Corruption in the pharmaceutical sector

Diagnosing the challenges, Transparency International UK, 2016

Summary

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes. Whether it is a pharmaceutical company bribing a doctor for prescribing its medicines irrespective of a health need or a government employee facilitating the infiltration of substandard medicines into the distribution system, public resources can be wasted and patient health put at risk.

For policy makers to implement successful anti-corruption measures there is a need to identify and understand corruption vulnerabilities in the pharmaceutical sector. To support this task this paper identifies key policy and structural issues in selected activities of the pharmaceutical value chain, along with relevant anti-corruption policies. This analysis showed that anti-corruption policies are needed throughout the pharmaceutical value chain to increase transparency around key decision points and strengthen the accountability of actors.

Four overarching challenges derived from structural issues and anti-corruption policies across the selected activities of the value chain have been identified. These are:

  • A lack of objective data and understanding of corruption inhibited by environmental context, the complexity of issues in the sector and policy makers not viewing corruption as an issue.
  • A weak legislative and regulatory framework because of poor investment, a lack of oversight and national regulatory frameworks that are often decentralised and reliant on self-regulation for key decision-point.
  • The potential for undue influence from companies due to a high degree of autonomy over key decision points and unparalleled resources, on policy and regulation so profit maximisation goes beyond ethical norms and negatively impacts health outcomes and public health objectives.
  • A lack of leadership committed to anti-corruption efforts from all actors. National leaders often only implement reforms after a crisis, with their inaction regularly hindering other actors.

Similarly, three key action areas to mitigate corruption vulnerabilities in the pharmaceutical sector are examined. These include establishing leadership committed to addressing corruption, adopting technology throughout the value chain and ensuring accountability through increased monitoring, enforcement and sanctions.

These overarching challenges and action areas are neither novel nor resource-intensive, stressing the lack of effective action in the past; as well as the difficulty of dealing with corruption in a sector that is extremely complex, has a high level of government intervention and often has regulatory systems in place that are inadequate to properly govern the value chain. Only by overcoming these challenges and focusing on these action areas will the global health community be better able to meet the health Sustainable Development Goals.

Declining malformation rates with changed antiepileptic drug prescribing – An observational study

Reducing birth defects in women with epilepsy : prescribing responsively leading to results – Aug 2019

Abstract

Objective
Changes in prescribing patterns of antiepileptic drugs (AEDs) in pregnant women with epilepsy would be expected to affect the risk of major congenital malformations (MCMs). To test this hypothesis, we analyzed data from an international pregnancy registry (EURAP).

Methods
EURAP is an observational prospective cohort study designed to determine the risk of MCMs after prenatal exposure to AEDs. The Cochrane-Armitage linear trend analysis was used to assess changes in AED treatment, prevalence of MCMs, and occurrence of generalized tonic-clonic seizures (GTCs) over 3 time periods: 2000–2005 (n = 4,760), 2006–2009 (n = 3,599), and 2010–2013 (n = 2,949).

Results
There were pronounced changes in the use of specific AEDs over time, with a decrease in the use of valproic acid and carbamazepine and an increase in the use of lamotrigine and levetiracetam. The prevalence of MCMs with monotherapy exposure decreased from 6.0% in 2000–2005 to 4.4% in 2010–2013. The change over time in MCM frequency after monotherapy exposure showed a significant linear trend in the crude analysis (p = 0.0087), which was no longer present after adjustment for changes in AED treatment (p = 0.9923). There was no indication of an increase over time in occurrence of GTCs during pregnancy.

Conclusions
There have been major changes in AED prescription patterns over the years covered by the study. In parallel, we observed a significant 27% decrease in the prevalence of MCMs. The results of adjusting the trend analysis for MCMs for changes in AED treatment suggest that changes in prescription patterns played a major role in the reduction of teratogenic events.

Avoid taking drugs unless they are absolutely necessary ; very few meds are indispensable

Trust me, I’m a doctor. Perhaps not…

“Most people let their doctor make the decisions for them, but the evidence tells us that we should be cautious. Doctors make many errors of judgment, and they get much of their information from the drug industry. They therefore use far too many drugs, often because they do not know better.

We live in a world that is so overdiagnosed and overtreated that in high-income countries, our medications are the third leading cause of death after heart disease and cancer. This has been demonstrated by several independent studies in Europe and North America. It has also been shown that medical errors, including incidents apart from drug-related errors, are the third leading cause of death even when only counting hospital patients’ deaths.”

Read Trust me, I’m a doctor, by Professor Peter C. Gøtzsche, on crossfit, June 16, 2019.

