When referring to most small towns in America, you first need to identify the state and county they’re in before the average person has some idea of where it is located. Simply say the word “Newtown,” however, and hardly anyone would not be able to tell you exactly where it is.

After a lone gunman systematically murdered 20 six- and seven-year old children and six adults at the Sandy Hook Elementary School in Newtown, Connecticut on December 14, 2012, a school principal 2,500 miles away declared:  “That day pretty much shook American schools to their core.”

More than that, though, the tragic events in that small elementary school nestled in an idyllic section of Fairfield County have made the immediate review and reassessment of school security plans a top priority. Whether examining individual schools or entire school districts, many daunting financial and logistical problems face those attempting to ensure a greater degree of safety for our children.

Budgets already stretched to the limit and buildings with numerous access points and very little protection make it necessary to implement safety plans that combine effectiveness with economy.  Bureaucratic red tape and partisan politics can also present additional stumbling blocks to prompt and efficient planning.

One thing is certain, however, the next attack on a lower school, high school, or college is already being contemplated in the mind of one or more people who, for whatever the reason, see such an act, no matter how violent or irrational, as their response to some perceived wrong or injustice done to them.

However, as history shows, some of the worst mass killings involving “lone wolf” terrorists have been perpetrated by individuals who believe they are making some type of social or political statement.

Consider the anti-government attack on July 22, 2011 at a summer camp on the island of Utøya in Norway. The camp was organized by the youth division of the ruling Norwegian Labor Party. A lone gunman dressed in a homemade police uniform and showing false identification gained access to the island and subsequently opened fire on the campers killing 69 and injuring at least 110, 55 of them seriously.

The gunman (Anders Behring Breivik) claimed to have been planning terrorist acts for 9 years, since the age of 23. He had been part of Internet debates where he had spoken against Islam and immigration. He planned the 2011 attack from at least as early as 2009. He had carefully concealed his violent intentions.

The Oklahoma City terrorist bombing of the Alfred P. Murrah Federal Building in Oklahoma City occurred on April 19, 1995 and claimed 168 lives, including 19 children under the age of 6, and injured more than 680 people. The blast destroyed or damaged 324 buildings within a sixteen-block radius and caused at least $652 million in damages.

The bomber, Timothy McVeigh,  an American militia movement sympathizer, was a Gulf War veteran motivated by his hatred of the federal government and angered by what he perceived to be the mishandling of the Waco (Texas) Siege (1993) and the Ruby Ridge incident (1992). The attack was meant to coincide with the second anniversary of the deadly fire that ended the siege at Waco.

All of this demonstrates that what triggers these mass murders can vary from deep-seated psychological problems in young attackers to extreme (albeit irrational) social or political beliefs cultivated over many years by older assailants.

As a result, attempting to identify potential attackers before they act is a daunting task that offers no assurance of any success. It diverts valuable and scarce resources to hunt for people who might never be identified or who may not be planning to attack anyone.

Many school safety consultants, this writer included, believe the better approach is to formulate individualized safety plans which prepare for an attack regardless of who the attacker eventually turns out to be. In other words, plan for the attack and not the attacker.

Accordingly, careful attention should be paid to the following critical issues: (1) securing the points of entry into any building(s) in order to delay or prevent an intruder before he gets in; (2) the utilization of cameras, alarms, and other devices that will alert building personnel to any attempt at unauthorized entry. (The sounding of alarms may, for example, startle an intruder and cause him to abandon his plan of attack.); (3) installation of a direct emergency connection to law enforcement that will ensure an immediate response with appropriate personnel and equipment; and (4) mandatory training of all personnel (with regular refresher sessions) in terms of their response to this type of threat, including how to “lockdown” the building under attack. (This would be no different than required fire drills.)

The suggestion by some that every school in America should be guarded by armed personnel is, for want of a better word, extreme. Such a plan would introduce deadly weapons into an environment that, by its very nature is supposed to be free of such ominous instrumentalities. Accidents, mistakes, overreactions, inadequate training, false alarms and other situations having nothing at all to do with an armed intruder, present countless scenarios in which the very harm sought to be prevented is exactly what ends up happening.

The overly simplistic notion that; “The only thing that stops a bad guy with a gun is a good guy with a gun,” is hardly a “plan” in and of itself. The image of a shootout in an elementary school hallway simply does not provide the type of comprehensive program needed to make a school, school district, or college safer. Most experts with expertise in antiterrorism, hostage negotiations, armed standoffs and targeted attacks on unarmed civilians do not look at the “good guy/bad guy” solution as the answer to the problem.

While the “meeting force with force” proposal could be called extreme, it can be held up for comparison as moderate alternatives are considered. A Bloomberg Businessweek article looked at levels of personnel who would provide protection in schools, identifying them as, first, trained law enforcement officers; then, armed guards; finally, a vaguely-described level known as volunteers.

Asa Hutchinson, a former U.S. Representative from Arkansas and Department of Homeland Security official, currently lobbies for the NRA and is often the person explaining or modifying that organization’s position. Hutchinson “plan” would give schools “up-to-date technical information” from top law enforcement experts in law enforcement. The armed security personnel would be but one element of the security force assisted by volunteers. This support staff might draw its members from the ranks of retired police, military, or rescue personnel.

In the past, highly trained police officers with expertise in tactical units such as SWAT (special weapons and tactics) have worked in various schools as security guards while training a number of school workers in emergency procedures such as how to “lockdown” and evacuate the building in an emergency. Teachers were taught to lock doors, close curtains and turn off lights. Students were also instructed as to how they should conduct themselves if an incident occurred.

In a 2001 California case, a man with a shotgun (and a pistol) blew out a window in a San Diego County high school being guarded by a police officer involved in this type of security program. The officer pursued the gunman while the people he had trained at the school went about their assignments. The officer confronted and wounded the assailant before he could gain entry into the school. The injuries in the school were limited to cuts from flying glass.

What this approach has shown to school officials and safety experts, however, is that security guards with guns assisted by volunteers are not a substitute for trained law enforcement officers.

It should be noted, though, that a trained police officer was at Columbine High School in Littleton, Colorado in April 1999 when two students shot and killed 13. This suggests to some people that there should be larger security forces in schools, while to others it implies there should be none at all.

“It’s a school.  It’s not a place where guns should be,” said Dennis Van Roeckel, president of the National Education Association, a teachers’ union.  The chairman of the Orange County School Board in Orlando, Florida reacted similarly to a city plan to put sheriff’s deputies in 60 elementary schools in the county for the rest of 2013.

“Frankly, I don’t think it’s something the school board wants going forward,” he said.  “We don’t want to turn our elementaries into armed camps; we don’t want to turn into fortresses.  They’re elementary schools.”

Jeffrey Rutzky, superintendent of a K-6 district in Roseland, New Jersey, said security plans there are being developed “without losing the understanding that school is supposed to be a . . . safe place for kids” and without taking away “the purpose of what school is supposed to look like.”

He disagreed with the decision made in a neighboring school district to put a police officer in every school and added that his local police chief also didn’t think that a wise measure.  Rutzky even ventured the opinion that had there been a police officer at Sandy Hook Elementary School, he would likely have been killed by the gunman. Other experts disagree with that assessment and believe the several minutes the attacker needed to force his way into the school would have allowed a trained police office to gain the advantage needed to stop the attacker before he was able to enter the building.

Although many sympathize with Rutzky’s sentiments, a great deal more than wishful thinking is needed to provide the type of protection necessary to anticipate and effectively deal with the type of violent attack that is becoming all too frequent in our society. Some level of armed deterrent may very well be needed as a component of any realistic school safety plan.

In an Atlantic article, written in response to the Aurora, Colorado movie theatre massacre in July 2012, but published weeks before the Newtown shootings in December, Jeffrey Goldberg offers an opinion that students and other people who might one day find themselves confronted by a person or persons intent on mayhem might very well be better able to defend themselves if they too were armed.

Against that he lists recommendations for conduct during such perilous situations, which were drawn up at colleges and universities after the 2007 Virginia Tech attack, which left 32 people dead and another 17 wounded, and intended for students who are assumed to be unarmed.

Some instructional literature even includes suggestions that seem counterintuitive and a product of the hysteria such sudden acts of mass violence arouse.

One such questionable “plan” in the University of Colorado’s guidelines states:  “If such an event occurs, quickly develop a plan to attack the shooter . . . tackle the shooter, take away his weapon, and hold him until the police arrive.”  It is easy to envision a terrifyingly chaotic situation in which many would be wounded or killed attempting to storm a heavily armed assailant (often wearing various forms of body armor) with no real appreciation for the destructive power of an assault rifle being wielded by an irrational person who probably sees his own death as the anticipated end of his attack (whether by his own hand or in some variation of “suicide by cop”).  

Goldberg says reading that recommendation and the others is “depressing because they reflect a denial of reality.”  He further charges that “encouraging learned helplessness is morally corrupt.”  (Of course, on September 11, this was the very plan adopted by the 40 passengers [or at least several of them] on United Airlines Flight 93. Unfortunately, all of the passengers as well as the four highjackers were killed when the jetliner crashed.)

Economic constraints are certain to make school boards or other decision-makers choose what to apportion, and to which schools, regarding school security.  At a forum held in January at a hotel in Melville, New York (and covered in CommackPatch), more than 90 school officials met to discuss suggestions to either establish new security plans or improve existing ones .

“The strategies we adopt must be scalable, must be sustainable, must be flexible and must be cost-effective within the resources we have,” Michael Balboni, former New York state deputy secretary for public safety, told the meeting.  “There are fiscal realities to our school systems.”

But, others stressed, the Sandy Hook incident has made it imperative that the budget and a program for the protection of students be handled in such a way that the latter gives every appearance of effectiveness and money well spent, even if everyone dreads the thought of the occasion when it would have to impede an armed intruder.

“If you haven’t done a safety audit in quite some time, now is the time to do it,” said Tom Rogers, superintendent of Nassau County BOCES (Boards of Cooperative Educational Services).

Others at the meeting, including a school safety officer, Don Flynn, formerly of the New York City Police Department, and David Antar, President of a security company that has provided safety instruction and drills for school staffs as well as suggestions for establishing safety perimeters around school buildings.

Flynn stressed centralized surveillance monitoring, which could be established through “funding streams that exist through the state from BOCES” and would allow cooperation with local police, who would have access to cameras and floor plan layouts, for faster response to an emergency, or even the power to lock building doors electronically and sound duress alarms.

Across the country from Long Island, in Coeur d’Alene, Indiana, Tammy Fuller, Principal of East Farms Elementary school, who made note of how the Connecticut killings affected school districts all over America, said that she and neighboring school officials are “now analyzing what we do and what we should do, always thinking about what if.”

According to the Spokane Spokesman-Review, the Coeur d’Alene School District, having evaluated the security program in its schools, was requesting increased funding from the board for a wide variety of protective measures.

Among them were perimeter fencing, metal detectors for all school entrance points, bulletproof glass, video surveillance, key cards for building access, and more school resource officers—though there was no mention of arming them, as there was west of the Washington state border in Spokane.

In New Jersey, four days after the killings in Connecticut, state Education Commissioner Christopher D. Cerf, sent a letter to public, non-public and charter school administrators, outlining the State’s mandated security drills and crisis literature, including School Safety and Security Plans, Minimum Requirements, issued in 2011.

Monthly school security drills, he stated, are by statute.  Additionally, schools “are required to hold a minimum of two of each of the following security drills annually:  active shooter; non-fire evacuation; bomb threat; and lockdown.”  Another requirement is for schools to invite local law enforcement to observe these drills.

