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.

An editorial in the Journal of the National Cancer Institute has questioned the routine use of expensive cancer drugs that prolong lives by just weeks or months.

NCI oncologist Tito Fojo and NIH ethicist Christine Grady called-out Erbitux as a particularly egregious example. An 18-week regimen of Bristol-Meyers Squibb’s cancer-fighter costs $80,000 and prolongs life by 1.2 months on average, they say.

“Many Americans would not regard a 1.2-month survival advantage as ‘significant’ progress,” the authors stated. “Would an individual patient disagree? The death of a mother of four at age 37 years would be no less painful were it to occur at age 37 years and 1 month, nor would the passing of a 67-year-old be any less difficult for the spouse were it to have occurred one month later.”

Complicating the debate is the fact that the drugs do work miracles in some patients, and it’s impossible to predict who will be so lucky.

“A drug like Erbitux is not very impressive when you look at the statistics, but for some it’s just remarkable,” Marti Nelson Cancer Foundation chief Robert Erwin told the Wall Street Journal. “How much does it cost for a person to have the opportunity to benefit?”

For their part, drug makers said the NCI article did not capture true costs of the cancer-fighters.  BMS spokesperson Brian Henry said the actual costs paid by patients for Erbitux is much less than $80,000.

“We can’t add on Mercedes-like drugs one after another and have every single patient cost the system phenomenal amounts of money,” said Eric Winer, chief scientific adviser to Susan G. Komen for the Cure, a breast-cancer advocacy group.

“But we have to be careful not to slow down the process of drug development. Ultimately, medical therapy will make a huge difference in people’s lives.”

Most of us are no longer surprised to learn that people from politicians to priests lie and cheat. Scientists do too. Take for example, the notorious case of Hwang Woo-Suk, who claimed to have cloned human embryonic stem cells, a lie so spectacular it was sure to be exposed with time.

But low-level fudging is harder to detect: the subtraction of a data point to enhance the appearance of a graph or to render results statistically significant, for example, or Photoshopping a jpeg to enhance a key feature.

Daniele Fanelli of the University of Edinburgh decided to quantify the pervasiveness of minor fraud among scientists, and concluded it is more common than most would have suspected.

Fanelli reviewed 18 published surveys of the matter. He found that only 2% of scientists confessed to outright fraud (such has modifying data to improve study results) at least once in their careers.

But nearly 10% fessed-up to dicey practices like “dropping data points based on a gut feeling” or “failing to present data that contradict one’s previous research.”

And survey participants proved more willing to point fingers at their colleagues than at themselves. Fully 14% of them said they’d seen colleagues falsify or fabricate data.

When the question was phrased in general terms like carrying-out experiments using substandard techniques or misrepresenting data, 46% of those queried said they saw their colleagues engaged in such misconduct.

Surprisingly, survey responders chose to intervene only half the time when they witnessed the shenanigans.

Come to think of it, the findings of Gregor Mendel, generally considered to be the father of modern genetics, were impossibly accurate given what we now know of his methods.

Fanelli’s write-up appears in the Public Library of Science.

Fourteen years ago, Harvard researchers revealed that insurance companies were big-time investors in tobacco companies. The seemingly hypocritical position prompted outrage and calls for them to divest.

But when the same scientists recently re-examined the matter, they found the industry had failed to kick the habit.

By reviewing SEC filings and news reports from 2008, J. Wesley Boyd and colleagues determined that US, UK and Canadian-based insurance companies owned at least $4.4 billion worth of stock in companies whose subsidiaries produce cigarettes, cigars, chewing tobacco and related products.

“Despite calls upon the insurance industry to get out of the tobacco business by physicians and others, insurers continue to put their profits above people’s health,” Boyd told Medical News Today. “It’s clear their top priority is making money, not safeguarding people’s well-being.”

The World Health Organization estimates that tobacco products contribute to 5.4 million deaths per year worldwide.

New Jersey-based Prudential Financial Inc., which markets life and disability insurance, has holdings in tobacco firms like Reynolds American and Philip Morris, that total $264 million.
 
These numbers are dwarfed by Toronto-based Sun Life which sells health, disability, life and long-term care insurance. It owns just north of $1 billion in tobacco company stock.

Meanwhile, London-based Prudential Plc, which offers disability, health and long-term care insurance, holds $1.38 billion in British American Tobacco and other such companies.

“Insurance firms have figured out ways to profit from both… investing in tobacco (and) selling life or health insurance. (They) exclude smokers from coverage or, more commonly, charge them higher premiums. Insurers profit -- and smokers lose -- twice over,” wrote the authors.

Boyd’s group first reported on the matter in a 1995 Lancet article.

