Allergan to Pay $600 Million in Botox Cases
FDA has sent a third warning to Baxter regarding its Aralast NP emphysema treatment brochure that contains misleading efficacy claims.
Physicians have better sources than salesmen and advertisements to guide prescribing choices.
Concern about payments to doctors to encourage prescribing drugs and paying doctors in other countries to oversee clinical trials, has led US prosecuters to investigate a number of drug manufacutres. The vast majority of clinical trials take place outside the U.S.
A new bill sponsored by Senator Michael Bennet (D-CO) would give the the FDA additional regulatory authority to monitor pharmaceutical supply chains.
FDA just issued a new alert regarding yet another supplement for weight loss.
FDA releases a new alert regarding yet another supplement for sexual dysfunction.
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.
You've seen drug commercials but there are other sneaky ways drug companies try to sell their products: ghostwritten manuscripts, composed by the employees of pharmaceutical companies in cooperation with their marketing departments and then published under the byline of academic researchers.
"An effort in Massachusetts to repeal a controversial law that prohibits drugmakers from giving gifts and meals to doctors and other healthcare professional has apparently ended."
"The arthritis pill Vioxx was withdrawn but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on.
Coroner’s inquest into suicide of Ontario teen recommends sweeping changes to drug safety regulations
"Safety questions around the diabetes pill Avandia pose a major test for the U.S. Food and Drug Administration's leadership and how it will handle drug risks under President Barack Obama."
FDA social media guidelines for regulating online drug ads to be broken up into multiple documents
Drug company funded medical studies often skew the truth about drugs, putting patient safety at risk.
Major drug company is resisting investigation by Congress and FDA for the recent recall of children's Tylenol and pediatric medications.
Investigation into Johnson and Johnson's Drug recall for variouis children's over the counter medication reveals problems in the manufacturing process.
Some drug companies are using Twitter to promote their products and overplay the benefits versus the risks. The FDA is now asking drug companies and other interested parties to submit opinions on how it might regulate the promotion of products using social media and the Internet.
Responding to charges that the agency is too slow to disclose drug safety issues, the FDA is proposing to reveal more information about drugs and devices under review.
The World Health Organization calls antibiotic resistance one of the three greatest threats to human health.
The FDA monitors consumer ads but has not, until now, tried to track the effacacy of direct to doctor promotion. The industry spends nearly three times as much on this than direct to consumer advertising.
This Community Catalyst blog discusses the Physician Payments Sunshine Act passed in the health care reform legislation. It creates a national public website where drug and device companies will report payments and gifts to doctors. Consumers will be able to search the site.
Two subsidiaries of Johnson & Johnson have settled with the Justice Department for civil and criminal claims concerning the illegal promotion of Topamax, an epilepsy drug, for psychiatric use.
The Empowered Patient Project has created a patient oriented survey on adverse medical events. Aggregate information from the surveys will be posted on their website.
The Vermont health care bill provision requiring drug companies to report when they give free medication samples to doctors is being misinterpreted as a ban on all free samples.
FDA's device transparency page: Information about the medical device approval process.
Heavy direct marketing of drugs to doctors may have more of an effect on prescription practices than you think.
Even though it's illegal to market drugs for unapproved uses, according to this article about one in five prescriptions in the US are for an off-label use.
From the Consumer Reports AdWatch team
AARP: Older Adults Still the Most Affected by Dangerous Medical Errors
"Nebraska health officials have admitted that 23-month-old Almariah Duque may have died from an overdose of the blood-thinner heparin, raising more questions about the use of the drug on infants."
Betsy Imholz of Consumers Union challenges the decision the California Pharmacy Board has signaled it will adopt regarding presription drug labeling standards.
"When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers. "
A 23 month old died from an overdose of blood thinner while in the hospital to be treated for an infection.
More reforms are needed to protect patients from preventable medical harm, but the new health reform law creates a solid foundation that will help ensure that the health care we are paying for is safe.
Drug company giant reveals the amount it paid to doctors and hospitals during the second half of last year. The health overhaul passed recently requires disclosures of certain physician payments starting in 2013.
Many patients report experiencing bad side effects taking BONIVA, including broken bones, which BONIVA drug marketers claim it prevents.
