Facebook’s FTC settlement doesn’t protect privacy of users’ health information

On the surface, Facebook’s recent settlement with the Federal Trade Commission says a lot about privacy. But if you use Facebook to share information about health, be warned: The settlement does not include health information as part of its carefully defined “Covered Information,” and releases the company from liability for mistakes it made with patient data.

For patient groups that have submitted complaints about Facebook privacy issues, this adds insult to injury.

The FTC first sued Facebook in 2011, alleging that the company misled consumers about its privacy practices. The resulting FTC ruling, finalized in 2012, required Facebook to obtain consumers’ express consent before sharing their information with third parties, along with other requirements intended to reinforce consumer privacy protections. In 2018, in the wake of the Facebook-Cambridge Analytica breach, the FTC began investigating Facebook again for alleged violations of the 2012 ruling. Last week, the FTC settled that investigation with a $5 billion fine against Facebook and an order intended to establish stricter privacy policies surrounding the company’s handling of sensitive “Covered Information.”

In the settlement, “Covered Information” includes 14 types of protected information, such as name, street address, telephone number, date of birth, and Social Security number. These share a remarkable degree of overlap with the “Protected Health Information” defined in the HIPAA Privacy Rule (2002) to protect patients’ health data, with one key exception: “Health information” is conspicuously absent from the Facebook-FTC settlement. Health data is mentioned just twice in the supporting role of an example (once in the settlement order and once in the Department of Justice complaint). This omission leaves patient groups on Facebook vulnerable to ongoing surveillance and privacy violations by the company.

That’s a problem because Facebook’s interest in moving into the digital health market is no secret. While some patient groups formed organically on the site, many others were strategically cultivated through the company’s marketing strategies. As recently as the 2018 Facebook Developer Conference, Mark Zuckerberg described the Groups feature as a place to connect with others about “a disease you might have.”

Facebook actively promoted this feature through public statements by company leadership on the value of groups for managing opioid abuse, caring for transgender children, drug and alcohol addiction, and more. Patient groups have found these online communities to be powerful resources, but now feel trapped: They fear giving up the support and information they are able to exchange on Facebook but know they are being exploited as they do it.

The new FTC-mandated oversight does not prevent Facebook from collecting health information — it only requires the company to report what it plans to do with the information. There is no enforcement mechanism to prevent Facebook from gathering personal health information or even releasing it.

In theory, the added oversight could mean greater protections for health groups — but only if the company’s board of directors collectively decides to prohibit the company’s collection and monetization of users’ health data. As a dissenting statement from FTC Commissioner Rohit Chopra noted, the proposed settlement “imposes no meaningful changes to the company’s structure or financial incentives,” which led to the privacy violations in the first place.

The special case of patient groups and privacy on Facebook had been brought to the FTC’s attention in December 2018, when one of us (F.T.), health privacy lawyer David Harlow, and patient moderators of several Facebook groups submitted a complaintabout privacy breaches in Facebook’s health groups. The complaint alleged that Facebook deceptively solicited patients to use groups to share personal information about their health issues and then marketed the resulting health data goldmine, exposing highly sensitive information to third-party data brokers. The complaint also provided detailed documentation of the privacy loophole that allowed third-party scraping of user data from closed cancer patient groups on Facebook.

The FTC apparently ignored this complaint; it is not referenced anywhere in last week’s ruling.

The new settlement says little about how Facebook will protect the privacy of health-related groups on the site, though the company’s role in collecting health information was acknowledged in two statements. In the Department of Justice’s complaint against Facebook, filed on behalf of the FTC, “membership in health-related and other support groups” was listed as an example of the types of personal information that are shared by users on Facebook. In the FTC’s 20-year settlement order, “health” was listed alongside “financial, biometric, or other similarly sensitive information” as an example of information that, when collected by Facebook, “presents a material risk to the privacy, confidentiality, or Integrity of the Covered Information,” and will therefore be subject to additional review under the new terms.

The FTC seems aware that Facebook continues to invest in health care data, but provides no special rules for how these data should be handled, the way the FTC specified for passwords, facial recognition, and telephone number data.

Like the problems with Facebook’s API and “Apps,” that have been documented in relation to the Cambridge Analytica breach, the heart of the problem with groups is that they allow one Facebook user to make decisions about privacy for other users. For example, a group administrator can install third-party apps to access posts and comments without the other participants’ knowledge. In addition, the complaint documented a security vulnerability that allowed any Facebook user to download the membership lists of closed Facebook groups, including patient groups on sensitive topics who were attempting to protect their privacy through strict inclusion requirements. And under a previous loophole that has now been closed, a user who was not a group administrator could add other users to a group without their permission.

