Chinese-made new drugs big hit overseas

 Pharmaceutical sector spurred by global market boom

"The surge in overseas expansion of domestic innovative drugs highlights the enhanced innovation capabilities of China's biopharmaceutical sector

Employees examine drug samples at a laboratory in Shenyang, Liaoning province, in May.

 [Photo/Xinhua]

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With more Chinese-developed innovative drugs entering both US and European markets, China's pharmaceutical sector is showing escalating prowess in innovation and global market penetration, said industry experts.

"This (entering the European market) is a significant milestone. Fruquintinib is the first product approved in Europe completed by our research and development engine," said Su Weiguo, CEO and chief scientific officer of Shanghai-based biopharmaceutical company Hutchmed.

Su added that the drug is already improving treatment prospects in the United States and China, and the company is looking forward to extending its impact to European market.

Su's statement came after the company announced last month that its independently developed antitumor drug Fruquintinib received approval from the European Commission for use in the treatment of metastatic colorectal cancer.

Following the drug's US market debut in November, the milestone marks its second entry into a major global market within seven months.

In November, the Chinese-made new drug was approved by the US Food and Drug Administration, with the first prescription issued within 48 hours of approval, Hutchmed said. According to data from the company's overseas commercialization partner Takeda, Fruquintinib's sales in the US market exceeded $50 million in the first quarter.

The innovative drug is also in the process of being approved for sale in other global markets, such as Japan, with a focus on enlarging its global footprint and reaching out to more patients worldwide, said Hutchmed in a recent statement.

In a related development, Hangzhou, Zhejiang-based Yifan Pharmaceutical announced in March that its innovative product, Ryzneuta, also received approval for sale in the European market.

Previously approved by the US FDA in November for treating chemotherapy-induced neutropenia, the approval marks this year's first innovative drug approval for a Chinese pharmaceutical company in a foreign market.

Last year was widely recognized as a significant watershed for Chinese innovative drugs that aim to go global, with the number of "license-out" deals surpassing "license-in "ones for the first time.

According to data from online pharmaceutical platform Pharmacube, there were about 70 out-licensing deals in China in 2023, up 32 percent from 2022, with a total transaction value of over $46.5 billion, up 69 percent from the previous year.

Out-licensing in the pharmaceutical industry is a practice where a company grants another foreign organization the rights to use its product, technology or intellectual property. It allows the licensor to enter new markets through the licensee's established presence. In-licensing, on the other hand, allows the licensee to expand its product portfolio and access innovative technologies without having to develop the product or technology in-house.

In the first half of this year, the enthusiasm for "going global "among domestic innovative pharmaceutical companies has remained high. According to a report by Chinese media Yicai, as of June 30, there were approximately 30 out-licensing deals by innovative Chinese drugmakers, with a transaction value of over $10 billion, significantly more than a year earlier.

"The surge in overseas expansion of domestic innovative drugs highlights the enhanced innovation capabilities of China's biopharmaceutical sector and reflects international regulatory bodies' recognition of China's drug innovation," said Yu Meng, deputy director of the information department at the China Chamber of Commerce for Import and Export of Medicines and Health Products.

Yu said commercialization serves as the major reason for Chinese pharmaceutical companies to target foreign markets, as lucrative pricing of innovative drugs abroad presents a vast profit potential and prompts some globally competitive companies to explore overseas markets for higher returns.

In fact, due to the significant market size of innovative drugs, the US and European markets have become prime targets for such drugmakers. The US accounted for over half of global innovative drug sales in 2021, with Europe at 16 percent, while China stood at merely 3 percent, far below that of developed countries, according to a report by consultancy Market Monitor.

In order to strengthen policy support for the growth of the innovative drug sector, on July 5, the State Council, China's Cabinet, issued a guideline that supports improved price management, medical insurance payments, commercial insurance coverage, allocation and usage, as well as investment and financing in the sector.

Specifically, efforts will also include improving scientific and technological resource allocation, strengthening fundamental research in new drug development and solidifying the R&D foundation for China's innovative drugs, according to the guideline.

Domestic pharma firms' enthusiasm for going global driving business abroad

Technicians run drug experiments at a pharmaceutical company's lab in Haikou, Hainan province, in May. [SU BIKUN/FOR CHINA DAILY]

"I see there are a lot of companies in China that have big potential to develop global-level new drugs. For example, the number of drugs the country is running for clinical trials is massively bigger than other countries in Asia," said Chris Shim, general manager for Asia R&D and quality at US cloud-based pharmaceutical software company Veeva Systems.

