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Posts Tagged ‘generic drugs

The Economic Impact of Biosimilars on Healthcare

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By: Devika Kapuria, MD

          Biologic drugs, also defined as large molecules, are an ever-increasing source of healthcare costs in the US. In contrast to small, chemically manufactured molecules, classic active substances that make up 90 percent of the drugs on the market today, biologics are therapeutic proteins that undergo production through biotechnological processes, some of which may require over 1000 steps. The average daily cost of a biologic in the US is $45 when compared with a chemical drug that costs only $2. Though expensive, their advent has significantly changed disease management and improved outcomes for patients with chronic diseases such as inflammatory bowel disease, rheumatoid arthritis and various forms of cancer. Between 2015-2016, biologics accounted for 20% of the global health market, and they are predicted to increase to almost 30% by 2020. Worldwide revenue from biologic drugs quadrupled from US $47 billion in 2002 to over US $200 billion in 2013.

The United States’ Food and Drug Administration (FDA) has defined a biosimilar as a biologic product that is highly similar to the reference product, notwithstanding minor differences in clinically-inactive components, and for which there are no clinically meaningful differences between the biologic product and the innovator product in terms of safety, purity and efficacy. For example, CT-P13 (Inflectra) is a biosimilar to infliximab (chimeric monoclonal antibody against TNF-α) that has recently obtained approval from the FDA for use of treatment of inflammatory bowel disease. CT-P13 has similar but slightly different pharmacokinetics and efficacy compared to infliximab. With many biologics going off patent, the biosimilar industry has expanded greatly. In the last two years alone, the FDA approved 4 biosimilar medications: Zarxio (filgrastim-sndz), Inflectra (infliximab-dyyb), Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto).

Unlike generic versions of chemical drugs (small molecules that are significantly cheaper than their branded counterparts), the price difference between a biosimilar and the original biologic is not huge. This is due to several reasons. First, the development time and cost for biosimilars is much more than for generic medications. It takes 8-10 years and several hundred million dollars for the development of a biosimilar compared to around 5 years and $1-$5 million for the generic version of a small molecule drug. With only single entrants per category in the US, biosimilars are priced 15-20% lower than their brand name rivals, which, though cheaper, still amount to hundreds of thousands of dollars. By the end of 2016, the estimated global sales from biosimilars amounted to US $2.6 billion, and nearly $4 billion by 2019. Estimates for the cost savings of biosimilars for the US market are variable; the Congressional Budget Office estimated that the BPCI (Biologics Price Competition and Innovation) Act of 2009 would reduce expenditures on biologics by $25 billion by 2018. Another analysis from the Rand Corporation estimated that biosimilars would result in a $44.2 billion reduction in biologic spending between 2014 and 2024.

In the United States, a regulatory approval pathway for biosimilars was not established till the Patient Protection and Affordable Care Act of 2010. However, biosimilars have been used in Europe for over a decade, and this has led to the development of strategies for quicker adaptation, including changes in manufacturing, scaling up production and adapting to local healthcare policies. These changes have led to a competitive performance of biosimilars in the European market, with first generation biosimilars taking up between 50-80% of the market across 5 European countries, with an expected cost savings of $15 to$44 billion by 2020. One example that demonstrates a significant discount involves the marketing of Remsima, a biosimilar of Remicade (infliximab). In Norway, an aggressive approach towards marketing of Remsima was adopted with a 69% discount in comparison to the reference product. After two years, Remsima has garnered 92.9% of the market share in the country.

The shift to biosimilars may be challenging for both physicians and patients. While safety concerns related to biosimilars have been alleviated with post marketing studies from Europe, there still remains a significant lack of awareness about biosimilars amongst healthcare providers, especially about prescribing and administering them. Patient acceptance remains an important aspect as well, with several patients loyal to the reference brand who may not have the same level of confidence in the biosimilar. Also, like with generics, patients may believe that biosimilars are, in some way, inferior to the reference product. Increased reporting of post marketing studies and pharmacovigilance can play a role in alleviating some of these concerns.

