Beijing aims to refill medicine chest with ‘Made in China’ drugs

China, already a global powerhouse in high-tech areas from solar panels to bullet trains, is turning its industrial might to the challenge of making more of its own drugs for a vast and aging population.

Given the 10 years or more it typically takes to bring a new medicine to market, original “Made in China” treatments won’t arrive overnight, but multinationals are already encountering more competition from local generic drugs that look set for a quantum leap in quality.

The stakes are high. China is the world’s second biggest drugs market behind the United States, and fast food, smoking and pollution have fueled a rise in cancers and chronic heart and lung diseases.

The country also has more diabetics than any other in the world, with numbers expected to hit 151 million by 2040 from 110 million today, according to the International Diabetes Federation.

That has made China a sweet spot for Denmark’s Novo Nordisk; the world’s biggest insulin producer has mined a rich seam in the country since opening production facilities here in 1995.

By 2010, it dominated 63 percent of China’s insulin market. But it has recently been losing ground to local competitors cheered on by Beijing.

“China is going to be tough for us for the next couple of years,” said Chief Science Officer Mads Krogsgaard Thomsen. “Right now, the country is very focused on building domestic production.”

Local rivals are selling both cut-price basic insulin and sophisticated modern versions, including a biosimilar copy of Sanofi’s Lantus made by Chinese biotech specialist Gan & Lee Pharmaceuticals.

END OF BRANDED GENERICS?

Greater local competition is also evident in other areas, helping the top 10 Chinese drugmakers grow sales 12 percent on average this year, according to IMS Consulting – twice the rate of multinationals, which suffered a setback from a bribery scandal at GlaxoSmithKline two years ago.

GSK itself has seen its drug sales slump.

Increasing local competition is part of a structural upheaval in China’s hospital-dominated prescription drug market. Selling drugs to patients at a hefty mark-up – especially off-patent Western “branded generics” – often accounts for 40-50 percent of Chinese hospitals’ revenues. But the authorities are now pushing a policy of zero mark-ups, initially in smaller county hospitals.

“Branded generics are something that exist today, but the need for them in 10 years time is not going to be there,” said Luke Miels, AstraZeneca’s global portfolio head.

That means foreign firms will be more reliant on new, patented medicines, although the scale of demand for such expensive products is uncertain in a country with only basic health insurance cover.

At the other end of the spectrum, multinationals aim to build up volume, often in partnership with local players, in the big markets outside China’s top cities, where distribution costs are high and prices low.

“It’s the right thing to do, even if profit margins shrink,” said the head of one big multinational.

REGULATOR REFORM

Pivotal to the transformation of the market is the China Food and Drug Administration, led by reformist boss Bi Jingquan since January.

The watchdog has promised to speed up approval of innovative new drugs, which can take 5-7 years, while cracking down on substandard local generics.

“This creates lots of opportunities for local Chinese companies that have a strong focus on innovation,” said a spokesman for China’s Fosun Pharma, which sees itself among the winners.

It is not alone. A cluster of drug research labs in eastern Shanghai highlights the promise of China’s life sciences sector. The area brings together multinational and local firms, alongside contract research businesses and small biotech operations.

Among the latter is Hua Medicine, led by Chinese-born, Western-educated Chief Executive Li Chen, who used to run Roche’s China R&D center. Now he is developing a novel diabetes treatment, licensed from Roche, while working on Hua’s own promising leads.

Another standard-bearer for Chinese biotech is Beijing-based cancer specialist BeiGene, which last month announced plans for a $100 million initial public offering on Nasdaq.

At a time when China’s academic researchers have grabbed headlines by editing the genes of human embryos, such start-ups highlight the commercial potential of China’s biotech know-how.

The history of failure in drug development suggests they won’t have an easy ride, but GSK’s China R&D head Min Li, a returnee from America, believes “there is a real chance for China to leap ahead in life sciences”.

Dennis Gillings, executive chairman of leading contract research organization Quintiles, said the number of Chinese-developed drugs in the pipeline was rising fast.

“It’s probably been taking everyone a little by surprise, the sheer scale of that,” he said. “As we hit the next decade in the 2020s, I’d be very surprised if there wasn’t at least a top 20, if not top 10, global pharma player that was headquartered in China.”

(Reporting by Ben Hirschler and Adam Jourdan; Editing by Will Waterman)


[“source-reuters”]

Some Topical Anti-Inflammatory Drugs Can Rival Oral Versions

Gels and patches provide pain relief with low levels of drug entering the bloodstream, say makers of the products.ENLARGE
Gels and patches provide pain relief with low levels of drug entering the bloodstream, say makers of the products. PHOTO: ISTOCK PHOTO/GETTY IMAGES

The Ache: Oral nonsteroidal anti-inflammatory drugs, or NSAIDs, are widely used to reduce pain and swelling from arthritis and sprains and strains, but they can raise the risk for ulcers, heart attacks and stroke.

