The new Personal Injury Protection (PIP) legislation being trumpeted by Rick Scott and Kevin McCarty (insurance commissioner) is simply a series of methods to attack a problem by saddling honest consumers with more regulation and less benefit. The claim is that the PIP system is so filled with fraud that more laws must be passed to combat it.

Let me say that I am opposed to fraud of any kind.

I believe that someone who actually commits a fraud should be prosecuted and punished.

I believe that people actually do stage accidents with the intent of profiting from it. Those people should be found and punished.

I suspect that, much like other professions, there are unscrupulous lawyers and doctors who may be involved in these types of fraudulent activities. Those professionals should be found and punished.

I do not believe that passing legislation that may have a chance to limit fraud, but also acts to limit innocent consumer rights while further increasing bottom line profits of insurance companies is the best way to fight fraud.

We do not need new laws on the books to police fraud in the insurance industry. What we need is aggressive enforcement of the already existing laws and an active investment in that enforcement by the industry that profits most – the insurance industry.

Florida’s politicians have done little to alter a fundamental problem with Florida’s regulation of insurance companies, which we have been writing about for years. Insurance companies in Florida have developed a strategy for tricking the system and limiting insurance coverage while maintaining high premium rates. The industry was successful in last year’s legislature by removing certain coverage from homeowner’s policies; while consumers received no corresponding consideration on the premium side.

This new proposed legislation requires that in order to be eligible for PIP to pay for medical treatment, the injured person must seek emergency medical care at an emergency care facility within 72 hours. First, not all injuries develop in a 72 hour window and, second, many honestly injured people try to “tough it out” for days and weeks before seeking medical treatment. For those honest people who have real injuries, but who have not run to the hospital within 72 hours, the insurance company is going to be permitted to deny PIP claims. So, who will pay for those bills?

Based upon a Florida Senate Bill Analysis, the following factors are set forth as the motivation for new legislation and a reduction in consumer rights:

• PIP payouts have increased from approximately $1.5 billion in 2008 to approximately $2.5 billion in 2010.
• From 2006 to 2010, the number of lawsuits pending at year-end increased by 387%, while the number of settlements increased 315%.
• Florida PIP claims involve approximately 100 medical treatments at an average total cost of $12,000, well above the national average excluding Florida of approximately 50 treatments at an average total cost of $8,000
• The PIP pure premium in Florida, which is the amount of premium needed to cover losses, has increased 50 percent, from just under $100 per car in the 4th quarter of 2008 to over $150 per car in the 3rd quarter of 2010 (the most recent period for which data was collected).
• The rise in PIP payouts and the corresponding increase in premium costs are occurring despite the fact that the number of crashes and crashes with injuries decreased from 2005 to 2009, according to the Department of Highway Safety and Motor Vehicles.

These bases for the new legislation ignore the following influential facts:

• PIP payouts increased by 40% in three years, but rising health care costs overall have increased those costs by as much as 10% to 28% without fraud.
• Lawsuits may have increased under PIP laws, but no lawsuit can be filed without a denial of full benefits by the insurance carrier. So, who is driving the increase? If these lawsuits have no merit, why are courts not sanctioning lawyers and parties under current frivolous lawsuit laws?
• Insurance companies and legislators can work to control the rising medical charges from physicians and hospitals by going to the source of those charges and without attacking consumers’ rights.
• Premiums for personal injury protection (PIP) coverage may very well have increased 50%, but what has the state done to examine the very suspect accounting practices used by insurance companies writing coverage in Florida?
• If health care clinic ownership is too easy to obtain and maintain, there already exists plenty of laws not being aggressively applied by state agencies. Those agencies are well equipped legally to police any charlatans who may operate sham facilities.
• If law enforcement officers are failing to identify all occupants of motor vehicles in crashes, provide them with methods to accomplish it. Allow videos of accident scenes and witnesses. Provide a technology solution for law enforcement officers to capture license and ID information at the scene.
• Create alliances between insurance companies and law enforcement to pursue and prosecute fraud. Require insurance companies to reactivate the “special investigation units” that most of them had in the 1970’s and 1980’s.

Without aggressively enforcing laws already on the books, I suggest it is most likely that those trying to defraud the system will simply adapt. They will take up the time and expense of emergency medical units to be shuttled directly to the hospital so they can make the 72 hour window and will find ways to work the new system. This will do nothing but increase overhead and time for emergency medical personnel and local governments.

Although this new legislation, if passed, might have some impact on fraud; it will do so at the cost of honest consumers. If government’s approach is to continue not enforcing laws already in existence, why should anyone believe that this new legislation will have any impact on fraud?

I think it is more likely, as with similar laws, defrauders and insurance companies will maintain or improve their bottom line profits; while honest consumers will be the ultimate losers.

