A decision in the latest court case to threaten the future of the Affordable Care Act could come as soon as this month. The ruling will come from the panel of judges in the 5th Circuit Court of Appeals, which heard oral arguments in the Texas v. Azar lawsuit.

An estimated 24 million people get their health coverage through programs created under the law, which has faced countless court challenges since it passed.

In court in July, only two of the three judges — both appointed by Republican presidents — asked questions. “Oral argument in front of the circuit went about as badly for the defenders of the Affordable Care Act as it could have gone,” says Nicholas Bagley, a professor of law at the University of Michigan. “To the extent that oral argument offers an insight into how judges are thinking about the case, I think we should be prepared for the worst — the invalidation of all or a significant part of the Affordable Care Act.”

Important caveat: Regardless of this ruling, the Affordable Care Act is still the law of the land. Whatever the 5th Circuit rules, it will be a long time before anything actually changes. Still, the timing of the ruling matters, says Sabrina Corlette, director of the Center on Health Insurance Reforms at Georgetown University.

“If that decision comes out before or during open enrollment, it could lead to a lot of consumer confusion about the security of their coverage and may actually discourage people from enrolling, which I think would be a bad thing,” she says.

Don’t be confused. Open enrollment begins Nov. 1 and runs at least through Dec. 15, and the insurance marketplaces set up by the law aren’t going anywhere anytime soon.

That’s not to underplay the stakes here. Down the line, sometime next year, if the Supreme Court ends up taking the case and ruling the ACA unconstitutional, “the chaos that would ensue is almost possible impossible to wrap your brain around,” Corlette says. “The marketplaces would just simply disappear and millions of people would become uninsured overnight, probably leaving hospitals and doctors with millions and millions of dollars in unpaid medical bills. Medicaid expansion would disappear overnight.

“I don’t see any sector of our health care economy being untouched or unaffected,” she adds.

So what is this case that — yet again — threatens the Affordable Care Act’s very existence?

A quick refresher: When the Republican-led Congress passed the Tax Cuts and Jobs Act in 2017, it zeroed out the Affordable Care Act’s penalty for people who did not have health insurance. That penalty was a key part of the Supreme Court’s decision to uphold the law in 2012, so after the change to the penalty, the ACA’s opponents decided to challenge it anew.

Significantly, the Trump administration decided in June not to defend the ACA in this case. “It’s extremely rare for an administration not to defend the constitutionality of an existing law,” says Abbe Gluck, a law professor and the director of the Solomon Center for Health Law and Policy at Yale University. “The administration is not defending any of it — that’s a really big deal.”

The basic argument made by the state of Texas and the other plaintiffs? The zero dollar fine now outlined in the ACA is a “naked, penalty-free command to buy insurance,” says Bagley.

Here’s how the argument goes, as Bagley explains it: “We know from the Supreme Court’s first decision on the individual mandate case that Congress doesn’t have the power to adopt a freestanding mandate, it just has the power to impose a tax.” So therefore, the argument is that “the naked mandate that remains in the Affordable Care Act must be unconstitutional.”

The case made by the plaintiffs goes further, asserting that because the individual mandate was described by the Congress that enacted it as essential to the functioning of the law, this unconstitutional command cannot be cut off from the rest of the law. If the zero dollar penalty is unconstitutional, the whole law must fall.

Last December, a federal judge in Texas agreed with that entire argument. His judgement was appealed to the panel of judges in the 5th Circuit. Even if those judges agree that the whole law is unconstitutional, that would not be the end of the story — the case will almost certainly end up before the Supreme Court. It would be the third case to challenge the Affordable Care Act in the nation’s highest court.

So if the ruling will be appealed anyway, does it matter? “It matters for at least two reasons,” Bagley says. “First of all, if the 5th Circuit rejects the lower court holding and decides that the whole law is, in fact, perfectly constitutional, I think there’s a good chance the Supreme Court would sit this one out.”

On the other hand, if the 5th Circuit invalidates the law, it almost certainly will go the Supreme Court, “which will take a fresh look at the legal question,” he says. Even if the Supreme Court ultimately decides whether the ACA stands, “you never want to discount the role that lower court decisions can play over the lifespan of a case,” Bagley says.

