As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing?  It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’”  A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real.  Thankfully, it isn’t.

However, the good news that hypogonadism isn’t so prevalent may likely be eclipsed by the prevalence of AndroGel use and the accompanying negative side effects — which include a dramatically-increased risk for heart attack and stroke.

WARNING: Research shows AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) is overprescribed and can lead to “serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.”

AndroGel is a topically-applied gel containing testosterone at concentrations of either 1% or 1.62% used by patients suffering from hypogonadism, or “low-testosterone”.  While this condition does persist in American society today, “Low-T” isn’t nearly as prevalent as the aforementioned companies have led many to believe through what has become an award-winning marketing campaign.

As of February 7th 2014, the United States District Court for the Northern Division of Illinois (Eastern Division) began handling a lawsuit against the manufacturers of AndroGel, in which it is alleged that these companies “participated in, authorized, and directed the production and promotion of [AndroGel] when they knew, or with the exercise of reasonable care should have known, of the hazards and dangerous propensities of [AndroGel] and thereby actively participated in the tortious conduct which resulted in the injuries suffered by [our client].”

It is also noted that the client mentioned above could not have come to know the dangers posed by AndroGel sooner due to the fact that AbbVie and Abbott Laboratories “misrepresented and continue to misrepresent to the public and to the medical profession that the drug AndroGel is safe and free from serious side effects,” stating that these companies “have fraudulently concealed facts and information that could have led [our client] to discover a potential cause of [the side effects experienced].”

This is one of three similar such lawsuits filed that day, all raising the same concerns regarding AndroGel safety and marketing.  To elucidate those concerns, this lawsuit cites several scientific studies.  First, the team cites a 2010 New England Journal of Medicine Study titled “Adverse Events Associated with Testosterone Administration” that was stopped because too many men experienced negative side effects.  Next, the team cites a 2013 Journal of the American Medical Association study titled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels,” “which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%.”

Another study released January 29th of this year was cited, titled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” determining testosterone therapy doubled the risk for heart attack in men over 65 and younger than 65 who had a history of heart disease.

Though AndroGel commercials describe some of the possible negative side effects of the product, particularly those that can follow by secondary contact (handling the clothes of a person who had applied AndroGel), the risk for heart attack and stroke is absent from their warnings.

As more information becomes available regarding AndroGel lawsuits and the danger of AndroGel, we will be sure to pass the knowledge on to you.  If you or a loved one used AndroGel, you too may be eligible for significant financial compensation as this AndroGel lawsuit proceeds.  For more information, or a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the compassion, experience, and resources to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry.

To that end, Congress passed the Drug Quality and Security Act (DQSA) on 11/27/2013, a law with two aims: to ensure the quality of compounded drugs, and to ensure the security of compounded drugs.  Toward the goal of ensuring drug quality, the law “Establishes annual registration requirement for any outsourcing facility” (for clarity, “outsourcing facility” means compounding pharmacy), “Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports”, and “Subjects such facilities to a risk-based inspection schedule.” (DQSA)

Toward the goal of ensuring drug security, the law “Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain” (DQSA).  According to an article by FDA Commissioner Dr. Margaret Hamburg, this will be a stepwise process taking ten years to become fully effective.  At that point, the law “will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.”

Jill Wechsler, Washington editor of the Pharmaceutical Technology blog, PharmaTech Talk, writes that of yet (just three months after the passage of DQSA), only 14 compounding pharmacies have registered with the FDA – of over 3,000 currently operating in the United States.  However, these figures ought not to be discouraging, she writes, as “this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act”.

Further, there is a disincentive for compounding pharmacies to register with the FDA including significant fees and the obligation to submit to federal regulations and inspections, and Wechsler writes the FDA is currently implementing three strategies to encourage compounding pharmacy registration.  First, the FDA is asking “hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system” by sending letters to “hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.”

Next, Commissioner Hamburg has sent letters to state governors and “members of state boards of pharmacy and state health officials” touting the benefits of the Drug Quality and Security Act, seeking state assistance in “dealing with distant compounders that ship into a state.”

Though there are certain disincentives for compounding pharmacies to register with the FDA, it must be made clear the possibilities of their commercial benefit and legal protection await.

Lastly, the FDA is aiming to encourage compounding pharmacy registration by re-establishing Pharmacy Compounding Advisory Committee, which will make new regulations.  The committee will likely be composed of “leading experts in the field” and “nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders.”

Wechsler concludes, “One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will ‘take aggressive action’ when necessary to protect the public health.”

Though I find it incredible that compounding pharmacies had not as yet been subject to federal inspection and other such requirements, DQSA is absolutely a step in the right direction.

 

Jill Wechsler’s article from PharmaTech Talk is available here:

FDA Expands Oversight of Large Compounders

Also, the FDA provides a helpful Frequently Asked Questions page on compounding pharmacies available here:

Compounding and the FDA: Questions and Answers

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention.

