Pregnancy + Drugs
Taking paracetamol while pregnant 'could harm your daughter's fertility': Study links popular painkiller to smaller ovaries and fewer eggs
- Female offspring had smaller ovaries and gave birth to fewer babies
- Prolonged use also causes levels of the hormone testosterone to plummet
- Medicines appeared to have a similar effect on subsequent generations
- Experts advise against prolonged use of the painkiller during pregnancy
Pregnant women who take common painkillers like paracetamol could unwittingly be putting the fertility of their daughters at risk, a study suggests.
Paracetamol is the most widely-used painkiller in the world - and is deemed the only painkiller that is safe for mothers-to-be
But tests found when a mother took paracetamol or was prescribed the aspirin-like drug indomethacin, her female offspring had fewer eggs than those not exposed to the medicines.
Previous research by the same Scottish scientists found paracetamol had lifelong effects on baby boys, raising their risk of everything from infertility to cancer.
They say mothers-to-be have become 'blasé' about paracetamol's potential dangers – have and urged them to think twice before taking the drug.
If the tablets are taken, they should be used in the lowest possible dose, for the shortest possible time, they add.
The new research, which was performed on rats, found mothers given paracetamol had daughters with smaller ovaries and who gave birth to smaller litters of babies.
Males were affected too, having fewer cells that give rise to sperm later in life.
However, their fertility recovered to normal levels by the time they matured into adults.
Despite the fact that foetal development is slower in humans than in rats, the scientists say the findings are significant given the similarity of the two species' reproductive systems.
Paracetamol is widely used to treat headaches, while prescription-only indomethacin reduces inflammation and the pain of fever and arthritis.
Study co-author Professor Richard Sharpe, from the University of Edinburgh's MRC Centre for Reproductive Health, said: 'It's important to remember that this study was conducted in rats, not humans. However, there are many similarities between the two reproductive systems.
'We now need to understand how these drugs affect a baby's reproductive development in the womb so that we can further understand their full effect.'
Rats were given the drugs over several days and experienced effects after one to four days.
As well as affecting a mother's immediate offspring, the medicines also appeared to have an impact on subsequent generations.
Granddaughters of the animals given the painkillers while pregnant also had smaller ovaries and altered reproductive function.
Some painkillers may affect the development of 'germ cells' that mature into eggs and sperm within the womb, according to the study published in the journal Scientific Reports.
The reason could be that the drugs act on hormones called prostaglandins which are known to regulate ovulation, the menstrual cycle, and the induction of labour.
The Royal College of Midwives said mothers-to-be should seek medical advice before taking paracetamol at all.
Several studies have suggested it interferes with the development of the male reproductive system while still in the womb.
This is important because it is thought that if this programming goes wrong, it has lifelong effects, putting the child at higher risk of a range of problems from genital birth defects to infertility and testicular cancer.
Testosterone, which is made in the testicles, is thought to be key to the whole process, so the researchers carried out an experiment designed to show if exposure to paracetamol in the womb cuts levels of the hormone.
Experiments on babies in the womb would be impossible, so the researchers have previously studied mice that had pieces of human foetal testicular tissue grafted onto them.
The animals were given paracetamol in doses equivalent to those taken by people and the amount of testosterone they made was measured.
Taking paracetamol for just one day had no effect on testosterone levels.
However, treatment three times a day for seven days caused it to almost halve, the journal Science Translational Medicine reports.
A second test confirmed levels of the male sex hormone had plummeted.
The researchers urged pregnant women to follow existing NHS guidance, which is to take paracetamol for at the lowest effective dose for the shortest possible time.
Co-author of the latest study Professor Richard Anderson, said: 'These studies involved the use of painkillers over a relatively long period.
'We now need to explore whether a shorter dose would have a similar effect, and how this information can be usefully translated to human use.'
The work was funded by the Medical Research Council and the Wellcome Trust.
Professor Adam Balen, chairman of the British Fertility Society, said: 'This is an interesting study of long-term use of paracetamol in pregnant rats and so, whilst we must be cautious extrapolating to humans, it is sensible for pregnant women to minimise use of paracetamol and other painkillers and seek medical advice if they experience problems with significant pain in pregnancy.'