In 2015, the FDA approved the first biosimilar in the US, after which, it has published a series of guidelines for biosimilar approval, under the BPCA act, including demonstrating biosimilarity and interchangeability with the reference product. This includes a total of 3 final guideline documents and 5 draft guidance documents. Starting in September 2017, the World Health Organization will accept applications for prequalification into their Essential Medication list for biosimilar versions of rituximab and trastuzumab, for the treatment of cancer. This program ensures that medications purchased by international agencies like the UNICEF meet standards for quality, safety and efficacy. Hopefully, this will increase competition in the biosimilar market to reduce price and increase access to medications in low-income countries.

Both human and economic factors need to be considered in this rapidly growing field. Increasing awareness among prescribers and patients about the safety and efficacy of biosimilars as well as improving regulatory aspects are essential for the widespread adaptation of biosimilars.

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July 19, 2017 at 10:42 am

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)

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June 23, 2017 at 11:00 am

Science Policy Around the Web – October 27, 2015

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By: Amy Kullas, Ph.D.

Drug pricing

After the price gouging by Turing, competitor announces it will offer $1 pill

Martin Shrkeli became infamous after he became CEO of Turing Pharmaceuticals and skyrocketed the price of a Daraprim pill, used to treat toxoplasmosis, from$13.50 to $750, a price hike of over 5000%! At that price, the Infectious Diseases Society of America had estimated that it would cost $336,000/year to treat a patient with toxoplasmosis. Turing acquired marketing rights for Daraprim from Impax Laboratories in August for $55 million; though it had initially been made and sold by GlaxoSmithKline for $1 a pill. The United States has no price control on medicines even though in they are common in Europe.

This move by Shrkeli and the news that other drug makers have bought the rights to old, cheap medicines that are the last resort for serious diseases subsequently raising prices has not only angered patients and physicians. It has triggered government investigations, heavy scrutiny by the media and a plunge in biotech stock prices, as well as becoming a political talk point in the upcoming election to fight “price gouging”.

However, there is a new player in the field. Imprimis Pharmaceuticals announced that it can make a ‘close, customized version’ of Daraprim for about $1 per pill. A current caveat is Imprimis’ formulation itself is not FDA approved, and can only be used when prescribed by a doctor for a particular patient. Imprimis CEO, Mark Baum, released the following statement that “Imprimis is forming a new program called Imprimis Cares which is aligned to our corporate mission of making novel and customizable medicines available to physicians and patients today at accessible prices.” (Maggie Fox, NBC news)

Infectious Diseases

Yersinia pestis has been plaguing humans for over 3000 years

In a recent article published in Cell, Rasmussen et al. published that the plague-causing bacteria Yersinia pestis (Y. pestis) DNA was found in human teeth from Asia and Europe dating from the Bronze Age or ~2500-5000 years ago. This is well before any record of plague. These scientists examined over 100 human skeletons and found that the teeth in seven tested positive Y. pestis DNA. The oldest skeleton was 5783 years old! The authors suggest, “plague may have shaped early human populations.” Their data implies that Y. pestis did not become the flea-borne mammalian pathogen it is today (by acquiring the ymt gene), until sometime in the first millennium BC, well before the historically recorded plagues. (Simon Rasmussen, et al, Cell and James Gallager, BBC News website)

Global Health/Infectious Diseases

Interview with Margaret Chan, director general the World Health Organization

On October 14, 2015, Kai Kupferschmidt, a contributing correspondent for Science, had the opportunity to interview the director general of the World Health Organization, Margaret Chan.  The previous week was the first week that there was not a single new case of Ebola reported. This Ebola outbreak has killed over 11,000 people in almost two years.

During the course of the interview, two discussed many aspects of the current outbreak, including the lack of an initial response and how critical it is to get proper resources to those who need most. She stressed that countries impacted by an outbreak should report the disease while countries not affected by the outbreak should not impose their own trade or travel restrictions other than those recommended by the WHO. Chan has said to the WHO’s member states, “If you want WHO to be strong and fit for purpose, keep your promises. Put your money where your mouth is.”

