(1) A friend of the shooter reports that a few years ago:
“We were having a conversation in a kitchen, and I don’t know how he worded it. He said the devil is after him,” Bathurst told the CBC. “I think he must have been mentally ill.”
That seems extremely weak evidence, however, especially in a person who has recently converted to or is considering converting to a religion such as Islam. In Islam the devil, whose “primary characteristic…[is] hubris,…has no power other than the power to cast evil suggestions into humans and jinn, although the Quran mentions appointing jinn to assist those who are far from God in a general context.” So the shooter’s speaking the way Bathurst reports would not necessarily be a sign of mental illness.
(2) I repeat my question of yesterday: if Zehaf-Bibeau, the shooter, and Couture-Rouleau, a Quebec man who on Monday had run down two soldiers with his car, were both on watch lists and had had their passports revoked for planning trips to Muslim countries to join militant jihadists, why on earth were neither actually watched more carefully? It’s not as though blocking a jihadi from trips abroad is going to defuse his desire to fight you, it just will keep it local. And ISIS had called for attacks on the military. These two incidents should have been easy to predict, not just in general but in particular regarding both of these perpetrators.
(3) I haven’t seen an article about this, but I heard a Canadian commentator on Fox (unfortunately I didn’t catch his name) describe the shooting in more detail, particularly what occurred inside the building. He said that the way Zehaf-Bibeau entered the Parliament building was through a back door with lax security, although the front entrance has pretty good security. The back door is the way MPs usually exit. I imagine that Zehaf-Bibeau must have known about the lax security there and entered that way for that reason. There are guards at the exit but they are unarmed. So the shooter (much like the White House fence jumper who entered the White House not long ago) was able to get fairly far inside.
However (and this is where it gets really interesting, if this report is true), at the top of a staircase the shooter had to pass by two armed guards. Neither shot him, although they could clearly see he was armed and dangerous. The reason, according to the speaker, was that the hallway was full of schoolchildren finishing up a tour, and the guards were afraid of causing carnage among the schoolchildren (although it seems logical that they might have been even more afraid of the shooter causing carnage among either the schoolchildren or in Parliament itself). At any rate, making a split-second decision, one of the guards grabbed the end of the shooter’s rifle and jerked it downward (perhaps trying to get it away from him?) and was shot, although not fatally. The other doesn’t seem to have done anything; at least not anything effective, and the shooter kept going down the hall.
Zehaf-Bibeau had gotten very close to the entrance of Parliament when sergeant–at-arms Kevin Vickers shot and killed him. Vickers, a former member of the RCMP, has a largely ceremonial role now. He has an office towards the end of the hall near the entrance to the House of Commons, heard the commotion and violence, “grabbed his sidearm” (that’s a quote from the guy being interviewed on Fox), stepped out into the hall, assessed the situation rapidly, and shot Zehaf-Bibeau dead. If not for Vickers and his sidearm (which may have been something he carried as a private citizen rather than in his official capacity?), I am almost certain we’d be reading a different, and much more dreadful, story today.
It is pretty clear that Zehaf-Bibeau wasn’t intent on killing random people; he didn’t fire at the schoolchildren or other visitors. He targeted the soldier at the tomb, and he was going for the government officials. Only Vickers and his sidearm stood in his way.
I was waiting for more information about the terrorist attack in Canada today before writing about it, but I thought I’d offer a quick post so you can comment on it if you like.
It seems to me the new pattern is for Muslims—perhaps especially home-grown Muslim converts—to take up the glorious call of ISIS and free-lance in Western countries and go on a killing spree. This was a bold one:
Prime Minister Stephen Harper said in an evening address that Canada would not be intimidated by Wednesday’s “brutal and violent attack” in Ottawa, in which an armed attacker shot and fatally wounded a Canadian Forces member at the National War Memorial before being shot dead in Parliament’s Centre Block.
The slain soldier is Cpl. Nathan Cirillo, 24, a reservist from Hamilton.
Moments after Cirillo was shot at his post by the Tomb of the Unknown Soldier, MPs and other witnesses reported 30 to 50 shots fired inside the main Parliament building.
