Where Are They Now? Top 10 for 2011

Where Are They Now? Top 10 for 2011

Every year, Cleveland Clinic releases its list of the Top 10 Medical Innovations for the year that follows. Recently approved or up-and-coming in the space, these solutions grabbed the attention of our thought leaders for the waves they were making in medicine. But what happens to these innovations after they’re rolled out on stage? Join us as we move back through time and ask of the Top 10 Medical Innovations, ‘Where Are They Now?’

#1: New Molecular Imaging Biomarker for Early Detection, Prevention, and Treatment of Alzheimer’s

In 2010, a new brain imaging compound known as florbetapir was slated to make early detection of Alzheimer’s disease possible through identification of the initiation of brain damage. Injection of this radioactive molecular imaging compound allowed it to ‘bind’ to amyloid plaques – the telltale signature characteristic of Alzheimer’s. Follow-up imaging by positron emission tomography (PET) allowed physicians to effectively peer into the brain of a patient and assess it for dyed plaques and subsequent Alzheimer’s diagnosis. At the time, it was thought florbetapir could also be used to monitor the disease progress and drug efficacy. The drug was expected to receive FDA approval in 2011.

WATN: Florbetapir received FDA approval in 2012 for use in PET scans to detect accumulation of amyloid plaques to determine if Alzheimer’s disease is present. It is now sold under the brand name Amyvid®. Today the compound is used nationwide, alongside two other follow-on FDA-approved amyloid PET imaging radiopharmaceuticals (flutemetamol and florbetaben) to evaluate patients for possible Alzheimer’s disease and other causes of cognitive decline. In December 2020, Eli Lilly, manufacturer of Amyvid®, announced the active enrollment of its New IDEAS study to further assess the utility of amyloid brain PET scans for Alzheimer’s disease. The study will make use of the compound and build upon results from the original IDEAS study launched in 2016.

#2: Anti-CTLA-4 Drug (ipilimumab), Targeted T-Cell Antibody for Metastatic Melanoma

A type of skin cancer characterized by the uncontrolled growth of pigment-producing cells located in the skin, melanoma causes the most skin cancer deaths despite accounting for barely 3% of cases. In 2010, a new drug called ipilimumab was being explored for use in metastatic melanoma. A targeted T-cell antibody, ipilimumab specifically blocked the action of the protein molecule, CTLA, which is found on white blood cells and suppresses the immune system from fighting disease. Through target of CLTA, the patient's immune system was able to fight the cancer more vigorously. Based on its extraordinary response in improving the survival rates of patients with previously treated advanced melanoma, ipilimumab received FDA priority review status in 2010 – with potential to become the first new melanoma drug available in decades.

WATN: Ipilimumab was approved by the FDA in March 2011 to treat people with late-stage melanoma that had spread or could not be removed by surgery. In 2015, the FDA approved ipilimumab as an adjuvant therapy (after surgery) for patients with stage III melanoma. The goal of this new use of ipilimumab was to reduce the risk of melanoma recurrence. The compound is commercially known as Yervoy® and is sold by Bristol Myers Squibb.

In Phase III trials, the combination therapy of ipilimumab plus the compound nivolumab was found to significantly increase progression-free survival of melanoma patients by as much as 60% when compared to treatment with ipilimumab alone. Professionals believe that this novel combination of two cancer therapies will become the new standard of care for treatment of melanoma.

Ipilimumab is also being actively explored in other cancers for its anti-CLTA properties. In 2018, the FDA approved nivolumab and ipilimumab in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. As recently as May 2020, the FDA approved the use of ipilimumab plus nivolumab given with 2 cycles of platinum-doublet chemotherapy as a first-line treatment for adult patients with metastatic or recurrent non-small cell lung cancer. 

#3: First Therapeutic Cancer Vaccine Approved by the FDA

Making waves in prostate cancer care, sipuleucel-T became the first therapeutic cancer vaccine ever approved by the FDA in 2010. Following 15 years of research and a roller-coaster ride of FDA decisions, the compound was approved for use in men with advanced prostate cancer to elicit an immune response against the disease, and improve survival. The new vaccine worked differently than other prostate cancer drugs – using dendritic cells to seek and destroy circulating tumor cells throughout the body. Sipuleucel-T was the first vaccine to demonstrate a survival benefit – extending the lives of patients with advanced, metastatic, androgen-independent prostate cancer by an average of four months when compared to patients given a placebo in a Phase III clinical trial.

