Foundation 41

Last updated

Foundation 41 was a medical research organisation, principally investigating the causes of mental and physical handicaps in babies, and was based at the Crown Street Women's Hospital, Sydney, Australia. It was founded in 1971 by Dr William McBride [1] and largely supported by the Apex Clubs of Australia. [2]

Contents

The name Foundation 41 derives from the normal duration of human gestation (40 weeks) plus the first week of life after birth.

Funding

McBride created Foundation 41 using prize money given by France's L'Institut de la Vie in connection with his discovery that thalidomide (N-α-phthalimidoglutarimide) caused malformations by interacting with the DNA of dividing embryonic cells.

Ongoing funding was by public philanthropy. This essentially ceased with the Debenox case.

Debenox

McBride's later involvement with Debenox (pyridoxine/doxylamine) is less illustrious, and had a marked effect on Foundation 41. [3] In 1981 McBride published a paper indicating that the drug Debenox (marketed in the US as Bendectin) caused birth defects. His coauthors noted that the published paper contained manipulated data and protested [4] but their voices went unheard. Multiple lawsuits were undertaken by patients and McBride was a willing witness for the claimants. Eventually, the research was investigated and, as a result, McBride was struck off the Australian medical register in 1993 for deliberately falsifying data. [5] [6] An inquiry determined, "we are forced to conclude that Dr. McBride did publish statements which he either knew were untrue or which he did not genuinely believe to be true, and in that respect was guilty of scientific fraud." McBride was reinstated to the medical register in 1998. [7] [8] [9]

See also

Related Research Articles

Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research.

<span class="mw-page-title-main">Thalidomide</span> Immunomodulatory drug known for its ability to cause birth defects

Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers, graft-versus-host disease, and many skin disorders. While thalidomide has been used in a number of HIV-associated conditions, such use is associated with increased levels of the virus.

<span class="mw-page-title-main">Phocomelia</span> Medical condition

Phocomelia is a congenital condition that involves malformations of human arms and legs which results in a flipper like appendage. A prominent cause of phocomelia comes from the use of the drug thalidomide during pregnancy; however, the causes of most cases are to be determined.

Teratology is the study of abnormalities of physiological development in organisms during their life span. It is a sub-discipline in medical genetics which focuses on the classification of congenital abnormalities in dysmorphology caused by teratogens. Teratogens are substances that may cause non-heritable birth defects via a toxic effect on an embryo or fetus. Defects include malformations, disruptions, deformations, and dysplasia that may cause stunted growth, delayed mental development, or other congenital disorders that lack structural malformations. The related term developmental toxicity includes all manifestations of abnormal development that are caused by environmental insult. The extent to which teratogens will impact an embryo is dependent on several factors, such as how long the embryo has been exposed, the stage of development the embryo was in when exposed, the genetic makeup of the embryo, and the transfer rate of the teratogen.

In academic publishing, a retraction is a mechanism by which a published paper in an academic journal is flagged for being seriously flawed to the extent that their results and conclusions can no longer be relied upon. Retracted articles are not removed from the published literature but marked as retracted. In some cases it may be necessary to remove an article from publication, such as when the article is clearly defamatory, violates personal privacy, is the subject of a court order, or might pose a serious health risk to the general public.

William Griffith McBride was an Australian obstetrician. He published a letter on the teratogenicity of thalidomide following the findings of a midwife named Pat Sparrow, which resulted in the reduction of the number of drugs prescribed during pregnancy. Later in his life, McBride was found guilty of separate counts of medical malpractice and scientific fraud for falsifying data in a paper that claimed that the drug Debendox was also responsible for birth defects.

<span class="mw-page-title-main">Frances Oldham Kelsey</span> Canadian-American physician and pharmacologist (1914–2015)

Frances Kathleen Oldham Kelsey was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.

<i>The Sunday Times</i> British newspaper, founded 1821

The Sunday Times is a British Sunday newspaper whose circulation makes it the largest in Britain's quality press market category. It was founded in 1821 as The New Observer. It is published by Times Newspapers Ltd, a subsidiary of News UK, which is owned by News Corp. Times Newspapers also publishes The Times. The two papers, founded separately and independently, have been under the same ownership since 1966. They were bought by News International in 1981.

In scientific inquiry and academic research, data fabrication is the intentional misrepresentation of research results. As with other forms of scientific misconduct, it is the intent to deceive that marks fabrication as unethical, and thus different from scientists deceiving themselves. There are many ways data can be fabricated. Experimental data can be fabricated by reporting experiments that were never conducted, and accurate data can be manipulated or misrepresented to suit a desired outcome. One of the biggest problems with this form of scientific fraud is that "university investigations into research misconduct are often inadequate, opaque and poorly conducted. They challenge the idea that institutions can police themselves on research integrity."

Ranjit Kumar Chandra is an Indian-born Canadian researcher and self-proclaimed "father of nutritional immunology" who committed scientific and health care fraud. Chandra's misconduct was the subject of a 2006 documentary by the Canadian Broadcasting Corporation (CBC). A libel trial in July 2015, concluded that the allegations of fraud against Chandra were truthful; he was ordered to pay $1.6 million to cover CBC's legal fees, and later that year was stripped of his membership in the Order of Canada. As of 2020, four of Chandra's research publications have been retracted, and one has been corrected.

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes.

