Tagged Pharmaceuticals

Local Ties In Suit Against Opioid Manufacturer Makes Case Personal For New Jersey Officials

The Johnson & Johnson subsidiary that New Jersey says minimized the risks of opioid addiction in its marketing messages is based in the state. “It is especially troubling that so much of the alleged misconduct took place right here in our own backyard,”said Gurbir Grewal, the New Jersey attorney general, at a news conference announcing the legal action. “New Jersey’s pharmaceutical industry is the envy of the world, with a long history of developing vital, lifesaving drugs. But we cannot turn a blind eye when a New Jersey company like Janssen violates our laws and threatens the lives of our residents.” Meanwhile, Naloxone can be a lifesaving drug, but not all pharmacies are on board with offering it. News on the epidemic comes out of Oregon, Kansas, New Hampshire and California, as well.

Childbirth In The Age Of Addiction: New Mom Worries About Maintaining Sobriety

When she was in her early 20s, Nicole Veum says, she made a lot of mistakes.

“I was really sad and I didn’t want to feel my feelings,” she said. “I turned to the most natural way I could find to cover that all up and I started using drugs: prescription pills, heroin for a little bit of time.”

Veum’s family got her into treatment. She’d been sober for nine years when she and her husband, Ben, decided to have a baby. Motherhood was something she wanted to feel.

If she needed an epidural during labor, Veum told her doctor, she didn’t want any fentanyl in it. She didn’t want to feel high.

“I remembered seeing other friends,” she said. “They’d used it, and they were feeling good and stuff. I didn’t want that to be a part of my story.”

An epidural is a form of regional anesthesia given via an injection of drugs into the space around the spinal cord. It is typically a mix of two types of medication: a numbing agent, usually from the lidocaine family, and a painkiller, usually fentanyl.

The amount of fentanyl in the mix is limited, and little passes into the bloodstream, anesthesiologists say. But if a woman doesn’t want the fentanyl, it’s easy to formulate an epidural solution without it. Doctors either use a substitute medication or boost the concentration of the numbing agent.

“There’s no medical reason why someone should be forced to be exposed to opioids if they don’t want to,” said Dr. Kelly Pfeifer, a family physician and addiction expert who now works as director of high-value care at the California Health Care Foundation. (Kaiser Health News produces California Healthline, an editorially independent publication of the California Health Care Foundation.)

Pfeifer said there’s another situation to be aware of: pregnant women who are taking methadone or suboxone to manage opioid addiction. During labor, anesthesiologists often prescribe narcotics to help manage pain, but some of those commonly used — like Nubain — can immediately reverse the effects of methadone or suboxone.

“Suddenly, you’re in the middle of labor — which is already painful — and now you’re in the middle of the worst withdrawal of your life,” Pfeifer said.

Adrian Veum plays at home. Nicole Veum says she’s loving being his mom, and feels “reborn.”(Adam Grossberg/KQED)

For Veum, one of the worst wildfires in California’s recorded history is what interrupted her birth plan. She and her husband live in Santa Rosa, Calif., and she was in active labor when devastating fires ignited nearby on Oct. 8, 2017. What are now known as the “Wine Country Wildfires” burned more than 5,000 homes and killed 44 people.

“There was a ton of smoke in the hospital,” Veum said. “Like you could visibly see it outside — and smell it.”

Nurses told her everybody had to evacuate. Veum was transferred to another hospital, 5 miles away. And the special instructions for her epidural got lost in the chaos.

“Then, when they went to change the drug, I saw the tube said ‘Fentanyl’ on it,” she recalled. “And by that point I was starting to feel ‘the itchies’” — one of the familiar physical signs she would experience when starting to get high.

Most women without a history of addiction wouldn’t experience these sensations when given opioid anesthesia, said Dr. Jennifer Lucero, chief of obstetric anesthesiology at the University of California-San Francisco Medical Center. Anytime a woman who is not in recovery asks for an epidural without fentanyl (usually out of the mom’s concern for the baby), Lucero explains why it’s there.

The fentanyl allows the anesthesiologist to balance out the numbing agent in the solution, she said, so women don’t have as much pain from the contractions but can still feel the pressure and are able to move their legs a bit or shift in bed during labor.

