Several commentators are picking up on the mention of her never wearing cosmetics, which comes right after the mention that she let her hair go gray and spoke softly. It simply illustrates that she was a modest person who lacked vanity. I would bet she dressed simply and didn't wear much jewelry. I picture her as more comfortable in a lab coat than cashmere. It was probably someone who knew her that pointed this out and the writer considered it worth mentioning here as an illustration of what she was like.
25
And now the U.S. government and over half a billion tax dollars support the dismemberment of second and third trimester foetuses. Hardly as nobel as this heroic former government employee and physician. Doctor Kelsey's portrait belongs on the 20 dollar bill. She is a true hero.
6
One thing's for sure: none of the knucklehead Republicans now running for President would have supported her, much less stood up to a big corporation.
43
One thing's for sure: none of the Republicans now running for President would have supported her, much less stood up to a big corporation.
36
A wonderful person who did save countless of children by her courageous action . . . but wait. There is an untold story about the several hundred children who were damaged by thalidomide because the scurrilous American drug company, expecting they would obtain FDA approval, sneaked past the FDA and distributed free samples of the drug to thousands of doctors who did give it to their pregnant patients. At the time, that company was reeling business-wise because a cholesterol-reducing drug it sold had caused blindness in so many users (that had been foretold in animal testing by the company that the company altered to make it appear as though the drug was safe) that criminal charges were brought. The untold part of the story is that when the thalidomide damage was revealed, the medical director of this company scurried around to doctors' offices all around the country asking them to destroy their records if they'd seen the damaged babies in their practices after giving the samples to the mothers. That same company pulled the same tricks later with another birth-defect producing drug that damaged thousands of children. The litigation with respect to that product started the ball rolling with respect to the currently prevailing judicial position that 'big business always wins.' Thank you, Dr. Kelsey. You deserve to be recognized and honored with your face and name on American paper money.
51
Would be good to have another like her at the FDA now.
in the next to the last paragraph, why did the author feel the need to mention that she spoke softly "and never wore cosmetics"?
in the next to the last paragraph, why did the author feel the need to mention that she spoke softly "and never wore cosmetics"?
19
What an interesting woman. I'm curious about why we need to know that she "never wore cosmetics."
27
She developed the concept of sentinel signals in adverse events databases and the benefits will live on. While she kept thalidomide off the market, she also approved a lot of drugs as well. We owe a lot of our current drug labeling to the idea that there are no "good or bad drugs". All drugs have benefits and side effects. Some don't deserve to be marketed because their benefits outweigh the side effects so greatly. But drugs have side effects and they need to be monitored and updated.
In the early 1960s, she acted correctly and bravely when a lot of folks pressured her. But she was backed up by her superiors. They deserve credit as well.
In the early 1960s, she acted correctly and bravely when a lot of folks pressured her. But she was backed up by her superiors. They deserve credit as well.
30
Next time some Republican corporate shill tells you the government can't do anything right, tell them to read this obit.
42
Generously interpreted, this obit's mention of her absence of cosmetics could have been included to support the writer's description of her 'modesty almost to shyness.' What came quickly to my mind, however, was a previous case of an NYT obit about a woman scientist whose skills as cook, parent and wife were the first things about her readers learned: http://publiceditor.blogs.nytimes.com/2013/04/01/gender-questions-arise-...
At least in the Frances Oldham Kelsey obit, this cosmetics reference appeared near the end of the story. The larger problem with the mention is that women choose not to wear make-up for reasons that may or may not include modesty.
At least in the Frances Oldham Kelsey obit, this cosmetics reference appeared near the end of the story. The larger problem with the mention is that women choose not to wear make-up for reasons that may or may not include modesty.
16
I wonder why she didn't win a Nobel Prize for Medicine - would have been very appropriate.
29
Wonderful obituary about a courageous woman. Curious reference to her lack of use of cosmetics. I'm wondering whether it was included to illustrate that she was an independent free thinker, willing to withstand conventional trends or whether the reference was more insidious (indicating sexism or the dangers of make up). Oddly, I can't remember reading an obituary of a male where it was mentioned whether or not he wore cologne or deodorant.
46
I would have been a perfect candidate for thalidomide. I will always be grateful and thankful to this courageous and strong woman! During my second pregnancy, I was sick with pernicious vomiting for three months. I was admitted to the in hospital on Thanksgiving Day ,1959 and stayed for four days on IV's.I will never forget the fact that my ob/gyn doctor sat in my room holding my hand on Thanksgiving Day . Nor will I forget the wonderful neighbor and friend who was a nurse and came to my home every four hours 24/7 to give m shots so I would no have to return to the hospital. I gave birth to a healthy baby girl!! Sylvia Scottsdale
36
Bless the good woman! give her status and honour so that her name and brave deeds never ever fade with time, so that her light shines forever as a guide, a beacon, and leader in care for the People/s. And sorry for the too many who did not escape the terrible consequences of Thalidamide. One decent act right now would be to properly settle and compensate the victims, as a gesture to elevate Dr Kelsey to the place she deserves in our pantheon of world models. Warmest thought to her extended family. From Raymond in Dublin, Ireland
23
"Never wore cosmetics" Really? A sour note in an otherwise well written tribute to a heroic figure.
26
I wonder what Libertarians, Tea-Partiers and similar anti-government conservatives would say about this "petty bureaucrat"?
The story of Dr. Kelsey illustrates the absolute necessity of regulatory agencies. They are crucial players in preserving our nation's public health and ensuring economic justice for its citizens, but they need the funding, support and power to do their jobs.
The story of Dr. Kelsey illustrates the absolute necessity of regulatory agencies. They are crucial players in preserving our nation's public health and ensuring economic justice for its citizens, but they need the funding, support and power to do their jobs.
56
Every person should learn this story, and tell it each time someone complains about "government bureaucracy."
31
This is exactly what Government is supposed to do... protect us from snake oil salesmen, especially when the snake oil may actually be toxic! Ms. Kelsey is a hero for demanding solid scientific data and not cowering before the Merrell company's smear campaign.
But let it also be noted she worked at a time when corporations didn't tell our government how to conduct business, but rather government told them. And we were better off for it. Because no one is surprised that a corporation wants to make money, but they must not do that at the expense of our clean air and water, and certainly not at the expense of our bodies. Period. And that is where Government comes in. Because we elect those people to do what is right for us. Or that was the idea when the U.S. Constitution was drafted. Now the snake oil salesmen tell us not to worry and impartial data goes untested because the FDA is completely underfunded/understaffed. And for that, we all suffer.
But let it also be noted she worked at a time when corporations didn't tell our government how to conduct business, but rather government told them. And we were better off for it. Because no one is surprised that a corporation wants to make money, but they must not do that at the expense of our clean air and water, and certainly not at the expense of our bodies. Period. And that is where Government comes in. Because we elect those people to do what is right for us. Or that was the idea when the U.S. Constitution was drafted. Now the snake oil salesmen tell us not to worry and impartial data goes untested because the FDA is completely underfunded/understaffed. And for that, we all suffer.
35
A true hero. Bless her. I'm old enough to remember when these terrible thalidomide events occurred, and how, because of the courage of Dr. Kelsey and her immediate co-workers/supervisors at the FDA, so much tragedy and heartbreak was averted. I'm also glad to know that Merrell no longer exists, as the phrase "stood to make millions and was anxious to get moving..." shows that back then it was just business as usual to discount or even hide important data. (But not to discount prices, of course.) We can thank Dr. Kelsey and President Kennedy for putting safety above profits, honor above greed, and right and above wrong. If more people were like them, and fewer were like the stonewallers at Merrell, the world would be a better place without so much struggle to make it so. The checks and balances in the drug-approval process now are a direct result of this brave scientist. May her actions and the memory of her heroism last forever. Sometimes, just doing one's job honestly and with conviction can indeed lead to greatness and affect many other people.
30
I was born in 1951. My mother was an RN working in a doctor's office. Every week she would bring home the discarded LIFE magazines along with others.
I have never forgotten the LIFE issues of thalidomide babies when I was not 11 years old. There was also a story about an American woman whose husband had brought the drug home from Europe & she had taken it for morning sickness. Rather than take the chance of having a baby with "phocomelia, a rare but monstrous malformation of limbs in newborns" & since abortions were illegal in the USA, she had to go to a Scandinavian country where the pregnancy could be terminated.
So, not only did thalidomide raise the consciousness of Americans about drug safety, it raised the consciousness of many Americans that a woman should not have to fly halfway around the world to avoid having a child who would have to endure a life with "monstrous malformation of limbs" & other deformities.
Today, we have some clamoring for fast track FDA approval of this or that drug when we all know that drug companies are headed by even more amoral executives today than they were then. &, the fact that way too many approvals are still getting through can be read about here in NYT & seen in the personal injury lawyer commercials that are omnipresent on TV.
And, we are living in an era where there is clamoring for women to again be denied the most basic control over their lives.
History repeats...
I have never forgotten the LIFE issues of thalidomide babies when I was not 11 years old. There was also a story about an American woman whose husband had brought the drug home from Europe & she had taken it for morning sickness. Rather than take the chance of having a baby with "phocomelia, a rare but monstrous malformation of limbs in newborns" & since abortions were illegal in the USA, she had to go to a Scandinavian country where the pregnancy could be terminated.
