Are these medical breakthroughs or science fiction?
The speed of science is often excruciatingly slow. But over the last decade we’ve made significant strides in medical research, disease treatment and the improvement of patients’ quality of life.
Although designer babies and a disease-free world may or may not come to pass, the Cleveland Clinic offers a glimpse of the most promising and upcoming medical innovations each year via its annual medical innovations list.
The list, which has been an undertaking since 2007, contains treatments and technologies that are expected to significantly change patient care and save lives.
To find out which breakthroughs are set to reshape healthcare in 2015, the clinic asked 110 of its top experts (individuals who focus on patient care every day) to offer their insight.
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This is what they came up with.
Leadless cardiac pacemaker
Since 1958, the technology involved in cardiac pacemakers hasn’t changed much. A silver-dollar-sized pulse generator and a thin wire, or lead, inserted through the vein kept the heart beating at a steady pace. Leads, though, can break and crack, and become infection sites in 2 percent of cases. Vitamin-sized wireless cardiac pacemakers can be implanted directly in the heart without surgery and eliminate malfunction complications and restriction on daily physical activities.
Mobile stroke unit
Time lost is brain lost. High-tech ambulances bring the emergency department straight to the patient with stroke symptoms. Using telemedicine, in-hospital stroke neurologists interpret symptoms via broadband video link while an onboard paramedic, critical care nurse and CT technologist perform neurological evaluation and administer t-PA after stroke detection, providing faster, effective treatment for the affected patient.
PCSK9 inhibitors for cholesterol reduction
Effective statin medications have been used to reduce cholesterol in heart disease patients for over two decades, but some people are intolerant and cannot benefit from them. Several PCSK9 inhibitors, or injectable cholesterol lowering drugs, are in development for those who don’t benefit from statins. The FDA is expected to approve the first PCSK9 in 2015 for its ability to significantly lower LDL cholesterol to levels never seen before.
Dengue fever vaccine
One mosquito bite is all it takes. The World Health Organization reports that about half of the world’s population is now at risk for dengue fever, which up until now was preventable only by avoiding mosquito bites. More than 50 to 100 million people in more than 100 countries contract the dengue virus each year. The world’s first vaccine has been developed and tested, and is expected to be submitted to regularly groups in 2015 with commercialization expected later that year.
Cost-effective, fast, painless blood-testing
Have the days of needles and vials come to an end? The new art of blood collection uses a drop of blood drawn from the fingertip in a virtually painless procedure. Test results are available within hours of the original draw and are estimated to cost as little as 10 percent of the traditional Medicare reimbursement.
Chemotherapy, the only form of treatment available for treating some cancers, destroys cancer cells and harms healthy cells at the same time. A promising new approach for advanced cancer selectively delivers cytotoxic agents to tumor cells while avoiding normal, healthy tissue.
New drug for heart failure
Angiotensin-receptor neprilysin inhibitor, or ARNI, has been granted “fast-track status” by the FDA because of its impressive survival advantage over the ACE inhibitor enalapril, the current “gold standard” for treating patients with heart failure. The unique drug compound represents a paradigm shift in heart failure therapy.
Single-dose intra-operative radiation therapy for breast cancer
Finding and treating breast cancer in its earliest stages can oftentimes lead to a cure. For most women with early-stage breast cancer, a lumpectomy is performed followed by weeks of radiation therapy to reduce the likelihood of recurrence. Intra-operative radiation therapy, or IORT, focuses the radiation on the tumor during surgery as a single-dose, and has proven effective as whole breast radiation.
New drugs for idiopathic pulmonary fibrosis
Nearly 80,000 American adults with idiopathic pulmonary fibrosis may breathe easier in 2015 with the recent FDA-approval of two new experimental drugs. Pirfenidone and nintedanib slow the disease progress of the lethal lung disease, which causes scarring of the air sacs. Prior to these developments, there was no known treatment for IPF, where life expectancy after diagnosis is just 3 to 5 years.
Cancer kills approximately 8 million people annually and is difficult to treat, let alone cure. Immune checkpoint inhibitors have allowed physicians to make significantly more progress against advanced cancer than they’ve achieved in decades. Combined with traditional chemotherapy and radiation treatment, the novel drugs boost the immune system and offer significant, long-term cancer remissions for patients with metastatic melanoma, and there is increasing evidence that they can work on other types of malignancies.
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.