World Health Organization Demands Pharmaceutical Companies Stop Withholding Clinical Trials as Study Finds Over Half of Registered Clinical Trials Are Never Published


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Shocking as it may seem, it is currently fairly standard practice for drug companies to withhold clinical trials with negative results, allowing doctors to blindly prescribe drugs that don’t work or are even dangerous. In the United States, failing to publish clinical trials is punishable by a fine of $10,000 per day, but shockingly the fine has never actually been issued as Dr. Ben Goldacre explains in his editorial in PloS Medicine. This is particularly unbelievable given that a recent study found that more than half of the clinical trials registered on clinicaltrials.gov within a given time period were never actually published (within the time period allowed by law). An earlier study, which found similar results, also demonstrated that even when the results are published, negative side effects and even serious adverse events are routinely left out of the published version.

Now, the World Health Organization (WHO) has joined in the chorus calling for the registration and publication of all clinical trials, by issuing a definitive statement. The WHO has demanded that all clinical trials are registered in a publicly available, free-to-access database before any trial is initiated and that the main findings of any study are submitted to an open-access, peer-reviewed journal within 12 months of completion, or otherwise be made publicly available within 24 months.

Sadly, the WHO’s demands are not legally binding. The WHO is merely the latest in a very long list of organizations to call for the publication of clinical trials

 

Just in case you’re reading this on your mobile, here’s that list in text form. I hope you have your scrolling finger ready:

Academy of Medical Royal Colleges

ACHSE e.V. (German National Alliance for Chronic Rare Diseases)

Action for M.E.

Action for Sick Children

Addison’s Disease Self Help Group

Adelaide Health Technology Assessment

Advertising Health

AEP (Spanish Evidence-based Paediatrics)

AFAssociation

Afiya Trust

Age UK

AIDS Coalition to Unleash Power Paris

AIDS Treatment Activists Coalition

Alkaptonuria Society

All Ireland Institute of Hospice and Palliative Care

Allen Carr’s Easyway

Alpha 1 Awareness UK

Alzheimer’s Australia Dementia Research Foundation

Alzheimer’s Society

American Board of Sport Psychology

American Institute for Technology and Science Education

American Medical Student Association

amfAR The Foundation for AIDS Research

Anticoagulation Europe

Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesselschaften

Arrhythmia Alliance

Arthritis and Musculoskeletal Alliance

Arthritis Care

Arthritis Research UK

ASH Scotland

Asociación Española de Pediatría de Atención Primaria

Association for the Advancement of Experimental and Applied Hypnosis

Association of Medical Research Charities

Associazione Alessandro Liberati – Network Italiano Cochrane

Associazione Salute Attiva Onlus

Asthma UK

Australasian College for Emergency Medicine

Australasian College of Nutritional and Environmental Medicine

Australasian Medical Writers Association

Australian Medical Students’ Association

Australian Pain Management Association

Autism Rights Group Highland

Avon Primary Care Research Collaborative

Bad Science Watch

Balance – Familienplanungszentrum

Beat

Beating Bowel Cancer

Behcet’s Syndrome Society

Belgian Centre for Evidence Based Medicine (cebam)

Belgian Health Care Knowledge Centre (KCE)

Berne Declaration

BEUC The European Consumer Organisation

BioMantra

BioMed Central

BioNorte – Basque Health Sciences Society

Birmingham Skeptics in the Pub

Birth Trauma Association

BJOG

Bladder Cancer Support UK

BLISS

Blood Pressure Association

Bond University

Bone Cancer Research Trust

Bowel Cancer UK

Brain and Spine Foundation UK

Brains Trust

BRCA Netzwerk

Breakthrough Breast Cancer

Breast Cancer Campaign

Bristol and Avon Chinese Women’s Group

British Association for Counselling and Psychotherapy

British Association of Dermatologists

British Dietetic Association

British Dupuytren’s Society

British Heart Foundation

British HIV Association (BHIVA)

British Institute of Radiology

British Library

British Liver Trust

British Lung Foundation

British Medical Association

British Nutrition Foundation

British Obesity Surgery Patients

British Pharmaceutical Students’ Association

British Pharmacological Society

British Porphyria Association

British Psychological Society

British Science Association

British Society for Gene and Cell Therapy

British Society for Immunology

British Society for Sexual Health and HIV

British Society for the Study of Vulval Diseases

British Society of Periodontology

British Thyroid Foundation

British Tinnitus Association

British Veterinary Association

BUKO Pharma-Kampagne

Bundesverband Prostatakrebs Selbsthilfe e. V.

Bury Knowle Patient Participation Group

Canadian Agency for Drugs and Technologies in Health

Canadian Cancer Research Alliance

Canadian Cancer Society

Canadian Cochrane Centre

Canadian HIV Trials Network

Canadian Medical Association

Cancer Research UK

Cancer52

Cardiff University

Cardiff University Systematic Review Network (SysNet)

Cardiomyopathy Association

Cavernoma Alliance UK

CEBM Laboratory

CEMBE (Centro de Estudos de Medicina Baseada na Evidência)

