Tuesday, January 31, 2017

ANNE FRANK | U.S. Center Blasts Trump Ban

President Donald Trump (L) and Anne Frank (R), who was
captured by the Nazis and died in captivity. 
The Anne Frank Center for Mutual Respect (formerly the Anne Frank Center USA) has issued this statement signed by Steven Goldstein, the Center's Executive Director:

As President Trump prepares orders to wall out Mexicans and shut out refugees from America, today marks one of the most hateful days in our nation’s history. Donald Trump is retracting the promise of American freedom to an extent we have not seen from a President since Franklin Roosevelt forced Japanese Americans into internment camps during World War II. Today the Statue of Liberty weeps over President Trump’s discrimination.

President Trump is beyond the wrong side of history. He is driving our nation off a moral cliff.

When President Trump uses national security as a guise for racism, he doesn’t strengthen our national security. He compromises our national security by engendering disrespect for America by people around the world.

Make no mistake, suspending visas for citizens of Middle Eastern and African countries is not called national security. It’s called prejudice.

President Trump is now exacerbating the largest global refugee crisis in history. His slamming America’s doors on the starving, the wounded and the abused is a grotesque blot on our nation’s history of freedom. The President’s actions are an embarrassment to the timeless vision of America as inscribed by Emma Lazarus to “give us your tired, your poor, your huddled masses yearning to breathe free.”

Demonizing refugees and immigrants, and spending billions of taxpayer dollars to keep them out of our nation, will go down in American history as one of the most tragic deviations from our national conscience.

Related Links: Remembering the Holocaust . The Nazi Occupation and Resistance in Holland . Majority of Americans Now Disapprove of Trump's Actions . Trump's First Five Days . Time Coverage of Anne Frank Center

Monday, January 30, 2017

TRUMP | Disapproval Exceeds 50%

Disapproval of Trump actions already passes 50 percent.

A majority of Americans say they do not approve of President Trump's actions as of Saturday, Jan. 28.

The Gallup Poll keeps a daily tab on the percentage of Americans who approve or disapprove of the job Donald Trump is doing as president. 

The tab is based on telephone interviews taken every day with approximately 1,500 adults throughout the United States.

Gallup claims its sample is reliably constructed and the margin of error is only ±3 percentage points. Margins of error are typically computed for the 95 percent confidence level, meaning once every 20 polls the error will exceed the margin, even if there are no flaws in the design of the survey.

In this case, the same survey has been conducted for many years, which makes it more useful and reliable. President Trump's approval ratings can be compared with  those of past presidents in the Gallup Presidential Job Approval Center.

Sunday, January 29, 2017

NYC COMPTROLLER | 2nd Annual Florida Meeting

Standing, L to R: Steve Newman and
Eric Wollman. Seated: John Tepper
Marlin. Photo by Alice Tepper Marlin.
The second annual Florida meeting of the Former Office of the Comptroller Employees Association (FOCEA) took place in Vero Beach, Fla., with a 50 percent increase in attendance over last year! That is, attendance of full members rose from two to three:
  • Deputy Director, Contracts, Bureau of Asset Management, Eric Wollman, Esq.
  • Former First Deputy Comptroller Steve Newman.
  • Former Chief Economist John Tepper Marlin. 
The combined number of years of NYC Comptroller's Office service of those attending the Florida meeting was 40+24+13=79.

The meeting occurs annually during the week following a collectors' convention in Titusville, Fla. But this is not a rule–FOCEA has no rules.

The meeting started at 12:30 pm with drinks, chips and avocado dip, and continued with crusted tuna slices and salad, finishing with blueberries and ice cream and coffee.

Spouses, FOCEA Florida Meetup, 2017. L to R:
Alice Tepper Marlin, Rosemary Polsky-Newman.
Photo by JT Marlin.
The main topic was Transitions, it being the end of the first week of the Trump Administration.

(The lineup of NYC Mayors and Comptrollers is unchanged from the 40-year list shown in the 2016 meeting report.)

