Tag Archives: Theranos

Walgreens (US-based pharmacy), As You Sow (civil society), and engineered hydroxyapatite (HA) nanoparticles

As You Sow has graced this blog before, notably in a March 13, 2015 posting about their success getting the corporate giant, Dunkin’ Donuts, to stop its practice of making powdered sugar whiter by adding nanoscale (and other scales) of titanium dioxide. What’s notable about As You Sow is that it files shareholder resolutions (in other words, the society owns shares of their corporate target) as one of its protest tactics.

This time, As You Sow has focused on Walgreens, a US pharmacy giant. This company has chosen a response that differs from Dunkin’ Donuts’ according to a Sept. 21, 2016 news item on Nanotechnology Now,

Rather than respond to shareholder concerns that Walgreens’ store-brand infant formula may contain harmful, “needle-like” nanomaterials, Walgreens filed a motion with the SEC [US Securities and Regulatory Commission] to block the inquiry.

A Sept. 21, 2016 As You Sow press release, which originated the news item, fills in a few details,

Walgreen’s Well Beginnings™ Advantage® infant formula has been reported to contain engineered hydroxyapatite (HA) nanoparticles, according to independent laboratory testing commissioned by nonprofit group Friends of the Earth. The E.U. Scientific Committee on Consumer Safety (SCCS) has determined that nano-HA may be toxic to humans and that the needle-form of nano-HA should not be used in products.

Walgreens’ “no-action letter” to the SEC argues that the company can exclude the shareholder proposal because “the use of nanomaterials in products … does not involve a significant social policy issue.” The company also claims its infant formula does not contain engineered nanomaterials, contrary to the independent laboratory testing.

“Walgreens is effectively silencing shareholder discussion of this subject,” said Austin Wilson, Environmental Health Program Manager of shareholder advocacy group As You Sow. “If Walgreens had responded to consumers’ and investors’ concerns, there would be no need for shareholders to file a proposal.”

“Shareholders will ultimately bear the burden of litigation if infants are harmed,” said Danielle Fugere, President and Chief Counsel of As You Sow. “Walgreens’ attempt to silence, rather than address, shareholder concerns raises red flags. To be successful, Walgreens must remain a trusted name for consumers and it can’t do that by sweeping new health studies under the rug.”

Nanoparticles are extremely small particles that can permeate cell membranes and travel throughout the body, including into organs, in ways that larger ingredients cannot. The extremely small size of nanoparticles may result in greater toxicity for human health and the environment.

The shareholder proposal asks the company to issue a report about actions the company is taking to reduce or eliminate the risk of nanoparticles.

In 2014, Dunkin’ Donuts reached an agreement with As You Sow to remove the nanoparticle titanium dioxide from its donuts. Starbucks plans to remove it from all products by 2017, and Krispy Kreme is reformulating its products to exclude titanium dioxide and other nanoparticles.

To seemingly dismiss concerns about their brand infant formula appears to be an odd tactic for Walgreens. After all this is infant safety and it’s the kind of thing that makes people very, very angry. On the other hand, Friends of the Earth has not always been scrupulous in its presentation of ‘facts’ (see my Feb. 9, 2012 posting).

2016 hasn’t been a good year for Walgreens. In June they ended their high profile partnership with blood testing startup, Theranos. From a June 13, 2016 article by Abigail Tracy for Vanity Fair,

After months of getting pummeled at the hands of regulators and the media over its questionable blood-testing technology, Theranos may have just been dealt its final blow. Walgreens, the main source of Theranos’s customers, has officially ended its partnership with the embattled biotech company, cutting off a critical revenue stream for founder Elizabeth Holmes’s once-promising start-up.

