CDC Study Breaks Down Diabetes Risk for Hispanic, Asian Subgroups

There are significant differences in rates of diagnosed and undiagnosed diabetes between subgroups of Hispanic and Asian Americans, a federal government study finds.

Hispanics and Asians represent 23% of the U.S. population and are expected to account for 38% by 2060.

And, these groups may be at higher risk for type 2 diabetes due to genetic, lifestyle and environmental factors, the researchers said.

The U.S. Centers for Disease Control and Prevention (CDC) study analyzed federal health survey data for 2011 through 2016. Among Hispanics, 25% of Mexicans, 22% of Puerto Ricans, 21% of Cuban/Dominicans, 19% of Central Americans, and 12% of South Americans were living with diagnosed or undiagnosed diabetes, the study found.

Among Asians, the percentages were 23% for South Asians, 22% for Southeast Asians, and 14% for East Asians, according to findings published Dec. 20 in JAMA Internal Medicine.

As in previous research, this study found that Asians tend to have a lower body mass index (BMI) than other racial/ethnic groups. BMI is an estimate of body fat based on weight and height. The higher the BMI, the greater the risk of type 2 diabetes.

“This landmark diabetes survey provides essential data that will better inform public health efforts to reach more Americans with tailored, effective prevention and treatment strategies,” CDC director Dr. Robert Redfield said in an agency news release.

“This defined data on the prevalence of diabetes among Hispanic and Asian demographic groups can help health care providers and patients reduce the risk for type 2 diabetes,” he added.

Ann Albright, director of CDC’s division of diabetes translation, said the findings establish a baseline for future estimates and highlight differences in the diabetes burden among Hispanic and non-Hispanic Asian subgroups.

“These data also provide insights that allow us to reach groups at higher risk and provide opportunities to strengthen diabetes detection and type 2 diabetes prevention and care in these groups,” she said in the news release.

More information

The American Academy of Family Physicians has more on diabetes.

SOURCE: U.S. Centers for Disease Control and Prevention, news release, Dec. 20, 2019

https://consumer.healthday.com/diabetes-information-10/type-ii-diabetes-news-183/cdc-study-breaks-down-diabetes-risk-for-hispanic-asian-subgroups-753259.html

Novartis in talks with patients upset about lottery-like gene therapy giveaway

Novartis is in discussion with patient groups over its lottery-style free drug program for its multi-million-dollar gene therapy for spinal muscular atrophy (SMA) after criticism that the process could be unfair to some babies with the deadly disease.

The company said on Friday that it will be open to refining the process in the future, but it is not making any changes at this time. The program is for patients in countries where the medicine, called Zolgensma, is not yet approved for the rare genetic disorder, which can lead to death and profound physical disabilities.

At $2.1 million per patient, Zolgensma is the world’s costliest single-dose treatment.

Novartis said the program will open for submission on Jan. 2 and the first allocation of drugs would begin in February. Novartis’s AveXis unit, which developed the drug, will give out 50 doses of the treatment through June for babies under 2 years old, it said on Thursday, with up to 100 total doses to be distributed through 2020.

Patient advocacy group SMA Europe had a conference call with the company on Friday, according to Kacper Rucinski, a board member of the patient and research group who was on the call.

“There are a lot of ethical questions, a lot of design questions that need to be addresses. We will be trying to address them in January,” Rucinski said. He said the program has no method of prioritizing who needs the treatment most, calling it a “Russian roulette.”

The company said it developed the plan with the help of bioethicists with an eye toward fairness.

“This may feel like you’re blindly passing it out, but it may be the best we can do,” said Alan Regenberg, who is on the faculty at Johns Hopkins’ Berman Institute of Bioethics and was not among the bioethicists Novartis consulted with on the decision. “It may be impossible to separate people on the basis of prognosis out of the pool of kids under 2,” he said.

According to Rucinski, the parties will continue their discussion in January “to see what can be improved in the design” of the program.

Novartis said on Thursday that because of manufacturing constraints it is focused on providing treatment to countries where the medicine is approved or pending approval. It has one licensed U.S. facility, with two plants due to come on line in 2020.

Zolgensma, hit by turmoil including data manipulation allegations and suspension of a trial over safety concerns, is the second SMA treatment, after Biogen’s Spinraza.

Not all of the SMA community are opposed to Novartis’ program.

Rajdeep Patgiri moved from the United Kingdom to the United States in April so his daughter could receive Zolgensma. She has responded well to the treatment, and Patgiri worries that negative attention to the program could keep patients from receiving the drug.

“The best outcome for all patients would be if everybody could get the treatment. Given all the constraints, a lottery is probably the fairest way to determine who” receives the treatment, he said.

https://www.reuters.com/article/us-novartis-gene-therapy/novartis-in-talks-with-patients-upset-about-lottery-like-gene-therapy-giveaway-idUSKBN1YO2BR

Canadian drug distributors say no to Trump import plan

The administration on Wednesday proposed new regulations that would allow states to import prescription drugs from Canada. They would require a state such as Florida to partner with a wholesaler licensed by Health Canada, which regulates drugs.

Florida and other states have said they are eager to start importation programs, and the proposal took the federal government one step closer to approving that plan. But there are practical barriers to actually bringing in drugs.

