Posts tagged with "Medicine"

Natalist offers monthly subscription boxes curated to help couples conceive

August 28, 2019

Getting pregnant is life’s lottery: Some couples hit the jackpot the first time they try; others start to feel as if it’s never going to happen. But for most, it’s an emotional journey, with ups and downs, insecurities and hopes.

That’s the thinking behind a new “get pregnant bundle” delivered each month by a startup company called Natalist to the homes of those who are trying to conceive.

After all, says Dr. Nazaneen Homaifar, the chief medical advisor of Natalist—and a Duke Univesity-trained OBGYN—“Trying to get pregnant can be confusing, frustrating, and not as romantic as we imagined it to be. At Natalist, we understand. And we want to help support you through this journey.”

In addition to “Dr. Naz,” the company’s founders include CEO Halle Tecco and Chief Scientific Officer Elizabeth Kane. Together, they have the business and medical knowledge that a couple trying to would appreciate.

“We’re moms, doctors, and scientists building Natlist to give you what you need—from concept to conception,” they say on their new website.

 Starting this week, according to a report by Fast Company, Natalist will discreetly deliver its first boxes (and individually purchased products) to customers’ doors.

As founder and CEO, Halle Tecco envisions arming consumers with everything they need before starting a family, including plenty of TLC. Consider it the self-care of conceiving.

The monthly “Get Pregnant Bundle” subscription box ($90 for a one-time purchase; $81 monthly) changes as one progresses through the fertility journey and continues on until birth. (Customers can cancel at any time.) The first month, for example, includes an illustrated Conception 101 guidebook complete with the basics of human reproduction and practical tips on getting pregnant.

In addition, buyers can expect a range of items ranging from ovulation tests to prenatal vitamins, the majority of which physicians recommend during a preconception visit. The cost is on par with drugstore prices, if not less, Fast Company notes.

In many ways, the business news outlet says, Natalist resembles other startups streamlining transformative stages of a woman’s life: Fridababy sells postpartum recovery products for new moms; Blume is the first cohesive line of self-care products for girls navigating puberty; while Genneve is a complete telehealth and product line for women going through menopause.

While Natalist isn’t bringing new conception products to the market, it did redesign them with a modern feminine look. The pregnancy test is sleek, compact, eco-friendly, and in a warm color palette. Such improvements stem, in part, from a Natalist survey of 1,200 women with planned pregnancies.

“If you look at the pregnancy and ovulation tests that are on the market today, they don’t feel like they belong on your bed stand or in your bathroom next to beauty products,” says Tecco.

The collection features more personal—and less clinical—language along with elegant illustrated instructions. There’s none of the medical jargon typically found on a traditional pregnancy test box.

The website features materials on conception and pregnancy—from both a medical and lifestyle perspective. On-staff doctors quash junk information from actual science-backed studies, with articles ranging from miscarriage grief to debunking sex-position myths. The team also shares their own personal pregnancy journeys on social media and a private Facebook group. The goal is to be approachable while projecting authority.

Over the long-term, Natalist envisions physicians and clinics suggesting its boxes to patients. Currently, the company is in talks with multiple employers interested in subsidizing subscriptions: They’re looking to help their employees get pregnant naturally, thereby bringing down the cost of fertility treatments.

Research contact: @FastCompany

‘Drug sponge’ could minimize side effects of chemotherapy

January 14, 2019

Is there anything more “sponge-worthy” (in the parlance of a 1995 Seinfeld episode) than mitigating the debilitating side effects of toxic cancer treatments? 

On January 9, doctors at UC Berkeley announced that they have developed a “drug sponge” to do just that—and they are hoping to fast-track approval by the FDA.

How does it work? With the help of a sponge inserted into a blood vessel near a tumor site—and designed to absorb excess or residual chemotherapy drugs that an affected organ cannot use—the researchers said that they are hoping to prevent the dangerous side effects of toxic chemotherapy agents; or even to deliver higher doses to knock back tumors, like liver cancer, that don’t respond to more benign treatments.

The “drug sponge” is an absorbent polymer-coated cylinder that is 3D printed to fit precisely into a vein located downstream from the target organ – the liver in liver cancer, for example. There, it would sop up any drug not absorbed by the tumor, preventing it from reaching and potentially poisoning other organs.

In early tests in pigs, the polymer-coated drug absorber took up, on average, 64% of a liver cancer drugthe chemotherapy agent doxorubicin injected upstream.

“Surgeons snake a wire into the bloodstream and place the sponge like a stent, and just leave it in for the amount of time you give chemotherapy, perhaps a few hours,” said Nitash Balsara, a professor of Chemical and Biomolecular Engineering at the University of California-Berkeley, and a faculty scientist at Lawrence Berkeley National Laboratory.

“Because it is a temporary device, there is a lower bar in terms of approval by the FDA,” said Steven Hetts, an interventional radiologist at UC San Francisco who first approached Balsara in search of a way to remove drugs from the bloodstream. “I think this type of chemofilter is one of the shortest pathways to patients.”

Most anticancer drugs are poisonous, so doctors walk a delicate line when administering chemotherapy. A dose must be sufficient to kill or stop the growth of cancer cells, but not high enough to irreparably damage the patient’s other organs. Even so, chemotherapy is typically accompanied by major side effects, including nausea, vomiting, diarrhea and suppression of the immune system—not to mention hair loss and ulcers.

