Tag: pharmaceuticals

Categories : Ethics and Law Medical IndustryTags :

Systematic Bias in Industry-sponsored Cost-effectiveness Studies

On By ModernMedia
Photo by Marek Studzinski on Unsplash

Industry-sponsored studies on a new drug or health technology are more likely to be found ‘cost-effective’ than independent studies, across a range of diseases, according to findings from a study published in The BMJ.

In a linked editorial, experts make a call for better reporting of results, more transparency, open-source cost-effectiveness models, and more independent studies, to reduce decision makers’ reliance on potentially biased cost-effectiveness analyses.

A cost-effectiveness analysis (CEA) provided the manufacturer is required by some countries to weigh up a product’s costs and effects.

This cost analysis evidence can be used to set the price for a drug or health technology or decide whether insurance policies will cover them. New drugs covered by insurance plans can be much more profitable than those not covered, which could lead to bias in CEAs funded by the drug and technology manufacturing industry.

While previous studies have consistently shown sponsorship bias in CEAs, most studies were limited to specific diseases, and are out of date. To fill in the gaps, Feng Xie and Ting Zhou from McMaster University, Canada, analysed data from all eligible CEAs published between 1976 and March 2021. 

They selected CEAs that reported an incremental cost-effectiveness ratio (ICER) using quality-adjusted life years or QALYs – a ‘value for money’ metric of years lived in good health.

The authors used data from the Tufts Cost-Effectiveness Analysis Registry. In total, 8192 CEAs were included in the study, of which nearly 30% were sponsored by industry. 

The study defined CEA industry sponsorship as an analysis funded by drug, medical device, or biotechnology companies, either wholly or in part. 

The results show that the industry-sponsored CEAs were significantly more likely to conclude that the new medicine or health technology was cost-effective than those not sponsored by industry.

For example, industry-sponsored studies were more likely to report the intervention being studied as cost-effective below the commonly used threshold of $50 000 per QALY gained than non-industry sponsored studies.

Among 5877 CEAs that reported the intervention was more effective but more expensive than the comparator, the ICERs from industry sponsored studies were one third (33%) lower than those from non-industry sponsored studies.

While only having the registry information to work with was a limitation, the authors said their analysis provides a basis for comparison with previous investigations.

As such, they suggested that “sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs.”

In lower and middle-income countries, industry bias can increase drug prices, where fewer resources mean decision-makers often need to rely on published, rather than independent CEAs. 

In a linked editorial, Adam Raymakers at Cancer Control Research, Canada, and Aaron Kesselheim at Brigham and Women’s Hospital, USA, argue that decision-makers “should exercise caution when using published cost-effectiveness analysis in coverage decisions.”

They say finding solutions to tackle bias is more important than ever, and make the case for open-source analysis models, increased transparency, and increased funding for independent analyses, to help minimise reliance on industry-sponsored cost analyses.

Source: The BMJ

Categories : Ethics and Law Medical IndustryTags :

‘Extensive Network’ of Opaque Medical Industry Ties

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Image: Pixabay CC0

A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!

Categories : Ethics and LawTags :

Pharmaceutical Companies Score Weak on Data Transparency

On By ModernMedia
Source: Carlos Muza from Unsplash

Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.

The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.

The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.

“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.

“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”

From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary.
In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.

For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.

Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures

“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”

The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.

Source: Yale University

Journal information:  Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb

Categories : New Compounds and TreatmentsTags :

Harnessing Magnetic Fields to Produce Safer and Cheaper Medicines

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An image of ferrofluid reacting to a magnetic field. Photo by Etienne Desclides on Unsplash

By using magnetism to eliminate unwanted ‘mirror’ counterparts inherent to the production of certain medications, they could be made safer and produced more cheaply, according to new investigations underway at Texas A&M University.

Everyday drugs, such as ibuprofen, may have an inherent flaw in their molecular structure, pairing the active, beneficial ingredient with a potentially ineffective, or even toxic, ‘mirror’ counterpart, due to being of the wrong chirality, or structural twist. New research using electromagnetic fields could help keep the effective ingredients while eliminating the unwanted counterparts. Chirality is already an important consideration in the development of new drugs.