Once she explains the trade-offs, and assures women that the opioid will have no effect on their fetus, most of her patients opt to keep fentanyl in the epidural solution.

But doctors have been trying to cut down on administering opioids in other ways during labor and delivery, namely in what they prescribe for pain after the birth.

For years, women who had a normal, vaginal birth were sent home with a 30-day supply of Norco, Percocet or another opioid, Lucero said.

“Some people would think they’re supposed to take them all,” Lucero said, while other women “would not use it, and it would just be sitting in the bathroom cabinet.”

While most people who get a bottle of pills when leaving the hospital won’t develop dependence or an addiction, some will. When a patient is prescribed opioids for short-term pain, the risk of chronic use starts to increase as early as the third day of the prescription, according to a report published last year by the Centers for Disease Control and Prevention. A study out this year suggests that every week of opioid use increases the risk of misuse.

As recently as 2017, postpartum women were routinely being prescribed three- to five-day supplies of opioids — even after an uncomplicated vaginal delivery. A study published that year of 164,720 Pennsylvania women on Medicaid who gave birth vaginally found that 12 percent of them filled an opioid prescription after they gave birth — even though most did not have a clear medical need for a painkiller, such as vaginal tearing or an episiotomy.

Now obstetricians are issuing new guidelines to patients, Lucero said, and they’re trying to prescribe limited amounts of opioids, and only post-surgically, to women who have had a cesarean section.

Nicole Veum ended up being one of those women. After she was transferred to the second hospital during the wildfire evacuation, she spent another 12 hours in the early stages of labor, but she wasn’t progressing. She agreed to a C-section.

After the birth of her son, doctors sent her home with a bottle of Percocet — another opioid. They told her that if she was worried about being able to maintain her sobriety, she could have her husband or a friend hold on to the bottle and control the dosage.

Pfeifer, the physician and addiction specialist, said that in a situation like that, sending Veum home with just a few Percocet pills, or even suggesting she take only ibuprofen, would have been fine.

“Any parent will tell you there’s nothing more stressful than the first week of being a parent and having a baby and being in sleep deprivation,” Pfeifer said. “And here you have a little bottle of Vicodin that you used to turn to, to make you feel better when you’re stressed.”

First the fires. Then the fentanyl in her epidural. Then the Percocet. It was Veum’s first test in seeing how her sobriety and motherhood would line up. She called a friend who was also in recovery. They talked it all through, and Veum was fine.

“I was OK. I was OK with it. It was just something that happened,” she said as her baby, Adrian, now a year old, plays with a new toy.

Veum is 32 now. She’s returned to school this fall to work toward her college degree, after a 14-year break. And she is loving being a mom.

“A lot of people, metaphorically, felt it as a baby coming out of the ash — the life coming from the ashes,” she said about her child born in the midst of the 2017 wildfires.

“And I feel that,” Veum said. “I feel like it was a big time for our community — and me personally — to be reborn in some way.”

This story is part of a partnership that includes KQEDNPR and Kaiser Health News.


KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.

Fish Oil And Vitamin D Pills No Guard Against Cancer Or Serious Heart Trouble

A widely anticipated study has concluded that neither vitamin D nor fish oil supplements prevent cancer or serious heart-related problems in healthy older people, according to research presented Saturday at the American Heart Association Scientific Sessions. Researchers defined serious heart problems as the combined rate of heart attacks, stroke and heart-related deaths.

Although hundreds of studies of these supplements have been published over the years, the new clinical trial — a federally funded project involving nearly 26,000 people — is the strongest and most definitive examination yet, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute who was not involved in the research.

Doctors have been keenly interested in learning the supplements’ true value, given their tremendous popularity with patients. A 2017 study found that 26 percent of Americans age 60 and older take vitamin D supplements, while 22 percent take pills containing omega-3 fatty acids, a key ingredient in fish oil.

The new study also suggests there’s no reason for people to undergo routine blood tests for vitamin D, said Rosen, who co-wrote an accompanying editorial. (Both were published in the New England Journal of Medicine.). That’s because the study found that patients’ vitamin D levels made no difference in their risk of cancer or serious heart issues, Rosen said. Even people who began the study with clear vitamin D deficiency got no benefit from taking the supplements, which provided 2,000 international units a day. This amount is equal to one or two of the vitamin D pills typically sold in stores.

