In the world of pharmaceuticals, a “blockbuster” is the term reserved for a prescription drug which has annual sales in the billion-dollar plus range (with the emphasis on “plus”).

While annual sales in the $500 million range are nothing to sneeze at, the many drugs that attain that level are looked upon as revenue producers. The blockbusters are looked upon as king-makers.

Thus, when drug has the potential to attain the elusive “10-figure” status, some very questionable marketing strategies take place. These include:

•    Failing to disclose or report negative test or clinical trial results;
•    Failing to report adverse reactions;
•    Failing to finalize post-approval testing or reporting;
•    Spending more on advertising a drug than on developing and testing it;
•    Withholding negative information from doctors or using questionable incentives to encourage the writing of prescriptions for a specific drug;
•    Indirectly engineering a campaign to stimulate (while not actually promoting) one or more “off-label” uses of a drug that may actually generate more income for that drug than the approved uses. (The “off-label” market will be described below.)

These revenue-driven strategies do not make a drug better or safer. In fact, every case is little more than marketing winning out over science, safety, and even ethical considerations. In the case of Natrecor nothing good can be said concerning the manner in which the drug was promoted and marketed.

Natrecor, or nesiritide, was approved by the FDA in 2001 to treat congestive heart failure or acute decompensating heart failure in which patients experience shortness of breath and the heart fails to adequately pump blood to other organs in the body.  The drug works by mimicking a hormone-like molecule that dilates vessels to prevent blood from gathering in the heart and lungs thereby allowing the patient to breathe.

 Natrecor is manufactured by Scios, a company which was bought by Johnson & Johnson in 2003.  As many as 600,000 patients have been treated with the drug since its approval.

Natrecor was, and still is, supposed to be used for the sole purpose of treating hospitalized patients with the aforementioned heart conditions. Despite this express limitation on its approved use; Natrecor has become an increasingly popular option in outpatient clinics nationwide where it is used for far longer periods than it was originally approved for. 

Some outpatient clinics even administer Natrecor twice weekly for up to 12 weeks.  This type of use is considered to be extremely dangerous as no study has been conducted to confirm whether long-term use is either safe or effective. 

This “off-label” use of Natrecor has lead to the discovery of severe side-effects and a subsequent push from medical experts and consumer advocates for the manufacturer to conduct further large-scale, longitudinal studies of the drug.

The off-label prescribing of drugs beyond the scope of their approval by the FDA has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. At its worst, the practice can be downright deadly.

It is for this reason that the FDA regularly discourages and even warns against such uses of drugs. This has been especially true in the case of powerful drugs like antipsychotics, heart medications, and antidepressants.

The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the FDA has even denied approval. Thus, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.    

Thus, if a pharmaceutical company is able to subtly (or, even not so subtly) stimulate off-label use of one of its drugs, the return in unanticipated profits can be quite significant. In fact, a clever marketing scheme can turn a restricted approval drug with limited sales potential into a billion-dollar blockbuster.

Many times, off-label use of a drug is stimulated by doctors themselves who are acting more like marketing agents than as responsible health professionals.

Dr. Jonathan Sackner-Bernstein, a cardiologist at North Shore University Hospital in New York and an avid opponent of the overuse of Natrecor, co-wrote several journal articles that provide data which links Natrecor to kidney problems and elevated death rates. 

Sackner-Bernstein’s patients taking Natrecor were 80% more likely to die within the next 30 days than patients who had received other treatments such as diuretics or vasodilators. 

The issues relating to kidney safety were known prior to and during the process of FDA approval of the drug and are specifically noted in the drug’s labeling. Yet the increased risk of mortality was not entirely known or appreciated until the drug became widely used in outpatient clinics for extended periods of time. 

Although Scios argued that the Sackner-Bernstein paper included studies done at higher doses than are advised on the drug’s label, those higher doses are precisely what patients are being exposed to when they receive the treatment outside of hospitals.
 
Natrecor was never approved to be used as frequently as it is being used in outpatient clinics.  Sackner-Bernstien and other experts, including fellow cardiologist Keith Aaronson, have attempted to show that Natrecor should not be administered in outpatient settings and that the drug’s label should indicate the serious problems associated with unrestricted off-label usage.