School Safety and Security Plans, Minimum Requirements is a 20-page guide that begins by explaining that all school districts in the state must have a school safety and security plan, of local design and aided by law enforcement, emergency management, public health officials “and all other key stakeholders.”

There are eight sections, each listing a set of requirements in a left-hand column and corresponding resources and guidance in the right-hand column.  Constant references are made to School Safety and Security Manual:  Best Practice Guidelines.

This is a revised edition of a 212-page report, School Safety Manual:  Best Practice Guidelines, issued by the state’s Department of Education in September 2004.  It was ostensibly produced in response to the September 11, 2001 attacks on New York City and Washington D.C. but contains extensive material on securing school safety.

Securing a school is largely a mechanical process which, in the case of an armed attacker, must be designed to confront highly irrational human behavior at its worst. As pointed out above, while some advocate finding out why particular people want to exert violence on the defenseless, it is the job of security professionals to prevent the evil plans of such people from coming to fruition.

“Although we cannot prevent all crises and acts of violence from occurring in our schools,” Cerf wrote in his letter to the state’s school administrators, “we

can work toward reducing the risk and minimize the harmful effects through continued coordinated planning, preparing, training and exercising.”

Budgetary constraints, bureaucratic “red tape” and philosophical differences of opinion are everyday impediments to the rapid implementation of all types of well-meaning programs.  However, school safety programs are not the same as health care, taxes or highway maintenance.        The formulation, deployment and maintenance of effective safety plans for individual schools, school districts, colleges and universities cannot fall victim to such delays since those who carry out these horrific attacks operate well outside the rules of civilized society and every day rational people debate what should be done is one more day for the irrational among us to cause yet more heartbreak and sorrow on a catastrophic scale.

Agency scientists and officials have maintained a years-long dispute about review procedures that the scientists have deemed faulty.  Scientists assert that questionable reviews have resulted in grants of approval for medical imaging devices used in mammograms and colonoscopies, thereby exposing patients to perilous levels of radiation.  

The Times report said the FDA used “spy” software initially to obtain screen images from the laptops of five agency scientists working in their offices and at home.  Keystrokes were tracked, personal email intercepted, documents copied from the scientists’ flash drives and personal messages read as they were being drafted, Lichtblau and Shane said.  

Wider surveillance yielded letters to Congressional offices and oversight committees, legal filing drafts and emails back and forth.  The operation was handled by a private contractor hired by the FDA, which evidently blundered when it later posted much of the material on a public Web site, a move that, among other things, allowed the Times to review it closely and at length.  The site was taken down in July, a day before the article was published.

A January 2011 article in the Washington Post first revealed the monitoring program. Current and former FDA scientists filed a lawsuit against the agency in September 2011, when they discovered that dozens of their emails had been intercepted and four of those scientists had been dismissed.  With implications of the wide range of the FDA’s surveillance program quickly transpiring, the FDA issued a memo explaining that the original five scientists’ emails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.”  The agency further insisted that while the Congressional recipients of the emails and those it called other “actors” were in league with the scientists to generate negative publicity, they were never FDA surveillance targets, even though they were suspected of having received confidential information.  

The Times article said that even with federal agencies’ power to monitor employees’ computer use, the FDA might have behaved illegally by seizing confidential information protected by law—which would include attorney-client exchanges, complaints to Congress by “whistle-blowers” and workplace grievances filed with the
Government. Expressing its concern about the situation, the White House Office of Management and Budget issued a memo this past June that deferred to the agency’s power of internal monitoring but deplored any attempt to intimidate whistle-blowers or otherwise interfere with “employees’ use of appropriate channels to disclose wrongdoing.”

Dismissed FDA scientists allege in one of the lawsuits that intimidation and interference were exactly what the FDA practiced in retaliation to the criticisms they made about the agency; particularly about its medical reviews.  The Times article said that Stephen Kohn, the attorney representing six scientists who are suing the FDA, was seeking an injunction in federal court to end any surveillance that might be conducted against two medical researchers still in the agency’s employ.  Within the documents that have already been made public there is no indication either that the FDA surveillance program is still going on or has been discontinued.

The Times could and did refer to a case and an article that might have led the FDA to initiate its surveillance program.  In March 2010, the paper published an article revealing the concerns of two FDA scientists about the safety of two imaging devices submitted to the agency by GE Healthcare for approval.  The two scientists, Dr. Robert C. Smith and Dr. Julian Nicholas, were later the subject of heavy surveillance, and Dr. Smith was identified in an agency memo as a “point man” for disgruntled scientists, since he wrote hundreds of emails advising them how to make their complaints known.

Attorneys for GE Healthcare said the Times article included proprietary information about the imaging devices, which may have been leaked to the press.  The writer of the article, Gardiner Harris, later showed up high on the list of “media outlet actors” compiled by the FDA’s surveillance program monitors.  FDA officials went to the Department of Health and Human Services, hoping to get its Inspector General to seek a criminal investigation of that alleged leak.  The IG turned them down, saying there was no evidence of a crime and that “matters of public safety” are legal material for the media.  That setback probably led to initiation of the surveillance program.

Dr. Smith’s “point man” status soon did him in.  That same year, 2010, FDA monitors read emails that said several agency scientists were drafting a complaint they were going to take to the Office of Special Counsel.  Before they could, Dr. Smith and another scientist were dismissed and a third person was suspended.  At another time, the captured emails indicated that Paul T. Hardy, formerly a dissident employee but by then no longer with the FDA, had reapplied for a job there.  He was described as “being considered for a position,” but he did not get it.  Among the items pulled from his emails was one about possibly getting in contact with the people from Frontline, the Public Broadcasting System’s documentary program.

When the whole surveillance presentation was mistakenly put on a public Web site, it first of all defeated the efforts of GE Healthcare and other companies to keep proprietary information secret, since such information was extensively discussed in the myriad documents created by both the insurgent employees and the defense-minded.
 
Eventually, perhaps inevitably, it led to the employees’ discovery of the site.  A researcher, making Google searches for the involved scientists, was tracking instances of negative publicity that might impinge on their chances of finding post-FDA employment.  Soon, like Balboa beholding the Pacific, he was looking at the agency’s surveillance program.

“I couldn’t believe what I was seeing,” he told the Times, while requesting anonymity because of his own job search.  “I thought,” ‘Oh my God, everything is out there. It’s all about us.’ It was just outrageous.”

At one time, writing about a dangerous prescription drug was an infrequent occurrence. Today, however, it has become difficult to keep up with the negative publicity generated by the seemingly unending list of unsafe drugs. In fact, a review of current online postings from various law firms engaged in pharmaceutical products litigation reveals well over 250 different drugs currently being investigated or actually involved in ongoing litigation.

Amazingly, between 1997 and the end of 2011, in the U.S. alone, 34 prescription drugs as well as numerous over-the-counter medications have been withdrawn from the market. In addition to this large number of outright withdrawals, dozens of other dangerous drugs have managed to stay on the U.S. market only because the Food and Drug Administration (“FDA”) has seen fit to require the manufacturers to include black box (the strongest and most serious) warnings in the drugs’ informational materials. Of course, those warnings, no matter how ominous, often go unheeded by the people taking the drugs much the same way as cigarette-package warnings are regularly ignored. There are also many dangerous drugs that have been withdrawn from the market in other countries (Avandia – withdrawn in Europe) that remain available in the U.S.

Approximately 20% of the prescription drugs that find their way to market have serious side effects that do not show up until long after they are approved. This unenviable record primarily results from two serious flaws in the “fast track” or “accelerated” approval process currently favored by the FDA, namely, the lack of longitudinal (long-term) testing and the use of small test groups that do not represent a true sample of the range of patients likely to take a particular drug.

For this reason, the public watchdog organization, Public Citizen, strongly recommends consumers follow its “Seven Year Rule” by not taking any potentially dangerous prescription drug until it has been safely marketed for 7 years. Most drugs pulled from the market do not even survive for 5 years and some even fail within two years of being approved.

Gradually, the FDA has gone from a guardian of the public’s safety to a conflict-ridden agency that, time after time, acts as little more than a “rubber stamp” for the drug manufacturers by prematurely approving dangerous drugs, failing to enforce post-approval reporting requirements, and delaying (or avoiding) ordering a drug off the market.

One reason the FDA is now viewed in such an anti-consumer light is because it has opted to accept huge sums of money from the pharmaceutical industry to fund the agency’s Approval Division which now favors “fast tracking” drugs to market when that is probably the last thing that should be happening with prescription drugs. Unfortunately, post-approval monitoring of adverse reactions and side effects receives far less funding and has only a fraction of the personnel allocated to the approval process. Fast-track approvals, which are usually based on short-term testing of small test groups, have had disastrous results when used for drugs which are specifically designed for long-term or lifetime use by large segments of the population.

As a result of the “rush-to-market” approach, it is now only a question of “when” and not “if” a suspect drug will fail and, when it does, the failure is, more often then not, catastrophic since it affects the public-at-large and not a small group of test subjects who

Zithromax has now fallen into the category of drugs that, because of over-expanded permissible applications or inadequate post-marketing testing, fall outside of any acceptable risk/benefit analysis. In short, it is being used for too many conditions and by too great a segment of the population. The drug was never intended for such widespread use.

Zithromax (Pfizer) was approved by the FDA in June 1996 for the treatment of Mycobacterium avium complex (MAC) in subjects with advanced HIV infection. At that time, Zithromax was to be taken in a once-weekly 1200 mg dose (two 600 mg tablets). Clinical trials found that “prophylaxis with once-weekly Zithromax reduced the risk of developing MAC bacteria in the bloodstream” as well as the clinical signs and symptoms associated with it.

Of course, even in the early 1990s, when Zithromax was being tested, advanced HIV infection was the precursor to AIDS which is 100% fatal (regardless of how long that takes to occur). Accordingly, the “risk/benefit” analysis was a no-brainer. (Even today, there is no “cure” for HIV/AIDS).

Risk/benefit, in short, is the analytical standard whereby a drug’s potential benefit is weighed against its potential risks. Thus, a drug that effectively treats a 100% fatal disease would be of great benefit and, as a result, a potential risk of 20 deaths per 1,000 users (1/50 or 2%) would be regarded as acceptable. However, a drug that treats toenail fungus but which may prove fatal to one out of every 10,000 users (1/10,000 or .01%) would not be seen as being worth the risk.

Unfortunately, that very logical standard, which was once a critical factor in the decision making process as to whether a drug was approved or not, has been seriously compromised and drugs with comparatively minimal benefits, or designed to treat relatively minor conditions, are frequently approved despite very serious potential risks or side effects.

Zithromax was originally developed as a treatment for people with advanced HIV infection and was shown to be effective in reducing the risk of developing disseminated MAC in two randomized, double-blind trials using people with advanced HIV infection. In fact, in one of the studies, Zithromax was compared to rifabutin as well as to the combination of the two. The finding was that there was a statistically significant difference in favor of Zithromax and the Zithromax-rifabutin combination therapy was more effective than rifabutin alone.

In addition, the “overall” side effects associated with Zithromax were primarily believed to be mild to moderate in nature consisting primarily of diarrhea, nausea, abdominal pain, and loose stools.

However, through the years, Zithromax (and levofloxacin) gradually became accepted as a treatment for a wide range of bacterial infections and by 2010, over 48 million yearly prescriptions for azithromycin and over 9 million for levofloxacin were written. In fact, many of these millions of prescriptions were (and are) written pointlessly for viral (as opposed to bacterial) infections, for which azithromycin, levofloxacin and other antibiotics are of no benefit. Moreover, while azithromycin (and levofloxacin) can be effective in some cases, there are many safer options for the treatment of bacterial infections. Zithromax was even approved for children.

