Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Direct-to-Consumer Genetic Tests (DTC-GT), Easy to Purchase, But Pretty Useless

Direct-to-Consumer Genetic Tests (DTC-GT), Easy to Purchase, But Pretty Useless | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Data from studies that investigate the quality of the tests offered confirm that they are not informative, have little predictive power, and do not measure genetic risk appropriately.


BackgroundDirect-to-consumer genetic tests (DTC-GT) are easily purchased through the Internet, independent of a physician referral or approval for testing, allowing the retrieval of genetic information outside the clinical context. There is a broad debate about the testing validity, their impact on individuals, and what people know and perceive about them.


ObjectiveThe aim of this review was to collect evidence on DTC-GT from a comprehensive perspective that unravels the complexity of the phenomenon.


MethodsA systematic search was carried out through PubMed, Web of Knowledge, and Embase, in addition to Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist with the key term “Direct-to-consumer genetic test.”


ResultsIn the final sample, 118 articles were identified. Articles were summarized in five categories according to their focus on (1) knowledge of, attitude toward use of, and perception of DTC-GT (n=37), (2) the impact of genetic risk information on users (n=37), (3) the opinion of health professionals (n=20), (4) the content of websites selling DTC-GT (n=16), and (5) the scientific evidence and clinical utility of the tests (n=14). Most of the articles analyzed the attitude, knowledge, and perception of DTC-GT, highlighting an interest in using DTC-GT, along with the need for a health care professional to help interpret the results. The articles investigating the content analysis of the websites selling these tests are in agreement that the information provided by the companies about genetic testing is not completely comprehensive for the consumer. Given that risk information can modify consumers’ health behavior, there are surprisingly few studies carried out on actual consumers and they do not confirm the overall concerns on the possible impact of DTC-GT.


ConclusionsThe impact of DTC-GT on consumers’ health perceptions and behaviors is an emerging concern. However, negative effects on consumers or health benefits have yet to be observed. Nevertheless, since the online market of DTC-GT is expected to grow, it is important to remain aware of a possible impact.


Pharma Guy's insight:

As our age transitions to one where more consumers are more actively involved in their own healthcare, FDA has once again acted on the matter of genetic tests that are marketed directly to consumers. Recently, the agency sent three untitled letters – as opposed to warning letters (and note, these are not letters from the Office of Prescription Drug Promotion – OPDP) to manufacturers and marketers of genetic tests meant to inform the consumer whether they have a genetic predisposition to various conditions. This follows other actions the agency has taken with respect to this topic, some going back to 2010. The letters, including a warning letter sent in 2013 to another manufacturer, can be found here.

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23andMe and "e-Patient Davide": the Rise of the Chief Patient Kibitzer!

23andMe and "e-Patient Davide": the Rise of the Chief Patient Kibitzer! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

MOUNTAIN VIEW, Calif., – April 1 2015 – 23andMe today announced the appointment of Davide deBellagio, also known as “e-Patient Davide,” to the newly created position of Chief Patient Officer.

“The appointment of a Chief Patient Officer at 23andMe, the first for a Silicon Valley pharmaceutical company, shows our commitment to go further than mainstream pharma1 in meeting the needs of patients and our investors,” said Steve Woz, an unspecified 23and Me executive“Interactions with patients are a source of strength -- and wealth -- for the company and e-Patient Davide’s appointment will help ensure the patient perspective advances our profits and our approach to meeting the unmet needs of our investors, which include Roche and Johnson & Johnson.”

e-Patient Davide -- a pre-Alzheimer’s survivor -- is an international keynote speaker on healthcare who consistently earns extraordinary fees from consulting with various healthcare organizations.

I am incredibly honored to be 23andMe's first Chief Patient Officer, or as I like to call it, Chief Patient Kibitzer,” said e-Patient Davide. The Internet has altered the balance of power in healthcare. Patients are managing their own health and, in partnership with the pharmaceutical industry, making some money to boot.

