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Vol. 20 No. 5 — June 2012
THE MEDICAL DIGITAL
How Safe Are the Prescription Drugs We Take?
Monitoring Adverse Events and Recalls

by Stephanie C. Ardito, Principal, Ardito Information & Research, Inc.

In September 2010, the Centers for Disease Control and Prevention (CDC) released the latest U.S. prescription use drug data. From 2007 to 2008, 48% of American adults used at least one prescription drug; 31% of adults were prescribed two or more drugs; and 11% of the population took five or more drugs. One in every five children and nine out of 10 older Americans used at least one prescription drug; 37% of Americans 60 and older took five or more medications daily [www.cdc.gov/nchs/data/databriefs/db42.pdf].

Increasingly, more and more children are taking medications for asthma, attention deficit disorder (ADD), and antidepressant/social anxiety. This is in addition to their growing use of diabetes drugs arising from the obesity epidemic that is affecting all age groups. As we grow older, many of us will be prescribed medications to treat high blood pressure, cholesterol, arthritis, bone loss, and a plethora of other age-related conditions.

Nearly every day, we are bombarded with news about drug safety issues, shortages of vital anesthesia and cancer drugs, the shutting down of contaminated pharmaceutical manufacturing plants, or the settlement of class action suits due to life-threatening damages caused by prescription drugs.

With the number of possible prescriptions to choose from, how do we determine what drugs are safe from serious side effects? How do we know our physicians are staying current and not being swayed by pharmaceutical reps in recommending newer drugs that are, in actuality, no more effective than older, safer drugs? Can we be assured that pharmaceutical companies are not hiding clinical trial results when launching new drugs?

The Number of Adverse Events Is Rising

In 2010, the Food & Drug Administration (FDA) received nearly 759,000 reports of adverse drug events, an increase of almost 169,000 from the 581,000 cases in 2009 [www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm]. When the private, nonprofit National Committee for Quality Assurance (NCQA) issued its 2011 report, “State of Health Care Quality” [www.ncqa.org/LinkClick.aspx?fileticket=wmpxiKWVgP0%3d&tabid=36], the organization found that 700,000 emergency department visits a year were a direct result of adverse drug events, with 25% of those visits coming from adults 65 years and older. In addition, 49% of patients received at least one inappropriate medication, with nearly 25% of all Medicare patients prescribed one potentially harmful medication. NCQA estimated that adverse drug events are responsible for $4 billion of extra medical costs annually.

Compounding the drug safety problem is the rising number of fraud cases being brought against pharmaceutical companies. Many prescription medications have been marketed by some of the major drug companies for uses other than what the FDA approved them for. Other companies are overcharging Medicare and Medicaid beneficiaries for prescription drugs. Moreover, some companies have paid competitors not to manufacture and sell cheaper generic versions of their drugs. When caught, in most cases, the pharmaceutical companies have paid exorbitant fines, often billions of dollars.

Beside the fines, the government can require companies to enter into corporate integrity agreements, in which the offending firm agrees to regulatory oversight, making assurances that it will not defraud the government again. However, because many pharmaceutical companies are the sole suppliers of critical drugs, the companies will remain in business and are not punished any further. The Department of Justice and the FDA are working on additional solutions to the problem, such as taking away a company’s patent rights if the company is accused of fraud. Furthermore, a bill has been introduced in Congress that would allow the Department of Justice to go after individuals within the company who knowingly defraud the public, as well as the company itself, as is customary now.

The U.S. is not the only country facing censure. The European Medicines Agency (EMA, the FDA equivalent for this area of the world) has come under criticism for its lack of transparency both for not releasing drug clinical trial and safety data as well as for the large number of drug evalution experts who have ties to pharmaceutical companies. Seventeen of 64 experts, or nearly 27% of the membership who sit on EMA’s Committee for Medicinal Products for Human Use, the equivalent of the FDA advisory panels, have such ties [www.bmj.com/content/344/bmj.e976.full?ijkey=mM8c2Oz8LzaQSwo&keytype=ref].

So — what do we do to ensure our safety?

Public Citizen as Consumer Advocate

Several years ago, I discovered the advocacy group Public Citizen [www.citizen.org], founded by Ralph Nader in 1971. In that same year, along with Sidney Wolfe, Nader created the Health Research Group, one of five Public Citizen policy divisions, “to investigate public health threats and press for reforms.” The division is famous among consumers for its monthly print newsletter, Worst Pills, Best Pills News, and its online equivalent, Worst Pills [www.WorstPills.org]. More than 600 of the best-selling drugs are covered in the WorstPills.org database, which offers extensive safety and efficacy information. Public Citizen does not recommend 202 of these drugs “under any circumstances,” but the group does advise about “safer alternatives to harmful drugs” and will deliver “up-to-the-minute email alerts about newly discovered drug dangers.”

