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.
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.”
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.”
https://www.medscape.com/viewarticle/924871#vp_1
