West Palm Beach Personal Injury Lawyer - Defective & Dangerous Products - Most Commented

E-Cigarette…Anyone Else?

Armand Rossetti — Fri, 24 Jul 2009 10:00:17 GMT

The FDA has alleged that one of several E-cigarette distributors in the United States, Smoking Everywhere, Inc. (SE), has marketed a product that is both an unapproved drug (nicotine) and an unapproved medical device (synthetic cigarette body).

The FDA made this determination after examining the product, several claims made about the product, and information that SE, itself, provided to the FDA. For further information, please read E-cigarette Anyone?

While class I medical devices (gauze pads, throat sticks and the like) do not necessarily need FDA approval, class II or III medical devices do require FDA clearance before legal marketing can occur. The FDA has classified the E-cigarette as a class III medical device, and as such that device must undergo the strictest FDA scrutiny before it can reach the marketplace.

Depending on the manufacturer and type, the cost of entry to use E-cigarettes can vary from $14.99 for the “disposable” version all the way up to more than $200.00 for reusable deluxe models. Complete “starter kits” with cartridges and batteries included have been advertized at around $100. While the $200.00 price tag might discourage younger users, the chic of it all and the curiosity to try an E-cigarette at the price of about three packs of cigarettes ($14.99) might entice a younger demographic to give it a try.

Most people who use E-cigarettes do so with the intention of cutting down on smoking, or with the anticipation being able to get a nicotine high while working indoors (no smoke = no ban). Other consumers use the device to quit smoking altogether. Cessation is possible because the nicotine concentrations in the cartridges can range from 16 mg all the way down to zero mg. The choice remains with the consumer.

There can be no dispute that well designed and well regulated E-cigarettes have a potential to aid smokers in reducing or eliminating their habits. And several manufacturers are heading in the direction of making the E-cigarette device as safe as possible.

However, E-cigarettes might also provide an avenue for further addiction. A first time E-Cigarette user with the handle, “Utada” recently posted an after purchase review on Amazon.com. Although Utada was going to give the SE distributed E-cigarette five (5) stars, Utada only gave the product three (3) stars because he or she felt that the product was addictive since it had nicotine.

But here's the catch. When Utada was smoking real cigarettes, she smoked only 5 or 6 a day. However, with the E-cigarette, Utada wound up smoking two cartridges a day (each cartridge being equal to 20 regular cigarettes). Utada continued her review by advising the purchase of “e-cig juice” an after market nicotine cartridge rejuvenator, which comes in different flavors. With e-cig juice (or E.LIQUID, as one example), Utada expected to save a lot of money. In fact, using e-cig juice to extend the life of the device, reduces the cost of “smoking” significantly to far less than $5.00+ a pack for 20 smokes (see below). But there is a potential health hazard in using an E-cigarette beyond the number of cycles that the manufacturer has built into the device; an example follows.

Recently, several complaints have surfaced about a burning taste that consumers experience after cycling the E-cigarette through a number of puffs. This phenomenon may or may not involve SE’s version of the E-cigarette, but it would be prudent to obtain more information from the manufacturer.

As one blogger illustrated, most E-cigarette devices contain a wick inside a filament that soaks up the liquid in the cylinder that contains nicotine. A battery powered filament then heats the liquid that finds its way to the wick to form a vapor. After a while, the wick dries out fairly easily and starts to burn forming “burnt e-liquid”). Thereafter, the residual E-liquid has a propensity to turn into a solid and begin to burn. That sequence is what creates an unwelcome taste, and a possible, device-related health hazard. With little regulation, the possibilities for serious health risks seem as endless as human creativity will permit.

For example, some ardent E-cigarette consumers have expressed concern that manufacturers may be using a cheap polyester material to make the filter portion of the cigarette. Polyester filters could turn out to be dangerous when burned and inhaled.

Moreover, E-cig liquid is sold in 15 milliliter bottles in several flavors and nicotine strengths for $14.99. According to one distributor, only 2 or 3 drops of the liquid will regenerate a cartridge. Since there are 20 drops per milliliter, that means that one 15 milliliter bottle contains from 100 to 150 cartridge refills, and one cartridge equals 20 cigarettes. Doing some simple math, like many young people are able to do, a cigarette equivalent could cost as little as $14.99 divided by 3000, or about half a cent (or 10 cents a pack). It’s a great way to beat the cigarette tax.

To reiterate, the E-cigarette is a device, nicotine is a drug, and the FDA will be regulating both. Therefore it is within the purview of the FDA to ensure the safety of the E-cigarette device and its delivery of a drug. Otherwise, problems associated with misuse and/or device alteration might abound

Bottom line: In the interest of consumer safety, the FDA should require all E-cigarette manufacturers list materials used in respective devices. In addition, the FDA should require E-cigarette manufacturers to conduct studies to determine whether any materials subject to heat during cycling, including polyester, might produce toxins. Smart manufacturers should be forthcoming with appropriate warnings and, lastly, all forms of nicotine, including E-cig juice should be FDA regulated.

Originally posted at InjuryBoard by Armand Rossetti

E-cigarette Anyone?

Armand Rossetti — Thu, 23 Jul 2009 10:28:44 GMT

That’s right. The quest to deliver controlled nicotine doses to people of all ages never ends. Cigarettes are now on the technological cutting edge. There’s no secondhand smoke to worry about, but do worries about personal health still exist? The truth is that those health concerns are still apparent.

E-cigarettes, also know as electronic cigarettes are battery operated devices consisting of cartridges filled with nicotine, flavor and other chemicals. The consumer switches on the device, inhales the vapor and receives a dose of flavored, highly addictive nicotine. Young consumers who favor cover up flavors like chocolate and mint will definitely enjoy the high.

