FDA Execs Received "Lavish" Bonuses

As if the FDA's weekly bludgeoning at the hands of Congress is not enough, there is this news:

Congressman Bart Stupak informs that 28 senior FDA executives took in a combined $1 million in bonuses last year. To me, this news is obscene. Clearly the FDA is a weak guardian when it comes to the safety of drugs and food. Yet, with this news, you would think that perhaps the entire system has gone mad.

Bonuses for FDA bureaucrats? Yep. Look at these examples:

$48,000 in a cash award and retention bonus went to an associate commissioner whose plan to overhaul FDA field labs was rejected by Congress as poorly thought-out.

$41,000 went to the director of the office of criminal investigations, pushing his total income to enforce one statute to $208,000 - more than the director of the FBI makes.

What's most galling? CBS News notes that "The person who was hired to reform the bonus system received the biggest bonus, $58,000."

Nearly 25% of the $35 million in bonuses the FDA handed out last year went to bureaucrats, not technical experts.

For more go here.

Selenium: Link to Diabetes?

From various sites:

A new analysis of data from a large national study found that people who took a 200 microgram selenium supplement each day for almost eight years had an increased risk of developing type 2 diabetes than those who took a placebo or dummy pill.

The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial. It was designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.

Link to at least one site here.

Digitek Recall

My good friend Angel Reyes and his firm are based in Dallas, Texas and his firm has a national reputation. From their site:

"Heygood, Orr, Reyes, Pearson & Bartolomei is a business litigation and personal injury law firm, based in Dallas, Texas. We have worked with executives, business owners, and individuals to try over 300 cases to a jury verdict."


The firm is a drug known as Digitek.

Eric Pearson's report - it's copyrighted:

Digitek is the trade name for digoxin tablets manufactured in the United States by Actavis Totowa, LLC, the U.S. manufacturing division of international generic pharmaceutical company Actavis Group. The tablets are distributed in the U.S. by Mylan Pharmaceuticals, based in Morgantown, West Virginia and by UDL Laboratories, based in Rockford, Illinois. Both Mylan Pharmaceuticals and UDL are owned by parent company Mylan, a drug company based in Pittsburgh, Pennsylvania with a market cap of $4 billion. The tablets are distributed by Mylan under a “Bertek” label and by UDL under a “UDL” label. It appears that the tablets distributed under the UDL label are distributed to hospitals and other health care facilities in unit dose form in a foil blister pack. The tablets distributed by Mylan under the Bertek label are believed to have been distributed in standard pill bottles.

The Digitek tablets are manufactured by Actavis Totowa in their Elizabeth, New Jersey plant. Their website describes the plant as a “solid-oral-does facility for tablets and capsules supporting a broad therapeutic range” with a “core competency on modified-release products.” The FDA has a different take on the competency of this facility. As set forth in the Warning Letter attached hereto as Exhibit A, the FDA conducted a plant inspection from January 10 through February 6, 2006 and found numerous issues of concern, including:

● Failure to submit required FDA Adverse Drug Experience (“ADE”) Reports;

● Failure to promptly investigate serious and unexpected ADE reports;

● Failure to ever file a required Periodic Safety Report;

● Manufacturing numerous prescription drug products without approved applications.

Digitek was approved by the FDA through a process known as an Abbreviated New Drug Application (“ANDA”). An ANDA applies to a generic equivalent of a prescription drug that has already received FDA approval. The already-approved drug on which Actavis based its ANDA was Lanoxin, a digoxin tablet manufactured by GlaxoSmithKline. In order to secure FDA approval, Actavis was required to demonstrate that its Digitek tablets were “bioequivalent” in comparison to Lanoxin. Bioequivalence factors scrutinized by the relevant authorities concern active ingredient(s), quality, safety, dosage forms and strengths, performance characteristics and intended use. Actavis’ ANDA No. 40-282 was approved by the FDA by letter dated December 23, 1999.

III. The Digitek recall.

On April 25, 2008, Actavis announced a recall of all lots of Bertek and UDL Laboratories Digitek tablets. According to its Press Release, attached hereto as Exhibit B, Actavis initiated the voluntary all-lot recall because “due to the possibility that tablets with double the appropriate thickness may have been commercially released.” Actavis further stated that “[t]hese tablets may contain twice the approved level of active ingredient than is appropriate.” Further, according to the Actavis Press Release:

The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.


IV. Dosing issues.

Digitek tablets are sold in two doses, .125 mg and .25 mg. A study of patients given a single .25 mg daily dose of digoxin showed a median digoxin concentration level of .9 ng/mL for women and .8 ng/mL for men. Rathore, Sex-Based differences in the Effect of Digoxin for the Treatment of Heart Failure. Long-term results from the same study showed a mean digoxin concentration of .97 to 1.01 ng/mL between all sexes. Id. Similar data was obtained from a large scale study completed in 1997. Among 1485 patients, the mean digoxin level for patients taking a .25 mg tablet was .89 ng/mL.”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. That same study showed a mean digoxin level for patients taking a .125 mg tablet of .76 ng/mL. Id.

According to data provided to the FDA in Actavis’ NDA, a patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. The concentration level is expected to rapidly decline to a level of less than .6 ng/mL within six to eight hours.

According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. About two-thirds of patients suffering from digitalis toxicity have serum digoxin concentrations above 2.0 ng/mL while one-third have levels below 2.0 ng/mL.

According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage. Baselt also states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL with a range from 1.6 ng/mL to 13.7 ng/mL. another study of some 1000 patients found a mean serum digoxin level in nontoxic patients of 1.4 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Although the serum digoxin level in patients with toxicity was two to three times higher, “there was considerable overlap between the two groups of patients.” Id.

The foregoing data demonstrates that digoxin has a very narrow therapeutic range. As one medical publication has explained:

Digoxin has a narrow therapeutic window: that is to say, there is only a small range of plasma concentration between the drug being ineffective through underdosing, and toxic through overdosing.

This conclusion has been borne out by a variety of studies found in the medical literature. See, e.g., THCP Education Consortium, Digoxin Toxicity (“There is a narrow therapeutic range for digoxin – which means that the patient can easily have too much or too little of the drug on board.”). Based on the available literature, it appears clear that a double dose of digoxin could lead to digoxin toxicity.

V. Possible side effects of digoxin use.

According to the Lanoxin Product Insert (which is identical to the Digitek product insert), attached hereto as Exhibit C, various side effects may arise from the use of digoxin. Adverse reactions are generally dose-dependent. Exhibit C at p. 7. In the past, approximately one-half of all adverse reactions were cardiac in nature. Id. One-fourth of all adverse reactions were gastrointestinal and the final one-fourth were related to the central nervous system (“CNS”).

A.Cardiac events.

As stated above, about one-half of previously reported adverse events were cardiac in nature. According to the product insert, among the cardiac problems that may be caused from a high dose of digoxin are the following:

first-degree, second-degree (Wenckebach) or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation.

Exhibit C at p. 7. Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, lists possible cardiac side effects as “cardiac disturbances such as tachycardia, premature contractions, atrial fibrillation and atrioventricular block.” Manifestations of these cardiac events include palpitations, loss of consciousness and difficulty breathing.

B.Gastrointestinal events.

Gastrointestinal events caused by digoxin may include anorexia, nausea, vomiting and diarrhea. Other, less frequent, events include abdominal pain, intestinal ischemia and hemorrhagic necrosis of the intestines.

