Archive for February 2012

Increased Death, Cancer Rates in Patients Taking Sleeping Pills

February 29, 2012

(February 29, 2012) A new study from Scripps Clinic, published in the British Medical Journal, indicates that sleeping pills may be associated with higher death rates, up to 4.6 times higher, as well as an increase in cases of cancer. Adults who take hypnotics for insomnia, as few as 18 times a year, might face increased mortality risk.

 

The two most common sleeping pills studied were zolpidem (brand name Ambien) and temazepam (brand name Restoril). Sleeping pills have become more and more popular for a good night’s sleep. The pharmaceutical industry expanded by 23% in the sleep medication segment from 2006 to 2010. The industry generated approximately $2 million in annual sales during this time.

 

As of January, 2012, there were 24 published studies relating to the mortality risks of sleeping pills. We now have a new study of more than 10,000 patients who took sleeping pills and more than 20,000 matched patients who did not take sleeping pills. The patients who took sleeping pills died 4.6 times as often during follow-ups averaging 2.5 years. Patients taking higher doses (averaging over 132 pills per year) died 5.3 times as often. Even for the patients who took less than 18 pills per year, had very significantly increased mortality, 3.6 times than the patients who took no hypnotics. 

 

In addition, those who averaged over 132 sleeping pills per year were 35% more likely to develop a new cancer.  This being said, it is true that showing that sleeping pill use is associated with early death does not prove that the sleeping pills are the cause of the deaths. It is not known if these sleeping pills were taken with alcohol, or in conjunction with other medications. In most cases, patients aged 65 years and older generally experience sleep apnea more than younger patients. Additionally, older patients have other health issues, which could be contributing to their death, as well.  If sleeping pills cause even a small part of the excess deaths, and cancers are associated with their use, then hypnotics are too dangerous to use.

 

As far as the evidence that sleeping pills cause cancer in people, according to the FDA, there were nine new skin cancers and four other cancers among study participants, but no new cancers among those who only received placebo. Even considering that there was over two times as much exposure to the sleeping pills, it appears that this indicates that new sleeping pills caused cancer.

 

There are some people with severe sleep deprivation who cannot function during the day without a few hours of sleep. Some patients say the newer sleeping pills that have a shorter window of action have changed their lives. It is very difficult and unproductive to function during the day without a few hours of sleep, needless to say unpleasant for the people around you. It must be difficult to keep a job when you cannot get a good night’s sleep. It is ironic that for some people, these sleeping pills may increase the risk of death when for others, these sleeping pills are a life saver!

 

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Victim Wins $15 Million in Medical Malpractice Case Linked to Breast Cancer

February 28, 2012

(February 28, 2012) Stephanie Tesoiero, a 50-year-old mother of three from Long Island, New York, discovered a marble-sized lump in her breast in 2002.

 

Dr. Paul Fisher of the Carol M. Baldwin Breast Care Center in Stony Brook, New York, concluded there was “no evidence of malignancy” after reviewing her mammogram.  Dr. Fisher ordered no further tests, according to Tesoiero.  The doctor told her to return in one year for a follow-up.  But the lump did not go away.

 

When another doctor reviewed her tests 16 months after the initial mammogram, he reported that the lump was as big as a golf ball and determined that it was, in fact, breast cancer.

 

If she had a complete work-up when she first visited Dr. Fisher complaining of a “lump”, such as an ultrasound of the breast or a biopsy, she could have been spared so much pain, aggravation, and most of all, cancer.

 

“Why didn’t they find it the first time?” Tesoiero asked. “Why didn’t they go the extra step and do a sonogram?”

 

Following a mastectomy, chemotherapy and radiation treatments, the cancer went into remission…for a while.  That is when Tesoiero decided to sue her negligent doctor.

 

The trial lasted two weeks and consisted of six women approving the multi million dollar award.

 

“I just wanted him to admit he made a mistake,” Tesoriero said of her doctor. “Doctors do make mistakes.”

