DC Medical Malpractice & Patient Safety Blog

When you read an enticing ad for a weight loss product that effortlessly melts away fat, bear in mind, before you get out your credit card, that the product may be running a few steps ahead of the law. Never assume, just because the ad is out there in public, that the product really works.

Last week the Federal Trade Commission (FTC) published its annual report, FTC Highlights, covering a range of activity by the federal agency charged with protecting consumers and promoting competition.

Two sections of the report might be of particular interest to medical consumers: “Containing Health Care and Drug Costs,” and “Challenging Deceptive Advertising and Marketing.”

As noted on FDA Law Blog, “[T]he FTC remains as focused as ever on health-related advertising – especially where advertising allegedly promotes products for weight loss or disease treatment or prevention.”

A summary of significant advertising matters litigated or settled by the FTC’s Bureau of Consumer Protection (BCP) is included in the report, and, as usual, big players last year were advertisers of weight-loss products. Products that purported to treat and/or prevent disease—food and dietary supplements, toning sneakers and smartphone apps and exercise equipment—also made their legal mark.

As Law Blog notes, a settlement over advertising for toning sneakers was the second highest amount: $40 million; a settlement over alleged order violations by a weight-loss marketer was third: $3.7 million. To satisfy the FTC, health-related product claims must show reliable, relevant supporting science.

Although many people have suffered from allergies as long as they can remember, others are new to this often annoying and, at times, potentially lethal immune response. You can develop an allergy any time, even to something that never used to bother you.

A common later-onset allergy is latex. As discussed in the Harvard Men’s Health Watch newsletter, people who develop an allergy to latex usually have had repeated exposure to certain proteins in natural rubber that their bodies perceive as threatening. Accounts of latex allergies boomed in the 1990s, the newsletter suggests, as increasing numbers of people in health care and associated professions were required to wear gloves in many situations as a measure of infection control.

But if you think the label “latex-free” is your ticket to product security, think again: As the newsletter notes, a consumer update by the FDA says “There’s No Guarantee of ‘Latex Free.’”

Latex is a component of many useful products—adhesive bandages, condoms, balloons, rubber bands, elastic socks and waistbands, baby bottle nipples, pillows …

As many as 12 in 100 health-care workers and 6 in 100 people in general have a latex allergy or sensitivity, according to the newsletter.

No test exists to verify that a product is completely free from latex. “Labeling that suggests a product doesn’t contain the substance could cause trouble for individuals with a latex allergy or sensitivity,” the newsletter warns.

You can be sensitive to an allergen without actually having an allergy. You might get a rash, sneeze and have watery eyes—irritating, but you’re not in danger of anaphylactic shock. That’s a life-threatening, whole-body reaction to an allergen in which the lips and throat may swell, and airways become restricted. (See our blog, “Doctors Often Fall Short in Treating Anaphylactic Allergy Attacks”.)

As the Harvard newsletter notes, even products made without latex can threaten people with latex allergies because sometimes they’re contaminated with latex proteins during the manufacturing or packaging process.

To better inform consumers of what they’re buying and using, the FDA wants to replace “latex free” and “does not contain latex” labels with ones that say “not made with natural rubber latex.” As the newsletter says, because it’s not possible to certify something as truly “latex-free,” those labels still would leave some people at risk, but at least products wouldn’t be promising something they cannot deliver.

Learn more about latex sensitivity and allergy on the websites of the Asthma and Allergy Foundation of America and the American Academy of Allergy, Asthma and Immunology.

Beyond unpleasant itchy, teary eyes, runny nose and mild headache, be aware of the signs of a dangerous allergic response. Seek immediate medical help if you have:

• hives or welts


• swelling of the lips, face or throat


• abdominal cramps


• chest tightness, wheezing, or shortness of breath.

The public lost the latest round of safety versus commerce when the federal government gave up its effort to require cigarette manufacturers to include prominent images on cigarette labels warning of the dangers of smoking.

As reported last week by the Washington Post, the FDA decided it couldn’t make a court-imposed deadline, and succumbed to the formidable opposition by the tobacco industry. (We recently wrote about the ongoing shiftiness of this industry.) Two years ago, the agency announced it would compel tobacco companies to include grisly images such as disease-riddled lungs, a smoker’s corpse and a man exhaling smoke through a tracheotomy hole in his throat on all cigarette packages.

The labels also were supposed to include the stop-smoking hotline telephone number, (800) QUIT-NOW.

The FDA, according to The Post, said it would “undertake research to support a new rulemaking consistent with the Tobacco Control Act.” That’s the 2009 law requiring the agency to find ways to reduce the estimated 440,000 annual deaths attributable to tobacco use. We also wrote recently about how states' budget cuts are compromising their ability to help smokers quit the lethal habit.

Big Tobacco, with its unlimited resources and zeal to keep people hooked on its deadly products, sued the FDA after it initiated the requirements in 2011. The industry said the required labels were too broad and violated its First Amendment rights. A federal judge issued a temporary injunction late that year, and in early 2012 ruled in favor of tobacco. He said that the proposed labels went too far, and were “neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks.”

He said they were intended, according to The Post, “to evoke emotional responses that would provoke people to quit smoking or never start.”

In his ruling, he wrote that “an interest in informing or educating the public about the dangers of smoking might be compelling,” but that “an interest in simply advocating that the public not purchase a legal product is not.”

Last summer he was upheld by the U.S. Court of Appeals on the grounds the requirements breached the First Amendment. The government decided it couldn’t meet the deadline to appeal that ruling to the U.S. Supreme Court.

Several countries use horrifyingly graphic labels on cigarette packages. A World Health Organization survey, according to The Post, found that they were more effective as a deterrent to smoking than labels that issue warnings only in text.

Sometimes, reality is lost in the love for medical device technology. Just because something’s new doesn’t mean it’s better. A recent statement by the president of the American College of Obstetricians and Gynecologists advises caution when it comes to robotic surgery for hysterectomies.

Dr. James T. Breeden states, “Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.”

As in other surgeries, patients are given general anesthesia for robotic surgery. The surgeon uses a computer to direct a robotic arm in the control of tiny instruments inserted through small surgical incisions. An endoscope—a thin tube with a camera at the end—enables the surgeon to see magnified, three-dimensional images on a monitor.

We’ve noted some of the harms of robotic surgery, including tearing internal tissue and burning internal organs, and that in some procedures, their outcomes are no better than those of traditional surgery.

Lawsuits are rising against surgeons who commit malpractice with robotic machines and against the manufacturers who make them.

As Breeden points out, outcomes are directly associated with a surgeon’s skill, not just the tools he or she uses. Skill comes with years of training and practice, and any new technology comes with increased complications while the learning curve is mastered.

“Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons,” Breeden says. “While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes.

Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.”

Because the incisions are smaller and the procedure less invasive, robotic hysterectomy usually means shorter hospitalization, less discomfort and faster recovery compared with other approaches. But, often, a hysterectomy can be performed vaginally, without any abdominal incision. That’s the least invasive and least expensive option. “Based on its well-documented advantages and low complication rates, this is the procedure of choice whenever technically feasible,” Breeden says.

When vaginal hysterectomy isn’t possible, laparoscopic hysterectomy is the second least invasive and costly option for patients. That involves a smaller abdominal incision than total abdominal hysterectomy (TAH).

Both vaginal and laparoscopic procedures require fewer days of hospitalization and shorter recovery than TAH, and they have proven records for excellent outcomes and cost efficiencies.

But hospitals spend a lot of money on fancy robotic technology, and many surgeons are like kids with the latest Game Boy—as the saying goes, when you’re a hammer, everything looks like a nail.

Even if safety weren’t a consideration—and it always should be the primary concern—robotic hysterectomy should be scrutinized for its expense, Breeden says. Robots cost more than $1.7 million, and have $125,000 in annual maintenance costs.

Breeden refers to a recent study in the Journal of the American Medical Association (JAMA) finding that the percentage of hysterectomies performed robotically jumped in the last three years from less than 1 in 100 to 1 in 10. They were more than $2,000 more expensive for the patient and showed no demonstrable benefit.

“Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that [robotic hysterectomy is] the best choice,” Breeden says. “Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health-care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.”

Cost concerns aside, patients must consider safety. As reported by AboutLawsuits.com, an increasing number of lawsuits have been filed resulting from the use specifically of the da Vinci robotic device.

Bloomberg News told the story of one patient. Uterine growths were removed with a da Vinci robot, described by her gynecologist as “the latest, greatest” technique available.

Five weeks later, she felt something pop while she was using the toilet, and glanced down to see her intestine protruding from her vagina. The vaginal wound had failed to heal properly. Four years later, Blooomberg reports, the 41-year-old has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life.

“It didn’t help me one bit, the robot,” she told the news site. “It forever changed my life for the worse.”

Robot systems made by Intuitive Surgical Inc., including the da Vinci, are linked to at least 70 deaths since 2009, says Bloomberg.

“Many of the complaints allege that a potential cause of the da Vinci problems is a lack of training provided for doctors who use the device, particularly at smaller hospitals where there is not a large volume of procedures,” AboutLawsuits notes. “In addition, lawsuits indicate that many hospitals feel pressured by competition and marketing to buy a da Vinci, and then doctors are encouraged to use the machine as often as possible to help the hospital recoup costs.”

Those are not compelling reasons for patients to agree to undergo the robotic knife.

In 2008, the Consumer Product Safety Improvement Act established a database to enable consumers to report and become informed about hazardous products. The law was a response to product scandals such as toys made in China that contained unsafe levels of lead.

Two years ago the U.S. Consumer Product Safety Commission (CPSC) launched SaferProducts.gov. It was expected that businesses appearing on the site would try to keep consumer complaints private, but, as reported on the public interest journalism site FairWarning.org, no one really anticipated that the first legal challenge would be a shocking example of judicial secrecy.

Even the most basic details of the case, FairWarning reports, are unknown thanks to private hearings, sealed records and a 73-page ruling with chunks of information blacked out. Shockingly, in a country where legal proceedings are supposed to exemplify transparency and fairness, even the identity of the plaintiff is unknown. It’s referred to only as “Company Doe.” We don’t know what the product at issue is, nor the incident that prompted the complaint.

And why did the CPSC choose not to appeal a federal judge’s ruling blocking the complaint from being posted on the website? Why won’t it say why it accepted the ruling and allowed the company to remain anonymous?

What kind of star chamber deal is this?

Consumer groups have called the court ruling a serious violation of the public’s right to know and have sought to have an appeals court unseal the case records. Company Doe, of course, claims that the Consumers Union, Public Citizen and the Consumer Federation of America have no standing in the lawsuit, and is seeking dismissal of the appeal.

FairWarning interviewed several legal experts who said they had never heard of such a case, in which a company was allowed to use a fake name to protect its reputation.

“The general price tag for wanting to submit things to a court to get a ruling in your favor is that they become public,” Richard Marcus, a law professor and expert on civil procedure at the University of California Hastings College of the Law in San Francisco told FairWarning.

“We don’t have closed trials in this country,” Marcus said. “We don’t allow witnesses to come in and testify wearing bags over their heads. Maybe there are some very, very, very unusual exceptions to that but that’s our general mode of operation.”

Joan E. Steinman, a professor at Chicago-Kent College of Law has studied pseudonymous litigation. She told FairWarning that plaintiffs who use pseudonyms in court usually are individuals trying not to disclose details that could embarrass or even endanger them. One of the most well-known examples occurred in Roe v. Wade, when “Jane Roe” was used in 1972 as an alias for Norma L. McCorvey, the woman who started the national debate on abortion rights.

And you don’t see so many court records in one case sealed unless national security is at stake.

Consumer complaints about products—and deficient products generally—are hardly “unusual”; they’re a fact of life in the developed world, and the federal law passed five years ago signifies the importance of shining light into the dark corners of product manufacture and safety.

The CPSC does not investigate every complaint filed; the database, which has about 13,000 incident reports, carries this disclaimer: The agency “does not guarantee the accuracy, completeness, or adequacy of the contents” of the database.

But according to Scott Wolfson, spokesman for the commission, the majority of inaccuracy claims relate to consumers not naming the correct manufacturer for the product, an issue officials usually resolve.

So it’s no wonder that consumer advocates say that the decision in the Company Doe case threatens the integrity of the consumer product database. If allowed to stand, any company whose products are likely to end up as complaint subjects has precedent to seek secrecy.

The Company Doe case against the CPSC started in October 2011, eight months after the database went public. It concerned a complaint submitted by a local government agency that a product allegedly had harmed a child.

The CPSC followed standard procedure. It notified Company Doe and gave it a chance to address the complaint on the site. The company argued that the complaint was inaccurate. The CPSC wrote four different versions of the grievance to eliminate inaccuracies, but none satisfied Company Doe. So it sued to keep the product complaint out of the database altogether.

A federal judge in Maryland issued the ruling in Company Doe’s favor in July, saying that a link between the product and the harm suffered by the child had not been established and enabling secret proceedings through sealed court records. When FairWarning posted its story last week, only about eight of approximately 86 documents filed in the lawsuit were available publicly.

It’s impossible to figure out what allegedly happened to the child involved. So how do we know there’s not a product out there that poses harm to additional children?