A recent Kaiser Health News story reported that vitamin D testing has become a huge business for commercial labs — and an enormous expense for taxpayers. Doctors ordered more than 10 million vitamin D tests for Medicare patients in 2016 — an increase of 547 percent since 2007 — at a cost of $365 million.

“It’s time to stop it,” said Rosen of vitamin D testing. “There’s no justification.”

Dr. JoAnn Manson, the study’s lead author, agrees that her results don’t support screening healthy people for vitamin D deficiency.

But she doesn’t see her study as entirely negative.

Manson notes that her team found no serious side effects from taking either fish oil or vitamin D supplements.

“If you’re already taking fish oil or vitamin D, our results would not provide a clear reason to stop,” Manson said.

Manson notes that a deeper look into the data suggested possible benefits.

When researchers singled out heart attacks — rather than the rate of all serious heart problems combined — they saw that fish oil appeared to reduce heart attacks by 28 percent, Manson said. As for vitamin D, it appeared to reduce cancer deaths — although not cancer diagnoses — by 25 percent.

But slicing the data into smaller segments — with fewer patients in each group — can produce unreliable results, said Dr. Barnett Kramer, director of the cancer prevention division at the National Cancer Institute. The links between fish oil and heart attacks — and vitamin D and cancer death — could be due to chance, Kramer said.

Experts agree that vitamin D is important for bone health. Researchers didn’t report on its effect on bones in these papers, however. Instead, they looked at areas where vitamin D’s benefits haven’t been definitely proven, such as cancer and heart disease. Although preliminary studies have suggested vitamin D can prevent heart disease and cancer, more rigorous studies have disputed those findings.

Manson and her colleagues plan to publish data on the supplements’ effects on other areas of health in coming months, including diabetes, memory and mental functioning, autoimmune disease, respiratory infections and depression.

Consumers who want to reduce their risk of cancer and heart disease can follow other proven strategies.

“People should continue to focus on known factors to reduce cancer and heart disease: Eat right, exercise, don’t smoke, control high blood pressure, take a statin if you are high risk,” said Dr. Alex Krist, a professor of family medicine and population health at Virginia Commonwealth University.

Fish Oil And Vitamin D Pills No Guard Against Cancer Or Serious Heart Trouble

A widely anticipated study has concluded that neither vitamin D nor fish oil supplements prevent cancer or serious heart-related problems in healthy older people, according to research presented Saturday at the American Heart Association Scientific Sessions. Researchers defined serious heart problems as the combined rate of heart attacks, stroke and heart-related deaths.

Although hundreds of studies of these supplements have been published over the years, the new clinical trial — a federally funded project involving nearly 26,000 people — is the strongest and most definitive examination yet, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute who was not involved in the research.

Doctors have been keenly interested in learning the supplements’ true value, given their tremendous popularity with patients. A 2017 study found that 26 percent of Americans age 60 and older take vitamin D supplements, while 22 percent take pills containing omega-3 fatty acids, a key ingredient in fish oil.

The new study also suggests there’s no reason for people to undergo routine blood tests for vitamin D, said Rosen, who co-wrote an accompanying editorial. (Both were published in the New England Journal of Medicine.). That’s because the study found that patients’ vitamin D levels made no difference in their risk of cancer or serious heart issues, Rosen said. Even people who began the study with clear vitamin D deficiency got no benefit from taking the supplements, which provided 2,000 international units a day. This amount is equal to one or two of the vitamin D pills typically sold in stores.

A recent Kaiser Health News story reported that vitamin D testing has become a huge business for commercial labs — and an enormous expense for taxpayers. Doctors ordered more than 10 million vitamin D tests for Medicare patients in 2016 — an increase of 547 percent since 2007 — at a cost of $365 million.

“It’s time to stop it,” said Rosen of vitamin D testing. “There’s no justification.”

Dr. JoAnn Manson, the study’s lead author, agrees that her results don’t support screening healthy people for vitamin D deficiency.

But she doesn’t see her study as entirely negative.

