Retractions Of Scientific Studies Are Surging

By Ed Silverman
http://www.pharmalot.com/

Over the past decade, the number of medical journals that have issued retractions has climbed precipitously. Since 2001, the overall number of papers that were published in research journals increased 44 percent, but at the same time, the number of papers that were retracted climbed more than 15-fold, according to The Wall Street Journal, citing data from Thomson Reuters.

Put another way, there were just 22 retraction notices that appeared in journals 10 years ago, but 139 were published in 2006 and by last year, the number reached 339. Through July of this year, there were a total 210 retractions, according to Thomson Reuters Web of Science, which maintains an index of 11,600 peer-reviewed journals.

Meanwhile, retractions related to fraud rose more than sevenfold between 2004 and 2009, exceeding a twofold rise traced to mistakes, according to an analysis published in the Journal of Medical Ethics. After studying 742 papers that were withdrawn from 2000 to 2010, the analysis found that 73.5 percent were retracted simply for error, but 26.6 percent were retracted for fraud. Ominously, 31.8 percent of retracted papers were not noted as retracted (read the abstract).

The conclusion? Either there is more fraud or more policing? Ivan Oransky, the executive editor of Reuters Health and a co-founder of the Retraction Watch blog that began recently in response to the spate of retractions, writes us that the simple use of eyeballs and software that can detect plagiarism has made it possible to root out bad papers.

He also notes, however, that there are more journals, which explains why there are more papers, in general, being published. “So the question is whether there have been more retractions per paper published,” Oransky writes, and then points to this chart to note that were, indeed, many more.

“That’s really no surprise, given the increasing numbers of eyeballs on studies, and the introduction of plagiarism detection software. It’s unclear whether the actual amount of misconduct and legitimate error has grown; it may just be that we’re picking up on more of it,” he continues. “What makes it difficult to tell is a problem we often see at Retraction Watch: Opaque and unhelpful retraction notices saying only ‘this study was withdrawn by the authors.’ How does that make for transparent science? We think journals can do a lot better, by demanding that authors and institutions come clean about what went wrong.”

And why is there more fraud? As the Wall Street Journal notes, there is a lot to be gained - by both researchers and journal editors - to publish influential papers. “The stakes are so high,” The Lancet editor Richard Horton tells the Journal. “A single paper in Lancet and you get your chair and you get your money. It’s your passport to success.”

The entire story can be read here.

Psychologists with Cancer: Clinical, Ethical, and Practical Challenges

Helen L. Coons, Ph.D., ABPP

Jana N. Martin, Ph.D.

From The Pennsylvania Psychologist

Psychologists living with cancer face clinical, ethical and practical challenges while coping with their own diagnosis and treatments. This brief article offers several suggestions to psychologists in practice and other professional settings who are coping with an early or advanced diagnosis of cancer.

Seek support and supervision. While most individuals are remarkably resilient in coping with cancer and its treatments, a new or recurrent diagnosis and the complex treatment decisions which follow can be highly stressful and frightening. Reaching out to colleagues early for support and supervision is important for psychologists with cancer. Ask colleagues if they know psychologists (or other mental health providers) who have experienced cancer treatment. Practical, informational and emotional support from someone with an insiders’ view is invaluable. The PPA listserv and APA Division listservs may also be helpful in identifying other psychologists with cancer.

Formal supervision from a respected colleague is essential to address clinical, ethical and practical issues that emerge as psychologists cope with cancer, and to support them in developing a practice management plan during and after treatments.

Develop a practice management plan. A cancer diagnosis will typically be followed by  treatment decisions related to surgery, chemotherapy, and/or radiation as well as acute, late, and long-term side effects. At any point in the treatment course, psychologists often face a series of challenging questions related to their practice and other professional roles. Some individuals are too ill, tired, or uncomfortable to work during treatment; some will have to work to maintain their income; and most will likely work part- or full-time with breaks for treatment. Psychologists undergoing cancer treatment are confronted with questions such as: (1) should they continue to see patients, teach, supervise, etc; (2) should they work full- or part-time; (3) if, how and when to disclose their diagnosis to patients, keeping in the mind their practice focus (e.g., children, teens, adults); (4) how to deal with breaks in treatment resulting from additional surgery or side effects of chemotherapy and/or radiation; (5) whether or not to treat patients who have or had cancer, are “at risk” for cancer, have lost a loved one to cancer, have significant attachment issues, or require a high degree of treatment consistency, etc; and (6) clinical, ethical and practical issues when closing a practice. Developing a practice management plan in consultation with a supervisor to address these and other questions can be helpful and empowering (Coons, 2010).