According to an FDA news release, e-cigarettes are available online and companies market those cigarettes to the young consumer. However, electronic cigarettes could increase nicotine addiction and tobacco use in young people. Margaret Hamburg, MD, commissioner of food and drugs indicated that “the FDA is concerned about the safety of these products and how they are marketed to the public.

So far, the FDA has not had the opportunity to evaluate the safety of or to approve marketing of e-cigarettes, and the agency has conducted only limited testing, concerning the levels of chemicals and nicotine that various brands of the devices will deliver to the consumer.

In one tested sample, the FDA detected diethylene glycol (a toxic chemical used in antifreeze), and in several other samples, the FDA detected cancer causing chemicals, including nitrosamines.

Evidently, e-cigarettes are reaching our borders from foreign sources. The FDA has intercepted and examined shipments of e-cigarettes at the border and has determined that those devices meet the definition of being a combination drug-device under the Federal Food, Drug and Cosmetic Act.

A concern called Smoking Everywhere is challenging the FDA’s jurisdiction and the case is pending in federal district court, District of Columbia. Healthcare providers and consumers may report serious adverse events (side effects) that concern the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting Program (please scroll to the bottom of the page).

Originally posted at InjuryBoard by Armand Rossetti

Zicam Nasal Gel: Questions about Efficacy, Risk of Use, and Timing of the Warning

Armand Rossetti — Fri, 19 Jun 2009 17:14:06 GMT

The three Zicam products included in the recent FDA warning letter that Matrixx received in June 2009 are:

Zicam Cold Remedy Nasal Gel (NDC 62750-003-10)
Zicam Cold Remedy Swabs (NDC 62750-003-20)
Zicam Cold Remedy Swabs, Kids Size (NDC 62750-003-21) (discontinued)

Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Nasal Gel were both introduced in 1999 and each contain the active ingredient, zinc gluconate (10% ).

There are many questions to consider when analyzing the reason for, and the timing of the FDA’s warning. However, it might be best to take a brief look at whether zinc products such as Zicam Cold Remedy actually work as homeopathic remedies.

The trademark, Zicam, is taken from “Z” for zinc and I-CAM, a type of receptor site found on epithelial cells and in viruses. Purportedly, Zn2+ ions complex with intercellular adhesion molecular receptor sites on rhinovirus surfaces, and prevent cold viruses from binding to human cells. In other words, zinc allegedly prevents cold viruses from gaining entry to human cells and causing cold symptoms.

It all looks pretty simple and straight forward. However over the years, Zinc’s efficacy as a virus blocker has been the subject of notable controversy.

In 2000, Michael Hirt’s group published a study in the Ear, Nose & Throat Journal that suggested that zinc lozenges shortened the number of days from onset to the complete resolution of common colds. Hirt found that zinc lozenges reduced the duration of symptoms by 75%, which was consistent with the 85% figure that Hensley (in an unpublished zinc nasal gel study) had reported. However, another investigator found otherwise.

In 2001, Ronald Turner found that there was no significant effect, i.e., no difference in common cold duration between active zinc treated and placebo treated subjects. Turner noted that the infection rate in challenge volunteers was 93% while it was 90% the placebo volunteers. During the study, Turner measured signs and symptoms such as rhinovirus severity, nasal obstruction, and headache. In 2002 Samuel Yiu corresponded with Turner. While Yiu supported Turner’s challenge model, he found fault with the sample population number and protocol of the study. In his correspondence, Yiu also suggested that further evaluation was necessary in order to draw any conclusion regarding efficacy.

In 2004, Hulisz published an overview concerning zinc’s efficacy against the common cold Hulisz found that zinc attached to “I-CAM receptor sites found on retroviruses and on nasal epithelial cells. However, Hulisz also determined that there was a 24-hour window, beginning onset, for the most effective treatment to occur. A question might arise whether the average consumer can accurately determine when that window opens and when it closes.

Is nasal zinc treatment worth the risk? We have seen some evidence (above) that zinc may or may not work under certain circumstances. However, what is the risk of using nasal zinc products?

In 1938, amidst a polio epidemic that prompted physicians to arrive at ways to prevent the poliovirus from spreading, Smith submitted a study to the Canadian Medical Association Journal that addressed epithelial treatment with 1% zinc sulphate. Although zinc sulphate is not exactly the same as zinc gluconate, it seems evident that both are severe irritants at higher concentrations.

In his basic science study, Smith found evidence that zinc sulfate at 1% destroyed the three types of cells in the olfactory sensory epithelium that gives humans the ability to smell known in scientific circles as “anosmia.” More importantly, those sensory cells disappeared forever because they cannot regenerate. Instead, regular non-sensory epithelial cells replaced those sensory cells.

Given all of the above, it is not unreasonable to question whether the risk of using nasal zinc treatment might outweigh the benefit of receiving such treatment. After all, the FDA’s concerns about reported adverse events of anosmia were underscored by published scientific literature that provided evidence, such as the 1938 Smith study, showing a connection between intranasal zinc and anosmia.

Next we should question when the risk of using Zicam gel nasal spray became obvious.

As early as October 2003, Zicam, LLC and parent, Matrixx Initiatives, Inc. became defendants in a lawsuit that alleged that the plaintiff had lost his sense of smell after only a single treatment with Zicam. In fact by 2004, large numbers of similar complaints prompted the FDA to inquire about Zicam’s safety.

As time progressed, claimants continued filing complaints, alleging that treatment with Zicam nasal spray (a gel) had caused loss of smell. It is interesting to know that that FDA was not regulating homeopathic zinc preparations such as the Zicam Cold Remedy.

