Decisions based on the pharmaceutical market
Baltic States pharma market review
SoftDent is providing quarter and annual Lithuanian, Latvian, and Estonian pharma markets' secondary sales analysis based on the data collected by PharmaZOOM project.
Summarized Lithuania, Latvia and Estonia pharma market overview reports for 2020 m. II quarter is already generated with the forecast for 202.
2020 10 20
New LT data
Data for the period October 12-18, 2020 is uploaded to PharmaZOOM LT.
2020 10 12
New LV data
Data for September 2020 is uploaded to PharmaZOOM LV.
2020 07 17
Integration with Power BI tool
With the help of Power BI, SoftDent prepares individualized interactive reports according to specific customer needs.
This solution includes the integration of pharmaceutical market data with the PowerBI business analytics tool, which allows you to effectively monitor pharmaceutical market changes and analyze data using interactive visuals.
2020 01 07
Additional data sources
Every month together with regularly updated wholesalers sales, we are importing VVKT sales of packages which sales we did not have before.
Information on Procurement Contract Data has been integrated into the PharmaZOOM LT system. Every month together with updated wholesalers sales it is possible to analyze data of the concluded contracts.
Pharmaceutical Market News
2020 10 12
The Pandemic’s Impact On Pharmacy
The Covid-19 pandemic continues to have a major impact on the pharmaceutical space. The global health crisis has emphasized the role of pharmacists as part of the front-line care team and exacerbated long-standing issues like drug shortages, drug recalls and drug diversion. As pharmacists continue to step up, address these challenges and adjust to the “new normal,” it is important to recognize the tools and technology that can help.
The Evolving Role Of Pharmacists
The pandemic has altered the role of the pharmacist and further emphasized their position as an integral part of a patient’s care team. Gone are the days of pharmacists being perceived as just distributors of medication. As front-line medical workers and physicians remain busy and focused on combating Covid-19, pharmacists continue to take an active part in providing counsel, education and support to patients who have concerns about the virus.
In fact, the U.S. Department of Health and Human Services (HHS) recently permitted pharmacists to administer childhood vaccines to prevent the outbreak of preventable diseases. Pharmacies have also shifted operations to best support patients through means like at-home delivery, ensuring that every patient receives the medication and care they need. The pandemic has revealed the need for a holistic, all-encompassing approach to patient care — one that is not possible without the input and expertise of pharmacists. While their role has only expanded in scope amid the pandemic, pharmacists are still combatting surprisingly quotidian challenges like drug shortages, diversion and recalls at an increased rate.
The Impact On Common Challenges Faced By Pharma
The pharmaceutical industry faces a number of challenges that have been further compounded by the pandemic. For example, the global health crisis has worsened drug shortages, a long-standing obstacle for pharmacists. According to recent data from my company’s Annual Hospital Pharmacy Operations Report, about 60% of pharmacy staff reported dealing with up to 20 medications on shortage at a time, and nearly 30% with more than 20 shortages at a time. Additionally, the American Medical Association shared that “[r]oughly half of all drugs in shortage are injectables, including analgesics, sedatives and paralytics used for intubating critically ill patients.”
Drug recalls are another major issue that has only intensified. According to my company’s annual report above, 79% of surveyed medical professionals reported that each recall can require up to 10 staff hours to sort through, and 35% reported that they are experiencing more than 10 recalls annually. As the industry continues to focus on testing and learning about new treatment options for Covid-19, it can be difficult for organizations to keep up with drug recalls, potentially inadvertently putting dangerous medications in front of patients. Take metformin, for example.
The global health crisis is also shedding light on another major concern — mental health strain on frontline care workers. Medical professionals are under immense amounts of pressure between caring for patients with Covid-19, keeping track of vital medications and maintaining their own health. According to the National Institute on Drug Abuse, “Many clinicians and addiction medicine specialists suggest that stress is the number one cause of relapse to drug abuse.” This means that drug diversion, or theft of controlled substances by a medical professional — an extremely under-reported part of the opioid epidemic — is much more likely to occur during times of high-demand and stress, like the pandemic.
Adjusting To Healthcare’s New Normal
As medical professionals navigate a changed healthcare landscape and address issues further compounded by the pandemic, it’s important for them to understand and embrace the technology available to ease the transition.
For starters, keeping track of medication inventory throughout the supply chain is more important than ever, particularly to address drug recalls and shortages. RFID technology, combined with cloud-based solutions that monitor the chain of custody from manufacturer to patient, hold a lot of promise — particularly for pharmacists.
RFID is a reliable way to track medication from manufacturer through to patient use. It can help pharmacists keep track of drug shortages and recalls by providing reliable, item-level visibility, allowing pharmacists to keep track of drugs that are in danger of shortage or consider alternatives where appropriate. However, according to a press release from DoseID, a consortium of which my company is a part, “It is only with participation across the entire pharmaceutical supply chain — from drug manufacturers, to inlay providers, to automation vendors and hospitals — that RFID unit-level medication tracking can achieve the DoseID goals of interoperability, reliable tag performance and complete and accurate data.” We’re seeing this promise manifest through the formulation of organizations like DoseID, which was created to improve insight into the pharmacy supply chain, ultimately protecting patients and making the lives of pharmacists easier in the process.