C.Central nervous system and other adverse events.

Events related to the central nervous system include visual disturbances such as blurred or yellow vision, headaches, weakness, dizziness, apathy and confusion. Other possible side effects include mental disturbances such as anxiety, depression, delirium and hallucinations. Gynecomastia, or breast enlargement in males, has also been reported.

VI. Digoxin toxicity.

A.General principles.

Digitek tablets are sold in two doses, .125 mg and .25 mg. A patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage.

While the highest strength Digitek tablet is .25 mg, Lanoxin used to be prescribed in doses up to .5 mg. In fact, when Actavis did testing of their .25 mg pill, they gave the subjects two of the pills (or .5 mg) because they were attempting to replicate studies that GlaxoSmithKline had done on their .5 mg pills. Thus, a patient taking one .25 mg Digitek tablet that contained a double dose of digoxin would arguably be expected to achieve the same digoxin serum level as did those patients in the clinical trials conducted by Actavis: a mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL.

Unfortunately, there are many problems with drawing a bright-line rule from the available data and studies. First, the effects of digoxin are highly variable among patients. Second, the narrow therapeutic range of digoxin makes it difficult to determine whether a particular digoxin level is therapeutic or toxic in a particular patient:

Considering there is some overlap between therapeutic and toxic serum digoxin levels, symptoms of toxicity may be reported in patients whose levels are within the therapeutic range, while others may have no symptoms hen their serum digoxin levels are above the therapeutic threshold.

Hixson-Wallace, Digoxin Toxicity: A Review. Finally, digoxin levels taken less than 6 hours after the administration of digoxin may overstate the true digoxin level. See Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. As stated in the Lanoxin Product Insert:

Following drug administration, a 6- to 8-hour distribution phase is observed. . . . clinical evidence indicates that the early high serum concentrations do not reflect the concentration of digoxin at its site of action . . . . To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formula used.

Exhibit C at pp. 3, 9. When reviewing any digoxin serum concentration level, it is important to know when it was drawn relative to the ingestion of digoxin.

B.Digoxin levels as a predictor of digoxin toxicity.

Despite the foregoing issues, properly obtained digoxin levels remain the best indicator of digoxin toxicity. A digoxin level of 3.0 ng/mL or greater is a strong predictor of digoxin toxicity:

Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL.

Another study of some 1000 patients found a mean serum digoxin level in patients suffering from digoxin toxicity of 2.8 ng/mL to 4.2 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.

A study of nearly 800 patients in Japan found that all patients with a digoxin level over 3.0 ng/mL exhibited clinical evidence of digoxin toxicity.” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.

One study showed that “the risk of toxicity at a digoxin concentration of higher than 3.0 ng/mL was 12-fold the risk of at a serum concentration of 0 to .99 ng/mL.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.

A study of more than 2000 patients found that the mean digoxin serum concentration level for patients with definite digoxin toxicity was 3.6 ng/mL and the mean level for patients with possible digoxin toxicity was 3.4 ng/mL. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.

One author has concluded that “although no serum digoxin level proves or disproves toxicity, a level higher than 3.0 ng/mL in the appropriate setting lend strong support to diagnosis of digitalis excess.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.

A digoxin level greater than 2.0 ng/mL is also a fair predictor of digoxin intoxication. A study from North Carolina showed that 60% of patients with a digoxin level over 2.0 ng/mL that was measured more than 6 hours after administration of digoxin had clinical evidence of digoxin toxicity. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.

A digoxin level below 2.0 ng/mL is a possible indicator of digoxin toxicity. Anywhere from 10% to 33% of patients with such a level may experience adverse side effects as a result of digoxin toxicity:

One study of some 1000 patients showed that 10% of patents with digoxin toxicity had serum concentrations of less than 2.0 ng/mL. Smith, Digitalis Glycosides: Mechanism and Manifestation of Toxicity.

As stated in the Lanoxin Product Insert: “since one-third of patients with clinical toxicity have serum digoxin concentrations less than 2.0 ng/mL, values below 2.0 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy.”

A study in Japan “showed that there was an overlapping (toxic and nontoxic) range of serum digoxin concentrations in which the incidence of digoxin toxicity was patient dependent (1.4 – 2/9 ng/mL).” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.

Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average digoxin serum concentrations ranging from 1.6 to 13.7 ng/mL.

Another study of some 1000 patients found “considerable overlap” in the digoxin serum concentration levels of nontoxic and toxic patients. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.

Clearly, there will be many patients --- perhaps between 10 and 33% -- with a digoxin level below 2.0 ng/mL who will suffer the effects of digoxin toxicity.

C.At-risk patients.

Of course, certain patients are more susceptible to digoxin toxicity, and the above conclusions do not apply to those patients. This includes elderly patients. See Schreiber, Digitalis Toxicity (“Advanced age (>80) is an independent risk factor and is associated with increased morbidity and mortality.”); Miura, Effect of Aging on the Incidence of Digoxin Toxicity (“clinical evidence of digoxin toxicity in patients > 71 years old was 26.5%, despite their SDCs falling between 1.4 and 2.0 ng/mL . . . . “[t]his raises the possibility that patients > 71 years show clinical evidence of digoxin toxicity despite having SDCs within the recommended therapeutic range.”).

Patients who have previously suffered from renal failure are also particularly susceptible to digoxin toxicity. Exhibit C at p. 5 (“[i]f appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function.”). Other at-risk patients are those with electrolyte disorders such as hypokalemia (low blood potassium), hypomagnesemia (magnesium deficiency) or hypocalcemia (low blood calcium levels). Exhibit C at p. 5. Patients with thyroid disorders are also especially at risk. Exhibit C at p. 5.

D.Symptoms of digoxin toxicity.

Although increased digoxin levels may be a good predictor of digoxin toxicity, the ultimate issue from a damage perspective is whether a patient suffered any injury because of digoxin toxicity. As one author has noted, “clinically stable patients receiving digoxin who have elevated SDCs but are without signs or symptoms of digoxin toxicity are at low risk of developing serious digoxin toxicity and do not generally require treatment beyond the discontinuation of digoxin therapy.” Park, Digoxin Toxicity in Patients with High Serum Digoxin Concentrations. Thus, it is important to be aware of the most prevalent symptoms of digoxin toxicity.

1.Cardiac events.

Increased congestive heart failure may be the initial manifestation of digitalis toxicity in as many as 7.5% of patients. Dysrhythmia, or an abnormal heart rate, occurs in 80% to 90% of patients with digitalis toxicity. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Perhaps the earliest cardiac manifestation of digoxin toxicity in many patients is premature ventricular contraction (”PVC”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. Ventricular fibrillation and tachycardia are also common symptoms.

The type of arrhythmia will often indicate whether a cardiac event has been caused by digitalis toxicity. Among the types of arrhythmias most suggestive of digitalis toxicity are the following:

● Bidirectional ventricular tachycardia

● Bigeminal ventricular Rhythm

● Multiform premature ventricular complexes

● Atrial tachycardia with block

● Nonparoxysmal AV junctional tachycardia

● Supraventricular rhythm (atrial fibrillation) with ventricular ectopy

● Nonconducted premature atrial complexes

● Ventricular tachycardia with exit block

Bhatia, Digitalis Toxicity—Turning Over a New Leaf. HJJ Wellens has developed four criteria for the electrocardiographic diagnosis of digitalis toxicity. They are:

1.Appearance of a slow heart rate in a patent with a fast or normal heart rate;

2.Appearance of a fast heart rate in a patient with a normal heart rate;

3.Appearance of a regular heart rhythm in a patient with an irregular rhythm; and

4.Appearance of a regularly irregular rhythm.