The judge justified his favorable ruling for secrecy by saying that revealing Company Doe’s identity and unsealing court papers could harm its reputation, defeating the point of the legal challenge.

At issue, reports FairWarning, is “a company’s ability to keep our court system secret and anonymous in order to protect their brand,” said Rachel Weintraub, senior counsel for the Consumer Federation of America. “It’s all about retaining the status quo that existed before where manufacturers completely controlled information about their product.”

Pamela Gilbert, a lawyer in Washington D.C. who formerly was executive director of the Consumer Product Safety Commission, told FairWarning that even if Company Doe’s identify was revealed, there was little likelihood of significant harm to it.

“As far as I know no one has ever gone out of business because there has been a complaint made against them in a government database,” she said.

To learn more about the Safer Products database, link here. To register your feelings about secrecy in legal proceedings involving product complaints, contact your Congressional representatives; you can find them here.

Patrick Malone speaks out frequently against secrecy in court proceedings involving injuries caused by wrongful conduct or defective products. Read our website page about our stand against secret settlements of lawsuits.

How does a medical device company talk internally about design flaws discovered in a hip implant it is promoting to thousands of surgeons?

“We will ultimately need a cup redesign, but the short-term action is manage perceptions.”

That's what one sales official of DePuy, the Johnson & Johnson unit that makes hip implants, wrote in an email to a colleague in 2008, about its ASR hip device.

The "cup" this official referred to is the acetabular or socket component of the metal-on-metal ball-and-socket hip replacement.

And in a report the previous year about engineering tests on the ASR hip, the company's officials wrote:

“The current results for A.S.R. do not meet the set acceptance criteria for this test."

That was a reference to excessive wearing of the device, which was thought to lead to the high rate of failures of the ASR implant.

The upshot is that thousands of patients continued to get the defective device placed in their bodies before DePuy finally admitted the design defect and recalled the device in 2010.

Meantime, it was "managing perceptions."

The newly revealed internal documents were disclosed in a product liability trial of the first lawsuit against DePuy to reach the courtroom. Barry Meier of the New York Times wrote the report quoting the DePuy documents.

Popping the cork on a bottle of Champagne (or other sparkling wine) is a satisfying seasonal ritual. Except when it hits a holiday reveler in the eye.

According to the American Academy of Ophthalmology, (AAO) untold numbers of eye injuries occur each year as a result of a lightning-fast projectile (a cork) meeting an immobile object (someone’s face). As your mother used to warn, “You can put your eye out with that thing.”

As noted on ScienceDaily.com, a warm bottle of bubbly and an improper cork-removal technique is a recipe for serious, potentially blinding eye injuries. A Champagne bottle is under as much as 90 pounds of pressure per square inch, and a cork launched from it can reach a speed of 50 miles per hour. That’s fast enough to shatter glass.

Also fast enough to rupture an eye wall and cause:

1. acute glaucoma


2. retinal detachment


3. ocular bleeding


4. dislocation of the lens


5. damage to the eye's bone structure.

To avoid ringing in the New Year from a hospital bed, follow the AAO guidelines for opening your bubbly (watch the video by linking here ):

1. Chill sparkling wines to 45 degrees or colder before opening. The cork of a warm bottle is more likely to pop unexpectedly.

Don't shake the bottle. That increases the speed at which the cork explodes from the bottle.

2. Point the bottle at a 45-degree angle away from yourself and any bystanders; hold down the cork with the palm of your hand while removing the wire hood on the bottle.


3. Place a towel over the entire top of the bottle and grasp the cork.


4. Twist the bottle while holding the cork at the 45-degree angle to break the seal. Counter the force of the cork using downward pressure as the cork breaks free from the bottle.

Although it has many supporters (also known as nicotine addicts), the tobacco industry has few friends. That’s not only because it markets a lethal product, but because of its inability to cop to its health-corroding properties and its history of lying. According to the Centers for Disease Control and Prevention (CDC), tobacco use kills more than 400,000 people every year in the U.S.

Under the Master Settlement Agreement in 1998, as described by the California Department of Justice, seven tobacco companies agreed to change the way their products are marketed and pay the states an estimated $206 billion. They agreed to finance a $1.5 billion anti-smoking campaign, open previously secret industry documents and disband industry trade groups that state attorneys general said conspired to conceal damaging research from the public.

Fourteen years after the settlement, the annual study sponsored by the Campaign for Tobacco Free Kids reports that “states continue to spend only a minuscule portion of their tobacco revenues to fight tobacco use. The states have also failed to reverse deep cuts to tobacco prevention and cessation programs that have undermined the nation’s efforts to reduce tobacco use.” This is so even though in this budget year the states will collect a record $25.7 billion in revenue from the tobacco settlement and tobacco taxes.

The study concluded that states:

• will spend only 1.8 percent of the $25.7 billion ($459. 5 million) on programs to prevent kids from smoking and help smokers quit—that’s less than two cents of every dollar in tobacco revenue spent to fight its use.


• have failed to reverse deep cuts that reduced tobacco prevention funding by 36 percent from fiscal year 2008 to fiscal year 2012. The $459.5 million the states have allocated this year is the second lowest amount they have spent on tobacco prevention programs since 1999, when they first received settlement funds.


• are falling woefully short of recommended funding levels for tobacco prevention
  programs set by the CDC—only 12.4 percent of the $3.7 billion the CDC
  recommends for all the states combined.

In the last four fiscal years, federal funds for smoking prevention amounted to about $522 million. As The Times notes, tobacco companies spend $8 billion a year promoting their product.

Public health officials strongly believe that anti-smoking programs work. California’s smoking rate was above the national average 20 years ago; today it’s the second-lowest in the country. Officials attribute that decline to, as The Times puts it, “modest but consistent spending on programs that help people quit and prevent children from starting.”

According to the report, Washington State saved $5 in tobacco-related hospitalization costs for every $1 it spent during the first 10 years of its program.

But thanks to budget cuts, some states have as much as abandoned their efforts to curb smoking. State financing for North Carolina’s program has been eliminated, Ohio has not allocated any funds for its once-successful program and for three successive years Washington State has cut its program by about 90 percent.

Another threat to what has been a promising national effort to reduce smoking and its ill effects came in a court ruling earlier this month. An appeals court in Washington, D.C., reaffirmed a decision that forcing tobacco companies to put graphic warnings on cigarette packages violates their free-speech rights (see our post from August).

You might recall the shock value of the labels at issue—they included images of sewn-up cadavers and diseased lungs and gums. The images were approved by the FDA in 2011 and were to appear in September.

According to the Winston-Salem Journal, the court denied the FDA’s request to reconsider affirming the earlier ruling to block the images with a two-sentence order. “[T]he government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.”

“The graphic images are neither factual nor accurate.”

The FDA has 90 days to appeal, and if it does, the case goes to the U.S. Supreme Court.

In what some people might call an only-in-America episode, an Ohio federal appeals court in March upheld use of the graphic labels. Tobacco manufacturers, of course, have petitioned the U.S. Supreme Court to review the Ohio decision. The feds have until Dec. 26 to file a response, and it could be February at the earliest before the justices decide whether to take the case.

'Tis the season, apparently, for adjudicating tobacco cases. In November, a federal judge ruled that tobacco companies must spend their own money on an advertising campaign telling people that they lied about the dangers of smoking cigarettes. As described in a story by Reuters, this might be the harshest sanction arising from the 1999 Justice Department case accusing tobacco companies of racketeering.

The campaign will appear in various media for as long as two years. If that seems extreme, consider that the court referred to “past deception” by cigarette makers dating to at least 1964.

The judge ordered the advertising campaign in 2006, and six years later the companies are still arguing about the wording. And the tobacco companies could always appeal this decision, too. So it will be a while before any public act of contrition occurs. But here, according to Reuters, are a couple of the potential apologies:

• "A federal court has ruled that the defendant tobacco companies deliberately deceived the American public by falsely selling and advertising low tar and light cigarettes as less harmful than regular cigarettes."


• "Smoking kills, on average, 1,200 Americans. Every day."

If anyone still doubts that tobacco and tobacco smoke are harmful, consider a story recently published on ScienceDaily.com. “It is a known fact that active maternal smoking during pregnancy has negative effects on child health, such as attention deficit and hyperactivity disorder (ADHD),” it said, and “new research suggests that second-hand smoke, or environmental tobacco smoke (ETS), may be just as harmful.”

The study by researchers at the University of Pennsylvania School of Nursing examined data from 646 mother-child pairs in China, where more than 7 in 10 men smoke. One in 4 children whose mothers were exposed to smoke exhibited behavior problems compared to 16 in 100 children of unexposed mothers. The children whose mothers were exposed to passive smoke performed worse on speech, language skills and intelligence tests. They also showed more conduct disorders.

As the study’s lead author said, "The key message for pregnant women is to protect their growing fetus from exposure to second-hand smoke."

Stay tuned—although there is no doubt tobacco is a deadly product, the powerful forces that turn it into consumer goods have lots of money to indulge their irresponsible and venal instincts.

Bed rails seem like such a good idea—metal bars installed on beds to help people pull themselves up or get out of bed, and to prevent them from rolling out of bed. But the clamor to make them safer is growing louder because some portable bed rails promoted as a safety device can pose a risk of injury and death.

Recent articles published in the journal Biomedical Safety & Standards(BS&S) and the New York Times describe a longstanding awareness of the problem, and illustrate it with sad tales of people losing their lives when their caregivers thought they were safe.

Two consumer watchdog organizations, Public Citizen and the National Consumer Voice for Quality Long-Term Care, have asked the Federal Trade Commission to stop one manufacturer from making false claims. Last year, a similar appeal was made to the FDA, and to recall certain bed rail models. Safety advocates want the feds to study the design and use of all similar devices that pose risks from entrapment and strangulation.

The groups said that more than 525 deaths had been reported to the FDA, and more than 155 to the Consumer Product Safety Commission (CPSC). The actual number of incidents, however, is probably much higher—home users and maybe even some health-care providers might not know that such events should be reported to these agencies. As BS&S reports, “Some facilities may seek to conceal a person's cause of death for fear of liability or suggest that the patient bore some responsibility for the event.”

Bed Handles Inc. still claims that its Bedside Assistant “makes any bed a safer bed,” and “stable in all directions and can be firmly pulled, pushed, lifted, and leaned on,” Claims for other portable rails, BS&S says, are similarly inaccurate.

In 2008, the Consumer Product Safety Improvement Act set mandatory safety standards for many infant nursery products, including portable children's bed rails in light of well-documented injuries and deaths in young children. After the standards were implemented, childhood crib and bed-related injuries declined significantly. In 2012, the CPSC enacted Safety Standard for Portable Bed Rails, but only for those affixed to beds for youngsters, not adults.

But elderly patients are particularly vulnerable to falls, which can be catastrophic. According to BS&S:

• The presence of bed rails does not deter adults or children from trying to get out of bed.


• There is no evidence that side rails prevent falls.


• Other evidence-based methods reduce the incidence of bed-related falls--lowering bed height and placing anti-slip matting at the bedside.


• Bed rails can be more dangerous to patients than falls.


• A fall with a bed rail in place is more dangerous than a fall without a rail.

As reported by The Times, from 2003 to 2012, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed-rail injuries.

Clara Marshall, whose story was told in The Times, was a member of that at-risk older demographic. In 2006 she was suffering from dementia, and her family moved her into an assisted living facility offering round-the-clock care. Five months later, she was found dead in her room from apparent strangulation. She caught her neck in bed rails that were supposed to keep her from rolling out of bed.

Her daughter, Gloria Black, contacted the CPSC and FDA, and learned that both agencies had known for more than a decade about deaths from bed rails. In 2010, after appeals by Black, the CPSC helped prompt a review of bed-rail deaths. “I wish it was done years ago,” Black told The Times. “Maybe my mother would still be alive.”

If safety experts call for more and stronger warnings, regulatory questions trump common sense: Who’s responsible for bed rails, the FDA, which monitors medical devices, or the Consumer Products Safety Commission, which monitors consumer products?

“This is an entirely preventable problem,” Dr. Steven Miles of the Center for Bioethics at the University of Minnesota, told The Times.

To review product recall information and file a report with the CPSC, link here. To review device recalls and alerts and file a report with the FDA, link here.

From the meningitis outbreak, something good may come out of something bad. Earlier this month, U.S. Rep. Edward J. Markey of Massachusetts introduced a bill in Congress to boost the federal government’s authority to regulate compounding pharmacies.

As we’ve been reporting in the last several weeks (most recently last week), compounding pharmacies have been able to operate in often sketchy ways without the kind of oversight necessary to protect patients from harm. As reported on FDA Law Blog, Markey’s bill, the Verifying Authority and Legality in Drug Compounding Act of 2012 (VALID):

• Ensures that compounding pharmacies operating as drug manufacturers are regulated by the FDA as drug manufacturers (they do not currently fall under FDA scrutiny).


• Preserves state regulatory authority for traditional small compounding pharmacy activities and the requirement that drugs are compounded per each patient’s prescription. The FDA may waive this requirement in the event of a drug shortage or to protect the public health or well-being, but not for longer than one year unless the Secretary of Health and Human Services deems an extension necessary.


