Could Fido lead us to better cancer drugs?

A recent study offers up a trove of data on dog cancer health outcomes from targeted therapies that could help improve care for people.

A company that pairs dogs with cancer care, The One Health Company, has sequenced genetic mutations in more than 1,000 dogs with cancer and then treated them with medicines targeted to specific genes or proteins available to humans. Both the genetic mutations and the doggie patient outcomes were similar to that of humans. Researchers believe this data, which is pulled from veterinary clinics, can help lead research into better treating some canine cancers, which in turn could help pharmaceutical companies develop human drugs for harder-to-treat cancers.

“Some of the most common predictive biomarkers that we’re seeing in the dogs are also some of the most common for human non-small cell lung cancer, breast cancer — some of the big tumor types,” One Health CEO Christina Lopes told Ruth.

Researchers know dogs and humans have a lot of genetic similarities that can be mined to better understand cancer. Dogs and humans share the BRCA1 gene mutation most associated with breast cancer, for example. The National Institutes of Health has run a comparative oncology program with dogs for 20 years.

But studying dog patients is expensive and obtaining large-scale data, particularly genomic data, can be difficult. One Health has been able to get that data by erecting a veterinary business around it. The company charges pet owners for the sequencing and medicine, which they try to keep lower than chemotherapy costs (on average $4,317 in the U.S., according to medical expense credit card company CareCredit).

Why it matters: Instead of forcing researchers to hunt for grant dollars to cover the cost of sequencing and medications for dog clinical trial patients, dog owners pay for it. Pet insurance can cover the cost of One Health’s precision medicine product, the company said. But not all pet owners have pet insurance, which can be expensive compared with typical veterinary treatments.

On the regulatory front: The FDA has pushed for a shift away from using cheaper lab animals. That could make veterinary patients more promising prospects for clinical trials.

The pitch from One Health is that pharmaceutical companies could use its insights to inform future cancer research in humans. Lopes said that pharmaceutical researchers might have a signal in their human data they want to see replicated in One Health’s canine data. Alternatively: “Do we have a signal in our data set that they can then interrogate in their data set?”

For example, dogs suffer from a cancer called hemangiosarcoma, which is associated with the genetic mutation PIK3CA. This mutation correlates to a rare form of cancer in humans known as angiosarcoma. Hemangiosarcoma makes up a significant chunk of dog cancer cases. Lopes wonders whether testing drugs targeted to PIK3CA in dogs might help give researchers some answers on how to treat angiosarcoma.

There’s also an opportunity for research into drug repurposing. In the study, researchers found that dogs with BCRA1 mutations had better outcomes when treated with dasatinib — a drug used to treat certain types of blood cancer in humans, and considered a potential breast cancer treatment.

“Human biopharma companies want to de-risk drugs,” said Lopes. Her platform could help them do that, she added.

This is where we explore the ideas and innovators shaping health care.

Mosquitoes carrying yellow fever first hitched rides on slave ships to the Americas some 500 years ago. A new study also hints at when mosquitoes evolved to transmit the virus: some 5,000 years ago, during a period of natural climate change at the southern border of the Sahara desert.

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Today on our Pulse Check podcast, host Katherine Ellen Foley talks with Alice Miranda Ollstein about internal divisions that are splitting the abortion-rights movement over their efforts to keep abortion legal by putting it to a popular vote.

Walgreens-backed VillageMD is forging a primary and urgent care mashup that may rejigger what care looks like for millions in the Northeast and beyond.

VillageMD wants to expand into rural America and has already acquired one of the biggest urgent care chains in the New York City area, moving closer to that goal.

Last month, VillageMD finalized its $8.9 billion acquisition of Summit Health-CityMD. It also announced a deal with Connecticut-based Starling Physicians, which offers primary, specialty and urgent care.

The acquisitions are an extension of VillageMD’s value-focused health care model, Tim Barry, co-founder and CEO of VillageMD, told Erin. They’re also a counterbalance to the current U.S. health care system, which Barry says is too hospital-centric.

Barry’s vision is to offer 24-hours-a-day, seven-days-a-week accessibility for patients — no ER visits, no hospitalizations. “We want to make sure you get access wherever you need it, whenever you need it – period,” Barry said.

What that looks like: In New York City, a VillageMD patient who lives in New Jersey and commutes into Manhattan could stop at a CityMD clinic near their office to get treatment for a sinus infection.

