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Drug’s ability to lower frequency of migraines by 50 percent sounds pretty good–until you read the fine print

Rating

3 Star

Categories

Tags

FDA approves new drug that prevents migraines without side effects

Our Review Summary

This NBC News story takes a look at a newly approved migraine drug.

We liked how the story included the cost of the drug, and discussed the lack of effective options for many patients.

But the story could leave readers thinking the drug works better than it really does, because it only quotes the drug company’s rosy summary, and not what the FDA reported.

 

Why This Matters

Millions of Americans suffer from migraine attacks that greatly diminish their quality of life. There is currently no preventive medication with no side effects approved for patients who suffer from chronic or episodic migraines. This new drug has been hyped by Novartis’ and Amgen’s PR machines since clinical trials for them first began. It is important that people with migraines and their family members and friends (who often forward on anything and everything written about products that claim to reduce migraine attacks) are given accurate information about who a new drug is for and the extent to which it can actually improve people’s lives.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story accurately reports that the list price for the self-injection will be $575 per month or $6,900 annually.

Even so, it’s disconcerting that the story includes this language from a news release: “The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers and employers, while also factoring in critical issues such as patient affordability, and fair and timely access.”

The article does note that Amgen said this in a statement. However, the claims go unchallenged by any individual or organization who might not agree that the drug’s price reflects its value.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The article, using text adapted from the Amgen/Novartis news release, makes the reduction in headache days sound very impressive, explaining it “reduced the average number of monthly migraine headaches by more than 50 percent for nearly half of study participants. After three months, patients treated with the human antibody were nearly three times more likely to have reduced their migraine days by 50 percent or more than those treated with placebo.”

This is followed by “Participants of the study also had a greater average reduction in the number of days with headaches and the number of days they needed to take drugs to stop the migraines.”

The FDA news release makes the benefits seem less rosy when describing the findings from the three studies that led to the drug’s approval. It explains that in one study, “over the course of six months, Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo.” The release also notes that in a second study, also in patents with episodic migraine, the patients on Aimovig had, on average, one fewer migraine day per month than those on placebo” while the third study, which enrolled patients with chronic migraine (15 migraine days or more per month) found patients had, on average, 2 1/2 fewer monthly migraine days than those on placebo.

We noted a similar problem in a Reuters article about the drug published in April.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The headline shouts “no side effects.” Yet, the FDA press release says the most common side effects were injection site reactions and constipation.

To date, there is virtually no long-term data on the drug and that needed to be emphasized. One study that led to the drug’s approval reported on patients who had taken the drug for six months. The two other studies reported on patients who had taken the drug for three months. The patient quoted in the article has been on the drug for four years, without side effects. But that is an anecdote. There is no data on long-term use.

The story states: “No patients taking erenumab stopped treatment due to adverse side effects, but the scientists noted that more research will needed to investigate if the benefits continue.”

The story also states that drug is “formulated as an injection to provide long-lasting protection.” It is given by injection because it was designed as a monoclonal antibody. These drugs are given only by injection, and they are known to cause side effects.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story does not contain enough information about the evidence. For example, did patients in the placebo groups also receive an injection?

Does the story commit disease-mongering?

Satisfactory

The story did not disease-monger; there are millions of people who get migraines. That is not in question. Which of the people who get migraines who may potentially be candidates for this drug is less clear.

The drug’s marketing materials released along with press release announcing FDA approval say “preventive medication may be an option for approximately 10 million Americans with migraine.”

The article notes that the Migraine Research Foundation estimates that more than 39 million Americans suffer from migraine attacks. However, it then goes on to confuse definitions and statistics for chronic and episodic migraine, stating that of that 38 million, “about 4 million have chronic migraine and suffer headache for 10 to 14 days per month.

In the medical field, a person with 15 or more migraine days a month is considered chronic;  a person with 14 or fewer migraine days has episodic migraine.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story quotes the study’s lead researcher, Dr. Peter Goadsby, a professor of neurology at Kings College London and the University of California, San Francisco. It does not include the information that Dr. Goadsby is an advisor or consultant for, among others, Amgen and Novartis. He also received grants for clinical research from Amgen–a clear potential conflict of interest.

A second source in the story is Dr. Dario Zagar. CMS Open Payment reveals he has received payments from Amgen and numerous other drug companies. This information should have been disclosed.

The story quotes one patient who has been on the drug, and who says she now never has migraines. It does not quote anyone who was in the study who did not benefit from the new drug.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story explains that there are other treatments that migraine patients can use to prevent or abort migraines. It also notes that these alternatives do not work for everyone.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story tells readers that the drug has received FDA approval and “should also be paid for by health insurance.”

As STAT News points out in this article, it is not yet known whether private insurers or Medicaid or Medicare will cover the medication. Even if private insurers do cover it, patients may be responsible for a co-pay or coinsurance that puts the drug out of their reach financially.

The article also does not tell readers that Amgen and Novartis have a patient assistance program called Aimovig Ally that can help them learn about their insurance coverage or possibly get the drug for a reduced cost.

Does the story establish the true novelty of the approach?

Satisfactory

The story states that this is a new class of drug for migraines.

Does the story appear to rely solely or largely on a news release?

Satisfactory

Sources are quoted who were not included in the news release put out by Amgen and Novartis.

Total Score: 6 of 10 Satisfactory

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