Later on in February 2006, Matrixx settled 340 anosmia-related Zicam lawsuits. Then, as previously mentioned, more than three years later on June 16, 2009, the FDA issued a warning letter to Matrixx . The warning letter notified Matrixx that it had crossed the line when making efficacy claims for its self-declared “homeopathic,” nasal zinc products. Therefore, Matrixx could no longer qualify those products as being homeopathic preparations. According to the FDA, Matrixx had taken a step further and was actually marketing new drugs intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, all without FDA approval. As required before marketing Zicam Cold Remedy Nasal Gel and Swabs, Matrix had not submitted a new drug application (NDA), and it had not participated in the FDA approval process. As a result, the FDA suggested that Matrixx promptly remove Zicam Cold Remedy nasal products from store shelves.

To this day, however, Matrixx maintains its original position that Zicam nasal preparations are scientifically proven to be safe and efficacious, and that they do not cause anosmia. Yet, only three days after receiving the FDA warning, Matrixx issued a message, suggesting, among other actions, that consumers discard any previously purchased Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs.

These precautions are all “good and well,” but at what point should consumers have received a formal manufacturer’s warning concerning the possible danger associated with nasal application of Zicam Cold Remedy? Would the right time have been in 1999, when Matrixx introduced Zicam nasal zinc products? How about in 2003, when plaintiffs allegedly suffering with anosmia filed 340 lawsuits? Should Matrixx have issued a voluntary preliminary warning in 2004, when the FDA began investigating complaints; or should Matrixx have then instructed consumers concerning proper application and use?

It seems plausible that Matrixx might have issued a voluntary warning in 2006, when it settled 340 Zicam lawsuits for 12 million dollars. In fact, George Eby submitted an article to Alternative Therapies in 2006 that contained the following statement:

“We contend that it is unethical to introduce any potentially permanent anosmia-inducing agent such as zinc or other heavy metals into the interior of the nose in a manner that could result in contact with the olfactory region to treat a temporary discomfort such as a common cold or allergy. We found no reason to recommend intranasal zinc gluconate or zinc orotate lozenges in treating common colds. (Altern Ther Health Med. 2006;12(1):34-38.) [Emphasis added].”

In 2006, additional information about the danger in using Zicam gel continued emerging. For example, the Denver Naturopathic Clinic issued a Zicam caution in 2006; the clinic provided a well reasoned opinion why Zicam was not homeopathic, and at least one clinic had raised a question about Zicam’s efficacy.

Maybe after receiving 800 aftermarket consumer complaints involving anosmia, the FDA might have suggested that Matrixx issue a warning in 2007 or 2008. What standard would be necessary to analyze whether a warning was warranted?

Perhaps Justice Royal in McClain v. Metabolife, 401 F.3d 1233 (11^th Cir. 2005) mentioned the difference between assessing consumer risk (a lower, more encompassing standard) and determining scientifically based causation (a more demanding and higher standard):

“The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability. The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances....”

Therefore in Matrixx' case, it should be reasonable to conclude that whenever that lesser showing of harm occurred, and I suspect that it occurred at least a few years before 2009, Matrixx should have issued a voluntarily warning, or the FDA should have suggested that it do so.

Originally posted at InjuryBoard by Armand Rossetti

Medtronic...Beleaguered Consumers and Yet Another Recall

Brenda Fulmer — Tue, 29 Sep 2009 15:31:58 GMT

On August 27, 2009, the Food & Drug Administration issued yet another recall for a device manufactured by Minnesota-based Medtronic (who also has experienced recalls of its pain medication infusion pumps, defibrillators, defibrillator leads, and insulin pumps recently). This Class I recall, the most serious level of recall of an FDA-approved medical device, involved the Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. These devices are used in connection with the popular Medtronic SynchroMed II and SynchroMed EL infusion pumps; these pumps deliver pain medications such as baclofen and other drugs directly into the spine. Chronic pain patients have been led to believe that implanted pain pumps such as the Medtronic devices would provide a panacea and avoid all of the pitfalls of chronic use of narcotic pain medication, including the stigma and potential addiction associated with such drugs, their side effects, and recent safety concerns (including manufacturing defects in Fentanyl pain patches that leach toxic levels of the drug due to improper sealing techniques and Ethex morphine pills manufactured at double strength).

The latest recall for Medtronic and its pain pump line stems from design defects that prevent the catheter from properly connecting to the infusion pump, which could lead to disconnection of the pump or a blockage. The inability of the device to properly administer a steady stream of pain medications to a patient creates the potential for an inadvertent overdose or unnecessary suffering for the patient who receives an inadequate level of pain medication. The SynchroMed II line of infusion pumps has been in the news a great deal over the past couple of years with numerous advisories of potential safety problems. These are located on the Medtronic site and can be accessed by clicking on "Medical Device Safety Alerts". They include:

July 2009 -- Premature Battery Removal
August 2008 -- Potential Effects of MRI Imaging on Pump Performance
June 2008 -- Potential Disconnection of Sutureless Connector Catheters
May 2008 -- Pump Malfunction Due to Missing Propellant
January 2008 -- Formation of Inflammatory Mass at Catheter Tip Leading to Serious Injuries
August 2007 --Notification of Malfunction of Synchromed El Pump with Stalling Due to Gear Shaft Wear
November 2006 -- Educational Brief to Physicians on proper monitoring of patients to reduce risk of death or serious injury during initiation of intrathecal opioid therapy for pain
July 2006 -- Voluntary Worldwide Medical Device Recall for Model 8731 Intrathecal Catheter and Model 8958 Intrathecal Catheter Distal Revision Kit (due to platinum-iridium tip becoming dislodged by guide wire during implantation)
May 2006 -- Medical Device Recall of Model 8627 SynchroMed EL Due to Pump Reliability Concerns
January 2006 -- Education Brief for Patients regarding drug formulations using preservatives that may be neurotoxic or compromise the safe use of the Medtronic infusion pumps

Patients who have received these devices should contact their physician for more information regarding the impact of these various recalls on the functioning and safety of their implanted infusion pumps. Medtronic has a sales force that regularly calls upon physicians and should be able to provide current safety data to healthcare providers and their patients. There are also tools available on Medtronic’s web site that enable physicians and patients to input the serial number for a particular infusion pump device to determine whether it is impacted by the various safety alerts and recalls.

