The research article responds to the need for assessing a steadily increasing number of publication material devoted to contraceptive products. By way of a critical analysis it is found that an unexpected high number of health agencies and publishers disseminate heterodoxies and flawed science on contraception. To avert continuation of flawed science and perpetuation of error, it is suggested that health agencies involve only competent researchers in the production of their information material, that editors refrain from publishing adulterated research conducted by authors with conflicting interests, and that pharmacovigilance expands its activities and assesses -- under the nomenclature “pharmaceuticovigilance” -- the documents generated by manufacturers for approval as well as for effective marketing of their products. 

On the background of a growing number of publications on contraceptive methods it is imperative to assess the quality of these publications not only with respect to their usefulness for consumers but also with respect to their accuracy and reliability.  The aim of this research article is to assess the publications emanating from opinion leaders, namely most influential organizations and high-impact journals by means of a critical analysis and to identify the sources providing the most reliable and accurate information. 

The material comprises publications by the most authoritative health agencies such as the WHO, the FDA and the CDC and by the highest impact research journals. The method applied is a critical analysis which assesses the content of these publications as to its verifiability and accuracy. 

The result of the critical analysis is evidence that an unexpected high number of information material disseminated by the most influential health authorities as well as scientific journals contain heterodoxies and flawed science. To remedy this situation and to avoid perpetuation of error it is suggested that health organizations entrust the production of their publications only to qualified and competent researchers capable of appreciating statistical precision and historical veracity. 

Remedy of the present situation appears necessary not only for reasons of research integrity but also for socioeconomic reasons. Inability of the consumer to rely on accurate data can lead to inappropriate decisions. Choice of unsuitable methods can entail unexpected adverse events which may necessitate intervention by care providers and/or hospitalization. Such measures are a heavy burden for the health system, not to speak of the personal harm of the individual and her family. In addition, error-prone publications emanating from government agencies raise the question of inappropriate use of taxpayer money. Allocation of such money should not result in flawed publications including free pamphlets and leaflets or other worthless products. Pharmacovigilance should expand its activities and assess not only pills and devices but also publications generated by manufacturers as part of their marketing strategies. 

Ratings and rankings of contraceptive methods

Clinical experience shows that women worldwide consider contraception and birth control as one of their fundamental health concerns. It is not surprising therefore that an ever-increasing literature, is devoted to this topic. From a historical perspective it should be noted that as early as 1935, chemical contraception was the topic of laboratory research which considered itself as an essential complement of clinical research [1]. Presently, there exists information which is prone to mislead rather than to enlighten both patients and care providers. Heterodoxies and flawed science are particularly conspicuous in tables and charts. These instruments are important tools for women in search of a personally suitable method for contraception, in the sense of precision medicine.  If properly designed ratings and rankings can provide concise and comprehensive information. Ratings and rankings have been propounded not only by various minor organizations, such as Planned Parenthood, but also by the highest authorities in public health, namely the WHO, the US FDA, and the US CDC. In high-impact research the so-called CTFailure table, developed by Contraceptive Technology, has assumed a leading role [2]. If the methods contained in this rating are ranked according to efficacy, the following table emerges.

Table 1: Ranking according to perfect-use, based on CTFailure Table of 2011. 

Albeit based on sound statistical research, the table is not without flaw, especially regarding estimates for typical use of the so-called “fertility-awareness based” methods, ie, Symptothermal, Ovulation, TwoDay, and Standard Days. These estimates have not been derived from recent research but were taken from unreliable obsolete sources. Nevertheless, due to its accuracy and precision the table has been used as a source by various health agencies, including the FDA (Cf. Appendix 1) [3].

However, in a comparison of the table proposed by Contraceptive Technology with the FDA survey [3] -- which ranks methods according to the absence of pregnancies- it becomes obvious that the FDA survey lacks the precision inherent in the CTFailure Table. While the latter shows unambiguously that the implant Implanon with a 0.05 Percentage failure rate for both perfect and typical use is by far more effective than Evra patch (0.3% perfect and 9% typical use), the FDA survey does not reflect this superiority. For example, the woman who follows the FDA survey and opts for the ParaGard (copper T) intrauterine device (<99>

Contrary to its predecessor of 2017, the most recent FDA survey of 2021, entitled “birth control chart,” still contains the vaguely formulated estimates but contains at least one undeniable recommendation for achieving highest efficacy namely abstinence:  “The only sure way to avoid pregnancy is not to have sex” [4]. 