A practice management plan during and after cancer treatment may include creating flexibility in the psychologist’s schedule. For example, some psychologists reduce their patient and teaching load, and/or block their schedule after each chemotherapy cycle when side effects (e.g., nausea, fatigue, pain, low blood counts, etc.) are more likely to emerge and may adversely affect one’s ability to work. Some individuals undergoing chemotherapy have also shifted the focus of their clinical work to more testing or consultation so that they can schedule evaluations between cycles when they have more energy. Others have found that the familiarity of work is a healthy break from cancer treatment. A management plan should include finding colleagues to be on standby to call and re-schedule clients (who have provided informed consent) so that psychologists do not have to explain to patients how they are feeling.

Pace yourself during and after treatment. Throughout and after cancer treatment, psychologists need to be mindful of their physical, emotional and cognitive well-being. Psychologists have an ethical obligation to ensure that their own physical and psychological well-being is healthy enough to care for patients, teach, supervise, etc. Fatigue, pain, nausea and vomiting and the medications used to treat these symptoms or side effects may compromise some individuals’ ability to meet the demands of clinical practice. Chemotherapy and other medications used in cancer treatment, for example, can diminish cognitive functioning. While changes in concentration, memory, processing speed, and the ability to multitask are likely to be mild and time-limited, high level clinical decision-making is essential for differential diagnosis and treatment. Psychologists undergoing cancer treatment must evaluate if they are healthy enough to meet the demands of practice and other professional responsibilities.

Designate a clinical power of attorney. Consistent with the APA Ethical Principles of Psychologists and Code of Conduct (2002), psychologists are obligated to ensure that patients will be taken care of if they are not able to meet professional responsibilities because of personal problems or when there are interruptions in therapy or termination. While many psychologists with cancer will continue to practice during and after treatment, it is important to designate a clinical power of attorney in the event that the psychologist is unable to take care of patients. This colleague should be able to access the psychologist’s office (i.e., they have door and file keys), patient lists, appointment schedules, and records; will contact patients and can either reschedule or provide care to patients, or refer them to other colleagues with the appropriate clinical expertise. See Pope and Vasquez, (2007); Spayd & O’Leary Wiley (2009); and www.apapracticecentral.org for more detailed discussions on closing a practice.

Personal experience with cancer and expertise in psychosocial oncology.  Psychologists who undergo their own cancer treatment will have a special understanding of the experience faced by so many adults across the life span. After treatment, they may even consider taking care of patients with cancer. While well meaning, the psychologist’s own treatment experience is very different from having the expertise in psychosocial oncology necessary to provide evidence-based assessment and treatment to adults with early and advanced cancers. Treating patients with cancer requires a highly specialized fund of knowledge and clinical competencies to ensure quality care and outcomes. While psychologists may want to help others deal with this challenge, they still have the ethical obligation to practice within their scope of expertise. Again, supervision from a respected colleague can be invaluable to sort out if and when a psychologist should treat others with or affected by cancer.

References

American Psychological Association (2002). Ethical principles of psychologists and code of conduct. Washington, DC: Author.

Coons, H. L. (2010). Psychologists with early and advanced breast cancer: Clinical, ethical and practical challenges. Manuscript submitted for publication.

Pope, K. S., & Vasquez, M. J. T. (2007). Ethics in psychotherapy and counseling: A practical guide. San Francisco: John Wiley.

Spayd, C. S., & O’Leary Wiley, M. (2009, December). Closing a professional practice: Clinical and practical considerations. The Pennsylvania Psychologist, 69(11), 15-17.

Helen L. Coons, Ph.D., ABPP, is a board certified clinical health psychologist who is President and Clinical Director of Women’s Mental Health Associates in Philadelphia. She has specialized in psychosocial oncology for 30 years, mentors psychologists and other health care providers with cancer, and underwent treatment for breast cancer. Dr. Coons may be reached at hcoons@verizon.net or 215-732-5590.