The Claim: Gels, patches and other topical NSAIDs can be used directly on the painful area, providing relief with very low levels of the medication entering the bloodstream, say companies that sell the products.

The Verdict: Topical anti-inflammatory medications show similar efficacy to oral drugs in clinical trials, and studies show comparatively small amounts of the medication gets into the bloodstream. Some scientists say it is logical that a lower exposure will result in lower risk, but so far a safety benefit hasn’t been proven.

The topical medications, available only by prescription in the U.S., contain an anti-inflammatory drug called diclofenac. Topical medications work the same way as oral drugs, by inhibiting enzymes involved in pain and inflammation. But they go directly through skin and underlying tissue to the problem area, instead of first traveling through the bloodstream, says Jeff Sherman, chief medical officer of Horizon Pharma PLC of Dublin.

Horizon’s Pennsaid has the consistency of hand sanitizer.ENLARGE
Horizon’s Pennsaid has the consistency of hand sanitizer. PHOTO: HORIZON PHARMA PLC

Horizon’s Pennsaid 2%, a solution with the consistency of hand sanitizer, used twice a day for arthritis pain, hit the U.S. market last year. Other products include Voltaren Gel, sold byEndo Pharmaceuticals Inc., of Malvern, Pa., a four-times-daily treatment for knee arthritis; and Flector Patch, sold by Pfizer Inc. and applied twice a day for sprains and strains. Insurers generally cover all three products, but prior authorization may be required, physicians say. Topical NSAIDs are popular in Europe and world-wide, sold over-the-counter in many countries.

Based on the data, the topical products “can work as effectively” for pain relief as oral medications, says David Jevsevar, acting chairman of orthopedics at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and chairman of an expert panel that developed the 2012 American Academy of Orthopaedic Surgeons guidelines on knee arthritis, which suggest topicals as an option.

Advertisement

The medications are best used on superficial joints—such as the knee and elbow—and are less likely to be effective for deeper joints, such as the hip, he adds.

Flector Patches are sold by Pfizer.ENLARGE
Flector Patches are sold by Pfizer. PHOTO: PFIZER

In a 2012 review of 34 studies involving 7,688 participants, the Cochrane Collaboration, an independent scientific group, found topicals “equivalent” to oral medications for knee and hand arthritis. Another Cochrane review earlier this year also concluded that topicals provide good pain relief for sprains and strains. Side effects can include skin dryness and irritation, according to the scientific studies.

The three U.S. products haven’t been tested against each other in published clinical trials, so “there’s no way of predicting which one will work best for the individual patient,” says Marc C. Hochberg, a professor at the University of Maryland School of Medicine in Baltimore and head of the division of rheumatology and clinical immunology.

The topical medications in the U.S. carry the same boxed warning required by the Food and Drug Administration as oral NSAIDs, cautioning of a higher risk of serious cardiovascular and gastrointestinal problems.

Endo sells Voltaren Gel.ENLARGE
Endo sells Voltaren Gel. PHOTO: NOVARTIS

This warning is necessary because the medications haven’t been shown in large, rigorous “outcome studies” to be safer than oral medications, says Dr. Hochberg, who has worked as a paid consultant on Voltaren.

Despite the lack of large studies, some physicians think topicals are likely safer because less of the medication reaches the bloodstream. For example, in a 2008 study of Flector Patch, blood concentrations of diclofenac after four days of twice-a-day use was less than 1% of that seen with a comparable amount of oral medication. The study, published in the Journal of Pain, was funded by a company that formerly marketed the patch.

Other experts remain cautious given the lack of data. “We don’t know if there is a decrease in gastrointestinal toxicity or cardiovascular toxicity, because it’s a topical,” says Lee S. Simon, a former FDA director of analgesic, anti-inflammatory and ophthalmologic drug products. Dr. Simon—a principal at SDG LLC, a Cambridge, Mass., drug-development consulting firm that works with Horizon and other companies—added: “There are plenty of people who think it’s obvious, but I don’t.”

[“source-wsj”]

 

‘Chemobrain’ Is Real — and More Likely With Certain Drugs

10041188
Larry Dale Gordon—Getty Images

Researchers pinpoint the type of chemotherapy that is more likely to harm the brain of breast cancer patients

Studies have documented the damaging effect that chemotherapy can have on brain functions like memory and cognitive skills, but few have compared different agents to find out which are more harmful than others.

In a small study published inJAMA Oncology, Shelli Kesler, associate professor of neuro-oncology at the University of Texas MD Anderson Cancer Center, and her colleagues did just that. They compared the commonly prescribed anthracycline chemotherapy agents to non-anthracycline agents. They also studied women with earlier-stage breast cancer who didn’t require chemotherapy as part of their treatment. All of the 62 women who had had breast cancer took cognitive tests and agreed to have their brains imaged using functional MRI while they performed certain recall and thinking tasks.

