Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, July 20, 2016

Dead Baby Parts Have NEVER Cured Disease: Congress

While Planned Parenthood insists that their baby-killing business furthers medical science, the Congressional Select Investigative Panel on Infant Lives of the House Energy and Commerce Committee has found no such benefits.
“Fetal tissue has been used in biomedical research for over 90 years. In this time, not a single medical cure has resulted from this research.”
-- Rep. Marsha Blackburn (R-TN)
UPDATE 8/27/16: Congressional Panel Finds Criminality — High Schoolers Dissected Aborted Baby Brains

For background, read Planned Parenthood Sells Aborted Baby Parts for Research

Also read Stem Cell Breakthrough: Embryos Needn't Be Killed

-- From "Congressional Report: ‘Fetal Tissue Has Not Been Directly Linked to a Single Medical Cure’" by Jeannette Richard, CNSNews.com 7/19/16

“While it is commonly claimed that fetal tissue was used to produce the polio vaccine, this is largely false. The polio vaccine was developed by Jonas Salk in 1955 using a monkey cell line, and is still produced using monkey cells.

“Some might object that while fetal tissue research has not directly resulted in medical cures, it has helped advance the overall body of scientific knowledge and thereby assisted in producing cures. It is impossible to determine whether this claim is true, and if so to what extent. Yet the fact is that no one can point to a single medical advancement that critically depended on the use of fetal tissue.”

“In fact, vaccines against eight diseases (Rabies, Diphtheria, Typhoid, Cholera, Plague, Tetanus, Pertussis and Bacille-Calmette-Guerin disease) were all developed in the 1800s and early 1900s, well before the first use of fetal tissue in research,” according to the report.

The panel examined the Food and Drug Administration’s (FDA) list of approved vaccines which prevent 26 different diseases, and found only three (Varicella, Hepatitis A, and Zoster) for which vaccines were developed using fetal tissue. However, these vaccines rely on fetal cell lines only for “economic, not scientific reasons,” the panel reported.

To read the entire article above, CLICK HERE.

From "How fetal tissue is used in medical research" by The Week Staff 10/24/15

How do scientists use fetal tissue?

It's used to find potential treatments for a wide range of common diseases and afflictions, including cancer, diabetes, birth defects, HIV, multiple sclerosis, ALS, and Alzheimer's. Unlike adult tissue cells, fetal tissue cells can be manipulated into almost any kind of tissue, are less likely to be rejected by a host, and have the capacity to replicate rapidly — making them perfect for analysis into how diseases work. They are also being tried as actual treatments for Parkinson's disease, spinal cord injuries, and diabetes, with researchers injecting fetal cells directly into organs in hopes of regenerating them. Fetal tissue was also a vital component in the development of vaccines for polio, chicken pox, rubella, and shingles. The polio vaccine alone saves 550,000 lives a year. Alta Charo, a bioethicist at the University of Wisconsin at Madison, says fetal tissue research has benefited "virtually every person in this country."

To read the entire article above, CLICK HERE.

From "The Transfer of Fetal Tissue and Related Matters" a report to Select Investigative Panel of the U. S. House of Representatives 7/14/16

Fetal Cell Research is Outdated Technology - Beginning in the 1930s, viruses were propagated using fetal tissue and some laboratories continued to this method until the 1970s. During that time, scientists did not yet know how to work with more mature human cells, and fetal tissue was easier to grow in the laboratory. Science has now advanced beyond these earlier approaches. In short, human fetal tissue is outdated technology that is not necessary for modern vaccine research. For example, current vaccine research for HIV/AIDS, Cancer, Malaria and Ebola does not rely on fetal tissue.

Fetal Tissue is not Mainstream Science - In 2014, the most recent year for which data is available,200 NIH funded a total of 76,081 research grants, only 160 of which (less than 1%) involved the use of human fetal tissue. In contrast, in the same year, NIH funded 1,136 grants using adult stem cells. The fact that fetal research is such a tiny fraction of all scientific research calls into serious question the claim that fetal research is vital and that science will not advance without it. In reality, use of human fetal tissue is increasingly an outdated and unnecessary scientific technology, used only by a handful of scientists.

To read the entire report above, CLICK HERE.

Also read Mutant Human-pigs Created for Organs in U.S.

Thursday, February 04, 2016

3-Parent Babies are Ethical: Experts to Obama FDA

Experts from the National Academy of Sciences, Engineering and Medicine are advising President Obama's Food and Drug Administration (FDA) to approve mitochondrial DNA replacement techniques (MRTs) to help about a hundred Americans give birth to creatures fabricated in a laboratory using genetic material from three unrelated people.  The experts promise that no scientists in the future will misuse the techniques to "play god" and create any Frankenstein babies.

For background, read President Obama's FDA Pushes 3-parent Babies

Click headlines below to read previous articles:

UK Government OKs Frankenstein Designer Babies

Secret Designer Babies via Gene-editing Science

Scientists Create Artificial Human Eggs and Sperm

Genetic Scientists Worshiped as Creators of Life

Also read Unborn Must Die so Others Can Live, Scientists Say

-- From "Three-parent babies are ok, experts say" by NBC News 2/4/16

Such "three-parent" babies could be a way for people with a high risk of rare, devastating genetic diseases to have healthy children that are genetically their own, the National Academy of Medicine panel said.

And at first, the panel advised, only male embryos should be made this way until it's clear that dangerous mutations would not be passed down to future generations.

The FDA asked the academy, formerly known as the Institute of Medicine, to look at the three-person embryo processes, called mitochondrial replacement techniques (MRT). These are variations of in vitro fertilization, or IVF — the method that creates so-called "test-tube babies."

MRT adds a step [to IVF]: The mother's nuclear DNA would be removed and placed into the egg cell of another woman. The father's sperm would then be used to fertilize that hybrid egg.

The new techniques would be used to prevent the transmission of certain types of diseases that occur at the mitochondrial DNA level, the experts said.

To read the entire article above, CLICK HERE.

From "Babies With Genes From 3 People Could Be Ethical, Panel Says" by Rob Stein, WBEZ-FM91.5 NPR (Chicago, IL) 2/3/16

Critics of the research, meanwhile, say the number of women who could benefit from the experiments is so small that it's not worth crossing a line that's long been considered off-limits — making genetic changes that could be passed down for generations.

"The possibility of what you could call 'mission creep' is very real," says Marcy Darnovsky, executive director of the Center for Genetics and Society, a watchdog group based in Berkeley, Calif. "People are talking about going forward not just with this but with the kind of genetic engineering that will produce outright genetically modified human beings."

Once that happens, Darnovsky says, "I think you get into a situation of where some people are genetically enhanced and other people are the regular old variety of human being. And I don't think that's a world we want to live in."

