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GAY PEOPLE'S CHRONICLE
Speaker
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wading into a controversy for which its members have no particular expertise at all," Gallagher opined.
A one-time single mother with a B.A. degree in religious studies, Gallagher testified before a Senate committee on behalf of the federal marriage amendment in 2003, declaring that its passage was about “getting children the mothers and fathers they need."
Gallagher co-authored The Case for Marriage: Why Married People Are Happier, Healthier and Better Off Financially in 2001. The book only advocates opposite-sex marriage.
Other than the book, Gallagher has no credentials as a researcher, nor any legal training.
Gallagher was dropped from many newspapers after the January discovery that she had been paid $21,500 by the Bush administration to produce materials promoting the
Patient Information
TRUVADA® (tru-VAH-dah) Tablets
Generic name: emtricitabine and tenofovir disoproxil fumarate
(em tri SIT uh bean and te NOE fo veer dye soe PROX il FYOU-mar-ate)
September 2, 2005
president's marriage initiatives, then wrote newspaper columns supporting the initiatives without disclosing her financial interest to readers. The papers, including Ohio's Canton Repository and Middletown Journal, dropped her for ethical reasons.
Valerie Huber, who directs the state health department's abstinence education unit, confirmed that Gallagher's contract was written to cover fees and expenses up to $5,000.
AIDS Taskforce of Greater Cleveland director Earl Pike, a critic of the conference, said he called other abstinence educators to see what their fees were. None were higher than $2,000, which was the fee of Dr. Douglas Kirby, formerly of the National Campaign to Prevent Teen Pregnancy.
Kirby's work, however, is of a scientific nature, and far more critical of abstinenceonly claims than Gallagher's opinion pieces. It also lacks the overt anti-gay message.
Huber said that the conference, which costs participants $100-150 to attend, pays for itself and requires "very little” money that can be sourced to taxpayers.
Read the Patient Information that comes with TRUVADA before you start taking it and each time you get a refill There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider's care when taking TRUVADA Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about TRUVADA. What is the most important information I should know about TRUVADA?
• Some people who have taken medicine like TRUVADA (nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis.
• You feel very weak or tired.
You have unusual (not normal) muscle pain.
You have trouble breathing.
You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
You feel dizzy or lightheaded.
• You have a fast or irregular heartbeat.
• Some people who have taken medicines like TRUVADA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems.
• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
You don't feel like eating food for several days or longer.
•You feel sick to your stomach (nausea).
You have lower stomach area (abdominal) pain.
• You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like TRUVADA, for a long time.
• TRUVADA is not for the treatment of Hepatitis B Virus infection. Patients infected with both HBV and human immunodeficiency virus (HIV) who take TRUVADA need close medical follow-up for several months after stopping treatment with TRUVADA. Follow-up includes medical exams and blood tests to check for HBV that could be getting worse. Patients with Hepatitis B Virus infection, who take TRUVADA and then stop it, may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.
What is TRUVADA?
TRUVADA is a type of medicine called an HIV (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitor (NRTI). TRUVADA contains 2 medicines, EMTRIVA (emtricitabine) and VIREAD (tenofovir disoproxil fumarate, or tenofovir DF) combined in one pill. TRUVADA is always used with other anti HIV medicines to treat people with HIV infection. TRUVADA is for adults age 18 and older. TRUVADA has not been studied in children under age 18 or adults over age 65.
HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells. are destroyed, acquired immune deficiency syndrome (AIDS) develops. TRUVADA helps block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. TRUVADA lowers the amount of 200 HIV in the blood (viral load) TRUVADA may also help to increase the number of I cells (CD4 cells). Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).
mg
How should I take TRUVADA?
She promised to provide the financial information from last year's conference, but had not done so by press time.
Huber said this year's conference is expected to draw 300-350 participants.
Huber said Gallagher was chosen to speak because marriage is "a big part" of what the conference is about.