Jana N. Martin, Ph.D., is a licensed psychologist in independent practice in Long Beach, CA. Some of her work with children, adults, and families has focused on coping with chronic diseases such as cancer, and she is in remission from lymphoma. She may be reached at drjanamartin@verizon.net.

Professional Competence in the Face of Life-Threatening Illness

The new issue of *Professional Psychology* includes an article: "Preventing Problems of Professional Competence in the Face of Life-Threatening Illness."

The authors are W. Brad Johnson & Jeffrey E. Barnett.

Psychologists are human. Like our clients, we are nearly certain to encounter difficult life stressors such as relational break-downs, emotional low points, phase-of-life problems, serious medical challenges, or the onset of cognitive decline. Sadly, being a psychologist does little to insulate us from life's tribulations.

At some point during his or her career, nearly every mental health professional will confront a significant health problem. Medical issues may run the gamut from relatively minor (e.g., pneumonia, minor surgery, thyroid dysfunction) to life-threatening (e.g., cardiovascular disease requiring open heart surgery, neuromuscular disorders with a short life-expectancy, various forms of cancer).

Because many psychologists expect to work beyond the typical retirement age, with nearly a fifth reporting that they plan to work until death (Guy, Stark, Poelstra, & Souder, 1987), the probability of life-threatening medical diagnoses occurring during the course of one's career are significant.

But even early career psychologists are vulnerable to life-altering and potentially fatal medical problems (Philip, 1993).

Recent epidemiologic data for U. S. adults between the ages of 45 and 64 indicate that 13% suffer from some form of heart disease and 9.4% have been diagnosed with cancer; between the ages of 65 and 74, these numbers jump to 25.8% for heart disease and 22.5% for cancer (Centers for Disease Control & Prevention, 2010).

Although practitioner emotional health is considered essential and fundamental to the delivery of competent services (Vasquez, 1992), few things may threaten a psychologist's emotional stability more acutely than the diagnosis of a life-threatening illness.

Unfortunately, psychologists are not always effective when it comes to accepting their own vulnerabilities, taking time for self-care, and identifying decrements in their own competence due to either emotional or physical distress (Barnett & Johnson, 2008).

In this article, we direct our focus to the prospect of a life-threatening illness in the psychologist and the subsequent implications for professional competence.

By life-threatening we mean a terminal disease or a progressive medical condition leading to increasing disability and, in most cases, premature death.

Although psychologists are enjoined by the Ethical Principles of Psychologists and Code of Conduct (American Psychological Association; APA, 2010) to ensure their own competence, psychologists struggling with life-altering medical problems may be especially vulnerable to problems in this area.

We highlight how seriously ill and subsequently distressed psychologists may be ineffective at self-assessing and monitoring their professional competence, as well as in making essential decisions about continued clinical practice.

We conclude with numerous recommendations for psychologists designed to both prevent and manage threats to professional competence caused by a life-threatening illness.

Thanks to Ken Pope for this information.

Norway: Insanity Defense Not Likely

AP Exclusive

It's unlikely that the right-wing extremist who admitted killing dozens in Norway last week will be declared legally insane because he appears to have been in control of his actions, the head of the panel that will review his psychiatric evaluation told The Associated Press.

The decision on Anders Behring Breivik's mental state will determine whether he can be held criminally liable and punished with a prison sentence or sent to a psychiatric ward for treatment.

The July 22 attacks were so carefully planned and executed that it would be difficult to argue they were the work of a delusional madman, said Dr. Tarjei Rygnestad, who heads the Norwegian Board of Forensic Medicine.

In Norway, an insanity defense requires that a defendant be in a state of psychosis while committing the crime with which he or she is charged. That means the defendant has lost contact with reality to the point that he's no longer in control of his own actions.

"It's not very likely he was psychotic," Rygnestad told the AP.

The forensic board must review and approve the examination by two court-appointed psychiatrists before the report goes to the judge hearing the case. The judge will then decide whether Breivik can be held criminally liable.

