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Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.
The urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk.
More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.
The petition also was prompted by the most recent study, involving the experience of 55,000 men before and after starting testosterone. The risk of heart attacks among men 65 and older during the first three months of using the drug was twice the risk seen in the year before use. Further, the study found, for the first time, a 2.9-fold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.
The FDA-approved labeling for testosterone-containing products does not mention testosterone-induced cardiovascular risk.
Despite all of these studies, the FDA stated on Jan. 31 that it "has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death."
"In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA's role as an agency in the U.S. Public Health Service," said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. "It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks."
Although the FDA agrees that testosterone is "only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition," the hyped-up nature of the low-T[estosterone] advertising campaigns, not adequately regulated by the FDA, assures that many men in the U.S. prescribed testosterone do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism. Evidence can be seen in the recent finding that almost 25 percent of men prescribed testosterone in this country had not previously had a blood test to even determine if their testosterone level was low.
"Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue," Wolfe said. "At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks."
In addition, the petition urges the FDA to delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo), now set for Feb. 28, because its approval, absent the new black box warning, would cause further cardiovascular damage to new users.
The petition is available at https://www.citizen.org/hrg2184.
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
(202) 588-1000Big-money special interests "want to divide us up," said the indepedent senator at a living wage rally in South Carolina, "and we are determined to bring working people together."
As President Joe Biden signed into law an agreement Saturday that would shield wealthy tax cheats from stronger IRS enforcement while at the same time enacting cuts to key anti-poverty programs, Senator Bernie Sanders and other progressive allies were busy denouncing the immoral, low-wage economic system in the United States in which just a small handful of mega-billionaires have accumulated more wealth than tens of millions of hard-working but low-paid workers and their families.
At a "Rally to Raise the Wage" in Charleston, South Carolina on Saturday, the independent politician and two-time presidential candidate railed against the inequality that remains so pervasive in the country and the political forces that seek to divide the working class.
"The reason we are here today is not complicated," Sanders said. "In the richest country in the world, we demand an economy that works for all, not just the few."
"In every age, moral people have had to rise up and decide to make the moral case that things have to change and injustice has to move." —Bishop William J. Barber II
"It is not moral that three people on top own more wealth than the bottom half of American society, 165 million Americans," Sanders declared during his speech. "That's not moral. That's not right. That's not what should exist in a democratic society."
\u201c"It is not moral that 3 people on top own more wealth than the bottom half of American society, 165 million Americans. \n\nThat's not moral.\n\nThat's not right.\n\nThat's not what should exist in a democratic society."\n\n@BernieSanders in South Carolina rallying to #RaiseTheWage\u201d— Union of Southern Service Workers (@Union of Southern Service Workers) 1685827759
Sanders was joined on the tour through the south—which also included stops in Durham, North Carolina and Nashville, Tennessee—by Bishop William J. Barber II, founding director of the Center for Public Theology and Public Policy at Yale Divinity School, who said Sanders had asked him to attend specifically to discuss the moral case for combating poverty and raising wages.
"When Jesus started his ministry," said Barber, surrounded by members of the audience he had called up to gather around him on stage, "he said I'm coming to preach good news to the poor[...] meaning those who had been made poor by the economic exploitation of Rome."
Barber told the crowd that "there are over 2,000 scriptures in the Bible" detailing the worth of the poor and the value of laborers.
"So what our movement is about, is precisely the opposite of what the big-money interests want. They want to divide us up and we are determined to bring working people together." —Sen. Bernie Sanders
"The Bible does not talk about taking a women's right from her body," Barber said. "The Bible does not talk about hating people because of their sexuality. The Bible does not talk about prayer in the school. The Bible does not talk about putting up the Ten Commandments. But more than 2,000 times—more than any other subject other than self-worship idolatry—the Bible says the way to please God is how we treat the least of these and those in the margins."
"In every age," he continued, "moral people have had to rise up and decide to make the moral case that things have to change and injustice has to move."
In contrast to a living wage of $17 an hour at the heart of the rally, Bishop Barver said the current federal minimum wage of $7.25 should be seen as a "death wage," given the rate at which poverty kills in the country.
\u201c"Poverty is the 4th leading cause of death in America. It's higher than homicide. $7.25 is a poverty wage which means $7.25 is a death wage. \n\nWe've got to fight against people dying." @RevDrBarber with @BernieSanders in South Carolina rallying to #RaiseTheWage\u201d— Union of Southern Service Workers (@Union of Southern Service Workers) 1685827249
Barber told the diverse South Carolina audience in attendance—including those standing beside him who were older people and younger people of different racial, religious, and sexual identities—that their unity and solidarity in the face of economic inequality and social injustice remains their greatest asset.
The people in power, said Barber, "They are afraid of this room."
Invoking Rev. Martin Luther King Jr., Barber explained how in 1965, Dr. King stood on the steps of the Alabama state house "and said that the greatest fear of the southern aristocracy and the oligarchy was for the masses of poor Negroes and poor white folk to get together and form a powerful new voting bloc that would shift the economic architecture of the nation."