. . . The FDA email praised the "thoughtful work" of the panel and said the agency would be "reviewing" the recommendations. But it noted that the latest federal budget "prevents the FDA from using funds to review applications in which a human embryo is intentionally created or modified to include" changes that could be passed down to future generations. As a result, the email says, any such research "cannot be performed in the United States" at this time.

"I think it's a great step in the right direction," Mark Sauer, a professor of obstetrics and gynecology at Columbia University who is a member of one of the teams . . . "Politics as usual often gets in way of progress," Sauer said in a subsequent email. While the FDA statement would cause "undue delays" in his research, he added that he hoped it wouldn't permanently "necessarily halt the efforts."

To read the entire article above, CLICK HERE.

From "Should scientists be allowed to change DNA to prevent genetic disease?" by Daphne Chen, Deseret News 2/3/16

"I think the field has come together to say, 'Let’s think about this together and go forward carefully,'" said Dr. Jeffrey Botkin, a professor of pediatrics and chief of medical ethics and humanities at the University of Utah.

Botkin sat on the 12-person committee that included top bioethics experts from Johns Hopkins, Caltech and Harvard.

"There's not a bright line between where this kicks over into unethical," [University of Utah, Department of Biochemistry Dr. Jared] Rutter said. "The technology that we have is expanding … more rapidly than our sophistication with thinking about how to use it."

To read the entire article above, CLICK HERE.

From "Ethicists approve ‘3 parent’ embryos to stop diseases, but congressional ban remains" by Joel Achenbach, Washington Post 2/3/16

The committee, which was convened last year at the request of the Food and Drug Administration, concluded that it is ethically permissible to “go forward, but with caution” with mitochondrial replacement techniques (MRT), said the chairman, Jeffrey Kahn, a bioethicist at Johns Hopkins University.

But the advisory panel’s conclusions have slammed into a congressional ban: The omnibus fiscal 2016 budget bill passed by Congress late last year contained language prohibiting the government from using any funds to handle applications for experiments that genetically alter human embryos.

Thus the green light from the scientists and ethicists won't translate anytime soon into clinical applications that could potentially help families that want healthy babies, said Shoukhrat Mitalipov, a pioneer of the new technique at Oregon Health & Science University in Portland, Ore.

“It seems like the FDA is disabled in this case by Congress," Mitalipov said. “At this point we’re still not clear how to proceed."

To read the entire article above, CLICK HERE.

From "Report: It's ethical to test embryos from DNA of 3 people" by Lauran Neergaard, Medical Xpress 2/3/16

The genes that give us our hair and eye color, our height and other family traits—and some common diseases such as cancer—come from DNA in the nucleus of cells, the kind we inherit from both mom and dad.

But only mothers pass on mitochondrial DNA, to both daughters and sons. It encodes a mere 37 genes, but defects can leave cells without enough energy and can lead to blindness, seizures, muscle degeneration, developmental disorders, even death. Severity varies widely, and researchers estimate 1 in 5,000 children may inherit some degree of mitochondrial disease.

Critics have argued that the first such births would have to be tracked for decades to be sure they're really healthy, and that families could try adoption or standard IVF with a donated egg instead. And they say it crosses a fundamental scientific boundary by altering what's called the germline—eggs, sperm or embryos—in a way that could affect future generations.

"It is reckless to proceed with this form of germline modification," said Marcy Darnovsky of the Center for Genetics and Society, an advocacy group.

To read the entire article above, CLICK HERE.

Sunday, October 18, 2015

Birth Control Device Hazardous: Gov't Wrong Again

In 2002, the federal FDA approved Essure, a device consisting of metal coils and other synthetic materials designed to be permanently implanted into the fallopian tubes of healthy women in order to sterilize them.  After years of negative health effects by thousands of women, the FDA is reconsidering the safety of this device produced by Bayer Healthcare Pharmaceuticals, Inc.
"This is a high priority issue for the agency.  The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device . . ."
-- Food and Drug Administration (FDA) statement
For background, click headlines below to read previous articles:

Birth Control Pill Causes Breast Cancer, Vasectomies Cause Prostate Cancer

Contraceptive Pill 'Yaz' Causes Disease, Death

Federal Government Says Pill is Dangerous, but Keep Taking it

'The Pill' Reaches Age 50, but Do the Women Who Use It?

Fictional 'Safe Sex' - Government Losing War on STDs

Pediatricians Push IUDs & Implants on Teen Girls

Also read President Obama's CDC Wants More Worry-free Sex for Teen Girls (fewer pregnancies), but admit Government Failure: Carefree Sex is NOT Possible

On the other hand, studies show that Women Who Give Birth Live Longer and Healthier.





-- From "Essure Sterilization Device Causes 'Serious Safety Concern': Study" by Maggie Fox, NBC News 10/14/15

Dr. Art Sedrakyan of Weill Cornell Medicine in New York and colleagues analyzed data from 8,048 women who got Essure implants and compared them to 44,278 who had standard surgery to block or "tie" their fallopian tubes between 2005 and 2013 in New York State.

"A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern," the team wrote in their report.

"And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering."

The FDA is not considering pulling the device off the market, but will determine whether extra warnings should be added.

To read the entire article above, CLICK HERE.

From "Essure sterilization method under fire" by Elizabeth Cohen, Senior Medical Correspondent, CNN 9/27/15

From November 2002 through May 2015, more than 5,000 women complained to the Food and Drug Administration about the sterilization device, saying it caused problems including unintended pregnancies, stillbirths and debilitating pain and bleeding. On Thursday, the FDA held an all-day hearing on Essure, taking testimony from patients and experts, and promising to announce next steps in the near future.

. . . [Kristiana] Burrell, who also has three stepchildren, said she became pregnant while using the Essure device, even though at the time she was also using a back-up method of birth control.

That baby, whom she and her husband named Ariel Grace, was born in June, nearly three months early. She never took a breath.

Burrell said her obstetrician blamed Essure for the stillbirth, saying the device's coil ruptured her amniotic sac, causing Burrell to go into labor prematurely. She said she now needs a hysterectomy because the device has perforated her uterus.

To read the entire article above, CLICK HERE.

From "Essure Birth Control Implant and Reoperation Need" by Randy Dotinga, HealthDay Reporter (posted at WebMD) 10/13/15

Sterilization with Essure (called hysteroscopic sterilization) does offer benefits compared to other kinds of procedures, Sedrakyan team said, and it's not clear how many of the reoperations were required due to serious medical problems.

Essure procedures were more expensive (a median of $7,800 compared to $5,100) than surgical procedures, the researchers said. And 30 days after the procedure, the odds of a major medical complication were lower for Essure procedures than for surgery.

However, 2 percent of Essure patients required reoperations later on compared to just 0.2 percent of surgical patients. The difference remained after the researchers adjusted their statistics to account for age and other health problems.

To read the entire article above, CLICK HERE.