The law has been dogged by legal challenges and repeal attempts from the very beginning, and experts have warned many times about the dire consequences of the law suddenly going away. Nine years in, “the Affordable Care Act is now part of the plumbing of our nation’s health care system,” Bagley says. “Ripping it out would cause untold damage and would create a whole lot of uncertainty.”

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Last March, Canada’s department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.

Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period. These company-generated documents, often running more than 1,000 pages, summarize the methods, goals, and results of clinical trials, which test the safety and efficacy of promising medical interventions. The reports play an important role in helping regulators make their decisions, along with other information, such as raw data about individual patients in clinical trials.

So far, Health Canada has posted reports for four newly approved drugs — one to treat plaque psoriasis in adults, two to treat two different types of skin cancer, and the fourth for advanced hormone-related breast cancer — and is preparing to release reports for another 13 drugs and three medical devices approved or rejected since March.

Canada’s move follows a similar policy enacted four years ago by the European Medicines Agency of the European Union. The U.S. Food and Drug Administration, on the other hand, continues to treat this information as confidential to companies and rarely makes it public.

The argument for more transparency

Transparency advocates say clinical study reports need to be made public in order to understand how regulators make decisions and to independently assess the safety and efficacy of a drug or device. They also say the reports provide medical societies with more thorough data to establish guidelines for a treatment’s use, and to determine whether articles about clinical trials published in medical journals — a key source of information for clinicians and medical societies — are accurate.

“Sometimes regulators miss things that have been hidden in those clinical study reports,” says Matthew Herder, director of the Health Law Institute at Dalhousie University in Nova Scotia. “Regulators often face resource constraints, they have deadlines, other priorities.”

Last year, for example, Canadian researchers used a clinical study report and other previously non-public information from a clinical trial to call into question the efficacy of Diclectin (known as Diclegis in the United States), a commonly prescribed drug to treat nausea and vomiting in pregnancy. The team had requested the information from Health Canada under an older policy, which required researchers to sign a confidentiality agreement and keep the underlying data secret when they published their results. (It “had a chilling effect,” Herder says of the now-discontinued policy, and not many researchers made requests.)

Duchesnay, the Quebec-based manufacturer of Diclectin, defended the drug, and the Canadian and American professional societies of obstetricians and gynecologists continue to recommend it. Yet the new analysis gave pause to the College of Family Physicians of Canada, which had previously published two articles recommending Diclectin’s use in its medical journal, Canadian Family Physician. The organization took the unusual step in January of publishing a correction, which criticized the independence and accuracy of the two earlier articles. And, citing the new research, it advised physicians to use caution when interpreting recommendations for the drug’s use.

Herder and other lawyers and independent researchers who want to see greater transparency in medical research are urging the FDA to follow the example of Canada and the E.U., but without success thus far. To date, the European program, which has been in effect since 2016, has posted clinical study reports for 132 medicinal products whose applications were submitted after January 2015.

Canadian and European regulators lead the way

It is important to have multiple regulators making the data public, says Peter Doshi, an associate editor at the BMJ, an international medical journal, and an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. As it stands now, “If FDA approves first, which often it does, we won’t know anything until Health Canada or the EMA makes a decision,” says Doshi. “And not every drug, device, biologic out there is going to be approved by these other regulators or even submitted to these other markets.”

In addition, redundancy lessens the impact if one regulator changes policy. The EMA, for example, earlier this year moved its operations from London to Amsterdam because of Britain’s anticipated exit from the European Union. Clinical data publication “was one of the activities suspended until we are more settled in Amsterdam,” says Anne-Sophie Henry-Eude, head of documents access and clinical data publication. No date has yet been announced for its resumption.

Sandy Walsh, a spokesperson for the FDA, says the agency does not have the same freedom as Canadian and European regulators to release clinical study reports. “U.S. laws on disclosure of trade secret, confidential commercial information, and personal privacy information differ from those governing EMA and Health Canada’s disclosure of clinical study reports,” she wrote in an email.

