Saundersblog.com

How Safe is Bottled Water?

Thu, 09 Jul 2009 13:37:48 -0500

Aggressive marketing efforts have sent sales of bottled water skyrocketing in the last 10 years. Part of the allure is the notion that bottled water is cleaner and purer than tap water. That's not necessarily the case according to the Government Accounting Office. The EPA has oversight regarding tap water while the FDA has responsibility for bottled water. It's an important distinction since the FDA doesn't have the regulatory authority to demand that bottled water submit to testing and report violations. On the other hand, thanks to the Safe Water Drinking Act, the EPA mandates testing and reporting of water quality results. Essentially, we know more about the safety of our tap water than we do about the bottled water we purchase and presume to be healthier than the tap water. This discrepancy has caught the attention of Congress. Congressmen Waxman and Stupak have sent letters to 13 companies that sell bottled water asking them for testing and water quality data. "Neither the public nor federal regulators know nearly enough about where bottled water comes and what safeguards are in place to ensure its safety," Stupak said. This is somewhat similar to the concerns raised last week about acetaminophen. The general assumption has been that the drug is safe because its ubiquitous. Yet, we probably lack information to make such a judgement. In the cases of acetaminophen and bottled water, we've allowed good marketing to hold sway over science. That's a dangerous notion.

Darvocet Gets Stronger Warning from FDA

Tue, 07 Jul 2009 15:01:08 -0500

It's not only Vicodin and Percocet that are drawing unwanted attention from the FDA. Today, the FDA ordered stronger warnings on Darvocet and Darvon. While Darvocet and Darvon are considered milder painkillers than Vicodin and Percocet, they've been linked to hundreds of overdose deaths and suicides in their 50 year history. Also known by its generic name propoxyphene, Darvocet is a widely prescribed pain reliever for health related issues from kidney stones, minor dental procedures, and other minor surgeries.

St. Louis Archbishop Carlson's Record on Sex Abuse

Mon, 06 Jul 2009 09:41:54 -0500

Robert Carlson's systematic rise in the power structure of the Catholic Church is inextricably linked to the sexual abuse crisis in the United States. As a priest of the Archdiocese of Minneapolis-St. Paul, Carlson served his Archbishop faithfully and obediently-at least in terms of how he carried out his assignments. When Carlson was a top aide to then Archbishop John Roach, he was in charge of dealing with priests who'd been accused of the sexual abuse of minors. One case in particular stands out. The Rev. Thomas Adamson had been accused of grabbing a young boy's genitals in a whirlpool. When the complaint reached Carlson, Carlson confronted Adamson who admitted the action claiming it was an isolated incident. Instead of reporting the incident to police, Carlson chose to report it to the Archbishop. Adamson appealed to Roach who left him at Immaculate Conception with strict orders to cease all youth involvement. Adamson ignored the order and continued his involvement with parish youth. While Carlson has stated in deposition testimony that he never trusted Adamson, he didn't confront his Archbishop either. Roach, on the other hand, remained Adamson's cheerleader and continued to give him assignments after more revelations of youth contact. After several more allegations surfaced about Adamson, Carlson wrote a memo to Roach concerning Adamson stating, " that it probably would be first-degree criminal sexual contact." Robert Carlson, now an auxiliary bishop, never reported what he believed to be criminal behavior to the police. His silence and complicity in allowing a pedophile priest to remain in ministry served him well. In 1994, Carlson became the bishop of Sioux Falls. In 2005, he was transferred to a larger diocese, Saginaw, before being named as Archbishop of St. Louis. Now, that he's reached the pinnacle of power, Carlson says he should have reported the abuse to authorities, characterizing his actions as a "mistake". The troubling fact remains that this ambitious priest could've prevented the sexual abuse of other children if he had done the right thing in the Adamson case. Of course, that would have meant putting his ecclesiastical career in jeopardy. The institutional Church doesn't reward whistleblowers. I doubt that if Carlson had done the right thing, he would be an archbishop today. Now that he's archbishop, Carlson vows to take a tough stand on priest abusers. However, his public pronouncements ring hollow. When he had the opportunity to do the right thing, he chose to protect his career rather than children. He got what he wanted and countless children were sacrificed on the altar of his ambivavlence and ambition. Kudos to the St. Louis Post Dispatch for their research, investigation, and reporting on this sad case.

