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Topic: Pharmaceuticals
September 9, 2014 | Posted By Bruce D. White, DO, JD

On August 30, 2014, cardiovascular drug researchers managing the PARADIGM-HF Study and its Committees announced that they were terminating their Phase III trial of LCZ696 because of observed “overwhelming benefit.” As reported in The Daily Mail: “Thousands of lives could be saved by a new drug for heart failure that researchers claim outperforms the current best treatments. … Research on more than 8,000 patients found that it saved 20 per cent more lives than the current ‘gold standard’ treatment – the ACE inhibitor enalapril.” The findings were announced at the annual meeting of the European Society of Cardiology and published the same day in the The New England Journal of Medicine. In a news release, the Switzerland-based Novartis International AG – the drug manufacturer sponsor – said that it would submit an FDA application to market the drug in the US by the end of 2014. Novartis anticipates submitting a similar application to the European Union by early 2015.

Analysts say “that [the new drug] might cost $7 a day in the United States, or about $2,500 a year. Existing [standard] drugs are generic, costing as little as [$48 a year] … .”

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 4, 2014 | Posted By Bruce D. White, DO, JD

In December 2013, the FDA approved Sovaldi® (sofosbuvir, Gilead Sciences, Inc.) for treatment of hepatitis C. A truly wonderful medical breakthrough, the oral drug effectively cures 90% of patients who take it correctly. The online physician resource Web site Medscape has referred to this drug as a “game changer.” Clearly it will change the health care delivery game in any number of ways.

But the miracle comes with a catch: the cost is prohibitive. The full treatment course is so expensive that very few can afford it even with good health insurance. Each pill costs about $1000; patients will need to take the medicine once a day for about 12 weeks for a full course. The total cost will be about $90-120,000 per patient. Many are asking how is it possible to justify the cost? Is this fair?

Of course, the principal difficulty at first glace is that the costs will strain the system to a degree never before seen with the introduction of a new drug. The strain may break the bank. Recently Reuters has reported that one Florida health insurer – WellCare Health Plans – has sustained significant corporate losses attributable to the fact that Florida requires insurers to prove sofosbuvir to Medicaid patients. It has been reported that 47 state Medicaid programs are covering the drug, and about half have some form of preauthorization. Illinois Medicaid has recently changed its preauthorization criteria to provide the drug only to those patients with advanced liver disease, and to those who can tolerate interferon as an adjunctive treatment, and to exclude individuals with a history of alcohol or drug abuse. It has been projected that drug availability to California residents alone will add $18 billion to health care costs in one year.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

July 14, 2014 | Posted By Bruce D. White, DO, JD

On the very last day of the 2014 legislative session, the New York Senate passed “The Compassionate Care Act” (S.1682-A, Savino) approving the legalization of medical marijuana.  The Assembly had previously passed a companion bill (A.6357-A, Gottfried). The Senate bill has been sent to Governor Cuomo for his signature. The governor endorsed the bill in the legislature, but as of July 4, 2014, has yet to sign it.

New York medical marijuana proponents have been advocating for the availability of cannabis for several years. Neighboring states Connecticut, New Jersey, and Vermont, and 18 other states and the District of Columbia currently allow medical marijuana. However, last minute compromise changes to the New York law will severely restrict access to medical cannabis. In fact, the limitations are so rigid that some might say the bill is a hallow shell, a sham, one designed to appear to allow medical marijuana yet really not. Regardless of how one feels about medical cannabis, to hype the public into believing that marijuana will be available for medical purposes and then establishing barriers to its accessibility that is a fraud. It would be unconscionable to raise the hopes of distressed patients, many suffering with chronic and painful conditions, only to see those hopes dashed.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 19, 2013 | Posted By Jane Jankowski, LMSW, MS
Overshadowed by the brouhaha about the faulty Obamacare enrollment websites was an article that illustrated a far more egregious oversight in healthcare delivery priorities. A brief piece published in the New York Times noted that drug development priorities have continued to neglect diseases that primarily affect the world’s poorest. Though the supporting article published in The Lancet notes that drug development for such disease has not halted, vaccines and new treatments for conditions including malaria, worm and diarrheal disease, and tuberculosis are not being developed at a rate that reflects appropriate concern given the numbers of people afflicted by these conditions.

With just 4% of new drugs targeting what are considered neglected diseases, it seems reasonable to question the broader goals of those who conduct research and development endeavors. Historically, vaccination has been proven to be remarkably effective at preventing diseases that were once considered scourges, such as smallpox, polio, and diphtheria to give a very short list. The goals were simple – to halt the spread of disease through prevention. Grounded in the principle of beneficence, the research and development was aimed at reducing loss of life, suffering, and serving mankind. While I want to believe that medical research remains intent of the same principles, it is concerning that the world’s poorest are left behind when it comes to the scourges that still affect their regions.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 28, 2013 | Posted By Jane Jankowski, LMSW, MS

With contentious changes afoot in the US healthcare system these days, one old problem seems to be gaining important attention as the public reflects on what will change with the advent of the Affordable Care Act. The cost of prescription medications is often so high; patients are forced to make tough choices in order to maintain their health without going broke. This topic was front page news in the New York Times (New York Times October 2013 ) this month where the focus was on escalating costs of asthma drugs. Compared to other nations, the expense of many common – and even not so common – medications is dramatically higher for consumers in the US. This is hardly news, and studies have been done showing that senior citizens were historically the hardest hit by medication costs given the intersection of age related health problems and fixed incomes with no prescription benefits. Though somewhat ameliorated when Medicare D was added, not all of the medication problems are resolved, particularly when an individual requires skilled nursing care in a nursing home (Medicare D and Nursing Home Residents.)