Unfortunately, the WHO reported two new cases of Ebola in Guinea only two days after the interview on October 16, ending a two-week period in which no new cases had been detected across West Africa. The WHO does not consider a region Ebola-free until 42 days, or double the potential incubation time, have passed without a new case. The other two countries, Liberia and Sierra Leone, which were also heavily impacted by this outbreak, are further out from their last reported cases: Liberia is has met the deadline and is considered Ebola-free, while Sierra Leone is over halfway through the 42 day time period. The 42-day guideline may in fact be just that ‘a guideline’ as the Ebola virus has been isolated from seminal fluid 82 days after symptom onset. (Kai Kupferschmidt, Science)

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October 27, 2015 at 9:00 am

Science Policy Around the Web – May 12, 2015

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By: Daniël P. Melters, Ph.D.

Image credit: money faucet from Gts/Shutterstock

Science Funding

Uncertainly about science funding in the UK after Tories win elections

An outright victory for the Tories (conservatives) in the recent general election in the United Kingdom was unexpected based on poll-results. This means an end to the previous governing coalition and five more years for David Cameron as Prime Minister. One question that remains is what will this change in power mean for science in the UK? One of the spear points of the Tories’ program are austerity measures to reduce the deficit ($46B). Notably, no promise was made to protect science funding, even after five years of a frozen science budget. In addition, a high turnover of Members of Parliament (MP) and loss of MPs who favor science in combination with the rise of the Scottish National Party is suspected to result in policy focused on regional projects. The biggest fear is the the upcoming referendum on whether the UK will stay in the European Union (EU). Leaving the EU would be a major set-back for UK science research as about 20% of its science funding comes from the EU. The new Minister for Universities and Science is Jo Johnson, the brother of London Mayor Boris Johnson. Although not much is known where he stands on the topic of science and research, Mr. Johnson is thought to be supportive of the EU and he as spoken out on the importance of allowing students to come to the UK.

At the same time, fellow EU-member Greece has decided to use the money allocated for funding Greek science for paying for public salaries and the US House Science Committee in the US has suggested to cut NASA’s earth science budget. On the other hands, some in US congress have called for a doubling of the NIH budget, making this a very volatile time for scientific research funding around the globe. (Elizabeth Gibney, Nature News)

Global Health

Liberia is Ebola free as complications for survivors become apparent

In December 2013, one-year Emile Ouamouno died in a small village in Guinea. This is believed to be patient zero for the current Ebola epidemic in West Africa. Over 14 thousand laboratory-confirmed cases (and many more suspected) have been reported to date and 11 thousand people have died. The last confirmed case of Ebola in Liberia was on March 28th, 2015. On May 9th the World Health Organization (WHO) declared Liberia Ebola-free, the first of the three principally affected countries to successfully quell the epidemic. This is a monumental achievement for a country that reported the highest number of deaths and was made possible by community-driven societal changes around especially mourning rituals. At the peak of the epidemic in August/September 2014, Liberia reported about 400 new cases each week.

At the same time as the good news from Liberia, other reports are emerging about the many survivors of Ebola. Dr. Ian Crozier, an American volunteer with the WHO who worked in a treatment ward in Sierra Leone and who survived Ebola with treatment in the United States, has returned to Emory University Hospital. He was considered cured two months ago, but fading eye sight, intense pain, and soaring pressure in his left eye appears to be the result from a persistent Ebola infection. Besides eye problems, Crozier continues to suffer from debilitating joint and muscle pain, deep fatigue, and hearing loss. Similar problems are being reported by survivors in West Africa. The impact of these newly observed complications on society remain to be seen, besides the trauma from the Ebola epidemic and feared secondary wave of other infectious diseases. (WHO; Denise Grady, The New York Times)

Global Drug Policy

Expensive new hepatitis C and cancer drugs make it on WHO Essential Medicines List

