Michigan Personal Injury Blog - Drug

Pharmaceutical Companies Use Rx Data Mining to Boost Sales Tactics, Patient Advocates Argue

David Mittleman — Thu, 03 Dec 2009 16:06:36 GMT

When your doctor prescribes you a medication you probably expect that the information stays between you, the doctor, and your insurance company. However, prescription data miners are changing that dynamic in scary ways: by spying on your prescription data they are able to provide pharmaceutical companies with information to entice doctors to prescribe their medications more frequently. In fact, pharmaceutical companies are able to learn how to “fine-tune” their messages so that when a sales-rep calls a doctor, they are able to give a good pitch. Furthermore, pharmaceutical companies can entice doctors to prescribe their medications with free samples of drugs. While the individual identities of patients is not disclosed in data mining, government officials are concerned about doctors’ decision-making becoming distorted because of the new sales tactics of pharmaceutical companies with access to prescription information.

The process of prescription data mining begins with medical data firms. Medical data firms have access to billions of prescription records, which they purchase from pharmacies and health insurers who have physician data from the American Medical Association, as well as other sources. They then are able to sell this information to pharmaceutical companies. According to critics, the end result is that drug companies are able to sell their newest and costliest medications, not necessarily the most effective medications.

Patient advocates and government officials are also concerned about the interference in the patient-doctor relationship, as well as increased spending on expensive drugs. However, data miners argue that they are actually helping contain the cost of prescription medications by improving quality and by quickly providing doctors with information on which drugs work best.

Originally posted at InjuryBoard by David Mittleman

FDA Trying to Reduce Preventable Medical Error from Prescription and Over the Counter Drug Use

David Mittleman — Sun, 29 Nov 2009 10:39:08 GMT

Over 3 billion prescriptions are written annually in the United States, and tens of millions of people rely on prescription and over-the-counter (OTC) drugs to sustain their health. With such high numbers of drugs being used, the risk of preventable medical error from improper drug combination or the misuse of medication has led the Food and Drug Administration (FDA) to start the Safe Use Initiative.

As my Virginia-based colleague Greg Webb noted, the initiative calls upon doctors, health care professionals, and even patients to help the FDA identify specific, preventable medication risks and develop interventions to such risks. The initiative has a goal to implement some interventions within the first 12 months of the Initiative's existence.

Among the target groups the Initiative seeks to protect is children. One study cited by the FDA found that over 9,000 children were exposed to prescription opioid drugs from 2003 to 2006. Just as startling was the fact that 60,000 emergency room visits occur annually as a result of unsupervised ingestion of medication by children under the age of 12.

Some of the changes consumers can expect will be better information of the prescription and OTC drugs they take, including the proper dosage to take along with calibrated spoons or cups that are easier to read and correspond with the product's packaging.

Originally posted at InjuryBoard by David Mittleman

Drug Makers Raise Prices Despite Promises of Cost Reform

David Mittleman — Wed, 18 Nov 2009 09:39:28 GMT

Drug makers pledged to help cut down healthcare costs by $8 billion a year, but now it doesn’t look like they are making good on that promise. Instead, in the last year alone, the pharmaceutical industry has raised their wholesale prescription drug prices by 9%. Instead of cutting down on costs, that raises the nation’s drug-related healthcare costs by $10 billion, and represents the highest annual rate of inflation on drug prices since 1992.

Originally, drug makers had touted their agreement with the White House and the Senate Finance Agreement chairman to trim $8 billion a year from the nation’s drug costs, or $80 billion over 10 years, by giving rebates to older Americans and the government. However, the recent increase in prices would essentially cancel out the savings for at least the first year of the plan, if not the entire 10 years.

Nevertheless, drug makers argue that there are valid business reasons for raising prices. Specifically, they argue that they are forced to raise their prices in order to invest in future research and development of new drugs, especially as patents expire on previous drugs. While drug makers claim their “reasons” for raising their prices, many Americans who do have drug insurance will be forced to pay out-of-pocket for the leftover cost of overpriced drugs that insurance won’t entirely cover.

Originally posted at InjuryBoard by David Mittleman

Dangerous Prescription Errors Far Too Common

David Mittleman — Sat, 07 Nov 2009 10:29:00 GMT

Each year, over 3 billion prescriptions are dispensed in the United States. Patients depend on these medications for their well-being, and it is important that the dispensing pharmacy accurately fill each prescription with the correct drug and dosage. In addition, pharmacists and pharmacy technicians are under enormous pressure to keep costs low by filling high volumes of prescriptions quickly.

All of this adds up to a shockingly high risk for injury as a result of pharmacy error. A recent investigation into prescription error identified several potential pitfalls:

The pharmacy dispenses a drug other than that which was prescribed
The pharmacy fails to identify a potentially dangerous drug interaction
A pharmacist fails to counsel the patient about the drug
The dosage is incorrectly provided on the label

These are just four possible types of pharmacy error. While some errors may not result in any harm to the patient, those that do injure the patient present a very serious safety concern. According to some studies, perhaps as many as one in ten prescriptions result in a significant adverse outcome. By taking an active role in your health care and asking questions of your doctor and pharmacist, you may be able to avoid becoming a victim of pharmacy error.

