Why Dissent Matters

Because Some People See Things the Rest of Us Miss

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?

Because Some People See Things the Rest of Us Miss

The nature writer Rachel Carson identified an emerging environmental disaster and pulled the fire alarm. Public protests, individual dissenters, judges, and juries can change the world – and they do.

A wide-ranging and provocative work on controversial subjects, Why Dissent Matters tells a story of dissent and dissenters – people who have been attacked, bullied, ostracized, jailed, and, sometimes when it is all over, celebrated.

William Kaplan shows that dissent is noisy, messy, inconvenient, and almost always time-consuming, but that suppressing it is usually a mistake – it’s bad for the dissenter but worse for the rest of us. Drawing attention to the voices behind international protests such as Occupy Wall Street and Boycott, Divest, and Sanction, he contends that we don’t have to do what dissenters want, but we should listen to what they say. Our problems are not going away. There will always be abuses of power to confront, wrongs to right, and new opportunities for dissenting voices to say, “Stop, listen to me.” Why Dissent Matters may well lead to a different and more just future.

Read This is Dr. Frances Kelsey’s story, the globe and mail, MAY 11, 2017.

Problems of Birth Defects

From Hippocrates to Thalidomide and After

From Hippocrates to thalidomide and after : original papers with commentaries by T.V.N. Persaud

A collection of 57 papers and commentaries, arranged in eight sections, discuss the historical aspects, epidemiology, mechanisms, genetics, etiology, prenatal diagnosis, management, and social aspects of birth defects.

  • Paperback: 399 pages
  • Publisher: University Park Press (1977).
  1. Beliefs, Mythology, Magic and Superstition.
    • Congenital malformations in the past.
    • A brief history of teratology to the early 20th century.
  2. Epidemiology of Birth Defects.
    • Classification and nomenclature of morphological defects.
    • Epidemiologic aspects of the problem of congenital malformations.
    • Congenital malformations. A report of a study of series of consecutive births in 24 centres. (Extracts).
    • The incidence of developmental and other genetic abnormalities.
  3. Teratological Mechanisms.
    • Interrelation of the common congenital malformations. Some aetiological implications.
    • Defective regulatory mechanisms in teratogenesis.
    • Mechanisms of teratogenesis.
    • Congenital postural deformities: perinatal associations.
  4. Cytogenetic and Chromosomal Studies.
    • A morphological distinction between neurones of the male and female, and the behaviour of the nucleolar satellite during accelerated nucleoprotein synthesis.
    • The detection of chromosomal sex in hermaphrodites from a skin biopsy.
    • The chromosome number of man.
    • Retrospective and prospective epidemiological studies of 1500 karyotyped spontaneous human abortions.
    • Chromosome abnormality and perinatal death.
    • Cytogenetics of fetal wastage.
    • Spontaneous abortion and aging of human ova and spermatozoa.
    • Where have all the conceptions gone?
    • Genetics of common disorders.
    • Genetic hazards to man from environmental agents.
  5. Environmental Influences and Congenital Abnormalities.
    • Pigs born without eye balls.
    • Congenital cataract following German measles in the mother.
    • The role of viruses in congenital defects.
    • Congenital toxoplasmosis. A prospective study of 378 pregnancies.
    • Therapeutic abortions with a folic acid antagonist, 4-aminopteroyl-glutamic acid (4-amino P.G.A.) administered by the oral route. (Extract).
    • Diskussionsbemerkung von Privatdozent Dr. W. Lenz, Hamburg, zu dem Vortrag von R. A. Pfeiffer und K. Kosenow: Zur Frage der exogenen Entstehung schwerer Extremitatenmissbildungen.
    • Thalidomide and congenital abnormalities.
    • Foetal malformations due to thalidomide.
    • Nonadrenal female pseudohermaphrodism after administration of testosterone to mother during pregnancy.
    • Masculinization of female fetus due to use of orally given progestins.-
    • Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women.
    • Are anti-epileptics harmful in pregnancy? (Extract).
    • Anticonvulsant drugs and congenital abnormalities.
    • Congenital abnormalities and anticonvulsant drugs.
    • A clinical look at the problem of drugs in pregnancy and their effect on the fetus.
    • Intra-uterine methylmercury poisoning in Iraq.
    • Assessing the impact of low level chemicals on development: behavioral and latent effects.
    • A preliminary report of cigarette smoking and the incidence of prematurity. (Extract).
    • Effect of mothers’ smoking habits on birth weight of their children.
    • The fetal alcohol syndrome.
    • Potatoes and spina bifida.
    • The outcome of 625 pregnancies in women subjected to pelvic radium or roentgen irradiation. (Extract).
    • Radiation and pregnancy.
  6. Detection of Environmental Teratogens.
    • Environmental factors in the etiology of human malformations: perspectives and problems of evaluation.
    • Hazards of the first nine months: an epidemiologist’s nightmare.
  7. Prenatal Diagnosis and Management of Congenital Abnormalities.
    • Prenatal diagnosis of genetic disorders. An analysis of experience with 600 cases.
    • Prenatal diagnosis of mongolism by X-ray.
    • Diagnosis of congenital fetal abnormalities by sonography.
    • Amniography for detection of congenital malformations.
    • Diagnosis of human fetal abnormalities by fetography.
    • Genetic counselling-or what can we tell parents?.
    • Pre-, peri- and postnatal prevention of major neuropediatric handicaps.
  8. Social, Ethical, and Medico-Legal Problems.
    • Moral and ethical problems of pre-natal diagnosis.
    • Attitudes toward defective newborns.
    • Ethical and social aspects of treatment of spina bifida.
    • Moral and ethical dilemmas in the special-care nursery.
    • Further References.
More DES DiEthylStilbestrol Resources

