IMMDS Review listens to Professor Carl Heneghan about Primodos Studies

Independent Medicines and Medical Devices Safety Review Oral Hearing, 27th November 2018

The Independent Medicines and Medical Devices Safety Review is Chaired by Baroness Julia Cumberlege CBE DL.

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh.

About Primodos

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • To read some real stories told by the Primodos victims, go to this post comment section.  Read our posts tagged primodos.

IMMDS Review listens to Journalist Jason Farrell about Primodos

Independent Medicines and Medical Devices Safety Review Oral Hearing, 26th November 2018

The Independent Medicines and Medical Devices Safety Review is Chaired by Baroness Julia Cumberlege CBE DL.

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh.

About Primodos

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • To read some real stories told by the Primodos victims, go to this post comment section.  Read our posts tagged primodos.

IMMDS Review listens to Professor Neil Vargesson about Primodos Studies

Independent Medicines and Medical Devices Safety Review Oral Hearing, 27th November 2018

The Independent Medicines and Medical Devices Safety Review is Chaired by Baroness Julia Cumberlege CBE DL.

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh.

About Primodos

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • To read some real stories told by the Primodos victims, go to this post comment section.  Read our posts tagged primodos.

IMMDS Review listens to the Association for Children damaged by Hormone Pregnancy Tests

Independent Medicines and Medical Devices Safety Review Oral Hearing, 26th November 2018

The Independent Medicines and Medical Devices Safety Review is Chaired by Baroness Julia Cumberlege CBE DL.

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh.

About Primodos

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • To read some real stories told by the Primodos victims, go to this post comment section.  Our posts tagged primodos.

Attacking the Devil

Harold Evans and the Last Nazi War Crime

Intrepid newspaper editor Harold Evans wages an ongoing battle to expose the truth about a dangerous drug and obtain compensation for its victims.

More info and Videos

  • Xan Brooks, Peter Bradshaw and Henry Barnes review a documentary on the Thalidomide scandal that digs into the drug’s history as an experimental compound developed by the Nazis and pays tribute to the heroic efforts of the Sunday Times, lead by Harold Evans, which persisted in an investigation into Thalidomide-affected children in the face of cover ups and lawsuits. Released in the UK on Friday 22 January 2016.
  • Watch on Netflix. Read The Guardian press release.

Prescribed Drug Spending in Canada, 2018

Canada’s love affair with prescription meds…

Drug spending is increasing more than the other major areas of health spending — with a large proportion of drug spending going toward high-cost drugs for a small number of individuals.

Key findings

  • In 2018, $14.4 billion (42.7%) of prescribed drug spending will be financed by the public sector.
  • About 1 in 4 Canadians received a benefit from a public drug program in 2017. Individuals living in low-income and rural/remote neighbourhoods were more likely to receive a benefit.
  • Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017.

More Information

In 2017 : $40 Billion

Take an in-depth look at prescribed drug spending in Canada and learn more about how different drug classes contribute to current trends in total public drug spending.

In 2013 : $29.3 Billion

Prescribed Drug Spending in Canada 2012 cover image
Canada’s love affair with prescription meds…

Millions of Canadians buy prescription drugs; we spent a record $30 billion in 2013. But the annual rate of growth that year —2.3%— was one of the lowest in more than two decades. This is due in part to an increase in the use of less-expensive generic drugs as well as government policies that help keep prices low. ”

Key findings
  • More than 40% of prescribed drug spending was paid for by the public sector, totalling more than $12 billion. In the public sector, payers include provincial and federal drug programs and social security funds (such as workers’ compensation boards).
  • Generic drugs account for almost three-quarters of use but less than half of spending in public drug programs.
  • The number of Canadians who are taking more than $10,000 worth of prescription drugs every year is on the rise, because public drug programs are spending more on high-cost drugs.
  • In 2012, high-cost beneficiaries accounted for about 25% of public drug spending, compared with only 15% in 2007.
  • Almost half of these people were taking a high-cost drug used to treat conditions such as rheumatoid arthritis, Crohn’s disease and macular degeneration.
Sources

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.

Sodium Valproate Review : Who knew What and When ?

Cumulative meta-analysis gives extra insights

2018 Abstract

Sodium valproate is licensed in the EU for treating generalised, partial or other forms of epilepsy. It has also been used to treat bipolar disorder and to prevent migraine. In February of this year, the European Medicines Agency recommended that sodium valproate should not be used during pregnancy unless no other effective treatment is available, and that it must not be used in women able to have children, unless the conditions of a pregnancy prevention programme are met. These measures to protect women and their children are welcome, but we argue that they should have been instituted several years ago, as the evidence was clear as far back as 1990 that there were risks of congenital malformations in women exposed to valproate.

Our analysis shows the value of cumulative meta-analysis, which, in our view, should be performed as standard in systematic reviews when any concerns about harms arise during the use of medications. …

…, we consider that drug companies, journal editors, prescribers and systematic reviewers have all acted too late. We, therefore, consider that from 1990 individuals should have been offered the opportunity to switch to treatments with lower risks, where they existed, and given minimum effective doses of valproate if alternative treatments were not available or advisable. In the intervening years, many women’s children will have been harmed. Manufacturers and regulators should be responsible for ensuring that cumulative analyses are carried out as part of postmarketing risk management plans.

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.