PPS - Below is the history of thalidomide and America's greatest heroine Dr Frances Kelsey.

Concern over the tragic effects of the new sedative thalidomide prompts President Kennedy at his press conference to call for stronger better administered drug laws. He announces a staff increase for the FDA who's Dr Frances Kelsey kept it off the United States market. Asked about other safeguards he replies that the Food and Drug Administration have had nearly 200 people working on this. Every doctor, every hospital, every nurse have been notified "Every woman in this country I think must be aware that it's most important that they check their medicine cabinet and that they do not take this drug and they turn it in. Every citizen of course should be aware of the hazards and I'm sure they are now. Now what we have to concern ourselves about is firstly, of appreciation to Dr Kelsey who spared us this terrible human tragedy which has been visited on families in Germany, and to provide both administrative and legislative safeguards to lessen the chance of such action coming in this country again. Also, to see if we can assist other countries in still providing effective safeguards for their own citizens because the interrelationship between them and us is very intimate.

Thalidomide... Was this just an innocent case of a tranquilizer turning out to have monstrous side-effects on children to be born? Or was something uglier at work in its destructive career?... They argue that thalidomide was known to be dangerous (for the damage it could do to the nervous system) when it was put on the market: that the threat represented to children in the womb was recognized for some time before it was withdrawn.... The authors do not hesitate to name the scientists working for the companies and quote from their evidence and memoranda. Their story strongly suggests that the mysteries of science may place too much power in the hands of those who are out for profits, and in their final chapter they propose ways of preventing the tragic case of thalidomide being repeated.

On 12 September 1960, Richardson-Merrell Inc, submitted material for an application of registration of thalidomide to the US Federal Food and Drug Administration, but they were unable to convince the officials that the product was safe for use, especially during pregnancy. Nevbertheless, they continued to make great efforts to secure positive reports from clinical investigators throughout the USA to bring about registration by FDA; their campaign is outlined in a manual entitled the 'Kevadon-Hospital Clinical Program'. ('Kevadon' was the name used by the Merrell company in Canada for the drug)...

'The objective of the Kevadon Hospital Clinical Program are threefold' the manual explained:... The manual then proceeded to instruct 'how to influence people'..."Appeal to the doctor's ego -- we think he is important enough to be selected as one of the first to use Kevadon in that section of the country...

page 114 ...Dr Kelsey's suspiciouns had been aroused when she heard about the reports of peripheral neuritis published in the British Medical Journal... In a letter to Merrell the reasons for Kelsey's reluctance to clear thalidomide are further expanded: "...The application is incomplete under section 505(b)(1) of the act as follows: It fails to report the animal studies in full detail. In particular we note the incomplete nature of the long-term animal toxicity experiments which are still in progress. It is felt that complete autopsy reports, includihng appropriate histologic studies of the central and peripheral nervous systems, should be availabe on these animals after they have received the drug for at least 1 year. This seems particularly indicated in view of the recent reports that prolonged use of this drug may give rise to peripheral sensory neuropathy in patients... In this connection, we are asking you to submit a complete list of investigators to whom the drug has been furnished so that we can ascertain whether similar adverse effects have been recorded with shorter term usse of the drug. Since the application is incomplete under section 505(b)(1) of the act, it may not be filed ass an application provided for in section 505(b)

page 115 ...On 27 February 1961 Dr Murray of Richardson Merrell was in touch with von Scvchrader-Beilstein on the telephone. He told him, 'The FDA has referred to a publication in the British Medical Journal both on the telephone and in writing, and we are considering whether to carry out toxicity trials over a longer period or to include a polyneuritis warning in the package inserts. In the latter case discussions must first be held with the FDA who must then give authorization'...

page 122 ...At this same conference Dr Kelsey brought out a new aspect of toxic potentialities of the drug. Could the company furnish evidence that thalidomide was safe when used during pregnancy? If the nervous system of adults could be damaged by thalidomide, what about the sensitive tissues of the foetus? The problem of the effect of thalidomide on the foetus was evidently not new to the Richardson-Merrel Co....