Major risk factors for Type 2 diabetes include a lack of exercise, being overweight and making poor diet choices. Eating a hamburger served between doughnuts; a recipe for which Paula Deen is famous certainly fits into the “poor diet choice category.

Typically, when a celebrity reveals that he or she is battling a disease, the motivation for going public is to create awareness and maybe raise funds for research. Michael J. Fox and Parkinson’s, Magic Johnson and HIV and Lance Armstrong and testicular cancer all come to mind. These people created foundations, took control of their health and inspired others to have hope.

And then there’s celebrity chef Paula Deen. On Jan. 17, the 65-year-old announced that she has been living with Type 2 diabetes for three years. This disorder that usually strikes in adulthood is associated with insulin resistance that causes high glucose levels in the blood. Complications from diabetes include heart disease, stroke, blindness, circulatory problems and early death. According to the American Diabetes Association, 26.9 percent of Americans age 65 and older have diabetes. This is not a disease to be taken lightly and it is sad for anyone to develop this very serious disease.

So did Deen kick off an awareness campaign that might alert other people to their risk for developing the disease? Did she promise to overhaul her sauce filled recipes and the buttered-up message she puts out into the world?

No. On the Today show she dodged questions about her own diet, threw out some vague and worthless advice about practicing moderation, and then bragged about her new gig as spokeswoman for Danish firm Novo Nordisk’s injectable diabetes drug Victoza (Liraglutide).

A day later, under a mound of criticism after the Today interview, Deen announced that she would donate an undisclosed “certain percentage” of her income from Novo Nordisk to the American Diabetes Association.

Celebrity product endorsements are nothing new, but they’re more powerful than ever.

What would Nike Air tennis shoes be without Michael Jordan?

Do you believe that Weight Watchers works after watching Jennifer Hudson drop 80 pounds?

What would we call a George Foreman Grill without, well, George Foreman?

As a celebrity chef on the Food Network, Deen is positioned to make a significant impact, if she cared to do so. She has the ideal platform for inspiring Americans to change their diets, with two hit television shows and a huge audience. Were she to impart education about lifestyle choices and diabetes, she could tell thousands of viewers that in 2010, studies in the New England Journal of Medicine revealed that diabetes drugs don’t help patients avoid heart disease and that lifestyle changes, like diet and exercise, are far more effective in managing—and reversing—Type 2 diabetes.

[youtube]http://www.youtube.com/watch?v=zv8yEMRDe_w[/youtube]

Yet, where’s the payoff for Deen in that message? Victoza made $784 million for Novo Nordisk in the third quarter of 2011, and now she’ll get a piece of that despite the fact that she’s pushing a drug with a Food and Drug Administration warning about its likelihood to cause thyroid tumors and cancer.

Celebrities, modern-day demigods who wield much influence over the American masses, should be responsible for the products they endorse. Do you recall the 1950s ads with actor/six-pack-a-day smoker/lung cancer patient John Wayne touting the benefits of non-irritating “mild” Camel cigarettes that didn’t harm his voice? Didn’t we learn from that?

One person did. According to the New York Post, Nancy Assuncao quit her post as Deen’s publicist last month, citing her distaste for Deen’s deal with Novo Nordisk.

Before her announcement, Deen brushed aside rumors that she had diabetes for a few years, and said she didn’t go public so she could “figure things out in my own head” and that she wanted to “bring something to the table” when she revealed her condition. But what she brought to the table wasn’t a diabetes-fighting, low-cal, low-sugar, healthier version of her famous doughnut burger. Instead she has decided to hawk a diabetes drug that made its manufacturer, Novo Nordisk, $784 million just in the third quarter last year. Ms. Deen has decided to avoid how diabetes can be prevented and accept a pay check for promoting an answer that is akin to “closing the barn door after the horses have escaped”.

You have to wonder: Did Deen keep her diabetes under wraps to protect her reputation as the queen of fattening comfort food, or did she stay quiet until she inked her deal with Novo Nordisk? Either way, this is an irresponsible, uninspiring, disappointing move that hopefully won’t influence other stars to encourage their fans to hand over their lives to irresponsibility to be solved by drugs and the companies that make them.

When faced with a possible danger, how much of a warning do you need? As far as the Food and Drug Administration is concerned, your tolerance for risk is pretty high. And what about its responsibility for sounding the alarm? Eh, that can wait a while.

When picking up a prescription drug from your pharmacist, you usually receive a few sheets of paper detailing how to use the medication and its possible side effects. Some warnings don’t sound so bad—nausea, loss of appetite, drowsiness. But then there are more extreme warnings…suicidal tendencies, liver failure, heart attack or even death. The text of these stronger warnings is outlined with a black square. Hopefully your doctor or pharmacist will point it out.

Called “black box warnings,” this wording is printing on drug packaging inserts after a drug has shown, through medical studies, to be quite harmful—even deadly—and the FDA deems it worthy of its strictest caution (yet seemingly not serious enough to remove it from pharmacy shelves).

