Monday, August 8, 2016

Monday Morning Loss of Momenta

Got off to good start last week:

"Embattled Theranos promises first-ever peek at its science — but doubts abound" by Meghana Keshavan, July 29, 2016

After more than a decade of evasion, Theranos is finally stepping into the scientific spotlight.

And that’s creating quite a stir.

Elizabeth Holmes, the turtleneck-clad CEO of the once dazzling diagnostics startup, is slated to deliver the first comprehensive rundown of the science behind Theranos’s blood tests on Monday, in front of industry professionals at the American Association for Clinical Chemistry conference in Philadelphia.

But she does not yet have any peer-reviewed data to present. And it’s not clear how much information Holmes will be able to divulge, given that the company is the subject of both a federal criminal probe and a congressional investigation. Holmes has also been banned for two years from the industry she set out to revolutionize, after federal regulators found deficiencies that posed “immediate jeopardy to patient health and safety” in a Theranos lab.

Given all that, Holmes’ very presence at the prestigious scientific conference — which draws nearly 20,000 members a year — is proving divisive.

“Would you have Al Capone come and talk about his novel accounting practices?” asked Geoff Baird, a clinical pathologist at the University of Washington. “Is it acceptable to allow someone to talk about science if they’ve used that science so horribly inappropriately?”

We have war criminal politicians and banking looters wandering around all over the place. They are often quoted in my paper.

But others are willing to listen, in part because Theranos has made notable efforts to improve its image in recent months.

The company’s been working to strengthen its scientific backbone: Four former AACC presidents joined Theranos’s board in April. And last week, the company brought on two new executives: a vice president for regulatory and quality issues and a chief compliance officer. (None of Theranos’s board members — or leadership team — were available for comment.)

“The people on her board are people I respect — and if they say [Holmes] has real science, then I am willing to listen and hear her science,” said Patricia Jones, president of the AACC.

I once was.

Jones calls herself an “eternal optimist,” hopeful that Holmes may, indeed, have substantive data to share. “We’re not endorsing her,” Jones said. “We’re just giving her an opportunity to show us what we’ve been asking her for years — to show us the science.”

Or $cience.

Among the key questions Holmes faces: Are Theranos’s woes simply due to poor lab practices? Or is the underlying technology a bust?

In March, a study published in the Journal of Clinical Investigation found that Theranos’s cholesterol tests reported abnormal results more often than rivals Quest Diagnostics and LabCorp. Theranos contested the accuracy of the study — but in May, the company voided results for blood tests run on its signature Edison device in 2014 and 2015. Theranos is now the target of at least nine class-action lawsuits from angry patients.

Launched in 2005, Theranos shot to prominence — and a $9 billion valuation — based on Holmes’s claims that its Edison machines could run an array of diagnostic tests with just a few drops of blood.

The startup attracted support from big-name investors and politicians. But Holmes never disclosed the scientific underpinnings of the technology. A series of Wall Street Journal stories cast doubt on the accuracy of the lab tests. Then federal regulators from the Centers for Medicare and Medicaid Services found flaws.

Today, the company’s worth effectively is zero.

Among AACC members, the company is “uniformly viewed as a fraud,” Baird said, and giving Holmes the plenary stage is “tremendously embarrassing.” He said the group’s private online message board has played host to a heated discussion over whether AACC should have anything to do with Theranos.

“If they presented something that was absolutely fabulous, would I change my mind?” Baird said. “I’m not actually sure that even if they came up with something like a Star Trek Tricorder device that I would care.”

See: Leaving the Nest 

He also takes exception with some of the guidelines in place for Holmes’s presentation: Audience questions are permitted, but only as they pertain to Theranos’s science. AACC has explicitly told attendees that questions about the company’s finances or regulatory concerns won’t be entertained.

Monday’s presentation is so controversial that the AACC put an unusual disclaimer on its official announcement: “Holmes’s appearance does not reflect an endorsement of Theranos or its technology by AACC, and Theranos has not provided any financial contribution to AACC in exchange for the invitation to speak, nor has it provided any sponsorship monies or other forms of grants to AACC.”

Theranos has been trying to present a more open image in recent weeks.

It's all about imagery and its illusions with thee people!

Much of that job has fallen to William Foege, a former director of the Centers for Disease Control and Prevention — and a long time advisor and board member at Theranos.

Look at that revolving door!