Dr. Shoufeng Lan, assistant professor in the J Mike Walker ’66 Department of Mechanical Engineering at Texas A&M University, is leading a team investigating the use of electromagnetic control over the synthesis of chiral compounds — a technique which could open up a host of applications including in the pharmaceutical industry.

“Mysteriously, all living organisms on the Earth consist of only left-handed amino acids and right-handed sugars, but not their mirrored counterparts,” Prof Lan said. “The phenomenon is the so-called homochirality of life and it is the ultimate form of asymmetric synthesis.”

Prof Lan gave the example of a human hand to demonstrate the concept of chirality, noting that if you created a mirror image of your hand, it could not be perfectly superimposed over the original.

By identifying a successful method of using asymmetrical synthesis to create new versions of structures for items like ibuprofen, Prof Lan said that improved versions of generic pharmaceuticals with reduced toxicity could be produced at a lower cost than currently available due to the current purification process.

However, to achieve success, the researchers will first need figure out how to implement this magnetic effect on asymmetric synthesis at practical temperatures. The effect is currently fairly weak, even using a powerful magnetic field or at a temperature as low as -268°C.

Prof Lan noted that the 2001 Nobel Prize in chemistry’s topic was addressing chirality, which uses an existing chiral object—a catalyst molecule—to transfer chirality to the desired mirror image form as the final product.

“This Nature Communications paper demonstrated a giant atomic-scale magneto-chiral effect that is orders of magnitude stronger,” Prof Lan said. “By applying this effect, it is arguably possible to master an asymmetric synthesis or asymmetric self-assembling.”

Prof Lan said his team’s research could revolutionise the field by creating a new iteration of biomedical, chemical and pharmaceutical applications. For example, by asymmetrically synthesising only the active component of racemic Lexapro (the most common medication in the US with more than 25 million prescriptions) the research might reduce the drug’s side effects.

“We anticipate that our demonstration could lead to the creation of chiral seeds at the atomic scale,” Prof Lan said. “Upon them, we hope to transfer the chirality using cutting-edge technologies, such as a metal-organic framework, to create chiral materials from nanoscales to macroscales.”

Source: Phys.org

Journal information: Shoufeng Lan et al, Observation of strong excitonic magneto-chiral anisotropy in twisted bilayer van der Waals crystals, Nature Communications (2021). DOI: 10.1038/s41467-021-22412-9

Categories : Expert Opinion Medical IndustryTags :

Like 60s Cars, Brand Drugs Have no Price Competition

On By ModernMedia

Brand name drugs, like American cars in the 1960s, are subject to broadly rising prices with little evidence of competing on cost.

Before the oil embargo by Arab countries in 1973 allowed competition from more affordable, fuel efficient cars that we take for granted today, the Big Three car manufacturers, Ford, Chrysler and General Motors, would annually announce price increases at about the same time. Any adjustment by one manufacturer, for example, in size, was quickly matched by competitors.New research analysed the prices for five classes of drugs, and found them to be increasing in lock-step from 2015 to 2020. These classes are direct-acting oral anticoagulants (DOACs), P2Y12 inhibitors, glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl dipeptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein-2 (SGLT-2) inhibitors.

The study had limitations due to not taking into account measures such as rebates, which would affect the price for the patient. However, even if these were taken into consideration, the researchers believe the overall prices would still increase and have to be borne by some patients who would not benefit from certain rebates. “Rebates, list prices, and net prices have been growing for brand-name medications, and rebate growth has been shown to positively correlate with list price growth, thereby impacting costs faced by patients paying a percentage of (or the full) list price,” the researchers noted. “Therefore, the lock-step price increases of brand-name medications, without evidence of price competition, raise concerns and would be expected to adversely affect patient adherence to medications and thus clinical outcomes.”

Unlike the oil crisis which broke open the automobile market to foreign competitors, the solution with “Big Pharma” is less clear. The researchers recommend policies which would limit such lock-step price increases, reduced patent exclusivity periods, and quicker introduction of generic equivalents.

Source: MedPage Today

Journal information: Liu P, et al “Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020” JAMA Netw Open 2021; DOI: 10.1001/jamanetworkopen.2020.35064.