For instance, Seattle Genetics Inc. announced last week that its Hodgkin lymphoma drug, Adcetris (brentuximab), will carry a box warning due to brain infection risk called progressive multifocal leukoencephalopathy (PML). This is a fatal condition that starts with memory loss, clumsiness and aphasia, an inability to communicate using language. There’s no known cure.

The box will also warn that taking Adcetris with cancer drug bleomycin may cause lung toxicity. Since it was approved in August 2011, three people have developed PML and about 2,000 people continue to take the drug.

So why doesn’t the FDA pull Adcetris off the market? According to Bloomberg estimates, Adcetris sales may surpass $275 million in 2014. Even if prescriptions wane between now and then, there’s still plenty for the drug to bring in. Will the FDA stand in the way? Not yet, it appears.

This is just one of many drugs that carries a box warning. In 2007, the FDA issued a black box warning for all antidepressants for users 18 to 24 years old who risk committing suicide when taking drugs like Paxil and Prozac and the other 37 antidepressants on the market. However, millions continue to take antidepressants, even though they’ve also been proven to cause pulmonary hypertension in babies of mothers who took them during pregnancy and triple the risk of potentially fatal falls for people with dementia living in nursing homes.

And there are many other popular drugs with black box warnings … Pfizer has a few you’ve heard of: the anti-inflammatory Celebrex, contraceptive Depo-Provera and smoking cessation drug Chantix. And although they’ve been shown to cause cardiovascular problems, bone loss and suicidal actions (respectively), they remain on the market.

A classic case of prolonging a drug’s availability through a black box warning is Avandia (rosiglitazone), used to increase the body’s sensitivity to insulin in type 2 (adult-onset) diabetes. Its risk? A 43 percent increase chance of having a heart attack. Manufacturer GlaxoSmithKline provided less-than-transparent clinical data that focused on efficacy rather than safety, which the FDA used to fast-track its approval in 1999.

Eight years later, Avandia was making more than $2 billion a year for GSK before it got a black box warning. Some experts estimate that 100,000 heart attacks can be attributed to Avandia. In November 2011, the FDA severely restricted access to the drug, making it no longer available at retail pharmacies (but not pulled from the market completely). But there was still time for GSK to rake in more than $655 million in 2009 and $355 million in 2010 in U.S. sales alone, according to the firm’s annual report. In December 2011, GSK settled an illegal marketing suit related to Avandia and other drugs for $3 billion. The drug maker still came out ahead. Way ahead.

But the bigger point is: Why isn’t the FDA acting faster? You have to wonder who the FDA is truly looking out for. The drug manufacturers? They get to continue business as usual. Americans whose hearts, livers and lives are on the line? Well, at least we get a warning.

You wouldn’t let your toddler play in a busy street. That’s just good common sense that you already know. However, if you’re in a more precarious position—perhaps you’re pregnant and depressed—you need expert guidance you can trust to keep you healthy and your baby out of danger. You should be able to turn to the medical profession to steer you in a safe direction, right?

In your highly vulnerable state, the pharmaceutical and medical industries have assured you that there’s almost no risk in taking medications like antidepressants during pregnancy. But are they using common sense?

The British Medical Journal released a study last week that examined 1.6 million births from 1996 to 2007 and found that women who take selective serotonin reuptake inhibitors (SSRI) antidepressants late in their pregnancy are twice as likely to give birth to a baby with pulmonary hypertension.

This condition occurs when a newborn has high blood pressure in its lung and the lungs do not adequately adapt to breathing on their own after birth. It’s a dangerous disorder that can lead to organ failure, brain damage or even death. About one in every 1,000 babies is born with the condition.

Yet some experts are discounting the severity of the study’s findings. “You’re doubling the risk of extremely low risk to again, an extremely low risk,” Dr. Marjorie Greenfield, division director of obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland, told ABC News.*

Yes, and maybe there’s an extremely low risk that a driver won’t swerve his car in time to avoid hitting your kid.

But there’s a lot at stake in maintaining the “good name” of antidepressants. SSRIs hit the market in the 1980s and ’90s and gave hope to many people battling depression, eating disorders, post-traumatic stress disorder and obsessive-compulsive disorder. Medications like Prozac (fluoxetine), Zoloft (sertraline) and Lexapro (escitalopram) offered a safer, more effective answer to their side effect-plagued predecessors.

Today, antidepressants are the third most widely prescribed drugs in America, with 1 in 10 Americans taking some form of the drug, according to the Centers for Disease Control and Prevention. This translates into $20 billion in annual profits for pharmaceutical giants like Eli Lilly, Pfizer and Forest Pharmaceutical.

