More on therapeutic misconception

The ACRP (Association of Clinical Research Professionals) Wire has another article on the important topic of clinical research participation and the therapeutic misconception. It is worth the continued discussion.

Therapeutic misconception and participation in clinical research

In her column this week, Dr. Pauline Chen touches on a serious concern for clinical researchers: therapeutic misconception. Clinical research is dependent on the voluntary, informed participation of research participants. Researchers, coordinators and institutional review boards, put a great deal of time and effort into making sure that potentially participants are fully informed about the nature of their participation in research, including the fact that they themselves may not directly benefit from participating in the trial. But when potential participants face serious, life-threatening illnesses, they may view participation in the trial as their only hope, even if the researcher tells them there is only a small chance they will benefit. Dr. Chen's column ultimately explores the ethics of hope. Is it OK for researchers to enroll participants who are enrolling with unrealistic expectations, despite the researcher's best efforts at informed consent? Is there any way to prevent unrealistic expectations? Should we prevent unrealistic expectations if they give hope?

Ongoing debate regarding physician's speaking fees at University of Wisconsin

The Milwaukee Journal-Sentinel had a story today about the ongoing debate at University of Wisconsin about the speaking fees UW physicians can receive from pharmaceutical and medical device companies. Earlier this year a new conflict of interest policy was proposed which would ban UW physicians from giving presentations paid for by pharmaceutical and medical device companies. But uproar from orthopedic physicians has meant an exemption for presentations about medical devices but maintains the ban for drug talks. The proposed policy has raised debates about ethics in medicine, conflicts of interest, and power and influence in medical schools. Some physicians are concerned about their own autonomy to conduct their medical practices and supplement their incomes as they see fit. Others are concerned about how one group of physicians was able to influence the policy in their favor.

Whatever the outcomes, it seems that these debates are only beginning, as medical schools and physicians continue to consider the interaction between pharmaceutical and medical device companies and medical practitioners.

More on ghostwriting in medical journals

A study that was reported this week at a conference of journal editors sheds some new light on the use of ghostwriters in medical journal articles. Ghostwriters are paid writers who do not appear on the list of academic authors, who may be paid by pharmaceutical or medical device companies. The concern is that the unattributed authors introduce bias into a source where physicians turn for the latest in scientific developments.

It appears that some of the discrepancies in the study may be due to different journal policies having different authorship disclosure requirements. But this remains an important issue. Transparency in medical research and reporting is absolutely necessary in order to evaluate the evidence and make the best treatment decisions for the patients. Failing to disclose all the authors and their affiliations withholds an important key to sound medical-decision making. I hope that this study will encourage more journals to evaluate their current policies and work to make their author reporting requirements more transparent, so we can all learn from and evaluate the latest in medical research.

How can physicians and patients find reliable information?

The New York Times had two articles in two different sections that together highlighted the problems both physicians and patients can encounter in accessing reliable health information. In the first article, the "Room for Debate" feature in the Opinion section, several contributors debated whether direct-to-consumer prescription drug advertising should be banned. The second article in the Health section examined the use of ghostwriters in medical journals, and the lack of disclosure when pharmaceutical companies sponsor journal articles.

Both articles, and the accompanying comments, demonstrate the desire and need for both physicians and patients to find reliable health information. But that task is often difficult. The argument often presented in favor of direct-to-consumer prescription drug ads is that they make information available and accessible to the patient. But that information is obviously one-sided, and some fear that the ads interfere with another important source of information: the patient's physician. Physicians on the other hand, turn to medical journals to find the latest in medical research. But when articles are influenced by pharmaceutical companies, with or without disclosure of that influence, it makes it all the harder for physicians to discern which new practices are best. Both articles demonstrate the need for transparent communication, whether it is transparency in advertising or transparency in research. But that transparency is easier said than achieved.

Fighting for unapproved drugs

The New York Times had a compelling article yesterday about one family's fight to access a new drug to treat ALS that has not been approved by the FDA. The story is gut-wrenching. It's hard not to feel for the patients, who are fighting for any shred of hope of treatment. But at the same time, it's hard not to see the side of the FDA, who doesn't want to release harmful drugs or promote false hope.