MORE: When Chemotherapy Does More Harm than Good

The group that received anthracycline showed lower verbal memory and recall scores than both the control group (who got not chemo) and the women who were given non-anthracycline chemo. “Given the results of this study, I strongly advise patients to request a referral for neuro-psychological evaluation,” says Kesler. “This should be ongoing throughout the treatment and into survivorship.” She notes that people on chemotherapy routinely get checked by heart experts for potential harm to the heart, and says that the brain might be just as vulnerable to the toxic anti-cancer drugs. “We really should be doing the same with chemotherapy related neuro-toxicity,” she says.

MORE: Some Chemotherapy Is More Toxic Than Others

She admits that the results need to be confirmed with a larger group of people, and that scientists should also look closely at whether the changes in brain function can be mostly attributed to the chemotherapy or whether in women with advanced cancer, the disease itself might be affecting their thinking. While she and her colleagues adjusted for the possible effect of more advanced disease, a more detailed look at this factor in more patients would help to confirm the finding.

For now, there is no reason to avoid anthracycline therapy, especially if it’s prescribed to control potentially life-threatening tumors. But further studies like this that parse apart how each of the chemotherapy agents might affect the brain, and research that identifies genetic factors that might make certain women more vulnerable to the effects of certain agents, could help doctors to better match patients with the right drug for them.

 

[“source-time”]

Dutch ‘handyman’ guilty of £1.6bn drug smuggling in fake ambulance

Media captionThe BBC’s Sian Lloyd: “They used hiding places throughout the ambulance and even carried a bogus patient”

A Dutch man has been found guilty over an operation to use a fleet of fake ambulances to smuggle drugs with a street value of £1.6bn into the UK.

Father-of-four Leonardus Bijlsma, 55, was described as the “right-hand man” in the operation involving specially adapted vehicles and using ports from Essex to East Yorkshire.

He will be sentenced at a later date.

Co-defendant Dennis Vogelaar, 28, was found not guilty by a jury at Birmingham Crown Court.

Olof Schoon, 38, and 51-year-old Richard Engelsbel, had already pleaded guilty at an earlier hearing.

The drugsImage copyrightNational Crime Agency
Image captionPolice found packages of cocaine, heroin and amphetamine as well as thousands of suspected ecstasy pills

‘Audacious’ operation

Schoon was described as “the central player” in the operation, which saw a fleet of fully taxed and insured ambulances created in the Netherlands under the pretence of transporting patients to the UK.

Fake invoices and paperwork for false patient transfers to The Royal London Hospital were produced by Schoon’s company, despite the hospital having no records of any trips, with false addresses and phone numbers for patients also made.

The scheme ran from April last year until all four men were arrested after a raid by officers from the National Crime Agency in Smethwick in June.

At the time of the arrests, Schoon was believed to have made 39 separate journeys.


In court: BBC News reporter Phil Mackie

We have called them ‘fake’ ambulances because they weren’t used for their intended purpose, but they were the real thing. The drugs smugglers were making so much money they were able to buy a small fleet of vehicles and have them all painted in their “company” livery to make them look like genuine medical transport vehicles.

The conspirators – all Dutch nationals – pretended to run a business repatriating sick British patients for insurance companies. They created fake invoices and receipts and they even hired people to pretend to be patients. It is possible the same vehicles were used to transport narcotics along different routes in Europe.

This was a sophisticated and well funded operation that successfully imported a huge quantity of class A drugs before it was discovered.


Following the arrests, officers uncovered four more ambulances in a raid on two premises in the Netherlands, with analysis finding 45 trips to locations in Essex, London, Manchester, Merseyside, the Midlands and West Yorkshire.

In total an estimated £420m of high-purity drugs with a street value of £1.6bn are believed to have been smuggled into the UK.

Prosecutor Robert Davies said the smugglers acted “arrogantly” in carrying out their deals.

“This was a top-level, audacious, and – up to the point of interception and the arrests – successful and lucrative criminal conspiracy,” he said.

Inside the ambulanceImage copyrightNational Crime agency
Image captionPolice believe two men posed as paramedics to avoid unwanted attention

The court heard Bijlsma was the “right-hand man” in the operation to bring large quantities of drugs into the UK.

When officers examined the ambulance, they found concealed compartments behind metal rivet panels containing colour-coded parcels.

Inside was 193kg of cocaine worth £30m, 74kg of heroin worth £8m in individual deals, and ecstasy tablets and crystal worth £60,000.

Bijlsma had said he was paid 250 euros (£176) per journey by Schoon to be his “co-driver” and handyman on 16 trips across the Channel.

When his DNA was found on a rivet gun and gloves in one of the hidden compartments, he claimed it was because he had used them, adding he was too “dirty” to go into the “sterilised” part of the ambulance reserved for patients.