In the 1950s, millions of people all over the world were looking for something to make them feel better. The demand for barbiturates, sleeping pills and amphetamines was huge -- and growing. Most of the sedatives were barbiturates, which made people feel relaxed and euphoric, but the death toll from overdoses, deliberate and accidental, was rising. Thalidomide promised to change all that: Marketed under the trade name Contergan in West Germany, Distaval in Britain and Talimol in Canada, it may have been the best sleeping pill ever invented: It actually cured insomnia and provided prompt, deep and natural sleep. It also relieved pain, headaches, coughs and colds. It was especially effective for pregnant women suffering from morning sickness. The manufacturer insisted there were no side effects.

In 1960, Frances Kelsey was a recently appointed medical reviewer at the U.S. Food and Drug Administration. The new drug application (NDA) for thalidomide was her second file. "They gave it to me because they thought it would be an easy one to start on", she said. "As it turned out, it wasn't all that easy". Frances Oldham was born on July 24, 1914, in Cobble Hill -- a village just north of Victoria on Vancouver Island. Her English father, Colonel Frank Trevor Oldham, a retired British Army officer, had married a young Scotswoman, Frances Katherine Stuart. Their daughter was one smart tomboy, graduating from high school when she was only 15. "I always knew I'd be some kind of scientist," she recalled. Frances Kelsey received her PhD in pharmacology in 1938 from the University of Chicago. At war's end, she began medical school there. She accepted a position with the Journal of the American Medical Association and, together with her PhD supervisor Dr Geiling and her husband, Dr Ellis Kelsey, published Essentials of Pharmacology. Then, in 1960, a job offer arrived from the FDA's director of the Bureau of Medicine, Dr Ralph Smith, who, like Dr Kelsey, was from Canada and a pharmacologist.

Dr Kelsey, who had become an American citizen in the mid-1950s, began work in 1960 in Washington in a ratty, uncarpeted cubicle in a dingy temporary office building on the National Mall. She was appointed one of a handful of medical reviewers of new drug applications (NDAs). Dr Kelsey didn't know it at the time, but her predecessor, Dr Barbara Moulton, had quit the FDA in disgust because her superiors regularly overruled her. One month after Dr Kelsey was hired, the NDA for a drug called Kevadon, or thalidomide as it is better known, arrived at the FDA offices. The applicant was William Merrell Inc of Cincinnati, an American pharmaceutical company with plans to manufacture thalidomide under licence from Chemie Grunenthal, a family-owned West German company. As it turned out, Grunenthal had a record of rushing bad and inadequately tested drugs to market. The company claimed it was impossible to overdose on the drug. This claim was untrue: Taken in syrup form, thalidomide killed laboratory animals, but Merrell kept quiet about these results. There was another bonus: Thalidomide was not addictive, or so they said. The NDA rules required a decision from the FDA within 60 days. Merrell was so confident of speedy approval that it planned a massive marketing campaign for the beginning of March, 1961, and began to stockpile supplies. The long-term plan was for the drug to be made available over the counter, but first the FDA had to say yes.

Under the leadership of FDA Commissioner George P Larrick, the relationship between the regulator and the pharmaceutical industry was closer than it should have been. There was the usual wining and dining at the top, and from time to time the coziness decayed into outright criminality. One senior official was exposed in 1960 after he accepted more than $250,000 from the antibiotics industry. When the Merrell NDA arrived, three FDA employees were assigned to the file: Dr Kelsey, the medical officer; a chemist named Lee Geismar; and a pharmacologist, Oyam Jiro. Soon after they began their investigations, Ms Geismar and Mr Jiro had some concerns, and Dr Kelsey had a lot of questions. The way the approval system worked at the FDA, if staff identified issues within the 60 days, a notice could be sent requesting further information. The company would have to submit a new NDA, and the 60-day clock would begin to run all over again. Two days before the deadline, after which approval would be automatic if she did nothing, Dr Kelsey mailed a notice declaring the application incomplete; in her words, "the chronic toxicity data are incomplete and, therefore, no evaluation can be made of the safety of the drug when used for a prolonged period of time". She also asked for more information on the animal studies, and many other items. As one analyst has written, "Kelsey's doubts were piqued early on by the vagueness of the application and the grandiosity of the claims". Dr Kelsey was particularly concerned about the clinical trials and wanted more detail. "My job", she said at the time, "is to pick these new-drug applications to pieces". American law allowed the experimental use of drugs while the approval process was in process. Drug companies routinely sent free samples to doctors -- to begin laying the foundation for future sales. As for the patients, no informed consent was required by law.

