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Defective Drug Lawyers: J&J Hearings Prompt Ethics Questions & PediaCare Recall

Defective Drugs, washington defective drug attorney

May 31st, 2010: Law Blogger

PeciaCare RecallJohnson and Johnson (J&J) has been facing some major problems lately connected to pulling 40 types of children’s drugs from store shelves this month after a Food and Drug Administration (FDA) inspection in April found contaminated materials at a manufacturing facility run by the company’s McNeil Consumer Healthcare unit.

FDA officials and a J&J executive testified about the manufacturing problems on Thursday at a U.S. House Committee on Health, Education, Labor, and Pensions hearing. These hearings took an unexpected turn that revealed serious violations and a scathing breech of ethics.

Following the hearings another unit of J&J that produces children’s medicine, Blacksmith Brands Inc., announced a recall Friday of about 100,000 units of four PediaCare items sold nationwide. These recalled items include PediaCare Multi-Symptom Cold, PediaCare Long Acting Cough, PediaCare Decongestant and PediaCare Allergy and Cold.

One resounding theme of all of the happenings surrounding J&J last week revealed that the giant pharmaceutical company’s efforts to restructure and cut costs over the last three to four years resulted in putting children in serious danger. This has further besmirched the already tainted reputation of a company that had a very public recall of their Tylenol products in 1984 regarding tampered products containing poison. This scandal drastically changed packaging standards. Perhaps J&J will once again change the over the counter policies in the US.

PediaCare Recall

Blacksmith Brands said on Friday it was recalling the four PediaCare items because they were made at the same manufacturing facility run by McNeil Consumer Healthcare. Apparently, there have been no reported incidents linked to the recalled PediaCare products, but tiny particles have been found in other products that were made at the McNeil plant, Blacksmith Brands said.

The PediaCare items involved in the recall are:

  • PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
  • PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
  • PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
  • PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

Ingredients used by J&J in some of the 40 varieties of previously recalled children and infant medicines were contaminated with bacteria, according to an FDA report released this month. The report lists more than 20 manufacturing problems at the McNeil plant where the newly recalled PediaCare products were produced.

Tylenol Recall Hearings

Rep. HarkinThe FDA’s principal deputy commissioner, Joshua Sharfstein, told committee members at a hearing on Thursday that McNeil Consumer Healthcare had a “pattern of noncompliance” with good manufacturing practices. He said FDA regulators were considering such punitive measures as “seizure, injunction or criminal penalties.”

The FDA’s criminal investigations office is looking into the matter, an aide said. Dr. Sharfstein said the agency was now working well with J&J and its McNeil unit, but he described a history of troubles getting the unit to fix violations.

The hearing then took a surprising turn into a new controversy that had not been previously revealed to the press. The committee began questioning the lone J&J executive, Colleen Goggins, who oversees J&J’s consumer business, as to why, after the company discovered some defective Motrin products, J&J instructed a contractor to send out workers to buy the entire available product off retail shelves.

Under pressure from the FDA, the company issued a recall of 88,104 packages of Motrin in July 2009. “I don’t think we fully understood what was going on,” Dr. Sharfstein said.

J&J had learned as early as November 2008 that certain Motrin pills wouldn’t dissolve appropriately, thus reducing or completely negating their effectiveness. The company put a hold on lots at its distribution center. Then, instead of issuing a recall, they hired a contractor to sample some of the eight-count packages on store shelves to see if a recall was necessary, according to an FDA PowerPoint document.

The contractor appeared to take their job farther and instructed workers to visit all of the stores “on your schedule to locate and purchase” all of the Motrin eight-count packages, according to a memo shown at the House committee hearing. The memo said “you should simply ‘act’ like a regular customer in making these purchases,” and advised the workers not to talk about a recall.

Goggins told the committee that she didn’t know what instructions had been given to the contractor. She also said that it’s unclear what prompted the contractor to direct its workers to buy up all packages on store shelves, thus neatly hanging the issue on the contractor and leaving them out to dry.

Some on the committee suggested that the lower standards displayed by McNeil have occurred amid J&J’s cost-cutting and consolidation of some functions. Last year, J&J announced plans to cut 8,200 jobs, or 7% of its work force, as part of a broad restructuring that aims to achieve $1.7 billion in yearly savings by 2011. J&J executives also recently moved to standardize compensation across the company.

The consumer business’s overall spending on property, plant and equipment fell to $439 million last year from $499 million the year before. Goggins said the cost-cutting measures didn’t overall quality control at the problematic Fort Washington facility. She said the head count among Fort Washington’s quality staff was flat from 2006 to 2009, while the plant’s quality-control spending during that time rose 17%.