It appears from the documents published on Medtronic’s web site that it has also enhanced its warranty coverage to include some of the out of pocket expenses incurred by patients. A review of these warranty supplements, however, indicates that patients are only being reimbursed up to $1,000 for out of pocket expenses associated with surgery and medical care necessitated by the defective product and that health insurers are left without recourse for the tens of thousands of dollars that they might be required to pay for medical care necessitated by the litany of defects associated with these pain pumps. This is an excellent example as to why federal preemption for FDA-approved medical devices (as outlined in the Medtronic v. Riegel decision) is a travesty for patients, physicians, and health insurers, all of whom are shouldering the burdens created by poorly designed and manufactured medical devices. It is for this reason that the Medical Device Safety Act, which would once again hold device manufacturers such as Medtronic responsible for their defective products, is gaining significant, bi-partisan support in Congress. More information about federal preemption and how it unfairly shields manufacturers of defective products can be found on our firm’s web site. We urge you to contact members of Congress to voice your support for this very important safety legislation.

Originally posted at InjuryBoard by Brenda Fulmer

Is Intellectual Property Management a Missing Piece of the FDA’s Regulatory Puzzle?

Armand Rossetti — Wed, 05 Nov 2008 11:04:53 GMT

Should the FDA establish an Intellectual Property Committee (IPC) to oversee licensing and distribution of pharmaceutical and medical device intellectual property?

The following discussion outlines some reasons why the FDA should step in and require intellectual property pooling as a requirement for those manufacturers that are seeking FDA approval for commercial distribution of pharmaceuticals and medical devices, and how the FDA might go about managing intellectual property pooling.

It is obvious that US manufacturers operate within the umbrella of a free enterprise system. While free enterprise in a health care setting might produce patient safety concerns from time to time, it would not be wise to stifle innovation by prohibiting manufacturers from operating under the free enterprise system. However, it might be beneficial to change free enterprise operating policies to enhance patient safety. The FDA might accomplish this by imbedding intellectual property management within the FDA’s regulatory scheme.

Under the current patent system, manufacturers conduct research and invent new pharmaceutical substances and medical devices. Thereafter, those manufacturers usually seek utility patents on those products that provide product manufacturing and distribution exclusivity for up to 21 years.

Manufacturers holding patents can prevent other manufacturers or entities from making, using or selling a same or substantially similar product. The limited patent “monopoly” provides a manufacturer with a means to accumulate wealth for the corporation and to fund future research and development. This is and has always been highly beneficial to the public.

However, when other manufacturers interested in developing alternatives to a blockbuster drug or medical device find themselves with their backs up against the technological wall, attempting at all costs to reverse engineer a same or similar drug or device, frustration could spell and sometimes has spelled trouble for patient safety. Here is an example.

By now, we are all aware of problems that plagued the contact lens solution industry. During the past decade, contact lens solution manufacturers, such as Alcon, Bausch & Lomb (B&L) and Advanced Medical Optics (AMO) were in stiff competition with each other to remain on the cutting edge of contact lens care solution technology. The first to develop the right contact lens solution active ingredients would win, and the others would either reverse engineer that effort or lose.

During its contact lens solution research and development phase, Alcon discovered an active called polyquaternium-1 (PQ-1), a polymer that provided a unique combination of lubrication and disinfection capabilities in a single ingredient, and a unique polymer that was relatively cornea friendly. Although Alcon did not hold a patent for this substance, the company quickly realized the uniqueness of PQ-1 and it negotiated with PQ-1's manufacturer and patent holder to enter an exclusive contract. These types of contracts are not uncommon. An exclusive contract acts like a patent because no other entity can obtain the particular ingredient from the supplier or manufacturer. Thereafter, Alcon successfully incorporated PQ-1 into its Opti-Free line of multipurpose disinfecting solutions, and produced a line that was unparalleled in safety and effectiveness. What were the competitors to do?

With the advent of PQ-1 and Alcon's exclusive contract, B&L was faced with a dilemma. B&L was faced with reverse engineering a similar active or losing its competitive edge. For the next three years, B&L searched its R&D files in an attempt to arrive at a solution. In addition, B&L looked at Alcon’s PQ-1, and at the family of PQ chemicals to try to come up with an alternative active with the same beneficial properties.

Needless to say, the task was not that easy, because all of the other PQ substances were either too harsh, did not disinfect effectively, or presented other problems that disqualified them as possibilities.

After a comprehensive review, B&L’s investigators felt that PQ-10 came closest to Alcon’s PQ-1. However, PQ-10 had little or no disinfecting capability. As a result, B&L had to find a complimentary active ingredient to provide adequate disinfection. The first choice for added disinfection was PHMB (which B&L was already using as an ingredient in its MultiPlus multipurpose disinfecting solution).

