Health
Drug Company to Share Revenues With Indigenous People Who Donated Their Genes
When Stephane Castel first met with a group of Māori people and other Pacific Islanders in New Zealand to talk about his drug company’s plans for genetic research, locals worried he might be seeking to profit from the genes of community members without much thought to them.
Instead, Dr. Castel and his colleagues explained, they were aiming to strike an unconventional bargain: In exchange for entrusting them with their genetic heritage, participating communities would receive a share of the company’s revenues. Dr. Castel also vowed not to patent any genes — as many other companies had done — but rather the drugs his company developed from the partnership.
“A lot of people told us this was a crazy idea, and it wouldn’t work,” Dr. Castel said. But five years after that first conversation during an Indigenous health research conference in March 2019, Dr. Castel’s gambit is beginning to pay off for both parties.
On Tuesday, his company, Variant Bio, based in Seattle, announced a $50 million collaboration with the drugmaker Novo Nordisk to develop drugs for metabolic disorders, including diabetes and obesity, using data collected from Indigenous populations. Variant Bio will distribute a portion of those funds to the communities it worked with in nine countries or territories, including the Māori, and will seek to make any medicines that result from its work available to those communities at an affordable price.
Experts on Indigenous genetics said the deal was a positive step for a field that has been plagued by accusations of exploitation and a gulf of mistrust.
“In the past, researchers would enter Indigenous communities with empty promises,” said Krystal Tsosie, a geneticist and bioethicist at Arizona State University who runs a nonprofit genetic repository for Indigenous people. “Variant Bio is the only company, to the best of my knowledge, that has explicitly talked about benefit-sharing as part of their mission.”
The concept for Variant Bio was hatched in a Manhattan bar in August 2018 over drinks between Dr. Castel and Kaja Wasik, who had become friends during their graduate studies in genetics at Cold Spring Harbor Laboratory on Long Island.
Though their laboratory research kept them under the glare of fluorescent lights, they shared a zest for international travel, which they indulged during backpacking trips together in Peru and Chile. They dreamed of building a company that could get them to remote places.
At the time, drugmakers were establishing partnerships with biological repositories such as UK Biobank, which contains biological samples and health records from a half-million people living in Britain, in order to hunt for associations between genes and disease.
But these databases are primarily made up of genes from people of European descent.
“What’s the value of sequencing the 500,001st British person?” Dr. Castel said. “There are only so many insights to find by studying the same group of people.”
He and Dr. Wasik were more enthusiastic about recent findings from underrepresented groups, such as the discovery of novel gene variants affecting metabolism that were first identified in Inuit populations in Greenland.
Such variants may be more common, and consequently easier to identify, in historically isolated populations because they confer some functional benefit to people with a certain diet or lifestyle, or simply because of chance events in their history. Yet they can also serve as promising drug targets that will help a wider swath of the global population.
With $16 million in seed funding from Lux Capital, a venture capital firm in New York City, Dr. Castel and Dr. Wasik quit their jobs and began working full-time for their startup. Dr. Wasik hopped across eight countries in Africa, Asia, Europe and the Pacific in the company’s first year, while Dr. Castel, for the most part, dutifully built their software platform from his base in the United States.
They enlisted ethical advisers to develop a benefit-sharing model and went on a listening tour. They knew from the get-go they would have to tread carefully.
In 2007, a member of the Karitiana tribe in Brazil told The New York Times that his community had been “duped, lied to and exploited” by scientists who had collected their blood and DNA, which was later sold for $85 per sample. The tribe members, who said they had been wooed with promises of medicines, received nothing.
Ten years later, there was still no consensus about the optimal way to conduct such work. To protect against so-called biopiracy, many countries ratified the Nagoya Protocol under the United Nations Convention on Biological Diversity, which requires the “equitable sharing of benefits” emerging from genetic resources. But the protocol excluded human genomic information.