SSRIs work by targeting serotonin, a neurotransmitter that sends messages in the brain. The theory is that a serotonin imbalance will lead to mood variations and depression—or, conversely—that depression will cause a serotonin imbalance. It’s not known which comes first or even exactly how SSRIs work in the brain, other than that they seem to wash away the blues.

People who take SSRIs are subject to side effects that range from restlessness to committing suicide. And while depression during pregnancy can also be dangerous, is the risk worth the benefit? This isn’t the first time that question has been asked. To wit:

• In 2009, a Dutch study of 39,000 children found that those who had mothers who took antidepressants were more likely to have respiratory and digestive problems.
• A Denmark study released in 2010 followed 82,000 babies and discovered that those whose mothers took antidepressants had slight delays in reaching developmental milestones like sitting up and walking.
• A small Kaiser Permanente study in 2011 suggested a link between a pregnant woman’s SSRI intake and her baby’s chance of developing autism.

In addition, it is well known that newborns of mothers who take antidepressants like SSRIs are often jittery and cry excessively during their first month of life, likely due to the fact that stopping SSRIs abruptly causes irritability and is highly discouraged due to these withdrawal symptoms. But when you leave the womb laced with SSRIs, you don’t have much of a choice.

Yet antidepressants are still widely prescribed to pregnant women who are battling mood swings, highs and lows and emotion turmoil during their babies’ development. Are the manufacturers of these medications and physicians who dole them out trying to lead you through a healthy pregnancy and offering a variety of feasible treatment options…or are they sending your unborn baby out into oncoming traffic? Where’s the common sense there?

Let’s say you want to form a committee to evaluate the safety of a drug; say for example the drugs Yaz, Ocella and Yasmin.

You begin by looking for people who are “experts” about the drug, the ingredients in the drug and the use of the drug.

You find 26 or so people who fit your criteria.

Do you want to eliminate those people who may, might, could, have a conflict of interest; a “dog in the fight”; a prejudice one way or the other about the drug or its ingredients or its use?

If you are forming this committee as a public safety body, wouldn’t you also want to eliminate those individuals who even have “an appearance of conflict” in being independent about their evaluation of the drug?

I think any objective person would answer “yes” to both these questions. The Food & Drug Administration – well, they apparently do not subscribe to the same tenets for evaluating potential conflicts of interest as most of the rest of us.

On December 8, 2010, the FDA convened a committee to evaluate the safety and continued sale of Bayer’s drug Yaz. Yaz, Yasmin and Ocella and drospirenone as an ingredient. These drugs have been linked to an increased level of stroke, heart attack, pulmonary embolus and a number of other life threatening conditions in women who used them and otherwise had no risk factors for these conditions. It has been fairly established that these birth control drugs caused the life threatening and, in some cases, life ending conditions for thousands of women.

It also seems pretty clear that Bayer was less than forthcoming about the dangers associated with Yaz, Ocella, and Yasmin. In fact, there have been allegations that Bayer actually knew and consciously withheld important data from the Food & Drug Administration.

So, given all this “gray matter” surrounding the drug, you would want your conduct, as a regulator, to be beyond reproach, right? Testimony from a former FDA regulator, David Kessler, about some of the committee members raises concerns; perhaps not actual conflicts, but certainly potential conflicts suggesting that Bayer may have felt “owed” something by these committee members:

• One of the committee members was considered a “Bayer trained speaker” and was involved in promotional programs for Bayer. This same physician was in the Bayer speaker program and helped Bayer by reviewing research materials related to Yaz. This member also participated in video promotions on behalf of Bayer.
• A second committee member was listed as a “Bayer Contraception Expert” and apparently conducted research for a company that Bayer eventually purchased. The research the physician was involved in related to the use of drospirenone, which, of course, is the key ingredient in Yaz, Yasmin and Ocella.
• A third is listed by Bayer as a “key opinion leader” and an “external expert”.
• The fourth committee member apparently performed at least four research projects for Bayer; including one involving, yes, you guessed it, drospirenone. All four research projects seem to relate directly to contraceptive drugs.

In a paper filed with the court, Bayer now seeks to exclude the testimony of Dr. David Kessler; who believes these potential conflicts are important. In their court paper, Bayer does not argue that what Dr. Kessler states is untrue; rather Bayer argues that, for legal reasons, he should not be permitted to testify about his findings.

Does this all mean that the members, and possibly others, in the committee voted in favor of Bayer being allowed to keep its billion dollar money maker drug on the market? Not necessarily. That is not the point.

The point is that we will never know for certain.

No one should sit in judgment of whether a drug is or is not too dangerous to remain on the market if they have even the “appearance of” a conflict of interest. Why risk it? Why risk the potential of exposing the public to unnecessary risk if, in fact, a drug is too dangerous, but remains on the market because someone did have a “dog in the fight”?

The point is that these circumstances fairly raise the question of exactly who is really running the FDA and who does the Food & Drug Administration really work for in safety vs. marketing situations.