Charlottesville Personal Injury Lawyer - FDA & Prescription Drugs

New FDA Initiative Seeks To Decrease Drug Dosage Errors

Greg Webb — Sun, 22 Nov 2009 08:52:53 GMT

In an attempt to curb the number of serious deaths and illnesses caused by misuse of medication, the Food and Drug Administration (FDA) is attempting to identify the most serious threats and find ways to avoid them through their Safe Use Initiative. The FDA called on doctors, other healthcare professionals and consumers in order to gain information about which drugs and circumstances may be particular problems; they will also be calling public hearings as well.

One of the main issues the FDA has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage if taken in excess; because the drug is used in so many different medications, it is hard for the consumer to know how much he or she is taking. The FDA will also investigate information given to patients, such as labels, package inserts and directions that pharmacists use when distributing prescriptions. Such an investigation is long overdue since about 99.5% of pamphlets contain unregulated information that is missing critical information.

According to a 2007 study conducted by the Institute of Medicine, about 1.5 million preventable “drug accident events” occur annually in the United States; aside from the toll on health, this costs an estimated $4 billion each year as well. FDA officials acknowledged they do not have these hard figures since the term "preventable harm" encompasses a range of poorly tracked activities including accidental overdoses, distributing the wrong medication or the wrong dosage, abuse of medication and drug-quality defects; medication errors do not contain common side-effects.

This writer thinks this is a good initiative. One wonders how many incidents there are per year of unintended “misuse” of medications, through lack of education or information about the particular drug at issue. Many people overuse over-the-counter pain medications because they cannot afford prescription strength drugs.

Originally posted at InjuryBoard by Greg Webb

AstraZeneca’s Seroquel Subject of $520 Million Settlement

Greg Webb — Wed, 04 Nov 2009 17:58:05 GMT

AstraZeneca, a pharmaceutical company, has reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its best-selling psychiatric drug Seroquel. According to research firm IMS Health, Seroquel was the top selling anti-psychotic medication in 2004 with about $17 billion in sales. AstraZeneca joins a list of drug manufacturers forced to pay billions of dollars to settle inquiries filed by former company insiders.

AstraZeneca disclosed one of the investigations related to physicians who participated in clinical trials involving Seroquel and another related to off-label promotion of the drug. However, a company spokesman refused to give more specifics about the physicians or clinical trials under investigation. He also said the company was in final negotiations to settle the whistle-blower lawsuits and reach a corporate integrity agreement with the U.S. Justice Department.

As a result to the company’s aggressive marketing campaign, Seroquel has been used for children and elderly patients for indications not approved by the Food and Drug Administration (FDA); doctors are allowed to prescribe any approved medication for off-label uses. AstraZeneca has also said that as of October 9, it has been served with 14,444 civil lawsuits over Seroquel’s misleading marketing because many of the patients using the drug have developed diabetes and other health problems.

Originally posted at InjuryBoard by Greg Webb

FDA Slow In Banning Fraudulent Drug Researchers

Greg Webb — Sun, 01 Nov 2009 09:52:38 GMT

In a report scheduled for release on Thursday, Congressional investigators say the Food and Drug Administration (FDA) pays little attention to its duty to ban investigators that are convicted of fraud; it is so disorganized that it takes an average of four years to complete its actions. For example, Delfina Hernandez helped to implement one of the most audacious drug research frauds in American history. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, California that federal agents raided in 1997. The institute conducted more than 170 drug studies for almost every major drug manufacturer in the world and regularly falsified patient records and data while doing so. Hernandez plead guilty to fraud, thus requiring the FDA to ban her from participating in further drug research. The agency had five years after her conviction to act, however, because regulators sent her a legal notice years late and to the wrong address, she can legally continue to conduct research. When the agency finally learned of its mistake, it was too late for the ban to take affect.

In a review of eighteen proceedings, investigators from the Government Accountability Office ("GAO") found it took anywhere between one to eleven years to complete its ban on fraudulent researchers. This means the researchers were able to conduct experiments for years following their supposed ban. The FDA has claimed it has corrected this problem with increased staffing and centralized coordination. House Representative Joe Barton, the senior Republican on the House Energy and Commerce Committee, criticized the FDA’s slowness in banning fraudulent investigators and has promised to introduce legislation to give the agency more power to ban researchers convicted of fraud from later participating in any kind of human research.

Congress needs to act quickly and decisively to correct this "loophole". This type of governmental oversight is unacceptable.