The Medicines and Healthcare products Regulatory Agency (MHRA), which issues guidance on medicines, said the study findings would be 'carefully evaluated'.
A spokesman said: 'Women should avoid taking medicines during pregnancy unless absolutely necessary and should speak to their doctor, midwife or pharmacist before doing so.
'Paracetamol is generally considered to be a safe treatment for pain relief during pregnancy but should be taken at the lowest possible dose for the shortest time.'
Source : LaLeva.org (Jan. 2016)
Examination of Antidepressant Use in Late Pregnancy and Newborn Respiratory Disorder
An analysis of approximately 3.8 million pregnancies finds that use of antidepressants late in pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN), according to a study in the June 2 issue of JAMA. However, the absolute risk was small and the risk increase appears more modest than suggested in previous studies. PPHN is a rare but life-threatening condition that occurs when a newborn's circulation system doesn't adapt to breathing outside the womb.
Persistent pulmonary hypertension of the newborn is associated with substantial illness and death: 10 percent to 20 percent of affected infants will not survive, and infants who survive face serious long-term consequences, including chronic lung disease, seizures, and neurodevelopmental problems. An association between selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and risk of PPHN has been controversial since the U.S. Food and Drug Administration issued a public health advisory in 2006. Studies that found no increased risk tended to be small, raising the possibility that they had insufficient power to detect an increased risk, according to background information in the article.
Krista F. Huybrechts, M.S., Ph.D., of Brigham and Women's Hospital, Boston, and colleagues examined the risk of PPHN associated with both SSRI and non-SSRI antidepressants among 3,789,330 pregnant women enrolled in Medicaid (from 46 U.S. states and Washington, D.C.; data from 2000-2010).
Of the study population, 128,950 women (3.4 percent) used an antidepressant during the 90 days before delivery: 102,179 (2.7 percent) were exposed to an SSRI and 26,771 (0.7 percent) to a non-SSRI antidepressant. Overall, 20.8 per 10,000 infants not exposed to antidepressants during the last 90 days of pregnancy had PPHN compared with 31.0 per 10,000 infants exposed to antidepressants. This higher risk among exposed infants was observed for both SSRI (31.5 per 10,000 infants) and non-SSRI (29.1 per 10,000 infants) antidepressants.
Associations between antidepressant use and PPHN were decreased with adjustment for confounders (factors that can influence outcomes that may improperly skew the results).
“Evidence from this large study of publicly insured pregnant women may be consistent with a potential increased risk of PPHN associated with maternal use of SSRIs in late pregnancy. However the absolute risk was small, and the risk increase appears more modest than suggested in previous studies,” the authors write.
“The findings in the largest cohort studied to date, using advanced epidemiologic methods to mitigate confounding by the underlying psychiatric illness and its associated conditions and behaviors, suggest that the risk of PPHN associated with late pregnancy exposure to SSRI antidepressants—if present—is smaller than previous studies have reported. Clinicians and patients need to balance the potential small increase in the risk of PPHN, along with other risks that have been attributed to SSRI use during pregnancy, with the benefits attributable to these drugs in improving maternal health and well-being.”
Source : Newswise (June 2015)
FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
The U.S. Food and Drug Administration (FDA) is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, we evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. We urge pregnant women to always discuss all medicines with their health care professionals before using them.
Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother.1 Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy.
The published studies we reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy (see Data Summary section for more information about these studies):
- Prescription NSAIDs and the risk of miscarriage in the first half of pregnancy.2-6 Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
- Opioids, which are available only by prescription, and the risk of birth defects of the brain, spine, or spinal cord in babies born to women who took these products during the first trimester of pregnancy.7, 8Examples of opioids include oxycodone, hydrocodone, hydromorphone, morphine, and codeine.
- Acetaminophen in both OTC and prescription products and the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medicine at any time during pregnancy.9Acetaminophen is a common pain reducer and fever reducer found in hundreds of medicines including those used for colds, flu, allergies, and sleep.
Pregnant women should always consult with their health care professional before taking any prescription or OTC medicine. Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use. Health care professionals should continue to follow the recommendations in the drug labels when prescribing pain medicines to pregnant patients.
