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Tag Archives: Medicine

Chart: Americans Spend Much More on Pharmaceuticals

Source : Stastista

Want That Pill to Work Fast? Your Body Position Matters

If you need to take a pill, you might want to take it lying down — on your right side, that is.

Researchers studying how body positioning affects the absorption of pills found that one taken when a person was lying on the right side speeded pills to the deepest part of the stomach. That pill could then dissolve 2.3 times faster than if the person was upright.

“We were very surprised that posture had such an immense effect on the dissolution rate of a pill,” said senior author Rajat Mittal, a professor at Johns Hopkins Whiting School of Engineering and an expert in fluid dynamics. “I never thought about whether I was doing it right or wrong but now I’ll definitely think about it every time I take a pill.”

For the study, researchers used a model called StomachSim, which relies on physics, biomechanics and fluid mechanics to mimic what happens inside one’s gut as it digests food or medicine.

Researchers knew that most pills don’t start working until the stomach ejects its contents into the intestine. That would mean that a pill landing in the last part of the stomach, an area called the antrum, would begin dissolving faster. It would also begin emptying its contents more quickly through the pylorus into the duodenum, the first part of the small intestine.

To land a pill there would require a posture that uses both gravity and the natural asymmetry of the stomach to its benefit.

In addition to the right side, the team tested taking pills on the left side, standing upright and lying straight back.

Surprisingly, a pill that dissolves in 10 minutes with a patient lying on his or her right side could take 23 minutes to dissolve in an upright posture and more than 100 minutes with the person on his or her left side. Lying straight back tied with standing upright in terms of pill dissolution.

“For elderly, sedentary or bedridden people, whether they’re turning to left or to the right can have a huge impact,” Mittal said in a Hopkins news release.

Lead author Jae Ho “Mike” Lee, a former postdoctoral researcher at Johns Hopkins, noted that even small changes in stomach conditions could significantly affect dissolution — when someone’s gut isn’t functioning at its best because of conditions such as diabetes and Parkinson’s syndrome, for example.

The impacts of posture and stomach disease were similar on drug dissolution.

“Posture itself has such a huge impact … it’s equivalent to somebody’s stomach having a very significant dysfunction as far as pill dissolution is concerned,” Mittal said.

Plans for future work include attempting to predict how changes in the biomechanics of the stomach affect how the body absorbs drugs.

The findings were recently published in the journal Physics of Fluids.


Source: HealthDay

Aching Backs in Seniors: An Expert’s Guide to Pain Meds

Amy Norton wrote . . . . . . . . .

Back and neck pain are often an unfortunate part of aging, but older adults can safely find relief with various medications, a new research review concludes.

The review of 138 clinical trials breaks down the evidence on medication options for seniors with “spine-related” pain — essentially any aches along the neck and back.

An overarching point is, there is no one-size-fits-all remedy, according to senior researcher Dr. Michael Perloff, a neurologist at Boston University School of Medicine and Boston Medical Center.

Medication choices, he said, depend partly on the underlying cause of the pain. But particularly with older adults, any co-existing health conditions and medications they are taking are also a factor.

“You do have to be careful about medication interactions and side effects,” Perloff said.

At the same time, those issues should not bar older adults from getting pain relief, he stressed.

“If you’re an older person and you’ve been told there are no options for managing your pain, you may need to see a pain specialist,” Perloff noted.

“There’s a lot we can do with the weapons of medication, injections, physical therapy and, in some cases, surgery,” he added.

With younger adults, back and neck aches are often muscle-related. While that can be true for older adults, too, Perloff said, they often have pain related to degenerative changes in the spine — such as wear-and-tear breakdown in the discs or cartilage cushioning the spinal joints.

For that type of pain, common painkillers, including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, can help, the review found.

NSAIDs, like ibuprofen and naproxen (Motrin, Aleve), are more effective than acetaminophen (Tylenol), Perloff said. But acetaminophen may be the safer choice for some seniors, including those who are at increased risk of stomach bleeding, or who have kidney or heart disease.

With NSAIDs, limited use is key. Perloff’s team recommends that older people take them for two or three days during a pain flare-up, but avoid using them for weeks at a time.

“With chronic pain, it’s often up and down,” Perloff noted. “So your treatment needs are different at different times.”

In some cases, pain stems from a pinched nerve. One example is sciatica, where the sciatic nerve is compressed — often by a disc in the lower spine that slips out of place. That can cause pain that radiates from the lower back down the back of the leg.

NSAIDs can help ease sciatica, the review found. But another option, Perloff said, is medication specific to nerve pain — namely, gabapentin and pregabalin.

Those medications come with their own potential side effects, including dizziness and balance problems. So, the review found, any benefits have to be weighed against those risks, especially for older people who are taking other medications that can cause dizziness and falls, such as benzodiazepines.

Among the other findings:

  • Certain muscle relaxants, like carisoprodol and chlorzoxazone, carry a risk of sedation and falls. But some others, including tizanidine and baclofen, can safely ease older adults’ neck or back pain, in low doses.
  • For chronic low back pain, some antidepressants — especially duloxetine (Cymbalta) — have proven helpful in trials. They may be good choices, Perloff said, when an older adult has both pain and depression symptoms.
  • When oral drugs fail, injections of painkillers or anti-inflammatory corticosteroids may help with chronic pain.

The review, published recently in the journal Drugs & Aging, focused on medications. But Perloff said that when his patients have chronic pain — generally three months or more — he’s probably also prescribing physical therapy.

“Physical therapy can be valuable for optimizing and maintaining function,” agreed Dr. Robert Griffin, an anesthesiologist at the Hospital for Special Surgery in New York City who specializes in evaluating and treating back and neck issues.

Griffin, who reviewed the findings, also pointed to some other options. They include trigger point injections, where medication is injected into painful “knots” in the muscles; radiofrequency ablation, where radio-wave heat is applied to specific nerve tissue, to decrease pain signals from that area; and acupuncture and meditation, which may help ease symptoms or provide help in coping with them.

As for when people should see a health care provider for a painful back or neck, Griffin said “anytime they feel help is needed.”

He stressed, though, that people should seek medical care right away if they have additional symptoms that could indicate a serious health condition. Those include limb weakness, changes in bladder or bowel function, fever or unexplained weight loss.