Azithromycin is now used to treat bacterial infections, such as bronchitis, pneumonia, sexually transmitted diseases (STDs), and ear, lung, skin, and throat infections.

As far back as 2001, however, the Zithromax label was updated to include warnings about potential liver damage.  Since Zithromax is a very strong antibiotic and, as with all “macrolides,” is eliminated from the body through the liver, the potential for liver damage and liver failure is significant. The warning states that abnormal liver function, jaundice, necrosis, hepatic failure and death have been reported.

Significantly, Pfizer actually began receiving reports of liver damage associated with Zithromax as early as 1996.  Many of those reports noted the liver damage linked to Zithromax was severe and sometimes fatal.  However, it was not until 2000 (and only after an FDA directive) that Pfizer warned the public about these reports.

On May 17, 2012, the FDA notified healthcare professionals of the study published in the New England Journal Medicine that day (http://www.nejm.org/doi/full/10.1056/NEJMoa1003833) that reported an increase in cardiovascular deaths, and in the risk of death from any cause, in patients treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. (levofloxacin [LEVAQUIN] was also included in the study report).

The study showed azithromycin to be associated with cardiovascular effects; specifically, prolongation of the QT interval. The study was based on an examination of the medical records of 3.5 million Tennessee Medicaid patients. The analysis showed that those who took azithromycin (commonly dispensed in a five-day “Z-pak”) were almost 300% more likely to die from cardiovascular causes, such as sudden cardiac death, during the five days of therapy than those who took no antibiotics and 250% more likely to die from cardiovascular causes than those who took amoxicillin (AMOXIL). In real numbers, there were 47 to 245 more cardiovascular deaths for every 1 million patients than those who were treated with amoxicillin. The highest risks were in Zithromax patients with existing heart problems.

As a result of the study, many major law firms involved in mass-tort as well as pharmaceutical products litigation have launched their own investigations into whether to pursue claims for damages resulting from injuries associated with Zithromax. Those damages would likely include past and future pain and suffering, wrongful death, medical expenses, lost earnings, medical monitoring, and past and future medical expenses.

Some important lessons to take away from the Zithromax story are: (1) the FDA is not always on the side of the consumer; (2) the pharmaceutical industry is hardly in the business of worrying about the damage done by dangerous prescription drugs as long as profits outpace liability awards and settlements; (3) the longer a drug remains on the market, the more likely it is that it will be granted application to a broader range of conditions as well as to more segments of the general population. (Of course, if the drug turns out to be dangerous or defective, this means that more people will be injured or killed by it); (4) the FDA is more likely to opt for Black Box warnings than it is to order a drug pulled from the market (A close corollary to #1, above); (5) the “Seven Year Rule” is quite sensible and, if followed, would probably prevent a great deal of suffering and death; and (6) drugs, unlike fine wines, do not get better with age. Thus, if they start out with problems, the problems will only get worse, and worse, and worse…

Zithromax side effects can be reported to the FDA’s MedWatch Adverse Event Reporting program at http://www.fda.gov/Safety/MedWatch or 1-800-332-1088.

Balancing a checkbook, comprehending newspaper articles, and calculating the cost of gas are just a few tasks that many college seniors cannot handle, according to the American Institutes for Research. The study analyzed the competency level of 1,827 individuals attending 2- and 4-year colleges. Researchers administered the National Assessment of Adult Literacy to collect the data, which revealed that over 75% of 2-year college students and 50% of 4-year college students are incapable of completing everyday tasks.

These tasks range from straightforward to complex, and fall into three categories: reading comprehension, critical thinking and analysis, and practical mathematics. Most participants easily carried out simple activities such as utilizing a map or consulting a nutrition label. The latter category –which includes calculating restaurant tips, utility bills, order totals, and supply costs – yielded more surprising results. About 20% of students in 4-year schools demonstrated only basic mathematical ability, while a steeper 30% of community college students could not progress past elementary arithmetic.

Several behavioral and social science experts express deep concern for this rising adult generation. Though many study subjects have already graduated with a degree or intend to do so, Joni Finney, Vice President of the National Center for Public Policy and Higher Education, says that “states have no idea about the knowledge and skills of their college graduates.” Study director Stephane Baldi takes a similar stance. “It is kind of disturbing that a lot of folks are graduating with a degree and they’re not going to be able to do these things,” he explains.

A positive correlation was found, however, among course rigor and study results, notably in research tasks such as finding specific information in textual resources. Students who took part in interactive, communications-based classes showed a greater understanding of debates and op-ed pieces. When compared to adults at the same education level, these students displayed exceptional skill at applying theoretical concepts to real-world situations.

But they remain outside of the main body of students considered in the study, even in the post-college climate. NBC News reported that Fortune 500 companies shell out $3 billion annually to train employees in “basic English.” Sending workers to “remedial business writing classes” was common practice at Valor, a former telecommunications company that merged in 2006.

Finney and Baldi view the recent study as a profound glimpse into the weaknesses of higher education. Both hope that data will inspire government and university officials to raise graduation requirements and make intellectual rigor the new standard.

Did you ever think a hospital’s surgical team would use dirty equipment when operating on a patient? John Harrison didn’t think so. When he went to The Methodist Hospital in Houston in 2009 for routine rotator cuff surgery, he did not expect to come out of it with a dangerous infection that would lead to more surgeries and a lawsuit.

According to iwatchnews.org, “Harrison was one of at least seven joint surgery patients at Methodist who acquired dangerous infections during a two-week period.”

During the first few weeks after the surgery, Harrison’s scar turned bright red and had a liquid oozing from it that was “like butter squeezed from a bag,” John’s wife, Laura, told the hospital.

Initially, John thought it may have been his fault – maybe he didn’t treat the wound correctly. However, after the seven hour drive to Houston, the hospital came to the conclusion that the infection ate away at his shoulder bone. The metal pieces the surgeons installed into the shoulder had become loose and “sutures had come undone.”

After repairs were made to Harrison’s shoulder and antibiotics were given to fight the infection, the Center for Disease Control (CDC) was called in to assess the situation – especially since Harrison was not the only patient at the hospital to encounter this problem.

During their investigation, the CDC came across two tools used during the surgery that seemed to have caused the infection – an arthroscopic shaver (to trim bone and tissue) and an inflow/outflow cannula (for irrigation and suction). The instruments, themselves, worked properly, the problem was due to the fact that they were not cleaned thoroughly enough.

It was reported that tap water was used to “clean” the instruments.

According to “The Care and Handling of Surgical Instruments,” an information packet from Pfiedler Enterprises, “Decontamination can be done manually, mechanically or with a combination of both methods. It typically involves the use of a chemical cleaning solution.”

In this professional syllabus, Pfiedler provides a step-by-step guide to proper cleaning and maintenance of all surgical instruments. It states that mechanical cleaning is the preferred method, however, “some instruments cannot tolerate mechanical cleaning and will need to be manually cleaned.”

Regardless of whether mechanical or manual cleaning is done, there are a number of chemical cleaning products that need to be used during the decontamination process to ensure that the instruments are not just visibly clean.

Many of these cleaning solutions are used to eliminate microscopic residue that may be left on the equipment after a surgical procedure is performed.

According to the iwatchnews.org report, “human tissue and bone were stuck in both devices,” and a cleaning brush’s bristle was also found in the shaver.

A 2011 article written by Dr. Pritish Tosh, a former investigator at the Centers for Disease Control and Prevention Epidemic Intelligence Service, stated, “Evidence from the investigation suggests the Methodist infection outbreak was most likely caused by retained tissue…”

NBC News Chief Medical Editor, Dr. Nancy Snyderman, noted that the people responsible for cleaning and sterilizing the surgical instruments are not technicians, but rather paid-by-the-hour laborers.

New Jersey is the only state that requires hospital sterilization workers to undergo training.

The Center for Public Integrity (CPI) in Washington, D.C. reported that those workers feel that they are pressured to do their job quickly in order to get patients in and out of “surgical suites” faster. However, the cons of that method seem to outweigh the pros.

Granted, even simple procedures can have unforeseen complications, however, too many patients like John Harrison find themselves in potentially dangerous situations that could have been prevented. More regulations are needed from the government to make sure hospitals are sterilizing surgical equipment in the best way possible to reduce the risk of post-surgery infections and other complications.

I – The Statins

Although more people worldwide suffer from high cholesterol than ever before, the problem has reached epidemic proportions in the United States. Fast food, junk food, exceptionally large portions, poor eating habits, misleading or inadequate labeling, and lack of exercise, among other things, have produced the highest percentage of overweight Americans in history. Morbidly obese men, women, and even children are no longer oddities, they are commonplace. In addition, many foods now contain high amounts of saturated fat and/or trans fatty acids.

Trans fatty acids are found in many foods such as packaged cookies, crackers, and snacks, commercially fried fast food, vegetable shortening, and some margarine. Packaged goods containing “partially-hydrogenated vegetable oils” or “shortening” probably contain trans fats, too.

Before the advent of trans fatty acids, foods were cooked in or with lard, palm oil, butter, or other substances high in saturated fats. Saturated fats increase low-density lipoprotein (LDL), which is commonly referred to simply as “bad” cholesterol and are associated with an increased risk of heart disease. As a result, manufacturers and restaurants started using vegetable oils in their food production. Since liquid vegetable oils are not stable to heat and spoil easily, the process of “hydrogenation” is used to stabilize the liquid oils in food production and to increase their shelf life. The process of hydrogenation causes the formation of trans fatty acids.

Unfortunately, it has been discovered that trans fatty acids also increase LDL (bad) cholesterol and lower the high-density lipoproteins (HDL or good) cholesterol and, thus, also create an increased risk of heart disease. There have been some studies that have shown a diet high in trans fatty acids may also be linked to a greater risk of Type 2 Diabetes.

Untreated levels of high LDL cholesterol are therefore a very serious public health problem which is associated with a number of serious medical problems – some of which are life-threatening.
Not surprisingly, pharmaceutical manufacturers quickly discovered that there was a vast market for prescription drugs that would help lower cholesterol. This has led to the development of several cholesterol medications. Some of these drugs are better than others, some are safe than others, and some even have beneficial secondary effects. Others, however, are extremely dangerous and all of them need to be carefully monitored.

The medications which are currently available fall into a number of categories or classes. These include (chemical names – the brand names will be given in the actual discussion of each drug):

• Resins (cholestyramine, colesevelam, and colestipol)

• Fibrates (bezafibrate, clofibrate, penofibrate, and gemfibrozil)

• Statins (atorvastatin, fluvastatin, itavastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin)

• Niacin

The statins consist of eight brand name drugs in seven sub-categories. Mevacor, Altocor, and Advicor (lovastatin), Pravachol (pravastatin), Zocor (simvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Crestor (rosuvastatin), and Baycol (cerivastatin) (withdrawn from the market in August 2001).
Many people, especially those with high cholesterol, have come to see all cholesterol as a “bad,” yet cholesterol is needed to form important hormones and perform other vital cell functions. The truly “bad” cholesterol is known as low-density lipoprotein (LDL) and it clogs arteries. “Good” cholesterol, or high-density lipoprotein (HDL), however, works like a drain cleaner for arteries.

Statin drugs work by inhibiting HMG CoA, an enzyme that enables the liver to make cholesterol. When the liver cannot produce its own cholesterol, it removes it from the blood. This causes blood levels of cholesterol to fall which, in turn, decreases the risk of clogged arteries. Statins are designed to reduce LDL levels. Yet, for many people, their HDL levels can rise while taking a statin drug.
For all the good they were supposed to do, statin drugs have been quite problematic for those taking them. While some side effects of statins are mild, they have been responsible for causing severe muscle breakdown known as rhabdomyolysis, liver disorder, kidney failure, and death.

