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WHAT DO AN OCTOPUS AND THE FDA HAVE IN COMMON? BOTH HAVE EIGHT LEGS.


FDA stands for Food and Drug Administration. While most Americans view the FDA as the country’s drug enforcement arm, it does so much more and its responsibilities are wide and varied. It deals with human and animal food, drugs, medical devices, radiation emitting devices, vaccines, blood and biologics, cosmetics, and tobacco. The majority of what the FDA does do is not what we think it spends its time on.

The FDA reported that for the first 3 months of 2013, it has recalled 46 human food products. That is 3 times the number of animal & veterinary food products it recalled and 4+ times more than the drugs it has recalled. Further, it is 23 times higher than the medical devices it has recalled.

FDA RECALLS AND WITHDRAWALS January 1, 2003 – March 26, 2013
46 FOOD
10 DRUGS
02 MEDICAL DEVICES
0 RADIATION-EMITTING PRODUCTS
0 VACCINES,
0 BLOOD & BIOLOGICS
14 ANIMAL & VETERINARY
0 COSMETICS
O TOBACCO

Clearly, each of these responsibilities it important for human health and safety, save and except the animal & veterinary arm. It is amazing that the FDA has to devote so much time, energy and resources to making sure our food supply is safe, not to mention the number of recalls it has to initiate to keep it that way. By simple extrapolation, it could be expected that by the end of 2013, the FDA will have recalled 184 food products, 40 drugs, 8 medical devices and 56 animal & veterinary products. No one should believe that this means that drugs are safer than food. Rest assured that they are not. Remember that all drugs have side effects. The FDA gets involved when it receives information that a particular drug is causing side effects not disclosed to the FDA in the approval or post-approval process, or when the reports of know side effects are more than represented by the drug’s manufacturer.

Let’s put this into perspective:
1. The FDA issued 10 recalls and withdrawals in the first 3 months of 2013.
2. The FDA issued 13 safety alerts for human medical products and 12 for medical devices for that same period.
3. The FDA has taken some action 35 times in 2013 on drugs and/or devices. That is only 5 actions less than it took on food products.
4. The FDA likely watches a hundred thousand more food products than drugs and devices.
5. The numbers of recalls, withdrawals and safety alerts on drugs and devices is far greater than any other action the FDA takes on it other areas of responsibility.

The importance of each of the FDA’s functions cannot be overstated in its responsibility for protecting and advancing public health.

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Texas™ 83rd Legislative Session is Underway, and You Aren’t Safe


It is commonly known that when the Texas Legislature is in session, no one is safe. Texas 83rd legislative session is well underway, and that saying is as true as ever. The legislature is taking aim at Texans through laws it hopes to pass that attack insurance policyholders rights. That’s right, attacking the policyholders who pay the premiums and protecting the insurance companies that delay and deny claims and force Texans to hire trial lawyers to get their claims paid. Further, it is not just one or two laws it wants to pass. As of the day before the March 8, 2013, deadline to file bills, over 400 insurance bills had been filed in the Texas Legislature. Rest assured that none of them are consumer friendly. Here are some low-lights and an explanation why they hurt Texans:
1. One of the laws the legislators want to pass will prohibit recovery of non-economic and punitive damages by uninsured drivers except in very limited circumstances. The Texas legislature previously succeeded in capping non-economic damages in medical malpractice cases, and has capped punitive damages in all cases. Non-economic damages are compensation for an innocent victim’s pain and suffering. Texas laws should never punish innocent victims of someone else’s negligence and gross negligence by denying them compensation for their pain and suffering and capping punitive damages. It should punish the wrongdoer who caused the damages, injuries and losses with uncapped punitive damages.
This bill would prohibit the recovery of non-economic (pain and suffering) damages and punitive (to punish and deter similar, future conduct) damages by someone who for whatever reason is driving without insurance when they did absolutely nothing to cause the collision or their injuries. Texas should be fully able to hold wrongdoers responsible and Texas legislators should strive to preserve innocent victims access to the courts and rights to be compensated. If the innocent victims were negligent and caused some or all of their own damages, Texas law already provides a remedy by which the jury and judge can proportionately reduce any such award. If the party seeking compensation’s comparative or contributory fault the equals or is greater than 50%, that person will not be compensated.
All Texas drives should follow the law and have auto liability insurance. Many do not, mostly for economic reasons. Their inability to afford auto insurance should not be used to deny them just compensation when they are injured through no fault of their own in the incident.

