DocuBase Article: Trading Away Access to Medicines – Revisited

DocuBase Article: Trading Away Access to Medicines – Revisited.

From the abstract

Tuesday, 13th January 2015
Trading Away Access to Medicines – Revisited
Source: Oxfam International

From Summary:

The failure of the current pharmaceutical research and development (R&D) system is revealed by the World Health Organization (WHO) alert about the lack of effective medicines to address antimicrobial resistance, and the absence of a treatment for the deadly Ebola virus that is ravaging communities in West Africa at the time of writing.

While low- and middle-income countries (LMICs) have being suffering from a lack of access to medicines for years, European public health systems have become unable to bear the burden of expensive new medicines. The rise of non-communicable diseases (NCDs) is affecting all people, but is more acutely hitting developing countries that are still struggling with the unfinished business of communicable diseases. Meanwhile, European health systems, badly hit by austerity measures, are under pressure to deliver more with less money, against a backdrop of rising medicine prices.

The European Union (EU) could play a leading role in improving pharmaceutical innovation and access to medicines around the world. However, the European Commission (EC) has implemented a trade agenda that favours the commercial interests of the multinational pharmaceutical industry over the health of people in LMICs. Such trade policies have triggered an outcry from European citizens, experts and organizations, who are asking for the public interest to be prioritized in trade discussions.

Opening statement

[Journal article] How Basic Scientists Help the Pharmaceutical Industry Market Drugs

Excerpt from the December 2013 PLoS article by Adriane Fugh-Berman 

In the 1970s, a Baltimore city senator who also owned a tavern backed legislation that helped his business. Accused of having a conflict of interest, Joseph J. Staszak, responded, “What conflict of interest? How does this conflict with my interest?” [1].

According to the Institute of Medicine, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence” [2]. More simply, conflicts of interest may be seen as circumstances in which “individuals’ professional responsibilities diverge from their personal interests (or when different professional responsibilities clash)” [3].

In biomedicine, discourse on conflicts of interest (also called competing interests) has focused on relationships between industry and physicians or clinical researchers. However, basic scientists are not immune to industry influence on research and publications, and may be important to industry in the production and dissemination of marketing messages.

Depending on Industry

In 2007, industry was the largest funder of biomedical research, paying for nearly twice as much research (58%) as the federal government (33%) [4]. Most of this funding goes to clinical research; the share of spending by pharmaceutical and device industry on preclinical research has decreased from about half (55%) in 1998 to a quarter (25%) in 2010 [5]. A 2007 survey of 3,080 academic life science researchers found that half (53%) have some form of relationship with industry [6]. Among the 1,663 research faculty at academic medical centers, 42% of basic scientists had a relationship with industry. This number was similar to health services researchers/clinical epidemiologists (40%), but less than clinical researchers (67%) translational researchers (61%), or “multimodal” researchers (71%) [7]. At the 50 universities that received the most NIH research funding, 43% of 2,167 life science researchers reported receiving a research-related gift in the late 1990s [8]. Gifts included biomaterials (24% of respondents), discretionary funds (15%), equipment (11%), travel funds to professional meetings (11%), student support (9%), and other (3%).

Researchers were aware that something was expected in return for the gift. Sponsor expectations that the gift be used for its intended purpose and not be re-gifted, and that the sponsor be acknowledged in publications, are certainly reasonable. Disturbingly, however, about a third (32%) of gift recipients reported that the funder wanted prepublication review of any articles or reports stemming from the use of the gift. This expectation was higher for gifts of biomaterials: 40% of respondents reported that the firm wanted to receive prepublication review of articles or reports. Also, 44% of firms wanted assurances that the biomaterial was not to be used for applications that competed with company products [8].

Industry Funding Affects Results

In clinical research, investigators who receive industry funding are more likely to publish results that favor a sponsor’s marketing goals than are investigators who do not receive industry funding. The Cochrane Collaboration, renowned for creating and publishing high-quality systematic reviews, analyzed 48 clinical studies, systematic reviews, and meta-analyses that compared results from studies of drugs or medical devices based on sponsorship. This systematic review found that industry-sponsored studies, compared to non-industry-sponsored studies, were more likely to report favorable efficacy results for drugs or medical devices; less likely to find harms; and more likely to conclude that a therapy was beneficial [9].

…

Selective Publication

Selective presentations and publications are important tactics for industry. Industry relies on abstracts and posters to convey marketing messages at scientific meetings, because abstracts and posters are usually not peer-reviewed and can be easily altered up to the time of presentation. Posters and abstracts are often used for preclinical studies, case reports, or preliminary results of clinical trials. Promising preliminary results might be presented as a poster, and the results may be publicized, but if the final results of the study do not support commercial goals, the full study may never be published – or may be buried in an obscure, low-impact journal. In either case, scientists may have a positive impression of a therapy from a poster, and never learn that the therapy failed to show efficacy in the final study.

