Facebook is bombarding cancer patients with ads for unproven treatments

 The ad reads like an offer of salvation: Cancer kills many people. But there is hope in Apatone, a proprietary vitamin C–based mixture, that is “KILLING cancer.” The substance, an unproven treatment that is not approved by the FDA, is not available in the United States. If you want Apatone, the ad suggests, you need to travel to a clinic in Mexico.

If you’re on Facebook or Instagram and Meta has determined you may be interested in cancer treatments, it’s possible you’ve seen this ad, or one of the 20 or so others recently running from the CHIPSA hospital in Mexico near the US border, all of which are publicly listed in Meta’s Ad Library. They are part of a pattern on Facebook of ads that make misleading or false health claims, targeted at cancer patients.

Evidence from Facebook and Instagram users, medical researchers, and its own Ad Library suggests that Meta is rife with ads containing sensational health claims, which the company directly profits from. The misleading ads may remain unchallenged for months and even years. Some of the ads reviewed by MIT Technology Review promoted treatments that have been proved to cause acute physical harm in some cases. Other ads pointed users toward highly expensive treatments with dubious outcomes. 

CHIPSA, which stands for Centro Hospitalario Internacional del Pacifico, S.A, was founded in 1979 and refers to itself as a community hospital offering integrative treatments for cancer. On Facebook, the facility describes itself as being at the “cutting edge” of cancer research. But the hospital’s foundational diet-based therapy, called the Gerson Protocol, is “all nonsense,” says David Gorski, a surgical oncologist at Wayne State University in Michigan and the managing editor of the website Science-Based Medicine. Developed by a German doctor in the 1920s to treat migraines, the regimen consists of a special diet and frequent “detox” procedures. It has been discredited for decades in the medical community

CHIPSA did not respond to repeated requests via phone and email for comment.

MIT Technology Review alerted Meta to five CHIPSA ads, along with three ads from another international clinic called Verita Life. In response, Meta spokesperson Mark Ranneberger said that it had removed “several of the ads for violating our misleading claims policy, which prohibits claims of cures for incurable diseases.”  

When asked for the specifics of the ads removed, Ranneberger said that two were rejected: the one claiming that Apatone was “killing” cancer and another that mentioned “growing distrust” of the US health-care system while advertising exclusive cancer treatments. Another ad using identical text to that second one but a different image remains active. On Monday, after the publication of this article, Meta noted that it had removed three additional ads using the same language.

“Us cancer patients and survivors, we are just bombarded with all these kinds of alternative things all the time,” says Nikhil Autar, a medical student in Australia who has acute myeloid leukemia. Autar started seeing ads for cancer treatment centers on Facebook in 2019—just as Facebook and other platforms began rolling out new policies designed to limit the reach of health misinformation.

Facebook has drastically stepped up its efforts to stop the spread of sensational and false health claims over the past few years. After a series of local measles outbreaks in the US in 2019, it announced it would start treating misleading health claims like spam, reducing their reach on news feeds and limiting the visibility of private Facebook groups promoting dubious treatments. When the covid-19 pandemic began, the company rolled out more comprehensive efforts to remove or limit such claims as conspiracies about the virus, masks, and vaccines spread on its platform. 

These attempts to combat pitches for miracle cures and dubious medical advice have been a step in the right direction, says Rachel Moran, a postdoctoral fellow at the Center for an Informed Public at the University of Washington. However, many such ads continue to slip through. 

One from Verita Life, in Bangkok, Thailand, targeted Australians like Autar, falsely claiming that a hypothermia treatment offered there would “destroy cancer cells.” When Autar took a screenshot of the ad in his news feed in August of 2020, it had more than a thousand likes and 600 shares. 

Autar reported the ads he saw to Facebook using its in-platform systems, but they remained up. At one point, he says, he used a Silicon Valley connection to try to flag the ads directly to Facebook management. He stopped seeing the clinic’s ads in the Ad Library and on his own feed after that, but they returned a few months later. 

Both CHIPSA and Verita Life had several ads running on Facebook and Instagram before MIT Technology Review inquired about them, according to the Ad Library. Verita Life was able to place an ad as recently as June 18, 2022, promoting the testimonial of a patient with prostate cancer. MIT Technology Review flagged that ad, along with two others promoting the same testimonial. All three remain active.