• Increases transparency to the public by requiring compounded drugs to include this statement: “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA at _____” (phone number and a website).

Pharmacists and pharmacies compounding a drug product are required to report to the Secretary of Health and Human Services (HHS) any adverse event associated with the use of it within 10 days after becoming aware of it. If a pharmacist or pharmacy knows of any kind of contamination, chemical or physical change or deterioration of a drug that has been distributed and “could cause serious injury or death,” the pharmacist has five days to report it to the Secretary.

Some compounding operations are excused from some of the Act’s provisions, but not pharmacies required to be registered as drug manufacturers. Pharmacies or pharmacists might be waived if they: work within a hospital system compounding drug products exclusively for its patients; compound sterile drug products; compound drug products in limited quantities before receiving a valid prescription for an individual patient in their state.

As noted on FDA Law Blog, Markey, whose district is home to the New England Compounding Center (NECC) that distributed the contaminated steroid medicine that caused meningitis, said the VALID Compounding Act would close the “regulatory black hole.”

Additional developments in the NECC case were reported last week by the Boston Globe.

First, Massachusetts regulators ordered all the pharmacists and technicians employed by the NECC to stop working in the drug-compounding industry. That indicates, the paper said, that state regulators are concerned that the workers failed to follow proper procedures.

Duh. A letter from the Massachusetts Board of Registration in Pharmacy obtained by The Globe said that pharmacy staff “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”

The state board had already decided to seek surrender of NECC’s license. And the outfit shut down last month and recalled all of its products.

Later in the week, The Globe reported that the director of the state pharmacy board was fired and the board’s attorney placed on administrative leave for allegedly ignoring a complaint in the summer that NECC was distributing bulk shipments of drugs to hospitals in Colorado. That violates its state license.

NECC has long been a problem. As the Globe noted, The Colorado Board of Pharmacy issued a cease and desist order to the pharmacy in April 2011 after discovering its “unlawful distribution of prescription drugs.” This summer, when a Colorado hospital discovered a bulk shipment of a drug from NECC, Colorado authorities notified their Massachusetts counterparts.

They blew it off.

The House of Representatives’ Energy and Commerce Committee is convening public hearings Nov. 14 about the problems at NECC.

There’s been a lot of news lately about energy drinks, and none of it’s good. We recently wrote about how little is known about their contents, and their link to heart disease and high blood pressure.

Now, as reported in the New York Times, five people died in the last three years after drinking Monster Energy. And the parent of a 14-year-old Maryland girl has sued Monster Beverage, its manufacturer, for failing to warn consumers about its risks after her daughter died of heart arrhythmia.

The FDA released an incident report (which doesn’t prove Monster Energy caused the deaths or any other health issues) about the high-caffeine beverage, which was obtained by Wendy Crossland, the teenager’s mother. The girl had drunk large cans of Monster Energy on two consecutive days. In addition to the five deaths, the FDA has received a report of a nonfatal heart attack possibly associated with the drink.

Other incident reports, according to The Times, included other adverse events including abdominal pain, vomiting, tremors and abnormal heart rate. The reports covered the period from 2004 to June 2012; all the deaths occurred in 2009 or later. According to Bloomberg News, there were 37 adverse reaction reports since 2004 that mentioned Monster drinks.

The reports are not exhaustive—they aren’t clear for example, if the incidents involved other factors, such as alcohol or drugs. The reports are voluntary, so generally the number the FDA receives about any product it regulates represents only a fraction of all incidents.

Monster Energy is only one representative of the energy-blast product niche. Others include Red Bull, Rock Star and 5-hour Energy. Monster Energy has several derivative drinks—Monster Rehab, Monster Assault and Monster Heavy Metal. As their names indicate, the target market is teenagers and young adults. An FDA statement said manufacturers were responsible for investigating reports of death or injuries associated with their products, and that the agency had not established a causal link between the deaths and the beverage.

Still, the report raises concern about how well manufacturers monitor their products for safety and whether the feds exercise oversight of them. Product labels indicate that they’re “not recommended” for children under 12 and people “sensitive” to caffeine. The stimulant can pose risks for people with heart disorders, so there’s a lot of real estate between not being recommended and being deadly.

Manufacturers are not obliged to disclose caffeine content, and it is they who decide whether to call them drinks or dietary supplements. The latter are not subject to FDA oversight for ingredients and labeling.

Anais Fournier, the Marylander teen who died, drank 24-ounce cans of Monster Energy that each contained 240 milligrams of caffeine. An 8-ounce cup of brewed, generic coffee has about 133 mg of caffeine, according to the Center for Science in the Public Interest.

The lawsuit filed on her behalf, The Times reported, quoted autopsy and medical examiner reports that she had died of “cardiac arrhythmia due to caffeine toxicity” that had exacerbated an existing heart problem. Fournier apparently had Ehlers-Danlos syndrome, which can affect blood vessels. She and her family were aware of her underlying heart condition but apparently her doctors had not told her to restrict her physical activities or her caffeine use.

In April, Sen. Richard J. Durbin invoked Fournier’s death in a letter urging the FDA to enforce caffeine levels in energy drinks. In August, agency officials said that there was insufficient evidence to take action on caffeine levels in energy drinks, noting, however, that it had not received medical reports related to Fournier’s death. According to Bloomberg News, emergency room visits involving energy drinks increased tenfold from 2005 through 2009. About half of them, according to Bloomberg, were patients 18 to 25 years old and some involved drugs or alcohol,

If you want Congress to impose stricter ingredient and labeling practices on the energy drink industry, contact your representative. You can find out who and where they are by linking here. To report a problem with a food, drug or dietary supplement, contact the FDA's MedWatch program.

As the horror builds with the increasing number of meningitis casualties from contaminated steroid medication provided by a Massachusetts compounding pharmacy, a disturbing report was published last week in the New York Times that details how such problems aren’t limited to that niche of the drug-manufacturing sector.

Weevils in vials of heparin; morphine containing as much as twice the labeled dose; manufacturing plants with rusty tools and mold. All were found at big drug companies that are supposed to be regulated much more rigorously by the federal government than compounding pharmacies, which are regulated by individual states.

In the last three years, The Times says, six major manufacturers of sterile injectable drugs have been warned by the FDA about serious violations of manufacturing rules. Four closed factories or slowed production to fix the problems. Nearly one-third of pharmaceutical manufacturing has been shuttered because of quality issues.

Although it’s essential that dangerous plants be closed, less production has contributed to a shortage of critical drugs, as we’ve previously noted. Shortages have encouraged compounding pharmacies to breach the gap. Supplies of the injectable steroid that was contaminated in the meningitis outbreak, The Times reports, were in short supply because two manufacturers had stopped making it.

Although worrisome, the situation doesn’t describe all drugs. Most sterile injectable drugs sold in the U.S. are safe. But both industry observers and former plant employees say that manufacturers are slow to address problems because it’s too expensive—drug profits are driven by volume. Some inexpensive drugs are made in huge volume on production lines that operate around the clock.

Big Pharma, of course, rejects the idea that plants are deteriorating and that their owners don’t care. In The Times, an executive of the Generic Pharmaceutical Association compared some facilities to vintage cars. Some are old and decrepit, but some, he said, are “maintained [like] muscle cars.”

Manufacturing scrutiny has increased since 2009, when the FDA cited Teva for violations at an injectable drug plant, charging that it had failed to catch bacterial contamination of propofol, the anesthesia drug. And Hospira, the leading manufacturer of injectable drugs, has been the subject of several major product recalls because of poor quality control at several of its plants. The faulty products included infusion pumps (see our story) and morphine vials.

Apparently Hospira didn’t care if its muscle cars stalled—as The Times reports, its manufacturing problems became public after the company initiated a plan designed to save more than $100 million a year by, for example, shrinking the work force. Some shareholders filed a lawsuit against Hospira claiming that the initiative led to deep cuts in quality control and the failure to maintain equipment. An Hospira executive, The Times said, acknowledged the company had gotten “a little lazy” and was “skating behind the puck.”

There must be a lot of errant pharmaceutical industry pucks. Last year, Ben Venue closed a plant after FDA inspectors found rusty tools, mold and a barrel of an “unknown liquid” later determined to be urine. A.P.P. Pharmaceuticals received a warning letters when FDA inspectors said it failed to investigate problems including human hair and fungal growth in vials. There were also reports of vials infested with weevils and spiders.

A former plant supervisor told The Times that managers were reluctant to stop the production lines. “It’s like trying to fix your car when you’re driving down the Thruway,” he said. (What is it with Big Pharma and car metaphors?)

The FDA message seems to be getting results. Several manufacturers, including Ben Venue, Teva and Hospira, are spending significant amounts to upgrade factories and open new ones, even if full production has not yet resumed. Dr. Sandra Kweder of the FDA’s Office of New Drugs told The Times, “I would say we are encouraged. But we also know it takes three to five years to get one of these plants up and running.”

Anyone who’s ever had an owie after cleaning out the garage or trying to match Paul Ryan’s P90X regimen is probably familiar with names like Bengay, Flexall and Icy Hot. They are topical analgesics you apply to sore, complaining muscles and joints.

As of last month, the FDA has issued a warning about such creams, gels or skin patches because some people have reported burning pain and blistering ranging from mild to severe. Some injuries have required medical attention.

In some cases, the FDA reports, these over-the-counter (OTC) treatments caused first- to third-degree chemical burns after only one application. Symptoms appeared within 24 hours, and some people had complications serious enough to be hospitalized.

There have been 43 reported cases of burns associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin. They came to light through the FDA's adverse event reporting database and the medical literature.

Millions of people use these products, so the number of reported adverse events represents a tiny fraction of consumers. But, "There's no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints," said Dr. Jane Filie of the FDA's Division of Nonprescription Regulation Development.

Menthol, methyl salicylate and capsaicin create sensations of local warmth or coolness when applied directly to the skin, but they should not burn. Most of the severe cases occurred with products containing menthol or a menthol/methyl salicylate combination. Most involved concentrations of menthol and methyl salicylate greater than 3 percent and 10 percent, respectively. Few burn cases involved capsaicin.

If you are using an OTC topical analgesic for the first time, choose one that isn’t a combination product and one with lower concentrations of active ingredients. If your pain persists, and you have tolerated those compounds, graduate to a more powerful treatment.

Otherwise, the FDA advises:

• Don't apply these products onto damaged or irritated skin.


• Don't apply bandages to the area where you've applied a topical muscle and joint pain reliever.


• Don't apply heat to the area (heating pads, hot water bottles, lamps). Doing so increases the risk of serious burns.


• Keep these products away from eyes and mucous membranes (such as the skin inside your nose, mouth or genitals).


• If, instead of a warming or cooling sensation, you feel pain where you’ve applied the product, if it looks blistered or burned, stop using the product and seek medical attention.

Last month, we wrote about the danger of drug and medical device warnings and recalls that go unnoticed by hospitals and doctors, much less patients. A recent story reported by CNN demonstrates the tragic consequences of such ignorance.

When Florinda Gotcher entered the hospital to donate one of her kidneys to her brother, recalled her daughter, Melinda Williams, "She was so happy. She was overwhelmed that she was able to save her brother's life."

Kidney donor surgery is relative safe: According to CNN, in 2010, the year before Gotcher's surgery, 6,276 people donated a kidney. Thirty days later, they were all still alive. Mere hours after her surgery, Gotcher was dead.

Williams said that surgeons from University Medical Center in Lubbock, Texas told her Gotcher experienced massive, sudden internal bleeding after her laparoscopic procedure, and that they’d done everything possible, but that nothing could save her.

Really?

Kidney donation surgery requires cutting the renal artery. If it’s not properly closed, patients bleed to death. Staples or clips typically are used to close the artery, and both methods are considered safe. Except for laparoscopic kidney donation.

Clips are not indicated for the arterial stump because they can slip off. Four people are known to have died from exactly this circumstance, and 12 others suffered injuries. When Gotcher was taken back into the operating room after her collapse, her clips were found floating in the pool of blood that had collected in her abdomen.

This should have surprised no one, as the clips’ manufacturer, Teleflex, in 2006 began sending warning letters to hospitals that the clips were unsafe for use in laparoscopic kidney donor surgeries. Hospitals received at least three and as many as six such letters.

In addition, the product package bears a warning symbol directing doctors to review the instructions accompanying a separate tool used to apply the clips, which make clear that the clips should not be used on kidney donors.

Officials at University Medical Center acknowledged receiving the letters in 2006, but said they hadn’t purchased those clips that year. By the time they did, the letters had been forgotten, simply one more of the dozens the hospital received every year concerning safety issues.

Many medical professionals believe warning letters don’t go far enough, and that warnings should be posted directly on the devices themselves. The FDA disagrees, stating that the letters are “effective,” never mind that only about half the hospitals mentioned in documents obtained by one researcher acknowledged receipt of the warning notifications.

And the agency appears to have undercut its initial analysis, given that after Gotcher’s death it issued another notice reminding surgeons of the clips’ unsuitability for kidney donor surgeries.

As the FDA told CNN, "despite repeated efforts to communicate this important safety information, some transplant surgeons continue to improperly use these clips. While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine."

