 Medications:
Another issue of concern
Questionable
practices by pharmaceutical companies make decisions about medications
tougher
The past 20
years have seen dramatic increases in the use of medications to
treat children's mental health disorders. A
recent study estimated that in just ten years, from 1987 to
1996, the number of children taking psychotropic medications tripled.
Within that group, the number of children taking more than one such
medication rose from 4.7 to 11.6 percent. For some families with
children who have emotional or behavioral disorders, medication
can be a key part of a treatment strategy that results in vastly
improved quality of life. For other families—or even for these
same families at different times—medication can be a source
of great concern.
Families often
have to make difficult choices about medications, and frequently
the information they need to make these choices is simply not available.
Many of the medications commonly prescribed for children were developed
for adults, and the drugs have not been tested for safety and effectiveness
in children and adolescents. Questions arise around determining
appropriate doses and dose frequency for children of different ages,
different body sizes, and different stages of development. There
is also great uncertainty about possible effects of long-term use
of medications, and this is another area in which there is little
research to provide guidance. For families with a child who is taking
several medications, the concerns become compounded. When symptoms
worsen, it can be difficult to know whether to reduce, increase,
or change medications. Making such choices is extremely stressful,
particularly when the consequences are so important.
One way to reduce
the uncertainty and stress associated with these difficult decisions
is through seeking out information from trusted sources. However,
a series of studies published in the
May issue of the British Medical Journal provide a sobering
caution to consumers, and raise difficult questions about which
sources of information are trustworthy. The articles examine how
pharmaceutical companies are gaining increasing control over the
production and dissemination of information about the effectiveness
of medications. The issue presents evidence that drug companies
systematically mislead consumers and governments about the benefits
of new drug treatments and therapies.
One study examines
implications of the trend for drug companies to replace the government
as funders of research. Researchers from York University in Canada
found that published clinical studies sponsored by pharmaceutical
companies were four times more likely to report results favorable
to the company's products. The authors propose several explanations
for their results.
- Positive
results are based on unfair comparisons. The authors described
studies in which the medication from the sponsoring company was
compared with an alternative that was given at an inappropriate
dose or that was unlikely to be effective for some other reason.
- Manufacturers
suppress studies that provide evidence unfavorable to their products.
This practice has been documented in several recent instances.
- Industry
studies interpret results inappropriately. Industry sponsored
research appears more frequently in non-peer reviewed publications.
Without peer review oversight, sponsors publish favorable interpretations
that are not supported by the data in a study.
Pharmaceutical
companies also use various practices that result in bias in the
overall evidence base for the effectiveness of medications. Focusing
on the process through which companies gained government approval
for antidepressants in Sweden, authors of another study in May's
BMJ documented several tactics that contributed to bias, including
- publishing
the same (favorable) data as several "different" studies
- selectively
submitting only favorable results for publication, and
- selectively
reporting only types of analyses more likely to produce favorable
results.
A third article
in the journal reports on studies finding that general practitioners
in Britain who had frequent contact with drug industry representatives
were most willing to prescribe newer (higher cost) drugs and to
comply with patients' requests for drugs that were not clinically
indicated. Finally, a pair of commentaries focuses on how pharmaceutical
companies in Britain are increasingly sponsoring consumers' advocacy
organizations as part of their marketing strategies.
While the studies
in the BMJ are focused mostly on practices in European countries,
such practices have been documented in the United States as well.
Relative to Europe, there may be even more reason for concern in
the US, where the regulatory climate tends to be more relaxed than
in Europe. What is more, in the United States, drug companies market
directly to consumers through advertising on television and in print.
This increases pressure on physicians to prescribe the advertised
medications.
So when parents
and caregivers of children with emotional or behavioral disorders
need to make decisions about medications, one concern is this: How
can we find reliable, unbiased information? One strategy is to develop
a long-term, empowered relationship with a child and adolescent
psychiatrist or family physician who you feel is knowledgeable and
trustworthy. In general, child and adolescent psychiatrists are
likely to have more detailed knowledge about psychotropic medications,
as well as greater personal experience to guide prescribing. This
greater experience puts child and adolescent psychiatrists in a
better position to sort through available information to separate
scientific evidence from marketing ploys.