"Drug and device companies will soon have to report payments to physicians in a national database, thanks to a little noted section of the health care reform bill called the Physician Payments Sunshine Act."
Merrill Goozner points out another little-noticed provision in the bill: "Drug and device companies will soon have to report payments to physicians in a national database, thanks to a little noted section of the health care reform bill called the Physician Payments Sunshine Act."
According to a study published this month in the journal Medical Care hospital occupancy, weekend admissions, nurse staffing and the seasonal flu are major factors that increase the risk of dying in a hospital.
The following films from Transparent Learning are the first in a series of educational stories that feature patient safety advocates including Helen Haskell, Rosemary Gibson and Dr. Lucian Leape.
Leading patient safey advocate Dr. Lucian Leape released report. He makes a strong statement on public reporting: "Transparency is an idea whose time has come and both hospitals and the public will be better off because of it." His statement and report are online now.
This survey was created for patients who have experienced medical harm, their loved ones and their advocates. This survey was created by the Empowered Patient Coalition and we have jointly published this survey on our websites. This survey is designed to answer questions that are important to patients. This is a way for patients to report their experience as they have lived it, and to know that their report will be counted.The Empowered Patient Coalition will be entering the events annonymously on a map so you can see your error and others in your state by clciking on the map.
"Should doctors around the country use e-prescribing to decrease prescription errors? A study led by physician-scientists from Weill Cornell Medical College found that health care providers using an electronic system to write prescriptions were seven times less likely to make errors than those writing their prescriptions by hand."
A combination of drugs is being prescribed to treat post traumatic stress disorder (PTSD) in returning soldiers including Seroquel, an anti-psychotic, despite a disturbing number of veteran deaths associated with the treatment. Seroquel has not been approved for PTSD by the FDA.
AstraZeneca has been linked to the deaths of soldiers returning from war.
Legislation in CT this year would require limits on drug company compensation to doctors instead of an outright gift ban. A 2009 gift ban bill was strongly opposed and failed to pass.
Patients who seek psychiatric help today for mood disorders stand a good chance of being diagnosed with a disease that doesn't exist and treated with a medication little more effective than a placebo.
For some medical conditions, the cost of care does not directly correlate to the quality of care according to a study in the Archives of Internal Medicine.
Drug industry funding of more than half of US medical residency programs, calls into question conflicts of interest.
New Hampshire ranks fourth in the nation for deadly methadone overdoses, and health professionals and law enforcement are battling to keep it and other prescription drugs out of the wrong hands.
Responding to a continuing push from lawmakers to reveal how much the pharmaceutical industry is influencing America's doctors, two more major drug makers have made public their payments to physicians, but an industry expert says the data are of limited value.
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday in the Journal of American Medical Association.
The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.
A proposed amendment to the Senate health care bill would prohibit drug companies from mining pharmacy records in order to craft their marketing to a doctor's prescribing history.
"Millions of people are needlessly popping an aspirin every day in the false belief that it will ward off heart attacks and strokes, according to HeartWire."
"Drugs made in China are imported legally to the U.S. as if they were “American” drugs. The drug industry merely opposes allowing Americans to buy the same Chinese-made drugs from Canada, where price controls have rendered them cheaper."
Wound therapy devices can have adverse outcomes, leading to injuries or death. The FDA has recommendation for proper use.
Major drug makers are pushing for online advertising flexibility. Congress is considering new advertising laws that will limit on line ad claims that exaggerate drug capabilities and eliminating the corporate tax deductions for drug promotion.
The Government Accountability Office report "finds the agency FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market. "
With Plavix as an example, study finds no added use but higher costs.
James Woods, his mother and the hospital president announced the withdrawal of the lawsuit and a new joint effort by the hospital and the family to improve patient care.
FDA Urged to Maintain Strict Risk-Disclosure Rules for Web 2.0
The FDA is holding a meeting this week to get input on “making policy decisions on the promotion” of drugs and medical devices on “the Internet and social media tools. PhRMA, the drug industry trade group, recommends that FDA adopt some kind of standardized online warning language, such as “All drugs have risks. Click here for more information from the manufacturer.”
A new documentary film, "Money-Driven Medicine", tackles the economic underpinnings of an American healthcare system that kills four times as many people through medical error and preventable infections as die in highway accident. Consumers Union has encouraged activists to view this film and take action to make our health care system safer.