So, not only did thalidomide raise the consciousness of Americans about drug safety, it raised the consciousness of many Americans that a woman should not have to fly halfway around the world to avoid having a child who would have to endure a life with "monstrous malformation of limbs" & other deformities.
Today, we have some clamoring for fast track FDA approval of this or that drug when we all know that drug companies are headed by even more amoral executives today than they were then. &, the fact that way too many approvals are still getting through can be read about here in NYT & seen in the personal injury lawyer commercials that are omnipresent on TV.
And, we are living in an era where there is clamoring for women to again be denied the most basic control over their lives.
History repeats...
43
I'm sure my neighbor and friend, Susie (as well as her children and grandchildren) is quite grateful that her mother did not fly to Scandinavia to abort her. You see, she was a thalidomide baby, and went on to have a productive, wonderful life. Yes, she had a tough time, but overcame it and loves her life. Each child is a gift from the moment of conception.
3
Back in the 1950's and the day after my mother had given birth to me, her third child, a nurse came into her hospital room with four pills. My mother reacted by doing what most women in those days did not do: she asked what each pill was for. After the nurse grudgingly explained, my mother swallowed only the antibiotic because I had "ripped her up" a little during birth (I had refused to come gently into this world). She then told the nurse she did not need and would not take the other medications. The nurse reported this to the doctor, who knew my mother and decided to respect her wishes.
As I grew up, I often heard my mother praise "that woman doctor" at the FDA who saved countless American women and babies from the horror of Thalidomide-caused deformities. In time I also wondered if I and my siblings dodged another bullet by having a stubborn, "unreasonable" mother who asked tough questions and trusted her gut.
Rest in peace, and thank you, thank you, Dr. Kelsey.
As I grew up, I often heard my mother praise "that woman doctor" at the FDA who saved countless American women and babies from the horror of Thalidomide-caused deformities. In time I also wondered if I and my siblings dodged another bullet by having a stubborn, "unreasonable" mother who asked tough questions and trusted her gut.
Rest in peace, and thank you, thank you, Dr. Kelsey.
39
In life and in death Dr. Kelsey sticks in the craw of republicans everywhere. The diligent federal employee who saved countless children from crippling deformities. An American icon who made all Americans safer by her persistence and skill. To day she would have been hounded by the republican Congress for not conforming to their level of ignorance.
45
For a real world view of the fate of of a diligent federal employee with an oversight role in this administration, see the Carmen Segura story. Here's a courageous woman who was fired for refusing to walk back copiously documented evidence of collusion between Goldman Sachs and the NY Fed, including noncompliance with ant-conflict laws.http://dealbook.nytimes.com/2013/10/10/bank-examiner-was-told-to-back-of...
9
In today's print version, this story of how Dr. Kelsey "helped rewrite the nation’s medical-testing regulations, strengthening protections for people and against medical conflicts of interest" is juxtaposed with an article about the weakening of the FDA, http://www.nytimes.com/2015/08/08/business/court-forbids-fda-from-blocki.... Another example of 60's era regulation and legislation being reversed after 50 years.
18
A remarkable fearless lady who will be remembered for her contribution saved tens of thousands of untold misery of thalidomide tragedy.
Kelsey whose job in the F.D.A. was to evaluate applications for licenses to market new drugs happen to have Merrell’s medication as one of the first to cross her desk.
I am a strong believer of Swiss psychiatrist Carl Jung's theory which states that remarkable coincidences occur because of what he called "synchronicity," which he defined as an "acausal connecting principle."
" Jung’s theory of synchronicity posited that certain events-often called coincidences-actually reveal the operation of an acausal connection between mental and physical events through meaning.... Events .. occur often enough to be more than meaningless coincidence, Jung and Pauli believed."
(http://www.metanexus.net/essay/wolfgang-pauli-carl-jung-and-acausal-conn...
Kelsey whose job in the F.D.A. was to evaluate applications for licenses to market new drugs happen to have Merrell’s medication as one of the first to cross her desk.
I am a strong believer of Swiss psychiatrist Carl Jung's theory which states that remarkable coincidences occur because of what he called "synchronicity," which he defined as an "acausal connecting principle."
" Jung’s theory of synchronicity posited that certain events-often called coincidences-actually reveal the operation of an acausal connection between mental and physical events through meaning.... Events .. occur often enough to be more than meaningless coincidence, Jung and Pauli believed."
(http://www.metanexus.net/essay/wolfgang-pauli-carl-jung-and-acausal-conn...
4
Only seventeen Thalidomide babies were born in the United States? That is remarkable, and so heartening. I went to school with two little boys in Philadelphia who were among that group. Thank goodness it was a time when voices of scientific reason could win out over Big Pharma. She was a hero.
21
Meanwhile, conservatives still complain about overregulation.
32
This story speaks volume as to why I don't watch movies. Had a movie of an American immigrant in early 1900s hardworking her way through college, building a family, and saving tens of thousands of families the grief of losing children, become a movie, it would be unheard of.
9
@Brian Thornton. I totally agree with you. In my youth, I watched motion picture biographies of Marie and Pierre Curie, Louis Pasteur and Joseph Lister, Albert Schweitzer and other scientist and humanitarians. Though I have not come even close to matching their achievements, they inspired me to utilize my talents and abilities to the best of my ability not only for my personal gain but for the good of everyone. Which of today's movies inspire youth in such a manner?
10
Read Silent Shock by Michael Magazanik, that is the movie you want to "read".
1
It wasn't that fetuses lacked an ability to metabolize drugs. It is that thalidomide interferes with the development of blood vessels. It is now used to discourage the growth of cancerous tumors (which need to develop new blood supplies).
9
"If you smell something, say something."
15
A cautionary tale for any public servant besieged by lobbyists. There is a vast difference between well paid golden tongued hucksters and the truth. Learn to recognize the truth at your peril.
17
My wife feels it is important to point out that even though this obituary highlights the accomplishments and contributions of this groundbreaking woman physician, the author still felt the need to comment that she "never wore cosmetics." So what? Why is that aspect of her appearance important enough to mention? What is the implication?
24
The implication seems to be that it's important to point out that she was not a glamorous woman. It is a very old-fashioned and inappropriate statement and frankly, should not have made it past the editors of the uber-liberal NYT.
10
I think the implication is that Dr. Kelsey disdained cosmetics not because she was unconcerned about her appearance but more likely because she was aware of some potentially not-so-nice ingredients in them. She obviously found that she didn't need them unlike the rest of us vain consumers.
8
She'd be a good one to put om the Dollar Bill.
19
Or the $20.
14
So sad, so thankful and so bitterly disappointed, all at the same time.
I suspect Frances' dedication, held in that murky region where agency (govt) & assets (corp) often co-mingle (lobby), was rare even in the hopeful 60s. I'll try to remember the names Kelsey, Jiro, Geismar & "superiors (?)" whenever I may struggle for sufficient courage, wisdom & compassion in the face of fear, ignorance & arrogance. I'll try.
I suspect Frances' dedication, held in that murky region where agency (govt) & assets (corp) often co-mingle (lobby), was rare even in the hopeful 60s. I'll try to remember the names Kelsey, Jiro, Geismar & "superiors (?)" whenever I may struggle for sufficient courage, wisdom & compassion in the face of fear, ignorance & arrogance. I'll try.
6
As one who was conceived around this time, I'm sitting here with tears in my eyes. But for Dr. Kelsey, it could have been me. God bless Dr. Kelsey and all others who think differently. Who stand up, come what may, for their principles.
21
I'm forwarding this article to many friends: What an extraordinary and inspirational woman! Thank you for this obituary of a life to be celebrated.
9
Many commenters are ignoring the Obama administration's unprecedented war on whistle blowers and truth tellers, while falsely claiming to be their champion. It's no surprise that fatal auto defects known for years by federal employees never saw daylight or the honorable federal employees who called out the needless VA deaths have been put through the wringer—never mind the employees and journalists in the national security arena who have been harassed and prosecuted (more than all previous administrations combined) under this democratic party president.
4
The strength of Dr Frances did not come from something she picked up in the chem lab at the University of Chicgago. It came from the pull of an infallible conscience and the intestinal fortitude to do the right thing. There are a lot of baby boomers out there who are free of handicap, thanks to this woman's quiet courage. The right thing and the easy thing are not always the same thing. I salute Dr Frances for making the right choice.
14
Dr. Kelsey's brave stand against the drug lobby, using evidence that her trusted experts had proven to be true, helped the world to see that this evidence did speak the truth. That Thalidomide was dangerous and shouldn't be used in drugs. She deserved the honor that this stand earned for her. And we now have an FDA that still listens to people like her!
5
Her diligence and thoroughness as a regulator reminds me of the case of Brooksley Born, the former head of the Commodities Futures Trading Commission from 1996 to 1999. She acted alone to try to prevent the use of over-the-counter derivatives such as credit default swaps. She lobbied Congress, issued regulations, and did everything in her power to stop their spread. She was ultimately overruled by the rest of the financial establishment, including Alan Greenspan, Robert Rubin, and ultimately Congress. Sadly, she was proven right in 2008.
The lesson is that many times, the single voice of an informed, reasonable person needs to be heeded to prevent medical and economic disasters.
