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Older drug retested for managing Parkinson’s disease symptoms: What are the costs and harms?

150-year-old Drug May Provide ‘Off’ Time Relief for People with Advanced Parkinson’s Disease

Our Review Summary

No mention of the harms and costs of apomorphine in treating Parkinson’s disease symptoms are found in this American Academy of Neurology news release.

The study followed 107 people with advanced Parkinson’s disease for 12 weeks after treating them with either apomorphine or placebo. The study measured the participants’ “off” times, which refer to periods when a medication isn’t working well, causing symptoms to worsen.

Although the news release provides in-depth historical context and information on the availability of the drug, we wish it could have more critically evaluated the evidence, as well as provided more numbers to illustrate the benefit claims.

A discussion on the limitations of evidence, namely how this study may have been through limited peer review, would have been useful. The news release does disclose the funding source — Britannia Pharmaceuticals, the maker of apomorphine — but it doesn’t mention that the first author has received speaking and consulting fees from Britannia for at least 8 years.

 

Why This Matters

Parkinson’s disease is a progressive disorder affecting the nervous system caused by the loss of dopamine-producing brain cells. It affects more than 4 million people worldwide, according to the US National Library of Medicine. About 60,000 new cases are identified each year in the United States.

Although there is no cure, many of its symptoms (including tremor, slowed movement, rigidity and problems with balance) can be managed with drug therapies, the main one being levodopa. After long-term use, however, the benefits of levodopa may wear off more quickly after each dose, prolonging “off” times in Parkinson’s patients. If there is another medication that is safe and shortens “off” times, it may provide help to patients who develop resistance to a certain drug, especially with long-term use.

Criteria

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

Not Satisfactory

According to GoodRx.com, 20 cartridges or 3 mL of apomorphine cost between $20,000 to $21,800 depending on the pharmacy. The exact dosage isn’t disclosed, but we know that the infusion was administered via a small portable pump for 14 to 18 hours each day for 12 weeks.

Since costs are not discussed in this news release, we give it a Not Satisfactory rating here.

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

Satisfactory

The news release says that on average, volunteers assigned to apomorphine had 2.5 hours less “off” time per day, while those who received the placebo infusion had an average 30 minutes per day reduction in “off” time during the first week of the trial.

Participant-reported scores on how well they thought the treatment worked were also provided:

“Participants were also asked to evaluate how well they thought the treatment worked. Those who received apomorphine gave their treatment higher scores at week 12 than those who received the placebo infusion. In the apomorphine group, 71 percent of patients felt improved, compared to 18 percent on placebo, whereas 19 percent worsened on apomorphine compared to 45 percent on placebo.”

While improvement is given in percentages (and we like to see absolute numbers as well) this does illustrate an absolute rate of improvement and we rate it Satisfactory.

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

Not Satisfactory

Apomorphine is associated with a slew of side effects – the more common ones being chest pain, chills, cold sweats, confusion, falling asleep during activity, dizziness, mood changes, swelling and twitching. Less common include fainting, low blood pressure, sweating and vomiting. Rare adverse events are irregular heartbeat and recurrent fainting.

In the study, apomorphine was generally well tolerated, and no serious side effects were observed, the news release states. No other safety information is given.

One 2009 study looked at the safety of apomorphine when treating “off” episodes in subjects with advanced Parkinson disease. Out of the 546 subjects in the study population, 187 participants discontinued treatment because of side effects, which included nausea and vomiting, dizziness, somnolence, hallucination, yawning, and injection site bruising. The authors concluded, “Long-term use of intermittent apomorphine dosing for treatment of ‘off’ episodes was generally associated with mild-to-moderate adverse effects.”

Another recent 10-year observational study concluded, “Many patients cannot be maintained on AI in the longer term” due to adverse effects and inadequate motor benefit.

We wish the news release talked more in depth about the drug’s potential harms, which is why we give it a Not Satisfactory rating here.

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

Not Satisfactory

The news release does a good job outlining the study design. This was a placebo-controlled, randomized, multicenter phase III study, in which researchers followed 107 people with advanced Parkinson’s disease for 12 weeks. The infusion was administered via a small portable pump from 14 to 18 hours per day.

What’s missing here is a discussion on the study’s limitations, namely the lack of peer review. Since this study was presented at a medical conference, it may only include preliminary findings and probably also went through a limited peer review process. Peer review is important in establishing the quality and integrity of the science before publication in a journal.

Since limitations of the evidence are not discussed, we give the news release a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release. It provides context about the history of the drug. A statement on the incidence of Parkinson’s disease would also have been helpful in understanding the scope of the problem.

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

Not Satisfactory

The funding source of this study was Britannia Pharmaceuticals, a UK-based pharmaceutical company specializing in the neurology market, according to its website.

However, the release doesn’t mention that the first author of the study had received research grants from numerous pharmaceutical companies, including Britannia and that the principal investigator is also a consultant for Britannia and serves on its advisory board.

We rate this Not Satisfactory for not disclosing a long-term financial relationship between the author and the drug sponsor.

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

Satisfactory

The release gets a Satisfactory for noting that the oral drug levodopa is the gold standard treatment for Parkinson’s disease. The release would have been better had it also addressed some comparison between levodopa and the drug discussed in this release.

Also not mentioned are other treatment possibilities include dopamine agonists and deep brain stimulation, a surgical procedure that sends electrical pulses to the brain and helps stabilize medication fluctuations.

We think it would present a clearer picture had the release mentioned some of the other existing and newer emerging treatments for this condition.

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

Satisfactory

The news release makes it clear from the start that apomorphine is not a new drug, as the headline refers to it as a “150-year-old drug.” Since the news release gives a brief historical overview of the drug, we feel it merits a Satisfactory rating here.

The release would have been better if it had mentioned whether or not it’s covered by insurance as an FDA approved treatment for Parkinson’s disease.

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

Satisfactory

The news release makes clear that apomorphine is not a new drug and also states that the new study contributes to the existing body of literature. We give it a Satisfactory rating for explaining that high-level evidence from randomized, blinded studies on the drug’s safety and effectiveness is lacking until now.

The study abstract on the American Academy of Neurology website states that this was the first prospective, randomized, multi-center, double-blind study to evaluate the efficacy of apomorphine infusions versus placebo in Parkinson’s patients.

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

Satisfactory

The news release does not use include unjustifiable, sensational language.

Total Score: 6 of 10 Satisfactory

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