Tag Archives: Food & Drug Administration (FDA)

The Republican Taliban?

Posted on by under education, History, Law and justice, Political commentary, Racism & Bigotry, religion, Social commentary

It would be a misstatement to say that Republican males hate women.  They don’t hate us, but they also don’t see us as equals, either physically, intellectually, or culturally.  We are, it would appear, put on this earth for their pleasure, to meet all their needs – sexually, taking care of their homes, cooking their meals, etc.  Sadly, they have convinced many Republican women that this is the case, and those women dutifully, as Loretta Lynn once sang, Stand By Your Man.  Thus, the majority of Republicans are trying in this, the 21st century, to return women to their ‘place’ as they were in the last century and before.  When we speak of “women’s rights”, Republicans roll their eyes as if we were ignorant children and completely ignore the laws that have given us such rights as equality in the workplace, the right to vote, to own property, divorce our husbands, and the rights to make our own healthcare decisions, just as men do.  We women would be well-advised to stock up on clothes hangers before they ban those, too!

Joyce Vance of Substack, has written of the latest decision by a Texas judge to further strip us of our rights, and she does so far better than I could …

No More Mifepristone

Joyce Vance

08 April 2023

On the Friday before Easter, just after the end of the work week in Texas, a federal judge in Amarillo decided that Mifepristone, one of two key drugs used for medicated abortion, should be banned. This despite 20 years of data showing it’s safe and effective. Mifepristone has a lower rate of complications than Tylenol.

The judge also entered a stay, which means his order won’t go into effect for seven days. He did it to give the government an opportunity to appeal. But if neither the Fifth Circuit Court of Appeals, deeply conservative after a tranche of Trump appointments, nor the Supreme Court orders a lengthier extension, legal access to Mifepristone will come to an end. Not just in Texas, but nationwide.

The government didn’t need seven days. It filed its appeal to the Fifth Circuit Court of Appeals a few hours after the decision.

DOJ was prepared to file immediately because they understood the inevitable ruling in this case. Judge Kacsmaryk, who the plaintiffs judge-shopped for by filing this case in the Amarillo division where virtually all cases are assigned to him, has a background of deep antagonism to letting pregnant people make their own decisions. Kacsmaryk’s legal ruling affects the entire country, not just Texas. A federal district judge in Washington state entered a ruling ordering the FDA to keep Mifepristone on the market, just moments after the Texas ruling.  But Kacsmaryk  entered a nationwide injunction that rescinds the FDA’s approval of Mifepristone nationwide—even in states where abortion is still legal and without exception for the mother’s health.

That’s not the legal landscape the Supreme Court said it was creating when it ended 50 years of abortion rights under Roe v. Wade in the Dobbs case. When the Court decided Dobbs, it said decisions about whether and under what circumstances abortion should be legal would be left up to each state. But now, Judge Kacsmaryk has made that decision for all of us—you and me, for our mothers, daughters, sisters, aunts and friends, regardless of medical necessity or our personal religious and moral beliefs. Judge Kacsmaryk knows best.

Challenged legal rulings are typically stayed to preserve the status quo while appeals work their way through the courts. But the post-Trump, uber-conservative Supreme Court has always had a different jurisprudence when it comes to abortion, permitting restrictive measures like Texas’s SB-8 vigilante justice law to go into effect while the appeal was pending. Nothing says “result-oriented” like special rules for anti-abortion litigants (to say nothing of reversing the long-standing precedent of Roe that had worked well to balance rights and did not meet the Court’s test for when precedent should be reversed). It’s tempting to think the Court might decide the Mifepristone decision is a bridge too far, if not based on legal principles and the expectations it set when it decided Dobbs, then out of purely pragmatic political considerations some of Justice Clarence Thomas’s billionaire friends might want to see in order to avoid steep Republican losses at the polls following yet another anti-abortion decision. But it’s difficult to imagine this Court walking it back so close to its goal of extinguishing abortion rights. DOJ has strong arguments to make on appeal—compelling ones on threshold issues like whether the plaintiffs had standing to bring this case, as well as on the merits. Whether the Court will give them a fair hearing is an entirely different matter.

Soon, we’ll find out if the Court meant it when it said abortion would be up to the states. Or, can one judge in Texas resurrect the long-disfavored Comstock Act and terminate people’s rights across America. The Act is an 1873 law that makes it illegal to advertise or mail anything, including information, related to preventing contraception or producing abortion (as well as outlawing sending “obscene, lewd or lascivious,” “immoral,” or “indecent” publications). The Comstock Act fell into disuse because of its effect on 1st Amendment rights—it involves prior restraint by the government on speech. The prohibition on materials and items related to contraception was removed after the Supreme Court’s 1965 decision in Griswold v. Connecticut, which held that Connecticut’s “mini-Comstock” law unconstitutionally invaded the privacy rights of married couples. Be concerned about where a resuscitation of this law could lead.