In an op-ed earlier this month, Foege noted that many scientists were cynical when invited to tour Theranos’s California headquarters and lab. “Initially skeptical, that group of scientists came to realize the tremendous promise of Theranos’s technologies,” he wrote. They later agreed to sign on as scientific and medical advisors.

The company has been “vilified,” Foege told Becker’s Hospital Review this week, for problems with its lab operations, and the lack of peer-reviewed publications. But “changes are being made,” he said.

A Theranos spokeswoman said the company is “in the process of preparing material to submit to publication for peer review.”

But the scientific community isn’t just waiting on publications. It’s also looking for third-party validation — and on that front, Theranos is still coming up short.

Theranos struck up an alliance with the Cleveland Clinic to validate its technology back in October of 2014. Nearly two years later, the parties still have not agreed on protocols to allow the work to proceed. “We are trying to reach an agreement to conduct a study, but that has not occurred yet,” said a clinic spokeswoman, Eileen Sheil.

The Theranos spokeswoman said the company would still like to go ahead with the study.

She also said Theranos is still hiring.


I already gave my la$t drop of blood to that devil.

"Theranos tries to quell doubts with new blood test platform" by Meghana Keshavan STAT  August 02, 2016

PHILADELPHIA — A long-awaited scientific presentation by Theranos CEO Elizabeth Holmes on Monday amounted to a plea and a promise:

Forget the past. We’ll redeem ourselves soon.

Holmes declined to provide any data about the company’s controversial Edison platform for running diagnostic tests based on the blood from a single finger prick. The company voided results for thousands of those tests earlier this year, after their accuracy came under fire.

Instead, Holmes unveiled a new device called the miniLab, which has been in development for the past five years. It’s meant to condense blood-testing technology that would normally require several large machines into a single desktop device, but Theranos did not release any data that has been validated by a third party or subjected to peer review.

They are trying to piggyback on the Zika $care.

Holmes said the company is working on letting other labs validate the new technology. So far, though, all Theranos has to offer is internal data.

And it might have trouble winning trust based on that, after the fiascos of the past two years.

The fact that it is an issue means it's already gone and not coming back.

Federal regulators have banned Holmes from the diagnostics industry for two years, after the Centers for Medicare & Medicaid Services found that Theranos’s lab practices led to “immediate jeopardy to patient health and safety.” The company is also under a federal criminal investigation for possibly misleading investors about its activities and the value of its technology.

Oh, that is what made the blood flow.

The presentation Monday at the annual American Association for Clinical Chemistry in Philadelphia was widely seen as Holmes’s last chance to regain credibility in the industry. The valuation of her company has slid to near zero, from a high of $9 billion.

That $ays it all, and is one more chance than has what I read each morning.

There was a full house for the presentation, with a long line to get in the door. The crowd watched in silence for the 45-minute talk, which included photos of the inside of the miniLab and the miniature centrifuge, “nanotainers” for blood samples, and robotics used to perform the tests. Then audience members peppered Holmes with questions, breaking into applause for particularly tough queries.

Holmes did take a minute to acknowledge the controversy swirling around Theranos, but she wouldn’t go much further than that. Instead, Holmes sought to distance the company from the blood-testing platform it had been touting for several years as a revolutionary technology.

“We know there’s a lot of questions about the past, and in the appropriate forum, we’ll address those,” she said.


Related: Sunday Globe Special: 4-F Exemption

That hit a nerve?

"Google spinoff teams with pharma giant to treat disease by zapping nerves" by Stephanie Simon, August 1, 2016

Electroceuticals have been a hot field of late — so hot that at one scientific confab, researchers jokingly added “world peace” to the list of cures the mini electrical devices should bring about.

I'm willing to give anything a shock at this point. 

So where do we hook the western war criminal scum up?

The dream is to use electrical devices, either implanted or placed on the skin, to target specific organs quite precisely, and without the side effects of drugs. Projects in the works aim to treat diseases ranging from obesity to heart failure to incontinence.

That's $eriou$ bu$ine$$.

GlaxoSmithKline has been a leader in the field, investing about $50 million in a bioelectronics fund in just the past four years. Other heavy hitters have jumped in as well, including the Pentagon, which has created an $80 million ElectRx initiative through its futuristic DARPA research arm, and the National Institutes of Health, which has dedicated nearly $250 million to a project it calls SPARC (for Stimulating Peripheral Activity to Relieve Conditions).

Wait, go back there again....

But the optimism about electroceuticals is based on a small number of studies with relatively few patients. Researchers still don’t fully understand the body’s electrical pathways, or know precisely how to manipulate those currents to treat diseases....


