THURSDAY, Aug. 25, 2022 (HealthDay News) — An experimental antibody remedy for a number of sclerosis can minimize symptom flare-ups by half, versus a regular therapy, a brand new medical trial has discovered.

The drug, referred to as ublituximab, beat a regular oral remedy for MS in lowering sufferers’ relapses — intervals of recent or worsening signs. It additionally proved higher at stopping areas of inflammatory injury within the mind.

Ublituximab is just not but accepted for treating MS; the U.S. Food and Drug Administration is reviewing the trial knowledge and is anticipated to decide by the yr’s finish, in accordance with drugmaker TG Therapeutics.

If accepted, ublituximab can be the most recent in a more recent group of MS therapies referred to as anti-CD20 monoclonal antibodies: lab-engineered antibodies that concentrate on particular immune system cells that drive the MS course of.

The new findings supply extra proof that the strategy advantages sufferers, in accordance with an knowledgeable who was not concerned within the trial.

“Is this revolutionary? No. But it is additional affirmation of a medical profit from concentrating on this inhabitants of cells within the blood,” mentioned Dr. Lauren Krupp, who directs NYU Langone’s Multiple Sclerosis Comprehensive Care Center in New York City.

MS is a neurological dysfunction that normally arises between the ages of 20 and 40. It’s attributable to a misguided immune system assault on the physique’s personal myelin — the protecting sheath round nerve fibers within the backbone and mind. Depending on the place the injury happens, signs embrace imaginative and prescient issues, muscle weak spot, numbness, and issue with stability and coordination.

Most folks with MS have the relapsing-remitting type, the place signs flare for a interval, then ease. Over time, the illness turns into extra steadily progressive.

Immune system cells referred to as B cells appear to play an particularly key function in driving MS. So current years have seen the event of monoclonal antibodies that deplete the blood of B cells. One, referred to as ocrelizumab (Ocrevus), was accepted within the United States in 2017. A second — ofatumumab (Kesimpta) — adopted in 2020.

Both antibodies deplete B cells by concentrating on a protein on the cells referred to as CD20. Ublituximab has the identical goal, but it surely’s engineered to be stronger at killing B cells, mentioned Dr. Lawrence Steinman, lead researcher on the brand new trial.

The trial didn’t evaluate ublituximab in opposition to both current anti-CD20 antibody, harassed Steinman, a professor of neurology at Stanford University. So it is not identified whether or not it is any kind of efficient.

But a possible benefit of the brand new antibody, Steinman mentioned, is that it may be administered quickly.

Both Ocrevus and ublituximab require sufferers to go to a medical facility for infusions each six months. But an Ocrevus infusion takes about three hours, whereas ublituximab might be given in a single hour.

Kesimpta, in the meantime, avoids infusions altogether. It’s taken at house as soon as a month, utilizing an auto-injector.

“There are totally different options for various folks,” Steinman mentioned. “I believe it is all the time good to have choices.”

The findings, revealed Aug. 25 within the New England Journal of Medicine , are based mostly on greater than 1,000 sufferers with MS, principally the relapsing-remitting type. A small share had secondary progressive MS, a second section of the illness that follows the relapsing-remitting years.

About half have been randomly assigned to ublituximab infusions, whereas the opposite half took the oral remedy Aubagio (teriflunomide).

Over 96 weeks, ublituximab sufferers have been half as prone to have a relapse — with a mean annual fee of slightly below 0.1, versus nearly 0.2 amongst Aubagio sufferers. And on MRI scans, they confirmed fewer areas of irritation within the mind.

B cells are liable for churning out infection-fighting antibodies. So a major security concern with B-cell depletion is that it will probably go away folks extra susceptible to an infection. That was the case on this trial: 5% of ublituximab sufferers developed a critical an infection, together with pneumonia, versus 3% of Aubagio sufferers.

There are many medicine accepted to deal with MS. But Krupp mentioned some current research are displaying that sufferers fare higher long run after they get “high-efficacy” medicines — which embrace anti-CD20 antibodies — versus older medicine with more-moderate results.

To Steinman, earlier is healthier in the case of beginning high-efficacy therapy.

“My philosophy is, if insurance coverage will cowl it, knock the illness down laborious and quick,” he mentioned.