It should be noted that the FDA admits the incompleteness of the table containing only 17 methods and refers for additional information to the most widely acknowledged authority on contraceptive methods who provided insights into the failure rates of contraceptive methods within the USA from a statistician's viewpoint [5].

Despite the widespread use of the CTFailure table its data have not been acknowledged by the most recent WHO survey of 2020, entitled „Family planing/contraception methods”(cf. Appendix 2).[6] Unfortunately, the WHO table of 2020 restricts its scope to only two parameters, namely  effectiveness and mechanism of action. This simplification must be seen as a deterioration of the quality of the table, because its version of 2018 contained also information on adverse events. Attention should be drawn also to the nomenclature “consistent and correct” use instead of “perfect use” and “common” use instead of “typical use.” In contrast to the 2020 WHO table, the FDA chart of 2021 does indeed provide information of adverse events in a rubric entitled “Some Risks or Side Effects,” albeit this information is only rudimentary.  

The most astonishing estimate in the WHO table of 2020 is the one for the symptothermal method, namely < 1>

Second, satisfaction of the need for family planning: “The proportion of the need for family planning satisfied by modern methods, Sustainable Development Goals (SDG) indicator 3.7.1, was 75.7% globally in 2019, yet less than half of the need for family planning was met in Middle and Western Africa” [6]. 

Third, the importance of preventing sexually transmitted infections (STI): “Only one contraceptive method, condoms, can prevent both a pregnancy and the transmission of sexually transmitted infections, including HIV” [6]. 

Fourth, the relevance of contraception for human rights: “Use of contraception advances the human right of people to determine the number and spacing of their children” [6].

As it is difficult to verify the data furnished by the WHO they have to be accepted until proven otherwise. However at least one claim made by the WHO can be proven wrong, namely the statement that condoms are the only way to prevent STI. Concerning female condoms it is far from being proven that they have preventative properties because correct placement - a precondition for efficacy - of the female condom is commonly considered a serious problem.

Concerning the WHO table it proves the existence of striking differences between its own data, those of the CTFailure table, and those of the FDA chart. If tables propounded by international research are included in an analysis, additional heterodoxies appear. German research, for example, furnished as early as 2000 a table for contraceptive methods based on Pearl Indices (PI). [7] On the basis of the Pearl-Index (number of unwanted pregnancies per 100 woman years or 1200 months of application) the table ranks 15 methods in the following fashion [7, p. 60].

Table

In comparing these Pearl indices to the estimates presented in the CTFailure table noteworthy differences appear, above all in case of the Ovulation method. This method –synonymous with “cervical mucus” method – shows a disappointing Pearl index of 15-32 according to German research, but a notable perfect use estimate of 3 Percentage according to Contraceptive Technology. The most deplorable drawback of the German research is the lack of verifiability of the data indicated, a drawback that is true also for other German sources [8].

Safety – the neglected parameter in hitherto presented ratings and rankings

As can be seen, the tables and charts proposed over the years emphasize the parameter efficacy and devote only sporadic comments —or no information at all -- to the parameter safety. However, the clinical practice shows that safety is a central concern of a great number of women.  To respond to the needs of these women, a table has been developed with a ranking that prioritizes safety but also takes into account efficacy [9]. 

Concerning the parameter safety, attention must be drawn to the disregard towards some of the safest methods, the so-called natural family planning methods, or abstinence methods, nowadays known as fertility-awareness based methods. Thus, the US CDC (Centers for Disease Control and Prevention) in its publication “Effectiveness of Family Planning Methods” considers them as the “least effective” [10]. Given the CDC's role as opinion leader it is not surprising that other government agencies disseminated the same erroneous concepts. The US Department of Health and Human Services (Office on Women's Health) [11] adapted WHO data to provide information on family planning and assigned collectively 24% (“number out of every 100 women who experienced an unintended pregnancy within the first year of typical use“) to the fertility-awareness based methods. These were considered as the least effective, just slightly superior to the “spermicide method “with an estimate of 28%. Along the same line, the Office of Population Affairs [12] indicated a common failure rate of 25% for the four methods, considering all of them as equally effective. 