It was confirmed later the gunman was shot dead inside the building, felled by the House of Commons sergeant-at-arms and RCMP, according to MPs’ accounts.
A few thoughts: the soldier guarding the Tomb of the Unknown Soldier was apparently unarmed and therefore a sitting duck (although with a surprise attack, being armed would not necessarily have made a difference). The sergeant-at-arms in the House oF Commons, however, whose role I would have thought merely colorful and ceremonial, was apparently armed, as befitting his title.
I just heard on the news that the suspect, Michael Zehaf-Bibeau, had a criminal record. I’m wondering whether this might have been another case of a prison conversion to Islam.
Bibeau, who was born in 1982, was a convert to Islam and had a history of drug use before he converted, two sources said.
His passport had been confiscated by Canadian authorities when they learned he planned to go fight overseas, a U.S. law enforcement official told CNN’s Susan Candiotti. The official said it was not clear when that happened.
So, did they know he was planning to fight with ISIS or a similar group? And did they just let him go after taking away the passport? Was he not under surveillance?
My prediction is that the left will call this another lone-wolf operation. Certain people such as Zehaf-Bibeau may be acting solo in the actual murders they commit (although there are some reports that Zehaf-Bibeau may have had an accomplice), but they are not alone. They are part of a global movement, and are inspired and encouraged by that movement.
UPDATE 11:04: I’m hearing on Bill O’Reilly from Mark Sutcliffe, a Canadian talk show host, that the Canadian government has almost no security. I find that shocking.
UPDATE 11:17: Several photos of the soldier who was murdered, Cpl. Nathan Cirillo, 24. Heartbreaking, RIP.
…[M]ore than a half-dozen unnamed black witnesses have provided testimony to a St. Louis County grand jury that largely supports Wilson’s account of events of Aug. 9, according to several people familiar with the investigation who spoke with The Washington Post.
Some of the physical evidence — including blood spatter analysis, shell casings and ballistics tests — also supports Wilson’s account of the shooting, The Post’s sources said, which cast Brown as an aggressor who threatened the officer’s life. The sources spoke on condition of anonymity because they are prohibited from publicly discussing the case…
The St. Louis Post-Dispatch late Tuesday night published Brown’s official county autopsy report, an analysis of which also suggests the 18-year-old may not have had his hands raised when he was fatally shot, as has been the contention of protesters who have demanded Wilson’s arrest.
Experts told the newspaper that Brown was first shot at close range and may have been reaching for Wilson’s weapon while the officer was still in his vehicle and Brown was standing at the driver’s side window. The autopsy found material “consistent with products that are discharged from the barrel of a firearm” in a wound on Brown’s thumb, the autopsy says.
I have yet to see any forensic evidence that supports the contentions of the anti-Wilson camp.
But that probably won’t be enough to stop the furor if Wilson isn’t indicted. Here’s an interesting theory, though, on why so much of this information is being allowed to be leaked now:
…[F]ormer St. Louis County Police Chief Tim Fitch says it’s no accident the feds are allowing the information.
…Fitch calls the information from the investigation coming out as phase two – to “coordinate leaks to the media, and to start getting some of the facts out there to kind of let people down slowly,” he says. “When I say this is phase two – phase one was really Eric Holder’s announcement how they were going to basically do a complete review and take over the Ferguson Police Department.”
Fitch says he thinks the feds recognize that it’s “probably very unlikely” that there’s going to be charges against Ferguson police officer Darren Wilson.
…Fitch believes the New York Times story is just a preview of what’s to come over the next few weeks.
In other words, he believes the press and the feds are trying to soothe the anger—anger they had a role in encouraging by their initial coverage—in order to avoid a scene like the 1992 riots in LA after the Rodney King verdict.
Fan the flames of rage for sensationalistic coverage, and then try to put out the fire? I’m not even sure that’s what the MSM is trying to do here, but if so, it’s like closing the stable door after the horse has bolted.