 

Unfortunately, the cancer has spread to her bones. The prognosis is uncertain, but she must now undergo chemotherapy treatments weekly for the rest of her life.

 

Just because someone is a doctor, does not mean they do not make mistakes (or admit to them, for that matter).  Mrs. Tesoiero has spoken out to warn other women. She states, “If you have any suspicions, any doubts, speak to the doctor and ask for another test.” Sometimes, you have to follow your intuition. It is always best to seek another opinion when it comes to your health. Perhaps if she went to another doctor, he would have ordered further testing, but the doctor she initially went to, should have been more thorough, giving her the care she deserved. Not only had she endured pain, anxiety and a mastectomy, she now has cancer throughout her bones, and three children will be without their mother.  All because of the carelessness of a doctor she put her trust in. Is this justice?

 

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Accutane May Lead to IBD, Crohn’s or Ulcerative Colitis

February 27, 2012

(February 26, 2012) Accutane lawsuits are being filed across the country against its drugmaker, Hoffman-LaRoche, currently known as Roche Laboratories.  There is a direct link between Accutane and Inflammatory Bowel Disease (IBD), Ulcerative Colitis, or Crohn’s Disease.

 

Accutane was approved in 1982 by the U.S. Food and Drug Administration (FDA) to treat severe acne, and is classified as a retinoid. The main ingredient in Accutane is isotretionoin, derived from vitamin A. It works by drying up sebum (oil) produced by the skin glands. When too much sebum is produced, it leads to bacteria, inflaming the skin follicles, leading to acne. Generics are also available for Accutane, known as Amnesteem (from Genpharm and Mylam), Claravis (from Teva-Barr), and Sotret (from Ranbaxy).

 

But as productive as Accutane is, both as a moneymaker and a therapy, it also has the potential to destroy lives. Because of its exceptional power to cure acne, Accutane had been praised as a “miracle drug” by the FDA when it was first introduced.

 

However, Accutane has been associated with several, serious side effects for many years. There is currently a Black Box warning cautioning consumers about the potential to unborn children, which is the highest warning label the FDA can designate. There are additional, serious side effects, including depression, IBD, liver disease, Crohn’s disease, and ulcerative colitis.

 

Inflammatory bowel disease, Crohn’s disease, and ulcerative colitis affect more than a million Americans, for which there is no cure.  Symptoms vary for each of these specific diseases, but abdominal pain and cramping are common in all of them. Many patients experience diarrhea, sometimes with blood, fatigue, poor appetite, fever, irritation of the intestines, pain in the joints, skin conditions, and in severe cases, surgery is necessary to remove the affected area. Treatment for these conditions require dietary changes, anti-inflammatory medications, antibiotics if bacteria is present, and at times, immunosuppressants may be necessary. In the worst of cases, surgery would be the only solution.

 

In a retrial, a New Jersey jury has awarded $25.16 million (nearly 10 times the original award) to an Alabama man with inflammatory bowel disease.  The jury ruled that Roche Laboratories failed to warn Andrew McCarrell’s doctor about the risk of IBD from its Accutane drug. He was a 24 year-old college athlete when he began Accutane to treat his acne. Shortly after discontinuing the drug, he developed chronic ulcerative colitis and within a year had to have his colon removed. He was originally awarded $2.62 million in damaged by a jury, but the verdict was reversed on appeal and remanded for a new trial. Although McCarrell was “very happy” with the verdict, his lawyer added that in view of all he has been through, “nobody in their right mind would change places with Andy.”

 

So far, six plaintiffs have won a total of $56 million in damages over allegations that Roche knew, or should have known, about the risks of IBD from Accutane. Many other verdicts are being appealed, and there are currently over 7,000 Accutane lawsuits pending in N.J. state court.

 

Nobody in their right mind would opt for the risk of developing IBD, Crohn’s, or Colitis, just to get rid of a few pimples. That being the case, it should be left up to the consumers to decide whether they want to take this risk. But, because Roche Laboratories decided not to warn of these risks, many people are left debilitated, stuck with an inflammatory disease of which there is currently no cure. Is this justice?