University Medical Center settled a lawsuit over this tragedy, and acknowledged that its process to track warnings failed. Now it uses an outside contractor to document and track warnings and recalls.

But it’s too late for Florinda Gotcher.

Just in time for summer the FDA has granted manufacturers of sunscreen an extension for complying with new rules for labeling.

The decision to delay for six months imposition of rules that would have compelled manufacturers to be more truthful about the capabilities of their products reflects a concern that products will bear misinformation and that there will be a shortage of product. Some manufacturers said they wouldn’t be able to complete testing in time to accurately label all of their products.

As reported on MedPage Today, last summer the FDA said that sunscreens with SPF-15 or lower would be required by this summer to warn users on the packaging that they’re not getting as much protection as they might think.

The new rules were supposed to take effect June 17, and require manufacturers not to refer to their products as "sunblock," "waterproof" and "sweatproof," or as providing "all day protection." The FDA says such claims are inflated.

Now, it will be December before the changes take effect. Small companies get an additional year.

Manufacturers of lotions and sprays with an SPF—sun protection factor—of at least 15 may claim on the label that they protect against sunburn, early signs of aging and skin cancer. And if a sunscreen offers adequate protection against ultraviolet B (UVB) as well ultraviolet A (UVA) rays, they may be labeled "broad spectrum."

UVB rays are responsible for burns. UVA rays penetrate deeper and are responsible for wrinkling and other signs of aging. Both contribute to the risk of skin cancer. (To learn more about melanoma, or skin cancer, link here.)

The numerical value of a sunscreen is a measure of time. The numbers denote how long someone is expected to be protected from sunburn. They are NOT a measure of the strength of the compound’s protection. Different people require different periods of exposure to burn.

Someone with fair skin who begins to burn after five minutes would be protected, theoretically, for 75 minutes with use of an SPF 15—5 x 15. Someone with darker skin might get twice as much protection with the same application. Women’s skin is thinner, and burns more quickly then men’s. Black skin also burns, but it takes longer.

The intensity of UV radiation varies across the course of a day. Other factors influence the efficacy of sunscreen:

• user’s skin type;


• activities in which the user engages (swimmers, for example, lose efficacy sooner than sedentary sunbathers);


• amount of lotion the skin has absorbed.

Use a broad spectrum product and read the labels, misleading though they may be until the end of the year. For maximum UVA protection, look for these ingredients: zinc oxide, avobenzone and/or ecamsule.

Contact the Skin Cancer Foundation for more information about the risks of sun exposure and how to minimize them.

Beauty’s only skin deep, they say, but ugly cuts to the bone.

And by “ugly” we’re talking about the potential for cosmetics to have unattractive consequences. At least that’s the thinking behind the push for more accurate product labeling on makeup, sunscreen, bath and other personal products.

As explained in a story by the Detroit Free Press, the chemicals, minerals and unknowns that are constituents of these lotions and soaps and hair applications do not undergo routine review by the FDA or USDA or any other regulatory agency. Only when consumer problems necessitate attention are these products scrutinized.

Between the fundamental human desire to look good and the overwhelming marketing hype characteristic of the cosmetics industry, consumers are hard-pressed to get accurate, helpful information about the ingredients with which they have such a close, personal relationship.

That’s not acceptable to U.S. Rep. John Dingell, D-MI. He’s conducting the first congressional hearings in decades about cosmetics safety. Several pieces of legislation have been introduced to give the FDA the power to register cosmetics and enable recalls if products prove unsafe.

Last year we wrote about one risky product, Brazilian Blowout, a hair-straightening formula that was found to contain dangerous levels of formaldehyde. Consumers suffered respiratory problems and skin rashes, and now Brazilian Blowout labels carry a warning. But it’s still a legal product and the FDA has no further authority to regulate it.

Lack of research into the long-term effects of low-level exposure to cosmetic chemicals makes clear harm uncertain. In the cosmetics industry, according to the co-founder of a cosmetics company quoted by the Free Press, "everyone's intentions are safe levels. But then, everyone is using 20 products a day. It's this geometric explosion of chemicals in our lives. ... It's not one thing."

"The question is whether the occasional application on the skin is really dangerous," said Dr. Scott Ramsey, director of the Cancer Prevention Program at the Seattle-based Fred Hutchinson Cancer Research Center.

Years ago paraben -- a preservative used in cosmetics and deodorant – was suspect in breast tumors. People dumped these products, but it’s still unclear if paraben is harmful. Preservatives prevent the growth of harmful bacteria in a product that sits on a bathroom shelf or at the bottom of a purse, and it’s impossible to completely escape exposure to toxins. Even antibacterial soap, a product that’s supposed to confer protection, has been host to a chemical suspected of causing hormonal issues.

But consumer safety advocates at least want to cut down on exposure you can control. One salon customer interviewed by the Free Press put it concisely: "Better health is not a science problem; it's an information problem."

Don’t use a product without reading the label. If ingredients are not listed, Google the manufacturer for more information or opt for a product you can vet. Search for information about the safety of a given product on the Consumer Products Safety Commission’s Safer Products (CPSC) site.

If a product causes problems—anything from minor skin irritation to more serious issues such as swelling or breathing problems—contact the FDA’s cosmetic topics website, the CPSC and the manufacturer.

If you want the federal government to improve cosmetic product oversight, contact your congressional representative.

Who doesn’t like a good deal? The popularity of Groupon, the online deal-of-the-hour/day/week service has spawned a whole family of mimics. Unfortunately, suggests Gary Schwitzer on Health News Review, it’s a dysfunctional family when it comes to dubious medical treatments.

In the space of mere days, irresistible deals were available for:

• laser toenail fungus treatment;


• MRI for “headache prevention screening”;


• -lipolaser treatments;


• botox;


• B12 injections or allergy test.

But Schwitzer was amused most by an offer from Living Social for Colon Hydrotherapy:

“The foliage may be in bloom outside, but if you’re feeling less than fresh inside, today’s deal could help you stem the problem: Pay $35 and get one colon hydrotherapy session (a $75 value). Colon hydrotherapy is a safe, effective method of cleansing the large intestine using water instead of drugs. The gentle infusion of warm filtered water moves naturally through your large intestine, leaving you feeling cleansed and refreshed. The treatment is safe, quick and pain-free. The certified staff uses an advanced state-of-the-art technology to provide you with natural wellness therapies. Don’t be a shrinking violet — nab today’s deal before it goes to seed.”

Commented one guy on the Health News Review site, “Personally, I await the Groupon lobotomy offer…”

Absent pernicious anemia, almost no one needs injections of B12. And no one’s colon is crying out for cleansing. But … got a coupon for hype eradication? We’re in!

A few weeks ago we wrote about the unknowable contents of energy drinks, particularly caffeine, and their potential to cause problems.

Now, the feds are homing in on Aeroshot Breathable Energy, a dietary supplement that promotes its “unique blend of caffeine and B vitamins in a fine powder that dissolves quickly in your mouth.” The FDA is investigating Aeroshot amid concerns that it’s as much a party drug as a legitimate—and safe—energy booster. Using Aeroshot and alcohol simultaneously, the thinking goes, enables people to drink larger amounts of alcohol than normal because its effects are masked until consumers are extremely inebriated.

Inhaled via dispenser, Aeroshot imparts a large coffee cup’s worth of caffeine with every spray; each container yields 4 to 6 puffs.

In 2010, the FDA and the Federal Trade Commission (FTC) warned people that caffeinated malt beverages might not be “generally recognized as safe” (GRAS), the standard used to analyze food with added ingredients that haven’t been subject to approval. As a result, caffeinated malt beverages such as Four Loko effectively were banned.

But because Aeroshot is marketed as a dietary supplement, not as food, it isn’t subject to the regulatory muscle the FDA can flex for food products. “[I]t bears watching,” said the FDA Law Blog, “whether FDA takes account of the manufacturer’s marketing practices, and of whether the product is associated with ‘adverse behavioral effects’–factors that the agency cited in support of its conclusion that the use of caffeine in caffeinated malt beverages such as Four Loko is not GRAS.”

The investigation, then, will focus on whether Aeroshot is safe and legally marketable as a dietary supplement. If such products make no claims about curing medical problems, they may be sold without FDA approval. But they may not contain active pharmaceutical ingredients that are regulated by the agency. Supplements often have been found in violation of this rule, but the FDA generally does nothing until adverse effects become known.

Although Aeroshot is promoted as a “breathable” product, it actually dissolves in the mouth, and is swallowed, which complicates its categorization for regulatory oversight. The almost incomprehensible category of “breathable” food is not unfamiliar to some food scientists, but it’s a concept few other people can wrap their minds around. Really, who wants to inhale, in the literal sense, their Thanksgiving dinner?

So what’s a consumer to do about Aeroshot? Certainly, if you’ve used the product to ill effect, make a report to the FDA by linking here. If you’re only considering using Aeroshot and questioning its value, think about this: If you can’t even define the category under which something you’re contemplating eating, drinking or inhaling falls, if the full nature of its contents are unknown and have the potential to cause or exacerbate a problem, do you really want it in your body?

A couple of home furnishing products recalled this month affect thousands of consumers, as reported on AboutLawsuits.com. Here’s a heads-up if you own either a Honeywell portable electric heater or a Big Lots floor lamp.

The Honeywell recall affects about 19,000 Surround Select portable electric heaters. According to the U.S. Consumer Product Safety Commission (CPSC), their internal housing (the fan, heating element and circuitry) can detach, exposing consumers to a burn hazard. So far, no injuries have been reported.

The heaters were sold at Best Buy, Meijer and Wal-Mart stores nationwide last year for $50 to $70. Consumers who have these heaters should stop using them immediately, unplug them and can contact the manufacturer, Kaz USA, Inc., for a full refund. Call Kaz at (800) 370-8137 or visit its website for recall information.

The CPSC recalled the floor lamps after Big Lots receives at least four reports of melting lampshades. No injuries have been reported, but there’s a consumer hazard that the 40-watt bulbs might generate too much heat in the 43,700 lamps sold.

Also, the wiring in the light socket can become exposed, posing a risk of being shocked.

The recall affects Classic Quarters Five Light Floor Lamps. The lamps are about five feet tall and feature five adjustable lights mounted on flexible tubes. Some have dark plastic shades while others are multicolored.

The lamps were sold exclusively at Big Lots stores nationwide from April 2010 through November 2011 for $30 to $50.

If you have one, stop using it immediately. Return it to a Big Lots store for a full refund. You can also call Big Lots at (866) 244-5687. Its website does not appear to have information about the recall.

If you're facing a hip or knee replacement, today's story in the New York Times is a fresh reminder of something we patient safety mavens see over and over with new drugs and devices: the new ones often work no better, and sometimes worse, than older versions on the market for a long time. But it takes much longer for the safety track record to develop for the new devices, and meantime billions in profits have been pulled down.

Barry Meier of the Times is on top of this story, as he is on so many of the ongoing troubles in the medical device industry.

The new study finds that new technology in hip and knee replacements, such as metal-on-metal hip joints, don't turn out to last any longer than their older cousins. Many Americans who have had early failures of new hip replacements can attest to that.

Another interesting angle is the source of the study: an Australian patient registry. We don't have such mandatory registries in the United States. When all patients are entered into a common database, it's easier to pick up early warning signals of safety issues.

In two recent decisions, the FDA determined that the eyes have it. And that’s not a positive outcome.

In November, the agency issued a class I recall of Avaira Toric Soft Contact Lenses, manufactured by CooperVision. (Class I is the most serious of the FDA’s graduated scale; see below for a description.) Last week, the feds issued the same recall for another of CooperVision’s products, the Avaira Aquaform Sphere Soft Contact Lens.

These lenses, the agency determined, put users at risk of serious eye injury because of silicone oil residue. Initial symptoms of the problem include hazy or blurry vision, discomfort and corneal abrasions. If you use either of these products, visit CooperVision’s website to see if the lot number on your lens package is included in the recall. If you don’t have the number, or if you simply want to exercise caution, cease using the lenses immediately and call your eye doctor.

According to AboutLawsuits.com, a class action lawsuit was filed last month by stockholders against CooperVision. They allege that CooperVision’s parent company artificially inflated its stock value by minimizing problems with the contact lenses and failing to take sufficient steps to make sure the public was aware of the initial recall.

The website says that the FDA came down on the company in October for failing to provide detail about the lenses’ problems and for issuing its own recall of the Toric lenses in August in a manner so secretive as to leave consumers unaware of the risk. The company expanded the recall in November, and the increased visibility prompted the stock to decline.

In what certainly looks bad even if it’s legitimate, the company’s chief executive officer and chief financial officer sold off millions of dollars in company shares despite their awareness of the growing problem with the contact lenses, according to the lawsuit. Then, the claim says, they boosted expectations for 2011 revenues by minimizing the recall, artificially inflating the value of the company’s stock.

Here’s a primer on the FDA’s approach to recalling suspect, deficient or dangerous products. “Recalls are actions taken by a firm to remove a product from the market,” according to its website. “Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.”

A Class I recall denotes “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

A Class II recall denotes “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences” or when “the probability of serious adverse health consequences is remote.”