With its enormous domestic market size, sufficient talent supply and large number of biotech and biopharma players, China's pharmaceutical industry is endowed with great potential to witness an increasing number of global-level innovative drugmakers, Shim said.

He added that in order to better adapt to local market conditions during their global outreach, Chinese companies are setting up concise strategies based on different market compliance issues and business performances, with a focus on the usage of cutting-edge technologies such as cloud platforms and artificial intelligence.

"Take cooperation ecosystem, for example. If Chinese companies want to manage different partners and patient dynamics abroad, they'll have to manage all the data and solutions across different countries, where lie cultural and regulatory differences and other kinds of complexities," he said, adding that digitalization can facilitate cross-regional communication and operation process to a large extent.

Shim's view is echoed by Yang Bin, clinical operations vice-president at Hutchmed, "The digitalization of overseas data collection, analysis and management ensures the timeliness of our data processing and analysis. For example, clinical data might contain some anomalies, but through a comprehensive digital management system, we can promptly detect and address these issues, ensuring the overall quality of the experiments.

"It can be said that the success of approvals in the US and Europe markets can't be separated from the application of a fully digitalized system."

In addition, Shim mentioned the role of AI in facilitating the going-global process.

"AI is helping people improve their productivity by eliminating routine jobs. For example, the documentation process of clinical trials can involve a lot of human work of writing, uploading, scanning and analyzing, but now all of them can be done by AI by simply taking a picture and AI will take care of the rest. AI is going to be the key differentiator for industry players," he said.

  

Pfizer VP Blows Whistle: Vaccine Designed To Cause Lucrative Health Problems We Could Monetize

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But it gets even worse, according to Dr. Peter Rost.

The former Pfizer Vice President turned whistleblower has got proof that Pfizer intentionally designed their vaccines to cause a global explosion in heart disease and turbo cancer, providing themselves with billions of highly lucrative new patients.

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Former Pfizer VP and author of “The Whistleblower, Confessions of a Healthcare Hitman,” Dr. Peter Rost is an insider expert on big pharma marketing.

He first made his name as a whistleblower back in 2007 when he testified before the Senate that Big Pharma company’s were intentionally ripping off US customers.

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About Baxter Dmitry 6190 Articles Baxter Dmitry is a writer at The People's Voice. He covers politics, business and entertainment. Speaking truth to power since he learned to talk, Baxter has travelled in over 80 countries and won arguments in every single one. Live without fear       

How dangerous are India’s generic drugs? Very

 

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there. — Bloomberg

 

FOR a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight.

In the last six months, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated.

The children who died – mostly under the age of five years – were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.

The eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centres for Disease Control and Prevention reported on March 21.

The Indian company, Global Pharma Healthcare, issued a voluntary nationwide recall for the drops. India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the government’s Economic Survey.

Its US$50bil (RM220bil) drug-manufacturing industry exports medicines to over 200 nations and makes 60% of all vaccines. It boasts “the highest number” of US Food and Drug Administration or FDA-compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-quality medicines.

That may well provide consumers with a level of comfort, but history suggests it is unwise to trust that feeling.

The latest drug recalls just add to a long line of scandals that have tainted the sector.

In 2013, a US subsidiary of major Indian drug manufacturer Ranbaxy Laboratories Ltd pleaded guilty to US federal criminal charges and agreed to pay US$500mil (RM2.2bil) lion for selling adulterated generic drugs, fabricating data, and committing fraud. Serious flaws in the FDA compliance regime allowed these breaches to go undiscovered, until a years-long investigation laid bare the endemic corruption.

A generic drug made in India and modelled on Lipitor sold in the US to treat high cholesterol, for example, was contaminated with shards of blue glass, as journalist Katherine Eban documented in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Her book draws in part on the experience of whistleblower Dinesh Thakur, who worked at Ranbaxy.

You would think such a damning indictment would prompt India to develop a safer, better pharmaceutical oversight regime. Think again.

The systemic fraud exposed by the investigation – where data was routinely falsified to fool inspectors, increase production and maximise profit – did not result in a regulatory overhaul.

Still, a two-day “brainstorming session” held in February appeared to acknowledge the system’s inherent weaknesses, with Health Minister Mansukh Mandaviya telling participants India needed to “move from generic to quality-generic drugs.”

Discussions involved “how to make the country’s drugs regulatory systems transparent, predictable and verifiable,” according to a health ministry media release.

Consumers shouldn’t hold their breath, though. A national law on drug recalls has been under discussion since 1976 without resolution, and the government – at least publicly –remains in denial: Since the Ranbaxy scandal, Thakur has campaigned for the reform of India’s main regulator, the Central Drugs Standard Control Organisation, and, with lawyer T. Prashant Reddy, has written his own book, The Truth Pill: The Myth of Drug Regulation in India, which was published in October.