From "F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant" by Sabrina Tavernise, New York Times 9/24/15

A panel of experts convened by the Food and Drug Administration excoriated the manufacturer of a contraceptive device for not collecting data that they say could have helped predict risks for women. . . .

Women told of autoimmune problems such as eczema, lupus, celiac disease, of cysts, abscesses and tumors, of severe fatigue and losing control of their bowels, and of odysseys through the health care system in search of diagnoses. Many women have sued the company. The company’s supporters say it is not clear what share of those problems, if any, were caused by the device.

Perhaps most troubling was an account by Gabriella Avina, who said she had taken part in the original clinical trials and had worked for the company, explaining the device to women when it first came on the market. . . . She was found to have celiac disease, a thyroid disorder and myasthenia gravis, illnesses that required multiple hospitalizations, chemotherapy and transfusions.

. . . Bayer continued to stand by the device, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied.” . . . It estimates that a million Essure devices have been distributed around the world, about 60 percent of them in the United States.

To read the entire article above, CLICK HERE.

Also read how public schools across America provide sex training for children, and read how various government entities are being injected into the teenage uterus.

And read how the FDA put Unlimited Plan B Abortion Pills in Stores for Kids

In addition, read how increased use of long-acting contraceptives is causing a trend in America: Fewer Children, More Animals/Pets

Wednesday, December 24, 2014

'Safe Gays' Defined by Obama's FDA as Celibate

The federal Food and Drug Administration (FDA) has created a new classification of homosexual men:  Those who've not had anal sex for at least a year.  This new FDA action means that all other men who claim the mantle of "gay" will continue to be excluded from donating their blood because it may be contaminated with HIV.
"This new policy does not require heterosexual blood donors to be celibate for one year. Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban."
-- Statement from the Gay Men's Health Crisis
UPDATE 12/21/15: FDA Final Policy Holds to Celibacy Requirement for Homosexual Blood Donors (see excerpts below)

For background, read Federal Government Says HIV/AIDS is Mostly a Gay Disease and also just reported that Soaring Syphilis Rates Among Homosexual Men Point to HIV Risk

The basis for the FDA decision is that Anal Sex is Main Cause of HIV Pandemic, Study Shows

Also, a recent federal CDC Report Shows Most HIV Homosexual Men Have Unprotected Sex



-- From "FDA favors ending blanket ban on gay blood donors" by Doug Stanglin, USA TODAY 12/23/14

Last month a panel of blood safety experts convened by Department of Health and Human Services voted 16-2 in favor of doing away with the lifetime ban. The panel recommended moving to a one-year ban, which bars donors who have had male-on-male sex during the previous 12 months.

The proposed policy change, which will be offered for public comment next year, would allow gay men to donate blood if they had not engaged in sex with another man for at least a year.

In a prepared statement, FDA commissioner Margaret Hamburg said the proposed policy would "better align the deferral period with that of other men and women at increased risk for HIV infection."

In September, the Centers for Disease Control noted in a report that men who have sex with men represent about 2 percent of the U.S. population. It also noted that another CDC survey from 2007 to 2010 found that men who engaged in gay sex accounted for 63%of all new HIV infections.

To read the entire article above, CLICK HERE.

From "Gay Groups Decry New FDA Rule Requiring Celibacy to Donate Blood" by Miranda Leitsinger, NBC News 12/23/14

Gay rights groups rejected a decision by the FDA to ease the blanket ban on gay and bisexual men donating blood, saying the agency's requirement that this group of donors abstain from sex for a year before giving was "offensive" and imposed a "de facto lifetime ban."

The new rule was a step in the right direction, "but blood donation policy should be based on current scientific knowledge and experience, not unfounded fear, generalizations and stereotypes," said Scott Schoettes, Lambda Legal's director of HIV Policy. He said policy should be focused on the conduct of the potential donor and not on sexual orientation or gender identity.

. . . the Gay and Lesbian Medical Association challenged [the FDA], saying any "categorical" donation deferment for gay or bisexual men for any length of time was "arbitrary, stigmatizing and not scientifically supported." The group called on the FDA to commit to developing a policy addressing specific at-risk sexual behavior regardless of sexual orientation or gender.

To read the entire article above, CLICK HERE.

From "F.D.A. Lifting Ban on Gay Blood Donors" by Sabrina Tavernise, New York Times 12/23/14

The F.D.A. enacted the ban in 1983, early in the AIDS epidemic. At the time, little was known about the human immunodeficiency virus, which causes the disease, and there was no quick test to determine whether somebody had it. But science — and the understanding of H.I.V. in particular — has advanced in the intervening decades, and on Tuesday the F.D.A. acknowledged as much, lifting the lifetime ban but keeping in place a more modest block on donations by men who have had sex with other men in the last 12 months.

The shift puts the United States on par with European countries like Britain, which adjusted its lifetime ban in favor of a 12-month restriction in 2011. Men’s health advocates welcomed the move, saying that the ban was not based on the latest science and that it perpetuated stigma about gay men as a risk to the health of the nation. Legal experts said the change brings an important national health policy in line with other legal and political rights, such as permitting gay and people to marry and to serve openly in the military.

“This is a major victory for gay civil rights,” said I. Glenn Cohen, a law professor at Harvard University who specializes in bioethics and health. “We’re leaving behind the old view that every gay man is a potential infection source." He said, however, that the policy was “still not rational enough."

To read the entire article above, CLICK HERE.

From "FDA to propose altering ban on gay and bisexual men who want to donate blood" by Julie Zauzmer, Washington Post 12/23/14

Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said in a telephone call with reporters Tuesday . . . “At this time, the scientific evidence is not compelling that we can change to anything less than a one-year deferral and still maintain the current level of safety of the blood supply,” he said.

“A ban of one year doesn’t really make sense, from a scientific or a medical perspective,” said Daniel Bruner, director of legal services at Whitman-Walker Health, a D.C. health-care provider that caters to lesbian, gay, bisexual and transgender patients. “It’s overly broad, in that you sweep in a lot of people who pose no risk whatsoever to the blood supply. And you are stigmatizing an entire population by telling people that they need to remain celibate for an entire year — whether they are monogamous, whether they practice safe sex, whether they are on medication like the prophylactic that makes the chance that they become infected almost zero.”

The Human Rights Campaign and Lambda Legal, among other gay rights groups, also issued statements saying the policy change is welcome but does not go far enough.

Based on models that the FDA created, Marks said he expects about half of the would-be blood donors who are kept away because they have had sex with other men would become eligible to donate. He said he could not provide a number of men he expected would become eligible donors.

Men and women of any sexual orientation are barred from donating blood for a year after having sex with someone with HIV, with a commercial sex worker [prostitute, a.k.a. "whore"] or with an intravenous drug user.

To read the entire article above, CLICK HERE.