Center for Evidence-Based Physiotherapy

Center for Information and Study on Clinical Research Participation

Center for Open Science

Centre for Evidence Based Policy

Centre for Evidence-based Veterinary Medicine

Centre for Reviews and Dissemination, University of York

Centre for Statistics in Medicine

Centre for Sustainable Healthcare

Centre of Evidence Based Dermatology

Changing Faces

Chemist and Druggist Magazine

Children’s Liver Disease Foundation

Chronic Granulomatous Disorder Society

Chronic Pain Research Alliance

CILIP: the Chartered Institute of Library and Information Professionals

Clinical Pharmacist

Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford

Cochrane Eyes and Vision Group

Cochrane Skin Group

College of Mental Health Pharmacists

College of Optometrists

College of Psychiatric and Neurologic Pharmacists

Colombia Médica

COMCEPT – The Portuguese Skeptics Community

Committee On Publication Ethics

Community Service Volunteers

Consumers United for Evidence-based Healthcare

CONSORT

Consumers Health Forum of Australia

Contact Help Advice Information Network

Copenhagen Trials Unit

Corporate Europe Observatory

CRA School Group

Critical Appraisal Skills Programme International Network

Critical Appraisal Skills Programme Mexico

Critical Appraisal Skills Programme Spain

Critical Appraisal Skills Programme UK

Cuban Journal for Information in Health Science (Revista Cubana de Información en Ciencias de la Salud)

Cure Crohn’s Colitis

Cystic Fibrosis Unite

Dalhousie AllTrials Student Society

Depression Alliance

Deutsche Dupuytren-Gesellschaft

Deutsche Gesellschaft für Neurologie

Diabetes UK

Dianthus Medical Ltd

Dietitians of Canada

Different Strokes

DIPEx

Disabilities Trust

Doctors Reform Society

Drug and Therapeutics Bulletin

Drug Commission of the German Medical Association

Drug Information Center of National University of Colombia (CIMUN)

Duchenne Foundation Australia

Dutch Association of Pharmaceutical Medicine

DXY

eCancer

eLife

Elsevier

Empower: Access to Medicine

Encaphalitis Society

Epilepsy Action

Epilepsy Society

Epistemonikos

Equator Network

Ethics Committee of Provincies of Verona and Rovigo

European AIDS Treatment Group

European Association of Hospital Pharmacists

European Association of Science Editors

European Cancer Patient Coalition

European Central Council of Homeopaths

European Continuing Medical Education Forum

European Federation of Clinical Chemistry and Laboratory Medicine

European Federation of the Associations of Dietitians

European Journal of Hospital Pharmacy

European Patients’ Forum

European Prostate Cancer Coalition (Europa UOMO)

European Public Health Alliance

European Public Health Association (EUPHA)

European Society of Clinical Pharmacy

EVALMED

Evidence for Democracy

Evidence-Based Veterinary Medicine Association

Evidencias en Pediatria

F1000 Research

F1000Trials

Faculty of Pharmaceutical Medicine

Faculty of Public Health

Faculty of Sexual and Reproductive Healthcare

Failed Implant Device Alliance

Farmacriticxs

Farmaka

Farnham Humanists

Feel Yourself Campaign

Fetal Anti-Convulsant Trust

Figshare

Genesis Research Trust

Genetic Alliance UK

Genetics Disorders UK

German Association of Hospital Pharmacists (ADKA)

German Clinical Trials Register

German Institute for Quality and Efficiency in Health Care (IQWiG)

German League of People Against Rheumatism

German Medical Association of Applied Kinesiology DÄGAK

German Network for Evidence Based Medicine (ebm)

German Public Health Association

German Society for Health Technology Assessment (HTA.de)

German Society for Wound Healing and Wound Treatment

Gesellschaft zur wissenschatlichen Untersuchung von Parawissenschaften e.V.

Gesundheit Aktiv

GIMBE Foundation

Global Healthcare Information Network

Green Party Ireland

Group B Strep Support

Groupe de Recherche et d’Action pour la Santé

GSK

Guild of Healthcare Pharmacists

Guildford Skeptics in the Pub

Haematology Clinical Trials Unit

Health Action International Europe

Health Action International Global

Health Care Without Harm

Health Faculty at Universidad del Valle

Health Press

Health Projects for Latvia

Health Research Authority

Healthcare Information For All

Healthtalkonline.org

HealthWatch

Healthy Skepticism UK

Histologie Zytologie Laboratorium Nussdorf

Hospital Pediatrico de Sinaloa (HSP)

Hospital Pharmacists Association Ireland

Hull York Medical School

Hungarian League Against Cancer

Hypermobility Syndromes Association

i-base

Iberoamerican Cochrane Centre

Idea Pharma

Ideal

Imperial Clinical Trials Unit

INC-Argentina

Independent Age

Independent Cancer Patients’ Voice

InDependent Diabetes Trust

INPUT

Institute for Evidence Based Medicine, College of Medicine, Korea University

Institute of Physics and Engineering in Medicine

Integrative Psychological Services of New York City

Intensive Care Foundation

Intensive Care National Audit and Research Centre

Intensive Care Society

International Alliance of Patients’ Organizations

International Brain Tumour Alliance

International Coalition for treatment preparedness in Eastern Europe and Central Asia

International Federation of Anthroposophical Medical Associations

International Federation of Medical Students’ Associations

International Institute for Advanced Studies of Psychotherapy and Applied Mental Health

International Journal of Gynecology and Obstetrics

International Physicians for the Prevention of Nuclear War

International Society for Evidence Based Health Care

International Society of Drug Bulletins

International Union of Basic & Clinical Pharmacology (IUPHAR)