"If they are cynical enough to be together, we oughta be smart enough to come together around the moral agenda."
"And I want to suggest," he continued, "if that's what they're afraid of: Let's build it! Let's built it and maybe in the process some of them will even be redeemed and stop hurting people. Who gets up in the morning and all you can think about is how you can take somebody's healthcare? Who gets up in the morning and asks, 'How I can use my power to hurt somebody?'"
He made a final point about those in power and how the forces at work denying freedom and dignity to certain people in society are also the same forces attacking democracy and economic equality.
"The same people who are attacking gay people, are attacking our voting rights," Barber said. "The same people who are attacking trans people, are attacking our healthcare. The same people trying to take away a woman's right are also against living wages. If they are cynical enough to be together, we oughta be smart enough to come together around the moral agenda."
Barber said the southern states are "key" and must not be ignored by federal politicians, arguing that the Carolinas, Tennessee, and others are not necessarily red states, but just states that have been "intentionally divided" and where workers have been disempowered.
"We need a living wage and we need it now," Barber declared. "It's time for change and justice has got to move. You've got to make them hear you. You've got to make them see you. You've got to make them feel your power."
He added: "This is a moral fight. We can't allow corporate greed to sell out and tear the souls and substance of this nation apart. This is a nation-saving fight."
Prior to Barber, local hairdresser Lydia Stewart spoke about working conditions at the salon business that employs her, Great Clips, and the organizing effort she and her colleagues have undertaken with the Union of Southern Service Workers to increase workplace safety and win higher wages.
\u201c"At my job we're organizing [with @RaiseUpTheSouth] because change has to be brought. My store is mostly Black women and they have no respect for us, they treat us like a pair of hands." @GreatClips worker Lydia Steward with @BernieSanders and @RevDrBarber #RaiseTheWage\u201d— Union of Southern Service Workers (@Union of Southern Service Workers) 1685824077
During the rally, State Rep. Wendell Gilliard (D-111) also spoke and talked about the need for a true living wage in the state that should be no less than $17 an hour.
"We have come a long way," Gilliard said during his remarks, "fighting for the rights of 'We the People.' This is not about party, it's always been about the people. Charlestonians work hard and deserve more for what they do to keep this region running. They deserve more than a minimum wage—they deserve a living wage!"
"With rising costs of living," Gilliard continued, "more and more of our neighbors, our friends, and our family members will slip into poverty unless they see an increase... $17 an hour is a living wage. It will help poverty from swallowing up more victims and help increase the standard of living here in Charleston."
\u201cLIVE from CHARLESTON: No one in America should be forced to work for starvation wages. Join us as we rally in South Carolina for an increase in the minimum wage. https://t.co/5aQjgGGlnw\u201d— Bernie Sanders (@Bernie Sanders) 1685823586
In closing his speech for the rally, Gilliard said the event with Sanders and Barber could not simply be a moment in time, but must signify the existence of a movement ready to fight for the long haul.
"It cannot be a moment in time," the state lawmaker said. "It has to be a movement that will live until we get it done."
In his headliner address, Sanders echoed what Bishop Barber argued, that the ruling elite and monied oligarchy "wins" when they divide up the working class and those living in poverty.
"In every way that you can think," said Sanders, "there are really smart people—out there polling today—saying: How do I get you to vote against your own self-interest? How do I get black and white and Latino and Native American, Asian American, gay, and straight against each other so that the big-money interest laugh all the way to the bank."
"So what our movement is about, is precisely the opposite of what the big-money interests want," he continued. "They want to divide us up and we are determined to bring working people together—black and white and Latino—all of us together around an agenda that works for us not just the billionaire class!"
Abortion bans in 14 U.S. states since the 2022 Dobbs decision "have made abortion services largely inaccessible and denied women and girls their fundamental human rights to comprehensive healthcare including sexual and reproductive health."
High-level experts with the United Nations have issued a joint statement condemning the impact of the U.S. Supreme Court ruling last year that reversed decades of legal precedent protecting abortion rights for women.
"The regressive position taken by the US Supreme Court in June 2022, by essentially dismantling 50 years of precedent protecting the right to abortion in the country, puts millions of women and girls at serious risk," said the 13 experts, all appointed by the U.N. Human Rights Council, on Friday.
According to a statement issued by the UN's Human Rights Office of the High Commissioner (OHCHR):
Abortion bans in 14 States have made abortion services largely inaccessible and denied women and girls their fundamental human rights to comprehensive healthcare including sexual and reproductive health. The experts said the bans could lead to violations of women's rights to privacy, bodily integrity and autonomy, freedom of expression, freedom of thought, conscience, religion or belief, equality and non-discrimination, and freedom from torture and cruel, inhuman and degrading treatment and gender-based violence.
Such state-level bans on abortion and other restrictions to reproductive care, say the experts, are having far-reaching and negative impacts. In addition, they are a violation of international human rights law.