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 27, 2012 | Posted By Bruce D. White, DO, JD

In 2012, the percentage of money spent on providing drugs to patients in the United States continued to rise (Hoffman et al., 2012). However, this is a US trend not seen in other developing countries – such as Canada – where national drug expenditure percentages are slowing year after year (CBC News, 2012). In fact, in Canada, the rate of drug cost growth for this year is the lowest of the last 15 years. 

So, why? Simply put, the American pharmaceutical industry has fueled new drug innovation worldwide for decades. Now, the pharmaceutical companies have less money for research and development and are innovating less. When they do innovate, the companies spend their R&D allocations either on “me too” (imitation) drugs, or very, very expensive drugs for which insurance reimbursement is maximized. Market forces drive both these new drug lines. But now, the R&D well is clearly drying up (Adams, 2011).

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 12, 2012 | Posted By Jane Jankowski, LMSW, MS

A patient walks into her local Emergency Department complaining of back pain. She appears uncomfortable, and states that she was injured in a car accident about a year ago and now has chronic pain in her back. Her x-ray looks normal. She states that her pain is best managed with regular doses of oxycodone, but she ran out and has not been able to see her regular doctor for a refill. She came to the Emergency Department for a prescription instead. Imagine you are the physician. What action would you take?

a. Provide a dose of medication to the patient in the ER to be sure it will be adequate and give the patient a prescription for a couple days’ worth of the requested medication.

b. Call her regular doctor to confirm the medication and dose before providing any medication.

c. Check the state database to be sure this patient is not seeking prescriptions from multiple providers.

d. Offer only non-narcotic pain medications.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

September 26, 2012 | Posted By Hayley Dittus-Doria, MPH

An article about the concept of overtreatment recently caught my eye. We live in a world of excess-bigger houses and larger food portions, among others. These are necessarily bad, just perhaps more than we need. The same goes for medical treatment. Like many things in the U.S., people equate “more” or “bigger” with “better.”

The problem with this mentality when it comes to healthcare procedures is the large cost that comes with it. According to the article, overtreatment is costing the U.S. healthcare system $210 billion each year. And spending that money doesn’t earn us high marks in terms of our health outcomes compared to the rest of theworld. Between “one fifth and one third of our health care dollars” are spent “on care that does nothing to improve our health” according to Shannon Brownlee, author of “Overtreated.” In a 2009 New Yorker article, Dr. Atul Gwande also points out the fact that simply because you’re receiving more aggressive healthcare doesn’t necessarily mean you’re healthier. 

Overtreatment has additional, non-financial ramifications as well. Emotional consequences can be quite serious. What if you had a cough for a few weeks? And when looking into the cough, you discover something else? And when looking into that new diagnosis, yet another problem comes to light? When your expectation was just to be treated for your cough, would you want to find out all of the other illnesses you might have? Maybe. But maybe not. Perhaps, other than your cough, you felt fine, but now your days are spent getting test done, blood work run, procedures scheduled.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 3, 2012 | Posted By Ricki Lewis, PhD

On Sunday morning, July 21, I faced a room of people from families with Leber congenital amaurosis (LCA), an inherited blindness caused by mutations in any of at least 18 genes. It was the final session of the Foundation for Retinal Research’s bi-annual LCA family conference, and I was there to discuss the history of gene therapy. But I zapped through that quickly, because the future is much more intriguing.

The excitement pervading the room that day was palpable, following a day of scientific updates, and not only because those with young children were soon to visit Sesame World and the sights of Philadelphia.


E
xome sequencing identified the rare mutation that causes Gavin Stevens’ hereditary blindness (Leber congenital amaurosis, or LCA). (Photo: Jennifer Stevens)

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 2, 2012 | Posted By John Kaplan, PhD

It was reported in the New York Times earlier this month that GlaxoSmithKline was fined three billion (yes billion!) dollars by the feds to settle civil and criminal penalties for illegally promoting ten of its drugs. In Maythe drug firm Abbott Laboratories was fined 1.6 billion (yes billion!) dollars for illegally promoting their drug Depakote. In April Johnson & Johnson was fined 1.2 billion (yes billion!) dollars in Arkansas for marketing practices of their drug Risperdal. We can keep this short by primarily reporting fines from this year and those in the billion-plus range. I do feel the need to recall Pfizer’s 2.3 (yes billion!) dollar fine in 2009 for illegal marketing of Bextra. Taxpayers Against Fraud reports over ten billion in such settlements and civil and criminal penalties during the current fiscal year.

How can pharmaceutical companies engage in such costly activities on an ongoing basis? It turns out that what seems like a lot of money to you and me is not so much to these huge corporations. Avandia, Paxil, and Wellbutrin, just three of the ten drugs that GlaxoSmithKline was marketing this way had sales of over 25 billion (again, yes billion!) during the ten year period covered by the settlement. According to Patrick Burns, spokesman for Taxpayers Against Fraud, this “can be rationalized as the cost of doing business.” The market apparently agrees that this is a reasonable cost to do business as these fines barely registered in terms of the valuation of stock in these companies. Implicit in this conclusion is that these companies are making a purposeful decision to act in this manner and thus could be considered criminal enterprises.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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