Stop Smoking Drugs Get Black Box Warnings

Mon, 06 Jul 2009 09:33:05 -0500

Pfizer's smoking cessation drug Chantix and GlaxoSmithKline's Zyban will both receive black box warnings for their potentially fatal side effects. Both drugs have been linked to suicidal tendencies and the FDA has issued a public health advisory about them. In part, the FDA advisory states, "People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away. Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away." Behavioral changes in those taking the stop smoking drugs have been noted for since 2007 and there have been reports of suicides among those taking Chantix. The black box warnings will appear prominently in the packaging inserts as well as any marketing materials associated with the drugs. The black box warning for Zyban caught some industry insiders by surprise. While the problems associated with Chantix have been well known, Zyban's troubles began when officials began examining Chantix. Zyban, a re-branded version of the anti-depressant Wellbutrin, was approved for use as a stop smoking drug in 1997.

Diprivan the Culprit in Michael Jackson's Death?

Wed, 01 Jul 2009 20:39:53 -0500

Diprivan, a sedative normally reserved for hospital settings where anesthesia is administered,may very well be the culprit in pop sensation Michael Jackson's sudden death. Cherilyn Lee, a registered nurse who served as the king of pop's nutrionist, told ABC News, that Jackson begged her for the drug due to severe insomnia. According to Lee, she begged him not to take the drug. Diprivan whose generic name is Propofol, is administered to start or maintain anesthesia for surgery. The drug is not used in normal circumstances outside of a surgical or hospital setting since it require constant monitoring. Induction of anesthesia with Diprivan is frequently associated with apnea or cessation of breathing. Patients should be continuously monitored for early signs of apnea, low blood pressure, airway obstruction, and oxygen desaturation – cardiorespiratory effects more likely to follow rapid bolus administration. Because Diprivan is rapidly acting with a steep dose response curve, the drug is hugely dangerous in the absence of continuous monitoring. The dangers increase if the patient is using any type of narcotic. While we won't know for certain the exact cause of Michael Jackson's death for weeks, one thing is certain according to his nutritionist-he was pleading for the drug prior to his death.

Bone Proteins Exorbitantly Costly

Wed, 01 Jul 2009 10:02:30 -0500

A report in this week's edition of the Journal of the American Medical Association (JAMA) notes the skyrocketing costs of using bone proteins over conventional surgeries. The study concludes that costs increased anywhere from 11% to 41% nationwide when the bone proteins were used. This news comes on the heels of reports that Medtronic's Infuse bone graft aren't as effective as previously thought. It has come to light that the doctor who was touting Medtronic's Infuse product was padding his results and forged the signatures of other doctors on a medical research report outlining the benefits of Infuse. So, what we're left with is a questionable medical device that's outrageously expensive. In the end, the cost is passed on to the consumer who's relying on the integrity and experience of the doctor using the medical device. The doctor, in turn, is relying on the accuracy of reports he/she has read about that medical device. Like most industries, trust is a key factor. If one constituency can't rely on the accuracy and integrity of another group, the whole system collapses. Medical devices and pharmaceutical drugs have to be tested and independently shown to be effective and reliable. If consumers don't have that confidence, the healthcare system is in peril.