When Dr Kelsey asked for more information, Merrell pushed back -- hard. Because of concerns that the FDA was captive to the industry, Commissioner Larrick had recently promised Congress that pharmaceutical companies would not be allowed to contact examiners during the approval process. That did not stop Merrell: On more than 50 occasions, aggressive industry representatives visited the FDA and hounded Dr Kelsey and the other medical reviewers. Sometimes they sent a good cop, offering assistance, and other times a threatening bad cop. Some representatives were accompanied by respected clinical investigators -- window dressing, really – to bolster their case. Company executives insisted that Dr Kelsey was depriving the American people of an amazing drug. They complained to Dr Kelsey's superiors that she was fussy, nitpicking, stubborn, unreasonable and obstructionist, a completely gendered critique that almost certainly would never have been applied to a man. "Most of the things they called me, you couldn't print", she said. It was clear to Dr Kelsey that Merrell considered her "an unreasonable female". Many pharmaceutical companies applied pressure to obtain FDA approval, but "in no instances was it as severe as with this application". But still she would not budge. Dr Kelsey's thorough approach seems to have "put her at odds" with older members of her organization. Internal disagreements have been described as a "civil war". But Dr Kelsey had the support of her boss -- Ralph Smith -- and she was not being obstinate without reason: She followed the best scientific practices. She conducted a thorough literature review, consulted colleagues and other researchers, carefully studied the underlying research design of Merrell's supporting studies, scrutinized thalidomide's chemical composition and stability, and did her best to verify Merrell's various claims.

In mid-January, 1961, Merrell resubmitted the Kevadon NDA. All the questions about the drug's metabolism, excretion, absorption levels and toxicity remained unanswered. Dr Kelsey was not prepared to rush: It was a sleeping pill, after all, and plenty of safe brands were already available. Then, in late January or early February, she read a short letter in the British Medical Journal from a Dr A Leslie Florence. Titled "Is Thalidomide To Blame?" Dr Florence reported that some patients taking thalidomide were experiencing peripheral neuritis -- a painful tingling in the arms and legs. Although a pharmacologist and a physician, Dr Kelsey could make no sense of this report from any scientific or medical perspective. "Peripheral neuritis did not seem the sort of side effect that should come from a simple sleeping pill", she reasoned. Dr Kelsey got some reassurance at home. Her husband was a respected scientist in his own right. He looked at the revised NDA and described it as a "collection of meaningless, pseudoscientific jargon, apparently intended to impress chemically unsophisticated readers". It was worse than bad: "I cannot believe this to be honest incompetence", he concluded. Relieved to have her suspicions confirmed, Dr Kelsey deemed the second application incomplete.

Again she wrote Merrell asking for additional information and more proof about safety. Dr Kelsey soon learned that the side effects mentioned in the doctor's letter were already documented in Europe, though they had never been mentioned in the NDA. When Grunenthal's American representative was asked about them, he replied, like Sergeant Schultz in Hogan's Heroes, that he knew nothing. "I had the feeling", Dr Kelsey wrote after one meeting with company representatives, "that they were at no time being wholly frank with me". Merrell then made matters worse by claiming, after an investigation, including a trip to England and West Germany, that the reports about neuritis proved not to be serious, and were, Grunenthal advised, reversible; moreover, they were possibly connected to vitamin deficiencies and poor diet, not to thalidomide. The truth, however, was that the side effects were severe, widespread and directly related to the drug.