In the July 14 edition of the New England Journal of Medicine, Dr. Eric Topol of the Cleveland Clinic was highly critical of the way in which Scios was marketing Natrecor and he even went so far as to state that the drug should be off the market because the FDA was never given sufficient data upon which to have based its approval. 

Natrecor has been aggressively marketed with sales of the drug now reaching almost $700 million this year.  This is because Natrecor is an expensive option, costing nearly 50 times more than standard therapy options. 

Natrecor is billed to insurance companies at up to $700 per session.  When used in hospitals for emergency situations, as intended, the cost, while high, is controllable.  However, when patients are receiving this treatment dozens of times in outpatient clinics, the cost quickly spirals out of control. 

In addition to other questionable marketing strategies, Scios provided doctors with promotional materials advising them on how to bill Medicare for Natrecor uses that are clearly not approved by the FDA. 

The Scios reimbursement guide, also available through a toll-free number, told doctors to use Medicare codes that treat Natrecor like chemotherapy allowing them to bill for lager Medicare reimbursements.

As a result, Medicare managers became concerned that reimbursements for Natrecor treatments in outpatient clinics would skyrocket as a result of the information that Scios has been giving to medical professionals.

In May 2005, Johnson & Johnson announced that in compliance with the FDA, it would revise the labeling for Natrecor to include data indicating an increased risk of mortality within 30 days for Natrecor patients compared with patients taking a placebo or other treatments. 

This was a good start but doctors and other medical professionals were still advocating further studies of Natrecor to determine the health risks associated with the drug.  Milton Packer, a cardiologist at the University of Texas, Southwestern, is concerned that Scios, like Vioxx maker Merck, has not done adequate studies to make sure that its drug is safe.  Although the FDA approved the drug in 2001, many doctors argue that today the vote might be closer and Natrecor would probably wind up with a tougher label.

Then, in May of this year, an independent expert panel, convened by Johnson & Johnson itself, recommended that Natrecor be restricted to severely ill hospitalized patients.  Most experts also agreed that a large-scale clinical trial is needed in order to determine the risks of Natrecor.   

Although a spokesperson for Scios argued that the company could not control how doctors prescribe the drug, Scios itself greatly contributed (or even created) the problem by affirmatively providing doctors with information on how to maximize their billing of Natrecor for off-label uses. 

Many experts consider it ethically irresponsible for a pharmaceutical company to promote an off-label (and potentially harmful) use of a medication for no other apparent reason than financial gain.

Such questionable conduct could have caused significant problems for Scios and Johnson & Johnson if the drug does prove to be as dangerous as it appears to be and it continued to be prescribed in outpatient settings as opposed to hospital situations where it is a life-or-death situation. 

In June, the panel of cardiologists convened by Johnson & Johnson and headed by the highly respected heart researcher, Harvard’s Dr. Eugene Braunwald, recommended strict limitations on Natrecor, including not using it for scheduled “tune-ups” or even administering it outside the hospital.

The panel specifically recommended that Natrecor only be used in cases of an acute type of heart failure when the patient actually shows up at the hospital; that it should not be used in place of diuretics, the first-line treatment for heart failure; and never used for outpatients, scheduled appointments, or to improve kidney function. 

Furthermore, the panel believed that: “Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used.”

A member of the panel, Barry Massie (professor of medicine at University of California in San Francisco) also expressed disapproval of the manner in which doctors flagrantly engage in the off-label prescribing of drugs. He believes it is important for doctors to take responsibility for their actions and only prescribe drugs for their approved uses. “It shouldn’t all be blamed on the pharmaceutical companies, no matter what they do to encourage unproven indications.”

On July 20, Johnson & Johnson acknowledged it had received a subpoena from the United States Attorney’s office in Boston requesting documents related to the sales and marketing of Natrecor.

As a result of this virtual tidal wave of disapproval concerning the questionable tactics associated with the marketing of Natrecor, Johnson & Johnson added a clear disclaimer to its hotline used by doctors seeking information on how to charge Medicare and insurance carriers for the drug. The disclaimer clearly seeks to discourage the heretofore rampant off-label use of Natrecor. 