Wellens, HHJ, The Electrocardiogram in Digitalis Intoxication. Other authors suggest that the most common EKG changes in digoxin toxicity are PR-segment prolongation and cupping of the ST segment. Another author has stated that the typical “digitalis effect” found in electrocardiogram readings are manifested by a shortened QT interval and a characteristic down-sloping ST depression with the T wave opposite in polarity to the QRS complex. TCHP Education Consortium, Digoxin Toxicity.

2.Other events.

The first symptoms of digitalis are often gastrointestinal – anorexia, nausea, vomiting, and diarrhea. THCP Edcuation Consortium, Digoxin Toxicity. The most common symptom associated with digoxin toxicity is nausea. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. Other, non-cardiac events associated with digoxin toxicity include:

● fatigue

● dizziness

● confusion

● delirium

● blurred vision
● disturbed color perception

● hallucinations

● abdominal pain

● headaches

The most common vital sign abnormality is bradycardia.

3.Death.

According to the Lanoxin Product Insert, “manifestations of life-threatening toxicity include ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhymthias, or heart block.” Exhibit C at p. 8. The Product Insert also states that “the administration of more than 10 mg of dioxin in a previously healthy adult . . . often results in cardiac arrest.” Id. Of course, this information is of limited utility because most patients taking dioxin tablets already suffer from some type of heart problem and cannot be considered “healthy adults.” As a result, they are more susceptible to cardiac arrest. This fact also complicates the diagnosis of cardiac events attributable to digitalis toxicity.

A 2005 study by K.F. Adams and others “demonstrated a significant linear relationship between serum digoxin concentration and mortality.” Adams, Relationship of Serum Digoxin Concentration to Mortality. According to a 1997 study by the American Association of Poison Control Centers, of the patients who reported digitalis toxicity, approximately 1% died. Another study showed that 3 of 20 (15%) of patients diagnosed with digoxin toxicity died despite appropriate intervention. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. The Emergency Response Card for Digoxin published by the National Institute for Occupational Safety and Health states that severe exposures to digoxin may result in death, Perhaps most importantly, in its Recall Notice submitted to the FDA, Actavis stated that “[d]eath can result from excessive digitalis intake.” Exhibit B. Clearly, digitalis toxicity can lead to death.

Some of the predictors of whether digoxin toxicity can cause death are the serum digoxin concentration and the age of the patient. My compilation and analysis of data from the last five years of the Annual Report of the American Association of Poison Control Centers’ National Poison Data System yielded valuable insight into these predictors. According to the data, the mean serum digoxin level of patients who died from digoxin toxicity was 4.27 ng/mL. Further, 75% of fatalities from digoxin toxicity occurred with digoxin levels of 3.0 ng/mL or greater. With respect to age, the mean age of a patient judged to have died from digoxin toxicity was 78.5 years. Nearly 80% of all digoxin toxicity fatalities occurred in patients aged 70 years or older. None occurred in patients under the age of 60.

Finally, it is stating the obvious to note that the more pills a patient is taking, the greater the likelihood that a double-dose pill would cause death due to digoxin toxicity. Digitek is manufactured in .125 and .25 mg tablets. A typical daily therapeutic dose is .25 mg. However, patients are sometimes instructed to take several tablets per day in order to reach the desired digoxin level. As set forth in the Lanoxin Product Insert, “if rapid digitialization is considered medically appropriate, it may be achieved by administering a loading dose based upon projected peak digoxin body stores.” Exhibit C at p. 10 (“digitalization” simply refers to the use of digitalis glycosides such as dioxin to treat heart failure). Although the Lanoxin Product Insert provides information regarding an appropriate “loading dose,” it does so only with respect to digoxin injections. Medical literature, however, suggests that an appropriate loading does for digoxin tablets would an initial dose of .5 mg followed by additional doses of .25 mg to .5 mg every 6 hours until digitalization is achieved. Arnsdorf, Method of Digitalization. The total oral dose needed for digitalization is typically 1 to 2 mg using oral digoxin tablets.

Thus, in patients where rapid digitalization has been ordered, the patient may take up to 2 mg of digoxin tablets in one 24-hour period. Patients taking multiple doses of Digitek during a 24-hour period are much more likely to suffer a fatal digoxin overdose from a double-strength pill than those taking one .125 or .25 mg pill per day. We should therefore be on the lookout for injuries and deaths suffered by patients undergoing an initial “loading dose” of Digitek.

VII. What to look for in a case.

Given all of the above, what questions should an attorney ask when assessing potential cases against Actavis as a result of a double-dose of Digitek?

● Does the patient have the pills?

● What strength pills were prescribed?

● How frequently were they taking the pills?

● Was the patient in the middle of an initial loading dose?

● What was the patient’s digoxin serum concentration level?

● When was the digoxin level measured?

● How soon after taking the double dose pill did symptoms of digoxin intoxication develop?

● Was there a diagnosis of digoxin intoxication?

● What non-cardiac symptoms, if any, did the patient have?

● Did the patient suffer from renal failure or deficiency?

● What other drugs was the patient taking?

● Is there any evidence the patient was given treatment for digoxin toxicity such as administration of activated charcoal or digoxin-specific antibody fragments (Digibind or DigiFab).

● If the patient died, what was the listed cause of death?

● How old was the patient?

Total Body Formula Recall Makes News In Georgia Paper

My office has filed several lawsuits - NOT a class action - involving the Total Body Formula and Total Body Mega Formula recall.

In March, the FDA had warned consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

From an Athens, Georgia paper there was an article regarding the recalled products. The article refers to Total Body Formula as a "diet aid," although I would not have used those two words to describe the product.

More here.

Gardisil: Problems Looming?

From a news website:

Gardisil is a vaccine given to protect women against certain types of cervical cancer.

There have been complaints of paralysis, blood clots and death. The Centers for Disease Control and Prevention has recently stated that despite the complaint, none of the side effects can be linked to Gardasil.

From another site:

"Lisa Ericzon tells the New York Post that her daughter Jessica received her third dose of the vaccine on February 20th of last year. Ericzon says in the article that two days late, her daughter collapsed and died and she says her daughter had complained of pain in the back of her head following both the second and third vaccine shots. An autopsy could not determine the cause of death.

Merck, the company that makes Gardasil, says the New York Post never contacted them for comment on the story. The FDA, CDC and State Health Department continue to recommend Gardasil." Source.

For more go here.

Epilepsy Drug May Increase Risk of Birth Defects

So says the American Academy of Neurology (find more here):

Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.

Research has shown that many epilepsy drugs increase the risk of birth defects, but little research has been done on topiramate. Studies have shown that topiramate increases the risk of birth defects in animals. Maintaining effective epilepsy treatment during pregnancy is crucial because seizures may cause harm to the fetus.

For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.

Friday Tech: Searching All Craigslist Sites

Craigslist.org is a website that at least in Atlanta is to me the best free version of classified ads around. I've been able to find a vehicle, temporary office workers, concert tickets, and a desk on it. In other cities I have found affordable by owner short term rentals, and even auto parts.

