Monthly Archives: July 2009

Acetaminophen Dosage Dangers

Acetaminophen is everywhere and enjoys an excellent reputation as a safe, effective, pain reliever. It’s in our over-the-counter drugs that we purchase when we have a cold, the flu, or any type of muscle ache or joint stiffness.
Since the 1980’s Tylenol scare, marketing firms have carefully branded acetaminophen as a safe,effective drug for just about any common ailment.
Yet, there a downside to acetaminophen’s success. The drug is also combined in such narcotic prescription pain medicines as Percocet. When prescribing drugs like Percocet after a procedure or a surgery, doctors often fail to take into account the amount of acetaminophen contained in the Percocet they’re prescribing. The doctor may write a prescription and instruct the patient to “take one every four hours for pain”. Such instructions may exceed the daily limit allowable of acetaminophen (4 grams). The pharmacist in filling such a prescription may also neglect to notice the harmful amounts of acetaminophen prescribed even though that same pharmacist may be liable for such an overdosage.
In these scenarios, which are not uncommon, both the doctor and the pharmacist are legally liable for the acetaminophen overdosage. It’s a dangerous situation for the patient because that very same prescription, legally obtained, may lead to liver damage and/or liver failure.
In cases of acetaminophen overdosage, it’s more than buyer beware. Doctors and pharmacists must pay attention to the amounts of acetaminophen prescribed as well as the over-the-counter acetaminophen the patient may have already ingested. Doctors and pharmacists need to ask what types of over-the-counter medicines are being taken prior to writing and filling potentially lethal prescriptions.

Medtronic Recalls Insulin Equipment

Medtronic Corp. is voluntarily recalling its Lot 8 Quick-set insulin infusion equipment used in conjunction with insulin pumps because it may transmit too much or too little insulin to diabetes patients. Diabetics using the equipment have been warned to immediately stop using such equipment. The affected lots include reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers that begin with 8.
According to Medtronic, the recall affects approximately 60,000 units of the insulin equipment. The infusion set is a thin piece of plastic tubing that is replaced every three days. The tubing connects the insulin pump to the patient. While there are no reports of injuries, the medical device malfunction could lead to serious injury or death.
Medtronic Corporation is no stranger to faulty medical device that require recalls. Just last month, the FDA ordered a Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. A few years ago, Medtronic suspended sales of its Sprint Fidelis defibrillator leads for similar issues.

Bed Bug Resurgence

Since the forced exile of DDT, beg bugs have enjoyed a renaissance in hotels, condos, college dormitories, and other seemingly innocent residential haunts. The problem has become so severe that it’s caught the attention of the EPA which held a seminar this past April on the matter.
According to today’s article in the NY Times, the only sure way to get rid of the pesky critters is exposure to high temperatures. This means put your belongings, at least those that are appropriate and fit, into your dryer. Bed bugs can’t sustain the high temperatures and die as a result. According to the Times article, beg bugs aren’t killed by the regular spray of pesticides that the average bug control company offers.
The Times article offers some helpful tips in ridding yourself of the biting bed bugs-
“ENCASE YOUR MATTRESS All bed bug experts agree that you must encase your mattress and box spring with a durable, leak-proof cover that will trap existing bugs inside the bedding and prevent new bugs from entering. (Even if you don’t currently suspect bed bugs, you might want to do this preventively, if you live in a highly infested area.)
The best covers are made from tightly woven cloth and have enclosed zippers and zipper locks to ensure there are no openings anywhere on the covering. A good cover will cost $70 to $150, depending on the size of your bed. Don’t bother with cheaper covers made of vinyl, which is uncomfortable to sleep on and is likely to crack and tear over time.
BEFORE YOU TOSS … Often, the first response to bed bugs is to throw stuff out. But replacing contaminated furniture, clothes and other possessions can be one of the biggest unnecessary bed bug expenses.
“Nothing kills bed bugs and their eggs better than high temperatures,” said Mr. Bloom, “so the dryer is your new best friend.”
Bedding, clothes, stuffed animals, backpacks and anything else you can fit into the clothes dryer can be decontaminated by 20 minutes on the high setting. Carry the items to the dryer in a cloth laundry bag that you can throw into the machine. If you use a plastic bag, discard it immediately; bed bugs or eggs might be lurking.
For items that can’t go in the dryer, consider packing them in plastic bins or bags and storing them for a year to make sure any hidden insects die.
For furniture and other large items, you may want to consider a professional fumigation service that will decontaminate the items away from your home and return them within a week or so. This can easily add $1,000 to your bed bug bill. But for antiques, heirlooms and other hard-to-replace items, it may well be worth the cost.”

How Safe is Bottled Water?

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

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

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

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?

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

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

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.