Rygnestad told the AP a psychotic person can only perform simple tasks. Even driving from downtown Oslo to the lake northwest of the capital, where Breivik opened fire at a political youth camp, would be too complicated.

"If you have voices in your head telling you to do this and that, it will disturb everything, and driving a car is very complex," Rygnestad said.

"How he prepared" for the rampage — meticulously acquiring the materials and skills he needed to carry out his attack while maintaining silence to avoid detection — argues against psychosis, Rygnestad added.

By his own account, the 32-year-old Norwegian spent years plotting the attack. On July 22, he set off a car bomb that killed eight people in downtown Oslo's government district, then drove north to a youth camp on Utoya, a small lake island set amid a quiet countryside of pines and spruces.

There, he spent 90 minutes executing 69 people, mostly teenage members of the youth wing of Norway's governing Labor Party.

The entire story can be found here.

Expert Witnesses on Trial

State legislators, physician organizations and courts are taking steps to ensure that the experts provide ethical and appropriate testimony.

By Alicia Gallegos, amednews staff.

The ideal goal of an expert witness during testimony is to be "an indifferent advocate for the truth," said neurosurgeon Jeffrey Segal, MD.

Too often, though, physicians make careers as such experts and use unethical tactics to sway jurors, said Dr. Segal, founder and CEO of Medical Justice, a company that sells medical liability insurance and provides legal resources to combat frivolous claims.

"Expert witnesses are the weak or strong link in any medical liability case," he said.

Lawmakers, physician organizations and courts are taking steps to combat unethical testimony by these so-called hired guns.

In recent years, several states have enacted tighter restrictions on expert witness testimony in medical negligence cases. At the same time, more medical associations and state medical boards have created standards for proper expert witness testimony and acted against experts who violate those rules.

Courts also are taking stronger stances against questionable experts. For example, high courts in Arizona and Maryland in 2009 upheld as constitutional state restrictions against expert witnesses.

"There is a growing awareness on the part of expert witnesses -- for both sides -- that what they are doing is not necessarily going to be kept behind closed doors, which definitely was not the case 10 years ago," said Louise B. Andrew, MD, an attorney and independent consultant for physicians on litigation and expert witness issues. "They can't just go and say whatever they are paid to say and expect that peers will never know."

Florida is the latest state to pass restrictions on the use of expert witnesses in medical liability cases. Under a law signed July 1 by the governor, out-of-state physicians offering expert testimony must apply for a certificate to testify. The state medical board can discipline them if they provide deceptive testimony.

"Before, there was absolutely no accountability for what [expert witnesses] did in Florida," said Jeff Scott, general counsel for the Florida Medical Assn. With the new law, "you can't come into Florida and testify falsely and hope to get away with it."

At least 30 states have similar expert witness laws. Some statutes, such as Arizona's, require witnesses to practice in the same specialty as the physician defendant. Others, like Maryland's, mandate that doctors spend a certain amount of time actively practicing medicine.

The whole story can be found here.

McGill reprimands prof over ghostwriting scandal

By AARON DERFEL, Gazette Health Reporter

Barbara Sherwin

McGill University has formally reprimanded senior professor and researcher Barbara Sherwin for failing to acknowledge a ghostwriter hired by drug company Wyeth Pharmaceuticals in a paper Sherwin wrote in 2000.

However, the university has decided against sanctioning Sherwin, who is a James McGill professor of psychology, obstetrics and gynecology.

In August 2009, Sherwin's name appeared in court documents in a class-action suit launched by 8,400 women against Wyeth. The documents revealed that Wyeth paid a New Jersey professional-writing firm, DesignWrite, to produce a paper on treatment options for ageassociated memory loss that was eventually published in the Journal of the American Geriatrics Society.

Sherwin was listed as the sole author of that paper, even though Karen Mittleman, an employee of DesignWrite, was involved in the process. The paper was published just when critics started raising doubts about hormone-replacement therapy.

Wyeth - through DesignWrite - had commissioned at least 40 scientific papers endorsing the therapy. The drug company (now part of Pfizer) had a vested interest in HRT, as sales of its hormone drugs soared to almost $2 billion in 2001.

Shortly after the revelations from the court documents were made public, Sherwin issued a written statement in which she admitted to making "an error" in agreeing to have her name attached to the article without making it clear that there was another author.

