August 29, 2020

Once your reputation is lost....

My father was an aerospace engineer, so when I first moved to Seattle in 1990, I was fascinated by Boeing’s presence in the city. The Seattle newspapers, both the Seattle Times and the Seattle P.I (there were still two new local newspapers then), would devote huge space to what was happening with the company. Whenever there was a crash of a commercial airliner, even if not a Boeing plane, both papers would dive deep into the search for the cause and illuminate Boeing’s goal to correct whatever the flaw might be. Boeing’s pursuit to admit mistakes and find solutions, as well as having impeccable ethics impressed me.

So, it was with dismay, I watched the mess over the failed Boeing 737 Max unfold in 2019. The Seattle Times won a Pulitzer Prize for its year long investigative reporting into the crash. It showed issues with Boeing’s ethics, as well flawed changes in the FAA regulatory structure that occurred since 2016. Needless, to say Boeing’s reputation has taken a huge hit. In my opinion, the company did not weather this as well as they would have in the past. Already hurting economically before the coronavirus arrived, they are struggling now with many orders on hold. I am not sure what it will take to get their stellar reputation back.

And now I watch as two other Federal Agencies are put in ethically challenged situations that will effect their reputations for years. I wrote about the thalidomide tragedy that affected Europe more than the US in the 50’s. Thalidomide caused severe, disfiguring birth defects. Subsequently, the FDA tightened up the regulations for approval of new medications and their indications. At times, this strictness drives people crazy, because it feels like approval for medications moves at a snail’s pace. People want access to new meds that might save lives. The reasoning is to avoid harm when there are a lot of unknowns, but when people are dying, the stakes change. Dr. Fauci clashed with AIDS activists during the 80’s and 90’s about this. Eventually, he came around to their view and helped get compassionate use meds approved for use in specific cases. This is the humane thing to do; and then the FDA would continue their scrutiny of medications, looking for rare but severe adverse events. I also believe that this strictness and attention to detail has saved lives overall, due to avoiding adverse events.

Compassionate use was used with remdesivir early on in the pandemic. Approval to use hydroxychloroquine early in the pandemic was given emergency approval while awaiting data from clinical trials. Ultimately, evidence showed it doesn’t work and is not safe due to cardiac side effects. That emergency authorization was revoked by the FDA. Now the FDA has approved emergency use of ‘Convalescent Plasma’, which is serum donated by patients who have recovered from COVID-19. The full data from the trials is not fully available. What data is available is not convincing. Approving it can put the results of those trials in peril, which is not good because we need the data. Dr. Sax has a good explanation in the link below (blogs.jwatch).

Sadly, the announcement of its approval was announced at a press conference by President Trump, who also tweeted about the “deep state” at the FDA. This effectively makes the FDA look politically compromised. The agency has always stayed out of politics to avoid conflicts of interest. Oh, my. Will we ever be able to trust the FDA again? Not because there are “deep state” employees, but because now all approvals will appear politically biased. Will we trust a vaccine, especially if approved by the FDA before Nov. 3? I probably won’t.

And almost the same day, or was it the next? I can’t keep track. The CDC suddenly changed their guidelines on testing asymptomatic people who have been exposed. This would dramatically decrease the number of people tested and thus the number of positive cases, but hamper our ability to limit spread. Again, it seemed to be political pressure on the CDC, especially when the decision was made when Dr. Fauci was not at the meeting because he was having surgery on his vocal cords. Further, there is no data to support the decision. Immediately, multiple physician groups pushed back. The Infectious Disease Society of America, the AMA, and Critical Care Physicians all made statements denouncing the change. The CDC has stepped back, at least a little, but states are continuing to test because they understand that testing and identifying infections early is the key to preventing spread.

I am completely saddened by these actions. Science and medicine should remain free from outside influences like politics. I know most of the hard working people at the FDA and CDC are dismayed by these actions. I have written about the CDC before. They work there because they are dedicated and care. How will we be able to trust the CDC’s recommendations again? They are still my ‘go to’ to website for many answers and advice, because I know of the dedicated people who work there. But will I be able to keep trusting it? Right now, it depends on what I am looking for and what interference politics may have on the subject. So sad and so unnecessary.

Wash your hands, cover your nose, keep safe six, and register and plan to vote like your life depends on it, because it does.

And finally, my caveat is that this is my experience and my opinions, which are subject to change as more information is available, and not related to the organization I work for. Thanks for reading.