WATN: As of 2020, sipuleucel- T (now known as Provenge® by Dendreon Pharmaceuticals) remains one of only two approved therapeutic cancer vaccines. Provenge® for prostate cancer was joined by T-VEC (Imlygic® by Amgen) for advanced melanoma in 2015. The dendritic cell cancer vaccine market, however, continues to grow with a robust CAGR predicted from 2020 to 2027 as several different vaccines undergo investigation for use against other cancers.

#4: JUPITER Study, Statins for Healthy Individuals

Historically, low levels of blood cholesterol were assumed to indicate a reduced risk for heart attack and premature death. However, the JUPITER trial (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) with released results in 2008, changed this conventional wisdom – demonstrating that some individuals with normal cholesterol levels could benefit from early intervention with a statin medication (to prevent disability and premature death from coronary heart disease). Data from the trial reported that, compared to patients taking the placebo, patients taking a statin had a 54% lower chance of heart attack, 48% lower chance of stroke, 46% lower chance of needing angioplasty or coronary artery bypass surgery, and a 20% lower chance of dying from any cause. The JUPITER trial also provided the first results to show that statins are highly effective in female and minority patients – groups typically excluded in clinical trials. In 2010, acting on the advice of an independent advisory committee, the FDA added language to the label of the drug rosuvastatin based upon the JUPITER results.

WATN: Despite JUPITER’s promising findings, subsequent reviews of the study found potential flaws in its design and interpretation, partly due to an over-reliance on biomarkers as endpoints. The reviews cast doubts on the efficacy and safety of statin medications. However, many physicians maintain there is evidence from the study that statins help prevent heart disease in certain groups of healthy people. Controversy with the treatment continues over a decade later – 2021 data cites only about 70% of adults over age 60 who are eligible for statins are taking them, and less than 70% of adults over 75.

#5: Hepatitis C Protease Inhibiting Drugs

In 2010, the best cure rates for hepatitis C came from a combination of the oral antiviral medicine ribavirin and an injectable interferon. The flu-like side effects of these drugs were known to debilitate patients – leading an estimated 300,000 Americans to fail the treatment protocol. In 2010, two advanced hepatitis protease inhibitors were awaiting approval by the FDA. The protease inhibitors worked by blocking a key enzyme that the virus needed in order to copy itself and proliferate in the body. Cure and toleration rates with these protease inhibitors were significantly higher than existing disease therapy.

WATN: Made available in 2013, a new class of medications known as polymerase inhibitors have taken the hepatitis C treatment scene from protease inhibiting drugs. Due to a significant decline in utilization and the availability of effective alternative therapies, many protease inhibitors have been discontinued. Janssen’s Olysio® (simeprevir) and AbbiVie’s Viekira® and Technivie® (ombitasvir/paritaprevir/ritonavir) were discontinued in 2018. Protease inhibitors Incivek® (telaprevir) by Vertex Pharmaceuticals and Victrelis® (boceprevir) by Merck were previously discontinued in 2014 and 2015, respectively. FDA-approved pan-genotypic antivirals are now standard of care.

#6: Telehealth Monitoring for Individuals with Heart Failure/ Implanted Wireless Cardiac Device for Monitoring Heart Failure

A weakening of the heart’s ability to pump blood throughout the body causes heart failure. Between 500,000 and 900,000 new cases are diagnosed each year in the US. In 2010, wireless healthcare and a variety of technology-based remote patient monitoring devices began to play a major role in heart failure management – providing a more effective way for physicians to gain critical information about their patient (adjusting medication when necessary, keeping the patient healthy and out of the hospital, etc.). Various sophisticated methods of assessing heart failure control were in use or in final testing phases, including an implantable, miniature monitor with communication technologies to measure and transmit daily pulmonary artery pressure levels – a key indicator of heart health.

WATN: In 2021, remote monitoring of cardiac implantable electronic devices is considered standard of care. Device advances over the years have led to increasing connectivity, with nearly all modern implanted devices capable of remote monitoring. Some newer devices even allow patients to use a smartphone app rather than a home monitoring device to send their remote monitoring transmissions. The technology is widely accepted by physicians and patients alike and is more cost-effective than conventional follow-up. Additionally, patients have been cited to value the security of a near-immediate alert if something appears wrong in their data.

#7: Endoscopic Weight Loss Procedure Transoral Gastroplasty (TOGA)

In an effort to reduce or eliminate complications and offer a “scar-less” procedure for weight-loss, transoral gastroplasty (TOGA®) procedures were being explored in 2010. Instead of making incisions in the abdominal wall, the incision-less procedure and system placed on the Top 10 list combined two flexible endoscopic staplers passed through the mouth to create a small restrictive pouch in the stomach. After eating a small meal, patients would be left with a feeling of satiety, thereby decreasing caloric intake, and eventually shedding excess pounds. Final Phase III results of a pivotal multi-center TOGA® study were anticipated in late 2010, with FDA approval to follow soon after.

