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Easing the Pain: New Hope for Migraine Sufferers

Rating

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Easing the Pain: New Hope for Migraine Sufferers

Our Review Summary

This television news story discusses drug treatments for the relief of migraines, namely, a drug called Trexima, which is a combination of naproxen sodium and sumatriptan. While the pill is being promoted as a “newer treatment”, there is absolutely nothing new about these drugs. Sumatriptan is a drug that is effective in relieving pain and sometimes aborting an acute migraine by blocking some of the inflammatory substances from nerve endings; naproxen sodium reduces inflammation already begun. Some of the accompanying effects of a migraine, such as nausea and sensitivity to light or sound, may be reduced by sumatriptan or the combination of the two drugs. There is no mention of prevention anywhere in the story, which is an oversight, as the key to migraine management is prevention. This is done first with identification of triggers and then with prophylactic drugs such as beta blockers. The reporter mentions Trexima as if FDA approval was a fait accompli, yet the combination drug is still being studied. Methods of medication delivery other than Trexima in pill form are also still under investigation, although sumatriptan alone was approved as a nasal spray in 1997. Other than mentioning sumatriptan or naproxen sodium alone, there is no comparison with other well-tested “current migraine medications”, such as the combination of aspirin, acetaminophen and caffeine available OTC. In one large trial (ASSET), this combination did better than sumatriptan (without the combination of naproxen sodium) at reducing headache intensity and migraine symptoms. It may be a “decade since a major new treatment for migraines hit the market”, however, the focus here is on pharmaceutical treatments alone. While 30 million people may suffer from migraines, not all migraines are incapacitating or require a prescription medication, and there are some effective behavioral and lifestyle modification treatments for reducing the severity of migraine pain. The news story provides anecdotal evidence from two people whose migraine pain decreased (but did not stop completely) with the combination drug; however, no quantitative evidence on the effectiveness of Trexima vs. other migraine medications is discussed. More importantly, there is no discussion of side effects of the combination pill, which included chest tightness, dizziness and sleepiness in a small number of people involved in clinical trials. Nausea due to the migraines may be decreased, but NSAIDs such as naproxen sodium can cause gastrointestinal problems. Migraines can be chronic and longer-term pain relief (beyond 24 hours) is also not discussed. No information is provided on the cost of treatment for any migraine mediation, including the new combination drug, other prescription headache medications or other methods of medication delivery for migraine relief. NSAIDs, including certain strengths of naproxen sodium, are available OTC and would likely be less expensive than Trexima. It might be important to note that the patent for sumatriptan expires on December 28, 2006. The combination drug will cost considerably more than the individual components. One wonders if this story is the start of a PR push to promote the “newer” drug combination. Lastly, there is no mention of a possible conflict of interest for Dr. Richard Lipton or Dr. Merle Diamond, the headache specialists interviewed. We do not know if their headache centers or research are funded by pharmaceutical money, including Glaxo, makers of Trexima.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No information provided on the cost of treatment, either new combination drug or other methods of delivery for migraine relief. NSAIDs are OTC and would likely be less expensive alone than in combination with a prescription.

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

Not Satisfactory

The story gave no quantitative evidence from trials on Trexima or other migraine medication delivery methods. Migraines can be chronic and longer-term pain relief (beyond 24 hours) was not discussed. Non-drug alternatives were not discussed.

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

Not Satisfactory

The story didn’t discuss side effects of the combination pill, which included chest tightness, dizziness and sleepiness in a small number of people involved in clinical trials. Does not provide disadvantages of this combination. Nausea due to the migraines may be decreased, however, NSAIDs can cause gastrointestinal problems.

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

Not Satisfactory

The story gives no quantitative evidence from trials on Trexima or other migraine medication delivery methods. There is anecdotal evidence from two people whose migraine pain decreased (but didn’t stop completely) with the combination drug. In a trial of 50 mg sumatriptan and 500mg of naproxen sodium there was greater pain-relief for acute migraines than either drug alone or placebo (Smith, T. R., A. Sunshine, et al. (2005). “Sumatriptan and naproxen sodium for the acute treatment of migraine.” Headache 45(8): 983-91.)

Does the story commit disease-mongering?

Not Satisfactory

30 million people may suffer from migraines, but not all migraines are incapacitating or require a prescription medication.

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

Not Satisfactory

No mention of possible conflicts of interest for Dr. Richard Lipton or Dr. Merle Diamond, headache specialists. Did the reporter ask?

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is no discussion or comparison with other well-tested “current migraine medications” such as the combination OTC of aspirin, acetaminophen and caffeine. In one large trial (ASSET) this combination did better than sumatriptan (without the combination of naproxen sodium) at reducing headache intensity and migraine symptoms. It may be a “decade since a major new treatment for migraines hit the market”, but that’s only talking about drug treatments. There are, indeed, several well-tested drug options currently available for migraine and a comparison of these with Trexima is warranted. There are some effective behavioral and lifestyle modification treatments for reducing the severity and incidence of migraines.

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

Not Satisfactory

Treats FDA approval of Trexima as a fait accompli – “could be on the market within a year is Trexima.” The just-as-accurate flip side of that is that it may not be on the market within a year. Things go wrong in the FDA approval process. Methods of medication delivery other than pill form are also still under investigation.

Does the story establish the true novelty of the approach?

Not Satisfactory

Mentions that combination drug is new, but neither drug by itself is new for treating headache pain. Sumatriptan tablets were FDA approved in 1995; sumatriptan nasal spray in 1997. ME: There is absolutely nothing new about the drugs or the concept. Also there is no mention of prevention anywhere in this story. The key to migraine management is prevention. This is done first with identification of triggers and then with prophylactic drugs such as beta blockers.

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

Not Applicable

We can’t be sure if the story relied solely on a news release.

Total Score: 0 of 9 Satisfactory

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