Des Moines Personal Injury Lawyer - Defective Drugs

You've been exposed to Cadmium - now what?

Megan Roth — Mon, 05 May 2008 00:00:15 GMT

Cadmium poisoning and how to effectively treat it is a conundrum.

Alright, let's say you've done everything we recommended in order to prevent cadmium poisoning. You've altered your diet to include a well-balanced mix of all major food groups, you've replaced your rusty, out-dated pipes, and you've stopped smoking (cold turkey, of course). So now there's no risk of cadmium exposure, right? Wishful thinking. Though you've decreased your risk, there's no way to completely eliminate it. Let's pretend that, one way or another; you've been exposed to the toxin. How do you know you've been exposed and how should you react?

First and foremost, you should know the symptoms of cadmium poisoning, which adversely affects respiratory and kidney functions. Anytime cadmium exposure is suspected or symptoms resemble those of cadmium poisoning, seek medical attention; there's no effective treatment for the poison, so it's important to diagnose it and begin work against it right away.

If you've been exposed to the toxin, immediately remove yourself from the environment in which exposure has occurred and administer oxygen. If exposure occurred through the ingestion of cadmium salts, induce vomiting ASAP; as happens when any toxin is ingested, our bodies react naturally as a means of warding off the harmful substance. The easiest way to eliminate this is to rid the body of the toxin, through whatever means necessary.

It's important to note that, to date, no treatment has been proven effective for cadmium poisoning. As a result, exposure to the toxin must be treated symptomatically. For example, cadmium poisoning often causes headaches, chest pains, muscle aches, coughing and fevers; though they may not be cured, each of these symptoms can be lessened with the use of over-the-counter medications.

Similarly, one who's experiencing the common symptoms of dizziness and fatigue will no doubt benefit from the ever-popular doctors' recommendation to get a little R&R - yup, you guessed it: rest and relaxation. While having an excuse to curl up on the couch without feeling guilty may seem nice, it'll undoubtedly get old when you have to do it day after day because your symptoms aren't going away.

This is the major problem: there may be means of providing temporary relief from symptoms of cadmium poisoning, but they are just that: temporary. The effects of cadmium poisoning will not go away and, in the long-term, they will not get better. Thus, it is essential to avoid exposure to the harmful element at all costs (regardless of how expensive they may be).

Originally posted at InjuryBoard by Megan Roth

The High Cost of Cheap Batteries

Megan Roth — Sat, 03 May 2008 00:00:15 GMT

While we're doing our best to keep our wallets thick, we're contributing to the health deterioration of any factory worker or distributor. Though the negative effects of cadmium batteries are well-known and well-publicized, we buy them because of their cheap cost and quick surge of power.

Alright, we've all heard of the infamous documentary: The High Cost of Low Prices. The film provides an overview of the negative aspects and consequences Wal-Mart's cheap goods have on both employees and manufacturers and prompts consumers not to shop at the superstore. While it presents an overview of the negative effects cheap goods have on employee lifestyles, it fails to adequately educate consumers of the effects those low prices have on factory workers' health.

It's well-known that our economy is struggling and that it's necessary for consumers to squeeze every penny for what it's worth; thus, it comes as no surprise that generic brands and cheaper alternatives are popping up at every corner at lesser costs than name-brands. But are these alternatives really beneficial? While it's great that they cost less, we can't help but take note of the effects these not-so-great products have on the rest of society.

One example of a seemingly beneficial but realistically harmful alternative is cadmium batteries, which have been known to save consumers approximately $1.50 a pack. But while we're doing our best to keep our wallets thick, we're contributing to the health deterioration of each and every factory worker involved in the construction of such products.

Take, for example, Ms. Wang Fengping. Sound familiar? Probably not. Until this past January, Ms. Wang was just another factory worker in China. However, after the WallStreet Journal wrote an article on her deteriorating health and its correlation with cadmium poisoning, she became a representative of the adverse effects cadmium batteries have on human health. And Ms. Wang isn't alone.