Manson notes that her team found no serious side effects from taking either fish oil or vitamin D supplements.

“If you’re already taking fish oil or vitamin D, our results would not provide a clear reason to stop,” Manson said.

Manson notes that a deeper look into the data suggested possible benefits.

When researchers singled out heart attacks — rather than the rate of all serious heart problems combined — they saw that fish oil appeared to reduce heart attacks by 28 percent, Manson said. As for vitamin D, it appeared to reduce cancer deaths — although not cancer diagnoses — by 25 percent.

But slicing the data into smaller segments — with fewer patients in each group — can produce unreliable results, said Dr. Barnett Kramer, director of the cancer prevention division at the National Cancer Institute. The links between fish oil and heart attacks — and vitamin D and cancer death — could be due to chance, Kramer said.

Experts agree that vitamin D is important for bone health. Researchers didn’t report on its effect on bones in these papers, however. Instead, they looked at areas where vitamin D’s benefits haven’t been definitely proven, such as cancer and heart disease. Although preliminary studies have suggested vitamin D can prevent heart disease and cancer, more rigorous studies have disputed those findings.

Manson and her colleagues plan to publish data on the supplements’ effects on other areas of health in coming months, including diabetes, memory and mental functioning, autoimmune disease, respiratory infections and depression.

Consumers who want to reduce their risk of cancer and heart disease can follow other proven strategies.

“People should continue to focus on known factors to reduce cancer and heart disease: Eat right, exercise, don’t smoke, control high blood pressure, take a statin if you are high risk,” said Dr. Alex Krist, a professor of family medicine and population health at Virginia Commonwealth University.

Podcast: KHN’s ‘What The Health?’ Split Decision On Health Care

Voters on Election Day gave control of the U.S. House to the Democrats but kept the U.S. Senate Republican. That will mean Republicans will no longer be able to pursue partisan changes to the Affordable Care Act or Medicare. But it also may mean that not much else will get done that does not have broad bipartisan support.

Then the day after the election, the Trump administration issued rules aimed at pleasing its anti-abortion backers. One would make it easier for employers to exclude birth control as a benefit in their insurance plans. The other would require health plans on the ACA exchanges that offer abortion as a covered service to bill consumers separately for that coverage.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Rebecca Adams of CQ Roll Call, Margot Sanger-Katz of The New York Times and Joanne Kenen of Politico.

Among the takeaways from this week’s podcast:

  • The Trump administration’s new contraception coverage rule comes after an earlier, stricter regulation was blocked by federal courts.
  • The insurance bills that the Trump administration is now requiring marketplace plans to send to customers for abortion coverage will be for such a small amount of money that they could become a nuisance and may persuade insurers to give up on the benefit.
  • House Democrats, when they take control in January, say they want to move legislation that will allow Medicare to negotiate drug prices. But fiscal experts say that may not have a big impact on costs unless federal officials are willing to limit the number of drugs that Medicare covers.
  • It appears that both Democrats and Republicans in Congress are interested in doing something to protect consumers from surprise medical bills. The issue, however, may fall to the back of the line given all the more pressing issues that Congress will face.
  • One of the big winners Tuesday was Medicaid. Three states approved expanding their programs, and in several other states new governors are interested in advancing legislation that would expand Medicaid.

Plus, for extra credit, the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: Kaiser Health News’ “Hello? It’s I, Robot, And Have I Got An Insurance Plan For You!” by Barbara Feder Ostrov

Margot Sanger-Katz: Stat News’ “Life Span Has Little to Do With Genes, Analysis of Large Ancestry Database Shows,” by Sharon Begley

Joanne Kenen: The Washington Post’s “How Science Fared in the Midterm Elections,” by Ben Guarino and Sarah Kaplan

Rebecca Adams: The New Yorker’s “Why Doctors Hate Their Computers,” by Atul Gawande

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

House Dems In New Seats Of Power Will Steer Health Policy, Attack Drug Prices

For the first time since passing the Affordable Care Act, Democrats will soon control the House of Representatives and its powerful health committees. But Republicans’ tightened grip on the Senate means those hoping for another round of dramatic, progressive reforms may be disappointed.