Originally posted at InjuryBoard by Greg Webb

Procter And Gamble Scolded By FDA For Using Vitamin C In Products

Greg Webb — Sun, 25 Oct 2009 20:19:22 GMT

FDA (Food and Drug Administration) regulators are scolding Procter and Gamble for adding Vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations; the FDA issued a warning to the consumer products company, stating medications such as Vicks Nyquil and Dayquil have not been approved to contain Vitamin C. Though Procter and Gamble claims Vitamin C can help to “blunt” the effects of a cold, an FDA expert panel found that Vitamin C is not explicitly effective for the prevention or treatment of the common cold. The FDA is tasked with verifying marketing claims about drugs.

Anecdotally, a lot of people swear by Vitamin C for cold prevention. Studies do not seem to support that, however. I would be interested to know how many people believe that Vitamin C has prevented them from getting a cold, or prevented the cold from getting worse.

Originally posted at InjuryBoard by Greg Webb

Popular Contraceptives Raise Health Concerns

Greg Webb — Thu, 08 Oct 2009 07:00:00 GMT

Oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer Healthcare, largely because the products’ marketing presents them as much more than just pregnancy prevention. In fact, the franchise had worldwide sales of $1.8 billion last year, based on Bayer successfully positioning the brands as the go-to medication for women under the age of thirty-five. Yaz, which contains less estrogen than Yasmin, is the top-selling birth control pill in the U.S., garnering much of its popularity from a multi-million dollar ad campaign that promotes the drug as one that combats acne and severe pre-menstrual depression.

Recently, however, the Yaz franchise has faced criticism from several researchers, trial lawyers and health advocates who fear the drugs place women at a higher risk for developing blood clots, strokes and other health problems, as opposed to other birth control medications; because the drug contains drospirenone, which can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems. The critics of Yaz are up against a recent European study, sponsored by Bayer, which reported the opposite conclusion. This study claims the cardiovascular risks in women taking Bayer products that contain drospirenone were the same as those taking an older formula of birth control pills that contain levonorgestrel. One doctor, who is a paid consultant for Bayer, claims the risk of developing blood clots is far less in taking birth control pills than being pregnant and having a baby.

Despite Bayer’s report, regulators and other scientists are finding other problems with the company. For example, two other studies on Danish and Dutch women did find a higher risk of venous blood clots for women taking newer progestins, including drospirenone. One of the doctors who authored the Dutch study says the reports of an increased risk were worth acting on by switching the pills from drospirenone to levonorgestrel; he said, "Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?" Earlier this year, the Food and Drug Administration (FDA) also asked Bayer to correct misleading television commercials that overstated the drug’s efficacy, promoted it for conditions for which the drug is not approved and minimized serious risks associated with the drug. In September, the FDA also cited the company for failing to follow proper quality control procedures at a German plant that makes drospirenone and other hormone ingredients

Attorneys suing Bayer on behalf of patients who claim they developed blood clots and other health problems due to the drugs are arguing the company knew or should have known the pills created a higher risk. One such patient has lost partial function in her right lung after developing a blood clot from the birth control pill; she claims to have not known there was a higher risk using Yaz than any other birth control pill. Because Yaz and Yasmin contain warnings on their packages about the risk of side effects like blood clots and strokes, it may be hard for plaintiffs to win lawsuits. The one ray of hope may be the argument that due to misleading Yaz commercials, women were enticed to take the drug, thereby becoming exposed to health risks they may not have otherwise incurred.

In response to a reporter’s inquiries, Bayer stated its birth-control pills had been and continue to be studied extensively and the company stands behind their safety. The drugmaker also claims to have responded to the FDA’s inquiry into its manufacturing practices. Even if Bayer can adequately respond to the safety and other concerns, some industry analysts believe the outpouring of criticism may tarnish Yaz’s line image. Bayer said it has been served with seventy-four lawsuits brought by women who claim to have developed problems after taking Yaz or Yasmin; the company says it will defend itself vigorously against the allegations. While the lawsuits may rattle some consumer confidence, the warnings from federal health authorities concerning quality control and advertising raise larger questions regarding Bayer’s compliance with government rules.

Originally posted at InjuryBoard by Greg Webb

Bayer Warned By FDA Regarding Birth Control Products Quality

Greg Webb — Thu, 24 Sep 2009 22:00:35 GMT

Food and Drug Administration (FDA) regulators have written a letter warning drugmaker Bayer about quality control issues in the company’s plant in Berghamen, Germany. This plant is responsible for making drospirenone, the key ingredient for popular birth control drugs like Yaz and Yasmin; these products were Bayer’s top selling pharmaceuticals last year, with global sales of $1.8 billion. Instead of reporting individual tests results, FDA officials said the company measured the quality of its drug ingredients based on an average of several samples; Bayer shipped eight drug batches to the U.S. to be tested for quality using the sample average method, however the FDA does not allow this.