Meta reviews new ads through a largely automated process before they go live. The company noted that ads and posts from CHIPSA’s Facebook page and Instagram account are eligible to be flagged and fact-checked by third-party fact checkers. If a company repeatedly violates its policies, Meta says, it will temporarily suspend the company’s ability to place ads. 

While Meta has rules pertaining to, for instance, misleading claims in ads, all Facebook and Instagram ads must also follow Meta’s community guidelines. The guidelines ban content “promoting or advocating for harmful miracle cures for health issues” when those claims both contribute to serious injury or death and have no legitimate health use. 

Those rules, even when swiftly enforced, can leave a lot of gray area for sensational claims, Gorski says, because “a lot of quackery could have a legitimate health use.” For instance, he says, “vitamin C obviously has legitimate health uses; it just doesn’t cure cancer.” 

So what about Apatone, the treatment advertised by CHIPSA? Pre-clinical research indicates some anti-cancer effect, but it “has not been demonstrated to be more beneficial than standard treatments we are using currently in humans,” says Skyler Johnson, a cancer researcher who studies misinformation at the University of Utah.

The danger is not simply that the treatments are unproven or ineffective. Some alternative cancer treatments advertised on the platform can cause physical harm. Coley’s toxins, a treatment developed in the late 19th century and offered at CHIPSA, comes with risks including infection, site reactions, anaphylaxis, and in severe cases shock, says Johnson. 

Unproven treatments can also interact poorly with conventional treatments like chemotherapy should a patient decide to pursue alternative care on their own. Moreover, simply delaying the start of proven therapies by detouring into unproven ones can allow the cancer to advance, complicating and diminishing the effectiveness of further treatment. 

Johnson’s research has demonstrated worse survival rates for patients who seek unproven cancer treatments at first. In a 2017 study, he found that after about five years, patients with breast cancer who delayed conventional treatment in favor of alternative medicine were more than five times more likely to die. 

There’s the financial burden, too—because clinics like CHIPSA aren’t generally covered by insurance, patients often have to raise money to afford their treatments. One recent GoFundMe campaign for a cancer patient seeking treatment at CHIPSA included a screenshot of a bill for the “base amount” he’d have to pay. It was $36,500 for three weeks of inpatient care in Mexico. That cost would increase once the facility decided on a treatment plan.   

CHIPSA has spent about $5,000 since mid-2018 advertising on Meta about social issues, politics, or elections, according to information available in the Ad Library before Meta removed two of its ads. CHIPSA did not respond to requests for details on its ad spending or the cost of the treatments it offers.

Gorski is blunt about his view on whether Facebook will effectively address cancer misinformation: “The only real way to combat such misinformation on Facebook would require an army of fact checkers that Facebook is never going to pay for, given its past record even on covid-19 misinformation and dangerous political conspiracy theories.” 

And as the University of Washington’s Moran points out, misinformation like this rarely stays confined to the platform where it’s originally posted. While Facebook plays a key role in getting sensational claims about dubious cancer treatments in front of desperate patients, the groups and ads carrying those claims often link to other sites and networks that reinforce them.

Johnson, using data from 2017 to 2019, has observed that articles and videos containing myths about cancer treatment often receive more social media engagement than those from “safe” sources. And although it’s tricky to say for sure, his and other research in this area suggests that as many as one in three online articles or videos posted online about cancer may contain harmful misinformation. 

“Especially when you are experiencing a medical crisis, you are looking at an incredible amount of information,” Moran says. “It seems good to you that you are doing your research, you're going from one site to the next. But they all belong to the same ecosystem.” 