The lesson is that many times, the single voice of an informed, reasonable person needs to be heeded to prevent medical and economic disasters.
19
It's the voice of an informed, unbiased expert with nothing to gain financially that needs to be heeded instead of the rich, politically powerful people who stand to gain financially or in prestige to prevent health or economic disasters. Two experts, Dr. Judy Carman of Australia and Dr. Stephanie Seffen (?) of MIT, are voices straining to be heard over the din of the pesticide/chemical giants like Monsanto and Syngenta. Carman described the astounding laxity of the FDA and its Australian counterpart in protecting the public. Seffen(?) described the .99 correlation between the use of Roundup (main ingredient glyphosphate) and the geometric increase in conditions like autism in the U.S. in the past 20-30 years.
3
A truly wonderful, memorable, and remarkable woman !
6
"President John F. Kennedy signed the landmark law that she had inspired, and presented her with the nation’s highest federal civilian service award."
Uh, would that be the Presidential Medal of Freedom? One might have thought that the Times' reporter would take the trouble to find out.
Uh, would that be the Presidential Medal of Freedom? One might have thought that the Times' reporter would take the trouble to find out.
12
What a hero! At times Change.org would petition the FDA to put a drug on the fast track to approval. Maybe it should be done. Maybe not. Maybe it's simply Big Pharma being greedy. Whatever, the FDA has done a remarkable job in preventing a new drug to be approved that has caused any major affliction.
4
The FDA scientists have often tried to prevent drugs from being approved but have been overruled by their politically appointed bosses. They come from and return to the industry they're supposedly regulating, where they are rewarded with good jobs and fat salaries/benefits.
4
I think the word, "Stickler" in the headline is inappropriate to the facts of Dr. Kelsey's achievements. She had an impact on the health of every person born on this planet in the 60's and beyond. "Scientist" or "Pioneer" would have been a better choice. (And I could have done without the reference to her non-use of cosmetics in the article.)
14
Dr. Kelsey is a good example of what is wrong with the FDA today. She was an MD, PhD. She was able to combine clinical with pharmacological insights. Now you have MD's (and especially MD, JDs) running the show. These people have no idea how to conduct clinical research for the simple reason that it is not taught in medical schools. Instead they depend on pharmaceutical companies for the science and cannot distinguish between best practices and worst practices. PhDs who do have the training have been relegated to a second-class scientist status.
9
We need more people like this heroic woman. Our son has diabetes, and the damage done by FDA-approved drugs is staggering. He now follows the "7 year rule", and will not take any "approved" medication until that time has passed.
11
Are these diabetic drugs being referred too?
Wise decision. Dr. Judy Carman, Australian research scientist, says most drugs are tested for only 30 days, 90 days at most, even drugs for long-term conditions like diabetes, high blood pressure, heart disease. They're usually tested if at all on animals like chickens and rats instead of animals more like humans such as pigs due to cost. Human users of new drugs are guinea pigs.
2
Dr. Kelsey serves as a good example of someone with integrity and steadfastness, not intimidated by big powerful interests whose only concern is profit -- regardless of the consequences. She rightly persevered even in the face of ad hominem attacks. Rather to be a “stickler” than a murderer or baby disfigurer. This is why we need good government oversight of not only pharmaceuticals, but every item single-dimensional for profit-only business tries to foist into the public that affects our health and quality of life.
The leaders of the Merrell Company responsible for the attacks on her and their insistence of release of the drug should have been criminally prosecuted. Simply withdrawing the application and walking away with an “oh well” is not sufficient. These people knew what they were doing and placed their slimy profits ahead of the health of babies and the extreme emotional distress of the parents of those babies. Only when such individuals have to pay (and I don’t mean just fines) for their crimes will we have a chance of stopping a repeat.
The leaders of the Merrell Company responsible for the attacks on her and their insistence of release of the drug should have been criminally prosecuted. Simply withdrawing the application and walking away with an “oh well” is not sufficient. These people knew what they were doing and placed their slimy profits ahead of the health of babies and the extreme emotional distress of the parents of those babies. Only when such individuals have to pay (and I don’t mean just fines) for their crimes will we have a chance of stopping a repeat.
5
Big corporations are still doing it today. The high level appointees who should be prosecuting them won't do it because those corporate elites are friends of the appointee or the appointee will be returning to those corporate elites and can't afford to antagonize them.
2
In today's political environment she would be fired and the drug would be on the market. It's called integrity and courage people. There was a time, not so long ago, when America had an abundance of both.
9
Dr. Kelsey is an inspiration to us all. I wish she had worked in the FDA Medical Devices unit. If so, she might have moved decades ago on the harm for those who do not methylate (clear toxins) well from such devices as dental amalgam, and from other device that are not "right for you" if you are not in the plump part of the bell curve. I was sick for 20 years before learning I had mercury poisoning, and have now recovered, as have many, many others at least in part. So many friends have been harmed by medical and dental devices, from implants and joints to Essure, Mesh, stents, morcellators and mercury fillings the FDA still allows to be callled "silver fillings." Device regulations are nearly 40 years old. In this era of Precision Medicine, we need Precision Devices. In her honor, I am sharing a petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE): http://www.petition2congress.com/18325/medical-dental-device-safety-urge...
5
What a shame that our supposedly "liberal" White House is now stumping on behalf of our corporate overlords to implement a series of global "trade" pacts specifically designed to quash oversight of the pharmaceutical industry by the FDA and its counterparts in other hapless soon-to-be-former democracies!
Meanwhile, whistleblowers like the formidable Ms. Kelsey are squelched, if not overtly persecuted.
Meanwhile, whistleblowers like the formidable Ms. Kelsey are squelched, if not overtly persecuted.
5
Heartwarming and courageous to stand up to the bullying of the profiteers, this Doctor is most inspiring and has set an exemplary path for those who are tempted to knuckle under to the forces of big pharma (the trips, the fees, the drugs at discount prices, etc. which are used to seduce Doctors into going along with profits over efficacy). Having seen a child with flippers for arms is an unforgettable sight. Dr. Kelsey was in the right position at the right time, and she stood her ground.
4
I remember the big, black scary headlines, and how quickly it was taken off the market. These days, Republicans would launch a 10 year study and executives would argue that thalidomide was perfectly safe. It was an age of great ladies -- Rachel Carson wrote "Silent Spring" around that same time.
5
Dr. Kelsey and her team, a truly heroic group. What an incredible accomplishment for the greater good of the world. Words cannot express the thanks we all owe them.
2
Why can't we have someone like this on the $20 bill instead of Andrew "Trail of Tears" Jackson?
12
My immediate response to this story was to wonder how many NON-Frances Kelseys have been in the FDA in the previous 30 or so years.
2
All too many. Googling their professional background will tell you most came from industry and returned to it, richly rewarded for their failure to adequately regulate the industry for the public's protection.
2
While Dr. Kelsey deserves the accolades for having the courage and the integrity to make sure that a drug is safe before it is put into the marketplace, her actions alone did not forever terminate the use of Thalidomide. Within the last ten years or so, Celgene, a pharmaceutical manufacturer which was understandably loathe to completely give up on its investment, discovered through its research that Thalidomide had efficacy in controlling a specific form of an incurable blood cancer called Multiple Myeloma. So, they have since then re-branded Thalidomide as Thalomid, and they have made it available—with very tight restrictions placed upon its use—for use in chemotherapy. I know, because I happen to be a beneficiary of the re-branding and re-use of this previously banned drug: the addition of Thalidomide to the other three-drug cocktail of my treatment regimen has halted the progression of my cancer for the time being, a medical miracle for which I must be grateful both for the watchdog efforts of the FDA which looks out for our safety, as well as for the diligence of the medical researchers at places like Celgene for being thorough in discovering positive uses of a drug that was shrouded for decades inside a hateful cloud. Such discoveries, however belated and made in the face of long-standing justified opprobrium, imply that the approval process for drugs is not as simplistic as one would expect.
59
This is great example of how capitalism works favorably. If it weren't for fear of losing their financial interest (liberals call it greed) the drug might have been forever banished.
There are many reader comments about the seemingly random remark in the article that Dr. Kelsey never wore cosmetics. I hope The NYTimes responds with clarification to let us know whether or not that was because she was concerned about the chemicals.
10
I think that , taken in context, (soft spoken, modest to the point of shyness, wore no makeup), the point was that she did not feel the need to call attention to herself. That's all.
4
I am a member of an Institutional Review Board, or IRB, research ethics committees that exist at hospitals and medical universities to approve (or disallow) proposed experiments involving human beings. There are more than 3,000 IRBs in the United States, and the FDA regulations we use in our determinations are the direct result of two momentous occurrences: the egregious actions of the US Public Health Service in the case of the Tuskegee Syphilis Study, and the work of Dr. Kelsey in the case of thalidomide. She is a true hero. In addition to directly preventing the tragedy of “thalidomide babies” in the United States, she has ensured that the level of drug safety verification enshrined in FDA regulations occurred much earlier and is much more stringent than would otherwise be the case.