AI solutions are also proving to be beneficial when it comes to researching and testing possible drug treatments for Covid-19. In an effort to prevent shortages, researchers have figured out how to use AI technology to create alternative preparations and routes for drugs that are now being used in clinical trials to treat Covid-19. Hopefully, this will make treatments more widely available.
Furthermore, AI solutions that can monitor the prescribing habits of medical professionals can help organizations keep a constant pulse on where medication — especially high-demand controlled substances like propofol and fentanyl — is throughout the hospital and flag any concerning or suspicious behavior, preventing issues like drug diversion. Additionally, item-level inventory management systems ensure proper sanitization occurs if a medication cart or tray enters a room with a Covid-positive patient. Some technology solutions can actually incorporate a sanitation check as part of the standard medication dispatch workflow, ensuring that it remains top of mind for busy medical staff.
There’s no denying that the pandemic has changed the pharmaceutical industry forever. It has expedited and highlighted the need for pharmacists as a part of the patient care team and continues to exacerbate existing issues. While there is still plenty of uncertainty, there is one thing we know for sure: configurable technology is critical to the future of pharmacy.
2020 10 12
The Evolution of Pharma Marketing
Integrating advanced technologies with the current approach to pharma marketing will work best in the evolving new world of patient advocacy.
FREMONT, CA: The availability of life-saving pharmaceutical products by their very nature plays a prominent role in the wellbeing of a society. In fact, the marketing cost in the pharmaceutical sector has increased by nearly 70 per cent in the past 20 years and now totals nearly 30 billion dollars. Only those businesses that embrace the power of digital innovation and a customer-first business model will succeed in building more effective interactions, deeper loyalty, and lasting brand preference. Hence it can be said that the marketing world of pharma will adapt going forward to focus on the user, not the drugs. Here is more to it.
With technological advancement, many existing methods and practices of pharma marketing have been replaced or modified in combination with technologies. Electronic detailing is one of the methods of drug promotion introduced a few years back as technologically developed. In the pharma industry, it has been introduced as a new communication channel for the promotion of drugs among physicians. For e-detailing digital technologies like the internet, video conferencing, and interactive voice response are adapted to communicate with physicians.
The fast-changing market demands more value from pharmaceutical manufacturers than ever before. In this case, value stands for more cost efficiency, proven patient outcomes, and better contribution to the health care experience throughout the value chain. The key will be emerging as a key player in the integrated health management model that combines pharmaceutical marketing into mobile communications, and other online platforms for marketing.
As the result-based approach to health care grows in popularity, now is the time for pharmaceutical marketing agencies to drive value from a new personalized, omnichannel approach to marketing. This means allowing different strategies for marketing directly to customers and in detailing to physicians and payers. Advanced pharma marketers are shifting into precision marketing, which is all about focusing on digital platforms with custom messaging for a segment of consumers who want the information most.
For pharmaceutical firms to continue thriving, they need to engage with patients, who are more focused on holistic health outcomes. This means expanding their products and its capabilities with a focus on continuous patient outcomes, using new methods to drive market-specific drugs, and using the appropriate channels to provide the right information.
2020 09 22
Pharma and the modern patient: creating a real connection
Over the past few years, our digital world has moulded a new kind of patient – engaged and empowered individuals who want to be actively involved in their health journey.
With access to different treatment paths and complementary approaches based on location, physician, insurance, funds and more, therapies are becoming more personalised than ever before. The market is evolving – the patient voice has been amplified, forcing pharma companies to develop new ways to listen and interact, creating new opportunities to understand and prioritise patient needs and preferences.
What Do Patients Really Want?
Today, the expert knowledge that once exclusively belonged to physicians is now easily accessible to patients, thanks to the internet. As a result, patients have become active consumers instead of passive participants in their medical care. Their expectations have risen in conjunction with their increased participation and they want to be personally engaged. Patients want to be treated as people, and in our digital age this is not always easy. Like any other business, healthcare providers and pharmaceutical companies can appear as faceless entities. Pharma can benefit greatly from bridging this gap and creating an approachable brand that patients feel they can engage with.
What Can Pharma Do?
To engage patients, pharma must create trust and opportunities for genuine, two-way interactions. Traditionally, pharma has only interfaced with healthcare professionals and patient advocacy groups about patients’ needs, but for various reasons have spent less effort communicating with individual patients directly about their experiences, needs and wants. The time has come for this to change!