<span class="mw-page-title-main">Marc Hauser</span> American biologist

Marc D. Hauser is an American evolutionary biologist and a researcher in primate behavior, animal cognition and human behavior and neuroscience. Hauser was a professor of psychology at Harvard University from 1998 to 2011. In 2010 Harvard found him guilty of research misconduct, specifically fabricating and falsifying data, after which he resigned. Because Hauser's research was financed by government grants, the Office of Research Integrity of the Health and Human Services Department also investigated, finding in 2012 that Hauser had fabricated data, manipulated experimental results, and published falsified findings.

Pyridoxine/doxylamine, sold under the brand name Diclectin among others, is a combination of pyridoxine hydrochloride (vitamin B6) and doxylamine succinate. It is generally used for nausea and vomiting of pregnancy (morning sickness); even though its efficacy has not been proven and subsequent research has led to the removal of recommendations in medical journals.

Claims of a link between the MMR vaccine and autism have been extensively investigated and found to be false. The link was first suggested in the early 1990s and came to public notice largely as a result of the 1998 Lancet MMR autism fraud, characterised as "perhaps the most damaging medical hoax of the last 100 years". The fraudulent research paper authored by Andrew Wakefield and published in The Lancet claimed to link the vaccine to colitis and autism spectrum disorders. The paper was retracted in 2010 but is still cited by anti-vaccinationists.

<span class="mw-page-title-main">Andrew Wakefield</span> Discredited British former doctor (born 1956)

Andrew Jeremy Wakefield is a British anti-vaccine activist, former physician, and discredited academic who was struck off the medical register for his involvement in The Lancet MMR autism fraud, a 1998 study that falsely claimed a link between the measles, mumps, and rubella (MMR) vaccine and autism. He has subsequently become known for anti-vaccination activism. Publicity around the 1998 study caused a sharp decline in vaccination uptake, leading to a number of outbreaks of measles around the world. He was a surgeon on the liver transplant programme at the Royal Free Hospital in London and became senior lecturer and honorary consultant in experimental gastroenterology at the Royal Free and University College School of Medicine. He resigned from his positions there in 2001, "by mutual agreement", then moved to the United States. In 2004, Wakefield co-founded and began working at the Thoughtful House research center in Austin, Texas, serving as executive director there until February 2010, when he resigned in the wake of findings against him by the British General Medical Council.

<span class="mw-page-title-main">Thalidomide scandal</span> Medical condition

In the late 1950s and early 1960s, the use of thalidomide in 46 countries by women who were pregnant or who subsequently became pregnant resulted in the "biggest man-made medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as phocomelia, as well as thousands of miscarriages.

Joachim Boldt is a German anesthesiologist who fabricated or falsified data, including those reporting clinical trial results. Boldt was previously considered to be a leading researcher of medicinal colloids. He was an advocate for the use of colloidal hydroxyethyl starch (HES) to boost blood pressure during surgery. However, a meta-analysis of trials that excluded Boldt's fabricated data found that the intravenous use of hydroxyethyl starch is associated with a significant increased risk of death and acute kidney injury compared with other resuscitation solutions. He has been stripped of his professorship and is under criminal investigation for possible forgery of up to 90 research studies.

The Lancet MMR autism fraud centered on the publication in February 1998 of a fraudulent research paper titled "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children" in The Lancet. The paper, authored by now discredited and deregistered Andrew Wakefield, and twelve coauthors, falsely claimed causative links between the MMR vaccine and colitis and between colitis and autism. The fraud was exposed in a lengthy Sunday Times investigation by reporter Brian Deer, resulting in the paper's retraction in February 2010 and Wakefield being struck off the UK medical register three months later. Wakefield reportedly stood to earn up to $43 million per year selling diagnostic kits for a non-existent syndrome he claimed to have discovered. He also held a patent to a rival vaccine at the time, and he had been employed by a lawyer representing parents in lawsuits against vaccine producers.

Sophie Jamal is a Canadian endocrinologist and former osteoporosis researcher who was at the centre of a scientific misconduct case in the mid-to-late 2010s. Jamal published a high-profile paper suggesting that the heart medication nitroglycerin was a treatment for osteoporosis, and was later demonstrated to have misrepresented her results. She received a lifetime ban from receiving funding from the Canadian Institutes of Health Research and was named directly in their disclosure report, becoming the first person mentioned by name by the institute for scientific misconduct. Jamal was later stripped of her medical license for two years, regaining it in a controversial 3–2 decision.

References

  1. Papers of William McBride, ca. 1953–1996, National Library of Australia, accessed 26 July 2010
  2. V. M. Branson (1981). The Golden Years of Apex 1956–1981. Association of Apex Clubs of Australia. p. 27. ISBN   0909854106.
  3. Grant J (2007). Corrupted Science . Facts, Figures & Fun. p.  49f. ISBN   978-1-904332-73-2.
  4. The Insider, Australian Story , 22 February 2001, accessed 26 July 2010
  5. "Thalidomide hero found guilty of scientific fraud". New Scientist . 27 February 1991.
  6. Dr. William McBride Case Archived 24 May 2011 at the Wayback Machine — Parliament of New South Wales
  7. Clausen, Lisa (3 November 1999). "Pioneers of Medicine". Time . Archived from the original on 3 September 2009.
  8. "Medical Tribunal of New South Wales" (PDF). Archived from the original (PDF) on 20 September 2009. Retrieved 26 July 2010.
  9. "Dr. McBride hails end of the affair". The Australian .