Source: HealthDay

Injected ‘Hydrogel’ May Be New Option Against Back Pain

Dennis Thompson wrote . . . . . . . . .

Like fixing a flat on the roadside, a new injectable hydrogel is showing promise as a remedy for worn-down spinal discs — pumping them back up and relieving chronic back pain.

The gel, with the brand name Hydrafil, is injected directly into worn discs using X-rays to guide the needle, said lead researcher Dr. Douglas Beall, chief of radiology services at Clinical Radiology of Oklahoma in Edmond. As outlined in a pilot study,. the gel fills in cracks and tears in the spinal disc, adhering to the disc’s center and outer layer.

“It goes in as a heated liquid that cools off and becomes kind of the consistency of a medium hard eraser,” Beall said. “It creates kind of a Fix-a-Flat, filling the disc back up and returning the biomechanical integrity of the disc.”

Twenty patients treated with the gel experienced a 67% reduction in their back pain during a one-year follow-up, Beall said.

The patients also experienced an 85% improvement in disability caused by their back pain. Beall said the gel caused no harmful reactions in any of the patients.

The bones in your spinal column — the vertebrae — are separated by rubbery cushions called spinal discs. These discs act as shock absorbers, preventing the vertebrae from rubbing together and allowing you to move, bend and twist comfortably.

Degenerative disc disease occurs as people age. Spinal discs tend to dry out and wear away over time. They also can be torn or injured as a result of daily activities or sports.

By Beall’s estimates, as many two-thirds of people with back pain caused by degenerative disc disease could be considered candidates for this hydrogel therapy.

He is scheduled to present these findings Sunday in Boston at a meeting of the Society of Interventional Radiology. Findings presented at meetings are considered preliminary until published in a peer-reviewed journal.

Hydrafil was designated as a breakthrough device in 2020 by the U.S. Food and Drug Administration, which allows expedited review when evidence suggests an experimental product could provide more effective treatment for a serious condition compared to current options, researchers said.

Other hydrogels already are being used to treat injured or worn discs, but those products are inserted surgically as a soft solid, “which can pop out of place if you’re not highly skilled in placing it,” Beall said.

“Because this gel is injectable, it requires no incision, and it augments the whole disc, restoring its structural integrity, which nothing we have currently can do,” he said.

Dr. J. David Prologo, an interventional radiologist at Emory University School of Medicine in Atlanta, reacted to the findings.

“The impact of this study I don’t think can be overstated — degenerated disc disease is a condition that affects hundreds of millions of people worldwide, for which there is really no definitive treatment other than a big surgery, with all of the associated costs and risks,” he said.

“Dr. Beall is spearheading the ability to literally inject a liquid replacement to the disc using only a needle and image guidance, removing the needle after the injection and sending the patient home with a replaced disc and Band-Aid over the puncture site,” said Prologo, who chairs the Society for Interventional Radiology’s Pain Management/MSK Clinical Specialty Council.

Dr. Alan Hilibrand, co-director of spinal surgery at the Rothman Orthopaedic Institute in Philadelphia, agreed.

Disc repairs conducted via injection are “almost like the holy grail of treatment for back problems,” he said.

Hilibrand noted that other research groups are trying to repair discs by injecting growth factors or biologic agents intended to promote regrowth of healthy disc material.

These new results come from what Beall characterized as an early feasibility trial, which was conducted among 20 patients ages 22 to 69 in Colombia. All had chronic low back pain due to degenerative disc disease.

A pilot trial involving more patients is underway in Canada, and based on those results a full-scale clinical trial will be conducted in the United States.

The hydrogel therapy is new, but relies on existing techniques and skills regularly used by interventional radiologists, surgeons and other specialists, Beall and Prologo said.

“Interventional radiologists already embody the skillset to perform this procedure,” Prologo said. “Widespread dissemination should follow FDA approval and U.S. studies reproducing its effectiveness. The cost will be many multiples less than an open surgical alternative.”

One major question remains, and should be answered by the full clinical trial: How long will the hydrogel last in a repaired disc?

Beall said Hydrafil has been subjected to a “repetitive stress simulation that simulates 90 years of stress and strain, so hopefully this will be a forever fix.”

But that will need to be demonstrated in actual humans over time, Hilibrand said.

Trials will need to show that the gel “can be maintained in the disc and doesn’t wear out or leak out over time,” he said.

“If something lasts for six months or even 12 months, I don’t think that we as a society can afford to pay for that,” Hilibrand said. “It may not be very cost-effective if it only lasts for a short period of time.”

ReGelTec Inc. is the company that developed Hydrafil, and paid for this early feasibility study, Beall said. Beall is a medical adviser to the company.


Source: HealthDay

Pharmacy of the World: China’s Quest to be the No. 1 Drugmaker

Anna Nishino wrote . . . . . . . . .

In the late 1990s, Samantha Du was a researcher for the U.S. pharmaceuticals giant Pfizer when she received a tough assignment: getting drug approvals in China, her home country. She soon saw the difference between the stateside market geared toward branded products and its Chinese counterpart centered on generic and traditional medicines.

“It took seven years longer for new drugs to get approval in China than the U.S. or Europe,” she said, recalling the dawning sense of responsibility she felt to do something about it. She realized China would “need local companies, just like the global pharmaceutical and biotech companies in Europe and the U.S.”

China has changed much from the country Du experienced two decades ago, and she has played a role in its transformation. Her story is symbolic of how policy, people and plenty of money have driven China’s great pharma expansion.

In 2014, Du founded Zai Lab. The company has grown rapidly thanks to its advanced therapeutics for cancer and immunological diseases, listing on both the Nasdaq and Hong Kong stock exchanges and drawing attention from global investors.

Du’s endeavor dovetailed with the Xi Jinping administration’s push to advance China’s pharmaceuticals industry. Now a country long known for producing generics and raw materials for precursors, called active pharmaceutical ingredients (APIs), has also begun to discover new drugs. In particular, it has seen strong growth in biological pharmaceuticals, or biologics, which are considered more difficult to produce than ordinary drugs.

China’s pharmaceuticals market is already the second biggest in the world after the U.S., thanks in large part to domestic demand from hospitals. Now, it wants to take the final step and surpass the U.S. However, its methods — from suspicions of intellectual property theft to questions over quality — have prompted significant criticism.