Here are some ways this change can be achieved, keeping current regulations in mind:
* Always be there: Deliver value to patients all the time, even before they use your drug
* Take a holistic approach: Go beyond the medicine and try to understand the ecosystem they are navigating and their challenges. This may especially help when trying to optimise adherence
* Be patient-centric: Focus on the patients’ needs, personalise your value and timing, and focus on how to improve patient quality of life and quality of care
* Provide emotional support: Build a community around a medical condition/medication, encouraging patients to share their experiences with others going through the same
* Research and improve care: Listen, understand and evaluate real- world patient experiences to help shape future decision-making
* Use artificial intelligence (AI): The world is data driven. If you engage patients, you can use advanced tools to discover patterns that let you anticipate patient needs and create an even more personalised experience, providing information and support exactly when it is needed
A Strengthened Connection
Just as Amazon revolutionised the way we consume products, so too digital health is changing the way patients consume medical care. Patients are becoming digital consumers with the ability to manage their own treatments, and the results are significant. Over the next few years, patients will continue to play a crucial role in pharma decision-making – impacting millions of lives and billions of dollars. Making this shift is undoubtedly challenging as it requires shifting mindset and business models. However, the future is undoubtedly patient engagement. Companies who can successfully achieve the above points will have a far greater understanding of patient needs and market demands. Furthermore, they will help patients better appreciate the critical role of pharma in the healthcare continuum. Ultimately, this shift is a win-win for pharma and patients and will improve healthcare for everyone.
2020 07 28
Technologies Shaping The Future Of Pharma
Digital health is poised to bring its disruptive force across the healthcare landscape, and the pharmaceutical industry isn’t immune to the upcoming changes. Turning the point-of-care towards patients and empowering them with their health data, this cultural transformation brings about a radical shift in the traditional functioning of the drug industry.
1. Integrating A.I. in drug development slashes time and cost
From finding suitable candidates to animal trials, from unexpected side effects in clinical trials to multiple trial-and-error sequences, drug development is understandably a lengthy and costly process. In fact, estimates put the numbers at about 12 years and $2.9 billion for an experimental drug to advance from a lab to the market. However, developments in the field of artificial intelligence can now help diminish the cost and time traditionally associated with drug development.
To exemplify this possibility, Insilico Medicine, an A.I. pharma startup, identified a potential new drug in only 46 days. Its algorithm achieved this by analysing vast amounts of data which would otherwise take humans years to go through. The drug didn’t result in a commercial one as this achievement was to prove the potential of A.I. in drug development. However, practical examples do exist within the industry.
Partnering with IBM and the University of Toronto in 2015, A. I. startup Atomwise used its algorithm to identify two drugs with significant potential to reduce Ebola infectivity. It accomplished this effort in less than a day. In 2020, the company teamed with researchers to find broad-spectrum treatments for COVID-19 and future coronavirus strains.
Also on the COVID-19 pandemic, the BarabasiLab paired its network medicine toolset with A.I. to find potential treatments. The team managed to obtain a list of such drug candidates in less than 10 days. The latter are undergoing tests on human cell lines in experimental labs. These are only a few examples of drug companies employing A.I.’s benefits in drug development. In fact, there are more than 230 such startups and this number will only keep climbing.
2. With 3D-printing, pharma companies can make personalised medicine a reality
Despite being a relatively new technology adopted in healthcare, 3D-printed drugs show great promise. The first FDA approval of a 3D-printed pill was issued only in 2015, but the technology already paves the way for personalised medicine. This was, in fact, the conclusion of a 2019 research. The researchers involved successfully 3D-printed 6 different drugs into a single, multilayered polypill. With this technique, pills of specific dose tailored to individual patients are made possible.
Medical 3D-printing company FabRx is aggressively working towards this goal. This April, they released M3DIMAKER – the first pharmaceutical 3D printer to manufacture personalised medicines. It allows for the printing of medicines according to the user’s manufacturing needs, which in some cases means one-month’s medication (28 pills) in around 8 minutes!
Traditionally, pills were manufactured in standard doses and had to be manually adjusted, for example, by crushing or splitting them in order to fit the dose for children. This method potentially leads to dosage errors or even improper drug use. With M3DIMAKER, this issue is a thing of the past. The printer allows pharmacists to make pills with the precise dose for individual patients. “I truly believe that we are one step closer to personalised medicine thanks to the M3DIMAKER,” said Dr. Alvaro Goyanes, Director of Development at FabRx.
3. Boosting adherence of chronic care patients with digital pills
Yearly, lack of adherence to one’s medication amounts to 125,000 deaths and around $300 billion in healthcare costs; all of these are in fact preventable. However, adhering to treatment plans with multiple medications is especially challenging for patients suffering from chronic conditions such as schizophrenia or cardiovascular diseases. To remedy this pressing issue, digital pills can boost adherence while preventing deaths.
The FDA first approved of such a digital pill in 2017 produced by Otsuka Pharmaceutical and Proteus for chronic mental disorders. This pill contains an ingestible sensor which is a wearable patch sensor and an app track. This allows physicians to monitor a patient’s compliance to the treatment.