That brings up the real-world situation of value: CD20 monoclonal antibodies are costly; the present record value for Ocrevus is about $68,000 per yr, in accordance with drugmaker Genentech.

So typically, each Krupp and Steinman mentioned, remedy choices rely on which of them are lined by a affected person’s insurance coverage plan.

More data

The National Multiple Sclerosis Society has extra on treating MS.

SOURCES: Lawrence Steinman, MD, director and professor, neurology and neurological sciences, and pediatrics, Beckman Center for Molecular Medicine, Stanford University, Stanford, Calif.; Lauren Krupp, MD, director, NYU Langone Multiple Sclerosis Comprehensive Care Center, and professor, pediatric neuropsychiatry, NYU Grossman School of Medicine, New York City; New England Journal of Medicine, Aug. 25, 2022

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May 26, 2022 – Trishna Bharadia has a number of sclerosis and works as a affected person engagement advisor and is commonly requested to participate in medical trials. Mostly, although, she turns them down. She has to: A resident of rural England, Bharadia lives hours away from most medical trial websites. Even if one had been nearer, the trials sometimes require time without work work, which is difficult for her to get.

She took half in a single trial to determine the most effective sort of bodily train for folks with MS shortly after she was recognized in 2008. But she hasn’t been capable of take part in another research since.

Finding folks to fill trials is commonly one of many greatest obstacles in medical analysis. Nearly 80% of trials do not meet enrollment deadlines.

And though 70% of Americans say sufferers ought to have extra alternatives to be part of analysis, not more than 5% of most cancers sufferers, for instance, in the end do. It’s why Bharadia and a rising group of well being advocates and docs have been pushing for a brand new sort of medical trial.

Unlike normal medical trials, which require an individual to journey to a central testing facility for every thing from bloodwork to remedy to follow-up, distant trials use a mixture of telemedicine, residence well being, and different applied sciences to convey the trial to the affected person.

“There’s potential right here to open up accessibility to medical analysis as a result of I’m not the one one which finds it tough to journey to websites,” Bharadia says.

Remote Clinical Care

Although most of these trials are greater than a decade outdated, Andrea Coravos, co-founder and CEO at HumanFirst, a software program platform designed to increase entry to analysis and well being care, says the pandemic has stirred curiosity, each from pharmaceutical firm sponsors and regulators.

On March 29, the corporate THREAD, a digital well being platform that helps telemedicine for medical analysis, introduced it could work with Amazon Web Services to make trials extra environment friendly utilizing synthetic intelligence and different automation methods.

Supporters of decentralized trials say the brand new method will assist make medical trials extra numerous and make it simpler to participate. That would not simply imply for sufferers, says Craig Lipset, co-chair of the Decentralized Trials and Research Alliance, but in addition for docs, who will be a part of trials from their very own workplaces. The outcome, he says, is an entire reimagining of medical analysis.

“If this works, this may create a brand new approach for us to have interaction with physicians,” he says. “What we have to deal with is giving folks alternative about how one can take part.”

For practically 80 years, medical trials have fashioned the spine of advancing life-saving medicines. Despite the sphere’s unquestionable success, conventional medical trials aren’t with out drawbacks. They sometimes take years to run and may price a whole lot of tens of millions of {dollars}, all with a 90% failure fee.

One of the explanations that trials fail is the medication merely do not work. But an absence of enough participation is definitely the most typical motive a medical trial is stopped early, in keeping with a 2021 paper within the journal BMC Trials.

Reimaging Medical Research

Like many drug corporations, Pfizer needed a medical trial choice that was simpler, sooner, and cheaper. The rise of cellular applied sciences meant that in 2011, the pharma large might launch its first totally distant trial of an already-approved drug, known as Detrol LA, used to deal with overactive bladder.

Despite early enthusiasm from each Pfizer and the FDA, the trial, known as REMOTE, revealed that decentralization alone wasn’t going to remedy all that ails medical trial work. After a number of months, the brand new trial folded as a result of it nonetheless could not recruit sufficient ladies with extreme bladder points.

These early challenges forged a pall over the concept of decentralized trials, and the sphere returned to the drafting board to rethink a approach ahead. The rise of smartphones and wearable well being trackers introduced this know-how to extra houses and elevated consolation with the concept of utilizing know-how as part of on a regular basis well being care.

