Happy 4th of July!
Please take a few minutes on this day filled with picnics and fireworks to remember why we celebrate this day. Read the Declaration of Independence, and consider the hardships and dangers our Founding Fathers endured to bring us this extraordinary document and the principles behind it.
Here's another one of those simple little U.S. geography games that make me feel so dumb. I've never lived anywhere but Texas - how am I supposed to know which one is Vermont and which one is New Hampshire?
NBC Nightly News (7/1, story 6, 0:30, Williams) reported, "The FDA says patients taking Chantix [varenicline] and Zyban [bupropion] should be watched closely for any signs of mental illness. There have been a growing number of reports of suicide, among patients who take the drugs." Regulators stressed, however, that the agency "is not trying to scare people away from the medicines because, as they put it, quitting is the most important thing."
The New York Times reports that Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration, said, "Stopping smoking is a goal we should all be working towards," adding that patients "should just be careful." Chantix-maker Pfizer "will add a so-called black box warning" to the drug's "packaging information." GlaxoSmithKline, Zyban's maker, will also "expand its existing black box warning on Wellbutrin [bupropion], citing suicidal thoughts by patients who use it for depression, to include Zyban."
The Wall Street Journal reports that both Pfizer and Glaxo claim "there is no evidence that their drugs actually cause suicides or mood swings."
From the American Association for Justice news release.
CNN International reports, "The toll of the nationwide E. coli outbreak linked to tainted cookie dough has continued to mount, federal health authorities said Tuesday." So far, the CDC said, "Seventy-two people infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 30 states," and 51 "have been confirmed as having the outbreak strain; confirmation was pending on the others."
In the Wall Street Journal Health Blog, Shirley Wang writes, "This is the same plant that refused to give FDA inspectors access to certain records in the past." Also it is "still a mystery" how the E. coli "ended up in the product." Normally, "the concern with eating raw cookie dough usually is...salmonella since it can be found in raw eggs."
From the American Association for Justice news release.
The CBS Evening News (4/30, lead story, 3:05, Couric) reported, "An FDA panel recommended today that prescription Vicodin [hydrocodone bitartrate and acetaminophen] and Percocet [oxycodone and acetaminophen] be banned, and that over-the-counter Tylenol, Excedrin, Nyquil, and Theraflu contain stronger warning labels...The problem, according to FDA advisors, is that they all contain acetaminophen, which can cause liver damage."
The FDA "panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect," the New York Times reports in a front-page story. "The two drugs combine a narcotic with acetaminophen," and the panel's vote to "recommend a ban on the combination drugs was one of 11 it took" at the meeting. The experts also recommended "that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills...to 325 milligrams, from 500," and "to reduce the maximum daily dosage to less than 4,000 milligrams."
The Wall Street Journal notes that the panel "of 37 doctors, pharmacists, and researchers voted on the recommendations Tuesday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses." Gerald Dal Pan, director of the FDA's office of drug surveillance, said, "Whatever we do on any of these options, it will really affect the whole healthcare system." The agency also noted that the recommendation to pull "from the market a number of prescription products" may "affect 240 pending drug applications."
"But some on the panel opposed a sweeping withdraw of" prescription acetaminophen combination drugs "that are widely used to control severe, chronic pain," the AP reports. The panel decided that "if the drugs stay on the market, they should carry a black box warning, the most serious safety label available." Notably, "drug companies avoided the most damaging potential outcome with the defeat of [a] proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs."
From the American Association for Justice news release.
The Associated Press is reporting that Matrixx Initiatives Inc. has started the recall of Zicam nasal cold remedies. Here are excerpts from the article:
Matrixx Initiatives Inc. said Wednesday it started a previously announced recall of Zicam nasal cold remedies following last week's Food and Drug Administration warning that the products were unsafe.
Meanwhile, the company is being investigated by the Securities and Exchange Commission over the FDA warning letter.
The Scottsdale, Ariz., company said the recall was voluntary. Still, it occurred as the FDA warned consumers to not use the nasal cold remedies due to hundreds of reports of patients losing their sense of smell. Matrixx said it disagrees with the FDA's safety warning, but "voluntarily" recalled the product to cooperate with the regulatory agency.