Some legal experts argue the FDA has more flexibility than it acknowledges. Federal agencies are “entitled to substantial deference” in determining “what constitutes confidential commercial information,” Amy Kapczynski, a Yale law professor and a co-director of the university’s Collaboration for Research Integrity and Transparency, in The Journal of Law, Medicine & Ethics.

Why drugmakers balk

In response to an interview request sent to the Pharmaceutical Research and Manufacturers of America, Megan Van Etten, the trade group’s senior director for public affairs, emailed a statement expressing concern from the industry that Health Canada’s new regulations “could discourage investment in biomedical research by revealing confidential commercial information.”

Joseph Ross, an associate professor of medicine and public health at Yale University and a co-director, along with Kapczynski and others, of CRIT, maintains that clinical study reports contain little information that companies need to keep secret, and that any such information could be redacted before release. A 2015 report by the Institute of Medicine, now known as the National Academy of Medicine, also called for the FDA to release redacted clinical study reports.

That is the strategy of Health Canada, which discusses possible redactions with the manufacturer. “Health Canada retains the final decision on what information is redacted and published,” Geoffroy Legault-Thivierge, a spokesperson, wrote in an email.

So does the EMA, which goes through a similar negotiating process with manufacturers. “We often are in disagreement but at least there is a dialogue,” says Henry-Eude. The EMA might agree to redact manufacturing details, for example.

Journal reports often underplay harms, emphasize benefits

Researchers who independently re-evaluate drugs say the reports are critical because the data they need is not readily available in medical journal articles. One analysis showed that only about half of clinical trials examined were written up in journals in a timely fashion and a third went unpublished. And when articles are published, they contain much less data than the reports, says Tom Jefferson, an epidemiologist based in Rome who works with Cochrane, an international collaboration of researchers who conduct and publish reviews of the scientific evidence for medical treatments.

In addition, “journal articles emphasize benefits and underplay or, in some cases, even ignore harms” that can be found in the clinical study report data, says Jefferson. An analysis by experts at the Institute for Quality and Efficiency in Health Care in Cologne, Germany, found “considerable” bias in how patient outcomes were reported in journal articles and other publicly available sources. Public access to clinical study reports can shine a light on such discrepancies.

The FDA has flirted in the past with releasing clinical study reports to the public. In January 2018, it launched a pilot program to post portions of reports for up to nine recently approved drugs if the drug companies would agree.

“We’re committed to enhancing transparency about the work we do at the FDA,” commissioner Scott Gottlieb, who resigned in March, said at the time.

But only Janssen Biotech, a subsidiary of Johnson & Johnson, volunteered, and its prostate cancer drug Erleada is the lone entry. In June, the FDA announced it is considering shifting its focus from the pilot program to another designed to better communicate the analyses of FDA experts who review drug applications, which the agency has been making public for approved medicinal products since 2012.

But these analyses by FDA reviewers are no substitute for the actual clinical study reports, says Doshi. The reviews reflect “an FDA scientist’s take on the sponsor’s application,” he said. “Without the clinical study report, somebody like me is largely deprived of looking at the underlying data and developing my own take.”

Independent researchers like those who took a hard look at Diclectin also want access to clinical study reports connected to regulatory decisions made before the European and Canadian portals were opened.

Since 2010, the EMA has been providing researchers and others with access to clinical study reports for such legacy drugs upon request, while Health Canada is even more transparent, posting requested clinical study reports for drugs and devices approved or rejected before March to its new online portal for anyone to see. So far, 12 information packages are available for older drugs and devices and 11 more requests are being processed.

The FDA has, on occasion, provided reports in response to a Freedom of Information Act request, but researchers seeking this information typically invest “a tremendous amount of time and effort,” says Ross. For example, a Yale Law School clinic sued the FDA on behalf of two public health advocacy groups after the agency said it could take years to respond to their FOIA request for clinical trial data for two hepatitis C drugs. In 2017, it won the case and the groups received the data, which they are currently evaluating.