Image credit theguardian.

The Depression Pill Epidemic

The medicine drugs do not cure, lead to much harm, and should be avoided

“In some countries, including the United States, about 10% of the entire population is in treatment with depression pills. This is a tragedy. These drugs do not have relevant effects on depression; they increase the risk of suicide and violence; and they make it more difficult for patients to live normal lives. They should therefore be avoided. We have been fooled by the drug industry, corrupt doctors on industry payroll, and by our drug regulators.

Surely, many patients and doctors believe the pills are helpful, but they cannot know this, because people tend to become much better with time even if they are not treated. This is why we need placebo-controlled trials to find out what the drugs do to people. Unfortunately, virtually all trials are flawed, exaggerate the benefits of the drugs, and underestimate their harms.” …

Overview

  • Cold turkey in the placebo group
  • Lack of blinding
  • Irrelevant outcomes

continue reading The Depression Pill Epidemic, by Professor Peter C. Gøtzsche, on crossfit, June 4, 2019.

Pharma industry marketing linked to increased prescribing and elevated mortality

Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses

The new study concluded that drug companies’ marketing of opioids to physicians was “associated with increased opioid prescribing and, subsequently, with elevated mortality from overdoses.”

Read Opioid crisis shows partnering with industry can be bad for public health, theconversation, March 6, 2019.

2019 Study Key Points

Question
To what extent is pharmaceutical industry marketing of opioids to physicians associated with subsequent mortality from prescription opioid overdoses?

Findings
In this population-based, cross-sectional study, $39.7 million in opioid marketing was targeted to 67 507 physicians across 2208 US counties between August 1, 2013, and December 31, 2015. Increased county-level opioid marketing was associated with elevated overdose mortality 1 year later, an association mediated by opioid prescribing rates; per capita, the number of marketing interactions with physicians demonstrated a stronger association with mortality than the dollar value of marketing.

Meaning
The potential role of pharmaceutical industry marketing in contributing to opioid prescribing and mortality from overdoses merits ongoing examination.

Abstract

Importance
Prescription opioids are involved in 40% of all deaths from opioid overdose in the United States and are commonly the first opioids encountered by individuals with opioid use disorder. It is unclear whether the pharmaceutical industry marketing of opioids to physicians is associated with mortality from overdoses.

Objective
To identify the association between direct-to-physician marketing of opioid products by pharmaceutical companies and mortality from prescription opioid overdoses across US counties.

Design, Setting, and Participants
This population-based, county-level analysis of industry marketing information used data from the Centers for Medicare & Medicaid Services Open Payments database linked with data from the Centers for Disease Control and Prevention on opioid prescribing and mortality from overdoses. All US counties were included, with data on overdoses from August 1, 2014, to December 31, 2016, linked to marketing data from August 1, 2013, to December 31, 2015, using a 1-year lag. Statistical analyses were conducted between February 1 and June 1, 2018.

Main Outcomes and Measures
County-level mortality from prescription opioid overdoses, total cost of marketing of opioid products to physicians, number of marketing interactions, opioid prescribing rates, and sociodemographic factors.

Results
Between August 1, 2013, and December 31, 2015, there were 434 754 payments totaling $39.7 million in nonresearch-based opioid marketing distributed to 67 507 physicians across 2208 US counties. After adjustment for county-level sociodemographic factors, mortality from opioid overdoses increased with each 1-SD increase in marketing value in dollars per capita (adjusted relative risk, 1.09; 95% CI, 1.05-1.12), number of payments to physicians per capita (adjusted relative risk, 1.18; 95% CI, 1.14-1.21, and number of physicians receiving marketing per capita (adjusted relative risk, 1.12; 95% CI, 1.08-1.16). Opioid prescribing rates also increased with marketing and partially mediated the association between marketing and mortality.

Conclusions and Relevance
In this study, across US counties, marketing of opioid products to physicians was associated with increased opioid prescribing and, subsequently, with elevated mortality from overdoses. Amid a national opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.

Meet the people who lived with defective devices

Implant Files, video published by ICIJ, 25 November 2018

ICIJ listened to hundreds of stories from patients with poorly-functioning medical devices. Here are just five of their testimonies.

Read more about ICIJ implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Why join the Implant Files investigation ?

Implant Files, video published by ICIJ, 25 November 2018

Journalists explain why they decided to investigate medical device harm with ICIJ reporters.

Read more about ICIJ implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

A global investigation into medical device harm

Implant Files, video published by ICIJ, 24 November 2018

Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.

Read more about the their implant files investigation.

ICIJfights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks”.