There is no easy or final answer to this dilemma. It will likely continue as long as there are new drugs in development and patients and their families are looking for any hope for treatment.

physician disclosure rules

The Boston Herald has an interesting article today about proposed new disclosure requirement for Massachusetts physicians banning expensive meals and trips paid for by pharmaceutical companies and requiring disclosure of payments to physicians to promote certain drugs. The proposed laws are believed to be the toughest in the nation, but one group is still critical of the rule because of what it leaves out: physicians will not be required to disclose payments from pharmaceutical companies for clinical research. The proposal's creators said the exception was made to keep clinical trials in the state, but some activists want the state to do more to encourage physicians to disclose all possible financial interests.

You can find the article here: http://www.bostonherald.com/business/general/view/2008_12_11_Doctor-gift_regulations_loophole_hit:_Pay_for_research_stays_secret/srvc=business&position=recent_bullet

What do you think? Should doctors have to disclose payments from drug companies for medical research? What are the possible pitfalls?

ethics of research in developing countries

An article in the New York Times today reports on an article from the Bulletin of the World Health Organization about the ethical questions that arise when conducting research in developing countries. Even with survey research special consideration of the customs, culture and ability to access health care must be considered. Especially relevant is the potential for coercion to participate as some community members may pressure others to participate to access free health care that would not otherwise be available.

You can find the NYT article here: http://www.nytimes.com/2008/08/05/health/research/05glob.html?ex=1375588800&en=f8c5f4265ff56c35&ei=5124&partner=permalink&exprod=permalink

And the WHO article here: http://www.who.int/bulletin/volumes/86/8/08-051037/en/index.html

Compassionate use

The New York Times published an article today that sheds insight into the complexities of medical research, desperate patients and investigational drugs. One mother fought hard to raise money and awareness for her son's disorder, thinking it would help get her son new treatments. But clinical research follows a set of strict protocols for who they enroll in trials with unproven medications. Those guidelines are both patient/research subject safety. But things get complicated when not everyone understands how and why medical research proceeds in certain ways.

It's compelling reading. You can find the article here: http://www.nytimes.com/2008/07/17/business/17dystrophy.html?ex=1373947200&en=9e58936b75dd9b17&ei=5124&partner=permalink&exprod=permalink.

Ghostwriters and clinical drug studies

The New York Times reports on an article published today in JAMA about ghostwriters, hired by Merck, to write up reports on Vioxx. Merck then found prestigious physician researchers to put their names on the reports as they appeared in medical journals.

Some of the physicians argued that they were actively involved in the research. The researchers in question may have been involved, but the troubling point is that the drug company was also involved in the drafting of their journal piece. The practice of the drug companies being actively involved in the drafting of reports raises questions about the objectivity of the research, especially if the company's involvement is not disclosed. The general public will have greater cause to trust the research published, if there is transparency about the research methods and personnel involved.

You can find the NYT article here, with a link to the JAMA article: http://www.nytimes.com/2008/04/16/business/16vioxx.html?ex=1366084800&en=ef29a5f6ea0a6e76&ei=5124&partner=permalink&exprod=permalink

risky trials

The New York Times ran an interesting article about parents choosing to enroll their child with an incurable cancer into a risky clinical trial. Clinical research professionals consider something called "therapeutic misconception" when informing potential participants in clinical trials. People sometimes go into clinical trials with unrealistic expectations of a clinical benefit and positive outcome, when really the purpose of a clinical trial is for research and there are no guarantees of benefit to participants. Though in this story, it had a good outcome, it is a reminder that as researchers we need to explain the risks of clinical trials and the reality that there are no guarantees. The parents in this story realize their daughter's story is only the beginning, and that their daughter is a part of a larger body of research in cancer tumors. And they realize the cancer could come back and say they are ready with knowledge if it does.