The attendance of spouses doubled, from one to two:
  • Rosemary Polsky-Newman.
  • Alice Tepper Marlin.
The meeting adjourned at 4:30 pm. 

More photos
2016 Florida FOCEA Meeting.
1992-93 NYC Gatherings.

TRUMP | Has He Revoked Pardons for Obama's Turkeys?

President Obama pardoning a turkey.
Reports are circulating on social media that President Trump has issued an Executive Order to revoke all turkey pardons granted by former President Obama and immediately execute the turkeys.

It is, of course, too late for Trump to execute the earlier turkeys (there were reportedly 16 in all over Obama's eight years) who have gone on by now to Turkey Heaven.

The average life of a turkey is only about three years; the maximum recorded longevity for a turkey is reportedly 12 years.

The reports of the Pardon Revocations are satirical, says Snopes.

Saturday, January 28, 2017

TRUMP | The First Five Days

What's Wrong with This Picture? (Six Men
Cutting Funds for Programs to Assist Women)
January 19, 2017
DT cut funds for:
The DOJ’s Violence Against Women programs.
The National Endowment for the Arts.
The National Endowment for the Humanities.
The Corporation for Public Broadcasting.
The Minority Business Development Agency.
The Economic Development Administration.
The International Trade Administration.
The Manufacturing Extension Partnership.
The Office of Community Oriented Policing Services.
The Legal Services Corporation.
The Civil Rights Division of the DOJ.
The Environmental and Natural Resources Division of the DOJ.
The Overseas Private Investment Corporation.
The UN Intergovernmental Panel on Climate Change.
The Office of Electricity Deliverability and Energy Reliability.
The Office of Energy Efficiency and Renewable Energy.
The Office of Fossil Energy.

January 20, 2017
All regulatory powers of all federal agencies frozen.
The National Parks Service ordered to stop using social media after RTing factual, side by side photos of the crowds for the 2009 and 2017 inaugurations.
Approximately 230 protestors were arrested in DC and face unprecedented felony riot charges. Among them were legal observers, journalists, and medics.
A member of the International Workers of the World was shot in the stomach at an anti-fascist protest in Seattle and is in critical condition.

January 21, 2017
DT brought a group of 40 cheerleaders to a meeting with the CIA to cheer for him during a speech that consisted almost entirely of framing himself as the victim of dishonest press.
White House Press Secretary Sean Spicer held a press conference largely to attack the press for accurately reporting the size of attendance at the inaugural festivities, saying that the inauguration had the largest audience of any in history, “period.”

January 22, 2017
White House advisor Kellyann Conway defended Spicer’s lies as “alternative facts” on national television news.
DT appeared to blow a kiss to director James Comey during a meeting with the FBI, and then opened his arms in a gesture of strange, paternal affection, before hugging him with a pat on the back.

January 23, 2017
DT reinstated the global gag order, which defunds international organizations that even mention abortion as a medical option.
Spicer said that the US will not tolerate China’s expansion onto islands in the South China Sea, essentially threatening war with China.
DT repeated the lie that 3-5 million people voted “illegally” thus costing him the popular vote.
It was announced that the man who shot the anti-fascist protester in Seattle was released without charges, despite turning himself in.

January 24, 2017
Spicer reiterated the lie that 3-5 million people voted “illegally” thus costing DT the popular vote.
DT tweeted a picture from his personal Twitter account of a photo he says depicts the crowd at his inauguration and will hang in the White House press room. The photo is of the 2009 inauguration of 44th President Barack Obama, and is curiously dated January 21, 2017, the day AFTER the inauguration and the day of the Women’s March, the largest inauguration related protest in history.
The EPA was ordered to stop communicating with the public through social media or the press and to freeze all grants and contracts.
The USDA was ordered to stop communicating with the public through social media or the press and to stop publishing any papers or research. All communication with the press would also have to be authorized and vetted by the White House.
HR7, a bill that would prohibit federal funding not only to abortion service providers, but to any insurance coverage, including Medicaid, that provides abortion coverage, went to the floor of the House for a vote.
Director of the Department of Health and Human Service nominee Tom Price characterized federal guidelines on transgender equality as “absurd.”
DT ordered the resumption of construction on the Dakota Access Pipeline, while the North Dakota state congress considers a bill that would legalize hitting and killing protestors with cars if they are on roadways.
It was discovered that police officers had used confiscated cell phones to search the emails and messages of the 230 demonstrators now facing felony riot charges for protesting on January 20th, including lawyers and journalists whose email accounts contain privileged information of clients and sources.
James Comey, who released unsubstantiated allegations concerning Hillary Clinton during the 2016 presidential campaign, asked to stay on as FBI Director.