Restricting abortion today does not seem to be about good faith conservative values and protecting the sanctity of life. It’s hard to believe that a party that denies access to basic medical care and education, and that lets school kids die at the hands of mass shooters in the name of the Second Amendment is deeply committed to unborn children, unless it’s become somehow morally righteous to protect them only until they leave the womb. Ending abortion is a political rallying cry, used to bring voters to the polls and raise money, with a healthy side-effect of owning uppity liberal women.

It’s really not that difficult. If you’re against abortion, don’t get one. We live in a pluralistic society and there are religions other than conservative Christianity, for instance Judaism, that command their followers to protect the life of a mother over that of an unborn fetus. Somehow, their rights are now ignored, while a minority that has gained control of the Supreme Court dictates to the rest of us.

Interestingly, banning Mifepristone isn’t just part of the trend to make abortion less available, it’s also part of the trend to make it less safe and to endanger women’s lives. I spoke with Jesanna Cooper, a friend and a doctor in Birmingham, who is an experienced Ob-Gyn. She told me, “the take home is that without mifepristone more people will hemorrhage and/or get septic from incomplete expulsion of the products of conception.” Using Misoprostol, the other drug used in a medication abortion procedure, alone is “less effective,” she told me. It involves the “same amount of pain but [is] more likely to be incomplete, which can be dangerous.” It doesn’t sound very pro-life.

More information about the two drugs, if you want to read some of the science, here.

In 1996, then-Congresswoman Patricia Schroeder (D-CO), tried to convince the House to take the Comstock Act off the books. They didn’t. But her floor speech has resonance today. She explained that the Act was named for a man named Anthony Comstock, who “was one of these people who decided only he knew what was virtuous and right, and somehow he managed to convince all sorts of people that this was correct.” That sounds familiar.

She continued, “Anthony Comstock was a religious fanatic who spent his life in a personal crusade for moral purity–as defined, of course, by himself. This crusade resulted in the arrest and imprisonment of a multitude of Americans whose only crime was to exercise their constitutional right of free speech in ways that offended Anthony Comstock. Women seemed to particularly offend Anthony Comstock, most particularly women who believed in the right to plan their families through the use of contraceptives, or in the right of women to engage in discussions and debate about matters involving sexuality, including contraception and abortion.” We don’t need a new Anthony Comstock and we don’t need Judge Kacsmaryk to dictate the health care—or absence of it—to people across the country.

You know what the solution is: go vote. Democrats will need sufficient majorities in both houses of Congress to restore protections for abortion. It’s not enough to win the House or the Senate, Democrats must take both to ensure access to abortion, and 2024 is not that far off.

We’re in this together,

Joyce

Joyce Vance is an American lawyer who served as the United States Attorney for the Northern District of Alabama from 2009 to 2017. She was one of the first five U.S. Attorneys, and the first female U.S. Attorney, nominated by President Barack Obama.

Our good friend Annie also has an excellent take on this that I hope you’ll take time to read.

Profit Over People — Again

Posted on by under Election 2020, Environmental Issues, Global Issues, Law and justice, Political commentary, Social commentary

The Food and Drug Administration (FDA) exists for a reason, as do other government agencies like the Environmental Protection Agency (EPA) and the Centers for Disease Control and Protection (CDC).  The reason for all three of these agencies is the health and safety of the people in this nation … the people around the world.  And yet, all three of these agencies have been criticized and shackled by Donald Trump during his time in office, and the health of the nation has suffered.

The latest in a series of poor decisions that may prove lethal to the people in this country is that the FDA proposed stricter guidelines for emergency approval of a coronavirus vaccine, but Trump & Co are rejecting them.  Now, I don’t know about you folks, but I’m not about to be injected with some chemicals that have not been thoroughly tested and for which the side effects and long-term effects are not fully known.  Not gonna happen.

There is some debate as to why Trump & Co are attempting to block the FDA guidelines.  One reason, the most obvious, is that the additional testing requirements would make the release of any vaccine impossible before election day, and Donnie is counting on that being the boost his failing campaign needs to push past Joe Biden on November 3rd.  But, according to administration officials, there is another reason:  the pharmaceutical industry objected.  Now, I have enough issues already with the pharmaceutical guys, for they have made it impossible for many of us to afford the life-saving medications we need.  And now this.