Every two years since 1977, a committee of experts of the World Health Organization (WHO) select medications that are considered minimum medicines for a basic health-care system, based on their efficacy, safety record, and cost effectiveness. Currently, over 400 drugs and vaccines have been selected, especially drugs that target the most pressing needs in developing nations. On May 8th, this year’s Essential Medicines List (EML) was released and includes five new drugs that target hepatitis C virus (HCV) and 16 new cancer medications. Most notably, new members on this list are the pricey anti-HCV drug sofosbuvir and the anti-leukemia drug Imatinib. In the United States, a full course treatment with these drugs will cost more than $84,000 per patient. Many developing nations use the EML to help determine in which drugs they have to invest. Nevertheless, Magrini, an Italian pharmocologist who oversees the EML, says that it still takes too long for many life-saving medicines to become widely available. The EML highlights the gaps. For example, sofosbuvir’s manufacturer, Gilead Sciences Inc. of Foster City, California, sells the drug to Egypt at a discount and allows generic manufacturers in India to produce and sell in 91 poorer countries. Yet advocates criticize Gilead for not offering deals to over 50 middle-income countries. Magrini says that the list is clever tool to build momentum to lower pricing for essential drugs worldwide. (

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May 12, 2015 at 10:50 am

Science Policy Around the Web – March 31, 2015

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By: Julia Shaw, Ph.D.

An Ebola treatment unit in Guinea. Photo by Samuel Hanryon/MSF

Ebola Drug and Vaccine Trials

Scientists Argue over Access to Remaining Ebola Hotspots

In contrast to previous outbreaks which were much smaller and relatively quickly contained, the current Ebola outbreak in West Africa is the worst the world has seen, causing close to 25,000 cases and 10,000 deaths. Although tragic, the scale of the outbreak should benefit the development of future vaccines and treatments for Ebola as studies advance through phase I safety studies to begin phase III efficacy testing. However, as the epidemic winds down, tensions are mounting as multiple organizations seek to complete their large-scale vaccine and drug studies.

Researchers at the National Institutes of Health (NIH) are hoping to move a vaccine study from Liberia, where new cases are few and far between, to Guinea, which reported 45 new cases last week. Yet Guinea is already host to a vaccine trial sponsored by Doctors Without Borders (MSF) and the World Health Organization (WHO) which began vaccinating last Monday. While Clifford Lane of NIH suggests “a country like Guinea is big enough to do at least two studies,” Peter Smith, an epidemiologist and chair of the board of the Norwegian Global health and Vaccination Research Program (which is co-funding the MSF/WHO vaccination trial) stated, “it would not be feasible to successfully run both trial in Guinea at the same time (unless there is a radical change in the epidemiology of the disease in Guinea and disease rates increase. . .).” The two sides have yet to meet in person to discuss the options. An assistant director-general at WHO, Marie-Paule Kieny, noted that “A compromise could be to run the two trials one after the other.” Lane contends that the ring-vaccination study approach adapted by WHO-MSF does not adequately assess longer term protection and that the NIH’s randomized controlled trial is a better approach “to get the most effective vaccine as quickly as possible to the largest number of people possible” and should not be delayed. Similarly, an NIH-led trial to test the therapeutic antibody cocktail, ZMapp, is expanding from Liberia to Sierra Leone where researchers from the University of Oxford have already begun a therapeutic trial of TKM-Ebola, another treatment which uses small interfering RNAs to limit viral replication. Lane is working with the government of Sierra Leone to provide patients with access to ZMapp which has shown better results in animal studies compared to TKM-Ebola. According to Lane, the government of Sierra Leone decides what treatment units will participate, and Port Loko, site of the TKM-Ebloa study, is currently not included in the list. However, if  ZMapp is introduced into treatment units that already have trials underway, Peter Horby, lead investigator of the TKM-Ebola study, says this would “jeopardize ongoing trials and lead to conflict.” (Kai Kupferschmidt, ScienceInsider)

Scientific Peer Review

Major Publisher Retracts 43 Scientific Papers Amid Wider Fake Peer-Review Scandal