Of the seven statins mentioned above, the worst of the lot are Baycol and Crestor. Baycol was removed from the market in August of 2001 and Crestor may soon be on its way to the prescription drug graveyard since it has already gained the reputation of being “new but more dangerous.”

Baycol

Although this drug has been removed from the market, it was taken by millions of people for significant periods of time.
Baycol, a statin drug manufactured by Bayer and GlaxoSmithKline, is currently the only cholesterol-lowering drug to be withdrawn from the market because of adverse effects. On August 8, 2001, the Bayer Pharmaceutical Division announced Baycol was being removed from the U.S. market because of reports of an adverse reaction of rhabdomyolysis (rhabdo). Unfortunately, by that point at least 6 million people worldwide had taken the drug.

Rhabdomyolysis is a muscle disease which causes kidney injury. It is categorized by the destruction of muscle cells that are subsequently released into the bloodstream. Symptoms of rhabdo include isolated or generalized muscle pain, weakness, tenderness, fatigue, malaise, fever, dark urine, nausea, and vomiting.
All drugs in the statin group have been linked to reports of rhabdo, but Baycol has been responsible for more fatal cases of the muscle disease. Before taking Baycol off the market, the U.S. Food and Drug Administration (FDA) received reports of more than 50 rhabdo-related deaths among Baycol users worldwide. The fatal cases primarily involved elderly patients, interactions with other prescription drugs, and higher dosages. Even after the drug was finally removed, fatalities continued to climb to more than 100.

After Baycol was pulled off the market, numerous lawsuits were filed by people injured by the drug. 3,500 lawsuits were filed and 2,825 claims were settled for a total of $1.08 billion. During that litigation, it was discovered that Bayer and GlaxoSmithKline knew of the harmful effects of Baycol before its release in 1997. In fact, memos from Bayer’s safety officials in 1999 revealed that its staff was struggling to respond to the growing number of patients who developed rhabdo. While the risk of rhabdo was described in the drug’s warning label, Bayer may not have conducted an appropriate amount of research to determine just how severe the risk was and what was necessary to prevent this risk from becoming fatal. In order to avoid having to report negative data to the FDA, Bayer did not do a sufficient amount of testing regarding the higher dosage, 0.8mg pills.

The Baycol situation is disturbing for several reasons. It serves as a reminder that drugs are often rushed to market (“fast tracked”) without adequate testing and research. In fact, the majority of drugs that are recalled are recalled within their first 5 years on the market. This proves that longitudinal testing is often absent and therefore long-term effects of certain drugs are never revealed until it is too late. (The recent Vioxx debacle is another example of this serious problem). Even in situations where drugs are properly tested, there is no guarantee that negative results will force a manufacturer to withdraw it from the market. Many drugs are being released and kept on the market despite evidence of serious side effects. Such decisions are usually motivated by financial considerations since a successful drug can often generation billions of dollars in annual revenue.

Crestor

Crestor, another statin drug, seemed to have been following in Baycol’s footsteps. However, it remains on the market. After reports of kidney damage and muscle weakness, a precursor to rhabdo, AstraZeneca abruptly stopped ongoing clinical trials for Crestor involving patients taking 80 milligrams per day. Crestor has been listed by Public Citizen as a “DO NOT USE” drug because, like Lipitor and Lescor, it has not demonstrated a significant health benefit in terms of lowering cholesterol and minimizing the risk of heart attack or stroke. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, has gone on record as stating: “It becomes clearer by the day that this drug is uniquely toxic but offers no unique benefit, and must be removed from the market.”

AstraZeneca, however, countered the medical and scientific evidence of the drug’s dangers with an expensive direct to consumer marketing campaign featuring actor Patrick Stewart (Captain Jean-Luc Picard of Star Trek: The Next Generation). Thus, Crestor, like all too many other dangerous drugs, remains a “cash cow” because of creative marketing and not because it is a safe and effective treatment for the medical condition it was designed to alleviate.

Crestor has been labeled particularly dangerous because of the threat of kidney toxicity in addition to rhabdo, a relatively common side effect connected to statin usage. Unlike other statins, however, Crestor causes abnormal elevations in urine protein and blood, both of which are indicators of severe kidney toxicity. While other statins have been responsible for sporadic cases of rhabdo, Crestor is the only statin that has revealed the potential for life-threatening rhabdo development prior to FDA approval. As reported in PharmaLive: “The FDA had evidence before approving the cholesterol drug Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration), yet the agency approved it anyway, erroneously believing that this toxicity was limited to an 80 milligram dose that was not ultimately approved.”

The warning label for all statin drugs, including Crestor, indicates that liver function tests are recommended both before and 12 weeks after beginning treatment or changing dosage. Periodic tests are recommended for as long as treatment continues. Rhabdo is also mentioned as a rare side effect as is acute renal failure. Rare or not, however, these side effects need to be taken seriously as they are potentially fatal.

Public Citizen’s Health Research Group believes that the FDA should have required routine urine testing for Crestor patients taking both available dosages as this would have revealed traces of protein, an indicator of kidney problems. In a letter to the FDA dated October 29, 2004, the organization has petitioned for the drug to be taken off the market. (Public Citizen made a similar petition in March, 2003).

As of now, regular urine testing is only required for people who have diabetes or are pregnant. Urine testing is just one way in which treatment should be continually and closely monitored. Ongoing monitoring by a physician is perhaps the only way to catch serious medical problems before they become fatal.

Cases of serious Crestor-related side effects began surfacing even before the drug was released on the global market. (As reported in PharmaLive: “The rate of reports of kidney failure or damage among patients taking the cholesterol drug Crestor is 75 times higher than in all patients taking all other statins, according to a Public Citizen analysis of government data.”) The reports of 65 Crestor-related cases of rhabdomyolysis in the United States is a rate approaching that of Baycol which was taken off the market for that very reason. As a result, two major U.S. insurance companies, WellPoint, and Group Health Cooperative of Puget Sound, have refused to reimburse for Crestor citing Baycol as a precursor.

Pravachol and Lipitor

Pravachol, another member of the statin family manufactured by Bristol-Meyers Squibb, has been connected to rhabdo as well as liver and kidney problems. Other side effects include difficulty breathing, closing of the throat, swelling of the face, hives, decreased urine or rust-colored urine, blurred vision, gas, bloating, nausea, heartburn, abdominal pain, constipation, diarrhea, coughing, headache, and insomnia. Any of these side effects can be indicators for more serious health problems.

Lipitor, manufactured by Pfizer, is one of the well-known statins and is widely advertised on television and in periodicals. Warning labels for Lipitor indicate the risk for rhabdo and kidney failure as the two most serious side effects with gas, constipation, heartburn, and stomach pain as the less serious side effects. Lipitor, like all statins, is not recommended for use by pregnant women or people with pre-existing liver problems.

In a study comparing the benefits of Pravachol and Lipitor, Pravachol proved to be inferior. In those patients taking Pravachol, arthrosclerosis worsened during the 18-month treatment period. Despite these findings, however, Pravachol is still being prescribed to patients looking to lower their cholesterol.

Dr. Steven Nissen, an eminent cardiologist at the Cleveland Clinic who directed the study of 502 patients, said that while he had changed his practices based on the findings of the study, he would not force his decision on any of his colleagues and leave them to make their own minds up. However, if a uniform system for prescription drug distribution by physicians is not adopted, some conscientious doctors may choose to stop prescribing a drug which has been deemed harmful while others may continue to promote it.

Pravachol should not be taken by anyone with liver disease. It also should not be used to lower high cholesterol that stems from medical conditions such as alcoholism, poorly controlled diabetes, an under active thyroid, or kidney problems. Pravachol may have significant interactions with other drugs such as: Questran, Tagamet, Colestid, Cardizem, Dilacor, Tiazac, Sandimmune, Neoral, Erythromycin, Lopid, Sopranox, Niacor, Niaspan, and Coumadin.

There is also some suspicion that Pravachol may cause birth defects and so it should not be taken by pregnant women. It should also not be prescribed to women who are breastfeeding.

Lipitor should not be taken by anyone with liver disease, during pregnancy, or while breastfeeding. Serious drug interactions may occur if Lipitor is taken with: Antacids such as Maalox TC Suspension, Atromid-S, Colestid, Sandimmune, Neoral, Digoxin, Lanoxin, immune system suppressors, Erythromycin, Tricor, Diflucan, Lopid, Sporanox, Nizoral, Niaspan, Niacor, Slo-Niacin, and oral contraceptives.

Zocor

Although Zocor, also known as simvastatin, was not recalled for its potentially fatal issues, the FDA has put additional warnings out for the product. The FDA recommends “that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity.” Zocor, which is marketed by Merck, has become one of the more popular statins as it is widely advertised on television and in periodicals.

While some side effects such as pain or weakness, liver complications, and harmful drug interactions do exist, Zocor is promoted as being “a cholesterol medication proven to significantly reduce the risk of heart attack and stroke in people with heart disease or diabetes – regardless of cholesterol level.” This may be one benefit to Zocor but new dangers were discovered in 2002.

In July of 2002, Merck was forced to revise the warning label for Zocor to include information about the potential risk for developing myopathy and rhabdo from taking the drug alone or in combination with other medicines. Again, this is a persistent problem for all statins and while some may have benefits that seem to place them at a level above the rest, the risk for these muscle illnesses should not be overlooked. A spokesperson for Merck said that the new FDA-required warning adds clarity but does not change the pre-established safety and “efficacy” of Zocor.

Zocor should be discontinued before major surgical procedures. Its interaction with certain other drugs must be carefully monitored. For example: Zocor tends to enhance he effects of Coumadin and Lanoxin. It also increases the chance of muscle damage when combined with: Cordarone, Biaxin, Atromid-S, Sandimmune, Neoral, Erythromycin, Tricor, Lopid, Sporanox, Nizoral, Serzone, Niaspan, Protease inhibitors (used in treatment of HIV), Calan. Zocor may also cause serious problems when combined with significant quantities of grapefruit juice. Zocor should be avoided by women who are pregnant or breastfeeding.

Lescol

Lescol is available in standard capsules and extended-release tablets (Lescol XL). As with all statins, liver damage is a possibility. Thus, liver enzyme levels should be tested on a regular basis. Signs of damage to muscle tissue should also be reported immediately. Serious drug interactions may occur when Lescol is taken with: Questran, Tagamet, Atromid-S, Sandimmune, Neoral, Voltaren, Lanoxin, Lanoxicaps, Erythromycin, Lopid, Micronase, Niaspan, Prilosec, Dilantin, Zantac, and Rifadin. Lescol should not be taken by women who are pregnant or breastfeeding.

Lovastatin (Altocor, Mevacor, and Advicor)

These three drugs are essentially the same. Mevacor is the “standard” form of lovastatin, Altocor is an extended-release form of the drug, and Advicor is Mevacor combined with extended-release Niacin.

Again, since the various forms of lovastatin are members of the statin class of drugs, liver and muscle tissue damage are possible side effects. Women who are pregnant or breastfeeding should avoid the drug as should those with liver disease. Altocor is not recommended for people below the age of 20. Advicor is not recommended for children. Mevacor may be prescribed for children between 10 and 17 but only if introduced in intervals of 4 weeks or more and in girls who have been menstruating for at least one year. The safety and effectiveness of Mevacor has not been studied in children under 10 or in children of any age in doses larger than 40 milligrams per day.