Contrary to past flawed information regarding the inferiority of these methods, recent research has furnished data which suggest a revision of statements made by the CDC and other organizations. This research can benefit from the most salient findings which go back to the last century and elucidate the basic physiological processes for contraception and fertility, namely ovulation and changes in cervical mucus due to the primary hormones involved in the menstrual cycle, namely estrogens (17beta-estradiol, estrone, and estriol) and progesterone [13].

The Standard Days method has been reassessed regarding efficacy in 2002 with the following result: “A single decrement multi-censoring life table analysis of the data indicate a cumulative probability of pregnancy of 4.75% over 13 cycles of correct use of the method, and a 11.96% probability of pregnancy under typical use” [14].

The TwoDay method has been reassessed in 2004 with the outcome: “The first-year pregnancy rate was 3.5 (pregnancies per 100 women/years) with correct use of the method (pregnancies and cycles with no intercourse on identified fertile days), 6.3 with use of a backup method on the fertile days, and 13.7 including all cycles and all pregnancies in the analysis” [15].

The practical implementation of the fertility-awareness methods has been facilitated recently by innovative technologies [16]. At this moment a device is available which indicates the time of ovulation by measuring the CO2 pressure. This technology is the result of research on the effects of progesterone on respiration which go back to the past century where endocrinological research had illuminated not only the thermogenic effect of progesterone but also its stimulatory effect on respiration: “Progesterone is thermogenic and is probably responsible for the rise in basal body temperature at the time of ovulation. It stimulates respiration, and the alveolar partial pressure, PCO2 (PACO2), in women during the luteal phase of the menstrual cycle is lower than that in men. In pregnancy, the alveolar PACO2 falls as progesterone secretion rises” [17, p.409]. 

Clinically relevant findings on progesterone and its effect on respiration were published in the year 2002, when authors presented a study on the expiratory CO2 measurement for determining accurately the fertile days of the menstrual cycle [18]. In outlining their study design the authors specify that the end tidal CO2 (etpCO2) was determined at several occasions in 195 menstrual cycles of altogether 160 women. Luteinizing hormone (LH), estradiol, and progesterone were determined by immunoassay with the goal of detecting the preovulatory LH-surge. A biphasic pattern of the end tidal pCO2 was observed during each cycle.  During luteal phase values were on the average 6.5 mm Hg lower than during follicular phase. End tidal pCO2 started to decrease one to eight days (median 4.5) prior to the preovulatory LH-surge and coincided with both, the appearance of a dominant follicle and the rise of estradiol in serum previous to ovulation.  At the end of the luteal phase, the end tidal pCO2 increased within only 2 to 3 days. Of particular importance is the fact that, according to the authors, the etpCO2 does not depend on circadian rhythms and is not influenced by physical activity. On the basis of their findings, the authors claim: “it is a reliable and easy to use technique to predict the fertile phase in a menstrual cycle.”[18] Not surprisingly, the authors also draw attention to the importance of their findings for natural family planning: “In the perspective of natural family planning it is a promising, practical and nowadays easily affordable method to detect the LHsurge and predict ovulation.”[18] If this research is reliable it would support the arguments of proponents of contraception, who emphasize the importance of the parameter safety. Indeed a growing popular medical literature emphasizes the virtues of non-hormonal, ie, natural methods. This literature owes its emergence to women who consider themselves as victims of hormonal methods, having endured many years of suffering, until they discovered the benefits of non-hormonal methods [19].

In times troubled by a pandemic due to Corona virus, it is important to observe closely phenomena pertaining to contraception and vaccines. Thus reports by women experiencing irregularities of their menstrual cycle, such as permanent vaginal blood loss, has led to the publication of several data. According to the Paul-Ehrlich Institut it is 0.4 to 2.6 cases per million of vaccinated women who experience menstrual irregularities.[20] In the face of these figures it seems mandatory  to obtain more specific information about the nature of the menstrual irregularities and about the association of these adverse events with the type of vaccines. By definition, this research is the domain of pharmacovigilance, and it seems appropriate to discuss the role pharmacovigilance has assumed thus far in the area of birth control and contraception. 

Pharmacovigilance- failures and limitations 

Pharmacovigilance has endeavored for many years to investigate adverse events, risks, and complications. According to the WHO definition “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem” [21] In proposing this noble target the WHO responds not only to the ethical principle of “nil nocere” (do not harm) but also to the requirements of the principle of informed consent which demands complete and comprehensible information to enable “an intelligent choice” on the part of the patient [23].