As many as 30 congressmen involved in drafting health reform legislation hold health care stocks worth at least $11 million. The true value of these holdings could approach $27 million, since the congressional disclosure forms released last week don’t require reporting on precise values of asset holdings.

At least 8 Senators on the Health, Education, Labor, and Pensions Committee hold health care stocks worth a minimum of $600,000 and possibly as much as $1.9 million.

This group is currently deliberating on the Big O’s pet project, a “public option” that would compete against Big Insurance.

Similarly, at least 6 Senators on the Finance Committee hold stakes in health-care companies, including John Kerry, who with his wife holds at least $5.2 million in Merck, Lilly and other playahs.

In the House, where the Energy and Commerce Committee is drafting critical health reform legislation, the family of Jane Harman, a senior member, has stashed $3.2 million in a portfolio of 20 health care companies.

Congressional rules do not prevent members from holding stock in the industries they regulate, but ethicists raise concern that such behavior creates possible conflicts, especially if the legislation could be perceived as positively impacting their portfolios.

“If someone is going to be substantially enriched by the consequences of the vote…then there is a problem,” Harlan Krumholz, a Yale professor, told the Washington Post. “You don’t want to be tainted by any conflict.”

Yea, but Robert Walker, a former House and Senate ethics counsel, points  out that the Congressmen are “simply one of perhaps thousands or more” investors in a particular corporation. Such investments, he claims, do not constitute “prohibitive conflicts.”

And in many cases, the congressmen’s holdings are but a sliver of their total assets. Harman, whose husband started the global electronics company Harman International, is reported to be worth $120 million, for example.

Studies from Germany, Sweden and Scotland, published last Friday in Diabetologia, suggest a “possible link” between the use of Lantus insulin and cancer.

The findings prompted the European Association for the Study of Diabetes to make an urgent call for additional research into the association.

The EASD added that patients who are presently taking the relatively new, synthetic insulin should continue to do so, although some might wish to consider alternative types of insulin.

Human insulin, the older form of the hormone, has been used for decades. Its safety is beyond doubt, according to the EASD. Lantus has been used widely, but only since 2000.

The German study looked at an insurance database containing information regarding 127,000 insulin-treated patients. Scientists found that patients who had used Lantus were more likely to be diagnosed with cancer, and the effect was dose-dependent.

Thus, in patients receiving a dose of 10u, patients taking Lantus had cancer rates that were 9% higher than those taking human insulin. For those receiving 50u, the increased risk associated with Lantus was 31%.
 
Diabetologia editor Edwin Gale and EASD president Ulf Smith had become aware of the German findings awhile ago, according to an EASD press release. They decided to seek confirmatory evidence prior to announcing them formally.

As a result, similar database-driven studies were carried out in Sweden, Scotland, and the UK.

The Swedish study showed that patients taking Lantus insulin alone had twice the risk of breast cancer. The Scottish study revealed a statistically insignificant increased risk for breast cancer. The UK study was entirely negative.

Gale and Smith, in their press release, emphasize that all the studies have important methodological limitations.

In particular, patients taking Lantus insulin tended to be older, more obese and to have higher blood pressure than those receiving other forms of insulin. These pre-treatment differences could by themselves explain any differences in cancer rates between the groups. (more…)

When the Big O lifted the curtain on federal funding for embryonic stem cell research in March, scientists applauded the move as a long-overdue boost for the promising field.

Now, these same scientists worry his plan may have the unintended effect of dampening progress by forcing researchers to comply with ethical standards that were enacted after their research began.

“We’re very concerned,” Amy Rick, chief executive of the Coalition for the Advancement of Medical Research told the Washington Post. “If they don’t change this, very little current research would be eligible. It’s a huge issue.”

Ongoing stem cell research has already passed ethical scrutiny, but when Obama lifted the ban, he charged the NIH to develop new guidelines governing the field. Those guidelines would be difficult to meet in retrospect.

This is essentially moving the goal post,” the Harvard Stem Cell Institute’s George Daley told the Post.

For example, the new NIH guidelines require that couples sign documents stating that they agree to donate their embryos for research and that they have been informed about other options like donating the embryos to other couples instead.

Many clinics did just this, but their consent forms did not necessarily specify as such.

No one knows how many stem cell lines would be affected by retrospective enforcement of the NIH guidelines, but experts believe most would not pass muster.

The NIH has a chance to clean up the mess when it releases the final version of its guidelines on or before July 7. 

“We know issues like this have been raised, and we will take them into consideration,” Raynard Kington, the NIH’s acting director told the Post. “The intent of the president was to expand opportunities and research in this area.”