…

Perhaps because negative outcomes from industry-funded studies are less likely to be submitted for publication, industry-funded clinical trials overall are less likely to be published. An analysis of 546 drug trials listed in ClinicalTrials.gov found that within two years of study completion, about a third of studies that received full (32%) or partial (39%) industry support were published. In contrast, more than half (54%) of trials funded by government, and 56% of trials funded entirely through nonprofit/nonfederal funds, were published [19].

The majority of meeting abstracts and posters are never published. Posters and abstracts with positive results are far more likely to be published than negative studies [14],[15].

..

Once a drug is on the market, it can be prescribed “off-label” – that is, for any condition other than that for which the drug was approved. Although it is legal for physicians and other prescribers to prescribe a drug off-label, it is illegal for pharmaceutical companies to promote drugs off-label. Off-label use is common, accounting for about one in five prescriptions [23]. It is unknown how much off-label use is due to promotion.

Pharmaceutical companies use paid speakers, consultants, and researchers to promote off-label use [24].

,,,

Companies have paid billions of dollars in fines for off-label promotion, often using company-generated research, company-paid speakers, and ghostwritten articles to imply clinical benefits in the absence of clinical trials (or the presence of negative trials); fines have also been imposed for suppressing risks or misleading clinicians about risks [34].

…

Read the entire article here

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The Cause of the Productivity Crisis in Pharmaceutical R&D; the CBCD Draws Conclusions from a Recent Example

Excerpt from the 15 October 2013 report

The Cause of the Productivity Crisis in Pharmaceutical R&D; the CBCD Draws Conclusions from a Recent Example (PRWeb)

“The pharmaceutical industry is experiencing a productivity crisis in R&D. What is this crisis? First, every year, the pharmaceutical industry is introducing fewer new drugs. Second, a portion of the FDA approved drugs are withdrawn from the market. Third, an analysis of Drugs.com shows that all other FDA approved drugs have many side effects.

What is the source of the productivity crisis?

A compelling explanation is offered in a paper published on March, 2012 in the medical journal Nature Reviews. The paper said that “Much of the pharmaceutical industry’s R&D is now based on the idea that high-affinity binding to a single biological target linked to a disease will lead to medical benefit in humans. Indeed, drug-like small molecules tend to bind promiscuously, and this sometimes turns out to have an important role in their efficacy as well as their so-called off-target effects. Targets are parts of complex networks leading to unpredictable effects, and biological systems show a high degree of redundancy, which could blunt the effects of highly targeted drugs (2).”

In simple terms, the idea that a drug binds with only one target is wishful thinking. As it turns out, every drug binds with many targets in the body, the desired one, and many others. Binding to the ‘other’ targets usually causes all the unwanted, surprising, side effects. [my emphasis]

“The CBCD believes that the current understanding of biology is limited and therefore, the Single Target paradigm is bound to fail.” – Greg Bennett, CBCD” “

 

Drug Side Effects Successfully Predicted By Computer Model (with Fast Stats on Drug Failure Rates)

Cost efficient way to develop safer compounds

 From the 13 June 2012 Medical News Today article

A new set of computer models has successfully predicted negative side effects in hundreds of current drugs, based on the similarity between their chemical structures and those molecules known to cause side effects, according to a paper appearing online this week in the journal Nature. …

Drugs frequently interact with more than one target, with hundreds of these targets linked to the side effects of clinically used therapeutics. Focusing on 656 drugs that are currently prescribed, with known safety records or side effects, the team was able to predict such undesirable targets – and thus potential side effects – half of the time.

That’s a significant leap forward from previous work, which has never tackled hundreds of compounds at once, according to Brian Shoichet, PhD, a UCSF professor of pharmaceutical chemistry who was the joint advisor on the project alongside Laszlo Urban, MD, PhD, at Novartis.

As a result, it offers a possible new way for researchers to focus their efforts on developing the compounds that will be safest for patients, while potentially saving billions of dollars each year that goes into studying and developing drugs that fail. …

…

Drug Failure Rates

• Estimated cost of bringing a drug to market: $1.2 billion
• Only one in 5,000 drug candidates that enter preclinical testing ever reaches the market
• For every five drugs that start clinical trials, only one succeeds
• Of the 4,300 companies engaged in drug innovation, only 6% (261) have registered a new drug since 1950.
• Worldwide, the pharmaceutical industry spends $50 Billion per year on R&D, but produces only 21 new drugs per year (2008)
  

  A Side Effect of Vicodin (Photo credit: thehoneybunny)

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