Hot Topics: Pharmaceuticals

Blog Posts (10)

October 6, 2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

<p><span style="line-height: 22.3999996185303px;">The September 24, 2014, issue of </span><em style="line-height: 22.3999996185303px;">USA Today</em><span style="line-height: 22.3999996185303px;"> carried a story titled, “<a href="http://www.usatoday.com/story/news/nation/2014/09/24/addiction-painkillers-fda-margaret-hamburg/16150421/">Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.</a>” </span><span style="line-height: 22.3999996185303px;">The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “<a href="http://abcnews.go.com/Health/print?id=25717411">Anti-Addiction Groups Call for New FDA Chief.</a>” </span><span style="line-height: 22.3999996185303px;">In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called <a href="http://www.zogenix.com/content/products/zohydro.htm">Zohydro</a> [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], </span><span style="line-height: 22.3999996185303px;">against the recommendation of its own medical advisers.” Both the print and newscast reports came from an <a href="http://bigstory.ap.org/article/fda-chief-defends-approval-hydrocodone-drug">Associated Press report</a> written by Matthew Perrone about a controversy that has been brewing for sometime. </span><span style="line-height: 22.3999996185303px;">The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is <a href="http://feduprally.org/wp-content/uploads/2014/09/Burwell-Letter-completed-with-signature-Final.pdf">available online</a> and states their position clearly. </span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">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 <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
October 1, 2014

Life Enhancement Pills: Did you take yours today?

<p><span style="line-height: 19.0400009155273px;">Who decides when a problem is worthy of clinical attention? Symptoms may prompt individuals to seek medical attention, but part of this recent review of the Prozac revolution (</span><a style="line-height: 19.0400009155273px;" href="http://www.nytimes.com/2014/09/22/us/selling-prozac-as-the-life-enhancing-cure-for-mental-woes.html?action=click&amp;contentCollection=Health&amp;region=Footer&amp;module=MoreInSection&amp;pgtype=Blogs">selling-prozac-as-the-life-enhancing-cure-for-mental-woes</a><span style="line-height: 19.0400009155273px;"> )in the US suggests that public perception of medication for some problems was launched into a new era when Prozac hit the market in 1987. Truly revolutionary in its ability to target serotonin in order to treat depression, the additional impact of rolling out Prozac was the perhaps unintended consequence of marketing drugs to address issues which enhance people’s daily life.</span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">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 <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
September 9, 2014

Drug Innovation and Government-Operated Health Systems

<p style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">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 “<a href="http://www.dailymail.co.uk/health/article-2738993/Remarkable-new-heart-drug-cut-deaths-fifth-available-early-year.html">overwhelming benefit</a>.” 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 <a href="http://www.reuters.com/article/2014/08/30/us-health-heart-novartis-idUSKBN0GU0CQ20140830">findings were announced</a> at the annual meeting of the European Society of Cardiology and published the same day in the <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1409077">The New England Journal of Medicine</a>. 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 <a href="http://www.novartis.com/newsroom/media-releases/en/2014/1852531.shtml">submitting a similar application</a> to the European Union by early 2015.</span></p> <p style="line-height: 19.0400009155273px;">Analysts say “that [the new drug] might <a href="http://www.nytimes.com/2014/08/31/business/new-novartis-drug-shows-striking-efficacy-in-treating-heart-failure.html">cost $7 a day in the United States</a>, or about $2,500 a year. Existing [standard] drugs are generic, costing as little as [$48 a year] … .”</p> <p style="line-height: 19.0400009155273px;"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">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 <a style="text-decoration: underline; color: #000099;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
August 7, 2014

The Ethics of Ebola and Scarce and Experimental Drugs

by: J.S. Blumenthal-Barby

Yesterday I was contacted by the L.A. Times to answer a simple question: Should we give people access to the experimental Ebola drug, ZMapp?…

August 3, 2014

A Cure So Expensive No One Can Afford It

<p>In December 2013, the FDA approved <a href="http://www.sovaldi.com">Sovaldi</a>® (sofosbuvir, Gilead Sciences, Inc.) for treatment of hepatitis C. A truly wonderful <a href="http://www.hcvguidelines.org/full-report/introduction">medical breakthrough</a>, the oral drug effectively <a href="https://www.ncbi.nlm.nih.gov/pubmed/23281974">cures 90% of patients</a> who take it correctly. The online physician resource Web site <a href="http://www.medscape.com/viewarticle/817371">Medscape</a> has referred to this drug as a “game changer.” Clearly it will change the health care delivery game in any number of ways.</p> <p>But the miracle comes with a catch: the cost is prohibitive. The full treatment course is <a href="http://www.newsweek.com/insurers-worry-84000-hepatitis-c-drug-sovaldi-could-break-bank-252539">so expensive</a> 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 <a href="http://www.nytimes.com/2014/03/16/opinion/sunday/how-much-should-hepatitis-c-treatment-cost.html">$90-120,000 per patient</a>. Many are asking how is it possible to justify the cost? <a href="http://jama.jamanetwork.com/article.aspx?articleid=1890401">Is this fair?</a></p> <p>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 <a href="http://www.reuters.com/article/2014/07/25/wellcare-health-stocks-idUSL4N0Q047L20140725">significant corporate losses</a> 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 <a href="http://www.chicagobusiness.com/article/20140729/NEWS03/140729819/ill…estricts-who-can-get-game-changing-hepatitis-drug">exclude individuals</a> 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.</p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">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 <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
July 14, 2014

New York’s Medical Marijuana Law May Just Be a Political Hoax?