This caper by James O’Keefe doesn’t prove voter fraud exists, of course. But it certainly proves how easy it would be in a state like Colorado, and that there are plenty of people willing and eager to commit it. So, what are the chances it doesn’t happen? Very small, in my opinion.
And I’ve never understood the argument that not having a lot of proven cases of voter fraud is some sort of proof that it’s not already happening. If the fraud is good, the perps wouldn’t be caught, or there wouldn’t be enough proof to convict even it caught. It reminds me a bit of people saying they can always detect a false hairpiece; it’s false reasoning, because if a hairpiece were very good they wouldn’t know they’d failed to detect it.
This is what O’Keefe did:
Today, he is releasing some new undercover footage that raises disturbing questions about ballot integrity in Colorado, the site of fiercely contested races for the U.S. Senate, the U.S. House, and the governorship. When he raised the issue of filling out some of the unused ballots that are mailed to every household in the state this month, he was told by Meredith Hicks, the director of Work for Progress, a liberal group funded by Democratic Super PACS.: “That is not even like lying or something, if someone throws out a ballot, like if you want to fill it out you should do it.” She then brazenly offered O’Keefe, disguised as a middle-aged college instructor, a job with her group.
Actually, what’s even more shocking than that incident (and there were other similar ones that O’Keefe documented as well) is the incredibly lax election law passed in Colorado. It facilitates cheating, and was sponsored by Democrats. So far the protests against it have not been effective. Here’s the way it works:
Colorado secretary of state Scott Gessler, along with several county election clerks, have raised warning flags that a new state law that automatically mails a ballot to everyone is an engraved invitation to commit fraud. “Sending ballots to people who did not even ask for them or have moved out of state is asking for trouble” he told me. For example, little can stop someone who collects discarded ballots from trash cans, fills out the ballots, and mails them in. Election workers are supposed to compare signatures on registration records with signed ballots. But if a person has a “witness” who signs the ballot on the witness line, then the signatures do not have to match and the vote is counted.
Secretary of State Gessler had futile arguments with Democratic state legislators last year who insisted on ramming a bill through that mandated Colorado become the only state in the nation with both all-mail balloting and same-day registration. Under same-day registration someone can register to vote online, have a mail ballot sent to them, and never physically show up to register or vote. Other places that use same-day registration treat the vote as a provisional ballot pending verification. Colorado immediately counts the vote and there is no way to separate it out if the person who votes is later found ineligible.
I haven’t been able to find a record of any court challenges, but these laws seem outrageous to me.
Judea Pearl is the father of Daniel Pearl, and he has written a stirring letter of protest about the Klinghoffer opera. It’s well worth reading in its entirety, but here’s an excerpt:
There is nothing more enticing to a would-be terrorist than the prospect of broadcasting his “grievences” in Lincoln Center, the icon of American culture
Yet civilized society, from the time of our caveman ancestors, has learned to protect itself by codifying right from wrong, separating the holy from the profane, distinguishing that which deserves the sound of orchestras from that which deserves our unconditional revulsion. The Met has smeared this distinction and thus betrayed their contract with society.
I submit to you that choreographing an operatic drama around criminal pathology is not an artistic prerogative, but a blatant betrayal of public trust.
We do not stage operas for rapists and child molesters, and we do not compose symphonies for penetrating the minds of ISIS executioners.
No! Composer John Adams, some sides do not have two sides, and what was done to Leon Klinghoffer has one side only.
By the way, people often criticize the opera protestors as being for “censorship.” You can see it in the comments to Pearl’s letter. But that argument is a strawman. There is nothing in Pearl’s letter that advocates banning the opera. He is saying that people who compose operas and their libretti, and opera directors, have choices, and that they are making very poor choices here in deciding to present the case of these terrorists and to give a beautiful musical expression to their grievances—a morally bankrupt choice.
And Judea Pearl and others have every right to condemn and protest it, and to ask the Met not to give such evil an artistic expression on their stage. The decision, of course, is up to the Met.
It’s not censorship to protest something. It’s not censorship to suggest that people not attend, or to say an opera should not be produced by a certain group. It’s censorship to ban it, and censorship is ordinarily done by the government.