January 25, 2017
The Trump administrated mandated that EPA scientific studies, data undergo review by political staff before public release.
DT orders a crackdown on immigration and that a wall be built across the Mexico border. 
DT orders an investigation into alleged voter fraud in only the states he lost with a concentration on "urban areas." He also tells Republicans to move forward with more voter suppression measures.

(Please send additions, corrections.) (Here's another list.)

Friday, January 27, 2017

HOLOCAUST | Remembrance Day–It Started with Words

International Holocaust Remembrance Day
Jan. 27, 2017–Today is International Holocaust Remembrance Day.

As @MoreUnitedUK reminded us today, "the Holocaust did not begin with killing. It began with words."

That is the theme of The Borrowed House, by my mother Hilda van Stockum. The young Germans in the Hitler Youth camps began their training by being taught theories of racial superiority.

Not until later does Janna, the heroine of the book, figure out the connection between these theories and the deadly implementation of the Holocaust.

One writer, @nickdangerca, says–"It is not enough to remember. We cannot repeat the same mistakes."

Here is an excerpt from what I wrote in July 2016 as a preface to my mother's book in the new edition published last year by the Purple House Press:

The Borrowed House is about Hitler’s Occupation of Holland in 1940-1945, from the perspective of a German girl, Janna Oster. She travels from the Black Forest in Germany with her parents to Amsterdam. When we first meet her, Janna is memorizing Hitler’s theories of racial supremacy for a school test. How could she know, or even imagine, the ultimate implications of these theories, fulfilled in death camps like Auschwitz and Treblinka?

Later, when Janna discovers that someone she actually cares about is from one of the races she was taught were “inferior”, it comes as a shock to her. She is angry that the theories she was carefully taught conflict with her warm feelings for a real human being. Can she reconcile her feelings with the theories?

Those who resisted Hitler paid the ultimate price. Many people in World War II were reluctant heroes, acting against a monstrous evil. When Queen Juliana in exile called Dutch Resistance leaders heroes, they objected. “We only did our duty,” they said. “Can you say No, when you are the only person who can prevent someone’s death?”

Today, we often complacently believe our country would ever succumb to a demagogue like Hitler. In the wake of the 9/11 attacks we saw widespread signs in America of selflessness, of men and women in uniform rushing to save innocent people, and our hearts were with them. But the same uniting behind the victims of 9/11 also generated a wish for revenge and exacerbated fears of people with certain religious beliefs or appearance. If a time comes when we again have to make difficult choices, how thoughtful and brave will we be?

As a young boy growing up in Washington, D.C. and then Montreal, I heard a lot about bravery and moral choices made at great personal cost. My mother, Hilda van Stockum, talked for hours with her mother about the wartime suffering and courageous acts of their Dutch relatives. They didn't want to upset a boy of five or six so they spoke in Dutch. But I heard and understood the pain in their voices.

They had reason to lament. Dozens of my mother’s Dutch cousins died. Many were very brave and some are buried in the Dutch Cemetery of Heroes. More are honored with Yad Vashem awards for sheltering Jewish people. We know the story of Anne Frank; here we see that she was one of many. My mother’s closest relative, her brother Willem, was an RAF bomber pilot; he was shot down in June 1944 and he is buried in Laval, France.