Pharma Guy's insight:


Happy April Fools' Day! Although I would like to see pharma hire REAL patient advocates as Chief Patient Officers rather than medical professionals. With the latter it just sounds like a new name for Chief Medical Officer, although Dr. Anne Beal - Chief Patient Officer at Sanofi - explained how the two differ. Listen to my interview of her here: http://bit.ly/PMT232

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FDA Approves Marketing of First Direct-to-Consumer Genetic Test After 23andMe Conducted Studies

FDA Approves Marketing of First Direct-to-Consumer Genetic Test After 23andMe Conducted Studies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The U.S. Food and Drug Administration today authorized for marketing 23andMe’sBloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.


Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market. 


“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”


In general, carrier testing is a type of genetic testing performed on people who display no symptoms for a genetic disorder but may be at risk for passing it on to their children. A carrier for a genetic disorder has inherited one normal and one abnormal allele for a gene associated with the disorder. A child must inherit two abnormal alleles, one copy from each parent, in order for symptoms to appear.


No test is perfect. Given the probability of erroneous results and the rarity of these mutations, professional societies typically recommend that only prospective parents with a family history of a genetic disorder undergo carrier screening. For example, when a gene mutation is expected to be very rare, a positive result for the mutation may have a high probability of being wrong.


Like other home-use tests for medical purposes, the FDA requires the results to be conveyed in a way that consumers can understand and use. This is the same approach the FDA has taken with other over-the-counter consumer products such as pregnancy, cholesterol and HIV tests for home use


While the FDA is not limiting who should or should not use these tests, it is requiring that the company explain to the consumer in the product labeling what the results might mean for prospective parents interested in seeing if they carry a genetic disorder.  

If sold over the counter, the FDA is also requiring 23andMe to provide information to consumers about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.  


23andMe performed two separate studies to demonstrate that their test is accurate in detecting Bloom syndrome carrier status. One study conducted at two laboratories tested a total of 123 samples, including samples from known carriers of the disease. An additional study evaluated 105 samples at two additional laboratories. Both studies showed equivalent results in detecting carrier status of Bloom syndrome when the same samples were tested.


The company also conducted a usability study with 295 people not familiar with the 23andMe saliva collection device to demonstrate consumers could understand the test instructions and collect an adequate saliva sample.


Finally, the company conducted a user study of 302 randomly recruited participants representing the U.S. general population in age, gender, race and education level to show the test instructions and results were easy to follow and understand.

Pharma Guy's insight:


It's been a twisted path. Here's some background on that:


FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit


"Heavy regulation makes healthcare a painful business," Says Google's Brin


FDA Says "Accurate" Genomic Tests Empower Consumers


23andMe CEO Ann Wojcicki Learned Her Lesson

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23andMe CEO Anne Wojcicki Learned Her Lesson!

23andMe CEO Anne Wojcicki Learned Her Lesson! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
23andMe CEO and cofounder Anne Wojcicki explains how she intends to get FDA approval for health-related genetic tests and move ahead on what she says is a 10-year goal of revolutionizing healthcare.


Q: What’s the status with the FDA right now?


A: They’re a very willing partner. We are extremely lucky in the sense that when we call them, they call us right back. I think that they genuinely want to make this all work. I really do believe there’s that genuine partnership with them.

[FDA Commissioner] Peggy Hamburg wrote in a New York Times [opinion piece] that the FDA is committed to finding a path to direct-to-consumer [genetic tests]. I do believe there is a genuine intention to try to find a path. It’s probably not going to be exactly what we wanted and it’s going to take time. In Silicon Valley, you want things done instantly. It’s not going to be that. But we’ve learned that. We’re going to figure out some kind of path.

Pharma Guy's insight:


It's been a twisted path. Here's some background on that:


FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit


"Heavy regulation makes healthcare a painful business," Says Google's Brin


FDA Says "Accurate" Genomic Tests Empower Consumers


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"Heavy regulation makes healthcare a painful business," Says Google's Brin

"Heavy regulation makes healthcare a painful business," Says Google's Brin | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The heavily regulated healthcare technology environment makes it a difficult business to pursue, according to Google's two co-founders, but they remain entranced by its possibilities.


"Generally, health is just so heavily regulated. It's just a painful business to be in," Sergey Brin told technology venture capitalist Vinod Khosla, adding: "I think the regulatory burden in the US is so high that think it would dissuade a lot of entrepreneurs.