President Obama delivered a blow to Democratic Senate candidates looking to distance themselves from his flagging approval ratings Monday…
“The bottom line is though, these are all folks who vote with me; they have supported my agenda in Congress; they are on the right side of minimum wage; they are on the right side of fair pay; they are on the right side of rebuilding our infrastructure; they’re on the right side of early childhood education.”
Obama went on to say that his feelings weren’t hurt by Democrats who were reluctant to campaign with him.
“These are folks who are strong allies and supporters of me, and I tell them, I said, ‘You know what, you do what you need to do to win. I will be responsible for making sure our voters turn out.’”
The president’s remarks appear tailor-made for Republican attack ads in states like Georgia, Louisiana, North Carolina, Kentucky and Alaska, where GOP candidates have painted their Democratic opponents as rubber stamps for the administration’s policies.
What’s going on here? Does Obama want those Democrats to lose?
There are two possibilities. The first is that he doesn’t realize how toxic he’s become. He’s isolated in the White House with his fawning sycophants, and that and the depth of his narcissism protect him. So he actually thinks these sorts of statements are helpful.
The second is that he doesn’t care if these people win or not, and that he’s sticking it to them in his narcissistic rage at their desertion. His message is that, if they think they can run away from him, they’ve got another think coming. Take that!
But why wouldn’t he care if they lose? Doesn’t he need them to be effective in his last two years as president? There’s a good chance that Obama doesn’t think so. He’s got this imperial presidency thing down pretty well by now. If he loses the Senate, he’s still got the veto, his pen, and his phone—and the excuse that he has to use them because the Republicans just won’t cooperate.
[ADDENDUM: This piece by Ace suggests to me a third possibility: that Obama's just trying to rally his base and get them to vote, saying (wink, wink) that these candidates' distancing from him is just a pose, and that they'll be good and loyal liberals once they're safely elected.
And the three possibilities are not mutually exlusive, either.]
Ace has a post about people who’ve soured on Obama that contains some extraordinary quotes from the past. It’s easy to forget exactly how fulsome the praise was back then in its cultlike extremity.
Here’s a passage Tina Brown wrote in 2008, but it could have been any number of other supposedly intelligent people. That sort of hero-worship is truly frightening, not just because it’s about Obama—who has turned out so badly as president, a fact someone astute could have foreseen quite easily—but because it’s about any mere human:
This has been an election full of magic. White Magic that only the black man from everywhere and nowhere could perform. Even his adored grandmother dying on the eve of the victory had a mythic feeling of completion to it in a candidacy full of signs and symbols. Remember the three-point basketball shot when he played with the soldiers in Kuwait? It’s as if Obama is the prince who lifts the curse in a fairy story, a curse that began eight years ago with an election wrenched away from the rightful winner and begetting as a consequence the wrathful visitation of tragedy and wars and hurricanes and economic collapse.
Magic. Curse. Fairy story. These are the words of a child, not an adult. And yet the woman who wrote them was in her mid-50s at the time. She was not alone, either, and it was by no means just women who felt that way. However, it is a fact that Obama always had more support among women than among men, and this is true of the Democratic Party as a whole.
Why is that? Probably another story for another time, but I’ll take a stab at a few possible reasons: on average, women are more interested in protection and a feeling of security than men, and they think Democrats offer that in terms of economics and health because they promise it (although some woman have been learning that Obama hasn’t offered much safety even in those arenas, and especially in the areas of Islamic terrorism and ebola). In general, women aren’t as keen to follow the nitty-gritty details of politics as men; at least, I’ve observed that among my friends and acquaintances.
Some would also say that, in general, women are less logical. But my observation is that lack of logic, at least regarding politics and/or history, is close to endemic among both sexes.
If you want some equal-opportunity Obamamanic insanity from a man back in 2008, I offer this article by SF Gate columnist Mark Morford. An excerpt will give you an idea of its flavor:
Barack Obama isn’t really one of us. Not in the normal way, anyway.