Many workers are employed by similar corporations' factories in Singapore, Thailand, and other third-world countries where the options for making a living are relatively few and far between; thus, they can't leave their factory job in search of a better opportunity because there is no other opportunity - at least not there.

Remember ten years ago when Nike was publicly scorned for its dangerous working conditions within its factories? We didn't accept it then, so why is it accepted now?

Though the negative effects of cadmium batteries are well-known and well-publicized, we buy them because of their cheap cost and quick surge of power. True to the American way, we continue to purchase low-cost products simply they're cheaper; but is what we save monetarily really worth the cost such products have on human health?

Originally posted at InjuryBoard by Megan Roth

House and Senate Bills Creating New CPSC Powers is Long Overdue

Steve Lombardi — Mon, 31 Mar 2008 00:00:49 GMT

Editorials like one appearing in the Wall Street Journal on Tuesday, March 4, 2008 are examples of irresponsible journalism. Just as the public tired of "liberal media" so are they sick and tired of the other extreme form of journalism that adds nothing to solving problems. The editorial board should go back to the basic foundation of good solid journalism and save their opinions for personal gatherings. I have one further suggestion. They should sharpen the lead in their pencils and as their mothers surely warned them, keep it out of your mouth.

In the Tuesday, March 4, 2008 edition of the Wall Street Journal there is an editorial titled "Lawyers 'R' Us. It discussed the house and senate versions of bills trying to strengthen the Consumer Product Safety Commission. Included in the editorial are claims that both bills include provisions that would "more than double the agency's budget by 2015...", increase "civil penalties faced by companies in violation of consumer safety rules.", a "whistleblower provision", "distribute enforcement power among the nation's dozens of state Attorneys General", allow the AG's the right "to file lawsuits and enforce rules against manufacturers"; "making matters worse, the Senate bill would create a new product safety database to provide "disclosure" of safety complaints - ostensibly for the benefit of consumers.", and lastly, "complaints from consumers would be listed on an official CPSC searchable database without any requirement to verify the claim or alleged defect."

At first glance I thought they were trying to be funny. In light of what we've recently experienced with lead paint on toys and how that affected the Christmas spending by consumers it appeared completely off the mark. But reading it again didn't shed any further light on the point of this editorial. The title suggests envy about what the editorial board perceives lawyers earn. If you don't like what your job pays then by all means get a new one. But don't throw your ethics away just to sell newspapers. Let's analyze each point the editorial makes to see if there's lead in the editorial staff's pencils. In considering each point they make and reflecting on current stories of toys covered in lead paint it's difficult to appreciate how anyone on the editorial board would consider this to be responsible journalism. Not even if they own stock in Mattel does this make sense to criticize. Let's examine each point they make and ask ourselves if this is a reasonable response to the proposed legislation.

WSJ COMPLAINT #1: Included in the editorial are provisions that would "more than double the agency's budget by 2015..."

RESPONSE #1: From all appearances the CPSC has been underfunded and is incapable of carrying out its legal mandate. So what is that mandate? On the website the mission is stated as:

"The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $800 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years. "

And in its annual report to the Congress the mission is described as follows: "CPSC's mission is to protect children and families against unreasonable risk of injury and death from over 15,000 types of consumer products. It is the only Federal agency that both identifies and acts on a wide range of product hazards. Our work ensures a uniform level of safety for the nation's families and provides businesses with a national level playing field for domestic and imported consumer products. CPSC addresses consumer product hazards through: the voluntary standards process; consumer information; safety guidelines; cooperative product recalls and corrective actions; and as a last resort, mandatory rulemaking and litigation. We operate advanced hazard identification systems, including a national hospital emergency room injury reporting system and provide safety information to the public through a toll-free telephone hotline, a clearinghouse, and a web site."