In part one of this series, Nikkei Asia explored how China became the top global supplier of COVID-19 vaccines. Here, we look at how the jab gambit is part of a much broader effort by Beijing to dominate the international drugs market.

China’s mRNA vaccines

During the COVID-19 pandemic, China has so far supplied “conventional” vaccines, in which the inactivated virus causes an immune response. Conversely, the vaccines made by Western giants Pfizer and Moderna are a new type of inoculation, called messenger RNA, that trains the immune system to fight the virus.

The narrative of this East-West technological divide may be about to change. Hangwen Li, CEO of Stemirna Therapeutics — founded in 2016 to focus on RNA products — predicted two years ago that within five years the market for mRNA technology would “explode.” That statement proved prophetic. And contrary to popular perception, China is very much in the mRNA game too, underscoring its rise as a pharmaceutical powerhouse.

An mRNA COVID-19 jab being developed by Stemirna, for example, has shown effectiveness against some variants including delta, according to the company.

Or consider Fosun Pharma, one of the biggest drugmakers in China. In March 2020 it partnered with BioNTech, the German company that co-developed an mRNA jab with Pfizer, to advance the development and commercialization of the vaccine in China.

Everest Medicines, a Chinese biopharmaceutical company, this past September also obtained the rights to supply mRNA vaccines developed by Providence Therapeutics, a Canadian biotech company, in Greater China and some Southeast Asian countries. Both Everest and Fosun have announced that they are also developing new vaccines for the omicron variant.

All told, there were 20 COVID-19 vaccines from Chinese entities under clinical trial as of November 2021, according to the Vaccine Centre at the London School of Hygiene & Tropical Medicine. They range from those that use old-school technology to the newest RNA innovations. Chinese companies Sinopharm and CanSino, which have marketed non-mRNA jabs globally, have now set their sights on developing mRNA vaccines as well.

Some companies in China are working on their own mRNA vaccines without foreign partners.

Suzhou Abogen, a two-year old Chinese startup, has teamed up with Walvax, one of China’s largest vaccine companies, and the Institute of Military Medicine under the Academy of Military Sciences. They have developed the first mRNA vaccine approved for clinical trials in China, known as ARCoV. Trials of ARCoV have also been approved or conducted in Mexico, Indonesia and Nepal. According to a paper published in Cell, an American science journal, ARCoV requires less stringent cold storage than the Moderna and Pfizer shots.

It has become increasingly clear that all existing coronavirus jabs, including mRNA shots, become less effective over time. That opens big opportunities for new rivals, including those from China, to join the vaccine race.

That Chinese players are in a position to compete is a testament to how far they have come.

The nation’s decades of making generics and APIs have served it well. “China is the main producer of APIs globally, possesses immense bio-manufacturing capacity, and tends to excel in scaling up operations generally,” said Dr. Abigail Coplin, Assistant Professor of Sociology and Science, Technology, and Society at Vassar College.

That capacity helped make China the single biggest exporter of COVID-19 shots, heralding a major shift in the structure of the global pharmaceutical supply.

“To be honest, it would be very difficult to imagine that Chinese drugs could be sold to overseas markets five years ago,” said Michelle Yu, investment director at Value Partners, a Hong Kong-based asset management company. The reason, she said, was that most drugs developed in China were just “me too” products for the domestic market.

Many emerging pharmaceutical companies are already showing global ambitions. BeiGene, whose Brukinsa cancer treatment won approval from the U.S. Food and Drug Administration in 2019 — a first for a Chinese company — has a couple of offices and sites outside of China. Its manufacturing sites in China are designed to follow the standards issued not only by China but also the U.S. and European regulators, according to the company.

WuXi Biologics, a China-based pharmaceutical research group, has manufacturing bases in Ireland, Germany and the U.S.

Shanghai Junshi Biosciences licensed out its Toripalimab cancer antibody treatment, including two option programs, to U.S.-based Coherus, receiving an aggregate of $1.11 billion in an upfront payment, exercise fees and milestone payments. Junshi also won approvals of its COVID-19 antibody treatment from over 15 countries and regions, including the U.S. “We sacrificed other important projects like PD-1 treatments for a couple of months to advance the COVID-19 neutralizing antibody therapy to the clinical stage early last year,” Ning Li, chief executive officer at Junshi, told Nikkei Asia.

When it comes to mRNA COVID vaccines, some Chinese companies claim that the raw materials they are using are also mostly domestic.

“Chinese pharmaceutical companies can be on par with the mega pharmas in the future,” said Koji Kawashima, assistant general manager of the health care and medical business at Marubeni, a Japanese trading house that has a joint venture with Fosun Pharma in Shanghai called Fobeni.

A Communist Party priority

“China’s strategy in the biopharmaceutical sector is based on a long-term perspective, just like its policy clearly states”

Toshiyuki Murai, a product specialist at Sumitomo Mitsui DS Asset Management

Beyond economic considerations, drugs — especially biologic drugs — have become a priority of the Chinese government because of demographic changes. The country is aging rapidly, partly due to its previous longstanding “one child” policy, and the Communist Party is seeking innovative ways to manage the growing medical burden.

Many of its pharmaceutical ventures are focusing on chronic diseases and cancers, and biologics can target such illnesses.

“China’s strategy in the biopharmaceutical sector is based on a long-term perspective, just like its policy clearly states,” said Toshiyuki Murai, a product specialist at Sumitomo Mitsui DS Asset Management. Biopharmaceuticals are one of the key industries named in the government’s “Made in China 2025” strategy.

Since 2015, the government has made numerous changes to pharmaceutical-related policies, many designed to encourage innovation at domestic companies.

First, Chinese authorities have sought to harmonize their standards with those of their global counterparts. China in 2017 joined the International Council for Harmonization, which sets international rules for the manufacture of pharmaceuticals, like specifying the number of patients in clinical trials.

China has also overhauled its drug trial and approval process. Six years ago, it took about a year to get a green light to conduct a clinical trial of Junshi’s antibody treatment; its antibody for COVID-19, developed in 2020, took only two weeks. The regulating body has accelerated the process by taking on more staff and enabled priority reviews for rare diseases.