Although Dr Kelsey had no way of knowing, by the time Dr Florence's letter was published, Grunenthal had received hundreds of reports of severe peripheral neuritis attributable to thalidomide, and 1,500 reports of other side effects, all of which the company summarily dismissed. Privately, however, the company was worried, and with good reason. It took a baby step and ended over-the-counter sales in Germany, but it was too little and too late. Documents uncovered as part of a class-action lawsuit in Australia started by a thalidomide victim named Lynette Rowe revealed that Grunenthal's lawyers were, at the time, repeatedly warning it of a legal "avalanche coming at us". As if on cue, the West German medical press was soon filled with articles about the dangers of thalidomide. It was now revealed that doctors, including those paid by Grunenthal to test the drug, had complained from the start about its safety. In response to these complaints, Grunenthal always played dumb: "We feel obliged to say that this is the first time such effects have been reported to us" was a standard and completely untrue response. Based on Dr Florence's letter alone, however, Dr Kelsey had demanded all the background clinical reports and research. When Merrell failed to follow through on its promise to provide the documentation, Dr Kelsey became convinced that thalidomide really was too good to be true.

In April, 1961, Merrell changed tack with its application for approval. Thalidomide might have problems, company representatives advised Dr Kelsey, but it was better than most barbiturates that were commonly used to induce sleep. It now admitted that its own studies had shown that rats could be killed by the drug. Dr Kelsey asked the company point blank how it could submit an NDA without disclosing the evidence of neurological toxicity. In her opinion, it was impossible to approve this application: The animal and clinical studies were unpersuasive and incomplete, there was no proof the drug was safe, and information indicating other problems had been withheld. But Merrell did not see it that way. "They thought I was nuts", Dr Kelsey recalled. When she wrote Merrell observing that "evidence with respect to the occurrence of peripheral neuritis in England was known to you but not forthrightly disclosed in the application", the company appealed to her boss and grumbled about "libel" and the "meddlesome fool" who was standing in their way. Still Dr Kelsey would not give in -- and upped the ante.

Just at this time the FDA was becoming interested in the effect of drugs on fetuses and had begun to develop guidelines. Dr Kelsey knew from her time at Chicago, when working in Dr Geiling's laboratory, that drugs affected adult rabbits and rabbit fetuses differently. She also knew that drugs could and did pass through the placental barrier. Some drugs caused malformations, or teratogen, in fetuses. When steroid hormones were prescribed in threatened miscarriages, for instance, some babies were born with heightened masculine qualities. This was not rocket science, but established science. There were hundreds of published papers, references in leading texts and international medical conferences devoted to the phenomenon. Dr Kelsey now asked Merrell about thalidomide in pregnancy. "Here was a drug that, given for three or four months, could cause severe neuropathy. With thalidomide, a growing infant might, perhaps, be exposed to it for five or six or up to nine months", she remarked, and so she wanted to know whether it might have an adverse effect on a child. Merrell had no answer. Apart from one study conducted during late pregnancy, the company had not even considered the question. It later turned out that thalidomide, even a single pill, caused deformities if taken between the 27th and 40th day after conception. Testing for birth defects should have been normative. Merrell had conducted reproductive testing on several of its drugs, but not this one, having relied on Grunenthal's assurances. While Grunenthal would endlessly repeat that it followed best practices, this was not so. The one thing Grunenthal did say that was correct was that there was, at the time, no legal obligation to conduct these tests. Maybe that is why Merrell rejected Dr Kelsey's invitation to conduct a study, offering instead, in return for FDA approval, to put a warning on the label that thalidomide should not be taken during pregnancy and that peripheral neuritis was one possible side effect. When this offer was rejected, Merrell "ordered" Dr Kelsey to approve the drug within one week or else, and provided some of what would soon turn out to be completely fabricated studies attesting to thalidomide's safety. Again, she stood firm: If the drug could save lives, that would have been one thing, but it was just a sedative in a market saturated with them. "The field of usefulness of the drug is such that untoward reactions would be highly inexcusable", Dr. Kelsey replied coolly. By now a year had passed since Merrell first submitted the NDA for thalidomide in September 1960. Formal approval had been prevented by a slim, well-mannered and shy woman who turned out to be an obstreperous and obdurate bureaucrat -- at least in the manufacturer's eyes.

