By Jasper Craven FEBRUARY 3,
2020
A
partnership between the Department of Veterans Affairs and Silicon Valley
startup Virta Health Corp. is focusing attention on the company’s claim that it
provides treatment “clinically-proven to safely and
sustainably reverse type 2 diabetes” without medication or surgery.
The
assertion is at the heart of an ongoing debate about the keto diet’s effect on
diabetes. Some diabetes experts are skeptical of Virta’s promise and are
expressing concerns that the company’s partnership with the federal government
is giving the diet too much credence.
The
agreement has helped raise the national profile of Virta, a fledgling health company that has
developed a proprietary system of remote coaching and monitoring for people
with Type 2 diabetes to help them follow the keto diet, which is high in fat
and low in carbohydrates.
Despite
its strict requirements, the keto diet has gained popularity in recent years
with consumers and studies noting it helps shed pounds and can lead to improved
health. But the company’s claim about reversing diabetes is unusual. Type 2
diabetes is often linked to excess weight, and the company said its studies
suggest that significant weight loss through keto can lower patients’ blood
sugar and need for diabetic medications.
The
diet has won support among some diabetes researchers and patient groups. But
other public health advocates are concerned that the science of treating
diabetes with a keto diet is not well studied. They worry about keto’s effect
on the heart and the paucity of vegetables and fruits generally in the diet.
In
a press release announcing
the collaboration, VA Secretary Robert Wilkie said Virta’s regimen would help
the department create “a more comprehensive approach to care.”
Under
the accord, Virta is providing its services free to about 400 VA patients for a
year while federal officials evaluate the service and their health.
In
November, Virta announced in a news
release that the initial 90-day results were promising. It said veterans
reported weight loss, reduced blood sugar and lower reliance on diabetes
medication.
But
Virta declined to provide KHN with underlying data, citing the need to protect
patient information. It did arrange an interview with its then-chief counsel
and vice president of finance, Anand Parikh. He said he expected the
partnership with the VA to soon expand. Parikh, who left the company in
December, said that future government collaboration will likely involve payment
to Virta but that it was too early to estimate a price. The treatment currently
costs other patients $370 per month, plus a one-time $500 initiation fee.
A VA
spokesperson did not respond to detailed written questions concerning the
partnership.
The VA
runs the country’s largest integrated health care system and is
considered a leader in diabetes care. Roughly 25% of its patients have the
disease, which is twice the national average. Inside the VA, diabetes is the
leading cause of blindness, renal disease and amputations.
Virta
offers diet coaching, monitoring and support through a smartphone application.
Patients can use the services around the clock and regularly upload their blood
sugar readings and other medical details, such as weight and blood pressure.
“One of
the most important things about our approach is that we individualize for each
person,” Parikh said.
The
VA’s work with Virta has raised alarm bells, including on Capitol Hill.
In
October, Rep. Josh Gottheimer (D-N.J.) sent a letter to Wilkie saying that the
“partnership between the VA and Virta Health Corporation provides tacit
approval of the ketogenic diet as a means to reverse the impacts of type 2
diabetes.” His letter also added, “Promoting a ketogenic diet for patients with
diabetes may put them at increased health risk.”
Neither
Gottheimer nor his staff returned repeated requests for comment about what
prompted his letter.
Virta’s
Studies Find Benefits Of Keto
Virta
officials first floated the idea of a partnership during President Barack
Obama’s administration. A deal was finalized last year after former Rep. Jeff Miller (R-Fla.), who is now a Washington
lobbyist, signed up to work for the company. Miller retired from his seat in
January 2017 after serving as the powerful chairman of the House Veterans’
Affairs Committee for six years.
The day
after registering as a lobbyist for Virta, Miller sent a note to Darin Selnick,
then a senior VA political appointee, with proposed language for an agreement
between Virta and the VA, according to emails obtained through the Freedom of
Information Act. Selnick reviewed it, then passed it along to an official in
the VA’s research department.
Parikh
said the VA thoroughly evaluated Virta’s research before the deal was done. The
partnership was announced in May.
Virta
was founded in 2014 by venture capitalist Sami Inkinen after doctors told him
he had signs of a prediabetes condition. Joining him were Dr. Stephen Phinney
and Jeff Volek, who researches low-carb diets. The two had written a book about
the Atkins diet, which also emphasizes severely limiting carbohydrates and
instead turning to some high-fat foods.
A
spokesperson for the American Diabetes Association declined to comment on
Virta’s treatment regimen but pointed to an article in its magazine that
noted some benefits of a keto diet, such as lowering blood sugar and weight,
while listing its potential drawbacks, including missing nutrients, risk of
dehydration and high cost.
Still,
many health experts said there is little evidence the diet can produce
long-term results that ameliorate diabetes.
Moreover,
some studies suggest that low-fat or plant-based nutrition, like the
Mediterranean diet, produces similar results and has fewer health risks.
The VA’s clinical guidelines for
diabetes care, while acknowledging potential benefits of
low-carb diets like keto, make clear that “the evidence in support of the
Mediterranean diet was more uniform and robust than that for the lower
carbohydrate dietary approaches.”
Proponents
of the keto diet note that a vegetarian option is also available.
Virta’s
website lists six research papers as
proof that the company’s assistance for diabetes results in significant
improvements in various clinical markers of diabetes, including obesity and
blood sugar levels.
The
papers were peer-reviewed, yet they are all based on a single, non-randomized
clinical trial of 262 patients, which was funded by Virta. Among the authors of
these papers are Volek and Phinney.
In
April, two Virta consultants co-authored a journal article reviewing various
studies and said they showed low-carb diets were “effective in reversing
diabetes in the short term.”
Concerns
About Missing Nutrients In The Diet
Dr.
Randall Stafford, who directs Stanford University’s Program on Prevention
Outcomes and Practices, reviewed Virta’s research and called the results
“encouraging.” Yet he said the comparison group — called the “control” in
scientific circles — was “fairly useless, given that it was composed of people
who did not want to change their diets.”
Stafford
said results don’t suggest that Virta’s treatment alters diabetes.
“My
interpretation is that the keto diet is a temporizing measure, not a cure,” he
said.
In
April, the Physicians Committee for Responsible Medicine, a nonprofit research
and advocacy organization that advocates for plant-based diets, urged Wilkie in
a letter to cancel the Virta partnership.
“The company’s
approach is to place patients with diabetes on a low-carb ketogenic diet,” the
letter reads. “At best, this type of diet may act as a ‘Band-Aid’ for diabetes,
yet it carries serious health risks,” including higher cholesterol levels and
nutrient deficiencies.
A large study by the
European Society of Cardiology published in 2018 found those who ate a
low-carbohydrate diet were at greater risk of coronary heart disease, stroke
and cancer.
In
an opinion article in
the Journal of the American Medical Association, Dr. Shivam Joshi, a lifestyle
medicine physician associated with NYU Langone Health, suggested that Virta’s
April review of studies should “be interpreted with caution” as the group of
participants was self-selecting and said the review “presents an overly
enthusiastic narrative” that passed over studies critical of the ketogenic
lifestyle.
“Any
diet can be effective when bundled with intense lifestyle interventions,” Joshi
said in an interview. “The real question needs to be over the long-term
benefits of the diet itself.”
Clarification:
This story was updated on Feb. 4 at 4:40 p.m. ET to add a description of the
Physicians Committee for Responsible Medicine from its website.
Jasper
Craven: @Jasper_Craven
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