Whatever the budget may be in 2015 is anybody's guess but in light of the recent spate of defective toys coming into this country from abroad the one for 2008 seemed to be reasonable and realistically geared towards identifying and correcting current problems. For 2008 the CPSC requested $63,250,000. That amount represents a net increase of $880,000 over the 2007 funding level. That's an increase of 1.39%. Considering the CPSC deals with defects that are a fire hazard, those that can cause carbon monoxide poisoning and those concerning the safety of children's toys a 1.39% increase appears reasonable.

The 2009 Performance Budget Request includes the provision of $6,000,000 remaining available through 2011 for costs associated with the relocation of CPSC's laboratory to a modern facility and the upgrade of laboratory equipment. The 2009 request increases its budget to $80,000,000 for fiscal year 2009. This is in line with the goals set by Congress to enhance import safety and product testing capabilities. Simply put, if the manufacturers won't do the testing then we will.

WSJ COMPLAINT #2: Increase "civil penalties faced by companies in violation of consumer safety rules." The CPSC has been a commission seeking voluntary solutions to product hazards.

RESPONSE #2: What's wrong with putting teeth into enforcement? If after you warn the delivery boy about throwing the newspaper through your window, but continue to buy the newspaper he'll never stop. We've known for centuries how little we can trust the word of the Chinese government. Why then not make penalties real? As it is the CPSC is too nice.

Here is what I'm referring:

Whenever possible, the Commission seeks a voluntary solution to product hazards. This voluntary approach is demonstrated by our high ratio of voluntary to mandatory safety standards (almost ten-to-one since 1990) and our success at getting voluntary recalls (100 percent in 2006). (Page 9 of the report.)
HOW WE REDUCE HAZARDS -
The Commission uses a number of strategies to reduce the risks associated with hazardous consumer products. These strategies include (1) participating in the voluntary standards process or developing mandatory safety standards; (2) conducting compliance activities such as recalls, corrective actions, and enforcement of existing regulations; and (3) alerting the public to safety hazards and informing them about safe practices. We also recently developed an international program to focus on reducing hazards from imported products. The agency bases its actions to reduce the risks from hazardous consumer products on information developed from its extensive data collection systems that assess the causes and scope of product-related injuries.

Consumers already think it's the fox watching the henhouse. Maybe if consumers read about a few large fines, consumer confidence would improve and it's consumer confidence that drives this economy.

WSJ COMPLAINT #3: A "whistleblower provision".

RESPONSE #3: If the manufacturer isn't doing anything wrong they have nothing to fear from those working in the manufacturing process.

"Staff participates in the development of voluntary standards at a number of steps in the process. Staff first submits recommendations for new standards, or modifications of existing standards, to voluntary standards organizations. On acceptance of our recommendations, the organizations complete technical work to support the requirements, publish a proposal for public comment, receive and evaluate comments, and publish a standard. This process may take months or several years. Staff participates in the process by providing expert advice, technical assistance, and information based on data analyses of how deaths, injuries and/or incidents occurred. Our voluntary standards policy does not permit us to vote on proposed changes or new standards. However, our comments are considered throughout the process."

It's been reported that whistleblowers attempting to report safety issues face an uphill battle just trying to keep their jobs.

"Whistle-blowers have faced hostility not only under Republican administrations. During President Clinton's tenure, Bogdan Dzakovic, an undercover security agent with the Federal Aviation Administration, suffered retribution for speaking out about weak airport security -- three years before Sept. 11, 2001. Dzakovic was passed up for promotion time and again, and today, he says, he remains consigned to data entry duties for the Transportation Security Administration.
But a six-month investigation by the Center for Investigative Reporting, in collaboration with Salon, has found that federal whistle-blowers almost never receive legal protection after they take action. Instead, they often face agency managers and White House appointees intent upon silencing them rather than addressing the problems they raise. They are left fighting for their jobs in a special administrative court system, little known to the American public, that is mired in bureaucracy and vulnerable to partisan politics."

And so the fox stretched and yawned... and was heard to mutter, "Will they ever learn?"