Iranian Food & Drug Organisation

IRCCS – Mario Negri Institute for Pharmacological Research

Irish Cancer Society

Irish Hospice Foundation

Irish Medical Organisation

Italian Association of Neuroepidemiology

Italian Federation of Volunteer-based Cancer Organisations (FAVO)

ITP Support Association

ITPCru

James Lind Institute

James Whale Fund for Kidney Cancer

Joanna Briggs Institute

Joining Jack

Journal of Cognitive and Behavioural Psychotherapies

Journal of Kathmandu Medical College

June Hancock Mesothelioma Research Fund

Kidney Cancer Support Network

King’s Clinical Trials Unit

King’s College London

La Leche League GB

Laarkarin Sosiaalinen Vatsuu – Physicians for Social Responsibility

Langland

Leukaemia CARE

LILA Onlus – Lega Italiana per la Lotta contro l’Aids (Italian League for Fighting Aids)

Liverpool School of Tropical Medicine

London School of Hygiene & Tropical Medicine

Lyme Disease Action

Lymphoma Association

Macmillan Cancer Support

Macular Society

Marie Curie Cancer Care

Más Ciencia por México (More Science for Mexico)

MDS UK Patient Support Group

Medact

MedBravo

MedBunker

medDigital

Medical Journal of Australia

Medical Research Council

Medical Sciences Division, University of Oxford

Medicos Sin Marca

MedSci

Medsin

Medwave

Mental Health Europe

Mezis

Mind

Minervation

Mission Arogya Health and Information Technology Research Foundation

Mobility and Sickness Information Service

Modepharma

Motor Neurone Disease Association

Mouth Cancer Foundation

MRSA Action UK

MS Discovery Forum

Multiple Sclerosis Society

Muscular Dystrophy Campaign

Muscular Dystrophy Support Group

Myeloma UK

National Ankylosing Spondylitis Society

National Association of Deafened People

National Childbirth Trust

National Collaborating Centre for Mental Health

National Committee for Research Ethics in Norway

National Health and Medical Research Council of Australia

National Institute for Health and Care Excellence (NICE)

National Osteoporosis Society

National Physicians Alliance

National Rheumatoid Arthritis Society

National Union of Scientific Medical Information

National Voices

NEPI Foundation

Netherlands Cancer Institute

Netherlands Epidemiological Society

NeurologyFirst

Neurowikia

New Zealand Medical Association

NHS Blood and Transplant

NHS Research & Development Forum

NHS Vale of York Clinical Commissioning Group

NI Chest & Stroke

NISCHR Clinical Research Centre

No Gracias

No Grazie Pago Io

No Panic

North London Humanist Group

North Wales Organisation for Randomised Trials in Healthcare

North Yorkshire Humanist Group

Northern California Regional Organization of Child and Adolescent Psychiatry

Norwegian Cancer Society

Norwegian Knowledge Centre for Health Services (Kunnskapssenteret)

Nottingham Clinical Trials Unit

OCD Action

Open Knowledge Foundation

OPEN Project

Open Science Federation

Organisation for Anti-Convulsant Syndromes

Otago Medical Research Foundation

Otago University Medical Students Association

Ovarian Cancer Action

Ovarian Cancer Alliance of San Diego

Oxford Clinical Trials Research Unit

Oxford Humanists

Oxford Skeptics in the Pub

Oxford University Hospitals NHS Trust

Oxford Vaccine Group

Pain UK

Pancreatic Cancer UK

Parkinson Society Canada

Parkinsons UK

Patient Coalition Switzerland

Patients Association

Patients Involved in NICE

PeerJ

Pelvic Pain Support Network

PerioCourses

Pharmaceutical Journal (PJ Online)

Pharmaware

PharmaXL

PHG Foundation

PhUSE

Plaid Cymru

PLOS

Plymouth Community Healthcare

Plymouth University Peninsula Clinical Trials Unit

Plymouth University Peninsula Schools of Medicine & Dentistry

Positive People Armenian Network

Pragmatic Clinical Trials Unit

Primary Care Diabetes Society

Primary Care Respiratory Society UK

Primary Immunodeficiency UK

PRISMA

Prostate Cancer UK

PXE (PiXiE) Europe

QResearch

Radical Statistics

Reconstructive Surgery Trials Network

Red Whale

Research Autism

Research Design and Conduct Service

Rethink

Rett Syndrome Research Trust

Royal College of General Practitioners

Royal College of Obstetricians and Gynaecologists

Royal College of Paediatrics and Child Health

Royal College of Pathologists

Royal College of Physicians

Royal College of Physicians of Edinburgh

Royal College of Psychiatrists

Royal College of Radiologists

Royal College of Veterinary Surgeons Charitable Trust

Royal National Institute of Blind People

Royal Pharmaceutical Society

Royal Society of Medicine

Royal Statistical Society

Russian Society for Evidence Based Medicine

SABRE Research UK

Safer Medicines Campaign

SAGE

Sage Bionetworks

Salamander Trust

Salud y Fármacos

Sarcoma Patients EuroNet

Sarcoma UK

Scientists for Global Responsibility

Scleroderma Society

Scottish Intercollegiate Guidelines Network

Sealed Envelope

SEISIDA

Selling Sickness

SLE Lupus Foundation

Society for Clinical Trials

Society for the Improvement of Science

Society of Biology

Sopharma

South African Medical Research Council

South East Wales Trials Unit

Spanish Society of Medical Radiology

Stichting Tekenbeetziekten

Stonewall

Stop AIDS Campaign

Stroke Association

Students 4 Best Evidence

Support in Mind in Scotland

Swedish College of General Practice (SFAM)