Two New England States Ban Company Gifts to Docs

Wed, 01 Jul 2009 09:52:09 -0500

Beginning today, Vermont and Massachusetts have banned pharmaceutical companies and medical device companies from giving doctors gifts. This means no more high priced vacations, meals, or even trinkets. Vermont has taken it one step further by barring such companies from providing meals to doctors. Massachusetts has restricted the practice. The new laws taking effect today are part of a nationwide effort to remove the conflictual links between doctors and medical device makers and pharmaceutical companies. Hopefully, along with the gift ban a heightened form of transparency will be seen in dealings between doctors and these companies. For far too long, doctors and researchers were paid handsomely to do research, write favorable articles, and use the drugs and devices that were manufactured by the same companies lavishing gifts and money on the doctors. In the medical world, it was a dangerous game of pay for play that wound up costing the consumer in confidence and safety. For instance, Medtronic, a leading medical device manufacturer, agreed to pay $40 million in 2006 because of allegations it paid doctors to use their spine products. In 2004, Pfizer pleaded guilty to a criminal charge and paid $430 million in wrongdoing concerning the marketing of its drug Neurontin. In the end, criminal charges and stiff penalties were never enough to stem the tide of pay for play. The medical device companies and pharmaceutical industry were large enough and awash with enough cash to absorb such penalties. Often, these costs were passed on to the consumer in the form of higher drug prices and explained as the cost of doing business. The new legislative efforts at banning conflict of interest relationships between doctors and these companies gets to the heart of the matter. If there's a ban on such practice, there's no pay for play and no loophole. The law bans such practices. It's about time.

EPA Lists 44 Hazardous Coal Ash Sites

Tue, 30 Jun 2009 10:42:29 -0500

The Environmental Protection Agency has issued a statement concerning the potential hazards of 44 coal ash sites around the country that could pose lethal consequences for nearby residents. Heightened attention has been given to the coal ash sites after one such site in Tennessee flooded last year. The coal ash sites contain hazardous materials including arsenic, selenium, cadmium, lead and mercury. The EPA plans to inspect the sites to determine if they are structurally sound. "The high hazard potential means there will be probable loss of human life if there is a significant dam failure," said Matt Hale, director of EPA's office of research, conservation and recovery. "It is a measure of what would happen if the dam would fail. It is not a measure of the stability of the dam." Coal ash, a by-product of coal burning plants, is stored in ponds or dams. The 44 cited in the EPA report are considered dangerous because of their close proximity to homes. A leak or flood could cause catastrophic damage, including the loss of life. Coal ash dump sites had not been previously made public due to national security issues. The sites listed in the EPA report are as follows: The 10 states, the number of sites, and communities are: _North Carolina, 12 (Belmont, Walnut Cove, Spencer, Eden, Mount Holy, Terrell and Arden). _Arizona, 9 (Cochise, Joseph City). _Kentucky, 7 (Louisa, Harrodsburg, Ghent and Louisville). _Ohio, 6 (Waterford, Brilliant and Cheshire). _West Virginia, 4 (Willow Island, St. Albans, Moundsville, New Haven). _Illiniois, 2 (Havana, Alton). _Indiana, 1 (Lawrenceburg). _Pennsylvania, 1 (Shippingport). _Georgia, 1 (Milledgeville). _Montana, 1 (Colstrip).

FDA Will Take Another Look at Safety of Bisphenol A

Mon, 29 Jun 2009 21:41:33 -0500

In a move lauded by consumer safety advocates, the FDA will reassess the safety of the highly controversial chemical found in many plastic products from baby bottles to drinking containers. The FDA decision comes in the wake of a letter sent by Democratic lawmakers serving on the House Energy and Commerce Committee. Bisphenol-A has been used for the past 60 years to make plastics hard and shatter-proof. It's also been known to seep into the contents of the plastic containers. Bishpenol A has been linked to cancer, diabetes, developmental damage, as well as heart disease in animals. According to the CDC, the toxin has been found in the urine samples of 90% of those tested. Recently, 6 of the country's baby bottle manufacturers have announced they'll phase out use of the controversial chemical in production of their plastics. The FDA has been under fire for relying too heavily on industry information about Bisphenol A which has defended use of the product in plastics production. According to the new FDA chief Margaret Hamburg, the review should be completed by the end of the summer.