WATN: The TOGA® system for transoral gastroplasty was being developed by Satiety, Inc., a medical device company based in Palo Alto, Calif. When its clinical trials did not reach set targets, research and development were halted indefinitely in 2011.

#8: Exhaled Nitric Oxide (NO) Breath Analysis for Monitoring Asthma

Asthma is a chronic inflammatory lung disease affecting more than 23 million Americans in 2010. The standard diagnostic for efficiency of patients’ lungs was an exam given by a doctor using a spirometer. However, it had been increasingly recognized by pulmonary experts that these in-office exams told only part of the asthma story. Nitric oxide (NO) is produced by epithelial cells that line the inner walls of the lung’s airways and is identified as a biomarker for asthma. Regular monitoring of NO levels was anticipated to help doctors and patients develop a good understanding of the way their airway inflammation was progressing – for example, a drop in NO values would indicate that inflammation had been reduced and the asthma was well controlled with the patient’s medical therapy. Our experts predicted that NO testing would play a valuable role in adding precision and accuracy to the diagnosing, monitoring, and pharmacological management of people with asthma – helping to avoid both under- and over-treatment of the disease.

WATN: This groundbreaking and non-invasive diagnostic technique is now a reality in clinical practice. New guidelines from the American Thoracic Society were introduced in 2011 to provide clinicians with a user-friendly reference for the standardized interpretation of the exhaled NO results. As technology advances, these diagnostic testing devices are becoming smaller and lighter, as the goal is to one day monitor nitric oxide content from a wearable device or smartphone attachment. Though spirometry is still the main method doctors use to diagnose asthma in people five years or older, the exhaled nitric oxide test is present in the repertoire of diagnostics and management for the condition.

#9: Oral Disease Modifying Treatment for Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disease that causes the body’s immune system to mistakenly attack the myelin in the central nervous system (CNS). In 2010, seven FDA-approved drugs existed to modify the course of the disease, but said drugs required daily or frequent injection/infusion – enough to discourage many people from consistent treatment. The new fingolimod capsules worked differently from other first-line MS therapies – successfully preventing the migration of T-cells from the lymph glands to the brain and spinal cord, keeping them from attacking the fatty myelin sheaths that cover nerve fibers. FDA approved in 2010, the drug represented a big step forward in treating the underlying causes of this debilitating disease, slowing the progression of disability, reducing its frequency and severity, and ultimately improving the lives of people with MS.

WATN: Fingolimod is now sold under the brand name Gilenya™ by Novartis. Following the 2010 FDA approval, the drug was cleared for use in Europe and Canada in 2011. Long-term study results of over 1600 patients were released in 2015 that confirmed it’s efficacy in treating multiple sclerosis patients. It was the second best-selling MS drug in 2019 and continues to be sold today. On the side, the compound is currently being explored in studies for varied conditions including, but not limited to, Alzheimer’s disease, Rett syndrome, and intracerebral hemorrhage. These studies are met with mixed results. Past fingolimod, novel advances continue to be made in the multiple sclerosis space – with 2017 bringing the first-ever FDA approved drug for the primary progressive population.

#10: Capsule Endoscopy for Diagnosis of Pediatric GI Disorders

One of the most challenging problems in pediatric digestive medicine has been finding the source of hidden bleeding in the gastrointestinal (GI) tract. When traditional endoscopic imaging techniques using a fiber optic scope or x-ray failed to reveal the source of unexplained bleeding in the area between the stomach and colon, surgery was often a next step. However, in 2010, many doctors were turning to a high-tech imaging tool called video capsule endoscopy for difficult-to-diagnose cases. The capsule’s ability to produce detailed, high-resolution images of the small intestine, made it superior to x-rays for detection of small-bowel ulcerations, polyps, and areas of bleeding. Swallowed like a pill, the capsule transmitted tens of thousands of images to clinicians in the six to eight hours it was inside the body.

WATN: Capsule endoscopy is becoming a standard method of assessing pediatric GI disorders. Innovation continues to refine the technique. In 2011, Japanese researchers developed a self-propelled endoscopy capsule. In 2015, Wi-Fi-enabled capsules became available. Current research is attempting to create bigger capsules that are able to thoroughly image the large intestine, possibly replacing the need for colonoscopies. The technology is still considered relatively new, but physicians believe it is useful in diagnostic procedures where traditional methods haven’t allowed for exploration before.  

View the full Top 10 list from 2011 here and learn more about Cleveland Clinic’s Top 10 Medical Innovations program.

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