However, Proteus filed for bankruptcy in June 2020. Despite one company’s struggles, the technology it employed isn’t at fault. In fact, an independent study in 2019 showed the improved adherence to treatment by tuberculosis-infected patients using oral pills equipped with Proteus’ system. Their adherence rate was even comparable to in-person medication adherence programs. As such, the technology has the potential to boost adherence and can be further developed by other companies.
2020 07 13
Pharma sales to increasingly rely on virtual platforms due to COVID-19
Virtual tools are being increasingly utilised by pharma companies to replace in-person meetings following the outbreak of the COVID-19 pandemic.
According to researchers at GlobalData, virtual platforms will experience an extra boost after already having a transformational impact on the healthcare landscape, due to the impacts of the COVID-19 coronavirus.
Dr Valentina Gburcik, Senior Director of Cardiovascular and Metabolic Diseases, Gender Health and Digital at GlobalData, commented:
“The shift from in-person to digital is seen in advertising, medical conferences and sales rep meetings with physicians. Virtual health tools are already there enabling companies to have broader engagement with patients and physicians throughout various phases of the patient journey. Sales forces from pharma companies are now using this technology even more to interact virtually with physicians – particularly during the COVID-19 outbreak.”
The COVID-19 pandemic has seen cancellations of clinical events and conferences, as well as a surge of virtual meetings while all face-to-face contacts halt, highlight the researchers.
Gburcik added: “In-person meetings have their own advantages such as people being able to express themselves by using body language and facial expressions that can better convey a message and create a deeper bond with a customer.
The lack of a physical component in human interaction may lead to a weaker influence of reps over respective physicians and therefore reduced drug sales. Nevertheless, the ever-increasing internet speed, with 5G on our doorstep and evolving video conferencing software such as WebEx, Zoom and Skype for Business, will somewhat alleviate these problems.”
However, the researchers emphasise that it remains to be seen whether the current conditions will push humanity further into virtual space with no return to the circumstances seen before the COVID-19 pandemic.
Gburcik concluded: “The pharma sales forces and physicians may get used to the new reality and thus the use of the virtual meetings and tools may get boosted far beyond the pandemic.”
2020 01 02
Key trends studied for diabetes drug development in 2020
Functional links between metabolic, cardiovascular and renal diseases, as well as a focus on digital and a personalised approach will shape diabetes drug development in 2020, says new analysis.
Valentina Gburcik, PhD, Senior Director of Cardiovascular and Metabolic Disorders and researchers from GlobalData have looked at the key trends that will shape the metabolic disorders pharmaceutical space in 2020, focusing on diabetes.
Gburcik says that the diabetes market has long been a lucrative space for drug developers. According to a GlobalData study, 165 million people were diagnosed with type 2 diabetes globally in 2018, a number that is going to increase to 212 million by 2028.
“It comes as no surprise that many major pharmaceutical companies have been investing in this area,” Gburcik said, “leading to an enormous number of marketed branded therapies, as well as a rich pipeline, which is predominantly filled with ‘me-too’ therapies entering a very saturated market.”
According to the researchers, a growing body of scientific evidence is showing interconnectedness between metabolic disorders and cardiovascular and renal diseases and an increasing number of scientists and drug developers are now focusing on understanding the functional links between these diseases to jointly address cardio-renal-metabolic risks, which should eventually lead to better and more holistic treatments.
Gburcik further continued that digital transformation in healthcare, including the use of artificial intelligence (AI) and big data, will be a game-changer to diabetes prevention and management.
“These technologies have the potential to revolutionise the treatment of diabetes by employing continuous remote monitoring of patients’ symptoms, physiological data and environmental factors through the use of wearable tech, sensors and smartphone technologies,” Gburcik said.
Patient centricity and personalised medicine are another rising theme in healthcare, Gburcik said. “Oncology is currently the most advanced field in terms of personalised molecular diagnosis and treatments tailored based on genetics. However, diabetes research is experiencing rapid progress too,” Gburcik explained.
“Although the studies so far have not shed enough light on the genetic contribution to the phenotype of heterogeneous metabolic diseases such as diabetes, big data that is currently being accumulated through the use of digital technology will soon lead to better characterisation of clusters, which may define specific subtypes of the disease, leading to more tailored treatments and better outcomes.”
2019 12 31
Packaging security trends in the pharmaceutical industry
Drug safety is a huge concern for big pharma and tampering and counterfeiting in the market is dangerous for both consumers and brands. In this article, Prakash Shetty shares the latest innovations in packaging design and highlights how tamper proofing and developments in technology can protect all concerned.
THE $20 BILLION pharmaceutical packaging industry is the frontrunner in deploying technology for advanced security through packaging. The rise of e-commerce and efficient logistics have made sophisticated drugs accessible worldwide, irrespective of their manufacturing locations. However, this presents a challenge to protect products throughout their lifecycle and against counterfeiting. Pharmaceutical packaging innovations are important not only for the effectiveness of drugs, but also to ensure authenticity, traceability, product protection and patients’ comfort.
