Final Voyage of FDA and MPW Epidural Saga: Victory for Practicing Interventional Pain Physicians

 

On October 5, 2015, the Center for Drug Evaluation and Research, the U.S. Food and Drug Administration (FDA), and the Department of Health and Human Services, notified the American Society of Interventional Pain Physicians (ASIPP) of the status of the citizen's petition concerning the rejection of the 17 recommendations developed by the Multisociety Pain Workgroup (MPW). See Letter 

 

The rejection was in response to the FDA citizen's petition filed by ASIPP and the letter sent to the FDA from 1,040 practicing pain physicians to amend the April 23, 2014, Drug Safety Communication regarding epidural corticosteroid injections for pain urging the rejection of the 17 recommendations developed by MPW.

 

The letter signed by 1,040 interventional pain physicians was sent on June 26, 2014, and ASIPP filed a citizen petition on September 3, 2014. The FDA held hearings on November 24-25, 2014 on the safety of epidural steroid injections. On March 4, 2015, the FDA informed ASIPP that they were unable to reach a decision on our petition because it raised complex issues requiring extensive review and analysis by agency officials.

 

The FDA has now determined that they will not amend the drug safety communication; however, they will not adopt the 17 recommendations made by the MPW. This ruling by the FDA is a major victory for practicing interventional pain physicians that avoids micromanagement and the additional bureaucracy created by the MPW. The FDA also published an article in the New England Journal of Medicine  which essentially alludes to the same facts as described, and in no uncertain terms, they emphasize the fact that they are not withdrawing the issued warning, but they also were not endorsing the standards from MPW, even though they facilitated the discussion.

 

It is sad that despite the FDA's and other agencies' inability to identify what patients are receiving, ASA, ISIS, and other organizations on the CPT Committee blocked our CPT codes specifying the epidural approach, such as caudal or interlaminar, and the use of particulate steroids or nonparticulate steroids or other agents.

 

Sadly, ISIS has issued a practice advisory stating how they protected the performance of epidural steroid injections and they are standing by the 17 standards refused to be adopted by the FDA.

 

Consequently, the epidural saga continues even though this may be the final chapter.

  

1. Approximately 77 percent of physicians said they would work if they had diarrhea, and 54 percent said they would work if they were vomiting.
2. Around half of physicians surveyed said they'd work if they had a fever between 101 and 103 degrees Fahrenheit. About a quarter said they'd work with a fever over 103 degrees.
3. Only 30 percent of physicians said they would wear protective gear such as face masks while working if they had the flu.
4. The survey found physicians in their medical residency training and physicians who worked in emergency medicine or surgery were more likely to come in while sick.
5. According to study researchers, the notion of coming in sick stems from a deeply-seated sense of motivation. "There's such a strong sense of work ethic in physicians, and a strong sense of duty that we have," said study researcher Kimberly K. Truong, MD, a resident physician at UC Irvine.

The Skinny on Artificial Sweeteners

 

Substituting artificial sweeteners for sugar-sweetened drinks and other baked goods has been a staple method for decreasing energy intake for a long time now, but there has been debate regarding the actual risks and benefits, even when discussing energy balance, obesity, and obesity-related complications. A new meta-analysis published in the International Journal of Obesity sought to decipher the body of evidence looking at "low-energy sweeteners" (LES) and energy intake plus body weight. The outcomes of the analysis may surprise some, concluding that the use of LES in place of sugar results in beneficial effects, possibly even compared with water.

Traditionally, it seemed obvious that if energy intake could be decreased by replacing sugar-sweetened beverages like soda, juice, and other soft drinks with those utilizing artificial sweeteners, there would be benefit including weight loss and glycemic control. We know that sugar-sweetened beverages  promote weight gain and are associated with obesity, metabolic syndrome, and type 2 diabetes, so replacing them with low-calorie alternatives seems legitimate and has been  recommended by the AHA and ADA. In the Health Professionals Follow-Up Study, sugar-sweetened beverages were also associated with coronary heart disease, while artificially sweetened beverages were not.

  

MedPage Today

  

1. PHI recognition: Outlook can now recognize protected health information in an attachment and warn the user before sending to avoid the common mishap of PHI landing in the inbox of someone who should not receive it. And different permissions can be set to stop some users from even sending PHI at all.
2. Smart Attachments: This feature gives users the option of sending a link in lieu of heavy documents that consume a lot of memory. The reason that matters: When clinicians send a link via OneDrive for Business, the security mechanism authenticates the user and Exchange can track whether a recipient even clicked on that link - which could help account for what happens should data be sent to unintended recipients.
3. Encryption, single sign-on and authentication: This is kind of a threefer, admittedly. They are connected enough to group together. In addition to Office, Microsoft injected encryption into Office 365 services, so now both documents and emails are encrypted, while Windows Hello serves as a single sign-on capability and Windows Passport is now being used by third-party apps, such as Allscripts EMR, for facial recognition.