At the same time, generic drugs are becoming less profitable due to the government’s centralized purchasing policy. Drug prices were halved on average when the new system was piloted in 2018, in response to growing national health insurance costs.

This has forced many generic manufacturers to redirect their resources to the development of advanced products such as biologics. “The Chinese government was quite wise, since it successfully depresses the margin of generic drugs while raising the bar for R&D” so that Chinese pharmaceuticals can compete globally, said Yu from Value Partners.

The expanding National Reimbursement Drug List — the dominant public reimbursement mechanism in China — reflects growing support for new drugs. The authorities began updating the list annually in 2017. In 2021, 74 drugs made it, the second highest number after 119 in 2020. More importantly, 62% of the additions were new products launched since 2020, underscoring China’s willingness to adopt innovative therapies at a faster pace. This has helped improve affordability and access to new drugs, shorten the time gap between launch and reimbursement, and “played an important role in encouraging innovations,” according to Bruce Liu, a partner at leading strategy consultancy Simon Kucher & Partners.

China’s government has promoted biopharmaceuticals as a key industry since 2015.

The People’s Liberation Army has also played an important role in the push for drug innovation.

The army has been hiring scientists in recent years to participate in national biologics projects. Chen Wei, a well-known military scientist who has worked on immunizations against Ebola and SARS, was involved in the development of the CanSino vaccine against the coronavirus.

The science team at the Beijing Institute of Biotechnology, part of the Academy of Military Medical Sciences, helped in the conceptual stage of the vaccines, said Pierre Armand Morgon, senior vice president of international business operation at CanSino.

CanSino’s team has completed a Phase 2 study on the first inhalable vaccine for COVID-19. Local reports suggested it is as easy to take as “drinking a bubble tea.” CanSino is planning to submit the vaccine for approval globally.

Adam Ni, an editor of China Neican, a newsletter on Chinese current affairs, said this kind of civil-military fusion was characteristic of Beijing’s industrial policy. He added that “the PLA has been tasked by the Chinese state to develop these vaccines as we know in collaboration with a number of other partners.”

Return of the “sea turtles”

A second factor behind China’s rapid growth in the pharmaceutical industry is the return of researchers from jobs overseas. Within China the returnees are often referred to as “sea turtles,” evoking the idea of how the marine reptiles cross oceans but ultimately return to their birthplaces. Biologics companies including CanSino and Abogen were set up by sea turtles.

Three years ago, Reiji Morishima, a vice president at Fobeni, was surprised by the working culture in China when he first moved to Shanghai from Tokyo. He said it felt “pretty Western” when he found that employees were already highly specialized in Chinese pharmaceutical companies.

Junshi’s chief executive officer, Ning Li, worked at the U.S. FDA and French drugmaker Sanofi. He says this enabled his company to “have a faster way to move forward,” because he brought experience from both the commercial and regulatory sides of the industry. According to Li, most researchers at Junshi hail from multinational companies as well. “Research scientists are the most precious assets,” he said.

Morgon of CanSino said the “sea turtles” have helped the Chinese industry reach international standards of quality, compliance and good manufacturing. He met CanSino’s CEO and chairman, Xuefeng Yu, while working at Sanofi Pasteur 20 years ago.

Various incentives are in place to lure the sea turtles home. Jin Li, CEO of Sichuan-based Hitgen, joined the government’s Thousand Talents program, according to China Daily. The program offers funding and generous benefits for researchers and their families. Li had been working at AstraZeneca prior to Hitgen.

In some cases, Chinese pharmaceutical companies also offer shares to hire talent with overseas experience.

COVID-19 and the U.S.-China tensions have further benefited local pharmaceutical companies, according to John Wong, chairman for Greater China at Boston Consulting Group. “With the U.S. government so hostile to Chinese in universities in the U.S.,” he said, talented young researchers “may prefer to be in China.”

Money flows in

The third pillar supporting China’s pharmaceutical industry is simple: cash. Investment from private equity and venture capital firms in China’s pharmaceutical sector hit a record $2 billion in 2021, according to market research company Pitchbook.

China’s life sciences sector has also seen a flurry of acquisitions. According to Deloitte’s research, there were 93 R&D-related M&A deals in the life science industry in 2020, worth a total of $14.1 billion. That is up from 76 deals valued at $13.5 billion in 2019.

Some big-name global investors have targeted Chinese ventures. Innovent Biologics, a drug discovery company founded in 2011, raised money mainly from international companies, including Singapore’s Temasek and U.S.-based Capital Group Private Markets, before its IPO in 2018. Innovent Executive Director Ronald Hao Xi Ede suggested funding from well-known international funds led the company to a smooth IPO as well. Innovent is collaborating with U.S. pharmaceutical company Eli Lilly — a partnership that started out with a funding round from Lilly Asia Ventures, according to Ede.

Abogen raised over $700 million for the development of its mRNA vaccine in August 2021. This fundraising round included Lilly Asia Ventures and Temasek Holdings and was reportedly a record for a pre-IPO Chinese biopharmaceutical company. It raised another $300 million from investors, including SoftBank Group’s Vision Fund, in November 2021.

Biologics startups have seen an influx of funding since Hong Kong allowed such listings in 2018, in an attempt to emulate the Nasdaq. Innovent’s Ede said management’s initial plan was to go public on the Nasdaq, but the rule change in Hong Kong persuaded the company to list there instead.

The Science and Technology Innovation Board on the Shanghai Stock Exchange, or STAR board, has also become a popular choice for biopharmaceutical startups. Biopharmaceuticals account for more than one-fifth of STAR board companies as of December 2021. Nicolas Zhu, head of the life sciences and health care sector group at law firm CMS China, said that biotech startups have enjoyed flexible listing rules on the STAR board.

Many are loss-makers that spend heavily on R&D, though part of the appeal of Chinese players is that their research costs tend to be much lower than those of Western rivals.

Yu from Value Partners highlighted the attractiveness of China’s relatively cheap R&D. By some estimates, such costs are one-tenth those in the U.S. Labor costs in China are much lower, and according to Yu, a typical engineer only costs one-fifth the cost in the U.S. It is also much easier and cheaper to recruit patients for clinical trials, thanks in part to China’s huge population.

Compared with companies in the U.S., Chinese players generally spend less on R&D as a proportion of net sales. However, their R&D costs are rising as they conduct more global trials in an effort to win approval from overseas regulators.