Sometimes, even in spite of your best efforts, a pharmacy may make a mistake that causes you injury. The attorneys at our firm handle pharmacy negligence cases regularly and we may be able to help hold the pharmacy accountable for their actions. In doing so, we can help compensate you and help prevent such an error from happening again.

Originally posted at InjuryBoard by David Mittleman

CDC Links Two Antibiotics Taken During Pregnancy to Subsequent Birth Defects

David Mittleman — Fri, 06 Nov 2009 10:00:00 GMT

Researchers at the Centers for Disease Control who studied the effect of antibiotics during pregnancy have discovered a link between birth defects and several types of antibiotics, specifically those to treat urinary tract infections, which are referred to as sulfa drugs and nitrofurantoins. However, the most common antibiotic given during pregnancy, penicillin, appears to be the safest.

The new study is the first large-scale research effort to study the effects of antibiotics on pregnancy. Furthermore, it was the first time that researchers were able to find an association between urinary tract treatments and birth defects. The study, which will be published in the November Archive of Pediatrics and Adolescent Medicine, looked at 13,000 mothers whose infants had birth defects as well as 5,000 women with healthy babies who lived in the same regions. The women were interviewed by phone for six weeks to two years after their pregnancies and any that reported having taken antibiotics during the month before conception through the first three months of pregnancy, were identified as exposed to antibiotics.

While the study is revealing and could help doctors decide which antibiotics to avoid giving to pregnant women, the researchers cited a weakness in the study: the women’s memories of which antibiotics they took could be faulty. Furthermore, the underlying condition, rather than the antibiotics, could have also contributed to birth defects. Nevertheless, the researchers concluded that sulfa drugs caused birth defects such as rare brain and heart problems and shortened limbs. Similarly, nitrofurantoins contributed to heart problems and cleft palate. Overall, the drugs seemed to double or triple the risk of these specific types of birth defects.

For further information and links, please visit Jane Akre’s blog on antibiotics and pregnancy at the National Injury Board News Desk.

Originally posted at InjuryBoard by David Mittleman

GAO Report Reveals that FDA is Failing on Forcing Drug Makers to Prove Drugs Work

David Mittleman — Wed, 28 Oct 2009 09:49:14 GMT

According to a Government Accountability Office report released on Monday, between 1992 and 2008, the Food and Drug Administration asked pharmaceutical drug makers to complete 144 studies associated with 90 applications waiting for approval. However, drug makers only completed 2/3 of the requested studies. Overall, the study indicates that serious problems still exist: federal drug regulators have repeatedly failed to force drug makers to comply with FDA requests to prove that their pharmaceutical drugs work. This is particularly problematic for patients, who remain uninformed about whether or not their medications are actually beneficial.

In fact, concerns over the FDA’s ability to prompt drug makers to complete requested studies reached such a crescendo, that Congress passed a law in 2007 giving the FDA greater power in enforcing such rules. Since that law passed, the FDA can fine drug makers if they fail to follow through with promised studies.

All of the 90 applications cited in the recent GAO report were submitted to the FDA under a program that expedites the approval process for life-threatening conditions like cancer or HIV/AIDS. Under the accelerated-approval program, the FDA often approves medications that may or may not be beneficial in treating these diseases. However, after a drug is approved through the expedited process, the drug maker is supposed to conduct confirmatory trials to prove that the drug is beneficial. Nevertheless, the process is still risky: some patients may benefit from a drug. On the other hand, the most vulnerable could also suffer needlessly from the side effects of a medication, while experiencing very little improvement in their condition. In response to the recent GAO report, the FDA’s principal deputy commissioner has promised that the agency is overhauling their tracking system and that the problem will be fixed.

Originally posted at InjuryBoard by David Mittleman

Michigan's Drug Industry Immunity Law Persists Despite Ending to Recent Pfizer Case

David Mittleman — Thu, 15 Oct 2009 13:18:42 GMT

Henry Greenspan made a brilliant point in a recent op-ed piece in the Detroit Free Press in response to the $2.3 billion in criminal and civil penalties levied against Pfizer for illegally marketing several of its drugs. As Greenspan points out, this is not only the largest fine imposed on a drug company, it is also the largest fine levied against any company in American history. Nevertheless, because of a14-year-old drug industry immunity law in Michigan, Michigan residents cannot bring suit over injuries or deaths caused by Pfizer drugs.

What’s more astonishing is the fact that Pfizer pled guilty to felony charges. Indeed, Pfizer’s subsidiary companies promoted their drugs for uses that were explicitly rejected by the FDA because of safety concerns. As Greenspan points out, as far as these off-labeling tactics caused injury and death, Pfizer’s actions are paramount to negligent homicide. Pfizer is, therefore, a self-admitted felon. However, Michigan citizens are still left with no recourse to hold Pfizer accountable for their actions.