WSJ COMPLAINT #4: "[D]istribute enforcement power among the nation's dozens of state Attorneys General", allow the AG's the right "to file lawsuits and enforce rules against manufacturers"

RESPONSE #4: The CPSC is stretched thin and including state AG's in the process would go a long way to enforcing product standards. Spreading out the duties would reduce the CPSC's workload. The state AG's already assist as a valuable and credible enforcement arm so why be concerned about them lending a hand? Is there a specific complaint the editors have to present or is this just more whining?

WSJ COMPLAINT #5: "[M]aking matters worse, the Senate bill would create a new product safety database to provide "disclosure" of safety complaints - ostensibly for the benefit of consumers."

RESPONSE #5: You're kidding me right? You're whining about consumers telling each other what's wrong with the toys they buy for their kids? The Commission does this already and the manufacturers have input into any rules that may apply. What's wrong with a mother telling other mothers and fathers that a certain toy has been found to have lead in it? If you're worried about false reports then allow the CPSC to add editorial comment or for that matter let the manufacturers add comments.

"Safety standards may also be developed through mandatory rulemaking. If a voluntary standard exists, by law, we may issue a mandatory standard only when we find that the voluntary standard will not eliminate or adequately reduce the risk of injury or death or it is unlikely that there will be substantial compliance with the voluntary standard.

Generally, our statutes require us to go through a three-step rulemaking process (an advance notice of proposed rulemaking, a notice of proposed rulemaking, and a final rule). During this process, we seek input from all interested parties, including consumers, industry and other government agencies. We usually develop performance standards, rather than design standards, to give manufacturers the most flexibility in meeting our requirements. Examples of mandatory standards are requirements for child-resistant lighters and for bunk beds. We may initiate rulemaking based on petitions from outside parties or based on our own internal staff work."

WSJ COMPLAINT #6: "[C]omplaints from consumers would be listed on an official CPSC searchable database without any requirement to verify the claim or alleged defect."

RESPONSE #6: Why would a supposedly objective third-party see a downside to making complaint information readily available to end users? To some extent this is already occurring. By creating a portal with the CPSC it would funnel to the very agency responsible for enforcement.

"CPSC warns the public about product-related hazards through print and electronic media, our hotline and the Web sites (www.cpsc.gov, www.recalls.gov and www.atvsafety.gov) and other outreach activities such as the Neighborhood Safety Network (NSN). The NSN is a grassroots outreach program that provides timely, lifesaving information to 5,000 individuals and organizations who, in turn, share our safety posters and news alerts with underserved consumers who would have otherwise never heard or received the information from CPSC. Additionally, we develop and provide safety information for the public through safety and recall alerts, print and video news releases, public service announcements, publications, national and local television appearances, and hotline messages. When knowledge of a hazard requires immediate warnings to the public, such as the recall of a playpen that caused the death of a baby, we rely heavily on the media (newspapers, radio, TV, news wire services) to disseminate our message. For warnings that need to be repeated -- and most do
-- we often rely on outreach by partnering with other organizations and developing programs, such as the NSN, to more rapidly disseminate important safety information."

Allowing citizens to participate in safety issues will benefit everyone. Secrecy aids nothing but adds to the injured children. If you want to reduce the number of legal claims for personal injury then this is a perfect way to achieve that goal. Let citizens warn each other and you will reduce the number of unsuspecting children who are injured. Do that and you keep the parents put of the trial lawyer's office.

WSJ COMPLAINT #7: Another complaint of the WSJ editorial staff is that small manufacturers will be put at a disadvantage due to costs associated with enforcement.

RESPONSE #7: This doesn't seem to be a legitimate assumption. First of all we already are at a disadvantage with Chinese labor costs. Second, a disadvantage is not a legitimate reason to poison our children with lead paint. It may cost American manufacturers more to do business but it will equally impact the imported toys. The Commission is sensitive to the disparity across markets and tries to do what it can to work with manufacturers on a voluntary basis.