“Money-Driven Medicine” examines the medical industrial complex, and what’s wrong with our healthcare system. Watch the movie for free here until November 10 and sign our petition for reform.
Time reported earlier this month that the pharmaceutical industry has spent more than any other segment of the medical industry lobbying for health care legislation in 2009. Drug companies and their trade organizations spent more than $110 million, or $609,000 a day, to craft health care policy to their liking.
Lobbyist for the pharmaceutical device industry lobbied hard to keep results from clinical trials secret.
Many MRI patients are injected with a GE dye to enhance images. If they have weak kidneys, they might develop a rare and sometimes fatal disease.
The American College of Physicians (ACP) ACP argues that FDA should be authorized to require that new drugs carry labeling indicating their new-to-market status and that DTC advertising be restricted for the first two years a drug is on the market: Improving FDA Regulation of Prescription Drugs.
Study Shows Side Effects, Bad Drug Reactions Send Half a Million US Kids to The Doctor Each Year
The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.
Critics say popular birth control drugs Yaz and Yasmin put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.
Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa.
Dr. Jonathan Leo has again taken JAMA to task over its failure to disclose links between researchers publishing studies in its pages and Forest Labs, which funded them.
Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.
Pharma's misguided TV pitches -- Commercials for vanity pharmaceuticals are worse than insulting -- they divert attention from serious medical problems, increase healthcare costs and warp research priorities
The drug ( Effient ) must carry the agency's sternest warning because of its bleeding risks.
From NYT:: A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.
Do you want to know whether your doctor is influenced by drug or device makers? It's okay to ask, but you may also want to do some research ahead of time.
A New York Times commentary, Room for Debate, ran a discussion about prescription drug ads asking whether if they should or should not be reined in as some in Congress have suggested. Of the more than 300 comments the forum generated, it’s official: the overwhelming majority would like to see these ads altered or banned altogether.
Despite efforts to prevent medication errors, mix-ups like this are occurring across the country with alarming frequency.
The report, "Back to Basics," analyzed the results of scientific studies of treatment protocols for chronically recurring, avoidable medical errors.
The New York Times features several differing viewpoints on prescription drug direct-to-consumer advertising.
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia.
Former Treasury Secretary Paul O'Neil comments on reducing health care costs: "The president says he likes audacious goals. Here is one: ask medical providers to eliminate all hospital-acquired infections within two years."
The blog offers advice on how to take acetaminophen, a video on overusing OTC painkillers, and if you have concerns about your medications, take a look at some questions to ask your pharmacist. You can also read Consumer Reports Health's coverage of recommendations in May from an FDA working group to improve the safety of acetaminophen-containing products.
A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.
Consumers Union Assesses Lack of Progress Ten Years After Institute of Medicine Found Up To 98,000 Die From Preventable Errors
The Consumers Union report said lawmakers largely have failed to enact patient safety reforms recommended by a 1999 report by the Institute of Medicine that found that medical errors cost the U.S. as much as 29 billion U.S. dollars a year.
Despite a landmark report a decade ago detailing the deadly nature of the U.S. health care system, a consumer group finds that little has been done to prevent errors that cost the nation $17 billion to $29 billion and kill as many as 100,000 patients annually.
Report Shows 10-Year Effort to Curb Medical Errors Yields Few Results
Despite a decade of promises, little has been done to fix the problem of preventable medical errors that kill nearly 98,000 people in the United States each year, a consumer group said on Tuesday.
A bill passed by the Vermont House and Senate will close the loopholes in the state's existing gift disclosure law by requiring full disclosure of allowable gifts to physicians, health care organizations, non-profit groups and state-funded academic institutions.
In a scolding report, the nation’s most influential medical advisory group said that doctors should stop taking much of the money, gifts and free drug samples that they routinely accept from drug and device companies. Supports Grassley/Kohl legislation legislation that would require drug and device makers to publicly disclose all payments made to doctors.
comprehensive ban on drug company gifts to doctors will end the troubling financial conflicts of interest that undermine the quality of care to patients.
The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions.
Pharma's compromised credibility
The U.S. Supreme Court ruled against the drugmaker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators.
