Mamas on Bedrest: Introducing Beth Jackson Gagne, Creator Of Baby Stay Asleep

March 24th, 2011

I had the great pleasure to interview Beth Jackson Gagne; mama, licensed pediatric occupational therapist, entrepreneur and creator of the Baby Stay Asleep infant sleep system.  Jackson Gagne used her 15 years experience specializing in infants and children with developmental delays, reflux issues and other feeding concerns to create the sleep system.

In 2004, Jackson Gagne’s gave birth to son Luke who was   diagnosed with Gastro-Esophageal Reflux Disease (GERD) at 6 months. During the first few months of his life, Luke cried often, especially  after eating.  Sleeping was particularly difficult for him. Jackson Gagne and her husband were advised to raise his crib for sleeping and keep him upright after feedings. They raised his crib, but whenever they put in down to sleep, he would slide down to the bottom of the crib and and wake up.

Jackson Gagne purchased a product designed to hold him in place in his crib. After settling him to sleep, any attempt to  place him in this apparatus in the crib (which required us to fasten multiple straps), woke him up. Frustrated, Jackson Gagne finally designed her own positioning system.  “I felt we needed something that allowed us to settle him to sleep and put him in his crib without having to do any adjustments.” With his mama’s sleep system, Luke  slept more that first night then he had in 3 months!  (And so did his parents!)  Encouraged by conversations with other occupational and speech therapy professionals Jackson Gagne took her idea to a professor of Engineering at Tufts University. He collaborated on the design to ensure the safety of the product.

Jackson Gagne says, “I want to share this product,  so that other babies (and their parents) with infant acid reflux and similar concerns can also benefit and  get some much needed sleep!

The Baby Stay Asleep system consists of :

  1. The wrapper, which “wraps” around baby in the same manner that a diaper does.
  2. The bumpers, which keep your baby from rolling.
  3. The fitted sheet, which has built-in velcro to hold the bumpers and the wrapper, keeping baby secure.

The Baby Stay Asleep retails for $89.99 and comes with free shipping and a 30 day money back guarantee.

Mamas on Bedrest: The War against Mamas and Babies wages on.

March 22nd, 2011

On February 4, 2011, the US Food and Drug Administration approved the use of 17 alpha OHP (Alpha Hydroxyprogesterone Caproate) injections for the prevention of preterm labor. We in the high risk pregnancy world were jumping for joy! 17P (the name by which the injections are often referred) have been long shown to prevent preterm labor in studies carried out by the National Institute of Child and Health Development and have been used for decades “off label”. Everyone from the March of Dimes to The American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) and The Society of Maternal Fetal Medicine (SMFM) has recommended that the shots receive this particular indication. So yes, it was a great day when K-V Pharmaceutical Company and its subsidiary Ther-RX received the go-ahead from the FDA to market 17P injections as Makena for the treatment of preterm labor.

But our joy was very short lived. Immediately following approval from the FDA, K-V Pharmaceuticals jacked up the price of 17P injections from about $10 per shot to $1500 per shot. There has been no change to the formulation, no change to the method of administration and no change to how the medication acts once administered. The only change is that The FDA has given exclusive rights to K-V Pharmaceuticals and its subsidiary Ther-RX to market and distribute the 17P injections as Makena. Ther-RX has taken what was once a $150-$200 ($10 per injection for approximately 20 injections) treatment and turned it into a $30,000 treatment. Likewise, to date the drug is not covered my many insurance companies, so women who require the medication are required to pay for the drug out of pocket. KV Pharmaceuticals and Ther-RX have taken what is a lifesaving medication for thousands of unborn children and made it inaccessible to their mothers unless they can pay this “extortion” fee. Additionally, K-V Pharmaceuticals has launched a campaign against compounding pharmacies insisting that they “cease and desist” from compounding 17P.