A Class III recall denotes “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

Market withdrawal occurs when “a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.”

A Medical device safety alert is issued when “a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.”

When it comes to the green revolution, you’re a conscientious soldier. You care about the effect consumer products have on your health and the health of the planet. You read labels. You understand that chemical use has consequences.

Or you would, anyway, if manufacturers let you. While the law requires that food products list their ingredients on the package, the same rule does not apply to household cleaning products. And sometimes their brand names can be misleading.

A new study commissioned by a nonprofit environmental organization employed an independent lab to test 20 top household cleaning products. As it turns out, Tide’s “Free & Gentle” contained 1,4-dioxane, a solvent and suspected cancer agent. As it turns out, Simple Green is not simple, as it contains phthalates, a chemical suspected in endocrine (reproductive) disorders, especially in children. As it turns out, several products listed as “fragrance-free” contained allergens.

Not long ago, we wrote about potentially dangerous ingredients in antibacterial soap, an even more questionable compound, given its market branding as something that's supposed to ward off disease, not possibly promote it.

The report—“Dirty Secrets: What’s Hiding in Your Cleaning Products?”—was issued last week on the same day a Congressman from New York introduced the Cleaning Product Right-to-Know Act. Rep. Steve Israel wants manufacturers to disclose the chemicals used in products ranging from laundry detergent to air fresheners to furniture polish.

In a news release accompanying the report, Anne Steinemann, one of its scientific reviewers, said, "I've heard complaints from hundreds of people who said that air fresheners and other fragranced household products made them sick—causing headaches, breathing difficulties, seizures, asthma attacks and other health problems." Steinemann is professor of civil and environmental engineering and public affairs at the University of Washington. "This report does a tremendous service by revealing the hazardous chemicals that can be hidden in cleaning products, so that consumers can know to avoid fragrances and other chemicals that are linked to serious health problems."

We can’t speak to the scientific rigor of the report, as it has not been published in a peer-reviewed journal. But its approach and conclusions speak to common sense—people have a right to know what chemicals they are introducing into the environment. And manufacturers, it seems to us, should be obliged to disclose what goes into their products.

If you agree, contact your congressional representatives, and ask them to support the disclosure legislation.

Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…”

The paper was referring to “Health IT and Patient Safety: Building Safer Systems for Better Care," a report by the Institute of Medicine (IOM) calling for greater oversight of health-care technologies.

The U.S. Department of Health and Human Services (HHS) requested the IOM to evaluate electronic health records in the first place out of concern that some such products raised safety risks for patients. Practitioners were wondering if the boom in digital record-keeping is fostering a rash of medical errors thanks to balky, difficult or malfunctioning technology.

The report doesn’t decry the move – for reasons of both cost and care efficiency – from paper to electronic records, it just emphasizes that oversight must be part of the deal: “To achieve better health care, a robust infrastructure that supports learning and improving the safety of health IT is essential. Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus. If appropriately implemented, health IT can help improve health care providers’ performance, better communication between patients and providers, and enhance patient safety, which ultimately may lead to better care for Americans.”

The IOM said an investigative agency -- like the National Transportation Safety Board, which investigates airline accidents and examines safety issues -- should be established for health-care technology. And that it should include tracking the safety performance of electronic health records.

So far, such efforts have yielded mixed results: There are tales of success, such as hospitals that use computerized, bar-coded prescription systems, but also tales of patient harm, such as delayed treatment due to lost data and/or problems with human-computer communication.

The IOM advised the Department of Health and Human Services (HHS) to devise a plan within 12 months to monitor patient safety risks associated with health IT, and to report on that progress every year. If, within a year, such progress is insufficient, the scientists’ group said the FDA should regulate these technologies, and that the agency should start planning for that now.

The IOM report is big on transparency. It is the government’s job to ensure that the private sector demonstrates concern for consumers by freely exchanging information about product use, “including details relating to patient safety.” You can’t establish a body of knowledge and develop a functioning market of safe products if you don’t share details of their risks.

This is thwarted today by the common practice of including nondisclosure clauses in contracts with vendors of IT health products. Such provisions impede efforts to improve safety by discouraging users from sharing information.

The report notes that clauses that limit liability (known as “hold harmless”) also undermine best-product practice by shifting liability “from the vendor to the users when an adverse event occurs.” As the story in The Times said, “Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.”

No one wants to stifle technological developments or the will to manage health care more efficiently. The key, as the IOM says, is to foster innovation without compromising safety.

When you get up close and personal with your cellphone, what are you exposing yourself to, literally? Dangerous radiation? Maybe. Nasty germs? Most certainly.

Two studies examining different potential hazards of cellphones have been in the news lately. One concerns the ongoing debate about the radiation risks of extended close contact with your phone, and the other concerns its hospitality to surface germs.

The first study involved members of the advocacy group Environmental Health Trust and was published in the journal Electromagnetic Biology and Medicine. It says that exposure measures per FCC guidelines underestimate how much radiation most people receive from their cellphones, according to a story in the Los Angeles Times.

The study authors say that current assessment methods use a large, liquid-filled plastic model of the adult human head, but that more than 9 in 10 people have smaller heads and therefore higher proportional exposure than what is assessed. Most important, children receive twice as much microwave radiation to the head as adults, the study estimates, and 10 times the amount to bone marrow.

Not to mention the possible exposure to other body parts when, say, a phone is stowed in your pocket.

The scariest possible side effect of cellphone use is brain cancer, although whether microwave radiation from cellphones can damage DNA and cause cancer is a subject of debate. See the National Cancer Institute fact sheet.

The Electromagnetic Biology and Medicine paper requests that the cellphone industry use a different method to certify phones for use, one that considers different sizes of users, and those who are pregnant.

A Danish cellphone study found no relationship between cellular telephone use and the incidence of cancer, but the British Medical Journal found problems with some aspects of that study.

Bottom line, there are passionate researchers on both sides of this issue and we really have no definitive science to argue conclusively that cellphones do or do not pose a radiation risk. As in most things, moderation is in order. Use cellphones only as necessary, and store them, ideally, away from your body.

In contrast, it's unequivocal that your phone goes with germs like peanut butter goes with jelly.

As reported on WebMd, 9 in 10 cellphones in a United Kingdom study served as host to bacteria including E. coli. And the reason is simple: People don’t wash their hands after using the toilet.

In this study, the E. coli came from fecal bacteria, which can survive on hands and surfaces for hours.

The researchers studied cellphones in 12 cities across the U.K. and asked users about their hand hygiene. Here’s what they learned:

• 9 in 10 phones were carriers of bacteria


• 8 in 10 hands were carriers of bacteria


• 16 in 100 hands and 16 in 100 phones bore E. coli bacteria.

If dirty hands are touching cellphones, they’re also touching other surfaces. Said one of the researchers: “They're spreading fecal bugs on everything they touch really."

"We didn't ask people whether they'd used their phones in the toilet. That might be something that would be interesting to study," she said.

Well, interesting is an interesting word, but it definitely would be illuminating, probably in ways most people don’t want to know.

Wash your hands. Often. It’s really just that simple.

Perhaps you’ve heard the buzz about “bioidentical” hormones; that they’re safer and more effective than FDA-approved hormones.

Uh, no, says Harvard Women’s Health Watch. The buzz is not about health, it’s about hype.

Bioidentical hormones generally are described as compounds with the same chemical and molecular structure as those produced by the body. And, generally, they’re available by prescription: Estrace, Vivelle and Estring, for example, are drugs often prescribed as female hormone replacement therapy.

The “bioidentical” claims Harvard calls into question include:

• As replacement therapy, they’re not drugs but molecular copies of natural hormones. As the Harvard report says, “This is not true. Drugs are substances (other than food) that are intended to affect the structure or any function of the body. If custom-compounded hormones have effects in the body, they’re drugs.”


• Bioidenticals are safer than synthetic hormones. Harvard says, “Unknown. [They] haven’t been tested in large, long-term trials.”


• Estriol (a weak estrogen used in compounded hormones) offers women protection from breast cancer. Harvard says, “There is no evidence that this is true.”


• Saliva and blood tests are reliable indicators of hormone levels. Harvard says, “ This is not true. Such tests can only tell a women’s hormone level at one moment in time and thus are not useful for setting hormone doses.”



Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Advertising , Product Safety

It sounds like a World Cup Soccer match result, but in fact, Brazilian Blowout is a hair-straightening product. And thanks to a wave of unpleasant responses to its use, the FDA has issued a warning letter to its manufacture.

Because it contains chemicals that become formaldehyde when heated – thanks, for example, to a hair dryer – and because formaldehyde can cause eye irritation, blurred vision, headaches, faining, chest pains and breathing difficulty, this is probably not a product with which you want to establish a close, personal, ongoing relationship.

According to AboutLawsuits.com, formaldehyde is classified as a probable carcinogen by the EPA and is considered a known carcinogen by the International Agency for Research on Cancer.

Enough people with straight hair but compromised health have suffered its ill effects that in November, the National Healthy Nail and Beauty Salon Alliance sent a letter to the FDA and another to the Occupational Safety and Health Administration (OSHA) seeking a recall of Brazilian Blowout to protect salon workers and customers.

In its warning, the FDA said “Brazilian Blowout is misbranded because its label and labeling (including instructions for use) makes misleading statements regarding the product's ingredients and fails to reveal material facts with respect to consequences that may result from the use of the product.”

The manufacturer has until this week to respond to the warning letter. It could face enforcement action by the FDA, meaning seizure of the products and a court order to stop them from doing business.

Common sense says that putting stents into blocked arteries in the brain should help prevent strokes, just like propping open heart arteries cuts heart attacks.

But Medicare asked for a scientific study before it started paying for widespread use of the brain stents. So doctors tested stents versus medical therapy in high-risk patients. After one month, a dramatic answer: in one group, 6 in 100 patients got a stroke, but in the other group, 15 in 100 had strokes.

Problem is that the stent group was the one that had more than double the strokes of the medical treatment group.

The result was so big that doctors pulled the plug on the study, as they could no longer ethically put patients into the stent group.

This is yet another example of how therapies that seem like they should work, based on our knowledge of the body and medicine, turn out not to work. We have a lot left to learn.

In the case of brain arteries, bypass surgery to put in a new artery to go around blockages, also similar to what's done in the heart, also has failed to prove out in scientific studies.

You can read the new stent study in the New England Journal of Medicine.

The chemical triclosan has been a popular ingredient in many household cleaning products despite the fact that its supposed antibacterial properties have not been proved. Making a questionable claim is one thing; promoting an ingredient that also might have harmful side effects is quite another.

Triclosan is found in so many products ranging from soap to toothpaste to cutting boards that a survey by the Centers for Disease Control and Prevention found traces of the chemical in the urine of 3 in 4 people older than five.

That’s a pretty heavy concentration for a chemical that might pose hormonal problems, make bacteria more resistant to antibiotics and pose an environmental hazard. That’s why both the FDA and the Environmental Protection Agency are studying its effects. In April 2010, the FDA announced that “in light of animal studies raising questions about triclosan’s safety, the agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. … For some consumer products, there is clear evidence that triclosan provides a benefit. For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”

Manufacturers, as expected, disagree, and are lobbying hard to protect the $750 million they earn every year in sales of antimicrobial and antibacterial hand soaps. Some consumer groups and congressional representatives want an outright ban of triclosan in antiseptic products such as hand soap.

Recently, the FDA announced it was extending its scrutiny of triclosan. As reported by the New York Times, concern centers around studies showing that triclosan might alter hormone regulation in laboratory animals and/or promote resistance to antibiotics.

You have to wonder why, if soap manufacturers were truly sold on the safety of triclosan, a major player like Colgate-Palmolive would reformulate its Antibacterial Dish Liquid and Softsoap products, claiming that “changing consumer preferences” were responsible.

Dr. Douglas Throckmorton, the FDA’s deputy director for regulatory programs who was interviewed by The Times, said the ongoing review focused on hand soaps but could extend to other consumer products if the agency determined that triclosan raised health concerns. That apparently does not include Colgate Total, a toothpaste whose triclosan content helps fight gingivitis.

But soap? Because the FDA believes that traditional soap is just as effective as an antimicrobial variety, and because the possibility of hormonal disruption and the fostering of antibiotic-resistant bacteria are of much greater concern than whether your cleansing agent is trendy, you might think twice before washing up with triclosan.

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

In 2007, the FDA proposed guidelines for gluten-free labeling. The gluten component of foods is important to people with celiac disease, a disorder in which essential nutrients can’t be metabolized when gluten is consumed. Gluten is a constituent of many grains, such as wheat, barley and rye.

Now, the FDA-approved definition of "gluten-free" is up for review, and the agency is reopening the comment period. Rules for what can be deemed gluten-free were never adopted.

As reported in Food Safety News, last week Michael Taylor of the FDA said, "We want to get the most up-to-date information and data from affected consumers, from the food industry, researchers and others to ensure that we're making the right public health call in defining gluten-free."

Approximately 3 million Americans suffer from celiac disease. "We want to make sure that those suffering from celiac disease avoid adverse health consequences from being exposed to food that may trigger the symptoms and cause long-term health effects," said Taylor.