They note that adulterated Indian drugs aren’t just killing children in developing-world export markets like Gambia and Uzbekistan. They’re also killing children at home: In 2019, at least 11 infants died in the state of Jammu because of cough syrup containing diethylene glycol. 

The World Health Organisation (WHO) sent alerts in October and January, asking for the cough medicine to be removed from the shelves. (It also issued a warning last year for cough syrups made by four Indonesian manufacturers sold in that country, where 203 children died in similar circumstances.)

Maiden Pharmaceuticals, whose medicines were sold in Gambia and linked by the WHO to the deaths of at least 70 children, has denied wrongdoing. And India’s regulator rejected the WHO’s findings, saying no toxic substances had been found in samples taken from Maiden’s plant. 

It shouldn’t have taken more deaths for Prime Minister Narendra Modi’s administration to act. The red flags have been there for years. What’s lacking is political will, and transparency. The FDA publishes different reviews of new drug applications on its website, along with detailed notes. 

So why does contamination with such deadly substances occur so regularly?

“The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to market,” Thakur said.

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there.

In the absence of a global framework for pharmaceutical safety, what can be done to make the generic drugs that consumers around the world have come to rely on safer and effective?

For a start, the WHO’s prequalification programme, which facilitates the purchase of billions of dollars’ worth of medicines through international agencies such as Unicef, must be overhauled. Then there’s the question of holding these companies to account for the harm they cause inside and outside India via legal avenues and victims’ compensation. — Bloomberg 

- Ruth Pollard is a Bloomberg Opinion columnist. The views expressed here are the writer’s own.

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China makes steady progress towards coronavirus vaccines to market

 

Inactivated COVID-19 vaccine CoronaVac produced by Chinese vaccine developer Sinovac Photo: Courtesy of Sinovac

 Chinese vice premier Sun Chunlan stressed a scientific and rigorous preparation is required for the mass production of Chinese-developed COVID-19 vaccines during an inspection tour of vaccine production lines of some leading manufacturers in Beijing on Wednesday, the same day the UK became the first Western country to approve a coronavirus vaccine for widespread use.

Sun and State Councilor Wang Yong visited the National Institute for Food and Drug Control, and two leading vaccine producers Sinovac, National Vaccine & Serum Institute under Sinopharm in Beijing, the Xinhua News Agency reported late Wednesday.

The visit was seen as a prelude for the vaccine coming to market in a rigorous and scientific manner. Russia and the UK announced on Wednesday they will start mass vaccinations against the coronavirus next week.

Sun and Wang learned about COVID-19 vaccine research, visited production plants and checked preparation work, and fully affirmed the achievements of the vaccine developers.

Fourteen vaccines using five technology methods are in clinical trials and five vaccines are undergoing phase Ⅲ clinical trials. Emergency use, production preparation and other work are proceeding in an orderly manner.

Sun called for scientific and rigorous phase Ⅲ clinical trials to carry out review and approval work in strict accordance with laws, regulations and internationally recognized technical standards to ensure the safety and effectiveness.

She required Chinese companies prepare for mass production, strictly comply with laws, regulations, procedures and requirements on quality supervision and biosafety, improve the traceability system for vaccines, punish illegal activities for creating a favorable market environment.

Sun said it's necessary to formulate a vaccination distribution plan before the vaccines are made available to the public. The emergency use of the vaccine in high-risk groups, such as port workers and front-line supervisors, will be completed by the end of 2020, she said.

The UK's approval of Pfizer's coronavirus vaccine on Wednesday paved the way for widespread uses of the vaccine. The first doses are already on their way to the UK, with 800,000 due to arrive in the coming days, Pfizer said.

Analysts said the UK and Russia's quick approval for widespread use of vaccine is mainly in response to new outbreaks that may get worse during the coming winter.

China is very likely to introduce its first officially approved vaccine for mass use in December, but whether it would be approved only for limited use is still under discussion, a Beijing-based immunological professor who asks not to be named told the Global Times.

The first vaccines to get approval are likely the inactivated vaccine candidates from either Sinovac or state-owned Sinopharm, said the professor, noting that other frontrunner candidates such as recombinant adenovirus vector vaccine would be slightly behind or approved for emergency use first.

The Global Times learned from the Sinovac's Brazilian partner Butantan Institute which is carrying out the phase Ⅲ clinical trials of the inactivated vaccine CoronaVac that the data from the trials have been sent to the Brazilian National Health Surveillance Agency. Sinovac told the Global Times that analysis of the clinical data will take some time.

