Potential FDA Head Could Change Drug Approval Process Dramatically

One controversial aspect, O’Neill says the FDA should only regulate drugs for safety, not efficacy. 

 

Man at the supermarket pharmacy aisle.
Drugs are proven safe and effective before hitting pharmacy shelves. Jim O'Neill sees it differently.

President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. For the last 50 years, commissioners have all had a medical background, either as a doctor or a researcher, but not this Silicon Valley investor. He is familiar with government. In 2002 under the Bush administration, the candidate did a stint as the principal associate deputy secretary for the Department of Health and Human Services.


O’Neill has close ties with billionaire and PayPal co-founder Peter Thiel. Thiel is aiding the Trump team with its Defense Department transition. O’Neill and Thiel were colleagues at Clarium Capital Management. The possible appointee also spent some time managing the Thiel Foundation and a biotech incubator called Breakout Labs. At the latter, he helped biomedicine and food science startups develop and gain a foothold in the market.

Currently, the prospective commissioner is a managing director at Mithril Capital Management, a company owned by Thiel. An inside source close to the Trump team told Scientific American that Thiel was advocating for O’Neill. Yet, some of the investor’s past statements have raised concerns. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what he called “progressive approval.”

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety,” he said in that same speech. “Let’s prove efficacy after they’ve been legalized.”

Billionaire and PayPal founder Peter Thiel.

This is causing alarm among those in Big Pharma and the medical community. What about the placebo effect? Patients could falsely believe they are getting better, when in fact a new medication does nothing for them. What’s more, it may reveal a naiveté on the part of O’Neill, as many say it is impossible to separate safety from efficacy during the assessment process.  

President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, “throw the entire U.S. healthcare system into turmoil.” In a legal sense, the 1962 Kefauver amendment would have to be repealed, a law which states that drugs must be proven safe and effective before they can make it to market.

Jettisoning effectiveness is not his most eyebrow raising idea. O’Neill along with Theil, are board members of the first sea-based enclave, known as the Seasteading Institute. Here, like-minded individuals will inhabit a series of rigged platforms floating on the ocean. Seasteaders are looking to make their own libertarian utopia in international waters, free of existing governments, or so they claim.

Conceptual design for a seasteading enclave. By JackDayton at en.wikipedia (Transferred from en.wikipedia) [CC BY 3.0] GFDL from Wikimedia Commons

The staunch libertarian says that the problem with American healthcare is that government interference has suppressed the free market, which has made the process wasteful and expensive. O’Neill has said in past statements that no one should be forced to pay for another’s obesity, and organ transplant recipients ought to pay for the organs they receive. “There are plenty of healthy spare kidneys walking around, unused,” he said, in that same 2009 speech. O’Neill is also a proponent of anti-aging medicine, and believes that medically driven immortality is not outside the realm of possibility.

FDA insiders question how O’Neill might interact with the 17,000 permanent staff at the agency. The FDA commissioner is not the sole voice in approving medications or devices. Independent reviewers are employed for that weighty task. Peter Pitts, a staffer and former FDA associate commissioner for external relations, told Forbes, that O’Neill’s lack of a medical background was “counterproductive and almost insulting.” Since federal employees have some job security, if O’Neill were appointed, senior staff under and the commissioner could be ramming heads over policy changes to the agency for the next four years.

Some conservatives argue that O’Neill could shake up the agency, and help it to branch out in new ways. In a 2009 speech, he said the free market would liberate healthcare, driving down drug prices, improving delivery systems, and sparking innovation. This may fit into what the Trump administration said they want to do, which is “reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.” But few details on how that will be done have been offered. Trump has also vowed that he’d “bring down drug prices.”

O’Neill isn’t the only prospective pick. Former FDA bigwig Dr. Scott Gottlieb is also being considered. He was at the agency under the second Bush administration and is currently the head of the American Enterprise Institute. Gottlieb is considered a more conventional GOP pick.

To hear O’Neill speak for himself, click here: 

A landslide is imminent and so is its tsunami

An open letter predicts that a massive wall of rock is about to plunge into Barry Arm Fjord in Alaska.

Image source: Christian Zimmerman/USGS/Big Think
Surprising Science
  • A remote area visited by tourists and cruises, and home to fishing villages, is about to be visited by a devastating tsunami.
  • A wall of rock exposed by a receding glacier is about crash into the waters below.
  • Glaciers hold such areas together — and when they're gone, bad stuff can be left behind.

The Barry Glacier gives its name to Alaska's Barry Arm Fjord, and a new open letter forecasts trouble ahead.

Thanks to global warming, the glacier has been retreating, so far removing two-thirds of its support for a steep mile-long slope, or scarp, containing perhaps 500 million cubic meters of material. (Think the Hoover Dam times several hundred.) The slope has been moving slowly since 1957, but scientists say it's become an avalanche waiting to happen, maybe within the next year, and likely within 20. When it does come crashing down into the fjord, it could set in motion a frightening tsunami overwhelming the fjord's normally peaceful waters .

"It could happen anytime, but the risk just goes way up as this glacier recedes," says hydrologist Anna Liljedahl of Woods Hole, one of the signatories to the letter.