The FDA also alleges the products were unlawfully marketed. Matrixx also disagrees with that allegation.
Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, though it maintains the nasal spray does not harm users' sense of smell.
The Cleveland Plain Dealer reported that the FDA "recently told the makers of Singulair and three less widely used asthma drugs -- Accolate, Zyflo and Zyflo CR -- that the drugs' labels must list a dozen mood and behavior changes as possible side effects." The article focuses on a group of mothers who had pushed for the warning. "The group's goal now is to get a 'black box' warning for Singulair."
From the American Association for Justice news release.
The AP reported General Motors "has agreed to take on responsibility for future product liability claims, removing what could have been a sizable roadblock" on the company's way to a "quick sale of its assets" and emergence from bankruptcy. GM "wants to sell the bulk of its assets to a new company and leave behind unprofitable assets and other liabilities such as product-related lawsuits." But in a "concession to consumer groups and state officials who had threatened to block the sale because of product liability concerns, the new company will now assume responsibility for future claims involving vehicles made by the old company."
The Wall Street Journal reports that the agreement "represents a partial victory for more than a dozen state attorneys general and several consumer-advocacy groups."
The Washington Post reports, "Those with past claims would have to pursue the GM left behind in bankruptcy with nothing but unwanted assets, debts and other liabilities. That means these consumers are likely to recover little, if anything." On Friday "Rep. André Carson (D-Ind.) introduced legislation that would require automakers to purchase liability insurance if they are owned by the federal government or have federal loans. This insurance must protect against past and future claims, even after a bankruptcy filing.
From the American Association for Justice news release.
OK, this site isn't really fun, but it could be helpful, and it does relate to fun things like vacations.
Onebag.com is "packed" full of tips for traveling light, or at least lighter. Speaking as the world's worst packer, I can tell you that this site will help you lighten your load on vacations or business trips. If you have trouble going on an overnight trip without taking four suitcases, check it out.
New York state's Times Herald-Record reports, "Sen. Charles E. Schumer announced Wednesday he is introducing the Carmelo Rodriguez Military Medical Accountability Act, which will give military service members the right to pursue civil actions against the military for medical negligence experienced while receiving treatment for injuries unrelated to their service."
From the American Association for Justice news release.
KWTX-TV Waco, TX reports, "Seventy people in 30 states have been infected with a strain of E. coli O157:H7 and 41 of those cases have been linked to an outbreak associated with eating raw prepackaged cookie dough, including three in Texas." According to the CDC, "most of the patients reported eating refrigerated prepackaged Nestle Toll House cookie dough products raw." So far, "the FDA has received no reports of deaths associated with the products."
The Dallas Morning News points out that "the FDA and CDC are warning people to not eat any varieties of prepackaged Nestlé Toll House refrigerated cookie dough because they may be linked to an outbreak of E. coli. Nestlé has voluntarily recalled all of these Nestlé Toll House refrigerated cookie dough products and advises that you should either throw them away or return them to your grocery store for a refund."
KGO-TV San Francisco reports, "San Carlos teenager filed a lawsuit against food-giant Nestle on Monday, saying she became horribly ill after eating raw cookie dough. The FDA is investigating whether the dough is contaminated with E. coli bacteria. Nestle has already issued a recall."
USA Today adds, "Theories on how E. coli got into the dough include cross-contamination or a sick worker," the FDA's Acheson says. But "for this particular bug, it doesn't take many (bacteria) to make you sick; 10 to 100 is enough."
From the American Association for Justice news release.
The CBS Evening News (6/22, story 8, 2:00, Couric) reported that "no one wants to hear bad news from their doctor, but a" new "report...says keeping patients in the dark about abnormal test results is happening with much more frequency."
NBC Nightly News (6/22, story 4, 2:30, Williams) reported that the study suggests "that one out of every 14 times doctors fail to share abnormal test results with their patients."