Swedish Medical Association

Swedish Paediatric Society

Swedish Skeptics Association

Swiss MS Society

Swiss Multiple Sclerosis Society

Syncope Trust and Reflex anoxic Seizures

Target Ovarian Cancer

Tatarstan Medical Students’ Association

Teenage Cancer Trust

Teesside Skeptics in the Pub

Tenovus Cancer Care

Terrence Higgins Trust

Test Positive Aware Network

Test-Achats, Belgian Consumer Organisation

The Association for Clinical Biochemistry

The Association of Democratic Pharmacists (The VdPP)

The Association of Research Ethics Committees

The Brain Tumour Charity

The British Society for Rheumatology

The Chartered Society of Physiotherapy

The College of Podiatry

The Dupuytren Foundation

The Ear Foundation

The Faculty of Intensive Care Medicine

The Guidelines International Network G-I-N

The Health Cloud

The Information Standard

The Institute of Clinical Research

The Kidney Alliance

The Lupus Research Institute

The Lymphoedema Support Network

The Migraine Trust

The Open University

The Pernicious Anaemia Society

The Pituitary Foundation

The Renal Association

The Royal Institution

The Swiss Skeptics (Skeptiker Schwiez)

The TMJ Association

The Welsh Intensive Care Society

Therapeutic Guidelines Ltd

Thinkwell

This Theory

Throat Cancer Foundation

Thyroid Patient Advocacy

Thyroid UK

Together for short lives

Transform Drug Policy Foundation

Transparency International Deutschland e.V.

Transparency Life Sciences

Transverse Myelitis Society

TREAT-NMD Alliance

Treatment Action Campaign

Treatment Action Group

TrialReach

Trip

Turkish Clinical Research Association

UK Clinical Pharmacy Association

UK Cystic Fibrosis Gene Therapy Consortium

UK Dermatology Clinical Trials Network

UK Research Integrity Office

UK Sepsis Trust

UK Thalassaemia Society

UKCRC Registered Clinical Trials Unit Network

Uncover

United European Gastroenterology

University Hospitals Coventry and Warwickshire NHS Trust

University of Edinburgh

University of Lisbon Faculty of Medicine

University of Oxford Diabetes Trials Unit

University of York

Urostomy Association

Wales Cancer Trials Unit

Waverley Care

Well UK

Wellcome Trust

Western Australian Clinical Oncology Group

Wiley

Wilson’s Disease Support Group UK

Wings for Life

World Association of Medical Editors

World Confederation for Physical Therapy

Young Minds

ZonMw, the Netherlands Organisation for Health Research and Development

 

I think it is fair to say that the consensus is resounding. There is no excuse for the status quo. The surprisingly fascinating tale of how we came to be in this mess and why it matters such a great deal is told expertly by medical doctor and master storyteller Dr. Ben Goldacre, the brainchild of the All Trials campaign, in the book Bad Pharma. Don’t worry, you don’t need to be a doctor, a scientist, or an academic to understand it or find it interesting or useful, but if you do happen to be a doctor, you should certainly read it (if you haven’t already).

For the spark notes, check out Goldacre’s TED talk on the topic:

And/or his more recent and more detailed talk at the International Forum on Quality and Safety in Healthcare:

 

How Money From Pharmaceutical Companies Sways Doctors’ Prescriptions


f your doctor receives money or gifts from a drug company, be it payment for a lecture or a free meal, does it influence the medications he or she in turn prescribes? This represents the burning question in an industry saturated with pharmaceutical company involvement.

A ProPublica analysis revealed nearly nine in 10 cardiologists, and seven in 10 internists and family practitioners, included in their study received payments from drug or device companies in 2014.[1] But the analysis didn’t stop there.

It also looked into whether or not such payments were associated with prescribing practices, and here’s where things got interesting.

drug money

Doctors Who Received Drug-Company Money Prescribed More Brand-Name Drugs

ProPublica analyzed the prescribing habits of doctors who wrote at least 1,000 prescriptions in the Medicare Part D drug program. The doctors belonged to five common specialties: psychiatry, cardiovascular disease, family medicine, internal medicine and ophthalmology.

Not only was the receipt of drug-company money associated with a higher percentage of brand-name drug prescriptions, but the prescriptions rose with the amount of money received.[2]

The analysis included promotional speaking, consulting, business travel, meals, royalties and gifts as forms of drug company payments. Those who received more than $5,000 from industry in 2014 prescribed the most brand-name drugs. According to the analysis:

In all cases, the group receiving larger payments had a higher brand-name prescribing rate on average.

Additionally, the type of payment made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians who received no payments, and those who received speaking payments had a higher rate than those who received other types of payments.”

Are Drug-Company Payments ‘Thinly Veiled Kickbacks?’

Dr. Aaron Kesselheim, an associate professor of Medicine at Harvard Medical School, told The Atlantic regarding the featured study:[3]

“It again confirms the prevailing wisdom … that there is a relationship between payments and brand-name prescribing … This feeds into the ongoing conversation about the propriety of these sorts of relationships.