2. One of the laws the legislators want to pass will eliminate post-judgment interest on judgments involving Medicare, including when the defendant appeals. Texas legislators want to be paid interest on their campaign accounts, their personal accounts and their investments. They do not, however, want innocent victims to receive interest on the money they are entitled to for the 2 4+ years it takes to get the case to trial and through the inevitable appellate process.
Post judgment interest is important to behoove those found by the court and/or jury to be at fault from delaying and denying the compensation to which innocent victims that the judicial system has said they are entitled. Post judgment interest and prejudgment interest are important check and balances to keep and protect innocent victims right to be compensated after a trial by jury or judge.
If passed, this bill will protect those that need prosecution (the insurance companies) and not those who need protection (the innocent victims).

3. One of the laws the legislators want to pass will allow EMS providers to receive direct access to policyholder’s PIP and MedPay. The medical profession can make applications for patients PIP (Personal Injury Protection) and MedPay. It should not be mandatory, however. The legislature recently passed a law that punishes innocent victims when they pay their medical bills prior to the resolution of their case. Texas Civil Practice & Remedies Code 41.0105, limits the recovery of medical expenses to the amount actually paid or incurred. The exact language of the statute is as follows:
In addition to any other limitation under law, recovery of medical or health care expenses incurred is limited to the amount actually paid or incurred by or on behalf of the claimant. (Emphasis added.)
By codifying medical professionals ability to make PIP and MedPay applications, innocent victims lose the ability to preserve the value of their personal injury claim. Understand that if the medical professional makes the PIP and MedPay application and received the money, that bill (or portion thereof) is paid, and cannot be used to determine the value of a claim for personal injuries and pain and suffering. If this practice is not mandatory, then the innocent victim can choose not to pay the medical professional until the case is resolved, thereby preserving the dollar amount of medical care incurred. The higher the amount of the incurred medical bills is, the higher the potential value of the case. Conversely, the more of that medical that is paid, the less left unpaid for determining the potential value of the case, and the lower that value will be.
This is nothing more than another assault on innocent victims that they will not even know about until it is too late.
The innocent victim would be better served and protected legislation that requires that all Texas Auto Insurance policies have PIP (Personal Injury Protection) and/or MedPay. This is extremely affordable coverage and goes a long way to helping innocent victims receive the medical care and lost wages they need. Legislation should also require underinsured and uninsured coverage for those times when the injuries and damages suffered are greater that the coverage available and when the wrongdoer does not have insurance. The legislature should focus on protecting all innocent victims of someone else’s negligence and gross negligence, not special interests.

4. One of the laws the legislators want to pass will create a mandatory Appraisal process requiring appraisal for most insurance disputes on amount of accepted coverage in homeowner policies. Standard operating procedure for insurance companies and especially with regard to homeowner’s policies – is to delay and deny paying claims. Passage of this law would legalize and endorse that standard operating procedure. Requiring an appraisal process for most insurance disputes for a claim on homeowners policies will increase costs of the innocent victim and further delay their receiving just compensation. This bill does nothing to help the insured paying the premiums or the innocent victims of the insured’s negligence or gross negligence. We have procedures in place to verify claims before as well as after a lawsuit is filed for damages or injuries that would be covered by any kind of insurance policy. These procedures involve both the insurance companies and the innocent victims using experts, and a mediator, judge or jury making decisions if the parties cannot reach agreement. This appraisal will do nothing do preserve innocent victims rights and access to the courthouse to redress wrongs.

5. One of the laws the legislators want to pass will eliminate existing remedies and policyholder protections for unfair insurance practices and prompt payment violations.
This bill would remove the insured’s right to bring suit against their own insurance company for not paying THEIR own claim on THEIR insurance policy when the insurance company does not timely and fairly pay your claim. Unfair insurance practices and prompt payment violation provisions exist to regulate trade practices in the business of insurance by defining, or providing for the determination of, all such practices in this state which constitute unfair methods of competition or unfair or deceptive acts or practices and by prohibiting the trade practices so defined or determined. The current statutory provision can be found in the Texas Insurance Code Chapter 542, Subchapter A is entitled, Unfair Claim Settlement Practices has the same purpose of preventing unfair claim settlement practices. Again, if passed, this bill will protect those that need prosecution (the insurance companies) and not those who need protection (the innocent victims).