UPDATE 12/21/15: From "Gay men can once again donate blood — if they haven’t had sex for a year" by Brady Dennis, Washington Post

But some gay rights advocates were less than pleased with the 12-month deferral policy, which requires men who have sex with other men to remain abstinent for a year before giving blood. The National Gay Blood Drive, a group that has pushed for rolling back the decades-old ban, said that while it supports FDA’s updated approach, “the revised policy is still discriminatory.”

Daniel Bruner, senior policy director at the Whitman-Walker Health, a D.C. health-care provider that caters to lesbian, gay, bisexual and transgender patients, said in an interview Monday that the deferral period should be no longer than 30 days, given the ability of current testing to detect an HIV infection soon after exposure. He also criticized the new guidelines for continuing a lifetime donation ban on individuals who have engaged in sex work or used non-prescription injection drugs.

Peter Marks, deputy director of FDA’s Center for Biologics Evaluation and Research, told reporters Monday that the agency considered a range of approaches, but ultimately settled on the 12-month deferral window because it was backed by the most scientific evidence, and other large countries had adopted a similar approach. But he also called the change a "first step," saying the FDA will continue to conduct research and evaluate new data that emerges after the new approach goes into effect.

To read the entire article above, CLICK HERE.

Also read President Obama Pays Pre-teens to Learn Anal Sex in Hawaii because he Wants an End to Abstinence, Favoring Anal Sex

Wednesday, February 19, 2014

Obama's FDA: Why not Three Biological Parents?

This month, the federal Food and Drug Administration (FDA) is considering how to implement new IVF techniques that "create" human beings derived from three other people.

UPDATE 2/4/16: 3-Parent Babies ARE Ethical, Experts Tell President Obama's FDA

UPDATE 3/15/15: Secret Designer Babies via Gene-editing Science

Totalitarians ponder, How many ways can we destroy the family?  Divorce, welfare state, abortion, "gay marriage," pornography, "safe" sex, drug abuse, public school from birth — and of course, end religious liberty.

For background, read Lab 'Creates' Human Life with 3 Biological Parents

And read Donor Eggs & IVF 'Creates' Life, Causes More Death

And also read Multitude of Kid's Legal Parents, Yet No Marriage

-- From "FDA Advisory Committees: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting" government announcement for 2/25/14

Agenda: . . . the committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.

To read the entire announcement above, CLICK HERE.

From "The Era Of Genetically-Altered Humans Could Begin This Year" by David DiSalvo, Forbes 1/26/14

. . . At some point between now and July, the UK parliament is likely to vote on whether a new form of in vitro fertilization (IVF)—involving DNA from three parents—becomes legally available to couples. . . .

The procedure involves replacing mitochondrial DNA (mtDNA) to avoid destructive cell mutations. . . .

. . . the U.S. Food and Drug Administration will start reviewing the data in earnest in February.  Among the concerns on the table is whether the mtDNA donor mother could be considered a true “co-parent” of the child, and if so, can she claim parental rights?

Even though the donor would be contributing just 0.1 percent of the child’s total DNA (according to the New Scientist report), we don’t as yet have a DNA benchmark to judge the issue. Who is to say what percentage of a person’s DNA must come from another human to constitute biological parenthood?

To read the entire article above, CLICK HERE.

From "Freeing human eggs of mutant mitochondria" by Alla Katsnelson, Nature 4/14/2010

Researchers have successfully transplanted the genetic material in the nucleus of a fertilized human egg into another fertilized egg, without carrying over mitochondria, the energy-producing structures of the cell. The technique could be used to prevent babies from inheriting diseases caused by mutations in the DNA of mitochondria, which are present in the cytoplasm of the egg.

The British team carrying out the study used fertilized eggs donated by couples undergoing fertility treatment, and which were unsuitable for in vitro fertilization (IVF). At this early stage the sperm and egg nuclei, which contain most of the parental genes, have not yet fused. The researchers removed these nuclei and transferred them into another fertilized egg cell which had had its own nuclei removed.

[Shoukhrat Mitalipov at Oregon Health & Science University in Portland said,] Using fertilized eggs may pose an ethical problem . . . as the transplantation procedure destroys the donor embryo.

To read the entire article above, CLICK HERE.

From "FDA to study 'three-parent embryos'" by Michael Cook, BioEdge 2/16/14

This procedure, which involves removing the nucleus from one human egg whose cytoplasm contains defective mitochondria and placing it in an enucleated egg with healthy DNA for subsequent fertilisation, is also being debated in the UK.

The measure is strongly opposed by the Center for Genetics and Society, which is promoting an open letter to the FDA. It claims that mitochondrial transfer is unsafe, is effectively experimentation on unconsenting human subjects, and would only help a handful of women. Most importantly, it constitutes germline modification, a form of eugenics. This is a bright line which no country has ever stepped across.

To read the entire article above, CLICK HERE.

From "Urgent: Tell the FDA to Prohibit Three-Parent Embryo Technique" by Rebecca Taylor, LifeNews.com 2/17/14

Over 40 countries have banned such inheritable genetic modifications. Regrettably, the United States has no such laws and it is up the FDA to regulate the practice. . . .

This is a pivotal point in human history. Will we allow the intentional genetic modification of our children and grandchildren? I do not believe I am exaggerating when I say the future of our species depends on how we answer that question.

To read the entire opinion column above, CLICK HERE.

UPDATE 2/3/15: From "Britain votes to allow world's first 'three-parent' IVF babies" by Kate Kelland and Kylie MacLellan, Reuters

After an emotionally charged 90-minute debate that some lawmakers criticised as being too short for such a serious matter, parliament voted 382 to 128 in favour of the technique, called mitochondrial donation.

The vote paves the way for a medical world first for Britain -- which along with the United States has been at the forefront of scientific research on the treatments -- but one that is fiercely disputed by some religious groups and other critics.

Lawmakers were given a free vote on the issue, and Prime Minister David Cameron's spokesman said the British leader had voted to support it, adding it was not "about playing God".

. . . critics say the technique will lead to the creation of genetically modified "designer babies", with Conservative lawmaker Fiona Bruce saying it would amount to letting "the genie out of the bottle".

To read the entire article above, CLICK HERE.

Also read Pennsylvania Court Finds Three Adults Can Have Parental Rights

Monday, August 05, 2013

Unlimited Plan B Abortion Pill in Stores for Kids

For the cost of half a tank of gasoline, anyone can now purchase a potent drug (which is very harmful when directions are not followed specifically) for the explicit purpose, according to the product label, of flushing a fertilized egg -- a human being -- from its mother's womb.  The pill, quickly becoming the "contraceptive" of choice for doctors, sexual predators, and hedonists alike, is displayed on store shelves along side typical contraceptives.

For background, read how pediatricians are pushing the Plan B onto teens, and read the statistics of its increased usage.