In a statement issued Sunday [June 12, 2016], the drugstore chain announced that it was terminating its nearly three-year-long relationship with the once $9 billion company and would immediately close all 40 Theranos-testing locations in its Arizona stores, The Wall Street Journal reports. Like so many in Silicon Valley, Walgreens fell victim to Holmes’s claims that Theranos’s technology, and its proprietary diagnostic product, Edison, would revolutionize blood testing and put its rivals, Laboratory Corporation of America and Quest Diagnostics, out of business. When it inked its deal with Holmes in 2013, Walgreens failed to properly vet the Edison technology, which was billed as being capable of conducting hundreds of diagnostics tests with just a few drops of blood.

You can read more about the Theranos situation in Tracy’s June 13, 2016 article and I have some details in a Sept. 2, 2016 posting where I feature the scandal and the proposed movie about Theranos (and other ‘science’ movies).

Getting back to Walgreens, you can find the As You Sow resolution here.

Movies and science, science, science (Part 2 of 2)

Part 1 concerned the soon-to-be-released movie, Hidden Figures and a film which has yet to start production, Photograph 51 (about Rosalind Franklin and the discovery of the double helix structure DNA [deoxyribonucleic acid]). Now for Part 2:

A matter of blood, Theranos, and Elizabeth Holmes

A few months ago, a friend asked me if I’d heard of Theranos. Given that I have featured various kinds of cutting edge diagnostic tests here, it was a fair enough question. Some  of my first questions to her were about the science. My friend had read about the situation in The Economist where the focus of the story (which I later read) was about venture capital. I got back to my friend and said that if they hadn’t published any scientific papers, I most likely would not have stumbled across them. Since then I’ve heard much more about Theranos but it seems there’s not much scientific information to be had from the company.

Reportedly, US film star Jennifer Lawrence is set to star, from a June 10, 2016 posting by Lainey (at Lainey Gossip; Note: A link has been removed),

Deadline reported yesterday [June 9, 2016] that Jennifer Lawrence will star in Adam McKay’s upcoming film about Elizabeth Holmes and Theranos. Elizabeth Holmes was basically the Jennifer Lawrence of Silicon Valley after inventing what she claimed to be a revolutionary blood testing system. Instead of submitting full vials of blood for limited testing, her product promised more efficiency and quicker results with just a pinprick. You can imagine how that would change the health care industry.

Last year, The Wall Street Journal investigated the viability of Theranos’s business plan, exposing major problems in the company’s infrastructure. Elizabeth Holmes went from being called the world’s youngest self-made female billionaire, the millennial in a turtleneck, to a possible fraud. It’s a fascinating story. …

In a July 16, 2016 article The Economist provides an update to the evolving Theranos/Holmes story,

FIRST they think you’re crazy, then they fight you, and then all of the sudden you change the world,” said Elizabeth Holmes as troubles mounted for her blood-testing startup, Theranos, last year. Things look ever less likely to go beyond the fighting stage.

On July 7th [2016] a government regulator, the Centres for Medicare and Medicaid Services, said Ms Holmes would be barred from owning or running a laboratory for two years. It will also revoke her company’s licence to operate one of two laboratories where it conducts tests. As The Economist went to press the firm was due to reply to a letter from Congress, which asked how, exactly, Theranos is going to handle the tens of thousands of patients who were given incorrect test results. Even so, Ms Holmes looks set to remain in position even as the situation deteriorates around a firm that once commanded a multi-billion-dollar valuation.

These may be some of the last twists in a story which will be turned into a Hollywood film by the director of “The Big Short”.

For anyone wondering how a movie could be made when the story has come to any kind of resolution, there’s this from a June 24, 2016 posting by David Bruggeman for his Pasco Phronesis blog (Note: Links have been removed),

Since last I wrote about a possible film about the medical device/testing company Theranos, a studio has successfully bid on the project.  Legendary Studios won an auction on the film rights, beating out 9 other offers on the project, which has Jennifer Lawrence attached to star as Theranos CEO Elizabeth Holmes.  Adam McKay would write the script and direct the project, duplicating his roles on the Oscar-nominated film The Big Short.  The film now has a preliminary title of Bad Blood.  It is certainly too early to tell if the Taylor Swift song of the same name will be used in the movie.

