Three Ideas to Increase Clinical Trial Patient Enrollment Win Innovation Prize

Free to Breathe is a non-profit raising vital lung cancer research funding with our nationwide event series and helping patients with our free resources. Source: Three Ideas to Increase Clinical Tr…

Source: Three Ideas to Increase Clinical Trial Patient Enrollment Win Innovation Prize

Merck’s Keytruda wins a double-header with new FDA approval in head-and-neck cancer

Merck & Co.’s Keytruda saw its fortunes rise significantly Friday, and not just because its Bristol-Myers Squibb rival failed a key lung cancer study. Keytruda picked up a spanking-new FDA approval, too.

Source: Merck’s Keytruda wins a double-header with new FDA approval in head-and-neck cancer

Are Opiates Effective, Or Necessary, For Treating Chronic Pain?

Mary Pat Higley

After working in clinical research for years and observing first hand how difficult it is to get a new drug on the market it is amazing to learn how little the new classes of opiods were studied before approved.

An opiod is defined as an opium like compound that binds to one or more of the three opiate receptors in the body.  Opiate receptors are found widely in the brain, spinal cord and digestive tract.

Most opiod-related studies lasted for anywhere between 6-12 weeks. And good study design generally means there is a placebo control. No placebo-controlled studies ladted for even 6 months.

A recent review by Dr Chou, associate professor, medicine, Oregon Health and Science University, Portland determined that insufficient evidence was provided from clinical trials to determine the effectiveness of long-term (lasting longer than 3 months) treatment with opiods for improving chronic pain.

While studies could not show…

View original post 129 more words

Are Opiates Effective, Or Necessary, For Treating Chronic Pain?

After working in clinical research for years and observing first hand how difficult it is to get a new drug on the market it is amazing to learn how little the new classes of opiods were studied before approved.

An opiod is defined as an opium like compound that binds to one or more of the three opiate receptors in the body.  Opiate receptors are found widely in the brain, spinal cord and digestive tract.

Most opiod-related studies lasted for anywhere between 6-12 weeks. And good study design generally means there is a placebo control. No placebo-controlled studies ladted for even 6 months.

A recent review by Dr Chou, associate professor, medicine, Oregon Health and Science University, Portland determined that insufficient evidence was provided from clinical trials to determine the effectiveness of long-term (lasting longer than 3 months) treatment with opiods for improving chronic pain.

While studies could not show long-term outcomes for treatment of pain, function, or quality of life, they did show patients who are prescribed higher doses of opiods are at great risk for adverse effects, such as overdose and death.

Physicians report that there are patients who do benefit from treatment with opiods.

Not all opiods act the same in the same patient and one drug may not be a problem and another may lead to dependence, and addiction.

A study correlating how the human genome contributes to opiod response would be enlightening.

So the jury is still out on how these drugs should be used in the treatment of long-term chronic pain.  But what is painfully obvious is that they have been overprescribed with unfortunate consequences.

Mary Pat Higley, PharmD, MBA

Healthcare Consultant

marypathigleymedi@wordpress.com