Before filing their complaint with the FTC in December, Trotter, Harlow, and the patient groups voiced their concerns directly to Facebook in an email. The administrator who responded told the group there was no problem and that the system, in Facebook’s view, “worked as intended.” When the group brought its concerns to the FTC, it was told that the FTC could not provide any information about its enforcement activities until the investigation was complete.

The investigation is now complete, and the FTC-Facebook settlement “resolves all consumer-protection claims known by the FTC prior to June 12, 2019” — including the December 2018 complaint stemming from the patient groups. In other words, despite the FTC’s failure to address health data in its ruling, Facebook has been released from liability for those known breaches.

In another dissenting statement, FTC Commissioner Kelly Slaughter noted the gravity of this failure and expressed her skepticism that the terms of the settlement would result in meaningful changes to Facebook’s approach to data and privacy. “I cannot view the order as adequately deterrent without both meaningful limitations on how Facebook collects, uses, and shares data and public transparency regarding Facebook’s data use and order compliance,” she wrote, concluding that her “deepest concern with this order is that its release of Facebook and its officers from legal liability is far too broad.”

It is difficult to see Facebook’s settlement with the FTC as providing any new protection to the privacy of patient groups on the site. Instead, despite detailed documentation of previous and ongoing security breaches, Facebook refused to acknowledge the problem and the FTC ignored patients’ complaints.

Patients do, however, hold some power here. Since patient groups represent Facebook’s primary source of high-value health data, it may be time for a mass migration off the platform. Until tech companies and federal regulators can provide genuine, transparent protections and give patients the voice they deserve in setting privacy policies, sites like Facebook don’t deserve to hear patient voices at all.

Facebook’s FTC settlement doesn’t protect privacy of users’ health information

Almost everything you need to know about importing drugs from Canada

President Trump’s new plan to import cheaper drugs from Canada seems like a no-brainer. But like most things in health care, it’s complicated.

The logic is simple enough: Canadians buy the same drugs, made by the same manufacturers, but they get them at a much cheaper cost. So, says Trump, let’s take their drugs.

It’s also wildly popular: 80% of Americans said in a recent survey they support importing prescription drugs, making the idea one of the most well-liked drug pricing proposals currently being considered in Washington.

But the questions abound: Can Trump do this under existing law? Can Canada keep up with American demand? And can Trump get such an ambitious plan across the finish line before the 2020 election?

And then there’s the biggest concern of all: Is the Trump administration opening Americans up to dangerous, even deadly, counterfeit drugs?

Below STAT walks through everything you need to know about President Trump’s drug pricing plan, and how it’s likely to impact your budget.

What drugs will be imported?

Not the most expensive ones, quite frankly. Existing law prevents the importation of biologic drugs, which are new, high-tech drugs made from living organisms and which often carry seven- or eight-figure price tags. Insulin, too, which costs roughly 10 times more in the U.S. than it does in Canada, couldn’t be imported under the main part of the new plan.

Under a separate part of the plan, drug makers could bring in cheaper, foreign versions of their own drugs — including biologics and insulin — but they’d have to do that voluntarily — meaning, it wouldn’t be up to the state or a pharmacy. And it isn’t clear that there’s much of an incentive for drug makers to use this pathway.

So will this plan actually save me money?

Assuming you’re in a state that participates, yes. Most drugs are cheaper in Canada than in the U.S. For example, the high cholesterol medicine Crestor costs roughly $40 for a month’s supply in Canada, versus nearly $300 in the U.S.

The Congressional Budget Office estimated a similar proposal from Sen. Bernie Sanders (I-Vt.) would save the government roughly $7 billion over 10 years.

Who can import drugs under Trump’s plan?

Pharmacies, wholesalers, and states could all import drugs under the plan, so long as they meet the Trump administration’s requirements, such as having the ability to track drugs throughout the supply chain, and reporting any patient adverse events. Drug makers, too, could bring in versions of their drugs made in international factories.

The new proposal says nothing about patients importing drugs themselves, either by crossing the border, buying drugs online, or using one of the many storefront shops around the country that help customers import drugs. Personal importation, as it’s often called, is technically illegal, but there are exceptions. For example, consumers can import a drug that treats a serious condition but isn’t sold in the U.S.

When will the drugs from Canada start rolling in?

A long time from now. Trump is proposing a regulatory proposal to start a pilot program. In plain English, that means the administration needs to issue a proposed regulation, give the public at least a month or more to comment formally on it, and then finalize the regulation. Only after all that will it start reviewing proposals for states that want to try importing — as long as states and others have started to submit them by then.

