Last month FDA granted permission for “expanded access” to an experimental medicine for Ebola virus infection. The drug, currently designated TKM-Ebola, has barely begun to be tested for safety and efficacy and is available in extremely limited quantities. It will be administered to patients with confirmed or suspected Ebola infections but not as part of a clinical trial.
Henry Miller | All Articles
Donald Kennedy, president emeritus of Stanford University and former head of the FDA, once chided those “who give up the difficult task of finding out where the weight of scientific evidence lies, and instead attach equal value to each side in an effort to approximate fairness.” This results, he said, in “extraordinary opinions ... promoted to a form of respectability that approaches equal status.” National Public Radio – or as I prefer to call it, National Politically Correct Radio – often falls into this trap, offering extraordinary but discredited opinions that reflect a kind of back-to-nature, New Age fundamentalism that accepts environmental myths and hyperbole and is systematically antagonistic to certain sectors of science and technology.
Stanford Law School Professor Michael McConnell wrote in the Wall Street Journal in July that President Obama's decision to suspend the employer mandate of the Affordable Care Act (“Obamacare”) for a year “raises grave concerns about his understanding of the role of the executive in our system of government.” And with his epic announcement at a press conference last Thursday that he has decided to suspend the regulations that caused the termination of millions of Americans’ health insurance plans (supposedly because they were “substandard”), he was at it again.
With the “non-essential” functions of the federal government increasingly grinding to a halt, news outlets have incessantly covered the supposed consequences, ranging from tourists being turned away from national parks and memorials to cessation of food inspections by the FDA to the CDC's flu vaccine distribution to the interruption of clinical trials by NIH.
The Fifth Amendment to the U.S. Constitution guarantees that the federal government will not classify or treat individuals in a discriminatory manner. That fundamental right derives from England’s Magna Carta, in which King John promised that “no free man shall be taken or imprisoned ... or in any way destroyed, nor will we go upon him nor send upon him, except by the lawful judgment of his peers or by the law of the land.”
On April 29, the European Commission failed for the second time to get the votes necessary to pass a proposed two-year ban on several innovative agricultural pesticides known as neonicotinoids (“neonics”). But immediately after reporting that a “qualified majority” of member states had not been reached, the Commission’s health and consumer affairs commissioner, Tonio Borg, announced that he would institute the ban administratively.
STANFORD, Calif. --- Whole Foods markets are big business in this part of the world, upscale havens for rich shoppers seeking "healthy" foods. But notwithstanding their financial success, the two co-CEOs of the company are utterly clueless.
When I joined the Food and Drug Administration in 1979, I was essentially apolitical and knew next to nothing about federal regulation. A science nerd, I had spent the previous 16 years in college, graduate school, medical school and post-doctoral training. It didn't take long until I learned about the jungle of government bureaucracies. One of the harshest lessons concerned the perfidy and incompetence of one of FDA’s siblings, the Environmental Protection Agency.
David and Goliath stories have been around for a long time. It’s gratifying when justice is served and David slays his tormentor, as in the Biblical tale, but most often the little guy gets squashed. The latter is how I felt on October 23 when New York Times food writer Mark Bittman did a gratuitous hatchet-job on me. Yes, on me --- a nerdy gray-beard who works in an eight-by-twelve-foot office at a university think tank and doesn’t even have a secretary.
The first celebration of Earth Day, which was founded by former U.S. Senator Gaylord Nelson, was held in 1970 as a "symbol of environmental responsibility and stewardship." In the spirit of the time, it was a touchy-feely, consciousness-raising, New Age experience, and most activities were organized at the grassroots level.
In 1989 the American apple industry was sent reeling by an unexpected blow — a lurid “60 Minutes” segment that supposedly exposed the cancer-causing dangers of Alar, a chemical used by some apple growers to synchronize the ripening of fruit. The over-the-top alarmist segment seared into the minds of consumers across the country the image of an apple branded with a skull-and-crossbones.
In America’s Wild West, when law enforcement was spotty or nonexistent, vigilantes sometimes stepped in. A known cattle rustler might be found face-down in a gully with a terminal case of "lead poisoning," as they used to say in TV westerns.
The Nobel Peace Prize was awarded this year to Liu Xiaobo, a prominent Chinese dissident who has spent more than 20 years advocating for a freer society marked by greater civil liberties and an independent judiciary. Unfortunately, the government of the Peoples Republic of China not only prevented him or his representative from attending the ceremony today but pressured other nations to boycott it.
The New York Times’ editorial writers demonstrate with startling frequency that they exist in a parallel universe, one marked by irrationality, misdirected compassion and ignorance of history.
Democrats on Tuesday received the worst drubbing, nationally and locally, suffered by either political party in more than half a century. This battering of epic proportions, primarily a repudiation of the economic policies and high-handedness of Barack Obama, Nancy Pelosi and Harry Reid, was also an implicit condemnation of a left-wing regulatory philosophy that unnecessarily burdens those who create jobs and wealth.
According to the latest Gallup 2010 Confidence in Institutions poll, the U.S. Congress ranks dead last out of the 16 institutions rated. Only 11% of Americans have "a great deal" or "quite a lot" of confidence in those who populate the institution, down from 17% in 2009 and a percentage point lower than the previous low (2008).
Juan Williams’ dismissal by NPR because of supposedly inappropriate remarks he made on Bill O’Reilly’s TV program once again exposes the radio network’s hypocrisy and bias. The real reason is clearly that NPR officials disliked Williams' ongoing association with Fox News; they regularly permit other correspondents and analysts to get away with murder -- but on other TV networks.
Former leader of the Soviet Union Joseph Stalin famously said that a single death is a tragedy but a million deaths is just a statistic. His observation seems to have been proven yet again by the media feeding frenzy over the rescue operation in Chile for 33 copper miners trapped underground for two months.
California is often regarded as a regulatory policy bellwether for the rest of the nation, so there was a great deal of attention paid when in 2008 the state became the first to adopt a program of “green chemistry.” It was hailed by many as a victory for the environment and consumers and was said to augur well for chemicals regulation elsewhere.