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News

Last 50 News Postings

 (Click on title to be directed to posting, most recent listed first)

Determining if Drug Price Increases are Justified
Court Overturns CMS' Site-Neutral Payment Policy
Pulmonary Disease Linked to Vaping
CEO Compensation-One Reason Healthcare Costs So Much
Doctor or Money Shortage in California?
FDA Commissioner Gottlieb Resigns
Physicians Generate an Average $2.4 Million a Year Per Hospital
Drug Prices Continue to Rise
New Center for Physician Rights
CMS Decreases Clinic Visit Payments to Hospital-Employed Physicians
   and Expands Decreases in Drug Payments 340B Cuts
Big Pharma Gives Millions to Congress
Gilbert Hospital and Florence Hospital at Anthem Closed
CMS’ Star Ratings Miscalculated
VA Announces Aggressive New Approach to Produce Rapid Improvements
   in VA Medical Centers
Healthcare Payments Under the Budget Deal: Mostly Good News
   for Physicians
Hospitals Plan to Start Their Own Generic Drug Company
Flu Season and Trehalose
MedPAC Votes to Scrap MIPS
CMS Announces New Payment Model
Varenicline (Chantix®) Associated with Increased Cardiovascular Events
Tax Cuts Could Threaten Physicians
Trump Nominates Former Pharmaceutical Executive as HHS Secretary
Arizona Averages Over 25 Opioid Overdoses Per Day
Maryvale Hospital to Close
California Enacts Drug Pricing Transparency Bill
Senate Health Bill Lacks 50 Votes Needed to Proceed
Medi-Cal Blamed for Poor Care in Lawsuit
Senate Republican Leadership Releases Revised ACA Repeal and Replace Bill
Mortality Rate Will Likely Increase Under Senate Healthcare Bill
University of Arizona-Phoenix Receives Full Accreditation
Limited Choice of Obamacare Insurers in Some Parts of the Southwest
Gottlieb, the FDA and Dumbing Down Medicine
Salary Surveys Report Declines in Pulmonologist, Allergist and Nurse 
   Incomes
CDC Releases Ventilator-Associated Events Criteria
Medicare Bundled Payment Initiative Did Not Reduce COPD Readmissions
Younger Smokers Continue to Smoke as Adults: Implications for Raising the
   Smoking Age to 21
Most Drug Overdose Deaths from Nonprescription Opioids
Lawsuits Allege Price Fixing by Generic Drug Makers
Knox Named Phoenix Associate Dean of Faculty Affairs
Rating the VA Hospitals
Garcia Resigns as Arizona University VP
Combination Influenza Therapy with Clarithromycin-Naproxen-Oseltamivir
   Superior to Oseltamivir Alone
VAP Rates Unchanged
ABIM Overhauling MOC
Substitution of Assistants for Nurses Increases Mortality, Decreases Quality
CMS Releases Data on Drug Spending
Trump Proposes Initial Healthcare Agenda
Election Results of Southwest Ballot Measures Affecting Healthcare
Southwest Ballot Measures Affecting Healthcare
ACGME Proposes Dropping the 16 Hour Resident Shift Limit

 

For an excel file with complete news listings click here.

A report from Heartwire described a letter written by Peter Wilmshurst to the AHA asking for full disclosure of conflicts of interest in the MIST trial. Wilmshurst was portrayed in SWJPCC on April 27, 2012 in our Profiles of Medical Courage series. We felt the report of the letter might be of interest to the readership of SWJPCC but there was no good section to pass along the Heartwire article. For this reason, a new Section entitled “News” has been started to report developments outside the usual medical journal purview or from other sources which might interest our readers. We encourage bringing news-worthy articles to our attention and would welcome submission of written reports of such articles.

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Entries in nurse practitioner (1)

Friday
Apr142017

Gottlieb, the FDA and Dumbing Down Medicine

Gottlieb, the FDA and Dumbing Down Medicine

In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7.  However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1). Others praised Gottlieb as the right man to lead the FDA.

As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2). Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight answer when asked to share his thoughts on drug importation. While President Donald Trump has supported increased drug importation and is reported to be working with Democratic lawmakers on drug importation legislation, Dr. Gottlieb had previously opposed the measure (1). When asked if he opposes importing cheaper drugs from foreign countries, he said, "I can tell you I have a lot of ideas that I want to work on right away on how I think we can get more product competition onto the market."

Gottlieb stated that the FDA could speed up approval of new drugs and devices (1). However, a letter to the editor published in the New England Journal of Medicine examined compared review times for new therapeutic agents that were approved by the FDA or the European Medicines Agency (EMA), the primary drug regulator in Europe, between 2011 and 2015 (3). The median total review time was 306 days (interquartile range, 239 to 371) at the FDA, as compared with 383 days (interquartile range, 327 to 446) at the EMA.

In welcome news to many physicians, Gottlieb voiced uneasiness over increasing regulation of physicians’ practices (1). “My concern that the agency was losing confidence in physicians and felt it need[ed] …to supplant their judgment for the judgment of doctors,” Gottlieb said. He had previously referred to the FDA’s action on Arcoxia, a pain killer that was rejected in April 2007 because of concern that it could increase the risk of heart attack and stroke with prolonged use despite being meant for short-term pain relief. Gottlieb stated the opioid epidemic would be his "highest and most immediate priority." He added that the epidemic is a "public health emergency on the order of Ebola and Zika" that requires dramatic action from the FDA. "[T]o address it now, the types of actions that we are going to need to take are going to be more dramatic, perhaps, than the types of actions we would have taken 10 years ago."

Gottlieb did not note that some have linked the present opioid crisis to meddling by bureaucrats, administrations and politicians as an unattended consequence of the pain scale, opioid prescribing guidelines and patient satisfaction ratings (4). Furthermore, he did not note that increasing prescribing authority has been given to non-physicians with less education and clinical experience, e.g., unsupervised nurse practitioners in the Department of Veterans Affairs (5). Whether these non-physician clinicians will use drugs any more or less appropriately than physicians is unclear.

Richard A. Robbins, MD

Editor, SWJPCC

References

  1. Dickson V. Gottlieb favors regulations that empower doctors while keeping FDA standards. Modern Healthcare. April 5, 2017. Available at: http://www.modernhealthcare.com/article/20170405/NEWS/170409965 (requires subscription, accessed 4/11/17).
  2. Dodgson L. Trump has suggested vaccines cause autism — an idea that couldn't be more wrong. Business Insider. January 24, 2017. Available at: http://www.businessinsider.com/trump-vaccines-autism-wrong-2017-1 (accessed 4/11/17).
  3. Downing NS, Zhang AD, Ross JS. Regulatory review of new therapeutic agents — FDA versus EMA, 2011–2015. N Engl J Med. 2017Apr 6;376:1386-7. [CrossRef] [PubMed]
  4. Robbins RA. Pain scales and the opioid crisis. Southwest J Pulm Crit Care. 2017;14(3):119-22. [CrossRef]
  5. Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. December 14, 2016. Available at: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2847 (accessed 4/11/17).

Cite as: Robbins RA. Gottlieb, the FDA and dumbing down medicine. Southwest J Pulm Crit Care. 2017;14(4):166-7. doi: https://doi.org/10.13175/swjpcc047-17 PDF