It is the job of government, from the president down to the lowliest clerk, to do what is in the best interest of We the People.  Pandering to an industry to put corporate profits over the lives of people is simply NOT acceptable.  Our lives should matter more than the profits of robber baron CEOs … but they don’t, at least not to the people running the show up in Washington.  There appears to be no conscience left in the ‘Trump administration’, and yet we keep paying them to shoot us in the foot.

We’re not going to change Trump & Co.  If anything were going to change the megalomaniac in the Oval Office, one would think it would have been his own experience with the coronavirus, but no … that seems to have made him into an even bigger jerk than he was before, with not a care for our well-being, telling us that the virus is no big deal, to get on with the business of socializing, shopping, and boosting ‘his’ economy.

The tragedy is that if a vaccine is hastily brought to market before or even after election day, it may well cause more problems than it solves.  At the very least, it may cause problems for people with underlying conditions, and at the worst, it may cause cancer a year down the road.  The only vaccine I would trust at this point is one developed far from the shores of the U.S. by reliable scientists and approved by the World Health Organization (WHO).

For all we know, the vaccine Trump is hoping for might be made of peanut butter and lemon juice.  It doesn’t even have to work against the coronavirus … there only needs to be a perception that it will work, just long enough to get past the election, and then … Trump really won’t care anymore, but will wash his hands of it when people start dying not from the virus, but rather from the vaccine.  He will blame it on … somebody … anybody … possibly even the FDA for not putting out stronger guidelines!  Nothing should surprise us anymore.

Fortunately, the FDA is fighting back … sort of.  According to the New York Times …

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

When a government is not working for the vast majority of the people – and this one is not – then it’s time to throw them all out and start over.  Our very lives depend on electing a president, senators and representatives who possess a conscience, who care about all the people of this nation, not just the few wealthy ones.

Another … Sigh … Conspiracy Theory

Posted on by under Election 2020, Environmental Issues, Political commentary, Social commentary

Is it any wonder I seem to spend more time in the rabbit hole than above ground these days?  At least I have a small stash of bottled water and snacks down here now.

Where would Donald Trump be without conspiracy theories?  The entirety of his campaigns and term in office has been built, it seems, around conspiracy theories.  He has cozied up to the likes of Rush Limbaugh, Alex Jones and others whose entire lives seem to revolve around made-up b.s.  He sees a conspiracy theory ‘round every corner, behind every tree, and when he can’t find one, he creates his own.

Trump’s latest in a long string of such conspiracy theories is that the Food & Drug Administration (FDA) is attempting to squelch any coronavirus vaccines until post-election.  Yesterday, he tweeted …

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

As usual, there is absolutely no evidence to back up the claim and the FDA, drug companies, and researchers are, on the contrary, working at an unprecedented pace to deliver something that will curb the spread of the coronavirus.  One very real danger is that a vaccine will be approved prematurely and have long-term catastrophic effects that were not foreseen in the rush to get it to market.  But Trump doesn’t care, for he only cares about being able to brag that “HE” got a vaccine, in order to boost his popularity in the days leading up to the election.

This is the second time in one week that he has criticized the FDA without cause.  On Wednesday, he blamed government scientists for slow-walking convalescent plasma, a safe but unproven therapy, for political reasons. In that case, the FDA decided against authorizing emergency use of the plasma after scientists at the National Institutes of Health warned the clinical-trial data was still thin.

And, of course, he’s still claiming that the malaria drug hydroxochloroquine is a valid treatment for the coronavirus.  It has been proven over and over again that it does nothing to counter the virus, and that in some cases it causes serious cardiac issues!  Heck, I wouldn’t be surprised if he gets back on the bleach/disinfectant bandwagon again and tries to force the FDA to approve Clorox for human ingestion!  He is the epitome of a carnival snake oil salesman.

Folks, this crap is getting beyond old … it disgusts me to think that the one person who should be held to the highest of standards is actually the lowest of low.  It sickens me to see people slavishly praising such a nasty excuse for a ‘leader’.  It appalls me to realize that some people will actually vote for this clown/monster again in just over two months.

Trump could have done so many things that would have saved lives in this nation over the course of the past 8 months, but instead he chose to deny and ignore the real threat, focusing instead on his conspiracy theories that the pandemic was a ‘hoax’ or had been created by democrats in order to bring him down. Instead of choosing to be a leader, to save lives, he chose to be just what he is, an ignorant, self-centered clown, and it has cost us the lives of loved ones.  It’s all got to be about Trump, never about the well-being of this nation, of We the People.

We, as a nation, simply must learn to turn away when Trump speaks, to listen to the experts rather than the man-child who sits, inappropriately, in the Oval Office making decisions that are costing our very lives.  Those who listen to him, who follow his advice, do so at their own peril.

Back to the …

rabbit-hole