While getting a studio offer is important to the film getting produced, what is perhaps as interesting to our readers is that a book is connected to the film deal.  Two-time Pulitzer-prize winning writer John Carreyrou, who has written extensively on Theranos in The Wall Street Journal, will be writing a book that (presumably) serves as the basis for the script.  This follows the development arc for The Big Short, for which McKay shares an Adapted Screenplay Oscar (in addition to his nomination for directing the film)

So, are they going to wait until Holmes is either finally vindicated or vilified before going to film? Meanwhile, Holmes continues in a quest to save her company (from an Aug. 1, 2016 article for Fast Company by Christina Farr titled: Scientists Wanted Transparency From Theranos, But Got A Product Launch Instead (Note: A link has been removed),

Theranos once promised to revolutionize the blood testing industry. But its methodology remains secretive, despite calls for transparency from the scientific community. Now, it is facing federal investigations, private litigation, voided tests, and its CEO, Elizabeth Holmes, is banned from operating a lab for two years.

But all that was entirely glossed over today at the company’s much-awaited first presentation to the scientific community at the American Association for Clinical Chemistry’s conference in Philadelphia.

In an hour-long presentation (you can review the slides here), Holmes failed to discuss the fate of the company’s proprietary blood-testing technology, Edison, or address any of the controversy. Instead, she skipped right to pitching a new product, dubbed the MiniLab.

In fairness to Theranos, this was a positive step as the company did provide some internal data to show that the company could perform a small number of tests. But despite that, many took to social media to protest its failure to address and acknowledge its shortcomings before moving on to a new product.

“Clearly, the scientific and medical community was hoping for a data-driven discussion today, and instead got a new product announcement,” says John Torous, a psychiatrist and clinical informatics fellow at Harvard Medical School.

In an emailed response to Fast Company, a Theranos company spokesperson did not say whether components of Edison would be used in the miniLAB, but instead stressed that it’s one early iteration of the technology. “The miniLab is the latest iteration of the company’s testing platform and an evolution of Theranos’ technology,” they said.

Farr describes the MiniLab and notes that it is entering a competitive market,

The new product, the MiniLab, essentially takes equipment used in a standard lab and puts it in a single box. Holmes refers to this technique as “decentralizing the lab,” as in theory, clinicians could use this as an alternative to sending samples to a centralized facility and awaiting results. “Think of it as being a huge diagnostics lab that has been condensed down to the size of a microwave,” the company’s website explains.

..

But scientists are questioning whether the MiniLab technology is a breakthrough. The current market is already fairly saturated: Abbott’s iStat system, for instance, is a handheld device for clinicians to test patients for a plethora of common tests. Roche just received FDA [US Food and Drug Administration] clearance for its Cobas device, which can test for ailments like the flu and some strep infections in under 20 minutes. And Theranos competitors Quest and Labcorp already operate versions of this type of equipment in their own labs.

“I can’t imagine why they’re wasting their time,” says MIT-trained material scientist and biotech entrepreneur Kaveh Milaninia by phone. …

I recommend reading Farr’s article in its entirety as she provides more detail and analysis as to just how competitive the market Theranos proposes entering with its MiniLab actually is.

An Aug. 31, 2016 article by Lydia Ramsey for Slate.com the most recent update on the Theranos situation,

Theranos is withdrawing its bid for FDA approval of a diagnostic test for Zika that they announced earlier in August, according to a story in the Wall Street Journal.

Theranos confirmed to Business Insider that the test has been withdrawn, but said the company has plans to resubmit it.

John Carreyrou and Christopher Weaver report that an FDA inspection found that, as part of a study to validate the new test, the company had collected some data without a patient safety plan in place that was approved by an institutional review board.