The proposed language requires any food with the gluten-free label to contain fewer than 20 parts per million of gluten -- the equivalent of, roughly, about 2 grains of salt in a piece of bread. That recommendation includes a peer-reviewed assessment of the existing literature on gluten safety.

Some people believe that any amount of gluten is unacceptable in a product labeled “gluten-free.”

The rules are expected to be finalized next year.

To view the FDA documents related to the discussion, link here and here. The proposed regulations for gluten-free labeling are in the Federal Register, docket no. FDA-2005-N-0404 at www.regulations.gov.

Hold your cellphone against your head too long and you can get a brain tumor. Text too often and you can forget how to spell. Converse on your Bluetooth while waiting in line and annoy everyone around you.

One of those statements is undeniably true, one could be true, and one—about brain tumors—is probably false, according to a new study in Environmental Health Perspectives.

Because data is sparse about cellphone use by youngsters and about use periods longer than 15 years, be prepared for ongoing speculation about how cellphones affect your brain. And be mindful, the study says, that "Research cannot in principle prove the complete absence of an effect, but only place limits on its possible magnitude.”

Still, the conclusion is fairly compelling: “Although there remains some uncertainty, the trend in the accumulating evidence is increasingly against the hypothesis that mobile phone use can cause brain tumours in adults.”

Of course, we can’t promise that somebody won’t whack you in the head if you text and chat during the movie.

A couple of implantable devices recently received new scrutiny with negative results.

Medtronic issued a “medical device correction” about possible diminished battery life of its infusion pump, the SynchroMed II. The device is surgically implanted to deliver painkilling medication.

According to About Lawsuits.com, of 140,000 implants worldwide, 55 were reported to have reduced battery performance. Designed to last 84 months, some batteries failed as early as 48 months. Medtronic issued a caution about the problem in July 2009, and an update earlier this month. And in February, certain models of the SynchroMed infusion pump were recalled thanks to a defective design that could result in an overdose during refill.

Pump failure can result in the return of pain, can cause patients to experience drug withdrawal and, for patients with multiple sclerosis who receive the drug baclofen, can be life-threatening.

The SynchroMed II is not being recalled, nor is it recommended that it be removed. Patients who have the device and whose symptoms reappear, or who hear a device alarm should contact their doctors immediately. For additional information, call Medtronic Patient Services, (800) 510-6735.

For women with pelvic organ prolapse, in which urinary and/or sexual organs droop or slip out of place, surgery is sometimes indicated. The FDA warns that if surgical mesh, rather than stitches, is implanted to strengthen the vagina, the risk of complications including tissue erosion, pain, infection, bleeding and urinary problems is greater. (Sometimes the mesh is implanted through the abdomen, which is not subject to the advisory.)

According to MedPage Today, “the number of adverse events linked to the device has been increasing in recent years.” Between 2008 and 2010, five times as many such events were reported than between 2005 and 2007.

"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," William Maisel, M.D., M.P.H., deputy director of FDA's center for devices and radiological health, said in a statement. "Mesh is a permanent implant--complete removal may not be possible and may not result in complete resolution of complications."

Although the mesh often corrects the anatomical issue, after reviewing reports for a 14-year period of use, the FDA concluded that the greater risk was not accompanied by greater clinical benefit than nonmesh surgery. Its advisory was issued in advance of a committee meeting in September to examine the safety and effectiveness of surgical mesh for the treatment.

As quoted by the McClatchy-Tribune News Service, Diana Zuckerman, president of the National Research Center for Women & Families, said an advisory wasn’t strong enough. “The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available.”

If your doctor has advised surgery to correct pelvic organ prolapse, be sure to discuss the implications of both mesh and stitches.

You fill a prescription with a brand-name medication. The pills are light-blue ovals that come in a plastic bottle. When the generic version becomes available, your insurance company insists that you purchase only that, and your doctor agrees.

This time, the pills are round, white and come in a carboard blister pack. If the medicine works the same, who cares?

Two physicians writing in the New England Journal of Medicine, argue that we all should.

They say letting generics look like the brand name original makes for safer and even more effective medicine.

The doctors argue against a practice called "trade dress." The term refers to federal laws that protect the unique appearance of brand-name drugs by prohibiting generic pharmaceutical manufacturers from making similar-looking pills or designing similar packaging.

The researchers accept that trade dress has played a meaningful role in keeping drugs safe. It can prevent different medications from being mistaken for each other, thwart counterfeiting and prevent shady pharmacists from making unauthorized substitutions of generic for brand-name drugs and skimming the extra profit for themselves.

But drugs that are supposed to perform one way but look different every time you refill the prescription, suggest researchers Jeremy Greene and Aaron Kesselheim, can lead to medication errors, can be unnecessarily more expensive and can diminish the generic drugs' effectiveness, thanks to the placebo effect not kicking in for the generic drug.

A placebo, or "fake" drug, is a sugar pill or other inert substance used in medical trials to test different treatments among trial subjects who are unaware if they are being given medicine or something that just looks like it. Often, however, patients receiving the placebo respond positively, sometimes strongly so.

As reported on MedPage Today, The NEJM researchers note that "A resurgence of research on the placebo effect suggests that drug appearance can have a distinct functionality." They say a medication's packaging and the perceived dollar value of products can influence a product's effectiveness as well.

So because one medicine that always looks different can be confusing, because generics make up about 70% of all U.S. prescriptions but less than 20% of prescription-drug costs and because a patient's mind is a powerful player in his or her ability to heal an ailing body, the researchers support amending regulations to permit generic drugs to resemble their brand-name counterparts.

Such changes would codify a consistent, organized system of pill appearance that would:

• simplify the complexity of certain medical regimens;


• encourage the use of generic drugs when appropriate; and


• increase a patient's ability to take the medication as directed.

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

A couple of months ago we gave a shout-out to a physician who had written a commentary about Genentech's efforts to have the FDA bless the use of its drug Avastin for treatment of certain breast cancers. He had objected to the use of patient testimonials as compelling evidence to support such appeals because they're not science, they're marketing.

In what the company and its supporters probably consider honorable tenacity but thinking minds ascribe to naked greed and abuse of taxpayer resources, the FDA again this week is hearing the case for approving Avastin as a conditional treatment for certain breast cancers, never mind that studies have shown it to be neither life-prolonging nor markedly life-enhancing. In the face of life-threatening side effects, Genentech still champions the drug because it has helped some patients. Yes, Virginia, and some people make a living swallowing swords and eating fire, but such activity isn't, as they say in FDA-land, "generally recognized as safe."

Two editorials appearing this week in the New England Journal of Medicine speak in favor of science and respect for human life.

Genentech presented four arguments against the FDA’s proposed withdrawal of Avastin for breast cancer: one, the move has no precedent; two, the possibility of some patients benefiting justifies continued approval; three, individual patient choice should prevail; and four, ruling against Avastin will make future drug development confusing and discourage innovation. And, like the kid who throws the ball over the fence because he doesn't like the ump's call, Genentech also took a shot at the FDA committee considering the matter, calling it biased and requesting different judges.

We won’t dignify Genentech’s hissy fit, but, in order, here's why Genentech's appeal is folly.

One: Precedent for removing a drug’s indication for a specific disease is part and parcel of U.S. drug regulatory process.

Two: Just because some patients might benefit doesn’t mean there is enough benefit to outweigh the harm to many other patients taking this highly toxic drug. Such lazy extrapolation ignores the absence of Avastin data identifying the patient characteristics that are associated with the benefit. That's incomplete science, and it’s dangerous.

Three: Genentech’s position that “conflicting interpretations of data should be resolved in favor of retaining access and choice” is a direct contradiction of the FDA's mandate. As the NEJM commentary stated, "In a democratic republic, access and choice represent two among many values. The FDA must also protect scientific rigor, the integrity and legitimacy of federal regulations and guidance, and the public’s health. The agency’s reputation for using science to guide regulatory decisions in the public interest is its most critical institutional asset."

Four: FDA action to restrict a drug's use from some applications is common and practically perfunctory. Instead of chilling R&D, such a situation might effect more aggressive drug development--if Avastin offers little promise for patients with metastatic breast cancer, won't pharmaceutical companies be inspired to develop a better product? After all, that’s where the money is, and we all know what motivates Big Pharma.

On one side you have what Justice Hugo Black evocatively called "organized money" -- the corporate interests dressed, in this case, in the garb of drug manufacturers: White coats with hundred dollar bills stuffed in the pockets.

On the other side: Regular folks: consumers, patients, and individual doctors.

Who wins in the U.S. Supreme Court? This week, organized money won: twice.

By 5-4 votes in both cases, the Supreme Court decided:

* Generic drug manufacturers are immune from lawsuits for defective and misleading labeling on their products even if patients are injured.

* Drug manufacturers have a constitutional right to collect data on individual doctors' prescription-writing habits, to help them market to those doctors more effectively.

The second decision will help "Big Pharma," brand name manufacturers who work hard to goose sales of their drugs while still under patent, before the generics bring in cut-rate look-alike products. So in a way, the court was balanced: One bone thrown to the brand name drug makers, and the other to the generics. But consumers were on the short end of both cases.

Why is the drug marketing case bad for consumers and for patient safety? Because the state of Vermont, whose law was overturned by the Supreme Court ruling on "free speech", was trying to give some breathing space for doctors to make decisions about what drugs are safest and most effective for their individual patients, without having the manufacturers' sales people in essence spying on the doctors by tallying up their weekly patterns of drugs prescribed. Read more on this drug marketing case from Merrill Goozner's blog.

The other decision is even more obviously bad for consumers. This ruling, based on a bizarre interpretation of the federal law that lets generics copy brand name drugs once the patent has expired, gives generics absolute immunity from lawsuits by injured consumers -- so the generic companies will have no incentive to follow the safety records of the drugs they profit from and put out corrected labels. Read more on this one from the American Association for Justice.

The contest between flesh and bone versus the spinning blade of a table saw is always a
rout. The 40,000 Americans who land in emergency rooms every year with such injuries
are testimony that table saws are the country's most dangerous commonly used power
tool. This spring, the issue of table-saw safety
has found a more receptive audience among federal regulators than have
several previous efforts at raising consciousness about a bloody battle no one ever wants
to wage.

Consider:

4,000 victims of table-saw accidents suffer amputations every year;
a table-saw accident occurs every nine minutes.

So why have these numbers failed to diminish significantly since the 2004 introduction of
a technology that shuts off a saw when it senses contact with skin? Because, apart from
the company that introduced SawStop, no other power tool manufacturer has embraced
the technology, and federal regulators have not required its use. Although understandably
reluctant to endorse a product, the feds finally are acknowledging the bone-headedness of
ignoring a clear solution to a vexing problem.

Invented by a physicist, a SawStop blade carries an electric signal that changes upon
contact with skin, thanks to the fact that the human body is conductive. The change
activates a brake, and the blade stops spinning instantly. In a recent interview with NPR,
Bob Adler, a commissioner at the Consumer Product Safety Commission (CPSC), said,
"What you have is somebody who has invented a dramatic technology that seems to
reduce virtually all the injuries associated with table saws."

The potential benefit of imposing such a safety measure has been compared to that of
safety belts, air bags, disabling refrigerator door locks and other landmark regulations
that have saved lives and limbs.

The power tool industry claims that SawStop would increase the price of table saws
beyond consumer tolerance, essentially doubling the cost for the least expensive models.
It says that the blade guards on most models proved awkward, that users routinely
removed them, but that they've been redesigned. Their improved effectiveness, other
manufacturers say, bypasses the need to mandate use of the more expensive and
complicated SawStop.

Recently, the National Consumers League sponsored an effort by injured woodworkers to
lobby lawmakers and regulators to make the safety brake mandatory on all table saws.
Some weeks later, at a public meeting on table-saw safety, Inez Tenenbaum, chairwoman
of the CPSC, said, "It's clear that we need a standard that will truly address and help
reduce the tragically high number of finger and hand injuries that are occurring on a daily
basis around the country."

The CPSC wants to encourage major tool companies and SawStop to reach a licensing
agreement to enable the industry to use the technology voluntarily.

The commission has just directed its staff to draft a new regulation package. It should be
ready for public comment by the end of September.

Diabetes medication Avandia will be pulled from pharmacy shelves in November because it poses a major risk of heart attack, the Food and Drug Administration has announced.

Under a new program effective Nov. 18, 2011, only certified physicians will be allowed to prescribe the drug, and then only to patients who've been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.

The new FDA guidelines limit the drug to patients already successfully treated with it or to those for whom it's pretty much a last-ditch effort to control blood glucose medically. In addition, healthcare providers and patients have to enroll in the Avandia-Rosiglitazone Medicines Access Program to prescribe and receive rosiglitazone medicines.

The restrictions to access are so tough that virtually no one will be able to obtain the drug, says Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who has long advocated more restrictions on the use of rosiglitazone (Avandia's generic name).

Avandia is also sold as a component in the combination drugs Avandamet and Avandaryl. It was approved in 1999 to lower blood-sugar levels in patients with type 2 diabetes. In 2007, Nissen published an analysis showing that the drug increased heart attack risk by about 40% in people with type 2 diabetes, who are already much more prone to heart attacks than people without the disease.

