I came across these
couple of items on-line and could not resist sharing for those who might not
have otherwise come across them.
The first was posted by a physician named Dr. Michael A. Pritchett, a pulmonologist in Pinehurst, North Carolina.
https://www.facebook.com/drmpritchett
The second has been floating around on various sites for the past week or so.
Stay safe and well.
Love,
Rebecca
A couple of my statistician friends, former Pfizer colleagues, posted this cartoon on their Facebook pages yesterday:
I showed it to Barry and for the likes of us we just could not figure it out. Then, suddenly this morning I looked at it again and I finally got it. Spoiler alert: if you want to think about it a bit you should stop reading now.
Here is what I think it is trying to say. Every year, we hear horrible stories about people being attacked by sharks. The wide popularity of the 1975 movie, “Jaws,” certainly added to the impression that such attacks were rather frequent. But the reality is somewhat different, according to the University of Florida’s International Shark Attack File (emphasis mine):
The 2019 worldwide total of 64 confirmed unprovoked cases were lower than the most recent five-year (2014-2018) average of 82 incidents annually. There were five fatal shark attacks this year, two of which were confirmed to be unprovoked. This number is in line with the annual global average of four fatalities per year.
So, I urge everyone to continue to do everything you can to avoid beaches where sharks have been seen, and to avoid infection with COVID-19.
Stay safe and well.
Love,
Rebecca
A major news story of
the past week was the emergency authorization from the Food and Drug
Administration (FDA) for use of the first COVID-19 vaccine, developed by Pfizer.
A second, similar vaccine from Moderna is expected to receive similar
authorization within the next day or so.
Not surprisingly, during these times of so much discord and distrust, a number of friends have asked me whether I have confidence in this vaccine. This question reminded me of my very first project when I joined Pfizer in 1992.
Tandospirone was in the class of drugs known as selective 5-HT1A receptor partial agonists. Some years earlier, the drug had been shown in clinical trials to be an effective anti-depressant, but its development was halted due to the high rate of troublesome side effects, particularly dizziness. In the early 1990s, it was reformulated using a new modality called the gastrointestinal therapeutic system (GITS), with the thought that this would eliminate, or at least reduce, the side effects. Because the FDA usually requires results from two trials to approve such indications, we conducted two identical clinical trials in patients with moderate depression. Patients were randomly assigned to receive either the active drug or a placebo in a double-blind fashion (neither the patients nor the treating physicians knew which one they were taking), and followed for 12 weeks, with assessments using commonly accepted measures of severity of depression, the primary one being the Hamilton Depression Rating Scale (Ham-D).
When all the patients had completed the twelve weeks of observation, the data was collected and the blind broken. When we plotted the change in Ham-D over time for each study, the graphs were basically two nearly horizontal lines right on top of each other: in other words, the patients treated with active drug were no better off than those who had received a placebo. Further, the rates of dizziness in the patients on the active arm remained unacceptably high.
When it came time to present these results to our Senior Management, the medical director on the project asked me to make the presentation. I suppose he did not want to be associated with this “negative” study. I, perhaps naively, saw it as a good chance to interact with Senior Management. When I finished my presentation, the head of the department said (I’m paraphrasing here, these were probably not her precise words), “I know these results are disappointing, but you set out to answer a question and you answered the question. You did a fine job.”
Granted that the stakes for this or any of the other compounds on which I worked were not nearly so high as with the coronavirus vaccine, but throughout my 20-year career in research in the pharmaceutical industry I was fortunate to work with devoted scientists and clinicians who truly did strive to provide the best for patients. I certainly recognize that pharmaceutical companies sometimes market their products in aggressive ways; it is a business, after all. But in the face of a global pandemic to which all of us are vulnerable, it is inconceivable to me that anyone has cut corners or been less than honest. It is clear from having watched the FDA advisory panel evaluating the Pfizer vaccine last week that there are still some unanswered questions. That is not surprising given the speed at which this study was designed, carried out, and analyzed. At the end of the day, the potential benefit of having vaccines is unquestionably enormous, and the risk relative to that benefit seems quite small.
As I was writing this, I wondered whether anything had ever happened with tandospirone. I typed it into Wikipedia and found this:
Tandospirone (brand
name Sediel) is an anxiolytic and antidepressant drug used in China and Japan, where it is marketed by Dainippon Sumitomo Pharma. It is a member of the azapirone class of drugs and is closely related to other
azapirones like buspirone and gepirone.
In an on-line search, I
also found this:
A group of researchers from Queensland
University of Technology, Australia has identified a drug that could
potentially help our brains reboot and reverse the damage caused by heavy
alcohol consumption.