12
In 1962, Sherri Finkbine--a resident of Arizona--had to travel to Sweden in order to obtain the termination of a pregnancy during which she had ingested 36 Thalidomide pills during the first trimester. The intrusion into the personal affairs of Mrs. Finkbine was a media circus/feeding frenzy and resulted in public ridicule, death threats, and ultimately the loss of her employment as the host of a children's television program. Dr. Kelsey saved so many other women from the same fate or the even worst one of bearing a deformed or dead child. Dr. Kelsey, your scholarship, determination, and perseverance have more than earned you the right to "Rest in Peace" .
120
At least two of the GOP candidates (Hi, Scott Walker. Yo, Huckabee) would have arrested Finkbine and forced her to have the baby.
5
@Deering. One wonders if either Walker, Huckabee or those of like mind would have adopted her child or in any way assisted with the child's care. I think not.
7
She is a heroine...but one we need today more than ever! The FDA no longer protects us, if it ever fully did...I was prescribed Phenergan 21 years ago for my severe morning sickness while expecting my first child. My son has autism and from my research, Phenergan is probably the culprit. Yet, the drug continues to be prescribed to pregnant women and the FDA does not question it's safety. We know that women prescribed neuroleptics (which includes Phenergan) during pregnancy have double the rate of infant mortality and Phenergan has been shown to cause mortality in fetal rats, yet we still allow it for pregnant women...SSRI antidepressants have also been implicated in autism with some studies reporting that male offspring born to these women have 3 times the rate of autism. Autism rates are at an all time high...could it be all the prescribed drugs pregnant women are on? We need more Dr. Kelsey's !
6
In the mean time the FDA continues to do a job.....poorly , AND avoidable medical errors continue to kill 98,000 in US annually and one day antibiotics won't be overused.......
7
This is a powerful reminder of the importance of an independent and authoritative FDA that works for the public good.
Today that FDA no longer exists. The FDA has close ties to big pharma (called collaboration) and a large part of its budget is underwritten by pharmaceutical companies through so called 'user fees' mandated by Congress through the Prescription Drug User Fee Act.
In today's political landscape Frances Oldham Kelsey, or someone like her, would not be allowed to head the FDA.
Today that FDA no longer exists. The FDA has close ties to big pharma (called collaboration) and a large part of its budget is underwritten by pharmaceutical companies through so called 'user fees' mandated by Congress through the Prescription Drug User Fee Act.
In today's political landscape Frances Oldham Kelsey, or someone like her, would not be allowed to head the FDA.
15
Thank you, Dr. Kelsey. You saved a generation of American babies. We need to spend more time acknowledging true heroes like you, not actors, reality TV stars and sports figures. Your name should be the one people remember.
20
Amazing. Can you imagine her being heard in today's lobbyist-infested environment?
18
Yes. FDA is pretty strict, partly because of Dr. Kelsey's influence. And no drug company wants to be the cause of, and blamed for, widespread tragedy like this.
1
Or having a boss who supported her despite intense lobbying pressure?
2
What a shame our sellout legislators are stepping on themselves to undo her work :(
15
And we wonder if an individual can make a difference!
11
"In 2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame, joining the ranks of Helen Keller, Eleanor Roosevelt, Margaret Mead and other luminaries."
I'm certain that, for the drug industry, Dr. Kelsey's name will live in infamy as one of the most-hated government regulators of all time. Unfortunately, however, it appears that the regulatory enforcement resulting from Dr. Kelsey's labors has been subverted via the absolute capture of her agency by the industry it is supposed to regulate. Prescription drugs have been killing people by the thousands every year, regardless of FDA approvals and regulations. For example, Quaalude (23 years on the market), Accutane, Baycol, Bextra, Cylert (30 years on the market), DES (31 years), Darvon, and Propulsid were all FDA-approved as prescription drugs. They were taken off the market or put on restricted use only after years of use by patients, who, in effect, served as test subjects. Likewise, there are FDA-approved prescription drugs in use right now that are dangerous and will cause many deaths until they are eventually removed from the market.
I'm certain that, for the drug industry, Dr. Kelsey's name will live in infamy as one of the most-hated government regulators of all time. Unfortunately, however, it appears that the regulatory enforcement resulting from Dr. Kelsey's labors has been subverted via the absolute capture of her agency by the industry it is supposed to regulate. Prescription drugs have been killing people by the thousands every year, regardless of FDA approvals and regulations. For example, Quaalude (23 years on the market), Accutane, Baycol, Bextra, Cylert (30 years on the market), DES (31 years), Darvon, and Propulsid were all FDA-approved as prescription drugs. They were taken off the market or put on restricted use only after years of use by patients, who, in effect, served as test subjects. Likewise, there are FDA-approved prescription drugs in use right now that are dangerous and will cause many deaths until they are eventually removed from the market.
15
One "bossy bureaucrat's" determination saved countless babies from being born with deformities. This story should be in every Democrat's play book, to be used whenever the Republicans start talking about defunding government regulatory agencies that oversee what we eat and drink, what conditions we work in, and what medicines our doctors can prescribe for us.
28
What does funding have to do with it? Read the article, the FDA was rubber-stamping approval. It was her due diligence that saved us, not more funding. Stop making everything about your beliefs!
She is worthy of all the accolades, and much more, Dr Kelsey and her staff prevented the birth of god only knows how many " thalidomide babies" in the U.S, it would have been a horror. She is a hero on a giant scale, and lived to the ripe age of 101, if anybody ever deserved such longevity it is Dr Kelsey, rest in peace dear lady, rest in peace
22
This what government science is supposed to be about!
This woman scientist is an American Hero. An example to all of us of why we have government and how small "r" republican government is supposed to perform.
The fact that she was a woman and a doctor in a era before this was as comman as it will become.in the future is attribute to Fances Oldham Kelesy's intellect and courage. The same intelect and courage that she used to prevent a national tragedy.
This woman scientist is an American Hero. An example to all of us of why we have government and how small "r" republican government is supposed to perform.
The fact that she was a woman and a doctor in a era before this was as comman as it will become.in the future is attribute to Fances Oldham Kelesy's intellect and courage. The same intelect and courage that she used to prevent a national tragedy.
13
It seems more than a bit ironic to have the second part of Dr. Kelsey's obituary on the same page as an article about a recent ruling that a drug for controlling the level of triglycerides in the blood can be marketed by the manufacturer for uses not approved by the FDA. The ruling cites the drug company's "free speech" rights. Perhaps this was intentional on the part of The Times?
21
Off-label use of drugs is different from use of drugs that have not been approved. Sometimes the drug hasn't been approved for a specific use because it is legal and available, and no one has spent the money on the clinical trials to get it approved. I, like many people, use Primidone to control essential tremor. It's been around a long time as an anti-seizure drug. it works but this is an off-label use.
To know the truth of the greedy lying disgusting action of the German producer, their worldwide distributors, the effect on thousands of "thalidomiders" read "SILENT SHOCK" written by Michael Magazanik, an Australian lawyer who participated in a successful lawsuit on behalf of an Australian woman "thalidomider". It is available on Amazon
10
And instead of a woman director making a film about this woman, we get yet another movie about teen-age sexuality. Can't we at least do both?
4
If Dr. Kelsey had been a man, would the obit have included the information that he was short, fat, bald, and never wore deodorant? Perhaps the reference to cosmetics (and grey hair) is, as some writers suggest, related to a concern about chemicals -- although there is nothing in the obit to support that. Instead, as a 69-year-old woman who has never died her hair and seldom wears cosmetics, I find this description just one more sad example of the outmoded double standard our society applies to women's appearance. How long was this obit in the bank, anyway? Doesn't the Times have any (female) editors who review these before they go into print?
35
I agree it's an unnecessary comment re cosmetics, but actually it is something that causes me to admire her more. Incidentally, as a male academic, I have received student comments about my dress (I'm not exactly a fashion plate).
7
Amen, sister. I did a double-take as I read that cosmetic and grey hair nonsense.
5
I think people are missing the point. My first thought also was that she was skeptical of the safety of the cosmetics. In fact, Eli Lilly - a large pharmaceutical company - owned Elizabeth Arden during the 1970's. But I've come to expect this sort of reflexive reaction. In this case I think it's the opposite of being sexist. Don't you think Dr. Kelsey is a great role model? Young people emulate role models. If emulating this role model means more young people will forgo using cosmetics isn't that a good thing.
3
She is a HERO!!!!
8
As a teenager, I knew a woman who - denied an abortion after she had taken Thalidomide - flew to Europe to have the procedure. The fetus was shown to be malformed.
Many years later, my wife was diagnosed with Amyloidosis, an "incurable" systemic disease that gave her an estimated two years survival. Her oncologist suggested he could increase her chances with a regimen of Thalidomide, still manufactured by Celgene, and steroids. Despite numbing of her feet, she persisted. It is now sixteen years later. She is still with us, and asymptomatic.
Many years later, my wife was diagnosed with Amyloidosis, an "incurable" systemic disease that gave her an estimated two years survival. Her oncologist suggested he could increase her chances with a regimen of Thalidomide, still manufactured by Celgene, and steroids. Despite numbing of her feet, she persisted. It is now sixteen years later. She is still with us, and asymptomatic.
11
Sir, you make an excellent point. Some dangerous drugs have excellent uses in specific cases, but should never be mass-marketed to pregnant women - as this drug would have been, if not for the vigilance of this fine woman. Bless her!
And I'm glad to hear your wife is OK.
And I'm glad to hear your wife is OK.