FDA Seizes Generics from Caraco Pharmaceuticals

Fri, 26 Jun 2009 13:09:12 -0500

Federal authorities swooped down on Caraco Pharmaceuticals Detroit plant seizing between $15-20 million worth of generic drugs. The drugs were seized after the FDA determined that the generic drugs did not meet standard quality requirements concerning their manufacturing. Among the drugs seized were generic tablets for pain, heart problems, and psychiatric issues. This is not the first mention of manufacturing problems for the Detroit-based company. Since January, Caraco Pharmaceuticals has been issuing recalls of its generic drugs due to manufacturing problems including oversize tablets. According to Detroit News, "In response to the seizure, the company said in a statement that it believes "corrective actions have been made and continual improvements are in progress." Caraco, which replicates brand name drugs with expired patents, sells about 3.6 billion tablets annually to wholesalers, drug distributors and retail giants. Its drug lineup, which includes more than 50 generic products, spans everything from prescription treatments for gout to anti-depressants and anti-allergenics. Caraco has taken some steps to remedy production problems, CEO Daniel Movens said in a company release issued last month. In January, it changed manufacturing and quality control leadership, the company said. It reiterated those comments in its Thursday release."

FDA: Medical Device Registration a Daunting Task

Tue, 23 Jun 2009 13:57:43 -0500

Given all the issues confronting an overworked and underfunded federal agency such as the FDA, the mammoth project of registering medical devices is at best a daunting task. So says Jay Crowley CDRH senior advisor for patient safety and head of FDA's unique device identification (UDI) initiatives. Crowley is quoted in the Gray Sheet, "At 50,000 feet, unique device identification is very simple. We could get it done tomorrow, we could get it out there, we could get UDI on medical devices," says Jay Crowley, CDRH senior advisor for patient safety and head of FDA's unique device identification (UDI) initiatives. "But if it's not implemented, if it doesn't work its way through the supply chain, through distributors, into hospitals, to that point of patient encounter - we haven't done anything." However, other countries have devised and implemented such a system. That's not to say it would be easy but in terms of patient safety and medical device information and effectiveness, it's well worth the effort. Such obstacles were the subject of the Global GS1 Healthcare Conference held in Washington, DC on June 16. Crowley and other industry experts note that a barcode system would be necessary in order to track devices from the point of manufacture to delivery to the client. The myriad medical devices from artificial hips, knees, and cardiac defibrillators would have to be tracked from the time of creation to their eventual implantation in a human patient. The tracking would continue as long as the patient used the medical device. Even for layperson, this is indeed a daunting task. Yet, it's crucially important in order to ensure the safety of the consumer. Let's hope the FDA perseveres in this task.

Medtronic's Payment to Doctor Underscores Ethics Dilemna

Mon, 22 Jun 2009 09:06:44 -0500

The fact that Medtronic Inc., a leading medical device manufacturer, paid Dr. Timothy Kuklo $800,000 over the past three years is not as disturbing as the fact that Kuklo falsified and exaggerated the benefits of the company's Infuse bone graft in scientific medical journals. Making matters worse, Kuklo stands accused of forging the signatures of medical co-authors. The ethical quandary in this case has real life implications for the rest of us. This isn't some ivory tower academic falsifying reports to justify a bloated consulting salary. Kuklo's conclusions and writings promote a product that doctors around the country will rely upon to heal and restore health. The false claims can actually end up injuring patients. The scientific community that publishes these medical journals also suffers collateral damage from Kuklo's behavior. Presently, Congress is holding hearings regarding medical device safety. They're trying to determine whether the FDA needs more regulatory power. While they're investigating this issue, they also need to establish some basic groundrules concerning scientific research and the remuneration of the researchers. It seems to me that a researcher whose task it is to research a drug or medical device can't be compensated by that same drug company or medical device company. There's an inherent conflict of interest. The payment naturally predisposes the researcher to look favorably upon the drug or medical device. If medical journals, doctors, and the community at large are to place their confidence in this research, the research itself must be beyond reproach. These conflictual relationships have to stop. Perhaps the establishment of an independent funding source that is operated apart from the companies would work.

