The Courage to Look at the Evidence

We congratulate you. It takes a lot of courage to look at the facts yourself and not let advertising; a friend or even your doctor or clinic to tell you what is a safer birth control to use. We love our own doctors, but in reality they don’t always have time to read all the studies themselves and most will admit that they often rely on information provided to them through professional journals, drug representatives and professional contacts.  Some even get discounts to sell you a specific product or incentives to prescribe a specific product to you.

Do you know that the FDA approves drugs that appear to be safe and then waits for the effects to be known as things go badly for people using the product?

When the FDA approves a drug, the pharmaceutical company submitted an application with clinical evidence that the drug does what it says it is supposed to do and is basically safe. This evidence comes from testing the drug on animals and then in small trials  on humans.   The birth control methods approved by the FDA do prevent pregnancy, but what are their true risks? There are a lot of unknowns about a drug’s side effects until after it enters the market and more people start using it. The FDA has a surveillance program, which asks for reports from the drug manufacturer and voluntary input from health care professionals and consumers on the “real world” adverse affects. Somewhere between 1% and 13% of adverse events are actually reported to the FDA.

Studies are confusing. One study says this; another study says that. Who are you to believe?

We’d like to ask you to consider using information from studies that show the highest incidents of adverse reactions because this is the information that will give you the clearest picture of the worst that can happen.  The studies that show the least risks are often funded by the drug manufacturer. The problem with some of the use of studies is that some people don’t mind if 12 women per 10,000 women (for example) have a really bad reaction (such as death, deep vein thrombosis, thrombosis in other parts of the body, pulmonary embolism,  hypercoagulation, or a stroke), but your husband or boyfriend, your children, your parents and your friends will care that it is YOU. Those 12 (or more) women are the cost that the drug company is willing to pay to continue to sell their product and make money from you or your friends.  Those women mean nothing to them.

Don’t let statistics confuse you.

It is true that your risk of blood clots is higher if you are pregnant or postpartum.  You are not taking a birth control to get pregnant.  You are most likely trying not to get  pregnant. The reason the high risk of blood clots during pregnancy is used is that the medical community (and the pharmaceutical companies) want you to use some form of birth control.  The higher rates for blood clots during pregnancy and postpartum are true.  Unfortunately, this approach minimizes the risks taken when you use hormonal birth control that has higher risks. Our intent isn’t to scare you from using birth control.  We believe you deserve to know the truth, so you can choose wisely. Don’t be afraid of birth control; just be careful about the birth control you decide to use.

Choosing a birth control method is a serious decision.

You will hear that all hormonal birth control has risks.  Yes, that is true, but that statement implies that all hormonal birth control are equal in risk.  This is not true.  Some hormonal birth control, including NuvaRing, has MORE risk for these events according to several large studies.  In addition, some of the risks about NuvaRing aren’t adequately advertised. You may hear It’s safe, but ask yourself, How safe is it really?  Does it mean that 5 women suffer a really bad medical event or do 12 women suffer one?  If more bad things happen to women while on that particular drug, how can it be safer?

Sources: http://www.webmd.com/a-to-z-guides/drug-side-effects-explained (last accessed 3/6/2014)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1494803/ (last accessed 3/6/2014)

 ******

What is a Serious Adverse Event? An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

Death

Life-threatening

Hospitalization (initial or prolonged)

Disability or Permanent Damage

Congenital Anomaly/Birth Defect

Required Intervention to Prevent Permanent Impairment or Damage (Devices)

Other Serious (Important Medical Events) Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. Source: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm (last accessed 4/6/2014)

This entry was posted in Adverse Events, FDA, NuvaRing, NuvaRing Death, NuvaRing Risks, NuvaRing Safety and tagged , , , , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s