Lansing Personal Injury Lawyer - FDA & Prescription Drugs

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

Judge Orders Slew of Lawsuits Over Seroquel Back to Home Courts

David Mittleman — Sun, 22 Nov 2009 10:00:00 GMT

AstraZeneca is faced with loads of trouble lately. For instance, I recently wrote about a current federal lawsuit against the pharmaceutical giant, alleging that the company paid a Chicago-based psychiatrist to overprescribe the anti-psychotic drug Seroquel to his nursing home bound patients. According to recent reports, the company may have even more problems related to Seroquel.

AstraZeneca may face as many as 6,000 trials of lawsuits claiming that Seroquel caused diabetes. U.S. District Judge, Anne Conway, recently recommended sending the slew of suits back to their home courts for trial as test cases. The lawyers for former Seroquel users contend that they are ready to move forward with their clients’ claims that the London-based pharmaceutical company downplayed Seroquel’s diabetes risks.

Nevertheless, AstraZeneca’s lawyers asked the judge to send back only a limited number of the 14,000 lawsuits, arguing that the cases would place an undue burden on judges across the country. In spite of the company’s estimated $623 million in legal defense costs this year, the company’s stocks have risen by 11% this year on the New York Stock Exchange.

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

Alcoholic Energy Drinks Come Under FDA Scrutiny

David Mittleman — Mon, 16 Nov 2009 10:02:36 GMT

Alcoholic energy drinks have gained in popularity, particularly among younger drinkers. But now, the drinks, marketed under flashy names like Evil Eye or Max Fury, are coming under the Food and Drug Administration’s scrutiny. The FDA has never approved of the addition of caffeine to alcoholic drinks, but the producers of these beverages claim that their products are safe. Nevertheless, the FDA is concerned that the addition of caffeine can mask the effects of alcohol, potentially leading to more instances of drunk driving, sexual assaults or other destructive behaviors.

The burden of proving that the caffeine-laden alcoholic beverages are safe falls squarely on the shoulders of the manufacturers. In a September 25^th letter to the FDA, a task force, consisting of the attorney generals of several states as well as several other state, city, and territorial law enforcement officials, stated that “there is a strong emerging consensus of scientific opinion that the combination of caffeine and alcohol…poses a serious public health risk”. Ultimately, the goal is to remove the caffeinated alcoholic beverages from the market. Since the FDA received the letter from the task force, they also issued a letter to the manufacturers of caffeinated alcoholic beverages. Manufacturers have 30 days to respond to the FDA.

So far, larger corporations such as Anheuser-Busch have already removed caffeine from their alcoholic energy drinks. However, other smaller companies such as Los-Angeles based Joose Beverage and Portland, Oregon-based Charge Beverages continue to sell alcoholic energy drinks infused with caffeine. The companies could still challenge the FDA’s request by arguing that their products have already been approved by the Alcohol and Tobacco Tax and Trade Bureau.

Originally posted at InjuryBoard by David Mittleman

AstraZeneca Allegedly Paid Psychiatrist to Over-Prescribe Anti-Psychotic Medication to Patients

David Mittleman — Sun, 15 Nov 2009 10:00:00 GMT

The pharmaceutical giant AstraZeneca may have found it’s most lucrative salesman yet when they discovered Chicago psychiatrist Dr. Michael Reinstein. Indeed, Reinstein was allegedly bringing the company a small fortune in sales by promoting the anti-psychotic drug Seroquel to his mentally ill patients in Chicago-area nursing homes. Furthermore, Reinstein allegedly published research findings that promoted the effectiveness of the drug.

AstraZeneca allegedly paid Reinstein over $490,000 over a decade to peddle their drug. During the same time period, Reinstein faced accusations from his colleagues at the Maxwell Manor nursing home where he worked that he overmedicated his patients. In fact, complaints from patients were so bad that a security guard had to accompany Reinstein on his visits to the nursing home. Some staffers even accused him of convincing patients to take the powerful antipsychotic drug by promising them they would receive passes to leave the nursing home. However, Maxwell Manor closed its doors in 2000, after state officials shut it down for inadequate care and wretched conditions. Now Dr. Reinstein works for other Chicago-area nursing homes and apparently has continued his drug-peddling ways.

While it isn’t illegal for doctors to be paid for conducting research on behalf of drugmakers, health professionals who have encountered Dr. Reinstein have had similar concerns as those of his former colleagues at Maxwell Manor. For example, the case manager at Grasmere Place nursing home in Chicago wondered why Dr. Reinstein put his patients on twice as many drugs as other psychiatrists at the nursing home. There is not a federal lawsuit against AstraZeneca for their actions in paying Dr. Reinstein to allegedly over-prescribe Seroquel. Specifically, court documents show that Reinstein ordered Seroquel for as many as 1,000 Chicago-area Medicaid patients per year, which cost taxpayers as estimated $7.6 million per year. AstraZeneca maintains that they did not profit from the increase in Seroquel sales in Chicago. Rather, they continue to argue that they paid Dr. Reinstein for his promotional work and research only.

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

Researchers Urge FDA to Provide Consumer-Friendly Summaries of Prescription Medications

David Mittleman — Thu, 22 Oct 2009 14:53:51 GMT

The Food and Drug Administration may know all the risks associated with various pharmaceutical drugs, but chances are if you’re a consumer, you don’t. However, if several drug safety experts get their way that may change soon.

Several Dartmouth University researchers recently published an article in the New England Journal of Medicine, arguing that drug labels on prescription medications do not include enough of the information that FDA officials use to make their decision to approve a drug. The experts want this information included on drug labels because it could help patients weigh the benefits and risks of taking certain medications. Furthermore, the researchers say there’s a good reason why drug labels often exaggerate benefits and deemphasize risks: the drug makers are writing their own labels.

The FDA approval process is not as complicated as you may think: in fact, the FDA is required to approve a drug as long as the benefits of taking the drug outweigh the risks. However, as the Dartmouth researchers indicate, the benefits of a drug may be very minimal and potential harmful effects may not be fully understood. In one example, the researchers found that Lunesta, a prescription medication meant to help insomnia sufferers, did very little in helping patients get to sleep faster or sleep longer. Actually, in a clinical study, patients fell asleep only 15 minutes sooner than those taking a placebo and slept only 37 minutes longer. Furthermore, the researchers found similar results with a second drug. Zometa is a medication prescribed to cancer patients with brittle bones. The drug is meant to help reduce skeletal fractures and was approved by the FDA in 2001. However, the FDA found that the drug actually caused increased kidney damage and death when given in the higher dosage (8-mg). Essentially, a patient could still face other physical problems from taking a prescription medication to treat their primary symptoms. The researchers simply want reader-friendly summaries of FDA reviews of medications to supplement the pharmaceutical industry’s drug labels, so that consumers can make informed decisions prior to taking a pill.

Originally posted at InjuryBoard by David Mittleman