Compared to China, vaccines are more urgently needed in the West, said a Shanghai-based vaccine expert. "The epidemic battle left many Americans desperate, let's hope President-elect Joe Biden will take human rights seriously and not follow in Trump's footsteps."

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Counterfeit medicines and drugs, a public health menance !

Fake medicines may contain toxic substances that include heavy metals (e.g. aresenic) and additives (e.g. steroids). – AFP

The drugs you are taking may be fake

Counterfeit drugs are a booming criminal industry with serious consequences for public health.

Many of us have a strong faith in the power of modern medicine.

We go to the doctor or pharmacist, get the prescribed pills, take them religiously and expect to be cured of whatever ails us.

Oftentimes, this faith is justified, but in an age where fake products abound, have you ever wondered about the authenticity and quality of the drugs that you are ingesting?

According to a 2013 Emerging Markets Health Network report, 3-5% of all medicines being circulated in Malaysia were fakes.

Health Minister Datuk Seri Dr S. Subramaniam has also been reported as saying that the ministry had seized some 33,704 unregistered products worth RM43.22mil last year alone.

While this is not high compared to other middle- and low-income countries – for example, the International Pharmaceutical Manufacturers Group in Indonesia estimates that about one-quarter of medicines on the Indonesian market are fake – it is certainly something to be worried about as it concerns our health.

University of Oxford’s Reader in Tropical Medicine, Prof Dr Paul Newton says that it is difficult to estimate the global size of the problem as there is not enough data.

According to him, there are very few studies, and very few of those are done in a scientifically-rigorous manner, adding that there are certainly hotspots of such problems around the world.

Pfizer Global Security director Mark Robinson shares that the pharmaceutical company sees the highest number of fake drug seizures in Asia, compared to the rest of the world.

But he adds: “That’s because we are targeting (illegal) labs, seizing the drugs before they reach the market.” He observes that in 60 countries around the world, patients went into a legitimate, licensed pharmacy and got counterfeit drugs.

In addition, he notes that the World Health Organisation (WHO) estimates that over half of those who buy drugs online from unverified websites receive counterfeit medicines.

Two types of fake

Fake drugs, also called poor quality drugs, can be divided into two types: counterfeit and substandard.

Prof Newton explains that counterfeit medicines are made by criminals with the intent to deceive patients and healthcare workers for monetary gain.

According to Robinson, these criminals include entrepreneurs, terrorist organisations, drug syndicates and weapons dealers.

 Brick dust, used to hold the fake pill together, as well as boric acid, leaded highway paint to provide the yellow colour, and floor wax to provide shine, were found to be used in the production of counterfeit mefenamic acid by an illegal lab in Colombia. - AFP

They do it, he says, because it is profitable, because they are pretty sure they won’t get caught, and because even if they do get caught, the penalties are very low compared to the amount of money they can make.

The danger of these drugs is that they can vary from not having any active pharmaceutical ingredient to containing toxic materials. (See What’s in your fake drug)

Active pharmaceutical ingredients are the chemical compounds that treat the medical condition.

Unlike counterfeit drugs, substandard drugs are made by the original or licensed manufacturer, but do not conform to the proper standard of quality.

They are “medicines with mistakes”, says Prof Newton.

These medicines occur due to errors in the factories. Sometimes, they can be small errors, and sometimes, they can be large errors, like using the wrong active ingredient, he says.

He opines that this problem is more likely to occur in low-income countries where there is a lack of drug regulation and quality control measures.

However, as with counterfeit drugs, it is difficult to estimate the size of this problem due to the lack of data.

“Not many people are actually looking (for this problem), so we might have an unpleasant surprise,” he says, adding that in terms of public health, substandard medicines are as dangerous as counterfeit drugs.

He adds that some companies are very active in ensuring that their products are good, but, like any human activity, some cut corners and skip the quality control.

Poor regulation

According to the WHO, only one-fifth of its member states have well-developed drug regulation; half have varying levels of regulation and enforcement; and the remaining 30% have either very limited or no drug regulation at all.

In Malaysia, Dr Subramaniam was reported as saying that online drug sales are a particularly hard area to enforce as the Customs Department does not screen packages valued below RM500, due to the very high number of such packages.

“We have asked the Customs Department to screen all packages, and they are trying to do it, but I think it is quite expensive to put such a system in place,” he said after opening the Access to Safe Medicines Training Conference organised by Mediharta Sdn Bhd in January.

Prof Newton was a speaker at the same conference, while Robinson was a speaker at the launch of Pfizer’s anti-counterfeit technology, Patient Authentication for Safety via SMS (PASS), in Malaysia.