This post has been updated with additional information from Meta

If you or a loved one has been treated for cancer, we'd like to talk to you for future stories about sensational health claims on social media. If you are a member of support groups for cancer patients or their loved ones, or have experience with clinics like the ones mentioned in this story, please be in touch: abby.ohlheiser@technologyreview.com

https://www.technologyreview.com/2022/06/27/1054784/facebook-meta-cancer-treatment-ads-misinformation/

Fatal Flaw in Hospital Price Transparency Rules

 The Hospital Price Transparency rule celebrated its first birthday in January, and as of July 1, the enforcement of a similar requirement for payers and health plans began through the Transparency in Coverage rules. Regrettably, the U.S. is still far from achieving price transparency's intended outcomes (more shoppable healthcare), or perhaps even understanding what the outcomes are supposed to be. Key compliance metrics vary, and indeed there is also variance in the very definition of "compliance," which has resulted in estimates ranging from as low as 6% to more than 50%, depending on how you slice the data.

True "compliance" means that a hospital has published price data that is both user-friendly and located prominently on their website (and yes, this includes making the information easily retrievable via search engines). By this definition, compliance is undoubtedly low since many hospitals have not created accessible resources to locate and understand their pricing. This is perhaps unsurprising as hospitals balance myriad challenges like staffing crises, COVID-19 surges, and struggles in revenue recuperation.

Given these hurdles, hospitals that have yet to comply will not feel pressure to make changes unless additional incentives, either positive or negative, come into play. Vague requirements and a lack of repercussions have not created the sense of urgency that regulators hoped for. So where do we go from here?

While price transparency rules are well-intentioned, they suffer from a fatal flaw: too much room for interpretation in the definition of compliance. Healthcare stakeholders need to ask themselves what compliance actually entails. Are hospitals required to publish prices in well-labeled, easy-to-locate areas on their website, or can they get by in placing these numbers on a hidden page? If the industry hopes to improve compliance, then the Centers for Medicare & Medicaid Services (CMS) must lay out clear rules, including what is expected and what is forbidden, and ensure they have closed any potential loopholes in the process.

Many providers view this rule as more of a regulatory compliance burden than a potential opportunity to distinguish themselves from their competitors and increase market share, so they see little incentive to comply. Remember that hospitals tried and failed to block these transparency requirements in the courts. Additionally, the initial civil money penalties associated with noncompliance were laughably low if intended as deterrents. CMS did recently issue their first ever fines for noncompliance, which total over $1 million, so there is hope for an uptick in compliance efforts. On the contrary, only two hospitals were fined, despite CMS sending written warnings of noncompliance to hundreds of hospitals in recent months. While these fines may get the attention of a hospital chief financial officer, we still don't know if they will view these fines as merely a "cost of doing business" -- even a million dollar fine can be a rounding error on a hospital bottom line. CMS can significantly ramp up pressure on hospitals to comply if it so chooses, either by increasing civil monetary penalties, or by linking compliance with the transparency rules to the conditions of participation in the Medicare program, much like they did with their requirement that nursing home employees be vaccinated. However, it is not entirely clear if the statute covering conditions of participation would permit CMS to take this type of action.

Further, there are additional external factors that can impact the shift to greater price transparency, including the fact that the hospital rule does not exist in isolation. While it is difficult to predict the impact of the hospital price transparency rollout on the forthcoming payer transparency rule, one can only hope that payers have been paying attention to the struggles of their counterparts. There may be some confusion at first where payers learn of varying negotiated rates with the same provider organizations. However, these rules in conjunction may deliver an opportunity for greater synergy between payers and providers. I remain hopeful that this rollout can improve on the shortcomings of its predecessor and ultimately help us achieve our true end goal: empowering consumers with the best information to guide their care decisions.

It is important for me to end on an optimistic note. While we have endured clear setbacks on the road to greater transparency, that we remain on the road represents incredible progress in less than a decade. Until 2013, information on provider pricing was almost impossible to obtain, and in fact, CMS was legally prohibited from releasing information that could identify physician reimbursements. The release by CMS of physician-level reimbursement information was considered groundbreaking at the time, but information on prices for people with private sector health insurance remained hidden until recently. We have made unambiguous progress, and although the road is bumpy, our healthcare leaders owe it to patients to continue pushing ahead.

Niall Brennan, MPP, is chief analytics and privacy officer at Clarify Health. He previously served as the chief data officer at CMS, where he led the Obama administration's healthcare transparency efforts.

https://www.medpagetoday.com/opinion/second-opinions/99542

DOJ Says J&J Talc Bankruptcy 'Violates Congressional Mass Tort Rules'

 The U.S. Justice Department told a federal appeals court that Johnson & Johnson's strategy for moving talc injury litigation to chapter 11 violates the regime Congress has authorized for litigating mass torts.