That get your attention

Maybe this will: 

"Despite booming markets, biotech stocks remain well below their peak" by Robert Weisman Globe Staff  August 02, 2016

The stock market is back. But not the shares of biotechs.

Biotech was long a favored sector for investors with a stomach for risky bets on companies developing breakthrough medicines. For three years running, biotech stocks massively outperformed the broader markets before peaking last summer and then sliding in earnest when the rest of the stock market dropped at the beginning of 2016 on global economic jitters.

But since then, the Standard & Poor’s 500 index, for example, has recouped its losses and was trading at an all-time high last month. By contrast, biotech stocks remain in a bear market — called the Bio-Bust, by some — and are still more than 25 percent below their peak.

“The bloom has come off the rose,” said Jim Weiss, senior portfolio manager at investment firm Segall Bryant & Hamill. “In the euphoria, the biotech valuations went to astronomical levels. But there’s a feeling that they may have gotten ahead of themselves. Biotech stocks are more risky and volatile, and there’s been a drift to less volatile, more established companies.”

Mark Williams, finance and economics professor at the Boston University School of Management, said early-stage biotechs — including some that became public companies before even launching clinical trials of their experimental compounds — were “priced for perfection.” Subsequent setbacks sent their shares plunging 50 percent or more in some cases.

Investors have become more skeptical, Williams said. “If you look at many of these biotechs, there’s no there there. You’re buying a lottery ticket with a promise.”

Good luck!

There doesn’t seem to be a consensus about why biotech stocks — buoyed by the rise of precision medicine and the revolution in genomics — have diverged in 2016 from the general market, which has recovered partly because low interest rates have left investors with few other options.

Beyond feeling they were overpriced, some market watchers think biotechs are suffering from a growing backlash against prescription drug prices, including critical statements by presidential candidates Bernie Sanders, Hillary Clinton, and Donald Trump.

While some analysts have discounted the likelihood the next president would make good on calls to rein in prices, industry executives are clearly worried the US government’s hands-off approach to drug pricing will change — possibly by empowering Medicare, the federal health insurance program for older Americans, to negotiate for lower prices.

Joe Jimenez, chief executive of Swiss drug maker Novartis AG, which bases its global research and development in Cambridge, last month told the Financial Times, “We believe that, no matter which candidate wins, we will see a more difficult pricing environment in the US.”

That, in turn, could lower the ceiling on estimated returns from biotech shares.

“If you project that the pricing environment is going to become tougher going forward, that’s going to reduce the value of future earnings” that guide the calculations of investors, said John Dorfman, founder and chairman of Dorfman Value Investments in Boston.

Dorfman said the souring on biotech may be part of a broader shift in investor sentiment toward less risky stocks, including those paying dividends. “Biotechs always did well based on the promise of future earnings,” he said. “But investors have become more conservative. They want to see the performance now, not on the horizon, and they’re less willing to wait.”

Market watchers can’t point to a single event triggering the biotech swoon. But several early warnings came last year. Biogen Inc., one of the largest US biotech companies, lost $20 billion on July 24, 2015, nearly a quarter of its market value, after posting disappointing earnings and lowering its sales forecast for its multiple sclerosis drugs.

The catalyst was the talk of a takeover and potential future control.

In September, after Clinton on Twitter bashed drug “price gouging,” the biotech index tumbled nearly 5 percent.

The wary attitude of investors hasn’t deterred the parade of biotechs going public. Of the 62 initial public offerings completed at the end of July, no fewer than 17 have been biotechs, according to data tracked by the Nasdaq stock exchange. That would suggest the sophisticated investors who buy into IPOs continue to see value in the sector.

The flood of cash helps prop up the stock market.


Also seeHow biotech executives profit from legal insider trades

I think it is the ‘price gouging bothers me most. 

"NIH considering restarting funding for human-animal chimera research" by Andrew Joseph, August 4, 2016

Federal health officials said Thursday they are reconsidering a moratorium on the funding of research in which human tissues are transplanted into early, nonhuman embryos — creating organisms known as chimeras.

That sounds spooky and looks even spookier. 

The mate for the hound of hell?

The proposed rule changes, which the National Institutes of Health announced in a blog post, would allow the agency to pay for experiments that incorporate human tissue into early-stage animal embryos, except for those of primates like monkeys and chimps.

Was was that movie they made.... ?? 

I don't want my money going to some mad $cienti$ts!