…I’ve heard from far too many enormously smart, wise, spiritually attuned people who’ve been intuitively blown away by Obama’s presence – not speeches, not policies, but sheer presence – to say it’s just a clever marketing ploy…
Many spiritually advanced people I know (not coweringly religious, mind you, but deeply spiritual) identify Obama as a Lightworker, that rare kind of attuned being who has the ability to lead us not merely to new foreign policies or health care plans or whatnot, but who can actually help usher in a new way of being on the planet, of relating and connecting and engaging with this bizarre earthly experiment. These kinds of people actually help us evolve. They are philosophers and peacemakers of a very high order, and they speak not just to reason or emotion, but to the soul.
Last night was the opening of the controversial opera “The Death of Klinghoffer” at New York’s Lincoln Center. It was marked by protests:
Demonstrators, primarily associated with Jewish groups, plan to rally outside Lincoln Center with 100 wheelchairs, in honor of the slain handicapped Leon Klinghoffer, on whom “The Death of Klinghoffer” is based.
Klinghoffer was hurled from the Achille Lauro cruise ship by PLO terrorists in 1985 after it was hijacked. The opera, which centers on the terrorists who perpetrated the murder, has been accused of glorifying terrorism and incorporating anti-Semitic tropes.
The opera is not new; it was first produced in 1991, and has drawn protests wherever it goes. It’s not hard to see why.
As Thomas Sowell once asked, referring to Klinghoffer’s murderers:
What kind of people would throw an old man in a wheelchair off a cruise liner into the sea, simply because he was Jewish?
The answer, of course, is “terrorists,” and we’ve spent a lot of time and energy in recent years explaining them and fighting them. That they are also human beings doesn’t mean we need to sympathize with them.
I recall hearing the news of the hijacking and the shocking manner of Klinghoffer’s death at the time it occurred, but back then I was unaware of the almost immediate post-modern interest of some in understanding—empathizing with, and even sympathizing with—Klinghoffer’s murderers, or with their “narrative.” In the years since, and especially post-9/11, such enabling attitudes have become only too apparent.
“The Death of Klinghoffer” is an example of the genre. In the olden days, an opera on such a theme might have featured the terrorists as traditional villains steeped in evil, with thunderous and dissonant music to signify the horror of what they did. But in this version they are given sonorous and lovely melodies to sing and sympathetic words to utter. But it wasn’t enough to portray the murderers in a sensitive light; the Klinghoffers and their associates are portrayed less nobly:
More than 20 years ago, in his review of the Brooklyn Academy of Music’s premiere of the opera, The New York Times chief music critic, Edward Rothstein, questioned the presentation of Jews and Palestinian Arabs as “symmetrical victims of each other’s hatreds.” Rothstein later wrote that the opera’s depiction of its Jewish characters reduced them “to petty triviality” compared to their Palestinian counterparts.
The opera’s librettist, Alice Goodman, is an interesting tale herself. Born and raised as a Jew in Minnesota, educated in literature at Harvard, married to a British poet, she became an Anglican priest and opera librettist.
You can listen to Ms. Goodman discussing the opera here, in a BBC interview that features a selection from it sung by one of the terrorists. Without even being able to decipher the words of the libretto, just hearing the music and the voice of the kidnapper makes it clear that he is being given a respect and a certain esthetic elegance and dignity that could only serve to elevate him in the eyes of the listener.
Ms. Goodman’s answer to the question of whether the opera is anti-Semitic or an apology for terrorism is an interesting one. She says no (no surprise there); she believes that the charges of anti-Semitism and the rest are a result of her showing the terrorists as “human beings.”
Well, terrorists are most decidedly human beings, as were Hitler, Pol Pot, Stalin, and—well, every other human being who’s ever lived. We all know how Hitler loved dogs, and was a vegetarian. To be evil does not require that one be a devil; being a human being who does evil will suffice. But considering terrorists human beings does not require giving them a forum by writing lovely arias for them to sing.
Ms. Goodman says she speaks not just as the librettist, but as a priest, when she recognizes the perpetrators as human beings with ideals—wrongheaded, yes, but idealistic nevertheless—as though idealism somehow has a value in and of itself. She acknowledges that the music and the words she and her collaborator wrote for the terrorists who killed Klinghoffer were lyrical and heartfelt, and she understands that this fact created “a dissonance difficult for some people to take.”