11
I will try, once again, to bring another drug travesty to light, by using this wonderful eulogy as a platform. My apologies. www.cdc.gov/des America did have it's version of thalidomide, Big Pharma has been very successful in keeping it quiet. I am in the first generation of Americans who had their DNA change by in-utero poisoning as my Mother took this drug for miscarriage back in 1955. I was told when I was 17 I would be dead by age 30. Well, I am 59, but incredibly ill with multiple autoimmune diseases, which seems to be a side effect of being exposed in the womb to DES. If you haven't heard or know about DES, GO FIND OUT. There is a reason for all these ads for Rheumatoid Arthritis on the TV. If you are ill and cannot get help in what is wrong, go find out about DES. And it would really help if the NYT took a lead and finally stopped protecting the company who produced this drug and help us figure out why we are all so sick. It was still on the market in America until 1997, reformulated as a pre-natal vitamin. There's something to think about if you are thinking this has nothing to do with you. Thank you.
11
Interesting to note that 50+ years ago manufacturer Merrell described Kelsey's thoroughly appropriate scrutiny of their product as the work of "a fussy, stubborn, unreasonable bureaucrat" and yesterday Donald Trump characterized Megyn Kelly's thoroughly appropriate scrutiny of his record as "unprofessional" and the work of a "bimbo." While the first attack resorts to the stereotype of the proud fussbudget who has little grasp of her own unimportance (translation: she really belongs in the kitchen) and the second resorts to the stereotype of a woman of easy virtue (translation: she really belongs in the bedroom), both rely on the Catch-22 that a woman who takes the ethical demands of her job too seriously is by definition not professional. Pair that with Mommy-Track assumptions that the trouble with women workers is that they fail to take their jobs seriously, and conclude that there are only two ways to operate acceptably in the workplace--without a conscience or with an Adam's apple.
20
How about a set of stamps for these pioneers of fetal/infant health? The Virginia Apgar stamp of years ago isn't enough; people like Frances Kelsey deserve recognition.
14
OF course they do, but Dr. Kelsey died only yesterday. The Postal Service can't print stamps of a living person. Give it time.
2
This would never happen today. The cost-benefit analysis done by the drug company would mean that killing a few hundred people/babies would simply be a "cost of doing business" and they would be paid off (after 30 years or so of litigation until everyone involved had died) and the drug would stay on the market. How is a drug company to make a profit if some stupid "regulatory agency" is keeping them from their cash? Over-regulation is killing business today. Clean water, clean air, safe food, safe drugs--good grief, how can we make a profit and create jobs with all those dumb regulations? Thank you, Dr. Kelsey, for being the last of your ilk.
23
And if the drug were called a vaccine, the drug company would have no liability al all.
A woman who made contributions to science, to the nation and to humanity that far outweigh those of almost any politician. I can only guess today how Republicans would be screaming to end unjust regulation and have Thalidomide approved.
Unless you have served in some regulatory position in state or federal government you have no idea, no comprehension, how much courage it takes to say no when it needs to be said.
She had honor. Today few do or can. I believe even now she would have.
Unless you have served in some regulatory position in state or federal government you have no idea, no comprehension, how much courage it takes to say no when it needs to be said.
She had honor. Today few do or can. I believe even now she would have.
27
I had the opportunity to meet her several times, she was a wonderful person who valued science and what it could do to enhance people's lives.
9
You have no idea what people would do today and you denigrate many fine government workers with your tirade.
1
Perhaps the death of Dr. Oldham Kelsey is an opportunity to do a story of the return of the drug's use for other things, like Leprosy. It gets into the environment through the water system. The drug is expelled in good quantity through urine, old reports say.
4
Watch carefully the 21st Century Cures bill making its way through congress. This bill "streamlines" the drug and medical device approval process. One wonders if thalidomide-like disasters will be deflected if this fast track process is approved. The bill certainly fast tracks increased profits for the pharmaceutical companies.
29
We need to see this as as example of how we need and rely on government. That without it we would have an unregulated pharmaceutical industry, as well as much dirtier water and air. Yet Republican have sold America on a story of government failure. Well it will fail if we don't mean for it to succeed.
23
No, it is the story of principled people. Just spending more money does not assure anything. We spend more money on public education than any other nation. Do you say we have the best system, that our students are the best? What is needed is an ethical, honest workforce. Do we have that?
1
As a Republican I disagree. What we have and are complaining about is federal intervention in areas that can and should be regulated on a local level which is more familiar with the problem. An overextended government system of bureaucracies is failing us by trying to be all knowing in all situations.
Education in particular was run by municipalities and states for nearly two centuries and we turned out an educated work force that was the envy of the world. Since control has been turned over the the DOE we have been surpassed by even third world countries in particular Asia. The constant promulgation of new standards has roiled the education industry and given more power to the teachers unions that were the force behind this consolidation of power as a means to push harder for the Humanist Manifesto.
Education in particular was run by municipalities and states for nearly two centuries and we turned out an educated work force that was the envy of the world. Since control has been turned over the the DOE we have been surpassed by even third world countries in particular Asia. The constant promulgation of new standards has roiled the education industry and given more power to the teachers unions that were the force behind this consolidation of power as a means to push harder for the Humanist Manifesto.
Ah, but dead/ill babies, poisoned water and air are free-market opportunities to sell ever more medicines, medical supplies, treatment...and coffins. Why do you hate capitalism?
2
There is much to admire in Dr. Kelsey's career. She is a role model in the way she stood up to the bullying by the company manufacturing thalidomide. She was also not afraid to share the credit for her accomplishments with her colleagues. There was one detail in the obituary that seemed irrelevant and inappropriate: In describing her appearance, the writer mentioned that she never wore cosmetics. What is the point of mentioning that in the obituary of such an accomplished scientist? Unless the deceased had been in the business of cosmetics, I cannot see why such a fact should be included in the obituary of ANY woman.
27
The remark seems unnecessary but does convey the idea (to me) that Dr. Kelsey wasn't too concerned with herself so much as her mission in life. Ensuring that what she believed and said were important not what she wore. Eschewing decoration forced people to listen and not be distracted from that.
My wife delivered our third child in 1962, and I spent the last months of her pregnancy in quiet concern because of that drug's increasingly horrible reputation, and my wife's having taken a drug for morning sickness. When she delivered a healthy child we were relieved beyond measure. Put her on the ten dollar bill!
21
A very sad day indeed ... Hopefully Dr. Kelsey did not know of this...
http://www.washingtonpost.com/news/wonkblog/wp/2015/08/07/fda-barred-fro...
http://www.washingtonpost.com/news/wonkblog/wp/2015/08/07/fda-barred-fro...
7
Personally, I am very grateful to Dr Kelsey and all the people at FDA who prevented this terrible drug from coming to market in the USA. Thank you for publishing this article and reminding readers what good government accomplishes when it has committed and intelligent employees.
The discussion of Dr Kelsey's personal habits is rather revealing. Does no one recall that until the 1950's women who were not *on the stage or the streets* did not use heavy cosmetics. Slight face powder and a bit of lipstick perhaps. But very few serious, refined women used rouge, eyeliner or eye shadow, Most went completely without makeup. Makeup was regarded as cheap and vulgar. And for some today, it still is.
The discussion of Dr Kelsey's personal habits is rather revealing. Does no one recall that until the 1950's women who were not *on the stage or the streets* did not use heavy cosmetics. Slight face powder and a bit of lipstick perhaps. But very few serious, refined women used rouge, eyeliner or eye shadow, Most went completely without makeup. Makeup was regarded as cheap and vulgar. And for some today, it still is.
18
My title would have been "FDA Heroine"...not "Stickler"... as her brilliant analysis, integrity, and intellect saved tens of thousands from horror. But, perhaps the use of the word "stickler" is a great choice. When our own excellent US government employees are demeaned as "sticklers" for having integrity and enforcing proper rules and codes in order to ensure safety, we can thank them for their "Kelsey service." We Americans must keep this important societal analogy alive. It is up to all of us to help our government employees, many as dedicated as Dr. Kelsey, with our appreciation - and not join the "corporations rule" bandwagon. Good government has a critical role for a well-functioning and fair society.
I assume (and hope) your reference to Dr. Kelsey not wearing cosmetics was a subtle reference to OTC "drugs" being largely unregulated, which the smart doctor no doubt might have wanted to see. Did she? Now what about it, FDA? And what about the government requiring food labeling to show teaspoons of sugar per serving, not grams? Aand congress requiring proper testing of medical devices, versus what the house just passed? Cannot Congress use this moment to pause and hit the re-set button - and have their own "Kelsey service" moments? Or, has that time passed as "corporations" elect, and not mere breathing people.
I assume (and hope) your reference to Dr. Kelsey not wearing cosmetics was a subtle reference to OTC "drugs" being largely unregulated, which the smart doctor no doubt might have wanted to see. Did she? Now what about it, FDA? And what about the government requiring food labeling to show teaspoons of sugar per serving, not grams? Aand congress requiring proper testing of medical devices, versus what the house just passed? Cannot Congress use this moment to pause and hit the re-set button - and have their own "Kelsey service" moments? Or, has that time passed as "corporations" elect, and not mere breathing people.