Nevertheless, B&L’s first choice proved not to be ideal because it was unstable in combination with PQ-10 and certain buffers. As a result, B&L reached into its file cabinet of experimental disinfecting actives and came up with another substance that was closely related to PHMB, Alexidine. That ingredient had a lower molecular weight, it was from the same family and Alexidine was quite effective as a disinfectant. The only problem was that B&L had tried to use Alexidine in the 1990’s without success, because it was harsh. Yes, Alexidine was more stable in combination with PQ-10, but it was hard on corneas.

What could B&L do to alleviate this problem? The answer was to develop combinations of actives and buffers in solution to dampen Alexidine’s harshness, and that was not an easy task. In fact, B&L attempted to do just that for three years, with limited success.

B&L used every combination of substances it could muster to alleviate the Alexidine problem, and it was almost impossible to arrive at a "tame" solution. Then the deadline fell upon B&L to produce a solution or lose market, and B&L decided to chose the best of the worst, then to seek FDA approval, and proceed to market ASAP.

We all know what resulted.

The question remains: How might the FDA have preserved Alcon’s right to enter an exclusive contract with the sole PQ-1 manufacturer and intellectual property rights holder, yet have promoted consumer safety?

There is no easy answer except to suggest the following as a starting point:

The FDA should establish an intellectual property committee (IPC);
The IPC should have authority to require manufacturers to attach to all PMAs and 510(k) submissions, copies of all patents, exclusive contracts, agreements and, if applicable, affidavits that one or more actives are a trade secret;
Subsequently, the IPC should review the intellectual property submissions and decide on a public safety basis, whether the applicant should be required to provide non-exclusive licenses, or the substance itself, to competitors for profit to allow them to use a particular unique active;
The FDA should suggest fair compensation for the manufacturer holding exclusive rights to the intellectual property under review, in the form of royalties, perhaps as a percentage of sales; and
If the manufacturer does not agree to license its competitors that FDA may refuse to grant approval to the manufacturer to market the drug or device.

Here is the reason why the FDA would not be overstepping its authority. Where pharmaceuticals and medical devices are concerned, ublic safety is imperative. While manufacturers have a right to prevent others from making using, selling, distributing or contracting with another to obtain certain useful substances or technology, intellectual property rights do not give manufacturers the right to produce, distribute or to sell a substance or a technology. Manufacturers are free to place that technology on the shelf. Likewise, the FDA is well within its granting rights to manage intellectual property in a quest for consumer safety.

As a result of establishing an IPC, the FDA would learn more about new and esoteric drugs and devices, and it would be able to use that information to promote public safety.

Let’s take a look at what might be looming in our future if the FDA does not become proactive in intellectual property management.

Global pharmaceutical and device enterprises are rapidly emerging. For example, global companies are partnering with corporations like Ranbaxy in India to provide affordable medicines, in some cases to acquire older products that are off patent. Although substances are off patent, nothing prevents a manufacturer from enhancing those substances and keeping the technology as a trade secret. Likewise, nothing prevents a global manufacturer from contracting exclusively with a primary producer of an active ingredient that has sole proprietary large scale production capabilities.

Given the profit involved, other players such as China will be in a quest to compete with India. For example, Chinese manufacturers are posing a serious threat to their Indian counterparts by reverse engineering similar drugs and manufacturing alternatives at prices that are cheaper than Indian drugs. With all of this in mind, India is beginning to realize that Intellectual property management might play a major role in encouraging R&D and proper regulation.

In conclusion, the FDA should consider becoming more involved in reviewing and managing the intellectual property behind pharmaceuticals and medical devices. There will be a day when a competitive global, technological tsunami occurs, and the time for the FDA to prepare for that eventual tsunami is the present.

Originally posted at InjuryBoard by Armand Rossetti

Tobacco Companies to Kids: Be Cool, Try It!

Brian Denney — Mon, 05 Oct 2009 09:33:16 GMT

Would you believe that eating lots of apple sauce is no more dangerous than smoking cigarettes?

www.youtube.com/watch

Would you believe that some pregnant women like to smoke so they can have babies that are smaller?

www.youtube.com/watch

Would you believe the Flintstones smoked cigarettes?

www.youtube.com/watch

Chances are, if you are educated enough to access this blog, you wouldn’t believe any of the above statements and recognize them for what they are – poppycock (with the exception of the Flintstones, whose illustrators took part in advertisements for Winston cigarettes).

However, up until approximately twelve years ago, the tobacco industry would have had you believe that cigarettes were not bad for you, but were in fact good for you. Indeed, it wasn’t until 1997 that a single tobacco company finally admitted that cigarette smoking causes cancer, heart disease and that cigarettes were marketed to children.

www.youtube.com/watch

Here are some additional facts concerning children and cigarettes that may shock you:

Approximately 89% of people who smoke began smoking before the age of 18. Accordingly, most experts agree that the tobacco companies have traditionally targeted their advertisements to adolescents. Adolescents, as most of us know from experience, are impressionable and often suffer from a lack of self esteem (what teenager hasn’t gone through an awkward phase). Iconic figures created by the tobacco industry such as Joe Camel and the Marlboro Man provide adolescents with an example of confidence, strength and coolness, with a little rebellion mixed in (what teenager hasn’t wanted to rebel against authority). The message the tobacco industry is sending is clear: Kids, if you want to be strong, confident, cool and springboard into adulthood, light up a cigarette. Don’t take my word for it…the tobacco industry has admitted in numerous internal documents that kids as young as 14 were in their target group. Have a look at the chilling statistics cited at Tobacco Free Kids. While you’re there, take a look at some of the ads the tobacco industry has published in the USA and throughout the world with two goals in mind: To get people (kids, it would seem) to become and remain smokers.

