April 22nd, 2011 by admin in Health Policy, Opinion
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Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year.
A huge challenge facing consumers, insurers, and governments worldwide are the acquisition costs of drugs. On this point, the pharmaceutical industry makes a consistent argument: This is a risky business, and it costs a lot to bring a new drug to market. According to PhRMA, the U.S. pharmaceutical industry’s advocacy group, it cost $1.3 billion (in 2005 dollars) to bring a new drug to market. The industry argues that high acquisition costs are necessary to support the multi-year R&D investment, and considerable risks, in to meet the regulatory requirements demanded for new drugs.
But what goes into this $1.3 billion figure? Read more »
*This blog post was originally published at Science-Based Medicine*
April 13th, 2011 by Linda Burke-Galloway, M.D. in News, Opinion
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This post is written as a follow-up to The Hijacking of Pregnant Women.
It is said that sometimes you have to rock the boat in order to shift the course of progress. Well today pregnant women have reason to celebrate. The winds of change are apparent.
Bowing under pressure, K-V Pharmaceutical Company reduced the price of Makena from $1500 to $690. Makena is the trade name for hydroxyprogesterone caproate or 17OHP. It is a drug recently approved by the Federal Drug Administration (FDA) to reduce premature deliveries before 37 weeks if it is given before 21 weeks gestation. It has been used for years as an off-label drug and costs approximately $10 to $20 to make by compound pharmacists. When the FDA gave K-V an exclusive right to manufacture the drug, their integrity flew out the window. The pricing strategy of K-V is a case study of corporate greed. Most drug companies will use the “research and development” logic to explain their rationale for marking up the cost of a drug. In the case of Makena, that excuse is valid. The research and development of Makena had already been done by Squibb Pharmaceuticals who had sold the drug for years. Is it any wonder why U.S. citizens will cross geographic borders and purchase drugs from their Canadian and Mexican neighbors?
Kudos are in order to the American College of Obstetricians and Gynecologists (ACOG) who took the lead in questioning K‑V’s pricing strategies. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
April 2nd, 2011 by Toni Brayer, M.D. in Health Policy, Research
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The single most important medicine ever discovered is the antibiotic. Prior to 1930, humans died at early ages of simple infections and even childbirth was a major killer of women because of infection. The mortality rate from simple staph aureus was as high as 80%, but between 1944 and 1972 the human life expectancy jumped by 8 years because of antibiotics. By 1950 the golden age of antibiotics was already looking tarnished as organisms became resistant to the drugs. Now many medical advances that we take for granted, including cancer treatment, surgery, transplantation and neonatal care are endangered by increasing antibiotic resistance and a decline in new medications to combat the super germs.
Drug resistance is both a public health and global security threat. Resistance has emerged for all known antibiotics in use. For most antibiotics, resistant genes have created super bugs that require more combinations of antibiotics to treat and there are certain infections that we cannot effectively treat. Read more »
*This blog post was originally published at EverythingHealth*
March 29th, 2011 by admin in Health Policy, News, Opinion
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More and more patients these days are seeing their physician pull out an iPhone or iPad to look up drug dosing information, review lab and radiology data, or help teach them more about their medical condition. And as developers, and the increasing number of physician-developers, continue to find more creative ways to bring medical resources to the point of care, we can certainly expect smartphone platforms and medical apps to become pervasive at the bedside. However, just as healthcare providers and patients are noticing this trend, there are number of others who are paying attention as well – for WebMD, one of the largest companies in this industry, it is the lawyers who may be watching that are worrisome.
As they put it in their annual statement to the SEC,
If our content, or content we obtain from third parties, contains inaccuracies, it is possible that consumers, employees, health plan members or others may sue us for various causes of action.
We’ve talked in the past about potential liability issues for healthcare providers using medical apps and the developers who produce them, as well as similar issues related to electronic health records. The fact that WebMD found the issue significant enough to report it to the SEC and their investors clearly indicates the issue is still unresolved and the remainder of their statement adds some further interesting perspective. Read more »
*This blog post was originally published at iMedicalApps*
March 28th, 2011 by Linda Burke-Galloway, M.D. in Health Tips, News
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Periodically, the FDA publishes drug warnings that should be shared with the public, especially if it affects pregnant women. Each year, over 4 million babies are born in the US and 43% will continue to be breast fed at 6 months. All of these moms will invariably use meds at some point after birth, so which meds are helpful and which are potentially harmful? These questions may now be answered by the Infant Risk Center, at the Texas Tech University Health Center, in Amarillo, Texas. This center provides up-to-date information regarding the safety of medications that are taken both during pregnancy and after birth.
Most drugs enter breast milk immediately after birth and during the first 4 to 10 days of life at a fairly fast rate based on the physiology of breast cells. New moms must therefore be careful of pain medications that are prescribed during the post partum period. Hydrocodone aka Vicodin is a potentially addictive opiate that is given for pain management. When it is processed by the body, it breaks down into a component called hydromorphone that is even more potent. The University of California at San Diego Medical Center performed a small study to determine how much of the drug is secreted into breast milk and what percentage is absorbed by newborns. 3 to 4% of hydromorphone was found in breast milk which is considered safe. As a rule of thumb, nonopioid medication should be prescribed first during the post partum period for pain relief. If the pain persists, no more than 6 Vicodin (hydrocodone) tablets or 30 mg should be prescribed in one day. Dosages greater than 40 mg should be avoided and the newborn should be monitored carefully for depressed behavior or inadequate breastfeeding.
Recently the FDA sent a drug warning to healthcare providers regarding the risks associated with the entire class of antipsychotic medications such as Haldol, Risperdal®, Risperdal® Consta®, Invega® and Invega®Sustenna, Clozaril, Zyprexa, Seroquel, Abilify, and Geodon. These medications are used to treat schizophrenia and bipolar disorders but are associated with abnormal muscle movements and withdrawal symptoms of newborns whose mothers took these medications during the third trimester. However it is recommended that patients should not abruptly stop taking these medications without speaking with their healthcare professional first. For further information, readers may go to the FDA website http://www.fda.gov/Drugs/Drug Safety/ucm243903.htm.
Remember, a healthy pregnancy doesn’t just happen. It takes a smart mother who knows what to do.
*This blog post was originally published at Dr. Linda Burke-Galloway*