Defective Drug Lawyers

J&J’s consumer business, which includes the McNeil unit and other companies, had $15.8 billion in sales and $2.48 billion in profit. This looks fantastic to shareholders just as long as they don’t actually give their children these products.

As a defective drug law firm, it is our aim to protect consumers from some of the policies of giant pharmaceutical companies to profit off of drugs that they know may be harmful to consumers. Many of these policies result from lack of diligent research and lack of oversight. Other causes stem from irresponsible and dangerous cost-cutting measures the can result in putting the consumer’s health in jeopardy such as the current J&J issue.

Phillips Webster represents consumers and their loved ones in personal injury and wrongful death lawsuits resulting from defective drugs. If you or someone you know has been affected by the serious problems surrounding Children’s Tylenol or PediaCare products it is important to have experienced representation on your side to assure that your voice will be heard and that you receive the compensation that you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.

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Washington Orlistat Lawyers: FDA Warns of Severe Liver Damage in Xenical & Alli

Defective Drugs, washington defective drug attorney

May 26th, 2010: Law Blogger

Orlistat LawyersThe US Food and Drug Administration (FDA) announced revised labels for widely used weight-loss drug, Orlistat today. Orlistat is available by prescription under the trade name Xenical and over-the-counter as Alli. The announcement is in response to reports of rare but sometimes severe cases of liver damage.

There have recently been thirteen cases of severe liver injury associated with taking Orlistat. Twelve of the reported cases were outside the United States. Only one of them came from within in the United States derived from taking Alli, according to a statement from the U.S. Food and Drug Administration.

Of the 13 cases cited by the FDA, they said that there “were cases that, on review and categorization by the agency, received severity scores of 4 or 5 using the Drug Induced Liver Injury Network scoring system,” FDA spokeswoman Elaine Gansz Bobo explained. “Basically, a ’5′ means resulting in death or liver transplantation, and a ’4′ means it was severe and required hospitalization.”

“We are telling consumers and health-care providers to be vigilant should [patients] develop symptoms suggestive of liver impairment,” Gansz Bobo said “We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug. We were unable to identify any particular group that may be at increased risk.”

Orlistat and Liver Damage

The FDA first approved orlistat as a prescription medicine in 1999. In 2007, it became the first nonprescription drug approved to treat obesity in American adults. Current estimates are that 40 million women currently take the weightless drug. Orlistat is also approved in some 100 countries, with an over-the-counter form available in the European Union.

30% of American adults aged 20 and older, that’s more than 60 million people, are obese. Another 36% are considered overweight, according to the U.S. National Center for Health Statistics. That puts Americans, in particular, at higher risk since more and more of them need the drug.

The FDA began a research study looking into Orlistat for possible incidents of liver damage in August 2009. That study followed reports of 32 cases of serious liver injury, including six cases of liver failure between 1999 and October 2008. Two of those cases occurred in the United States.

The majority of the patients in the study reported having jaundice, weakness and abdominal pain, which are all signs of liver damage. For 27 patients, the symptoms were severe enough to require hospitalization.

Other symptoms of severe liver damage include:

  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Loss of appetite
  • Light-colored stools

Orlistat Lawsuits

FDA officials stressed that they are only stating that there is an association between the rare side effect and the drug. It’s not known if the drug actually causes the problem. It appears that some people simply metabolize the drug differently, putting them at higher risk. It’s also possible that a contaminant was introduced.

Wider studies must be conducted and the FDA needs to show closer scrutiny. Since Alli is the only FDA approved weight loss drug approved for the over the counter sale it is important that consumers are protected. A side effect like severe liver damage can considerably shorten a person’s life span, prohibit their day to day activities, and have an adverse effect on their quality of life.

If you or someone you know are currently taking Orlistat in the form of Alli or Xenical, and have either displayed the symptoms of severe liver damage or have been hospitalized, it is important that you first speak you your physician. Then call the experienced defective drug attorneys at Phillips Webster for a free consultation as to your legal options.

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Accutane Lawyers: Lawsuits Filed Against Roche for Serious Side Effects

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May 12th, 2010: Law Blogger

accutaneRoche Pharmaceuticals, otherwise known as Hoffman-Roche Ltd. of Switzerland, is the developer of an acne drug called Accutane. The active ingredient is Isotretinon and if you’ve survived either brain cancer or pancreatic cancer, both inoperable and generally fatal, then you most likely took it as part of your chemo-therapy treatment. That’s how the commercial effects were found, people were dying of cancer, but they had surprisingly clear skin.