Also read Schools Secretly Give 14-year-olds Plan B Pill as well as Abortifacients Given to Kids via Vending Machine for $25

In addition, read how Feminists are Enabling Men to Push The Pill on Girls

-- From "Plan B One-Step Now For Sale: What You Should Know" by Alexandra Sifferlin, Time Magazine 8/1/13

Since the early 2000s, women’s reproductive health groups have been pushing to get Plan B over-the-counter . . .

In 2011, the Food and Drug Administration granted its approval for making the birth control, which comes in one- and two-dose forms, available over-the-counter, but that decision was overruled by Health and Human Services (HHS) Secretary Kathleen Sebelius, who expressed concerns that girls as young as 11 would be able to purchase the product without a prescription. HHS placed an age restriction on the emergency contraceptive, requiring anyone under age 17 to have a prescription while allowing older women over-the-counter access.

However, this spring, U.S. District Judge Edward Korman in Brooklyn overturned the decision, saying it was made in “bad faith and improper political influence.” In response . . . the Department of Justice dropped an initial plan to appeal, making it possible for Plan B One-Step to be sold in pharmacies, without a prescription and without any age restrictions.

. . . The pill is designed to prevent pregnancy by keeping a woman’s ovary from releasing eggs for a longer period of time, by impeding fertilization or even by preventing a fertilized egg from implanting in the uterus. [In other words, aborting a fertilized egg.]

To read the entire article above, CLICK HERE.

From "'Morning after' pill goes on sale Thursday in pharmacies and grocery stores, available to anyone" by Lisa M. Krieger, San Jose Mercury News 7/31/13

At Walmart, "it is currently in the process of being shipped to stores, and will begin arriving in stores, to the family planning section, next week," said Walmart spokeswoman Danit Marquardt.

Nationwide chains such as Walgreens, CVS and Safeway all said they were moving the product Wednesday night to the health, feminine hygiene or family planning aisles of their stores. It is already available at Rite Aid.

"We are incredibly excited about this development," said Lupe Rodriguez of Planned Parenthood-Mar Monte, based in San Jose. "Access alongside other medications, like Tylenol, will make it incredibly more available to women."

To read the entire article above, CLICK HERE.

From "Major Drugstore Chains Now Selling Abortion-Inducing 'Plan B' Off the Shelf" by Penny Starr, CNSNews.com 8/1/13

. . . However, the Food and Drug Administrations also says it does not have any authority to require retailers to carry specific products, including Plan B. Thus, stores remain free to sell or not sell the abortion-inducing drug.

Spokespersons for CVS, Rite Aid, and Walgreens told CNSNews.com . . . that they would be selling the drug on shelves in their stores for anyone to access. . . .

“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

To read the entire article above, CLICK HERE.

Also read Abstinence Education Yields Lowest Teen Birth Rate Ever as well as Abstinent Teens the Norm, Moral Sex-Ed Works: Study

Sunday, July 08, 2012

HIV Cure: False Hope to Victims, Money to Others

Rather than comprehend, and thus admit, the inherent risks resulting from the sexual revolution, and the fact that much of health science is beyond human understanding, those who profit from disease insist that there are no permanent consequences to sexual immorality.
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For background, read Federal Government Reports Majority of New HIV Cases from Homosexual Behavior and also read Planned Parenthood Says Plan to Get Sexual Disease as well as Abstinence Education Effective, Federal Study Shows

UPDATE 7/30/12: HIV/AIDS conference experts admit talk of cure is hype
(These experts NEVER admit that the "cure" is sexual abstinence, until life-long marriage.)

-- From "Activists Issue Report on HIV Cure Research" by Enid Vázquez, From Test Positive Aware Network - July/August 2012

Activists from the AIDS Treatment Activists Coalition (ATAC), Project Inform (in San Francisco), and the Treatment Action Group (TAG, in New York City) issued a report summarizing the talks presented at the Community HIV Cure Workshop, which took place in March in Seattle before CROI. The report received funding support from Bionor Pharma, Gilead Sciences, and Merck.

"A cure for HIV will be essential to ending the AIDS pandemic, but science that is focused directly on a cure is still in early stages and will likely require the support of multiple stakeholders to proceed at the fastest pace," the report begins. "Among recent signs of progress, researchers have contributed new insights into where and why HIV persists despite potent ARV therapy."

To read the entire article above, CLICK HERE.

From "The Conversation: HIV cure in works, but issue is time, money" by David Lesher, Special to The Sacramento Bee 6/17/12

[Paula Cannon, a microbiologist at USC,] is working with a team of scientists . . . with funding from the $3 billion stem cell bond passed by California voters in 2004. It's going well. It has proved to be safe and to eliminate HIV in humanized mice. And in coming months, scientists hope it will receive federal approval to begin human trials.

None of the research under way will reach patients until long after the 10 years of funding by the [California] ballot measure runs out. With the HIV project, researchers hope to be in human trials by 2014, but it is likely to be at least 10 years before they can show it might work in humans. And in the case of a stem cell cure for AIDS, it would be many years after that before a treatment is widely available.

Even with rapid scientific advance, it also shows how much is still unknown.

To read the entire article above, CLICK HERE.

From "Evidence That Man Cured of HIV Harbors Viral Remnants Triggers Confusion" by Jon Cohen, Science Magazine 6/11/12

Only one person ever has been [believed to be] cured of an HIV infection, and a presentation about the man at a scientific meeting in Sitges, Spain, last week has caused an uproar about the possibility that he's still infected.

Timothy Brown, initially referred to as "the Berlin patient" until he went public about his cure, received unusual blood transplants 5 years ago to treat his leukemia. The blood came from a donor who had mutant cells resistant to HIV. Following the procedure, Brown stopped taking antiretrovirals (ARVs), the virus never returned, and his doctors reported that he had been cured.

But new research presented on 8 June at the International Workshop on HIV & Hepatitis Virus "challenge[s] these results," asserts Alain Lafeuillade of the General Hospital in Toulon, France, a well known HIV/AIDS cure researcher. Lafeuillade issued a press release, "The So Called HIV Cured 'Berlin' Patient Still Has Detectable HIV in His Body," that questions whether Brown was reinfected and may still be infectious to other people. Lafeuillade also posted a blog item, "The Weird Story of the Berlin Patient," raising similar questions.

To read the entire article above, CLICK HERE.

From "New optimism about stemming spread of AIDS virus" by Lauran Neergaard, Associated Press Medical Writer 7/7/12

. . . more than 20,000 international HIV researchers and activists will gather in the nation’s capital later this month with a sense of optimism not seen in many years — hope that it finally may be possible to dramatically stem the spread of the AIDS virus.

The big new focus is on trying to get more people with HIV treated early, when they’re first infected, instead of waiting until they’re weakened or sick, as the world largely has done until now. Staying healthier also makes them less likely to infect others.

Now, as the International AIDS Conference returns to the U.S. for the first time in 22 years, the question is whether the world will come up with the money and the know-how to put the best combinations of protections into practice, for AIDS-ravaged poor countries and hot spots in developed nations as well.