[“source-bbc”]

 

STAT-Harvard poll: Dismayed by drug prices, public supports Democrats’ ideas

WASHINGTON — Most Americans believe that the prices of brand-name prescription drugs have become unreasonable, and their dismay is leading to wide support for government action to keep costs down, including letting Medicare negotiate prices with drug companies, according to a new poll by STAT and the Harvard T.H. Chan School of Public Health.

The poll found strong support across party lines for the Medicare negotiations idea, which is a centerpiece of all of the Democratic presidential candidates’ proposals to contain drug costs.

About 7 out of 10 Americans, including two-thirds of Republicans, said Medicare, the federal health insurance program for older and disabled Americans, should be able to negotiate lower prices for all prescription drugs. Another 13 percent support negotiations for just high-cost drugs for illnesses such as hepatitis C or cancer.

But there are also signs that the strong public support may be less about a specific proposal and more about the general idea that the government should do something — mainly about sky-high prices for new drugs and the jaw-dropping increases for older medicines that have been trumpeted in headlines.

Read more: Public souring on drug industry

More than 9 out of 10 people said it was unreasonable to raise the price of a life-saving antiparasitic drug used by people with AIDS from $13.50 to $750 a pill, a step recently taken by Turing Pharmaceuticals. Similar numbers called it unreasonable to price a new drug that cures hepatitis C at $1,125 per pill — nearly $100,000 for a full course of treatment — a decision by Gilead Sciences that drew widespread scrutiny.

More broadly, about three-quarters of the public believe the prices of brand-name prescription drugs are unreasonable, while 1 in 4 expressed that view about generics.

STAT-Harvard Poll on Drug Prices

Based on a telephone poll of 1,023 US adults conducted Nov. 4-8.
Americans’ views about the federal Medicare program establishing price controls vs. negotiating prices for prescription drugs for seniors, by party identification (Democrat,RepublicanIndependent). Options include (from top) support for PRICE CONTROLS or NEGOTIATION for all prescription drugs, support only for high-cost drugs, generally support, or oppose.
DRUG PRICE CONTROLSDRUG PRICE NEGOTIATION

The poll found that the pharmaceutical industry’s reputation has suffered substantial damage. Barely half of all Americans now say drug companies are doing a good job for their customers, compared with the nearly 8 out of 10 who expressed that kind of confidence in a 1997 Harris Poll.

And they soundly rejected the industry’s argument that government action against rising drug costs would slow the development of new drugs. Sixty-four percent said they did not believe that would happen if Medicare negotiated lower prices, while 26 percent said they believed it could.

Read the full poll results here.

“I feel like there definitely needs to be something done … The government definitely needs to do something to crack down on the price gouging,” said Christine Lintz, a Michigan Republican who participated in the poll and agreed to a follow-up interview. She said she takes prescription medication for migraines that is “outrageously expensive” and would be unaffordable if she didn’t have health insurance.

That doesn’t mean most Americans are struggling with high drug costs themselves. Just 2 out of 10 said prescription drug prices are a major problem for them and their family. Among the uninsured, 3 out of 10 said drug prices are a major problem.

The fact that the support for Medicare negotiations is so high, even though few people are personally experiencing high drug costs, suggests that their reactions are being driven by the perception that drug prices have become “just unreasonable” for others, according to Robert Blendon, a professor of health policy and political analysis at Harvard who directed the poll.

“It’s not people’s experience. It’s people’s outrage,” said Blendon.

Looking to the future, the public said they were most concerned about rising prices of drugs for common conditions such as high blood pressure or high cholesterol rather than very high prices for medicines to treat serious diseases such as cancer or hepatitis.

The STAT-Harvard poll of 1,023 US adults was conducted by telephone from Nov. 4-8. It has a margin of error of 3.6 percentage points. 

In the race between the two leading Democratic presidential candidates, the survey found that Democrats overwhelmingly thought Hillary Clinton would do a better job than Bernie Sanders in restraining drug prices, by a margin of 60 percent to 25 percent. Independents, however, gave the edge to Sanders, 42 percent to 31 percent.

Both declared that the poll shows the public backs their solutions to rising drug prices.

“This new data underscores what Hillary Clinton has been saying for months: that we must get skyrocketing prescription drug costs under control so that families and seniors can keep more money in their pockets,” said Clinton campaign spokesman Ian Sams.

In a statement, Sanders said “we need to do everything we can to substantially lower drug prices. That means Medicare should be able to negotiate with the pharmaceutical companies for lower drug prices. That also means we should be able to import lower-cost drugs from Canada and Europe.”

On the Republican side, both Florida Senator Marco Rubio and Dr. Ben Carson have criticized the most widely publicized examples of high drug prices, and Texas Senator Ted Cruz and former Florida Governor Jeb Bush have proposed streamlining regulations by overhauling the Food and Drug Administration. Rubio and Cruz, declined to comment on the survey; Carson and Bush did not respond to requests for comment.