“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency. We are confident in the Zika tests and will resubmit it,” Theranos vice president of regulatory and quality Dave Wurtz said in a statement emailed to Business Insider. Wurtz joined the company in July [2016].

Getting back to the point of my story at the beginning of this piece, it seems that Theranos and Elizabeth Holmes have not been as forthcoming with scientific data as is common in the biotech field. Interestingly, I read somewhere that the top 10 venture capitalists in the biotech field had not invested a penny in Theranos. The money had come from venture capitalists expert in other fields. (If you can confirm or know differently, please let me know in the comments section.)

In its favour, the company does appear to be attempting to address its shortcomings.

*ETA Oct. 6, 2016: Theranos is closing down some of its labs according to an Oct. 6, 2016 news item on phys.org,

Theranos, a onetime star Silicon Valley startup focused on health technology, is closing its consumer blood-testing facilities amid its struggles with US regulators.

The company, which has been seeking to disrupt the medical testing sector with new technology, said the closings will mean cutting some 340 jobs.

“After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission,” company founder Elizabeth Holmes said in an open letter.

Theranos, which touts a new way of testing that uses far less blood and delivers faster results at much lower cost than traditional methods in US labs, has been under civil and criminal investigation over its claims.

Holmes said the company would focus on a so-called miniLab which can be commercialized with partners.

Things don’t look good.*

In any event, all these goings on should make for an interesting script writing challenge.

Bits and bobs of science and movies (The Man Who Knew Infinity, Ghostbusters, and Imagine Science Films)

The Man Who Knew Infinity had its debut at the 2015 Toronto International Film Festival. I haven’t seen it at any movie houses here (Vancouver, Canada) yet but a film trailer featuring its star, Dev Patel, was released in Feb. 2016,

Ramanujan must have been quite the mathematician, given the tenor of the times. Here’s more about the movie from its Wikipedia entry (Note: Links have been removed),

The Man Who Knew Infinity is a 2015 British biographical drama film based on the 1991 book of the same name by Robert Kanigel. The film stars Dev Patel as the real-life Srinivasa Ramanujan, a mathematician who after growing up poor in Madras, India, earns admittance to Cambridge University during World War I, where he becomes a pioneer in mathematical theories with the guidance of his professor, G. H. Hardy (played by Jeremy Irons despite Hardy being only 10 years older than Ramanujan).

Filming began in August 2014 at Trinity College, Cambridge.[4] The film had its world premiere as a gala presentation at the 2015 Toronto International Film Festival,[1][5] and was selected as the opening gala of the 2015 Zurich Film Festival.[6] It also played other film festivals including Singapore International Film Festival[7] and Dubai International Film Festival.[8]

Distinguished mathematicians Manjul Bhargava and Ken Ono are Associate Producers of the film.[9] Ono, the mathematics consultant, is a Guggenheim Fellow, and Bhargava is a winner of the Fields Medal.

Next up, Ghostbusters, the all woman edition. While it hasn’t become the blockbuster some were hoping for, I have some hope that it will become a quiet blockbuster over time. As I wait there is this information about how Ghostbuster: The All Woman Edition was grounded in real science. From a July 18, 2016 news item on phys.org,

Janet Conrad and Lindley Winslow, colleagues in the MIT [Massachusetts Institute of Technology] Department of Physics and researchers in MIT’s Lab for Nuclear Science, were key consultants for the all-female reboot of the classic 1984 supernatural comedy that is opening in theaters today. And the creative side of the STEM fields—science, technology, engineering, and mathematics—will be on full display.

A July 16, 2016 MIT news release, which originated the news item expands on the theme (Note: Links have been removed),

Kristin Wiig’s character, Erin Gilbert, a no-nonsense physicist at Columbia University, is all the more convincing because of Conrad’s toys. Her office features demos and other actual trappings from Conrad’s workspace: books, posters, and scientific models. She even created detailed academic papers and grant applications for use as desk props.

