VFC Blog

  • CFAS Position Statement Apr. 5, 11 - 9:14am


    April 1, 2011
    Montreal

    CFAS position statement on the possible clinical significance of prion proteins in urinary-derived human menopausal gonadotropins and human chorionic gonadotropin:

    Recent data published by van Dorsselaer et al indicate that urinary gonadotropins including, urinary-derived human chorionic gonadotropin, may contain normal prion proteins. Such proteins are often found in the urine of most healthy individuals. Abnormal prion proteins, in contrast, are not usually found in the urine of otherwise healthy individuals. The abnormal prion proteins have been implicated in certain neurological disorders, specifically Creutzfeldt-Jakob Disease (CJD). This is the human equivalent of “mad cow disease”. It is important to note that van Dorsselaer et al did not find any abnormal prion proteins in the urinary gonadotropins. The concern raised by the authors is that they suggest that the abnormal prion proteins could at some time contaminate urinary gonadotropins. Based upon the authors’ research as well as that of others, this has never occurred. Moreover van Dorsselaer et al acknowledge that there are no known cases of CJD associated with the use of urinary-derived human gonadotropins including FSH/LH or chorionic gonadotropins preparations. The authors conclude that with the availability of recombinant gonadotropins, the risk of prion contamination might be reduced even further. The study considers an important issue since the use of urinary gonadotropins is global.

    The CFAS has reviewed the study published by van Dorsselaer et al and find the data intriguing. However, the concern raised by the authors is not substantiated by clinical evidence as no cause and effect relationship has ever been demonstrated. The question of the clinical significance of these observations remains unanswered. Regardless, the CFAS is continuing to review this data and as well as other literature pertaining to this issue. Over the next few weeks we hope to offer more extensive comments on the safety of urinary hMG.

    At this point in time, the CFAS can conclude:

    1. Urinary gonadotropins may contain normal prion proteins. Presently, there appears to be no clinical consequence to this observation.
    2. Urinary hMGs have been available for over 50 years and used by millions of women worldwide. To date and to the best of our knowledge, there has never been a case of a prion-associated disease such as CJD reported in a woman previously exposed to urinary gonadotropins.
    3. Prions may be easily transmitted via an intra-muscular injection. The current urinary gonadotropin preparations however, are most often injected by the subcutaneous route. We are unaware of any risk of prion transmission following a subcutaneous injection.

    Based upon current knowledge and literature, there appears to be no confirmed clinical differences in the safety or efficacy among the currently available urinary gonadotropins compared to the newer recombinant gonadotropin products. The CFAS remains committed to protecting the safety and welfare of our patients. With that in mind, we shall continue to monitor the medical literature and await further evaluation by world experts in this field as the data are further scrutinized.




     



    Response to Publication Suggesting that Fertility Drugs Carry a Risk of Transmitting Prion Disease Mar. 25, 11 - 10:34am


    FERRING STATEMENT

    In response to press releases put out by PrioNet Canada
     
    Ferring Pharmaceuticals is fully aware of the study (conducted by Alain Van Dorsselaer, Dr. Neil Cashman et al) looking at the presence of prion proteins in urine-derived products and published in the Public Library of Science (PLoS) ONE.
     
    We are also aware of the press release put out to promote this paper by Gail Bergman PR in Canada, and believe that there are major discrepancies between the statements made in this press release (which we believe is grossly misleading) and the scientific paper it is referring to.
     
    We feel it is of utmost importance to clarify certain points that were not properly represented in this press release and therefore in subsequent media coverage:
     
    • Firstly, normal prions are present in yeasts, the human body and other animal life forms (with a high concentration in the central nervous system) and are believed to be essential to normal function of the body. Normal prions are therefore present in the bread that we eat and the milk that we drink everyday.
    • The only prions that cause disease are abnormal prions or ‘mutant prions’.
    • The study conducted by Van Dorsselaer, Cashman et al, did not identify any abnormal or ‘mutant prions’ in urinary-derived products.
    • In the study prion-proteins per se were identified and were barely detectable – that is close to the detection limits - in highly-purified gonadotrophin products (i.e. Ferring product).
    • In summary, no abnormal prion presence was identified by the study.
    • It is therefore completely incorrect and misleading to claim that the study shows risk of prion disease from urine-derived products. The study categorically does not show this.
    • In fact to date, although several studies have been completed, no study has ever managed to show that it is even possible to transmit prion disease through human urine.
    • The study authors (i.e. Dr. Daniel Krewski) also point out that globally, after 50 years of medical use of these treatments, not a single case of prion disease has been reported in the millions of women who have received infertility drugs.
     
    We at Ferring Pharmaceuticals put the needs and safety of our patients first. We have a stringent and effective screening process in place for our human-derived gondatrophin products, which have a proven quality, efficacy and safety track-record of over 40 years use, and over 2 and half million patients treated with Ferring gonadotrophin products without incidence of prion disease.
     
    We obtain all gonadotrophins from safe sources in countries designated ‘BSE-free or controlled BSE risk’ by the OIE and we make no use of bovine serum in the manufacture of our products.
     
    Our treatments have met the rigorous safety standards of the key global regulatory authorities, have been granted approval in over 50 countries and our production process is subject to regular inspections by key regulatory authorities from around the world. We offer our doctors, and their patients, fertility treatments with an exceptional safety profile and proven gold-standard efficacy.