Lovastatin taken with large quantities of grapefruit juice may cause serious problems and should not be combined with certain other drugs such as: Antipyrine, Coumadin, Dicumarol, Tagamret, Diflucan, Blaxin, Sandimmune, Neoral, Erythromycin, Lopid, HIV protease inhibitors, Sporanox, Nizoral, Aldactone, Serzone, Niaspan, Niacor, Calan, and Verelan.

Statins, as a group of drugs, are often an acceptable solution for people who have undergone a long and arduous battle with cholesterol maintenance. Although the drugs do have potentially serious side effects, such problems are usually avoidable with careful medical monitoring and by patients being thoroughly aware of the warning signs associated with those side effects. Patient awareness cannot be overemphasized. The key is for all patients taking any of the statins to ask questions, read the product information, be aware of potential drug and food interactions, follow dosage and other instructions carefully, and make every effort to follow a proper and healthy diet and exercise plan. We also strongly urge all potential statin users to avoid the more risky drugs such as Crestor and Pravachol.

In addition to the aforementioned side effects relating to specific statins, the following information should be taken into account as it relates to most or all statins.

• Statin drugs such as Lipitor, Zocor, Pravachol, Crestor, Lescol, Mevacor, and Baycol may be linked to birth defects. These drugs may cause severe central nervous system defects and limb deformities when used within the first trimester of pregnancy. These are the types of problems which can be expected when the embryo does not get enough cholesterol during the early stages of pregnancy.

• Young people are specifically at risk for developing ailments associated with the statins as the drugs’ effects on that age group are not yet well understood. Patients age 45 and under have been the least studied age group in terms of statin use. Statins have been prescribed to younger men and women in response to the growing realization that high cholesterol early in life can lead to life-threatening cardiovascular consequences later on.

• Statins can cause nerve damage, or polyneuropathy, in extremely rare circumstances. A Danish physician noticed this side effect in 14 statin patients. This has not been listed as a primary side effect because of its rarity.

• Statins have been linked to memory loss following the outcome of a study at University of California at San Diego. Cholesterol, which is related to heart disease, is also an essential organic molecule in the brain. Some researchers have postulated that if cholesterol production is blocked, such as when statins enter the body, it can interfere with the brain’s performance and cause memory loss. Risk factors of memory problems are heart disease and stroke. More research is being conducted on this matter.

• One very vocal lung cancer sufferer believes his long-term use of Lipitor played a role in his development of that disease. He has carefully analyzed animal testing data which suggests that the statins may be the most carcinogenic drugs ever approved for wide scale human consumption. (Significantly, lab animals were exposed to dosages on the order of those prescribed to humans). He also claims that this grave side effect has been “missed” because it is so long-term, possibly up to 20 years. His story and links to additional material relating to the cancer study can be found at http://www.captainclark.com?Pages/lipitorhorror.html.

Many of the statin drug labels were updated as of February 28, 2012. The changes include topics, such as: monitoring liver enzymes, adverse event information, drug interactions, and more. Details on the label changes can be found at http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm

II – The Non-Statins

Three other categories of cholesterol-lowering medications are fibrates, resins, and niacin (nicatonic acid). The fibrate group includes the drugs Bezalip, Atromid-S, Tricor, and Lopid. The resins are Cholybar, Questran, and Prevalite. Niacin based medications include Advicor, Niacor, Niaspan, Nicobid, and Nicolar.

In addition to these three categories of drugs, there are two new cholesterol medications on the market. These drugs are Zetia and Vytorin.

All cholesterol-lowering drugs are intended to supplement a healthy lifestyle of proper diet and exercise. They should never be seen as a means by which to continue (or start) poor eating habits or other problematic behavior.

FIBRATES

The cholesterol drugs known as fibrates lower LDL (“bad”) cholesterol and triglycerides while raising HDL (“good”) cholesterol. They achieve this result by inhibiting; (a) the liver’s production of proteins containing fat and cholesterol; and (b) the release of triglycerides from fat stores in the body. Generally, all of the fibrates act in a similar manner. It is important to know, however, that the severity of the side effects varies widely from one fibrate to another.

Lopid (gemfibrozil)

Lopid is used to help people who have had little success in lowering their cholesterol through diet and exercise alone as well as to reduce the risk of heart disease. Common side effects associated with Lopid include; abdominal pain, acute appendicitis, constipation, diarrhea, eczema, fatigue, headache, indigestion, nausea/vomiting, rash, and vertigo. Rare side effects have included; anemia, blood disorders, blurred vision, confusion, convulsions, decreased male fertility, decreased sex drive, depression, dizziness, fainting, hives, impotence, inflammation of the colon, irregular heartbeat, itching, joint pain, laryngeal swelling, muscle disease, muscle pain, muscle weakness, painful extremities, sleepiness, tingling sensation, weight loss, and yellow eyes and skin. Before taking Lopid, you should speak with your physician about the possibility that the drug may cause malignancy, gallbladder disease, abdominal pain leading to appendectomy, or other potentially fatal abdominal disorders.

Lopid should never be combined with any of the statin drugs as the combination can possibly cause serious muscle-wasting side effects. Blood-thinning drugs such as Coumadin should also be avoided while taking Lopid and anyone beginning treatment for high cholesterol with Lopid should consult their physician to find out about any other potentially harmful drug interactions.

The recommended dosage of Lopid is 2 doses of 600mg taken 30 minutes before breakfast and dinner. Lopid is not approved for use in children and should be used carefully by older adults. If you are experiencing sudden abdominal cramps, diarrhea, joint and muscle pain, nausea or vomiting, you may be having symptoms of an overdose and should seek medical help immediately.

Tricor (fenofibrate)

Tricor, or Lofibra, is used to lower triglyceride levels. Common side effects of Tricor include abdominal pain, headache, and various respiratory disorders. Less common side effects include constipation, diarrhea, flu-like symptoms, nausea, runny nose, and general weakness. Perhaps the most serious side effect is the rare, but possible, development of rhabdomyolysis, the muscle-wasting disease also associated with statins. Tricor also has the potential to cause gallstones and may affect liver function negatively.

Sometimes Tricor will be prescribed with other cholesterol lowering drugs, specifically in the resin group. If this is the case, always take Tricor at least 1 hour before or 4 to 6 hours after taking the other drug. Tricor should always be taken with meals and is not recommended for use by children or nursing mothers.

The dosage for Tricor depends on the level of cholesterol and triglycerides but usually, the initial dosage is 160mg per day which is also the maximum dosage. The initial dosage for Lofibra, however, is usually only 67mg per day with a maximum daily dosage of about 200mg.

Bezalip (bezafibrate)

Before beginning treatment with Bezalip, make sure to tell your doctor if you currently have or have ever had kidney or liver problems, or gallbladder disease (with or without gallstones). Women who are pregnant or breastfeeding should not take Bezalip.

Side effects associated with Bezalip include anemia, loss of appetite, unexplained bleeding, tendency to bruise more easily, cholestasis, dizziness, feelings of fullness, fever, gallstones, being more prone to infection, hair loss, headache, hypersensitivity reaction including angiodema, itchy skin, muscle weakness (potentially leading to rhabdo), myopathy, nausea, photosensitivity, sexual dysfunction, and sore throat.

Bezalip may interact negatively with hypoglycemics, insulin and sulphonylureas, MAOI inhibitors, warfarin (Coumadin) and other blood thinners, oral contraceptives, and, most notably, statins and resins.

Atromid-S (clofibrate)

The lipid-lowering agent Atromid-S works just like other fibrates yet it has been linked to more serious side effects. Although the most common side effect is nausea, there is a remarkably lengthy list of less common side effects, including; vomiting, loose stools, dyspepsia, flatulence, abdominal distress, headache, dizziness, fatigue, muscle pain, skin rash, dry brittle hair, alopecia, increased or decreased angina, cardiac arrhythmias, allergic reactions including urticaria, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, gallstones, hepatomegaly, gastritis, anemia, impotence and decreased libido, renal dysfunction, myalgia, rhabdo, and weight gain.

Pregnant and nursing women should not take Atromid-S. It is also not recommended for patients who have had clinically significant hepatic or renal dysfunction.

The extensive list of side effects relating to Atromid-S (as opposed to the other fibrates) is particularly problematic as it poses some sort of hazard to almost every part of, or system in, the body. As a result, both the doctor and the patient should be convinced that Atromid-S is, indeed, the right choice before a treatment regimen is commenced.

RESINS

Resins, otherwise called bile acid sequestrants, help to reduce high levels of bad cholesterol by binding with cholesterol-containing bile acids found in the intestines. By doing this, resins prevent the bile from being reabsorbed before it is eliminated by the body. The liver, which normally makes bile out of cholesterol, can then produce a replacement supply of bile acids and take the extra cholesterol out of the bloodstream. These medications lower LDL-cholesterol levels by about 10 to 20 percent but do not specifically lower triglyceride levels. Thus, resins are often used in combination with other cholesterol-lowering drugs.

Questran (cholestyramine)

Questran is prescribed to lower LDL levels in the blood as well as to relieve itching associated with gallbladder obstruction. It is also available in a less-potent form known as Questran Light. Questran prescribed in powder form, should never be taken dry. It should always be mixed with water or another liquid, applesauce, or crushed fruits.

The most common side effect associated with Questran is constipation. People with a history of constipation are often discouraged from using Questran. Less common or rare side effects include; abdominal discomfort, anemia, anxiety, arthritis, asthma, backache, belching, black stools, bleeding gums, blood in the urine, brittle bones, dental cavities, diarrhea, difficulty swallowing, dizziness, drowsiness, fainting, fatigue, fluid retention, gas, headache, heartburn, hiccups, hives, increased sex drive, increased tendency to bleed, inflammation of eye or pancreas, irritation around anal area or skin and tongue, joint pain, lack or loss of appetite, muscle pain, nausea, night blindness, painful or difficult urination, rash, rectal bleeding and/or pain, ringing in the ears, shortness of breath, sour taste, swollen glands, tingling sensations, ulcer attack, vertigo, vomiting, weight gain or loss, wheezing and vitamins A, D, E and K deficiencies.

People with phenylketonuria (an inherited disease characterized by inability to oxidize a metabolic product of phenylalanine and by severe mental deficiency — abbreviation PK) should be sure to check with their physician before taking Questran Light as it contains phenylalanine. Anyone taking drugs that may raise cholesterol levels or being treated for any disease contributing to increased blood cholesterol such as hypothyroidism, diabetes, nephritic syndrome, dysproteinemia, obstructive liver disease, or alcoholism should be especially careful when taking Questran.

Questran should not be taken in conjunction with hormones, oral diabetes drugs, Phenobarbital, thyroid medication such as Synthroid, and warfarin (Coumadin) amongst others. Consult your physician if you are taking any other medication prior to beginning treatment with Questran.

Welchol (colesevelam)

Welchol can be prescribed alone or in conjunction with statin drugs such as Lipitor or Zocor to help lower cholesterol. It should always be taken at mealtime with some kind of liquid unless your physician instructs you otherwise.

Side effects associated with Welchol include constipation, indigestion, muscle aches, sore throat, and weakness. If you have a bowel obstruction, have difficulty swallowing, or suffer from severe digestive problems, you should not take Welchol. There are no significant food or drug interactions pertaining to Welchol.

Colestid (colestipol)

Colestid can be prescribed in granule or tablet form. The granules must be mixed with liquids such as flavored drinks, milk, orange juice, pineapple juice, tomato juice, or water. Although carbonated beverages may also be used, they may sometimes cause stomach or intestinal discomfort. If Colestid granules are accidentally inhaled they may cause serious effects and thus should never be taken in their dry form.

