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Posts Tagged ‘patent

Science Policy Around the Web – June 23, 2017

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By: Saurav Seshadri, PhD

Drug Policy

Trump’s New Policy to Tackle Sky-High Drug Prices Makes Sense — Sort Of

Tackling high prescription drug prices was a repeated promise of the Trump campaign. The Trump administration has now taken its first step towards fulfilling this pledge, outlined in a blog post by Food and Drug Administration (FDA) commissioner Scott Gottlieb. The agency will pursue a Drug Competition Action Plan, whose goal will be to eliminate obstacles to the development of cheap generic drugs – particularly those caused by loopholes in existing FDA policies, which are exploited by pharmaceutical companies to extend their patent exclusivity period and maximize profits. An example of such ‘gaming’ the system, cited in the post, is the practice of limiting access to branded products for comparative testing by generic developers. Ultimately, the FDA will work closely with the Federal Trade Commission (FTC) to address such issues, since directly regulating business practices is outside its mandate.

On its face, the FDA’s effort is a step in the right direction. Availability of generics reduces the cost of medications by over half within the first year, and according to a recent Congressional report, manufacturers state that ‘competition…is the primary driver of generic drug prices’. However, it ignores evidence that the real driver of increased drug spending is new, branded medicines, not overpriced generics. In fact, early indications are that Trump’s policies will favor the pharmaceutical companies that produce such medicines, by reducing regulations and apparently abandoning his promise to enable the government to negotiate drug pricing through Medicare. Overall, these actions signal a commitment to promoting free market mechanisms in the pharmaceutical industry; time will tell whether this approach will actually lead to more affordable drugs. (Julia Belluz, Vox)

Cancer

In a Major Shift, Cancer Drugs go ‘Tissue-Agnostic’

With the landmark approval of Keytruda in May, the Food and Drug Administration (FDA) appears to have ushered in a new era of cancer drug development.  So far, cancer treatment and drug evaluation have largely used the tumor’s tissue of origin as a starting point. Keytruda (an immune system enabling drug developed by Merck and approved for melanoma in 2014) marked the first departure from this approach, receiving priority approval to treat any solid tumor containing a mutation in the mismatch repair pathway, regardless of context. Recently released data suggests that another tissue-agnostic cancer therapy is on the way: larotrectinib (a cell growth inhibitor developed by Loxo Oncology) showed high efficacy for any tumor with a certain biomarker (TRK fusion). Several other such drugs, whose indications will be based on tumor genetics rather than location, are in the clinical pipeline.

Although these advances have generated significant excitement in the cancer community, some caveats exist. First, identifying the patients that could benefit from tissue-agnostic treatments will require individual initiative and depend on the cost of screening, particularly when considering markers that are rare for a certain tumor type. A potential solution is suggested by the NCI-MATCH trial, part of the NIH’s Precision Medicine Initiative (PMI) – in it, patients can enroll in one of several parallel clinical trials if a corresponding drug-targeted mutation is found in their tumor’s genome. If these trials prove effective, patients could eventually be regularly matched with a personalized, tissue-agnostic, biologically valid treatment, based on a standardized screen.  Second, researchers caution that tissue-agnostic studies should have a strong scientific rationale and/or breakthrough-level efficacy. Otherwise, such efforts ‘could actually slow drug development if there are differential effects across tumor types by diverting resources from enrolling patients in a predominant population or in the tumor type most likely to respond’.

Despite these concerns, the tissue-agnostic paradigm offers great promise for cancer patients. NIH-funded resources such as The Cancer Genome Atlas could be invaluable to this field moving forward. (Ken Garber, Science)

Scientific Publishing

US Court Grants Elsevier Millions in Damages from Sci-Hub

A New York district court has awarded academic publishing giant Elsevier $15 million in damages from Alexandra Elbakyan, founder of the website Sci-Hub, for copyright infringement. Elbakyan, a 27-year-old neuroscientist turned programmer, started Sci-Hub in 2011 with the goal of ‘remov[ing] all barriers in the way of science’. The site allows users to download research papers that would normally be blocked by a paywall, by obtaining credentials from subscribing institutions and using them to access publisher-run databases like ScienceDirect. Over 60 million papers are posted on Sci-Hub, and users downloaded 28 million articles in 2016.

Elbakyan’s case is reminiscent of Aaron Swartz, another high-profile champion of open access to scientific research. Faced with federal charges related to his hacking of journal archive JSTOR, Swartz tragically committed suicide in 2013. Both Elbakyan and Swartz found publishers’ ability to profit from restricting access to scientific literature, effectively withholding knowledge from anyone outside of a privileged inner circle, as well as the legal protection provided to this system, to be deeply unethical. Their willingness to act upon these convictions has earned each a sizable following in the scientific community.