The poll suggests that the public hasn’t settled on a preferred option for dealing with high drug prices. There’s no strong party advantage on the issue, with 39 percent saying they have more confidence in Democrats to slow the growth of drug prices and 30 percent saying they have more confidence in the Republicans.

It also matters how potential government action on drug costs is framed. When it’s described as “price controls” under Medicare rather than “negotiating prices,” there’s a sharp drop-off in support among Republicans and senior citizens.

The difference is biggest with seniors — 71 percent of people age 65 and older support “negotiating prices,” but only 44 percent want “price controls.” That’s likely because they’ve had bad experiences with them, like the gasoline price controls in the 1970s that helped create long lines at gas pumps, said Blendon.

When given a choice of different options for dealing with extreme price hikes and the most expensive new drugs, Americans were divided between letting the government negotiate lower prices and approaches intended to promote competition: allowing people to import cheaper drugs from other countries — another proposal supported by the leading Democratic presidential candidates — and reducing regulations and letting the market work, the preferred Republican approach.

Government negotiations was the most popular option and importing drugs came in second. Reducing regulations was the least preferred option, with the support of 1 out of 5 Americans, but Republicans favored it more strongly than Democrats.

The options aren’t mutually exclusive, Blendon noted — people could have easily picked two out of three. Still, “most people don’t see making markets work as the first choice,” he said, so the survey suggests that Republican presidential candidates might have to consider more aggressive proposals too.

In follow-up interviews, people who participated in the poll expressed a common theme: They’re not sure what the best solution is — they just want the government to do something.

“I think it would probably be impossible to have the kinds of regulations that other countries have. It wouldn’t work here,” said Lintz. Still, she added, “we need to look at some of the models other countries are using.”

Even when they’re skeptical of government action, some people are open to it because of the recent news coverage of price hikes — and sometimes, their own experiences at pharmacies.

“Unbelievable. I can’t believe what they charge for some prescriptions,” said Mary Frieberg, an independent voter from Pittsburgh. She said she often sees big price variations for the same prescription drugs from one pharmacy to another.

Frieberg doesn’t want the government to get involved too deeply in drug prices: “They want their hand in it, and so that could make the price go up.” At the same time, though, she has heard of big price increases and wants the government to step in to prevent them, because “somebody has to do something about it.”

[“source-statnews”]

 

Pricey HCV Drugs Worth the Cost

Treating all patients with hepatitis C (HVC) genotype 1, fibrosis stages 0-4, with the expensive new drugs would be cost-effective compared with waiting until patients progress to stages F3 or F4, thanks to reductions in advanced disease complications and quality-of-life improvements, researchers reported.

Based on calculations from a patient simulation model, initiating treatment as early as possible, compared with stages F3 or F4, was cost-effective with 0.73 quality-adjusted life-years (QALYs) gained, and $28,899 per year, with an incremental cost-effectiveness ratio (ICER) of $39,475 per QALY gained, James G. Kahn, MD, MPH, of the University of California San Francisco, and colleagues, reported in JAMA Internal Medicine.

However, an early treatment strategy would also increase the aggregate costs, the researchers noted.

“Given an estimated 3 million U.S. patients with HCV, funding to treat every infected person immediately appears problematic,” Hal F. Yee Jr, MD, PhD, of the Los Angeles County Department of Health Services, wrote in an accompanying editorial. “Targeting those individuals at the greatest and most urgent risk for complications of HCV makes sense but only accomplishes a kind of triage.”

According to Yee, the American Association for the Study of Liver Diseases and the Infectious Disease Society of America (AASLD-IDSA) both recommend HCV treatment for patients at all stages of the disease, however those with the most severe stages, except those with limited life expectancy due to nonliver related conditions, should receive treatment first.

But with total spending on oral antiviral HCV treatment reaching $12 billion in 2014, as individual courses of treatment run close to $100,000, Yee suggested that policy and market initiatives to reduce the cost of medication would allow for widening the treatment population. “We must ensure also that as many individuals with HCV as possible are treated with available resources by driving efficiencies through innovation.”

“There is a current shortage of health professionals who are equipped to deal with the nuances of fibrosis staging, surveillance for disease-related complications (e.g., portal hypertension and hepatocellular carcinoma), and potential metabolic interactions between antiviral drugs and other prescription and nonprescription medications,” Steven D. Lidofsky, MD, PhD, of the University of Vermont College of Medicine. “Consequently, factors that exacerbate inequities in access to HVC treatment are likely to be amplified in economically disadvantaged areas and rural regions.”

ADVERTISEMENT

“Overall, I think that the manuscript is well written and the model that they developed was comprehensive and reasonable in an effort to determine cost-effectiveness of current direct-acting antiviral therapies in a disease that disproportionately impacts adults and baby boomers in our society and has been under the radar screen of the general public, Congress, etc. for decades with an overall prevalence four times that of HIV infection,” Robert John Fontana, MD, of the University of Michigan, said in an email to MedPage Today.

