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Too Much Medicine, a Campaign by The BMJ

The threat to human health posed by overdiagnosis and the waste of resources on unnecessary care

BMJ Launched ‘its Too Much Medicine‘ Campaign in 2013 To Tackle The Harms Of Overdiagnosis And Overtreatment.

In 2002 the BMJ published a theme issue called “Too Much Medicine?” with articles on the medicalisation of birth, sex, and death, among other aspects of ordinary life. Its opening editorial wondered whether doctors could become pioneers of de-medicalisation, handing back power to patients, resisting disease mongering, and demanding fairer global distribution of effective treatments.

A decade later, as data on overuse and overdiagnosis mount the BMJ announces its Too Much Medicine campaign aiming to highlight the threat to human health posed by overdiagnosis and the waste of resources on unnecessary care.

There is growing evidence that many people are overdiagnosed and overtreated for a wide range of conditions, such as prostate and thyroid cancers, asthma, and chronic kidney disease.

Through the campaign, the journal plans to work with others to increase awareness of the benefits and harms of treatments and technologies and develop ways to wind back medical excess, safely and fairly. This editorial by Fiona Godlee, editor in chief of The BMJ and overdiagnosis researcher Ray Moynihan, senior research fellow at Bond University, Australia, explains more about the campaign:

Dr Godlee said: “Like the evidence based medicine and quality and safety movements of previous decades, combatting excess is a contemporary manifestation of a much older desire to avoid doing harm when we try to help or heal.

Making such efforts even more necessary are the growing concerns about escalating healthcare spending and the threats to health from climate change. Winding back unnecessary tests and treatments, unhelpful labels and diagnoses won’t only benefit those who directly avoid harm, it can also help us create a more sustainable future.”

The BMJ was a partner in the international scientific conference, Preventing Overdiagnosis, held in September 2013 in Hanover, New Hampshire. The conference brought together the research and researchers, advanced the science of the problem and its solutions, and developed ways to better communicate about this modern epidemic.

Sources and More Information:

Too much medicine, BMJ, 2013.
BMJ Launches ‘Too Much Medicine’ Campaign To Tackle The Harms Of Overdiagnosis And Overtreatment, MNT, releases/256903, 26 February 2013.
Winding back the harms of too much medicine, BMJ, 346:f1271, 26 February 2013.

Patients receiving Palliative Chemotherapy tied to Worse Deaths, likely in an Intensive Care Unit

Associations between palliative chemotherapy and adult cancer patients’ end of life care and place of death

Abstract

The BMJ aims to lead the debate on health, and to engage doctors, researchers and health professionals to improve outcomes for patients.

Objectives
To determine whether the receipt of chemotherapy among terminally ill cancer patients months before death was associated with patients’ subsequent intensive medical care and place of death.

Design
Secondary analysis of a prospective, multi-institution, longitudinal study of patients with advanced cancer.

Setting
Eight outpatient oncology clinics in the United States.

Participants
386 adult patients with metastatic cancers refractory to at least one chemotherapy regimen, whom physicians identified as terminally ill at study enrollment and who subsequently died.

Main outcome measures
Primary outcomes: intensive medical care (cardiopulmonary resuscitation, mechanical ventilation, or both) in the last week of life and patients’ place of death (for example, intensive care unit). Secondary outcomes: survival, late hospice referrals (≤1 week before death), and dying in preferred place of death.

Results
216 (56%) of 386 terminally ill cancer patients were receiving palliative chemotherapy at study enrollment, a median of 4.0 months before death. After propensity score weighted adjustment, use of chemotherapy at enrollment was associated with higher rates of cardiopulmonary resuscitation, mechanical ventilation, or both in the last week of life (14% v 2%; adjusted risk difference 10.5%, 95% confidence interval 5.0% to 15.5%) and late hospice referrals (54% v 37%; 13.6%, 3.6% to 23.6%) but no difference in survival (hazard ratio 1.11, 95% confidence interval 0.90 to 1.38). Patients receiving palliative chemotherapy were more likely to die in an intensive care unit (11% v 2%; adjusted risk difference 6.1%, 1.1% to 11.1%) and less likely to die at home (47% v 66%; −10.8%, −1.0% to −20.6%), compared with those who were not. Patients receiving palliative chemotherapy were also less likely to die in their preferred place, compared with those who were not (65% v 80%; adjusted risk difference −9.4%, −0.8% to −18.1%).

