番茄社区

The following is a transcript of the podcast episode:

Rachael Robertson: Hey everybody. Welcome to MedPod Today, the podcast series where 番茄社区 reporters share deeper insight into the week's biggest healthcare stories. I'm your host, Rachael Robertson.

Today, we are talking with Cheryl Clark about how major medical journals' conflict of interest policies are all over the map. Then, Sophie Putka is going to tell us about one doctor's fight for insurance coverage for her baby daughter's rare cancer. Last up, I'll tell you some of the major changes to the CDC's practice recommendations on contraception.

番茄社区 has been wondering what reputable medical journals require their submitting authors to report in terms of financial or other relationships that could pose conflicts of interest – or the appearance of it. And reporter Cheryl Clark has surveyed a lot of these journals to find out. She's here to tell us what she found.

Cheryl, can you start by telling us how you surveyed these major journals' policies?

Cheryl Clark: Yeah, Rachael, it was really quite fascinating. We asked about 16 leading medical journals – the ones you know, whose articles we often write about – what they require their authors to disclose regarding financial or other relationships, like with advocacy organizations, pharma, or the biotech industry. It's important to understand context -- where the authors might be coming from. And what we found, perhaps not all that surprising, was that the journal's policies were pretty much all over the map.

Some journals required their authors to reveal relationships going back 2 years, some 3 years, some 5 years, and some didn't have a year requirement. They just said, "tell us everything." Some journals had separate policies for studies about trial results versus commentaries or letters to the editor, and in my experience, something taken from a commentary might be just as influential for a physician or a patient making treatment decisions. The reporting windows varied in other ways too. For some, it was going back to the time of submission. For others, it was the time that the paper was accepted, and some to the date of publication, and for others, it was just whenever the disclosure form was submitted.

Of course, if an author does have a conflicting interest or received money from a company, it doesn't mean, of course, that what got published or is being considered for publication is biased or inaccurate. But disclosure just gives editors and readers more context and leads to transparency in the process.

Robertson: Got it. So a lot of variance across the board. What else did you find?

Clark: One of the most surprising things, at least to me, was that none of the journals said they systematically check for potential conflicts the authors didn't disclose. I mean, this is so easy. Because, for example, with just a few clicks, you can look up the open payments database that CMS operates and see healthcare industry payments to physicians going back much longer than 5 years. The journals just said they don't do that. They said they don't have the time or the staff. And one journal spokesman just said, hey, our publication relies on the honor system, and that seemed to be the prevailing sentiment. Typically, journals said they only look further for conflicts if a reviewer, or after publication, a reader, raises a question about it.

Robertson: Yikes. Are there any efforts to pressure these journals to strengthen their policies?

Clark: Well, after I got the results from our survey, I called around and asked a number of experts in medical ethics what they thought about all of this, and they weren't surprised about the variation that we found. They all said they are troubled by the seemingly casual nature of disclosure requirements, especially since reports of manuscript hanky panky seem to be more common lately. None of these experts knew of any real efforts to influence the journals to strengthen or coordinate their policies. These are largely private publications, and they get to set their own standards.

Now, for example, Dr. Bernard Lo, director emeritus of the medical ethics program at the University of California San Francisco, said the windows for reporting conflicts should be much longer, but that isn't going to happen, he told me. "Why not?" I asked him. The problem is the journals all "have little fiefdoms," he said, No one tells the New England Journal what to do. No one tells Lancet what to do, he said.

Robertson: Thanks for your reporting on this, Cheryl.

Clark: Thank you, Rachael, for the time. Appreciate it.

Robertson: Next we'll hear from Sophie Putka about one doctor's struggle with her health insurance over coverage of a drug for her baby daughter's rare cancer. Last summer, 8-month-old Zoey started having seizures and couldn't use her right hand normally. When her mom, a psychiatrist at a state hospital, and her father took her to the hospital, a workup revealed a large tumor in Zoey's brain. She had what is called an infant-type hemispheric glioma, which would put her life in danger if it wasn't treated urgently. Let's hear more.

All right. Sophie, tell us what happened next with Zoey?

Sophie Putka: Sure, so obviously this was an extremely scary situation for Zoey's mom, Eunice Stallman, and her whole family. Zoey's brain tumor was really large and it was growing over some major blood vessels in her brain, which would make it pretty close to impossible to operate without a huge risk of something going really wrong. So that was out, and chemotherapy and radiation would also have been pretty risky. They could have done it, but it would have put her development as such a young kid and physical health in danger.

The tumor did end up testing positive for a mutation called ALK, however, and it turns out there is a drug that had been used pretty successfully in treating cancers with that particular mutation. Zoey's medical team all agreed that the best option for Zoey would be this newer drug. It's called lorlatinib, or Lorbrena, and they all thought it would be the least invasive option for her.

Robertson: Okay, so if they determined that was the best treatment, then what's the problem?

