Pediatric Drug Formulations — Unintended Consequences of Legislation

N Engl J Med 2017; 376:795-796
Authors: Luke A. Probst, Thomas R. Welch
“The media have been replete with reports of ways in which the pharmaceutical industry has been able to increase revenue from medications that have been available for decades. We report a new variation of particular consequence to pediatricians and children.”
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MEDICAL BOARD OF AUSTRALIA and SINGH [2017] WASAT 33

Decision delivered: 23 February 2017
“The Medical Board’s allegations pertained to Dr Singh’s general practice which included failing to keep proper records, prescribing drugs or other treatments when there was no therapeutic basis and prescribing some drugs and treatments which had potential adverse effects.The Medical Board of Australia also made the same allegations in relation to Dr Singh’s treatment of two specific patients.”
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A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed

Forbes, 22 February 2017
Author: John LaMattina
“As the new Trump administration begins to take shape, there are concerns that new leadership at the FDA will call for less bureaucracy and red tape, thereby lowering the bar for new drug approvals. The view is that onerous regulations are preventing life-saving medications from getting to those who most need them. Lowering the standards for drug approvals may indeed allow for earlier patient access to drugs but, as has been discussed here in the past, liberalization of current regulations would be a mistake. Such actions will unleash drugs that will ultimately prove to be ineffective and, in some cases, harmful rather than beneficial.”
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Exclusive: Canada seeks warnings on prescription painkillers amid rising deaths

Reuters, 23 January 2017
Author: Anna Mehler Paperny
“As deaths from powerful painkillers continue to rise, Canada is pursuing unprecedented measures to curb their use, including requiring cigarette-style warning stickers on every prescription, Health Minister Jane Philpott told Reuters.”
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Letting Seriously Ill Patients Try Drugs Whose Safety, Efficacy Hasn’t Been Proven Could Be Deadly

Forbes, 20 January 2017
Author: Rita Rubin
“The new FDA report, released practically on the eve of President Donald Trump’s inauguration, challenges critics who want to make drugs available to patients as soon as possible. It includes several examples of drugs and vaccines that had a favorable effect on biomarkers–measurable indicators of health, such as blood cholesterol levels–but did not improve symptoms or reduce the risk of a disease.”
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Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies

Kaiser Health News, 17 January 2017
Author: Sarah Jane Tribble and Sydney Lupkin
“A Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren’t breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn’t foresee or intend. Today, many orphan medicines, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.”
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Direct-to-consumer advertising of success rates for medically assisted reproduction: a review of national clinic websites

BMJ Open 2017; 7:e012218.
Authors: Wilkinson J, Vail A, Roberts SA
“Direct-to-consumer advertising of prescription drugs is permitted only in the USA and New Zealand. However, concerns that direct advertising drives demand for more expensive, rather than more effective, treatments do not extend to bans on direct advertising of other medical practices.”
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Novartis is under investigation for allegedly bribing thousands of Greek doctors

BMJ 2017; 356:j130
Author: Owen Dyer
“Greece’s financial police have raided the Athens headquarters of Novartis, and a team of agents from the US Federal Bureau of Investigation have flown in to study seized company records, as part of an expanding probe into claims that the drug company has bribed over 4000 Greek doctors to prescribe or support the reimbursement of its drugs.”
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