Then, quite suddenly, the news came in from Europe about horrible deformities. In November, 1961, a German pediatrician, Widukind Lenz, head of the children's clinic at Hamburg University, determined that a growing number of mothers with deformed children had taken thalidomide during their first trimester -- the period scientists call organogenesis, when limbs and organs are formed. Dr Lenz called Grunenthal and spoke to the chemist, Heinrich Muckter, who was disturbingly nonchalant. Dr Lenz thereupon put his concerns in writing to Grunenthal, outlining the epidemic of a "certain type of deformity" that could be traced back to 1957. The one common denominator was thalidomide. At almost this exact moment, information came in from Australia that left no doubt that thalidomide was causing serious side effects (as did private reports from the British manufacturer). The German press got hold of the story, which became big news throughout the fall of 1962. Welt am Sonntag (World on Sunday) reported that a popular sleeping drug was injuring babies. It did not have to name thalidomide -- everyone knew. And so it was that Grunenthal finally agreed to withdraw the drug. Reports of massive numbers of birth defects, spontaneous abortions and stillbirths began to come in from all over the globe. Astonishingly, Grunenthal continued international marketing until the end of January 1963. Some countries like Canada dithered and dallied: There were 30 more victims before regulatory authorities finally woke up in March 1962 (including some truly remarkable Canadians like Fiona Sampson, the tireless human-rights advocate who received the Order of Canada in 2015).

Around the world, in contrast to the United States, the thalidomide story was just starting. It is hard to know for sure, but perhaps as many as 10,000 people were affected in about 50 countries, not counting the thousands of spontaneous abortions and stillbirths. Many infants did not survive their first birthday. Whole families were destroyed by the guilt, shame, rage and terror. The financial burdens were overwhelming. In Canada the situation was made much worse than it should have been. Thalidomide was not ordered off the shelves until March 1962, and it could still be found in some pharmacies as late as mid-May, three months after West Germany, England and dozens of other countries had banned its sale. In April 1962, notwithstanding the weight of the evidence, the head of Canada's Food and Drug Directorate mused that thalidomide approval might be reinstated. Fortunately, saner heads prevailed. Today, estimates indicate that there are about 3,000 survivors worldwide, with just less than 100 in Canada. While formally approved for sale in April 1961, free samples of thalidomide had been given to doctors as early as 1959. Senseless tragedy could have easily been avoided if Canadian regulators had exercised proper vigilance.

There were lawsuits and demands for justice. It was not easy anywhere; it was a pitched fight everywhere. In Britain, survivors now receive an annual pension of around $88,000 a year. In West Germany, it's about $110,000 a year. In Canada, the then minister of health, Jay Waldo Monteith, promised in 1963 to care for the victims in "the best possible manner", which apparently meant doing nothing. Canada provided a one-time payment in 1991 -- a pittance -- and the process was a farce. Desperate people in financial need will often compromise their legitimate claims. Many survivors were in terrible shape. By and large, they could no longer rely on their parents -- some abandoned them immediately, others struggled and did their best, but almost all are now deceased. Many of the victims were too disabled ever to work -- the average annual income was only $14,000 -- and most of them endured decades of grinding poverty and social isolation, fear and shame. All of them experienced a lifetime of chronic pain and physical ailments. That changed in May, 2015, when the Conservative government of Stephen Harper, bowing to public and media pressure, and in one of the few compassionate actions in its entire 10-year term, and thanks in large part to Health Minister Rona Ambrose, announced a generous funding package. It did not go as far as the victims and their advocates had requested, but it was a long overdue step in the right direction.