"[Gallager's book] is the standard-bearer of that research," said Huber, adding that criticism of Gallagher as anti-gay is an "incredulous assertion."
"This is not a gay marriage debate,” said Huber, "We're talking about the health of youth, and what is best for children born out of that [married] relationship."
According to Huber, four other speakers are confirmed, including Assistant U.S. Deputy Secretary of Education Deborah Price, who is the former director of the National Prayer Breakfast; U.S. Department of Education abstinence educator Jeff Trimbath, formerly of the Pennsylvania Catholic Conference; U.S. Department of Health and Human Services special assistant for marriage educa-
• Take TRUVADA exactly as your healthcare provider prescribed it. Follow the directions from your healthcare provider, exactly as written on the label.
• The usual dose of TRUVADA is 1 tablet once a day. TRUVADA is always used with other anti-HIV medicines. If you have kidney problems, you may need to take TRUVADA less often.
• TRUVADA may be taken with or without a meal. Food does not affect how TRUVADA works. Take TRUVADA at the same time each day.
• If you forget to take TRUVADA, take it as soon as you remember that day. Do not take more than 1 dose of TRUVADA in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of TRUVADA or your anti-HIV medicines.
• When your TRUVADA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TRUVADA and become harder to treat.
• Do not change your dose or stop taking TRUVADA without first talking with your healthcare provider. Stay under a healthcare provider's care when taking TRUVADA.
• If you take too much TRUVADA, call your local poison control center or emergency room right away. What should I avoid while taking TRUVADA?
• Do not breast-feed. See "What should I tell my healthcare provider before taking TRUVADA?"
• Avoid doing things that can spread HIV infection since TRUVADA doesn't stop you from passing the HIV infection to others.
• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
• COMBIVIR, EMTRIVA, EPIVIR, EPIVIR-HBV, EPZICOM, TRIZIVIR, or VIREAD. TRUVADA should not be used with these medicines.
What are the possible side effects of TRUVADA?
TRUVADA may cause the following serious side effects (see "What is the most important information | should know about TRUVADA?"):
• Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor right away if you get signs of lactic acidosis. (See "What is the most important information I should know about TRUVADA?")
• Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See "What is the most important information I should know about TRUVADA?")
"Flare-ups" of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking TRUVADA. Your healthcare provider will monitor your condition for several months aftepping TRUVADA if you have both HIV and HBV infection. TRUVADA is not for the treatment of Hepatitis BVirus infection.
دار
Truvada emtricitabine -tenofovir disoproxil fumarate
TRUVADA does not cure HIV infection or AIDS. The long-term effects of TRUVADA are not known at this time. People taking TRUVADA may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking TRUVADA. TRUVADA does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles. Who should not take TRUVADA?
Do not take TRUVADA if you are allergic to TRUVADA or any of its ingredients. The active ingredients of TRUVADA are emtricitabine and tenofovir DF. See the end of this leaflet for a complete list of ingredients. What should I tell my healthcare provider before taking TRUVADA? Tell your healthcare provider if you:
⚫ are pregnant or planning to become pregnant. We do not know if TRUVADA can harm your unborn child. You and your healthcare provider will need to decide if TRUVADA is right for you. If you use TRUVADA while you are pregnant, talk to your healthcare provider about how you can be on the TRUVADA Antiviral Pregnancy Registry.
⚫ are breast-feeding. You should not breast feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, it is not known . TRUVADA can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.
• have kidney problems or are undergoing kidney dialysis treatment.
⚫ have bone problems.
⚫ have liver problems including Hepatitis B Virus infection.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: COMBIVIR, EMTRIVA, EPIVIR, EPIVIR HBV, EPZICOMTM, TRIZIVIR, or VIREAD. TRUVADA should not be used with those medicines.
Drugs that contain didanosine (VIDEX", VIDEX EC). Tenofovir DF (a component of TRUVADA) may increase the amount of VIDEX in your blood. You may need to be followed more carefully if you are taking TRUVADA and VIDEX together.