“That doctor is gonna have access to their medical record and know their whole health history,” Barry said.

The strategy works in reverse, too. If a new patient who has a chronic disease visits a CityMD, the team can connect them with one of its primary care doctors in the broader New York area. “We know that the best thing for that patient would be to have a relationship with a primary care doc,” Barry said.

RuralMD: True to its name, CityMD operates primarily in the greater New York City metro area.

But that’s slated to change, Barry says. Post-merger, the organization has its sights set on moving CityMD into dense metro areas VillageMD already operates in, like Houston, Phoenix and Atlanta.

Then it will turn its sights on the last frontier: rural America.

While health care in rural areas is known for being expensive and difficult to access, Barry, who grew up in Sturgeon Bay, Wis., noted that people who live in rural America are used to driving farther to get care, especially if there’s a dearth of options. “You either have the doctor’s office open or the hospital’s open, and there’s nothing really in between,” he said.

VillageMD could create an in-between option for those communities, Barry added.

Barry’s bottom line: More in-person health care touches, fewer ER visits, lower costs.

“We’re bankrupting more and more people every year because of medical debt,” he said. “People aren’t getting bankrupted in the health care system because they had a $60 PCP visit. They get bankrupted because they had a $30,000 hospital bill that they didn’t expect.”

Expanding a popular decades-old program into rural America could improve access for older adults, says a new report from a Health Resources and Services Administration advisory committee.

To be eligible for Medicaid and Medicare’s Programs of All-Inclusive Care for the Elderly, individuals must be 55 or older, need nursing home–level care and be capable of living safely in their community with assistance.

Almost 90 percent of participants are dual eligibles, who qualify for both Medicare and Medicaid by virtue of their age or disability and low incomes.

The committee found that PACE programs met five key criteria: improved patient experience, better outcomes, lower costs, clinician well-being and health equity.

“Healthy aging that includes aging in place is not currently a feasible option in many rural communities,” the report concluded. “PACE is uniquely situated to adapt and meet the complex needs of rural older adults.”

But the program faces some challenges before states and CMS can implement it rural areas:

— PACE can’t charge co-pays or deductibles, and PACE participants can’t enroll in other Medicare prescription drug plans, meaning higher costs for patients.

— Rural areas tend to have small populations so it’s harder to spread costs across the group if there are fewer patients.

— Patients in rural areas have less access to broadband than those in more populated areas.

— More than 140 rural hospitals closed between 2010 and 2023, and others are financially distressed, putting them at risk of closing, which could lead to a shortage of facilities where PACE can be implemented.

— Medicare and Medicaid patients in rural areas have limited awareness of PACE.

Why it matters: In the U.S., 1 in 5 adults older than 65 lives in a rural area, according to the Kaiser Family Foundation. Rural Americans are more likely to be elderly, have a disability and live in poverty. At the same time, they typically travel farther for health services, receive lower quality services than their urban counterparts and pay more for the services they get.

PACE programs, which include doctors, nurses, physical therapists, social workers, dietitians and transportation drivers, aim to improve health care access for older adults and maintain low costs by keeping participants out of hospitals and nursing facilities as long as possible.

What’s next: There are 149 PACE programs operating in 32 states, according to the report, with a number of program applications under consideration.

The committee offered a series of policy recommendations to the FCC, Congress and the White House to overcome rural-specific challenges to starting PACE programs, including making PACE sites eligible for broadband funding resources, providing start-up grants to new rural PACE sites, considering public-private partnerships and encouraging state Medicaid directors to send letters to long-term care providers to increase awareness of the program.

Biden admin to limit telehealth prescriptions for some controlled drugs

The Biden administration is shifting to involve clients to be evaluated by a medical doctor in particular person just before receiving prescriptions for some controlled prescription drugs, which includes Adderall and OxyContin.

The proposal would reverse a policy enacted through the coronavirus pandemic that authorized physicians to prescribe these medicines via telehealth appointments. The move will make it much more challenging for Individuals to entry some prescription drugs employed for dealing with ache and psychological wellness disorders.

The Drug Enforcement Administration declared the proposed guidelines on Friday, which point out that telehealth flexibilities will be prolonged for frequent, non-controlled medicines but plan II medicines and narcotics will be prohibited with out an in-individual appointment.