Pharmaceutical products require responsible packaging, especially for life-saving drugs, medical devices and nutraceuticals. The possible threats to these products include misuse and counterfeiting.
The World Health Organization (WHO) reports that about 10 percent of drugs are counterfeited globally. While counterfeiting is a result of human antisocial practices, tampering can occur due to inefficient handling or storage. However, technology and digitilisation can prevent counterfeiting, as well as tampering, to a great extent.
Pharmaceutical packaging – security through technology
Technology can help identify unauthorised access by making tampering evident and also creating a barrier to it. Tamper-proofing solutions ensure product safety during storage and transit. Tamper-resistant packaging relies on two principles: the requirement for multiple layers of protection and making tampering evident in case of unauthorised access or when the package integrity is compromised. Tamper proofing is challenging, as the package requires protection from external intervention. One strategy for tamper proofing that is popular in the pharmaceutical industry involves the following five layers of protection:
Primary closure: This involves securing the lid of the container such that any adjustments made after dispatch are recognizable.
Sealing: The process of making the primary closure permanent against transit pressure
Isolating: Shrink wraps are used to safeguard the sealed container from moisture and other shipments
Identification: Unique identification numbers prevent replication. It also makes the product identifiable in the supply chain.
Secondary packaging: The outer shipping containers that are designed in accordance with the shippers’ guidelines.
Tampering can be made evident through overt security features. Overt technology involves authentication through visual inspection without any expert knowledge. Hologram, colour shift inks and tear tapes are scalable and cost-effective systems for tamper evidence. Consumers can refuse to accept the package or report it if they spot damage.
Holograms: Brands usually use hologram techniques on their logo to indicate authenticity. Wear and tear on the hologram indicates rough handling and/or inappropriate storage.
Colour shift inks: Colour shift inks may appear as two or more distinct colours when shifted to different angles and give an illusional 3D effect.
Tear tapes: These are single-use polypropylene tapes. Consumers can identify tampering if the package lacks sealing tape or the tape is broken. Tear tapes are impossible to remove without destroying, hence making unauthorised access evident.
Tamper-proofing technology combined with covert security features can help in preventing counterfeiting. Covert technology includes infrared (IR) and ultraviolet (UV) pigments, microtext and microscopic tagging, which are invisible through naked eyes. These are difficult to detect and replicate without specialist detection equipment. Security graphics and digital watermarks are the other techniques widely used in pharmaceutical packaging to confront counterfeiting.
Security graphics: Design elements like line modulation and line embossing can produce a fine line colour printing similar to currency printing. Furthermore, microtext and latent images can make replication detectable.
Digital watermarks: Digital watermarking or encoding involves invisible markings within graphics. Special software and readers are available to verify these markers.
Security through digitilisation
Digitilisation refers to the process of converting information into computer-readable format, which is easy to access irrespective of geographical location. The pharmaceutical packaging industry is deploying digital technology to combat counterfeiting and introduce efficient supply chain tracking.
By simply scanning the medicine, anti-counterfeiting apps can tell the consumer whether the drug is fake or authentic. For example, the Drugsafe app, winner of the Big Data award at the 2018 Microsoft Imagine Cup, uses optical character recognition (OCR) to check the medicine’s authenticity in accordance with the Azure Cosmos database.
Digital mass serialisation
Counterfeiting in the pharmaceutical market is dangerous for consumers and brands. While consumers may become victims of poor medicines, brands can lose their credibility. Digital packaging solutions are a saviour, especially in supply chain management. Digital mass serialisation is one of the most common and scalable techniques employed; involving generation of a sequence of pseudo code that enters the consumers’ database for verification at later stages.
Security through product design
Ensuring safety for consumers is another important aspect of pharmaceutical packaging. Sophisticated drugs need careful handling and include age restrictions. Patients can become the victim of taking expired drugs, or children might access medicines that are not meant for them. The following packaging solutions are solving these consumer-centric challenges through design:
Expiry date validation – “A picture speaks a thousand words and a QR code encodes a maximum of 4,296 alphanumeric characters.” A QR code is capable of coding the dose regimen for medicine along with its manufacturing and expiry date. Post consumption, the consumer can rescan the pack, enabling the app to update the regimen and send notifications accordingly.
Childproofing and senior-friendly packaging – Uflex introduced an innovative packaging known as Child Resistant and Senior Friendly (CRSF) foils. These are available in two variants: push-through and peel-push, based on their operating mechanism. While it requires some amount of pressure for a child to open it, the procedure is easy for a senior citizen. This prevents unintentional handling damage to conventional blister foils.
Timely drug dosage – Taking the right medicine in the right dosage is essential. Pill Pack, an Amazon company, took the initiative of coordinating with the patients’ drugs requirement and automatically shipping them refills as required.