"I believe the article, which was peer-reviewed, represented sound and thorough scholarship, and in no way could be construed as promotion for any particular product or company," her statement read.

Still, an eight-month investigation found that Sherwin should have credited Mittleman.

The entire story can be read here.

Ghostwritten medical articles called fraud

CBC News

It's fraudulent for academics to give their names to medical articles ghostwritten by pharmaceutical industry writers, say two Canadian law professors who call for potential legal sanctions.

Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues, said Trudo Lemmens, a law professor at the University of Toronto. The integrity of medical research is also harmed by ghostwritten articles, he said.

Ghostwriting is part of marketing that can distort the evidence on a drug, Lemmens said. Industry authors are concealed to insert marketing messages and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analyzing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in Tuesday's issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.

The institutions have divided loyalties, the authors say, which may explain why they've been slow to act. For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

A legal response could act as a powerful deterrent, Stern said.

"Our theory does not depend on the accuracy of the data," Lemmens said in an email. "False representation of authorship is in our view fraud, regardless of the accuracy of the reporting."

Doctors and patients perceive published studies to be independent assessments made by academic experts, the authors noted.

Ghostwritten publications are used in court to support a manufacturer's arguments about a drug's safety and effectiveness, and academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with the publications on their CV, Lemmens said.

The entire story can be found here.

Texas: Doctoral Degree in Psychology Required for Independent Practice

Austin, TX ‐ Today, Judge Rhonda Hurley in Travis County District Court, Austin, Texas, upheld the ruling that the entry level to independent practice of psychology in Texas is the doctoral degree. Judge Hurley ruled that the Texas State Board of Examiners of Psychologists (TSBEP) has the authority to regulate the practice of Licensed Psychological Associates (LPAs) through its rule making authority which states only doctoral‐trained, Licensed Psychologists may practice independently.

In September, 2010 the organization which represents Licensed Psychological Associates, the Texas Association of Psychological Associates (TAPA), filed a lawsuit in Austin, Texas, against the TSBEP on the grounds that the Board has no statutory authority to prevent Licensed Psychological Associates from practicing independently. According to Texas statute, Licensed Psychological Associates are defined as individuals trained in psychology at the Master’s level. By Board Rule, LPAs must practice under the supervision of a doctoral‐trained Licensed Psychologist. The Texas Psychological Association (TPA) was granted permission by the court to intervene in this case; arguing the intention of the legislature was that only doctoral‐trained individuals could provide independent psychological services. TPA claimed that TSBEP rule, which clearly states the supervision requirement for LPAs, does define how psychology is to be practiced in this state even though the supervision requirement is void in the statute.

David White, TPA’s Executive Director, states “We thank Judge Hurley for her judgment in this case and for clarifying this issue that has been debated for so many years in the psychology community. We appreciate the services provided by Licensed Psychological Associates but are fully committed to assuring that independent psychological practice in Texas remains solely for individuals trained at the doctoral level.”

Conflict disclosure plan dropped

The NIH will not require universities to create websites detailing researchers' financial ties.

Meredith Wadman

Francis Collins hailed it as a "new era of clarity and transparency in the management of financial conflicts of interest" (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers.

Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. "They have pulled the rug out from under this," says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer-protection organization based in Washington DC. "It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH." It will also make it more difficult for "scholars to study the effects of conflicts of interest in universities", adds Sheldon Krimsky, who studies science ethics at Tufts University School of Medicine in Boston, Massachusetts.

The NIH's parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research. The DHHS called the proposed websites "an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust". Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, "that could directly and significantly affect the design, conduct, or reporting" of the research. The institutions would post the details online, where they would stay for at least five years.

But a government official with knowledge of the ongoing negotiations on the rule says that the institutions will now be allowed to choose how to disclose this information, and will not be obliged to post it online. This is likely to make it much harder for members of the public to find these details, says Ned Feder, a senior staff scientist with the Project on Government Oversight. The watchdog group, based in Washington DC, wrote last month to the White House Office of Management and Budget (OMB) urging that the website requirement be protected. The OMB must sign off on the finalized form of the rule before it is published.

The entire story can be found here.
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