The backlash

The rapid growth of China’s pharmaceutical sector has triggered accusations of technology theft from the U.S.

Several Chinese scientists have been charged with stealing materials and research from American institutions and companies, including Cornell University and GlaxoSmithKline. The National Institutes of Health accused Chinese scientists of not disclosing their foreign ties, and 93% of the concerned cases in a 2020 NIH investigation involved Chinese funding. Some scientists have been fired from research institutes, such as the MD Anderson Cancer Center in Houston, for research theft.

During the COVID-19 pandemic, China-backed hackers were reportedly involved in spying on or stealing vaccine-related information in the U.S., Spain and India. In May 2020, the FBI and the U.S. Cybersecurity and Infrastructure Security Agency jointly warned organizations researching the coronavirus that they faced a threat of “likely targeting and network compromise” by China.

China’s intellectual property laws also help its companies draw on international rivals’ ideas. Robert Atkinson, the founder and president of the Information Technology and Innovation Foundation, a U.S. think tank, said the Chinese patent system is “designed to allow Chinese companies to access patent information” from multinationals. Many businesses are reluctant to retaliate for fear of compromising their presence in the massive Chinese market.

Chinese pharma companies face other criticisms as well. Some say their data does not meet international standards, that the industry is rife with bribery, and that quality problems persist.

Despite China’s clear advances in recent years, the country still has “a long way” to go to become a true global player, according to Tomoyuki Shibuguchi, chief researcher at Japan’s Office of Pharmaceutical Industry Research. His research shows only 15% of all products that originated from China have gone through global clinical trials in Europe, the U.S. and Japan. He pointed out that less innovative drugs — which may be similar to existing innovative drugs with small modifications and cheaper prices — still make up a large share of Chinese drug development.

Innovent’s Ede, too, said “the whole industry is still [in its] infancy.”

Jens Ewert, Deloitte’s China life sciences and health care leader, pointed out that innovative drugs developed by local companies tend “to be homogenous with only a small number of originated targets.” While the proportion of approved local innovative drugs is increasing, many new drugs for rare diseases are still imported into China.

At the same time, China ruthlessly protects its pharmaceutical industry, and foreign competitors are at the mercy of government regulators. While this has helped fuel the domestic sector’s brisk growth, it may hamper China’s efforts to achieve the top global status it covets.

Ryo Hanamura, partner at Arthur D. Little Japan, argued succinctly: “If China wants to make innovation happen with global knowledge, it cannot stay like this.”


Source : Nikkei Asia

In China, People Are Risking Everything for a Box of Ritalin

Ni Dandan wrote . . . . . . . . .

They came for Jiang Ruiyang on Sept. 2. Ten police officers burst into the factory where he was working in north China’s Shanxi province, told him he was being detained on drugs-related charges, and marched him across the shop floor in handcuffs.

The 25-year-old’s crime: buying a few boxes of Ritalin on the internet.

Similar scenes have played out across China in recent months, as hundreds of people with attention deficit hyperactivity disorder (ADHD) have become unexpected targets in the country’s war on drugs.

The wave of police raids is the result of a series of policy failures that have left people with ADHD feeling increasingly desperate. For years, China’s health system has made it extremely challenging for adults with the disorder to access vital medication. Many have turned to the black market as a result, but that’s now putting them in the police’s crosshairs.

Stimulants like Ritalin, Concerta, and Adderall are strictly controlled in China, and anyone found buying them illegally can be prosecuted for drug trafficking. Patients like Jiang are effectively being forced to risk a prison sentence to protect their health.

“I still can’t figure out why they did this to me,” says Jiang, who spoke with Sixth Tone using a pseudonym for privacy reasons. “I’m just sick, but they treated me like a criminal.”

Though there’s a widely held assumption in China that ADHD only affects children, millions of Chinese adults have the condition. Lu Zheng, director of clinical psychiatry at the Shanghai Mental Health Center and a specialist who helped draft China’s clinical guidelines for adult ADHD, says the prevalence among Chinese adults is 2.8% — roughly consistent with the global average.

But the epidemic is almost entirely invisible. China’s health system has no designated centers for diagnosing and treating adult ADHD, and Lu estimates only 5% to 10% of Chinese adults with the disorder receive a diagnosis.

“Most ADHD patients have other psychiatric comorbidities, such as anxiety, depression, and bipolar disorder,” says Lu. “These disorders can make ADHD very hidden. And very few specialists are aware of adult ADHD.”

Failing to treat ADHD only makes the condition more serious. Studies have found that people living with untreated ADHD can suffer lifelong harm: They are more likely to be unemployed, experience addiction and mental health issues, and go to prison.

In Jiang’s case, his untreated ADHD almost killed him. As a child growing up in Shanxi, he often found it difficult to concentrate and stay calm. But it wasn’t until he finished college and started working at a local state-run factory that he realized he may have a mental disorder.

“My parents never took it seriously,” he says. “They believed it was just a problem with me.”

The wake-up call came in November 2018, after Jiang — then aged 22 — was involved in a near-fatal accident at the factory. As he was fixing some faulty equipment on the production line, a mechanical failure occurred. Jiang failed to react, surviving only because his colleagues pulled him to safety.

“I lost my attention at that moment,” says Jiang. “My subconscious was telling me something was wrong … but my brain was receiving too much other information.”

The incident convinced Jiang to consult a psychiatrist, but doing so was easier said than done. In Shanxi, there are only two hospitals able to diagnose and treat ADHD — and neither accept adult patients.

This is far from rare in China. Only a handful of facilities nationwide will help adults with ADHD, and they’re all located in major cities such as Beijing, Shanghai, and Nanjing. Very few officially cater to adults; they are overwhelmingly pediatrics wards that make exceptions for some over-14s out of compassion.

There are several reasons behind the lack of provision, Lu says. Few mental health specialists have experience with adult ADHD, which tends to be a difficult disorder to diagnose. Chinese hospitals, meanwhile, are reluctant to keep methylphenidate — the stimulant used in Ritalin and Concerta — in stock. Use of the drug, which is chemically similar to cocaine, is heavily restricted.

“Methylphenidate can be made use of by criminals,” says Lu. “That’s why even some hospitals that meet the criteria to use the medication are unwilling to: There are large legal risks involved.”