Indeed. I guess we’re not all highly evolved enough to understand the convoluted mental gymnastics required in comprehending how that doesn’t constitute some sort of sympathy and apology—if not for the devil, then for the human beings who perpetrated this heinous act.
[NOTE: This is a re-written update based on an old post.]
[ADDENDUM: More background on Klinghoffer's death here:
Holding the passengers and crew hostage, [the Achille Lauro hijackers] ordered the captain to sail to Tartus, Syria, and demanded the release of 50 Palestinians then in Israeli prisons, including the Lebanese prisoner Samir Kuntar.
The next day, after being refused permission by the Syrian government to dock at Tartus, the hijackers singled out Klinghoffer, a Jew, for murder, shooting him in the forehead and chest as he sat in his wheelchair. They then forced the ship’s barber and a waiter to throw his body and wheelchair overboard. Marilyn Klinghoffer, who did not witness the shooting, was told by the hijackers that he had been moved to the infirmary. She only learned the truth after the hijackers left the ship at Port Said. PLO Foreign Secretary Farouq Qaddumi said that perhaps the terminally ill Marilyn Klinghoffer had killed her husband for insurance money. However, the PLO later accepted full responsibility for murdering Mr. Klinghoffer.
Initially, the hijackers were granted safe passage to Tunisia, but U.S. President Ronald Reagan ordered a U.S. fighter plane to force the get-away plane to land at Naval Air Station Sigonella in Italy. After an extradition dispute, Italian authorities arrested and later tried the Palestinian terrorists, but let Abu Abbas fly to Yugoslavia.
I highlighted the above for two reasons. The first is the statement of Farouq Qaddumi. The second is the action of President Reagan.
I wonder if Qaddumi is given an aria in the opera, too.]
I’m not much of a Streisand fan. She’s just not all that much to my taste, but I recognize her outstanding talent and understand why for many people she’s their favorite singer.
I noticed that Yahoo is pushing a video of Streisand talking about her son’s singing, and singing a duet with him.
Now, that interested me. Mothers and sons interest me. And of course I was curious: what kind of voice does Jason Gould, 47-year-old sometime-actor son of Streisand and her first husband, actor Elliot Gould, have?
Well, it’s not like Streisand’s. But it’s good, not just passable or okay (like some of the Sinatra kids) but really good. Jason Gould’s voice may represent a regression towards the mean, but not very far towards the mean.
I think the story is interesting as well. It makes sense that he kept his voice under wraps all these years. Streisand would be a tough act to follow:
He has a different style from his mother’s. More subdued, but still expressive:
Musicality and singing voices seem to be highly hereditary, although it’s hard to separate nature/nurture because children of singers tend to grow up surrounded by music. Children of singers often try make it in the music biz, too, although the spawn of great singers almost never make it as big as their famous parents (Liza Minelli comes to mind as a big exception, but I still don’t think she’s as good as her mother).
It works both ways, though. Famous singers often have a less-famous singer-parent, one who had a lovely voice but didn’t make it all the way to the big time. Or, they have sibling singers, sometimes very successful—the Everly brothers, the Pointer sisters, and countless others. Here, for example, are some singing sisters not everybody knows are sisters:
[NOTE: Yes, I know you don't like Streisand's politics. This isn't about her politics.]
Posted by neo-neocon at 2:59 pm. Filed under: Music
Articles like this one accuse the FDA of unnecessary slowness in approving diagnostic techniques, treatments, and vaccines:
Pandemic vaccines and drugs don’t move through the FDA approval process faster. Instead, drug- and device-development times actually increased more than 70 percent over the past decade because the FDA keeps demanding more studies and more data using outdated techniques.
It’s easy to blame the FDA, and as a federal agency I’m sure there’s plenty to blame. But don’t forget that the American people demand (and I mean exactly that: demand) contradictory things from new drugs, treatments, and vaccines: speed of development and use, and absolute safety. And if we don’t get that “absolute safety” part, we’ll sue the pants off you.
