s study had focused on 12 children that had gastrointestinal problems. Eight had symptoms that their parents or a doctor thought were caused by the MMR vaccine, and 9 exhibited autistic behaviors.

That study triggered widespread concern that measles-mumps-rubella vaccine caused autism. Parents decided against immunizing their children as a result. Roughly 2.1% of US children weren’t immunized with the MMR vaccine in 2000, nearly triple the rate of 0.77% in 1995, according to a study in Pediatrics.

This occurred despite the publication of several subsequent studies which showed that vaccines were safe. The most notable among these were a 2004 review of the literature by the Institute of Medicine and a 2008 study by the CDC which looked specifically at children with GI problems.

“This retraction by the Lancet came far too late,” Paul Offit, chief of infectious diseases at Children’s Hospital of Philadelphia told the Wall Street Journal. “It’s very easy to scare people; it’s very hard to unscare them.”

The Lancet pulled the plug after a UK-based health care regulator concluded the Wakefield study was bogus. The General Medical Council’s report included allegations of ethical violations by some investigators, including “cherry-picking” children for the study, rather than taking kids as they presented randomly to the hospital, as had been implied in the paper.

Democratic lawmakers and watchdog groups resumed demands last week that the Department of Justice should explain how emails from Bush administration lawyers that supported harsh interrogation tactics were lost. The same groups raised concerns that their absence might taint the findings of a recent ethics report which cleared the lawyers of charges that they engaged in professional misconduct.

The emails in question cover a critical period in 2002 when attorneys from Justice prepared a memo that cleared the way for CIA operatives to use waterboarding, sleep deprivation and other techniques against al-Qaeda suspects, according to the Washington Post.

“Why were these critical records deleted? Why were they kept from investigators?” Senate Judiciary Committee Chairman Patrick J. Leahy asked at last week’s hearing.

Acting Deputy Attorney General Gary Grindler responded that the ethics report “does not suggest there is anything nefarious” about the lost emails, but that he had asked a department administrator “to determine what was going on with respect to the archiving of these emails.” “If they are retrievable, I will retrieve them,” Grindler said.

Also last week, the National Archives asked why Justice had not notified it about the missing emails before the ethics report was released. And Citizens for Responsibility and Ethics in Washington has asked Justice to launch a criminal inquiry into the lost emails.

Months ago in an internal review, Justice’s Office of Professional Responsibility concluded that former department lawyers John Yoo and Jay Bybee had committed misconduct in preparing those emails and memos. That decision was later overruled by Associate Deputy Attorney General David Margolis who found instead that the lawyers had exercised poor judgment.

At the last week’s Senate hearing Grindler said that Margolis’ ruling was made “without interference” by senior Justice Department officials.

The Massachusetts anesthesiologist accused of cooking up data for use in trials of pain medications has agreed to plead guilty to criminal charges in a deal with federal prosecutors.

Scott Reuben, who had been among the nation’s most respected investigators on the subject, had been charged with one count of healthcare fraud.

Reuben’s trouble began last year, when an internal audit conducted by Baystate Medical Center in Springfield, Mass., revealed he fabricated data for 21 studies he had conducted during the last 15 years.

The criminal charge had focused on one of these, a trial of Celebrex as part of a “multimodal” pain regimen for knee surgery. The study showed the drug was effective and was published in 2007 in Anesthesia & Analgesia.

“In fact,” the prosecution wrote in a court filing, “Reuben had not enrolled any patients into that study, and the results reported…to Anesthesia & Analgesia were wholly made up by Reuben .”

Had he not copped a plea, Reuben could have spent 10 years behind bars and been fined $250,000. The plea convinced prosecutors to recommend lighter penalties.

After Baystate spilled the beans, journals that had published his tainted articles retracted them.

Baystate terminated its contract with Reuben last spring. At the same time, he reportedly agreed to suspend his practice and was stripped of a professorship at Tufts.

Several widely accepted medical beliefs need to be re-examined in light of the scandal. Topping the list are the effect of COX-2 inhibitors on bone healing and the role of multimodal analgesic regimens in managing chronic pain.

With respect to the former, Reuben’s studies suggested the drugs had no effect on bone fusion, a finding that was contrary to the results of several animal studies.

Employees of Xe Services, formerly known as Blackwater Worldwide occasionally operated alongside CIA and Special Forces operatives during missions to kill or capture members of al-Qaeda and other undesirables in Iraq and Afghanistan, former government officials have told the Washington Post.

Such behavior would exceed the protective role assigned to Blackwater in a contract with the CIA, the sources said.

The missions were approved and planned by CIA officials. But when it came time came to carry out those raids, local CIA operatives delegated responsibilities to available personnel regardless of whether they were contractors or federal employees.

A former CIA official with experience in Middle East covert operations confirmed that such decisions would be “practical…there was no bench strength with either the CIA or Special Forces, so sometimes they would turn to contractors, who often had the same skills,” he told the Post.

Former CIA officer Robert Baer said that such arrangements would short-circuit normal chains of command that CIA and military personnel must abide by. “Once you cede your authorities, people are no longer restrained by regulations and federal law,” Baer said. 