6. One of the laws the legislators want to pass will allow insurers to cancel policies after a reduced number of claims, including claims caused by natural causes. Insurance companies do not like paying claims. This bill would allow the insurance companies to accept Texans premiums and then cancel the policies when a claim is made that the insurance company thinks amounts to too many by the insured. This bill protects the insurance companies who already have all of the power and money. An insurance policy is a contract, and this law will simply give the insurance companies another out in your time of need. After a devastating loss, you will find a cancellation notice in the mailbox. Then when you try to bring a lawsuit against the insurance company for bad faith, that right will have been eliminated by the bill discussed above.

7. One of the laws the legislators want to pass will subject disputed claims to the appraisal process with severe limits on attorney fees. Every time the legislature has passed any tort reform measure it has made it more difficult for Texans to hold wrongdoer accountable. In medical malpractice law reform, for example, the legislature put caps on non-economic and punitive damages and severely restrict the ability to hold emergency room facilities and staff responsible for the injuries and death caused by their medical errors. Since trial lawyers who handle these cases only get paid if there is a recovery, when the case costs more to develop that the expected recovery, the case becomes non-economical. That means that the lawyers’ share of the reduced recover does not justify the lawyer’s six-figure investment in the case. It follows then, that if the legislature reduces attorneys fees on cases no matter how they do it it will reduce the innocent victims™ ability to hire a lawyer to hold wrongdoers accountable. Limiting attorneys fees on any kind of cases is not in the innocent victims’ best interest and only serves the special interests who want to run lawyers out of business. Rest assured that there is no do-it-yourself guide to handing your own personal injury or business litigation case. You need a lawyer.

8. One of the laws the legislators want to pass will remove adjusters employed by an insurer or agent from regulation (licensing, examination, continuing education, and enforcement related requirements). This is stupid. Why would we remove examination, licensing, continuing education and enforcement related requirements for any professionals. Is the legislature going to next remove these requirements for lawyers and doctors? Would you go to a lawyer or doctor who did not have to take and examination to prove his knowledge and worthiness, get licensed to show he has met the minimum requirements to hold himself out as a professional in that field, take continuing education to keep up on all of the latest developments in that field, and be subject to enforcement related requirements to make sure the professional always abides by the rules and standards that guide that profession? No one would, and the legislature should not pass insurance-favored legislation that prejudices their insureds.

9. One of the laws the legislators want to pass will abolish Office of Public Insurance Counsel.
Why would the legislature do this? The answer is found in the Mission Statement of the Office of Public Insurance Counsel:
Our Mission
The mission of the Office of Public Insurance Counsel (OPIC) is to represent the interests of consumers in insurance matters. This means promoting public understanding of insurance issues, advocating fairness and stability in insurance rates and coverage, working to make the overall insurance market more responsive to consumers, and striving to ensure consumers receive the services they have purchased. (Emphasis added.)
OPIC represents consumers! OPIC advocates for Texas insurance consumers primarily before the Texas Department of Insurance (TDI). OPIC is an irritant to The Texas Department of Insurance and the legislators pushing its agenda regarding self serving rate increases, rules, and forms. These issues affect Texans’ property and casualty, life, accident, and health insurance coverage and rates.
If the Texas Department of Insurance can eliminate OPIC, it eliminates much of the opposition to its agenda.

10. One of the laws the legislators want to pass will give insurers ability to require claims be made within one year.
Texas already has laws that state the length of time one has to make a claim by filing a lawsuit. It is called the Statute of Limitations. For Bad Faith claims, there is a 2 year statute of limitations, and for Breach of Contract the statute of limitation is 4 years. The legislature wants to reduce the time allowed to file all claims against an insurer to 1 year to reduce the number of claims made against it and the amount of money the insurance companies have to pay out on claims. This is a very anti-consumer bill that, again, protects the insurance companies and not the innocent victims and consumers.
Do not let your elected Texas Senator and Representative pass laws that restrict your right and ability to hold wrongdoers accountable and be compensated by insurance. We Texans who have insurance do so to protect ourselves in the event we are injured or damaged through no fault of our own, or if we injure or damage another person. If you do not speak up, these new laws will injured and damage you through your own fault. You may have elected these folks to the legislature because of their party affiliation, but understand that the debt they owe to special interests is adverse to and far outweighs your interests and what benefits and protects you.