Health and Human Services declined to provide a specific timeline for implementation. “The FDA remains committed to advancing these policies as quickly as possible,” an HHS spokesperson wrote in a statement. “We expect to have additional announcements in the coming months.”

And the states, too, have to take the time to write their proposals. The first state to express interest in importing drugs, Vermont, has been working on its proposal for more than a year, and has blown through its previous pledge to submit a plan to the federal government by July 1, 2019. Florida, which recently passed a law directing the state government to come up with an importation plan, is planning to submit its own by July 2020.

This all means that it’s unlikely any importation plans will be ready before the 2020 election. If Trump loses, that’ll throw an even bigger wrench in the project.

Are there actually enough drugs in Canada for U.S. patients?

No. The Canadian drug market is much smaller than the U.S. market, and if Americans start buying Canadian drugs, it’ll cause serious supply issues for both countries. A 2018 study found that if 20% of U.S. prescriptions were filled in Canada, our neighbor to the north would see its drug supply depleted in roughly 200 days. Even proponents of drug importation have said the U.S. shouldn’t depend on Canada alone, and have called for importation from a number of European Union countries, as well as Japan.

Supply issues are such a concern that Canadian officials, reportedly, have already begun readying their talking points against the proposal. In a written statement, the Canadian ministry of health said it looks forward to discussing the proposal with the Trump administration, although it emphasized its concerns with supply issues.

“Ensuring that Canadians have access to the medicines they need is one of our top priorities: we constantly monitor Canada’s drug supply, will be working closely with health experts to better understand the implications for Canadians and will ensure there are no adverse effects to the supply or cost of prescription drugs in Canada,” the ministry wrote.

Health secretary Alex Azar has yet to acknowledge that fact, however. When asked about Canada’s concerns, he told reporters it was up to the states and pharmacies to make their plans work.

Is this safe?

This is the most contentious question you can ask. Drug makers, and nearly every FDA commissioner in recent history, have insisted that drug importation simply can’t be done safely. Even Azar once opposed the idea.

Skeptics point out that drug counterfeiting is a huge criminal enterprise, and that counterfeiters can trick even the most sophisticated expert. They also point to a few high-profile examples of imported drugs causing serious harm — chief among them, a string of deaths in 2008 from counterfeit versions of the blood clot drug Heparin.

Proponents, however, insist that these sorts of issues are remedied when drugs are imported carefully.

Azar is now insisting that new technology has made safe to import drugs. On a call with reporters, he defended his about-face on the issue. He cited the increasing globalization of drug distributors and pharmacies and the implementation of a 2013 law requiring the FDA to stand up a tracking system for drugs. He said those are  examples of “a real maturation and development of the supply chain,” which, he argues, now makes importation safe.

Who supports the idea? Who opposes it?

Pharmaceutical companies are the most vocal skeptics of the idea. Both of the top trade associations representing drug companies, PhRMA and BIO, almost immediately fired off statements opposing the new plan. (BIO CEO Jim Greenwood even called the plan “a misguided attempt to keep an ill-informed campaign promise.”)

The loudest proponents of importation include seniors groups like AARP. Drug pricing advocacy groups like Patients for Affordable Drugs and Families USA also support the idea of importing drugs.

The American Medical Association, the nation’s top doctors group, has said it supports in-person importation, but has opposed importation over the internet. (The AMA has not yet weighed in specifically on Trump’s proposal.)

On Capitol Hill, the idea has most loudly been championed by Democrats. Sanders has introduced a number of bills on the topic over the decades and has made it a pillar of his presidential campaign. He also recently led a pilgrimage to Canada to buy cheaper insulin. Some Republicans too, support the idea: The Senate’s most senior Republican, Sen. Chuck Grassley (R-Iowa) has backed it, as did the late Sen. John McCain of Arizona.

Everything (or almost everything) you need to know about importing drugs from Canada

Hospital lets employees swap unused paid time off to help pay student loans

Medical professionals are often saddled with student loan debt that they struggle to pay off, but a not-for-profit community hospital in New York state has come up with a way to help.

Montefiore St. Luke’s Cornwall, which has hospital campuses in Newburgh and Cornwall in the Hudson Valley, is offering a new benefit to its employees to help them pay down their student loan debt.

Eligible employees will be able to convert unused paid time off (PTO) into an employer contribution of up to $5,000 per year to help pay off those student loans, the hospital said in an announcement.

Montefiore is one of the first hospitals in the country to offer such a plan, which is being administered by Tuition.io, a student loan repayment platform that has worked with companies of all sizes, including Live Nation, HP, Estee Lauder Companies, Staples and others.