The disclaimer warns of the “lack of clinical data” regarding off-label use of the drug and that Scios “does not recommend Natrecor for this use.” Johnson & Johnson now plans to follow up on the panel’s suggestions.

Fortunately, in the case of Natrecor, the often ineffective checks and balances in the healthcare system finally worked to forever deprive Natrecor of the blockbuster status its manufacturers had so desperately attempted to achieve.

The CPSC, in cooperation with Lamplight Farms Inc., of Menomonee Falls, Wisconsin, has announced a voluntary recall of some 963,000Tiki® Bamboo Torches and approximately Replacement Fuel Canisters manufactured in China. Consumers should stop using the recalled products immediately.

The surface coating of some flame guards on these bamboo torches and replacement canisters can absorb the fuel and ignite. This can cause the torch and nearby combustibles to catch on fire, posing a risk of burn injuries and property damage.

Lamplight Farms has received 33 reports of torches catching on fire. There were six reports of minor injuries and nine reports of minor property damage.

These 5-foot-tall Tiki® bamboo torches consist of a bamboo pole with a weaved basket at the top and a metal flame guard, which is a circular black piece that holds the wick in place and attaches to the fuel canister.

The recall includes the Tiki® Beachcomber, Seagrass, and Sandpiper model torches. The recall also involves replacement canisters that have the metal flame guards. Recalled units have the following UPC numbers: 086861010372 (Beachcomber), 086861013335 (Seagrass), 086861010457 (Sandpiper) and 076354995262 (Replacement Canister). The UPC number and the model name are written on the packaging or attached tag.

The products were sold at Wal-Mart, The Home Depot, Lowe’s and other home and hardware stores nationwide from December 2004 through July 2005 for between $5 and $6. The replacement canisters were sold for about $1.40.

Consumers should immediately stop using these torches and contact Lamplight Farms to determine if they are included in the recall. If so, they will receive free replacement flame guards.
Lamplight Farms can be reached, toll-free, at (866) 239-6664 anytime, or by visiting their Web site at www.lamplightfarms.com

A series of significant lawsuits against the government of Ontario involving Toronto nurses infected by SARS (Severe Acute Respiratory Syndrome) have been allowed to continue after a ruling by a judge of the Ontario Superior Court.

The three lawsuits affected by the ruling include:

·A $600-million class-action brought by a nurse (Andrea Williams) infected with SARS in May 2003

·A $12-million lawsuit brought by the family of a nurse (Nelia Laroza) who died in June 2003

·A lawsuit on behalf of 53 infected nurses (each seeking over $17 million in damages) including one by the family of a nurse (Tecia Lin) who died in July 2003 

Although some parts of the lawsuits were dismissed, the remaining claims were permitted to continue. Two of the lawsuits allege that prior to the second outbreak known as SARS2, as Toronto was the subject of a World Health Organization travel advisory, government officials lowered their guard, eased hospital infection-control measures, and publicly declaring that the outbreak had been contained.

The suit by the Ontario Nurses’ Association alleges negligence in the handling of the SARS outbreak, arguing officials failed to provide adequate and timely information alerting nurses on how to protect themselves.

Although nurse Laroza began showing symptoms of SARS in May 2003 and believed she had contracted the illness, an emergency-room doctor sent her home with instructions to take Tylenol. Laroza died of SARS-related complications in late June 2003 after having infected her teenaged son. Six patients in the orthopedic ward where Laroza worked also died of SARS.

Her son stated: "Winning this motion and allowing our case to go to trial is a huge step towards finding out why our mother was allowed to die."

The plaintiffs claim that provincial officials pressured WHO to lift its travel advisory prematurely because it had severely affected tourism to Canada’s largest city. The government is accused of favoring tourism and economic considerations over infection control and the health of the Ontario residents.

The province of Ontario is considering whether to appeal this ruling.

A new, minimally invasive procedure may help in the diagnosis of lung cancer stage   thereby preventing unnecessary surgery. Lung cancer is currently the number one cause of cancer death for Americans.

The study, which appears in the August 24/31 issue of The Journal of the American Medical Association, is the result of research by Jouke Annema, MD, PhD at the pulmonary medicine division of Leiden University Medical Center in the Netherlands.