Pharma Guy's insight:


But Brin said he was very excited about Google's glucose reading contact lenses, which "should be coming along pretty well".


I'm not surprised by Brin's comments. Google and the Brin family (including the Mrs. - Anne Wojcicki) have had run-ins with the FDA.  Google, for example, settled a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws (see "How FDA, in Cahoots with DOJ, Brought Google Down"). That's a serious felonious offense, yet nobody from Google went to jail!


And Mrs. Brin was caught trying to sell a genetic test kit with unproven accuracy. She just decided to ignore all of FDA's many inquiries until FDA had no choice but to shut down her business, at least temporarily (see "FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). Even then, she remained defiant to the point where one wonders if wealth gives her the feeling of superiority uber alles. Nowadays, however, she is greasing the wheels with her wealth to get the FDA more in line with her business plan. Now, that wasn't so painful, Anne, was it?


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FDA Opens Door For 23andMe To Market Some Direct-To-Consumer Genome Tests

FDA Opens Door For 23andMe To Market Some Direct-To-Consumer Genome Tests | Pharmaguy's Insights Into Drug Industry News | Scoop.it

An FDA decision summary released today allows DNA-testing company 23andMeto market a genome test that screens for Bloom syndrome, a rare disorder that leads to a predisposition in carriers toward the development of cancer. While, on the surface, this may seem like a minor change in policy, it is significant given the complex relationship the FDA has had with 23andMe over the last two years.


In 2013, the FDA sent 23andMe a letter ordering it to stop offering its main product, a personal genome service that gave customers insight into whether or not they were carriers for various diseases. According to the FDA, 23andMe had not obtained the correct legal approvals. As a result, 23andMe stopped selling personal genome tests and results in the U.S., but continued to offer a product that allows customers to better understand their ancestry. (The health-related tests continued to be available in Canada and the U.K., where government regulations are different.)


Over the last two years, 23andMe has been working closely with the FDA to discuss how their tests might be federally approved. They focused first on the Bloom test because it was a fairly straightforward genetic condition and the company assumed that it would have to clear one genetic test at a time with the FDA. Today's news that the Bloom test was approved is particularly compelling given that Anne Wojcicki, 23andMe's cofounder and CEO, is a carrier of the disease.


But today's decision is surprising because not only does the FDA clear 23andMe's Bloom syndrome report, it also says that the whole category of diseases like Bloom syndrome—autosomal recessive disorders which require one copy of the abnormal gene to be present in each parent in order for the disease to manifest in their child—will no longer require pre-market review by the FDA. Other diseases in this category include cystic fibrosis and Tay-Sachs disease. However, the decision does not allow for 23andMe to issue reports relating to illnesses such as Alzheimer's or Parkinson's, or for BRCA genes that predispose carriers to breast cancer.

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Technology Companies Use CrowdSourced Big Data to Help Develop New Drugs

Technology Companies Use CrowdSourced Big Data to Help Develop New Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

23andMe's original business model may have been thwarted by the feds, but that isn't stopping the company from trying new ways to generate revenue. Its latest idea could be a lucrative one: invent new drugs.


23andMe is sitting on a mountain of genetic data culled from the more than 800,000 people who took its genetic tests before they were pulled from the market. The idea here is to mine that massive data set for as-yet-unseen insights, which could informpharmaceutical research. The company intends to then use those insights to create entirely new drugs.


The move would be a huge shift for the company, which started out by offering $99 DNA testing kits that allowed consumers to take a closer look at their genetic profiles and better understand their overall health. That is, until November 2013, when theU.S. Food and Drug Administration sent a letter asking 23andMe to stop selling its saliva collection kits.


Pharmaceutical research is also an area that's ripe for disruption, and 23andMe isn't the only tech company eyeing that opportunity. Flexing the unique potential of its own computing resources, Google is now using large-scale . And the power of big data for medical research isn't lost on Apple, which just announced its crowdsourced research framework ResearchKit on Monday.