"We use a Small Business Ombudsman to help small firms comply more easily with product safety regulations and guidelines by providing them with a single point of contact for assistance and information. The Ombudsman coordinates a clear and understandable response from our technical staff so that firms receive the information they need within three business days.

In 2003, we initiated the creation of www.recalls.gov, an innovative "one-stop shop" for all federal product recalls, in partnership with five other federal health and safety regulatory agencies. This Web site is an easy-to-use portal to all federal agencies that have the authority to conduct safety recalls. In 2006, there were 1.2 million visitors to the site. The hotline receives consumer complaints and provides information on product hazards and recalls to the public. The National Injury Information Clearinghouse provides injury data to our staff and the public and provides manufacturers with consumer complaints, reported incidents, and investigations involving their products."

The editorial makes it seem as if this is an agency that is out of control, interfering with the business of making toys and one that has gone too far. In reality that's just not true.

"For 2006 and 2007, we reduced resource levels and reduced some annual performance targets to reflect resource reductions, as appropriate. In 2008, we set ambitious targets given the proposed reduction in staff. After further analysis by the Commission, and based on actual funding, targets may have to be adjusted in the 2008 Operating Plan."

CONCLUSION: Editorials like the one appearing in the Wall Street Journal on Tuesday, March 4, 2008 are examples of irresponsible journalism. And just as the public grew tired of the "liberal media" so too have they become sick and tired of the other extreme flavor of journalism that adds nothing to solving problems. The editorial board should go back to the basic foundation of good solid journalism and save this baseless opinion for personal gatherings. I have one further suggestion. They should sharpen the lead in their pencils and as their mothers surely warned them, keep it out of your mouth.

http://www.cpsc.gov/CPSCPUB/PUBS/REPORTS/2008plan.pdf

http://www.cpsc.gov/CPSCPUB/PUBS/REPORTS/2009plan.pdf

Originally posted at InjuryBoard by Steve Lombardi

FDA Warning - Heparin - more Heparin products recalled

Steve Lombardi — Tue, 25 Mar 2008 00:36:09 GMT

Another Heparin product recall. You should know that this anticoagulant drug is manufactured from pig intestines. Surprised? From where do you think the ingredients for the widely taken menapause drug Premarin are found? Read today's blawg post to find out.

More Heparin products have been voluntarily recalled on a nationwide basis.

The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

If you've been injected with any drug products and have any of these reactions you should immediately contact your doctor or health care provider for a thorough examination. The manufacturer on this latest recall is B. Braun Medical Inc. who was notified by its supplier, Scientific Protein Laboratories LLC (SPL).

You may want to know what Heparin is used for and from where it's ingredients are found. It is an anticoagulant and it's ingredients are processed from pig intestines or bovine lungs. Here is how Wikipedia describes Heparin.

Heparin, a highly-sulfated glycosaminoglycan, is widely used as an injectable anticoagulant and has the highest negative charge density of any known biological molecule. It can also be used to form an inner anticoagulant surface on various experimental and medical devices such as test tubes and renal dialysis machines. Pharmaceutical grade heparin is derived from mucosal tissues of slaughtered meat animals such as porcine (pig) intestine or bovine (cow) lung.

If this surprises you or grosses you out consider the following description of Premarin.

Premarin is the commercial name for compound drug consisting primarily of conjugated estrogens. Isolated from mare's urine (PREgnant MARes' urINe), it is manufactured by Wyeth Pharmaceuticals and has been marketed since 1942. It is available in oral (0.3/ 0.45/ 0.625/ 1.25mg), IV, and topical form.

Originally posted at InjuryBoard by Steve Lombardi

Trial Lawyers - Evidence Based Medicine

Steve Lombardi — Thu, 20 Mar 2008 00:00:31 GMT

We've heard all about the necessity of expert witnesses using evidence based medicine to formulate opinions in law suits. Of course many of us have not bought into "evidence based medicine" as the cure for what some characterize as "fairer judicial decisions". We've been around too long and heard it previously suggested that the jury system needs to be fixed by those with a financial interest in the outcome of trials.