Over the past years the most important findings in pharmacovigilance concerned leukemia in children born to mothers who had been using oral contraceptive pills, [23] suicidal action, [24] and glaucoma. [25].

Notwithstanding these accomplishments, recent events have shown shortcomings of pharmacovigilance. In the case of an intratubal implant for permanent contraception, pharmacovigilance has failed to accomplish its mission. This device for sterilization had been approved by the US FDA in 2002 and withdrawn from the US market by the manufacturer in 2018, after previous removal from the Australian market in 2017. The medical problems and legal reverberations have been cogently delineated by the US press: “The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it“[26].

In France the device has been subjected to a scrutiny by the National Agency for the Safety of medicines and health products (Agence nationale de sécurité du médicament et des produits de santé) with involvement of a technical board for materiovigilance and reactovigilence [27].  In Australia, the  Australian Therapeutic Goods Administration (ATGA) has succeeded in insisting on its removal from the Australian market in 2017, ie, one year previously to the removal from the US market.[28]  Press reports from Australia highlighted appropriately the nature of the device and the dilemma faced by users. “The device, known as Essure, is a soft, flexible insert placed into each of the patient’s fallopian tubes. Over three months a barrier forms around the inserts, which is intended to block the fallopian tubes and permanently prevent pregnancy. But there have been reports women experienced changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergic reactions and immune-type reactions after being implanted with the device, which is manufactured by the pharmaceutical company Bayer“[29]. After having withdrawn its product also from the US market and in the face of numerous court actions, the manufacturer agreed to pay $1.6 billion to settle claims that its contraceptive device Essure causes serious health complications [30].

Regarding the claims of pharmacovigilance in the case of the Essure implant the present author holds that the FDA procrastinated for too long a period of time before it reacted to numerous complaints by women who had suffered severe harm while using the product. The FDA's reaction, moreover, was far too modest because it requested only documentation that women had been informed appropriately by their doctors about adverse events. Finally, it was the company’s own decision to withdraw its product “for business reasons” without any pressure on the part of the FDA. 

The reluctance of the FDA to take appropriate action in response to consumers' complaints demonstrates the limitations of pharmacovigilance, as defined by the WHO.  According to this definition, it is medicines and vaccines which are the focus of pharmacovigilance. Such a focus, however, seems to be too restrictive if one considers the importance of the documents generated by the manufacturer for approval by the FDA, by the European Medicines Agency (EMA), or other health agencies as well as for marketing reasons. This author stipulates the recognition of a discipline with the aim of assessing and controlling documents created by pharmaceutical companies, such as “instructions for use,” ”information for the user,” ”packaging labels” and similar publications. The most appropriate designation of such a discipline would be “pharmaceuticovigilance” because its focus is not so much on substances per se but on pharmaceutical companies and their strategies to achieve profit maximizing. 

Pharmaceuticovigilance - a potentially useful control mechanism 

In an analysis of the documents devoted to the Essure implant the mission of pharmaceuticovigilance comes to light as a mechanism capable of  preventing early enough adverse events, risks, and complications. Concerning the Essure implant,  two documents disseminated by the manufacturer are  of interest to pharmaceuticovigilance: first,  a 51-page “Instructions for Use,“ copyrighted in 2002, [31] and second,  a “News Release“ of 2018 announcing the withdrawal from the US market ”for business reasons“[33]. 

The most problematic aspect in the information provided by the manufacturer pertains to the mechanism of action.  In explaining the operating mechanism of the tubal implant the manufacturer describes how the device is anchored in the fallopian tubes. “The insert is a dynamic and flexible spring-like device. The outer coil expands upon deployment, conforms to and pushes against the fallopian tube wall, acutely anchoring the insert in the lumen of the fallopian tube“[31,p.4]. Dynamic anchoring in the fallopian tube, however, is not sufficient for avoiding fertilization; rather it is the occlusion of the fallopian tube through a tissue in-growth that results in sterilization. 

Although the manufacturer endeavors to provide comprehensive information on the device and mentions also the life-threatening risks of an anaphylactic reaction and of an ectopic pregnancy some serious shortcomings must be emphasized. Thus, in explaining the mechanism of action the manufacturer uses a terminology that is confusing for both health professionals and ordinary consumers: “Subsequently, the insert elicits a benign tissue in-growth that permanently occludes the lumen of the fallopian tube, resulting in permanent contraception“[31, p.1]. For the occlusion and tissue ingrowth “polyehtylene terephtalate (PET) fibers” are contained in the device.  What the manufacturer conceals from the user is the fact that it is an inflammation and an ensuing scar tissue that are responsible for the anchoring of the device.  “The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder. The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth “[33].