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AZITHROMYCIN WARNINGS GET STRONGER AFTER 19 YEARS


The FDA issued a warning on March 12, 2003 regarding the antibacterial drug, azithromycin. Also known as Zithromax or Zmax, azithromycin was approved to treat acute bacterial infections. Most commonly it is prescribed to treat acute bacterial sinusitis and community-acquired pneumonia, pharyngitis and tonsillitis.

The March 12, 2003 warning was about an increased risk of abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. However, it was just on May 17, 2012 that the FDA released a statement about a study that reported an increase in cardiovascular deaths and death from any cause in persons treated with a 5-day course of azithromycin. The FDA recommended at that time that health care professionals should consider this increased risk when prescribing azithromycin for patients already at risk for cardiovascular events.

It was a medical/scientific study published in the respected New England Journal of Medicine that led to the FDA’s May 17, 2012 statement. That study compared the risks of cardiovascular death in patients treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), and no antibacterial drug, and found what the FDA reported was a small increase in cardiovascular deaths.

The FDA also points out in its 2012 statement that in 2011, the FDA reviewed macrolide drug labeling information related to these very risks. That review resulted in the WARNINGS AND PRECAUTIONS section of the Zmax drug label being revised in March 2012 to include new information regarding risk for QT interval prolongation, still referring to the risk as low. So one year later, the FDA was able to conclude that the risk is low, not small.

So in 2011, the FDA determined the risk was small, in 2012 the FDA determined that same risk to be low, and in 2013 the FDA deletes these downplay of the risk and warns that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. However, this hide the ball game has been going on much longer than that.

The first azithromycin drug, Zithromax, was approved in September 1994, and in that first label through the October 2007 label, it had a very weak warning about this very serious side effect:

There has been a spontaneous report from the post-marketing experience of a patient with previous history of arrhythmias who experienced torsades de pointes and subsequent myocardial infarction following a course of azithromycin therapy. (Emphasis added.)

In 2010 and thereafter the warning mirrored that of Zmax (below).

The second azithromycin drug, Zmax, was approved in 2005, and its first and subsequent labels changes in August 2007, September 2008, and October 2010, list adverse reactions in post-marketing reports to include:

Cardiovascular: palpitations and arrhythmias including ventricular tachycardia and hypotension. There have been rare reports of QT prolongation and torsades de pointes.

It was not until the 2011 Zmax label that this warning was strengthened in content and placement, now appearing fifth in order of severity in the Warnings and Precautions section of the label:

Prolongation of the QT interval and cases of torsades de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. (5.5)

Doing its best to downplay the risk in the March, 2012 label, Zmax manufacturer Pfizer stated the following:

Although the absolute risk is unknown, it appears to be low with azithromycin likely due to the lack of appreciable drug interactions, and the observation that it is rarely reported as a post-marketing adverse event. (Emphasis added.)

In conclusion, it is evident from 1994 that Pfizer knew that its azithromycin could cause Prolongation of the QT interval and cases of torsades de pointes, both serious conditions that can result in death. The FDA knew this too because it approved the content of the original label and every change thereto. Yet, over the next 17 years, the FDA believed Pfizer’s representations that the risk was small and low, even though very serious. Then, after the FDA’s review of the New England Journal of Medicine study, it determined that the risk was greater than that and required strengthened warnings in 2012 and 2013.

The problem is that patients, their doctors, and the FDA are totally dependent upon the drug companies to provide accurate and complete information and warnings about the serious risks of their drugs. Remember, the FDA does not do its own testing or studies about the drugs it approves. The FDA gets its information from the drug company, and until it gets information from an independent source, such as a study published in a respected medical journal such as the New England Journal of Medicine, it knows no different. Further, the drug company is charged with the responsibility of collecting and reporting to the FDA all after-market reports of adverse events from their drugs.

Where is the drug companies motivation to provide accurate and complete information when billions of dollars are at stake? With the fox guarding the hen house, it is more likely than not that the drug companies pro