Empowered by voters outraged over Republican attempts to chip away at the law’s protections for the sick, Democrats owe much of their midterm takeback to health care issues. And Democratic leaders say they are ready to get back to work, this time training their sights on skyrocketing drug prices, among other policy conundrums, with a majority of House votes and a slate of new committee chairmanships in hand.

In a few weeks, House Democrats will meet to elect their leaders, including several committee chairs who will be responsible for the nation’s health care policy and spending in the coming years. Hill denizens expect those currently serving as the top Democrat on most House committees to ascend to the chairmanships, with few if any members mounting serious challenges.

Those basking in a post-“blue wave” glow would do well to temper their expectations, recalling that the Republican-controlled House had already voted 54 times to unravel some or all of the Affordable Care Act by its fourth birthday in 2014. In most cases, Democrats in the Senate and White House stopped those efforts in their tracks.

With the Senate (and the presidency) remaining under Republican control and even fewer moderate Republicans left in the House after this election, Democrats will struggle to move legislation without Republican support. What they can do is hold hearings, launch investigations and generally unnerve the pharmaceutical industry, among other likely adversaries.

And there’s a chance they could strike a deal with President Donald Trump, whose administration is moving to crack down on drug companies.

Who are the members most likely to wield the gavels? And what will they do with that power? Here’s a look at some of the major committees that influence health policy — and the people who may lead them.

The Committee on Energy and Commerce: Rep. Frank Pallone, New Jersey

Pallone, who has served in the House for 30 years, became the top Democrat on this influential committee in 2015. Should he become chairman, he would be responsible for the broadest health portfolio in the House, which includes Medicaid, public health, insurance and drug safety. This is the committee that marked up the Affordable Care Act in 2009 (when Pallone chaired the health subcommittee) and the House Republican repeal effort in 2017.

Under the Trump administration, Pallone has touted his stewardship of bipartisan legislation reauthorizing the fees charged to manufacturers to review the safety of prescription drugs and medical devices. He has also called for hearings on “mega-mergers” like the proposed merger between CVS and Aetna and worked with other Democrats to counter Republican attempts to undermine the Affordable Care Act.

Unsurprisingly, his influence over health care issues has attracted a lot of money from pharmaceutical companies, health professionals, HMOs and other industry players. By mid-October, Pallone had received more than $945,000 in campaign contributions from  the health sector for this election, according to the Center for Responsive Politics. According to a KHN analysis, nearly $170,000 came from political action committees associated with pharmaceutical companies.

The Committee on Oversight and Government Reform: Rep. Elijah Cummings, Maryland 

Cummings could prove the pharmaceutical industry’s biggest headache come next year. Having served as the committee’s ranking member since 2011 — a post that lacks the chairman’s subpoena power — he has been champing at the bit to hold drugmakers accountable.

Shortly after Trump’s inauguration, Cummings approached him about working together to lower the cost of prescription drugs (to no immediate avail), and he has partnered with other lawmakers to demand information from pharmaceutical companies about their drug pricing strategies. Previewing what a Cummings-led committee might look like, he has even launched his own investigations into drug costs, releasing reports with his findings.

Drugmakers have wasted few campaign contributions on Cummings: He has received just $1,000 from their PACs this election, according to data analysis by KHN.

In a statement to Kaiser Health News, Cummings said Democrats would conduct “credible, responsible oversight” of the Trump administration, adding: “For healthcare, that means investigating skyrocketing prescription drug prices, actions that would threaten protections for people with preexisting health conditions, and efforts to undermine the Medicaid program.” 

The Committee on Ways and Means: Rep. Richard Neal, Massachusetts

Ways and Means oversees Medicare and influences health policy through its jurisdiction over taxes. Though Neal became the top Democrat on this committee in 2017, he has been involved in health care much longer, having played a part in the crafting of both the Affordable Care Act and the failed reform effort under the Clinton administration in 1993.

Facing a primary challenger who touted her support for “Medicare-for-all” in his deep-blue district, Neal denied that he opposes the progressive single-payer proposal. But he also said Democrats should focus on shoring up the Affordable Care Act, particularly its protections for those with preexisting conditions and caps on out-of-pocket expenses. (He won handily.)