As useful as the site is, however, to me it was almost impossible to search all cities on Craigslist. From Lifehacker comes a solution (via wired.com):

Google's Advanced Search yields a way to limit results to domains, such as Craigslist.org. Advanced Search is the link located right next to the main search field on Google’s home page. Click on "Advanced Search" and follow the directions on the link posted above.

There is a shorthand method

* Type in the search field:

site:craigslist.org “antique coastal surveys ”

With or without quotes to broaden or narrow down the search.

* You can also use booleans to modify the range of your search:

site:craigslist.org antique|vintage coastal surveys

Vytorin: Dear Doctor Letter Readied

Vytorin is a drug made by a partnership of Merck & Schering-Plough. There's news that a letter has been readied to be sent to doctor who may be asking about recently released study results that showed patients taking the cholesterol drug were at higher risk of dying from cancer.

Video (less than 90 seconds)here: http://www.cnbc.com/id/15840232?video=801729653


From various sites:

The companies will take the stance that the increase in cancer deaths and higher incidence of cancer in a recent study involving 1,873 people should be considered an anomaly. The SEAS study were released this week, and it is in that study that the cancer connection is alleged. Source.

What is SEAS? It is the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. It is a randomized, multicenter, placebo-controlled study evaluating the effects of combination ezetimibe/simvastatin (Vytorin) on clinical outcomes in roughly 1800 patients with aortic stenosis, and the results showed that the controversial cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events. (Link)

Other sites note this:

What Do the SEAS Results Mean?

There was speculation that the trial could help rehabilitate Vytorin after the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial was published in March, but the placebo-controlled trial design, as well as the patient population, were likely to limit the clinical impact.

The SEAS results are the first clinical results for Vytorin since ENHANCE was published. In that study, investigators tested the effectiveness of combined ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia and found that the combination did no better than simvastatin monotherapy on several surrogate end points. The combination did not result in a significant difference in changes in intima-media thickness compared with simvastatin alone, despite significantly greater reductions in LDL cholesterol and C-reactive protein.(Link).

Truck driving while disabled: 'Major public safety problem'

From the Atlanta Journal Constitution comes news that thousands of drivers hold commercial licenses even though they also qualify for full federal disability payments.

From the article:

"The problems threatening highway travelers persist despite years of government warnings and hundreds of deaths and injuries blamed on commercial truck and bus drivers who blacked out, collapsed or suffered major health problems behind the wheels of vehicles that can weigh 40 tons or more. Georgia is among 12 states where drivers are sanctioned most often for violating medical rules."

The eye opener quote: "We have a major public safety problem, and we haven't corrected it," - says Gerald Donaldson. Donaldso is a director at the Washington-based Advocates for Highway and Auto Safety.

For more, go here.

Avastin Tied to Anemia

From various sources, including CNN:

The FDA has, this week, issued an alert regarding cancer drug Avastin. There has been an alleged link to the development of anemia in several patients.

According to the FDA, patients have reported that when Avastin was taken in combination with Sutent, another cancer drug, reported microangiopathic hemolytic anemia (a loss of red blood cells).

What is particularly important is that Avastin is not approved to be taken in combination with Sutent, a cancer drug manufactured by Pfizer.

Here's the link.

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

From the FDA site for these listed drugs:Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

The Release:

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.

Link here.

Botox News: Lawsuits Filed

A number of Botox users and relatives of those who had the drug administered filed suit in California, claiming that the drug injured or killed. The maker of the drug, Allergan Inc. is the company, and the company is based in Califoria.

Cases include one where an over 60 nurse allegedly died after receiving injections for neck and shoulder pain. Another involves a child with cerebral palsy, also from Texas, who died in 2004, allegedly after receiving injections to control limb spasticity.

Source here.

Perhaps the most famous claimed user of Botox to address spasticity is Robert F. Kennedy Jr. Kennedy is is said has a condition called spasmodic dysphonia, a specific form of an involuntary movement disorder called dystonia that affects only the voice box.

No Blackbox Warnings for Epilepsy Drugs

From various sources comes the news that anti-seizure drugs may allegedly cause increased suicidal tendencies in patients. Even so, it's not enough to result in the FDA imposition of the strongest warning label on them, according to the FDA law week.

A 20 member FDA panel vote unanimously to back findings on a number of antiepileptic drugs studied. Back at the start of 2008, FDA informed there could be a black box warning added after a study of 199 studies comparing the drugs, which are used by millions, to placebos.

For more, go here.

Verdict in AWP Case in Alabama: $100 Million +

Tom Methvin's law firm in Montgomery rendered a verdict for the State of Alabama yesterday.

Pharmaceutical companies charged for drugs based on the Average Wholesale Price (AWP). Average Wholesale Price” or AWP has long been used as a pricing benchmark for almost all prescription drug sales in the United States. Health plans, Medicaid and other government programs, and employers determine how much to pay pharmacies and doctors to reimburse them for drugs that are dispensed to patients by using formulas based on the AWP for individual drugs. Source.


A jury in Montgomery County Circuit Court returned a verdict in favor of the State of Alabama in a case involving AWP and allegations of fraud, finding defendants GlaxoSmithKline and Novartis Pharmaceuticals Corp. liable for a total of $114,247,233, of which $80,989,539 is from GlaxoSmithKline and $33,257,694 is from Novartis.

For more on Tom's Firm's victory for the State of Alabama, go here.

FDA: Avastin Useless against Breast Cancer

News from this week ...

Avastin: A metastatic colorectal cancer treatment and advanced non-small cell lung cancer treatment.

In a past clinical trial sponsored by the National Cancer Institute, researchers gave breast cancer patients either Avastin and the breast cancer drug paclitaxel (also marketed as Taxol) or just paclitaxel alone.

The results showed that the drug combination of Avastin and Taxol almost doubled the time before breast tumors worsened, from just less than six months with paclitaxel alone to 11.3 months with the combination. Preliminary results of the study were released in April 2005, before the end of the study. Source: Here.

In combination with another drug, Avastin posed problems as well. Researchers in February 2006 abruptly halted recruitment of patients for a study combining the anti-cancer drugs Avastin and Xelox after several patients involved in the clinical testing died. Xeloda, a medication used alone since 1998 as a first-line defense in the treatment of colon cancer.

Dangerous Lawn Mowers

A video worth watching as summer and lawn mowing season move foward in earnest:



About 85,000 Americans land in hospital emergency rooms with injuries sustained while mowing the lawn, according to the Consumer Product Safety Commission. And the authors of a 2006 study at the Johns Hopkins Bloomberg School of Public Health concluded the number of injuries is rising, with most happening to people younger than 15 or older than 60. Source.

Paxil: FDA In the Dark About Drug's Problems

The WSJ's Alicia Mundy has a report on how lawsuits over GlaxoSmithKline’s handling of information about the suicide risk from Paxil reveal documents "that say a lot about why the FDA often seems to be in the dark when problems with drugs" start showing up post approval. Source.


What is disturbing about the report: In the papers produced in the litigation was an exchange between lawyers suing Glaxo over Paxil and attorneys defending the company. "The upshot: FDA may not even have known all the information to ask for about Paxil. "

More at the link above. The real upshot? Once again there is another report about the FDA being left in the dark. Wow, what a surprise.