Hopefully we’re getting past the point where people will say, ‘Oh, there’s no evidence that these relationships change physicians’ prescribing practices.”

Indeed, this is far from the first time that such payments have been linked to prescribing practices.

A 2010 study published in the Archives of Internal Medicine also found that nearly 84 percent of physicians surveyed reported some type of relationship with industry during the previous year, and those with such a relationship were more likely to prescribe a brand-name drug even when a generic alternative was available.[4]

The finding isn’t only relevant for patients, who may be paying more unnecessarily for brand-name drugs, but also for taxpayers who spend billions each year subsidizing Medicare Part D. At least 1 in 4 U.S. prescriptions are paid for by Medicare.

Meanwhile, it’s worth repeating that the reason drug companies pay doctors and aggressively promote certain medications is not to benefit patients; it’s to benefit their bottom line. And there’s often a fine line between legitimate payments and illegal kickbacks. ProPublica noted:[5]

” … [F]ederal whistle-blower lawsuits against several pharmaceutical companies have alleged that payments are little more than thinly veiled kickbacks, which are illegal. Companies have paid billions of dollars to settle the cases.”

Drug Companies Heavily Promote ‘Me-Too Drugs’ to Doctors

Past research by ProPublica revealed the drugs most aggressively promoted to physicians, and they’re not medical breakthroughs or even, generally, top sellers.

Instead, they tend to be drugs that are newer to the market, sometimes underperforming and often face competition from other older, readily available drugs.

Dubbed “me-too” drugs, their makers may claim they carry fewer side effects, work faster or have other advantages over existing drugs on the market.[6]

Another ProPublica study revealed that top prescribers of some of the most heavily marketed drugs tended to receive promotional speaking payments from the drugs’ makers.[7]

Would You Still Trust Your Doctor If He or She Accepts Drug Company Payments?

In 2012, research showed that accepting gifts from the pharmaceutical industry does have implications for the doctor-patient relationship, and “doing so can undermine trust and affect patients’ intent to adhere to medical recommendations.”[8]

Not surprisingly, most people surveyed in one study said they would have less trust in their physician if they learned he or she accepted gifts worth more than $100 from the pharmaceutical industry, or went on industry-sponsored trips or sporting events.

One-quarter even said they would be less likely to take a prescribed medication “if their physician had recently accepted a gift in return for listening to a pharmaceutical representative’s presentation about that drug.”[9]

It’s no wonder that most physicians would rather their patients not know about any kickbacks they’ve received from the drug industry. But now that this has become public information, it may very well prompt some physicians to cut their ties to the industry.

Unfortunately, quite often — definitely too frequently for comfort — treatment recommendations are biased in favor of a specific drug simply because people making the decisions stand to profit from it.

If you find your doctor is receiving large amounts of money from industry, you may want to find another doctor or get a second opinion. At the very least, if you have concerns you might open a conversation about whether the drugs you’ve been prescribed are the best choices for you.

Whatever your health problem might be, I strongly recommend digging below the surface using all the resources available to you; including your own commonsense and reason, true independent experts’ advice and others’ experiences to determine what medical treatment or advice will be best for you.

You Can Find Out If Your Doctor Accepts Drug-Company Money (and How Much)

According to ProPublica’s “Dollar for Docs” website, which you can use to find out if your doctor accepts money from the drug industry, more than 1,500 companies have made payments to nearly 686,000 doctors, totaling close to $3.5 billion.[10]

You can also find out if your doctor receives payments from Big Pharma by visiting OpenPaymentsData.CMS.gov. This site has tallied nearly $6.5 billion in payments since 2013.[11] It hasn’t always been possible to find out what giftsyour owndoctor might be accepting.

The Physician Payments Sunshine Act, which is part of the Affordable Care Act, went into effect in 2013. For the first time, the Act requires drug and medical device makers to collect and disclose any payments of more than $10 made to physicians and teaching hospitals.

The Centers for Medicare and Medicaid Services (CMS) is in charge of implementing the Sunshine Act, which it has done via its Open Payments Program. You can easily search the site to find out what (if any) payments your doctor has received, along with the nature of the payments.

How Money From Pharmaceutical Companies Sways Doctors’ Prescriptions


Drug-Company Money

Story at-a-glance

  • Doctors who received drug-company money prescribed more brand-name drugs
  • The analysis included promotional speaking, consulting, business travel, meals, royalties and gifts as forms of drug company payments
  • The number of brand-name drug prescriptions rose with the amount of money received

If your doctor receives money or gifts from a drug company, be it payment for a lecture or a free meal, does it influence the medications he or she in turn prescribes? This represents the burning question in an industry saturated with pharmaceutical company involvement.

A ProPublica analysis revealed nearly nine in 10 cardiologists, and seven in 10 internists and family practitioners, included in their study received payments from drug or device companies in 2014.1 But the analysis didn’t stop there.

It also looked into whether or not such payments were associated with prescribing practices, and here’s where things got interesting.

Doctors Who Received Drug-Company Money Prescribed More Brand-Name Drugs

ProPublica analyzed the prescribing habits of doctors who wrote at least 1,000 prescriptions in the Medicare Part D drug program. The doctors belonged to five common specialties: psychiatry, cardiovascular disease, family medicine, internal medicine and ophthalmology.