Source : FDA (January 2015)
Settlement reached in Boston lawsuit claiming mom's pregnancy drug caused 4 daughters' cancer
Eli Lilly and Co. has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country. A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the second day of testimony.
DES, or diethylstilbestrol, was prescribed to millions of pregnant women over three decades to prevent miscarriages, premature births and other problems. It was taken off the market in the early 1970s after it was linked to a rare vaginal cancer in women whose mothers used it. Studies later showed the drug didn't prevent miscarriages.
Attorney Aaron Levine, representing the Melnick sisters, told the jury during opening statements that Eli Lilly failed to test the drug's effect on fetuses before promoting it as a way to prevent miscarriages.
Lawyer James Dillon, for Indianapolis-based Eli Lilly, told the jury that there was no evidence the drug causes breast cancer in the daughters of women who took it.
Dillon also said that no medical records show that the mother of the Melnick sisters took DES or that, if she did take it, it was made by Eli Lilly. Leading researchers at the time recommended that DES be used for pregnant women who had consecutive miscarriages, he said.
DES was not patented and was made by many companies.
Boston attorney Andrew Meyer, who's handled numerous medical malpractice cases, said the settlement in this case could signal settlements in other cases.
"When one settles a case, they recognize they can lose it," he said. "The reason they can lose it is because there's enough evidence for the plaintiffs to be able to win it. So it's not just optics, it isn't."
Columbus, Ohio, resident Irene Sawyer also is suing Eli Lilly, alleging that her prenatal exposure to DES caused her breast cancer. She called the settlement "a huge victory" for DES daughters.
"The bottom line is that this company put out a drug without testing, without knowing the consequences of this drug," she said.
It's wonderful, she said, that drug companies "are starting to realize this is not right, that there are consequences."
The Melnick sisters, who grew up in Tresckow, Pa., said they all developed breast cancer in their 40s.
Levine told the jury that their mother did not take DES while pregnant with a fifth sister and that sister has not developed breast cancer.
The four Melnick sisters also had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Thousands of lawsuits have been filed alleging links between DES and vaginal cancer, cervical cancer and fertility problems. Many of those cases were settled.
Source : Star Tribune
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Attorney Says CDS Study of Birth Defects Implicates Popular Fertility Drug
Report on Clomid study vindicates lawyer's 35-year battle to warn about birth defect risk.
On July 18, 1975, Terence Mix appeared before an FDA advisory committee to testify about how Clomid (clomiphene citrate) posed a risk of birth defects to the human embryo. He had hoped at the time to draw public attention to the risk and to compel the drug's manufacturer to add a warning to its labeling. Little did he know that it would be another 35 years before his message would reach the general public. But on November 26, 2010, the journal, "Human Reproduction," published over the internet the results of a study by the Centers for Disease Control and Prevention (CDC) that found a significant increased risk with 9 different types of birth defects following use of the popular fertility drug.
The implicated abnormalities included anencephaly (open cranium with absence of a brain), esophageal atresia (closed esophagus), omphalocele (protrusion of part of the intestine through the abdominal wall), craniosynostosis (premature fusion of the skull bones), 3 different types of heart defects and a defect of the brain (Dandy Walker malformation). The ninth defect (cloacal exstrophy) involves multiple abnormalities of the gastrointestinal and genitourinary tracts.
Drawing on 8 years of data from the National Birth Defects Prevention Study, CDC epidemiologist Dr. Jennita Reefhuis and her colleagues compared the drug's exposure to 36 types of birth defects with those of 6,500 live born babies born without major birth anomalies, used as controls. No less than 22 of the remaining 27 birth defect categories likewise showed an increased risk, ranging from 10% up to 170% after exposure to Clomid, although the numbers were insufficient to reach the scientific standard for "statistical significance."
Recalling his early efforts, Mix expressed his frustration. "I was winning most of the battles," he said, "but not the war." The trial attorney had recently won a big verdict against the manufacturer of the drug, and following a series of letters to the FDA, he had been invited to make a presentation before the advisory panel. Within a month after the hearing, the drug company had been ordered to conduct further clinical studies to evaluate whether the use of Clomid involved an increased risk of birth defects. But the studies were never initiated. Eight years later the FDA requested that a birth defect warning be included in the drug's package insert. This request was likewise ignored. "I was somewhat naive at the time," Mix said. "I thought that when the FDA issued a request or an order to a drug company that it would be enforced. Unfortunately, as I later learned, when it came to addressing resistance by its regulated industry, the agency had more bark than bite."