Through the wartime letters, my mother was frequently in touch with her Dutch cousins. The Borrowed House is dedicated to one of them, her “twin cousin” Nella de Beaufort.  Just as Hilda's brother Willem was killed by enemy anti-aircraft ordnance, Nella’s younger brother Hans de Beaufort was a Resistance hero. He wrote a moving letter from prison in Dijon before he was killed by the Nazis. The closing lines (translated by my mother) were:

I did what I thought my duty. I did what I could but at a certain moment it is too much and you can't manage any more. From that moment you have to leave it all to God's care. Now I can happily say: "Thy will be done" and give body and soul back to Him from Whom I got them. I greet you all with deepest love, all without exception just as I take leave of life with gratitude, hope of forgiveness, and trust in God. 

For two decades, the losses were too painful for my mother to write about. But nearly 20 years after the end of the war, she wrote the first of her two books about the Dutch Occupation, The Winged Watchman, which tells the story of how a rural family living in a windmill fought against Hitler and his followers. It was, like this book, fictionalized, but is based on her deep knowledge of Holland and the war, and wartime and postwar letters to her, and postwar visits with her relatives.

In 1975 she wrote this sequel based on a true story, The Borrowed House, about a German girl uprooted from her Hitler Youth program to accompany her parents to an Amsterdam house that is “borrowed” from a Dutch family. The 2013 Dutch translation by Boekencentrum calls it The Stolen House. It follows Janna from her first introduction to Amsterdam, where her parents were entertaining German troops, to her questioning of Hitler’s theories of racial superiority.

Both of her books lead the reader to ask: “Would today's generation show such courage or be willing to make sacrifices of the kind that people made in World War II?” Many people say no, but we don't know what people are made of until they are faced with a crisis. B. Kelly, a graduate in English Literature from Bard College, has thoughtfully noted two compelling features about this book:

First, this book offers views of the Dutch Occupation from the contrasting perspectives of the occupying Germans and the occupied Dutch. We meet many kinds of German and Dutch people, ranging from committed Nazis to people who are politically ambivalent. We glimpse the owners of the house, the van Arkels, through their home, art works and other possessions. We see how a transplanted German family adjusts to the sheltered life on Amsterdam’s Emperor’s Canal under the patronage of a German Baron and General. (The building on the back cover is surely the famed Keizersgracht 324.)

Second, Hilda van Stockum shows how Janna is startled by her experiences, such as the contradiction between the propaganda she has been taught and the reality she sees. This gradually rising moral awareness may well be uncomfortable for us readers, because it forces us to ask: “Would we have accepted Hitler’s racial dogma just the way Janna does, when other children and people in authority were aligned with these theories?”

Hitler’s propagandists were extremely good at what they did for their evil purpose. They linked Nazi views to ancient German and Greek myths through monument-building, music, children’s camps and theater. Hilda van Stockum shows us through Janna just how effective this can be. 

If we are sure that we would have been a hero like Hans de Beaufort in wartime, we should look closely at ourselves in the reflection from the windows of the van Arkel house. How immune are we really from racist and other ideology that continues to be sold and bought in a world where propaganda is a big business?

Monday, January 23, 2017

FOOD BIZ | Hi Costs Force Some NYC Restos to Close

Some long-established restaurants are closing because of higher costs

A combination of rising rents and higher labor costs are squeezing the owners' profit margins. 

Higher expectations for food are forcing up the talent required in the kitchen and the hours it takes to serve them.

This is not something new, but it is affecting some newer and highly prized restaurants, like Nick & Toni's in Manhattan, and others in New York City.



BLS | "Phony Numbers" on Their Way?

"Phony Numbers" Yesterday? Tomorrow? 
Jan. 23, 2017–The Trump Team attacked the BLS in 2016 for issuing misleadingly favorable numbers on unemployment. Trump called them "phony numbers".

In the second-last paragraph of his Op-Ed today, Paul Krugman wonders whether the Trump White House will be leaning on the BLS to do exactly what they were accused of under Obama.