My first encounter with Public Citizen came about as a result of a search request from a healthcare public relations agency, whose client was a major pharmaceutical company. The company had submitted a new drug application (NDA) to the FDA. The company was scheduled to present data to an FDA advisory committee (Note: FDA advisory panels are, in part, responsible for making recommendations to the FDA about whether or not to approve drugs. For further information, see www.fda.gov/AdvisoryCommittees/default.htm.) Public Citizen’s Wolfe asked to attend the meeting and was expected to sharply criticize the drug and to try to sway the panel members from approving the drug.

My research mission was to find out how successful Wolfe had been in influencing past advisory committees and whether or not he was a “force to be reckoned with.” The company expected the drug to become a blockbuster, generating more than $1 billion a year. Public Citizen had issued negative press releases about the drug, and the pharmaceutical company didn’t appreciate such publicity in advance of the FDA meeting.

The drug was approved by the FDA, despite Wolfe’s objections, did become a blockbluster, and was then withdrawn from the market 6 years after launch due to major safety issues.

At the time I did the research, I thought it interesting that Public Citizen recommended that a patient not take a new medication until it had been on the market for 7 years to prove its safety (although, Public Citizen does acknowledge that potentially dangerous drugs may offer a limited benefit to patients whose conditions don’t respond to other, more proven drugs). As with the case above, we know that many new drugs have been withdrawn from the market after serious side effects have been reported in the general population. Public Citizen’s research shows that dangerous adverse reactions generally appear within the 7-year period after a drug’s launch.

Public Citizen may also recommend not using a drug for reasons other than safety. The organization may find that research studies do not support any “evidence of effectiveness” or that the drug could be harmful to specific populations. A drug may also be considered a “smoke and mirrors” drug, in which the drug is “nearly chemically identical to an existing drug and received a new patent” (an economic reason for not using the drug).

For those of you who may be skeptical of Public Citizen — after all, Ralph Nader has a mixed reputation — you should know that I am a fan of Public Citizen’s WorstPills.org database. I think an annual subscription, at a cost of $15 at the time of my review, is worth it, especially if you are taking multiple medications, have a condition for which many brand and generic drugs are marketed (cholesterol and high blood pressure for example), or seek information about a new drug your doctor is recommending.

The database is searchable by drug name, by family of drugs, and by disease or condition. You will also receive email alerts about new safety issues that arise, as well as drug recalls. There is quite a bit of free prescription drug information on the website, so you might start with the site’s search engine [https://www.worstpills.org/search.cfm] to determine if you’re interested in getting a paid subscription. Public Citizen operates similarly to Consumer Reports, in that the nonprofit organization does not accept advertising or government or corporate money, nor does the group engage in political activities or endorse any candidate for elected office. Funding comes from foundation grants, publication sales, and member support.

Drug Recall and Adverse Events Resources

After WorstPills.org, my next stop would be the FDA website for lists of drug recalls [www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm], safety information [www.fda.gov/Drugs/DrugSafety/ucm199082.htm], or drug shortages, especially for people undergoing surgery requiring general anesthesia and/or cancer chemotherapy treatment [www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm]. These particular resources can be overwhelming with the breadth of information that will come up in your searches. I often bypass the FDA general Drugs site and go directly to the agency’s MedWatch program [www.fda.gov/Safety/MedWatch/default.htm]. MedWatch provides a more concise and clear picture of drug safety information and reports of adverse events. You can also sign up for free MedWatch Safety Alerts [www.fda.gov/Safety/MedWatch/ucm228488.htm] delivered to your email account or to your cell phone by text messaging.

Late in 2011, a startup company, AdverseEvents, Inc. [http://adverseevents.com], announced a new internet service aimed at synthesizing FDA content into more manageable and readable formats. AdverseEvents has organized the wealth of data available from the FDA’s Adverse Event Reporting System (AERS) [www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation Surveillance/AdverseDrugEffects/default.htm] into a database that provides information on more than 4,500 drugs.

Six Recommended Prescription Drug Websites

For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations:

CenterWatch Clinical Trials

www.centerwatch.com/clinical-trials/listings

Drugs.com

www.drugs.com/drug_information.html

Drugs@FDA

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

MedlinePlus

www.nlm.nih.gov/medlineplus/druginformation.html

RxList

www.rxlist.com/drugs/alpha_a.htm

WebMD

www.webmd.com/drugs

Simply type in the name of the drug of interest, and you will see a list of Drug Reports. Clicking on any one of the reports brings up a description of the drug, recent news about the drug’s safety, and a chart listing the drug’s top side effects. By clicking on Compare next to each side effect, you can see how the drug stacks up against other drugs in its class.