Other efforts over the years met with similar results, which led the lawyer to write a book. After 3 1/2 years of research and writing, "The Price of Ovulation" (Tendril Press) was released in 2009. Winner of 7 national book awards, the book captures Mix's 35-year battle to bring the birth defect risk to the attention of the general public, while revealing what goes on behind the scenes in the drug industry and how a company can conceal the results of adverse studies and manipulate the FDA. It also recites numerous incriminating studies involving Clomid and other fertility drugs ignored by the FDA, some going as far back as 1973.
During his research on the book, Mix made a startling discovery. "I was reviewing scientific papers over the internet one evening, when I learned that depriving an embryo of cholesterol during early pregnancy can by itself cause a number of different birth defects. This was one of those jaw-dropping moments," says the lawyer, "because I knew that one of Clomid's side effects was to impair the body's production of cholesterol similar to the action of statin drugs, such as Lipitor. I had discovered the causal link - the actual biological manner in which Clomid was causing birth defects." Not only does Mix explain this discovery and phenomenon in the book, he also proposes a means of offsetting the risk of birth defects posed by the drug. "Similar to the way folic acid is used to offset the risk of neural tube defects and other birth anomalies, this method has the potential of eliminating thousands of birth defects, including those occurring with natural conceptions."
The lawyer is hopeful that this new study will have an impact on the FDA. "To date, the FDA has turned its back on several published studies showing an increased risk of birth defects following the use of Clomid," he laments. "In fact, the current labeling on the drug suggests that the premarket studies show that the drug is completely safe for the unborn baby. But given the size and importance of the CDC study, and the fact that it was conducted by an arm of the federal government, might just catch its attention. After 35 years of frustration, maybe now it might just happen."
Terence Mix is an attorney/author who writes about drug safety and reform of the FDA and drug industry. For additional information, please contact him at [email protected] or visit http://www.terencemix.com.
Source : LaLeva.org (Dec 2010)
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Painkillers in pregnancy can affect boys' testicles:study
Women who take painkillers, such as acetaminophen or ASA, during pregnancy appear to be slightly more likely to have boys with undescended testicles, a study from Denmark has found.
The risk of having a son with the condition, called cryptorchidism, remains quite low. But the researchers say the finding may explain the sharp increase in the condition in recent decades.
It's estimated that about three per cent of full-term and 30 per cent of premature infant boys are born with at least one testicle that hasn't descended during fetal development from an abdominal position into the scrotum.
However, about 80 per cent of the testicles descend in the first year of life – usually within the first three months. But the condition can cause infertility in males whose testicles don't descend.
For this study, researchers from Finland, Denmark and France, looked at two groups of women: 834 in Denmark and 1,463 in Finland, who joined the study while they were pregnant. The researchers identified which women took acetaminophen, ASA, or ibuprofen for pain relief during pregnancy.
Their male babies were examined at birth for any signs of cryptorchidism and the results published in the journal Human Reproduction.
The researchers could find no statistically significant effect of painkillers on cryptorchidism in the Finnish women, but found significant effects amongst the Danish women. They note that the prevalence of cryptorchidism is much lower in Finland (2.4 per cent) compared to Denmark (9.3 per cent), though it's unclear why.
Among the Danish 834 boys, 42 were born with the condition, though the mothers of only 27 of these reported taking painkillers during their pregnancies.
The risk seemed higher in those who took painkillers for an extended period. In mothers who took any of the painkillers for more than two weeks, the risk of cryptorchidism rose to 2.47 times higher than for those taking no painkillers.
The risk rose seven-fold if the mothers used more than one type of painkiller at the same time. The second trimester appeared to be a particularly sensitive time for this; mothers who reported simultaneous use of more than one painkiller during this period appeared to have a 16-fold increase in having a boy with cryptorchidism.
