By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    UV damage to eyes
    Warning Signs of Long-Term UV Damage to Your Eyes
    December 9, 2021
    degree for healthcare job
    The Ultimate Healthcare Recruiting and Staffing Guidebook
    March 21, 2022
    medicare part d benefits
    Everything that You Need to Know About Medicare Part D
    August 15, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Conservatives: The Utah Health Exchange is Not a Model
    July 23, 2011
    Medical Malpractice Reform Losing Physician Support
    November 7, 2011
    Hospitals Aim to Apply Direct Payments of Care Delivery to Increase Resources
    August 28, 2012
    Latest News
    Top HIPAA-Compliant Messaging Apps for Healthcare Teams
    June 25, 2025
    When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
    June 20, 2025
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 2025
    Strengthening Healthcare Systems Through Clinical and Administrative Career Development
    June 13, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Medical Megatrends – Genomics
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Innovations > Medical Megatrends – Genomics
Medical Innovations

Medical Megatrends – Genomics

StephenSchimpff
Last updated: September 23, 2011 7:15 am
StephenSchimpff
Share
6 Min Read
SHARE

 

       EXCLUSIVE POST – Genomics promises to change much of medical care fundamentally, as described in the two prior posts on this subject.  But the ultimate value of this  understanding of basic human biology will come with fits and starts. The saga of belimumab (Benlysta) and Human Genome Sciences is illustrative.

 

       EXCLUSIVE POST – Genomics promises to change much of medical care fundamentally, as described in the two prior posts on this subject.  But the ultimate value of this  understanding of basic human biology will come with fits and starts. The saga of belimumab (Benlysta) and Human Genome Sciences is illustrative.

More Read

The White House Office of Science and Technology Policy (OSTP) “Grand Challenge”
The Top 10 Healthcare Innovations of 2012. How Well Did They Do?
Global Spine Surgery Finding Double Digit Growth from Innovation, Economics, and Clinical Trends According to MedMarket Diligence Report
Personalized Prevention, Part III: Applying the Model to Obesity
Innovative Medical Devices Save Lives of Heart Patients But Often at a High Cost

        Systemic lupus erythematosus (SLE) occurs in somewhere between 300,000 and 4 million Americans according to the Centers for Disease Control. It is more common in women than men and more common in African Americans than Caucasians. SLE is an autoimmune disease of unknown etiology which can affect many body organs and systems and lead to death. The disease can wax and wane and can flare with activity in the central nervous system and the kidneys. Genomic studies done by Human Genome Sciences (HGS) more than a decade ago showed that it might be possible to create a monoclonal antibody to react against the B lymphocyte stimulator, a cytokine that has been found to correlate with activity in SLE.

            HGS produced the monoclonal antibody – belimumab – and then conducted the required preclinical studies in test tubes and animals to demonstrate its activity and toxicities. With FDA approval it then conducted phase 1 and 2 studies in humans to determine toxicities, side effects and early suggestions of activity in humans. It then proceeded to complete two double blind randomized controlled trials comparing standard treatment to standard treatment plus belimumab in 1684 patients. The results were sufficient to win a 13 to 2 recommendation vote from the FDA’s advisory panel in November, 2010. The FDA announced its approval and the required package labeling in March, 2011. The FDA and HGS have both noted that this is the first new drug for SLE in 50 years and the approval was lauded by the Lupus Foundation of America. The intravenously administered drug will be available for about $35-40,000 per year.

            It all sounds straight forward – good science led to a new drug that should benefit many patients who have had limited treatment choices until now. But for HGS it has been a rocky road at best over the years. Founded in 1992, the company set out to use genomic discoveries to create new pharmaceuticals. By 2000, it was being hailed as an up and coming company and it stock price rose to over $100 per share. But the share price then plummeted along with those of other genomic-oriented companies. Fortunately for HGS, its CEO, Dr William Haseltine, made use of the high stock price to lock in a soon to be much needed cash stockpile. The company’s first drug candidate – to treat leg ulcers – met with failure and was dropped. A second drug – for hepatitis C- looked to be very promising and carried the hopes of staff and investors but a key trial was unsuccessful and HGS ultimately had to make the decision to pull the plug on this drug candidate as well – after expending many millions of dollars in the preclinical- and clinical testing phases. The stock price dropped to a low of 52 cents per share and the cash war chest was running lower and lower. Then – finally – came good news with the two belimumab patient studies and the stock price jumped immediately but to no where near the heights of a decade before.

            Belimumab looks to be a useful addition to the SLE treatment armamentarium. But there are questions and critics. SLE is much more common in African Americans but the two patient trials had relatively few blacks enrolled and there was some suggestion that perhaps they responded less well. The drug is also not without potential side effects including predisposing to serious infection. Further, some calculate that it will take about four (or more) patients treated to lead to one patient benefitting. At $35,000 per patient per year, that means a total expenditure of about $140,000 or more to benefit that one patient.

            My message is that genomics is and will be a transformational megatrend in medical care. But “targeted” therapy is not always all that narrowly targeted in a way that either is effective for all nor is the drug necessarily side effect free – and it may be quite expensive. The story of Human Genome Sciences demonstrates that the path from a genomic discovery in the laboratory to a marketed drug can be long, expensive and fraught with many disappointments along the way. But conversely, innovation as demonstrated here is and will be the lifeblood of continued future success and improved human health. Your comments on innovations in genomics will be appreciated.

 

 

 

TAGGED:genomicspersonalized medicinetargeted medicine
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

women dental care
What Is a Smile Makeover and How Much Does It Cost?
Dental health
June 30, 2025
HIPAA-Compliant Messaging Apps
Top HIPAA-Compliant Messaging Apps for Healthcare Teams
Global Healthcare Policy & Law Technology
June 25, 2025
recovering from injury
Rebuilding After Injury: Path to Physical and Emotional Recovery
News
June 22, 2025
scientist using microscope
When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
Global Healthcare
June 18, 2025

You Might also Like

Where is the Device Industry’s Seat at the “Network of Experts” Table?

December 9, 2011
medical research and the cloud
Medical InnovationsTechnology

The Future of Medicine: How Cloud Computing Is Paving the Way to Better Medical Research

July 24, 2014
Cell-tissue-applications
BusinessMedical InnovationsTechnology

Applications, Global Markets in Tissue Engineering and Cell Therapy

April 21, 2014
health and fitness
Medical InnovationsTechnologyWellness

Data-Driven Exercise for the Disabled

August 17, 2013
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?