App “as effective as the contraceptive pill”

A revolutionary form of contraception, especially available over-the-counter, has been long awaited. This year alone we have seen trials in male contraceptive injections and demands for numerous OTC contraceptive pills. Drastic change and action have long been in high demand.

What started out as a hobby project for Elina Berglund Scherwitzl has now become approved as the world’s first contraceptive app. The nuclear physicist, who had been working on the team that discovered the Higgs boson, felt finished with hormonal contraceptives and their physical and mental pitfalls, but was not yet ready to have a baby.

With a wealth of data skills, Elina was determined to find an alternative form of contraception. “Like many women I had tried many different contraception options since my teenage years and hadn’t really found a solution that fit me,” she explained. “It was in my quest for an effective natural alternative that I discovered that you can see when you’re fertile by your temperature, and for me that was really a revelation.”

Using complex mathematics and data analysis, Elina began developing an algorithm designed to be so accurate that it could identify exactly when in her cycle she would ovulate. This then enabled planning for when she would need to use protection, to a much higher degree of certainty than natural planning methods, which many women with timely periods are able to use.

These results proved to be so accurate that, together with her husband, fellow physicist, Raoul Scherwitzl, Elina set about founding her own business, Natural Cycles.

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Natural Cycles is an app designed to help women around the world with their fertility and contraception needs, allowing them to collect their own temperature datasets and closely monitor their cycle trends in the process.

Launched in 2014, the app now has some 300,000 users, who pay a monthly or annual fee for the service. Following several medical trials, the app became the first tech-based device on the planet to be formally certified for use as contraception, in February this year. It gained approval for use across the EU after getting the green light from the German inspection and certification organisation Tuv Sud.

The start-up now markets itself as being “as effective as the pill” following one of the largest clinical studies in contraception involving more than 4,000 women, published in the peer-reviewed European Journal of Contraception and Reproductive Health Care.

The researchers, which included the co-founding couple, found that 7% of women who used the app in a “typical” way (allowing for some human error) got pregnant, compared to 9% taking the pill and less than 1% using IUD coils. “Just like the pill we need some effort from the user on a daily basis. But we really hope to be the default alternative if you don’t want to use hormonal contraception or IUDs,” Elina commented.

While the product is only currently certified in the EU, where its users are concentrated in the UK and the Nordics, it is available worldwide and, despite its earlier controversies, has attracted users in some 160 countries.

Cognitive Boost For Children Whose Mothers Take Supplements In Pregnancy

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Maternal multi-micronutrient (MMN) supplementation during pregnancy could drastically improve cognitive ability in children, reports a study published on 17th January in The Lancet Global Health. This may be apparent in children between the ages of 9 to 12 years.

The Summit Institute of Development research team led a follow-up study involving 2,879 schoolchildren in Indonesia whose mothers were supplemented with MMN or iron + folic acid (IFA) in the Supplementation with Multiple Micronutrients Intervention Trial (2001-2004).

SID’s initial research was conducted with 31,290 pregnant women on Lombok Island. The women were selected randomly to receive multi-micronutrient supplements.

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The CEO of SID, Mandri Apriatni, commented: “Results of our initial research showed there had been an 18 percent decrease in infant mortality rates each year among mothers who had taken multi-micronutrient supplements during their pregnancy, much lower compared to those who only received iron and folate acid supplementation.”

In the follow up-study that saw children complete cognitive tests over a two-year period, researchers observed better procedural memory in MMN children vs IFA children. The difference between the two corresponded with the increase associated with an additional half-year of schooling.

Children of anaemic mothers in the MMN group scored considerably higher in general intellectual competence, equivalent to the increase associated with an additional full year of schooling. Overall, there was a positive coefficient of MMN vs IFA in 18 / 21 tests.

IBIS AND HRA AIM TO SWITCH THE PILL TO OTC

Ibis Reproductive Health and French-based HRA Pharma are working together to provide the research needed to submit an application to the US FDA to switch a progestin-only daily use oral contraceptive (OC) to OTC. For over a decade Ibis has worked with a broad coalition of healthcare providers, advocates and researchers in the Oral Contraceptives OTC Working group to build the evidence and make the case for the benefits of moving a birth control pill OTC.