For their part, publishers claim that fees go towards overhead, and point to significant efforts to expand free and open access programs. While judges have so far been sympathetic, Elsevier’s legal battle has been largely one-sided. Elbakyan has been ignoring rulings requiring her to shut down Sci-Hub since 2015, opting to simply change domains instead, and since she is currently based in Russia and has no American assets, she is unlikely to pay any damages. (Quirin Schiermeier, Nature News)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

June 23, 2017 at 11:00 am

Science Policy Around the Web – May 8, 2015

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By: Cameron J. Schweitzer, Ph.D.

Consumer Product Regulations

Nut So Fast, Kind Bars: FDA Smacks Snacks On Health Claims

In a letter dated March 17, the FDA stated that the snack food company Kind violated labeling rules by putting the word “healthy” on the packaging of some of its bars. The rules in question are the requirements the FDA places on foods that may be deemed healthy. For instance, “healthy” must contain 1 gram or less of saturated fat, which was not the case for some of the bars Kind produces.

The main problem seems to stem from the nuts used in the bar (in this case almonds). Almonds are considered high fat nuts and are the source of a majority of the saturated fats found in the Kind bars. Now many experts are speaking up and defending Kind and claiming that research has confirmed the health benefits of almonds.

For instance, Dr. David Katz wrote in his blog on the Huffington Post that “the failure of one-size-fits-all-regulation to, in fact, fit all; and the ineluctable law of unintended consequences. “ He goes on to claim that the same standard threshold for saturated fat would preclude calling salmon, hummus, and avocado “healthy.” A second nutrition expert, Walter Willet, has also chimed in saying “They’re [almonds] probably one of the healthiest choices you can make in a diet.” Willet goes on to say that the FDA’s letter is based on outdated guidelines when it comes to nuts. It’s likely the agency needs to update its guidelines to be in-line with research pertaining to almonds and nuts in general.

The company responded saying they will be changing the labels for the four bars mentioned in the letter as well as reviewing its entire line to ensure that it complies with FDA regulations. Of note, the word “healthy” has been on the label since 2004, but has only recently experienced a growth in sales. (Poncie Rutsch, NPR)

Patenting and Biotechnology

Patent debate heats up over CRISPR/Cas9 technology

The CRISPR/Cas9 genome editing technology has tremendous potential for human health and on April 15, 2014, a patent to edit eukaryotic genomes was awarded to Feng Zhang of the Broad Institute and MIT. However, Jennifer Doudna of the University of California, Berkley and Emmanuelle Charpentier at the Helmholtz Center for Infection Research in Germany, who first published on this system, filed a similar patent seven months earlier than Zhang. Zhang’s was accepted earlier because he filed for a fast-track patent, which was awarded just a mere six months after submission.

Now that Zhang’s patent is official there are three possible scenarios for the Doudna/Charpentier submission. First, the patent may not be granted without significant revisions that could limit the current scope of the application. Second, the patent that is still under review may be granted and consequently invalidate some of Zhang’s prior claims and diminish his current advantage. The last option includes a rejection of the Doudna/Charpentier application and likely a lengthy patent dispute in court. Realistically, it could be upwards of 3-5 years before this quarrel is fully resolved.

Despite the patent free-for-all several companies have been built entirely around the idea of using this technology to improve human health. Feng Zhang co-founded his own company called Editas Medicine, while Doudna and colleagues created Caribou Biosciences. Additionally, other startups are hoping to harness this tool by moving forward regardless of the outcome. Nessan Bermingham, CEO of Intelia Therapeutics sums it up by saying “We all need to be pragmatic and understand that our priority here is patients, we’re not here to fight about IP.” (Jenny Rood, The Scientist)

Communication Policy

UK scientists outraged by policy change that may prevent contact with the media

In the middle of March, the United Kingdom’s Parliament amended the Civil Service Code to prevent all civil servants from speaking with the media without ministerial authorization. However, there is now confusion as to whom this applies to and many within the government offices are asking for clarification. It is also unclear if this rule change will alter business as usual. Although Fiona Fox, the chief executive of the Science Media Centre claims that several scientists have already declined press interviews as a result of the rule change.

In a letter to the cabinet secretary, Francis Maude, science organizations expressed deep concerns over the change. Many feel it will leave the public far less informed than before and could have a negative impact on the public understanding of science. In response, the cabinet office has stated that individual departments could apply for exemption to get around the new amendment. (Ian Sample, The Guardian)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

May 8, 2015 at 4:06 pm

Posted in Linkposts

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