Cost efficient way to develop safer compounds
A new set of computer models has successfully predicted negative side effects in hundreds of current drugs, based on the similarity between their chemical structures and those molecules known to cause side effects, according to a paper appearing online this week in the journal Nature. …
Drugs frequently interact with more than one target, with hundreds of these targets linked to the side effects of clinically used therapeutics. Focusing on 656 drugs that are currently prescribed, with known safety records or side effects, the team was able to predict such undesirable targets – and thus potential side effects – half of the time.
That’s a significant leap forward from previous work, which has never tackled hundreds of compounds at once, according to Brian Shoichet, PhD, a UCSF professor of pharmaceutical chemistry who was the joint advisor on the project alongside Laszlo Urban, MD, PhD, at Novartis.
As a result, it offers a possible new way for researchers to focus their efforts on developing the compounds that will be safest for patients, while potentially saving billions of dollars each year that goes into studying and developing drugs that fail. …
Drug Failure Rates
- Estimated cost of bringing a drug to market: $1.2 billion
- Only one in 5,000 drug candidates that enter preclinical testing ever reaches the market
- For every five drugs that start clinical trials, only one succeeds
- Of the 4,300 companies engaged in drug innovation, only 6% (261) have registered a new drug since 1950.
- Worldwide, the pharmaceutical industry spends $50 Billion per year on R&D, but produces only 21 new drugs per year (2008)
- Computer Model Successfully Predicts Drug Side Effects (InnovationToronto.com)
- The cost of Pharma R&D failure (scienceintelligence.wordpress.com)
- Computer model successfully predicts drug side effects (eurekalert.org)
- Assessing Drug Target Association Using Semantic Linked Data (ploscompbiol.org)
- Novartis predicts drug side effects with computers (fiercebiotechit.com)
- Side Effects of Cholesterol-Lowering Treatments (everydayhealth.com)
- Infographic: A Chart That Helps Predict Drug Side Effects (fastcodesign.com)
Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Source: Institute of Medicine
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.
To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.
The free full text report is at
- Ethical and Scientific Issues in Studying the Safety of Approved Drugs (bespacific.com)
- IOM report concludes that the FDA is not doing its job (madinamerica.com)
- IOM report recommends US expand drug safety monitoring after approval (eurekalert.org)
- IOM report recommends US expand drug safety monitoring after approval (medicalxpress.com)
- How Do Docs Prescribe Kids’ Meds? Guess (abcnews.go.com)
- IOM Addresses Drug Safety (lawprofessors.typepad.com)
…The more complicated your problems, the more fragmented your care will be. The average Medicare patient sees two physicians and five specialists a year, (according to The Fragmentation of American Health Care: Cases and Solutions, edited by Einer Elhage). Those with a chronic illness see an average of 13 physicians a year. A Medicare patient with coronary artery disease sees ten physicians in six distinct practices annually. Indeed, the more physicians following someone after a heart attack, the lower the survival rates.
It’s important you know that there is no little Tinkerbell picking up your medical records and automatically delivering them to the physicians in your life who should know what’s happening with you. Consider yourself the the person most responsible to collect written updates, copies of test results and lists of new and changed medications and get them to all your other healthcare providers.
What can you do?
When you get a test result, procedure or have surgery, get the summary in writing, keep a copy, and send or bring copies to all your other healthcare providers. Attach a simple note: “Wanted to keep you up- to-date on my health status. Please put this in my chart.” If it’s an important healthcare issue, be sure to bring up the data or problem at your next visit and mention that you sent a written summary for inclusion in your medical record.
Keep a list of all your medications and update it any time a healthcare provider adds or deletes a drug or changes a dosage. Bring a copy of that list to your medical appointments and to the emergency room if you end up there.
Don’t leave your dentist or your optometrist/ophthalmologist out of the loop. They need to know the details of your general health status. It will help them diagnose and treat any issues they may identify with you. Be sure they know if you have any infections, immune issues, heart problems, chronic conditions or are taking blood thinners or antibiotics, as well as other medications.
If you have a test or procedure and you do not hear the results soon afterwards, do not assume the results were normal. Call the healthcare provider who ordered the test and ask the office staff to email or send you a written copy of the test summary. Keep a copy in your own “medical updates” file. If the test was indeed OK, you still should have copy for reference at a later time, if needed.
If you or someone you love ends up in the hospital, your role of communicator will be even more vital. Often multiple consulting physicians — specialists — are called by the admitting physician to weigh in on issues and questions that develop while you’re in the hospital. They don’t always talk to each other or even realize who has changed or added a medication, who has ordered a test, or what results are in. The more you communicate the better. If you are being asked to go back for a test you already had or if you have questions about what is happening, don’t assume someone at the “nurses’ station” has it all managed. Ask questions and be sure you understand what tests you’re getting and why. If you are being discharged from the hospital ask for the results of any tests or procedures you had in the hospital.
- How to create a pill card (US Agency for Healthcare and Research)
- Creating a Health Journal (American Academy of Family Physicians)
- Personal Health Records (MedlinePlus) has links to overviews, basics, news, “how to”, and more)
- Consumers and Patients (US Agency for Healthcare Research and Quality) contains information in areas as staying healthy, choosing quality care, getting safer care, and comparing medical treatments
- Electronic Medical Records Resource EMRApproved Launches Online Tech Savvy Doc Directory (prweb.com)
From the 23 January Medical News Today article
The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been “varied and unpredictable,” according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.
Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care. …
…The FDA has several standard tools to disseminate new evidence about drug safety. These include “Dear Healthcare Provider” letters to prescribers*, “public health advisories” and “Safety Alerts” targeting the general public, and “black box warnings”** added to a label when a drug’s risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications….
[Article summarizes the effectiveness of 4 categories of communication]
…Part of the problem, the authors emphasize, is the challenge of communicating complex risk messages to a large, diverse audience. “The most effective communications were the simplest, those that were specific, where alternatives were available, and where the messaging was reinforced over time,” said Stacie Dusetzina, PhD, lead author from Harvard Medical School.
*No direct links to “Dear Healthcare Provider” letters at
However, individual letters can be found through using search engines, as a recent one for the drug Promacta
- Beauty Byte: FDA Orders “Black Box” Warning For Botox (bellasugar.com)
- Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta – FDA (medicalnewstoday.com)
- FDA favors more risk info on birth control pills (goerie.com)
- Regulation and drug safety (blacktriangle.org)
- FDA favors more risk info on birth control pills (sfgate.com)
Concerned about the safety of your drugs or medical advices? Wish to report a serious medical product problem online?
The US Food and Drug Agency (FDA) can help.
Medwatch is the FDA gateway for clinically important safety information and reporting serious problems with human medical products.
- DailyMed (National Library of Medicine)
Current Drug Prescribing Information
- Medication Guides
- Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
- Postmarketing Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
- Current Drug Shortages
- Recalls and Alerts
Medwatch also encourages anyone to report serious problems with human medical products
- Report a Serious Medical Product Problem Online
- Reporting Unlawful Sales of Medical Products on the Internet
Want to stay informed with MedWatch updates? Here are some options…
Now available for free in the iTunes store!
Stay up to date with the latest news and government safety alerts for the prescription medicines you take. Submit any side effects you experience to the US Food and Drug Administration (FDA) to make drugs safer for everyone.
MedWatcher is a mobile tool for both healthcare professionals and the general public.
- Addition Of New Infant Acetaminophen Concentration, 160 Mg/5 ML, Says FDA (medicalnewstoday.com)
- FDA Targets Risks From Reused Medical Devices (fda.gov)
- An important FDA advisory update (in my dreams) (medcitynews.com)
- FDA: Do not use ShoulderFlex Massagers (gloucestercitynews.net)
- FDA Warns of Celexa Heart Risk (webmd.com)
- Pradaxa Benefit Outweighs Bleeding Risk – ABC News (abcnews.go.com)
- HCG Weight Loss Products Removed from the Market (fdarecalls.wordpress.com)
- Product Recall: Nostrilla Nasal Spray (habwwe.wordpress.com)
- FDA: Celexa May Damage Heart at High Doses (earlsview.com)
- Nostrilla Nasal Decongestant Recalled – Oct 2011 (wholefoodandmore.net)
- Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta – FDA (medicalnewstoday.com)
From the US Centers for Disease Control and Prevention (CDC) Press Release
New educational program reminds parents to keep medication “Up and Away and Out of Sight”
Each year, one of every 150 two–year–olds visits an emergency department in the United States for an unintentional medication overdose, most often after finding and eating or drinking medicines without adult supervision. To inform parents and caregivers about safe medication storage and what to do in case of an emergency, CDC, the Consumer Healthcare Products Association Education Foundation and a coalition of partners are launching an educational program, Up and Away and Out of Sight, encouraging parents to follow a few simple steps to protect children.
“Parents may not be aware of the danger posed by leaving medications where young children can reach them. In recent years, the number of accidental overdoses in young children has increased by 20 percent,” said Dan Budnitz, M.D., M.P.H., director of CDC’s Medication Safety Program. “A few simple steps – done every time – can protect our children.”
To protect children, parents and caregivers can:
- Pick a place children cannot reach. Find a storage place too high for a child to reach or see. Any medicine or vitamin can cause harm if taken the wrong way, even medicine you buy without a prescription.
- Put medicines and vitamins away every time you use them. Never leave medicines or vitamins out on a kitchen counter or at a sick child’s bedside, even if you have to give the medicine again in a few hours.
- Hear the click. Make sure the safety cap is locked. If the medicine has a locking cap that turns, twist it until the click is heard.
- Teach children about medicine safety. Never tell children that medicine is candy to get them to take it, even if the child does not like to take his or her medicine.
- Tell guests about medicine safety. Ask houseguests and visitors to keep purses, bags, or coats that have medicines in them up and away and out of sight when they are visiting.
- Be prepared in case of emergency. Program the poison control number into home and cell phones (1–800–222–1222).
- Many Young Children Overdosing from Medicines at Home (aa47.wordpress.com)
- Many young children overdosing from medicines at home (gloucestercitynews.net)
- Many Young Children Overdosing from Medicines at Home (cdc.gov)
- Many Toddlers Wind Up in ER After Accidental Overdose (nlm.nih.gov)
- Accidental Drug Overdoses on the Rise Among Kids (webmd.com)
- Over-the-Counter Medicine: Kids Aren’t Just Small Adults (education.com)