Useless Studies, Real Harm

By Carl Elliot

The New York Times

www.nytimes.com

LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not?

One reason is that the study was not quite what it seemed. It looked like a clinical trial, but as litigation documents have shown, it was actually a marketing device known as a “seeding trial.” The purpose of seeding trials is not to advance research but to make doctors familiar with a new drug.

In a typical seeding trial, a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.

In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used. Nobody really knows how often companies conduct such trials, but they appear with alarming regularity in pharmaceutical marketing documents. In the marketing plan for the antidepressant Lexapro for the 2004 fiscal year, Forest Laboratories described 102 Phase IV trials — the classification under which seeding trials fall — in a section labeled “Marketing Tactics.”

Oversight bodies like the Food and Drug Administration generally don’t view seeding trials as research scandals: seeding trials are not illegal, and the drugs in question have already received F.D.A. approval. But even after particularly egregious seeding trials have been exposed, the F.D.A. has not issued sanctions. Take the notorious Advantage study, a seeding trial of the pain reliever Vioxx conducted by Merck. According to a 2008 report in the Annals of Internal Medicine, litigation documents show that the Advantage study was conceived and managed by Merck’s marketing department. Three subjects died in the Advantage trial; five more subjects experienced heart attacks. Oversight bodies should treat the Advantage study as a violation of research ethics.

The entire story can be read here.

Vets face shortage of therapists

New program training clinicians in psychology of combat is an attempt to help fill the gap

By Peter Cameron, Special to the Tribune

When Daniel Brautigam tried to tell therapists how he felt having urine thrown in his face at Guantanamo Bay, he experienced the same frustration as thousands of other returning veterans who have sought counseling.

"They had no idea how to respond to that. It looked like to me that they were grossed out, and they're supposed to be helping me," said Brautigam, 31, who was diagnosed with post-traumatic stress disorder and depression following his return to Hoffman Estates from tours with the Navy in the Northern Arabian Gulf and Cuba.

The Department of Veterans Affairs estimates that 11 percent to 20 percent of veterans from the wars in Afghanistan and Iraq are suffering from PTSD. Others think the number is higher.
When vets seek therapy, they want a professional who can relate to soldiers in combat, and that usually means a therapist who has military experience. Without such empathy, therapy often is doomed, vets say.

Because most psychologists and mental health care professionals don't have a military background, there's a void in the safety net for vets. Some veterans' organizations have stepped up, training members to help their peers, and the Soldiers Project provides free counseling from licensed professionals and veterans by phone to newly returned vets.

A counselor to ex-soldiers for 35 years, Ray Parrish, 58, a self-described angry veteran, sees the problem on a daily basis. He is the benefits director for Vietnam Veterans Against the War in Chicago and helps those trying to navigate the bureaucracy of the Veterans Administration.

"There quite literally are not enough people that have knowledge of veterans' experiences and who have the professional expertise to provide them the health that they need," Parrish said. "That means that all of the veterans get inadequate care."

A new attempt to fill the gap is coming from the Adler School of Professional Psychology in Chicago, which this fall is launching a military specialization track for its doctorate of clinical psychology program. Joe Troiani, a faculty member and Navy veteran who created the track, said the school hopes to prepare students for the specific psychological problems that stem from military service. They will take such classes as the psychology of terrorism, and psychology of combat and conflict.

But some vets scoff at the idea of learning about the horrors of war in the classroom.

"You're dealing with a whole different mindset with a soldier," said Tim Miller, 30, of Chicago, a veteran of the Iraq war who is now studying to be a clinical psychologist at Argosy University. "You can't just wrap your head around that from reading a book."

Troiani called that criticism fair but said the school is training students how to treat the psychological effects of combat, rather than trying to re-create the experience of living in a war zone.

Read the story here.

Canadian Psychology: Ethical and Legal Considerations of record keeping

An updated account of the ethical and legal considerations of record keeping.

Bemister, Taryn B.; Dobson, Keith S.