Patients have to check out a health practitioner in human being at minimum once to acquire an first prescription for medicine the federal governing administration thinks have the maximum prospective for abuse, such as Vicodin, OxyContin, Adderall and Ritalin. Refills for these medicines could nevertheless be approved in excess of telehealth appointments.

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Biden admin to limit telehealth prescriptions for some controlled drugs

OxyContin supplements are organized for a picture at a pharmacy in Montpelier, Vermont. (AP Photo/Toby Talbot)

Health professionals will only be capable to prescribe managed remedies like Ambien and Xanaxas, as properly as medications applied to handle opioid habit, for 30 days. Any refills for these medications will need an in-particular person analysis.

The regulations intention to sustain expanded obtain to telehealth, which has been critical for hundreds of thousands of patients, notably all those dwelling in rural regions, when also balancing safety.

“DEA is dedicated to making sure that all Individuals can accessibility desired medicines,” DEA Administrator Anne Milgram claimed in a statement. “The permanent expansion of telemedicine flexibilities would continue larger access to treatment for clients across the nation even though making sure the protection of clients. DEA is dedicated to the growth of telemedicine with guardrails that stop the on the internet overprescribing of managed medicines that can cause harm.”

The shift arrives amid an ongoing opioid disaster and a developing selection of overdose deaths from managed drugs this kind of as fentanyl.

Adderall XR capsules are displayed in front of a medicine bottle.

Adderall XR capsules are displayed in front of a drugs bottle. (AP Photo/Jenny Kane)

The DEA mentioned the proposed telemedicine procedures will advance its aim of increasing obtain to medication for opioid use ailment to anybody in the country who needs it. 

“Medication for opioid use condition helps these who are battling to overcome material use condition by aiding persons obtain and maintain restoration and also avoid drug poisonings,” Milgram explained. “The telemedicine polices would continue on to develop access to buprenorphine for patients with opioid use problem.”

U.S. overdose deaths reached a document in 2021, and about a few-quarters of those had been from opioids. But the loss of life toll from synthetic opioids like fentanyl far exceeded people similar to prescription medicine that very same 12 months, according to Facilities for Condition Command data. Fentanyl is progressively existing in the black marketplace, as the capsules are normally pressed into phony prescription drugs or combined into other prescription drugs.

Facial area MASKS Produced ‘LITTLE TO NO DIFFERENCE’ IN Avoiding Spread OF COVID, SCIENTIFIC Review FINDS

DEA Administrator Anne Milgram speaks at a press conference.

DEA Administrator Anne Milgram speaks at a push convention. (Getty)

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Quite a few states have presently moved to restore restrictions for telehealth treatment. As of October, just about 40 states and Washington, D.C., had ended emergency pandemic declarations making it easier for doctors to see patients in other states.

The proposed rules come just after startups in the telehealth sector launched in new many years to treat and prescribe drugs for mental wellness or focus deficit disorders. The marketplace and persons with difficulty accessing in-particular person treatment have mostly benefitted from the pandemic-period policy.

The new guidelines are anticipated to be in put before the COVID-19 public overall health emergency expires on May well 11.

Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups

Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups
Credit: Pixabay/CC0 Public Domain

Despite widespread agreement that clinical trials should enroll a representative sampling of individuals from different age, gender, and racial and ethnic groups, a new Yale School of Medicine study shows that clinical trials on new cancer drugs still fall far short of including key data on several demographic groups. The findings were published in the journal BMJ Medicine.

For the study, the Yale team—led by Jennifer Miller, associate professor of medicine and senior author, and Tanvee Varma, a fourth-year medical student and lead author—developed a series of quality control metrics to assess how well pharmaceutical companies reported on and included demographic groups in cancer trials, conducted between 2012 and 2017, that led to U.S. Food and Drug Administration approval of new drugs.

Of the 24 companies submitting key trial results, all but one failed to publicly report at least some demographic data on participants, the researchers found. Although all of the companies reported participants’ sex, more than 60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} failed to report age and almost 80{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} did not report race and ethnicity data.

Half of the companies also failed to adequately represent women in at least one trial supporting their product approvals. About 75{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of companies did not adequately represent older adults and more than 4 out of 5 did not adequately represent patients identifying as Black or Latinx.

“We created a baseline scorecard for companies to spur a race to the top in reporting and including under-represented groups in clinical trials,” Miller said.

The importance of including diverse populations in drug and treatment trials has been known for decades; people can respond differently to diagnostic tests or treatments depending upon their sex, age, or racial background, which can affect the quality of treatment they receive.

