Lara Marks

Using technology to address recruitment issues in the clinical trial process

It takes nearly ten years to get a drug through the discovery and development pipeline and onto the market; most of this time is spent in the clinical phase. Clinical development times vary widely from drug to drug, but a drug typically spends just over 6 years going through clinical trials and regulatory processes. At least 3 years of this time is spent recruiting patients. Every month by which the development process can be shortened is worth US

MIGRANTS, MINORITIES AND HEALTH: Historical and contemporary studies

25 million in additional income for the average drug. Can the recruitment time be shortened?

The birth pangs of monoclonal antibody therapeutics: the failure and legacy of Centoxin.

Migrants, Minorities and Health looks at a number of types of migrant and minority groups from different societies around the world. Each chapter examines how health issues have interacted with developing ideas of ethnicity. Challenging our common assumptions about migrants, minorities and health, the collection offers new perspectives from a number of disciplines.

Not just a statistic: the history of USA and UK policy over thrombotic disease and the oral contraceptive pill, 1960s-1970s

This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocors development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development.

Collaboration – a competitor's tool: The story of Centocor, an entrepreneurial biotechnology company

Today it is estimated that over 100 million women worldwide have taken the oral contraceptive pill since 1956, when the first clinical trials were undertaken. Since its introduction on to the American market in 1960 and the British one in 1961, the pill has become one of the most popular contraceptives in both countries. Unlike other forms of drugs, which have primarily been formulated to prevent or cure illness, the oral contraceptive pill was designed to be given to healthy women over long periods of time, making the necessity for regulation and medical monitoring that much more pertinent. Focusing on the USA and Britain, this paper concentrates on the different ways in which each country has monitored and secured the safety of the pill between 1960 and 1970. While the British government decided to phase-out high dose oestrogen contraceptive pills associated with thrombotic disease in 1969, such pills continued to be available in the USA through to the 1980s, with measures instead being directed towards supplying better information to patients about the possible side-effects of the pill. The paper explores the reasons for this difference in policy, showing how it was shaped by the particular research orientation of each country as well as the specific legal, medical, social and political traditions within Britain and the USA.

Human guinea pigs? The history of the early oral contraceptive clinical trials

Biotechnology companies have relied on alliances for survival and growth since their inception. This history of Centocor illustrates the pivotal role collaborations played for pioneers in the industry. Five years after its founding Centocor had become a competitive and profitable diagnostics company based on partnerships with research institutes and larger health care companies. In 1992, however, Centocor faced collapse, brought on by a departure from collaboration and going it alone in the development and marketing of the companys first therapeutic. What saved the company and enabled it to prosper in therapeutics was a reversion to the old strategy of collaboration.

Carers and servers of the Jewish community: The marginalized heritage of Jewish women in Britain

Abstract Today it is estimated that over 100 million women worldwide have taken oral contraceptives since their first clinical trials in 1956. Despite their popularity, however, contraceptive pills have been under constant scrutiny for their safety since the time of their marketing. This paper considers the degree to which the pill was tested before it was introduced on to the market and challenges many assumptions that have been made about the use scientists made of women in its development. Examining the early testing of the pill, the paper makes clear that the success of the pill and its testing depended on the active co‐operation of the women who swallowed the tablet in its experimental stage. Far from being guinea‐pigs, women were thus active participants in the making of the pill.

Monoclonal antibodies and the transformation of blood typing

Jewish women have played a vital role in the heritage of the Jewish community in Britain. Yet while they have been revered as good wives and mothers and held up as good models to non‐Jewish women, their history has been obscured by such idealizations and much of their contributions outside the sphere of motherhood has been ignored by historians. This article examines the reasons for this neglect and shows the valuable part Jewish women played not only as wives and mothers but also as single women in a wide range of areas including the family economy, political mobilization, organization of the workplace, education, health, leisure and philanthropic work. It questions the traditional roles Jewish men and women have been expected to play and highlights the complexity of gender and its relationship with class and ethnicity.