Canadian Psychology/Psychologie canadienne, Jul 25, 2011

Abstract:

The Canadian literature is void of contemporary guidelines for clinical record keeping for psychologists, as the most recent article was published more than two decades ago (Eberlein, 1990). However, the techniques used in record keeping have greatly advanced, specifically with regard to the role of computers and the use of electronic documents. Furthermore, new legislation and guidelines have been developed in response to these technological advancements. The purpose of this article is to provide a concise, accessible, and up-to-date set of guidelines on record keeping in psychology. The professional and legal requirements of psychologists are discussed with regard to the use, content, access, ownership, and retention of records with special consideration given to electronic documents. Recommendations are made for Canadian psychologists that are consistent with the current legal and professional standards of the field.

Beginning of the article:

The Canadian literature is void of contemporary guidelines for clinical record keeping.

Although books that contain information regarding record keeping have been published more recently (e.g., Evans, 2004 and Truscott & Crook, 2004), the most recent article dates back to 1990 (Eberlein, 1990).
Eberlein's article was written largely in response to the establishment of the Canadian Code of Ethics for Psychologists (Canadian Psychological Association [CPA], 1988; herein referred to as the Code of Ethics).

However, two revisions of the Code of Ethics have been published (1999 and 2001), and the techniques used in record keeping have advanced, specifically with regard to the role of computers and the use of electronic documents.

Beyond the above developments, the federal Personal Information Protection and Electronic Documents Act (PIPEDA) was introduced in 2000, and it has modified the statutes relevant to records.

Similarly, a draft of guidelines for psychologists who provide psychological services via electronic media was developed (CPA, 2006; to be finalized).

A second exerpt:

The purpose of this article is to provide a concise and accessible resource on record keeping that is up-to-date with the advances that have occurred since 1990.

This article provides a comprehensive overview of the issues related to record keeping and provides recommendations for Canadian psychologists.

More specifically, the professional and legal requirements of psychologists are discussed with regard to the use, content, access, ownership, and retention of records with special consideration given to electronic documents.

The implications of technological advances on client confidentiality and privacy are also considered.
The suggestions made in this paper are consistent with the Code of Ethics, as well as legislative and provincial laws and regulations, including the Code of Conduct (or its equivalent) of each province and territory.

The author note provides the following contact information: Taryn B. Bemister, Department of Psychology, University of Calgary, Calgary, AB T2N 1N4, Canada. E-mail: tbbemist@ucalgary.ca.

Thanks to Ken Pope for the information.

We are adding a link!!

One of the great features of blogging is the ability to connect similar sites.  When we originally started our site, we only had a few relevant links.

Anyone interested in ethics can link to Mitch Handelsman's site, The Ethical Professor.

Hit the hyperlink and bookmark it.

Mitchell Handelsman, PhD

It is really that easy.

Blog Comment on British Psychological Society on DSM-5

Dr. Will Meek is a psychologist practicing in Vancouver, WA. He writes regularly about mental health on his blog: Vancouver Psychologist

Some of you may be following the development of the forthcoming fifth revision to the Diagnostic and Statistical Manual of Mental Disorders (DSM), the major book used for psychiatric diagnosis. There has been a lot of criticism due to the secrecy of the process this time around, but the British Psychological Society (BPS), the major mental health organization in the UK, is taking an even more interesting and refreshing angle: criticizing the entire current framework of diagnosis.

The DSM takes a medical approach to diagnosis. In short, this means that a ‘patient’ is assumed to have an underlying ‘pathology’ that manifests as various ‘symptoms’ that are assessed to make a ‘diagnosis’ and then apply a ‘treatment’ to said diagnosis. This approach basically makes various human conditions into ‘illnesses’ that need ‘interventions’ like medication or cognitive behavioral therapy. In a recent paper, BPS has criticized this framework as harmful to individuals and the public.