You can find the article here: http://www.nytimes.com/2008/03/18/health/18seco.html?ex=1363752000&en=6ee45f0ce2097996&ei=5124&partner=permalink&exprod=permalink

When a celebrity gets cancer

The New York Times Health blog ran a series of two interesting blog posts in relation to the actor Patrick Swayze's announcement that he is receiving treatment for pancreatic cancer. The first blog is about the attention a celebrity brings to a disease: http://well.blogs.nytimes.com/2008/03/05/an-actors-diagnosis-may-bring-attention-to-a-neglected-cancer/. The second is about how limited cancer research funds are, and how they should be, divided: http://well.blogs.nytimes.com/2008/03/06/cancer-funding-does-it-add-up/.

Several studies in the past have studied the effect a celebrity face brings to disease awareness and disease screening. It's probably impossible to predict what effect, if any, this latest discussion about pancreatic cancer will bring. But such a high profile cancer diagnosis has the potential to perhaps start a conversation about a difficult diagnosis.

therapeutic misconception

The Association for Clinical Research Professionals December Wire reported on a study that many research participants do not understand the difference between research and standard treatment and may be under the misconception that enrolling a clinical trial means they will receive better treatment. You can find the article here: http://newsmanager.commpartners.com/acrpwire/issues/2007-12-31/1.html.

The idea of therapeutic misconception highlights the importance of clear and honest communication between the research coordinator and the research participant. The research staff has an absolute imperative to make sure the patient understands the implications of participating in clinical research, including treatment alternatives. That's what informed consent is all about.

Sharing the benefits of government-funded research

The Wall Street Journal Health blog commented that the spending bill President Bush signed last week included a provision that researchers have long been fighting for: NIH-funded research results need to be posted online, for free, one year after the results are published in an academic journal http://blogs.wsj.com/health/2007/12/27/congress-gives-fda-a-raise-sets-information-free/.

This is an exciting development for researchers. Academic institutions have financial limitations to how many journals and databases to which they can subscribe. Having access to emerging research data from NIH-funded research in a searchable, accessible database will facilitate medical research and encourage collaboration.

Miss Evers' Boys

The Tuskegee syphilis study is a horrific example of medical researchers abusing participants in the name of science. The abuse is almost hard to fathom in the abstract: researchers allowing African American men to die from syphilis despite known effective treatment. The abuse becomes all the more real when you hear the individual stories of the men affected by the 40 year study. The stories come alive in the movie Miss Evers' Boys. No one advocated on behalf of these men. No one spoke up to protect them. Those who tried to speak up went unheard. Nurse Evers tried her best to care for the men and nurse them in their time of need, but even she was lead to believe that letting these men die was the best she could do for the future of science.

Jumping through institutional review board hoops can be aggravating at times, and may even seem to inhibit research. But these regulations are in place to protect real people. And protecting the rights and safety of research subjects needs to be as important as the data being collected.

research safety and efficiency

Research safety and efficiency? Does that seem like an odd combination? Might someone even say impossible? Well I don't know about that, but I do know some of the mechanisms in place to keep research safe and to protect the rights of participants can seemingly bog down the research experience, not to mention increase the cost. The Wall Street Journal Health blog reports on an effort by Duke University and the FDA to improve the nation's clinical trial process http://blogs.wsj.com/health/2007/11/20/duke-fda-put-clinical-trials-on-the-examining-table/.

No matter the changes to the clinical trial process, patient safety must remain paramount. Every regulation has a face behind it. The regulations are in place because there has been terrible abuse among research participants. But efficiency is also a worthwhile goal. And an efficient clinical trials process may mean that drugs get approved sooner, at less cost, but are still properly examined for safety and efficacy.

Reforming the clinical trials process will be an arduous task. But it is a process that will only succeed if the parties involved keep their eye on the goal of safe and efficient clinical trials and not exclusively on the fiscal bottom line.