Security in pharmaceutical packaging is essential for both consumers’ safety and maintaining a brand’s integrity. Pharma is a sophisticated sector and its investment in secure packaging is essential. With innovations, technology and consumer acceptance, the serious problems of counterfeiting and tampering can be conquered.
2019 05 31
Algae could prevent limb amputation
A new algae-based treatment could reduce the need for amputation in people with critical limb ischaemia, according to new research funded by the British Heart Foundation, published today in the journal npj Regenerative Medicine. Researchers at St Thomas' Hospital and King's College London have made small capsules from brown algae which hold macrophages, a type of white blood cell. Tests in mice have shown that these algae capsules may be able to increase blood flow in the limbs where tissue has been damaged. The researchers now hope to progress this research into human clinical trials to help the people visiting hospital with critical limb ischaemia (CLI). It is estimated that there are up to 60,000 new cases of CLI per year in the UK.
Scientists have been experimenting with cells as a treatment to grow arteries in the leg for years, however, these treatments have not been effective in humans. A big challenge is that many of the cells injected into the injured area die, move away to surrounding areas, or are detected as 'foreign' by the immune system and rejected.
In this study, surgeon Professor Bijan Modarai and his team of scientists delivered the new algae-based capsules containing macrophages to areas of injured muscle tissue in the back legs of mice. Alginate from the cell walls of brown algae, which is mainly found in cold waters in the Northern Hemisphere, was used to form the capsules. They found that these macrophages successfully remained in the injured area, new blood vessels formed, and as a result more blood reached the damaged area.
CLI is a serious condition which occurs when the arteries in the limbs become blocked as a result of a build-up of fatty deposits, reducing blood flow to the hands and feet. Smoking, diabetes, obesity and high blood pressure can all lead to CLI. If blood flow is not restored, up to 50 per cent of people with CLI will either die or need amputation within one year.
Currently, to treat CLI and restore blood flow in the limbs, the blocked section of the artery has to be either bypassed during surgery or widened using a small piece of expandable mesh called a stent. However, in up to a third of patients, these methods will eventually fail or are not possible to begin with and amputation is the only option.
Professor Bijan Modarai therefore hopes that this new way of delivering cells could be the key to creating an effective treatment for people suffering with CLI.
Professor Bijan Modarai, Professor of Vascular Surgery and BHF Senior Fellow at King's College London/St Thomas' Hospital, said:
"We hope that this new method of cell therapy will greatly reduce the need for limb amputations in those people whose CLI is untreatable, and would otherwise have no other option.
"The beauty of this new algae-based treatment is that it harnesses the potential of natural materials. Not only does this make it a very attractive solution, but we know we can use it to safely treat people with CLI."
Professor Metin Avkiran, Associate Medical Director at the British Heart Foundation which funded the research said:
"You might associate algae with your garden pond, but our researchers are proving these diverse organisms could hold the key to a new treatment for one of the leading causes of limb amputation - CLI.
"Losing a limb is an all too devastating reality for many patients with CLI. The condition is caused by blockages in arteries that supply blood to the legs and feet, and is triggered by the same process that blocks coronary arteries when someone has a heart attack.
"This research brings us a step closer to finding treatments for the thousands of people affected by this disabling condition in the UK."
2019 02 15
New pill can deliver insulin
An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 2 diabetes have to give themselves every day. About the size of a blueberry, the capsule contains a small needle made of compressed insulin, which is injected after the capsule reaches the stomach. In tests in animals, the researchers showed that they could deliver enough insulin to lower blood sugar to levels comparable to those produced by injections given through skin. They also demonstrated that the device can be adapted to deliver other protein drugs.
"We are really hopeful that this new type of capsule could someday help diabetic patients and perhaps anyone who requires therapies that can now only be given by injection or infusion," says Robert Langer, the David H. Koch Institute Professor, a member of MIT's Koch Institute for Integrative Cancer Research, and one of the senior authors of the study.
Giovanni Traverso, an assistant professor at Brigham and Women's Hospital, Harvard Medical School, and a visiting scientist in MIT's Department of Mechanical Engineering, where he is starting as a faculty member in 2019, is also a senior author of the study. The first author of the paper, which appears in the February 8 issue of Science, is MIT graduate student Alex Abramson. The research team also includes scientists from the pharmaceutical company Novo Nordisk.
Several years ago, Traverso, Langer, and their colleagues developed a pill coated with many tiny needles that could be used to inject drugs into the lining of the stomach or the small intestine. For the new capsule, the researchers changed the design to have just one needle, allowing them to avoid injecting drugs into the interior of the stomach, where they would be broken down by stomach acids before having any effect.
The tip of the needle is made of nearly 100 percent compressed, freeze-dried insulin, using the same process used to form tablets of medicine. The shaft of the needle, which does not enter the stomach wall, is made from another biodegradable material.