VA Will Warn Vet about Chantix

The Veterans Affairs Department will mail out notices to nearly 33,000 veterans who are taking the anti-smoking drug Chantix, warning them about possible side effects, including thoughts of suicide.

VA Secretary James Peake said VA doctors will continue to prescribe the drug because they are seeing no serious problems or trends with its use.

Source: Here.

New FDA Report on Heparin

The FDA updated the number of deaths of patients who took heparin, nearly doubling it to 149. The FDA reported the new death toll of patients who took heparin.

For more, go here.

Georgia Watch - Georgia State Court Annual Report

The Georgia Court Watch issued its annual report on appellate courts.


ATLANTA – Court Watch today released its first annual report analyzing consumer-related decisions issued by the Supreme Court of Georgia and the Georgia Court of Appeals. Court Watch is a project of Georgia Watch, a nonprofit and nonpartisan group committed to strengthening the rights of consumers in Georgia .


The “2007 Annual Report” identifies and profiles the most noteworthy consumer-related decisions released by the appellate courts throughout the year, and identifies emerging trends.


“Many of the decisions reached by the state Supreme Court and Court of Appeals significantly impact the rights that consumers have under law,” said Georgia Watch Executive Director Allison Wall. “Georgia Watch launched this project to provide ongoing, thoughtful, fact-based analysis.”


Notable consumer cases discussed include:


* Glenn v. State, a case in which the court upheld Georgia ’s Payday Lending Law. Two individuals convicted of issuing payday loans argued that the statewide ban on payday lending was unconstitutionally vague and did not specifically prohibit the schemes they utilized in issuing loans, such as a “sales-leaseback” of a cell phone or coffee maker. The lenders also claimed they were not subject to the ban because they were located out-of-state.


* Kaminer v. Canas, in which the court upheld the two-year statute of limitations for medical misdiagnosis, regardless of futures failures to properly diagnosis, even in the presence of a patient’s additional or significantly worsened symptoms. In Georgia , a claim must be filed within two years of the date of the first misdiagnosis, whether or not the patient knows they have been misdiagnosed. In Kaminer v. Canas, the patient unsuccessfully argued that repeated misdiagnosis over a decade of treatment by multiple medical providers should have restarted the statute of limitations.

* Dees v. Logan, in which the court established that insurance companies are prohibited from creating offset clauses to reduce the amount owed to drivers who purchased uninsured motorist (UM) insurance. Offsets deny policyholders benefits already purchased that are needed to cover medical and property damage resulting from an accident with an underinsured driver. The court ruled that insurance policies containing offsets for personal injury benefits are in conflict with Georgia ’s Uninsured Motorist Act. This year, the Georgia General Assembly responded to this decision by passing Senate Bill 276, which expressly permits insurance carriers to use offsets for workers’ compensation benefits, effectively overturning part of this decision. SB 276 also expanded drivers’ access to UM coverage.


“Generally speaking, Georgia laws are not consumer-friendly,” Wall said. “As this report demonstrates, our courts generally follow those laws unless they explicitly run afoul of the state constitution.”


The Court Watch Fellowship is a collaborative effort of the 2007 Court Watch Fellowship recipient and primary researcher, Nathan Gaffney, and the Court Watch Advisory Committee, which includes three members of the Executive Committee of the State Bar of Georgia Board of Governors.


“Any contention that our appellate judges are activists who stray from the letter of the law is not supported by these decisions concerning consumer rights,” said Tom Stubbs, Court Watch Advisory Committee member. “Indeed, even when statutes can reasonably be interpreted in different ways, our courts have a pronounced bent not to interpret them so as to enhance protection of consumers in our state.”

Did Glaxo Suppress Paxil Safety Data and "Bamboozle" the FDA?

A U.S. Senator thinks so.

From various reports: GOP Senator Grassley has asked the FDA to study an overseas report issued several months ago that concluded that Glaxo suppressed Paxil data going back to 1998. Glaxo had said risks came to light in in 2006.

``It looks like GlaxoSmithKline bamboozled the FDA,'' Grassley said this week. speech. ``We cannot live in a nation where drug companies are less than candid, hide information and attempt to mislead the FDA and the public." Per Bloomberg.

Well Senator, we do and it's not going to change unless there is a seismic shift in the way the FDA does business.

FDA's Abysmal Failures

This time, tomatoes.

From various reports:

"As foodborne illness outbreaks continue, FDA is missing valuable opportunities to reassure Congress and the public that it is doing all it can to protect the nation's food supply," said the report by the investigative arm of Congress. Source.

One word used by Bart Stupak, chairman of the House subcommittee on oversight and investigation aptly describes this mess. "Pathetic."

This is an agency that is supposed to address safety when it comes to unsafe drugs, but can't even get to the source of bad vegetables. "Too bad that the federal government and the FDA have bowed to big corporate interests in refusing to fund or implement U.S. law requiring country-of-origin labeling for produce: labeling that could have nipped this latest outbreak in the bud." So says Mr. Dobbs. The FDA may "never" find the source.

Video here.

Epilepsy Drugs (Topamax and others) to get Suicide Warning

The FDA is in the final states of including language warning about suicidal behavior on labels of 11 epilepsy drugs. Sales of the affected drugs, widely used for nonepilepsy problems such as chronic pain, topped $8 billion last year.

From various sources, including the WSJ Blog.

The drugs include:

* Carbatrol, Equetro, Tegretol, Tegretol XR,
* Felbatol,
* Neurontin,
* Lyrica,
* Gabitril,
* Topamax, and
* Depakote

Regranex Warning from the FDA

Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

For more, go here.

News on Tumor Necrosis Factor Blockers

Tumor Necrosis Factor blockers like Remicade, Enbrel, Humira, and Cimzia may be impacted by a recent FDA investigation.

From the FDA:

The FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases. JIA is the new name for what was called Juvenile Rheumatoid Arthritis (JRA).

Source here.

More Bad News on Chantix

Hundreds of accidents have been linked to Chantix according to a study by outside researchers. The report was issued by the Institute for Safe Medication Practices.

The researchers say the number of convulsions for people taking Chantix is at least 86 since the drug went on the market in 2006. (Per the WSJ Blog).The WSJ Blog is worth a read.

FDA: Baby Formula Recalled

Two lots of baby formula have been recalled.


Abbott Laboratories says it is voluntarily recalling two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder.

The formula is specially designed for infants and children with hypercalcemia - high levels of calcium - in their blood.

The FDA web site says the formula was distributed in Canada and the U.S. between June 6, 2006 and April 17, 2008. It is only available by special order.


The recall is limited to Calcilo XD in 400g cans, with stock code number 00378 and lot numbers 39973RB or 47239RB6 printed on the bottom of the cans. No other Calcilo XD powdered infant formulas are affected.

The company says small amounts of air may have entered the can, resulting in oxidation of the formula, which can often be detected by an off odour.

The FDA says consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. If parents have questions or concerns, the release says they should contact a health care professional.

Source here.

Depo Provera Class Action in Canada

From Bloomberg:

Pfizer's being sued by Canadian women who claim the company failed to provide proper notice the contraceptive Depo-Provera causes loss of bone density. The pending case won a broad (for Canada) national class-action certification.

For more go here.