While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems”, due to a lack of data and a failure by the company to demonstrate the benefits of Xarelto outweigh the risk for bleeding associated with the drug, the FDA advisory panel decided that “Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack”.

If the drug had been approved for acute coronary syndrome, it could be prescribed for “any condition brought on by a sudden, reduced blood flow to the heart, including heart attack and chest pain.”

Sadly, it seems Johnson and Johnson made its case based on evidence from only one research study.  Dr. Stephen Grant, consulting professor of medicine at Stanford University School of Medicine, gave an interview to Reuters, stating “Looking at the overall study it wasn’t robust enough in terms of statistical significance to be considered a positive study, and with that it was not possible to look at subgroups.”

“Dr. Stephen Grant, deputy director of the FDA’s division of cardiovascular and renal drugs, said the benefit of the drug met the criteria required to approve a drug based on a single trial – namely, proof it was superior in some way to existing products.”

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration conducted an investigation into the safety of the drug and found there was not a significant increase in risk for heart attacks with Avandia, and their recommendation led health regulators to lift the restrictions of use for the drug.

Type I diabetes is an autoimmune disease that inhibits the body from properly controlling the amount of sugar in the blood.  Type I diabetics do not produce insulin, which acts like a key that allows sugar to enter the cells.  Cells gain energy from sugar, and will die without the proper supply.  Type II diabetes can come as a result of a poor diet and lack of exercise that causes the pancreas to form defective insulin molecules that do not adequately perform their function.  Both types of diabetes are serious medical conditions that can be fatal if not properly handled.

A 2007 report that claimed Avandia was dangerous prompted a halting of the distribution of the drug from Europe, and resulted in restrictions on the sale of the drug in the US.  The chemical name of Avandia is rosiglitazone had been one of the best selling medications for Glaxo, earning the company billions of dollars before rumors of the drugs dangerous characteristics came about.  Despite the fact that recent studies have shown there is no increased risk for heart attack while using Avandia, it is still assumed the drug will only be prescribed to patients who have tried other diabetes medications without success.  Only a small fraction of Americans continue to take Avandia since the restrictions were put in place.

Salmonella is a food-borne bacteria, typically present in meat and poultry products.  An estimated 1.3 million illnesses can be attributed to Salmonella every year.  To address outbreaks of salmonella, the US Department of Agriculture’s (USDA) Food and Safety Inspection Service (FSIS) has released its Salmonella Action Plan that outlines the steps it will take to address Salmonella contamination of meat and poultry products.  The plan has been released to make meat and poultry products safer for consumption.

As reported by Adam Tarr of FSIS, one of the top priorities of the action plan is to modernize the outdated poultry slaughter inspection system.  Focusing on food safety should help prevent at least 5,000 illnesses.  Additionally, the plan includes enhancing sampling and testing programs, which will include the latest scientific information available, ensuring that the best available methods will be used to monitor the food products.  Furthermore, the plan includes “several actions FSIS will take to drive innovations that will lower Salmonella contamination rates, including establishing new performance standards; developing new strategies for inspection and throughout the full farm-to-table continuum; addressing all potential sources of Salmonella; and focusing the Agency’s education and outreach tools on Salmonella.”

These new efforts are meant to build upon the previous work done by the USDA to lower contamination rates.  In 2011, the new performance standards for Salmonella were set to reduce illnesses by 20,000 per year. After implementing these new strategies, Salmonella rates in young chickens have dropped over 75% since 2006.  Hopefully, this will let us all breathe a little easier this holiday season.

On October 26th, a federal court in California allowed a lawsuit against Google Inc. to proceed in which it is alleged that Google has violated privacy laws by scanning the emails of persons who do not use Google’s email service, Gmail, for the purpose of advertisement optimization.

While it is currently legal for Google and other email service providers to scan the emails of their users in effort to advertise more effectively, it seems that Judge Lucy Koh of the Northern District Court of California is suspect of the legality of a company tapping emails of those to whom it does not provide service, and who have not agreed to the relevant Terms of Service.

According to The Washington Post “Google says that the automated scanning of all e-mails that come through its servers — used to work its spam filter but also to build user profiles and target advertisements — is vital to running its e-mail service. [ ] But Koh rejected that argument, saying Google’s privacy policy does not mention that the site collects the content of e-mails, either between Gmail users or between Gmail users and non-Gmail users.”

This is not the only such lawsuit faced by our nation’s “best company to work for” (2013); in another case it is alleged that the web giant has infringed on the privacy of Americans in the photographing of millions of US addresses for the Street View function of Google Maps.  As was reported by the New York Times, because hundreds of millions of people use Google’s services around the world, “if it is, as expected, certified as a class action, the fines could be enormous.”