Putka: So they basically just had to get help paying for it. It would have cost $13,000 or more a month out of pocket. So Zoey's doctor submitted a prior authorization to Blue Cross Idaho, which was their insurer -- and it was denied. They said the drug was not FDA approved for use in cases like this one, and it was considered investigational, and her plan wouldn't cover investigational drugs. But even after her doctor submitted more information and appealed the decision urgently, Blue Cross Idaho again denied the appeal.

This newer drug had been used mostly for people with lung cancer with that same ALK mutation, but it had been successful in the brain when those types of cancers had spread. And there were also a handful of case studies with young children like Zoey that had the same rare cancer and shown dramatic turnarounds. Clinical trials for approval in children, which was what the insurance was basically looking for, were not really possible because there just weren't enough kids with the same type of rare cancer to do them.

So Stallman spent hours on the phone with Blue Cross of Idaho. You know, she was getting desperate, Zoey's seizures were getting worse, and they eventually sent the case out – Blue Cross sent the case out – to what's called an independent review organization, which supposedly hires specialists to give an impartial second opinion on insurance claims. The doctor also said that the drug would not be covered by the plan, and the medical directors at Blue Cross agreed with him. They even had what's known as a peer-to-peer phone call between Zoey's doctors and the medical directors at Blue Cross, and still didn't change their minds.

Robertson: So what did Stallman do?

Putka: She and her husband were looking everywhere. They started a GoFundMe, they went to all their personal networks and asked around for advice. She applied to St Jude's, she contacted Pfizer, who actually makes the drug -- none of those really went anywhere.

Another doctor with a big following on Twitter tweeted about the situation, and Stallman contacted a reporter at another news outlet who actually reached out to Blue Cross, and it was right around then – 2 weeks after the diagnosis – that Blue Cross of Idaho called a meeting and decided to reverse their decision.They told Stallman that they'd make an exception in her case and would cover most of the cost of the drug.

They didn't really give a reason, but Stallman told me that she knows, as an MD, you know, with lots of knowledgeable people in her corner and all the resources to dispute insurance decisions and call them day after day, was really well positioned to fight this type of battle. But more than two-thirds of patients with denied insurance claims don't even know that they can appeal them, according to KFF.

The good news is, a month after Zoey started the lorlatinib, her tumor has almost disappeared. She's still on it, she's maintaining, and Eunice said that she started learning to crawl, she's talking, and as her mom describes it, she is just a happy, affectionate little girl. So it worked out.

Robertson: Thanks for this reporting, Sophie, and I'm really glad there was a happy ending for Zoey.

Putka: Thanks so much, Rachael. Let's just swap for a second for the last segment.

The CDC just updated their practice recommendations on contraception, which were last updated in 2016. So I would love to hear about some of the highlights. How come the CDC came to make these changes?

Robertson: So the CDC conducted a thorough review of all the scientific evidence and everything that has changed since then, and they also held some listening sessions with patients and patient advocacy organizations. Dr. Antoinette Nguyen, who works for the CDC – she coauthored both of these updates – she told me that the goal of these listening sessions was "to gather insights about participants' experiences, values, preferences, and information needs related to contraceptive method use and decision making." So those things together informed the changes that were published last week.

Putka: Okay, great. So what are the major changes to the guidelines?

Robertson: The item that is getting the most attention is that physicians are now encouraged to counsel patients on pain associated with IUD insertion, which in some ways feels like a bit of a no brainer to anyone who has heard of or knows someone who has gotten an IUD inserted before. You might remember, earlier this year, we reported on how some people went viral for filming their facial expressions as they had an IUD inserted. Previous research has also shown that doctors have underestimated patients' pain during IUD insertion.

Another change to the guidelines is that lidocaine, either used as a paracervical block or topically, might be helpful for reducing a patient's pain. While some doctors have offered this treatment already when inserting IUDs, it wasn't previously part of the guidelines themselves. Misoprostol is not recommended, except for in select circumstances, like if a patient had a recently failed placement.

Putka: Really interesting. So were there any other additions here?

Robertson: Yeah, so there's also now specific guidance for trans and nonbinary people who have uteruses who take testosterone. Taking T may not prevent pregnancy, so the CDC now recommends further contraceptive counseling for these folks who may not want to risk pregnancy. Another addition is that self-administration of an injectable contraception called subcutaneous DMPA should be made available as an additional method. This was already kind of added back in 2021 in the practice recommendations, but now it's in the full package, too.

There's plenty of other changes that I detailed in my article, but these are some of the headline items that people might want to know about.

Putka: Thanks, Rachael.

Robertson: And thank you, Sophie.

And that is it for today. If you like what you heard, please leave us a review wherever you listen to podcasts (, ) – and hit subscribe if you haven't already. We'll see you again soon.

This episode was hosted and produced by me, Rachael Robertson. Sound engineering by Greg Laub. Our guests were 番茄社区 reporters Cheryl Clark, Sophie Putka, and Rachael Robertson, links to their stories are in the show notes.

MedPod Today is a production of 番茄社区. For more information about the show, check out medpagetoday.com/podcasts.

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