Tell your child's
physician or psychiatrist that you are concerned about the way that
marketing may be driving prescribing and research, and ask her what
she does to be sure that her practice is informed by an unbiased
appreciation of available information. Her willingness to have a
thorough conversation with you on this topic, and the answers she
gives, can help you decide if this is a person you can trust to
provide unbiased information.
You should feel
that your psychiatrist or physician welcomes hearing about concerns
you may have about the medications your child is taking. People
respond differently to psychotropic medications, and even those
that are most effective on average may not be helpful to your child.
If your child is not responding, or if the side effects are troubling,
raise these issues with your child's doctor or psychiatrist. He
should be able and willing to discuss a treatment strategy in a
way which addresses your concerns.
Advocacy organizations
that focus on mental health often provide training, peer support,
and other information that can help you learn how to interact with
physicians and psychiatrists in an empowered way. These organizations
can also assist you in locating information about treatment options;
however, you may also want to explore whether or not a given organization
receives funding from pharmaceutical companies. If it does, ask
the organization about how much funding is received, from what companies,
and for what purpose.
Maintain a healthy
skepticism about the claims made or implied in advertisements for
medications. Don't allow yourself to be "sold" on a given
medication on the basis of the images or information presented in
advertising. Seek out other sources of information.
The Internet
can be a very good source of information. The web sites of the
American Academy of Child and Adolescent Psychiatrists (http://www.aacap.org/)
and the National
Institutes of Mental Health (http://www.nimh.nih.gov/publicat/index.cfm)
have a great deal of accessible information about children's mental
health disorders and treatments. The information on these sites
is carefully screened. Whenever you seek information from the Internet,
it is important to be careful in evaluating the sources of information
you find on the Internet. Our online
tutorial, eResearch (http://www.rtc.pdx.edu/pgeResearchMain.shtml),
provides information that can help you do this. Many health web
sites receive funding from the pharmaceutical industry, so knowing
about a site's sponsorship can help you evaluate the information
you find there. Some sites do not accept industry funding at all,
and normally they will publicize this fact. It is wise to be cautious
about information from a web site that publishes press releases
from pharmaceutical companies or displays drug advertising.
Concerned stakeholders
can also be involved in promoting policies that encourage the production
of unbiased information about medications and their effectiveness.
Stakeholders can
- demand increased
public funding of pharmacological research, particularly for research
on children, where federal funding has been lacking in the past.
- advocate
for policies that mandate disclosure of potential conflicts of
interest on the part of researchers.
- support publishers
of scientific journals and consumer literature who reject industry
funding, and they can pressure other publishers to do likewise.
- urge groups
with which they are affiliated to remain independent of industry
sponsorship, or to be clear about the kinds and amounts of industry
sponsorship they do accept.
Yet even as
we cultivate a healthy skepticism, we also recognize the important,
positive impact that medications can have on the quality of life
for children with mental health disorders and their families. We
continue to hope that pharmaceutical companies will be successful
in developing new, more effective medications, as well as medications
with fewer side effects. Consumers and independent researchers need
to work together with government and industry to seek solutions
that will encourage the production of high quality medications and
high quality information.
Janet S. Walker,
Web editor
We invite you
to post your comments on this topic. The articles
in the BMJ can be accessed at http://bmj.com/content/vol326/issue7400/
Your
thoughts…
Comments:
 Not all children who misbehave need to be medicated. The impression that my wife and I are getting is that there is a selfish desire to find a quick fix. WBR LeoP Posted Friday, March 30, 2007 at 04:48 PM
trying to maximize their take. These medications are not meant for someone so young. WBR LeoP Posted Friday, March 30, 2007 at 05:40 AM
All medications have side effects. Even taking too many Naturopathic vitamins or drinking too much water results in death. WBR LeoP Posted Monday, March 26, 2007 at 04:26 PM
"Noting there are no scientific or otherwise reliable bases for mental illness diagnoses or treatments and that current Mental Health Law and implementation breach Universal Human Rights we Petition for:
A. The current Biomedical Model of Mental Illness approach to be imediately done away with in favour of the Social Model of Mental Health which would be far more productive and less costly over the long run.