Shorter courses will help reduce unnecessary use of antibiotics

Duration of antibiotic treatment for common infections in English primary care: cross sectional analysis and comparison with guidelines

Abstract

Objective
To evaluate the duration of prescriptions for antibiotic treatment for common infections in English primary care and to compare this with guideline recommendations.

Design
Cross sectional study.

Setting
General practices contributing to The Health Improvement Network database, 2013-15.

Participants
931 015 consultations that resulted in an antibiotic prescription for one of several indications: acute sinusitis, acute sore throat, acute cough and bronchitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease (COPD), acute otitis media, acute cystitis, acute prostatitis, pyelonephritis, cellulitis, impetigo, scarlet fever, and gastroenteritis.

Main outcome measures
The main outcomes were the percentage of antibiotic prescriptions with a duration exceeding the guideline recommendation and the total number of days beyond the recommended duration for each indication.

Results
The most common reasons for antibiotics being prescribed were acute cough and bronchitis (386 972, 41.6% of the included consultations), acute sore throat (239 231, 25.7%), acute otitis media (83 054, 8.9%), and acute sinusitis (76 683, 8.2%). Antibiotic treatments for upper respiratory tract indications and acute cough and bronchitis accounted for more than two thirds of the total prescriptions considered, and 80% or more of these treatment courses exceeded guideline recommendations. Notable exceptions were acute sinusitis, where only 9.6% (95% confidence interval 9.4% to 9.9%) of prescriptions exceeded seven days and acute sore throat where only 2.1% (2.0% to 2.1%) exceeded 10 days (recent guidance recommends five days). More than half of the antibiotic prescriptions were for longer than guidelines recommend for acute cystitis among females (54.6%, 54.1% to 55.0%). The percentage of antibiotic prescriptions exceeding the recommended duration was lower for most non-respiratory infections. For the 931 015 included consultations resulting in antibiotic prescriptions, about 1.3 million days were beyond the durations recommended by guidelines.

Conclusion
For most common infections treated in primary care, a substantial proportion of antibiotic prescriptions have durations exceeding those recommended in guidelines. Substantial reductions in antibiotic exposure can be accomplished by aligning antibiotic prescription durations with guidelines.

Evaluating the Strength of the Association Between Industry Payments and Prescribing Practices in Oncology

Doctor payments drove scripts for cancer drugs from Pfizer, Novartis and more: study

New study showed that physicians who received payments over three consecutive years and tied to a specific drug boosted their prescriptions of that product.

Abstract

Background
Financial relationships between physicians and the pharmaceutical industry are common, but factors that may determine whether such relationships result in physician practice changes are unknown.

Materials and Methods
We evaluated physician use of orally administered cancer drugs for four cancers: prostate (abiraterone, enzalutamide), renal cell (axitinib, everolimus, pazopanib, sorafenib, sunitinib), lung (afatinib, erlotinib), and chronic myeloid leukemia (CML; dasatinib, imatinib, nilotinib). Separate physician cohorts were defined for each cancer type by prescribing history. The primary exposure was the number of calendar years during 2013–2015 in which a physician received payments from the manufacturer of one of the studied drugs; the outcome was relative prescribing of that drug in 2015, compared with the other drugs for that cancer. We evaluated whether practice setting at a National Cancer Institute (NCI)‐designated Comprehensive Cancer Center, receipt of payments for purposes other than education or research (compensation payments), maximum annual dollar value received, and institutional conflict‐of‐interest policies were associated with the strength of the payment‐prescribing association. We used modified Poisson regression to control confounding by other physician characteristics.

Results
Physicians who received payments for a drug in all 3 years had increased prescribing of that drug (compared with 0 years), for renal cell (relative risk [RR] 1.81, 95% confidence interval [CI] 1.58–2.07), CML (RR 1.22, 95% CI 1.08–1.39), and lung (RR 1.69, 95% CI 1.58–1.82), but not prostate (RR 0.97, 95% CI 0.93–1.02). Physicians who received compensation payments or >$100 annually had increased prescribing compared with those who did not, but NCI setting and institutional conflict‐of‐interest policies were not consistently associated with the direction of prescribing change.

Conclusion
The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year). Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing.

Implications for Practice
Financial payments from pharmaceutical companies are common among oncologists. It is known from prior work that oncologists tend to prescribe more of the drugs made by companies that have given them money. By combining records of industry gifts with prescribing records, this study identifies the consistency of payments over time, the dollar value of payments, and payments for compensation as factors that may strengthen the association between receiving payments and increased prescribing of that company’s drug.

Press release.