While a great deal of information is available on the site at no cost, AdverseEvents does charge fees, ranging from $10 per month for consumers and $25 per month for health professionals, to higher fees for group and enterprise customers (depending on the number of users expected to search the database within an organization). For the fee, users can view expanded coverage about each drug, condition, and adverse event reported, as well as receive email alerts, custom analysis provided by AdverseEvents experts, and personalized support. Although too soon to tell whether or not AdverseEvents will appeal to the public, I was initially impressed with the simplicity of the search results compared to the FDA site and believe AdverseEvents to be a service we should watch.

DrugCite.com [www.drugcite.com] is another new side effects database, made available to the public more than a year ago. As with AdverseEvents.com, the site has gone to great pains to create a “friendly interface” for those who wish to view simple summaries of the data available through the FDA’s AERS system. The opening page is straightforward, only featuring a search box. You can type in a drug name or a disease condition. Initially, you will see a graph plotting adverse events over a period of time and a list of the most commonly reported adverse events, ranked from the most common to the least common. The number of side effects cases and percentages are also furnished. Across the top of this first page of results, you can restrict the adverse events to specific ages and genders, or click on Drug Profile, Learn More, and Reference to view additional detailed information (such as the total number of adverse events, the average age of a person when the side effect occurs, and male/female percentage breakdowns). Many of the charts and graphs can be exported to Excel.

My only disappointment was the Reference page, where case reports are listed for each drug and disease condition in which safety concerns by physicians and researchers have been published in the medical literature. Citations are pulled from PubMed and presented in chronological order from the most recent case report to the oldest. For example, I searched DrugCite for cholesterol case reports and came up with nearly 800 citations. My feeling is that one would be better off searching PubMed directly, where search results could be further refined and made more manageable to view. But this is my only complaint about DrugCite. If I had to choose between this service and AdverseEvents, my preference would be DrugCite.

The Next Time You Watch an Ad on TV

How often do our eyes — and ears — glaze over when we hear all the side effect warnings presented in TV drug ads (as required by the FDA)? With our appetite for the “newest and greatest” electronic innovations (think how often we upgrade to the latest smartphones, tablets, computers, and televisions), it makes sense to me that we also want to take state-of-the-art medications. While there is evidence that prescription drug advertising encourages consumers to engage in dialogues with their doctors about their conditions and available treatment protocols, we must be careful that new generation drugs are really new, not simply reformulated or combined with other drugs. If cheaper, safer generic drugs are available, these options most definitely should be discussed with your doctor as alternative treatments to drugs that haven’t been on the market long enough to truly judge their safety. But I also recognize that after a patient has taken a number of older, more established drugs to treat a condition and nothing has worked, then he or she might not have any choice choice but to try something new.

We also have to be careful about not being too paranoid when we hear about new warnings from the FDA. Recently, I was disappointed to hear about revised FDA labeling for the statin class of drugs prescribed to control high cholesterol [www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm?utm_source=
fdaSearch&utm_medium=website&utm_term=statins&utm_content=2
]. Perhaps the most famous statin, Lipitor, is a drug I’ve taken since 2002 (6 years after approval!). Lipitor has generally been considered a safe drug with peer-reviewed published accounts of benefits other than maintaining normal cholesterol levels. Apparently, there are rare reports of serious liver problems, not-so-serious memory loss and confusion events that go away once the drug is no longer taken, and increased blood sugar levels associated with diabetes.

Am I going to stop taking Lipitor? No. I tried a number of cholesterol-lowering drugs that weren’t effective before agreeing with my doctor that I should give Lipitor a chance. I did talk to my physician about the new warnings, and he reminded me that at least annually, I have blood work done to check my liver and blood sugar. If memory loss should become a problem, to tell the truth, I’m not sure if it will be a result of taking Lipitor or just a normal sign of aging!

Pharma’s Reputation and Lobbying Power

In August 2011, Gallup released a poll ranking industries according to the public’s positive, negative, and neutral views [www.gallup.com/poll/12748/Business-Industry-Sector-Ratings.aspx]. Pharma was ranked near the bottom, with 43% of consumers viewing the industry as negative.

The pharmaceutical industry is a powerful lobbying group. According to the Center for Responsive Politics — a nonpartisan, independent, and nonprofit research group “tracking money in U.S. politics and its effect on elections and public policy” — the drug industry has spent nearly $2.3 billion on lobbying efforts since 1998 and was ranked No. 1 among all industries in lobbying money spent in 2011 (more than $240 million) [www.opensecrets.org/lobby/top.php?showYear=a&indexType=i].


Stephanie C. Ardito, an independent consultant to the healthcare and pharmaceutical industries, is based in Laurel, Md. Her email address is sardito@ardito.com.

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