Truckers: Don't Take Chantix

The Federal Motor Carrier Safety Administration, which regulates the trucking and bus industries, says that anyone taking Chantix shouldn't be allowed to drive. The Department of Transportation has alerted the heads of its myriad sub-agencies to the Chantix study and told them to take note of its findings and recommendations.set

The study found 988 cases of Chantix causing serious health problems, including seizures and heart trouble, in the last quarter of 2007 alone. It also found possible links to seizures, dizziness, heart irregularity, diabetes and more than 100 accidents.

For more go here.

Lawyers/Firms With Bad Web Sites: Why Bother?

This week, not once but three times I have been searching out lawyers for various matters in other states. I am pretty sure that the litigators I sought out would not dare take even a basic deposition without being prepared, yet I am amazed at how little time is spent on a firm's web site. Several sites, to be blunt, conveyed a podunk image. The firms deserve better.

What did I find (or not find)? One site did not list a telephone number on any page except the contact us page.

One firm did not list any email contact, nor did it have a Consultation Form anywhere on the site. (For a good example of this form, go to my friend Richard Shapiro's site, here). No toll free number either.

These types of mistakes cost a firm money - lost opportunity, lost referral, lost potential clients. To me it shows a lack of understanding of the basics of the web. Worse, it means that I just move on to the next firm.

Is your firm's site one that I visited?

Oral Hormone Therapy Doubles Clot Risk

From Reuters:

Menopausal women taking hormone-replacement therapy pills may be at risk in excess of two times normal of developing a blood clot.

"This meta-analysis ... showed that current use of oral oestrogen increases the risk of (blood clots) by two-fold to three-fold," Pierre-Yves Scarabin and Marianne Canonico of the Paul Brousse Hospital in France wrote.

Link is here.

Tech: Zombies Among Us?

Tech Zombies that is. I am seeing what (to me) is a new phenomenon - texting or emailing while walking. I saw a man lurching oddly across a parking lot, and honestly thought something was wrong ... it was. Seems that he was working a phone --- hard --- while maneuvering the hazards of parking spaces.

Like this:



Someone is going to get killed doing this, don't you think?

Ad comes back to bite Life Lock

Have you seen the Life Lock ad, the one where the company chief gives out his Social Security Number and dares anyone to use it?



From the web:

"Davis (the company honcho) acknowledged in an interview with The Associated Press that his stunt has led to at least 87 instances in which people have tried to steal his identity, and one succeeded: a guy in Texas who duped an online payday loan operation last year into giving him $500 using Davis' Social Security number."

And there is more ... "Attorney David Paris said he found records of other people applying for or receiving driver's licenses at least 20 times using Davis' Social Security number, though some of the applications may have been rejected because data in them didn't match what the Social Security Administration had on file."

Go here for more.

Is this the end for Lifelock?

The U.S. Supreme Court, the FDA and Reality

While the U.S. Supreme Court traces the history of how a device gets approved, the reality of the FDA is to me much different.

From the Denver Post:

The Food and Drug Administration has finally acknowledged that it needs more resources to protect consumers from tainted food and drugs.

Unfortunately, it took the deaths of 81 people, a browbeating by members of Congress and a report detailing the FDA's woeful inability to expand overseas inspections before top agency officials would ask for more money.

It was a puzzling situation and one that has to make you wonder whether the Bush administration was putting the bottom line ahead of the health and safety of the American public.

Last week, FDA Commissioner Andrew C. von Eschenbach finally wrote Congress to say the agency needs an extra $275 million to make sure that food, drugs and medical devices from overseas are safe. The Senate appropriations committee quickly approved the request.

Given the high-profile instances of tainted products in recent years, it has become abundantly clear that the FDA does not have the resources to adequately inspect rising numbers of imports.

Last year, there was a string of pet deaths from melamine-contaminated wheat gluten imported from China. This year, the deaths of 81 people have been linked to tainted batches of the blood-thinning drug Heparin, also imported from China.

It's long past time to fix the FDA.

Google Health, Part 2

I found this on the Google Health site: To join, users must agree to various terms of use, including this: "When you provide your information through Google Health, you give Google a license to use and distribute it in connection with Google Health and other Google services." Doesn't give me a warm and fuzzy feeling - do you feel better knowing that perhaps an old knee injury, or a diabetes condition may be "distribute[d]" by Google?

At the outset, there are companies such as Aetna and BCBS which have been in the online medical records business for some time. Google brings it together in 18 months ... and with only a limited set of partners, and an "advisory council."

Implementation: How will this work with the average consumer? I'm helping a client now who was badly injured in an incident. The medical records in this client's file from one incident exceeds 300 pages, none of which came to our office scanned. The client has an extensive history of medical problems, and this "unrelated" set of records is nearly 200 pages.

Let's presume that this person never went to an attorney, just had health issues. Person is more than age 50 - who scans 500 pages to upload to Google? Where does this person go to scan? Who will spend hours uploading?

From various sites, these comments:

One commentator says, "Early on, the program will rely mostly on a patient's own input because of the lack of partners outside of early signees such as The Cleveland Clinic Foundation and drug store chain Walgreens Co. "When it comes to lab data and medical history and those kinds of things, doctors rely today on reliable sources -- not the consumers themselves," Source here.

"Some observers have expressed concern that much of the information stored in Google Health will not be covered by the USA’s Health Insurance Portability and Accountability Act." Source here.

My prediction- ads from Big Pharma will debut on the site within 12 months, and I will be shocked if 1% of the population uses this site. Stay tuned.

Google Health Debuts

From the site, below. From the blog: "One of the most exciting and innovative parts of Google Health is our platform strategy. We're assembling a directory of third-party services that interoperate with Google Health. Right now, this means you'll be able to automatically import information such as your doctors' records, your prescription history, and your test results into Google Health in order to easily access and control your data. Later, this platform strategy will mean that you will be able to interact with services and tools easily, and will be able to do things like schedule appointments, refill prescriptions, and start using new wellness tools." Link here.

Page one of Google Health, here.

About Google Health



Google Health allows you to store and manage all of your health information in one central place. And it's completely free. All you need to get started is a Google username and password.

Google believes that you own your medical records and should have easy access to them. The way we see it, it's your information; why shouldn't you control it?

* Keep your doctors up-to-date
* Stop filling out the same paperwork every time you see a new doctor
* Avoid getting the same lab tests done over and over again because your doctor cannot get copies of your latest results
* Don't lose your medical records because of a move, change in jobs or health insurance

Heparin: Quaid Testifies

Compelling video last week on Heparin.



Worth a look.

Spy on Your Friends

Or so says the WSJ in today's paper version. There are tools/sites to make it easier to "snoop."

The sites include:

Zabasearch.com: The site's tagline is: Telephone Numbers and Addresses Revealed Free

Wink.com:From the site - Wink People Search provides free people search across over 400 Million profiles from across the Internet - including Facebook, MySpace, LinkedIn, and all the other big social networks. You can search for people by name, location, work,and more

Spokeo.com: The site's main page says: Spokeo searches your friends' blogs and photos across 41 social networks so you don't have to visit hundreds of websites one by one.

Worth a look.

My friend, attorney Ed Lake from New York is a fan of zabasearch.com. Ed's office is located at: 270 West Main Street, Sayville, New York.