All the 100 subjects in the study were suffering from non-small cell lung cancer, the most common kind according to the American Cancer Society. Two tests were performed on each subject.

The first test, transesophageal ultrasound-guided fine needle aspiration (EUS-FNA), uses ultrasound technology to direct a fine needle through the lung lymph nodes. The needle harvests cells from the lymph nodes, which are then checked for signs of cancer.

The second test, mediastinoscopy, is done by inserting a scope through a tiny hole in the chest to observe the patients’ lungs. This is another means for taking and examining tissue samples.
Although about 2% of the EUS-FNA tests turned up false positives for cancer, doctors believe the new procedure will reduce the number of thoracotomies (partial or total removal of a lung).

Currently as many as 40% of thoracotomies for non-small cell lung cancer were done unnecessarily because of imperfections in determining the extent of the disease prior to surgery.  Researchers conclude about 16% of thoracotomies in their study could have been avoided by using EUS-FNA.

Unsubstantiated online marketing claims by Emerson Direct Inc. about their anti-smoking product, Smoke Away, have lead to a $1.3 million settlement between the Florida company and the Federal Trade Commission (FTC).

The FTC complaint against Emerson Direct, Inc. (doing business as the Council on Natural Health) of Naples, Florida, and its owner Michael J. Connors charged that the company could not support claims that the product made quitting smoking easy and did so without cravings or side effects.

The FTC also alleged the credentials of doctors were misused and that one chiropractor did not have the expertise he was claimed to have.

Also implicated in the complaint were Thomas De Blasio, M.D., a physician from Manalapan, New Jersey, and Sherry Bresnahan, D.C., a chiropractor from Algonquin, Illinois, who were involved in advertisements endorsing the product.

The FTC disputed a number of statements made about Smoke Away in a variety of advertisements including a national television infomercial, 60- and 120-second national television ads, 60-second radio spots, and on Web sites.

The company claimed Smoke Away enables smokers: to quit smoking in seven days or less; to quit smoking quickly, effortlessly, and permanently; to eliminate nicotine cravings; and that the product caused no withdrawal symptoms or side-effects such as weight gain, insomnia, or tension.

Claims were also made that Smoke Away is more effective than nicotine patches, nicotine gum, and prescription medications for smoking cessation.

The FTC charged that these claims were false or unsubstantiated and that Connors also misrepresented the company’s policy of giving prompt refunds to dissatisfied consumers.

In addition to the significant settlement, the company is prohibited from making any claims about the benefits, performance, efficacy, safety, or side-effects of Smoke Away or any other smoking cessation product or program unless those claims are true, non-misleading, and substantiated.  Distributors and sales agents must also be notified about the settlement.

Likewise, the defendants are prohibited from making any claims about the benefits, performance, or efficacy of any food, drug, or dietary supplement unless those claims are backed by scientific evidence. Doctor’s claiming to be experts must have actually tested the product.

According to the Environmental Protection Agency (EPA) Americans should be aware and concerned about the level of radon gas in there homes.

Radon is a colorless, odorless, and radioactive gas that seeps into buildings from the underlying soil. Experts claim that long-term exposure to the gas can cause lung cancer.

While radon is present in low amounts in the air (about 0.4 picoCuries per liter), the problem occurs when it seeps into buildings from the soil and levels build up inside. Radon comes from the radioactive decay of uranium in the soil.
The gas itself does not pose an immediate health threat, but over time produces two radioactive isotopes of polonium that can lodge in the lungs and cause cancer.

Phil Jalbert, acting director of the EPA’s center for radon and air toxics, said that although radon does not pose as much of a health threat as smoking, which kills some 150,000 people annually, it is the second leading cause of lung cancer deaths in the country.  It may cause as many as 21,000 deaths each year, more than drunken driving, accidents in the home, or fires.

The EPA suggests homeowners have their houses tested for radon. If the average concentration is greater than their designation "action level" of 4 picoCuries per liter of air, the agency encourages measures to reduce the levels.

The connection between lung cancer and radon was first apparent in uranium miners surrounded by high levels of the gas as they worked underground according to Bill Field, Ph.D., of the University of Iowa’s College of Public Health been supported by recent research.

