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Tag Archives: HHS

Biotech Trends Update — Personalized Medicine: A Big Market, If We Can Just Figure Out How to Get People to Use It

Late last year, a PwC report made the rounds with a big headline number — $232 billion — as the size of the personalized medicine market.  FierceBiotech called it a “tipping point,” for personalized medicine.  George Church called us “the first genomic generation” in Newsweek, and Francis Collins’ new book “offers practical advice on how to utilize these discoveries for you and your family’s current and future health and well-being” (at least according to its publisher).

And this isn’t just idle speculation, it’s being reflected in real investments. Cancer Research UK, the Medical Research Council, University College London, and the Wellcome Trust are developing a £500 million new home for their partnership, called the UK Centre for Medical Research and Innovation (UKCMRI), where “genomic technologies will play a key role in the array of research its partners plan to pursue there.”

However, there are real challenges to realizing the 11% annual growth rate PwC predicts.

  1. Health care providers need to learn a whole new language and a whole new set of tools and approaches.  A new year-long project at Valparaiso University aims to meet the new criteria of the nursing curriculum essentials in genetics that are set by the American Association of Colleges of Nursing (AACN), but this is just the tip of the iceberg. (h/t @mikesgene)
  2. Even when health care providers are educated, it doesn’t mean that the market will grow.  For example, there is high awareness (80-90%) of a new genetic test designed to reveal a breast cancer patient’s sensitivity to tamoxifen.  However, according to research from Duke University Medical Center, “[a] greater awareness of the emerging data for this new test corresponded to less likelihood of ordering the test and lower likelihood of changing practice based on test results.” (emphasis added) (h/t @DukeIGSP)
  3. The Genetic Information Nondiscrimiation Act loopholes are still intimidating.  GINA does not expressly cover long-term care and other types of insurance and is focused to some extent on prohibitions on requiring genetic tests (which will be moot when everyone’s full genome is sequenced).  Some efforts to remedy or mitigate GINA loopholes are underway, including:

    However, many patients (and, anecdotally, everyone in the insurance industry) are vociferously refusing genetic testing and sequencing.

  4. FierceBiotech notes that the PwC report itself identifies another caveat: “Big Pharma will have to bury its blockbuster business model in favor of a more “collaborative model.”

My bottom line:  Those who are counting on seeing the growth predicted by PwC will have to make an unprecedented investment in educational and regulatory changes to sychronize with the unquestionably giant strides in product innovation that are occuring daily.

For more on personalized medicine, check out the Biotech Trends in 2010 page.

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Trends in 2009: Direct-to-Consumer Genetic Tests Come to Canada

B&W_DNA_sequenceThis week saw the introduction of what I believe is Canada’s first personal genomics service offering.  Toronto’s Medcan Clinic paired up with California-based Navigenics to scan individuals’ genomes for a variety of disease markers.

Personal genomics is a burgeoning trend this year, which according to a special report in April’s Economist, will only be further boosted by a Moore’s Law-type improvement in sequencing power and price.  Available service offerings range from whole genome sequencing (e.g., Illumina and Knome) that costs tens of thousands of dollars to targeted scans typically offered for under $500 by a much wider variety of providers (Navigenics, 23andMe, deCODE and Pathway Genomics).

Regulation of DTC Testing:

In the U.S., the regulatory environment has settled down somewhat over the last 6 months, with most U.S. states regulating DTC genetics companies as clinical labs and the providers registering as such on a regular basis, including CLIA certification.  However, the HHS Secretary’s Advisory Committee on Genetics, Health and Society is due to meet in October to further discuss whether DTC genetic tests should be regulated as medical devices.  The CDC has released a report entitled “Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions” setting out best practices both for testing and interpretation.

In Ontario, there are a number of regulatory considerations (thanks on these points for input from Will Chung, of our renowned Life Sciences team):

  1. Private labs and specimen collection centres require licenses and are governed by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). However, blood collection at such facilities is governed by separate legislation which controls who may draw blood and for what purpose.
  2. The LSCCLA requires that only “legally qualified medical practitioners” are permitted to examine specimens, which means that patients may not directly order testing of their own blood at private licensed labs.
  3. Ontario’s Regulated Health Professions Act stipulates that communicating a “diagnosis” is a “controlled act” which may only be performed by a person authorized by a health profession Act, although it is not clear that DTC genomics results are a “diagnosis.”