The outrage surrounding this fleecing of the medical community in general and pregnant women in particular has been swift and fiery. Angela Davids who created and runs has been following the 17P debate and posting responses and resources in the news section of These news items are truly worth reading because many of the leaders in the field of Maternal, child and Fetal Health have spoken out vehemently against the excessive rate hike and have demanded that Ther-RX change their pricing structure.  The Presidents of ACOG, AAP and SMFM got together and wrote a letter to the Sr. Vice President of Marketing for K-V Pharmaceuticals expressing their outrage. They are encouraging K-V Pharmaceuticals to re-evaluate their pricing structure and to consider making the cost of Makena affordable to the thousands of high risk pregnant women who need it. Dr. Jennifer Gunter has also been writing regularly about Makena on her blog on the Preemie Primer website.

While K-V Pharmaceuticals/Ther-RX  has not budged on its price, they have instituted an assistance program for those unable to afford Makena as part of their Makena Care Connection, a one stop resource for patients. Here is a summary of the program provided by

The financial support program for Makena offers assistance to both uninsured and insured patients, and is based on income. According to K-V Pharmaceutical:

Insured patients with annual household incomes of up to $100,000 who apply for and are eligible for co-pay assistance will have a co-pay of $20 or less per injection for Makena.

Uninsured patients with annual household incomes of up to $60,000 who apply for and are eligible for patient assistance will receive Makena at no cost. Uninsured patients with annual household incomes between $60,000 and $100,000 will be able to acquire Makena at a cost that is comparable to the average co-pay assigned by commercial insurance plans.

Makena will not be carried by retail pharmacies. The prescription process for Makena will be managed by the Makena Care Connection, which is available by calling 1-800-847-3418 from 8 a.m. to 9 p.m. EST, Monday through Friday.

While the Makena Care Connection is a step in the right direction, it in no way atones for the unspeakable markup of 17P by K-V Pharmaceuticals and Ther-Rx. It is truly a shame that a proven therapeutic treatment is now being hoarded and meted out by a single, selfish source. Because of this price gouging, thousands of women who need 17P to maintain their pregnancies and have a chance at having a healthy full term baby will not receive the treatment that they need. For those of you that qualify for the Makena Care Connection, do apply for any and all assistance that is available to you. For those of you that don’t qualify and need Makena, know that there are many still fighting on your behalf. The battle wages on.

Mamas on Bedrest & Beyond is standing with Dr. Jennifer Gunter, ACOG, Oklahoma Physicians and compounding pharmacies in speaking out against KV-Pharmaceuticals. This company needs to know that their business practices are unacceptable and that citizens of the United States, and mamas in particular, won’t stand for it. If you need Makena and must get the prescription, we support you in your decision to do all that you can to have a healthy happy baby. But if this whole situation even remotely turns your stomach, please write a letter, a blog, sign a petition or even write a congressman, senator or the FDA to voice your opposition to K-V Pharmaceuticals.

Mamas on Bedrest: One Newborn’s Near Death Experience

March 21st, 2011

I always love to hear back from my mamas on bed rest, so I was especially happy to receive news from Kris Gibson in Ireland about the birth of her son Oliver. However, her shocking story about how she nearly lost her infant son sent shivers through me.  With Kris and her family’s permission, I share the following summary of  little Oliver’s near death experience. This is a summary of the report in the Irish Times (March 8, 2011).

On Christmas morning, about 10 days after Oliver’s birth, Oliver was weak and lethargic. Like any mom, Kris stayed close to her son and later in the day, when her husband checked on them, he noted that the baby was having difficulty breathing and was turning blue. They immediately rushed him through the snow and ice back to the Rotunda, the hospital where he was born,  and within an hour he was on life support. Doctors told his parents he was extremely ill. Tests for meningitis were carried out and he was put on a range of antibiotics. He remained “floppy” for a number of days, showing no muscle tone, no reflexes and very little pupil dilation.

After being seen by a neurologist, his parents were told his problem was most likely neurological, muscular or metabolic. But an EEG test performed to monitor his brain activity seemed normal.

He was transferred, still on a ventilator, to the intensive care unit of Temple Street Children’s Hospital in Dublin where further testing including an MRI scan was performed. It was normal. Several possible causes for his symptoms were ruled out and the thinking was he probably had a neuromuscular disorder, which came as a devastating blow to his parents.