The thalidomide tragedy was averted in the United States because Dr Kelsey, alone and in the face of fierce opposition, did her job. Her perspective was educated, fresh and unique. If there had been no thalidomide crisis, the United States, with the rest of the world following, would still at some time have brought pharmaceutical regulation into the 20th century. But thalidomide created one of those moments when something had to be done. It could not be ignored in 1961-62, and it led immediately to a better and stronger regulatory system. Maybe someone else would have stopped thalidomide in the United States had Dr Kelsey not been assigned the NDA, but, interestingly, no one else stopped it anywhere else until it was too late. Dr Kelsey was the only person in the entire world who said no. She said no to a bad drug application, she said no to an overbearing pharmaceutical company and she said no to vested interests who put profits first. She was one brave dissenter. In the end, the question is not what made Frances Kelsey, but why aren't there more like her?

Frances Oldham Kelsey is old and frail now. At 98, she lives quietly in her home in Chevy Chase, Maryland. Almost no one remembers her. Yet this soft-spoken, impeccably mannered Canadian lady is one of America's greatest heroes. She single-handedly prevented a national catastrophe that could have caused 20 times the death toll of al-Qaeda's attacks on 9/11. If you are between the ages of 53 and 55, or if you have parents or grandparents of that age, this gentle, careful meticulous scientist is the reason you are alive today. She is the reason you or your parents or grandparents were not born hideously deformed. You are here because Frances O Kelsey single-handedly kept the drug thalidomide away from America's pregnant mothers.

One of the greatest avoidable pharmaceutical disasters of modern times occurred in the late 1950s and early 1960s when at least 10,000 children in 46 countries (the figure may have been as high as 20,000) were born with appalling birth defects after their mothers had taken the new sedative and tranquilizer drug thalidomide which was also marketed as an antiemetic cure for morning sickness in pregnant women. Countless more expectant mothers suffered miscarriages. The figure certainly ran into the multiple thousands. The full toll was never established. The defects were appalling and they were as horrifying as many of the mutations caused by radiation from nuclear tests around the world. Babies were born without limbs and with other bizarre distortions of brain and body: Around half of them died within several months. All of the survivors required extensive specialized care for the rest of their short, terrible and agonizing lives. In Britain, by 2010, only 466 of them were still alive.

Thalidomide was developed by the CIBA pharmaceutical company in 1954 and introduced into general sale by the Gruenenthal Company in West Germany on October 1, 1957. It was introduced on the British commercial market in 1958 and was subsequently marketed under at least 37 different names around the world. Thalidomide was widely used especially in Britain and West Germany, as well as in other Western European nations and families in those countries were hit disproportionately by the tragedy. To add to the suffering, the giant Distillers Corporation used all its hundreds of millions of dollars of resources to try and out wait the suffering families in an effort to avoid paying them appropriate damages to help them care for the surviving children.

Had thalidomide been marketed in the United States, the consequences would have been infinitely worse. America at that time had almost three times the population of either Britain or West Germany. Its market for medications was far larger. The tradition of buying over-the-counter medications or getting prescriptions from doctors to combat morning sickness and other symptoms during pregnancy was far more widespread and new medicines were marketed far more aggressively than in Europe, especially on television. The number of monstrously-deformed babies that would have been born had thalidomide been approved for sale in the U.S. could have been five or six times the toll in Europe.

However, the United States, the home of free enterprise, which historically has usually had far less government health inspections and regulations than most European nations, was spared all of this suffering, even though the U.S. Food and Drug Administration (FDA) was woefully undermanned at the time. In an era of dramatic economic and scientific progress when new medications were coming out for the US domestic market on an unprecedented scale, the FDA had only seven full-time researchers and four young part-time assistants for them to work through the massive backlog of drugs awaiting certification. Kelsey was already an expert on teratogens which may cause deformities in babies. So she was assigned to review the application by the Richardson Merrill company for the commercial sale of thalidomide using the trade name Kevadon. It had already been approved in Canada and over 20 European and African countries. However, Kelsey was cautious, methodical and skeptical. An English study linking thalidomide to side effects on the nervous system bothered her. She insisted that the drug be carefully tested before she would approve it for public use.