Not only was the receipt of drug-company money associated with a higher percentage of brand-name drug prescriptions, but the prescriptions rose with the amount of money received.2

The analysis included promotional speaking, consulting, business travel, meals, royalties and gifts as forms of drug company payments. Those who received more than $5,000 from industry in 2014 prescribed the most brand-name drugs. According to the analysis:

In all cases, the group receiving larger payments had a higher brand-name prescribing rate on average.

Additionally, the type of payment made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians who received no payments, and those who received speaking payments had a higher rate than those who received other types of payments.”

Are Drug-Company Payments ‘Thinly Veiled Kickbacks?’

Dr. Aaron Kesselheim, an associate professor of Medicine at Harvard Medical School, told The Atlantic regarding the featured study:3

“It again confirms the prevailing wisdom … that there is a relationship between payments and brand-name prescribing … This feeds into the ongoing conversation about the propriety of these sorts of relationships.

Hopefully we’re getting past the point where people will say, ‘Oh, there’s no evidence that these relationships change physicians’ prescribing practices.'”

Indeed, this is far from the first time that such payments have been linked to prescribing practices.

A 2010 study published in the Archives of Internal Medicine also found that nearly 84 percent of physicians surveyed reported some type of relationship with industry during the previous year, and those with such a relationship were more likely to prescribe a brand-name drug even when a generic alternative was available.4

The finding isn’t only relevant for patients, who may be paying more unnecessarily for brand-name drugs, but also for taxpayers who spend billions each year subsidizing Medicare Part D. At least 1 in 4 U.S. prescriptions are paid for by Medicare.

Meanwhile, it’s worth repeating that the reason drug companies pay doctors and aggressively promote certain medications is not to benefit patients; it’s to benefit their bottom line. And there’s often a fine line between legitimate payments and illegal kickbacks. ProPublica noted:5

” … [F]ederal whistle-blower lawsuits against several pharmaceutical companies have alleged that payments are little more than thinly veiled kickbacks, which are illegal. Companies have paid billions of dollars to settle the cases.”

Drug Companies Heavily Promote ‘Me-Too Drugs’ to Doctors

Past research by ProPublica revealed the drugs most aggressively promoted to physicians, and they’re not medical breakthroughs or even, generally, top sellers.

Instead, they tend to be drugs that are newer to the market, sometimes underperforming and often face competition from other older, readily available drugs.

Dubbed “me-too” drugs, their makers may claim they carry fewer side effects, work faster or have other advantages over existing drugs on the market.6

Another ProPublica study revealed that top prescribers of some of the most heavily marketed drugs tended to receive promotional speaking payments from the drugs’ makers.7

Would You Still Trust Your Doctor If He or She Accepts Drug Company Payments?

In 2012, research showed that accepting gifts from the pharmaceutical industry does have implications for the doctor-patient relationship, and “doing so can undermine trust and affect patients’ intent to adhere to medical recommendations.”8

Not surprisingly, most people surveyed in one study said they would have less trust in their physician if they learned he or she accepted gifts worth more than $100 from the pharmaceutical industry, or went on industry-sponsored trips or sporting events.

One-quarter even said they would be less likely to take a prescribed medication “if their physician had recently accepted a gift in return for listening to a pharmaceutical representative’s presentation about that drug.”9

It’s no wonder that most physicians would rather their patients not know about any kickbacks they’ve received from the drug industry. But now that this has become public information, it may very well prompt some physicians to cut their ties to the industry.

Unfortunately, quite often — definitely too frequently for comfort — treatment recommendations are biased in favor of a specific drug simply because people making the decisions stand to profit from it.

If you find your doctor is receiving large amounts of money from industry, you may want to find another doctor or get a second opinion. At the very least, if you have concerns you might open a conversation about whether the drugs you’ve been prescribed are the best choices for you.

Whatever your health problem might be, I strongly recommend digging below the surface using all the resources available to you; including your own commonsense and reason, true independent experts’ advice and others’ experiences to determine what medical treatment or advice will be best for you.

You Can Find Out If Your Doctor Accepts Drug-Company Money (and How Much)

According to ProPublica’s “Dollar for Docs” website, which you can use to find out if your doctor accepts money from the drug industry, more than 1,500 companies have made payments to nearly 686,000 doctors, totaling close to $3.5 billion.10

You can also find out if your doctor receives payments from Big Pharma by visiting OpenPaymentsData.CMS.gov. This site has tallied nearly $6.5 billion in payments since 2013.11 It hasn’t always been possible to find out what giftsyour own doctor might be accepting.

The Physician Payments Sunshine Act, which is part of the Affordable Care Act, went into effect in 2013. For the first time, the Act requires drug and medical device makers to collect and disclose any payments of more than $10 made to physicians and teaching hospitals.

The Centers for Medicare and Medicaid Services (CMS) is in charge of implementing the Sunshine Act, which it has done via its Open Payments Program. You can easily search the site to find out what (if any) payments your doctor has received, along with the nature of the payments.

Charities Pledge to Inject Millions to Jump Start Drug Development for Brain Diseases


Charities Pledge to Inject Millions to Jump Start Drug Development for Brain Diseases

MRC Technology to lead Neurodegeneration Medicines Acceleration Programme to uncover promising drugs in pharma libraries

A global coalition of charities and funding bodies has been formed to invest up to £30 million into restarting the development of promising drug candidates for neurodegenerative conditions such as dementia, motor neurone disease and Parkinson’s disease. The Neurodegeneration Medicines Acceleration Programme (Neuro-MAP), led by medical research charity MRC Technology, will identify promising drug projects that are no longer in development by the industry and help scientists to take them forward to the next stage, before returning them to pharmaceutical companies for further development into marketable treatments.

