We’re fully prepared to believe that there are ways to more accurately administer proton beam therapy with fewer side effects and lower costs. This release makes just those claims and yet provides nothing to back the claims up. There is no quantification of benefits. No true exploration of risks. No explanation of the quality of the evidence. And no true comparison of alternatives.
The release muddies the water on what kind of nod it got from the US’s regulatory agency. The company received FDA “clearance” to market the device but not an “approval.” (See the discussion under the Quality of Evidence criteria.)
Proton beam therapy represents an alternative form of radiotherapy compared to conventional x-rays. Interest in this form of therapy has grown based upon its ability to deliver higher doses of radiation to a smaller field. This may improve the benefit and reduce the harm for patients with cancer who need radiotherapy.
Although not a focus in this release, the proven outcomes of proton vs. conventional radiotherapy in terms of benefits (increased survival) and harms (less damage to surrounding normal tissue) are less clear than the proponents of proton therapy would like to admit. For many cancers, conventional therapy may be adequate. Here the question is whether the delivery of proton beam therapy to patients who are getting it can be enhanced by delivering the treatment to the patient in a seated compared to a flat position. One can imagine for some patients that may lead to a more comfortable treatment, but it isn’t clear how many would derive a measurable benefit.
The release focuses on decreases in the discomfort of treatment and implies that some who may not otherwise tolerate this therapy could now have it. All interesting, but no information is provided to support the release’s claims. Finally, the release focuses on the potential benefits to the proton beam center in terms of its costs — but patients will have other questions about cost such as whether the device is more expensive than what the center is currently using. If so, those costs may be passed on to insurers and thus patients based upon the specifics of their policy. As such, it isn’t clear whether the “clinical breakthrough” or “paradigm shift” will be apparent to the average patient undergoing this form of cancer treatment.
We were pleased to see the potential economic impacts of this therapy raised in the release. The release says, “In addition to the clinical benefits of P-Cure’s solution, there are also significant economic advantages to treating patients in a seated position.” However, the cost savings refer to the reduced capital investment for the proton beam center, not the cost for patients. The release is basically arguing that the device will decrease the cost for the center per patient treated, and will accomplish this by making it easier to get treatment done and make it more accessible, affording extra time to bring in more patients. This is not exactly the cost that the patient is thinking about.
We give the release credit for raising the financial issue but at least one cost-related number is needed here.
There are many claims of benefits in this release, none of them quantified:
For the patient, the real question is whether this device makes the treatment any better. If not, then does it make it any easier, more comfortable or shorter? There is no data provided.
The release makes no mention of any harms associated with this therapy. As noted above, it makes passing and not numerically defined, reference to the potential harms of standard proton therapy, meaning radiation hitting parts of the body that don’t need radiation treatment.
The release states indirectly who this wouldn’t work for by giving the cancers that may be treated. The question of harm/benefit also depends on what the goal of the device. Is it to help patients already selected for proton beam therapy or to bring in patients who otherwise would be treated using conventional radiotherapy? Consideration of benefits and harms would differ, but neither is addressed.
The release is less precise than it should be when using the term “approval” when it says the company “has received U.S. Food and Drug Administration (FDA) approval for its patented upright imaging solution.” The company received “clearance” to market the device but not an “approval.” The implication of a premarket “approval” is that the company had to provide proof of safety and effectiveness, whereas a “clearance” such as we have here indicates only that the devices was deemed similar to other approved devices. See the FDA’s discussion on “What does it mean when FDA “clears” or “approves” a medical device?”
According to an August 8, 2016 letter to P-Cure granting marketing approval, the FDA wrote that the agency has
“determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices…that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act.”
This is an extremely low bar. The clearance doesn’t require any proof that it benefits patients or doesn’t harm them. The device was deemed substantially similar to existing devices that are already FDA approved.
The FDA market clearance letter further stated the device’s “Indications for Use:”
“The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.”
There is no disease mongering in the release. It just plainly states that “Adult and pediatric patients who will initially benefit from this clinical breakthrough will be those treated for cancers of the lung, breast, chest, the head and neck, and lower torso.”
We’d like to point out, though, that the release implies that there is an abundance of demand for this type of therapy (whether evidence-based or not) and the only limit is the supply.
It is clear that the release comes from P-Cure, the company that is producing the proton therapy being touted in the release.
The device is being compared to existing devices used to deliver proton beam therapy. As such, there is a comparison. although it’s a bit opaque. It points out that standard proton therapy may radiate healthy body parts inadvertently. It causes more discomfort. It costs too much. These statements could have been elucidated, preferably through quantification, to create a meaningful comparison for reporters and patients.
The release makes it clear that this therapy has just been cleared and that proton therapy is currently not widely available.
The release refers to this as a “clinical breakthrough.” While that may be a heavy-handed statement, the device is a modification of prone delivery of proton therapy and is clearly a device that is not currently in wide use.
The release uses the terms “clinical breakthrough” and “paradigm shifting” to describe the device but without the evidence (as noted above), this falls short. It’s unclear that the benefits will be apparent to the average patient undergoing this form of cancer treatment.
It could be that the statement that the device is a “paradigm shifting change from the current method of treatment with the patient in the horizontal position” is justifiable — if a bit too ebullient — since the paradigm for proton therapy now has people lying down. If this treatment is successful it will have more people sitting up. We would prefer, though, that if a release is going to make as many claims as this one does that it provide some evidence.