Subsequent studies confirmed the greater heart attack risk. In June 2010, more than half of the members of an FDA advisory committee recommended pulling Avandia from the market or tightening restrictions on its use, and in September, the FDA decided to impose restrictions.

Source: TheHeart.org

You can read the FDA’s decision here.

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk. Only 21 devices (19%) had been approved through the more rigorous premarket approval (PMA) process, which requires clinical testing and inspections. (Eight other devices were exempt from any FDA regulation.)

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Originally, the 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids. It did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. Instead, it only required proof that the device was substantially equivalent in materials, purpose, and mechanism of action to another device that was already on the market, with the previous device serving as the “predicate” device with which the new device would be compared.

This approach was justified as a way to give manufacturers the opportunity to make small improvements on the devices already on the market and to allow companies with new products to compete with very similar devices without using the more extensive PMA process. If the FDA determined that the product was reasonably safe and effective according to the 510(k) review, it was said to be cleared for market rather than approved.

However, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which shifted the regulatory standard to "the least burdensome approach in all areas of medical device regulation." This had the practical effect of making 501(k) the dominant mechanism for new device clearance, with the FDA now reviewing only 1% of medical devices using the more rigorous PMA process.

To decrease the number of high-risk recalls, the study recommends:

1. The FDA fully implements current law that subjects "life-saving and life sustaining" (Class III) devices to the PMA process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

Source: The Los Angeles Times

You can read the complete study here.

Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein.

According to the complaint, Mylotec allegedly sold video-guided catheters to Rothstein, even though the catheters were not FDA approved for use with a laser. “Myelotec representatives were present during many of the spinal surgeries conducted in Ohio and knew or should have known that the company was placing patients at risk by promoting and permitting the alteration of its devices for non-FDA approved surgical use,” the complaint says.

Rothstein claims to have pioneered a non-invasive laser spine surgery called AccuraScope. The former patients allege Rothstein’s surgery left them with nerve damage, pain, weakness, numbness, paralysis and incontinence.

Rothstein declared bankruptcy in June 2010. At that time, there were 19 active malpractice cases against him. Previously, he had settled at least three cases and lost two trials, including a $5 million judgment for a Clark County woman who was left with permanent brain damage due to an overdose of pain medication. The bankruptcy case – which is still pending – halted the remaining malpractice cases.

Source: Dayton Daily News

To avoid the risk of "severe liver injury," the Food and Drug Administration (FDA) wants manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. Manufacturers also will have to update warning labels on these products to alert consumers about the potential risks.

Acetaminophen, better known as Tylenol, its most popular brand name, is a pain reliever and fever reducer sold over the counter (OTC) as well as in prescription products in combination with other ingredients, such as codeine (Tylenol & Codeine), oxycodone (Percocet) and hydrocodone (Vicodin). The FDA action affects prescription products only, not OTC medications.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

The elimination of higher-dose prescription combination acetaminophen products will be phased in over 3 years. “There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” Kweder said. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Because of continued reports of liver injury, FDA also wants to see boxed warnings, the agency’s strongest warning for prescription drugs, added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time or drank alcohol while taking acetaminophen products.

Source: Food and Drug Administration.

Click here for more information and a list of affected products.

Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the majority Republican House of Representatives pledged to shrink the federal bureaucracy – to fund it.

The law aims to shift the mission of the Food and Drug Administration (FDA) from reacting to tainted food after an illness occurs to preventing outbreaks in the first place.

Funding the new law would be “money extremely well spent to save money over the long run," Erik Olson, director of food and consumer safety programs at the Pew Health Group, says, pointing to a recent study that estimated that food-borne illnesses cost the country $152 billion a year in medical costs, lost productivity and other expenses – not including costs to the food industry when a product is recalled.

The Congressional Budget Office estimated that the food safety law would cost about $1.4 billion in its first five years, including the cost of hiring an estimated 2,000 additional food inspectors. Rep. Jack Kingston of Georgia, the ranking Republican on the Appropriations subcommittee that oversees the FDA, says the number of cases of food-borne illnesses in the U.S. does not justify the cost of the new law.

The FDA has yet to say how much of the new law can be implemented without additional funds from Congress, though FDA Commissioner Margaret Hamburg says that “some of the key elements of this bill need to be adopted no matter what.”

The new law requires manufacturers and farmers to develop strategies to prevent contamination and then continually test to make sure they work. The legislation also gives the FDA the authority to recall food; currently, it must rely on food companies to pull products voluntarily from the shelves. The law also gives the FDA access to internal records at farms and food-production facilities.

Under the law, importers would be required for the first time to verify that products and ingredients from overseas meet U.S. safety standards. Inspections of farms and food-processing operations would be stepped up and the FDA would be required to visit "high-risk" facilities --those where contamination is likely to occur -- once every five years initially and then once every three.

The measure will affect about 80 percent of the food supply that is regulated by the FDA, but does not affect meat, poultry and some egg products, which are overseen by the Department of Agriculture.

Source: Washington Post

There is growing concern among pharmacists in developed countries, including the U.S., that drug counterfeiting is a serious problem that current policies and technology have been unable to solve.

In a recently published survey commissioned by Pfizer and the International Pharmaceutical Federation (FIP), 63% of 2,000 community, retail and hospital pharmacists in the U.S., Europe and Australia believe current policies and technologies are insufficient to deal with drug counterfeiting, while 61% of those surveyed also say the prevalence of counterfeit medication is a serious issue in their country.

Long a problem in Africa and Southeast Asia -- where the World Health Organization has estimated that anywhere between 25% and 50% of medicines may be counterfeit – the number of these fake medications in the U.S. market has increased dramatically in recent years. In 2009, the U.S. Customs and Border Protection Agency stated that the value of seizures of counterfeit pharmaceuticals had increased by 500 percent over the previous 3 years. By some estimates, annual earnings from fake and substandard medicines worldwide is more than $32 billion.

A counterfeit drug is a pharmaceutical product produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. Generic drug products or drug products whose only violation is that of patent laws are not counterfeit drug products. A counterfeit drug may contain inappropriate quantities of active ingredients, may be improperly processed within the body (e.g., absorption by the body), or may contain ingredients that are not on the label (which may or may not be harmful), and is often sold with inaccurate, incorrect, or fake packaging and labeling.

Source: HealthcarePackaging.com

You'll find information on how to access an indepth study of the global drug counterfeiting problem here.

Patient safety advocates and brand-name drug makers lined up against companies that make generic drugs over just how flexible the standards should be for the clinical testing of biosimilars.

These drugs, also known as biogenerics, follow-on biologics and subsequent entry biologics, are officially approved subsequent versions of biopharmaceutical products following patent and exclusivity expiration on the original product. Until now, only a handful of biosimilars have been approved in the U.S., but that is about to change.

At the hearing, patient safety advocates argued that the only way to be sure that a drug is safe is through extensive clinical trials, while generic biosimilar manufacturers and distributors maintained that dangerous and expensive clinical tests are not required because they will be based on drugs that are already proven safe.

But are they? Biosimilars exhibit high molecular complexity and may be sensitive to manufacturing process changes. In addition, the biosimilar manufacturer doesn’t have access to any of the information or substances (e.g. molecular clone or cell bank) that the originator used to create the drug. As a result, patient safety advocates worry that biosimilars might perform differently than the branded versions, and could have potentially serious health implications.

Amgen, a brand-name biopharmaceutical manufacturer, called for biosimilars to undergo rigorous testing and recommended that the FDA:

1. Use well-designed clinical trials to establish biosimilarity

2. Ensure the product manufacturer and lot number is known for all administered biologics

3. Set scientific and practical criteria for interchangeability.

Critics of a rigorous clinical testing standard say that in addition to the expense, there are ethical questions involved in repeating potentially dangerous trials in humans. To avoid repeating human trials, U.S. Senator Bernie Sanders has proposed require generics makers to pay a fee for access to clinical data used in the manufacture of the brand name biologic.

Source: Wall Street Journal blogs

You can get more information about the FDA hearing and view video of the proceedings here.

The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA is recalling Hospira’s infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates. The company mailed an “urgent device field correction” to affected customers and issued a recall notification in February 2010. All the affected units were distributed from Dec. 23, 2006 to January 22, 2010.

Medtronic’s Octopus Nuvo tissue stabilizers were manufactured from February 19, 2010 through August 28, 2010 and distributed from March 8, 2010 through September 7, 2010. The device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity. The FDA ordered the recall because of the possibility that a component of the device could fracture during use and fragments could fall into the patient’s chest cavity and/or damage the heart tissue, causing serious injury or death. Fortunately, no action from patients is required, since any adverse event related to the device would occur at the time of surgery.

Medtronic sent an “urgent medical device recall notice” to its customers on September 14, requesting that they discontinue use of the device, quarantine all unused devices and return unused devices.

Hospira recall source: Bioscience Technology

To view the FDA ruling on Hospira, click here.

Medtronic recall source: Operating Theatre Journal

To view the FDA ruling on Medtronic, click here.

A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes.

“There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” said John Jenkins, MD, director of the office of new drugs at the FDA. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”

The move was described as “commendable but dangerously too late,” by Sidney Wolfe, MD, a member of the FDA’s Drug Safety and Risk Management Committee and director of the Health Research Group of Public Citizen, a consumer and health advocacy group.

The pressure from the FDA came after results of a clinical trial involving more than 10,000 patients showed that people who took Meridia had a 16% increase in relative risk of heart attacks. The trial also showed that individuals taking Meridia only lost approximately 2.5% more weight than those on placebo and that the weight loss didn't last very long.

Abbott maintained these results weren’t relevant because most of the individuals in the trial had cardiovascular disease and should not have taken the drug in the first place. The company continues to maintaion that for the right patients, the drug is safe.

European regulators took the drug off the market in January 2010. An FDA advisory committee was split on whether to remove the drug, but the ultimately decided to recommend doing so because “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” Jenkins said, adding that he did not believe Meridia users would have any residual increased risk once they stopped taking the drug.

Source: The New York Times

You can view an abstract of the clinical trial that led to the FDA recommendation here.

A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers.

They were developed using Failure Mode and Effect Analysis (FMEA), a scientific methodology that identifies where problems occur in the use of pain medications and the underlying causes of those problems. The FMEA research identified 79 areas where problems occur in the use of opioidsand 290 potential causes of those failures.

Tools now available include clinical materials and risk assessments for physicians, safe-use guides for patients and general education for all groups. The organization also plans to develop additional tools based on the research.

Jeffrey Gudin, MD, a pain management and addition specialist at the Englewood Hospital and Medical Center in Englewood, N.J., says that healthcare professionals need to do a better job of assessing our patients' pain medication needs and of communicating the risks of the medications they prescribe.

"Through the resources of the C.A.R.E.S. Alliance, patients, caregivers and health professionals will have access to information, tools and resources to help them better understand these risks and better ensure that the medications are used properly by only those for whom they are prescribed," he says.

The alliance, which is sponsored by Covidien, the largest producer of prescription pain medications in the U.S., also will work to ensure that patients suffering from chronic pain have access to necessary medications.

Source: Medical News Today
You can obtain tools and other resources here.

When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that's what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital.

Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once a New York Times reporting team found that the doses of radiation given to patients at the Huntsville Hospital were 13 times the normal dose for this type of scan, called a CT brain perfusion scan. The scan is used to test patients for stroke.

Even a properly done CT brain perfusion scan delivers about 200 times more radiation to a patient's head than a skull X-ray.

According to the Times, the hospital claims it used higher doses to get sharper images.

A quotable quote from the article, the latest in a series about medical radiation overdoses:

“It is absolutely shocking and mind-boggling that this facility would say the doses are acceptable,” said Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans.

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

Acetaminophen, the unpronounceable name for the active ingredient in Tylenol, is the most widely used pain reliever in the United States. But it can destroy the liver in ordinary or near-ordinary doses. That fact is news to many consumers but is old hat to liver specialists who every week treat patients at death's door from acute liver failure due to acetaminophen.

It has now been documented that acetaminophen is the most common cause in the U.S. of acute liver failure, which can result in death if a liver transplant cannot be done.

The Food and Drug Administration has recognized that acetaminophen poisoning is a public health issue and has slowly taken steps to educate the public to this popular drug's dangers. In April 2009, the FDA mandated a new warning label, which will say on 500-mg products (Extra Strength Tylenol and its generic equivalents): “Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than eight tablets in 24 hours, the maximum daily amount.” It will also warn against using it with other acetaminophen products or with alcohol use of three or more drinks a day. The FDA rejected a request from the Tylenol manufacturer McNeil to water down the warning by removing the word “severe” and adding the word “overdose,” which the agency said could lead consumers to believe they had to greatly exceed the recommended dosage before jeopardizing their livers.

This warning won't take effect until spring 2010. FDA advisors first recommended such a liver warning in 1977.

In the meantime, an FDA advisory panel will meet in late June to consider other steps intended to make it harder to accidentally cause liver failure from taking too much acetaminophen. A "working group" of advisors has recommended among other things:

• limiting the single adult dose to a maximum of 650 mg, and limiting tablet size to 325 mg (down from the current extra-strength size of 500 mg and single dose of 1000 mg);
• lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (and less than that for chronic alcohol users);
• restricting pediatric liquid formulations to a single mid-strength concentration;
• eliminating acetaminophen from combination products.