“The high price of each treatment course [per] patient has a lot of impact to patients, insurers, and society,” he added.

To analyze the implications of treatment at various stages of liver fibrosis, Kahn’s team created a simulation model comparing treatment cost for all treatment-naive patients with treatment for patients with advanced fibrosis. The model categorized treatment for each stage of fibrosis through the 5 METAVIR (Meta-analysis of Histological Data in Viral Hepatitis) liver fibrosis stages from no fibrosis (F0), portal fibrosis without septa (F1), portal fibrosis with rare septa (F2), numerous septa without cirrhosis (F3), and cirrhosis (F4).

Drug costs were based on 2015 wholesale acquisition price for 8 or 12 weeks of sofosbuvir-ledipasvir combo therapy.

The model assumed a single patient profile, and made projections for 1,000 patients based off data collected in 2014. Treatment duration were assigned based on baseline viral loads. Patients with less than 6 million IU/mL and no cirrhosis were assigned 8 weeks of treatment, and all the rest, as well as all F4 patients were assigned to 12 weeks. The patients were assumed to have been born in 1955 (age 60 at time to analysis), 75 kg, and aware of their HVC infection.

Kahn’s team found that the earlier patients were treated, the more cost-effective treatment became. Initiating treatment during stage F1 fibrosis was associated with $81,165 QALY gained compared with waiting until the patient progressed to F2, which added an extra $19,833 per QALY gained, compared with waiting until stage F3.

However, the earliest possible initiation of treatment, at stage F0, would result in $187,065 per QALY gained compared with waiting until the patient reached F1.

Kahn’s group did a 5-year estimate, and projected that treating 50% of all eligible HCV genotype 1 patients in the U.S. would cost $53 billion, though if the drug costs were reduced by 46%, that total treatment cost would drop to $29 billion. The cost of treating only F3 and F4 patients in this same model would run $30 billion for, which could drop to $16 billion if drug costs were reduced by 46%.

Kahn and colleagues argued that the $29 billion price tag could partially be offset by $3 billion in savings in the management of chronic HCV and advanced liver disease.

The researchers proposed that initiating treatment in the early stages of the disease would likely prevent advanced disease complications at risk for occurring in stages F3 and F4. The simulation model estimated that early treatment would avert 26% of liver transplant cases, 17% of decompensated cirrhosis cases, 27% of hepatocellular carcinoma, and 25% of deaths due to liver complications.

Kahn’s group reported several study limitations, including murky calculations around the impact of sustained virologic response (SVR) on disease progression and associated healthcare costs, and no calculations for how reducing the rates of HCV transmission could effect overall healthcare costs. Also, the simulation model used a single patient for the disease course model, and other model variables such adverse events and costs would likely not represent full treatment coverage in practice, they wrote.

“[T]he vast majority of payers currently restrict access to these medications to those with advanced liver disease, typically F3 and F4,” Joseph K. Lim, MD, of Yale Liver Center, said in an email to MedPage Today. “Patients with F0-F2 fibrosis are given the message that they must become sicker before they can undergo treatment when disease progression itself can be prevented.”

“Further evolution in drug pricing and discounting will likely be necessary to create meaningful expansion of drug access to patients with hepatitis C in the U.S.,” Lim said.

“This study has implications for third party payers, especially Medicaid programs which put restrictions on treatment of HCV on some of the most vulnerable patients,” Mamta Jain, MD, of UT Southwestern Medical Center in Dallas, said in an email to MedPage Today. “HVC treatment is costly, but this cost has to be balanced with the cost savings that is realized by reducing the number of complications of advanced liver disease. Treating hepatitis C at any stage of liver disease is cost-effective.”

None of the authors reported any relevant financial relationships with industry. Blue Shield of California Foundation and the California Health Care Foundation, the Clinical and Translational Sciences Institute, and the National Institute on Drug Abuse supported funding for this study.

[“source-medpagetoday”]

 

Doctors should prescribe generic drugs over branded medications, say experts

[Doctor writing a prescription]
The ACP say all doctors should prescribe patients generic drugs rather than branded drugs, where possible.

Conducted by members of the American College of Physicians’ (ACP) Clinical Guidelines Committee, the report is published in the Annals of Internal Medicine.

While the use of generic drugs has increased over time, the authors say that many health care providers continue to prescribe expensive brand-name drugs when cheaper generic alternatives are available – an issue that is likely to contributing to high health care costs; around $325 billion is spent on prescription drugs each year in the US.

By reviewing around 2,500 studies of prescription practices, the ACP assessed how often doctors prescribed brand-name drugs when generic alternatives were available.

The Committee also looked at how the prescription of generic medications affects treatment adherence, whether brand name and generic drugs produce similar clinical effects, what the barriers are to increasing use of generic medications and what can be done to overcome such barriers.

“The purpose of this article is to help guide internists and other clinicians in making high-value, cost-conscious decisions about the use of generic drugs,” the authors explain.