The health sector was by far one of the top contributors to Neal’s re-election campaign this year, giving more than $765,000, according to the Center for Responsive Politics. Neal’s district includes the headquarters of several health insurers and other medical companies, which makes him a prime target for campaign contributions.

The Committee on Appropriations: Rep. Nita Lowey, New York

If chosen, Lowey would become the first woman to chair the powerful House Committee on Appropriations, holding the nation’s purse strings.

Like Neal and Pallone, Lowey was first elected to Congress in 1988, and she became the committee’s top Democrat in 2013. She has been a dedicated and effective advocate for investing in biomedical research into major diseases like diabetes and Alzheimer’s, as well as public health programs like pandemic preparedness.

She has also long championed women’s health issues, proving a vocal critic of the Trump administration’s proposed gag rule on Title X funding, among other policies. Watch for her to continue to push back on the administration’s efforts to restrict access to abortion rights.

And on the Senate side, the Committee on Finance: Sen. Chuck Grassley, Iowa?

The rumor mill favors Grassley, the Republican who has served most recently as the chairman of the Senate Committee on the Judiciary, to replace retiring Sen. Orrin Hatch (R-Utah).

Senate Republican leaders have signaled that entitlement programs like Medicare and Medicaid could use trimming and, with Republicans emerging from the midterms with a slightly bigger majority, this committee could have its hands full.

Hatch proved a friend to the pharmaceutical industry, and his war chest reflected that, taking in more than $850,000 in campaign contributions from drugmaker PACs in the past decade alone, according to a Kaiser Health News analysis. But Grassley has taken a more adversarial approach to the industry, working with a Democratic colleague last summer to pressure drug companies to list their prices in direct-to-consumer ads, for instance.

Grassley held the chairmanship from 2003 to 2006, leaving him two more years at the top, should he want it. (Senate Republican chairs may serve for only six years.) But he might choose to stay on as head of the Judiciary Committee, in which case the next chairman may be the next-most-senior Republican: Sen. Mike Crapo of Idaho.

Drugmakers Switch Gears This Year With Big Bankroll For Democrats

Pharmaceutical companies have contributed heavily to candidates, with 63 percent of their donations going to Democrats, Stat reports. And in other election-related news, KHN explains the “Medicare-for-all” buzz. Plus, how anti-vaccine supporters are backing candidates and a look at where the Georgia gubernatorial candidates stand on health issues.

FDA OKs Strong Opioid Pill Ten Times Stronger Than Fentanyl Despite Abuse Concerns

Health experts said the pill isn’t needed and will only worsen the opioid epidemic. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. Other news on opioids focuses on the FDA’s armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.

FDA OKs Strong Opioid Pill Ten Times Stronger Than Fentanyl Despite Abuse Concerns

Health experts said the pill isn’t needed and will only worsen the opioid epidemic. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. Other news on opioids focuses on the FDA’s armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.

Safety-Net Hospitals Win With New Rule That Penalizes Drugmakers For Overcharging

Under a new Trump administration regulation, pharmaceutical companies face a fine of up to $5,000 for overcharging hospitals and clinics that qualify for the 340b program. In other drug pricing news, 40 large employers like IBM, Verizon, and American Express will use an online tool from startup Rx Savings Solutions to help employees get better deals on prescriptions.

New Heart Drug Spotlights Troubling Trends In Drug Marketing

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Dr. Eric Strong, a hospitalist and clinical assistant professor at Stanford School of Medicine. “It’s harder to change people’s minds once you have these rosy pictures.”

John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers, and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data — for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement — that illustrate whether a product is cost-effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products —arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, a biologist who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43 percent over five years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again — though Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz — is it too late?

Dr. Khurram Nasir, a Yale cardiologist, acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Nasir said.

Mason, the Amarin scientist, said FDA scrutiny can also alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Dr. Lisa Schwartz, who co-directs the Dartmouth Institute’s Center for Medicine and Media and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” — that is, the 25 percent relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah — when it may just reduce the least important one,” said Dr. Steven Woloshin, Schwartz’s research partner.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Woloshin and Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Schwartz said.

Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved — so long as the company doesn’t say anything untrue about the drug.

Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there … and its results in these populations,” said Dr. Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”