<p class="MsoNormal" style="line-height: 22.399999618530273px;">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 <a href="http://www.usatoday.com/story/news/nation/2014/06/20/ny-set-to-legalize-medical-marijuana-/11033195/">legalization of medical marijuana</a>.  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.</p> <p class="MsoNormal" style="line-height: 22.399999618530273px;">New York medical marijuana proponents have been <a href="http://www.compassionatecareny.org">advocating</a> for the <a href="http://www.drugpolicy.org/new-york">availability of cannabis</a> 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.</p> <p class="MsoNormal" style="line-height: 22.399999618530273px;"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">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 <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
April 10, 2014

Pharmaceutical or Illegal Drug: The Bizarre Case of Marijuana

by Craig Klugman, Ph.D.

After gay marriage, one of the most controversial issues in the United States today is the issue of marijuana.…

June 4, 2013

Data Aggregation and the Medical Marketplace

Craig Klugman, Ph.D.

Big brother is watching you. And calling you. And selling your medical information to a pharmaceutical corporation.

In the modern age of information as commodity, drugmakers buy database that tell them how much of what drug each doctor prescribes, which patients fill those prescriptions, and whether renewals are filled.…

August 14, 2011

What Scorpion Bites Can Teach Us About Placebo Trials

A recent story in Nature highlights a few important concepts in the conduct of placebo-controlled trials. This story is about a very small placebo-controlled trial involving only 15 children who were stung by bark scorpions in Arizona. The trial’s goal was to demonstrate effectiveness of a new antivenom, Anascorp. The bark scorpion is the only […]
June 3, 2011

Disclosing Conflicts of Interest: The Case of Tamiflu

An interesting story recently from CBC highlights some of the difficulties with the topic of conflict of interest in medicine and biomedical research. Here’s a link to the story: CBC Tamiflu Probe Sparks Drug Policy Review “In the course of the CBC investigation, Zalac also reported that three of Canada’s most prominent flu experts — […]

Published Articles (1)

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

News (74)

July 28, 2014 4:30 pm

Drugs to increase 'good' cholesterol may not cut deaths

Drugs that have been investigated to increase so-called “good” cholesterol may not prevent deaths, heart attacks or strokes as many hoped, according to a new analysis.

March 25, 2014 2:53 pm

Marijuana pills and sprays ease MS symptoms

There is no cure for the condition, and therapies have proven difficult, as many have serious side effects. But now, relief may come in the form of a medical marijuana pill.

March 24, 2014 2:34 pm

Crowdsourcing medical decisions: Ethicists worry Josh Hardy case may set bad precedent

Just hours after social-media supporters of a dying 7-year-old boy pressured a reluctant biotech company into giving him an experimental medication, the backlash began.

March 13, 2014 3:41 pm

Company Makes Drug Available To Ailing Boy Following Public Outcry

Chimerix, a small and unprofitable biotechnology company, will make an experimental drug available to a young Virginia boy who is suffering from an infection he contracted while being treated for cancer.

November 8, 2013 1:41 pm

Feds Have Beaten Pharma Into Submission Over Off-Label Drug Use, But At What Cost?

Regulatory policy should be based on rules that are clear, with a process that is transparent, and on decisions that are accountable and reviewable, and that are congruent with other public policy imperatives.

August 14, 2013 6:27 pm

Safety First? How the Current Drug Approval System Lets Some Patients Down

Licensed drugs have to go through rigorous trials. Even if an unlicensed drug works in some way, it might kill you in another way or cause problems.

June 18, 2013 2:47 pm

Supreme Court lets U.S. regulators challenge generic-drug deals

The Supreme Court rattled the pharmaceutical industry Monday when it ruled that antitrust regulators should be able to challenge the arrangements that allow rival drugmakers to delay the sale of a generic drug.

December 5, 2012 7:13 pm

Bigger Role Seen for Breast Cancer Drug (NYT)

The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long could upend the standard that has been in place for about 15 years.

November 13, 2012 5:29 pm

Injectable Sponge Delivers Drugs, Cells, and Structure (R&D)

Bioengineers at Harvard have developed a gel-based sponge that can be molded to any shape, loaded with drugs or stem cells, compressed to a fraction of its size, and delivered via injection. Once inside the body, it pops back to its original shape and gradually releases its cargo, before safely degrading.

June 6, 2012 12:04 pm

Cancer Doctors Say Some, Not All, Drug Shortages Have Eased (Wall Street Journal)

Doctors who treat cancer say a shortage of oncology drugs has eased, though shortages persist of some chemotherapy drugs that form the backbone of treatment for breast, colon, lung and some other cancers. Hospitals have been struggling with shortages of mostly older, generic drugs for cancer and other ailments for about two years.

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