The industry put massive pressure on the FDA, but the agency refused to approve the drug in the United States in 1960. Kelsey, the agency's newest reviewer, prevented a disaster by her refusal to clear thalidomide because documentation lacked concerning side effects. In this photo President Kennedy thanks her for her work.

She got no thanks for her caution. She was subjected to intense personal criticism and pressure to approve the drug. But she would not be rushed. Then, suddenly thousands of babies were born across Europe with horrific deformities of every kind. The cause was traced to their mothers taking thalidomide during their pregnancies. The drug could cross the placental barrier. Overnight, Kelsey went from being slandered and ridiculed as a power-hungry, bumbling government bureaucrat to hero. Eminent journalist Morton Mintz writing in The Washington Post correctly concluded that she had "prevented the birth of hundreds or indeed thousands of armless and legless children across America. Within a few months, a Democrat-controlled Congress imposed much stricter standards on the testing and distribution of new drugs.

Kelsey was unusual in being a hero who actually received her richly deserved recognition in good time. She didn't have to wait for decades or only be vindicated posthumously. President John F Kennedy awarded her the President's Award for Distinguished Civilian Service in 1962 and other honors followed. But then Kelsey was forgotten. She became a non-person in the American media and popular memory. In the Republican-conservative era, there was a loud, continuous rhetoric for decades ridiculing the need for sustained government regulation to ensure a safe and healthy society. And Kelsey's achievement in saving thousands of babies from early deaths or lives of monstrous suffering was dropped down an Orwellian memory hole.

Kelsey never became a folk-hero for the environmentalist movement the way Rachel Carson did for her book "Silent Spring". She never wrote a tear-jerking, romanticized potboiler with exaggerated claims the way Carson did. She was just a careful and rigorous scientist. So far no Hollywood alumni, not even Alec Baldwin, George Clooney or Jodie Foster, has shown any interest in dramatizing Kelsey's story as a movie or HBO mini-series. Shamefully, no American president for nearly half a century after John Kennedy recognized Kelsey's heroic work. She received honorable recognition from private associations but she was never awarded the Congressional Medal of Freedom. That went to such moral giants as Donald Rumsfeld, Tony Blair, Lucille Ball, hydrogen bomb creator Edward Teller and Rachel Carson, even though Carson's crusade against the pesticide DDT arguably led to the avoidable deaths of millions of African children from mosquito-borne malaria.

Being forgotten does not seem to have bothered Kelsey. She was happily married and raised two daughters. She continued to serve with distinction at the FDA for another 45 years, retiring only in 2005 at the age of 90. In 2010, the agency named its Dr Frances O Kelsey Drug Safety Excellence Award in her honor. In an age of triviality, real heroes are hard to find: Frances Kelsey's life and achievements fit that criterion. That's why it really doesn't matter that Tony Blair, Donald Rumsfeld and Edward Teller received the Presidential Medal of Freedom and she didn't: She will always be bigger than them.