In April, Bayer responded to the FDA’s allegations by stating the quality in all drug batches shipped to the U.S. between 2007 and 2009 were not affected. In response, the FDA wrote another letter disagreeing with Bayer’s “rationale and conclusion.” While the FDA has not advised patients to stop using the products, they have asked Bayer to supply an entire list of all shipments to the U.S. that may have used the averaging method and provide a plan that would prevent the problem from recurring. The agency also said it was considering delaying imports from the German factory until Bayer addresses the warning letter.

New FDA Commissioner Margaret Hamburg has announced many changes designed to speed the pace of warning letters. This includes a streamlined review process for sending letters and shorter deadlines for companies to respond.

Originally posted at InjuryBoard by Greg Webb

Feds Seek to Change Drugmakers' Practices With Pfizer Settlement

Greg Webb — Sun, 13 Sep 2009 14:41:06 GMT

A record $2.3 billion settlement with Pfizer has reinforced the Obama administration’s stance on health-care fraud. Recently, “Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.”

The investigation of Pfizer began four years ago when corporate insiders began to question the marketing practices that were being employed by the company in order to turn a profit. The methods used by Pfizer meant that employees were expected to “increase profits at all costs, even when sales meant endangering lives,” said John Kopchinksi, a Pfizer salesman from Florida. It was a group of employees, including Kopchinski, who called attention to the company’s illegal activity, which included bribing doctors into prescribing Bextra for conditions that it was not designed for, “[creating] sham requests for medical information as an excuse to send unsolicited advertising materials to physicians,” as well as writing articles to promote their product without disclosing the fact that they had a hand in preparing the promotional materials.

Pharmacia and Upjohn will pay $1.3 billion in fines and forfeiture and an additional $1 billion to state and federal authorities to “resolve civil allegations of improper marketing over Bextra and three more drugs,” with the former payment being the largest criminal penalty ever imposed in the U.S., according to prosecutors. The other drugs in question were: “Geodon, an antipsychotic medicine; Zyvox, an antibiotic; and Lyrica, an epilepsy medicine.”

The Pfizer settlement is one step in a long-term goal, with federal agencies more focused than ever on targeting and taking action against wrongdoing drugmakers in the health-care industry. In addition to the Pfizer settlement, the “task force” deployed by the Justice and Health and Human Services departments have been issuing indictments on smaller companies over the past several months for “[bilking] Medicare and Medicaid out of hundreds of millions of dollars through schemes involving wheelchairs, medical equipment and costly HIV/AIDS treatments.” With the Pfizer settlement, “the Justice Department’s civil division…has pledged to devote more attention to whistleblowers at drug companies and insurance firms who flag improper payments and marketing schemes.”

According to the acting U.S. attorney in Massachusetts, Mike Loucks, Pfizer, the world’s largest drugmaker, “has entered into four settlements with the Justice Department over the last decade.” With Bextra being voluntarily removed from the market in 2005 over its role in “strokes, heart attacks and blood clots in the lungs,” Health and Human services Secretary Kathleen Sebelius said scrutiny on the company will be heightened.

Despite the settlement, concerns grow that it will not be enough to sway drug companies from their “bad behavior.” With the pharmaceutical industry being one of the most profitable in the country (raking in close to $50 billion last year), Sidney Wolfe, director of Public Citizen’s Health Research Group notes: “The ever-escalating fines are unlikely to stop drug companies from continuing to bribe doctors because they represent just a fraction of drug company profits and no one has gone to jail.”

Originally posted at InjuryBoard by Greg Webb

Popular Dietary Supplements Alleged to Contain Steroids

Greg Webb — Wed, 12 Aug 2009 10:46:31 GMT

Federal authorities filed court papers last month alleging that two over-the-counter dietary supplements commonly used by high school football players contain steroids. Tren Extreme and Mass Extreme, manufactured by American Cellular Labs, are marketed as a potent legal alternative to steroids. However, search warrants were executed alleging that the supplements contain illegal designer steroids including Madol, a substance first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.

Authorities say that Max Muscle, a supplement store with approximately 100 locations across the country, paid American Cellular Labs to be the exclusive retailer of these products, which are also available online.

An individual at Max Muscle’s corporate office said that no one was available to comment on how many of the company’s stores carried American Cellular products. A Max Muscle outlet in Iowa was offering an online promotion of Tren Xtreme for free, but a salesman reported that the store no longer sold the brand.

Travis Tygart, head of the United States Anti-Doping Agency, said that the substance helps athletes quickly gain strength and muscle mass and is popular amount high school football players because it works. He did not offer an estimate regarding how many high school athletes have used the product.

The investigation into American Cellular Labs is led by Jeff Novitzky of the FDA and prosecutors from the U.S. attorney’s office for the Northern District of California. Novitzky has been the face of the government’s investigation into the distribution of performance-enhancing drugs since 2002.