Two drug distributors and two Canadian industry groups that between them represent all of the potential suppliers named in a proposal published by Florida in August said they are not interested in participating.

“We have not been contacted and we are not planning to participate,” said Loblaw Companies Ltd (L.TO), which owns Canada’s largest pharmacy chain Shoppers Drug Mart. “Canadian patients currently face product and drug shortages and we are concerned this initiative may exacerbate what is already a critical issue.”

Daniel Chiasson, president of the Canadian Association for Pharmacy Distribution Management (CAPDM), said none of its members would participate because their first priority was ensuring a safe and stable supply of medication for Canadians.

“It surprised everyone when their names appeared on that list,” said Chiasson.

Mary Mayhew, secretary of the Florida Agency for Health Care Administration, said she was “excited and enthusiastic” about Wednesday’s announcement.

“We are optimistic that Canadian suppliers will be interested, as the rule is understood, as there is more dialogue around this new and historic federal action,” she said.

Chiasson said agreements between manufacturers and distributors prevent the export of products made for the Canadian market, creating a commercial risk and deterrent to exporting.

“These are issues we continue to consider and are committed to exploring how we might overcome any challenges and issues as we advance the proposed rule,” U.S. Food and Drug Administration spokesman Michael Felberbaum said in a statement.

Some of Canada’s major distributors are subsidiaries of U.S. companies, who are unlikely to participate in a program to lower prices, since their revenue reflects a cut of the value of the drugs they provide to pharmacies in the much larger U.S. market.

McKesson Canada, a subsidiary of McKesson Corp (MCK.N) referred questions to Chiasson. The organization is also a listed member of the Alliance for Safe Online Pharmacies Canada, a lobby group that opposes drug exports to the United States.

AmerisourceBergen (ABC.N) said that protecting bottom lines was not the issue, because importation implied that distributors could buy low-cost drugs and sell them in high-cost markets.

“The reality is that legal and contractual barriers, as well as significant threat to the integrity of the supply chain, all stand in the way of importation being a viable solution,” it said in a statement.

Kohl & Frisch, a large closely-held distributor, did not respond to requests for comment. Metro Inc (MRU.TO) which owns major pharmacy chain Jean Coutu, declined to comment.

One company on Florida’s list is not a distributor in any traditional sense, but makes self-serve pharmacy kiosks that resemble vending machines. They confirmed they would have no role in any import plan.

The remaining companies are members of the Association québécoise des distributeurs en pharmacie, which takes the same position as CAPDM.

“Our members have no intention to sell drugs across the border, particularly in light of the rapidly increasing drug shortages in the Québec marketplace,” said Director General Hugues Mousseau in a statement.

https://www.reuters.com/article/us-usa-healthcare-canada/canadian-drug-distributors-say-no-to-trump-import-plan-idUSKBN1YO24O

J&J acquires Taris Biomedical

Johnson & Johnson (NYSE:JNJ) acquires privately held TARIS Biomedical LLC for an undisclosed sum.

The Lexington, MA-based biotech is developing a novel technology (TARIS System) enabling the continuous local delivery of therapies for bladder diseases. Lead candidate is TAR-200 for muscle invasive bladder cancer.

https://seekingalpha.com/news/3527955-j-and-j-acquires-taris-biomedical

FDA OKs expanded label of DexCom’s G5 CGM

The FDA approves the use of DexCom’s (NASDAQ:DXCM) G5 Mobile Continuous Glucose Monitoring (CGM) System for diabetes treatment decisions without the need for a confirmation test via fingerstick sample.

https://seekingalpha.com/news/3527956-fda-oks-expanded-label-of-dexcoms-g5-cgm

DOJ, EPA back Bayer in glyphosate court appeal

The U.S. Environmental Protection Agency, working with the Department of Justice, filed court papers today supporting Bayer’s (OTCPK:BAYRY) argument that glyphosate poses no cancer risk.

The filing backs Bayer’s appeal in federal court of a $25M verdict in the case of a California man who blamed the company’s Roundup herbicide, which contains glyphosate, for causing his non-Hodgkin lymphoma.

Lawyers for both the EPA and DoJ argued the verdict should be overturned because it would have been illegal for Bayer to print cancer risk warnings on Roundup labels, and that Congress granted the EPA the sole authority over safety labels on chemical products.

While this is not the first time a regulator has weighed in on such a case, legal scholars say the filing likely will catch the court’s attention.

https://seekingalpha.com/news/3527977-trump-administration-backs-bayer-in-glyphosate-court-appeal

FDA OKs Daiichi antibody-drug conjugate for HER2+ breast cancer

The FDA approves Daiichi Sankyo’s (OTCPK:DSKYF) antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior lines of HER2-based therapies.

HER2+ breast cancer-related tickers: MacroGenics (MGNX -1.6%), Roche (OTCQX:RHHBY +1.4%), Seattle Genetics (SGEN +2%), AstraZeneca (AZN +1.4%), Puma Biotechnology (PBYI -4.7%), Mustang Bio (MBIO +1.5%)

https://seekingalpha.com/news/3527927-fda-oks-daiichi-antibody-drug-conjugate-for-her2-breast-cancer