Increasingly, Lipset says, the concept of utilizing health trackers and smartphone apps as a part of medical trials appeared much less like a pie-in-the-sky dream and extra like a sensible choice.

Remote trials had been already poised to make a comeback when the pandemic struck. As the world screeched to a halt in early 2020, medical trials had been no exception. Amir Kalali, MD, who had co-founded the Decentralized Trials and Research Alliance with Lipset, was swamped with calls from former colleagues about how one can pivot present trials to the brand new, immediately distant, world. Almost in a single day, decentralizing trials had turn into a necessity.

Fast-Tracking Change

“People act not once they see the sunshine, however when the texture the warmth,” Kalali says.

COVID-19 offered that warmth.

In the previous 2 years, says Sally Okun, govt director of the Clinical Trials Transformation Initiative, distant trials have turn into a everlasting a part of the medical trial panorama and their affect continues to develop.

Openness to most of these trials from regulators within the United States, Europe, and across the globe has led to higher investments on this sphere, displaying that decentralized trials are usually not simply right here to remain, however have turn into a significant participant within the medical trials panorama.

“The medical trial ecosystem will be constructed extra across the sufferers themselves and the members concerned within the research, versus constructing it across the trial and having everybody accommodate that,” Okun says.

The distant trial firm THREAD is now working with Amazon Web Services. The purpose of teaming up, says THREAD’s CEO, John Reites, is to enhance the standard and velocity at which medical trials are accomplished, and to assist make most of these trials the norm.

“When we are saying ‘decentralized trial,’ I truly need a line by the phrase ‘decentralized’ within the subsequent 3 years,” he says.

The rise of decentralized trials doesn’t suggest the top of brick-and-mortar trial websites or tutorial medical facilities as hubs of analysis, Lipset stresses. The purpose of decentralization has by no means been to take away conventional trials however so as to add different choices to them, the way in which that many faculties have created hybrid studying choices that enable college students to mix on-campus and distance studying. Not everybody needs a well being aide visiting their residence or feels comfy utilizing an app or health tracker to watch their coronary heart fee. Instead, these gadgets ought to assist individuals who need to be a part of a trial, however would not in any other case be capable to, take part.

Adding More Doctors

The trials supply alternatives not simply to members, but in addition to docs, who’ve sometimes been shut out of analysis.

“Most physicians by no means go anyplace close to a medical trial after leaving their fellowship,” says Irfan Khan, MD, founder and CEO of Circuit Clinical, which works to convey medical trials to non-public practices. “There’s a paucity of docs doing analysis and a focus of the place work will get accomplished.”

He says this may assist put medical analysis into normal medical care. And since most sufferers hear about trials from their docs, it can allow extra folks to listen to about alternatives within the first place.

The newness of this method implies that a lot stays unknown about distant trials. Although regulators have offered draft steering on these trials, it will not be till companies can dig into the info that scientists will know whether or not they handed or failed. Nor is it clear whether or not the standard of the info collected by sufferers on telephones and wearables can be simply pretty much as good as that obtained in clinics. The abrupt shift to distant information assortment throughout COVID-19 provides scientists an opportunity to match measurements, Kalali says.

For Bharadia and sufferers like her, the shift cannot come quickly sufficient. “It can be a studying course of,” she says, “But you aren’t getting anyplace by saying that is too tough. We must discover a solution to do it.”

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MONDAY, Feb. 21, 2022 (HealthDay News) — An experimental drug might assist construct bone mass in some adults with a uncommon brittle-bone illness, a small preliminary research suggests.

The illness is named osteogenesis imperfecta. It’s brought on by defects in sure genes concerned in making collagen — a key protein within the physique’s connective tissue. Osteogenesis imperfecta (OI) is current at beginning, and should depart kids with mushy bones which are deformed or break simply — although the severity of the situation ranges extensively.

While specialists have identified the wrongdoer genes concerned in osteogenesis imperfecta, the brand new research factors to a mechanism within the illness course of: overactivity in a protein referred to as TGF-beta.

And when the researchers infused eight grownup sufferers with a drug that inhibits the protein, 5 confirmed a rise in bone density.