You can read the working group's recommendations at the FDA's web site here.

In the 1990s, Patrick Malone was one of the first attorneys in the United States to successfully sue the Tylenol manufacturer for hiding the dangers of acetaminophen from doctors and the public. Read about his case of Benedi v. McNeil here. Watch the ABC Prime Time Live segment on this subject by clicking here.

One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in the U.S. is Botox.

Botox and Dysport are injectable drugs developed from botulinum toxins, which temporarily paralyze the muscle into which they are injected. When administered for approved uses at approved doses, the botulinum toxins cause no harm. However, if used improperly, the toxins can travel from the injection site to other parts of the body, causing difficulty with swallowing or breathing.

Approved uses of injectable botulinum toxins include treatments for crossed eyes, eyelid spasms, severe underarm sweating, frown lines, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position.

According to the new FDA requirement, the drug manufacturers not only have to add the black-box warning labels, they also have to inform doctors of the risk information in writing, and make available a medication guide to patients at the time of injection.

Patients are well advised to read all handouts on drugs they take, especially something used for cosmetic purposes. Every drug has risks and must be taken with caution.

Ten rules for safer drug use can be found at Public Citizen's Health Research Group website. These rules and more tips for safe drug use are discussed by Patrick Malone in his book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

In its letters sent to 14 pharmaceutical companies in March 2009, FDA required risk information to be included in the Internet search advertisements of drugs – a move welcomed by consumer advocates, reports Stephanie Clifford in a New York Times story.

The short text ads that appear to the right of Google search results are limited to 95 characters, in which space pharmaceutical companies are now required to include not only the drug’s name but also its risk information. Although the drug companies had made risk information available just one click away from the search ads, which linked to a webpage containing detailed information of the drugs including side effects, the FDA issued this new requirement to ensure consumers are not misled.

Rita Chappelle of the FDA said in an NYT interview that it’s “vital and critical” that consumers do not mistakenly believe the drugs to be safer or more effective than they really are. This precaution is especially important in drugs that have frequently occurring or serious side effects, such as depression, liver damage, infections or severe allergic reactions.

On May 1, 2009, the FDA issued a warning for consumers to immediately stop using dietary supplements containing Hydroxycut, which has been linked to dozens of serious health problems including jaundice and liver damage. The dietary supplement is also responsible for one death from liver failure. Other reported health problems include seizures, muscle damage and cardiovascular disorders.

Patients who reported health problems were taking recommended dosage of Hydroxycut products, dietary supplements for weight loss. Therefore, the FDA urges consumers to stop taking Hydroxycut products immediately to avoid risks, many of which can involve permanent damage to your health.

The agency also advises consumers to consult a doctor if they experience these symptoms: jaundice (yellowing of the skin or whites of the eyes), brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Manufacturer of the dietary supplement, Iovate Health Sciences of Ontario, agreed to recall the products.

Diet supplements are promoted for their health benefits. Their “natural” ingredients are supposedly safer for a host of benefits like losing weight and gaining energy. The truth is that for most supplements, the benefits are unproven and untested, and the safety of these products is questionable.

Under federal law, diet supplements, unlike drugs, do not have to prove their safety and effectiveness before being sold to consumers. The supplement manufacturers are supposed to keep track of their own safety with very little government oversight until tragedy strikes.

Ironically, though, the diet supplements contain ingredients that mimic the actions of drugs and in some cases even contain actual prescription drug ingredients. Spiking a supplement with any prescription drug is illegal, and the FDA has been on a campaign to identify these products. Since December 2008, it has listed 70 brands of supplements that contained hidden and potentially dangerous drugs.

Another problem is that once reports start coming in of consumers sickened or injured after taking a supplement, it is often hard for safety officials to pin down what ingredient of the supplement was the culprit. Hydroxycut, for example, has a blend of a number of substances, the formula of which has changed over time. And for any of these products, because they are derived from plant materials, the strength can vary from batch to batch.

The best advice for consumers: Don’t be fooled by “natural.” When you’re taking a diet supplement, you are really ingesting a bunch of pharmacologically active substances, some of which won’t hurt you but won’t necessarily help you either. And sometimes, as with Hydroxycut, you can be hurt.

Salmonella, which causes serious gastrointestinal illnesses that can be life-threatening, was found in pistachios last week, according to the Los Angeles Times. The FDA has issued warnings for consumers to stop eating all foods containing pistachios, while investigations are underway.

Although salmonella contamination in pistachios is yet to be confirmed, Setton Pistachio of Terra Bella Inc., the nation’s second-largest pistachio processor, has voluntarily recalled more than 2 million pounds of nuts that it shipped out last fall. Kraft Foods Inc. and Kroger have also recalled some of their pistachio products.

Consumers are advised to stop eating pistachio products and monitor the investigations as more reports become available.

The U.S. Supreme Court has rejected a strong push by the pharmaceutical industry to win immunity from lawsuits filed by injured plaintiffs. In a 6-3 decision in the case of Wyeth v. Levine, the Supreme Court ruled that the Food and Drug Administration's approval of a drug's label does not mean that the manufacturer has no obligation to improve the warnings on the label if new information comes to the attention of the manufacturer.

This is a big victory for patient safety. The case will help doctors too, by keeping the pressure on the drug manufacturers to keep their product labels up-to-date so that doctors can be educated about the safest way to use drugs. Medical leaders, such as a group of editors of the New England Journal of Medicine, had filed "friends of the court" briefs urging the Supreme Court to take the side of the injured patient.

The heroic patient who pushed this case was Diana Levine, a Vermont musician who lost her arm and her career after being injected too rapidly with an anti-nausea drug called Phenergan. The drug is well known to cause terrible injuries if it gets into an artery. She contended, and the jury and the Vermont Supreme Court agreed, that the drug's manufacturer, Wyeth, knew about this risk and should have warned doctors on the label to avoid the "i.v. push" technique that carried a high risk of inadvertent injection into an artery.

In a recent initiative against contaminated weight-loss products, the FDA finds 69 drugs to be contaminated with prescription drugs and chemicals, and expects the list of brands to grow even longer in the next few weeks, reports Natasha Singer of the New York Times. A complete list of the tainted drugs found so far is available on FDA’s website.

One of the best known drugs on FDA’s list is StarCaps, endorsed by many celebrities, which was found to be tainted with bumentanide, a powerful diuretic that can give rise to serious side effects. FDA’s Michael Levy said that many of the products “either contain dangerous undeclared ingredients or…have no effect at all.”

These weight-loss products are not only illegal – FDA considers a supplement unapproved if it contains an undeclared active pharmaceutical ingredient – they also pose dangerous risks for consumers. For one thing, the ingredients on their own can cause problems like elevated blood pressure or seizures. Worse, the hidden ingredients can have toxic interactions with other medications, making it difficult for doctors to diagnose patients or manage their illnesses.

Although many of the distributors of these 69 drugs have voluntarily recalled the products, others continue to sell them on the internet. Consumers taking weight-loss supplements should monitor FDA’s growing list of products they should avoid and consult their doctors for a healthy and safe weight management plan.

Seroquel is an atypical antipsychotic drug used to treat mental illnesses, such as bipolar disorder and schizophrenia. But patients who take Seroquel are 70% more likely to become diabetic than those who don’t take this drug, a risk that the drug manufacturer AstraZeneca was aware of as early as 2000. Joe Schneider and Margaret C. Fisk of Bloomberg.com report AstraZeneca’s release of its internal studies that suggested causal links between Seroquel and “diabetes and related conditions.”

Not only should patients watch out for the increased risk of diabetes that Seroquel and similar drugs (they are in a class called “atypical antipsychotics,” including Abilify, Zyprexa, and others), they need to be aware of the mental illnesses that these drugs are approved to treat. A Reuters article reports that an AstraZeneca sales representative marketed Seroquel as a depression-treating drug to a physician, which is an unapproved use of the drug. Although it is not clear from the article what dangers are associated with treating depression with Seroquel, it is safest to limit use of these powerful drugs to what they're approved to treat.

The Institute for Safe Medication Practices, a watchdog group, points out that the number of deaths (4,825) and injuries (21,000) from prescription drugs have reached record levels in the first quarter of this year, representing nearly triple the number of deaths in the last quarter.

The blood thinner heparin and the anti-smoking drug varenicline are the most dangerous, according to the statistics.

And where do these statistics come from? That is the worrying part, because they are probably underestimating the reality of the situation:

The data came from voluntary reports of adverse effects to the Food and Drug Administration, which made the data public after stripping information that identified victims. Because the reporting is voluntary, researchers have speculated that fewer than 10% of adverse events actually makes it into the system.

However, the article points out that since the dangers associated with heparin have been recognized, deaths and injuries have gone down. Varenicline is a different story:

Varenicline remains an ongoing problem, however, according to institute officials. Since the drug -- sold in the United States by Pfizer Inc. under the brand name Chantix -- was approved in 2006, it has been linked to 3,325 serious injuries and 112 deaths.

Some reports were linked to people attempting suicide or causing injury to themselves after using the drug, which can evoke serious psychiatric problems. Others were linked to blackouts, seizures or loss of consciousness, perhaps tied to sudden disturbances in heart rhythm...

...One possible explanation for the link might have been the success of the drug and the large number of people using it, the report said. But investigation showed that, during the quarter, varenicline accounted for more reports of serious injury than the top 10 best-selling prescription drugs combined.

The Centers for Disease Control and Prevention have declared that the damaging and costly salmonella outbreak, which started in April and resulted in 1,442 reported illnesses across the country, is now over.

From the article:

Robert Tauxe, deputy director of the Division of Foodborne, Bacterial and Mycotic Diseases at the Centers for Disease Control and Prevention, said Aug. 28 that the number of illnesses being reported has dropped to a level that public health officials would expect to see in the absence of an outbreak.

Tauxe said that clusters of illnesses, created when multiple people fell ill after eating at the same restaurants, have not occurred since early July.

This is reassuring news.

Officials with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) say that the all types of fresh tomato associated with the recent salmonella warnings are now safe to eat.

From the article:

The FDA had been gradually clearing tomato-growing regions in the United States and Mexico since it issued the warning June 7. As the weeks passed, however, growers argued the warning was becoming moot because it was no longer possible for areas that were harvesting in April to still be producing tomatoes.

Criticism of the tomato warning intensified as people continued to get sick. Investigators began looking at other potential suspects and turned their attention to cilantro and jalapeño and serrano peppers.

Federal officials have identified the contaminant that was found in the blood-thinning medication heparin in 11 countries.

Chinese officials have denied that this contaminant has caused any deaths. As for U.S. officials, here is what one of them says:

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

Earlier this month, the anticoagulant (blood-thinning) drug heparin was linked to 19 deaths in the U.S.A. as well as several hundred allergic reactions. A contaminant was thought to be the cause of these deaths, and now the Food and Drug Administration has said they have identified the contaminant:

The contaminant, the regulators said, is a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain. The agency’s announcement followed a report Wednesday in The New York Times that was the first publicly to identify the modified substance as the likely contaminant.

Disturbingly, in that same article, the regulators implied that they believe the contaminant was intentionally mixed with the heparin.

Those who drink a can of diet soda a day are 34% more likely to develop metabolic syndrome than those who don't.

"Metabolic syndrome" is a cluster of symptoms that are risk factors for heart disease.

The reason for this link is still unknown: it might be chemical or it might have something to do with other behaviors that are, for whatever reason, common to diet soda drinkers.

Botox is a neurotoxin used to relax muscles. People take it to relieve pain as well as for cosmetic purposes.

However, the consumer advocacy group Public Citizen is arguing that it should come with a much stronger warning label because of 16 deaths and many serious injuries that the drug has been associated with.

For more information:

Botox, also known as Botulinum toxin type A

A new study, presented to the American Heart Association’s Scientific Sessions, has found that consumption of energy drinks is linked to heart disease and high blood pressure. The linked article contains a description of the study.

These results are unsurprising because most energy drinks contain caffeine. Any problems associated with coffee, particularly excessive coffee drinking habits, are therefore likely to show up with energy drinks as well.

Particularly risky activities include taking the energy drink before or during exercise, or in conjunction with alcohol.

Useful resources:

Brown University’s advisory page on energy drinks

ScienceDaily article on the subject

ConAgra, the world's largest popcorn supplier, has announced on Tuesday September 4th that it will stop using diacetyl--a synthetic butter flavoring.

Diacetyl has been linked to lung disease in workers, who developed severe symptoms (extreme wheezing, for example) after inhaling the vapors of this synthetic butter while on the job. The disease is known as bronchiolitis obliterans and can cause death or leave patients with no hope but lung transplants.

In dropping diacetyl, ConAgra---which produces the popular Act II and Orville Redenbacher brands of popcorn--is following in the footsteps of Pop Weaver, another large popcorn supplier, which pulled diacetyl one month previously.

For more information on diacetyl and its effects, see the following links:

Preventing Lung Disease in Workers Who Use or Make Flavorings (National Institute for Occupational Safety and Health)

Bronchiolitis Obliterans: The Disease Explained

Food Navigator