According to Robinson, the top three drugs produced by Pfizer that are found to be counterfeited in Malaysia are erectile dysfunction drug, sildenafil; non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation, celecoxib; and hypertension drug, amlodipine.

He adds that it is not only branded drugs that are counterfeited, but also generic drugs that are no longer patented, like the NSAID mefenamic acid.

“People just want to use our good name (to sell fake drugs),” he says.

Prof Newton notes that antibiotics and cardiovascular drugs are also being increasingly counterfeited in South-East Asia.

He adds that it is not only drugs that are counterfeited, but also medical devices like cardiac stents, rapid diagnostic tests and insecticide-treated bed nets – a problem particularly rampant in Africa.

Bad effects

The effects of fake drugs can be felt both on the individual level, as well as on a wider scale. For the patient, taking counterfeit drugs can range from death to developing more serious health complications.

These health complications may be caused by the actual illness being untreated due to a lack of active ingredients in the counterfeit drug, or the drug containing either toxic ingredients or the wrong active ingredients.

The latter will also make it more complicated for doctors to treat the patients, as they might be confused by the incongruent symptoms.

Counterfeit or substandard drugs that contain less active ingredients than required can also cause drug resistance, particularly if they are antibiotics.

Prof Newton adds that consuming fake drugs also ends up incurring more expense on the patients’ part, as they don’t get better and keep on buying more medications.

Patients might also lose faith in the healthcare system, he says. “If you don’t trust the pharmaceutical companies or doctors, you won’t go back and might seek other alternatives.

He notes that fake drugs will also affect genuine pharmaceutical companies, as well as government healthcare systems and non-governmental organisations that inadvertently purchase these drugs.

Both Prof Newton and Robinson hope that governments around the world will take a stronger stance against counterfeit medicines, both in terms of enacting relevant legislation with much stronger penalties for those producing fake drugs, as well as in terms of enforcement.

Patients should also be more careful of what they consume.

For example, signs that a medicine could be fake include an excessively low price, flimsy or unprofessional packaging, and not requiring a doctor’s or pharmacist’s prescription for non-OTC (over the counter) drugs.


An example of the holographic security label for registered Malaysian drugs, which features the hibiscus symbol, serial number and the letters PBKD and DCA. All drug packaging must have this label. – Photo:
An example of the holographic security label for registered Malaysian drugs, which features the hibiscus symbol, serial number and the letters PBKD and DCA. All drug packaging must have this label. – Photo: Health Ministry

In Malaysia, registered drugs also have a holographic security sticker on their packaging.

By Tan Shiow Chin The Star/Asia News Network

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European anti-crisis strategy: Sex, drugs, alcohol could boost economic growth

The euro sculpture is seen outside the headquarters of the European Central Bank (ECB) in Frankfurt, Germany. European governments are slowly turning to drugs, sex and contraband as a way to boost their respective economies. — Reuters pic

European governments are turning their attention to prostitution, drugs and contraband as possible ways of boosting their economic growth profiles, as they struggle away from their debt crises, AFP reports. 

Sex and drugs to add to Europe's murky GDP figures

Italy caused a stir when it announced last month that it would begin including revenues from drug trafficking and the sex trade, as well as contraband tobacco and alcohol, to calculate gross domestic product (GDP) from next year.

One effect would be to reduce the public deficit as a ratio of output, if EU authorities were to accept the idea. That would be a big help to countries trying to get their public deficits below the EU ceiling of 3.0 percent of output.

In 2012, Italy's central bank estimated the value of the criminal economy at 10.9 percent of GDP. Including these figures could therefore boost the country's growth to above the government's 1.3 percent estimate.

Last month, Britain said including illegal activities such as prostitution and drugs into national accounts would add about 10 billion pounds (12.3 billion euros, $16.8 billion) to GDP, equivalent to about one percent of national output.

Using the undeclared or so-called black economy to calculate national statistics is part of a range of changes recommended by the European Union's statistical institute, Eurostat, to be implemented in September.

Eurostat said including such data would allow a better comparison between countries with different laws.

"GDP is not an indicator of morality," said a spokesman, adding that only transactions carried out consensually would be included.

But others are less convinced.

Eric Vernier, researcher at the Institute of International Relations, said including "gross criminal product" in growth figures is a cynical attempt to combat the Eurozone's debt crisis.

"The problem is to put this new statistical method on the table at the moment when everyone has budget problems," he said.

"There has been a general acceptance of this accounting approach since the crisis: what matters most is what goes into the state coffers."