The Food and Drug Administration (FDA) approved Accutane in 1982 for use in treatment of severe acne that caused large painful nodules on the body that were unresponsive to conventional therapy, including antibiotics. If you’ve known anyone with this problem, cystic acne is disfiguring and painful, causing red cysts and deep nodules that can leave deep scars.

Accutane has proven to be highly effective in treating patients with this type of acne, and in many cases the problem has been completely cleared up after a single 4 to 5 month treatment course. Accutane can, however, be associated with serious adverse events including birth defects which forces female patients to go into a clinic monthly for a pregnancy test and checkup during the 4-6 month treatment.

For these reasons, it continues to be one of FDA’s most difficult challenges in the area of post-approval management and monitoring. There have been so many lawsuits against Roche for damage caused by Accutane that the company has ceased all marketing for the drug. Rather than recall the drug, Roche instead decided to keep Accutane on the market without promoting it. Though there are generic versions of the drug they have continued to be the largest producer.

What Are The Side Effects Of Accutane?

  • Severe depression
  • Suicidal thoughts – The FDA has voiced their concern over the severity of the psychological effects.
  • Behavior Changes
  • Birth defects
  • Crohn’s Disease – An incurable severe bowel disease that also attacks the immune system.
  • Inflammatory Bowel Disease – Debilitating and painful bowel problems
  • Ulcerative colitis – Requires surgery that could result in a catheter
  • Severe Liver Damage – loss of appetite, weight loss, and jaundice (yellowing of the eyes or skin)

These side effects can considerably hamper the patient’s quality of life and in some cases could shorten the patient’s life span. That’s probably why testing is so stringent on this drug and the FDA warns against taking the generic treatment without physician supervision.

Accutane Lawsuits

Colon XrayRecently a case was settled by Roche involving a New Jersey man who had to have his colon removed as result of the side effects of his Accutane treatment. The lawsuit filed against Roche alleged that Accutane gave him a severe inflammatory bowel disorder. After much deliberation the man was awarded $25 million in damages. The man is not the first to have had his colon removed because of Accutane and this verdict could lead to further settlements.

The FDA has chosen not to respond to the lawsuits surrounding Accutane and the residual side effects. The agency has also chosen not to address the growing list of patients who become seriously injured or die from taking Accutane. Some patients have actually reported that their acne got worse when they started taking Accutane, leaving them with permanent scars.

This may be the result of their reluctance to make a ruling regarding Isotretinon. It is still considered an effective treatment for brain and pancreatic cancer and the agency has said that the benefits overshadow the effects with regards to the side effects of cancer treatment.

But Accutane is a treatment that may cause far more harm when simply treating a non-lethal ailment such as cystic acne. Perhaps their reluctance regarding Accutane stems from the fact that reversing their decisions is not a policy of theirs, particularly after they have also approved it for the generic market and, upon realizing their mistake, have begun back pedaling in a “monitor from arms length” sort of way to avoid liability.

Accutane Lawyers

All of this comes down to the fact that Roche is still profiting from a drug treatment that can run into the thousands of dollars per month. The almost 30 years of consistent profit that the drug company has made far out weighs the total of lawsuits that they are now facing after the real side effects of the drug have been revealed.

Accutane remains in the body’s system for a while even after treatment and side effects could show up even after treatment. If you or someone you know has taken the Accutane treatment and suffered from the debilitating side effects or even lost their lives, it is important that you find an experienced defective drug attorney that can represent you in the face of a giant pharmaceutical company with seemly limitless resources. Call Phillips Webster for your free consultation.

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Avandia Faces Tough Scrutiny in House Subcommittee Over Heart Attack Risk

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April 30th, 2010: Law Blogger

Rosa DeLauro in CommitteeGlaxoSmithKline (GSK) representatives sat in the hall outside of a congressional chamber this week as a House of Representatives Appropriations subcommittee listened to Food and Drug Administration (FDA) representatives and outside experts give their opinions on the future of Avandia, GSK’s highly profitable and controversial diabetes treatment pill.

The importance of this subcommittee is that it oversees the FDA’s funding. If the committee finds that the FDA has acted inappropriately, they may find themselves in an awkward situation.

The FDA has recently taken a new look at the safety Avandia, which carries a warning about heart risks. The manufacturer says the drug is safe and effective, and the FDA is advising patients to keep taking the drug as directed. Yet, the Senate Finance Committee released and 374 page report regarding independent study of recent research done on Avandia and found that the drug was too risky to keep on the market.