Margaret Marsh and Wanda Ronner, The fertility doctor: John Rock and the reproductive revolution , Baltimore, Johns Hopkins University Press, 2008, pp. 374, £16.00,

Today, when monoclonal antibodies (mAbs) have become one of the most important classes of therapeutic drugs, it is easy to forget how much they have transformed our healthcare in other ways. One of the first clinical areas, as this paper shows, where mAbs made their mark was in the field of blood typing. The adoption of mAbs for this purpose was done with little public fanfare or funding. Nonetheless, it radically transformed the accuracy and cost of blood typing and shifted the procedure away from a dependence on reagents made from human blood donated by volunteers. This paper argues that the development of mAbs as reagents for blood typing laid the foundation for the first large-scale production of mAbs thereby paving the way to the advent of mAb diagnostics and therapeutics.

29.95 (hardback 978-0-8018-9001-7).

Today reproductive medicine has become an important component of health care in the developed world. Whether it be an infertile woman desperate to have a baby or a woman looking for a means to prevent conception, reproductive medicine has the potential to help whether it be in the form of in vitro fertilization or an oral contraceptive pill. The power of medicine to aid these women, however, is relatively recent. As this engaging and methodically researched biographical book by Marsh and Ronner points out, many of the reproductive tools available today stem from the work of one individual: John Rock. Rock’s work was not confined to women. He had a deep interest in male infertility, setting up one of the earliest separate infertility clinics for men in 1949, and was one of the first to explore the possibilities of developing a male contraceptive pill. Using the previously unavailable personal papers of John Rock, Marsh and Ronner provide a goldmine of information about a man whose life and work not only touched the lives of thousands of people but helped to transform social, political and religious attitudes to fertility and contraception. Starting at a time when reproductive medicine was barely recognized as a specialism, this biography provides an important reminder of the personal challenges pioneers face in developing new medical fields. While inundated with patients, Rock struggled to raise money and recognition for his work and his clinics, and was frequently penniless himself. The son of second-generation Catholic Irish American parents, Rock started his working life as a timekeeper on a banana plantation for the United Fruit Company in Guatemala. Sent originally to the country by his businessman father, Rock’s experiences there had a profound impact on his future career. Moved by the awful conditions which he witnessed among the fruit cutters, and miserable about his overall inability to change their dire circumstances, Rock realized his true vocation lay not in business, as his father had hoped, but in medicine. His interest in medicine was sparked by the friendship he had begun in Guatemala with Neil McPhail, a medical expert in tropical diseases. What stands out in this biography is the profound empathy Rock showed for the plight of his patients and his desire to provide the best medical care possible. This is a far cry from the unethical practice many feminist writers ascribed to Rock during the 1970s and 1980s. When treating infertile women with new drugs, for example, Rock would check for adverse reactions by first trying the compounds on himself. Initially fearful about possible side effects of the contraceptive pill, Rock also took great precautions when launching its first clinical trials, determined that his patients should not be exploited. Strikingly, Rock’s meticulous monitoring of participants in the first oral contraceptive clinical trials infuriated and frustrated Katharine McCormick, the chief feminist funder of the development of the pill, who viewed such steps as unnecessarily laborious and time-consuming. Only once the pill had passed many hurdles of safety and trial would Rock become an enthusiastic supporter, and indeed promoter, of the contraceptive. This biography of Rock provides detailed insight into the difficult challenges a doctor faced in pushing at the boundaries of reproductive health on the medical front as well as on the wider cultural, social and religious front. As both a Catholic and a doctor, Rock played a significant role in trying to change the Catholic Church’s stand on contraception. While failing to win the Pope’s approval of the contraceptive pill, Rock’s work helped millions of Catholic couples around the world to justify the use of contraception to their consciences and to each other, and paved the way for new meanings of sexuality and parenthood.