“I loved the original ‘Ghostbusters,’” says Conrad. “And I thought the switch to four women, the girl-power concept, was a great way to change it up for the reboot. Plus I love all of the stuff in my office. I was happy to have my books become stars.”

Conrad developed an affection for MIT while absorbing another piece of pop culture: “Doonesbury.” She remembers one cartoon strip featuring a girl doing Psets. She is discouraged until a robot comes to her door and beeps. All is right with the world again. The exchange made an impression. “Only at MIT do robots come by your door to cheer you up,” she thought.

Like her colleague, Winslow describes mainstream role models as powerful, particularly when fantasy elements in film and television enhance their childhood appeal. She, too, loved “Ghostbusters” as a kid. “I watched the original many times,” she recalls. “And my sister had a stuffed Slimer.”

Winslow jokes that she “probably put in too much time” helping with the remake. Indeed, Wired magazine recently detailed that: “In one scene in the movie, Wiig’s Gilbert stands in front of a lecture hall, speaking on challenges of reconciling quantum mechanics with Einstein’s gravity. On the whiteboards, behind her, a series of equations tells the same story: a self-contained narrative, written by Winslow and later transcribed on set, illustrating the failure of a once-promising physics theory called SU(5).”

Movie reviewers have been floored by the level of set detail. Also deserving of serious credit is James Maxwell, a postdoc at the Lab for Nuclear Science during the period he worked on “Ghostbusters.” He is now a staff scientist at Thomas Jefferson National Accelerator Facility in Newport News, Virginia.

Maxwell crafted realistic schematics of how proton packs, ghost traps, and other paranormal equipment might work. “I recalled myself as a kid, poring over the technical schematics of X-wings and Star Destroyers. I wanted to be sure that boys and especially girls of today could pore over my schematics, plug the components into Wikipedia, and find out about real tools that experimental physicists use to study the workings of the universe.”

He too hopes this behind-the-scenes MIT link with a Hollywood blockbuster will get people thinking. “I hope that it shows a little bit of the giddy side of science and of MIT; the laughs that can come with a spectacular experimental failure or an unexpected break-through.”

The movie depicts the worlds of science and engineering, as drawn from MIT, with remarkable conviction, says Maxwell. “So much of the feel of the movie, and to a great degree the personalities of the characters, is conveyed by the props,” he says.

Kate McKinnon’s character, Jillian Holtzmann, an eccentric engineer, is nearly inseparable from, as Maxwell says, “a mess of wires and magnets and lasers” — a pile of equipment replicated from his MIT lab. When she talks proton packs, her lines are drawn from his work.

Keep an eye out for treasures hidden in the props. For instance, Wiig’s character is the recipient of the Maria Goeppert Mayer “MGM Award” from the American Physical Society, which hangs on her office wall. Conrad and Winslow say the honor holds a special place in their hearts.

“We both think MGM was inspirational. She did amazing things at a time when it was tough for women to do anything in physics,” says Conrad. “She is one of our favorite women in physics,” adds Winslow. Clearly, some of the film’s props and scientific details reflect their personal predilections but Hollywood — and the nation — is also getting a real taste of MIT.

Finally and strictly speaking not a movie but it is an online magazine about science-based movies according to David Bruggeman’s Aug. 6, 2016 posting on his Pasco Phronesis blog (Note: Links have been removed),

LaboCine is an online film magazine from the people behind Imagine Science Films.  The films in each issue come from artists and scientists from around the world.  They are not restricted to documentary films, and mix live-action, animated and computer film styles.

The first issue of LaboCine is now online, so you can view the short films, which are organized around a common theme.  For August the theme is Model Organisms. …

You find the LaboCine magazine here and Imagine Science Films here. Btw, Raewyn Turner (NZ artist) has submitted our filmpoem, Steep (1) : A digital poetry of gold nanoparticles to the 9th Imagine Science Festival to be held Oct. 14-21, 2016 in New York City.

And that is it!

Here’s Part 1 for those who missed it.