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L-DOPA associated with delayed macular degeneration. There’s a patent for that.

Study: Drug may delay, prevent blindness for millions of older Americans

Our Review Summary

man with macular degenerationThis release explains results from a review of health records of thousands of patients with age-related macular degeneration (AMD) who also had taken the drug levodopa (L-DOPA). Researchers questioned whether the drug might slow or prevent the onset of this disease. They found an association between delayed onset of AMD in seniors who took L-DOPA. These patients were diagnosed with AMD up to eight years later than those not taking the drug. The release is mostly cautious about presenting the association but omitted some information we consider crucial, namely costs, alternative therapies, the absolute size of the benefit observed, and full disclosure on a significant conflict of interest.

 

Why This Matters

Age-related macular degeneration (AMD) is a serious illness affecting millions of the elderly. It is the number one cause of blindness among older people and robs them of their central vision, leaving only peripheral vision in most cases. This impairment severely affects their quality of life. The discovery of an association between the drug levodopa (L-DOPA) and AMD through a large data search may lead to better understanding of how AMD starts if a future randomized trial validates the hypothesis. If an existing drug is shown to be effective against AMD, it could save both time and expense in bringing a therapy to patients in need.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

While the release is relatively cautious, it fails to mention the costs of its suggested treatment in any way. One assumes from the release that patients would be taking L-DOPA for a considerable length of time, which could represent a substantial expense. L-DOPA has been prescribed for patients with Parkinson’s disease and other maladies for years and offering an estimate of yearly costs of the drug should have been easy, and would have helped readers gauge the value of this research in terms of patient care. Levodopa is generally prescribed in combination with another drug or drugs but the treatment cost of L-DOPA alone is several thousand dollars annually.

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

Not Satisfactory

The release states that, based on the evaluation of a 37,000 clinic records of patients who took L-DOPA and noting those from the group that also developed AMD, that there appears to be a correlation between patients’ taking of L-DOPA and their later development of AMD. It states that those taking the drug tend to develop the disease eight years later than those who don’t. The release also suggests that in addition to delaying onset of the disease, the drug may also prevent it, although it is less clear in that claim. However, these numbers only portray relative risk rather than absolute risk and the number needed to treat (NNT). The numbers of people who developed AMD was relatively small, making it likely that the NNT would be very large (very many need to be treated in order to prevent or delay one case of blindness). Because the statistics used do not give readers a complete sense of the benefits attributable to to L-DOPA, we’ll rule this Not Satisfactory.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

At no point does the release mention any harmful effects from taking L-DOPA.  And while patients might arguably be willing to face greater risks in order to retain their eyesight, it doesn’t excuse the release for omitting relevant details. L-DOPA has been given to patients for years and the list of possible side effects — both physical and mental — is considerable. Patients reading stories or releases touting the possible treatment use of new drugs deserve to know the full story including possible negative effects of the drug’s use.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

To its credit, the release explains early — in the second paragraph — that the research is a retrospective study of patient records. This informs knowledgeable readers of the inherent limitations of retrospective studies but readers not familiar with research may not understand that retrospective studies cannot show causality, that one thing leads to another. We’ll give them a grudging satisfactory in this category but with a caution about the overall message of the release — that L-DOPA can delay or prevent AMD. It may very well do so, but this kind of study cannot prove that. But again, transparency is offered when the authors of the study are quoted saying that this research justifies the performance of future randomized clinical trials specifically looking at the benefits and any additional risks of long term L-Dopa for prevention or delay of AMD.

Does the news release commit disease-mongering?

Satisfactory

While it describes the prevalence of AMD, the release doesn’t commit disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release identifies the funding sources of this research but does not alert readers to the conflict of interest disclosure found in the published results. While the lead author has not yet received income from the drug application, he is the patent holder. “Dr. McKay is an inventor on an approved patent for the use of L-DOPA to treat or delay AMD,” according to the published paper. Just because he hasn’t received royalties yet doesn’t mean he or his institution will never accept royalties if and when L-DOPA is approved for treating AMD. The release should have called attention to this. 

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

No alternatives are mentioned. While there is no known effective cure for AMD, there are treatments available to slow the progression of the disease or prevent severe vision loss including drug injection, laser therapy and vitamin supplementation.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

L-DOPA is readily available to patients now and the story makes this clear.

Does the news release establish the true novelty of the approach?

Satisfactory

The idea that an established drug might be effective against a disease other than what it was intended to treat is novel enough to justify a release touting the findings of an acceptable studyAnd the release makes clear that this study was prompted by earlier studies in mouse models that supported a role for L-DOPA in AMD.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We’ll give the benefit of the doubt here because the release does not use overtly unjustifiable language. But the use of words such as “prevention” implies causation, which this study was incapable of showing. A better way to phrase this might be to say “There is an association between taking L-Dopa and having AMD start at a later age.”

Total Score: 5 of 10 Satisfactory

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