Jiang had to travel to Beijing’s Peking University Sixth Hospital to find a specialist willing to see him. The three-hour train ride from Shanxi was just the start of his problems. Arriving on a freezing winter afternoon, Jiang found there were no appointments available that day — a common issue, as millions of patients travel from all over the country to see doctors in the capital.

He decided to spend a miserable night on the hospital’s doorsteps, to make sure he was first in line the next morning. But even that wasn’t enough: The following day’s appointments had all been booked up, too. Jiang eventually had to buy a ticket from a scalper for several hundred yuan.

After over 24 hours of waiting, Jiang finally saw a specialist and was diagnosed with ADHD. In hindsight, he mainly feels fortunate that the doctor agreed to see him at all.

“It was out of her sense of responsibility that she decided to diagnose me,” says Jiang. “I’m very grateful.”

Access to treatment remains highly insecure and unpredictable for most adults with ADHD. Bai Yichu, a 38-year-old from the eastern city of Hangzhou, visited Hangzhou Seventh People’s Hospital in the hope of receiving a diagnosis in September. But despite the facility having a reputation for helping non-minors with ADHD, the staff there turned her away.

“I visited them because another patient told me they’d just got a diagnosis there in August,” says Bai. “But the doctor said the hospital had standardized its procedures and banned the practice of receiving adults in the pediatrics department.”

Bai eventually managed to see a mental health specialist at Xinhua Hospital in Shanghai, who diagnosed her with ADHD. But she’s convinced that the disorder has already done irrevocable damage to her life. After nearly two decades of mental health issues — she has also had depression since the age of 20 — Bai finds herself single, jobless, and over 200,000 yuan ($31,300) in debt.

“I’ve likely been affected by the condition (ADHD) for decades,” she says. “I’ve had dozens of jobs, but none of them kept me for more than three months. I’m extremely impulsive — any small thing in life can make me furious or emotional.”

Medication like Ritalin and Concerta can help, but accessing it can also be challenging. Even when patients have been diagnosed with ADHD, they’re not guaranteed to receive a regular prescription due to the insecure nature of being an adult patient in a pediatrics department.

The tight restrictions on methylphenidate make things even more difficult. In April, China’s health authorities finally added adult ADHD to the official list of conditions for which Concerta can be prescribed. (Before then, all prescriptions for adult ADHD patients had technically been illegal.) But even now, doctors can only prescribe two weeks’ worth of pills at a time.

For working-class patients like Jiang, the two-week limit is a huge problem. Jiang had to travel from Shanxi to Beijing twice a month to pick up his medication — a trip that cost him around 1,500 yuan each time.

“Maybe that’s an acceptable sum for wage earners in big cities,” says Jiang. “But for people like me, who earn just under 6,000 yuan a month, it’s a huge expense.”

Jiang did his best to make things work. For several months, he continued to make regular trips to Peking University Sixth Hospital, taking pills only when he was on shift or needed to study to make the packs last longer. But he soon began to feel the arrangement was financially unsustainable.

So when he found out it was possible to buy methylphenidate directly from overseas vendors, Jiang leapt at the opportunity. In a chat group for adults with ADHD, several members said they’d done it, and the pills were just 30 yuan each — around one-third of the cost of buying them in Beijing. From early 2019, he began buying all his medication online.

“I bought the pills via a platform using bitcoin,” says Jiang. “In March, I purchased 30 pills, and then another 120 in May … These are quick-release pills and last for around four hours. I took them when I needed to focus.”

The transactions were illegal, but at the time, Jiang was only vaguely aware that he could face criminal charges for his actions. Chinese patients have begun buying cheap medication for all sorts of conditions from overseas in recent years. When the police raided Jiang’s factory this September, he was shocked.

“I was simply purchasing the drugs online because they’re cheaper,” he says. “I didn’t think that much.”

The arrest has destroyed Jiang’s reputation at work. His colleagues don’t really understand his disorder, but they all saw the police accuse him of taking drugs. They’ve come to their own conclusions.

“Rumors have spread among hundreds of staff here that I’m a drug addict and my mental illness is a result of me taking too many drugs,” says Jiang. “But, despite all the gossip, I have to go to work. Otherwise, how can I afford my medication?”

After showing the police the documents confirming his ADHD diagnosis and taking several drugs tests, Jiang was released on bail. He is now waiting for the authorities to confirm a date for his trial. His main hope is that he avoids going to prison.

“When I told other patients about this experience, some told me the best result would be the police dropping the case, since I can prove I’m truly ill,” says Jiang. “In other cases, some patients were given suspended sentences.”

Lu, the Shanghai Mental Health Center specialist, says several of his patients have encountered similar legal troubles. He’s currently working to set up China’s first dedicated clinic for adult ADHD, which would be a major step toward helping more patients access treatment legally. But it’ll be a long, complex process, and he’s still uncertain when any potential clinic might be able to open, he says.

“We’ll have to set up strict and standardized mechanisms for diagnosis — two or even more specialists will need to diagnose and confirm each case together,” says Lu. “We’ll also need to consult the drug regulators and public security authorities while creating our procedures, to ensure our well-intentioned efforts don’t end in failure.”

Jiang, meanwhile, is struggling to keep his head above water. He has been experiencing severe depression and recently broke up with his girlfriend. But he hasn’t returned to Beijing to ask for more medication yet. He can’t afford any more pills, he says.

“I just want to live well,” says Jiang. “But life seems hopeless.”


Source : Sixth Tone

Most People Unaware that Over-the-counter Pain Relievers May Increase Blood Pressure

While nearly half of U.S. adults have high blood pressure (HBP), only 29% think over-the-counter (OTC) pain relievers may raise blood pressure, according to a recent survey commissioned by the American Heart Association, the leading voluntary health organization devoted to a world of longer, healthier lives for all.

According to the American Heart Association’s 2017 Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure, high blood pressure is defined as a consistent blood pressure measurement of 130 over 80 or higher. The guidelines also state that some OTC pain relievers may elevate blood pressure.

While majority of adults in the general population, as well as people with high blood pressure, aren’t sure about the effect of OTC pain medicine on their blood pressure, only a little more than half of those diagnosed with high blood pressure, who take OTC pain relievers (53%) check with their doctor before taking this medicine.