Within the capsule, the needle is attached to a compressed spring that is held in place by a disk made of sugar. When the capsule is swallowed, water in the stomach dissolves the sugar disk, releasing the spring and injecting the needle into the stomach wall.
The stomach wall has no pain receptors, so the researchers believe that patients would not be able to feel the injection. To ensure that the drug is injected into the stomach wall, the researchers designed their system so that no matter how the capsule lands in the stomach, it can orient itself so the needle is in contact with the lining of the stomach.
"As soon as you take it, you want the system to self-right so that you can ensure contact with the tissue," Traverso says.
The researchers drew their inspiration for the self-orientation feature from a tortoise known as the leopard tortoise. This tortoise, which is found in Africa, has a shell with a high, steep dome, allowing it to right itself if it rolls onto its back. The researchers used computer modeling to come up with a variant of this shape for their capsule, which allows it to reorient itself even in the dynamic environment of the stomach.
"What's important is that we have the needle in contact with the tissue when it is injected," Abramson says. "Also, if a person were to move around or the stomach were to growl, the device would not move from its preferred orientation."
Once the tip of the needle is injected into the stomach wall, the insulin dissolves at a rate that can be controlled by the researchers as the capsule is prepared. In this study, it took about an hour for all of the insulin to be fully released into the bloodstream.
Easier for patients
In tests in pigs, the researchers showed that they could successfully deliver up to 300 micrograms of insulin. More recently, they have been able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with type 2 diabetes would need to inject.
After the capsule releases its contents, it can pass harmlessly through the digestive system. The researchers found no adverse effects from the capsule, which is made from biodegradable polymer and stainless steel components.
The MIT team is now continuing to work with Novo Nordisk to further develop the technology and optimize the manufacturing process for the capsules. They believe this type of drug delivery could be useful for any protein drug that normally has to be injected, such as immunosuppressants used to treat rheumatoid arthritis or inflammatory bowel disease. It may also work for nucleic acids such as DNA and RNA.
"Our motivation is to make it easier for patients to take medication, particularly medications that require an injection," Traverso says. "The classic one is insulin, but there are many others."
2018 03 28
Medical expansion has improved health - with one exception
While Americans debate the rising cost of health care, a new study of 30 countries over 27 years found that medical expansion has improved overall health - with one major exception. Researchers found that increased spending on health care and increases in specialized care were both associated with longer life expectancy and less mortality in the countries studied. But pharmaceutical industry expansion was linked to negative health effects.
"This study isn't the first to suggest prescription drugs can pose a health risk. But it is the first to find that the growth of the pharmaceutical industry itself may be associated with worse rather than better health," said Hui Zheng, lead author of the study and associate professor of sociology at The Ohio State University.
"The findings were surprising to us."
Zheng conducted the research with Linda George, professor of sociology at Duke University. Their study is published in the March 2018 issue of the Journal of Health and Social Behavior.
The medical industry has undergone a massive expansion all over the Western world since the mid-20th century, Zheng said. In the United States, health care expenditures as a percentage of the gross domestic product increased from 5.1 percent in 1960 to 17.1 percent in 2014.
But it has been unclear whether this expansion has benefited overall public health.
To help answer this question, the researchers used data from 30 countries, including the United States, that are members of the Organisation for Economic Co-operation and Development. This includes most of the world's affluent democracies.
Zheng and George looked at how different types of medical expansion were related to population health between 1981 and 2007. Specifically, they linked expansion to life expectancy at birth; men's and women's life expectancy at age 65; and all-cause mortality rate.
They controlled for a variety of social, economic and demographic variables that also might account for relationships between medical expansion and health.
Medical investment, pharmaceutical expansion and medical specialization increased over time for virtually all 30 countries, although the amount of increase varied substantially, Zheng said.
The United States had the largest increase in medical investment and a steep increase in pharmaceutical expansion, but one of the flattest trajectories over the 29 years in the increase of medical specialization.
All three types of medical expansion were associated with two or more indicators of population health, results showed.
Increased medical investment and increased medical specialization were related to growth in all three life-expectancy measures and a decrease in overall mortality.
Two measures of expansion in the pharmaceutical industry - increased sales and more money spent on research and development - were linked to lower life expectancy among women aged 65 and older, and with increased mortality rates. The pharmaceutical measures were not associated with the other health outcomes studied.
The researchers ran tests to confirm that it wasn't the other way around - that lower life expectancy and increased mortality were causing an expansion of the pharmaceutical industry. But that wasn't the case.
That wasn't the only negative finding about the growing drug industry.
"We found that as the pharmaceutical industry expands, there is a decrease in the beneficial impact of medical specialization on population health," Zheng said.
This study can't say why expansion in the pharmaceutical industry is leading to negative population health effects, Zheng said.
"It could be due to toxic side effects of drugs, doctors' prescribing practices, patients' misuse of prescription drugs, reasons related to pharmaceutical industry's marketing strategies or some combination of these factors," he said.
He said they plan on studying this issue further.