98
Contrast this with the treatment of the "sticklers" in the IRS, who were crucified for checking the veracity of the claims of political influence groups masquerading as "social welfare" organizations. Conspiracy!
1
The reference to her not wearing cosmetics strikes me as the Times writer's way of noting that she was a no-nonsnese person, as those who knew her here in Montgomery County, Maryland, have said.
2
Within the past year or so there was another shocking article about thalidomide. Apparently it has never been fully banned in some European countries, and in Spain is still prescribed to pregnant women. The widely-known effects of it are not--deliberately--disseminated there, and there are many doctors as well as patients who remain unaware of its disastrous potential. Adults deformed by thalidomide have banded together there for lawsuits, but so far have been unsuccessful. It's horrendous to know that the bullet North Americans have largely dodged thank to Dr. Kelsey are still striking Europeans.
7
Some lawsuits have been successful. Australia for one and others in the works. Read Silent Shock by Michael Magazanik
2
Many years ago while traveling in the Greek Islands I saw a young woman without arms having a drink in a sea side taverna. This young woman with her toes paid the server and managed to drink her beverage without spilling a drop. She also unfortunately managed to smoke cigarettes.
Later I asked a German physician whom I met what happened to this young woman and he told me the drug thalidomide was the cause.
I had always wondered who the person was who kept this terrible drug out of the US and now I know thanks to the NYT.
Later I asked a German physician whom I met what happened to this young woman and he told me the drug thalidomide was the cause.
I had always wondered who the person was who kept this terrible drug out of the US and now I know thanks to the NYT.
7
Our government should be Frances Kelsey in all ways. It's called objective analysis; free from political pressure, pandering and ideologues. Now, take a look at the Republican field for the 2016 nomination for president. Do you see an ounce of her in any of them?
10
A real American hero and I congratulate this paper for putting her obituary on the front page of the print edition. She is a shining example of why government service matters. In this new gilded age, she would probably be imprisoned as a whistle blower or driven out of government.
22
I wonder if Merrell ever thanked Dr. Kelsey for saving their bacon from the lawsuits that would surely have resulted if thalidomide had been approved. I doubt it.
15
Definitely put her on the 10 dollar bill. Her story is absolutely essential to be told again and again and again. Woman, immigrant, government official, hero.
7
I was born during the Thalidomide era. If it weren't for this hero-scientist I might well have been born without arms and legs.
4
She was my heroine.
1
Was, and is!
5
Noteworthy that Kelsey acknowledged her supervisors. Without their support she could have been overruled, as the FDA Commissioner Hamburg was overruled by HHS Secretary Sebelius for political reasons on the approval of Plan B for over the counter use. The FDA is under seige by the modern Merrell's who can now buy Congress to eviscerate the drug Agency, to push drugs and devices to the market prematurely in the name of saving lives when their safety and effectiveness have not been adequately proven. Dr. Kelsey is dead. So will FDA as a public health agency if its independence is diminished by the irrational anti-regulation forces. Then we will relearn the lessons of another thalidimide.
8
Coming from her home town of Cobble Hill, I find it shocking that it took the Canadian federal government until a few days ago, immediately prior to her passing, to name her to the Order of Canada. Luckily, more regional decision makers up here named the local secondary school after her. As for putting her image on one of your bills of legal tender, for Pete's sake, why not? You, like Canada, are built on a strong foundation of those who chose your country to be theirs rather than it being forced on them through birth. That would seem like good evidence of willing affirmation.
3
I was born in this country, an 11th generation American and and I've never felt forced to live here. I've been drafted had my paychecks docked for taxes to pay for things I disagree with but never do I feel forced to be a US citizen. If I had I would have left long ago.
While on Chapman College's World Campus Float in 1973, we stopped
at Suva, Fiji. We visited a small school for disabled children run by a wonderful British teacher. One of the students, a 13 year old girl, had no arms or legs. She would be carried from class by fellow students and placed in a large cylinder sitting on the sidewalk - to wait for the school bus to take her home.
It seemed that a European had visited the outlying island where this girl's mother lived and gave her some Thalidomide, thinking it would help with
a problem the woman had mentioned.
Thanksgiving for a Government employee's education, perseverence and integrity.
at Suva, Fiji. We visited a small school for disabled children run by a wonderful British teacher. One of the students, a 13 year old girl, had no arms or legs. She would be carried from class by fellow students and placed in a large cylinder sitting on the sidewalk - to wait for the school bus to take her home.
It seemed that a European had visited the outlying island where this girl's mother lived and gave her some Thalidomide, thinking it would help with
a problem the woman had mentioned.
Thanksgiving for a Government employee's education, perseverence and integrity.
3
What an amazing, inspiring woman.
Now we need a few more brave people like her to tackle the supplement/herbal industry and to make sure that their products are held to the standards as pharmaceuticals with regard to efficacy and safety.
Now we need a few more brave people like her to tackle the supplement/herbal industry and to make sure that their products are held to the standards as pharmaceuticals with regard to efficacy and safety.
5
Another great Canadian, exemplifying the intelligence, honesty, firmness and modesty that are the best of that nation. Too bad the US didn't respect that when Canada warned them about their Iraq adventure.
11
All textbooks of medicine and biochemistry should start with the story of thalidomide and dr. Kelsey. Unfortunately the situation has not improved, it has instead only deteriorated. The public has no idea of how strong the force of commerce is in medicine, and what one gets subject to if one does not want to join.
9
What an extraordinary saviour of the unborn child.
Dr Frances Oldham Kelsey showed that the Cautious seldom err.
Her intuition & her conviction to stand by her doubts in face of immense external pressure from well heeled Pharma conglomerate is laudable.
May the almighty grant her soul peace.
A life well lived in service of humankind.
Dr Frances Oldham Kelsey showed that the Cautious seldom err.
Her intuition & her conviction to stand by her doubts in face of immense external pressure from well heeled Pharma conglomerate is laudable.
May the almighty grant her soul peace.
A life well lived in service of humankind.
6
To this senior citizen, she was truly an American super-hero. Simply amazing what one person can do.
3
Here is why we have the FDA.
Of course we want 'cures' for disease, but complaints by big pharma and Republican libertarians, and Republican diddling with NSF and NIH budgets, and attempts to close the FDA or to go whole hog with deregulation, are as sound as sitting on Donald Trump's hair.
Nano pollution and toxicology up next!
Of course we want 'cures' for disease, but complaints by big pharma and Republican libertarians, and Republican diddling with NSF and NIH budgets, and attempts to close the FDA or to go whole hog with deregulation, are as sound as sitting on Donald Trump's hair.
Nano pollution and toxicology up next!
4
Notice how opposition to Woman always, through the ages, begin / include bullying by attacks to insinuate as if her gender is an issue "Fussy, petty, unreasonable", rather than the facts of the matter.
13
The letter Dr Kelsey read was in the Lancet Journal, written by a Sydney OBGYN, William McBride, who wrote a brief letter based on a remark from his resident.
I have this letter laminated in my office to show junior doctors how a chance observation in medicine can save human misery and lives.
You don't have to be a high powered scientist but vigilant.
I have this letter laminated in my office to show junior doctors how a chance observation in medicine can save human misery and lives.
You don't have to be a high powered scientist but vigilant.
177
Nor do you have to write a dense paper with twenty co-authors. I admire the Lanct for its publication of letters.
1
I couldn't recall her name, nor did I know anything of her personal life. Still her intelligence and courage have been with me all these decades. I was in college in the '60s and there were very few women physicians in those days. I wanted so to be be like her. I now practice medicine and it is the integrity of that act that I still aspire to. And I remain with a healthy skepticism of a pill for any/all discomfort.
But the larger thought is, does America still produce public servants with intellignece and integrity. Where are this generation's Watergate heroes who would resign rather than take part in corruption? I don't think the morass is limited to one political party or another. Our public servants are rotten to the core.
But the larger thought is, does America still produce public servants with intellignece and integrity. Where are this generation's Watergate heroes who would resign rather than take part in corruption? I don't think the morass is limited to one political party or another. Our public servants are rotten to the core.
1
Frances Kelsey exemplifies why diversity is important in any field of endeavor. What is the likelihood that Thalidomide sales would have been delayed in the U.S. if a well-connected man (usual) had been medical officer of the FDA instead of Frances Kelsey? Actually, we can know the answer because a woman (whose name escapes me) tried to stop the fast and loose use of CDOs but was stopped by Alan Greenspan and Lawrence Summers. Because these important men "understood" that markets are self-regulating.
11
Let's put Frances Oldham Kelsey on the $10 bill, a true American hero!
2
Put her on the $10 bill!
3
A Public Servant!!
1
Can we just be clear about this: she comes from an essentially socialist country, and made her name as a government regulator.
I hope people will work that one through carefully.
Just to help with the economics of it all, that socialist country, Canada, has a wealthier working and middle class than the United States.
Must be something about the bracing air...
-dlj.
11
Watching Richard Wolff's 'Alternatives to Capitalism' on KCET is a real
eye opener. He is so well informed and exposes the history of how and why
things have deteriorated so badly here.
eye opener. He is so well informed and exposes the history of how and why
things have deteriorated so badly here.
Why was it necessary to write that Ms. Kelsey was a "tall, graying woman who never wore cosmetics"? Is that really an important part of her story?