The findings are preliminary, and far work stays forward, burdened researcher Dr. Brendan Lee, a professor of molecular and human genetics at Baylor College of Medicine in Houston.

“One must be cautious,” he mentioned, “as a result of extra bone doesn’t essentially imply higher bone.”

But the broader hope is that by understanding the mechanisms of OI, higher remedies — presumably with advantages outdoors the bone — will be developed, in keeping with Lee.

“This shouldn’t be solely a bone illness,” he mentioned. “This is a connective tissue illness.”

Depending on the severity of the situation, individuals also can endure unstable joints, weak muscle tissue, pores and skin that bruises simply, listening to loss or underdeveloped lungs.

At this level, Lee mentioned, it’s unknown whether or not the drug used on this research, referred to as fresolimumab, can have an effect on these sorts of signs.

Osteogenesis imperfecta is uncommon, occurring in 1 out of each 10,000 to twenty,000 births worldwide, in keeping with the U.S. National Institutes of Health.

There aren’t any drugs authorised by the U.S. Food and Drug Administration particularly for the illness. But osteoporosis drugs referred to as bisphosphonates are a mainstay of therapy for kids with osteogenesis imperfecta.

The medicine can improve youngsters’ bone density and assist them be extra energetic, mentioned Dr. Cathleen Raggio, a pediatric orthopedic surgeon on the Hospital for Special Surgery in New York City.

But bisphosphonates aren’t particularly designed for OI. That means they aim a symptom and never the illness course of itself, mentioned Raggio, who researches and treats osteogenesis imperfecta.

She agreed that having drugs that focus on a “pathway” within the OI course of may “deal with the core downside, reasonably than signs.”

Raggio, who was not concerned within the new research, mentioned she was “cautiously optimistic” in regards to the findings. But like Lee, she burdened that rather more work must be completed.

Larger research of adults are wanted, Raggio mentioned, to take a look at the security and longer-term effectiveness of fresolimumab — and to raised perceive why some sufferers might reply, whereas others don’t.

The research, revealed lately within the Journal of Clinical Investigation, concerned two components. First, the researchers analyzed bone tissue samples from a small group of kids with and with out the brittle bone illness.

In earlier analysis, Lee’s group had discovered that TGF-beta “signaling” is ramped up in lab mice with an OI-like situation. So they wished to see whether or not that was true in human OI-affected bone.

It turned out that was the case.

Next, the researchers gave eight grownup sufferers a single infusion of fresolimumab — a lab-engineered antibody that inhibits TGF-beta. The drug has been below research as a therapy for sure cancers, amongst different circumstances.

In bone, Lee defined, TGF-beta seems to be a “grasp orchestrator” of transforming — the continuous course of by which previous bone is damaged down and new bone is shaped.

He and his colleagues discovered that 5 sufferers with extra average OI confirmed elevated bone density within the three to 6 months after the fresolimumab infusion. The three remaining sufferers, who had extra extreme illness, confirmed both no change or a decline in bone density.

Past analysis of fresolimumab for different circumstances has turned up some potential dangers, together with bleeding and pores and skin tumors.

In this research, sufferers had no severe unwanted effects from the only infusion, in keeping with Lee’s group.

The analysis was supported by the Brittle Bone Disorders Consortium, and a analysis settlement with Sanofi Genzyme, the maker of fresolimumab.

The firm will lead a bigger trial of adults with osteogenesis imperfecta, to additional check the drug’s security and results on bone.

If grownup research show constructive, then the query can be whether or not the drug can profit kids with OI, too — presumably added onto bisphosphonates, Raggio mentioned.

For now, she mentioned, dad and mom ought to know that researchers are engaged on understanding the mechanisms of the illness, and translating that to therapy.

No one is saying fresolimumab, or any single drug, would be the reply to a fancy illness like OI, Lee famous.

“Rarely in drugs does one dimension match all,” Lee mentioned.

More data

The OI Foundation has extra on osteogenesis imperfecta.

SOURCES: Brendan Lee, MD, PhD, professor and chair, division of molecular and human genetics, Baylor College of Medicine, Houston; Cathleen L. Raggio, MD, pediatric orthopedic surgeon, Hospital for Special Surgery, New York City; Journal of Clinical Investigation, Feb. 3, 2022, on-line

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Jan. 4, 2022 — A federal jury convicted Elizabeth Holmes, the founding father of the blood testing startup Theranos, on 4 of 11 expenses of fraud on Monday, based on The Wall Street Journal.