A new antibiotic being developed by a small San Diego company fared well in a clinical trial, holding promise in treating an intestinal superbug that is commonly spread in hospitals and is becoming more deadly.
"The drive toward greater efficiency by reducing the number of hospital beds and increasing patient throughput has led to highly stressed health-care systems with unwelcome side effects," the researchers wrote.
Direct-to-consumer drug ads on television should include a toll-free phone number that would allow consumers to report adverse side effects, U.S. health experts suggested Friday.
The heparin scare revealed problems the agency says it can fix. But it won't tell Congress how much that will cost.
The information would allow consumers to report serious side effects from prescription medication.
Special report takes a look at pharmaceutical manufacturing and how new drugs receive FDA approval.
Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the FDA announced.
An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years.
The FDA is supposed to be Americans’ main line of defense against tainted food, drugs, medical devices and other products. So it was especially chilling last week to hear the agency’s former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was “barely hanging on by its fingertips.”
Months after drugmakers pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers of their life-threatening side effects
Rapid test will enable faster treatment, containment of resistant staph germ
As evidence that pharmaceutical companies have suppressed unfavorable study results has grown, the need for publicly available clinical trial registries and results databases has gained increasing public currency.
Johann-Liang found herself in the media spotlight. The popular diabetes drug Avandia began making headlines because a prestigious medical journal aired concerns about its safety. She took her staff's advice and recommended in Feb. 2006 that Avandia get a "black box" warning about congestive heart failure.
Prescription drugs would be monitored more closely for side effects under legislation the Senate approved aimed at staving off future high-profile drug withdrawals.
60 Minutes tells the story of how pharmaceutical industry lobbyists literally wrote the historic Medicare Prescription Drug Bill and twisted arms to get the necessary votes to have it passed in the middle of the night.
U.S. regulators would have to conduct an additional review of a prescription drug's risks seven years after approval under a bill introduced on Monday that expands on a Senate measure requiring evaluations for the first three years.
More than a dozen families organize in Washington to lobby Congress today and tomorrow for tougher U.S. drug safety laws.
Lester M. Crawford, former chief of the FDA was charged yesterday with conflict of interest and lying about stock he and his wife owned in companies the agency regulates.
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.
For-profit ethical review, coming to a clinical trial near you.
Plaintiffs Allege Promotional Scheme to Boost Sales of World's Best-Selling Drug by Misleading Women and Seniors About Link Between the Drug and Heart Disease
The misuse and overuse of antibiotics has led to the rise of so-called superbugs--bacteria that have developed a resistance to widely used antibiotics and pose a threat to public health.
The TV commercial for the drug Enbrel was upbeat, engaging and, the Food and Drug Administration said, misleading.
Federal prosecutors charged last year that Neurontin's multibillion-dollar market arose from illegal strategies such as paying doctors to promote it off label for dozens of conditions, from back pain to psychiatric illnesses. The case was settled with a $430 million fine and guilty pleas by a Pfizer unit.
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects. It has some leading some lawmakers, academics and consumer advocates complaining that the agency is focused more on bolstering the pharmaceutical industry than protecting public health.
Gregory M. Lamb, Staff writer of the Christian Science Monitor
Firms are under pressure to release results of all their clinical trials, including the negative ones. The result could be a new level of industry openness.
Against a backdrop of spiraling prescription drug costs, questions are mounting about whether drugmakers — and the doctors who test and prescribe their products — always have patients' best interests in mind. Increasingly, critics say, money, not medicine, drives drug development and use.
U.S. Department of Health and Human Services
FDA asked the manufacturer of Rezulin (troglitazone) -- a drug used to treat type 2 diabetes mellitus-- to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.
FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.
Clinical trials have become marketing exercises for Big Pharma--and cash-strapped universities are helping make the sale. Article begins on page 54.
Reported patient deaths increased by 14% in 2009 from adverse drug events.
FDA warning letters and untitled letters to drug companies for marketing and communications violations.
ISMP QuarterWatch (Quarter 4 and 2009 totals) - Reported patient deaths increased by 14% in 2009. QuarterWatch is an ISMP program used to monitor adverse drug events (ADEs) in the US. During the most recent period of monitoring, ISMP analyzed 116,174 serious, disabling, and fatal ADEs reported to FDA during 2009. A 2.8-fold increase in reports has been observed since 2000. The volume of reports from health professionals has been relatively stable since 2004, while consumer reports have risen steadily since 2000.