During Dr. Castel’s and Dr. Wasik’s trip to New Zealand in 2019, the researchers and community members were troubled by a previous attempt by U.S. researchers to patent a test for obesity risk based on genetic studies carried out in Samoa. The researchers’ universities did not include their Samoan collaborators on their patent application as co-inventors, nor did they have formal benefit-sharing agreements in place with local institutions. (That patent application has since been abandoned, and the researchers said they always intended to share benefits with their partners.)
One of Variant’s first advisers was Keolu Fox, an outspoken geneticist at the University of California, San Diego, who had been harshly critical of the Samoan research.
“This is an extension of all these other forms of colonialism,” said Dr. Fox, who is Native Hawaiian and joined Dr. Wasik and Dr. Castel on their New Zealand outreach trip. He believed that Variant could lead by example.
In the company’s benefit-sharing program, up to 10 percent of a project’s budget goes toward community programs, typically by funding local organizations.
For example, as part of its New Zealand-based study into the genetic causes of kidney disease and other metabolic disorders in the Māori and other people of Pacific ancestry, the company spent $100,000 to fund several local health organizations along with scholarships and scientific conferences for Indigenous people.
“Before Variant came along, we didn’t do that because we couldn’t afford to do so,” said Tony Merriman, a gout expert at the University of Alabama at Birmingham who has collaborated with the company on two projects in the Pacific region.
Dr. Merriman said that he also appreciated that the company ensured that its findings were shared with the community. In French Polynesia, the company’s research has encouraged increased access to a gout medication after concluding that the local population did not have an elevated risk of a fatal drug reaction that had been observed in certain Asian populations.
The new Novo Nordisk deal kicks off a second, longer-term phase of the benefit-sharing program. Communities will share in a 4 percent slice of Variant’s revenue and, if the company is ever sold or goes public, 4 percent of its equity. That percentage is comparable to the royalties that universities receive for licenses to their patents.
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Health
Parasitic infection causing ‘explosive’ stomach illness exceeds 1,000 cases in northern state
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Cases of cyclosporiasis infections are rising across America, with more than 1,000 people diagnosed in Michigan and more than 500 in Ohio.
This is the largest outbreak of its kind in Michigan’s history and one of the country’s largest in years, according to the Associated Press.
The parasitic infection can cause weeks of watery diarrhea. The source of the infections has not been identified and no deaths have been reported.
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Michigan officials announced the outbreak last week following the identification of more than 170 cases since June 22 in the southeastern part of the state. Typically, only about 50 cases are identified in Michigan each year, according to AP.
A cyclospora infection often causes watery, “explosive” diarrhea that can last for weeks or even months if left untreated, the CDC says. (iStock)
Similar illnesses have been reported in 28 other states, including neighboring Ohio, where diagnoses have popped up across the Michigan border.
Cases have been climbing since the CDC identified an uptick in infections in mid-June, with illnesses now reported in dozens of states.
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Michigan has now reported more than 1,200 cases and at least 40 hospitalizations. In Ohio, northwest counties have identified more than 500 cases, including at least 306 in Lucas County, according to the latest available local figures.
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Texas has reported at least 48 cases, and illnesses have been identified in numerous other states as health officials investigate the source.
The hallmark symptom of a cyclospora infection is watery, often “explosive” diarrhea that can last for weeks or even months if left untreated, the CDC says.
Other symptoms of cyclosporiasis include severe abdominal cramping, bloating, nausea, fatigue and significant weight loss. (iStock)
Other symptoms include severe abdominal cramping, bloating, nausea, fatigue and significant weight loss.
The official outbreak season for the parasite runs from May 1 through Aug. 31, a window where warmer temperatures historically coincide with a spike in infections, according to the CDC.
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While the infection can sometimes clear up on its own, it frequently requires antibiotics. The CDC advises anyone experiencing symptoms of cyclosporiasis to contact a healthcare provider for testing and treatment.