The U.S. Trustee Program, a Justice Department unit monitoring bankruptcy courts, said in a Thursday filing with the Third U.S. Circuit Court of Appeals that Johnson & Johnson's decision to put a newly formed subsidiary into chapter 11 to drive settlements of talc litigation circumvented federal multidistrict litigation procedures which have been prescribed by Congress as the way to deal with mass torts. Johnson & Johnson used an emerging restructuring transaction called a Texas divisive merger to send the talc liability to the subsidiary before it filed bankruptcy, a strategy that will be scrutinized by the appeals court.

The U.S. Trustee and talc injury claimants want the Third Circuit to reverse a bankruptcy judge who authorized the Johnson & Johnson talc subsidiary to stay in chapter 11.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/DOJ-Says-J-J-Talc-Bankruptcy-Violates-Congressional-Mass-Tort-Rules-40879600/

After Layoffs, Big Life Sci Companies Advance and Small Firms Retrench

 After the spring reductions in the workforce that left thousands of biotech employees searching for jobs, larger companies are, for the most part, moving forward, while some of the smaller ones are struggling to optimize operations and cut costs.

Further reductions in the workforce can be expected, along with more mergers and acquisitions as some financial analysts say the U.S. is in – or will soon be in – a recession (defined as two consecutive quarters of declining economic growth), as the Federal Reserve Board increased the primary credit interest rate 1.75% – a 0.75 percentage point increase -  effective June 16. In contrast, NASDAQ, citing consumer spending, predicts a recession “probably won’t occur for at least the next year.”

Here’s a look at what some of the biotech companies are doing now, after their layoffs and what prompted their employee furloughs.

Athersys Considering Options Following Phase III Failure 

Athersys laid off 70% of its staff in June – including its COO, CSO and CFO – after its stroke therapy failed in Phase II/III trials. The company's stock closed at $0.27 on June 17, down from its 52-week high of $1.81. The company postponed its annual shareholder’s meeting from June 15 to July 28 to allow time for a proposal authorizing the board of directors to amend the company’s certificate of incorporation to create a reverse stock split in an attempt to return share prices to the $1 minimum required for NASDAQ listing.

After Aduhelm, Biogen Prioritizes Biosimilars, Emerging Markets

In March, Biogen began laying off employees after lower-than-anticipated sales of its Alzheimer's drug, Aduhelm. It also backed out of its agreement to purchase Karyopharm Therapeutics and its amyotrophic lateral sclerosis (ALS) asset. Biogen's stock opened at $192.11 per share on June 17, down from a 52-week high of $391. The company has stated plans “to continue to return cash to shareholders through share repurchases.”

In June the company announced positive Phase III data for its biosimilar version of tocilizumab for rheumatoid arthritis, a license and collaboration agreement for a GBA2 inhibitor to treat Parkinson’s disease and launched the biosimilar Byooviz (ranibizumab-nuna) in the U.S. for three ophthalmology indications.

Biogen expects two more regulatory filings this year and plans call for expanding its biosimilars business, as well as increasing its focus on R&D, reducing costs and enhancing productivity. The company said it will be focusing on “key emerging markets, such as China and certain markets in both Latin America and the Middle East.” It is also providing support for humanitarian efforts in Ukraine.

bluebird bio Bounces on Positive Gene Therapy Recommendation 

In April, bluebird bio announced a comprehensive restructuring that has resulted in a 30% reduction in the workforce as part of its effort to save approximately $160 million over the next two years. The company is transitioning to new headquarters in an effort to save $120 million over the next six years.

An FDA Advisory Committee unanimously recommended that the FDA approve betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) recently. Beti-cel is scheduled to come before the U.S. Food and Drug Administration on August 19, while eli-cel is scheduled for review on September 16. After falling from a 52-week high of $21.74, bluebird bio’s stock rallied on positive news, jumping more than 34% to $3.84 in midday trading on June 1 before closing at $3.56. The surge was attributed to a positive message from CEO Andrew Obenshain at the European Hematology Association Hybrid 2022 Congress regarding its cell therapies for sickle cell disease and beta thalassemia.