Generic drugs can be ‘just as effective as brand-name counterparts’

On assessing the frequency of brand-name drug prescription, the authors found that – as expected – health care providers often prescribe brand-name drugs over the generic equivalents.

They point to a 2008 study, for example, that found 23-45% of prescriptions for Medicare beneficiaries with diabetes were for branded medications that had generic equivalents.

Fast facts about prescription drug use

  • Around 48.7% of Americans have used at least one prescription drug in the past 30 days
  • More than 10% of Americans have used five or more prescription drugs in the past 30 days
  • In 2010, more than 75% of doctor’s visits results in a drug prescription.

Learn more about prescription drug use in the US

The authors estimated that for Medicare beneficiaries with diabetes alone, substituting brand-name prescription drugs for generic alternatives combined with therapeutic interchange – prescribing drugs that are chemically different but therapeutically similar – would save $1.4 billion.

The majority of peer-reviewed studies found that generic equivalents to brand-name drugs produced similar clinical outcomes, according to the authors, despite some physicians expressing concern that generic medications are less effective or cause more severe side effects.

“For example, a meta-analysis of 47 studies compared the effectiveness of generic and brand-name drugs in nine classes of cardiovascular medications and found no evidence of superiority of brand-name medication, including among anticoagulants and antiarrhythmics with narrow therapeutic windows,” they explain.

However, the ACP admit there are some situations where a brand-name drug may be more clinically appropriate than its generic alternative, or cases where prescribing an alternative is not possible.

The authors found that long-term adherence to treatment could be improved with increased prescription of generic medications, noting that prescriptions for branded medications are almost twice as likely to go uncollected after being filled than generic medications.

This is likely because brand-name drugs are significantly more costly than generic medications, though the authors note that the price of generic medications has been increasing recently.

Based on the findings of the report, ACP President Dr. Wayne J. Riley says:

“The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”

Concerns about safety, efficacy of generic drugs fueling underuse

The authors cite a national survey that found, while most patients believed generic drugs were cheaper and better value than brand-name drugs, only 36% of Americans said they preferred to use them.

They believe the underuse of generic drugs is likely fueled by patient concerns about their safety and efficacy, with many believing that because they are cheaper, they will be less effective.

“Differences in the physical appearance of molecularly identical generics and between generics and their brand-name counterparts could also influence patient perceptions of efficacy or safety; such variations in pill appearance have been associated with higher rates of nonadherence,” say the authors.

Physicians are also concerned about the safety and efficacy of generic medications, according to the report, with one survey finding that around a quarter of doctors preferred that themselves and their family did not use them. Such a perception means that many doctors are unlikely to prescribe generic medications to patients.

Recommendations to increase prescribing of generic medications

Given the improved treatment adherence and cost savings associated with use of generic medications over brand-name drugs, the ACP concludes.

[“source-medicalnewstoday”]

 

One dead, another critical after suspected drug overdoses at Stereosonic music festival in Adelaide

SA police said the above pills might be ‘related’ to the death. (Supplied)

A man has died and another is in a critical condition from suspected drug overdoses at Stereosonic music festival in Adelaide.

Police said the man received medical attention at the festival from paramedics around 5pm, but later died in Royal Adelaide Hospital.

Police said he was in possession of a number of pills and they believe he had taken an illicit substance.

Almost 11,000 people were at the Adelaide festival by 3pm. (9NEWS)

The second man fell ill around midday and was taken to hospital after a “medical episode”, where he remains in a critical condition.

The electronic music festival was taking place at Bonython Park in the West Parklands of the city.

The man’s death comes exactly one week after 25-year-old Oyster Bay pharmacist Sylvia Choi died after taking drugs at the music festival’s Sydney show.

A short time ago, festival organisers posted a statement on their Facebook page imploring people to “see the dangers”.

 

[“source-9news”]

More than 9 million Americans abuse drugs

[Illegal drugs]
Recent research generates some intriguing figures regarding drug use.

Drug abuse in America always has been and always will be a hot topic. Its heavy impact on the individuals concerned, their family unit and society at large needs no explanation.

It is well known that a myriad of factors impact on an individual’s propensity to abuse drugs.

An increase in unemployment, which has strong links to drug abuse, and the mass invasion of prescription opioid pain medication have all negatively influenced the arena of drug abuse in the US.

Bridget F. Grant, PhD, and her team at the National Institute on Alcohol Abuse and Alcoholism in Rockville, MD, investigated information taken from the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III).

The team specifically looked in detail at the prevalence and treatment of drug use disorders (DUDs) as described in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).

They poured over data taken from interviews with 36,309 adults, and the study focused on amphetamine, cannabis, club drug, cocaine, hallucinogen, heroin, nonheroin opioid, sedative/tranquilizer or solvent/inhalant use disorders.