Originally posted at InjuryBoard by Brian Denney

Dangerous Dietary Supplements – The unraveling of Enforcement

Alyssa DiEdwardo — Thu, 26 Feb 2009 15:52:07 GMT

According to data from the Third National Health and Nutrition Examination Survey (NHANES III), One in three, or 58 million American adults, aged 20 through 74 are overweight. So it should be no surprise that according to the Nutrition Business Journal, in 2007 out of the $24 billion dollars Americans spent on dietary supplements $1.7 billion went for weight loss supplements. In fact in a survey, 15% of Americans adults stated that they have used weight loss supplements and the majority did not inform their physician.

The big sellers in the industry are also no surprise; they include drugs for erectile dysfunction, diabetes, as well as obesity. The majority of these products are often labeled as “Dietary Supplements” or “Natural Supplements”, but what the public does not realize is that the FDA does not hold these manufacturers to the same standards as pharmaceuticals.

These products are highly susceptible to problems with efficacy, purity and contamination and spiking of undeclared substances. This is a supplement that has been in the headlines after it was found to have been spiked with the banned diuretic Bumetanide. This ingredient has been linked to electrolyte abnormalities, cardiovascular collapse, cardiac arrhythmias, heart attack, stroke and death. We should not forget is that this is not the first time StarCaps was found to have contained the banned substance. In 2007 a Lab in Tennessee tested StarCaps and it was found to have contained the same banned substance after several NFL players were suspended for failing a drug tests.

According to the FDA “Many of these products do not list the manufacturer on the label or in the advertisements. However, most of the products appear to have been manufactured in China.”

The FDA has now expanded the consumer warning and the list has grown over the last several weeks to over 69 products posted on the website as having contained undeclared and possible banned substances. Below is the link to the FDA site for the latest in this ongoing investigation.

In response to my recent Blog posted 2/26/09 titled “Dangerous Dietary Supplements – The unraveling of Enforcement”, We have received notification from attorneys for StarCaps that they have in fact issued a voluntarily recall of certain lot numbers which are posted on the FDA’s website, most recently updated 12/8/08. We have removed the references from the original blog posting, containing the incorrect information, and add this note for further clarification. For additional information on specific lot numbers that have been recalled we have provided the link to the FDA website below:

http://www.fda.gov/oc/po/firmrecalls/balancedhealth11_08.html

In addition a Press Release is posted the StarCaps website advising consumers that they have “temporarily suspended shipping of StarCaps pending the results of our (StarCaps) investigation” http://www.starcaps.com/

Originally posted at InjuryBoard by Alyssa DiEdwardo

Why did Yamaha call its Rhino Side by Side a UTV instead of an ATV?

Armand Rossetti — Tue, 20 Jan 2009 17:23:47 GMT

The answer is simple. A Utility Terrain Vehicle or UTV designation places the Rhino in a netherworld of unregulated motor vehicles. I have used the word netherworld because a Rhino UTV can look as innocent as this, or it can look like this, or even like this. There are hundreds of after market suppliers and modification services that can turn a very unsafe factory basic vehicle into a really unsafe modified monster.

In fact, Rhino owners can purchase a typical basic factory Rhino, with a narrow track, small tires and a high center of gravity, modify the vehicle accordingly, and subsequently perform some very dangerous maneuvers with a modified version, such as this hill climb,

this hill climb

these types of jumps,

types of jumps

or these extreme maneuvers (not all participating vehicles are Rhino UTVs)

extreme maneuvers

If anyone told me that Yamaha could not reasonably foresee the misuse that its unclassified Rhino UTV would be undergoing, I would not believe them for a minute. In fact, the Consumer Product Safety Commission (CPSC) should also have refused to believe Yamaha.

On a related matter in December 2006, the CPSC requested public commentary on its regulation entitled, Standards for All Terrain Vehicles and Ban of Three Wheeled All Terrain Vehicles. During the period for commentary, the Commission received a substantial number of responses (which begin on page six).

In any event, Yamaha has succeeded in circumventing ATV rules. As a result, the Rhino is neither a car nor an ATV. And as an unregulated “emerging hazard,” the Rhino provides children and unsuspecting adults with the unbridled freedom to drive a Rhino normally, and receive an all too frequent opportunity to create a netherworld of horror for themselves and their families.

Strangely enough, one of the few differences between a regulated ATV and an unregulated UTV is that a UTV has a steering wheel instead of handles. Therefore, the CPSC terms a UTV as an “emerging hazard.” Some in the industry have commented that crafty manufacturers have created the emerging hazard vehicle category to work around existing safety regulations.

Originally posted at InjuryBoard by Armand Rossetti

Chantix: Why the Rush?

Armand Rossetti — Sun, 16 Nov 2008 15:43:49 GMT

In May 2006, the Food and Drug Administration (FDA) approved Pfizer’s Chantix (varenicline tartrate), a smoking cessation drug. Reportedly under priority review, the FDA had cut the usual review period from 10 to six months. Reportedly, the FDA abbreviated its usual review period, because it had received preliminary efficacy studies showing that Chantix was superior to another approved smoking cessation drug, Zyban (bupropion).

The FDA’s Motivation to Reduce the Review Period:

At first blush, the FDA was impressed with evidence that Chantix acted in two ways to help individuals give up smoking: 1) it mimicked the effects of nicotine and eased withdrawal symptoms; and 2) Chantix actually blocked the effects of nicotine in case users resumed smoking. As a result for those on the Chantix cessation program, smoking would be futile because it would not provide a nicotine high.

Before reducing the review period, the FDA analyzed six Chantix clinical trials (five were controlled and randomized), which included 3,659 chronic cigarette smokers averaging 21 cigarettes a day for over 25 years, and those studies revealed that Chantix was superior to placebo in helping people to quit smoking. Two of the five controlled and randomized studies showed that Chantix was superior to Zyban.