Ibis highlights that too many people in the US face barriers to accessing the birth control they want and that a safe and effective OC would help people overcome some of those barriers. The coalition is committed to conducting the research and advocacy to ensure any OTC method is covered by health insurance and available to everyone who needs it.

HRA Pharma has already seen success in Rx-to-OTC switch in the EU, with its application to the European Medicines Agency to reclassify its emergency hormonal contraceptive ellaOne (ulipristal acetate 30mg) approved by the European Commission in early 2015 via the centralised procedure.

In an exclusive comment to the OTC.NewDirections team, Ibis Reproductive Health’s VP for Development & Public Affairs Britt Wahlin said: We are thrilled to be working with HRA Pharma in this effort that has been driven by demand from consumers and medical professionals. It’s past time we have an FDA approved OTC birth control pill, which would make it easier for women and men all across the country to determine how and when to have children and give them greater control over their lives and reproductive health. Currently, under the Affordable Care Act, most private insurance plans have to cover all types of FDA-approved birth control for women without any cost-sharing. This includes OTC methods used by women – though only if a healthcare provider prescribes them. We hope that women will be able to use their insurance for an OTC birth control pill without having to get a prescription.

A new law in Maryland is a promising direction. It will require coverage of OTC contraceptive medications without a prescription starting in 2018 and we hope more states will follow suit. Efforts are underway to dismantle the ACA and we have yet to learn what concrete plans there are to replace it. The birth control coverage provision is a crucial piece of the ACA. Millions of women have benefited from greater access to birth control and contraception is not one size fits all; insurance coverage of the full range of methods is critical so that women truly have a choice.

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Also, HRA Pharma’s US Portfolio Strategy Director Stéphanie Pradet told the OTC.NewDirections team: HRA Pharma is proud to partner with Ibis Reproductive Health and the OC OTC Working Group to bring to the US market a safe and effective over-the-counter contraceptive. At HRA, we are proud of our pioneering work to expand access to contraception for millions of women. We share the OC OTC Working Group’s commitment to increasing safe and effective options for preventing pregnancy and improving the reproductive health of women in the US.

Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts. The science is clear, and US experts including The American College of Obstetricians & Gynecologists, the American Medical Association and the American Academy of Family Physicians agree that oral contraceptives are appropriate as an over-the-counter option. We look forward to working together to build a future where each woman can get the safe and highly effective birth control method she prefers.

Male Contraceptive Has Moderate Trial Success

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The next frontier of sexual liberation is close – the male contraceptive is almost here!

For decades now, scientists have been progressively working towards developing birth control for men, and the recent news that the injected male contraceptive is now just as effective as its female counterpart is groundbreaking.

In a trial of 320 men, aged between 18 and 45, researchers found that, over a one-year period, a new hormone-based injection was 96% effective in preventing pregnancy.

The hormones injected into the men on the trial were shown to dramatically lower their sperm count by “switching off” the male reproductive system.

The drugs did however cause some unpleasant side-effects, meaning that the trial had to be halted early. Of the 320 participants, 20 experienced mood swings, depression, muscle pain and acne. Despite this, 75% of the participants said they would be happy to take the male contraceptive on a regular basis.

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Richard Anderson, a professor of clinical reproductive science and author of the study, said: “If you’re comparing it to other reversible male methods, it’s far better than the condom and it puts it in the same ballpark as the pill.”

The male contraceptive is not the only new and innovative form of protection that is set to be on offer. The predominantly male condom is now available in female form. The disposable contraceptive device, which is marketed by The Female Health Company, is the only female condom approved by the US FDA and cleared by the World Health Organization.

The condom provides dual protection against unintended pregnancy and sexually transmitted infections, offering what it claims to be a thoroughly safe sexual experience for both parties.

British Columbia Pharmacists Could Provide Abortion Pills

The British Columbia College of Pharmacists has been working with Canada’s Department of Health to make the combination of mifepristone and misoprostol (for the termination of a developing intra-uterine pregnancy up to a gestational age of 49 days) available directly from a pharmacist.