The New England Journal of Medicine (Volume 358:252-260, January 17, 2008, Number 3) astutely points out the fallacy that can exist behind this testimonial concept. If the evidence base is complete and unbiased the theory is that evidence based medicine as a concept works. I'm not buying any of it. What this concept does is simply create one more hurdle for common people to obtain a fair trial to obtain adequate compensation for injuries caused by the medical and pharmaceutical industries. The two most effective weapons against unfair trial results remain. They are common sense and cross examination.

Trial lawyers and Judges should not be fooled into believing the doctors know more about trial work and the rules of evidence. They don't and this evidence based medicine concept is nothing more than an old trick to fool us into one more attempt at intellectualization of what should be a common sense approach to society's decision making process. There is nothing wrong with the jury system or lay people making difficult decisions. As my father once said to me, "Never try to bullshit a bullshitter." In the wrong hands evidence based medicine is a sham.

Originally posted at InjuryBoard by Steve Lombardi

Trial Lawyers - What is evidence based medicine?

Steve Lombardi — Wed, 19 Mar 2008 00:00:09 GMT

Evidence based medicine is a medical concept that is being peddled to the legal profession, but especially the Courts as a fairer approach to deciding what evidence should or should not be admitted into evidence. It's a medical concept that some are attempting to turn into a legal concept. There are several definitions. A few are cataloged below.

There is even a Centre For Evidence-Based Medicine that is said to have been established in Oxford in 1995. "EBHC requires the integration of the best available research evidence with
our clinical expertise and our patient's unique values and circumstances."

What this all boils down to is what a medical expert is supposed to do before arriving at an opinion.

Step 1: Start with the patient or clinical problem or question that involves medicine.
Step 2: Construct a well built question derived from the case.
Step 3: Select the appropriate resources and conduct a search of the literature.
Step 4: Appraise the evidence for its validity (closeness to the truth) and applicability (usefulness in clinical practice).
Step 5: Return to the patient or question and integrate that evidence with clinical expertise, patient preferences and apply it to the practice.
Step 6: Evaluate the performance with the patient or question.

"Evidence-Based Medicine is ... a set of procedures, pre-appraised resources and information tools to assist practitioners to apply evidence from research in the care of individual patients." - K.A. McKibbon, McMaster University

MedicineNet.com quotes Dr. Sackett from McMasters University in Canada as follows: Evidence-based medicine: The judicious use of the best current evidence in making decisions about the care of the individual patient. Evidence-based medicine (EBM) is mean to integrate clinical expertise with the best available research evidence and patient values. EBM was initially proposed by Dr. David Sackett and colleagues at McMasters University in Ontario, Canada.

British Medical Journal - Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.

Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients. BMJ 1996;312(7023):71 (13 January)

Originally posted at InjuryBoard by Steve Lombardi

It's no wonder so much money is being spent to vilify the trial lawyer.

Steve Lombardi — Tue, 18 Mar 2008 00:00:00 GMT

Doesn't it seem like the fox is watching the hen house? Now you have to ask yourself:
Question: Who is watching out for your family?
Answer: Certainly not the drug companies and absolutely not the FDA.
Question: Why is the FDA allowing all of this advertising directly to the consumer? Why is this relationship between the FDA and the pharmaceutical companies so cozy?
Answer: ?????

According to The New England Journal of Medicine the effectiveness of dozens of widely prescribed and seemingly popular antidepressant drugs have been and are being exaggerated. It's being accomplished through selective publication of favorable results. The Wall Street Journal, a very conservative news source is even covering the story.

As a result, doctors and patients are getting a distorted view of how well blockbuster antidepressants like Wyeth's Effexor and Pfizer Inc.'s Zoloft really work; researchers asserted in this week's New England Journal of Medicine.