Well, those are contradictory demands. You can’t ordinarily get both. In fact, absolute safety, to the degree that people seem to be demanding it these days, is not possible even with a very slow development of the drug, treatment, or vaccine. Many problems only reveal themselves over time, and every treatment will have some problems for someone.
I am old enough to remember that America dodged the thalidomide bullet that hit Europe. It was through this more-cautious approach of the FDA:
In September 1960, Dr. Kelsey was a newly appointed member of the Food and Drug Administration (FDA). Her very first assignment was to review the application for the drug Kevadon. Synthesized in 1954 and introduced to the market on October 1, 1957 in West Germany, the drug—known there by the name Thalidomide—was hailed as a wonder cure for insomnia. Non-addictive and non-toxic, Thalidomide induced sleep and was prescribed as a sedative that promised no side effects. As its popularity grew, it soon became the drug of choice prescribed to pregnant women…
No side effects—at first. At least, not that anyone could see.
Of particular concern to Dr. Kelsey and her staff was one of the drug’s major selling points: unlike barbiturates which induced sleep but also induced death if taken in large quantities, Thalidomide could be ingested in large quantities, seemingly without toxic side effects. However, Dr. Kelsey recalled a study she conducted on rabbits as a young post-doctoral pharmacologist at the University of Chicago in 1942. Part of a team that was seeking to create a synthetic cure for malaria, Dr. Kelsey had noted that, although adult rabbits metabolized quinine rapidly, pregnant rabbits were less able to metabolize the drug and embryonic rabbits had no ability to metabolize the drug. Furthermore, Dr. Kelsey noted that the drug did indeed pass through the placental barrier between mother and developing fetus. Recalling those observations in reviewing the Thalidomide application, Dr. Kelsey was concerned that physiological changes such as pregnancy might change the absorption properties of Thalidomide, leading to harmful consequences.
Responding to Dr. Kelsey’s requests for more clinical proof of the drug’s safety, Richardson-Merrell submitted additional evidence, but she again rejected the application on the grounds that the reports were testimonial—not clinical—in nature.
As autumn closed in on the Christmas holiday season—the most lucrative time of the year for the sale of sedatives—the pharmaceutical company, frustrated by the repeated and, in their view, unnecessary delays, began to pressure Dr. Kelsey with visits and phone calls to her superiors. Despite the increasing pressure, Dr. Kelsey remained steadfast in her demand for thorough clinical studies demonstrating the drug’s safety.
Recalling this story (not every detail, but the main outline), I tend to think of it when people trash the FDA for being too cautious about new drugs. However, in the past, whenever I’ve brought it up in such conversations, nobody had ever heard of it (that is, they’d heard of thalidomide, but not that it was not approved in the US, or why). In fact, people often misremember, and think that the bulk of the thalidomide babies were born in the US rather than Europe. What actually happened was this:
In the few years that the drug was on the world market, thousands of children were born with Thalidomide-related deformities. Many did not survive until their first birthday. Countless more miscarriages were traced to the use of Thalidomide. The damage in the United States, due to the work of Dr. Kelsey, was small by comparison, with 17 children documented to have Thalidomide-associated deformities. (During an investigational period, Richardson-Merrell had distributed more than 2.5 million Thalidomide tablets to more than 1,000 doctors who, in turn, gave Thalidomide to nearly 20,000 patients, several hundred of whom were pregnant women.)
It was one of the times that the US and the FDA—and its caution—were the stars.
That doesn’t mean it’s always a good idea to go so slowly, or that the FDA’s caution hasn’t grown too great since then. I don’t know; I don’t pretend to be an expert on whether the FDA is using the right standards or not at this point. But ever since I learned some of the details of the thalidomide days (I was too young to fully understand it when it happened), I have been cautious about condemning the FDA’s caution.
Previously a lifelong Democrat, born in New York and living in New England, surrounded by liberals on all sides, I've found myself slowly but surely leaving the fold and becoming that dread thing: a neocon. Read More >>