Medscan seems to have navigated the regulatory waters, but time will tell how these laws are applied and/or modified.

In the EU, the European Society for Human Genetics advocates for pre-market review for “truthful labeling and promotion” as well as post-market evaluation of DTC genetic tests. In May, Germany passed a law restricting the availability of DTC genomics services by requiring testing to be carried out by a licensed doctor following the patient’s consent.”

How much protection do consumers need?

Many commentators are concerned with the public’s ability to understand these tests and distinguish between those that are clinically meaningful and those that are more … snake-oily.  Others object on the basis that there is little value added absent any available treatment — many preventive measures are things we already know we should do, like eat well, exercise, etc.  A number of groups, including advocacy group Genetic Alliance and the Genetics and Public Policy Center at Johns Hopkins University have called for a national registry of DTC genetic tests that would include performance data.

Others (and not just 23andMe’s founders) take a more libertarian view.  Ronald Bailey, the science columnist at Reason, agrees that people probably don’t need to be “protected against learning such information without the guidance of a knowledgeable physician or genetic counselor.”  In fact, a lawsuit in May brought by a girl born with Fragile X syndrome against the sperm bank that didn’t test for the predisposition may drive  higher demand for genetic testing in the fertility context which may in turn drive supply of services and diagnostic tools and may contribute to normalizing broader parental testing and pre-implantation screening.

Interestingly, a NEJM report a couple of weeks ago showed no lasting psychological damage from a genetic prognosis of increased Alzheimer’s risk.  By the time a year passed after the results, subjects who had an increased Alzheimer’s risk were no more depressed, anxious, or distressed than when they started the study.

Most importantly, 98% of patients in the Alzheimer’s study who tested positive said they would still get tested if offered the choice again.  98% is a lot. It suggests that DTC services will be increasingly popular, particularly as the price drops and the quality of the data, the analytics and the available counseling continue to improve.

Stay tuned to this page for further DTC genetics news and analysis.

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He Loves Me, He Loves Me Not: CSL Gets Mixed Messages from Uncle Sam

Godward-He_Loves_Me%2C_He_Loves_Me_Not-1896Last week, CSL heard from the Federal Trade Commission that the agency is opposed to CSL’s proposed $3.1 billion merger with Talecris Biotherapeutics.

Don’t worry, CSL, Health and Human Services still loves you.  To the tune of a $180 million order for CSL’s H1N1 swine flu vaccine bulk antigen.  HHS will also fund the clinical trials.

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BIO 2009: Monday Technology Transfer Breakfast

BIO 2009I was at breakfast yesterday morning with university and company members of the BIO Technology Transfer Committee.  Some interesting tidbits, colo(u)red by my preception and commentary and not to be attributed to any other attendees:

P.S. First time here at the Cross-Border Biotech Blog? Welcome! Check out who we are, check out our Trends in 2009 series, or hit the search and navigation tools on your right and see if you see anything interesting.

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Obama Budget 2010: HHS Highlights

The Obama Administration delivered its FY2010 Budget to Congress yesterday. Among the highlights of the Department of Health and Human Services Budget:

  • $511,000,000 increase to FDA’s budget with $259 million for food safety inspections, surveillance etc.
  • $584,000,000 for influenza preparedness, including purchase and development of vaccines, antivirals, diagnostics and supplies
  • $275,000,000 for advanced development of biodefense countermeasures (antivirals, vaccines, diagnostics)
  • $30,000,000,000 for NIH which is flat over last year, but remember NIH recieved $10bn in the American Recovery and Reinvestment Act
  • $44,000,000 for Office of National Coordinator for Health IT.  The budget projects a $432,000,000 spend in Recovery Act Health IT activities in 2009 and an $809,000,000 spend in 2010 (National Coordinator Office received $2bn in Recovery Act mostly for competitive grants for healthcare providers to incorporate health IT).

