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Can Pharmacological Research on Birth Control and Contraception Meet the Requirements of Bioethical Standards?

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Can Pharmacological Research on Birth Control and Contraception Meet the Requirements of Bioethical Standards? NorCal Open Access Publications Journal of Pharmacology and Clinical trials Volume 2019 ; Issue 01 Kraetschmer K Review article Topical Issues in Translational Pharmacology and Pharmaceuticovigilance: Can Pharmacological Research on Birth Control and Contraception Meet the Requirements of Bioethical Standards? Kurt Kraetschmer* Austrian-American Medical Research Institute, Agnesgasse 11, 1090 Vienna, Austria *Corresponding author: Kurt Kraetschmer, Austrian-American Medical Research Institute, Agnesgasse 11, 1090 Vienna, Austria. E-mail: [email protected] Received Date: 30th August 2019; Accepted Date: 01st October 2019; Published Date: 12th October 2019 Abstract autodidactic strategies by using not only print media but also social media via internet. Aim: On the background of media reports about serious harm to the health of thousands of women engaged in birth control and contraception, the research article aims pursued not only by individual healthcare providers but at emphasizing the importance of pharmaceuticovigilance alsoIntensification by editors who of frequently pharmacological publish education studies obscured should bybe for information on the safe use of contraceptive pills and devices. for the consumer and to avoid detrimental consequences for women’sconflicts ofhealth interest. research To remedy in pharmaceuticovigilance the lack of vital information - whose Method: The method consists in an in-depth analysis of those sources of information that are most widely used by women and their healthcare providers, ie, patient information foundationKeywords: is laid within this article - should be intensified. Contraception; Emergency and oral hormonal leaflets and packaging labels of manufacturers; statements contraception; Long-Acting Reversible Contraception by governmental health agencies; publications by the (LARC); Periodic abstinence/fertility awareness; containedEuropean inMedicines high-ranked Agency scholarly (EMA); journals, and infromation especially by those the IntroductionPharmaceuticovigilance; Pharmacology; Sterilization. inUS pharmacovigilance, Food and Drug Administration are critically (FDA). surveyed. In addition, findings companies became the target of press reports commenting Results: Presently, women are not provided with information on Recently, complaints one lodged of the byworld’s women leading who had pharmaceutical experienced suitable for safe contraceptive pursuits. Consumers are severe adverse events associated with the company’s not adequately informed about contraceptive products as product for permanent contraception. According to these pharmaceutical companies frequently fail to comply with the reports, not only medical problems were at stake but also principle of informed consent. Clinicians, under the pressure the company. ‘‘The implant has had a troubled history. It has to convey salient information to their patients. forensic issues owing to thousands of lawsuits filed against of economic maxims such as cost efficiency, apparently fail been the subject of an estimated 16,000 lawsuits or claims Conclusion: complete, comprehensible and reliable information on perforation of the uterus and the fallopian tubes. Several the safety of Asmethods it is difficult of contraception, for women toespecially obtain accurate, on vital deaths,filed by including women ofwho a few reported infants, severe have also injuries, been attributedincluding pharmacological parameters, they are advised to intensify to the device or to complications from it’’ [1]. 87 Citation: Kraetschmer K (2019) Topical Issues in Translational Pharmacology and Pharmaceuticovigilance: Can Pharmacological Research on Birth Control and Contraception Meet the Requirements of Bioethical Standards? J Pharm Sci Exp Pharmacol 2019: 87-104. From Australia similar reports reached the international changed, and we continue to stand behind the product’s insert placed into each of the patient’s fallopian tubes. Over 200.000 women. ‘‘The benefit-risk profile of Essure has not threereadership: months ‘‘The a barrier device, forms known around as Essure, the inserts,is a soft, which flexible is body of research, undertaken by Bayer and independent intended to block the fallopian tubes and permanently medicalsafety and researchers, efficacy, which involving are demonstrated more than 200,000 by an extensive women prevent pregnancy. But there have been reports women over the past two decades’’[4]. experienced changes in menstrual bleeding, unintended As its strongest argument for the safety of the device the pregnancy, chronic pain, perforation and migration of the company can refer to