This is the first time tandospirone has been
shown to reverse the deficit in brain neurogenesis induced by heavy alcohol
consumption. Tandospirone acts selectively on a serotonin receptor.
The researchers are constantly looking at new
treatment strategies for alcohol abuse and addiction, which is characterised by
extended periods of heavy alcohol use, binges and abstinence, and anxiety and
depression which contribute to relapse.
According to the researchers, this drug is
relatively new and available only in China and Japan. It is commonly used
there and shown to be highly effective in treating general anxiety and well
tolerated with limited adverse effects
Finally, thinking about this brought to mind my first project in the pharmaceutical industry, during the year I spent at Lederle Laboratories, where I worked on an HIV anti-retroviral drug known as FLT. The drug was in its first phase I study. We had enrolled maybe a dozen or so late-stage AIDs patients when, sadly, three of them died. The trial was halted. It was never 100% clear whether the deaths were due to side effects or simply due to lack of efficacy, but the development was halted. All I was able to find was a description of the trial on a clinical trials registry:
It was at that point that I happened to receive a call from a friend about a job at Pfizer, and the rest, as they say, is history. Thanks to my friend Sy for encouraging me to think and write about this.
So, will I take the vaccine? I am ready to roll up my sleeve as soon as I can!
Meanwhile, stay safe and well.
Love,
Rebecca
Less than a year after the first cases were identified here in the United States, over 300,000 Americans have now died from infection with COVID-19. The last global pandemic was the 1918 flu pandemic, which was estimated to have caused about 675,000 deaths in the United States and 50 million worldwide. We are already almost half way to that US total with COVID-19.
I started wondering
how this compares with combat deaths in various wars in which this country has
been involved, both here and abroad.
|
Rank |
War |
Years |
Deaths |
|
1 |
1941–45 |
291,557 |
|
|
2 |
1861–65 |
218,222 |
|
|
3 |
1917–18 |
53,402 |
|
|
4 |
1955–75 |
47,434 |
|
|
5 |
1950–53 |
33,686 |
|
|
6 |
1775–83 |
8,000 |
|
|
7 |
2003–2011 |
3,836 |
|
|
8 |
1812–15 |
2,260 |
|
|
9 |
2001–present |
1,833 |
|
|
10 |
1846–49 |
1,733 |
In other words, we have lost more American lives to this virus in less than a year than during four years of combat in World War II. Although I suppose one could argue that these numbers pale next to the 75 million total deaths during World War II, this is not a record any right-minded person would want to claim.
And that brought to mind the song “Find the Cost of Freedom” written by Stephen Stills in 1970:
Find
the cost of freedom
Buried in the ground
Mother Earth will swallow you
Lay your body down
Because it was often paired with David Crosby’s “Daylight Again,” a song about the Civil War, I always thought it was about that war, but in fact it may have been written more with the War in Vietnam in mind.
Why am I thinking about this song? Because it suddenly came into my head as a song about COVID-19. Many of the people who have denounced the public health measures required to bring this under control have cited “freedom” as justification. But for far too many Americans, the cost of freedom is now buried in the ground. If they continue to believe that their freedom includes their right to refuse to be vaccinated, Mother Earth may indeed swallow far more of us.
I am sorry to be so grim. Much as I should be feeling hopeful that help is on the way, I remain concerned that too many Americans may not be able to do the right thing.
So, continue to be careful!
Love,
Rebecca
A few days ago, I wrote about recognizing a long-ago colleague on the FDA Advisory Committee meeting evaluating the new COVID vaccine. Just now, the phone rang and the caller ID flashed a message I have never seen:
PROBABLY FRAUD
followed by a phone number.
I really do appreciate the warning! All of these robo-calls should have that. Needless to say, I did not answer the phone. Thank Gd for caller ID!
Tonight will be the fifth night of Chanukah, and we, presumably like many families, have made good use of Zoom this week. It is not the same as being there but at least we had a chance to light candles, sing, and watch our grandchildren open the gifts we had sent. This is literally a year for doing our best to find light in the darkness.
Unfortunately, there has been more darkness in the lives of long-time friends in Sharon. Some years ago, their daughter and her husband had a stillborn baby. The couple went on to have a healthy daughter in 2015. Then in May of 2018, they had a baby boy who was diagnosed with CHARGE Syndrome:
CHARGE syndrome is a recognizable genetic syndrome with known pattern of features. It is an extremely complex syndrome, involving extensive medical and physical difficulties that differ from child to child. Babies with CHARGE syndrome are often born with life-threatening birth defects. They spend many months in the hospital and undergo many surgeries and other treatments. Swallowing and breathing problems make life difficult even when they come home. Most have hearing loss, vision loss, and balance problems that delay their development and communication.