"Women and girls in disadvantaged situations are disproportionately affected by these bans," the experts said, referring to those in marginalized communities, living on low incomes, in abusive relationships, or in rural regions with little access to care or support services.
\u201c#UnitedStates:Since Jan abortion has been banned in 14 States & consequences of the Supreme Court decision overturning the constitutional right to abortion reverberate through the legal & policy system, putting millions of women & girls at risk: UN experts https://t.co/9BoUO3bPyo\u201d— UN Special Procedures (@UN Special Procedures) 1685706432
Last month, the U.S.-based National Abortion Federation (NAF) released a new report showing that "violence and disruption" against abortion providers and clinics rose sharply since the Dobbs vs. Jackson Women's Health Organization by the Court in the June of 2022 that overturned protections in Roe v. Wade.
NAF has been tracking such attacks since 1977, but Melissa Fowler, the group's chief program officer, said in May that the new statistics since last year prove "anti-abortion extremists have been emboldened by the Supreme Court’s decision to overturn Roe v. Wade and the cascade of abortion bans" passed by Republican-controlled legislatures nationwide.
"As clinics closed in states with bans, extremists have simply shifted their focus to the states where abortion remains legal and protected, where our members have reported major increases in assaults, stalking, and burglaries," said Fowler.
In Friday's statement, the UN experts said they were "particularly alarmed by the increasing reports of threats to the lives of abortion service providers across the country" as well as by a new pattern of surveillance—including electronic tracking—being used against people seeking abortion care.
The joint statement urged both federal and state governments in the U.S. "to take action to reverse the regressive rhetoric seeping through the legislative system and enact positive measures to ensure access to safe and legal abortion."
The experts who issued the statement were: Reem Alsalem, Special Rapporteur on violence against women and girls, its causes and consequences; Dorothy Estrada Tanck (chair), Ivana Radačić (vice-chair), Elizabeth Broderick, Meskerem Geset Techane and Melissa Upreti, Working Group on discrimination against women and girls; Nazila Ghanea, Special Rapporteur on freedom of religion or belief; Alice Jill Edwards, Special Rapporteur on Torture and other Cruel, Inhuman or Degrading Treatment or Punishment; Felipe González Morales, Special Rapporteur on the human rights of migrants; Olivier De Schutter, Special Rapporteur on extreme poverty and human rights; Ana Brian Nougrères, Special Rapporteur on the right to privacy; Gerard Quinn, Special Rapporteur on the rights of persons with disabilities; Ashwini K.P., Special Rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance.
"Similar to the countless battles the LGBTQ+ community has faced over the last several decades, our collective success relies upon everyone speaking out and taking a stand against bigotry," said the group who challenged the statute.
A federal judge on Friday evening ruled that Tennessee's anti-drag show law—the first of its kind in the nation signed by Republican Gov. Bill Lee earlier this year after approval by the GOP-controlled state legislature—represented an unconstitutional attack on free speech.
The 70-page ruling issued by U.S. District Judge Thomas L. Parker found that the law was "unconstitutionally vague and substantially overbroad," making it a clear violation of the free protections in the First Amendment.
"We Won!" declared Friends of George's, the non-profit performance group in the state who had challenged the law.
\u201cWE WON! Judge Parker has declared Tennessee's anti-drag law unconstitutional! Friends of George's would like to thank Brice Timmons and Melissa Stewart at Donati Law and all who have stood by us during this fight! #standwithfriendsofgeorges #pride #dragisnotacrime\u201d— Friends of George's (@Friends of George's) 1685795100
While the word "drag" or phrase "drag show" did not appear in the statute, Judge Parker said the examples offered by the defenders of the law during the hearing of the case exhibited clearly who and what the law was targeting and that it therefore encouraged "discriminatory enforcement" by the state.
"There is no question that obscenity is not protected by the First Amendment," states the ruling. "But there is a difference between material that is 'obscene' in the vernacular, and material that is 'obscene' under the law."
"Simply put," it continues, "no majority of the Supreme Court has held that sexually explicit—but not obscene—speech receives less protection than political, artistic, or scientific speech."
\u201cLast night, Tennessee\u2019s extreme drag show ban was struck down and ruled unconstitutional by a Trump-appointed federal judge. \n\nTried to tell my Republican colleagues when they introduced it on the House floor, but yet again they had to FIND OUT. \n\nHappy Pride, y\u2019all!! \ud83c\udff3\ufe0f\u200d\ud83c\udf08\u201d— Rep. Justin Jones (@Rep. Justin Jones) 1685805066
In a statement on Saturday, Friends of George's said the ruling "represents a triumph over hate."
"Similar to the countless battles the LGBTQ+ community has faced over the last several decades, our collective success relies upon everyone speaking out and taking a stand against bigotry," said the group, based in Memphis.
Jonathan Friedman, director of free expression & education programs for PEN America, also celebrated the ruling, calling it a "necessary victory for free speech" in Tennessee.