“While a few companies have done well in meeting diversity standards, most have substantial room for improving their fair inclusion of older adults and racial and ethnic minoritized patients, and to a lesser extent women, in cancer pivotal trials,” Miller said. “We still need to move the needle.”

More information:
Tanvee Varma et al, Ranking pharmaceutical companies on clinical trial diversity, BMJ (2023). DOI: 10.1136/bmj.p334

Provided by
Yale University


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Yale Study Finds Pharmaceutical Companies Focus Advertising On Expensive Brand-Name Drugs

Yale Study Finds Pharmaceutical Corporations Aim Promotion On Pricey Model-Identify Medication

MedicalResearch.com Interview with:

Yale Study Finds Pharmaceutical Companies Focus Advertising On Expensive Brand-Name Drugs

Neeraj Patel

Neeraj Patel
Clinical Pupil (MS-2), Yale College of Medication
New Haven, CT

MedicalResearch.com: What is the history for this research?

Response: Immediate-to-shopper pharmaceutical promotion has been expanding in reputation for the previous two a long time or so, specially through television. But it’s hugely controversial. Only two higher-income international locations (the U.S. and New Zealand) broadly allow this style of advertising and marketing for prescription prescription drugs. Critics have pointed to a increasing physique of literature that suggests that direct-to-shopper advertising for prescription medication can be deceptive, lead to inappropriate prescribing, and inflate healthcare charges. Proponents have argued that it increases community health by selling clinically helpful prescribing.

MedicalResearch.com: What are the principal conclusions?

Response:  Our study assessed the most-normally marketed medicine in these television ads and we had two key results:

Initially, we discovered that much less than one particular-3rd of prescription drugs typically promoted from 2015 to 2021 were rated as getting higher therapeutic value, described as supplying at least reasonable improvement in clinical outcomes compared to current therapies according to at the very least 1 of three unbiased wellbeing technology evaluation organizations.

Second, we found that drugs classified as “low benefit” accounted for $15.9 billion of the $22.3 billion (71.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}) in tv promotion shelling out associated with our 73-drug sample in excess of 6 many years.

MedicalResearch.com: What should audience choose absent from your report?

Response: Taken with each other with other analysis, our conclusions recommend that pharmaceutical providers concentration their marketing strategies on expensive, model-name medication that have little or no comparative reward versus current alternatives. In basic, I assume our conclusions increase queries about the general public overall health price that these ads are featuring to culture, specially when thinking of the human body of research on the misleading mother nature and adverse downstream consequences of such advertisements on prescribing styles and health care prices.

From a community overall health standpoint, it’s relating to to me that the healthcare procedure allocates billions of dollars each year toward drug ads, as opposed to bigger-excellent varieties of health-related conversation. In general, I hope that our investigation results will persuade and help allow policymakers to create a lot more arduous, proof-based mostly rules on prescription drug advertising and marketing.

MedicalResearch.com: What recommendations do you have for upcoming analysis as a results of this study?

Response: Policymakers and regulators need to look at demanding disclaimers on direct-to-purchaser pharmaceutical advertisements relating to the comparative effectiveness of the goods in such ads. An additional worry about prescription drug adverts is that they are likely to have incredibly reduced informational high quality (as proven in a selection of recent experiments like this a single). I think we must have far more rigorous standards for weeding out deceptive promotion and fund the Fda to utilize present-day expectations extra proactively. Ultimately, given new investigate on the harms and restricted benefit of direct-to-buyer advertising of prescription medication, I consider policymakers ought to rethink in which instances, if any, this kind of advertising and marketing must be permitted.

I have no conflicts of curiosity or other disclosures to report.

Citation:

Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Benefit of Medications Routinely Marketed Applying Immediate-to-Customer Tv Advertising, 2015 to 2021. JAMA Netw Open. 20236(1):e2250991. doi:10.1001/jamanetworkopen.2022.50991

The data on MedicalResearch.com is offered for academic needs only, and is in no way supposed to diagnose, cure, or deal with any healthcare or other issue. Often look for the assistance of your health practitioner or other experienced wellbeing and inquire your medical professional any queries you may perhaps have concerning a health care condition. In addition to all other limitations and disclaimers in this settlement, company service provider and its 3rd occasion companies disclaim any legal responsibility or loss in link with the material offered on this site.

 

 

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