The Barry Arm Fjord

Camping on the fjord's Black Sand Beach

Image source: Matt Zimmerman

The Barry Arm Fjord is a stretch of water between the Harriman Fjord and the Port Wills Fjord, located at the northwest corner of the well-known Prince William Sound. It's a beautiful area, home to a few hundred people supporting the local fishing industry, and it's also a popular destination for tourists — its Black Sand Beach is one of Alaska's most scenic — and cruise ships.

Not Alaska’s first watery rodeo, but likely the biggest

Image source: whrc.org

There have been at least two similar events in the state's recent history, though not on such a massive scale. On July 9, 1958, an earthquake nearby caused 40 million cubic yards of rock to suddenly slide 2,000 feet down into Lituya Bay, producing a tsunami whose peak waves reportedly reached 1,720 feet in height. By the time the wall of water reached the mouth of the bay, it was still 75 feet high. At Taan Fjord in 2015, a landslide caused a tsunami that crested at 600 feet. Both of these events thankfully occurred in sparsely populated areas, so few fatalities occurred.

The Barry Arm event will be larger than either of these by far.

"This is an enormous slope — the mass that could fail weighs over a billion tonnes," said geologist Dave Petley, speaking to Earther. "The internal structure of that rock mass, which will determine whether it collapses, is very complex. At the moment we don't know enough about it to be able to forecast its future behavior."

Outside of Alaska, on the west coast of Greenland, a landslide-produced tsunami towered 300 feet high, obliterating a fishing village in its path.

What the letter predicts for Barry Arm Fjord

Moving slowly at first...

Image source: whrc.org

"The effects would be especially severe near where the landslide enters the water at the head of Barry Arm. Additionally, areas of shallow water, or low-lying land near the shore, would be in danger even further from the source. A minor failure may not produce significant impacts beyond the inner parts of the fiord, while a complete failure could be destructive throughout Barry Arm, Harriman Fiord, and parts of Port Wells. Our initial results show complex impacts further from the landslide than Barry Arm, with over 30 foot waves in some distant bays, including Whittier."

The discovery of the impeding landslide began with an observation by the sister of geologist Hig Higman of Ground Truth, an organization in Seldovia, Alaska. Artist Valisa Higman was vacationing in the area and sent her brother some photos of worrying fractures she noticed in the slope, taken while she was on a boat cruising the fjord.

Higman confirmed his sister's hunch via available satellite imagery and, digging deeper, found that between 2009 and 2015 the slope had moved 600 feet downhill, leaving a prominent scar.

Ohio State's Chunli Dai unearthed a connection between the movement and the receding of the Barry Glacier. Comparison of the Barry Arm slope with other similar areas, combined with computer modeling of the possible resulting tsunamis, led to the publication of the group's letter.

While the full group of signatories from 14 organizations and institutions has only been working on the situation for a month, the implications were immediately clear. The signers include experts from Ohio State University, the University of Southern California, and the Anchorage and Fairbanks campuses of the University of Alaska.

Once informed of the open letter's contents, the Alaska's Department of Natural Resources immediately released a warning that "an increasingly likely landslide could generate a wave with devastating effects on fishermen and recreationalists."

How do you prepare for something like this?

Image source: whrc.org

The obvious question is what can be done to prepare for the landslide and tsunami? For one thing, there's more to understand about the upcoming event, and the researchers lay out their plan in the letter:

"To inform and refine hazard mitigation efforts, we would like to pursue several lines of investigation: Detect changes in the slope that might forewarn of a landslide, better understand what could trigger a landslide, and refine tsunami model projections. By mapping the landslide and nearby terrain, both above and below sea level, we can more accurately determine the basic physical dimensions of the landslide. This can be paired with GPS and seismic measurements made over time to see how the slope responds to changes in the glacier and to events like rainstorms and earthquakes. Field and satellite data can support near-real time hazard monitoring, while computer models of landslide and tsunami scenarios can help identify specific places that are most at risk."

In the letter, the authors reached out to those living in and visiting the area, asking, "What specific questions are most important to you?" and "What could be done to reduce the danger to people who want to visit or work in Barry Arm?" They also invited locals to let them know about any changes, including even small rock-falls and landslides.

Your genetics influence how resilient you are to the cold

What makes some people more likely to shiver than others?

KIRILL KUDRYAVTSEV/AFP via Getty Images
Surprising Science

Some people just aren't bothered by the cold, no matter how low the temperature dips. And the reason for this may be in a person's genes.

Keep reading Show less

Harvard study finds perfect blend of fruits and vegetables to lower risk of death

Eating veggies is good for you. Now we can stop debating how much we should eat.

Credit: Pixabay
Surprising Science
  • A massive new study confirms that five servings of fruit and veggies a day can lower the risk of death.
  • The maximum benefit is found at two servings of fruit and three of veggies—anything more offers no extra benefit according to the researchers.
  • Not all fruits and veggies are equal. Leafy greens are better for you than starchy corn and potatoes.
Keep reading Show less
Quantcast