Lawmaker Calls Medical Device Safety System Broken

Fri, 19 Jun 2009 13:45:00 -0500

Rep. Frank Pallone (D-NJ) who chairse a House Energy and Commerce subcommittee, characterized the country's oversight of medical devices "broken". Citing FDA inaction and lack of appropriate response in some instances, Pallone is trying to determine is new federal legislation or more FDA oversight is necessary to fix the problem. Pallone cited what many industry analysts have been saying for quite some time. The safety measures and quality control presently in place is inadequate and is not protecting the public from defective or unsafe medical devices. Examples of such recent defective medical devices are numerous. We've been involved in some of these matters including the Stryker hip, Kugel Mesh, Zimmer Durom Hip, and the Medtronic Sprint Fidelis defibrillator leads. These cases represent a danger to the general public who rely on these products for their safety and health. According to a Reuters report, "Cardiologist William Maisel, who heads the nonprofit Medical Devices Safety Institute, said recent recalls of defibrillator wires and other devices raised questions about the FDA's ability to identify safety problems promptly. "Additional consumer safeguards are needed. Only bydemanding more thorough, scientific device evaluations can theFDA hope to reestablish consumer confidence in its ability to protect the public's health," Maisel told a House of Representatives Energy and Commerce subcommittee.

Zicam Recall-Not

Wed, 17 Jun 2009 09:20:05 -0500

In response to the FDA warning letter concerning Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs, the company has stubbornly refused to recall the products in spite of the fact that the products have been associated with anosmia-a loss of the sense of smell. In those who've been injured by Zicam products, the loss of smell may be permanent. The company, Matrixx Initiatives, Inc. has already faced hundreds of lawsuits with many more anticipated after Zicam was suspended yesterday. In a company press release issued hours after the FDA warning letter, company officials complained that the FDA issued the public health advisory before contacting the company. Isn't that the purpose of the FDA? Isn't it the mission of the FDA to protect consumers not shield a healthcare company from lawsuits? Even at this early stage, it appears that the manufacturers of Zicam were well aware of the potential dangers of their product. Yet, they continue to market it as a healthy, homeopathic remedy to lessen the severity and duration of the common cold. Zicam was a best selling product for Matrixx and its suspension is sure to cause financial woes. Yet, the important issue here is consumer safety not a company's bottom line. The new, aggressive approach of the FDA in suspending sales of Zicam is laudable and a move in the right direction.

Zicam Recalled after FDA Warning Letter

Wed, 17 Jun 2009 07:00:41 -0500

Zicam Cold Remedy received a stern warning from the FDA after approximately 130 have lost their sense of smell. In the wake of the FDA warning letter, Matrix Initiatives, Inc. has voluntarily recalled the product. Zicam Cold Remedy is an over the counter medicine that delivers medicine in nasal swabs. However, the swabs have been linked to nasal nerve damage resulting in the loss of the sense of smell. Zicam Cold Remedy is considered by the FDA to belong to a small group of remedies knows as homeopathic. The FDA issued a warning letter to Mattrix, the manufacturer of the zinc-based homeopathic Zicam Cold Remedy, but stopped short of issuing a recall of the product. However, due to the warning letter, the makers of Zicam will now have to submit safety and effectiveness data concerning Zicam to the FDA. Because of the dangers determined to be associated with Zicam, the manufacturer will now have to go through an FDA approval process. Of course, a logical question to ask at this point is why does the designation "homeopathic" exempt Zicam and other similar products from FDA review and the approval process. As we're seeing with so-called "natural" diet supplements, they can be as dangerous as defective prescription drugs. There is nothing about a homeopathic product that inherently makes them safe. They should be forced to undergo the same rigorous evaluation as other drug products PRIOR to coming to market. The global market for homeopathic remedies is around $200 million but it's growing. This market includes Nutraceutical International Corp. and Natural Health Supply. On the Matrixx website, the company boasts that "no plaintiff has ever won a court case. . ." involving Zicam. The company has known for years about the potential harm caused by its homeopathic remedy Zicam and the loss of the sense of smell. Hundreds of lawsuits have been filed against the company. Yet, it takes an FDA warning letter to have the product removed from the market.