New FDA website allows for reporting of misleading drug ads.
Report adverse drug or device reactions and read the latest safety information.
Federal Register on FDA’s proposed study about adding the government’s toll free number on direct-to-consumer TV ads.
Senate Special Committee on Aging hearing on “Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?”
During a hearing of the House Energy and Commerce Subcommittee on Health, Representative Edward J. Markey (D-MA) questioned PhRMA representative, Dr. Caroline Lowe, senior vice president of scientific and regulatory affairs, about PhRMA’s opposition to Markey’s proposal for a stronger FDA drug safety system.
Sen. Chuck Grassley said that statements by the Commissioner of the FDA discourage agency employees and scientists from speaking up about problems with the way the FDA monitors drug safety.
Group says 60,500 lives have been saved in the first nine months of its one-year campaign to prevent unnecessary deaths at hospitals, including fatalities from infections.
Recent findings regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al.1 that raise concern about certain conclusions in the article.
In a trenchant postmortem to the Rezulin story published in the British medical journal Lancet, Dr. Edwin Gale, an English diabetes specialist wrote, “Access to information about new drugs is closely retained by the companies, and post-marketing studies are dictated by marketing policy. . . . One lesson from [Rezulin] is that the public interest is not well served by the current system of drug development.” To purchase the book, please visit www.powerfulmedicines.org, a nonprofit supporting public interest research.
GlaxoSmithKline (GSK) performed an analysis of suicidal behaviors in their paroxetine pediatric clinical trial database, and found that there was a statistically significant increase in suicide-related adverse events for paroxetine-treated subjects compared to placebo.
CT Center for Patient Safety works in our communities, within our healthcare systems, and with elected officials to improve the quality of healthcare and to protect the rights of injured patients through education, accountability and advocacy. We believe that quality healthcare is a right.
People who want to be more alert: don't take modafinil! It turns out to be very addictive! Modafinil binds to the same site on dopamine transporters as cocaine does.
http://www.time.com/time/health/article/0,8599,1885825,00.htmlEveryday another person is injured by the use of midalozam. This web site offers multiple stories and research links into why this is still happening.
http://versedbusters.blogspot.com/This web site includes up-to-date information about prescription and over-the-counter medications and includes details about associated side effects and drug information to aid in the protection of patients and consumers.
http://DrugWatch.com
More than 290,000 surgical site infections occur in U.S. hospitals each year. Patients who acquire infections from surgery spend, on average, an additional 6.5 days in the hospital, are five times more likely to be readmitted after discharge, and twice as likely to die.
Surgery patients are at risk for infection because surgical incisions create a pathway for germs to enter the body. Maintaining a sterile environment in the operating room is therefore critical to protect patients from being contaminated with bacteria, which can lead to infection.
How well is your hospital, state and the nation as a whole are performing on three key practices that help prevent infections during surgery? Find out here »
In October of last year, Terri wanted to become involved in her state's special election in a real way. With each passing day, she became angrier about the TV ads the drug companies were constantly running to defeat real drug price reform...
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We first contacted Laurie Yorke of Clark, NJ last year after we saw her on-line support group for those that have suffered from the side effects of Paxil and other anti-depressants. Three years ago, Laurie almost lost her then 15 year old son, Ryan due to a reaction to a off label use of Paxil. When Ryan started taking Paxil there were no warnings about suicide, aggression or personality changes. After a year on this drug she watched him change into someone she didn't recognize. He had gone from a social, A student to a lethargic, confrontational, failing student. It was during that time that Ryan attempted to take his own life. Desperate to find out what was happening to her son, Laurie started doing her own research on the Internet...
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Kim Witczak and Eric Swan take the fight for good information about prescription drugs very seriously.
In 2003, Kim's husband and Eric's brother-in-law, Woody, filled a new prescription from his family doctor for the antidepressant, Zoloft to reduce insomnia and "help manage the stress of a new job." Woody had just taken a position as Vice President of Sales with a start up company about 2 months prior.
After 5 weeks of being on the drug--Woody took his own life. He had no history of mental illness, depression or any other problem. Woody was not warned about the need to be closely monitored when first going on the drug or when the dose was increased...
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