Tag: Drugs

Prenatal opioid exposure could bring long-term harm to children, study says

Prenatal Risk Factors and Perinatal and Postnatal Outcomes Associated With Maternal Opioid Exposure in an Urban, Low-Income, Multiethnic US Population

According to a new study, children exposed to opioids in the womb may have heightened risks of long-term mental and physical health issues, medicalxpress reports.

Key Points

Question
What are the prenatal risk factors and perinatal and postnatal outcomes associated with maternal opioid use during pregnancy?

Findings
In this cohort study based on data from 8509 mother-child pairs in the Boston Birth Cohort, in utero opioid exposure was significantly associated with higher risks of fetal growth restriction, preterm birth, lack of expected physiological development, childhood conduct disorder or emotional disturbance in preschool-aged children, and attention-deficit/hyperactivity disorder in school-aged children.

Meaning
Prenatal opioid exposure was associated with higher risks of adverse perinatal and postnatal physical health and neurodevelopmental outcomes, suggesting that efforts to mitigate the health consequences of the opioid epidemic require more intergenerational research.

2019 Study Abstract

Importance
The opioid epidemic increasingly affects pregnant women and developing fetuses, resulting in high rates of neonatal abstinence syndrome. However, longitudinal studies that prospectively observe newborns with neonatal abstinence syndrome or with maternal opioid use and examine their long-term physical and neurodevelopmental outcomes are lacking.

Objective
To examine prenatal risk factors associated with maternal opioid use during pregnancy and the short-term and long-term health consequences on their children.

Design, Setting, and Participants
This cohort study analyzed data from the Boston Birth Cohort, an urban, low-income, multiethnic cohort that enrolled mother-newborn pairs at birth at Boston Medical Center (Boston, Massachusetts) starting in 1998, and a subset of children were prospectively observed at Boston Medical Center pediatric primary care and subspecialty clinics from birth to age 21 years. Data analysis began in June 2018 and was completed in May 2019.

Exposures
In utero opioid exposure was defined as maternal self-reported opioid use and/or clinical diagnosis of neonatal abstinence syndrome.

Main Outcomes and Measures
Pregnancy outcomes, postnatal child physical health, and major neurodevelopmental disabilities, documented in maternal and child medical records.

Results
This study included 8509 Boston Birth Cohort mother-newborn pairs for prenatal and perinatal analyses. Of those, 3153 children continued to receive pediatric care at Boston Medical Center and were included in assessing postnatal outcomes. Overall, 454 of the 8509 children (5.3%) in the Boston Birth Cohort had in utero opioid exposure. At birth, opioid exposure was associated with higher risks of fetal growth restriction (odds ratio [OR], 1.87; 95% CI, 1.41-2.47) and preterm birth (OR, 1.49; 95% CI, 1.19-1.86). Opioid exposure was associated with increased risks of lack of expected physiological development (OR, 1.80; 95% CI, 1.17-2.79) and conduct disorder/emotional disturbance (OR, 2.13; 95% CI, 1.20-3.77) among preschool-aged children. In school-aged children, opioid exposure was associated with a higher risk of attention-deficit/hyperactivity disorder (OR, 2.55; 95% CI, 1.42-4.57).

Conclusions and Relevance
In this sample of urban, high-risk, low-income mother-child pairs, in utero opioid exposure was significantly associated with adverse short-term and long-term outcomes across developmental stages, including higher rates of physical and neurodevelopmental disorders in affected children. Efforts to prevent the opioid epidemic and mitigate its health consequences would benefit from more intergenerational research.

Treating mental illness with drugs creates a chemical imbalance

The Harmful Myth About the Chemical Imbalance Causing Psychiatric Disorders

“A psychiatrist I respect highly, who only uses psychiatric drugs in rare cases as an aid when he withdraws drugs his colleagues have instituted, has said that most people are depressed because they live depressing lives. No drug can help them live better lives. It has never been shown in placebo-controlled trials that a psychiatric drug can improve people’s lives — e.g., help them return to work, improve their social relationships or performance at school, or prevent crime and delinquency. The drugs worsen people’s lives, at least in the long run.” …

Read The Harmful Myth About the Chemical Imbalance Causing Psychiatric Disorders, on crossfit, June 24, 2019.

