To All re: the motives of the NWHN
To All:
I found out about a national non-profit organization of women called SIDELINES. This group has helped over 22,000 pregnant women. SIDELINES is a legitimate women's help group who has been around for more than 4 years. They have about 50 chapters all over the U.S. and they have been commended for their volunteer work by President Clinton. The SIDELINES women's group is very concerned about the motives of the "National Women's Health Network" in trying to prevent women from being able to choose maternal homecare instead of the costly hospitalization of these pregnant women.
GM
_____________________________________________________
Important Information On Terbutaline Infusion Pumps
from Sidelines National Support Network
Sidelines is concerned about the recent media coverage regarding a letter the Food and Drug Administration released alerting 40 medical societies that Terbutaline infusion therapy may not be effective and may be dangerous in the treatment of preterm labor. This information came out on news reports and in newspapers over Associated Press on November 20, 1997.
Terbutaline is a commonly prescribed drug given to reduce preterm labor, and can be administered orally, by injection, or through a subcutaneous infusion pump. Some women experience side effects when prescribed Terbutaline, but those on the infusion pump often have less side effects than those prescribed oral Terbutaline. Continuous infusion through a pump delivers about 3 mg a day of terbutaline, which is approximately ten times less than the amount prescribed of oral terbutaline (30 mg per day or 5 mg every 4 hours).
Every year Sidelines volunteers support thousands of mothers who are prescribed Terbutaline for preterm labor. We have received thousands of letters with pictures of healthy babies sent to us from families convinced that it was Terbutaline infusion that prolonged their pregnancies to a healthy gestation.
We encourage you to read our press release and discuss any concerns you might have about your current treatment program with your obstetrician or perinatologist.
ÿÿÿÿÿÿÿÿAlso see our Frequently Asked Questions and Answers About Terbutaline at the end of the press release. We welcome your questions and e-mail. Please send your letters to: sidelines@earthlink.net. with the subject "Terbutaline".
Tracy Hoogenboom
Administrative Director
Sidelines National Support Network
------------------------------------------------------------------------
Volunteer Organization for High-Risk Pregnant Women
Questions Motives of National Women's Health Network
Sidelines National Support Network Says Thousands of Women
Benefited from Using Terbutaline for Treatment of Preterm Labor
Laguna Beach, CA, November 21, 1997...
A national non-profit organization that supports and educates women with complicated pregnancies expressed growing concern today about the motives of the National Women's Health Network (NWHN). Sidelines National Support Network, cited by President Clinton for its volunteer program and its efforts in improving birth outcomes, responded to a letter released by the FDA in response to a petition filed with the FDA by the NWHN complaining about the use of the Terbutaline infusion therapy to treat preterm labor at home.
ÿÿÿÿÿÿ Executive Director, Candace Hurley, said Sidelines volunteers have supported thousands of women whose high-risk pregnancies were prolonged because tocolytic infusion therapy delivered at home. Hurley issued the following statement:
"At every FDA panel hearing we have attended, the NWHN has been there to oppose any intervention aimed at prolonging pregnancies headed for preterm delivery. They protested Ritodrine, the only drug approved specifically for treating preterm labor. They opposed home uterine activity monitoring, now approved for use by the FDA, and obstetrical home care. Now they are opposing home Terbutaline infusion therapy. We are concerned that the NWHN is not willing to reveal who is sponsoring their efforts to deny high-risk mothers access to a higher standard of care at home."
"It is important that the public know the NWHN does not represent the interests of high-risk pregnant women. Five non-profit organizations, including Sidelines, were asked by 20,000+ high-risk mothers to represent them at FDA panel hearings, Congressional hearings and before medical societies. Their message is this: The decision to treat preterm labor and the method of treatment is between the physician and mother. Very few drugs are tested in pregnant women but the fact remains pregnant women have conditions that demand treatment - preterm labor, diabetes, hypertension, asthma, epilepsy and other disorders. The vast majority of drugs given to pregnant women are prescribed `off label' because drug manufacturers are reluctant to test their products in pregnant women. It is left to the discretion of the physician and patient to decide when to use drugs outside their specific indication."
"Terbutaline is not approved for use in preterm labor because the manufacturer has not applied for approval. Nevertheless, it has been the preferred drug for controlling preterm labor for decades. In long-term clinical application it has been shown safe and effective. The use of an infusion pump has been widely successful because it infuses a steady amount of labor-controlling medication at much lower doses than IV therapy. It also achieves therapeutic levels at lower doses than oral therapy."
"Women at risk for preterm delivery have enough to contend with without the NWHN trying to take away the few tools available for reducing the consequence of preterm birth. Any woman currently receiving tocolytic infusion therapy should not discontinue treatment based on the NWHN scare tactics. She should rely on her physician's judgment and experience."
"We urge the FDA to carefully reconsider the real life issues involved in treating preterm labor and compare them to the real life and death issues of preterm birth. That the FDA reports Terbutaline to be potentially dangerous after what we understand to be an unrelated maternal death is extremely misleading and dangerous. Our concern is that women will be falsely alarmed and risk their pregnancies by discontinuing their prescribed therapy."