The CDC, alongside the Food and Drug Administration and state health officials, is actively investigating several multistate clusters, but they have yet to find a cause behind the spread.
Fresh produce should be washed thoroughly before eating, although this may not eliminate the risk of infection, the AP noted. (iStock)
Past infections have reportedly been linked to consuming contamined fruits or vegetables, or being exposed to contaminated irrigation water.
Fresh produce should be washed thoroughly before being eaten, although this may not eliminate the risk of infection, the AP noted.
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Michigan officials recommend purchasing salad mixes or whole heads of lettuce instead of pre-washed, bagged lettuce. Remove two to three leaves from the outer layer of the lettuce head before washing and cook vegetables when possible.
Fox News Digital’s Khloe Quill contributed to this report.
Health
Dr Oz links obesity to chronic disease surge, says GLP-1s can ‘jumpstart’ better health
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Washington, DC – GLP-1 weight-loss drugs have become a prevalent part of American healthcare, and the current administration is getting behind the movement.
In an exclusive interview with Fox News Digital at the Great American State Fair in the nation’s capital on July 6, CMS Administrator Dr. Mehmet Oz voiced his support for the use of GLP-1 (glucagon-like peptide-1) medications, such as Ozempic, for appropriate uses.
“I’m a fan of GLP-1 drugs when used correctly,” he said. “They do help people who are overweight lose weight quite effectively. They’re not a replacement for diet and exercise, but they might jumpstart the system so it’s easier for you to use healthier tactics.”
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This is especially helpful for those who may have trouble moving due to joint pain or are experiencing internal dysfunction, Oz said.
Certain GLP-1 drugs are covered by Medicare for overweight candidates with certain conditions, such as high blood pressure and diabetes, and Oz projected the benefits will continue to benefit taxpayers.
Dr. Mehmet Oz is pictured in Washington, D.C., at the Great American State Fair, where he spoke about federal health policy. (Angelica Stabile/Fox News Digital)
“We believe these are so effective in reducing conditions like high blood pressure and diabetes that they’ll actually save money for the federal taxpayer, because [they’re] going to make you healthy enough that you don’t have to consume health services,” Oz said.
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“We think about 70% of all the money we spend on healthcare is caused by chronic conditions, and obesity is the No. 1 driver of all that, so it’s a smart decision.”
Oz recently announced the launch of the Medicare GLP-1 Bridge program, which will allow more seniors to access GLP-1 drugs for only $50 a month if they meet qualifying health criteria and receive prior authorization from a doctor.
The doctor expressed support for broadening affordable access to GLP-1 medications for Americans. (iStock)
“There are a lot of overweight people who don’t have high blood pressure, diabetes or other conditions, so they don’t get access to the drug normally,” he said. “We want them to have the ability to use it as well.”
Although these access shifts could boost Americans’ overall health — and in some cases could be lifesaving — Oz noted that there is “no silver bullet” when it comes to these medications.
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“I love the fact that the innovation that’s coming out of pharmaceutical companies is allowing us to save lives and make lives better,” he said. “But the real secret to longevity is eating right, exercising, sleeping, dealing with the stress of your life, finding some purpose in your existence [and] realizing you have agency over the future.”
“These are things that your mom would have told you [and that] you don’t need a doctor to be emphasizing.”
Medicating appropriately, combined with eating right, exercising and staying connected with others, can help make health goals attainable, the doctor said. (iStock)
While GLP-1s may not be a fix-all, combining these medications with foundational health practices “makes a lot of sense,” Oz said.
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“I don’t want people being fat-shamed … I don’t want you feeling guilty that you’re gaining weight even though everyone else around you seems to have figured it out,” he said. “It’s not that simple — our set points for hunger are different. We have different things going on in our lives.”
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“But if you realize how precious you are — the temple of the soul is so valuable. It’s the greatest gift your parents ever gave you, and you take advantage of every tool out there to make it work … which includes using medications when appropriate. That, to me, is MAHA.”
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