Conclusions
The use of chemotherapy in terminally ill cancer patients in the last months of life was associated with an increased risk of undergoing cardiopulmonary resuscitation, mechanical ventilation or both and of dying in an intensive care unit. Future research should determine the mechanisms by which palliative chemotherapy affects end of life outcomes and patients’ attainment of their goals.

More Information

Associations between palliative chemotherapy and adult cancer patients’ end of life care and place of death: prospective cohort study, BMJ 2014; 348:g1219, 04 March 2014.
Chemotherapy tied to worse deaths, study finds,
BostonGlobe, lifestyle/health-wellness, 07 March 2014.
Study: Chemotherapy May Lead To Less Peaceful Death,
CBS, atlanta.cbslocal, 08 March 2014.
Chemotherapy proven to cause long, agonizing, suffering death,
NaturalNews, 044378, 20 March 2014.

Communicating the Harmful Effects of Medicines – May Warnings have unintended Consequences?

Did suicide warnings around antidepressants cause more suicide?

Abstract

Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people.

Objective
To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people.

Design
Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends.

Setting
Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network.

Participants
Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million).

Main outcome measures
Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides.

Results
Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were −31.0% (95% confidence interval −33.0% to −29.0%) among adolescents, −24.3% (−25.4% to −23.2%) among young adults, and −14.5% (−16.0% to −12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100 000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, −6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100 000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group.

Conclusions
Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.

Sources

Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study, BMJ 2014;348:g3596, 18 June 2014.
Communicating the harmful effects of medicines,
BMJ 2014; 348 bmj.g4047, 18 June 2014.
Did suicide warnings around antidepressants cause more suicide?
a tweet from Ben Goldacre.

Balancing Obligations: should written Information about Life-Sustaining Treatment be Neutral?

Written info for patients: what’s balanced? what’s neutral?

Abstract

British Medical Journal aims to lead the debate on health, and to engage doctors, researchers and health professionals to improve outcomes for patients.

Parents who are facing decisions about life-sustaining treatment for their seriously ill or dying child are supported by their child’s doctors and nurses. They also frequently seek other information sources to help them deal with the medical and ethical questions that arise. This might include written or web-based information. As part of a project involving the development of such a resource to support parents facing difficult decisions, some ethical questions emerged. Should this information be presented in a strictly neutral fashion? Is it problematic if narratives, arguments or perspectives appear to favour stopping over continuing life-sustaining treatment? Similar questions might arise with written materials about decisions for adults, or for other ethically contentious decisions. This paper explores the meaning of ‘balance’ in information provision, focusing particularly on written information about life-sustaining treatment for children. We contrast the norm of non-directiveness in genetic counselling with the shared decision-making model often endorsed in end-of-life care. We review evidence that parents do not find neutrality from medical professionals helpful in discussions. We argue that balance in written information must be understood in the light of the aim of the document, the most common situation in which it will be used, and any existing biases. We conclude with four important strategies for ensuring that non-neutral information is nevertheless ethically appropriate.

Sources:

Balancing obligations: should written information about life-sustaining treatment be neutral?, NCBI, PMID: 24763219, 2014 Apr 24 doi: 10.1136/medethics-2013-101965.

Full Article:

Background
Excerpts from written information for parents about end-of-life decisions
Neutrality in information provision
Balance in information provision
In favour of the ‘balanced’ approach for counselling about life-sustaining treatment
Concerns about non-neutrality
- Inappropriate withdrawal/limitation of treatment
- Coercion/autonomy
- Balancing obligations
Balancing obligations: should written information about life-sustaining treatment be neutral?, BMJ, medethics-2013-101965, 24 April 2014 doi:10.1136.

Anti-Anxiety Drugs and Sleeping Pills doubling the Risk of Mortality

Several prescription meds linked to an increased risk of death

The large study, published in BMJ, shows that several anxiolytic (anti-anxiety) drugs or hypnotic drugs (sleeping pills) are associated with a doubling in the risk of mortality.