The most common side effects associated with Colestid are constipation and worsening of hemorrhoids. Less common side effects include abdominal bloating or distention/cramping/pain, aches and pains in arms and legs, angina (crushing chest pain), anxiety, arthritis, backache, belching, bleeding hemorrhoids, blood in stool, bone pain, chest pain, diarrhea, dizziness, drowsiness, fatigue, gas, headache, heartburn, hives, indigestion, insomnia, joint pain, light-headedness, loose stools, loss of appetite, migraine, muscle pain, nausea, rapid heartbeat, rash, shortness of breath, sinus headache, skin inflammation, swelling of hands or feet, vertigo, vomiting, and weakness.

People with diseases that may cause increased blood cholesterol, such as underactive thyroid gland, diabetes, nephritic syndrome, dysproteinemia, obstructive liver disease and alcoholism should not take Colestid before consulting a physician. Colestid may cause or worsen constipation and therefore anyone who should avoid aggravated constipation, such as those with coronary artery disease or severe hemorrhoids, should talk to their physician before taking the drug. When Colestid is taken with other drugs including folic acid, certain vitamins, Hydrocortizone, Penicillin G, and the fibrate Lopid it may have negative interactions.

NIACIN (Nicatonic Acid)

The cholesterol drugs in the niacin group are Niacor, Niaspan, Nicobid, Nicolar, Slonacin, and Advicor which is a combination of nicatonic acid and Lovostatin. While the aforementioned drugs have virtually the same effect, they fall into three different categories: immediate release, timed release, and extended release. Niacin, otherwise known as the vitamin B3, has been proven to help lower cholesterol levels when taken in high dosages. It works by inhibiting the liver’s production of fat and cholesterol containing proteins.

General side effects for nicatonic acid include flushing or hot flashes, nausea, indigestion, gas, vomiting, diarrhea and activation of peptic ulcers. Flushing can be accompanied by dizziness, fainting, heartbeat irregularities, chills, hives, itchiness, shortness of breath, or swelling. Taking aspirin or a nonsteroidal anti-inflammatory medication (NSAID) such as Motrin or Aleve 30 minutes before taking Niaspan can help minimize flushing.

If you are taking a form of niacin, you must follow the instructions very carefully since many unpleasant side effects will result from not doing so. You must take the drug with food and avoid taking it with any warm or hot liquid. It must be taken in high dosages to be effective so most physicians recommend a gradual increase in the dosage until the maximum is reached. A sudden jolt of large doses of niacin may trigger some very unpleasant and even dangerous reactions.

Although things like hot flashes and hives sound relatively harmless, many people are made so uncomfortable they are unable to take massive doses of niacin. Imagine being at work, at an important meeting, or in a movie theater when you suddenly break out in hives, feel as if you are burning up, and become so itchy that you begin scratching yourself until you bleed. You might also feel so lightheaded or dizzy that you become disoriented and unable to stand. While none of this is life-threatening, it can be so unpleasant that repeating it on a daily basis is simply unacceptable. Sometimes, a patient will develop a tolerance for niacin after several days or weeks. Most people who suffer these side effects, however, never reach that point and simply give up on the therapy.

Advicor

Advicor is a combination of extended-release niacin and lovostatin, or Mevacor. Common side effects include; abdominal pain, back pain, diarrhea, flu-like symptoms, flushing, headache, high blood sugar, indigestion, infection, itching, muscle pain, nausea, pain, rash, vomiting, and weakness.

There is, however, an even longer list of less-common side effects including various allergic reactions, anxiety, chest pain, chills, constipation, darkening of skin color, decreased sex drive, difficulty sleeping, dizziness, dry mouth, dry skin, enlarged breasts in men, eye irritation, fainting, gas, general feeling of unwellness, gout, hair loss, heartbeat irregularities, hives, inflammation of pancreas, impotence, joint pain, liver disorders, loss of appetite, low blood pressure, memory loss, mental changes, migraine, muscle cramps, muscle disorders, nerve disorders, runny nose, shortness of breath, skin and nail changes, sweating, swelling, tingling, tremor, ulcers, vertigo, vision disorders, and yellowing of skin and eyes.

You should not take Advicor if you have liver disease, an ulcer, or arterial bleeding. It should be taken at bedtime with food, specifically a low-fat snack unless you are instructed otherwise by your physician.

Drugs that may interact negatively with Advicor are: Antifungal drugs such as Sporanox and Nizoral, blood pressure medications, cholesterol-lowering fibrates such as Lopid and Atromid, Erythromycin (E.E.S., Erythrocin), HIV protease inhibitors such as Viracept and Norvir, Nefazodone (Serzone), Nitroglycerin, Nutritional supplements containing niacin or nicotinamide, and warfarin (Coumadin).

Niacor is the extended-release version of Advicor.

Niaspan

Niaspan can be taken in conjunction with drugs from the resin group as well as the statin group to achieve lower LDL-cholesterol levels when diet and exercise have failed. Side effects associated with Niaspan include abdominal pain, hot flashes, chills, diarrhea, dizziness, fainting, flushing, headache, indigestion, hives and itching, nasal inflammation, nausea, pain, rapid heartbeat, rash, shortness of breath, sweating, swelling due to fluid retention, and vomiting.

As is the case with other niacin-based drugs, Niaspan can be hazardous for people with diabetes, heart conditions, or problems with gout. If you experience a change in blood-sugar levels while on Niaspan, tell your physician immediately. Preexisting kidney and liver problems or weaknesses can lead to complications with Niacin as well.

Since niacin therapy is essentially taking a vitamin in large doses, overdosing with drugs such as Niaspan has occurred. An excessive amount of Niacin is more than 2,000 milligrams a day. This can cause liver damage and stomach ulcers. Other signs of long-term overdose could be nausea, vomiting, abdominal cramps, faintness, and yellowish skin and eyes.

Slo-Niacin is the extended release form of the drug.

A NEWER CATEGORY

Since drugs designed to lower LDL-cholesterol levels and triglycerides have become increasingly popular, pharmaceutical companies are always seeking to cash in on the trend by developing new alternatives. One of the problems with the existing cholesterol remedies is that, more often than not, the bad outweighs the good. The possibility of trading high cholesterol for kidney or liver disease is an unpleasant choice that is made every day by people taking many of the drugs we have been discussing.

In the past year, however, two new cholesterol medications have been approved which might prove to be better options once all the results are in. Of course, in the unpredictable world of prescription drugs, they might also turn out to be more dangerous.

Zetia (ezetimibe)

Schering-Plough pharmaceuticals developed the non-statin Zetia in hopes of competing with the current cholesterol drug leader, Lipitor. Zetia works slightly differently from statins by reducing the absorption of bad cholesterol in the digestive tract. While Zetia can be prescribed on its own, it is often prescribed in conjunction with a statin for optimal results.

Common side effects for Zetia are abdominal or back pain, diarrhea, joint pain, and sinusitis. Rare side effects include coughing, fatigue, sore throat, sexual dysfunction and viral infection. These minor side effects are similar to those associated with the other cholesterol lowering agents. More severe problems such as liver damage and serious muscle pain are also under investigation.

The recommended dose for Zetia is 10mg per day. Zetia should never be combined with any of the fibrates such as Lopid and Tricor but it can be taken with resins such as Colestid, Questran, or WelChol.

Vytorin

Following Zetia’s approval, Merck and Schering-Plough launched Vytorin, a combination of exetimibe, the active ingredient in Zetia, and simvastatin, the chemical found in Zocor. Vytorin was approved on July 23, 2004. Vytorin’s approval coincided with the guidelines issued by The National Cholesterol Education Program which indicated that now more Americans need cholesterol-lowering medications than previously thought.

The starting dose of Vytorin is 10mg of Zetia and 10mf of Zocor. Side effects include allergic reactions including rash, inflammation of the pancreas, nausea, headache, dizziness, gallstones, inflammation of the gallbladder, and swelling of the face, lips, tongue, and or throat that may cause difficulty in breathing. The risk of muscle breakdown, a precursor to rhabdo, does exist with Vytorin and is categorized by muscle pain, tenderness or weakness. If you are experiencing any unexplained muscle pain while taking Vytorin, consult your physician immediately.

Those with liver problems or liver disease as well as any women who are pregnant or may become pregnant should not take Vytorin.

At present, Vytorin seems to be the safest existing solution for management of cholesterol and triglyceride levels. It is the first drug to reduce LDL-cholesterol by inhibiting cholesterol production in the liver as well as cholesterol absorption in the intestine. (This process is known as Dual Inhibition.) Bassem El-Masri, a cardiologist and cholesterol researcher at Cornell Weill Medical School believes that Vytorin will allow doctors to treat heart disease forcefully without worrying as much about safety.

Currently, no cholesterol drug is without potentially serious side effects which may ultimately do more damage than the condition they are intended to treat. Ideally, these drugs should have beneficial side effects such as raising “good” cholesterol levels or preventing heart attacks. Unfortunately, that is not yet the case.

Thus, before beginning any type of drug regimen for high cholesterol, make sure to get all of the facts from your physician to be sure that you are selecting the medication that is best (or least risky) for you. The wide range of existing options provides some flexibility to those in need of such treatment. However, most medical experts continue to stress the fact that lifestyle modifications with respect to diet and exercise are the single most important “regimen” for the reduction of cholesterol levels.

How often should you clean out your medicine cabinet? Beth Israel Medical Center’s Clinical Pharmacy Manager, Dr. Elizabeth Palillo, says, “Once a year.” If you want prescription medications to work as expected, dispose of the expired ones. The antibiotics you were prescribed six months ago? Ditch them. Yes, even if you saved the last one “just in case.”

Products that can get easily contaminated – eye drops and liquid medications you may drink straight from the bottle – should get thrown out after three months. Do you still have sunscreen left from last summer? Throw it out and purchase a new bottle. “Sunscreens degrade after being exposed to heat,” Palillo states. Spending a few extra dollars once each year is worth not getting dangerously and even fatally ill.

Tin cans are your go-to container for disposing of medications. Place the pills and liquid medications in the can (make sure it comes with a sealable cover). Combine the meds with a “non-edible” substance. Common suggestions are powder detergents and kitty litter. Put the lid back onto the tin can and, for extra security, seal it with duct tape, gaff tape, or another industrial tape. Then, it is safe to put the whole can into the garbage.

Remember not to flush the medications, since it can be harmful to the environment. Narcotics and painkillers are considered the exception to that rule. Dr. Palillo says, “We advise you to flush those because of the potential for them to be found in the trash and abused.”

First Aide products are important to have access to at all times. Replenishing those supplies is a must. This includes:

• an antihistamine
• different sized bandages
• first aid ointment
• fever reducer

It is also very important to keep your local Poison Control Center’s Number with your medications. Having your doctor and pharmacy’s phone numbers on hand is also a good idea.

Storage is important as well. Contrary to popular belief, the medicine cabinet in your bathroom is not a safest place at all for your medications. “Too much heat and steam,” says Palillo. Safer options include a shelf in your kitchen or a desk drawer. Be sure to choose a place that is out of a child’s reach.

Remember: Spring cleaning doesn’t just mean dusting your furniture. Getting rid of old and unnecessary medications and restocking on essentials are just as important.

By Marty Grossman –

The health risks associated with smoking and the use of tobacco in any form are no secret. Over the past several years, the news has gotten progressively worse with respect to the number and severity of those risks. Additional studies and surveys indicate the problems created by smoking are potentially far more serious than previously believed.