Time Bomb: a Journey into Old Exposures, Gametic Glitches, and the Autism Explosion

Slides from Society for Neuroscience Wonder, February 2017

This presentation to a student-run chapter of SFN explained the history and science behind the “Time Bomb” hypothesis of autism.

DES DiEthylStilbestrol Resources

Out of the Past

Old Exposures, Heritable Effects, and Emerging Concepts for Autism Research

The presentation highlights a significant gap in autism research: what factors might be driving the heterogenous de novo genomic errors seen in autism?

Sources:
More DES DiEthylStilbestrol Resources

A snapshot of the thalidomide tragedy

An infographic via “The Conversation”

infographic snapshot-of-the-thalidomide
The Conversation is an independent news and commentary website produced by academics and journalists. Free to read and republish.
Health infographics
Related posts

Dr Frances Oldham Kelsey: 20th-century American heroine for her role in the Thalidomide case

Frances Oldham Kelsey, F.D.A. stickler who saved U.S. babies from Thalidomide, dies at 101

Dr-Frances-Oldham-Kelsey
Dr Frances Oldham Kelsey, the Canadian doctor who played a central role in preventing the drug thalidomide being distributed in the US, has died at 101. Image of Kelsey with President John F. Kennedy signing the 1962 Drug Amendments (FDA051) by the The U.S. Food and Drug Administration.

A Londoner who’s kept the scourge of thalidomide out of the United States has died, leaving behind a legacy of achievement that made her a heroine south of the border.

In 1962, President John F. Kennedy awarded Kelsey the highest honour given to a civilian in the U.S., the President’s Award for Distinguished Federal Civilian Service. Kelsey was only the second woman to receive the award. The new laws would pass and Kelsey would play a leading role giving them force.

Dr Frances Kelsey spent her final years here with family after a trail-blazing career that once led the Baltimore Post-Examiner to call her America’s greatest living heroine.

Sources and more information
  • Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide,
    Dies at 101
    , NYtimes, AUG. 7, 2015.
  • Frances Oldham Kelsey – a true American hero turns 100,
    Baltimore Post-Examiner, July 26, 2014.
  • America’s Greatest Living Heroine Frances Oldham Kelsey – 98 and forgotten,
    Baltimore Post-Examiner, February 11, 2013.
  • Thalidomide and the 1962 Kefauver-Harris Drug Amendments, FDA.
  • About the life and work of Dr. Kelsey: Autobiographical Reflections, FDA.

Thalidomide: how men who blighted lives of thousands evaded justice

Documents raise fresh questions about thalidomide criminal trial

Harold Evans cartoon image
Sir Harold Evans’ paper is about newly exposed files showing how victims were betrayed by political interference in trial – and how the pill has remained on sale .

The dark shadow of thalidomide is still with us. The original catastrophe maimed 20,000 babies and killed 80,000… …Now evidence has been uncovered that the pharmaceutical outrage was compounded by a judicial scandal that has suppurated all these years.