It is estimated that over 50 million people worldwide currently live with neurodegenerative diseases. However, research into these conditions is complex, expensive and has a high failure rate due to the complexity of brain and nervous system function. This means that pharmaceutical companies that may have promising drug candidates at an early stage of development have to side line them and turn their attention to more favourable research areas. With the number of people living with neurodegenerative conditions set to rise substantially during the next few decades, and too few treatments available to stop the progression of many brain disorders, there is an urgent need to revive research and development for both relatively common and rare brain and central nervous system disorders.

As a coalition of 9 charities and funders, Neuro-MAP will help ensure that the potential of fundamental early stage research into neurodegenerative disease is realised, taking promising drug candidates forward towards clinical testing. It will also look to repurpose existing drugs and compounds for other conditions, for example, the use of hypertension drugs for the treatment of vascular dementia.  The programme protects both charities’ and pharma’s investment and allows charities to maximise their impact on patient’s quality of life.

Partners in the Neuro–MAP are: Alzheimer’s Association US, Alzheimer Research UK, Alzheimer’s Society UK, ALS Association, Michael J Fox Foundation, MND Association, MRC Technology, Northern Health Science Alliance and Parkinson’s UK.

UK Government’s Secretary of State for Health, Jeremy Hunt said:

“New treatments for brain diseases are vital if we are to improve the lives of the millions of people around the world who live with them. Tackling conditions like dementia is one of our central priorities, which is why we are doing more than ever to identify new treatments and, ultimately, find a cure. This innovative project will make a vital contribution to our shared endeavour by accelerating drug development and research.”

Dr Doug Brown, Director of Research and Development at Alzheimer’s Society said:

“People are developing dementia on a scale of one case every three minutes in the UK.  Not only is there no cure, the treatments we have only work for some people and we haven’t had a new drug for a decade. Too many potential drugs are languishing in laboratories because the companies who own them have moved in other directions. By rescuing these projects and moving them forward we aim to bring these drugs closer to the people who desperately need them.

“By next year 850,000 people in the UK will have dementia. We need a massive step change in research funding in order to develop new treatments, but it’s not just about throwing money at the problem. Innovative projects like this will help demolish the barriers to dementia research and that’s why we’re delighted to be working as part of it.”

Mike Johnson, Director of Corporate Partnerships at MRC Technology said:

“We’re pleased to be able to use our unique position at the centre of charities, funders, academia and industry to bring together the right combination of funding, skills and capabilities to really impact quality of life for patients living with these debilitating and destructive diseases.  This is an amazing opportunity to accelerate the next generation of neurodegenerative drugs towards the patient.”

Dennis Gillings, UK’s World Dementia Envoy said:

“This is a hugely encouraging step forward in dementia research. Instead of potential treatments sitting idle on shelves, they have the possibility of being re-tested with new life breathed into them. Hopefully this kind of initiative brings the search for a cure one step closer.

MRC Technology to lead Neurodegeneration Medicines Acceleration Programme to uncover promising drugs in pharma libraries

A global coalition of charities and funding bodies has been formed to invest up to £30 million into restarting the development of promising drug candidates for neurodegenerative conditions such as dementia, motor neurone disease and Parkinson’s disease. The Neurodegeneration Medicines Acceleration Programme (Neuro-MAP), led by medical research charity MRC Technology, will identify promising drug projects that are no longer in development by the industry and help scientists to take them forward to the next stage, before returning them to pharmaceutical companies for further development into marketable treatments.

It is estimated that over 50 million people worldwide currently live with neurodegenerative diseases. However, research into these conditions is complex, expensive and has a high failure rate due to the complexity of brain and nervous system function. This means that pharmaceutical companies that may have promising drug candidates at an early stage of development have to side line them and turn their attention to more favourable research areas. With the number of people living with neurodegenerative conditions set to rise substantially during the next few decades, and too few treatments available to stop the progression of many brain disorders, there is an urgent need to revive research and development for both relatively common and rare brain and central nervous system disorders.

As a coalition of 9 charities and funders, Neuro-MAP will help ensure that the potential of fundamental early stage research into neurodegenerative disease is realised, taking promising drug candidates forward towards clinical testing. It will also look to repurpose existing drugs and compounds for other conditions, for example, the use of hypertension drugs for the treatment of vascular dementia.  The programme protects both charities’ and pharma’s investment and allows charities to maximise their impact on patient’s quality of life.

Partners in the Neuro–MAP are: Alzheimer’s Association US, Alzheimer Research UK, Alzheimer’s Society UK, ALS Association, Michael J Fox Foundation, MND Association, MRC Technology, Northern Health Science Alliance and Parkinson’s UK.

UK Government’s Secretary of State for Health, Jeremy Hunt said:

“New treatments for brain diseases are vital if we are to improve the lives of the millions of people around the world who live with them. Tackling conditions like dementia is one of our central priorities, which is why we are doing more than ever to identify new treatments and, ultimately, find a cure. This innovative project will make a vital contribution to our shared endeavour by accelerating drug development and research.”