"Denial of basic morality"

Many of Europe's struggling governments will welcome any boost to growth figures that will reassure both disillusioned voters and markets.

But the decision has sparked outrage among politicians and rights groups.

The French minister for women's rights Najat Vallaud-Belkacem and Belgium's Interior Minister Joelle Milquet, have both written to the European Commission to express their "astonishment" over the proposals.

"Prostitution is not a voluntary commercial activity. To believe that it can have an ideological bias is a mirage and an insult to the millions of victims of sexual exploitation worldwide", they said.

"Prostitution cannot be assumed to be a transaction freely agreed between parties. The question also arises concerning drugs, especially hard drugs, considering the issue of addiction," added Ronan Mahieu, head of INSEE, which calculates France's GDP.

A spokeswoman for the Association for the Protection of Women's Rights in Britain said the group was "surprised and saddened" by the decision.

While in France, Marine Le Pen, the leader of the extreme-right National Front party which came top in recent European Parliament elections, described it as a "denial of basic morality."

'Shadow market'

Europe's black market is already huge, according to experts.

Friedrich Schneider, professor at the Johannes Kepler University of Linz in Austria, estimates that the European Union's "shadow market" is equal to 18.6 percent of the bloc's 2014 GDP.

But calculating the value of illegal activities is no easy task.

An EU document from 2012, littered with acronyms and complex mathematical formulas, gives guidelines on how to calculate the "inputs" of the prostitution industry, such as the cost of renting an apartment, or "transport and storage" for drug traffickers.

It even includes how to interpret the "ratio of purity" in narcotics.

Schneider argues that undeclared illegal activities and "value creating" services such as prostitution should be included in the calculations, but not totally criminal activities.

On this basis, Germany, Italy and France account for about half of Europe's black-market activities.

In recession-hit Greece, he estimates that black market transactions account for an estimated 23 percent of GDP, lower than the estimated 40 percent of the less-developed economies of Eastern Europe, but far higher than the roughly eight percent in Luxembourg. - AFP

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Care for a study pill?

Use of ADHD drugs as study aid by students raises concerns. 

Like steroids?: Standard drugs for treating attention deficit/hyperactivity disorder are being used by some US sudents to help them stay awake as they cram for exams.

A UNIVERSITY of Kansas freshman took a break from shooting hoops with friends outside his dormitory to talk about what some students call “study pills”.

As final exams approached last semester, he took a few doses of a prescribed stimulant. “But all they did was make me feel nervous,” said the chemical engineering major. “I’m off of it now.”

He still has a vial of leftover pills he used for his attention issues in high school. And that’s why he asked that his name not appear in this article: He didn’t want to be pressed by dormmates to supply them with an illegal focus boost for upcoming finals.

The controlled stimulants that many college students seek, if only for a momentary edge, carry familiar brand names such as Adderall, Vyvanse, Focalin and Ritalin. They’re all standard drugs for treating attention deficit/hyperactivity disorder, often successfully.

Their misuse, however, is thought to be on the rise at campuses in the US – creating a potentially serious health hazard and trips to the emergency room for students not diagnosed for ADHD.

The extent of the problem is anyone’s guess. Because of what experts consider a lack of reliable research, illicit dealing of ADHD drugs either is infrequent on campus or something so commonplace as to be the college crowd’s best-kept secret.

“The only people who don’t know about it are the parents,” said University of Kentucky communications professor Alan D. DeSantis. “I’m sure the majority of my students will be using at some time during finals week. It’s really built into the climate and culture of today’s college life.”

‘Study pills’

DeSantis has analysed several years’ worth of surveys of Kentucky undergraduates to conclude that at least one-third of the student body has taken ADHD medication without prescriptions. Another 8% use the drugs legally under a doctor’s supervision, he said, and half of them provide pills to other students.

The incidence of use appears to be higher among Kentucky seniors and juniors than for younger students, DeSantis added.

Assessing a variety of surveys, a 2008 study published in the Journal of American Child Adolescent Psychiatry offered a not-so-precise range of 5 to 35% of college-aged people taking attention-deficit stimulants not prescribed for them.

A University of Missouri survey found a usage rate in between.

About 12% in a sample of Mizzou students admitted to using controlled stimulants or painkillers, prescribed or illegally, said Kim Dude, director of the University of Missouri’s Wellness Resource Center. “Eighty-five percent of the students don’t use any of that.”

But she does agree with the KU freshman – don’t let on if you’ve got attention-deficit pills.

“We urge students and their parents from the start: Don’t tell anybody,” Dude said. “They’ll run into peer pressure to sell it or give it away” to other students.

