Virginia Personal Injury Blog - 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

Ghost-writers Hired by Drug Companies Write Journal Articles, Then Find the Medical Authors

Rick Shapiro — Wed, 28 Oct 2009 22:45:41 GMT

An amazing series of documents were unsealed by a court in a dangerous drug injury case involving Prempro, a hormone drug. Injured plaintiffs argue that the drug causes breast cancer and other medical problems, but the bomb drop is not the allegations, but what drug giant Wyeth did to "help" create medical journal articles about the safety of its drug.

But the court documents reveal scandalous email and correspondence which purportedly shows that Wyeth "fraudulently and intentionally polluted the scientific literature related to hormone therapy in general and their hormone drugs in particular" in that Wyeth hired ghostwriter physicians or scientists to “author” biased scientific and medical journal articles-but the articles were largely written before the “author” was on board.

A medical journal PLoS Medicine posted about 1,500 of the documents on a website (www.plosmedicine.org/static/ghostwriting.action ). It was through the action of the medical journal and the New York Times that the court decided to unseal a massive number of documents which reveal exactly how the ghostwriting was done for the drug manufacturer-reaching the suggested conclusions well before a “reputable” doctor was ever part of the “study” findings as the study's author.

As further related in an article in Trial Magazine, American Association for Justice, October 2009, PLoS Medicine editors wrote an editorial that stated

"the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the healthcare decisions of physicians and the general public."

Here is how the ghostwriting generally occurs:

1. A drug manufacturer hires a professional medical writing or communications company which prepares a preferred title, outline and a possible draft of an article;

2. The drug company or its ghostwriters later find the names of proposed medical or scientific authors for the pre-determined article including its slant or bias;

3. The outline or draft is sent to the selected author for approval.

Can we imagine the day that newspaper advertisers write the headlines for newspaper’s and direct the content of the news stories? Or, if Newsweek magazine allowed the advertisers to dictate the topic of stories in exchange for ads in the magazine? But, the Medical journal ghost-writing issue is really more dangerous—as physicians are regularly prescribing medications based on the questionable results of ghost-written articles. It is fairly sickening.

In the Prempro litigation, Wyeth claims that the author, even if pre-selected, substantially controlled the editorial review of the originally ghostwritten articles and that there was no inaccurate science. The attorneys for the victims argue that the drug company exercised clear control over the message of the articles and that ghostwritten articles either downplay, dismiss or minimize a particular drug's adverse health effects. But, according to one physician, Adriane Fugh-Berman M.D, quoted in a Science Daily article, she was approached to be an “author” and the ghost writers often use an “intermediary” medical education company and the true party behind the article is fuzzy or obscured. Fugh-Berman believes that the current voluntary standards for declaring conflicts of interest to readers of medical journals and audiences at medical conferences are inadequate, and that a public database detailing physicians’ and researchers’ conflicts of interest is needed.

The most distressing part of the Prempro ghostwriting scandal is that physicians around the country must do research on the safety and on the health effects of prescription and over-the-counter drugs and look to journal articles as a respected source of information. If peer reviewed medical articles that downplay safety or health concerns seem legitimate, how is a family doctor or internist to know the difference in an unbiased, valid medical journal article or one that is simply ghostwritten on behalf of a drug manufacturer? The answer is there is no easy way to make this determination from reading a journal article that appears in any respected magazine or publication.

One of the ghosting company's indicates it attempts to "develop a consensus statement from [an expert] forum that would be endorsed by a national organization such as the American Heart Association."

A brochure released as part of litigation over health effects of Paxil, an antidepressant drug, also described a program that helped sales representatives facilitate having articles ghostwritten. The brochure said that publishing such articles "will benefit the sales force by expanding the database of published data to support Paxil."

PLoS Medicine in the above-referenced editorial has attacked the process of ghostwriting and called on medical journal editors to "decide whether they want to roll over and just join the marketing departments of pharmaceutical companies" or police the entire process in a more transparent way. Universities and medical journals have policies on ghostwriting but the policing of the process is far from reaching a level of transparency so that consumers as well as physicians can rely upon findings in a medical journal article.

This may require congressional action, because "self-policing" has a snowballs chance of gaining traction. U.S. Senator Charles Grassley has written a letter in August 2009 to the National Institute of Health asking for an investigation of this particular problem and specifically he noted that one or more ghostwriters were actually researchers who had obtained federal funds under NIH grants.

My Take: This is a troubling and growing problem that requires further investigation in order to keep the public safe from dangerous drugs. It has been only recently that the drug companies were forced to stop providing gifts and meals to doctors to foster prescriptions and the systematic "infection" of planted journal articles may be the next area requiring reforms.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our case results to see for yourself. Our primary office in based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our injury attorneys also host an extensive injury law video library on Youtube. Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

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

Risks From Avandia Mirror Those for Diabetes Itself

Emily Mapp Brannon — Sun, 04 Oct 2009 09:53:00 GMT

Patients with type 2 diabetes run the risk of losing a limb to the disease. Patients taking Avandia--GlaxoSmithKline's branded version of the medication rosiglitazone--also run the risk of fracturing an arm or leg because the drug weakens bones.

Likewise, people with diabetes often have liver disease. Taking Avandia increases patients' risk for experiencing liver disease and damage.

Certainly not last, having diabetes significantly raises a person's risk for having a fatal heart attack. GlaxoSmithKline was compelled to add heart warnings to Avandia's prescribing information in 2007. These warnings drew new attention recently with the publication of data in the Aug. 18 issue of the medical journal BMJ. Researchers examined treatment outcomes for nearly 40,000 patients with diabetes and found not only that Avandia had a greater heart attack risk but also worked no better than its chief competitor Actos, which is Takeda's brand name version of the medication pioglitazone.

All drugs pose some risk for patients, but no treatment should leave a patient worse off than she began. This does happen too often, however. Medical errors ranging from wrong-site surgeries to dispensing the wrong drug in the wrong dose harm patients every day. When the treatments themselves are at least as dangerous as the diseases, patients start two strikes down in their battle to return to or maintain their health.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury, and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our case results to see for yourself. Our primary office is based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

EJL

Originally posted at InjuryBoard by Emily Mapp Brannon

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