I. Researchers from the University of California Davis previously reported online, in BMC Cancer, that exposure to tobacco smoke may actually be causing a much greater proportion of cancer deaths than previously estimated.

Using data from the National Center for Health Statistics, the researchers examined cancer mortality rates among men living in Massachusetts from 1979 to 2003 and found there was a close correlation in changes in death rates from lung cancer and other cancers suggesting that the fraction of all cancer deaths attributable to smoking was 73%. The researchers said the study findings were strengthened because of the inclusion of all non-lung cancers, the use of sizeable, representative, and recent male populations, and the use of age-adjusted death rates.

Previously, a 2001 government estimate based on data from the Cancer Prevention Study II, placed the fraction at 34%, according to Dr. Bruce Leistikow, who headed the study.”

The full impact of tobacco smoke, including secondhand smoke, have been overlooked in the rush to examine such potential cancer factors as diet and environmental contaminants,” Dr. Leistikow said. “As it turns out, much of the answer was probably smoking all along.”

Previous estimates of the impact of smoke exposure on cancer death have traditionally been made using methods that are not universally applicable across population subgroups and that rely almost exclusively on self-reported smoking measures. Here, the researchers used a simpler, more representative, and less biased method for assessing the impact that involved examining the associations between mortality rates for lung and all other cancers.

The data analyzed by the researchers suggest “that tobacco smoke load is a potential cause of most prematurely fatal cancers in this population.” The findings infer that the percentage of all cancer deaths attributable to tobacco smoke exposure was 73% for all men and 74% for men ages 30 to 74.

II. Over the past several years, the significant health risks associated with exposure to second-hand smoke have become widely accepted, especially with respect to children.  It appears, however, that youngsters living in, or frequenting, environments where smoking is common may also be at risk for what is now being labeled as “third-hand smoke,” which is the term being applied to toxins left on surfaces once tobacco smoke has dissipated.

These toxins can remain for hours and, sometimes, days on clothing, carpets, blankets, and many other objects. Taking precautions, such as smoking outside, to keep others out of direct contact with cigarette smoke, are proving to be less effective than previously thought.

According to a 2010 study, the residue, alone, can produce compounds that cause cancer. This is especially true of the residue left on indoor items.

The research leader, Hugo Destaillats, at Lawrence Berkeley National Laboratory in California, stated, “Certain compounds – such as ambient nitrous acid or nitrogen dioxide – are present in higher quantities indoors rather than outdoors.”

According to Jonathan Winickoff, M.D., of the Massachusetts General Hospital for Children and his colleagues in an issue of Pediatrics, these residual toxins are particularly hazardous to children who breathe near the surfaces, crawl and play on them, or touch and mouth them.

Winickoff and his team’s conclusion that the potential risks posed by third-hand smoke are lesser known to the general public is based on the results of a nationally representative survey that examined beliefs about second-hand and third-hand smoke and behavioral responses derived from those beliefs.

In November of 2005, the annual Social Climate Survey of Tobacco Control was given to 1,478 adults. An analysis of the data found:

• 18.9% of respondents were current smokers.
• 15.6% of the sample reported a smoker living in the home.
• 8.4% of nonsmokers lived with a smoker.
• 25.6% of the homes surveyed had at least one smoker.
• 93% of the respondents thought second-hand smoke was dangerous to children, including 95.4% of nonsmokers and 84.1% of smokers.
• Only 61% of those surveyed thought third-hand smoke was hazardous, including 65.2% of non-smokers and 43.3% of smokers.
• Those who did not smoke were three times more likely to ban smoking in the home than those who smoked (88.4% to 26.7%).
• There was an independent association between the belief that third-hand smoke harms children and a strict home smoking ban.

Since tobacco smoke within a home will dissipate throughout the enclosed environment, the toxins left behind are deposited on every surface and are also found in loose household dust. The toxins include volatile compounds that will, themselves, release gas into the air, according to the researchers.

The researchers labeled this residual tobacco smoke contamination “third-hand smoke” and their study is the first to examine the concept in relation to home smoking bans. They believe their findings have a possible clinical implication and concluded: “Emphasizing that third-hand smoke harms the health of children may be an important element in encouraging home smoking bans.” Moreover, “health messages about third-hand smoke contamination could be easily incorporated into current tobacco control campaigns, programs, and routine clinical practice.”

III. In a meta-analysis of 106 observational studies (published in the Dec. 17, 2008 issue of the Journal of the American Medical Association), a research team in Milan, Italy, under Edoardo Botteri, M.Sc. of the European Institute of Oncology, concluded that smoking is associated with development of colorectal cancer and the likelihood of dying from it.

In the analysis, individuals who had smoked at some point in their lives were 18% more likely to develop colorectal cancer than those who had never smoked and, in a further analysis of 17 studies, those who had smoked were 25% more likely to die from colorectal cancer than those who had never smoked.  The researchers stated:  “We believe that smoking represents an important factor to consider when deciding on the age at which colorectal cancer screening should begin either by lowering the age in smokers or increasing the age in non-smokers.”

These same researchers previously found that smoking nearly doubles the risk of adenomatous colorectal polyps, which are precursors to colorectal cancer. (Other studies – see IV, below − have demonstrated colorectal cancer occurs at a younger age in smokers).

In reaching their conclusions, the researchers identified 106 studies addressing the relationship between smoking and occurrence of colorectal cancer and 17 studies looking at mortality from the disease. In the pooled data from 39,779 cases of colorectal cancer, the researchers found that smoking was associated with an increase from 54.7 to 65.5 cases per 100,000 person-years and the risk was increased by 7.8% for every additional 10 cigarettes smoked per day and by 4.4% for every additional 10 pack-years. Although longer duration of smoking also increased the risk, the relationship only became statistically significant after 30 years.

In terms of mortality, smoking was associated with an increase from 35.3 deaths per 100,000 person-years to 41.3. Every additional 10 cigarettes smoked per day increased the risk of mortality by 7.4% in those who had ever smoked and by 10.6% in those who currently smoked. The risk of death increased linearly by 9.5% for every additional 10 years of smoking.

For both occurrence and mortality, the risks were greater for cancer of the rectum than of the colon. Not surprisingly, two large studies − the Cancer Prevention Study II and the Nurses’ Health Study – indicated that individuals who had quit smoking were less likely to die from colorectal cancer than current smokers.

IV. In a related analysis, Luke J. Peppone, Ph.D., of the University of Rochester, and colleagues at the Roswell Park Cancer Institute in Buffalo reported online, in the Journal of Cancer Research and Clinical Oncology, that smokers, and those with a history of exposure to second-hand smoke, should be screened for colon cancer before age 50, because they are likely to develop the disease years earlier than nonsmokers.

In the retrospective analysis of more than 3,500 patients over 40 years, the researchers found current smokers were diagnosed with the disease an average of 6.8 years earlier than those who had never smoked (age 57.4 for smokers versus 64.2 for never-smokers). Patients who had never smoked but had been exposed to secondhand smoke in the past, e.g., growing up in a house in which their parents smoked, were an average of 8.6 years younger at colon cancer diagnosis than never-smokers without that exposure. Those with both current and past secondhand smoke exposure were an average of 11.6 years younger at diagnosis.

As a result of these findings, the researchers stated:  ”The implication of this finding is that screening for colorectal cancer, which is now recommended to begin at age 50 years for average risk individuals, should be initiated five to 10 years earlier for persons with a significant lifetime history of exposure to tobacco smoke.” Currently, age and family history are the only factors considered when making recommendations for colon cancer screening despite the fact that past studies have shown environmental and lifestyle factors may also be factors in predicting risk.

The amount smoked and ages at diagnosis were also found to be related. Compared with never-smokers, patients who smoked less than a pack a day, one pack a day, and more than a pack a day were diagnosed an average of 2.9, 3.6, and 4.7 years earlier, respectively. In addition, the age at which a patient started smoking was found to be relevant. Compared with never-smokers, those who started smoking before they were 17 were diagnosed 4.8 years earlier, those 17 to 21 at smoking initiation, four years earlier, and those 22 or older when they started, 2.7 years earlier.

While these conclusions should be regarded with caution because of the existence of several variables (confounders) such as body mass index, race, meat consumption, vegetable intake, non-steroidal anti-inflammatory drug (NSAID) use, and family history. It is clear that smoking, or the exposure to second-hand smoke, are anything but positive influences on health.

V. Finally, researchers in England have reported in the Journal of Clinical Endocrinology and Metabolism that smoking cigarettes during pregnancy is associated with small but potentially harmful changes in thyroid function both in mothers and their offspring.

When the mother’s thyroid does not function at its best, the results may include birth defects, such as miscarriage, premature birth, a lower birth weight and neuropsychological issues of the baby.

According to a cohort study of 2,355 pregnant women, Bijay Vaidya, Ph.D., of Peninsula Medical School at Royal Devon and Exeter Hospital and colleagues, those who smoked had lower levels of serum thyrotropin (TSH) and higher levels of free triiodothyronine (FT3) than nonsmokers, and babies born to smokers in the study also had lower serum TSH in cord blood.

The team pointed out that the magnitude of the changes in the direction of hyperthyroidism was small and additional research is needed to see if these levels of change result in adverse effects, although evidence is increasing that even minor abnormalities in maternal thyroid hormone levels during pregnancy are associated with both maternal and fetal adverse outcomes. “Therefore, finding of factors, such as smoking, which may modulate thyroid hormone levels in pregnancy, is important,” they said.  “Although, the magnitude of the effect of smoking on thyroid function in our study was small, the smoking-related changes in the thyroid function extended to the fetus, suggesting these changes could have a biological impact on the fetus.”

While it is known that smoking lowers TSH levels in the general population and several studies have shown that smokers have higher serum levels of thyroxine (T4), triiodothyronine, or both, few studies have considered the potential effects of smoking on thyroid function in pregnant women and their fetuses. Thus, the team looked at thyroid hormone levels in two independent groups (1,428 women in their first trimester, and 927 women in their third trimester). The researchers also studied the relationship between maternal smoking and thyroid hormones in the cord blood of 618 full-term babies born to women in the third-trimester group.

The researchers found women who had stopped smoking because of the pregnancy had little difference in thyroid hormone levels than nonsmokers.  According to Dr. Vaidya and his team, that finding suggests these smoking-related changes in thyroid hormone levels are “rapidly reversible.”

CONCLUSION: Tobacco smoke is made up of several components and 20 carcinogens that are believed to produce tumors on the lungs of laboratory animals and humans. Consequently, these carcinogens are part of the reasons some lung cancers develop.

Also, it is more obvious than ever that tobacco smoke, whether it be first-, second-, or even third-hand, poses widespread, significant, and ever increasing health risks to a large segment of the population (smokers as well as non-smokers) and particularly to children. Accordingly, you should make every effort to stop smoking if you are already a smoker and avoid any environment in which smoking is permitted. You should be especially vigilant when it comes to safeguarding children from exposure to second-hand smoke or to the residual toxins produced when tobacco smoke dissipates (third-hand smoke).

By Justin Di Joseph –

Doctors are often called upon to treat violent criminals who have been wounded by the police. Public defenders are routinely assigned to represent people accused of horrendous crimes. Professionals who are committed to helping people must frequently perform their duties despite serious personal, moral, or religious conflicts. Most do so with the belief that any right to refuse care or services must take a back seat to the oaths they have taken as professionals. Some doctors, lawyers, and even religious observers, however, maintain that they have the right to conscientiously object to participating in certain situations, and their decisions are, for the most part, respected and permitted without penalties being imposed.