“The Society is concerned that clients and the general public are negatively affected by the continued and continuous medicalisation of their natural and normal responses to their experiences; responses which undoubtedly have distressing consequences which demand helping responses, but which do not reflect illnesses so much as normal individual variation. (p.1)”

“We believe that classifying these problems as ‘illnesses’ misses the relational context of problems and the undeniable social causation of many such problems. For psychologists, our well-being and mental health stem from our frameworks of understanding of the world, frameworks which are themselves the product of the experiences and learning through our lives. (p.4)”

As a practicing psychologist who also teaches a class on diagnosis for master’s level therapists, I could not be more excited reading this paper. BPS essentially takes a more humanistic and social constructivist approach to the problems of living. The benefits of this include reducing stigma, a larger focus on the interpersonal dimensions of mental health, and normalizing the experience of having problems during life.

Cheers to you BPS, now if only your American counterparts would get the message…

Cyberharassment and Cyberstalking

Bruce E. Mapes, Ph.D., and Samuel Knapp, Ed.D.

                                                           

As the list of potential uses of technology to aid the practice of psychology grows, so does the list of potential misuses by disturbed or angry clients. For example, social network sites and public tax or utility records can provide personal information about a psychologist. A virus or worm may be embedded in or attached to an e-mail. An e-mail sent to a client may be modified. For example, in response to his client’s e-mail, Dr. Smith wrote “I am concerned about your distress and would like you to come to my office this evening.” The client edited the message to read “I am concerned about your wife’s distress and would like her to come to my office this evening”; the e-mail was forwarded to his attorney who was representing him in a custody hearing the following day. More recently, computers have become a means to harass or stalk psychologists.

Cyberstalking (CS) and cyberharassment (CH) are relatively new problems. Although they share many characteristics, the primary difference is CS most likely involves the risk of offline contact and physical harm, while CH involves the intent to attack character or reputation. Both may be driven by revenge, mental illness, jealousy, or anger, but CH may also be driven by the desire to intimidate or embarrass the victim. The anonymity of the Internet often empowers the individual to send multiple e-mails or text messages to the victim or to the victim’s significant others. Or the individual may hack into the victim’s computer; sign up the victim for spam or porn sites; send offensive e-mails in the name of the victim; or post on Web sites and include fabricated, misrepresented, or embellished information about the victim.

Although Canada has passed laws for both CH and CS, the United States has been slower in passing legislation, especially for CH. Some of the reasons for the lack of legislation include: (1) issues of legal jurisdiction since the Internet is an international medium; (2) limited resources to collect and authenticate evidence; and (3) the double-edged sword of free speech. Typically, CS is handled through the criminal courts and CH is handled through the civil courts. If CH is related to a custody matter, it may be possible to pursue criminal charges under laws related to intimidation or harassment of a court official or witness. Victims may try to file a complaint with the harasser’s ISP to have the account canceled or the Web site shut down. This is rarely successful since the ISP is not a publisher, but rather a means to access the Internet and therefore can rarely be held accountable for the “free speech” of the harasser.

When stalkers attempt to meet the victim offline, immediate consultation should be sought from law enforcement because this may pose a serious threat to the victim’s safety and welfare. Pursuing civil action in the case of CH can be more difficult. Harassers typically represent themselves which can result in a very lengthy process (years) and excessive attorney fees for victims. Even if victims are able to win damages and attorney fees, they may not actually collect any money, and it is unlikely the civil court will issue an order to shut the site down.

In the case of CH, the victim should keep a file of all offensive messages and posts, but should not provide intermittent reinforcers by responding. Typically, the harasser needs to be in control and wants to debate. Any response usually results in exchanges which escalate and can quickly get out of control (flaming wars). Harassers want to be recognized and will continue to make postings that are likely to become more outlandish and/or unbelievable, and ultimately discredit themselves. Most harassers discontinue when after a while they fail to elicit a response from the victim.