 

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Teva Pharmaceutical Pays $250 Million to Settle Propofol Lawsuits

February 26, 2012

(February 26, 2012) Teva Pharmaceutical Industries Ltd. reportedly will pay more than $250 million to settle nearly one hundred lawsuits over the sedative Propofol. The lawsuits allege that Teva intentionally sold the anesthetic, Propofol, in vials which were large enough to be reused by doctors, but caused some colonoscopy patients to develop Hepatitis C, as reported by Bloomberg News.

 

Among the claims that will be settled include a private school principal, Henry Chanin, from Nevada. Mr. Chanin contracted hepatitis C following a routine colonoscopy at the Desert Shadow Endoscopy Center, which is now closed. Hepatitis C is a serious infection of the liver, caused by a virus. It is a chronic disease for which there is no cure, contracted through blood contact.

 

Attorneys for Chanin argued that the companies (Teva and Baxter Healthcare) sold “inadequately labeled,” 50 mililiter vials of the drug to small clinics, which encouraged reuse by healthcare professionals on many patients, leaving these patients vulnerable to the Hepatitis virus.

 

In May, a Clark County jury found the two drug companies liable, reaching a state record of more than $500 million in punitive damages.  This was in addition to the $5.1 million in compensatory damages Chanin and his wife had already been awarded against Teva. Henry Chanin claimed that the sedative lacked appropriate warnings, and that large vials should not have been provided to doctors.

 

To date, Teva has settled about 120 Propofol lawsuits, and has reserved $270 million towards the litigation, as confirmed by a Teva spokeswoman who also noted that 15 lawsuits are still pending.

 

For those of you who think Propofol sounds familiar, this is the same drug that was to blame for the death of Michael Jackson.  His physician, Conrad Murray, was convicted of involuntary manslaughter, and sentenced to four years in jail after injecting Jackson with the fatal dose of this sedative to help him sleep.

 

Once again, it is the greed of the big pharmaceutical companies left to blame for the pain and suffering of others. Is this justice?

 

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The FDA Approval Process for New Medical Devices Should be Stronger

February 25, 2012

If the public knew what goes on in the world of the multi-billion dollar medical device manufacturing industry with regard to seeking approval, they would be very concerned, to say the least.

 

Lobbyists are hired by the industry, working overtime, hoping the Food and Drug Administration will quickly approve their medical devices, putting millions of lives at risk.  The approval process of a medical device should be thorough and complex, not hurried and made weaker. The public has no idea what goes on in Congress or at the FDA.  That is why these companies hire lobbyists who control what happens in Washington.

 

The weak regulation of medical devices is causing serious health and safety problems for the public. Just recently we reported about the defective artificial hips manufactured by Johnson & Johnson/DePuy. Approximately 40,000 American patients, as well as tens of thousands of patients worldwide, required additional, painful, costly revision surgeries after the implants were recalled. The metal-on-metal hip implants were recalled after it was discovered that they carried the risk of releasing metal toxins into hip tissue, causing pain, inflammation and serious internal damage. If the medical device approval process were stronger, the public would be safer.  These lobbyists that represent the powerful medical device industry are trying to persuade lawmakers to quickly approve these devices before adequate testing is done. Once again, they are putting their profits before safety.

 

According to a review by an Institute of Medicine panel, it was recommended that the FDA dismantle the 510(k) program for expediently approving medical devices because it does not guarantee their safety or efficacy, as reported by the AP/Washington Post.  The panel said that some medical devices considered by the FDA to be “predicate devices” have been on the market since before certain medical device amendments, meaning new devices are being approved because of their similarity to older ones that never were found to be safe and effective. The panel also said that it found “substantial problems” in how devices are examined after their approval by FDA. They recommend that the FDA develop a new regulatory framework instead of dedicating its resources to fixing the current process.