The scientists also pointed to work conducted on rats by two of the researchers who found that painkillers seemed to alter androgen production and led to decreased levels of testosterone during a critical time in the pregnancy when male fetal organs were forming.
"If exposure to endocrine disruptors is the mechanism behind the increasing reproductive problems among young men in the Western world, this research suggests that particular attention should be paid to the use of mild analgesics during pregnancy, as this could be a major reason for the problems," Henrik Leffers, a senior scientist at the Rigshospitalet in Copenhagen who led the research, said in a statement.
The researchers say that there has been a marked increase in the incidence of cryptorchidism in recent decades in Denmark, where it has increased from 1.8 per cent in 1959-1961 to 8.5 per cent in 1997-2001.
"The magnitude of this difference is too large to be accounted for by random fluctuations and differences in ascertainment," they write in their paper.
The researchers say that the risk from the painkillers is much higher than that seen from known endocrine disrupters, such as phthalates.
Dr. Leffers added: "Although we should be cautious about any over-extrapolation or over-statement, the use of mild analgesics constitutes by far the largest exposure to endocrine disruptors among pregnant women, and use of these compounds is, at present, the best suggestion for an exposure that can affect a large proportion of the human population."
Source: CTV News
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The 50-year global cover-up
SECRET files reveal the German maker of thalidomide ignored and covered up repeated warnings that its drug could damage unborn babies.
Read the affidavit material containing confidential Grunenthal files - Part 1 Part 2
The Age has obtained excerpts of never-before-published files from the archives of pharmaceutical giant Grunenthal which detail explicit warnings the company received about its drug's potential to harm foetuses well before it was withdrawn from sale in late 1961.
An estimated 10,000 babies worldwide - including hundreds in Australia - were born in the late 1950s and 1960s with severe physical deformities because their mothers had taken thalidomide drugs, which were marketed as a safe sedative and remedy for morning sickness.
The Grunenthal files expose a 50-year global cover-up and demolish the company's long-held position that the scandal was unforeseeable tragedy and that its ''actions were consistent with the state of scientific knowledge and prevailing standards of the 1950s''.
The files reveal that for at least two years before the drug was banned in late 1961, German medical professionals had told Grunenthal staff of concerns that children's deformities were caused by women taking thalidomide during pregnancy.
Between 1959 and 1961 - while the drug was still being marketed as safe - Grunenthal employees and their families began having deformed babies.
In one company file, it is noted that ''eight families, which, as dependants of the Chemie Grunenthal Company, during the years between 1959 until 1961, had had deformed children''.
Rather than act on the internal warnings, Grunenthal simply told concerned doctors there was no information to suggest the drug was unsafe.
The Grunenthal documents have come to light after they were lodged in the Victorian Supreme Court by Slater & Gordon lawyer Michael Magazanik in support of a compensation claim by Melbourne thalidomide victim Lynette Rowe.
Ms Rowe, in a case led by prominent plaintiff lawyer Peter Gordon, last week secured a multimillion-dollar payout from UK company Diageo, which bought thalidomide distributor Distillers in 1997.
Diageo is considering settlements with up to 130 other thalidomide victims in Australia and New Zealand. But Grunenthal continues to deny any culpability and is aggressively defending lawsuits.
The Grunenthal files include a statement by German pharmacist Friedrich Koch revealing that he wrote to the firm in late 1960, having spoken to a mother who took Contergan - a brand name for thalidomide - during pregnancy and whose child was born with internal injuries.
''After my discussions with (a patient), I felt compelled to write a letter to the company Grunenthal on 24 November 1960. In this letter … I inquired whether a child could develop injuries if the mother had taken Contergan regularly during pregnancy.
''The thought that medication might possibly affect a foetus … did not seem absurd to me, but rather worth investigating,'' Mr Koch wrote.
Grunenthal wrote back to Mr Koch enthusiastically giving the drug the all clear. ''Based on the contents of the letter, I was then able to tell the parents that according to the company, their babies injuries were not caused by the mother taking Contergan during pregnancy,'' Mr Koch's statement says.
''Naturally I presumed that the scientists in Stolberg [Germany] had already looked into the problem of their Contergan breaking through the foetus or that they would at least look into it after receiving my letter.''