During the 15-week trial, Holmes testified in her protection and confirmed remorse for missteps. She mentioned she by no means meant to mislead anybody when she claimed to revolutionize blood testing, the newspaper reported.

More than 3 years in the past, Holmes was charged with 9 counts of wire fraud and two counts of conspiracy to commit wire fraud. On Monday, she was discovered responsible on three counts of wire fraud and one depend of conspiracy to commit wire fraud. She was acquitted on 4 counts associated to defrauding sufferers who had used the corporate’s blood exams.

But the jury failed to achieve a verdict on three counts of wire fraud associated to traders, saying earlier Monday that it was robust for jurors to agree on the three expenses, the newspaper reported.

Holmes will probably be held on bond till sentencing. She will doubtless enchantment the decision, which might take years. She and her legal professionals declined to remark to reporters as they left the courthouse.

The timing of any new motion may very well be affected by the upcoming trial of Ramesh “Sunny” Balwani, who’s Holmes’s former boyfriend and chief working officer at Theranos, the Journal reported. He is charged with 10 counts of wire fraud and two counts of conspiracy to commit wire fraud. His trial is about for subsequent month.

Holmes might resist 20 years in jail for every depend, although white-collar crimes hardly ever carry such stiff sentences. The incontrovertible fact that she was acquitted of some expenses will doubtless scale back the general penalty.

Judge Edward Davila plans to carry a convention in a few week to debate the three counts that the jury didn’t resolve on, the newspaper reported, in addition to any plans for a retrial of these counts.

Holmes developed the concept for Theranos as a scholar at Stanford University. She wished to upend the blood testing enterprise by growing a finger-prick know-how that may take a look at for a spread of well being circumstances with a couple of drops of blood. At its peak, Theranos was valued at greater than $9 billion and employed lots of of scientists, engineers, and entrepreneurs, based on the Journal.

Holmes claimed the corporate’s proprietary know-how might run greater than 200 well being exams and detect a wide range of illnesses. But testimony through the trial confirmed that the corporate might solely use its know-how for 12 kinds of affected person exams, and the outcomes have been usually unreliable, the newspaper reported. At its lab, the corporate secretly ran most of its exams on industrial units from different corporations. During the trial, Holmes additionally conceded that she solid studies despatched to traders through the use of logos from drug corporations that hadn’t given permission.

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WEDNESDAY, Nov. 17, 2021 (HealthDay News) — The first human scientific trial of a nasal vaccine to gradual the development of Alzheimer’s illness is ready to start after practically 20 years of analysis.

This is a “exceptional milestone,” in accordance with Dr. Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital in Boston.

“Over the final 20 years, we have amassed preclinical proof suggesting the potential of this nasal vaccine for AD [Alzheimer’s disease],” Weiner mentioned in a hospital information launch. “If scientific trials in people present that the vaccine is secure and efficient, this might characterize a unhazardous remedy for individuals with Alzheimer’s, and it may be given early to assist forestall Alzheimer’s in individuals in danger.”

The vaccine options an experimental agent referred to as Protollin that stimulates the immune system. It’s designed to immediate white blood cells within the lymph nodes on the perimeters and again of the neck emigrate to the mind and clear beta amyloid plaques, a trademark of Alzheimer’s illness.

According to Dr. Tanuja Chitnis, principal investigator within the trial, “For 20 years, there was rising proof that the immune system performs a key position in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to deal with AD.” Chitnis is a professor of neurology on the hospital.

“Research on this space has paved the way in which for us to pursue an entire new avenue for probably treating not solely AD, but additionally different neurodegenerative ailments,” she added.

The part 1 trial will embrace 16 sufferers between 60 and 85 years of age who’ve early, symptomatic Alzheimer’s illness however are in any other case in good normal well being. They will obtain two doses of the nasal vaccine one week aside.

Along with assessing the vaccine’s security and the way properly sufferers tolerate it, the researchers will look at the way it impacts immune response, together with its influence on white blood cells.