 

Another serious issue is the approval process of prescription drugs. New prescription drugs are rushed to market, being approved by the FDA without adequate testing.  This is referred to as the Fast-Track by the FDA. Hundreds of drugs are rushed into production only to be recalled due to serious health and safety issues.  The public is not safe and we are badly in need of an FDA overhaul. The public should not settle for anything less.

Dirty Surgical Tools in Operating Rooms Putting Patients at Risk

February 23, 2012

When 63-year-old John Harrison had surgery to repair his rotator cuff in 2009, he thought he would have a better quality of life and be good as new in six weeks.  Instead, two weeks after the surgery, his scar turned bright red, felt hot to the touch, and a thick fluid oozed from his wound. After his wife frantically called the hospital, they were told to immediately make the seven-hour drive back to Houston to be checked. His doctor had to perform emergency surgery that evening and found an infection had eaten away part of his shoulder bone and rotator cuff, the metal screws and hardware became loose and sutures came undone. His surgeons cleaned out the infected shoulder, installed two drains and prescribed antibiotics to kill the infection. Instead of improving his range of motion in his shoulder, he was now fighting for his life.

Harrison was one of at least seven joint surgery patients at Methodist Hospital in Houston who had acquired serious infections during a two-week period. This outbreak forced Methodist to close operating rooms and call on the Centers for Disease Control and Prevention (CDC) to investigate.  The CDC found two probable sources – deep inside a hand-held arthroscopic shaver, used to shave away bone and tissue during surgery and inside a long, metal tube called an inflow/outflow cannula, used to irrigate and suction the surgical site. During the investigation, surgical tools were inspected with a tiny video camera revealing human tissue and bone stuck in both devices. The camera also found a bristle from a cleaning brush left in an arthroscopic shaver. Further investigation found that the hospital followed cleaning instructions provided by Stryker, the manufacturer of the arthroscopic shavers used on all the infected patients. The instruments were properly cleaned, but were still dirty. A former investigator at the Centers for Disease Control and Prevention Epidemic Intelligence Service blames the Methodist infections on those dirty devices. This is the probably the only explanation Harrison will get for why he had to undergo seven follow-up surgeries and still cannot raise his arm when he awakes in the morning.  Harrison filed a lawsuit against Stryker and Methodist.  Early this year, Harrison settled for an undisclosed amount with Methodist. His case against Stryker has been moved to federal court.

Sadly, Harrison’s case was not isolated. In 2009, the Department of Veterans Affairs admitted that 10,737 veterans in Florida, Tennessee and Georgia were given colonoscopies and endoscopies between 2002 and 2009 with endoscopies that were not properly sterilized. Many of these patients later tested positive for HIV, hepatitis C, or hepatitis B.  Many lawsuits filed against the VA are currently working their way through the courts and many more are expected to follow.  In 2008, an outbreak of hepatitis C that sickened six people in an outpatient surgical center in Las Vegas was due to improper cleaning of endoscopes, as well as the reusing of biopsy forceps, which were intended for a single use.  Following that incident, a Center for Medicare and Medicaid Services (CMS) pilot program inspected 1,500 outpatient surgery centers and cited 28 percent for infection control deficiencies related to equipment cleaning and sterilization.

Years ago, surgical tools were made of steel and glass, so sterilizing them was easy; just put them through a shot of steam. Today, doctors use high-tech flexible endoscopes and surgical robotics, which become clogged with debris unable to visualize with the naked eye.

A risk management clinical engineer at the University of Michigan Health System videotaped the insides of 350 surgery-ready suction tips and found that every single one of the tips contained blood, bone, tissue, and in some cases, rust.  Even after his team tried to clean the tips, all but seven were still dirty. A design flaw was to blame.

It is said that another reason for poorly cleaned surgical tools is that hospital employees who are hired to clean surgical instruments are underpaid and overworked, rushing to have the tools ready for the next surgery.  The cleaning process is usually done in hot, humid basements and in large hospitals, with about 40,000 surgical tools have to be cleaned daily. The dirty devices can sit around for days before someone gets around to cleaning them, and by then, human waste has been baked on them.