The payroll job numbers are fairly hard to manipulate. They are based on filings by employers for unemployment insurance. If states with Republican governors wanted to influence the numbers they might be able to do this for a single month–for example by changing deadlines or filing procedures. But it is hard to see how they could do this easily over several months or years.

Meanwhile, blue-state governors–and some red-state governors–would be on the lookout for misuse of their data. Economists and statisticians are often alert when numbers that don't make sense and in the tradition of whistle-blowers they sometimes they speak up regardless of the consequences.

The household employment numbers are based on a sample of households surveyed by the Census Bureau, which reports to the Secretary of Commerce. When I was actively working with the numbers the Census work was paid for by a contract with the Commissioner of Labor Statistics, who reports to the Secretary of Labor; I have not heard of any change in this procedure.

One has to have faith that any secret changes in collecting these numbers, which have long been subject to scrutiny, would be difficult because someone would soon speak out in private or public.

Sunday, January 22, 2017

SOCIALISM | Who Funded the Brave Magazines in 1910-1922?

Art Young (1866-1943)
January 22, 2017–In today's New York Times a photo takes up nearly half of p. 10, the first page of a section called "The Inauguration". The photo is of Inez Milholland on horseback, about to set off 104 years ago, on March 3, 1913, from Capitol Hill up Pennsylvania Avenue to Lafayette Square, where there was a viewing stand in front of the Treasury Building.

She and her 5,000 or more (the National Park Service estimated 8,000) fellow suffragist marchers attracted the attention of the rest of Washington and a crowd of half a million people gathered around, many of the onlookers deeply hostile. Violence ensued that the D.C. police did little to break up until cavalry arrived from Fort Myer. When President-Elect Woodrow Wilson arrived at the VIP entrance at Union Station, no one was there to greet him except a White House driver and a staff member from the outgoing President (Taft).

The march alone established Inez as a brave woman. But little remembered is the role she played in directing funding to in-your-face socialist publications, especially The Masses. I have just been reading Art Young's long and interesting first (1928) autobiography, My Life and Times, available online (http://bit.ly/2jSuoeO – the download is slow because the file is large), and he has some interesting things to say in this connection.

Inez Milholland was the daughter of a newspaperman who became wealthy by investing in underground tubes for moving mail in big cities. Her socialist views deeply upset him.

These views motivated her to help her friend Max Eastman start The Masses, and after her death in 1916 influenced her widower, Eugen Boissevain, to fund other socialist publications.

Boissevain made a small fortune with two of his five brothers, importing coffee from Java in what was then the Dutch East Indies.

The socialist publications in the 1911-1922 period covered by Art Young coincided with the creation of the traditions and energy that emanated for the rest of the century from Greenwich Village.

These traditions were also wrapped up with the energy of New York University. Inez Milholland attended NYU Law School – and thereby became part of the Triangle Shirtwaist Company strike in 1909 and a witness to the fire in 1911 – because her application to Harvard Law School and other more prestigious school was rejected because of her gender. The Harvard Law School faculty decided she could do the work, but the administration did not admit women for another four decades–not until 1950.

1. The Masses, 1911-17


Art Young shows how The Masses got started with a $2,000 contribution (equal to about $50,000 today says the BLS inflation calculator) from Alva Belmont, whose support was enlisted by Inez. Max Eastman hadn't thought of approaching her, because he knew that Alva wasn't a socialist. But Inez knew that Alva was a supporter of suffragist causes and correctly perceived that she would be open to supporting other issues if properly presented. (See Young, previously cited 1928 Autobiography, p. 297.)

Inez explained to him that Alva was a "militant" – which would be enough for her to want to enable militancy of other kinds.

Alva's gift was quickly matched by $1,000 from popular novelist John Fox and then another $2,000 from civil rights lawyer Amos Pinchot. That was sufficient to get the magazine under way. Belmont made subsequent contributions.

The magazine was ended when Woodrow Wilson's Postmaster General invoked wartime laws against sedition and refused to mail it. The magazine was succeeded by another one led by Max Eastman, The Liberator, and later by The New Masses.