However, this concept has not been openly accepted when it comes to pharmacists who unilaterally decide to refuse to fill prescriptions for a number of drugs on moral grounds. For example, three pharmacists in Texas were fired for refusing to fill a rape victim’s prescription for emergency contraception, because they claimed to do so would violate their morals. In Wisconsin, a pharmacist refused to fill, or even transfer out, a similar prescription claiming he did not want to commit a sin. As a result, he was put on trial for violating Wisconsin’s state regulation and licensing department’s standards of care. After being disciplined for refusing to fill similar prescriptions, a group of Illinois pharmacists sued their employer for religious discrimination. Some feel they should have thought about these possible personal conflicts before getting into this profession and taking oaths.

Surprisingly, some pharmacists may accept religious objections when it comes to abortifacients, but not when it comes to Plan B (the emergency contraceptive).

Although these and other examples of pharmacists refusing to fill prescriptions have been widely publicized and have received more public attention than in the past since they involve the issue of contraception, there has been an ongoing ethical controversy as to whether such conscientious objections are proper when they result in patients with valid (and needed) prescriptions being turned away.

Contraceptives, however, are hardly the end of the discussion in terms of the types of drugs that have spurred controversy among pharmacists, professional organizations, and state law makers. Among the classes of drugs that have met with increased resistance from some pharmacists on moral, religious, and ethical grounds are those used for assisted suicide, euthanasia, and capital punishment as well as erectile dysfunction drugs for convicted sex offenders and HIV-positive patients.

There are claims that some pharmacists have even refused to fill prescriptions for psychotropic and pain medications because of moral objections, although there do not appear to be any documented cases of pharmacists refusing to fill legitimate prescriptions for these particular classes of drugs.

There are many pharmacists who support the “right” to refuse to dispense particular prescriptions on the basis of religious, moral, or ethical objections and claim that this is a personal choice that should not be questioned by fellow pharmacists, professional organizations, or state (or federal) lawmakers.

Recently, in Idaho, a Planned Parenthood nurse practitioner called in a prescription for Methergine^, which, according to its label, is commonly used “for the prevention and control of postpartum hemorrhage.” The Walgreens pharmacist told the nurse that she would not fill the prescription and asked the nurse if this drug was going to be used for post-abortion care. The nurse informed the pharmacist that she could not give her that information, due to health information confidentiality. When asked for a referral to a different pharmacy, the pharmacist hung up the phone with no response. Planned Parenthood of the Great Northwest (PPGNW) filed complaints against the Idaho State Board of Pharmacy and the pharmacist’s employer.

In the end, the Idaho legislature passed a law that, if their conscience is violated, health care providers (including pharmacists) are granted the right to refuse to provide services or dispense medications.

The underlying societal principles cited for the belief that this type of conscientious objections amount to a “right” are the pharmacists’ duty to do no harm (nonmaleficence) and professional autonomy. Nonmaleficence would encompass the belief that dispensing certain drugs has the ultimate result of causing harm to another human being including an unborn fetus, a death-row prisoner, a terminally ill patient, the potential sex partners of HIV-positive patients, or a victim of a known sex offender. Professional autonomy is an even more important rallying cry; however, since the pharmacists in question insist that all they are seeking is the same right accorded doctors, lawyers, and clergymen who are able to decline services for ethical reasons.

Of course, those who oppose such refusals rely on the argument that a professional oath imposes a duty on the practitioner that makes conscientious objection, itself, wrong and immoral. Thus, when a pharmacist is not prepared to dispense unrestricted care that is legally permitted, efficient, and beneficial because of personal beliefs, many would have such an individual penalized, disciplined, or removed from the profession.

If the medical profession and lawmaking authorities (such as the FDA) have determined that a drug, or class of drugs, is approved for legitimate uses, it should not be for individual pharmacists to impose their personal beliefs in such a way as to deny patients access to those drugs when they are legally prescribed.

There is also the important factor that most pharmacists, who operate outside of a clinic or hospital setting, do not have access to a patient’s complete medical records. This makes the pharmacist far less able to make critical clinical decisions that impact a patient’s health or medical situation. This is why the doctor prescribes the medicine – the doctor can view those medical records and make a choice of what medicine, if any, to prescribe to someone.

In addition, once outside of a major urban area where there are numerous pharmacies with multiple pharmacists, the issue of conscientious objection becomes far more problematic. In areas where there are few (or only one) pharmacies or pharmacists, it may be impossible for a patient with a serious, immediate medical problem find an alternative source for the drug that has been prescribed. Moreover, demographics being what they are make it inevitable that certain areas of the country will be far more likely to have a higher percentage of pharmacists with conscientious objections to dispensing certain drugs. In such areas, it may be virtually impossible to find a willing pharmacist in a medical emergency.

In summary, the following arguments are advanced by each side in this debate:

Pro-Conscientious Objection Arguments include: (1) pharmacists can and should exercise independent professional judgment; (2) professionals should not abandon their morals as a condition of employment; and (3) conscientious objection is fundamental to democracy.

Anti-Conscientious Objection Arguments include: (1) pharmacists have chosen to enter a profession governed by well-defined fiduciary duties; (2) emergency contraception is not an abortifacient; (3) pharmacists’ refusals to dispense medications significantly affect patients’ health; and (4) refusal has significant potential for abuse and discrimination.

In 2006, bills were introduced in 21 state legislatures to permit pharmacists to refuse to fill certain prescriptions. Although none of the proposals made it out of committee, supporters have not given up and vow to be back with new bills to be filed in upcoming legislative sessions. Currently, only four states (Arkansas, Georgia, Mississippi, and South Dakota) have laws that allow pharmacists to refuse to fill emergency contraception prescriptions. Four other states (Colorado, Florida, Maine, and Tennessee) have refusal laws that could encompass pharmacists’ refusal to fill prescriptions for contraceptives. Illinois passed an emergency rule in 2005 requiring a pharmacist to dispense contraception under a legitimate prescription. California pharmacists have a duty to dispense prescriptions and can refuse to dispense them only when their employer approves the refusal and the patient can still access the medication elsewhere in a timely manner.

Since it must be assumed that even the most committed conscientious objector would not want to harm a patient with a serious medical condition who is in need of a drug that has been legally prescribed by a licensed physician, there must be room to compromise on the issue in order to avoid serious consequences to innocent patients. To that end, pharmacists’ organizations, educators, medical ethicists, legislators, and medical professionals continue to seek acceptable standards that respect a pharmacist’s professional autonomy and individual beliefs while ensuring the rights of all patients to receive proper and timely medical care requiring the dispensing of prescription drugs.

The American Society of Health-System Pharmacists (ASHP) and other professional organizations have developed policies addressing the issue. ASHP recognizes a pharmacist’s right to decline to participate in therapies on moral, religious, or ethical grounds and supports the establishment of systems that accommodates these considerations while still protecting a patient’s right to obtain legally prescribed and medically indicated treatments.

Some options that have been proposed to avoid harm and inconvenience to patients while respecting the pharmacist’s conscientious objections include:

• Pharmacists totally opposed to dispensing certain drugs such as oral contraception or abortion, or those who know precisely in what circumstances they would object, should accept the additional ethical obligations of avoiding surprise to a patient with a refusal to provide medication and ameliorate the consequences if it happens by revealing the problem ahead of time and planning for referral (inside or outside the pharmacy). If an entire practice is opposed to dispensing certain medications, a notice to that effect should be posted in their place of practice and the intention to refuse should be communicated to local physicians. It would be unconscionable to simply wait silently and then surprise an unsuspecting and often vulnerable patient when the problem could have been avoided by appropriate procedures set up in advance.
• If a pharmacist’s objection is based on fact, science, and ethical reason, the pharmacist should act responsibly by confirming the facts, science, and ethics in each case and consulting with colleagues before acting. Again, care should be taken to minimize the insult, inconvenience, or injury caused by the refusal and alternative means for the patient to obtain the medication should be provided or made available.
• Government regulators should adopt procedures to review conscientious refusals that are similar to other kinds of professional regulation. Objectors should be prepared to account for their actions and to describe how they balanced their consciences against the possibility that a patient might be injured by their refusal to dispense medicine.

It must be remembered that when the dispensing of prescription drugs is involved, time is almost always of the essence. Thus, remedial or compromise measures that look to administrative proceedings (initiated by complaints, for example) as the means by which to address the issue, may not offer a satisfactory solution to what may be an immediate medical crisis.

For this reason, any pharmacist or pharmacy that has conscientious objections to filling prescriptions for any particular drug (or class of drugs) or for multiple classes of drugs used to treat different medical problems, should make every effort to put in place a notification system that provides advance warning and a workable referral system that leaves patients with an alternative means by which to obtain the needed medications.

Off-label promotion has become an ongoing issue over the past several years as pharmaceutical companies continue to violate government policies by advertising drugs for uses not approved by the FDA. Doctors remain able to prescribe drugs for off-label use based on their expertise; provided they are acting with the best interest of the patient in mind and there is sufficient evidence that suggests the benefits outweigh the risks.

Off-label prescribing occurs when a drug is used in a way for which it was not intended or as a therapy, cure, or treatment for one or more conditions for which it has not been approved. While this type of use can lead to a more expansive application of a successful drug, it can also cause a higher incidence of known side effects as well as unforeseen adverse reactions that can be quite serious − even deadly.

The off-label prescribing of drugs beyond the scope of their FDA approval 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. There is also the problem of off-label prescribing to age groups (infants, adolescents, and seniors) for which no, or insufficient, clinical data exists. At its worst, the practice can be downright deadly.

According to a 2011 article, Off-label indications (those not approved by the FDA) doubled from 1995 to 2008.

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

In a 2010 article, the consumer advocacy program, Public Citizen said Johnson & Johnson was responsible for paying $81 million in criminal and civil penalties for illegal off-label promotion of TOPAMAX.

Now, TOPAMAX and Johnson & Johnson find themselves in trouble again.

Originally developed by Ortho-McNeil – a subsidiary of Johnson & Johnson – TOPAMAX is an anti-epilepsy drug. In the past, TOPAMX has been illegally marketed for a variety of psychiatric conditions, including drug and alcohol dependency.

To make matters worse, the FDA recently found that TOPAMAX may lead to serious birth defects.

According to Worst Pills, Best Pills, women who used the drug during their first trimester were much more likely to give birth to a baby with cleft lip or cleft palate. With these conditions, parts of the lip or palate do not completely fuse together; leaving anything from a small notch in the lip to a large gap that can extend into the roof of the mouth or nose. The resulting defects can lead to problems with eating, talking, ear infections and appearance.

While these complications only arose in women taking TOPAMAX as an anti-epileptic, it should be noted that the same risks are likely to apply to women taking the drug for psychiatric disorders and other off-label uses.

A psychiatrist and whistleblower who was instrumental in blowing the lid on TOPAMAX in the first place, called it “outrageous that Ortho-McNeil would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patients’ health.”

The pharmaceutical companies will continue this behavior as long as the fines are marginal compared to the amount of money they stand to make from the illegal advertisement of the drug.

In addition to larger financial penalties, some groups are calling for stricter punishments and criminal charges for corporate officials involved in these cases.

In fact, Eric Blumberg, the chief litigator of the FDA has said that “…unless the government shows more resolve to criminally charge individuals – at all levels of the corporate hierarchy – … we can not expect to make progress in deterring… off-label promotion.”

The rise in illegal advertisement of drugs and subsequent penalties handed down from the federal government provides strong evidence that the multi-billion dollar pharmaceutical industry requires a high degree of governmental oversight, especially when those drugs have potentially serious side effects.