About 34 million people worldwide have HIV, including almost 1.2 million Americans. It’s a very different epidemic from the last time the International AIDS Conference came to the United States, in 1990. Life-saving drugs emerged a few years later, turning HIV from a death sentence into a manageable chronic disease for people and countries that can afford the medications.

To read the entire article above, CLICK HERE.

From "FDA approves new home-use HIV test" by Ian Duncan, Los Angeles Times Washington Bureau 7/3/12

The Food and Drug Administration approved the first over-the-counter HIV test Tuesday, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

The FDA emphasized that any results from a self-administered test, which works by detecting antibodies in a swab from the gums, should not be considered final. In trials, the test failed to detect HIV in 1 in every 12 patients known to be infected . . .

To read the entire article above, CLICK HERE.

Also read Gay Agenda Lacks Power Against AIDS Reality as well as Anal Sex is Main Cause of HIV Pandemic: Study

UPDATE 2/25/15: Anal Sex Pill Pushed in Gay Men Study to Stop HIV

Thursday, December 08, 2011

White House Stuns Pro-abortion Crowd on Plan B

Although the FDA approved the morning-after abortion drug to be sold in grocery stores just like candy, Kathleen Sebelius, Obama's HHS secretary, overruled the bureaucrats lest the White House be the the subject of scorn by the vast majority of America.

President Obama has denied having anything to do with either the FDA approval or the decision of Kathleen Sebelius.

The morning-after pill remains available to girls seventeen and older without a prescription by simply asking the pharmacist behind the counter.

For background, read Illinois Pro-life Pharmacists Win Against Plan B and also read Enabling Men to Push The Pill on Girls as well as Federal Judge Orders "Plan B" Pill to Younger Teens

-- From "Morning-After Pill Curb is First Time Ever FDA Overruled by U.S. Chief" by Anna Edney and Drew Armstrong, Bloomberg 12/8/11

Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the Food and Drug Administration chief, to reject the application by Petach Tikva, Israel-based Teva, citing potential sales to girls younger than age 17. Hamburg said she was ready yesterday to approve sales of Plan B One-Step without a prescription to women of all ages based on “science-based evidence.” The FDA said it was the first time HHS has overruled an agency approval.

Teva’s product reduces pregnancy risk if taken within three days of sex. As a result of Sebelius’s order, the pill will continue to be kept behind pharmacy counters and sold without prescription only to women 17 and older. Younger girls may obtain the drug with a doctor’s order.

Nancy Northup, president of the Center for Reproductive Rights, compared the Obama administration to that of former President George W. Bush, saying both are guilty of “playing politics with women’s health.”

Susan Wood, who resigned as the FDA’s women’s health director in 2005 because of the delay in approving over-the-counter emergency contraception, said she was shocked and disturbed by the administration’s move.

To read the entire article above, CLICK HERE.

From "Obama Says He Didn't Intervene Over Plan B" by Laura Meckler and Jennifer Corbett Dooren, Wall Street Journal 12/8/11

The politics of the decision could have cut two ways for Mr. Obama. Had his administration allowed unrestricted sales of the drug, critics were sure to attack him from the political right. Some social conservatives view the use of the "morning after"drug as akin to abortion, and they were likely to accuse the president of affording young girls the ability to end a pregnancy on their own.

Administration officials said the White House learned from Ms. Sebelius her plans to maintain the restrictions on the drug's sales. White House officials said she made the decision on her own. But the president agreed with her, they said, and the White House didn't work to change her mind.

The Center for Reproductive Rights, a liberal advocacy group, petitioned the FDA in 2001 to make all brands of Plan B available over the counter, and sued the FDA in federal court over the issue in 2005. In 2009, the judge in the case ordered the FDA to "reconsider its decision regarding the Plan B switch to OTC use."

To read the entire article above, CLICK HERE.

From "Plan B Aftermath: Democratic Women In Congress Go Easy On Obama" reported by Huffington Post 12/8/11

Women's rights groups expressed outrage on Wednesday when a top Obama administration official overruled a recommendation from government scientists to expand access to the morning-after pill, but Democratic members of Congress are being far more cautious with their criticism.

Many reproductive rights groups openly questioned whether the Obama administration was putting electoral politics above sound science ahead of next year's election.

Obama said on Thursday that he had nothing to do with Sebelius' decision, but that he fully stood behind it. Democratic lawmakers who supported the FDA recommendation, for the most part, are holding their fire, breaking with the national organizations, at least for now.

The decision over whether to restrict access to emergency contraception has been embroiled in politics since 2005. The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have all strongly endorsed over-the-counter access to Plan B with no age restrictions, so that it could be found on pharmacy shelves as easily as Tylenol. But the FDA suspiciously delayed the decision under the George W. Bush administration in 2005, prompting a legal investigation.

To read the entire article above, CLICK HERE.

From "HHS Says No to Teens Buying Plan B Without Prescription" by Steven Ertelt, LifeNews.com 12/7/11

The decision is shocking given that the Obama administration [has] kowtowed to the abortion industry in every other area since Obama was elected in 2008 and this marks the first time Obama has crossed pro-abortion groups like Planned Parenthood and NARAL that lobbied for approval of selling the rug to minors without a doctor’s prescription.

Jeanne Monahan of the Family Research Council, told the Post the morning after pill can work as an abortion drug if it prevents a newly-conceived unborn child from implanting and continuing pregnancy.

“It’s not a drug that prevents life — it’s a drug that destroys life,” said Monahan. “If we define life as beginning at fertilization or conception, then this drug can be an abortifacient.”

The morning after pill has done nothing to significantly curb the number of abortions.

To read the entire article above, CLICK HERE.

From "FDA considers making abortifacient Plan B available to minor girls over-the-counter" by Ben Johnson, LifeSiteNews.com 12/7/11

Janice Shaw Crouse, a Senior Fellow at Concerned Women for America said allowing children to purchase the drug without parental knowledge or consent undermines their ability to raise their own children. She added, “Even young children would be subject to an unscrupulous man who wants to take advantage of their vulnerability.”

She added that forcing store employees to distribute a potential abortifacient would represent a “complete disregard for the religious beliefs of people who feel very strongly about taking innocent human life, who must choose between following their consciences and losing their jobs.”

Although WebMD notes the pill may prevent ovulation or fertilization, the medical website acknowledges, “this type of emergency birth control prevents implantation of a fertilized egg in your uterus by altering its lining.”

Recent evidence from Europe suggests Plan B does little to reduce overall pregnancy rates but may encourage riskier sexual behavior. A study of the United Kingdom’s Teenage Pregnancy Strategy program, in which the government distributes the Morning After Pill to teenagers free of charge, found that pregnancy rates of minors under 16 remained static, while sexually transmitted diseases increased by 12 percent.