“We are developing this around liver cancer because it is a big public health threat–there are tens of thousands of new cases every year–and we already treat liver cancer using intra-arterial chemotherapy,” Hetts said. “But if you think about it, you could use this sort of approach for any tumor or any disease that is confined to an organ, and you want to absorb the drug on the venous side before it can distribute and cause side effects elsewhere in the body. Ultimately we would like to use this technology in other organs to treat kidney tumors and brain tumors.”

Hetts, Balsara and their colleagues at UC Berkeley, UCSF and the University of North Carolina, Chapel Hill, have published their results in the journal ACS Central Science, an open-access publication of the American Chemical Society.

Research contact: nbalsara@berkeley.edu

A new wrinkle in cardiac research

August 28, 2018

Nobody likes wrinkles—unless they are on a Pug dog or a Sphinx cat. And even those breeds give some people the willies. But now, researchers have given us another reason to dislike these inevitable signs of aging: If they appear in certain places, they may portend health problems.

First it was earlobe creases that predicted heart disease, according to a 1973 letter published by the New England Journal of Medicine—and proven several times over by researchers. Now it’s a wrinkled forehead, based on a study conducted by Toulouse University Hospital in France.

Indeed, the European Society of Cardiology released results on August 26 of a study by Toulouse University Hospital clinicians that show that . “people who have lots of deep forehead wrinkles—more than is typical for their age may have a higher risk of dying of cardiovascular disease (CVD).”

And those risks are ten times higher than for people with smooth foreheads. The study has found that assessing brow wrinkles could be an easy, low-cost way [of identifying] people who are at high risk for a cardiac disease.

“You can’t see or feel risk factors like high cholesterol or hypertension,” says study author Yolande Esquirol, associate professor of Occupational Health at the Centre Hospitalier Universitaire de Toulouse in France.  “We explored forehead wrinkles as a marker because it’s so simple and visual. Just looking at a person’s face could sound an alarm; then we could give advice to lower risk …. The challenge is in identifying high-risk patients early enough to make a difference.”

According to the study authors, previous research has analyzed different visible signs of ageing to see if they can presage cardiovascular disease. In prior studies, crow’s feet showed no relationship with cardiovascular risk but these tiny wrinkles near the eyes are a consequence not just of age but also of facial movement. A link has been detected between male-pattern baldness, earlobe creases, xanthelasma (pockets of cholesterol under the skin) and a higher risk of heart disease, but not with an increased risk of actually dying.

The authors of the current study investigated a different visible marker of age—horizontal forehead wrinkles—to see if they had any value in assessing cardiovascular risk in a group of 3,200 working adults.  Participants, who were all healthy and were aged 32, 42, 52 and 62 at the beginning of the study, were examined by physicians who assigned scores depending on the number and depth of wrinkles on their foreheads. A score of zero meant no wrinkles while a score of three meant “numerous deep wrinkles.”

The study participants were followed for 20 years, during which time 233 died of various causes.  Of these, 15.2% had score two and three wrinkles; 6.6% had score one wrinkles; and 2.1% had no wrinkles.

The authors found that people with wrinkle score of one had a slightly higher risk of dying of cardiovascular disease than people with no wrinkles. Those who had wrinkle scores of two and three had almost 10 times the risk of dying compared with people who had wrinkle scores of zero, after adjustments for age, gender, education, smoking status, blood pressure, heart rate, diabetes and lipid levels,

“The higher your wrinkle score, the more your cardiovascular mortality risk increases,” explains Dr Esquirol.

Furrows in your brow are not a better method of evaluating cardiovascular risk than existing methods, such as blood pressure and lipid profiles, but they could raise a red flag earlier, at a simple glance.

The researchers don’t yet know the reason for the relationship, which persisted even when factors like job strain were taken into account, but theorize that it could have to do with atherosclerosis, or hardening of the arteries due to plaque build-up. Atherosclerosis is a major contributor to heart attacks and other cardiovascular events.

The study was presented on August 26 at the European Society of Cardiology Congress

Research contact: @cliniquepasteur

FDA approves first generic version of EpiPen

August 20, 2018

When it comes to life-threatening allergic reactions, time is of the essence. Whether it’s a peanut allergy, a bee sting, a reaction to a medicine, or some other serious hypersensitivity, it is crucial for many Americans to have the correct drug on-hand and ready-to-use at a moment’s notice. Anaphylaxis occurs in approximately one in 50 Americans. People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.

However, until now, the expense and frequent lack of availability of such pharmaceuticals has been a problem. Not anymore: The U.S. Food and Drug Administration announced on August 16 that the agency has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. Teva spokesperson Doris Saltkill said the price of the drug and the exact launch date were not yet available, but the company’s statement suggested it would not be in time for many parents who are scrambling to find EpiPen in their pharmacies now. “We’re applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market,” the statement said.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

“The path to developing generic drug-device combination products like this one is challenging,” Gottlieb commented.”We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines. Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.”

The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.

The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, use of epinephrine injection may cause chest pain (angina pectoris) or abnormal heart beats (ventricular arrhythmias). Following use of epinephrine injection, patients should seek immediate medical or hospital care. Epinephrine should not be injected into the vein, buttock, fingers, hands or feet. To minimize risk of injection-site injury, movement of the leg should be limited during injection.

Research contact: fdaoma@fda.hhs.gov