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FTC Proposed Rule for Medical Record Privacy for Non-HIPAA Entities

One of the concerns about the privacy of electronic medical records is that many of the major providers — notably Google and Microsoft —  are not “covered entities” under HIPAA and are therefore not subject to its privacy provisions.

The funding for Electronic Health Records in the American Recovery & Reinvestment Act of 2009 comes with a requirement that HHS study, in consultation with the FTC, “potential privacy, security, and breach notification requirements” with respect to entities not covered by HIPAA, and make recommendations within one year.

In the interim, Section 13407(g)(1) of the Recovery Act requires the FTC to promulgate regulations on breach of security notification provisions.

The FTC has proposed a breach notification rule, and is coordinating with HHS.  The proposed rule:

  • requires vendors of personal health records and related entities to provide notice to consumers following a breach, and reaches through to require the vendors’ service providers to notify the vendors;
  • sets the standard for what triggers the notice requirement, as well as the timing, method, and content of notice; and
  • requires FTC notification of any breaches.
Public comments are being accepted through June 1, 2009, and can be submitted online at https://secure.commentworks.com/ftc-healthbreachnotification.  In particular, the FTC is seeking comments on:
  1. the nature of entities to which its proposed rule would apply;
  2. the particular products and services they offer;
  3. the extent to which vendors of personal health records, PHR related entities, and third party service providers may be HIPAA-covered entities or business associates of HIPAA-covered entities;
  4. whether some vendors of personal health records may have dual roles as a business associate of a HIPAA-covered entity and a direct provider of personal health records to the public; and
  5. circumstances in which such a dual role might lead to consumers’ receiving multiple breach notices or receiving breach notices from an unexpected entity, and whether and how the rule should address such circumstances.

 

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About the Delayed Sebelius Confirmation

Contrary to expectations, Secretary of HHS-designate Kathleen Sebelius did not receive her Senate confirmation before the Congressional recess on April 3, due to the objection of one Senator.  Is Sebelius using the break to make greater assurances to Republican lawmakers before her vote is taken up again during the week of April 20? 

In her confirmation hearing, Sebelius addressed Republican concerns about comparative effectiveness research leading to “rationed care.”  Mike Enzi (R-Wyoming), top Republican on the Senate Health, Education, Labor and Pensions Committee questioned whether or not Sebelius would support a budget reconciliation measure opposed by Republicans to expedite Congressional approval of health reform. Republicans have also raised strong opposition to the idea of a government-run insurance plan to compete with private insurers.  The recess has provided more time for Republicans to press Sebelius on these matters and dangle them in front of her Senate confirmation.  Let’s see if this leads to more detailed commitments on comparative effectiveness and health reform!

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Updated – Sibelius Senate Hearing: Interesting Bits from Prepared Testimony

Update from the NY Times:

Gov. Kathleen Sebelius of Kansas appeared Thursday to be headed for confirmation as health and human services secretary, but several Republican senators objected to an immediate vote, so the Senate is unlikely to take up the nomination until later this month.

Following our initial posts on Sibelius and her Ag Secretary in Kansas, we thought we’d pull out some interesting bits from HHS Secretary-elect Sibelius’ testimony this week. Read on after the jump…

Wednesday Brain Dump: Around the World Edition

More Money: House of Representatives Release 2009 Spending Bill

The U.S. House of Representatives Appropriations Committee unveiled its Omnibus spending bill for Fiscal Year 2009 yesterday (pdf). The House is expected to vote on the package this week. For Health and Human Services, the Ombnibus contains $30 billion for the National Institutes of Health (NIH). This funding is in addition to the $10 billion added to NIH in the American Recovery and Reinvestment Act. The Omnibus also includes a new initiative to reduce hospital and clinic infections that cause nearly 100,000 deaths each year, and requires national and state plans to combat infections with $22 million.

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Flu and Stimulus

With new reported cases of avian flu in Canada and China  it’s encouraging to see that the U.S. economic stimulus plan boosts funding for development of vaccines and antiviral treatments for pandemic influenza.

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