United Kingdom-based BioMed Central, publisher of 277 peer-reviewed journals, recently retracted 43 papers due to “fabricated” peer reviews. Peer review is the process by which experts in a scientific field anonymously read and critique a submitted manuscript, judging whether it should be published based on scientific merit. Unfortunately, the process can be weakened or manipulated by poor reviewers, cronyism and outright fraud. In an investigation that began last year, BioMed Central’s associate editorial director for research integrity, Jigisha Patel, describes suspicions that surfaced due to a pattern of unusual e-mail addresses among reviewers and the discovery that the same author was reviewing different, highly specialized topics. Ultimately it was found that the scientists identified as reviewers had not actually written the reviews; someone else had simply used their names. A retraction associated with the articles states, “A systematic and detailed investigation suggests that a third party was involved in supplying fabricated details of potential peer reviewers for a large number of manuscripts submitted to different journals.” The pressure to publish may open the door for these third party agencies that offer language and publication assistance. According to Patel, “if authors are naïve and want to get their manuscripts published, they can be exploited.” The Committee on Publication Ethics, which includes over 9,000 journal editors, issued a statement calling attention to the “systemic, inappropriate attempts to manipulate the peer review processes of several journals across different publishers,” indicating this type of fraud is widespread and in no way limited to BioMed Central. (Fred Barbash, The Washington Post)

Pharmaceutical Regulation

Makers of Generic Drugs Challenge F.D.A. Plan for Updated Warnings

In 2013, the Food and Drug Administration (FDA) proposed requiring generic drug companies to update their labels if previously unknown health risks are discovered. Currently, generic drug producers cannot alter labels to reflect new health warnings unless it is ordered to do so by the FDA, while brand-name manufacturers do make changes as risks are discovered and the changes are later approved by the FDA. Public Citizen, a consumer advocacy group, supports the proposed rule, noting that the FDA lacks the resources to monitor changes for the numerous generics on the market. The drug industry counters that the proposed rule would make them vulnerable to expensive lawsuits resulting in increased costs. They further argue that they lack the full range of data available to the FDA from the brand-name producer and other sources with the end result being confusion as companies making the same drug might have different warning labels. The director of the health research group at Public Citizen, Dr. Michael Carome, admits generics are a great benefit to the public but maintains, “. . . because they dominate the market, it’s critical that they have full incentives to engage in robust monitoring of safety.” In response to the strong resistance from the generic industry including threats to sue, the FDA has reopened the period for public comment on the proposed rule until April 27th. (Sabrina Tavernise, The New York Times)

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March 31, 2015 at 9:00 am

Science Policy Around the Web – April 21, 2013

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By: Jennifer Plank

photo credit: limowreck666 via photopin cc

photo credit: limowreck666 via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

FDA’s rejection of generic OxyContin may have side effects – With the patent on the original OxyContin ending, the FDA has declared that they will not approve generic versions of the drug. In order for drug developers to compete in the prescription pain relief market, they will have to develop abuse resistant forms of the drug. In 2010, Purdue Pharma LP, the developer of the original OxyContin, produced a form of the drug that includes a polymer that makes it impossible to snort and inject the drug. The patent on the drug resistant form expires in 2025.  (Nancy Shute and Audrey Carlsen)

Stereotype threat for girls and STEM – According to Facebook executive and author Sheryl Sandberg, women are being held back by what social scientists call a “stereotype threat”- an idea that suggests that the more we are aware of the stereotype, the more likely we are to act in accordance with it. Sandberg suggests that the stereotype threat is what is responsible for preventing women to pursue leadership roles and careers in highly technical field, such as computer science. A recent study looking at author gender and gender typing of projects suggests that publications from male authors were more highly regarded scientifically. The author also presents many links aiming to encourage interest in STEM. (Chris Gunter)

Gene patents are sabotaging the future of medicine – A case currently being debated by the Supreme Court, Association of Molecular Pathology v. Myriad Genetics, has the potential to influence how clinicians can report the results of genome wide sequencing to their patients. Currently, Myriad holds the patents on the BRCA1 and BRCA2 genes, which are associated with the onset of breast and ovarian cancers. Therefore, Myriad has a monopoly on all diagnostics and therapeutics related to the BRCA genes. The Association for Molecular Pathology states that a person has a right to know their own genetic code and should not have to have permission from patent holders to know the sequence of their own genes. The Supreme Court will rule on the case in late June. (Daniela Hernandez)

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April 21, 2013 at 8:17 pm