These studies include a summary of recent of a number of radon studies in the journal Epidemiology in January, which showed an 11% to 21% increase in lung cancer risk corresponding with gas exposure.

Other research in the January 2005 British Medical Journal and by the World Health Organization (WHO) attributed between 6% and 15% percent of lung cancer deaths to radon. The WHO and the U.S. Surgeon General have both issued warnings against radon.

According to the EPA and many researchers radon is dangerous at all levels. Thus the lower levels found in buildings is claimed to be just as dangerous as the higher levels experienced by miners.

Some scientists, such as Bernard Cohen, Ph.D., a physicist at the University of Pittsburgh, take issue with this conclusion, however. In his study, Cohen considered average radon levels in 1,600 counties in the U.S., containing more than 90% of the nation’s population, and plotted them against lung cancer deaths.

He hypothesizes that if even small amounts of radon can cause harms, counties with the highest average radon levels should have the highest rates of lung cancer. However, "It’s just the other way around," he said. Cohen concludes "to worry about 4 picoCuries is really not justified."

Jalbert admits that the EPA cut off level is not really based on what levels of the gas pose a health concern, but was selected because at that number the problem is easier to treat.

If homeowners are concerned, the exposure to radon can usually be remedied by sub-slab depressurization, which requires drilling a hole through the basement floor and the insertion of a plastic pipe with a fan that will vent the gas into the outdoors through a wall in the side of the house.

The procedure can cost anywhere from $700 upward. Testing radon levels costs between $5 and $15 and should be done every few years.

As a result of an unusually high number of deaths since 2003 following cardiac bypass operations, UMass Memorial Medical Center stopped performing open heart surgeries this week.

According to an analysis by state public health officials, the hospital’s death rate for coronary artery bypass surgery patients was almost twice the average for hospitals in Massachusetts.

Doctors at UMass hospital have reportedly known about problems in the cardiac surgery program for two years, but have not taken any action until now, after the analysis was presented by state officials.

The state Department of Public of Health has enlisted three heart surgeons from other  hospitals to determine whether the death rate can be lowered, or whether the high mortality rate result from uncontrollable factors like race and class.

A probe will also be conducted by the Division of Health Care Quality to determine exactly when hospital executives became aware of the high mortality rate, and what they did to address it.

The president of UMass Memorial Medical Center, Dr. Walter Ettinger, Jr., has said that in 2003, physicians and hospital executives realized that the mortality rate for patients who had undergone bypass surgery and died within 30 days of their operations was around twice the state average (more than 4 %, compared to an average of 2-2.5 %).

Hospital officials also realized that the rate of chest infections among heart patients was high as well (6.4 % compared to an average of 1-4 %).

Hospital executives then hired outside consultants to examine the cardiac surgery program and recommend improvements. A number of changes in procedure were made as a result of the review, Ettinger said, including making sure patients received antibiotics through an I.V. within an hour before surgery begins.

According to hospital president, after the changes were adopted in 2004, the hospital’s chest infection rate lowered to 1.5 %. But the death rate has not been reduced.

During 2003, out of 371 cases, 16 patients who had coronary bypass surgery at the hospital died within 30 days of their surgery. Throughout Massachusetts, 99 patients died out of 4,393 cases. UMass had similar death rates in 2002, 2004, and 2005.

The mortality rates for the 13 hospitals in the state that perform cardiac surgery were made available to the public by health officials last October in an effort to aid patients with making decisions about where to get care and in order to motivate hospitals to improve their statistics.

The scenario at UMass, a teaching hospital, again calls attention to the lag in time between hospital reporting and public reporting of patient and death statistics.

It is not known when UMass Memorial Medical Center will reopen its heart surgery program.

The Morrison Milling Company of Denton, Texas, is voluntarily recalling all lots of HyTop® Blueberry Muffin Mix because it contains undeclared whey and eggs.

People who have an allergy or severe sensitivity to milk proteins or eggs run the risk of serious or even life-threatening allergic reactions if they consume the product.

The product was sold at retail stores in Texas, New Mexico, and Louisiana and is packaged in paper pouches. Net Wt. 7 oz. UPC 5070006006 all lot codes.
 