B. Imediate reduction in the prescribing of psychotropic medications and medical intervention to help titrate people off of these harmful, mind altering, addictive chemicals should they choose this since once adapted to taking these chemicals the withdrawals can be toxic and cause seizure and death exclusion of any penalties for those that are addicted to these medications and voluntarily want help in getting off of them
C. Significantly more stringent control of the pharmaceutical industry, doctors that prescribe these medications, and psychiatrist
D. For those that shall choose it provision of truly confidential (regardless of current law), appropriate, person centered counseling and appropriate non coercive or forced local social interventions supported by budgets enabling free choice, self actualization, and personal integrity
E. Serious questioning of the psychiatric profession through outside doctors of an ethical vocation and former psychiatric patients which is to be made public imediately
F. The psychiatic medical board to be made and held accountable to an independent regulatory body
G. Repeal of current psycho-social- civil Mental Health Law and its replacement with humane laws
ensuring the safety of all citizens and inclusiveness of all citizens; in turn recognising the full worth of
Human Rights, Self-determination; and Citizenship, consistent with other law requiring that citizens be responsible for their own actions"
Posted Friday, September 22, 2006 at 03:44 AM
I have a 14 year old boy who was recently diagnosed with ADHD and depression. He was given Ritalin and Wellbutrin at the same time. I know he needs help but I have also heard Ritalin is a bad medication for someone of his age. Please, if you have any input it would be greatly appreciated in Idaho. Thank You Posted Sunday, August 13, 2006 at 11:05 AM
There is no medical treatment that has had the benefits so overblown nor the adverse effects so completely played down as psychiatric medications. There is not one reliable, physical test to veryify ANY mental disorder, and there is not one mental disorder that can be cured by any medical intervention that I am aware of. Long-term outcome studies on stimulants show NO long-term benefits in ANY area of functioning for medicated vs. non-medicated subjects with the diagnosis. People experiencing psychosis are LESS likely to experience full recovery in countries providing more westernized medical care. I know of NO studies indicating better long-term outcomes for any mental health problem that has been identified. And when side effects do occur, they are almost always minimized or denied by the prescriber, in my experience. One has to see a pharmacist to get honest answers about adverse effects and drug interactions, because the doctors don't know or don't want to tell you, because then you might stop taking the prescription.
Clearly medication is about making symptoms go away, but not about finding causes and solutions. Of course, the pharmaceutical companies love this, because as long as the problem doesn't go away, they can continue to sell more pills. Finding real solutions costs them big money.
I'd be very skeptical about ANYONE telling you that medication is the total answer for any mental health problem. It may provide some short-term symptom relief, but just like taking morphine for a broken leg, when you stop taking the drug, your leg is still just as broken and hurts just as badly. It's time we put some energy into finding real solutions and reassign psychiatric medications to an ancillary role in our system of mental health care priorities. But don't expect it to happen without a fight! Posted Tuesday, May 24, 2005 at 12:29 PM
The Washington Post on 9/9/04 reported that a dozen editors of prestigious medical journals jointly announced they will refuse to publish drug research sponsored by pharmaceutical companies unless the studies are registered in a public database from the outset -- a step designed to ferret out unpublished studies that find medications to be ineffective or dangerous. The initiative creates a potent incentive for companies to register their drug trials and is expected to give physicians and the public a window on unfavorable studies that companies routinely suppress. The new requirement calls on companies to register their trials well before anyone knows whether a study will turn out positive. The Journal of the American Medical Association, the Annals of Internal Medicine, the Lancet, the New England Journal of Medicine and several other international publications have signed on to the initiative, and their editors hope that more will join in. The ClinicalTrials.gov database, which was a party to the journal editors' new initiative, recently expanded its format to include the primary and secondary outcome measures of a trial and details of when trials end Posted Wednesday, September 22, 2004 at 08:11 AM
Here is an article that shows some progress on the issues mentioned in the original essay:
MEDICAL JOURNALS TO REQUIRE REGISTRY OF STUDIES