At a press conference in Ottawa on Tuesday, a new organization, the Thalidomide Survivors' Task Group, said that at a meeting on Oct. 19, federal disabilities minister Kent Hehr "managed to insult and degrade us repeatedly". While those kinds of comments are sure to get the media's attention -- and they certainly did -- the group is demanding the federal government double the compensation it agreed to pay in 2015, pointing today to "the government's negligence". A documentary broadcast on CBC's Documentary Channel earlier this year, No Limits, says thalidomide "was the worst drug disaster in history", while in 2014 the Guardian called it a "pharmaceutical outrage". Thalidomide was first marketed in West Germany in 1957 by the Chemie Grunenthal company. The company promoted it as effective against a number of conditions but its primary use was as a sedative. Under the brand name Contergan, Grunenthal promoted the "absolute non-toxicity" and "safeness" of the drug. Thalidomide was soon given to pregnant women for nausea and morning sickness. In some countries it could be purchased without a prescription. Thalidomide was available in 46 countries, including Canada. Canadian doctors began to receive samples of thalidomide in 1959 but sales did not begin until April 1961, under the brand names Kevadon and Talimol. The licensee was the Merrell Company, based in the United States. By April 1961, there were already warnings about thalidomide and malformed babies, as well as nerve damage in adults. Thalidomide was not sold in the U.S. until 1998 (for treatment of complications related to leprosy, and in 2006 for multiple myeloma). A Canadian pharmacologist, Frances Oldham, is credited for blocking thalidomide approval in the U.S. when it was promoted as a wonder drug elsewhere. As an employee at the U.S. Food and Drug Administration, Oldham wasn't convinced the drug was safe. Oldham died in London, Ontario in 2015, aged 101.

A federal judge has locked in a compensation program for Canadians born with birth defects because of the drug thalidomide. Thalidomide was approved in Canada to treat morning sickness in pregnant women for less than a year in the early 1960s but it was available unofficially for several years both before and after that. The drug caused major problems in fetuses, particularly shortened and malformed limbs, and in 1990, the Canadian government set up one program to help people living with the consequences. In 2015, the federal government set up another, but it came under attack for demanding applicants prove they were eligible by supplying detailed documentation of things their mothers did more than 50 years before. After people who had been refused under that program filed a lawsuit, a third attempt in 2019 offered more money and somewhat looser standards -- roughly doubling the 135 people eligible for payments under the previous programs. The ruling by Federal Court Justice Michael Phelan locks in those payments and eligibility rules, and sets up an appeal process for people who are still denied compensation under the terms of a settlement between the government and the thalidomide victims. Though the judge accepts the settlement, his ruling says he's disappointed the federal government is insisting on limiting the period during which people eligible for compensation have to have been born. Alleged Thalidomide victims see hope in Federal budget. The government is resisting payouts to people whose mothers took thalidomide at "unauthorized" times, some by a matter of weeks. "Canada's explanation for its rigid approach, while coldly scientific, lacked the compassion for the individual which the government espoused", Phelan's ruling says, but acknowledges the judge can't change it without putting the whole settlement in jeopardy. "Regrettably, the Court is powerless to do anything about this issue, other than to encourage a compassionate reconsideration".

The defects were appalling and they were as horrifying as many of the mutations caused by radiation from nuclear tests around the world. Babies were born without limbs and with other bizarre distortions of brain and body: Around half of them died within several months. All of the survivors required extensive specialized care for the rest of their short, terrible and agonizing lives. In Britain, by 2010, only 466 of them were still alive. Thalidomide was developed by the CIBA pharmaceutical company in 1954 and introduced into general sale by the Gruenenthal Company in West Germany on October 1, 1957. It was introduced on the British commercial market in 1958 and was subsequently marketed under at least 37 different names around the world.

Capsules of the drug thalidomide are seen on April 7, 1998 at the Celgene Corp in Warren, New Jersey, printed with a symbol warning pregnant or soon-to-be pregnant women against use of the drug that had caused thousands of infant deformaties. A federal judge has locked in a federal compensation program for Canadians born with birth defects because of the drug Thalidomide. Thalidomide was officially approved to treat morning sickness in pregnant women in Canada for less than a year in the early 1960s but it was available unofficially for several years both before and afther that.

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BIG BROTHER BIO-CHEM WARFARE

OWED TO THE UNBORN

WHERE HAVE ALL OUR CHILDREN GONE?

JFK JUDGE WHITE PRO-LIFE

JFK TRUTHS & UNTRUTHS & JFK ASSASSINATION PUZZLE PIECES