The FDA has jurisdiction over dietary supplements, which are defined as products that offer general health benefits but do not claim to treat specific conditions. Manufacturers of dietary supplements are responsible for recording and ensuring the accuracy of the claims that they make regarding the safety and efficacy of their products. The FDA is only empowered to act in cases when it identifies a harmful or adulterated product on the market. If authorities find that a supplement contains an undeclared pharmaceutical ingredient like a steroid, the product is considered to be an illegal drug.

Steroids are naturally produced organic compounds that can be used legally to treat conditions like testosterone deficiency. Athletes have also used illegal forms of steroids for performance enhancement. Such usage is particularly concerning in preteen and teenage boys, because artificially high levels of testosterone can stop bone growth.

Investigators first became concerned about products made by American Cellular Labs after reports of severe liver and kidney problems in people who had used the two products. In one case, a liver transplant doctor reported that a 38-year-old male patient who had used the products had to be hospitalized with severe liver dysfunction and acute kidney failure which required dialysis.

While legal steroids entail risks, unknowingly taking supplements that contain illegal compounds is even riskier because the drugs come with unknown risks, according to Dr. Pieter Cohen of the Harvard Medical School. When prescribing similar drugs for men who have a deficiency, doctors closely monitor patients to avoid higher-than-normal hormone levels, but designer steroids have not been studied for safety. Cohen added that while there is no research showing that the new compounds are safe in humans, there is evidence that analogs of pharmaceutical compounds have let to life-threatening diseases that required transplantation in the past.

Originally posted at InjuryBoard by Greg Webb

Xolair Possibly Linked To Heart Problems

Greg Webb — Tue, 04 Aug 2009 08:00:00 GMT

The Food and Drug Administration (FDA) has announced that an ongoing clinical trial for the asthma drug omalizimub, commonly known as Xolair, and suggests patients taking the medication may have a stronger risk of blood clots, stroke, heart failure, cardiac arrhythmias and heart enlargement when compared to patients not treated with the drug. The agency said it was assessing the significance of the preliminary data to determine if further regulatory actions are needed to protect patients. In 2007, the FDA required Xolair include a black box warning on its label to warn patients that it may cause potentially fatal anaphylactic reactions.

Xolair is approved as treatment for adults and children over the age of 12 who suffer from moderate to severe asthma complicated by seasonal allergies. The concern regarding the possible side effects arose after a trial compared 5,000 Xolair users and 2,500 asthmatics not taking Xolair over a five-year period. The FDA claims “interim data” provided from the drug’s manufacturer, Genentech, suggested a disproportionate increase in cardiac failure, arrhythmias, pulmonary hypertension and many other disorders among users of Xolair.

The FDA’s announcement acknowledged that no causal link between the drug and the side effects has been determined and has advised patients who are taking the drug not to discontinue its use at this time; the agency called its announcement an “early communication”. Unless the FDA decides to stop the safety trial, it is expected to continue, with final results expected in 2012.

Originally posted at InjuryBoard by Greg Webb

FDA Panel Decides Acetaminophen Doses Should Be Changed

Greg Webb — Tue, 30 Jun 2009 22:07:43 GMT

On Tuesday, June 30, 2009, thirty-nine government safety experts, who were assembled by the Food and Drug Administration (FDA), recommended ways to reduce deadly overdoses of acetaminophen, which is the leading cause of liver failure in the United States. This liver failure sends about 56,000 people into the emergency room causing about 200 deaths each year. Due to these staggering numbers, the panel called for sweeping safety restrictions on the most widely used painkillers, including decreasing the maximum dose of Extra Strength Tylenol from eight pills of medication to a not yet determined amount and endorsed limiting the maximum single dose from 1,000 mg, or two tablets, to 650 mg; the 1,000 mg dosage should only be available by prescription.

The panel also narrowly voted to eliminate prescription drugs that combine painkilling ingredients with acetaminophen, such as Percocet and Vicodin, citing sixty percent of acetaminophen-related deaths are related to the prescription products. Some panel members, however, disagreed with this decision because so many Americans deal with chronic pain and depend on the medications. If these drugs stay on the market, members of the panel ask that the drugs’ label carry a black box warning, which is the most serious safety label available.

Drug companies avoided the most damaging potential outcome after the panel decided that over-the-counter cold medications, such as Nyquil and Theraflu, which combine other drugs with acetaminophen, could stay on the market. Though these drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, the FDA claims they only cause about ten percent of the acetaminophen-related deaths.

Although the FDA is not required to follow the advice of its panels, it usually does. Many doctors believe this is the opportunity to save a lot of people from inadvertent overdoses. For example, college sophomore Madalyn Byrne died after taking eight Tylenol a day for a week due to a toothache. Madalyn’s mother believes that had the bottle said to take four tablets a day instead of eight, her daughter would still be alive.

Originally posted at InjuryBoard by Greg Webb