Pharma Guy's insight:


Seems like the pharma industry has been caught napping. Technology companies are leading the way in using big data to advance medical research. It's not just data from DNA kits that technology companies like Google and Apple are collecting - it's all kinds of health data gleaned from from Web searches and wearable devices (e.g., Apple Watch). BTW, Google Glass isn't one of the wearables that collect real world health data on a daily basis from millions of people. That was a mistake on Google's part in terms of creating new business. Apple is cornering that market with the Apple Watch.

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23andMe Gets $50 Million from Genentech for DNA Data It Collected Without FDA Approval

23andMe Gets $50 Million from Genentech for DNA Data It Collected Without FDA Approval | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite setbacks from regulators, 23andMe is attracting serious interest from heavy-hitters in the pharmaceutical industry. The ambitious genetics startup has received a first payment of $10 million from biotech company Genentech in exchange for genetic data donated by customers of 23andMe’s personal genome service. Forbes reportsthat the Silicon Valley company — which is partly backed by Google Ventures — can look forward to additional payments of "as much as $50 million," with Genentech reportedly planning to dig out anonymous individuals from the company's database for further study.


23ANDME'S TEST KITS HAVE BEEN BANNED — BUT IT STILL HAS THE GENETIC DATA THAT THEY COLLECTED


For 23andMe, the investment is a lifeline. In late 2013, the company was banned from selling its only public product — the saliva test kits — after they were judged to to be in violation of the FDA’s marketing guidelines. Late last year, a stripped-down version became available in the US, with raw genetic information — but none of the contentious health reports. Some members of the medical community seized upon the ban as proof that 23andMe’s mission to make genetic testing available outside the doctor’s office was misguided. However, by this point the company had attracted some 800,000 customers, three-quarters of whom consented to have their data used anonymously for medical research. It’s this information that is now being sold on for use in for-profit medical research to keep 23andMe afloat.

Pharma Guy's insight:


23andMe, in conjunction with Genentech, launched the "Spit for Cancer" campaign, which aimed to collect spit to find out why people respond differently to Avastin -- Genentech's expensive (up to $100,000 per year per patient) drug for the treatment of metastatic colorectal cancer, among others. For more about that, read "Spit for Research: Will Genentech's Online Promotion Succeed?"


In November, 2013, the Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). 

"This product," says FDA, "is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." 


Aside from 23andMe's lack of response to FDA, Anne Wojcicki, CEO of 23andMe, may have pissed off the FDA with her combative stance viz-a-viz fighting the regulators for the sake of preserving the "customer experience."


Seriously... is fast but unreliable results the best customer service?


Read "FDA Orders 23andMe to Immediately Discontinue Marketing 'Spit for Cancer' Kit"

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FDA Says "Accurate" Genomic Tests Empower Consumers

FDA Says "Accurate" Genomic Tests Empower Consumers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

By: Jeffrey Shuren, M.D., J.D.


We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they’ll get back information about their genetic risk for development of future disease.


FDA understands and supports people’s interest in having access to their genetic information and believes such information can help them make more informed choices about their health – so long as that genetic information is accurate – that the results are correct, meaningful and written in a way that consumers can understand.


FDA is not standing in the way of 23andMe selling tests intended to help consumers trace their ancestry, identify relatives and tell them why they like or don’t like the taste of cilantro. Yes, that information can be fun. But Alzheimer’s disease, cancer and heart disease are serious matters. Our concern remains that genetic tests for diseases, just like other tests for medical conditions, such as hemoglobin A1C for diabetes (glucose control) should be accurate. Armed with that accurate information, consumers can take appropriate steps to take charge of their health. -

Pharma Guy's insight:


The Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). 

"This product," says FDA, "is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." 

Recall that Genentech teemed up with 23andMe -- a personal genetics firm -- to collect spit from volunteers to find out why people respond differently to Avastin -- Genentech's expensive (up to $100,000 per year per patient) drug for the treatment of metastatic colorectal cancer, among others (see "Spit for Research: Will Genentech's Online Promotion Succeed?").

The author of the letter -- Alberto Gutierrez, Director of FDA's Office of In vitro Diagnostics and Radiological Health -- seems pretty miffed at 23andme. (see "
FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). 

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