Tips: UpgradeYour Life

I'm not talking about learning CPR or adopting a child, just everyday upgrades. From Lifehacker:

A list that will help you start the handle the endless items each day that dog you. The list includes:

Hack 8: Consolidate Multiple Email Addresses with Gmail

Hack 12: Instantly Retrieve Files Stored on Your Hard Drive

Hack 21: Design Your Own Planner

Take the time to look at the post. It's the best 15 minutes you will spend this week.
Go here for more.

Walmart's $10 Meds

From the Walmart Releases:

Beginning today, Wal-Mart, Neighborhood Market and Sam's Club pharmacies will fill prescriptions for up to 350 generic medications at $10 for a 90-day supply. This option will give customers an additional choice and save them time and money without the hassle of purchasing or signing-up for a pharmacy discount card.


You can find the list of drugs here (PDF Alert).

.

Vioxx Deadline Extended: June 30, 2008

Merck report this week that more than ninety percent of eligible U.S. claimants have elected to participate in its $4.85 billion proposed Vioxx settlement, and the drugmaker extended the deadline to opt in.

Merck said that, while it was satisfied with signing up the vast majority of potential participants, it was extending by two months -- until June 30 -- the deadline for remaining eligible former users of its withdrawn arthritis drug to enroll in its proposed settlement.

Link here.

Total Body Formula Lawsuit Filed in Georgia

Today my office filed a lawsuit for a client who claims she was injured because of an unsafe supplement known as Total Body Formula.

You may view the first two pages of the Complaint here.

| View | Upload your own

The Total Body Formula product was sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The supplements were recalled, and the recalled Lots are: # 4016801, 4016802, 4024801, 4031801, 4031802 or 4031803.

The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

The FDA site informs:

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.

Source here.


On May 1, 2008, this news from the FDA:

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
Testing reveals high chromium levels in addition to selenium

The U.S. Food and Drug Administration’s final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula” has detected hazardous amounts of chromium.

On April 9, 2008, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor. Further FDA analysis of the products found high levels of chromium as well. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

The new FDA finding comes as the U.S. Centers for Disease Control and Prevention (CDC) reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor after receiving reports of adverse reactions. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html).

The FDA continues to investigate how excessive amounts of selenium and chromium got into the products.

The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products.

Central United Class Action

My friend and fellow attorney Joey James has asked me to post this about a pending class action and a proposed $650 payment to certain class members:


A national class action has been filed against Central United Life Insurance Company. Central United and the Class Representatives have agreed to enter into a settlement agreement in a state court in Alabama. Lawyers for Central United and lawyers for the two people that have brought this class action have negotiated a settlement between Central United and the Class Representatives.

This settlement agreement has been reached without any trial or open hearings where others could tell what has happened to them. This settlement agreement will be binding on every Central United insured in this country if a person does not opt out and the trial court finally approves the settlement without appeal.


What does this mean? This means that if you do not opt out by June 3, 2008, and the trial court agrees with this settlement and it is not appealed, you will be stuck with whatever Central United has agreed to pay and there will be absolutely nothing you can do about it. So, if your cancer insurance is important to you, you must read the agreement and opt out if you do not want to be bound by it.

If you are unsure of what to do, call Bunch & James toll free at 1-877-882-0095 or email the office at joey@bunchandjames.com

Total Body Formula Recalled

A Supplement has been recalled because of an error in its preparation.

The Total Body Formula products were sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.


Recalled Lots are: # 4016801, 4016802, 4024801, 4031801, 4031802 or 4031803.

The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

Link, here.

Audio: Heparin Hearings on Capitol Hill (From NPR)

A report from NPR, with the requisite table pounding by a Congressman. FDA representative lectured because "you do not have the resources" to do the job the FDA is required to do. You can get the audio here on the NPR site. Most startling about the report? There is a claim that 80% of active ingredients in meds are produced overseas.


Good stuff, and dead on. The FDA is broken. (See ABC report, "FDA Is Broken, Endangers American Lives", link here). "The wheels are coming off. In fact, I would say they're off. They're already off" at the FDA (See link).

The FDA has no translators on staff, so when there is an inspection in another country, what does the FDA do? FDA reps rely on an interpreter at the plant or company to translate.

FDA Links Tainted Heparin to China

From various sites:

FDA reps said they have new evidence linking many serious adverse reactions and deaths among patients given the blood thinner heparin to a man-made contaminant introduced during production in China.

The FDA traces the contaminant to 12 different Chinese companies and has been found in heparin batches shipped to 11 nations, all of it from China.

Chinese rep blame a US company - saying allergic reactions could have been created by impurities introduced when the imported raw heparin was refined by Scientific Protein Laboratories (SPL) of Wisconsin and then prepared for distribution in New Jersey

Link here.

Trasylol MDL: West Palm Beach

Judge Donald Middlebrooks, judge for the United States District Court for the Southern District of Florida will oversee the Trasylol Multi District Litigation. He served as General counsel to the Governor of Florida from 1974 - 1977, and in in 1997 was appointed by President Bill Clinton to serve as a United States District Judge.

Judge Middlebrooks heard the Bush lawsuit back in 2000. From the NY Times:

"The federal judge selected at random to hear the Bush campaign's lawsuit seeking to block hand-counting of ballots in some counties in Florida is a lifelong Democrat who has long been active in liberal causes ... . The judge, Donald M. Middlebrooks, is also highly regarded by Democrats and Republicans, as well as prosecutors and criminal defense lawyers, who after working with him or appearing in his court widely agree that he is fair and thoughtful." Source here.

Trasylol or Aprotinin, is also referred to as a bovine pancreatic trypsin inhibitor, BPTI. Trasylol is used as medication administered by injection to reduce bleeding during complex surgery - typically heart or liver surgery.

What does it do? The goal is to slow down fibrinolysis, a process that leads to the breakdown of blood clots.

In late 2007, The FDA asked Bayer Pharmaceuticals to suspend marketing of the drug, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death. From the FDA website:

The FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Source here.

Dangerous Plastic Bottles?

From Yahoo ...

A chemical in some plastic food and drink packaging including baby bottles may be tied to early puberty and prostate and breast cancer, the U.S. government said on Tuesday.

Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children.

The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.

Go here for more.

Merck Hid Vioxx Dangers

Merck suppressed documents that Vioxx could harm patients, according to a recent report. What a surprise.

JAMA writers claim that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo.

The most damning charge? "If these findings had been reported publicly in April of 2001, it is likely that many fewer patients would have chosen to use Vioxx and probably many fewer would have been injured,"

A separate analysis suggests Merck recruited academic researchers to lend their names and credibility to company-written studies used to give evidence of the drug's safety and effectiveness.

Merck Response:

"Generally, these allegations, we believe, are not true," said Kent Jarrell, a crisis management expert and spokesman for the law firm representing Merck in litigation over Vioxx. Notice the lawyer speak - "generally."

The source is here.

JAMA online is here. It's free.

You can find the documents here.

Did Heparin Price Surge Increase Adulteration of the Drug?

Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

The main ingredient produced for Heparin in China had a price increase of nearly double to the prior year. This was less than six months before hundreds of American patients began having severe and sometimes fatal allergic reactions to the medication.

The unusual increase of the price should have been a red flag to drugmakers that something significant—and perhaps dangerous—was happening to the ingredient of a medication widely used in life-threatening situations. Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

The FDA found that that heparin made in China had been contaminated with inexpensive over-sulfated chondroitin, an altered version of a widely used dietary supplement.