Drugs mentioned include: Bristol-Myers Squibb's Serzone; Wyeth's Effexor, Pfizer Inc.'s Zoloft, Schering-Plough Remeron, GlaxoSmithKline's Wellbutrin SR along with Paxil, Eli Lilly's Cymbalta among others.

Believe it or not, pharmaceutical companies are under no obligation to publish the studies they sponsor and submit to the FDA. The researchers they hire apparently have no ethical obligation to publish the studies or comment on claims made about the drugs in advertisements. The FDA, the agency charged with protecting the public has no compulsion to do publish.

"A total of 74 studies involving a dozen antidepressants and 12,564 patients were registered with the FDA from 1987 through 2004. The FDA considered 38 of the studies to be positive. All but one of those studies was published, the researchers said.

The other 36 were found to have negative or questionable results by the FDA. Most of those studies -- 22 out of 36 -- weren't published, the researchers found. Of the 14 that were published, the researchers said at least 11 of those studies mischaracterized the results and presented a negative study as positive."

It's a safe assumption that if the trial lawyer is a problem a few hundred million dollars in could easily be spent to eliminate their effectiveness with juries to preserve the cash flow of the multi-billion dollar pharmaceutical industry.
In this week's study, the researchers found that failing to publish negative findings inflated the reported effectiveness of all 12 of the antidepressants studied, which were approved between 1987 and 2004. The researchers used a measurement called effect size. The larger the effect size, the greater the impact of a treatment.

"The average effect size of the antidepressant Zoloft rose 64% by the failure to publish negative or questionable data on the drug, the researchers found."

Now you have to ask yourself: Who is watching out for your family?
Answer: Certainly not the drug companies and absolutely not the FDA.
Question: Why is the FDA allowing all of this advertising directly to the consumer? Why is this relationship between the FDA and the pharmaceutical companies so cozy?

Originally posted at InjuryBoard by Steve Lombardi

Scared of poison toys? Then hold on because drugs are next.

Steve Lombardi — Sat, 15 Mar 2008 00:00:03 GMT

The campaign to get the American public to hate trial lawyers is a well thought out plan to make billions of dollars in bonuses for corporate CEO's. The fact that it's working will only encourage the importation of more poison products coming into the Unites States.

If the general public isn't yet outraged about our children being poisoned by lead paint covered toys, then just wait. The toxic products situation will only get worse because pharmaceutical companies are ramping up outsourcing to third world countries. The campaign to get the American public to hate trial lawyers is a well thought out plan to make billions of dollars in bonuses for corporate CEO's. Now that they believe juries are firmly in their corner they will take the next step towards outsourcing. Hold on baby because you ain't seen nothing yet.

Originally posted at InjuryBoard by Steve Lombardi

Prescription Drugs - Liver Damage - FDA Warning - Tysabri

Steve Lombardi — Tue, 04 Mar 2008 00:00:01 GMT

FDA warning describes potentially severe liver damage associated with the prescription drug Tysabri. The warning link can be obtained through this blawg.

Potential liver damage that can result in the need for a liver transplant in some patients is the significance of an FDA and Biogen Idec, Elan warning associated with the drug Tysabi. Patients taking this drug can read the warning at the FDA link.

Tysabri is used in the treatment of Multiple Sclerosis and Crohn's Disease.

Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

See the FDA warning.

Originally posted at InjuryBoard by Steve Lombardi

The McDonald's Verdict, Tort Deform and other Riddles Revisited

Steve Lombardi — Mon, 03 Mar 2008 00:00:03 GMT

I have to admit that this one was too good to pass on without comment. I've written previously about tort deformers and their mantra and how Madison Avenue has brilliantly fooled most of the nation into believing the sky is falling and we can only save the nation with more tort deform. But as my mother is fond of saying, "This one is a real doozy!"

I have to admit that this one was too good to pass on without comment. I've written previously about tort deformers and their mantra and how Madison Avenue has brilliantly fooled most of the nation into believing the sky is falling and we can only save the insurance industry with more tort deform. But as my mother is fond of saying, "This one is a real doozy!" Here are the links to the previous blawgs.