“Psychiatrists routinely tell their patients that they are ill because they have a chemical imbalance in the brain and they will receive a drug that fixes this. The truth is just the opposite. There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract. This means that you get worse when you try to stop the medication.”…

Read Psychiatry Gone Astray, on davidhealy, January, 21, 2014.

Image credit /jayfeldmanwellness.

Sex, Lies and Pharmaceuticals

The merging of marketing and medical science : female sexual dysfunction

As the search for the so-called ‘Pink Viagra’ continues, controversy surrounds the nature of the medical ‘condition’ such a pill would treat.

  • Do women with a low libido really have a disease called ‘hypoactive-sexual desire disorder’?
  • Does it really affect one-in-ten women as drug companies claim?

There’s already a marketed treatment for HSDD in the form of a pill called Addyi, a drug whose 2015 FDA approval came with intense debate over whether sexual desire was indeed a medical issue. Addyi has since become a commercial nonentity, in large part because women are restricted from drinking alcohol before taking it. The controversy around the drug’s approval faded along with its meager sales.

But bremelanotide, which promises a similar effect with fewer side effects, has rekindled the conversation around whether sexual desire can be a matter of pharmaceutical science.

Continue reading on stat news.

In an article in the BMJ almost 10 years ago I described the making of female sexual dysfunction as the freshest, clearest example of the “corporate sponsored creation of a disease.”1 Looking back over the past decade, it has become clear that drug companies have not simply sponsored the science of this new condition; on occasions they have helped to construct it. Corporate employees have worked with paid key opinion leaders to help develop the disease entity; they have run prevalence surveys to portray it as widespread; and they helped create the measurement and diagnostic instruments to persuade women that their sexual difficulties deserve a medical label and treatment. Drug marketing is merging with medical science in a fascinating and frightening way, raising questions about whether a new approach to defining diseases is warranted.

Continue reading on the BMJ.

Condition branding is a marketing technique in which companies develop conditions concurrently with developing drugs; examples include gastro-oesophageal reflux disease, premenstrual dysphoric disorder, social anxiety disorder, erectile dysfunction and hypoactive sexual desire disorder. Although it is illegal for pharmaceutical companies to market drugs prior to regulatory approval, there are no restrictions on marketing diseases, and industry seeks to establish a disease state in the minds of clinicians years before an expected drug launch. Continuing medical education (CME) courses are an important part of promotion prior to drug approval and have become a key marketing tool for increasing clinician receptivity to new products. We systematically identified 14 free, internet-based, industry-funded, accredited CME modules on hypoactive sexual desire disorder in women which came out before a new drug, flibanserin, was being considered for regulatory approval in the USA. Common themes in these modules included the following: Hypoactive sexual desire disorder is common, underdiagnosed and can have a profound effect on quality of life. Women may not be aware that they are sick or distressed. Simple questionnaires can assist clinicians in diagnosing the disorder. It is problematic that there are medicines available to treat sexual problems for men but not women. In fact, there is no scientifically established norm for sexual activity, feelings or desire, and there is no evidence that hypoactive sexual desire disorder is a medical condition. Hypoactive sexual desire disorder is a typical example of a condition that was sponsored by industry to prepare the market for a specific treatment.

Continue reading on the BMJ.

Depression pills increase suicides in adults too

Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database

“In this re-analysis of the FDA safety summaries, we found evi-dence that the rate of (attempted) suicide was about 2.5 times high-er in antidepressant arms relative to placebo. Our findings thus conflict with the work by Khan et al., who based their effect estimates on PEY rather than the number of patients. When haz-ards are not constant over time, PEY is inappropriate and may obscure a true adverse drug effect, since (attempted) suicide most-ly occurs shortly after treatment initiation and not during con-tinuation or maintenance phases [6, 9]. Adverse-event risk should therefore be calculated based on the number of patients exposed to treatments rather than PEY, and this is also the approach ap-plied by the FDA. Thus, when based on the number of patients randomized rather than PEY, the data presented herein suggest that antidepressants significantly increase the suicide risk in adults with major depression. Further research is required to establish whether the increased suicide risk observed in RCT generalizes to real-world practice, and we acknowledge that suicide attempts constitute just one aspect of a thorough risk-benefit evaluation.”