Harassment and stalking are stressful. Psychologists who are victims may experience a variety of symptoms, including but not limited to anger, demoralization, withdrawing, hypervigilance, avoidance of the computer, excessive self-consciousness, sleep disturbance, nightmares, impairment in concentration and memory, hypersensitivity to the comments or actions of colleagues and clients, and other symptoms common to prolonged stress. Psychologists who are victims should continue regular personal and professional routines, and remain active in recreational activities, family activities, and other activities that will help to reduce the preoccupation with and the harm from the CH. As in other situations, if the “symptoms” begin to impact one’s daily functioning, the psychologist should consult with a colleague or contact PPA’s colleague assistance resources.

For additional information on CS, CH, topics such as cyber-bullying, ways to protect yourself, and other resources, the reader is referred to the Stalking Resource Center, a program of the National Center for Victims of Crime (www.ncvc.org), and Cyber911 Emergency at www.wiredsafety.org. Occasionally google your own name to see in what contexts it may be used on the Internet.

Man gets 4 years for stalking on Facebook

SACRAMENTO, Calif. (AP)
USA Today/News

A California man who trolled women's Facebook pages searching for clues that allowed him to take over their email accounts was sentenced Friday to more than four years in state prison after a judge rejected a plea for a lighter sentence and likened the man to a peeping Tom.

Once he took over women's email accounts, George Bronk searched their folders for nude or semi-nude photographs or videos sent to their husbands or boyfriends and distributed the images to their contact list, prosecutors said.

The emails went to families, friends and co-workers. Women in 17 states, the District of Columbia and England were victimized.

"This case serves as a stark example of what occurs in so-called cyberspace. It has very real consequences," Sacramento County Superior Court Judge Lawrence Brown said. "The intrusion of one's profile is no different than intruding one's home."

Bronk, 24, pleaded guilty in January to charges that included computer intrusion, false impersonation and possession of child pornography.

Brown sentenced him to four years in state prison for the charges related to the Facebook and email offenses, and added eight more months for charges related to child pornography.

Bronk's attorney, Monica Lynch, said her client took responsibility for his actions and showed remorse. She had sought a sentence of one year in local jail with probation afterward, or two years in state prison with no probation.

Brown based his decision on a sentencing recommendation by the California Department of Corrections and Rehabilitation. The evaluation stated that Bronk demonstrated remorse and quoted the self-identified alcoholic as saying, "If I could go back with the knowledge that I have now, I would not have done any of the things I did."

But the state expressed concern about his lack of understanding about the severity of his crime and noted Bronk had demonstrated "a high degree of callousness." The evaluation said he used the child pornographic videos and images "as an instrument designed to inflict pain and humiliation on the very people he stole the images from."

Read the entire story here.

Update: APA/ASPPB/APAIT Telepsychology Guidelines for Psychologists

Telepsych_TF



A full page link can be found here.

Informed-Consent Forms for HIV Research Too Long: Study

Randy Dotinga

Medicinenet.com

The informed-consent documents that study volunteers must sign before joining HIV/AIDSresearch trials in countries around the world -- including the United States -- are too long and complicated, researchers say.

The consent forms added up to more than 20 pages, according to an analysis of 124 such documents used in multinational research projects funded by the United States at home and abroad, the new study found.

"While we were familiar with many fairly long consent forms for several different types of studies, we were honestly surprised to see that the median length was 22 pages, and the median length for adult forms was a full 27 pages," study lead investigator Nancy Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, said in a news release from Johns Hopkins Medicine.

The forms gave very little information on research methods, such as explaining concepts like randomization and placebos, which means that study participants may not understand that they might get a different medication than other participants or no medicine at all, Kass said.

The researchers also found that most of the forms weren't easy enough to understand and often required higher-level reading skills, with most written for at least a ninth-grade reading comprehension level.

About half of the U.S. population reads at or below an eighth-grade reading level, the authors pointed out in the report published in the August issue of the Journal of General Internal Medicine.

The problems may begin with forms provided by funders. "In this study, the forms that researchers were given by their funders as models -- what we call 'template' forms -- were themselves very, very long," Kass said.

"I imagine many researchers wish they could use methods that were not only shorter, but maybe that used strategies other than written communication altogether," particularly in light of the rise of research trials in countries like India and Bangladesh, where much of the population cannot read, she added.