A year before Grunenthal assured Mr Koch the drug was safe, the firm was contacted by a German medical practitioner, Dr K, with similar concerns.
Dr K's statement reads: ''I can recall with certainty that I made a possible connection between Contergan and my son's deformities as early as 1959.
''In the same year, my wife and I had discussed this problem with [Grunenthal employee] Dr Mannheim at various times … He always explained that he just could not imagine thalidomide causing these types of injuries … I established at least a further two malformations during 1959 which I also connected to Contergan.''
Several files reveal Grunenthal was receiving an increasing number of queries about the drug's potential to harm babies at the same time it was telling the public it was safe.
An internal document dated February 1961 - almost a year before thalidomide was banned - poses a question about its potential to effect the foetus. Another document includes a reference to Grunenthal being told that thalidomide was ''known as an abortive drug''.
A March 1961 document says animal testing might shed light on the effect of thalidomide on a foetus while also acknowledging that the company had no idea what this impact could be. ''[We have] no experiences ourselves
regarding [thalidomide] and pregnancy,'' the March 1961 memo states.
Around this time, Grunenthal sales representatives wrote confidential memos to the firm about what doctors had told them about possible impacts of the drug. A February 1961 letter from a doctor working in sales for Grunenthal states that his ''main objective'' in responding to such concerns was ''once again … to generate general interest and cause confusion''.
An April 1961 memo from another Grunenthal sales representative deals with the drug's potential to cause nerve injury, finding that in one medical ward there were ''20 clear Contergan [thalidomide] allergies and 2 cases of polyneuritis''.
''On the psychiatric wards with huge use of 271 [thalidomide] no side effects at all (maybe the idiots are happy when they are tingling!),'' the sales representative noted.
Another file reveals that in the months before July 1961, a German doctor quizzed Grunenthal about the potentially harmful effects of the drug during his wife's second pregnancy, given she had previously miscarried after taking Contergan.
The doctor's wife gave birth to a severely deformed child in July 1961 and he immediately suspected ''the potentially harmful effect of Contergan on the child''.
In mid-1961, a Grunenthal doctor told a fellow employee ''that in regard to Contergan, significantly more severe injuries than those already known were to be anticipated in his opinion''.
Yet another company doctor also confidentially flagged concerns, telling a Grunenthal meeting that the firm ''needed to investigate the diaplacental transfer of [thalidomide] by way of animal test to determine the possibility of damage to the foetus."
According to one of Mr Magazanik's affidavits, ''by May 1961, Grunenthal knew that its own medically trained staff had 'a very real fear of [thalidomide] side effects' and were refusing to use thalidomide drugs within their own families.''
By late 1961, when United States regulators had refused to licence thalidomide due to safety concerns, Grunenthal's internal files reveal a growing acknowledgment inside the company that there may be a serious problem with its drug.
In September 1961, the company wrote to a medical expert querying if it could draw on his expertise on the ''effects of medication on the foetus''.
But no tests were done in the last six months of 1961, despite further concern expressed to Grunenthal that their drug might be harming or killing babies.
It wasn't until November 1961 that the company finally moved to ban the drug after getting now well-known reports by Dr Widikund Lenz and Australian obstetrician William McBride about the links between the epidemic of birth defects and thalidomide.
The company at this time began formulating its position that it was not to blame.
But privately, Grunenthal's own lawyers had their doubts about aspects of the company's behaviour, including its response to hundreds of reports of nerve damage caused by thalidomide which prompted them to warn it was facing ''a dangerous and uncomfortable situation so injurious to the reputation of the organisation''.
Source : The Sydney Morning Herald
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Thalidomiders win payout 50 years on
The government has agreed a historic deal to give annual payments of up to £8m to the surviving victims of the drug thalidomide while also publicly apologising for their suffering over the past 50 years.
The settlement, which is receiving its final clearance this weekend and is expected to be announced within days, comes after a successful campaign, backed by The Sunday Times, to secure vital state funding for the “thalidomiders”.
Under the terms of the deal the Department of Health (DoH) will pay a grant of £20m, spread over three years, to the Thalidomide Trust, which dispenses aid to the roughly 450 thalidomide victims living in the UK.