“People who have high blood pressure or are being treated with blood pressure medication – along with their loved ones and caretakers – need to be informed about safe over-the-counter pain relievers,” said Willie Lawrence, Jr., M.D., interventional cardiologist, medical director for health equity, Spectrum Health in Benton Harbor, Michigan, and volunteer lead of the American Heart Association’s National Hypertension Control Initiative oversight committee.

“Because some pain relievers may cause elevated blood pressure, the American Heart Association recommends consulting your doctor or pharmacist and making sure you read the label before taking any over-the-counter medication for pain, especially if you’ve been diagnosed with high blood pressure.”

Conducted by The Harris Poll, the survey polled 2,013 U.S. adults aged 18 and older. Additional findings from the survey include:

  • 38% of those with high blood pressure think over-the-counter pain relievers may raise blood pressure.
  • Only 21% of U.S. adults know that acetaminophen does not raise blood pressure, and those with high blood pressure are only slightly more aware of this fact (28%).
  • 39% of U.S. adults with high blood pressure report acetaminophen is the over-the-counter medication they take most often for pain.
  • Only 10% of U.S. adults with HBP self-measure their BP multiple times a day and only 14% do so at least once a day.

In the U.S., high blood pressure is the No. 1 preventable cause of heart disease and stroke and second only to cigarette smoking as a preventable cause of death for any reason. Checking your blood pressure regularly at home with a validated blood pressure device for the most accurate reading and working with your doctor on a plan to control it, is a proven way to manage your blood pressure.

Source: American Heart Association

Two Types of Blood Pressure Meds Prevent Heart Events Equally, But Side Effects Differ

People who are just beginning treatment for high blood pressure can benefit equally from two different classes of medicine – angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) – yet ARBs may be less likely to cause medication side effects, according to an analysis of real-world data published today in Hypertension, an American Heart Association journal.

While the class of blood pressure-lowering medicines called angiotensin-converting enzyme (ACE) inhibitors may be prescribed more commonly, angiotensin receptor blockers (ARBs) work just as well and may cause fewer side effects. Currently, ACE inhibitors are prescribed more commonly than ARBs as a first-time blood pressure control medicine.

The findings are based on an analysis of eight electronic health record and insurance claim databases in the United States, Germany and South Korea that include almost 3 million patients taking a high blood pressure medication for the first time with no history of heart disease or stroke.

Both types of medicines work on the renin-angiotensin-aldosterone system, a group of related hormones that act together to regulate blood pressure. ACE inhibitors lower blood pressure by blocking an enzyme early in the system so that less angiotensin, a chemical that narrows blood vessels, is produced, and blood vessels can remain wider and more relaxed. ARBs block receptors in the blood vessels that angiotensin attaches to, diminishing its vessel-constricting effect.

“In professional guidelines, several classes of medications are equally recommended as first-line therapies. With so many medicines to choose from, we felt we could help provide some clarity and guidance to patients and health care professionals,” said RuiJun Chen, M.D., M.A., lead author of the study, assistant professor in translational data science and informatics at Geisinger Medical Center in Danville, Pennsylvania, and NLM postdoctoral fellow at Columbia University at the time of the study.

The AHA/ACC 2017 Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults says the primary medications for treating high blood pressure are thiazide diuretics, ACE inhibitors, ARBs, and calcium channel blockers as they have been shown to reduce cardiovascular events. Physical activity and other lifestyle changes are recommended for managing all levels of high blood pressure, even if medication is required.

Health records for patients who began first-time blood pressure-lowering treatment with a single medicine between 1996-2018 were reviewed for this study. Researchers compared the occurrence of heart-related events and stroke among 2,297,881 patients treated with ACE inhibitors to those of 673,938 patients treated with ARBs. Heart-related events include heart attack, heart failure or stroke, or a combination of any of these events or sudden cardiac death recorded in the database. The researchers also compared the occurrence of 51 different side effects between the two groups. Follow-up times varied in the database records, but they ranged from about 4 months to more than 18 months.

They found no significant differences in the occurrence of heart attack, stroke, hospitalization for heart failure, or any cardiac event. However, they found significant differences in the occurrence of four medication side effects. Compared with those taking ARBs, people taking ACE inhibitors were:

  • 3.3 times more likely to develop fluid accumulation and swelling of the deeper layers of the skin and mucous membranes (angioedema);
  • 32% more likely to develop a cough (which may be dry, persistent, and bothersome);
  • 32% more likely to develop sudden inflammation of the pancreas (pancreatitis); and
  • 18% more likely to develop bleeding in the gastrointestinal tract;

“We did not detect a difference in how the two types of medicine reduced the complications of hypertension, but we did see a difference in side effects,” said George Hripcsak, M.D., senior author of the study and professor and chair of biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons and medical informatics services director at New York-Presbyterian/Columbia University Irving Medical Center. “If a patient is starting hypertension therapy for the first time, our results point to starting with the ARB over the ACE inhibitor.”

“ARBs do not differ in effectiveness and may have fewer side effects than ACE inhibitors among those just beginning treatment,” said Chen. “We unfortunately cannot extend these conclusions to people who are already taking ACE inhibitors or those who are taking multiple medications. We would reiterate that if you experience any side effects from your medicine, you should discuss with your doctor whether your antihypertensive regimen may need to be adjusted.”

The study is limited by wide variation in the length of time patients were included in the different databases. Although many people were followed for a long period of time, those who had shorter follow-up periods may not have taken the medications long enough to experience their full benefits in preventing cardiovascular disease events. Most of the participants taking ACE inhibitors (80%) were taking lisinopril, and the most used ARB (45% of those taking this class of medication) was losartan, so the results may not be fully generalizable to other medicines in these classes. It is also important to note that results from this analysis of first-line therapy may not be generalizable to people with hypertension who have been prescribed combination treatment or who switch from one type of medication to another.

“In addition to encouraging patients to live a healthy lifestyle and taking medication as prescribed to control blood pressure, the American Heart Association recommends regular self-blood pressure monitoring with a validated device and working with a health care professional on a plan to reduce blood pressure,” said Willie Lawrence, M.D., interventional cardiologist and medical director for Health Equity, Spectrum Health, Benton Harbor, Michigan and head of the American Heart Association’s National Hypertension Control Initiative Oversight Committee.