The New York Times reports that investigators "reviewed the records of 5,434 patients at 19 independent primary care practices and four based in academic medical centers." The researchers "extracted records that contained abnormal results for blood tests or X-rays and other imaging studies, and then searched for documentation that the patient had been properly informed of the problem in a timely way." According to the Times, "after accounting for" several "ambiguous cases, the researchers found that of 1,889 abnormal results, there were 135 failures to inform."
The AP reported that the study, published in the Archives of Internal Medicine, found that "few medical practices had explicit methods for how to tell patients, leaving each doctor to come up with a system."
HealthDay reported that while "the study found no difference in failure rates between facilities that relied exclusively on paper records and those that used only electronic filings, medical practices that used a hybrid of paper and electronic record-keeping had the highest failure rates."
From the American Association for Justice news release.
The Texas Lawyer reports that the Grievance Oversight Committee, which is appointed by the Texas Supreme Court, recently recommended that the court adopt a rule requiring lawyers who do not carry legal malpractice insurance to disclose their lack of coverage to clients.
This has been a controversial issue for several years in Texas. Personally, I've had malpractice insurance since I began practice, so a decision either way won't affect me. There are interesting arguments both for and against, and I'm sure there will be many voices heard in the next few weeks. Here is the beginning of the article:
In June 2008, the State Bar of Texas board of directors balked at taking a position on whether to require lawyers to disclose whether they have professional liability insurance coverage after a Bar task force that studied the issue voted 6-5 against recommending such a rule. The task force took that vote in May 2008.
But the State Bar may have to take another look at the issue. In its June 1 report to the Supreme Court, the oversight committee recommended that the high court direct the State Bar to implement a rule requiring a lawyer in private practice, when engaged by a client, to inform the client in writing if the lawyer does not have professional liability coverage with limits acceptable to the Bar — for instance, insurance in the amount of at least $100,000 per claim and $300,000 in the aggregate. The committee further recommended that, if an attorney's insurance lapses or is terminated during the representation, he or she notify the client of that fact.
USA Today says in an editorial that the "only thing" trial lawyers and doctors "have in common" on medical malpractice "is that they're both wrong. Doctors overestimate the degree to which lawsuits drive up medical costs (malpractice costs account for less than 2% of all health care spending, according to the Congressional Budget Office). Lawyers underestimate the degree to which even a few outsized verdicts spread fear and influence doctors' behavior." Unless "doctors and lawyers move from the extremes of the malpractice debate, the public will be denied what it wants most a reduction in the medical errors that occur all too often."
From the American Association for Justice news release.
No additional comment is necessary about this editorial from the Dallas Morning News today:
State Farm is masterful at working the legal system. For six years, it has danced in and out of court to thwart the Texas insurance department's order to refund millions to policyholders in alleged overcharges.
State Farm says it has done nothing wrong and owes nothing. However, the Office of Public Insurance Counsel, a state-funded advocate for consumers, pegs the refund at about $1 billion. The state insurance department's staff, whose commissioner, Mike Geeslin, eventually will decide who's right, puts the cost at $350 million.
Consumers are right to find this galling. State Farm collects premiums and conducts business as usual while policyholders continue to wait for expected refunds.
One wonders whether there is any real accountability for a big insurance company when its rates are called into question. Before insurance reform a few years ago, insurers complained of lengthy regulator reviews that prevented them from charging new rates in a timely fashion. So lawmakers loosened the reins and set up an appeals system that they thought insurers would accept in good faith. Instead, the result is marathon stonewalling.
State Farm's action is a blatant challenge to the state's authority to regulate rates. If the company prevails, no other major insurer whose rates are called into question will ever again settle outside a courtroom. For instance, Farmers Insurance recently filed for a rate hike. Anyone believe that if its rate request is rejected, Farmers will roll over quietly?
Gov. Rick Perry is expected to call lawmakers back into a special session to decide the future of the Texas Department of Insurance, which wasn't reauthorized during the just-completed regular session. In addition to that work, lawmakers should fix this unfair review process.
State Farm policyholders certainly are free to take their business elsewhere, which could do more to promote insurance competition than any measure regulators would demand. But shopping around now doesn't provide those policyholders with satisfaction or refunds.
This is a mockery, and it must end.
