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, 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.

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.

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.

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).

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.

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.”

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.

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.

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.