At the end of 12 weeks, the two studies provided evidence that 44 percent of the subjects taking Chantix stopped smoking, compared to 30 percent of subjects taking Zyban and only 17 percent of those given a placebo. A one year follow up revealed that 22 percent of those taking Chantix, 16 percent of those taking Zyban and 10 percent given a placebo remained smoke-free.

At the time of FDA approval, the most commonly observed adverse effects in order of declining occurrence were nausea, changes in dreaming, constipation, gas and vomiting.

Developments since FDA the Approved Chantix:

September 24, 2007:

CBS11, Dallas Fort Worth ran a story about a local musician named Carter Albrecht who took a few drinks and then swallowed his first 1 milligram Chantix tablet. Carter’s girlfriend, Ryann drove him home from a local bar and noticed and noticed that Carter didn’t seem himself, and later became abusive and delusional. By the time the couple arrived home, Carter became aggressive and hit Ryann several times, and she remembers being curled up in a fetal position for self protection when Carter asked…"Who did this to you and why are you crying?"

Later that night, Carter ran from the house and apparently broke into a neighbor’s house. Thereafter, a gun fired and Carter subsequently died from a gunshot wound. Family and friends said that Carter was never violent, and both Ryann and Carter’s father felt that Chantix had played a role in this tragedy.

The CBS11 report provided several examples of individuals all over the country who had used Chantix and had felt suicidal, become aggressive, had bad dreams accompanied by horrible suicidal ideations. This prompted CBS11 to access the FDA’s database of adverse side effects (the Manufacturer and User Facility Device Experience Database [MAUDE]) where CBS reporters found thousands of similar and very serious reactions to Chantix.

CBS11 noted that Pfizer had provided one package insert for consumers that listed only five “common” side effects, and another for doctors, listing frightening side effects printed in tiny, 1 millimeter size print. That second list included suicidal thoughts, aggression, and neurological and psychiatric disorders.

According to CBS11’s report, a Dallas addiction psychiatrist, Byron Adinoff said that taking Chantix with alcohol could lead to unpredictable results. However, Chantix contained no warning about possible dangers of taking the drug while consuming alcohol.

What the FDA (and Pfizer) Knew or Should Have Known before the FDA Abbreviated its Chantix Review:

Scientific American posted a November 24, 1997 story on the Internet, showing that people who are addicted to one substance are more likely to be addicted to others. For example, Alcohol and nicotine become habit forming in like ways. In fact, the strongest connection is evident between nicotine and alcohol, because smokers drink twice as much alcohol as non-smokers.

According to the Scientific American story, one study found that alcoholism is 10 to 14 times more prevalent among smokers than non-smokers. And while smoking has dropped 30% among American adults, it remains unchanged among alcoholics.

November 20, 2007:

After receiving thousands of adverse event reports, the FDA issued a release entitled, Early Communication About and Ongoing Safety Review Varenicline (marketed as Chantix). The Early Communication confirmed that there were increased reports of suicidal thoughts, aggressive erratic behavior, and drowsiness among a significant numbers of consumers who had been using Chantix. As a result, the FDA recommended that healthcare professionals monitor patients taking Chantix for behavior and mood changes; that patients contact their doctors if they experience such, and that patients should use caution while driving or operating heavy equipment until they knew how Chantix affected them.

January 18, 2008:

Pfizer released, Pfizer Statement on CHANTIX (varenicline) Labeling Update in the United States that reiterated the FDA’s November 20, 2007 Early Communication. However, Pfizer stated that a causal relationship between Chantix and the reported symptoms had not been established. Nevertheless, Pfizer cited complications, such as nicotine withdrawal, and worsened conditions in patients with pre-existing psychiatric illnesses.

Pfizer continued its Statement by indicating that Chantix was "a real breakthrough medicine" and that its Chantix clinical trial program with more than 5000 patients had shown no incidents of suicidal ideation, depressed mood or suicidal behavior different than placebo-treated patients. Moreover, clinical trials attributed no connection between suicides and Chantix consumption. However, it is important to note that Pfizer admittedly did not include patients with serious psychiatric illnesses such as schizophrenia, bipolar disorder and major depressive disorder in the controlled clinical program. One might want to question why this was the case.

February 1, 2008:

The "FDA News" posted the story: FDA Issues Public Health Advisory on Chantix. That story contained a request that Pfizer add new safety warnings for Chantix. The FDA reported that it had been continuously reviewing adverse event reports (AERs) and had concluded that an association between Chantix and serious neuropsychiatric symptoms was increasing likely. Therefore, the FDA suggested that Pfizer “elevate the prominence of its safety information to the warnings and precautions section of the Chantix prescribing information.” You may link to a related FDA video here.

May 21, 2008:

The Institute for Safe Medication Practices (ISMP) published a paper entitled, Strong Safety Signal Seen for New Varenicline Risks. The paper provided information that in the fourth quarter of 2007 alone, Chantix accounted for 988 FDA reported serious injuries in the US, more than any other individual drug in that time period. To compare, in the same period, the FDA received a median of 5 reports each for 769 different drugs. After seeing such a large number of Chantix reports, the ISMP conducted a further investigation.

In its February 2008 health advisory, The ISMP report pointed out that the FDA had not provided the numbers of reported neuropsychiatric events. The ISMP report showed that from May 2006 through December 2007, the FDA had received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. Among those events reported, there were 28 cases of suicide, 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination, categories not being mutually exclusive.