The Washington Post on 9/9/04 reported that a dozen editors of prestigious medical journals jointly announced they will refuse to publish drug research sponsored by pharmaceutical companies unless the studies are registered in a public database from the outset -- a step designed to ferret out unpublished studies that find medications to be ineffective or dangerous. The initiative creates a potent incentive for companies to register their drug trials and is expected to give physicians and the public a window on unfavorable studies that companies routinely suppress. The new requirement calls on companies to register their trials well before anyone knows whether a study will turn out positive. The Journal of the American Medical Association, the Annals of Internal Medicine, the Lancet, the New England Journal of Medicine and several other international publications have signed on to the initiative, and their editors hope that more will join in. The ClinicalTrials.gov database, which was a party to the journal editors' new initiative, recently expanded its format to include the primary and secondary outcome measures of a trial and details of when trials end. Posted Friday, September 17, 2004 at 09:20 AM
HOW DOES ON KNOW WHEN A PERSON SHOULD BE COMMITTED? Posted Sunday, May 23, 2004 at 07:45 PM
PLEAE TELL ME IF THIS IS ALRIGHT MY SON SAW A PSYCHARIST ONE TINE AND HE PRESCRIBE TWO TYPE WITHOUT DOING ANY KIND OF PHYSICAL TEST. SHOULD THRER HAVE BEEN SOE TYPE OF TEST BE FOR MED WERE GIVEN? Posted Sunday, May 23, 2004 by PDR at 07:37 PM
On Mar. 22.04 the FDA posted a warning about the 10 most common SSRI's (anti-depressants) perhaps causing suicidal ideation, as well as perhaps causing mania in those previously undiagnosed as bipolar.
My grown daughter had both of those awful effects.
However, she has now switched to EMPowerPlus, a vitamin and nutrient supplement that has been studied at Harvard, among other places.
Funny thing - the pharmaceutical companies are trying to block this product!
See TrueHope.com for more information. Posted Saturday, March 27, 2004 by Jackie - researcher, new PhD s at 02:15 PM
What current research is being done on the long-term affects of psychtropic drugs on children? Hopefully there is current research also on dose differentiation between ages, body weights, gender, etc... As a teacher I see the need for some (very few) children to have pharmaceutical assistance for biochemical instability. It seems that no matter who you talk to, there is much confusion as to what should be done to best benefit the child. Any current info? Posted Tuesday, March 2, 2004 at 06:19 PM
I recently had the experience of being offered a prescription for a medical condition I considered so mild as not to be a problem. I basically had to take the prescription slip because my doctor was so adamant-- certainly this left me wondering about his motives. Posted Thursday, July 10, 2003 at 11:36 AM
One of my concerns is the growing number of children - young children - who are being prescribed medication like Risperdal and Zyprexa - newer atypical antipsychotic medications - for "calming" purposes. Again, there is no long term research on the effects of these medications on children, and they are being prescribed to calm down acting out children. Posted Monday, July 7, 2003 at 10:36 AM
I am a child and adult psychiatrist and I share all of the above stated concerns. It is good to consult with a psychiatrist, but unfortunately we are very busy, particularly those of us who work with children and adolescents. There is a continual flood of promotional material from drug companies, and a good doctor should always try to reconcile good research with their ongoing clinical experiences (and to seperate out advertising.) Posted Tuesday, June 24, 2003 at 03:52 PM
I have a good friend who is a psychiatrist (for adults) and he is regularly wined, dined, and taken out to sporting events in very posh style by representatives of drug companies. He also gets free stays at resorts and other sorts of perks for listening to lectures and presentations from the same sources. Also he says that if you don't respond by prescribing certain drugs, you are no longer offered these perks so it's very quid pro quo. It sounds to me like this is becoming standard practice. Posted Monday, June 23, 2003 at 12:53 PM
I am very familiar with the situation you describe with a child on multiple medications. I trust my psychiatrist, but I fear that there is no one in the world who truly understands how all the different medicines interact and what the best dosage of each would be. Posted Sunday, June 22, 2003 at 11:01 AM
Talking frankly to your psychiatrist is a fine idea-- my concern is that ithat people often don't know what influences their decisions. There are numerous studies that show that consumers are drawn to products they have seen advertised even though they do not consciously remember being influenced by the advertising. I believe there is a small body of evidence showing a similar effect of drug advertising and drug company rep influence over physicians' prescribing practices. I assume the same could easily be true for psychiatrists, however much they do not believe that they are influenced. Posted Thursday, June 19, 2003 at 07:59 PM
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