Read Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database, on karger, June 24, 2019.

Image credit Ian Espinosa.

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.

Chronic use of tramadol after acute pain episode: cohort study

Tramadol use is associated with a higher risk of prolonged opioid use in patients with an acute episode of pain compared with other short acting opioids, finds new research

2019 Study Abstract

Objective
To determine the risk of prolonged opioid use in patients receiving tramadol compared with other short acting opioids.

Design
Observational study of administrative claims data.

Setting
United States commercial and Medicare Advantage insurance claims (OptumLabs Data Warehouse) January 1, 2009 through June 30, 2018.

Participants
Opioid-naive patients undergoing elective surgery.

Main outcome measure
Risk of persistent opioid use after discharge for patients treated with tramadol alone compared with other short acting opioids, using three commonly used definitions of prolonged opioid use from the literature: additional opioid use (defined as at least one opioid fill 90-180 days after surgery); persistent opioid use (any span of opioid use starting in the 180 days after surgery and lasting ≥90 days); and CONSORT definition (an opioid use episode starting in the 180 days after surgery that spans ≥90 days and includes either ≥10 opioid fills or ≥120 days’ supply of opioids).

Results
Of 444 764 patients who met the inclusion criteria, 357 884 filled a discharge prescription for one or more opioids associated with one of 20 included operations. The most commonly prescribed post-surgery opioid was hydrocodone (53.0% of those filling a single opioid), followed by short acting oxycodone (37.5%) and tramadol (4.0%). The unadjusted risk of prolonged opioid use after surgery was 7.1% (n=31 431) with additional opioid use, 1.0% (n=4457) with persistent opioid use, and 0.5% (n=2027) meeting the CONSORT definition. Receipt of tramadol alone was associated with a 6% increase in the risk of additional opioid use relative to people receiving other short acting opioids (incidence rate ratio 95% confidence interval 1.00 to 1.13; risk difference 0.5 percentage points; P=0.049), 47% increase in the adjusted risk of persistent opioid use (1.25 to 1.69; 0.5 percentage points; P<0.001), and 41% increase in the adjusted risk of a CONSORT chronic opioid use episode (1.08 to 1.75; 0.2 percentage points; P=0.013).

Conclusions
People receiving tramadol alone after surgery had similar to somewhat higher risks of prolonged opioid use compared with those receiving other short acting opioids. Federal governing bodies should consider reclassifying tramadol, and providers should use as much caution when prescribing tramadol in the setting of acute pain as for other short acting opioids.

The Primodos Issue ; debated by Lord Alton of Liverpool

UK Parliament, House of Lords Hansard, 28 February 2019

“They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.”

Safety of Medicines and Medical Devices, House of Lords Hansard Debate, 28 February 2019.

More information

Primodos, Sodium Valproate, Surgical Mesh : Baroness Cumberlege Talks

UK Parliament, House of Lords Hansard, 28 February 2019

“For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.”

“That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.”

More information

Lords debate Safety of Medicines and Medical Devices

UK Parliament, House of Lords Hansard, 28 February 2019

Lords debates medicinal safety in ref to the public health scandals involving the hormone-based pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.

  • Interventions from Lord O’Shaughnessy, Lord Hunt of Kings Heath, Baroness Walmsley, Baroness Masham of Ilton, Baroness Cumberlege 36:28 , Lord Brennan, Lord Carrington, Lord Bethell, Baroness Bryan of Partick, Lord Alton of Liverpool 1:17:29 , Lord Suri, Baroness Finlay of Llandaff, The Earl of Dundee, Baroness Jolly, Baroness Thornton, The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford).
  • Read the Lords Hansard transcript.
  • Parliamentary news, research briefing.
  • Parliament news, press release.
  • Video source, Parliament Tv.

More information