New Atlantic article: When Evidence Says No, but Doctors Say Yes

[TrixieStix]

When Evidence Says No, but Doctors Say Yes
Long after research contradicts common medical practices, patients continue to demand them and physicians continue to deliver. The result is an epidemic of unnecessary and unhelpful treatments.

"The 21st Century Cures Act—a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December—lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices."

"...two Johns Hopkins University physician-researchers wrote that the new 21st Century Cures Act will turn the label “FDA approved” into “a shadow of its former self.”

https://www.theatlantic.com/health/archive/2017/02/when-evidence-says-no-but-doctors-say-yes/517368/

 

[Mohawk1995]

The most significant sentence in the article (in my opinion) is "Striking the right balance between innovation and regulation is incredibly difficult,....

So just to be completely honest, my son who suffered with ME/CFS had two negative experiences at Washington University/Barnes Jewish (institution mentioned in the article):

1. He saw an immunologist whose treatment approach for ME/CFS was standard "immune hygiene" including saline nasal flushes as well as a Graded Exercise Program. This was after our son had an anaphylactic reaction to standard allergy testing in their office.
2. Had Pediatric Infectious Medicine Intern tell my wife that Dr. Lerner was a quack and that the treatment he was pursuing should never be done. We waited until our son was 18 years old and allowed him to make an informed decision for treatment which was later shown to be successful. Also of note Dr Lerner was a Washington University School of Medicine Graduate and studied at NIH. Of course the Intern had no treatment recommendations.

So to me the key is not necessarily more FDA processes/regulation, research that is not applicable to the clinic nor is it opening up the process so far that there is no real scrutiny in the process. It would be beneficial to have a more streamlined approach and for it to be less politicized which it is heavily now. It should also be noted that even with the more stringent post 1962 process, some medications and devices have been approved that caused harm.

The key is, for physicians to do two things:

1. Practice true Evidence Based Medicine which has 3 equally important pillars by definition (Sackett):
   1. Keeping up to date on the latest and best of medical research that pertains to the patients they see (Laboratory Science).
   2. Applying the principles of the research through the lens of their clinical experience including past successes, trends and nuances that have found to influence that success (Empirical or Clinical Science)
   3. Deliver the treatment in a way that acknowledges and respects the patients values (informed consent, emotional intelligence, compassion)
2. Practice and Follow the Hippocratic Oath in particular when it mentions "First Do No Harm". Physicians need to focus on less invasive means of treating Non-emergent patients. Honestly weigh (with the patient) the risk to benefit of any treatment. Err on the side of caution, but also be prepared to recommend treatment that is risky when there is a lot to loose and no other viable options (as was the case with our son).

In the end, Medicine is NOT an exact science. It involves risk. It is a tremendous responsibility and that responsibility is shared by not only the Physicians, but also all in health care including the insurances and the government. The biggest issues in my opinion are not related to the FDA process, they are related to Physicians not practicing and/or not being allowed to truly practice medicine. Ultimately the problems are related to selfishness, greed, power mongering, egos, laziness and lack of compassion of anyone involved in healthcare. If we would just move as a whole to rid medicine of these, we would see dramatic improvement in the health care delivered.