     


    Stress and Infertility Mar. 25, 11 - 10:33am


    February 28, 2011 — Stress and infertility have long been linked, with stress sometimes blamed when a woman can't get pregnant naturally or with fertility treatments.
     
    Now, a new report published in the prestigious British Medical Journal finds that a woman's stress levels don't adversely affect her chances of getting pregnant in a single fertility treatment cycle.
    ''A lot of people worry that their stress, anxiety, tension, and worry might reduce their chances of pregnancy with a specific treatment cycle, but there is no evidence of that," says researcher Jacky Boivin, PhD, a health psychologist at Cardiff University in Wales. Boivin's team evaluated the results of 14 previously published studies.
     
    The researchers aren't saying stress never has an effect on fertility treatment, Boivin says "It could be stress has an impact on treatment, in that you give up sooner," she says. And stress can reduce quality of life during the fertility treatments, so she does urge women undergoing fertility treatments to reduce excess stress.
    "All [the research] is saying is, whatever stress you are experiencing is not going to impact whether you get pregnant on that particular cycle," Boivin says.
     
    But U.S.-based experts, including Alice D. Domar, PhD, director of the Domar Center for Mind/Body Health in Boston, who has researched infertility, says the jury's still out on the stress and infertility link.
    "I think it's way too early to say stress has no impact on outcome, or to say stress does have an impact," she says. The new report, she says, ''counters the majority of the research."
     
     
    Measuring Stress Levels
    Boivin looked at 14 studies including 3,583 infertile women undergoing a cycle of fertility treatment in 10 countries. Only two of the 14 studies were U.S.-based.
    The women's average age ranged from nearly 30 to nearly 37 years old. They were infertile for a range of 2.6 to 7.8 years.
    Infertility affects up to 15% of the population of child-bearing age, Boivin says.
    The women's stress levels were measured before treatment started, using standard measures. The time of assessment varied from study to study -- sometimes a few days before treatment and sometimes a few months.
    The researchers found no effect of the stress on pregnancy outcome for the cycle studied.
    ''Forever and ever we hear these stories," Boivin says. People will say they knew a friend trying to get pregnant who adopted, and then got pregnant. Or a couple trying to conceive goes on a holiday and she comes back pregnant.
    ''Evolutionary models suggest that stress suppresses fertility in nonhuman mammals," she says, but adds that there is no evidence it happens in the context of fertility treatments in women.
    What she speculates might happen in stressed-out women undergoing fertility treatments is that the mechanism of suppression somehow turns itself off.
     
    ''Your body prefers to reproduce when all conditions are optimal," she says. But when those conditions don't become reality, the stressed-out woman may decide she is going ahead regardless, Boivin says.
    She's not suggesting infertile women ignore the stress of the treatment or everyday life. ''What the stress really does is decrease your quality of life," she says. "People should pay attention to stress and reduce that to improve their quality of life during the treatments."
    She gives patients suggestions on how to do so, including a list of tips meant to be helpful, for instance, when women are awaiting news about whether they have become pregnant with fertility treatment. Among the suggestions are to think more about the positive aspects of a difficult situation.
     
    Stress Reduction Helpful?
    Women who volunteer to be in the studies of stress and infertility are often among the less-stressed women, agreeable to putting in the time required for the study, says Domar, who reviewed the abstract of the study.
    The body of medical literature does suggest a stress and infertility link, she says."There have been close to 30 studies in the last 15 years looking at the impact of stress on IVF outcome, and most of them did show a positive relationship. The more stress there was, the less likely the woman was to get pregnant."
     
    Together with Boivin, Domar is planning on conducting a study  to see if stress reduction can reduce dropout rates of those undergoing infertility studies. A fertility expert in practice, Richard J. Paulson, MD, also sees value to reducing stress in women undergoing fertility treatment. "There are all kinds of studies that suggest ancillary stress-reducing treatments seem to make a difference in the outcome of ART [assisted reproductive technologies]," he says, including research on acupuncture, for instance.
    ''We think the mind-body approach seems to help," says Paulson, chief of the division of reproductive endocrinology and infertility at the University of Southern California's Keck School of Medicine, Los Angeles. He directs the fertility program there.
     
    While the study results may be reassuring to women, he says, ''it does not rule out the benefit of the kind of mind-body interventions that have been studied in other reports and shown to be beneficial."
     
    SOURCES:
    Jacky Boivin, PhD, health psychologist, Cardiff Fertility Studies Research Group, Cardiff University, Wales.
    Alice D. Domar, PhD, director, Domar Center for Mind/Body Health, Boston.
    Richard J. Paulson, MD, professor of obstetrics and gynecology; chief, division of reproductive endocrinology and infertility, University of Southern California's Keck School of Medicine, Los Angeles.
    Boivin, J. BMJ, online, Feb. 24, 2011



     


    Canadian Infertility Awareness BBQ 2011 Jan. 27, 11 - 9:36am


    Mark your calendars - this year's Canadian Infertility Awareness BBQ will take place on Sunday, May 15, 2011.
    More information will be posted soon.
    For more information or to receive an invitation please contact Clementine at clementine@victoriafertility.com