The £20m could be boosted by up to a further £5m if, as the DoH hopes, extra funds are procured from the devolved governments of Scotland, Wales and Northern Ireland.
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In an apology, which could be made by Gordon Brown, the prime minister, the government will express its “sincere regret and deep sympathy for the injuries and suffering” endured by thalidomide victims and their families.
The thalidomiders were born in the 1950s and 1960s with deformed and stunted limbs and even brain damage as a result of their mothers being prescribed the drug as a treatment for morning sickness or insomnia while pregnant.
After thalidomide was withdrawn from sale in 1961 the affected families fought a lengthy legal battle, backed by this newspaper, for compensation from its UK manufacturer, Distillers Biochemicals.
The money from Distillers — about £28m — was paid to the Thalidomide Trust in the 1970s, which handed out disbursements to its beneficiaries. Currently each victim receives an average of £18,000 a year from the trust. Many are unable to work and the money forms their only income.
However, as their contorted bodies have aged, the thalidomiders’ health problems — and the cost of treating them — have multiplied, leaving the victims financially pressed. They are forced to buy their own specialist wheelchairs and adapted cars, which can cost up to £60,000 each.
In 1958 a state agency, the Cohen committee, agreed that thalidomide, as a supposedly “proven remedy”, should be exempted from purchase tax, thereby in effect approving it for prescription on the NHS. Despite this, no British government has ever seen fit to offer a financial settlement to the victims or apologise for its role in the tragedy.
When The Sunday Times first announced the new campaign in February this year, the position of Alan Johnson, then the health secretary, was that he was “not persuaded” by their call for government compensation.
However, following the 10-month campaign, which saw one victim, Gary Skyner, go on hunger strike and a string of stories in The Sunday Times about the hardships being endured by other victims of the drug, the government has now met the campaigners’ demands in full.
Nick Dobrik, the leader of the campaign, expressed his satisfaction with the settlement and praised the role played by Mike O’Brien, the health minister, in agreeing it.
He said: “I was very impressed with the way Mike O’Brien handled the negotiations with the national advisory council of the trust.
“He was sympathetic and attentive to the difficulties facing our community and always acted in good faith and with integrity.”
Mikey Argy, chairwoman of the trust’s advisory council and a single mother of two girls, said the settlement would mean she would now be able to pay for £80,000-worth of life-enhancing alterations to her home.
Argy, who was born with drastically shortened arms, said: “I had architects draw up plans of how my house could be altered to make it more manageable for me, but until now I could never have afforded it. Now I may be able to secure a mortgage based on these new payments.”
Argy said that because her arms were unable to reach inside her overhead kitchen cupboards she has to climb up to use them.
New cupboards, however, would be fitted with sliding shelves, enabling her to use them safely.
Her bathroom would also be equipped with a walk-in shower, since at present she has to negotiate a normal bath in order to wash.
“Having short arms makes falling very dangerous and the last thing you want to be doing is stepping over a slippery- sided bath,” she said.
Argy added: “With this settlement the government is recognising its role and responsibility for the thalidomiders and this money will go some way to assisting us to get the adaptations we need to enable us to live as independently as possible and go towards getting the extra medical care we need.
“It’s not just about the money. I know quite a few thalidomiders who have said that all they ever wanted was an apology. It is a huge thing for us.”
Martin Johnson, the director of the trust, said he was pleased that the DoH would allow the trust to use its discretion as to how to distribute the money.
He said: “The money is set to be distributed on the basis of the trust now. We have jumped an awful lot of hurdles.”
Ministers tried to protect industry profits
The question of the state’s responsibility for part of the thalidomide tragedy has dogged governments since the 1960s.
Documents released by the National Archives show ministers and civil servants have repeatedly denied any official culpability and tried to protect drug industry profits.
In January 1973, in response to newspaper claims that the state had “moral responsibility” for the scandal, Sir George Godber, chief medical officer, wrote a memo for ministers in which he said the pharmaceutical industry should not be further burdened with checks in case profits were affected.
“There has to be some sort of a balance between the extent of the testing required and the possibility of recouping its loss from subsequent sales,” he wrote.
Source: Sunday Times Dec 2009
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