The NIH put a moratorium on funding early-stage embryonic chimeras in September because of ethical concerns. Some bioethicists raised concerns that animals with human brain tissue might absorb some ability to think like people. Others were concerned about what would happen if human-animal chimeras were allowed to breed.

Just brush those aside!

“I am confident that these proposed changes will enable the NIH research community to move this promising area of science forward in a responsible manner,” Carrie Wolinetz, the NIH’s associate director for science policy, wrote in the blog post.

Yeah, this government has a great record when it comes to unintended consequences. 

Since September’s moratorium, scientists have accused the NIH of stifling science with a draconian and rash decision, arguing it was preventing a deeper understanding of how embryos develop and how cells, tissues, and organs could be used to treat disease — a burgeoning field known as regenerative medicine. Scientists argue that steps can be taken to address the ethical concerns inherent in conducting chimera research.

In the blog post, Wolinetz said the NIH was creating a steering committee that would advise NIH officials on funding decisions regarding early embryonic human-animal chimeras.

Human-mouse chimeras have been used in studies for decades, but as scientists started transplanting brain tissue in more recent years, the ethical issues were kicked up a notch. Such research could provide new insights into conditions like Alzheimer’s and schizophrenia, but some people were left uneasy with the idea that a mouse could gain human cognition.


Wolinetz said the steering committee would act as an “extra set of eyes” as it advises the agency that will make a decision whether to fund research projects.

Oh, that makes me feel a whole pile of relief regarding this.

As for the pushback the agency got from some scientists, Wolinetz said it reflected an “understandable impatience.” Researchers in the field are eager to move ahead with their work, and the uncertainty around how long the moratorium would last caused some anxiety.

“This is a really exciting and promising area of research,” she said....


That's when I started to lose it:

"Momenta Pharmaceuticals Inc. said Thursday it halted a clinical trial of a pancreatic cancer drug after an independent panel concluded the experimental therapy wasn’t effective enough to justify continuing the study."

“Emotionally, this is a difficult one.”

Long-term care insurance rates soaring

Health files make for a juicy target for thieves

Tell them to contact the IRS!

Delta warns of ‘large-scale cancellations’

What do Boston colleges pay for city services?

I'm sure they took up a good collection, God willing.

Teen who posted weaponized drone videos fights expulsion

It just fell out of the sky before crashing into a mountain, and it was just a matter of time.

Sorry I no longer have the heart for this and don't want to talk about it anymore. 

I've just lost interest and it's getting late:

"The supervillain romp ‘‘Suicide Squad’’ shrugged off scathing reviews to open with an estimated $135.1 million in North American ticket sales, scoring one of the year’s biggest box-office debuts. Not everything was roses for ‘‘Suicide Squad,’’ though. (The other new wide release, the animated release ‘‘Nine Lives,’’ debuted in sixth with a mere $6.5 million.) After fans flocked to theaters Thursday night and Friday, audiences dropped steeply on Saturday. That could forecast further sharp declines for the $175 million film. The top five for the weekend box office was otherwise filled with holdovers: The Matt Damon spy sequel ‘‘Jason Bourne’’ grossed $22.7 million in its second weekend to finish second. ‘‘Bad Moms’’ was third with $14.2 million in its second week. “The Secret Life of Pets” ($11.5 million) and “Star Trek Beyond” ($10.2 million) were fourth and fifth." 

According to netflix, Bourne brought in less than half it's opening week. Must have been the speech he gave at convention

RelatedJason Bourne, the un-James Bond

Not even co-star Megan Hilty could help him. 

The appearance of the butterflies means the drought is over, and has this summer ever stunk.

Swimmer Michael Phelps is a man remade

Pretty good job of plastic surgery, wouldn't you say

Speaking of surgery, I've been going at it going at it pretty hard lately and am coming to a full stop for the day. 

Maybe I can get rolling again tomorrow.


Pharma should not be allowed a loophole for reporting financial ties to docs

Then we'll see you in court!

"A patent infringement lawsuit highlights a strategy designed to indefinitely delay the arrival of a lower-cost biosimilar indefinitely while the litigation plays out."

Next iPhones likely putting the focus on photography

NBC buys rights to ‘Harry Potter,’ ‘Fantastic Beasts’ franchises

Should Matt Damon be cast in an action film about ancient China?

The villains, of course, would be the Russians and maybe I won't get rolling after all.

Also see:

Biosimilar names may affect pharmacist dispensing habits

Vertex ends trial of cystic fibrosis drug combination