Bloomberg News reports, "Matrixx Initiatives Inc. said today it didn't turn over to US regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs." The company halted sales of "the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell." The agency "found 800 reports of consumer concerns in May during a routine inspection," according to William Hemelt, acting president and chief operating officer of Matrixx. He added that "he was told by lawyers that a 2007 regulation requiring companies to turn over reports of serious side effects didn't apply to the complaints received by Matrixx."
Dow Jones Newswires reports that the company "is defending its Zicam cold and allergy products," seeking "to meet with the agency to discuss the scientific data concerning the products and the safety concerns the FDA raised." Hemelt said, "We are hopeful that if we can tell our story to the FDA, that maybe we can get them to change their mind." He commented that "the safety concerns are 'erroneous' and said that the agency made no effort to communicate its concerns with the company prior to this week."
From the American Association for Justice news release.
I've been watching this guy For years, but realized I've never written about WhereTheHellIsMatt before. His videos are terrific, and his stories are fascinating. If you haven't stumbled across Dancing Matt before, check him out.
The Wall Street Journal reports, "Medtronic Inc. says it paid nearly $800,000 over the past three years to a former Army surgeon accused of fabricating a study that reported positive results for one of the company's key spine products." The company claims that "the payments were compensation for" Dr. Timothy R. Kuklo's "work developing products for the company, training doctors, and speaking at company events and that they weren't connected to" his "favorable study of Medtronic's Infuse bone-graft product." But, "some of the consulting payments occurred during the time that" he "was shopping his" study "to medical journals," and "the Army has said that the study is based on 'falsified information.'" Army investigators also contend that "Dr. Kuklo forged the signatures of purported co-authors."The New York Times also covered the story.
From the American Association for Justice news release.
The AP reported, "Zicam and hundreds of other homeopathic remedies - highly diluted drugs made from natural ingredients - are legally sold as treatments with explicit claims of medical benefit." These products "don't require federal checks for safety, effectiveness, or even the right ingredients," but "many scientists view homeopathic remedies as...mostly harmless because the drugs in them are present in such tiny amounts." One analysis, however, "found that more than 800 homeopathic ingredients were potentially implicated in health problems last year." And, although "the FDA has set strict limits for alcohol in medicine, especially for small children...they don't apply to homeopathic remedies."
From the American Association for Justice news release.
ABC World News (6/16, story 5, 2:05, Stephanopoulos) reported, "The Food and Drug Administration today told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam."
The CBS Evening News (6/16, story 6, 1:30, Ashton) reported that "the FDA is not responsible to regulate" the safety of products like Zicam, "an over-the-counter remedy containing some natural ingredients" before it "comes to market," but the agency is "responsible to regulate its safety after it's been on the shelf." NBC Nightly News (12/6, story 4, 0:25, Williams) added that Zicam manufacturer Matrixx "has suspended shipments of the products, but says the warning is not supported by scientific evidence and is asking the FDA for a review."
Wall Street Journal reports that William Hemelt, Matrixx's acting president and chief operating officer, said, "This isn't a new issue for us. We've certainly studied it for many years, and we think our products are safe." The agency warned against the use of "nasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs." Regulators "also warned against Zicam Cold Remedy Swabs, Kids Size." But, "the FDA's action doesn't affect other Zicam products."
Commenting on the products, Dr. Margaret Hamburg, FDA commissioner, "said the incidence of anosmia associated with Zicam 'strikes us as a fairly large problem,'" the New York Times reports. The company "paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell" in 2006, and "hundreds more such suits have since been filed."
The Los Angeles Times reports that the company will be required to "receive FDA approval" if it "wants to market the products in the future," Deborah Autor, director of compliance for the FDA's Center for Drug Evaluation and Research, explained. The company may have received 800 reports "of anosmia...associated with the use of the products from doctors and consumers," but has failed to "forward such reports to the FDA." Autor said that the agency has "asked Matrixx to provide" regulators with the reports.
The AP reports that the company said "it will consider withdrawing the products." Meanwhile, "government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including 'sore throat, stuffy nose, sneezing, coughing and congestion.'"
From the American Association for Justice news release.
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