An additional area where pharmaceuticovigilance should reveal shortcomings in the manufacturer's publications is Emergency Contraception (EC), a method described as an only temporary “backup” method by most health agencies and clinics. “The morning-after pill is intended for backup contraception only, not as a primary method of birth control. Morning-after pills contain either levonorgestrel (Plan B One-Step, Aftera, others) or ulipristal acetate (ella)” [34].

Commonly, ulipristal acetate is described as the most effective pill for EC [35]. The manufacturer of ulipristal acetete presents appropriate information on pharmacodynamics and pharmacokinetics but fails to inform the consumer adequately about several risks, such as ectopic pregnancy, and above all about the mechanism of action. 

In the product description, the manufacturer specifies that the ulipristal acetate-containing tablet “ella”  is for oral use and contains 30 mg of  a single active steroid ingredient, namely ulipristal acetate, which  is  a synthetic progesterone agonist/antagonist [17alpha acetoxy-11beta-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione].  Among the inactive ingredients are “lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate. “[36, p.4] The structural formula (Figure.1) is the following [36, p.5].

Figure1: Ulipristal acetate structural formula of C30H37NO4

According to the manufacturer, the assumed primary mechanism of action for emergency contraception is “inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy“[36, p.5].  The manufacturer's reference to implantation clearly calls for a clarification through pharmaceuticovigilance since this process needs further explanation, especially with respect to abortogenicity which some consumers might want to circumvent. In the “Patient Counseling Information “[36, p.9].  The manufacturer considers interference with implantation only a possible mechanism of action, while the primary mechanism is the release of an ovum. “ella is thought to work for emergency contraception primarily by stopping or delaying the release of an egg from the ovary. It is possible that ella may also work by preventing attachment (implantation) to the uterus “[36, p.9].  As can be seen, the crucial question for the consumer is not answered satisfactorily. What represents the stumbling block for the manufacturer's explanation from the viewpoint of pharmaceuticovigilance are findings in physiology which clearly underline the abortogenicity of antiprogestins [17, p.409].

As regards completeness of information it should be noted that the Highlights of Prescribing Information, Full Prescribing Information and FDA Approved Patient Labeling/Patient Counseling Information furnished by the manufacturer contain no more than 11 pages and provide only limited information. Thus, concerning ectopic pregnancy, the patient information leaflet makes no mention of the possibility of severe threats to the health of the user.  Moreover, regarding liver and renal impairment no data can be furnished as there are no studies available. “No studies have been conducted to evaluate the effect of hepatic disease on the disposition of ella. . . .  No studies have been conducted to evaluate the effect of renal disease on the disposition of ella [36, p.4]”. Clearly, in presenting information that is plagued by incompleteness, vagueness, and disregard for the seriousness of adverse events, the manufacturer leaves the door wide open for complaints by the consumer. 

The incompleteness of information revealed by pharmaceuticovigilance in the case of ulipristal acetate is characteristic also of a device that has been available for women in the European Union (EU) since the last century, namely the intrauterine device Gynefix, developed and distributed by a Belgian pharmaceutical company [37]. The manufacturer of Gynefix makes several claims in favor of its device but fails to prove the validity of these claims. Above all, the fundamental assertion that the device is virtually “trouble-free“has been disproved in a scholarly publication several years previously, [38] which investigated the complications of perforation with gynefix.

Besides the Essure device for permanent contraception and the GyneFix intrauterine device another of the so-called Long-Acting Reversible Contraception (LARC) methods, namely the implant Nexplanon needs to be analysed from the viewpoint of pharmaceuticovigilance [39].