Dr Doug Brown, Director of Research and Development at Alzheimer’s Society said:

“People are developing dementia on a scale of one case every three minutes in the UK.  Not only is there no cure, the treatments we have only work for some people and we haven’t had a new drug for a decade. Too many potential drugs are languishing in laboratories because the companies who own them have moved in other directions. By rescuing these projects and moving them forward we aim to bring these drugs closer to the people who desperately need them.

“By next year 850,000 people in the UK will have dementia. We need a massive step change in research funding in order to develop new treatments, but it’s not just about throwing money at the problem. Innovative projects like this will help demolish the barriers to dementia research and that’s why we’re delighted to be working as part of it.”

Mike Johnson, Director of Corporate Partnerships at MRC Technology said:

“We’re pleased to be able to use our unique position at the centre of charities, funders, academia and industry to bring together the right combination of funding, skills and capabilities to really impact quality of life for patients living with these debilitating and destructive diseases.  This is an amazing opportunity to accelerate the next generation of neurodegenerative drugs towards the patient.”

Dennis Gillings, UK’s World Dementia Envoy said:

“This is a hugely encouraging step forward in dementia research. Instead of potential treatments sitting idle on shelves, they have the possibility of being re-tested with new life breathed into them. Hopefully this kind of initiative brings the search for a cure one step closer.

Funding for smoking cessation campaigns – disclosures matter


An increasing awareness of the harms of tobacco smoking has coincided with the growth of a new industry – smoking cessation campaigns –  worldwide. With a high proportion of the world’s tobacco smokers, the Asia Pacific region is not an exception. A question of ethics now arises with regards to smoking cessation campaigns, which are being increasingly funded by pharmaceutical companies, in particular those with interests in nicotine replacement therapies (NRTs).

A key challenge faced by anti-smoking bodies is that there is a lack of funds for their campaigns. “There is still a lack of awareness of the risk factors associated with tobacco smoking, and smoking in general is often viewed as an issue of personal behavior, which is inaccurate,” said Dr. Carolyn Dresler, associate director for Medical and Health Sciences in the Office of Science at the US FDA Center for Tobacco Products Office. “It’s not just a behavioral problem we’re dealing with; it’s a chemical addiction – nicotine addiction – which is a serious disease.

“With regards to the relationship between the pharmaceutical industry and smoking cessation, to me it depends a little on the duplicity of the industries involved,” said Dresler. “In my opinion, the tobacco industry are convicted liars, but we cannot ignore that the pharmaceutical industry has had similar issues. However, the mission of pharmaceutical companies is ostensibly for good, whereas the product produced by the tobacco industry, when used as indicated, kills.”

Dresler noted that she was a former medical director of research and development for NRT products at a leading pharmaceutical company.

Market forces at play
“It is true that both smoking as well as smoking cessation are driven by market forces,” said Dresler, highlighting a recent case in which a US District Court in Washington D.C., ruled against the US FDA in favor of cigarette makers Lorillard Inc and Reynolds American Inc, who had sued the FDA in 2011, alleging conflicts of interest and bias by several members of the panel tasked with advising the FDA on tobacco-related issues. Their lawsuit specifically alleged that some committee members had conflicts of interest as they were paid expert witnesses, and possessed financial ties to pharmaceutical companies that manufactured smoking-cessation products.

In his ruling, which took place in July 2014, US District Judge Richard Leon said the FDA had erred in determining that the members did not have conflicts of interest and therefore, the agency’s appointment of those members was “arbitrary and capricious,” and tainted both the panel and its work. The FDA was ordered to reconstitute the tobacco panel and the use of its 2011 report on menthol cigarettes has been barred. [Available athttps://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82. Accessed on 13 November 2014]

“It is difficult to separate conflict of interests and biases from something like smoking cessation, especially when there’s funding involved,” Dresler admitted. “This is because, as I mentioned, there is already very little funding being allocated for smoking cessation campaigns,” said Dresler. “When you put it up against something as large as the tobacco industry, with their large resources, and their ability to influence government and political decisions, it’s an uphill battle.”

Is there an ideal source of funding?
“If you have sources of funding from non-pharmaceutical organizations, such as non-governmental organizations or the health ministry, that would be best,” said Associate Professor Dr. Mohamad Haniki Nik Mohamed, Deputy Dean at Kulliyyah of Pharmacy at the International Islamic University Malaysia. “However, given the limitations, sometimes we do have to consider accepting funding from pharmaceutical companies to facilitate certain events. In such cases, the funding company should not become involved in the planning of the advocacy program – it should be completely independent.”

The worst thing to do, he stressed, would be to accept funding from the tobacco industry, for whatever purpose. Dr. Zarihah Zain of the Disease Control Disease, Ministry of Health Malaysia, agrees. “According to Article 5.3 of the Framework Convention on Tobacco Control (FCTC), parties to the Convention should not partner with tobacco corporations to promote public health, nor accept the tobacco industry’s so-called corporate social responsibility schemes, which are really just marketing by another name,” she said.

The Article 5.3 Guidelines also outlined transparency measures including, “Disclosure of current or previous work with tobacco industry by applicants for government positions related to health policy, and of plans to work for tobacco industry by former public health officials.” Also, “disclosure of tobacco industry activities, including: production, manufacture, market share, revenues, marketing, expenditures, philanthropy – with penalties for providing false or misleading information.

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