The FDA does not keep track of how many clinical study reports it has released through FOIA, says Walsh. But Doshi and others say such releases are rare, and usually a result of lawsuits or the threat of legal action. In 2011, Doshi requested clinical study reports for Tamiflu, an antiviral medication used to treat the flu. “Eight years later, I think those requests are still alive,” he says now. “I don’t remember getting a denial. They just sit.”

Outside researchers can appeal to companies directly for access to clinical study reports. At least 24 of PhRMA’s 35-member companies have signed on to its six-year-old principles for “responsible clinical trial data sharing,” committing to the release of synopses of clinical study reports for approved medicines and to considering requests for data and the full reports from “qualified” medical and scientific researchers who submit research proposals.

But researchers are concerned they won’t be granted access if companies are not comfortable or sympathetic to their proposals, says Herder. And the companies control the amount of redaction.

The British-based pharmaceutical company GlaxoSmithKline (GSK) has gone further than most in providing public access to its data. In 2013, the company began posting clinical study reports through its own online portal, Clinical Study Register, which is open to the public. “We have published over 2,500 clinical study reports and nearly 6,000 summaries of results — both positive and negative — from our trials on Clinical Study Register,” Andrew Freeman, director and head of medical policy, said in an emailed statement. “GSK is leading the industry in transparency.”

Even so, GSK controls the level of redaction, says Jefferson of Cochrane, who tried to use clinical study reports posted on the company’s portal for a systematic review of HPV vaccines. “Important aspects, for instance the narratives of serious adverse events — those are all blocked out. Big black boxes,” he says. “So they are of moderate use.”

Meanwhile, many researchers do not realize that Health Canada and the EMA are making clinical study reports available. An online survey of 160 researchers around the world who conduct systematic reviews found that 133 “had never considered accessing regulatory data” and 117 of those 133 “were not aware (or were unsure) of where to access such material.” They continue to rely on the limited data in journal articles and other published literature, says Herder of Dalhousie University.

“Transparency is wonderful in theory but unless people actually do the work of getting data and independently analyzing it, transparency is window dressing,” he says.

Barbara Mantel is a New York-based reporter who writes about health care and other social issues.

This story was produced by Undark, a nonprofit, editorially independent digital magazine exploring the intersection of science and society.

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At a tiny kiosk on a Mumbai lane choked with rickshaws, Chandrabhaan Chaurasia is selling paan – betel leaves sprinkled with spices. They’re a cheap street snack across South Asia.

Chaurasia, 51, spreads a leaf with spicy herbal paste and then sprinkles it with dried tobacco. He folds the leaf into an edible little parcel, and sells it for 8 rupees — about $0.11. He also sells single-serving packs of chewing tobacco. Another kiosk nearby sells hand-rolled leaf cigarettes, called beedis.

India banned electronic cigarettes last month. With about 100 million smokers, India has the second-largest smoking population in the world, after China. Amid global reports of deaths and illnesses linked to vaping, India decided to ban e-cigarettes preventatively. They had yet to become popular.

But other forms of tobacco already are. In fact, twice as many Indians (about 200 million) use smokeless tobacco — like paan or chewing tobacco — than cigarettes. That’s the most in the world. Those products are harder to regulate because they’re mostly sold at street kiosks, for a fraction of the price of cigarettes.

Chaurasia’s tobacco kiosk is right outside Tata Memorial Hospital, one of the best cancer research facilities in India. Inside the hospital, Dr. Gauravi Mishra, a preventative oncologist, sees the harmful effects of those tobacco products on a daily basis.

“India has the highest number of oral cavity cancers. In fact, one-third of the global burden comes from only one country — and that’s India,” Mishra notes.

In the United States, oral cavity cancer represents 3% of all malignancies. But in India, it accounts for over 30% of all cancers.

When NPR visited her office, Mishra had just biopsied a boil inside the mouth of a patient who’s been chewing tobacco for 10 years.

“I had some idea that it was bad, but I didn’t know it could be so serious,” says Madhukar Patil, 42, his mouth filled with sterile gauze.