2017 08 24
A startling new cost estimate for new medicines is met with skepticism
In the pharmaceuticals business there are few issues more loaded than the cost of developing a new drug. For a number of years estimates from industry groups on either side of the Atlantic have put it at $1.2 billion-1.8 billion. A new study by the Centre for the Study of Drug Development at Tufts University in Massachusetts reckons the average cost for drugs developed between 1995 and 2007 was $2.6 billion. Among those rejecting this new figure as highly misleading are Médecins Sans Frontières, a charity, and the Union for Affordable Cancer Treatment, a patients’ group.
The main point of controversy over such estimates is that they roll in the costs of those drugs that failed to win approval and, for good measure, the cost of capital required for the R&D. Tufts’s estimate includes $1.2 billion for the return on capital forgone while a drug is in development, on the assumption it would have otherwise earned a generous 10.5% a year. The remaining $1.4 billion is the average R&D cost of a random selection of drugs, multiplied by risk factors that account for the chances of failure at each stage.
Successful drugs cost far less than even the lower, $1.4 billion figure. But the road to approvals is littered with casualties such as the $800m that Pfizer blew on torcetrapib, a potential treatment for high cholesterol, before giving up in 2006. Jeff Williams, the boss of Clinipace, a contract-research organisation, has said that the small to medium-sized drugs firms his company works for manage to get their candidate drugs through development for less than $500m.
Another criticism of Tufts’s work is that it is based on secret data provided by a self-selected group of drug companies. The Tufts study group gets much of its funding from the industry; it says the group’s members are independent academics. Another criticism is that although such estimates embrace all the risks of developing drugs, they say little of the rewards.
The industry inevitably quotes such figures whenever it is suffering criticism for the high price of patented drugs. James Love, the head of Knowledge Ecology International, a group that studies and comments on issues of social justice, says drugs giants have used these big estimates of average costs to try to talk developing countries like India out of breaking the patents on specific medicines that, in practice, cost a lot less to develop.
Joseph DiMasi, director of economic analysis at the Tufts centre, says the most useful aspect of the $2.6 billion figure in his study is that it is comparable with previous figures. In 2003 his centre put the cost of drug development at $802m. This implies that in real terms costs have risen by 145%. Mr DiMasi says the increase has been caused by larger and more complex trials, a greater focus on chronic and degenerative diseases, and higher failure rates.
However, the life-saving cancer drugs that feature in many of the most emotional disputes over pricing are far from typical. Regulators often pass them after far smaller clinical trials than for other, less urgent medicines, thereby greatly reducing the most costly element of their development. Such drugs are also likely to qualify for “orphan drug” tax credits—an issue the Tufts study does not consider. It may be that the average is being inflated by other types of new drug, such as psychotropics, which may be only a bit more effective than existing ones but require big, expensive trials to gain approval.
2017 08 09
Drug costs vary by more than 600% in study of 10 high-income countries
In a study of 10 high-income countries with universal health care, costs for prescription drugs in 6 of the largest categories of primary care medicines varied by more than 600%, according to research published in CMAJ (Canadian Medical Association Journal). All countries except Canada offered universal coverage of outpatient prescription drugs.
The study looked at data on the volume and daily cost of primary care prescriptions in 10 high-income countries with universal health care: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the United Kingdom. Because of the high cost of pharmaceutical drugs and the lack of universal health care, the United States was not included.
Researchers focused on 6 categories of widely used primary care drugs usually purchased at retail pharmacies rather than hospital pharmacies. These included hypertension treatments, pain medications (nonsteroidal anti-inflammatory drugs as well as opioids), cholesterol-lowering drugs, noninsulin diabetes treatments, gastrointestinal medications and antidepressants. They measured frequency of use of the medications by average number of days of therapy purchased per capita.
Medications for treating high blood pressure accounted for the largest number of days of therapy in all countries.
In the 5 countries with universal, single-payer coverage of prescription medications, the average per-person cost was $77. Average costs were $99 in the 4 countries with universal social insurance for prescription drugs and $158 in Canada, which has a mixed system of private and public financing. Higher costs of drugs and the mix of therapies chosen accounted for most of the cost differences between countries.
"The volume of therapy purchased in Canada was about the same as that in the comparator countries; however, Canadians spent an estimated $2.3 billion more than they would have in 2015 if these primary care treatments had had the same average cost per day in Canada as in the 9 comparator countries combined," writes Dr. Steven Morgan, School of Population and Public Health, University of British Columbia, with coauthors.
"Average expenditures are lower among single-payer financing systems, which appear to promote lower prices and selection of lower-cost treatment options within therapeutic categories," the study authors conclude.
In a related commentary, Dr. Joel Lexchin, York University, Toronto, Ontario, writes "Canada is not doing well when it comes to ensuring that its population has access to prescription medications; we can and must get to a better place."
He says that we need universal pharmacare to reduce drug prices so that Canadians are not deterred from taking their medications.