2. Good Morning, 1919-22


Cartoonist Art Young, a mainstay of The Masses, created his own magazine in 1919. He needed $4,500 to get it going, and received $1,000 of it (equal to about $25,000 today according to the BLS) from Inez's widower Eugen Boissevain. Eugen asked Art: "Are you sure this is enough?" (See his previously cited 1928 autobiography, p. 356.)

Art's magazine competed with Max Eastman's new magazine The Liberator. It only lasted three years. The value of these magazines is that they show an alternative point of view to the prevailing mood of capitalist acquisitiveness that lasted until FDR's election in 1932.

3. John Reed's Trip to Russia

Eugen Boissevain is credited by Max Eastman in his book Great Companions with contributing and raising the money that John Reed needed to go to Russia and write the book that became Seven Days that Shook the World.

Sunday, January 8, 2017

OBAMACARE | Probable Impact of Repeal

Senate and House Minority Leaders, Chuck Schumer
and Nancy Pelosi, challenge Obamacare repeal.
The following was just posted by David Posnett, MD. I repost with his permission:
[O]ne cannot repeal Obamacare and [at the same time] preserve coverage for kids until they are 26 years old under their parent’s policy, as well as the rule that forbids insurances from denying coverage for pre-existing conditions, etc. 
The math just doesn’t work. 
So far the insurance companies [have] benefited from (a) government subsidies for Obamacare policies, and (b) government pressure on individuals and businesses to increase the pool of insurance premiums.   
Imagine up to 20-30 million insurance policies disappearing with full repeal: Either insurance companies will go broke, or premiums will skyrocket, or deductibles will be huge, or the lifetime caps on benefits will return.
Dr. Posnett is a Democrat. To balance his views on the impact of a putative repeal of Obamacare, I consulted the Pulitzer-Prizewinning truth-checking site PolitiFact, which says, commenting on the probable impact of the repeal of Obamacare:
Today, roughly 28 million Americans are uninsured, down from 41.3 million in 2013, due in large part to the Affordable Care Act, with its expansion of Medicaid, the creation of online health insurance marketplaces, the ability of young people to stay on their parents’ coverage through age 26, and the mandates that everyone purchase a health insurance plan. 
In 2015, the Congressional Budget Office -- the nonpartisan number-crunching arm of Congress -- said that the number of additional Americans who would lose coverage or be unable to get it for the first time would start at 19 million in the first year and increase incrementally before leveling off to 24 million within a couple of years. (The incremental increases would stem from lags in when insurance options lapse as well as increases in the population from young people becoming old enough to secure insurance of their own.)
These statements are in sync. Repeal is going to be politically difficult. I am told by a knowledgable insider is that the states where government programs and private insurers are most ready to step in if Obamacare is scaled back are the blue states. So the biggest hit that repealing Obamacare will make is on the coverage of people in the red states that elected Donald Trump.

BLOG VIEWS | 310K–Top 10 Posts, December

The CityEconomist blogsite just passed 310,000 page views. 

Thank you for reading my blog.

The three most-read recent posts are about a World War II book featuring the Resistance in Holland, for which I wrote a foreword, and two posts relating to the November election of Donald Trump for President. 
– John Tepper Marlin.

MOST-READ POSTS IN DECEMBER 2016
WW2 | Foreword to "The Borrowed House," by Hilda v...
Dec 4, 2016
JOBS | Two Job Numbers for Trump to Beat (Updated ...
Dec 14, 2016
TRUMP | Mr. T Goes to Washington (Updated Nov. 11,...
Nov 10, 2016
DODD-FRANK | Maloney Asks Five Agencies for Data
Aug 30, 2016
GUTENBERG | Aug. 24–Bible First Published
Aug 24, 2016
ART BIZ | The Economics of the Art Auction Market
Nov 25, 2016
SCAMS | The IRS Is NOT Calling You!
Aug 25, 2016
NEW JERSEY | Huge Fire in North Bergen
Dec 21, 2016
BLOG VIEWS | Greetings–300K–Top Posts
Dec 20, 2016
ART BIZ | Some Forgers Are Good
Nov 1, 2016

Monday, January 2, 2017

DRUG BIZ | Danger–FDA Deregulation Ahead (by D. Posnett)

(Ill. by Patrick George)
The FDA's ability to ensure safe drugs has been
curtailed in the name of reducing costs and getting
more drugs to market. Caveat emptor! 