Difficult as these times are, I am fortunate to have so much for which to be grateful.
Love,
Rebecca
During most of today I watched
a meeting of the Food and Drug Administration Vaccines and Related Biological
Products Advisory Committee Meeting as they considered the COVID-19 vaccine
developed by Pfizer and BioNTech. These experts have spent the day weighing the
benefits and risks of this new vaccine with an eye towards approval of the drug
for “emergency use” (as opposed to a full and final approval) in the U.S.,
which would make it the first available here for immunization against the
disease.
The key question they
sought to answer was: Is the vaccine safe and effective enough to given to
millions of Americans? They were also quite keen on dealing with questions
about what happens to patients enrolled in the ongoing trial, half of whom have
received a placebo. There are complicated ethical issues here. No one questions
the value of “double-blind” studies, where neither the patients nor the
treating physicians know which drug each participant is receiving. But because
there are no other drugs approved for the treatment of this far-too-frequently fatal
infection, it seems a moral imperative to make the active compound available to
all the participants. It is really a difficult decision to make, because it
compromises what can be learned about longer term efficacy and safety.
But something else came to me this morning when I first logged in to the meeting, which is all being conducted virtually, and saw the introductions of the members of the FDA Advisory Committee. Lo and behold, the statistician on that committee was someone familiar to me from a Pfizer project some years ago, although I could not recall which one. I found an e-mail address for her and sent a message, figuring she might see it in a few days. I was quite surprised when I heard from her not long after I sent the note, and she remembers me, too. At the time, she was with an academic group consulting with us on our studies of voriconazole (Vfend) in the primary treatment of acute invasive aspergillosis. I was moved off that project to head the group of statisticians working on oncology and pain and inflammation before the New Drug Application for voriconazole was submitted, but I still remember celebrating that approval with the team. .
All in all, it was an extremely fascinating day, with a group of very bright people raising critical questions. At the end, I suspect that the FDA will allow this to go forward, so let’s all get ready to roll up our sleeves.
Meanwhile, stay safe and well.
Love,
Rebecca
For many Americans, yesterday, December 7th, was a “red letter day,” the 79th anniversary of the Japanese attack on American forces at Pearl Harbor. I am certainly aware of the significance of this date. My father served in the US Army stationed in Okinawa during World War II and received a Purple Heart and Bronze Star for his service.
Yet it is today’s date that is very much etched in my memory. It was forty years ago today, on December 8th of 1980, that a young man named Mark David Chapman shot and killed then 40-year-old singer/songwriter John Lennon, one of the four Beatles and subsequently a solo artist. We had moved to Dallas just a few months earlier, and I can still remember the endless stream of his songs playing on the radio in our condominium there. The murder took place on the Upper West Side of Manhattan outside the Dakota, where Lennon lived with his wife, Yoko Ono, and son Sean. I still notice that building and think of him every time we drive by it at #1 West 72nd Street just across from Central Park.
A memorial to Lennon lies just across the street in the park.
Chapman pled guilty to Lennon’s murder and was given a sentence of 20-years-to-life. He became eligible for parole 20 years ago but his bids have been denied eleven times, and he remains in a prison in upstate New York.
Lennon left an
enormous body of music. Many of the songs recorded by the Beatles were composed
by Lennon and bandmate Paul McCartney, who is still going strong at 78 years of
age. I have to admit I am less familiar with his later work, but the song that
really sticks out in my mind is “Imagine,” released in 1971, which was to be
the best-selling single of his solo career. I cannot agree with his view on
religion, but otherwise it is an inspiring song:
Imagine there's no heaven
It's easy if you try
No hell below us
Above us only sky
Imagine all the people living for today
Imagine there's no countries
It isn't hard to do
Nothing to kill or die for
And no religion too
Imagine all the people living life in peace, you
You may say I'm a dreamer
But I'm not the only one
I hope some day you'll join us
And the world will be as one
Imagine no possessions
I wonder if you can
No need for greed or hunger
A brotherhood of man
Imagine all the people sharing all the world, you
You
may say I'm a dreamer
But I'm not the only one
I hope some day you'll join us
And the world will be as one
As I was typing this, I wondered whether “some day” should be one word or two: the spell checker in MS Word seems to want me to treat it as one word. I did a search and found this:
Someday is an adverb and is defined as at an undetermined time in the future. It describes when an action or event will take place.
Some day is a phrase that refers to a 24-hour span of time in the future that has not yet been specified.
I wonder if, in fact, the lyric should read “someday you’ll join us.” I look forward to hearing from some of my readers who are grammar gurus! Meanwhile, I did find the lyric as “someday you’ll join us” on a number of sites, including
Meanwhile, peace and love and good health to all today and every day!
Love,
Rebecca