Dr. Drug Rep

I am still catching up on my reading after the holiday weekend, but one article garnering a great deal of attention is The New York Times article about the relationship between doctors and pharmaceutical companies in "Dr. Drug Rep" http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html?ex=1353560400&en=5681ba7698e69709&ei=5124&partner=permalink&exprod=permalink.

Dr. Daniel Carlat, an assistant clinical professor of psychiatry at Tufts University School of Medicine, found himself intoxicated by the quick cash he was making as a paid speaker for Wyeth Pharmaceuticals. At first, he felt OK about the talks he was giving and even justified the talks as important education for primary care doctors. But as more research emerged, Carlat was less enthusiastic in his talks. And after a year and a talk in which he was more candid about potential side effects, Carlat gave up the gig. He now publishes The Carlat Psychiatry Report, "a medical-education newsletter for psychiatrists that is not financed by the pharmaceutical industry and that tries to critically assess drug research and marketing claims."

Money is a powerful incentive and it has the potential power to cloud a researcher's judgment. The story is an important reminder to place safeguards on research and research incentives.

Every regulation has a face behind it

Today I attended the Association of Clinical Research Professionals Southern Wisconsin chapter Fall symposium. The most passionate and engaging speaker of the day was Barbara Davis of The Clinical Research Center of Northwest Florida, Inc. Her topic was the process of consent, a topic that is familiar territory for these types of conferences. But Barbara spoke with the kind of passion that can make any topic interesting. Her point was that informed consent should be a process and a conversation, not just a technical form. She was sincerely emotional when talking about the fact that every regulation we as research professionals have to go through has a face behind it. Every procedure for consent is because of some research atrocity that has happened in the past, whether Nazi doctors experiments on Jews and gypsies or American doctors in the 20th century withholding life-saving syphilis treatments from African American men in the name of research. She reminded the audience that it is the participants that take all the risks of medical research. We are in charge of protecting their rights.

It was refreshing to see the topic presented with such passion.

The importance of communication and trust

I am still catching up on The New York Times Health section and I came across this article on clinical trial participants who never hear the results of the trials in which they have participated http://www.nytimes.com/2007/10/30/business/30device.html?ex=1351483200&en=168720f2e6ca47ba&ei=5124&partner=permalink&exprod=permalink. Congress recently passed a law requiring drug and device manufacturers to release the results of clinical trials for products that are on the market. But there is no requirement to release the information for drugs and devices that never make it to market. There are reasons for this of course, including not wanting to disclose results for products still in development for competitive reasons. But the failure to disclose results is particularly problematic for participants in device trials, who may end up with the device well beyond the duration of the trial. And if a participant develops complications and finds out other people had similar problems and the manufacturers and doctors involved in the research never disclosed such problems, it can breed mistrust among research participants. Communication is the key to making sure participants are fully informed about the risks and benefits of trial participation. Anything less than full disclosure opens the door to mistrust.

the cost of publishing

This afternoon I went to the Bioethics Grand Rounds at the Medical College of Wisconsin where the speaker was Dr. Doug Diekema of the University of Washington. Dr. Diekema was the ethics consultant on the "Ashley Case." In 2004, the parents of a severely disabled 6.5 year old girl approached doctors to slow Ashley's growth so that they could continue to care for her at home. The ethics committee at Children's Hospital and Regional Medical Center in Seattle was convened and the 20 member panel ultimately decided it was in Ashley's best interest to agree with the parents request. Here is the parents story http://ashleytreatment.spaces.live.com/blog/.

What struck me about Dr. Diekema's recounting of this story was the fact that there was no media attention, no pubic outcry, until after the story was published in the journal Archives of Pediatric and Adolescent Medicine. This was an important case. It needed to be shared with the medical community. So much of medical and scientific research is about collaboration and learning from what others have tried. But in doing so, the doctors opened themselves up to so much criticism and misunderstanding from the mass media, from disability advocacy groups, and from other doctors. When the story was picked up by the media, two years after Ashley's treatment, it absolutely changed the lives of the doctors involved, the parents, and the institution where this all took place. Sometimes medical research carries a very personal cost, even for the researchers.