Earlier this year, CIA Director Leon Panetta terminated several contracts with Blackwater, but the agency still relies on the firm to provide security for agency employees and assets.

Former Washington-based CIA counterterrorism officials said CIA headquarters was not aware of such actions. They confirmed that Blackwater employees engaged in firefights while protecting CIA officers undertaking lethal raids, but characterized these actions as defensive, not offensive.

Currently, 5 Blackwater guards are standing trial in federal court on manslaughter and other charges stemming from the killing of 14 Iraqi civilians in Baghdad in September, 2007. In a separate civil case, 70 Iraqi civilians are alleging that Blackwater engaged in “lawless behavior” and covered up killings.

Add Selective Androgen Receptor Modulators, or SARMs to the list of substances used by athletes to enhance competitive performance.

SARMs have not yet been approved for any indication by any regulatory agency in the world. Nevertheless, scientists at the German Sport University in Cologne have shown there already is an Internet-based black market for the substances, which are believed to provide benefits similar to anabolic steroids with fewer side effects.

Many drug companies are developing SARMs for the treatment of osteoporosis, benign prostatic hyperplasia, and appetite loss associated with cancer.
 
Using mass spectroscopy, Mario Thevis and colleagues recently demonstrated the presence of Andarine, a potent SARM in containers labeled as green tea extract and face moisturizer that were purchased over the Internet for $100.

Their write-up appears in Drug Testing and Analysis.

“This product with considerable anabolic properties is readily available without sufficient research on its undesirable effects,” Thevis told BurrillReport. “This is especially significant where uncontrolled dosing is applied and drug impurities with unknown effects are present in considerable amounts as observed in the studied material.”

Thevis presented his findings at the Conference of Parties to the International Convention against Doping in Sport, which was held in Paris 2 months ago.

In 2008, the World Anti-Doping Agency (WADA) prohibited the use of SARMs in sports. WADA President John Fahey said at the time that in order to rid sport of doping, government agencies must adopt laws and regulations to combat the trafficking and supply of illegal substances.

In July, 2005, the prestigious Journal of the American Medical Association began requiring that all write-ups of research that had been funded by private sector sources must undergo separate statistical reviews before being accepted for publication.

Oddly, no other first-tier journal followed suit.

Benjamin Djulbegovic of the University of South Florida decided to see whether the unilateral move impacted the types of trials published in top medical peer-reviewed journals. Lo and behold, it did!

In a presentation at last month’s Peer Review Congress, Djulbegovic showed a significant drop the number of industry-funded trials published in JAMA and a coincident increase in such trials that were published in the New England Journal of Medicine and Lancet, the 2 other top-tier journals he studied.

Following Djulbegovic’s presentation, JAMA editor Catherine DeAngelis told an audience of fellow journal editors, “the cynic in me says that if you’re not submitting to JAMA because you have something to hide, so be it. God bless the rest of you for taking those [studies]!”

Djulbegovic reached his conclusion by examining all issues from the 3 journals for the 3 years before, and the 3 years after JAMA enacted its policy.

He found that compared with the preceding period, JAMA published 26% fewer commercially-funded studies after the policy was enacted (63% vs. 37%).

Meanwhile NEJM and Lancet published 12% and 10% more such trials after the JAMA policy went into effect.

The publishing rate for non-commercially funded studies was unchanged in all 3 journals.

Djulbegovic added that if industry-funded trials are simply rerouted from JAMA to another top-tier journal, then the JAMA policy wouldn’t have much impact.

That could only happen if other top-tier journals adopted similar policies.

When Thai and US Army scientists announced last month that their experimental HIV vaccine reduced the risk of contracting the disease by 31%, it caused quite a stir. After all, every one of the 100 or so previous HIV vaccine trials over the last 20 years had failed completely.

Alas, a second analysis of the $105 million study that was released weeks after the announcement suggests the apparent, moderate benefit may have been caused by a statistical fluke.

Worse yet, it turns out that the results of the second analysis were available to the scientists when they announced their original findings.

“We thought very hard about how to provide the clearest, most honest message,” said Jerome Kim, an Army scientist involved with the study. “We stand by the fact that this is a vaccine with a modest protective effect.”

Kim’s team based its initial announcement on a “modified intent to treat analysis,” which includes all volunteers that enrolled in the study, whether they received the full course of the vaccine or not. Such analyses reflect real world situations in which some people don’t show up for all shots in the vaccine sequence.

Using this analysis, the scientists determined that there was only a 3.9% chance that the observed 31% reduction in HIV among the vaccine-treated group was caused by a simple statistical fluke…in scientific parlance, this is considered to be a borderline significant result.

The second, so-called “per protocol” analysis included just the study participants that received all vaccines in the regimen at the right time.

Such analyses normally corroborate intent to treat findings, but for unknown reasons, it did just the opposite in this study. It suggested there was a 16% chance the results could have been due to chance alone—far too high to support claims that the vaccine was efficacious.