•REYATAZ (atazanavir sulfate) or KALETRA (lopinavir/ritonavir). These medicines may increase the amount of tenofovir DF (a component of TRUVADA) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking TRUVADA and REYATAZ or KALETRA together. Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers and pharmacist every time you visit your healthcare provider or fill a prescription.
· Kidney problems. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys.
·
Changes in bone mineral density (thinning bones). It is not known whether long-term use of TRUVADA will cause damage to your bones.
If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density.
Other side effects with TRUVADA when used with other anti-HIV medicines include:
·
300 Changes in body fat have been seen in-some patients taking TRUVADA and other anti-HIV medicines. These changes may include increased amount
of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
The most common side effects of EMTRIVA or VIREAD when used with other anti-HIV medicines are: dizziness, diarrhea, nausea, vomiting, headache, abdominal pain, depression, rash, and gas. Skin discoloration (small spots or freckles) may also happen with TRUVADA.
These are not all the side effects of TRUVADA. This list of side effects with TRUVADA is not complete at this time because TRUVADA is still being studied. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects. How do I store TRUVADA?
• Keep TRUVADA and all other medicines out of reach of children.
• Store at room temperature up to 77 °F (25 °C).
·
Keep TRUVADA in its original container and keep the container tightly closed.
• Do not keep medicine that is out of date or that you no longer need. If you throw sure that children will not find them.
General information about TRUVADA:
tion Bill Coffin, who is formerly the Marriage Preparation Coordinator for the Catholic Archdiocese of Washington; and Governor Taft's faith-based initiative coordinator Christa Sisterher.
A religious component?
Huber denies that religion will influence the conference.
"It will be a focused discussion," said Huber. "These are policy people talking about research and topics, not religion."
On religious entanglement at a state-sponsored event, health department spokesperson Jay Carey, also on the call with Huber, added, "What people do in some aspect of their private lives is not what we're asking them to talk about,"
Judy Price of the AIDS Taskforce, who attended the conference last year, disagrees.
"It is very definitely faith-based," said Price. "God was the most important thing at the conference, and the underlying message was that you will burn in hell if you have sex before you marry."
Price said the religious messages are subtle, but present.
"What they are talking about is that faith in God will help you stay a virgin," said Price, "and that message is what gets crowd applause."
"It felt cult-like," said Price. "I would never want my own children taught this." Price objected to a more overt message the conference has for girls.
"They are teaching girls that their bodies are sacred things to be given to men, and that [girls] should already love their [future] husbands by age 16, enough to give the men their purest self," said Price.
Price also objected to what was taught about condoms during a breakout session— that they have a high failure rate and cannot be trusted.
Former Taskforce employee Mikell Nagy, who is gay, said he was made so uncomfortable during one session last year that he had to walk out.
Nagy said during that session, replacement speaker Scott Phelps, who directs the Abstinence and Marriage Education Partnership, railed against gay men for spreading AIDS.
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Don Kramer Lakewood (216) 221-6263
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TRUVADA for a condition for which it was not prescribed. Do not give TRUVADA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about TRUVADA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TRÚVADA that is written for health professionals. For more information, you may also call 1-800-GILEAD-5 or access the TRUVADA website at www.TRUVADA.com.
Do not use TRUVADA if seal over bottle opening is broken or missing. What are the ingredients of TRUVADA? Active Ingredients: emtricitabine and tenofovir DF
Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y-30-10701 containing FD&C Blue #2 aluminum lake, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
Rx Only January 2005
TRUVADA, EMTRIVA, and VIREAD are registered trademarks of Gilead Sciences, Inc. REYATAZ and VIDEX are trademarks of Bristol-Myers Squibb. KALETRA is a trademark of Abbott Laboratories. COMBIVIR, EPIVIR, EPIVIR-HBV, EPZICOM, and TRIZIVIR are trademarks of GlaxoSmithKline.
2005 Gilead Sciences, Inc.
GILEAD
DON KRAMER
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(216) 529 0200
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