The recall was initiated after if was discovered that an incorrect ingredient statement was placed on the package. The packaging error was limited to two day’s production, and no other Morrison Milling or HyTop® products are part of this recall.

The company has received information about a reported allergic reaction concerning this product. An investigation is ongoing.
Consumers who have purchased this muffin mix and who are known to be allergic to milk proteins or eggs should contact The Morrison Milling Company at 800-866-5487 or 800-580-5487 for instructions for product disposal and a refund.

Just in case you thought you had heard about every sleazy way there is to make a buck, consider this one.

The state of Connecticut is taking legal action to stop the selling of fake replacement air bag covers by Hicks Air Bag Covers of Alabama which markets its product nationwide without the air bags as an inexpensive alternative to installing a complete replacement system.

The state’s Attorney General, Richard Blumenthal, along with Senator Leonard A. Fasano, and the Auto Body Association of Connecticut (ABAC) will argue for a complete ban on the sale and installation of air bag covers without air bags.

Currently, the law prevents the sale to repairers or dealer but not individuals. Such laws have already been adopted in Florida, New York and other states.

On its web site and in mailings to Connecticut auto body shops, Hicks openly markets its product as a cheap replacement for use in damaged vehicles. The covers come in 50 colors and fit almost all vehicle makes and models. They cost about $75 to $85.

A full air bag assembly costs between $600 and $700. Of course, that includes the air bags which are a nice touch especially if you are involved in an accident.

In 2003, the company’s owner, Lawrence G. Hicks, pled guilty in federal court to selling counterfeit General Motors air bag covers to individuals, auto body shops, and used car dealerships for use in repairing damaged vehicles.
 
Hicks admitted selling more 4,600 of the counterfeit air bag covers in 1999 and 2000.

According to 2003 National Highway Traffic Safety Administration statistics, air bags saved about 2,500 lives during that year. Nonetheless the Hicks catalog offers the covers alone without the life-saving air bags.

One auto repair specialist stated; "As an auto repairer, my top priority is to fix vehicles so they are safe to drive. ABAC is always very concerned about safety issues. These fake air bag covers endanger public safety and should be outlawed.”

For consumers, it may not always be obvious if air bag has been properly replaced. Thus, when buying a used vehicle, motorists should check for the maker’s logo on the bag cover. The absence of a logo is an indication that the cover is a fake and there may be no air bag underneath.

Just in case you thought you had heard about every sleazy way there is to make a buck, consider this one.

The state of Connecticut is taking legal action to stop the selling of fake replacement air bag covers by Hicks Air Bag Covers of Alabama which markets its product nationwide without the air bags as an inexpensive alternative to installing a complete replacement system.

The state’s Attorney General, Richard Blumenthal, along with Senator Leonard A. Fasano, and the Auto Body Association of Connecticut (ABAC) will argue for a complete ban on the sale and installation of air bag covers without air bags.

Currently, the law prevents the sale to repairers or dealer but not individuals. Such laws have already been adopted in Florida, New York and other states.

On its web site and in mailings to Connecticut auto body shops, Hicks openly markets its product as a cheap replacement for use in damaged vehicles. The covers come in 50 colors and fit almost all vehicle makes and models. They cost about $75 to $85.

A full air bag assembly costs between $600 and $700. Of course, that includes the air bags which are a nice touch especially if you are involved in an accident.

In 2003, the company’s owner, Lawrence G. Hicks, pled guilty in federal court to selling counterfeit General Motors air bag covers to individuals, auto body shops, and used car dealerships for use in repairing damaged vehicles.
 
Hicks admitted selling more 4,600 of the counterfeit air bag covers in 1999 and 2000.

According to 2003 National Highway Traffic Safety Administration statistics, air bags saved about 2,500 lives during that year. Nonetheless the Hicks catalog offers the covers alone without the life-saving air bags.

One auto repair specialist stated; "As an auto repairer, my top priority is to fix vehicles so they are safe to drive. ABAC is always very concerned about safety issues. These fake air bag covers endanger public safety and should be outlawed.”

For consumers, it may not always be obvious if air bag has been properly replaced. Thus, when buying a used vehicle, motorists should check for the maker’s logo on the bag cover. The absence of a logo is an indication that the cover is a fake and there may be no air bag underneath.