Anti-anxiety drugs and sleeping pills have been linked to an increased risk of death, according to new research from the University of Warwick. The large study shows that several anxiolytic (anti-anxiety) drugs or hypnotic drugs (sleeping pills) are associated with a doubling in the risk of mortality. Although these findings are based on routine data and need to be interpreted cautiously, the researchers recommended that a greater understanding of their impact is essential.

Sources

Anti-anxiety drugs and sleeping pills linked to risk of death
Warwick University press release, March 31, 2014
Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: retrospective cohort study
BMJ 2014;348:g1996, 19 March 2014

UK Medicines Regulator MHRA destroys Prozac Research and Clinical Trial Data after 15 Years on File

UK meds regulator destroys detailed information on the benefits and harms of drugs it has approved after it has held it for 15 years on file

The MHRA UK medicines regulator destroys detailed information on the benefits and harms of drugs it has approved after it has held it for 15 years on file.

BRITAIN’S medicines regulator has destroyed the original scientific data supporting the licensing of Prozac, the antidepressant drug that is provoking growing controversy over evidence that it is linked to suicide.

It means that scientists who have tried to re-examine the evidence justifying its release may now never be able to find out how good the science was. Patients making compensation claims will face the same problem.

The UK medicines regulator destroys detailed information on the benefits and harms of medicines it has approved after it has held it for 15 years. This means that for medicines which have been on the market for longer than 15 years, which is the majority of them, the Medicines and Healthcare Products Regulatory Agency (MHRA) no longer holds the data it based its licensing decision on.

This came to light after Professor Peter Gotzsche, co-founder of the Cochrane Collaboration, asked the European Medicines Agency for the data used to support the licensing of the antidepressant Prozac (fluoxetine). Gotzsche was referred to the MHRA as the UK is designated as the Reference Member State for Prozac meaning the MHRA is the nominated body within the EU that holds the information on the drug. Never the less, the MHRA had shredded clinical evidence about the benefits and harms of the product. It told Professor Gotzsche “Under MHRA record management policy, all application files and data for licences are held for 15 years. After this period, files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest.”

The Sunday Times reported yesterday that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings. Eli Lilly, the manufacturer, retains the data and the MHRA said it can order it to be submitted.”

Professor Gotzsche wrote in a letter in the BMJ in June 2011 “As citizens in the EU, we should not accept this state of affairs. … The UK government should introduce legislation that will prevent the MHRA in future from destroying the evidence in its possession.”

Dr Ben Goldacre, co-founder of AllTrials said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded. Doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible. Science progresses, and medicine improves, when we have many eyes on the data.”

Sources:

MHRA shreds clinical trial info after 15 years, AllTrials.net, News release, 24th March 2014

More information, letters, opinions and articles:

Drug regulator destroys Prozac research, TheSundayTimes, 23 March 2014
and take names… , 1boringoldman, 23 March 2014
MHRA destroys trial data after 15 years on file, PharmaTimes, 23 March 2014
Restoring invisible and abandoned trials: a call for people to publish the findings, BMJ 346:f2865, 13 June 2013
UK drug regulator destroys all evidence after 15 years, BMJ 343:d4203, 5 July 2011
Opening up data at the European Medicines Agency, BMJ rapid-response, 20 June 2011
Opening up data at the European Medicines Agency, BMJ 342:d2686, 10 May 2011
UK Drug Regulator Destroys All Trial Data After 15 Years, Medscape 746109, July 11, 2011

Are clinical trial data shared sufficiently today? No

Doctors need the evidence to make informed decisions about medicines

From trainee to consultant, BMJ Group offers doctors around the world tailored information, special events, learning resources and recruitment services at every step along their career path. The AllTrials campaign asks for all trials to be registered and their results published. John Castellani says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the information. Ben Goldacre says we need the evidence to make informed decisions about medicines.

Read Are clinical trial data shared sufficiently today? No
by Ben Goldacre, The BMJ, Published 9 July 2013

Tag: BMJ