Source: American Heart Association

Some Blood Pressure-lowering Meds Linked to Less Memory Decline in Older Adults

Older adults taking blood pressure-lowering medications known to cross the blood-brain barrier had better memory recall over time compared to those taking other types of medicines to treat high blood pressure, according to new research published today in the American Heart Association journal Hypertension.

High blood pressure, or hypertension, is a risk factor for cognitive decline and dementia in older adults. Nearly half of American adults have elevated blood pressure. Treating high blood pressure with blood pressure-lowering medicines reduced the cases of mild cognitive impairment by 19% in one large trial (SPRINT MIND).

ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers and diuretics are different classes of blood pressure-lowering medicines. Each class acts in a different way to reduce blood pressure, and some cross the blood-brain barrier, thereby impacting cognitive function.

“Research has been mixed on which medicines have the most benefit to cognition,” said study author Daniel A. Nation, Ph.D., ​an associate professor of psychological science in the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine. ”Studies of angiotensin II receptor blockers and angiotensin-converting-enzyme (ACE) inhibitors have suggested these medicines may confer the greatest benefit to long-term cognition, while other studies have shown the benefits of calcium channel blockers and diuretics on reducing dementia risk.”

This is the first meta-analysis to compare the potential impact over time of blood pressure lowering medicines that do vs. those that do not cross the blood-brain barrier. The medicines were evaluated for their effects on several cognitive domains, including attention, language, verbal memory, learning and recall.

“Hypertension occurs decades prior to the onset of dementia symptoms, affecting blood flow not only in the body but also to the brain,” Nation said . “Treating hypertension is likely to have long-term beneficial effects on brain health and cognitive function later.”

Researchers gathered information from 14 studies of nearly 12,900 adults ages 50 years and older. These included studies done in the United States, Australia, Canada, Germany, Ireland and Japan. The meta-analysis found:

  • Older adults taking blood pressure-lowering medicines that cross the blood-brain barrier had better memory recall for up to 3 years of follow-up compared to those taking medicines that do not cross the blood-brain barrier even though they had a higher level of vascular risk.
  • Adults taking hypertension medications that did not cross the blood-brain barrier had better attention for up to 3 years of follow-up.

“These findings represent the most powerful evidence to-date linking brain-penetrant ACE-inhibitors and angiotensin receptor blockers to better memory. It suggests that people who are being treated for hypertension may be protected from cognitive decline if they medications that cross the blood-brain barrier,” said study co-author Jean K. Ho, Ph.D., a postdoctoral fellow at the University of California, Irvine.

Blood pressure is considered elevated at 120/80 mm Hg and higher. The current American Heart Association/American College of Cardiology guidelines for treating high blood pressure suggest changes to diet and activity levels to lower blood pressure and adding blood pressure-lowering medication for people with levels of 130/80 mm Hg or higher depending on their risk status. If blood pressure reaches 140/90 mm Hg, blood pressure-lowering medication is recommended.

Limitations of this analysis are that the authors could not account for differences in racial/ethnic background based on the available studies, and there is a higher proportion of men vs. women in the group who took medications that cross the blood-brain barrier. This is an important area of future research since previous studies have shown that people from various racial/ethnic backgrounds may respond differently to different blood pressure medications.


Source: American Heart Association

Beta-blockers Not Likely to Cause Depression Yet May Contribute to Sleep Disturbances

Beta-blockers treat various cardiovascular diseases and were not more likely to cause depression compared to other similar treatments, according to new research published today in Hypertension, an American Heart Association journal. While depression may occur during beta-blocker therapy, the research suggests beta-blockers are not the likely cause.

Beta-blockers are a class of medications that reduce the heart rate, the heart’s workload and the heart’s output of blood, which, together, lower blood pressure. They are a common treatment for cardiovascular diseases, including heart failure, arrhythmias, chest pains and high blood pressure. Researchers have suspected beta-blockers of having negative psychological side effects, including depression, anxiety, drowsiness, insomnia, hallucinations and nightmares.

“The possible mental health side effects of beta-blockers have been the subject of discussion in the scientific community for many decades,” says Reinhold Kreutz, M.D., Ph.D., a professor at the Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology and the study’s supervising and corresponding author. “So, our results showing beta-blockers are not the cause of so many of these negative side effects are quite consequential.”

The study is the first of its kind to examine the entire spectrum of mental health side effects in relation to beta-blockers. The researchers analyzed data for more than 50,000 individuals from 258 studies including beta-blockers in double-blind, randomized controlled trials. Nearly 70% of the studies were clinical trials focused on high blood pressure treatment, and 31 assessed depression in placebo-controlled trials.

Results from the comprehensive analysis revealed:

  • Despite being the most frequently reported mental health side effect, depression did not occur more frequently during beta-blocker treatment compared to placebo treatment.
  • The rate of discontinuing medication use due to depression was not any different for those taking beta-blockers compared to those on other treatments.
  • Unusual dreams, insomnia and sleep disorders may be linked to beta-blockers.
  • Among the mental health events analyzed, the most common reason for discontinuing beta-blockers was fatigue/tiredness.

“Our results indicate that concerns about adverse mental health events, especially depression, should not affect the decision about beta blockers. Beta-blockers are mostly safe regarding psychological health,” said Kreutz. “We found no indication of an association between beta-blocker use and depression. The same was true for most of the other mental health symptoms, as reported in the studies that were included in our analyses. However, sleep-related symptoms such as unusual dreams or insomnia did emerge during beta‑blocker therapy for some patients.”

Kreutz added, “Patients with a history of cardiovascular events such as a heart attack or stroke were prone to develop psychological complications. Though we found beta-blockers were not causally linked, these patients should be monitored.”

The original studies did not include individual patient data, so for this analysis, researchers were unable to investigate whether sleep-related symptoms were persistent for those taking beta-blockers. Additional research is needed to address this question.

The researchers report there an important limitation to consider when interpreting the results of their analysis: most beta-blocker trials were conducted more than 20 years ago, before a uniform language to describe adverse events was established. Additionally, the authors only considered randomized, double-blind trials for their analysis, which left out some studies that might provide more data on long-term beta-blocker treatment.


Source: American Heart Association