John Simpson, of the Consumer Watchdog privacy project, remarks that “This is a historic step for holding Internet communications subject to the same privacy laws that exist in the rest of society,” and I agree, but cautiously: with a company as big as Google ($10.7 billion net profit FY2012) that has a history of avoiding penalty for privacy violation, anything is possible.

Ellen Beck recently wrote an article for the “Smart Blog on Food and Beverage” website titled “FBI Makes Threats to U.S. Food Supply a Bigger Priority”, that discusses the food industry’s vulnerability to intentional food contamination.  In light of all the terrorist attacks taking place throughout the world, the FBI is becoming increasingly concerned that food might be used to carry out a large scale attack on the American people, for intentional contamination can lead to widespread food borne illnesses that have the potential of infecting millions of people.

The FBI has been tracking incidents of intentional food contaminations and taking a closer look for ways to reduce these incidents from people or organizations that infect food supplies.  Motives for these intentional food contaminations may include terrorism or economic gains.  In recent years, a defense mission has been created through the FBI with the ability to activate thousands of agents to defend the food supply.  This mission uses the Joint Terrorism Task Forces and Hazardous Evidence Response Teams to cover all possibilities and situations that may arise from an intentional food contamination attack.

Beefing up on the ability of the FBI to investigate and predict possible threats related to intentional food contamination started after the 2001 9/11 terrorist attacks.  In Ellen Beck’s article she quotes FBI agent Thomas Rosato who states “We get the fact that because of its systemic nature, our food supply would be a very effective dispersal device for weapons of mass destruction”.  While the FBI has a lot of experience with the investigatory process, the Bureau needs help and input from the Food and Drug Administration and other agencies that have intimate knowledge of how the American food systems work to be effective in preventing these kinds of attacks.

A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats.

Nutrition is an ever-changing area of research.  Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health.  During the 1950’s, 1960’s, and 1970’s, trans fats exploded onto the American scene and were heavily used in major food chains and in popular foods we ate.  And this made economic sense: saturated fats such as butter (animal fat), are more expensive than partially hydrogenated oils (trans fats).

Now, heart disease as the leading cause of death in the United States, and health consciousness is becoming increasingly popular.  Rightly so.  While artificial trans fats have been significantly reduced in the everyday foods Americans eat, they are still found in microwave popcorn, frozen foods, and margarine.

However, writes Tavernise, “The Food and Drug Administration proposed measures on Thursday that would all but eliminate artery-clogging, artificial trans fats from the food supply, the culmination of three decades of effort by public health advocates to get the government to take action against them.”

Some experts believe that if trans fats were eliminated in the American diet, there would be 20,000 less heart attacks each year.  Though the American populace believed for many years that trans fats were healthy and safe to use, we must rid ourselves of this notion.  Medical research has determined there is no safe level of trans fat consumption, and that trans fats carry no nutritional value.  Now, the FDA “has proposed that partially hydrogenated oils, the source of trans fats, no longer be ‘generally recognized as safe.’”

The link between trans fats and heart attack is now being further explored, and in some places the use of trans fats is already illegal.  An F.D.A ruling in 2003 required food that contains trans fats to be properly labeled as such. (Foods that contain less that 0.5 grams per serving are labeled as containing 0.0 grams of trans fat, in general.)  Not long after, cities such as Cleveland, New York, and California established a similar stance on trans fats and are encouraging the practice of banning the use and sale altogether.  The steps taken by the F.D.A and like-minded cities have already produced beneficial results.  The Center for Disease Control and Prevention has claimed the blood levels of trans fats for many Americans has been reduced.  In 2006, Americans were eating an average of 4.6 grams a day.  We now see that number is down to 1.0 gram per day.

Thankfully, the freedom of American corporations is here limited in favor of better health for all.

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill.

The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source of some recent controversies and have taken the stoplight in the medical world.  A large outbreak of fungal meningitis linked to “tainted steroid injections” from a compounding pharmacy killed 64 people this year.  More than 750 cases of infection were reported in that outbreak.

Such problems with compounding centers are not novel, but this most recent incident has pushed some to call for more federal oversight of the compounding process.  While the FDA is not necessarily looking for new responsibilities to shoulder, in light of the developing health and safety problems the Administration feels it can help create a better national standard.

FDA Commissioner Margaret Hamburg praised a bill being brought to the Senate for a vote in the coming weeks titled, “The Drug Quality and Security Act,” a bill that will hopefully help tackle some of the problems we have seen with compounding pharmacies.  Hattem states, “It would give the FDA power to regulate large compounding facilities but leave smaller plants to be overseen by state boards of pharmacy.”  Margaret Hamburg notes that the bill would not solve all the problems we are facing, but is a step in the right direction, stating “I don’t think it’s going to be as comprehensive as we initially had hoped,” but recognizes that it is “a step.”

However, the White House is not yet completely sold on the new legislation and has some concerns over the authority that will be given to the federal government with the oversight process.