But over a number of days Oliver went from floppy to responsive and gradually recovered. On New Year’s Eve he was out of intensive care, a range of viral tests came back negative and it seemed he had fought off the mystery illness that had afflicted him. He was well enough to be sent home on January 5th, but his parents were still none the wiser as to what had actually happened to him.That evening a pediatrician from Temple Street called them at home to say they had finally obtained a positive result from all the testing they had done on Oliver. He had contracted infant botulism, which is rare and life-threatening, and his stools had tested positive for type E botulism toxin-only the seventh such case reported in an infant worldwide. It was also the first case of any type of infant botulism reported in the Irish Republic.

The hunt began to find the source of the infection. At first Kris was asked to stop breastfeeding in case that was the source. Public health officials visited their house and took a range of samples, including specimens of the supplements Kris took while pregnant and samples of foam used in a recording booth Kevin (Kris’s husband and Oliver’s father) had just constructed. Reading up on botulism on the internet Kris discovered the toxin can be found in soil and felt sure it emanated from their Christmas tree.

However, testing carried out by the HSE, and sent to the UK for analysis, eventually found the source. The toxin was in water in a tank housing two pet turtles in their home as well as in food bought for the pets. The turtles had to be put down, the walls and furniture in the room where they were kept disinfected and the carpet ripped up and replaced.

But the nightmare didn’t end there. Two days after he had been discharged from The Temple Street Childrens Hospital, Oliver showed all the same terrifying symptoms again and had to be rushed back to the hospital where he was put on life support for a second time.  This time the doctors knew what they were dealing with.

The toxic spores which he had inhaled were still in his system but their effect had temporarily been halted by him being on oxygen. Now that he was off oxygen they were attacking his nerve endings again, causing paralysis. Doctors at Temple Street consulted with experts in the UK and US who had previously treated cases of infant botulism. It was decided he needed to be given an antitoxin by IV infusion and the only one approved in Ireland for treating type E botulism toxin was not recommended for use in children, but it was given to him on the basis that the benefits outweighed the risks. Consultation with a world leader on infant botulism at the California Department of Public Health indicated that the type of antitoxin given to Oliver would be effective for only a couple of weeks and further doses in an infant could cause anaphylaxis. A different antitoxin, which would cover him for several months until the toxin was cleared from his system, was required. This antitoxin had been tested and found to be effective by the US government in anti-terrorism research, but which had only been approved by the FDA for use in infants with type A and B botulism. However, the experts agreed it was the best possible treatment available.

Once the experts agreed on the treatment, it was immediately purchased by the federally funded health service and imported to Ireland. This all occurred on Saturday and the medication was given to Oliver on Sunday.  The antitoxin cost about €35,000 (about $57,000) his parents were told, but a few days after receiving it Oliver was well enough to go home. He hasn’t relapsed since, but continues to undergo weekly tests. If three tests in a row are negative for the toxin, he will get the “all-clear”. So far, two tests have been negative.

In early March, the Irish National Health Protection Surveillance Center warned that reptiles such as snakes, lizards, tortoises, turtles and terrapins are not appropriate pets for children under the age of five, because they carry a risk of botulism infection and also salmonella. The reason botulism toxins are so hazardous to infants is because they haven’t yet built up defenses to fight them. These toxins are also a risk for adults with weakened immune systems including those who are pregnant or those with diseases such as cancer.

Over the past two years, a very small number of cases of infant botulism have also been diagnosed in the UK in babies with a history of having consumed honey. As a result, parents are now warned that honey should not be given to children under 12 months of age. However, Oliver’s mum, Kris Edlund Gibson, an actress who has starred in several TV dramas including Judging Amy and Frasier, says that in one of those UK cases the honey didn’t test positive for botulism toxin.

“So it was sort of a mystery how that baby got it. Well after Oliver, the HSE called them and said, ‘Hey, by any chance did you guys have turtles at home?’ They did, the exact same kind of turtles we had and the exact same manufacturer of the turtle food.”

It seems those treating little Oliver Gibson may have finally solved a riddle for more than one family.

This is a stark reminder to us all that the seemingly most insignificant things around our homes can have a huge impact on our newborns. As new parents, be vigilant to everything that even remotely comes in contact with your baby. You just never know. To quote Kris, “Err on the safe side if you’re wondering whether or not you should keep that pet because no pet was worth what we went through . . . it was the most painful situation in my life. It was truly just a waking nightmare.”