The trial is funded by I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical, builders and makers of Protollin.

More data

The Alzheimer’s Association has extra on Alzheimer’s illness.

SOURCE: Brigham and Women’s Hospital, information launch, Nov. 16, 2021

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Oct. 25, 2021 — The promise appeared too good to be true: Walk into your native drugstore, present a number of drops of blood through finger-prick, and get screened for a whole lot of various ailments, rapidly and cheaply. That’s what Silicon Valley startup Theranos, based by Elizabeth Holmes, touted. As it turned out, it wasn’t true. Now Holmes is on trial in federal courtroom in San Jose, CA.

The Theranos Story

Federal prosecutors have charged Holmes and Ramesh “Sunny” Balwani, Theranos’s president and chief working officer, with 9 counts of wire fraud and two counts of conspiracy to commit wire fraud. Both have pleaded not responsible. Their circumstances have been separated, and Balwani will go on trial in 2022.

Prosecutors say the pair knew Theranos couldn’t ship — the gear merely didn’t work — however continued to boost hundreds of thousands of {dollars} from buyers and market the product to docs and shoppers. If convicted, Holmes faces as much as 20 years in jail.

Holmes began Theranos (a mishmash of “therapy” and “diagnosis”) in 2003, when she was 19 years previous. The subsequent yr, she dropped out of Stanford University to run the corporate. The objective: to revolutionize the well being care {industry} by making blood exams broadly, simply, and inexpensively out there. Balwani joined the corporate in 2009. For a while, the pair had been romantically concerned, which can issue into the trial.

Thanks to Holmes’ charismatic presentation (full with TED Talk) and a board of administrators that included former secretaries of state George Shultz and Henry Kissinger, the corporate attracted main buyers. At one level, Theranos was valued at $9 billion.

In 2013, Theranos introduced a partnership with Walgreens drugstores. They deliberate to open Theranos Wellness Centers inside Walgreens areas, the place shoppers might stroll in and have a number of drops of blood taken, 1/1,000 the quantity of a typical draw. Their proprietary, automated laboratory gear would produce ends in just some hours at low price.

But the corporate had one massive drawback: Their expertise didn’t work. The FDA solely accredited it for a single check, for herpes simplex 1 virus.

In October 2015, The Wall Street Journal printed an exposé primarily based on the account of a whistleblower inside Theranos, who mentioned the corporate’s expertise had many flaws. Results had been typically inaccurate. As a outcome, the overwhelming majority of the 200+ exams Theranos carried out had been performed the standard approach, with vials of blood drawn from the arm, on industry-standard gear.

Things spiraled from there, and by June 2016 Walgreens stopped working with Theranos. Lawsuits, layoffs, and failed lab inspections adopted, and a pair of years’ price of exams carried out on Theranos gadgets had been voided. In 2018, the Securities and Exchange Commission charged Holmes and Balwani with “massive fraud.”

Could It Have Worked?

Holmes’ concept was certainly intriguing, but Theranos never managed to pull it off. And even if they’d had limitless amounts of time and money, experts doubt they ever could have. Because most tests are performed only on the liquid part of the blood sample, a single drop from a finger-prick would really provide half as much that’s usable.

“When people heard what appeared to be a revolutionary concept, it sounded like we’d finally reached the days of Star Trek. Do all these tests on a single drop of blood,” says Kimberly Sanford, MD, president of the American Society for Clinical Pathology. “I remember discussing it in a staff meeting, all of us saying this is scientifically impossible, and the entire pathology community said the same.”

Beyond the expertise, the concept of strolling right into a drugstore for blood exams poses different challenges. Interpreting blood check outcomes isn’t as simple because it appears. “Normal” ranges characterize 95% of the wholesome inhabitants, which implies that 5% of wholesome individuals may be anticipated to have outcomes exterior that vary. If you’re one of many 5% and also you’re irregular outcomes and not using a physician’s enter, you might wind up pressured and dealing with a bigger medical workup for nothing, says Amy Karger, MD, PhD, chair of the College of American Pathologists’ Point of Care Testing Committee.

As whistleblower Erika Cheung, a former Theranos lab affiliate, testified at Holmes’ trial, “You’d have about the identical luck flipping a coin as as to if your outcomes had been proper or mistaken.”

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