a statement made by the FDA drawing device, allergic reactions and immune-type reactions after ‘‘The FDA being implanted with the device, which is manufactured by the pharmaceutical company Bayer’’ [2]. outweighattention itsto risks’’a comparison[4]. of benefits and risks. The medical and legal problems affecting the company’s has maintained for several years that the benefits of Essure Despite insistence on the safety of the device, the business in a negative fashion originated from a small nickel- company felt compelled in 2018 to draw attention to titanium coil designed for permanent contraception by severe adverse events by providing important safety way of sterilization. In its instructions for use the company information including an explicit warning: ‘‘Some patients implanted with the Essure System for Permanent Birth insert. As such, the consumer envisages it as a foreign object thatexplains is inserted the components into a woman’s of the body device similar and definesto a diaphragm it as an or a patch. ‘‘Each insert consists of a Nitinol (nickel-titanium Control have experienced and/or reported adverse events, persistentincluding perforationpain, and suspected of the uterus allergic and/or or hypersensitivityfallopian tubes, reactions.identification If the of device inserts needs in the to abdominalbe removed or to pelvicaddress cavity, such bandsalloy) outer(2) and coil, a silver-tina 316L stainless solder’’. steelThe Instructionsinner coil wrapped for Use an adverse event, a surgical procedure will be required. This offerin polyethylene information terephtalate also on the (PET) characteristics fibers, platinum of the marker device information should be shared with patients considering concerning length and diameter: ‘‘The insert is 4 cm in length sterilization with the Essure System of Permanent Birth As soon as the outer coil is released it expands up to 2.0 mm and 0.8 mm in diameter in its wound-down configuration’’. device’’[4]. in diameter ‘‘conforming itself to the varied diameters and Control during discussion of the benefits and risks of the shapes of the fallopian tube [3]. As early as 2002, the company issued general warnings regarding perforation, embedment, and expulsion: As part of their marketing strategy the company ‘‘Unsatisfactory device location including perforation, emphasized the unique feature of the device by referring to uterine embedment and expulsion may result in pain’’. the FDA. ‘‘Essure is the only FDA-approved non-incisional Warnings about the risk of pregnancy draw attention also form of permanent birth control’’ [4]. Concerning the to some serious conditions: ‘‘While most pregnancies with Essure in situ have been reported as healthy deliveries at system’’ is intended for permanent contraception by means term, pregnancy loss, pre-term labor, pre-term rupture mechanism of action the company specifies that the ‘‘Essure of a ‘‘physical occlusion of the fallopian tubes’’ [3]. Through of membranes, pre-term delivery, stillbirth, and neonatal a transvaginal manoeuvre the Essure system is placed into complications have also been reported’’. The hysteroscopist the lumen of the proximal portion of the fallopian tube is advised to reduce the risk of hypervolemia and pay where it anchors upon release: ‘‘The insert is a dynamic attention to the possibility of tubal perforation: “Terminate deployment, conforms to and pushes against the fallopian reduce the risk of hypervolemia’’. and flexible spring-like device. The outer coil expands upon tube wall, acutely anchoring the insert in the lumen of the bethe aprocedure sign of uterine if distention or tubal fluid perforation, deficit exceeds the 1500cc,procedure to fallopian tube’’ [3]. Dynamic anchoring in the fallopian tube, should be discontinued and theAs patient excess fluidevaluated deficit “forcan possible perforation’’[3]. it is the occlusion of the fallopian tube through a tissue in- growthhowever, that does results not insuffice sterilization. to effect ‘‘Subsequently, contraception; the ratherinsert The “Patient Counseling Information’’ contained in the elicits a benign tissue in-growth that permanently occludes Instructions for Use warns about allergies to nickel or other the lumen of the fallopian tube, resulting in permanent component parts of the insert subsequent to placement. contraception’’ [3]. “Typical allergic symptoms reported for this device include hives, urticaria, rash, angioedema, facial edema and pruritis Although the company felt compelled to withdraw its product from the Australian market in 2017 - under patients be counseled on the materials contained in the the pressure of the Australian Therapeutic Goods /sic!/’’. The manufacturer requests, therefore, that all Administration (ATGA)[5] -- and from the US market by the prior to the Essure procedure’’. Patients are advised to familiarizeinsert and onthemselves the “potential with forthe
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