Gilead Realigns Following Immunomedics Acquisition 

Gilead laid off 114 employees in March after acquiring Immunomedics in 2020. First-quarter revenue this year was up 3% in year-over-year earnings. It made a $725 million collaboration opt-in payment to Arcus Biosciences, repaid $500 million in debt, paid $945 million in dividends and repurchased $352 million of common stock. Its stocks opened at $57.37 on June 19, down from a 52-week high of $74.12. The Q1 report said the company's effective tax rate for the quarter was 107.9%, compared to 23.9% for Q1 2021 because of a $2.7 billion in process research and development (IPR&D) impairment related to the Immunomedics deal in 2020.

Merck Invests in U.S. and Global R&D Infrastructure

After acquiring Acceleron in 2021, Merck laid off 143 employees in March. That doesn’t make a dent in its 71,000-employee headcount but is part of the larger biotech trend this spring as companies realign their workforces. Going forward, Merck says it is “making significant investments in [its] research and discovery facilities and infrastructure in the U.S. and around the world.” That includes the recent expansions of the Exploratory Science Center in Cambridge, MA and its West Point, PA site, as well as the development of the 220,000-square-foot London Discovery Center. Merck’s website lists hundreds of job openings throughout the company. 

Novartis Axes 8,000 Jobs in Accelerated Restructuring 

Novartis accelerated its restructuring in April to accelerate its overall growth and strengthen its pipeline. On Tuesday, the company revealed it would be cutting 8,000 jobs in hopes of saving at least $1 billion by 2024. 

Sales, operating income, net income and earnings per share all increased in Q1, although free cash flow, core net income and core earnings per share each decreased. Q2 results are not yet available. A Strategy and Growth function is being created, along with a new operations unit to generate economies of scale and enhance productivity.

Since its Q1 report was issued, Novartis has resumed its business in Ukraine and is supplying medical and humanitarian aid. It has signed a manufacturing deal with Samsung Biologics while Greece has filed a bribery lawsuit for €214 million, alleging a payout to doctors.

Overall

Layoffs didn’t cease with the March culling and may continue as the economy slows. For example, in June, Genocea ceased operations, Atreca announced layoffs are part of corporate restructuring and Praxis reduced its workforce after the failure of a Phase II/III clinical trial. Amarin and Vincerx Pharma also announced layoffs. Biotech employees, therefore, should prepare for tumultuous times ahead.

https://www.biospace.com/article/after-the-layoffs-big-companies-advance-and-small-firms-retrench/

S Korea says leaflets sent by defectors unlikely to be cause of Covid in N Korea

 South Korea's unification ministry said on Friday there is "no possibility" of Covid-19 entering North Korea via contaminated balloons sent by activists in the South.

North Korea said earlier in the day the country's first outbreak began with patients touching "alien things" near the border with South Korea, apparently shifting blame to its neighbour for the wave of infections that hit the isolated country.

The North's state media did not directly mention South Korea, but North Korean defectors and activists have for decades flown balloons from the South across the heavily fortified border, carrying leaflets and humanitarian aid.

https://www.tbsnews.net/coronavirus-chronicle/s-korea-says-leaflets-sent-defectors-unlikely-be-cause-covid-n-korea-450806

Ala. cites SCOTUS abortion ruling in treatments for transgender youth

 Days after the Supreme Court ruled that states can prohibit abortion, Alabama has seized on the decision to argue that the state should also be able to ban gender-affirming medical treatments for transgender youth.

The case marks one of the first known instances in which a conservative state has tried to apply the abortion ruling to other realms, just as LGBTQ advocates and others were afraid would happen.

Critics have expressed fear that the legal reasoning behind the high court ruling could lead to a rollback of decisions involving such matters as gay marriage and birth control.

The state is asking a federal appeals court to lift an injunction and let it enforce an Alabama law that would make it a felony to give puberty blockers or hormones to transgender minors to help affirm their gender identity.