Results of the investigation showed a level of prevalence that might, to many, be surprising: 3.9% of Americans – around 9.1 million people – had a 12-month DUD diagnosis, and 9.1% had a lifetime diagnosis.

Most affected sections of society

Specific sections of society were found to have an increased rate of DUDs. The following groups were most affected:

  • Men
  • White and Native American individuals
  • Young, and previously married or never married adults
  • Those with lower income and education
  • Individuals who live in the West of America.

The study also linked a number of other factors to 12-month DUDs, including:

  • Major depressive disorder
  • dysthymia (persistent mild depression)
  • Bipolar
  • Post-traumatic stress disorder
  • Personality disorders.

And, with lifetime DUDs, the following factors were added to that list:

  • Generalized anxiety disorders
  • Panic disorders
  • Social phobia.

The study found that individuals with a DUD diagnosis experienced lower social functioning, mental health and role emotional functioning.

Despite, or perhaps because of, the negative influence of DUDs on individuals, the research also found that the individual often went untreated.

Those with lifetime DUDs received treatment in 24.6% of cases; the 12-month DUDs received treatment in just 13.5% of cases. The average age of first treatment was 27.7 years, around 4 years after onset.

What can be taken from these findings?

The present study is the first of its kind since the 2013 update to the official DSM criteria for DUDs, and the update strengthened criteria for the diagnosis of DUDs. For instance, previously a diagnosis of substance abuse required only one symptom; in the updated version, a mild substance use disorder requires two to three symptoms.

The authors conclude:

“DSM-5 DUD is prevalent among US adults. The public is increasingly less likely to disapprove of specific types of drug use (e.g., marijuana) or to see it as risky, and consistent with these attitudes, laws governing drug use are becoming more permissive.

However, the present NESARC-III findings on disability and comorbidity indicate that DUDs, as defined by the new DSM-5 nosology, are serious conditions affecting many millions of Americans.”

The figures presented by the study make sobering reading, and a final caveat deepens the sobriety. Grant and her team acknowledge a limitation of the study; institutionalized individuals, such as those in prisons and active military service, were not included in the research.

The authors fear that their results could, in fact, underrepresent the true number of DUDs.

They conclude their research with a call to action; the widespread nature of DUDs elucidates the need for further investigation into areas such as the estimated cost of DUDs, their etiology and the causal factors involved.

“Findings also indicate an urgent need to destigmatize DUD and educate the public, clinicians, and policymakers about its treatment to encourage affected individuals to obtain help,” the researchers say.

Medical News Today recently published an article on the rise of prescription drug use in the US.

[“source-medicalnewstoday”]

 

RECEIPTS FROM BRITISH INDIA MAY FIGHT DRUGS TODAY

hundi for opium

Historical records from British India offer a new look at the economics of drug use—which can otherwise be difficult to study.

“You can’t simply go to Wal-Mart and look at the sticker price, and people don’t want to talk to you because drugs are illegal and they think they’ll get in trouble, ” says Siddharth Chandra, an economist and professor at Michigan State University.

“Our study is the first time the subject of how populations of consumers switch between drugs is being studied with data considered reliable.”

To find reliable economic data on drug use, Chandra, also the director of the university’s Asian Studies Center, had to look back to early 20th century India, when the region was still part of the British Empire.

“One hundred years ago these products were legal. In British India the government was actually selling these things to the public, and they kept meticulous records,” Chandra says.

weighing opium in India
(Credit: Shyamal via Wikimedia Commons)

In his study—the first of its kind—Chandra pored through stacks of 100-year-old ledgers, called Excise Administration Reports, kept by the governments of the various provinces of India. Interpreting these data, he found surprising results about the economics of drug use behaviors.

Despite the stark differences in the effects of opium vs. cannabis on the human body, the study shows that users would switch between the two drugs when the price of one went up—in economics, a phenomenon called substitution.

“The time, place, and context are different, but the phenomenon is there. You might think consumers would treat them differently,” Chandra says. “But just because the two drugs used are very different, doesn’t mean people won’t switch.”

[DRUG USERS DOUBLE UP ON HEROIN, PAINKILLERS]

Opium and cannabis have different effects on users, but those differences only came into consideration when analyzing cannabis in its weakest form, a drug called bhang, which consumers would not substitute for the more potent opium.

“There are many policy implications for these results,” Chandra says. “Targeting a particular drug with policies and enforcement might backfire.”

Chandra points to the epidemic of heroin, a product of opium that is relatively inexpensive and is devastating some communities in the United States.

“Many people know someone who has been affected by heroin—it is a very dangerous drug,” Chandra says. “But prohibiting harmful drugs selectively can be ineffective. Consumers may switch.”

Chandra worked on the project with Madhur Chandra, a postdoctoral fellow in the department of epidemiology and biostatistics, supported by the National Institute on Drug Abuse of the National Institutes of Health. The study appears in the journal Drug and Alcohol Dependence.

[“source-futurity”]