This story touts the FDA’s approval of a pricey injection to treat serious cases of chronic skin inflammation known as eczema. While it correctly portrays eczema as a potentially debilitating condition, it left out any meaningful discussion about the evidence behind the approval for the new drug Dupixent. Also lacking: Any independent sources who can serve as a backstop to over-the-top or anecdotal claims about the new drug.
And while we applaud any discussion of costs when it comes to blockbuster drugs, this story plays up the manufacturers’ justifications for their $37,000 annual price tag with no analysis from independent economists.
High costs for prescription drugs are one driver hobbling the U.S. healthcare system. Stories that portray the benefits of blockbuster drugs using selective patient anecdotes may prompt patients who aren’t as likely to benefit to pressure doctors into prescribing it, particularly when those patients are insulated from the cost by drug company patient assistance schemes.
This is a barely passing satisfactory rating–the story did disclose the cost of $37,000, but overlooked some important details when it then tried to explain that manufacturers think the actual cost to patients will be lower.
The full picture is more complicated. Drug company patient-assistance programs — which help patients cover co-payments and other out-of-pocket costs — are abhorred by economists because they shield patients from treatment costs and undermine the ability of insurers to steer patients to less expensive options.
In addition, an accompanying video states “a billion and a half dollars” was spent developing the drug but doesn’t point out that the purported development cost is small compared with the potential profits. If all 300,000 people the manufacturers of this drug say are “most in need of treatment options” receive this drug, the total cost could be as high as $11 billion a year, funds that must be diverted from other healthcare priorities or come from higher premiums or taxes. That broader analysis was missing in this story.
An independent draft analysis showed dupilumab did improve health outcomes compared to usual care but with additional costs, and that the drug did fall below commonly cited standards for cost-effectiveness. Still, the study relied on some uncertain variables and found the drug was most cost effective for patients with severe conditions.
The story states that studies in about 2,000 people showed injections “resulted in clear skin or nearly clear skin for about two-thirds of those who tried it, and it reduced itching sharply in 40 percent.”
This is enough for a satisfactory rating, but the story should have mentioned that close to 10 percent of patients on a placebo saw the same improvement in their rash. It also would have been stronger if it had explained how the benefits were measured (how is a “sharp” reduction in itching measured?), how much time it took to achieve the results, and if the results were sustained.
The story states that “the drug can cause serious allergic reactions and eye inflammation. ‘The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching,’ the FDA notes.”
This is sufficient, but one important detail we think is worth noting: The FDA gave the drug “breakthrough therapy status,” meaning that long-term impacts were not studied.
The story doesn’t give us enough details about the research, all readers are told is that there were “studies of about 2,000 people,” but nothing is said about when or where these studies were published, how high-quality the studies were (were they double blinded?), or whether there were important limitations to keep in mind.
The video portion of this story focuses on one dramatic patient anecdote involving actress Calico Cooper, the daughter of rock star Alice Cooper, who describes her condition as going from a “nightmare” to one in which she “will now be able to keep performing” as a result of the drug.
It’s important to keep in mind that not all patients experienced this benefit. In fact, just under 40 percent of patients who received dupilumab injections in clinical trials saw symptom improvements after 16 weeks, compared with 10 percent of those given a placebo. The story also doesn’t mention that longer trials are needed to assess the long-term effectiveness and safety of this medication.
While we would have liked to see independent sources used here, the story doesn’t go overboard in stating the impact of the disease, though it is pretty dramatic:
“People with moderate to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” Julie Block, president and CEO of the National Eczema Association, said in a statement provided by the company.
It also attempts to delineate who could benefit from this drug, quoting one of the manufacturers:
“Of the adults with uncontrolled moderate to severe atopic dermatitis in the United States, it is estimated that 300,000 are most in need of new treatment options,” Regeneron said.
It further states, “Dupixent is for the hard-core cases that aren’t helped by anything else.”
The story lacks independent sources. It uses a quote from the head of the National Eczema Association without mentioning that the association lists the manufacturers of this drug as among its top funders. According to the group’s web site, the companies are “sapphire” level sponsors, which have contributed $50,000 or more.
The video also doesn’t disclose that Dr. Paul Yamauchi of UCLA, who calls the drug a “game-changer,” has been hired by the manufacturers of this drug as an investigator as well as an advisor and/or speaker, according to public disclosures.
The story states:
There are many treatments out there now, from simple skin lotions to steroid creams and immune suppressant drugs like tacrolimus. But none of these works for everybody, and the immune suppressant drugs can raise the risk of cancers such as lymphoma.
The story makes it clear that the drug is now FDA approved for sale. It also says the drug “is a twice-a-month injection under the skin. Patients can do it at home.” However, it didn’t broach the topic of how likely insurance companies are to cover this drug. Patient demand is likely to be high, but insurers may push back due to the high cost.
The story alludes to distinguishing features of the drug and notes that the FDA “gave it both priority review and breakthrough therapy status, speeding it through the approval process.”
It could have done a better job of explaining how many people are likely to benefit, other than the 300,000 the manufacturers describe as “most in need of treatment options.”
This is barely passing: The story relies heavily on a news release but also contains material that isn’t from the news release.