Under Montefiore’s Student Loan Repayment Program, full-time and part-time employees can transfer their unused PTO—vacation days, sick days and personal time—to the repayment of their student debt, including federal and Parent PLUS loans. Eligible employees will be able to convert 30 to 75 hours of unused PTO into payment against student debt, which will be distributed semi-annually with a maximum of $5,000 in annual contribution.

“Medical graduates are often faced with what can seem like an insurmountable amount of debt as they transition from student to medical professional,” said Dan Bengyak, vice president of administrative services at Montefiore. The repayment program is a new employee benefit to help address the challenge faced by thousands of workers today, he said.

“This one has been a real home run,” he said, in an interview with FierceHealthcare.

National student loan debt currently stands at $1.4 trillion, with medical students bearing a larger-than-average financial burden after graduation. Some 75% of medical students leave school with education debt, holding an average balance of $196,000, according to the Association of American Medical Colleges.

The program helps employees while solving the issue of unutilized paid time off.

“It’s estimated American workers forfeit 212 million vacation days amounting to $62.2 billion in lost benefits in a year,” said Scott Thompson, CEO of Tuition.io. Rather than losing vacation days and other accrued paid time off, Montefiore’s program gives employees a new option, he said.

At Montefiore St. Luke’s Cornwall, employees are allowed to roll over unused PTO from year-to-year and the hospital found employees were building up large reserves of time, Bengyak said. The hospital was also aware of the big problem of student loan debt.

“Student loan debt has now surpassed any other kind of debt” facing people throughout the country, he said. With an eye toward employee wellness, including financial wellness, the hospital decided it could solve two problems at once.

The hospital rolled out the new benefit at the start of the year and has initially offered it to all non-union employees, he said. It plans to offer it to union employees during future contract negotiations.

“We’re targeting everyone,” he said, including physicians and other medical professionals who are employed by the hospital. Employees from ancillary departments, such as the hospital laboratory, have also benefitted.

It’s not just a popular benefit with younger employees, he noted. The hospital encourages life-long learning and some of its more senior employees who are continuing their education were among the happiest about the new benefit. Employees can also use the benefit to help pay off student loans they have taken to help pay for their children’s education.

The hospital has two windows each year when employees can decide how much PTO they want to exchange to help pay student loans. In the first window, employees exchanged PTO valued at about $90,000, Bengyak said. He expects that amount will increase slightly in the next window at the end of the year, as employees look at how much vacation time and other PTO they have left.

Bengyak estimates the hospital will pay out a total of $200,000 in the program’s first year to help pay down student loans.

But since the PTO is already accruing and accounted for in the hospital’s budget, “this is really net neutral. We’re giving them another way to spend it,” he said. “We’re not adding to our bottom line.”

When employees choose not to take PTO, the hospital does not have the cost of replacing those employees when they are out and does not lose productivity, he said.

The company looked at a number of private companies to administer the new benefit before choosing Tuition.io, which offered very competitive rates, he said. The cost for the hospital is “very minimal,” he said.

The new benefit is a recruitment tool, he said. “A lot of people have career aspirations beyond the job for which we hire them,” he said. Combined with a $6,000 tuition reimbursement, employees who choose to convert up to $5,000 in PTO to pay back student loans can get up to $11,000 in a calendar year to help fund their education.

The amount can cover nearly a year’s worth of an employee’s part-time schooling, he said. “It’s a really attractive benefit.”

The issue of student loan debt has become part of the national discussion. At a hearing in June before the House Small Business Committee, lawmakers heard testimony about how the burden of medical school debt impacts physician practices and primary care.

The committee’s chairman, Rep. Nydia M. Velázquez (D-NY), said she fears student loan debt has had a detrimental effect for medical professionals, including keeping physicians from starting or joining private practices, working in rural and underserved communities and influencing the choice of specialties as doctors chose higher-paying specialties rather than primary care.

Medical schools are aware of the issues and some are getting innovative. Last year, NYU’s medical school decided to offer free tuition to all its students, saying it hoped that would encourage more students to pursue careers in less lucrative specialties such as primary care. Kaiser Permanente also decided to offer free tuition to all the medical students in its first five graduating classes at its new medical school, saying it hoped by reducing the financial burden on future doctors for their education it would encourage students to go into primary care and other lower-paying specialties.

https://www.fiercehealthcare.com/practices/hospital-allows-employees-to-exchange-unused-paid-time-off-to-help-pay-off-student-loan

Kyowa Kirin eyeing ophthalmology use for cancer drug tivozanib?

Kyowa Kirin has bought back rights outside of cancer to tivozanib, amending an agreement dating back to 2006 with AVEO, and opening up the possibility of research in ophthalmology.