Politicians who continue to defend Michigan’s ridiculous law will have to face Michigan voters in years to come. Generally, these politicians are on the right and with a gubernatorial race within a little over a year, these Republicans will have to find a way to explain their position to their voting base. Election day is right around the corner: November 2, 2010, to be exact. So be careful of which box you check on the ballot. Electing the wrong candidate could mean your right to sue a company who cares so little for your well-being that they would purposefully sell you drugs that could injure or kill you or your loved ones.

Originally posted at InjuryBoard by David Mittleman

Drug Overdoses Overshadow Number of Deaths Caused by Auto Accidents in 15 States

David Mittleman — Sun, 04 Oct 2009 10:00:00 GMT

Prescription and non-prescription painkillers have pulled ahead as the leading cause of death in 15 states. Painkillers are easier to find, apparently so simple to obtain that in some states more people die from overdoses than the number that die in auto accidents.

For the past ten years, auto accidents have caused the most injury-related deaths. Overall, they still do: according to the Centers for Disease Control, in 2006 there were 45,000 auto accident related deaths as compared to 39,000 drug overdose deaths. However, 15 states including Michigan, Massachusetts, New Hampshire, Rhode Island, Connecticut, New York, New Jersey, Maryland, Pennsylvania, Ohio, Utah, Nevada, Oregon, Washington, and Illinois, have more drug deaths than auto accident deaths. Specifically, Michigan had 500 more drug related deaths than auto accident related deaths in 2006.

The CDC found that many drug related deaths were caused by abuse of opiate painkillers such as methadone, Oxycontin, and Vicodin. In fact, according to the CDC’s statistics, 1 in 5 adults and 1 in 10 adolescents are prescribed opiate painkillers each year. Back in February, regulators announced that they were stepping up their efforts to combat opiate painkiller abuse. Particularly, they targeted 24 powerful painkillers and sent letters to 16 drug companies to inform them that their drugs were subject to review by the Food and Drug Administration. Specifically, the FDA is concerned about high-potency painkillers, which can cause serious health problems, including death.

Originally posted at InjuryBoard by David Mittleman

FDA Issues Warning to Evenflo After Reports of Electrical Shock from Breast Pump Use

David Mittleman — Thu, 17 Sep 2009 10:00:00 GMT

Several women who used the Evenflo breast pump were shocked while expressing their breast milk—literally. Recently, the Food and Drug Administration issued a warning to the Evenflo Company for failing to properly investigate the complaints of several women who reported receiving electrical shocks while using the company’s breast pump.

In an August 25^th letter that was released on Tuesday, the FDA said it found manufacturing violations at two Ohio Evenflo plants. Inspections at the two facilities revealed that Evenflo wasn’t in compliance with the federal manufacturing rules that make it mandatory for companies to review and evaluate all complaints. In fact, Evenflo received a total of 55 various complaints and only reviewed 37 of those. The 18 other complaints were left uninvestigated, with at least three of those complaints specifically relating to reports of electrical shock from using the breast pumps.

Moreover, according to federal regulations, companies are required to report issues with medical devices to the FDA. However, Evenflo did not follow through on these requirements, and the FDA reports that the company has still failed to address these concerns. Lindsay Harris, Evenflo’s vice president of quality and product integrity, maintains that the company is “working cooperatively with the FDA” to address the agency’s concerns.

Originally posted at InjuryBoard by David Mittleman

Alli Weight Loss Medication Under Investigation, Potentially Linked to Cases of Liver Damage

David Mittleman — Thu, 03 Sep 2009 10:00:00 GMT

The weight loss pill, Alli, seemed like a welcome relief for many people struggling to lose weight. Tired of yo-yo dieting, overweight individuals were eager to try the first Food and Drug Administration approved weight loss pill, hopeful to lose the weight without the horrible and long-lasting side effects of other diet pills. Unfortunately, a diet pill receiving FDA approval is not proving to be a cure all for dieters. In fact, the FDA recently announced that they are investigating reports of 32 cases of serious liver injury after consumers took Alli.

Alli is the brand name of a drug called Orlistat, which works by blocking the absorption of fat into the body. The pill is aimed specifically at overweight adults who have a Body Mass Index (BMI) of 28 or more. The drug was named Alli, as its appeal is that it can “help people lose 50% more weight than dieting alone”. However, side effects include diarrhea and gas if a person continues to eat too much fat while taking the drug. Furthermore, there are more serious side effects such as yellowing of the skin and whites of the eyes, as well as weakness and stomach pain.

According to the FDA, there were 32 reports of serious liver damage and 6 reports of liver failure between 1999 and 2008. 30 of the reports of liver damage occurred outside of the U.S. In total, 27 cases required hospitalization. FDA experts are stressing that individuals go to the hospital immediately if they experience possible symptoms of liver injury such as fatigue, fever, jaundice, or brown urine.

GlaxoSmithKline, the maker of Alli, continues to defend the medication’s safety. They maintain that the drug was tested in clinical trials with 30,000 patients. Please remember that the simplest and safest way to lose weight is the old-fashioned way: eat moderate amounts of wholesome foods and get regular exercise.

Originally posted at InjuryBoard by David Mittleman