This month, data-miners at Brigham Young University issued a study that tracked Twitter references to study pills.

Searching keywords such as “Adderall,” “college” and “cramming” over a six-month period, lead researcher Carl Hanson revealed, “We don’t have all the answers” on the frequency of legal use or abuse. But the study did conclude that tweets about the drug were heaviest among students in the US Northeast and South, and lightest among students in the Plains and Southwestern states (including California).

Also, the report summary stated, “Tweets about Adderall peak sharply during final exam periods.”

Said Hanson: “I’m concerned about the social norm-ing thing. If students perceive (taking stimulant medication) as normal because it’s talked about and tweeted a lot, they’ll take the risk.”

Easy to get

Katharine Beach became addicted when she was a KU student.

“It’s sad how many doctors would fill prescriptions for me,” said Beach, 26 and now clean.

Diagnosed with attention deficit disorder when she was 18, the medication at first helped her focus and stay awake to study. But after she started drinking heavily, Beach chose to give up booze and find a new fix.

“It’s called cross-addiction,” said Beach, who graduated last year with a degree in applied behavioural science.

Student health services at KU required her to jump through too many hoops before filling prescriptions. (“They’re onto students who want something quick,” she said.) So, relying upon private medical clinics in Lawrence, Kansas City and her psychiatrist in Colorado, Beach procured five times the recommended dosage of Adderall to keep her buzz.

“Everyone around me knew I didn’t drink anymore ... but (that) something else was going on,” she said. “I’m positive I would have switched to cocaine or maybe meth down the road.”

Her health insurance carrier got wise and stopped funding her prescriptions. Her parents caught on after Beach maxed out their credit card. She entered treatment and works today at a University of Colorado rehabilitation centre, helping addicts.

Dealing with the consequences

Millions of Americans have taken prescribed ADHD medication – often intermittently – without experiencing negative side effects. But an under-30 generation raised on the practice might not be aware of the dangers of taking even modest dosages without a thorough diagnosis, said psychiatrist Tahir Rahman of the MU School of Medicine.

“If you’re depressive or have bipolar disorder, taking a drug such as Adderall could be throwing gasoline on a fire,” Rahman said.

In the US, the number of emergency room visits related to abuse of ADHD drugs rose to 31,224 in 2010 – more than double the number recorded five years earlier, according to a report released in January.

Such ER visits by people aged 18 to 25 nearly quadrupled during that time, the Substance Abuse & Mental Health Association reported.

It is not known how many of those patients were college students.

“I hear students talk about it all the time,” said Kate Baxendale, a junior studying journalism at the University of Missouri-Kansas City. She and another student wrote about the problem in the university newspaper after agreeing to not identify stimulant users by name.

Baxendale has never taken Adderall, she said, but others in her dorm have sold it. “At a time like this (finals week), they can sell for US$20 (RM60) a pill,” she said. The sellers ration their prescribed medication because they need some for themselves.

The university’s health services do not have medical doctors to prescribe controlled stimulants, so students taking them must get the drugs elsewhere.

Colleges around the US are tightening their procedures to limit student access to stimulant medicine.

“Some campuses have stopped prescribing stimulants outright,” said Stacy Andes of the American College Health Association. Others, including KU, require students to present copies of at least two diagnostic tests given by doctors or mental-health professionals.

The drugs easily can be obtained off campus in most college towns, said DeSantis of the University of Kentucky. A clinic or family practitioner may ask patients to fill out a questionnaire that asks if they have trouble focusing or completing assignments.

“For the most part, students (seeking medication) know how to answer those questions,” DeSantis said.

Downing Adderall to perform better on tests raises questions beyond medical ones: Is it the educational equivalent of using steroids to cheat in sports? Are students who choose not to use stimulants, or those who can’t afford them, chasing degrees at an unfair disadvantage?

Psychiatrists debate whether the drugs do much at all to help people not diagnosed with ADHD, other than to keep them awake so they can cram for tests.

Girding up for finals in a library study room at UMKC, Govinda Koirala wrinkled his nose when asked if he would ever consider a pharmaceutical boost.

“I drink coffee,” said the junior studying mechanical engineering. “And the latest I stay up studying is 11.30pm,” His secret to academic success? “Just relax. Sleep well. Do what’s good for your mind.”

Must work. Koirala is pulling a 3.91 grade-point average. – The Kansas City Star/McClatchy-Tribune Information Services

By RICK MONTGOMERY The Star/Asia News Network

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A victory for patients & generic drugmakers vs Novartis in landmark patent case

The Indian Supreme Court’s ruling that only genuinely new inventions should be granted patents means that medicines can still be affordable.