To read the entire article above, CLICK HERE.

Wednesday, September 28, 2011

The Pill is Dangerous; Feds Say Keep Taking it

Even though the federal Food and Drug Administration say some new birth-control pills could cause blood clots, the agency “advises women taking birth control pills with drospirenone not to stop the product before talking to their doctors first.”

The FDA reasoning is that these types of birth control pills perhaps are no worse than any other.

For background, read Contraceptive Pill 'Yaz' Causes Disease, Death

UPDATE 12/6/11: Birth Control Studies Needed to Assess Clot Risk, FDA Says

UPDATE 12/6/11 video:
video platformvideo managementvideo solutionsvideo player

UPDATE 10/27/11: Risks greater for several types of the pill

-- From "FDA Flags Concern on Birth-Control Pill" by Jennifer Corbett Dooren, Wall Street Journal 9/27/11

In a drug safety communication posted on the agency's website Monday, the FDA said preliminary results of an agency-funded study involving 800,000 women suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth-control pills, compared to users of other hormonal contraceptives.

Drospirenone is used in pills including Yaz and Yasmin, which are marketed by Bayer AG. Drospirenone is a type of female sex hormone called a progestin. Some drospirenone pills are also available in generic versions.

But the FDA said it hasn't reached a final conclusion that the products raise the risk of blood clots beyond that of other pills, and the agency will convene an outside panel of medical experts on Dec. 8 to discuss the matter.

Most birth-control pills contain two types of hormones, estrogen and progestin. All types of pills increase the risk of blood clots, and product labels warn of such risk.

To read the entire article above, CLICK HERE.

From "Yaz and newer birth control pills could raise risk of blood clots, FDA says" by Susan Todd, The Star-Ledger 9/26/11

The agency also noted that it plans to meet with two advisory panels in December — the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee — to sort through through some of the conflicting safety data generated by a half dozen different studies of the contraceptives.

Bayer Healthcare . . . faces thousands of lawsuits over health problems and, in some cases, deaths that are blamed on the [Yaz and Yasmin] drugs, which lawyers have said are often prescribed to teen-age girls for treating acne and premenstrual moodiness.

While the FDA study is new, warnings about the risks of the birth control pills are not. A year after Yasmin’s approval, Public Citizen, a non-profit consumer advocacy group, began warning of the drug’s dangers and placed Yasmin on its list of "Do Not Use Pills."

To read the entire article above, CLICK HERE.

From "FDA concerned about certain birth-control pills" posted at Nurse.com News 9/28/11

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, obesity and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.

Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. The FDA previously communicated preliminary information about these concerns to the public on May 31.

To read the entire article above, CLICK HERE.

Also read 'The Pill' Reaches Age 50, but Do the Women Who Use It?

Wednesday, February 16, 2011

Enabling Men to Push The Pill on Girls

It's ironic that feminists want to make it easier for men wanting sex to force medications on young girls by making birth control pills and abortifacients available without a prescription.

-- From "Catania bill seeks to provide birth-control pills over the-counter" by Tim Craig, Washington Post Staff Writer 2/15/11

A [Washington] D.C. Council member introduced a bill Tuesday aimed at allowing women to bypass the doctor's office and get birth-control pills directly from a pharmacist.

Council member David A. Catania (I-At Large), who introduced the bill . . . has the support of Planned Parenthood, which long has argued that birth control should be more readily available to women. The bill is viewed skeptically by doctors and could push the city into conflicts with antiabortion groups and Food and Drug Administration regulations.

Catania's legislation does not set age restrictions on who would be able to obtain birth control from a pharmacist . . .

In 2006, the FDA approved the sale of Plan B, the so-called morning-after pill, over the counter to women who are age 18 or older.

To read the entire article above, CLICK HERE.

From "Morning after pill faces test over access" by Susan Heavey, Reuters 2/11/11

Teva Pharmaceutical Industries Ltd earlier this week said it had asked the FDA for permission to sell [its Plan B morning-after pill] without any age limits, the latest salvo in a decade-long battle over the pill. Only those 17 and older can buy it now without a doctor's order.

Medical and women's groups have sought wider access for Plan B, which Teva acquired in 2008, since 2001. But the effort stalled under President George W. Bush and sparked multiple legal actions and congressional protests that the agency was letting politics trump science.

The FDA allowed limited "behind the counter" sales for women 18 and older in 2006 that required controversial identification checks. It later lowered the limit to age 17.

Planned Parenthood, the Reproductive Health Technologies Project and other supporters said this week they were thrilled Teva was seeking wider access.

To read the entire article above, CLICK HERE.

From "Morning after pill linked to STD rise" from the UPI 2/1/11

The morning after pill may not have reduced teen pregnancies in Britain but it may be linked to a rise in sexually-transmitted diseases, researchers say.

Professors David Paton and Sourafel Girma of The University of Nottingham used local health data to study the effects of the availability of emergency birth control at pharmacies on conception rates and the diagnosis of STIs in teens age 18 and under.

On average, areas operating a pharmacy emergency birth control program had an overall increase of 5 percent in the rate of STIs among teenagers -- 12 percent in those age 16 and under -- while the program was associated with a small increase in the number of teens pregnant, the study says.

Since 2000, local authorities in England have been encouraged to offer emergency birth control free of charge, over-the-counter at pharmacies, to teenagers age 16 and under.

The findings are published in the Journal of Health Economics.

To read the entire article above, CLICK HERE.

Tuesday, November 16, 2010

Prepubescent Gay Boys' HPV Vaccination: FDA Consideration

The massive risk of homosexual anal sex is prompting the Feds to consider a nationwide campaign to vaccinate the targets of adult homosexual men.

Jane J. Kim, Ph.D., of the Harvard School of Public Health says that ideally vaccines should be given to young "gay boys" before their "sexual debut."

-- From "Should young men who have sex with men be targeted for HPV vaccinations?" posted at American Council On Science And Health 11/3/10

Vaccinating men who have sex with men (MSM) against the human papillomavirus is a cost-effective method for preventing anal cancer and gential warts, a new analysis published in Lancet Infectious Diseases has found. Last year the FDA approved the use of Merck’s HPV vaccine Gardasil to prevent genital warts for boys and men ages 9 to 26 . . .

. . . Dr. Whelan notes: “Unfortunately, by that age [post-pubescent], most of the target group will likely have already acquired HPV infection, thereby reducing the efficacy of the vaccine. Earlier vaccination would also likely be protective against other HPV-related cancers, such as oral cancer.”

To read the entire article above, CLICK HERE.

From "HPV shot dilemma: Should gay boys be targeted?" by JoNel Aleccia, Health writer, MSNBC.com 11/12/2010

A government health panel [of the FDA] is expected to vote soon on whether to recommend vaccinating boys and young men against the human papillomavirus. Since 2006, the vaccine has been advised in girls and young women ages 9 to 26 to prevent cervical cancer and genital warts — though only about a third of those eligible actually have received it.