Regarding efficacy, implants   have been counted among the most effective methods of contraception and recommended for all women in a publication of 2017.   [41, p. 467]   Alas, as one of the authors of this publication had to declare conflicts of interest, the question of safety of implants cannot be considered as resolved. In fact, among the worst side effects of Nexplanon the following have been identified: blood clot formation, liver disease, ectopic pregnancy, and depression [42] as well as irregular menses, weight gain, and allergic reactions (rash; hives; itching; swollen red  blistered or peeling skin with or without fever;  unusual hoarseness; swelling of the face, mouth, lips tongue, or throat; trouble breathing, swallowing, or speaking; tightness in the throat or chest; and wheezing [43]. The manufacturer on the other hand, specifies in the Full Prescribing Information that Nexplanon is a progestin-only, flexible and soft radiopaque implant. Destined for subdermal use, Nexplanon is preloaded in a disposable sterile applicator. The length of the white/off-white, non-biodegradable implant is 4 cm, and its diameter is 2 mm. Its ethylene vinyl acetate (EVA), copolymer core contains 68 mg etonogestrel (a synthetic progestin), barium sulfate (radiopaque ingredient), but may contain also magnesium stearate, surrounded by an EVA copolymer skin.  “Once inserted subdermally, the release rate is 60-70 mcg/day in week 5-6” [40,I, p.13].  Thereafter it decreases to about 35-45 mcg per day by the end of the first year; by the end of the second year it decreases to about 30-40 mcg per day, and by the end of the third year to approximately 25-30 mcg per day.  As Nexplanon is a progestin-only implant it does not contain estrogen, nor does it contain latex [40, I, p.13].

The content of Nexplanon's core, Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18, 19-dinor-17α-pregn-4-en-20-yn-3-one], is structurally derived from 19-nortestosterone, which is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46, and its structural formula is shown in Figure. 2 [39, I, p.14].

Figure 2:  Structural formula of etonogestrel

Concerning clinical pharmacology, the manufacturer explains that the mechanism of action consists in suppressing ovulation, in increasing the viscosity of the cervical mucus, and in altering the endometrium. Regarding pharmacodynamics, it has been admitted that exposure-response relationships of the etonogestrel implants are unknown.  Regarding pharmacokinetics it is assumed that absorption takes place subsequent to subdermal insertion of the etonogestrel implant.  Etonogestrel is released into the circulation where it is approximately 100 Percentage bioavailable.

Despite the manufacturer's efforts to provide accurate information on adverse events, risks, and potential complications, the WHO had to intervene and issue an alert concerning a severe adverse event, namely migration of the device to the pulmonary artery: “The MHRA has issued a warning about rare reports of complications with etonogestrel (Nexplanon) contraceptive implants. In rare cases, such implants have moved from the insertion site and reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the earliest opportunity. If an implant cannot be located within the arm, chest imaging should be performed. Correct subdermal insertion reduces the risk of these events “[40, 389-390].

As can be seen, the WHO had to take action to inform the consumer about risks not mentioned by the manufacturer of the implants Nexplanon and Implanon. Despite this incompleteness with respect to serious complications, it must be admitted that the manufacturer's Patient Information Leaflet contains numerous precautions and warnings. Pertaining to risks the manufacturer mentions appropriately the possibility of death in the case of ectopic pregnancy and in association with blood clots. 

As can be seen, documents generated by manufacturers for the consumers of their products or for marketing purposes do not always stand up to the standards established by the bioethical principles “do not harm” and “informed consent.” It seems advisable therefore that parmaceuticovigilance assumes the role of assessing and evaluating these documents in order to enable the consumer to make an intelligent choice. Especially in free market economies where each manufacturer subscribes to the principle of profit maximising control mechanisms for the protection of consumers' health seem to be of highest importance [45]. Such a protection seems necessary also in the face of untrustworthy research adulterated by financial interests. As can be seen from a CDC publication on an invited meeting on contraception in 2015, an astounding number of participants had to declare conflicts of interest after having received grants and stipends from pharmaceutical companies [46].

A critical analysis of presently available publications pertaining to contraception and birth control shows that an unexpected high number are plagued by heterodoxies and flawed science. Such deficiencies make it difficult for consumers to find complete and comprehensible information to be enabled to make an intelligent choice – as required by the bioethical principle of infomed consent. Inadequate choice of contraceptive methods can lead to severe adverse events and complications, including hospitalization, all of which present a heavy burden for the health care system. As these publications emante from government supported sources the question of inappropriate use of taxpayer money has to be addressed. Allocation of this money entails the responsibility of the recipient to provide complete and accurate information in a comprehensible fashion. Regarding contraceptive products on the world market, pharmacovigilance defined its role in a too restrictive fashion as a control mechanism for medicines and vaccines.  What is needed also is a mechanism for monitoring the dissemination of information material generated by pharmaceutical companies for the purpose of informing consumers about their products and for marketing these products successfully on the world market. 

The author declares that there are no conflicting interests