According to the report, "the price of crude heparin exported from China went from $629 per kilogram in January 2007 to $1,507 per kilogram in December. The cost of refined heparin exported by China rose at about the same rate as that of raw heparin—strongly suggesting that the increase was driven by the price of the raw material rather than by processing problems."

This source informs that the price spike should have alerted the makers.

Exubera: Lung Cancer Risk?

Pfizer has report that clinical trials of the inhaled insulin Exubera found increased cases of lung cancer.

The lung-cancer news is a setback to Exubera, which held the promise of letting diabetics avoid needle sticks.

Pfizer has reported that six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.

Pfizer will update the product's labeling to include a warning with safety information about lung cancer cases found in patients who used Exubera, which U.S. regulators approved in January 2006.

The warning states all patients who developed lung cancer had a history of cigarette smoking, and that too few cases existed to determine whether the development of lung cancer is related to Exubera use.

Link and source here.

Heparin Update

From the FDA site more information:

The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA over the last fifteen months (i.e., from January 1, 2007 through March 31, 2008).

* The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.

* The second column indicates the number of deaths reported after heparin administration, regardless of cause.

* The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.

* There have been 103 reports of death since January 1, 2007; 91 were reported to FDA on or after January 1, 2008.

* Of the 62 reports of death that included one or more allergic symptom(s) or symptoms of hypotension, 56 were reported to FDA on or after January 1, 2008.

* The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.

* FDA received reports of 41 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.

The chart may be found here.

Drug Makers May Near Goal of a Legal Shield

The NYT has posted an insightful article about the realities of preemption, and specifically Johnson & Johnson and its Ortho Evra Patch. The shield is of course preemption.

From the article:

"For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.


More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent."

This IMHO is just another example of a drugmaker taking advantage of an overwhelmed system. The FDA is a mess in my view and is barely on top of 20th century advances, much less 21st century ones. In the rarefied air of academia or perhaps pro-business judicial chambers, the FDA works. Not in real life.

From a recent Bloomberg report:

Consumers are likely to die and suffer injuries because of an ``overwhelmed'' U.S. Food and Drug Administration that lacks enough funding, an adviser to the agency told lawmakers.

The FDA isn't inspecting enough manufacturers, has too few scientists who understand new technologies, and regulates a food supply that grows riskier every year, said Gail H. Cassell, an agency adviser who is a member of the FDA's Science Board, in written testimony today to a House subcommittee.

The Science Board adopted a report in December that said the FDA needs more money and better computer systems, and should be restructured to include a scientific leader. The agency, with a budget of more than $2 billion, regulates the sale of more than $1 trillion of products annually, including food, drugs, cosmetics and medical devices.

``Without immediate action, injuries and deaths from an overwhelmed regulatory system are certain, and the costs to our society will be far greater than any dollar figure upon which we can arrive,'' Cassell, vice president of scientific affairs at Eli Lilly & Co., told the investigative subcommittee of the House Energy and Commerce Committee.

The Science Board report described rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and said the FDA fails to adequately monitor products because it can't keep up with the science. The FDA suffers ``serious scientific deficiencies,'' the report concluded.


For more go here, which is the source of the article, and here for the Blomberg story.

Annuale

You owe it to yourself to watch the spot on pharma spoof from the 4/5/08 SNL:



Disclaimers include:

Do not take Annuale if you plan to ever become pregnant, as it may turn your baby into a firemonster. In the days around your period, you may develop a leathery tail. Annuale may cause you to develop a second vagina.

Two Monitors Are Better Than One

At the recently completed GTLA Tech Seminar, my friends Landon Harlan and Dave Swanner were preaching the vitures of dual monitors. Why?

Studies show dual monitors increase productivity. "Survey after survey shows that whether you measure your productivity in facts researched, alien spaceships vaporized, or articles written, adding an extra monitor will give your output a considerable boost — 20 percent to 30 percent, according to a survey by Jon Peddie Research." Source.

Setup for me was easier, since I am the guinea pig in the office for this experiment. Rather than open up the PC, I bought a USB-based cable called external video adapter:



The external version is more expensive; changin out the internal video card is about $29 per PC. After five minutes I was ready to go.

What do you see? This image shows what it is like:



I'm able to keep open my office database on one monitor, and work on the other. Already I am seeing a difference in output.

USDCT Denies Pfizer Attempt to Subpoena Journal Documents

A federal district court in Chicago dened a Pfizer subpoena that would have "threatened the integrity of [the journals'] peer-review process," as Journal of the American Medical Association (JAMA) editor Dr Catherine D DeAngelis writes in JAMA.

Magistrate Judge Arlander Keys ruled that the journals were not compelled to provide Pfizer with documents regarding how manuscripts are accepted/rejected, or hand over copies of rejected manuscripts, identities of peer reviewers and the manuscripts they reviewed, and comments by and among peer reviewers and editors. Pfizer had requested the documents as part of a broad request for information it hoped to use in its defense against more than 3000 lawsuits pertaining to how celecoxib and valdecoxib were advertised and marketed.

The editorial explains that JAMA and the Archives journals have always deliberately kept the names of peer reviewers confidential and have a policy of not disclosing the topics of papers ultimately not accepted for publication. "This promise to reviewers and authors allows the peer-review process to work in an unrestrained environment. Producing any of these documents, with or without names, would seriously compromise the process and the trusting relationship among the editors, authors, and reviewers."
Confidentiality Upheld

In her ruling, Judge Keys agreed with the journal editors that this information could be kept confidential from Pfizer and the public and that any information Pfizer's lawyers might need could be obtained from published articles.

For more go here.

Report: Auto Accidents - Workers on Cellphones Cost Employers

It should not surprise anyone that cellphones are a menace in the hands of some drivers. In my short commute to work, I see drivers backing up while on a cellphone, texting while driving more than 70 mph, and worse. In one congested intersection manned by police officers, even they are typically on cellphones.


In my Atlanta paper, this report on cellphone use:

"Cellphones have spurred fantastic advances in business productivity and employee availability, allowing workers and bosses to stay in constant contact. A 2007 study says three-quarters of Americans use cellphones while driving. And a good percentage of them are surely doing company business.

But for all the work-related benefits, the devices also allow personal-injury attorneys to reach into companies' deep pockets.

In December, McGrogan's employer, International Paper, agreed to pay $5.2 million to settle an accident in which a woman's car was forced off the road and her arm was later amputated ...

Recent settlements such as these and other big-money cases nationwide have caused companies to move to protect themselves from financial liability. With increasing frequency, businesses are mandating that workers not use cellphones when driving or at least employ hands-free sets."

Interesting reading from the AJC, and you can find the rest of the article here.

This will get worse, not better.

The Growing Vytorin Problem

Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries. It was thought that by using Vytorin to reduce both sources of cholesterol, the amount of artery clogging plaque would also be reduced.


Congress is investigating whether the makers of Vytorin withheld data that would have hurt sales. This week, there was a release of new evidence supporting the suspicions.


The Senate's committee has said that the researcher who led a crucial study of the drug accused Vytorin makers Merck & Co. and partner Schering-Plough Corp. actually withheld.

A letter from the committee's ranking Republican, Sen. Chuck Grassley of Iowa, states that delaying the results affected medical decisions and put financial burdens on patients and the federal government, which has paid hundreds of millions of dollars for Vytorin since the study ended nearly 2 years ago.

For more go here.