In addition, the ISMP saw evidence that reports of other kinds of serious harm suspected as being Chantix related that had no current manufacturer’s warnings. Among the most prominent were: accidents and injuries (123 reports); vision disturbances (148 reports); heart rhythm disturbances (224 reports); seizures and abnormal muscle spasms (372 reports); moderate and severe skin reactions (338 cases); and diabetes (544 reports).

The ISMP then offered the following recommendations and promptly notified the FDA:

“We have immediate safety concerns about the use of varenicline among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury. Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices. Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings. The extent to which varenicline has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported. The Federal Aviation Administration approved varenicline for use by airline pilots before most of these reports were available.

In addition, we recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.

Finally, we urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks.”

May 23, 2008:

Less than 48 hours after the Federal Aviation Administration (FAA) learned from reviewing the ISMP report that Chantix might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. Perhaps the following statement from the FAA underscores the caution that the air travel safety agency takes to assure public safety:

“In November 2007, the FDA began to receive reports of psychiatric problems associated with the medication. The FAA’s Federal Air Surgeon Fred Tilton said he was aware of the anecdotal information circulating about Chantix, but chose to rely on hard data as it became available. “There were indications, but no clear data,” he said. “We don't just act indiscriminately.”

When more conclusive data was published this week, Tilton's Office of Aerospace Medicine moved quickly in response.

Medications approved for pilot and controller use must undergo a rigorous review process before being considered acceptable. When a new class of drug comes on the market, members of FAA’s Office of Aerospace Medicine require at least a year for data to emerge regarding its effects, at which point a review board can then be convened. If any red flags are detected by the board during evaluation, the medication will be prohibited.”

October 23, 2008:

The Los Angeles Times ran a story entitled; Prescription drug injuries and deaths reach record levels, which pointed out that Chantix (varenicline) was the most dangerous medication in the first quarter of 2008. During that period ending in March 2008, Chantix was linked to 1,001 injuries and 50 deaths, followed by heparin, associated with 779 injuries and 102 deaths. In addition, The Times reported that during the first quarter of 2008, Chantix accounted for more reports of serious injury than the 10 bestselling prescription drugs combined.

It is important to note that these statistics were the result of reviewing voluntary adverse event reports that the FDA receives and posts in its Manufacturer and User Facility Device Experience Database (MAUDE). The Los Angeles Times reported that because adverse event reporting is voluntary, researchers have speculated that fewer than 10% of adverse events actually make it into MAUDE.

Although Chantix may have caused the most injuries of any drugi in the first quarter of 2008, it did not cause the most deaths, because 10 other drugs each caused more than 100 deaths. That statistic compared with an average of one to three drugs in previous quarters.

Conclusion:

We live in an era of esoteric drug manufacturing.

Since the rates of injuries and deaths seem to be speeding up, maybe the FDA should not be abbreviating review periods. Perhaps the FDA should review all manufacturer’s literature for one millimeter high typing that contains further, important information about possibilities of serious side effects.

If the FDA finds evidence of suspected danger, perhaps it should recommend a two year period of extreme caution when prescribing medications suspect of those dangers.

If the FAA can wait a year to review postmarketing reports before allowing pilots and air traffic controllers to take certain medications, the FDA should be able to demand that manufacturers that suspect certain dangers connected with the use of a new drug might manifest issue an immediate transitional boxed warning. The transitional boxed warning might also contain an explanation that the early warning is temporary until the two-year postmarketing period ends, and that the manufacturer may either withdraw the transitional warning, if the suspected dangers do not manifest, or make the warning permanent if the suspected dangers persist.

There are benefits that manufacturers, the FDA, health care personnel and consumers must weigh against the risk of taking a drug. However, while everyone reviews those risks that hurt and benefits that help, during the postmarket review, warnings will never hurt anyone.

Originally posted at InjuryBoard by Armand Rossetti

Profit Over Safety -- A $20 Decision

John Hopkins — Tue, 01 Dec 2009 10:04:27 GMT

A 46 year old woman is paralyzed when her sport utility vehicle rolls over and the roof collapses onto her. The manufacturer knew their SUV was prone to rollovers and in the event of a rollover, the roof was insufficiently reinforced to prevent the very injuries suffered by the woman. In the case, the woman alleges that a fix to the roof stability would have cost the SUV maker approximately $20 per vehicle.

This story sounds a great deal like a car prone to catching on fire and exploding when rear ended at relatively low speeds. In those cases, the auto maker consciously chose not to spend the money to recall and retrofit the vehicles. That decision unnecessarily cost many lives.

Oh, yeah, in both instances it was Ford. In the earlier case it was a little car called the Pinto and in this most recent case, a little SUV called the Explorer.

It boils down to making “business decisions” in the best interest of stock holders is what Big Corporations say. They are forced to weigh their overhead against the need for design modifications. They are charged with answering to stockholders who have hitched some portion of their financial future to these very decisions.

It boils down to making decisions that do not place profits over safety is what I say. Sorry Corporate America, but it should not be acceptable to place the public in peril of life or limb for $20. In fact, it should not be OK with anyone to have a 46 year old woman and mother of two children who will never walk again because it was not expedient or economical to either, first design or second retrofit a product to make it as safe as possible.

When Ford was hit with this jury verdict amounting to over $350 million for both compensatory and punitive damages, they appealed. The courts reduced the jury verdict to $82 million, for both compensatory and punitive damages. Ford cried foul and appealed; arguing that they made reasonable judgments in the design of the SUV and they should not be responsible for punitive damages.

When Corporate America demonstrates a conscious disregard for the safety of consumers, punitive damages are appropriate. When an industry makes billions marketing a 3000 pound object that moves at 70 mph “reasonable judgments” that include the failure to spend $20 additional for safety most certainly justifies these damages.

Originally posted at InjuryBoard by John Hopkins