But now, growing evidence shows that the vaccine also may prevent anal cancer, particularly in the high-risk groups of homosexual and bisexual men, who are about 20 times more likely than heterosexuals to develop the disease.

But HPV vaccine critics contend that it’s overkill to recommend vaccinating all boys and men in order to protect a small group from what’s estimated at about 5,000 cases of HPV-related invasive cancers each year.

To read the entire article above, CLICK HERE.

Tuesday, August 17, 2010

ObamaCare Terminates Adult Stem Cell Treatments

Obamacare has landed in Denver, where doctors at a pain-management clinic have been told they must stop treating patients with a successful process that extracts their own adult stem cells, cultivates them and then reinjects them to stimulate growth in damaged limbs.

-- From "FDA challenges stem-cell clinic" by David Cyranoski, Nature News 8/17/10

The FDA asserted its authority on 6 August, when it requested a federal injunction from the US District Court of the District of Columbia to prevent stem-cell clinic Regenerative Sciences in Broomfield, Colorado, from preparing its treatments. The company isolates, cultures and processes adult stem cells from a patient's bone marrow or synovial fluid. Doctors then inject the cells to treat fractures, torn tendons and other ailments.

In July 2008, the FDA told Regenerative Sciences that its treatments are drugs according to the Federal Food, Drug and Cosmetic Act, and biological products under the Public Health Service Act. But the company did not apply for FDA approval and continued to offer the treatment. Now the agency says that the company is not following good manufacturing practice, and that the treatment's safety and efficacy is unproven.

But Christopher Centeno, Regenerative Sciences' medical director, argues that as the treatment uses a patient's own stem cells, it is a medical procedure akin to in vitro fertilization, and therefore none of the FDA's business.

To read the entire article above, CLICK HERE.

From "Obamacare hits! Closes pain-treatment program" by Bob Unruh © 2010 WorldNetDaily 8/16/10

Centano confirms his work provides a much less costly and significantly more convenient alternative to knee or hip joint replacement surgeries, which sometimes require a year or more of recuperation.

But the Food and Drug Administration, in the wake of the adoption of President Obama's plan to nationalize health-care decision making, has ordered the company to halt, because the federal agency views the process as making "drugs."

Karen Midthun, acting director for the FDA's Center for Biologics Evaluation and Research, said in the announcement, "FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public's health at risk."

Centano told WND that despite the company's repeated efforts [since 2008] to obtain a resolution in the disagreement, the FDA continually declined to respond – until Obamacare was adopted.

Now the federal agency has moved to "enjoin" the company's operations, and Centano told WND his company will fight.

"I think what we're seeing is a massive federalist move here," he told WND. "I think this represents that [for] Obamacare to work there has to be strict federal control over medicine. . . . The government is trying to get more and more positive control over what your doctor does or doesn't do."

To read the entire article above, CLICK HERE.

Saturday, August 14, 2010

New Abortion Pill Approved For Sale

In contrast to the past, the Obama FDA's rush to put the latest "emergency contraceptive pill" on the market will result in more women harmed and more death of unborn babies.

UPDATE 10/1/10 video:


UPDATE 8/3/11: Don't be Misled, Ella Drug Causes Abortions

UPDATE 7/19/11: NPR, Planned Parenthood Mislead on Abortion Nature of Ella Drug

UPDATE 9/21/10: Dangers of ‘Emergency Contraception’ Drug

-- From "F.D.A. Approves 5-Day Emergency Contraceptive" by Gardiner Harris, New York Times 8/13/10

The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older.

That [Plan B] pill gradually loses efficacy and can be taken at most three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex.

Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella would cut that risk to about 1 in 50, regulators say. Studies show that ella is less effective in obese women.

Still, the decision by the Food and Drug Administration to approve ella, less than two months after a federal advisory committee voted unanimously to recommend approval, marks a decided shift for the agency.

To read the entire article above, CLICK HERE.

From "FDA approves ella as 5-day-after emergency contraceptive" by Rob Stein, Washington Post Staff Writer 8/14/10

The decision to allow the sale of the pill, which will be marketed under the brand name "ella," was welcomed by family-planning proponents as a crucial new option to prevent unwanted pregnancies. But critics condemned the decision, arguing that it was misleading to approve ella as a contraceptive because the drug could also be used to induce an abortion.

If the history of Plan B is any indication, ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug.

Critics are already concerned that ella's approval as a contraceptive will make it eligible to receive federal tax subsidies, which are banned for the abortion pill RU-486,. They also are concerned that ella will be included in the services that health plans will have to pay for under the new health-care overhaul law.

"By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion," said Rep. Christopher H. Smith (R-N.J.), who called on Obama to issue an executive order prohibiting federal funds from paying for ella.

Ella is also likely to exacerbate a long-running debate over whether doctors have an obligation to write prescriptions for medication they oppose on moral grounds and whether pharmacists have an obligation to fill them. Many doctors and pharmacists refuse to write or fill prescriptions for Plan B or refer patients elsewhere for it.

To read the entire article above, CLICK HERE.

Saturday, June 12, 2010

Feds Consider Approving Another Abortion Pill

The French drug (named "ella"), capable of preventing successful impregnation several days after fertilization, challenges "the Obama administration's pledge to keep ideology from influencing scientific decisions."

UPDATE 6/17/10: Federal advisory panel unanimously recommends pill for FDA approval

-- From "New 'morning-after' pill, ella, raises debate over similarity to abortion drug" by Rob Stein, Washington Post 6/12/10

The drug, dubbed ella, would be sold as a contraceptive -- one that could prevent pregnancy for as many as five days after unprotected sex. But the new drug is a close chemical relative of the abortion pill RU-486, raising the possibility that it could also induce abortion by making the womb inhospitable for an embryo.

The controversy sparked by that ambiguity promises to overshadow the work of a federal panel that will convene next week to consider endorsing the drug. The last time the Food and Drug Administration vetted an emergency contraceptive -- Plan B, the so-called morning-after pill -- the decision was mired in debate over such fundamental questions as when life begins and the distinction between preventing and terminating a pregnancy. Ella is raising many of those same politically charged questions -- but more sharply, testing the Obama administration's pledge to keep ideology from influencing scientific decisions.

Plan B, which works for up to 72 hours after sex, was eventually approved for sale without a prescription, although a doctor's order is required for girls younger than 17. The new drug promises to extend that period to at least 120 hours. Approved in Europe last year, ella is available as an emergency contraceptive in at least 22 countries.

Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to an abortion.

"The difference between preventing life and destroying life is hugely significant to many women," said Jeanne Monahan, director of the Family Research Council's Center for Human Dignity. "Women deserve to know that difference."

For details explaining these drugs, CLICK HERE to read the entire article.