The front office of Novartis in Mumbai, India, Monday, after India's Supreme Court rejected drug maker's attempt to patent a new version of a cancer drug Glivec. 

PATIENTS around the world who look to India for low-cost medicines to treat their ailments heaved a sigh of relief last week when the Indian Supreme Court turned down a claim for a patent for a cancer drug.

This means that drug companies in India can continue to produce generic versions of the same drug, Glivec or Gleevec, at a much lower price, thus making it affordable to thousands more cancer patients.

Glivec, produced by the Swiss-based company Norvartis, can cost a patient up to US$70,000 (RM217,000) for a year of treatment, whereas the generic versions of the same medicine made by Indian companies cost around US$2,500 (RM7,750). The drug is used to treat some forms of leukaemia as well as a rare type of stomach cancer.

The Supreme Court decision also seems to open the road for patents not to be granted for more medicines, since it confirmed that only drugs that are genuinely a new invention can be granted patents.

When a patent is granted to a company for a drug, other companies are not permitted to produce generic versions of the medicine for a period of 20 years or so.

The monopoly given to the patent holder enables it to charge high prices since there is a lack of competition.

Many or even most patients are unable to buy the medicines, giving rise to frustration and despair especially when their lives are at stake.

Some companies whose patents are about to expire apply for a new patent for the same drug after changing the composition slightly or changing the form of the drug.

The “new” drug is often not a new invention, but only a minor modification that is made with the aim of having the patent renewed for another period. This practice is popularly termed “evergreening” of the patent.

An extension of the patent term means that the company continues to enjoy the monopoly and high prices, which continue to be out of reach to many patients.

Although governments are obliged to have laws allowing for patents to be given for inventions under the World Trade Organisation’s TRIPS agreement, each country is allowed to set its own definition and standards for what is an invention.

The Supreme Court decision confirms that the Indian patent authorities exercised their powers lawfully and properly when they rejected the patent application for Gleevec on the ground that the medicine was not a new invention.

Novartis had challenged the interpretation given by the Indian Patent Office to Section 3 (d) of the Indian Patents Act that seeks to prevent the grant of patents for non-inventive new forms of known medicines.

The Novartis application had claimed a patent for a new salt form (imatinib mesylate), a medicine for the treatment of chronic myeloid leukaemia, sold under the brand name Gleevec (or Glivec in other countries).

The Indian patent office had rejected the patent application on the ground that the claimed new form was anticipated in an earlier US patent of 1996 for the compound imatinib and that the new form did not enhance the therapeutic efficacy of the drug. The decision was upheld by the Indian Patents Appellate Board.

The legal challenge from Novartis had caused anxiety among patients groups, governments of developing countries and some international organisations in view of the possible negative implications for access to affordable medicines if the Norvatis petition succeeded.

Most developing countries rely on Indian generic drug companies for the supply of low-priced medicines for many diseases.
A weakening of the interpretation or use of Section 3 (d) would have enabled multinational drug companies to extend their patent monopolies based on “evergreening” or “trivial” incremental improvements which could delay the supply of generic medicines for the treatment of HIV/AIDS, cancer and other diseases.

The decision by the Indian Supreme Court is thus of major significance not only for India but for patients and health authorities in the developing countries.

In interpreting Section 3 (d), the Supreme Court observed that this section was introduced in the 2005 amendment to the Patents Act to ensure that while India allowed product patents on medicines in accordance with its WTO obligations, it did not compromise public health through “evergreening” of pharmaceutical patents.

The court hence took into account the concerns about the impact of the TRIPS agreement on public health and on the development of an indigenous pharmaceutical industry.

Moreover, it considered the implications of the Novartis case for the availability of essential medicines at affordable prices globally.

The court decision reproduced two letters from Dr Jim Yong Kim, the former director of the Department of HIV/AIDS at the World Health Organisation (current president of the World Bank) and from UNAIDS to the Indian health minister expressing their concerns relating to the continuous availability of affordable Indian generic drugs in other developing countries.

Thus, the Supreme Court decision has implications beyond India. It upholds the high standards by which drug patent applications can be processed. While genuinely new inventions are granted patents, drugs that are not really new need not.

The implication is that Indian generic companies can be expected to produce many more medicines in future, and continue their reputation as the “pharmacy of the developing countries”.

It is also heartening that the court decision reaffirms the priority for concerns for the patients’ right to receive treatment at more affordable prices.

The court decision is also likely to spark interest among other developing countries about the Indian patent law and the policies guiding it. Developing countries can learn from the Indian approach of balancing patents and public health.

Global Trends
By MARTIN KHOR
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