The following Guest Post was sent to me as a draft letter to the editor by an MD friend, David Posnett. He describes a worrisome price that the GOP-controlled Congress has exacted to get funding restored to the NIH for medical research. I asked Dr. Posnett if I could post this today and he kindly gave his permission.

The 21st Century Cures Act passed Congress Dec. 7 and was signed into law Dec. 13 by President Obama. This is a huge bill with something in it for everyone, and lots to criticize. As a retired researcher who spent nearly 40 years of my life writing research grants mostly to the National Institutes of Health (NIH), I applaud the long-overdue increase in funding of the NIH. In fact funding had steadily decreased in an alarming fashion since sequestration in 2013—inflation-adjusted funding for the NIH fell 22 percent in 2013-15.

Now there is a chance to catch up on these losses, in part because of The 21st Century Cures Act. It is well documented that reduced federal funding leads to fewer grants, fewer new discoveries and a loss of talented scientists. I have seen this first hand. Research scientists and patient advocate groups welcome the prospect of more funding.
However, there is an ugly underbelly to the 21st Century Cures Act. Perhaps not so well appreciated is further erosion of the power of the FDA in keeping us safe from drugs that can be harmful, or that are just ineffectual.

Remember the Thalidomide Babies?
It took lots of courage for a young FDA scientist in 1960 to stand up to the powerful drug industry trying to promote a poorly researched drug named Thalidomide.  Frances Oldham Kelsey was the FDA scientist who kept Thalidomide off the U.S. market and blocked approval for 19 months, thus saving thousands of babies from being born with severe deformities in the US. In other countries, without a strong FDA, sales and marketing for pregnancy-associated nausea remained unchecked and tens of thousands of severely deformed babies were born resulting in untold suffering across the globe.
In the name of accelerating drug development the FDA’s authority and the lengthy process of FDA approval have been steadily been eroded over the last few decades and the 21st Century Cures Act could be a fatal blow, specially with a new government bent on deregulating. Lobbyists from the pharmaceutical and medical device industries, and allied patient advocacy organizations, are touting predicted miracle breakthroughs based on the law’s aim to weaken regulations and promote rapid drug development. 

Most egregious is the use of anecdotal clinical experience as evidence that drugs are safe and effective; allowing antibiotics on the market based on pre-clinical evidence, that is, laboratory or animal studies, with little testing in humans; weakening the already limited evidence needed to approve medical devices (for example a stent for a coronary artery), even allowing companies to farm out the certification of safety of modified devices to third parties, circumventing the FDA altogether.  Similar concerns have been voiced in several leading medical and science publications (New England Journal of Medicine, JAMA, Science and Nature).

"Giveaway" to the Drug Biz 
As stated by Michael Carome (Director, Health Research Group, at Public Citizen) in the LA Times, “If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track. The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives.” 
Nothing in this act addresses the main problem the public sees with the drug industry: unaffordable prices. Elizabeth Warren says: “When American voters say Congress is owned by big companies, this bill is exactly what they are talking about.”   
Consider Merck’s Vioxx, a painkiller and arthritis drug the FDA approved in 1999. Vioxx was pulled off the market in 2004 after it was shown to raise the risk of heart attacks. By then, according to research published in the Lancet (a premier British medical journal), 88,000 Americans had heart attacks from taking Vioxx, 38,000 of them fatal.
Personally, I will be a lot more reluctant to take a new medication that has not stood the test of time!  This position is what I would recommend to my patients.

David Posnett MD
Springs, East Hampton, N.Y.