12
Look at the remarkable questing eyes.
[And how fortunate for the United States that she moved to Washington and accepted the FDA position.]
Now, more than ever (after the disastrous effect of George W. Bush's tenure on federal agencies), the FDA needs to be strengthened and given all the funding it needs to perform its crucial tasks.
A physician MD
[And how fortunate for the United States that she moved to Washington and accepted the FDA position.]
Now, more than ever (after the disastrous effect of George W. Bush's tenure on federal agencies), the FDA needs to be strengthened and given all the funding it needs to perform its crucial tasks.
A physician MD
2
Thank you forever, Dr. Kelsey. Our babies thank you.
No doubt Merrell is very grateful to Dr. Kelsey for all the $$$ they avoided in malpractice suits.
No doubt Merrell is very grateful to Dr. Kelsey for all the $$$ they avoided in malpractice suits.
4
Hooray for us, and thank God for Frances Oldham Kelsey!
Perhaps Donald Trump and his supporters have a lesson to learn from this courageous woman's good judgment, high standards of professionalism and moral strength.
This is what a true hero looks like, and not those celebrating warmongering around the world. If the free market fundamentalists had their way, the FDA would have been neutered a long time ago.
7
Another darn government bureaucrat, throwing regulations in the path of American businesses, preventing them from competing internationally or making a profit. A communist by another name !
Thank god we have champions of the free market like the Koch Brothers to fight back in the name of Capitalism !
/snark/
Thank god we have champions of the free market like the Koch Brothers to fight back in the name of Capitalism !
/snark/
12
Thank you, Dr. Kelsey.
2
A real hero in anyone's book. Her story provides yet another cautionary tale as to what Big Pharma will do in the name of profit if given free rein. An award she be created in Dr. Kelsey's name and conferred annually on that person/organization that did the best job standing up against the greedy suits who run the pharmaceutical giants and the big pharmacy chains. Peace be upon her and praise be upon her name.
6
Only a chosen few are built with the right stuffs, Dr, Oldham Kelsey is...
Being bright, but combined with smart, patience, humility, humanity and foresight; these traits that are rarely found to be coexisting in a host. However, Dr. Oldham Kelsey, was able manifest them all at once, seamlessly.
Lets, all bow as this angel returns to the ether.
Being bright, but combined with smart, patience, humility, humanity and foresight; these traits that are rarely found to be coexisting in a host. However, Dr. Oldham Kelsey, was able manifest them all at once, seamlessly.
Lets, all bow as this angel returns to the ether.
2
Drown government in the bathtub and we'll all see what the 21st century version of thalidomide babies looks like... That any sensible person could even consider voting Republican astonishes me.
39
Your astonishment is remarkable.
Evidence of what one person acting with intelligence, integrity, care, and persistence can do. I remember pictures of those "thalidomide babies" well. What a tragedy if this drug company had been able to push through for profit destroying many more lives!
12
I can't help but wonder if she would have survived the onslaught from the Europhiles and Anglophiles of today.
3
This is a timely reminder that when people talk about "government regulations," what they mean is, "take the power to regulate away from people like Frances Oldham and give it to someone else."
The power and the need to regulate doesn't disappear simply because of politics - right, left or libertarian. It just gets passed on to others.
The power and the need to regulate doesn't disappear simply because of politics - right, left or libertarian. It just gets passed on to others.
11
What an admirable woman.I'm still concerned about all the side effects of drugs I've seen given to my patients from doctors...side effects of
Zyprexa, Lipitor...and all the generics...we did every test possible to figure out why older folks losing their memory and getting stuff joints just to find out these are side effects of many drugs.Medical doctors are wined, dined to use drug companies products.They used to take me to expensive hotels w lobster dinners etc hoping we'd test their drugs in our med school protocols...few doctors use nutrition and exercise and social changes such as a friend buddy system for depression, or other mental ills...they feel drugs are cute all.Thus a young relative became addicted to Soma, ended up in a Coma.Thus the lives of many are robbed by the irresponsible overmedication by those who took the oath to do no harm.
Zyprexa, Lipitor...and all the generics...we did every test possible to figure out why older folks losing their memory and getting stuff joints just to find out these are side effects of many drugs.Medical doctors are wined, dined to use drug companies products.They used to take me to expensive hotels w lobster dinners etc hoping we'd test their drugs in our med school protocols...few doctors use nutrition and exercise and social changes such as a friend buddy system for depression, or other mental ills...they feel drugs are cute all.Thus a young relative became addicted to Soma, ended up in a Coma.Thus the lives of many are robbed by the irresponsible overmedication by those who took the oath to do no harm.
53
Thank you Rikki for sharing those comments. I think that many doctors assuage their consciences by telling themselves there is no alternative to Pharma's drugs, which are the 3rd leading cause of death in the U.S. Meanwhile they mock alternatives out of pure ignorance. These days the FDA is busy raiding the offices of doctors who use vitamins while approving drugs that are destroying so many lives. When those drug ads on TV tell you that a drug can cause death, it's because it already has.
1
There are plenty of bad regulations (plenty of which are the ones corrupted by big business, aka regulatory capture), but the plutocrats who bankroll our congresscritters only care about getting rid of regulations that cost them money.
When you hear about getting rid of "evil regulations," remember Frances Kelsey and thalidomide, and think about what some big pharmaceutical company would have written about this "pesky woman" who was "costing them money."
When you hear about getting rid of "evil regulations," remember Frances Kelsey and thalidomide, and think about what some big pharmaceutical company would have written about this "pesky woman" who was "costing them money."
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Some may find it peculiar, sexist, or demeaning that this obituary includes an ending statement that Dr. Francis Kelsey, who led the F.D.A. branch to test and regulate new drugs, and rose to rewrite medical-testing regulations, never wore cosmetics. Given her roles, her significant contributions to protecting human health, and her accolades, I rather see this tidbit as a cautionary flag that perhaps the wise Dr. Kelsey deemed cosmetics to be useless at best, or harmful to people or the environment at worst. Maybe there is something to be pondered when such a smart woman, whose occupation was testing food and drugs, made such a personal choice about yet another lucrative, persuasive, questionably regulated industry.
221
Yes, insulting and a sign that misogyny is alive and well!
2
Actually, Dr, Kelsey was in a good position do do something about harmful cosmetics if she had been aware of any. People who knew her here in Montgomery County, Maryland, have suggested she was a no-nonsese person, so I suspect she just didn't think cosmetics were worth the time and trouble. I admire the Times writer for suggesting this merely by noting that she didn't use cosmetics.
2
". . . a tall, graying woman who spoke softly and never wore cosmetics.. ." um, I guess she rejected hair dye too. But I don't see the context you've created ^^^. I can only see what is there. Next time cosmetics or grooming products come up in a male scientist's obit (". . . .Dr. Einstein never used Brylcream on his unruly locks"), let me know.
5
I doubt today’s government employee would be regarded with such high esteem nor celebrated by both sides of the isle as Dr. Frances was during Kennedy's administration. My generation needs to once again celebrate our countless government researchers and scientists who work to better protect us from greed and indifference. Such a large portion of our nation continues to buy into the hegemonic view that our government is inefficient and needs to be privatized. Yet, even with government oversight 50 years later, corporations continue flood the market with dangerous products. It was only a few months ago that the NYTimes reported 79% of all herbal supplements sold by major retail drug stores was comprised mainly of grass clippings and unrelated filler materials that presented considerable risks to consumers. We need to save ourselves from our ill-informed beliefs.
259
The supplement "scandal" was a scam using improper testing. Why have none of these companies been shut down? I agree there should be oversight. The Dietary Supplement Health and Education Act of 1994 was very bad legislation. However, I use supplements deemed useless that actually work. Medical people a still fighting over vitamin doses and efficacy.
1
"Saved from ourselves"--the most cogent comment I've heard on the US's societal need. . .
It was the aforementioned government that also decided that said supplements would not be subjected to requirements for rigorous testing to demonstrate efficacy, safety, and manufacturing purity before they could be marketed to US residents.
What a hero Dr. Kelsey was!
And, what a fine example of good, government regulation and dedicated public service.
And, what a fine example of good, government regulation and dedicated public service.
102
Attention Ron and Rand Paul: Looks like the libertarian 'invisible hand of the market place' didn't do its job.
Ron Paul is on record saying the FDA should be abolished, and its functions should be privatized.
Ron Paul is on record saying the FDA should be abolished, and its functions should be privatized.
224
And these are Medical Doctors...
3
Looks like the doctor is in bed with the big pharma, and does not believe in first do no harm. What a jerk!
1
There is a pathology in the thinking of an OB-GYN of Ron Paul's age, who HAD to have been exposed to the entire thalidomide debacle early in his career to believe that drug manufacturers can police themselves (as that other Libertarian Alan Greenspan testified he believed the banks could, too) AND to oppose a woman's right to an abortion when her fetus has been horribly defored by a drug.
2
It's a historical irony that thalidomide is now approved and widely used to treat the blood cancer multiple myeloma, as are thalidomide derivatives lenalidomide and pomalidomide.
15
Even more ironic, it's a near-miracle drug in Hansen's Disease, the limb scourge formerly known as leprosy.