Under the terms of the deal Kyowa Kirin will buy back the non-cancer rights of tivozanib in territories included in the deal, which covers the US and EU.

This also excludes rights sublicensed to EUSA Pharma, which markets the drug under the brand name Fotivda in Europe for kidney cancer.

This amends the deal in 2006 which granted AVEO exclusive rights to tivozanib in all indications.

Kyowa Kirin will make an upfront payment of $25 million to AVEO and waive the latter’s obligation to make an $18 million milestone payment upon marketing approval, and up to $391 million in payments upon achievement of certain development and commercial objectives in non-oncology uses.

The Japanese pharma is not saying how it intends to develop tivozanib, but tivozanib is a vascular endothelial growth factor (VEGF) inhibitor, which works by inhibiting the growth of blood vessels that feed tumours.

VEGF inhibitors are also used in ophthalmology – Novartis’ Lucentis (ranibizumab) is an antibody that inhibits VEGF that has already been approved in ophthalmology indications such as wet age-related macular degeneration (AMD).

In this disease, blood vessels proliferate in the back of the eye, scarring it and leading to loss of central vision.

VEGF inhibitors work against these blood vessels, improving the vision of people affected by AMD and similar diseases.

Roche’s Avastin (bevacizumab), another VEGF drug used in cancer, is not approved in ophthalmology but is used off-label in diseases such as wet AMD as it is cheaper to administer than Lucentis.

Kyowa Kirin gave no further details about what the “non-oncology” uses agreement covers but ophthalmology has proven to be a highly lucrative market for Novartis and its rival Bayer, which markets another VEGF drug, Eylea (aflibercept).

Tivozanib has already been studied in mice with choroidal neovascularisation, with results suggesting a possible use in neovascular AMD.

And as the VEGF inhibitors on the market are expensive biologic drugs, repurposing a small molecule drug such as tivozanib could give Kyowa Kirin wiggle-room in terms of pricing should clinical trials go well.

Could Kyowa Kirin be eyeing ophthalmology use for cancer drug tivozanib?

Fluidigm down 33% after Q2 miss

Fluidigm (FLDM -32.6%) slumps on increased volume in early trade after the company posted less-than-expected Q2 results after the close yesterday.

Revenue was up 7% to $28.2M, mass cytometry revenue was up 28% to $17.5M.

Net loss: ($13.8M) (+15%); EPS: ($0.20) (+52%).

Q3 guidance: Revenue: $27M – 30M; cash consumption: $7M – 9M.

Previously: Fluidigm EPS misses by $0.03, misses on revenue (Aug. 1)

https://seekingalpha.com/news/3486253-fluidigm-33-percent-q2-miss

Coherus up 14% on strong ramp of Neulasta biosimilar

Coherus BioSciences (CHRS +14%) is up on increased volume following better-than-expected Q2 results released after the close yesterday.

Sales of its Neulasta biosimilar, UDENYCA (pegfilgrastim-cbqv) were $83.4M, up 125% from Q1. U.S. market share is now ~13% and could reach 20% by year-end.

Net income was up 154% to $23.6M while EPS was up 147% to $0.32.

Key pipeline candidates include biosimilars to AbbVie’s Humira, Amgen’s Enbrel, Roche’s Lucentis and Regeneron’s Eylea.

It expects to initiate a NASH program later this year.

Previously: Coherus BioSciences EPS beats by $0.07, beats on revenue(Aug. 1)

https://seekingalpha.com/news/3486304-coherus-14-percent-strong-ramp-neulasta-biosimilar

Adaptimmune down 17% on cell therapy safety signals

Thinly traded micro cap Adaptimmune (ADAP -17.3%) is down on more than double normal volume, albeit on turnover of only 674K shares, in apparent response to its Q2 report released today.

The report included a disclosure that three patients experienced serious adverse events, two of which appear to be treatment-related. One patient in the ADP-A2M10 study died after experiencing severe prolonged pancytopenia (profoundly low levels of red blood cells, white blood cells and platelets). Two patients in the ADP-A2M4 study died, one from severe prolonged pancytopenia and one from a stroke possibly related to neurotoxicity (the company does not believe the latter fatality was treatment-related).

The protocols for both trials have been amended to include changes in eligibility criteria and a reversion to a lower dose of cyclophosphamide (chemo agent used to deplete lymphocytes before the administration of the cell therapy) that was used previously.

Previously: Adaptimmune EPS beats by $0.29, misses on revenue (Aug. 1)

https://seekingalpha.com/news/3486323-adaptimmune-17-percent-cell-therapy-safety-signals