Some AIDS activists and scientists believe the vaccine merits further study, but worry that the botched announcement might undermine support for the vaccine and HIV vaccine trials generally.

“I would have preferred to have seen both results straight up. It might spring back on (the scientists), and that would be unfortunate,” Mitchell Warren, director of the AIDS Vaccine Advocacy Coalition said.

Amid growing public clamor for the H1N1 flu vaccine, the CDC’s top sheriff charged his posse to be on the lookout for instances in which people who don’t qualify for the woefully scarce resource are jumping the queue.

“Any vaccine distribution decisions that appear to direct vaccine to people outside the identified priority groups (can) undermine the credibility of the program,” Thomas Frieden warned state and local health departments in an email.

The call to action was prompted by reports that Wall Street bank employees and other well-heeled types were scoring the jab even as most of the 159 million people on the CDC’s priority groups couldn’t do the same.

Last Friday, some health officials denied that such transgressions had occurred. “Our system is designed to make the vaccine available to the priority groups established by CDC,” New York City’s health commissioner Thomas Farley told the Washington Post.

At the same time, the Wall Street bankers, who have truly endeared themselves to average citizens over the last year, were busy explaining they were providing the vaccines to qualified employees. 

The Feds own the entire H1N1 vaccine supply. They have contracted with McKesson to distribute the vaccines, as directed by city and state health departments, to 150,000 qualified providers including hospitals, clinics, physicians’ offices, pharmacies and the medical departments of corporations and schools.

CDC official Anne Schuchat said the rumors may have been sparked by legitimate deliveries to corporations, and that workplace medical departments are excellent venues to reach target groups like pregnant women and adults with chronic illnesses.

“When vaccine is shipped to an employer-based clinic, we expect it is being given to the target population,” she said.

When Pfizer coughed up $2.3 billion to settle criminal allegations that it promoted off-label use of Bextra, it was the biggest such settlement in history. But Pfizer is not the only drug company to have been nabbed for such activities.

Five years ago, Parke-Davis forked over $430 million to settle a similar suit involving Neurontin.

Now it has come to light that Parke-Davis took advantage of the half-baked policies of certain journals regarding ghostwriting and disclosure of the financial ties of authors to promote off-label utilization of the latter drug.

Between 1997 and 2000, these journals published 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by Parke-Davis without disclosing such arrangements, according to Jenny White, a research analyst at UCSF, who spoke at last months’ Peer Review Congress.

The journals have beefed up their disclosure policies since that time, White added.

To reach these conclusions, White and colleagues reviewed internal industry documents regarding Neurontin that had been archived at her school’s Drug Industry Document Archive. They subsequently asked the journals to delineate current and former policies regarding ghostwriting, conflict of interest and so on.

White’s group identified 24 articles and correspondences with editors that had either been produced with support from grants that Parke-Davis or  by Parke-Davis ghostwriters.

At least 13 of these articles were published in journals that included no disclosure of the fact that Parke-Davis had a role in producing the paper. Only 2 of these articles revealed that the authors had received honoraria from Parke-Davis.

These journals “generally had less stringent requirements [regarding disclosures] than those where articles were not published,” according to White. None of them had a policy regarding disclosure of ghost authorship.

White recommended that peer-reviewed journals adopt uniform policies to prohibit such shenanigans in the future.

Men that seek counseling from Warren Throckmorton are often deeply conflicted. They have read Scripture and prayed with considerable dedication, but they continue to be sexually attracted to other men — a desire that, according to their religious beliefs, is immoral.

Throckmorton, a PhD, teaches psychology at Christian-oriented Grove City College in Pennsylvania. He once was the president of the American Mental Health Counselors Association.

He advises such clients that their impulses are not indicative of mental illness, nor do they represent punishment for a lack of religious faith.  And he tells them he can’t make them straight.

But he also advises them they don’t have to be gay. They can divert their sexuality, or hide it, he says. They can live celibately.

Throckmorton has given such advice for years knowing it ran contrary to the now widely accepted “gay affirming” therapy which encourages folks to embrace their sexuality.

But last month, the American Psychological Association changed course on the mater, stating that it can be ethical for counselors to help selected clients repress or reject gay or lesbian desires if they conflict with their religious beliefs.

The APA has 150,000 members. Its new guidelines call for counselors to assure clients that homosexuality is not an illness and that gay people can lead happy, productive lives. Counselors are also supposed to emphasize that therapy can’t change sexual orientation.

But, the APA adds, for clients who believe that affirming gay orientation is sinful, counselors should help them reject, to the extent possible, those attractions. This might mean learning to deflect sexual impulses, living celibately, or reshaping one’s struggle with sexual desire into an opportunity to grow closer to God.

“We have to acknowledge that, for some people, religious identity is such an important part of their lives, it may transcend everything else.” said Judith Glassgold, who chaired the APA’s task force on the issue.

The task force had been formed in response to the growing prominence of sexual orientation “change therapists” who state it’s possible to alter sexual preference. After reviewing the literature, the task concluded that such claims are bogus.