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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Is the Era of DTC Diagnostics, Diagnosis and Drug Development Here?

Is the Era of DTC Diagnostics, Diagnosis and Drug Development Here? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Givi Topchishvili is founder and president of the 9.8 Group.


23andMe, the direct-to-consumer genetic testing and screening service, is back in the business of analyzing some health risks based on personal genetics.


That's probably good news for health-curious and health-conscious customers (or at least those in the US since 23andMe has been offering the service in Canada and Great Britain all along).


23andMe has pioneered a new health service business that could serve as an early working prototype for the entire medical industry over the next few years. Despite conventional wisdom that the 23andMe business breakthrough is the direct-to-consumer model, it's also the consolidation of genetic testing, diagnosis and drug development that has the potential to change the industry.


Pharma Guy's insight:

Before putting all your eggs in this basket, you should know that data from studies that investigate the quality of these DTC genetics tests confirm that they are not informative, have little predictive power, and do not measure genetic risk appropriately. See here: http://sco.lt/4o3AY5 

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FDA Letters Regarding DTC Genetic Test Marketing

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. This week 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.

Pharma Guy's insight:

By way of eyeonfda blog.

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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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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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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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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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