It is sad to learn that New Jersey is the only state in our country that requires cleaning technicians to be certified.  Imagine that our dog groomers, tattoo artists, and nail technicians need to be certified to work, but hospital sterilization workers undergo no training and need no certification. So many deaths occur annually from filthy, unsterilized surgical tools and most of the time, these patients die in vain. Very few of these cases have been documented, as they are difficult to prove. I have heard of surgeons leaving their tools inside of a patient, but maybe what the real problem was, was the fact that those tools were filthy and infected. It is frightening enough to undergo surgery, but having to worry about being sent home with a permanent, debilitating condition really makes you think twice before showing up for that procedure. In John Harrison’s case, it is fair to say that he would have been better off living with his poor range of motion than the constant pain and suffering he endures every day of his life.

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Can the FDA Ban AeroShot “Breathable” Caffeine?

February 22, 2012

(February 22, 2012) “The energy of the future is here,” says the website of AeroShot Pure Energy caffeine inhaler.  AeroShot went on the market a month ago in New York and Massachusetts, and is also available in France. Consumers put one end of the lipstick-sized canister into their mouths and breathe in, while the device shoots a lime-flavored, fine powder onto the tongue, which dissolves quickly. Each gray and yellow, plastic canister contains B vitamins and 100 milligrams of caffeine powder, equivalent to the amount of caffeine in a shot of espresso and a little less than in an 8 ounce can of Red Bull (in about 4-6 puffs).

 

Although this product did not require approval from the FDA because it was classified as a dietary supplement, New York Senator Charles Schumer said that he met with FDA Commissioner Dr. Margaret Hamburg, who agreed to review the safety and legality of AeroShot.  Senator Schumer explained, “I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit, in rapid succession.” He will announce the AeroShot review on Sunday. An FDA official who was at the meeting told the Associated Press that the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product will also be tested to decide if it is indeed safe for consumption, the official said.

 

A single dose cost $2.99 and is sold at some convenient stores, liquor stores, as well as online. The label on the package warns not to consume more than three AeroShots per day.

 

Although AeroShot maker, Breathable Foods, says it does not recommend the product to anyone under age 18, no ID is required to buy this product, which is also available online. Schumer’s main concern is that teens and college students will abuse AeroShot in order to stay awake, while drinking dangerous amounts of alcohol. He says that the product is being marketed as a party drug. Schumer says  “this is the new Four Loko,” which was banned last year largely due to the pressure he and others used to persuade the FDA to stop the marketing, distribution and sale of these beverages, dubbed “blackout in a can.”

 

As a matter of fact, AeroShot advertising in Europe focuses on drinking and partying. Like Schumer said, “the product is nothing more than a club drug designed to give users the ability to drink until they drop.”

 

Senator Schumer also noted that the American Academy of Pediatrics discourages the non-medical use of caffeine by children and adolescents. In December, The Elk Grove Village, Illinois-based doctor’s group wrote the AeroShot’s manufacturer about concerns over caffeine’s effect on developing neurologic and cardiovascular systems and the potential for the product to exacerbate asthma.

 

New York is fortunate to have a Senator who truly cares about the safety and well being of its residents.  All the time and energy he put forth in having Four Loko banned shows that he is serious about having AeroShot tested for its safety.  Teenagers feel that, because it is legal and easily attainable, it must be safe.

 

Why would something that poses a danger be so simple to purchase, even without identification? Not only is it risky to mix caffeine with alcohol, but the product is sweetened with Stevia to help mask the bitterness of the caffeine. Many people have ragweed allergies, making them sensitive to Stevia. In addition, AeroShot contains traces of soy and wheat, which can put many teens at risk.  It is such a shame that these companies care more about their profit than they do about the public’s safety, especially when children are at stake.  It will probably take a serious injury and a massive lawsuit to get this product off the market. What a shame.

 

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