1
Yes, it is a bit ironic. However, these diseases typically occur in patient populations, mostly older adults, who are unlikely to become pregnant. Plus, there is extensive education given to patients (and their partners) about proper handling of thalidomide and its derivative medications, and the imperative to avoid pregnancy while on treatment. Most (all?) anti-cancer treatments have serious side effects, which makes sense given that they're intended to kill cells. It all comes down to evaluating the risk-benefit of any medication and proper counseling of patients.
The evil in the whole thalidomide tragedy is not the compound itself, which clearly has therapeutic value, but the overwhelming greed and complete lack of ethics on the part of Merrill and the German creator of the compound, Grunenthal. Dr. Kelsey is truly a hero for standing up to them in the face of overwhelming pressure.
The evil in the whole thalidomide tragedy is not the compound itself, which clearly has therapeutic value, but the overwhelming greed and complete lack of ethics on the part of Merrill and the German creator of the compound, Grunenthal. Dr. Kelsey is truly a hero for standing up to them in the face of overwhelming pressure.
2
Nope, not ironic. In 1848 Louis Pasteur determined that crystals could be left or right handed. The problem with thalidomide was no-one could figure out why some fetuses were affected, but others not.
It turned out to be a production event: it was safe & effective if the crystals formed with a particular handedness (can't recall which way).
BTW the company that developed thalidomide didn't bother doing animal testing. When subsequent researchers used mice, the kits were born damaged, but randomly.
I was just emerging from childhood when this nightmare struck. Even now, decades beyond the risk of pregnancy, I gag at the thought of swallowing thalidomide.
Dr Kelsey is precisely the kind of person conservatives wish to silence, people having such less value to profits.
It turned out to be a production event: it was safe & effective if the crystals formed with a particular handedness (can't recall which way).
BTW the company that developed thalidomide didn't bother doing animal testing. When subsequent researchers used mice, the kits were born damaged, but randomly.
I was just emerging from childhood when this nightmare struck. Even now, decades beyond the risk of pregnancy, I gag at the thought of swallowing thalidomide.
Dr Kelsey is precisely the kind of person conservatives wish to silence, people having such less value to profits.
1
Vote for Republicans and we will then never have to worry about bureaucrats stifling the market like this woman did. The Market knows all. Signed Ayn Rand.
99
I'm quite certain that conservatives despised this 'stubborn, fussy' woman.
50
How was Dr. Kelsey's non-use of cosmetics in any way relevant to her extraordinary accomplishments?
120
She may not have wanted to coat her skin and line her eyelids and lips with chemical compounds that were outside FDA supervision.
5
It showed her independence from social norms of the time. It showed that it was possible for a woman to beat the sttep odds at that time, to have professional success not based on appearance or conforming to social norms.
Her acheivements were due to intellect and commitment to high standards.
Her acheivements were due to intellect and commitment to high standards.
2
This one time, it's absolutely pertinent. The FDA regulated their safety. An MD who also held a doctorate in Pharmacology would know enough to scare the blush right back in the pan.
This is a level of fortitude that is inspiring - to withstand such pressure and to stick to the facts and science, it's truly incredible.
194
Yes. I've studied and worked in science for a half century and can name no other scientist in this time who equals her in fortitude and character. I think you need go back to Louis Pasteur and other great scientists of there 19th century to find her equal.
1
Now, we need another heroine to trace the cause of autism.
9
God bless Dr. Kelsey, a woman who was not intimidated by the profit-seeking drug industry. She saved a generation of babies from severe birth defects. And as her integrity was obviously not for sale, I just figured out which woman I would like to see on the new ten-dollar bill!
363
100% in agreement. She is an unsung hero. I shudder to think how the corporate pharmaceutical wouls prevail today.
1
Hey, if you're Meryl Streep, you should consider playing her. I'm a playwright and science/med wonk. I'll write the script! No need to thank me now, thank me later.
It's helpful to know that she never wore cosmetics
30
Another candidate for the new ten dollar bills!
33
She never wore cosmetics? What a bizarre comment to include in the obituary of this brilliant and principled woman.
168
Perhaps it was important to Dr. Kelsey/her family to include the fact that she never wore cosmetics? And perhaps she avoided them because of their toxicity?
What a heroine, a great stickler, public servant, and former Canadian. Honoring her on U.S. currency? Not sure I agree when I think of the profits of Big -- HUGE -- Pharma.
What a heroine, a great stickler, public servant, and former Canadian. Honoring her on U.S. currency? Not sure I agree when I think of the profits of Big -- HUGE -- Pharma.
11
True, although the FDA does regulate cosmetics as well, so perhaps there's a warning in the anecdote somewhere...
10
She may have not trusted the cosmetics industry.
3
More big government. Can't the market take care of these sorts of things? Who needs the FDA?
14
I think that you have missed the point.
You ask: "Can't the market take care of these sorts of things?"
But who gets hurt in the meantime.
Think about it .......... clueless.
You ask: "Can't the market take care of these sorts of things?"
But who gets hurt in the meantime.
Think about it .......... clueless.
You're kidding, right? Tell me you're kidding. Please.
5
It was the unregulated market that gave Europe of the 1960's an epidemic of phocomelia. The unregulated market that gave us the Minamoto girl. Perhaps you want us to have the right to buy an automobile whose airbags explode with shrapnel, maiming, blinding, or killing the driver and/or the passenger. I suppose there is more than one interpretation of the public good.
19
I have arms and legs because of this woman's persistence and courage. How sad that the FDA of today has abandoned so much of the disinterested objectivity and integrity that Oldham Kelsey bequeathed it.
82
A proper way for the F.D.A. to honor Dr. Kelsey legacy would be to suggest and promote a legal framework to test the effectiveness and long-term safety of all over the counter "drugs."
31
Frances Oldham Kelsey ---- what a real-life saint !
31
Dr. Kelsey! - an American hero and an immigrant to boot. To this day regulatory agencies battle companies over adequate data, standards, testing protocols, public safety, and every aspect of the public good. This is not just the FDA, one of the most beleaguered, but EPA, NHTSA and others. These agencies garner huge amounts of scorn from too many today, especially Republicans, yet they prevent so much mortality, morbidity and tragedy. They deserve our support! RIP Dr. Kelsey!
266
The regulatory agencies, including the FDA, the USDA, the EPA and others, are seriously underfunded. I appreciate the support President Obama has shown for the EPA, but those whose job it is to protect people and research animals lack resources and backing.
Dr. Kelsey was a hero. She did the right thing. I'm glad she received recognition and lived to see changes made that outlive her. Those changes continue to be threatened, though, and must be vigorously defended.
Dr. Kelsey was a hero. She did the right thing. I'm glad she received recognition and lived to see changes made that outlive her. Those changes continue to be threatened, though, and must be vigorously defended.
2
She was a LEGAL immigrant. What is your point?
A true leader among the men and women of science, Dr. Kelsey understood clearly what protecting the public health is all about. She saved the U.S. from the scourge of thalidomide but was unable to spare her country of birth, where we lived when I was a child. My father saved in his personal documents, a manuscript written about her by an unknown author, typed on a manual typewriter. I discovered this after his death and only realized then how deep was his horror at how close we had come to the fate of many families north of the border. The FDA was and should be our gatekeeper. She is a heroine and her name should always remind this country of the importance of individuals in our government who are willing to forgo the easy path and do the right thing.
81
What a remarkable woman! I was born in 1961 - there but for the diligence of Dr. Kelsey go I...
40
I lived through the thalidomide horror and have always felt profoundly grateful for Dr Kelsey. I wish the conservatives who attack any form of government (save the military) would learn the lesson.
104
What a beautiful life! Thank you for this obituary.
26
What a great obit; thanks.
10
thank you for this fine article on a brave and conscientious woman. i did not know her story and i am a little richer for having read it.
not for this, however: "and never wore cosmetics". it seems no matter what a woman does, how she looked is going to always be a part of her obit.
not for this, however: "and never wore cosmetics". it seems no matter what a woman does, how she looked is going to always be a part of her obit.
64
She is a hero. She is an example of one of the many ways in which our government can serve the people and make our lives better. Drug and food testing, car safety, air and water quality - these and many other government activities improve make our world a safer place. Of course, today she would be called a "job killer', an impediment to the growth of the economy, an example of government interference in our lives. Just like Obama Care.
334
Actually, she was a called "job killer" at the time. She was a hero because she stood firmly on science, and had better sense than engage in the polemics you do by drawing the ACA/Obamacare not this discussion.
2
What an amazing thing she did at the FDA and what a life she led. Given that it was 1960 and she accomplished this in what must surely have been a male-dominated environment and industry at the time makes the fact that she stood her ground against Merrell simply remarkable.
154
If a change is made, Dr Kelsey should be a top candidate to replace Andrew Jackson on the $20 bill. She was elected to the National Women's Hall of fame, along with the better known former First Lady, Eleanor Roosevelt.
32
A story that periodically needs to be retold; we really dodged the bullet on this one. I hope eventually to see a prohibition against the advertizing of prescription drugs on TV; another indefensible practice.
98
I still remember the shocking photographs of the "thalidomide children." I applaud this amazing woman!! She is an inspiration to everyone everywhere. RIP Dr. Kelsey.
35
We need more people like Dr. Kelsey at the FDA. She had the courage to stand up to the drug manufacturers and not back down.
68