Coffee Warning - It's Hot! Tort Deformers Mantra

When did Iowa road kill take on more value than human life wrongfully taken?

Tort deformers usually won't identify themselves. Most add comments with anonymous monikers. They like to remain hidden from public scrutiny. Heaven forbid that the parents of the brain damaged baby who are neighbors might learn it was they who advocated taking away the rights of the injured to receive fair compensation. Oh no instead they hide behind a false name to continue their lies and deceit to compel emotions to deny fairness. The McDonald's coffee case is their mantra. With it they distort the facts and then claim that it was merely not warning of the coffee being hot that compelled an out of control jury to award a lotto ticket to the injured. Experience tells me this is an organized advertising campaign and that the current warning - "Warning coffee may be hot and cause injury!" is just more of the same advertising campaign. That warning is worthless. If you order a hot drink you expect it to be hot. Not 170 to 180 degrees hot, but hot enough to improve the taste but not so hot that it burns the inside of your mouth. After all if you ordered iced coffee you would expect it to be cold.

Here is the good part that I just couldn't pass up. I'm watching television and drinking hot coffee like I do most mornings. A commercial comes on for Flomax. It's a drug that improves urination in men with benign prostatic hyperplasia, aka an enlarged prostate. The commercial warning says: "Avoid situations where injury may result."
What a ridiculous warning. This warning couldn't get any sillier. And it's my opinion this warning has nothing to do with any real education about side effects. (See real warnings below.) And that is my point about "Warning coffee may be hot and cause injury!" It too is ridiculously simplistic and provides no real warning about the risk you take when tipping a vessel of 170 degree coffee into your mouth. The risk is not one of the coffee being hot, but how absurdly hot was her coffee.

Next Madison Avenue will be warning us that razor blades are sharp and may cause a cut. Or that a knife is pointy and can cause a puncture wound. How about warning that using a lawnmower can cause injury to your grass? Or how about that needles can cause a boo-boo. I'm also big on the warning "Ingesting poison may reduce your need for exercise."

I rest my case.

Real Warnings:

What is the most important information I should know about Flomax?

Flomax can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. You may feel dizzy when getting up from a sitting or lying position. Avoid standing up too quickly to keep from falling. Avoid drinking alcohol. It may increase dizziness caused by Flomax.
Before taking this medication, tell your doctor if you are allergic to sulfa drugs. You may also be allergic to Flomax.
Flomax can affect the pupils of your eyes during cataract surgery. If you have cataract surgery during your treatment with Flomax, tell the surgeon ahead of time that you are using this medication. Do not stop using Flomax before surgery unless your surgeon tells you to.
Stop using Flomax and call your doctor at once if you feel like you might pass out, or if you have an erection of your penis that is painful or lasts longer than 4 hours.
This medicine should not be used by women or children.

What should I discuss with my healthcare provider before taking Flomax?

Do not use Flomax if you are allergic to tamsulosin, or if you are also taking any other alpha adrenergic blockers such as alfusozin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), or Terazosin (Hytrin).
Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have prostate cancer.
If you will be having cataract surgery, tell the surgeon that you are taking Flomax.
Although Flomax should not be used by women, this drug is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Flomax is not for use in children.

How should I take Flomax?

Take Flomax exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take Flomax for longer than your doctor has prescribed. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from Flomax.
Take each dose with a full glass of water. Swallow the capsule whole. Do not crush, chew, or open the capsule. Flomax is usually taken once a day, approximately 30 minutes after a meal. Try to take Flomax at the same time each day. If you stop taking Flomax for several days in a row, call your doctor before starting the medication again. You may need to restart at a different dose.
To be sure this medication is helping your condition, your doctor will need to check you on a regular basis. Do not miss any scheduled appointments

Originally posted at InjuryBoard by Steve Lombardi