In its historic ruling last Friday, the U.S. Supreme Court said terminating a pregnancy is not a fundamental constitutional right because abortion is not mentioned in the Constitution and is not "deeply rooted in this nation's history and tradition."

In a brief filed Monday, the Alabama attorney general's office argued similarly that gender transition treatments are not "deeply rooted in our history or traditions," and thus the state has the authority to ban them. Alabama contends such treatments are dangerous and experimental, a view disputed by medical organizations.

Shannon Minter, legal director of the National Center for Lesbian Rights, said it is the first case he is aware of in which a state cited the abortion ruling on another issue, but added, "It won't be the last."

Supreme Court Justice Samuel Alito wrote in the majority opinion that the abortion ruling should not cast "doubt on precedents that do not concern abortion." But Justice Clarence Thomas wrote that the same legal reasoning should be used to reconsider high court rulings protecting same-sex marriage, gay sex and contraceptives.

"It is no surprise that Alabama and other extremely conservative states are going to take up that invitation as forcefully as they can," Minter said. "Justice Thomas' concurrence was a declaration of war on groups already under attack, and we expect the hostility to be escalated."

He said a rethinking of such constitutional protections could affect things like birth control and parental rights.

"They are not just talking about LGBT people," Minter said.

Alabama Attorney General Steve Marshall was unavailable for comment Thursday, a spokesman said.

Jeff Walker, who has a 15-year-old transgender daughter, said this spring that it felt as if Alabama were attacking families like his with legislation targeting transgender kids' medication and dictating their choice of school bathrooms, locker rooms and sports teams. He said the state's argument in this case is worrisome for everyone.

"I think everyone should be concerned by the wording of this appeal. By this logic, any health care the state feels isn't in line with its morals or beliefs should be banned," Walker said.

The Alabama case could become be an early test of where judges stand on the scope of the abortion ruling. The appeals court granted the state's request for an expedited schedule for submitting briefs, and a decision could come as early as this fall.

While Alabama was already appealing the injunction in the transgender medication case, the state quickly incorporated the abortion decision into its filing.

Alabama Gov. Kay Ivey this spring signed the law making it a crime punishable by up to 10 years in prison to dispense certain medication to minors to help with their gender transition.

A federal judge in May issued a preliminary injunction blocking the measure, siding with parents who said the law violates their children's rights and their own rights to direct their youngsters' medical care.

https://www.cbsnews.com/news/alabama-transgender-healthcare-abortion-ruling-roe-v-wade/

Abortion drug maker says Mississippi can't ban pill despite Supreme Court ruling

 The maker of a drug used in medication abortions has told a federal judge that the U.S. Supreme Court's recent ruling eliminating the nationwide right to abortion does not allow Mississippi to stop it from selling the pills in the state.

GenBioPro Inc, which makes a generic version of the drug mifepristone, said in a Thursday filing in Jackson, Mississippi federal court that the U.S. Food and Drug Administration's approval of the drug should override any state ban.

The Las Vegas-based company sued the state in 2020 to challenge regulations that restricted medication abortion specifically. Mississippi is now set to ban nearly all abortions under a 2007 "trigger law" following the Supreme Court's ruling in Dobbs v. Jackson Women's Health, which overturned its landmark 1973 ruling in Roe v. Wade establishing a constitutional right to abortion.

GenBioPro said that law will create a "that-much more direct and glaring conflict" with the FDA. It cited U.S. Attorney General Merrick Garland's statement last week that states "may not ban mifepristone based on disagreement with the FDA's expert judgment about its safety and efficacy."

Mississippi said in an opposing filing that "the legal landscape following Dobbs has shifted overwhelmingly in favor of the state's authority to regulate or prohibit abortion," and that there was no evidence that Congress ever intended the FDA to restrict states' ability to regulate abortion.

The U.S. Department of Justice has not intervened in the case, and declined to comment on it Friday.

Bans and restrictions on abortion are now taking effect or are poised to do so in 22 states, including 13 like Mississippi with so-called "trigger" laws designed to take effect when Roe v. Wade was overturned, according to the Guttmacher Institute, an abortion rights advocacy research group.

https://www.yahoo.com/news/abortion-drug-maker-says-mississippi-171739551.html