Patil is waiting for results to determine whether he has oral cancer. A father of two, he vows to quit tobacco now, for good.

“I realize now that if you want to be there for your family and enjoy precious moments with them, then you must leave this bad habit,” Patil says.

More than one in five Indians over the age of 15 uses some form of smokeless tobacco. (The figure is nearly one-third for men.) Poor laborers often chew tobacco as a stimulant, like chewing gum, to kill their appetite. Some even use tobacco ash as toothpaste. Patil used to chew gutka, a mixture of granular tobacco, betel nuts and spices.

Part of the problem is awareness.

“If someone is smoking, they might be looked down upon. But smokeless tobacco is culturally accepted. If you visit any rural area, people will greet you with paan,” Mishra says.

Another part of the problem is packaging.

Indian law requires cigarette companies to print health warnings on cigarette packs. Often, they carry graphic photos of tobacco-related tumors. So people know that smoking cigarettes is bad.

But other tobacco products are sold loose. Hand-rolled leaf cigarettes, or beedis, are green. They look organic. And they’re seven to eight times more common in India than conventional cigarettes, according to the World Health Organization.

Beedis also provide a livelihood to millions of mostly female, first-time workers.

In Mumbai’s oldest red light district, Balamani Sherla rolls beedis on the floor of her one-room home. At 60, Sherla has been doing this for half a century. It’s the only job she’s ever held.

She buys the ingredients wholesale: tendu leaves, dried loose tobacco, and string to tie off the rolled beedis. Sherla soaks the leaves in water to soften them, then cuts them round with giant shears, lines them with tobacco, and rolls them into short green cigarettes. She sells them to a middle man who then distributes them to street kiosks.

“It’s tedious work,” she says. “My arms ache, trying to roll the beedis very thin.”

Sherla doesn’t smoke. But studies show that beedi rollers often suffer from respiratory problems, burning eyes and asthma – just from breathing tobacco dust.

Nevertheless, it’s considered such a lucrative skill that women who can roll beedis are coveted as brides. Sherla makes about $0.14 an hour, which is a big help for her family, she says.

But wages used to be higher. The Indian government has repeatedly hiked tax on all tobacco products, including beedis — and that has cut into Sherla’s profits.

Most of the revenue India collects from taxing tobacco comes from packaged cigarettes, even though they’re less popular than beedis and smokeless tobacco. Tax rates on all tobacco products in India fall below the WHO’s recommendation of 75-percent of retail price.

Levying taxes on tobacco has long been considered an effective strategy to discourage its use and improve public health. But in India, where beedi workers often come from very low socio-economic backgrounds, that tax itself could be deadly, says Umesh Vishwad, general secretary of the Akhil Bharatiya Beedi Mazdoor Mahasangh (All India Beedi Workers Union).

If taxes on beedis keep rising, workers could “become homeless and starve to death,” Vishwad says.

They live that close to the bone, he says. His group wants the Indian government to retrain beedi workers for other jobs, before it chips away at their livelihood.

While Sherla and some of her neighbors roll beedis at home in urban Mumbai, the industry employs more people in rural areas, especially in the southern Indian states of Telangana and Andhra Pradesh. In central India, some of the beedi workers come from tribal areas where communist guerrillas are active. Vishwad worries that if their livelihoods are threatened, they could be vulnerable to insurgent recruiters.

“If these people lose their jobs as beedi rollers or beedi leaf collectors, they could be forced to join the militancy and pick up arms to survive,” he warns.

For Sherla, rolling beedis is a calculated decision. She knows that handling tobacco may not be good for her health. But she’s trading a long-term health risk for the ability to feed her family tomorrow.

“What other job can I do? I’m an old lady,” Sherla says. “This is the only option for me.”

As she works, Sherla’s 10-year-old granddaughter Siri bounces around the dank little room. The girl goes to school, and has learned English well. She interrupts often to tease her grandmother and translate for her. She’s the same age Sherla was when she started doing this work.

Will Siri follow in her grandmother’s footsteps?

“No way!” Sherla exclaims. “This little girl wants to be a doctor.”

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