Documents recently unearthed by the UK’s Thalidomide Trust will surely stoke fresh controversy about how and why the criminal trial against the drug’s makers ended without a verdict in December 1970.

And more than half a century since the pill’s threat to an embryo was proven, the company that produced the first disaster has continued to sell the drug in parts of Latin America. ”

No Hand to Hold and No Legs to Dance on, by Louise Medus

A Thalidomide survivor’s story, a triumph of the human spirit over adversity

no hands to hold and no legs to dance on book cover image
A Thalidomide survivor’s story, by Louise Medus.

While the battle for the compensation of Thalidomide victims was raging in the 1970s and is still very much in the news today, former Labour MP Jack Ashley asked in a parliamentary debate how Louise, then 11 years old, could look forward to ‘laughing and loving with no hand to hold and no legs to dance on‘.

Louise was born Louise Mason, a victim of the devastating drug Thalidomide. Born without arms and legs, she is the daughter of David Mason, who single-handedly held out against the drug company, the legal establishment and all the other parents of Thalidomide victims in the high-profile fight for proper compensation for the victims.

As she was photographed with her family and appeared on television meeting celebrities during the battle, few people realised that she did not live with her wealthy parents and three siblings at their spacious North London home but was being brought up in an institution, Chailey Heritage in Sussex. In fact, Louise had never gone home from hospital and, for the first five weeks of her life, her mother didn’t even see her.

This is a survivor’s story, a triumph of the human spirit over adversity. Louise married John, a partially sighted man, and had two beautiful children. She was devastated when she discovered that he was having an affair with their carer. She also had to undergo a kidney transplant, the first Thalidomide victim to do so. She has worked, been an active disability rights campaigner and has now found new love, with Darren, a fellow Thalidomide victim who was born without arms.

More Information
On Flickr®

Thalidomide – The Fifty Year Fight

After 52 years of injustice this is the Thalidomide survivors’ campaign against the German government and thalidomide manufacturer Grunenthal

the fifty year fight image
If you’re a member of the public and would like to help please contact both your MP and MEP to let them know you’re fully supportive and ask them to help the Campaign.

After 52 years of injustice this is the Thalidomide survivors’ campaign against the German government and thalidomide manufacturer Grunenthal.

FiftyYearFight.org Overview:

  • Why the Fifty Year Fight?
  • History
  • Timeline
  • Press Release – June 2014 – New Evidence
  • Health Reports Downloads
  • HOW YOU CAN GET INVOLVED
  • Meet Kevin, a Thalidomide survivor born without arms and legs
  • Meet Liz, Thalidomide survivor born without arms below the elbow

Visit fiftyyearfight.org and support @fiftyyearfight

Grunenthal and Sanofi Pharmaceutical Companies must face their obligations – 38 Degrees Petition

DRUG JUSTICE – PHARMACEUTICAL COMPANIES SHOULD PAY FOR THEIR MISTAKES

British thalidomider logo image
Campaigning to have Grunenthal and Sanofi face their obligations and to stop hiding behind the protection of European legislation, face their responsibility and their guilt, and pay adequate compensation to the thousands of victims affected by their #drugs.

We are campaigning to have Grunenthal and Sanofi face their obligations and to stop hiding behind the protection of European legislation, face their responsibility and their guilt, and pay adequate compensation to the thousands of victims affected by their drugs.

The drug thalidomide – marketed for pregnant women suffering with morning sickness – was invented and sold by a German pharmaceutical company called Grunenthal between 1957 and 1961. Thalidomide killed most babies in the womb and those who survived are severely injured and disabled. The drug Epilim (Sodium Valproate) was marketed in 1973 as a drug for Epilepsy and to date has affected approx. 20,000 babies in a similar disastrous way.

Grunenthal has never compensated any British thalidomider. We ask that Grunenthal face their responsibility and give financial compensation to thalidomide damaged people in the UK. Grunenthal’s CEO must sit down with the thalidomide representatives and discuss financial compensation not just for the suffering and pain of living with thalidomide but also for the ongoing extra costs of living with the pain caused by thalidomide

Read TO: GRUNENTHAL AND SANOFI – DRUG JUSTICE – PHARMACEUTICAL COMPANIES SHOULD PAY FOR THEIR MISTAKES, 38degrees.org.uk/petitions/
a Campaign created by Mikey Argy – SIGN THE PETITION.