------------------------------------------------------------------------
Your Questions and Answers About Terbutaline
Terbutaline Infusion Therapy Questions & Answers
Q. My doctor prescribed tocolytic infusion therapy. The recent publicity about this treatment scares me. What should I do?
A. Don't stop any treatment until you talk to your doctor. Your doctor knows you and your treatment needs better than anyone else. Your doctor is doing everything possible to help you and your baby.
Q. But what about the FDA contacting physicians to say this treatment hasn't been shown to be safe and effective?
A. The FDA is responding to a complaint filed by the National Women's Health Network - an organization that does not represent high-risk pregnant women. The FDA has no alternative. The manufacturer of terbutaline has not applied to the FDA to have their drug approved for use in pregnant women. So the FDA doesn't have the research data needed to approve the drug for treating preterm labor.
Q. Then how can my doctor prescribe it?
A. Physicians can prescribe a drug approved for a certain use to treat another kind of problem. The drug is then said to be used "off label". Many drugs are prescribed this way. Terbutaline is approved by the FDA as a safe, effective treatment for asthma patients. Many years ago, research discovered that terbutaline also helps control preterm labor contractions.
Each year terbutaline is prescribed for over 250,000 pregnancies in this country that have experienced signs and symptoms of preterm labor.
Here's another example. Drugs approved for treating high-blood pressure may not have been tested in pregnant women so they are not approved for these patients. Nevertheless, some pregnant women have high-blood pressure that, if untreated, would pose a serious risk to the mother and baby. So, physicians prescribe these medications even though the FDA doesn't approve them specifically for pregnant women.
Q. What is terbutaline infusion therapy?
A. Physicians use drugs like Ritodrine, magnesium sulfate and terbutaline (called tocolytics) to control contractions when women begin labor before they reach term. Ritodrine is the only drug approved for controlling preterm labor contractions because the manufacturer of Ritodrine invested in the research needed to gain FDA approval. Ritodrine and terbutaline are similar drugs (called betamimetics) but terbutaline is less expensive.
Q. Why doesn't the manufacturer get the FDA's approval for using terbutaline to treat preterm labor?
A. Terbutaline is already used far more than the FDA approved Ritodrine or any other tocolytic, to treat preterm labor. Perhaps, the manufacturer doesn't want to invest millions in research if the drug is already being used for this purpose. Or, the manufacturer may want to avoid any potential liability by obtaining approval for a drug used in pregnancy.
The FDA has encouraged the manufacturer of terbutaline to apply for approval of this drug for this indication. The manufacturer has not yet been willing to invest in the necessary clinical research.
Again, most drugs prescribed for treating problems during pregnancy are not approved for pregnant women. This is unfortunate because pregnant women have medical problems that need treatment - not only preterm labor and high-blood pressure, but diabetes, epilepsy, cancer, depression, etc. Any disease or disorder can develop during pregnancy. Hopefully,the National Institutes of Health and drug manufacturers will do more research to determine the safety and efficacy of common treatments given during pregnancy.
Q. What about the claim that two women have died who were receiving terbutaline infusion therapy?
A. First of all, there has been no evidence that these women died because of the terbutaline. Secondly, tens of thousands of women are treated safely and effectively with this kind of therapy each year. Even had these two deaths been caused by terbutaline.many more people die each year from taking aspirin. Patients receiving subcutaneous infusion therapy are monitored closely by high trained perinatal nurses.
Q. Does Sidelines support this therapy?
A. Sidelines does not support ANY therapy, drugs, medical products or services. What we support is women having access to the facts and the opportunity to participate in decisions made about their care. We support better access to care for all pregnant women. We support aggressive, determined efforts to improve birth outcomes.
What we oppose are the politically motivated attempts by the National Women's Health Network and others to misinform, mislead and unnecessarily frighten women.
Sidelines National Support Network and other non-profit organizations such as Mothers of Supertwins (M.O.S.T.), the March of Dimes, and the Triplet Connection legitimately represent more than 200,000 high-risk mothers and their families. The National Women's Health Network does not represent high-risk pregnant women and its motives are suspect.
Q. Then why would they file a petition with the FDA against the use of terbutaline infusion therapy?
A. We can't speak for the NWHN but this is a question that needs to be answered. Other questions include: Who funded the NWHN efforts to file this petition? Who actually wrote that petition? Are they affiliated in any way with a small group of hospital- based perinatologists who have tried to deny women access to obstetrical homecare, home uterine activity monitoring and terbutaline infusion therapy?
We only know that the NWHN has appeared at every FDA hearing when Sidelines, M.O.S.T., the Triplet Connection and other non-profit organizations advocated for high-risk mothers. In every case, the NWHN opposed advancements in high-risk care. They even opposed use of Ritodrine (the one drug approved by FDA for treatment of preterm labor). We believe this organization has a hidden agenda. Sadly, the media has failed to look closely at their motives and at whose interests they truly represent.
ONE FINAL WORD:
Your most important challenge is preventing preterm delivery. Your doctor and you must remain a strong team and your efforts directed at prolonging your pregnancy. If you are concerned about your treatment, talk to your doctor. You or your doctor can also consult with a perinatologist who is experienced in terbutaline infusion therapy. Stay healthy and optimistic.we are cheering you on from the SIDELINES. |