The product, Mifegymiso (Linepharma International), was approved by Health Canada in 2015, and was placed on the Prescription Drug List (PDL). The provincial drug schedules also classified the two ingredients as prescription drugs (requiring a physician’s intervention).

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The College of Physicians and Surgeons of B.C. and the College of Pharmacists of B.C. have been working behind the scenes for months to find a way to circumvent the federal drug regulator’s plan for physician-only dispensing of Mifegymiso. Abortion advocates say that because most doctors’ offices are not equipped to act as miniature pharmacies, the dispensing requirement is likely to discourage physicians.

It seems that the intention may be to work around the regulations, though this may not be well received by federal regulators. Health Canada also advised that working around the regulations would have an impact on the liability of pharmacists.

Mifepristone has been approved in more than 60 countries, including the United States, where it has been available since 2000. Canada did not approve the drug until July 2015, and manufacturing issues have since delayed its sale.

UK press misreports paracetamol’s autism / ADHD links

Paracetamol is the most widely used analgesic in the world and was once deemed the only painkiller that is safe for mothers-to-be.

However, women who take paracetamol during pregnancy “risk having a child with autism or ADHD”, the Mail Online reported last week. Other UK newspapers, The Times and The Daily Telegraph, are also ‘guilty’ of publishing headlines that could potentially cause unnecessary worry for pregnant women.

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The Spanish study that reported on the matter actually provided no direct link or solid evidence to ADHD or autism. Over 2,000 pregnant women using paracetamol, before and during pregnancy, were assessed between 2004 and 2008. Various developmental and behavioural tests on the children at the ages of one and five were then conducted.

Links were found between paracetamol use and hyperactivity / impulse symptoms at age five, and autism symptoms in boys. There was however no direct link to ADHD or autism symptoms, nor a link to intellect or development in the children being affected.

The study will most likely contribute to the long list of pregnancy “dos” and “don’ts” owing to its media focus. Most importantly, the NHS has confirmed that there was no link with the full diagnostic criteria for attention deficit hyperactivity disorder (ADHD) or autism; highlighting that the study cannot prove that using paracetamol in pregnancy caused these symptoms.

OTCs in Action: US access to OCs changing

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Digital Projects Executive, Holly Parmenter, looks at how access to oral contraceptives is evolving in the world’s No.1 OTC market.

It’s legitimate; three US states now officially allow you to get your daily birth control straight from your pharmacist at the local drugstore.

This week OTCs are in action in Oregon, Washington and California as these states have agreed to the new pharmacist-prescribed hormonal birth control plan; Hawaii, Missouri, South Carolina and Tennessee are all in discussions as to whether to follow.

Gone are the days where waiting and queuing for your contraceptives was a necessity – the entire process, start to finish, now takes just under 20 minutes!

This new and exciting development consists of filling out a simple health questionnaire and having your blood pressure taken. Your pharmacist will then recommended a brand of birth control pills. It has been on the cards for a while, as women’s healthcare providers have expressed how they would like to see birth control made easier to access.

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The matter, over various states, has been considered very political. Applications for switch must also show that the candidate is very safe in terms of health. With a large amount of oral contraceptives, there is a thrombotic stroke risk, and an applicant would have to be able to deal with this through labelling if, for example, progestin-based pills were to become OTC.

In June 2015, US Senator Patty Murray announced the Affordability is Access Act, a new bill that would build on contraception coverage mandated in the Affordable Care Act. “I believe strongly that women should be able to get the comprehensive healthcare they need, when they need it
 – without being charged extra, without asking permission and without politicians interfering,” said Senator Murray.

With support from NARAL Pro Choice America, Planned Parenthood Action Fund and the American Congress of Obstetricians & Gynecologists (ACOG), the Affordability is Access Act would allow women to have access to OTC OCs without being forced to pay extra out of pocket.

So far there seems to be no movement on this merging but here’s hoping that now California, Washington and Oregon have this OTC offering, the positives will become apparent and various partnerships can work together to make OCs truly OTC nationwide.