But the FDA felt that it was more appropriate to further study the drug. The 16,000-patient study of Avandia is designed to give a definitive picture of heart risks associated with it; they’re not fully understood even though the drug has been on the market since 1999. Some critics say that this study is ethically flawed because it needlessly puts patients at risk when there is other research to go off of and other methods to use that is less risky to patients.

The Experts Speak Out

Two drug safety reviewers have recommended that the drug come off the market after concluding it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd.

The FDA Commissioner Margaret Hamburg said in a statement in March that the FDA backed the Avandia-Actos study because it represents the most rigorous approach to evaluating the comparative safety of the two drugs. The agency plans a July hearing to examine the latest data on Avandia’s safety and air internal disagreement among its scientists over what should be done.

Dr. WolfePublic Citizen’s Dr. Sidney Wolfe told House lawmakers the FDA should stop a study comparing patients taking Avandia with those on a similar diabetes drug called Actos.

“Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage,” Wolfe told the subcommittee.

That has prompted new calls for more independence and power for the reviewers who analyze a drug’s risks after it reaches the market, an idea circulating for years. Critics say more authority lies with the staff that approve drugs and are therefore reluctant to withdraw a medicine they supported.

Wolfe reiterated that the FDA should pull Avandia off the market — a position Public Citizen has advocated since 2008.

Legislators Speak on Avandia

Subcommittee Chairwoman Rosa DeLauro, D-Conn., called the hearing to discuss the 374 page Senate report that raises questions the what-and-when regarding Glaxo and the FDA’s knowledge of Avandia’s risks. The report, issued in February, criticized FDA for overruling two safety specialists who recommended pulling it from the market.

The report said, “It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

It seems initially that legislators are inclined to agree with the Senate Finance Committee rather than the FDA on this issue.

“We should not take so long to study a drug about which such serious safety issues have been raised,” DeLauro said in her opening remarks.

DeLauro said that she wanted the committee to have an opportunity to provide input to the FDA ahead of the July advisory panel meeting. She also suggested that she might pursue FDA safety reforms when the panel is setting funding levels for the agency.

“We would like to address some of these issues,” she said.

Independent Research VS Corporate Research

PharmacistMayo Clinic researchers poured over more than 202 scientific papers, letters, and studies published in the wake of a 2007 study by the New England Journal of Medicine, one of the main studies used by the Senate Finance Committee.

Researchers found that of the 31 authors of the 202 studies that expressed favorable opinions of Avandia 27 of them (87%) had financial ties to GSK. The researchers also found that 72% scientists who considered Avandia to be dangerous were most likely independent and free of any pharmaceutical company ties or funding.

In lieu of this the FDA is conducting its own research, at the tax payer’s expense. This suits drug companies just fine since the longer the FDA conducts research, the more profit GSK. This delay until July alone puts more than $600 million dollars into GSK’s pockets.

That’s why the drugmakers as a whole have come to defend the FDA.

David Wheadon, a senior vice president at the Pharmaceutical Research and Manufacturers of America, said in a statement that the FDA already looks at the raw data. “An independent analysis of the raw scientific data already occurs” as part of the FDA review process.”

He went on to say that the FDA scientists are “best equipped” to evaluate the drug benefits and safety and often turn to outside experts on advisory panels for input.

This is somewhat of a contradictory statement since there are “outside experts” giving testimony that the drug is dangerous and should be taken off of the market.

Avandia Lawsuits

GSK’s drug Avandia was approved in 1998 and has sincethen has shown a considerable profit for the global drugmaker with an annual average of $3 billion in annual sales and $2 billion in annual profit. This profit is the very motivation behind the company aggressively trying to cover up the deaths of nearly 4000 diabetes sufferers linked to Avandia.

If you are an Avandia user or the loved one of an Avandia user who has suffered a loss of a loved one or serious personal injury related to taking Avandia you may be entitled to compensation for your pain and suffering.

Phillips Webster is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. Call them today for a free consultation and to find out your legal rights as a patient.

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Seroquel XR Gets Approved to Treat Depression despite Alleged Diabetes Connection

Defective Drugs, Seroquel, Seroquel Attorneys, Seroquel Lawyers, seroquel side effects, washington defective drug attorney

April 26th, 2010: Law Blogger

AstraZeneca HeadquartersAstraZeneca, of Britain, is an international pharmaceutical conglomerate who made between $25-$30 billion in annual sales last year. This makes them a lowly number 8 in the world on the list of annual profits for a pharmaceutical company. Being number eight can affect a pharmaceutical company’s self esteem, but yet, I’m sure it’s nothing a relaxing money-bath couldn’t take care of.

But they have gotten a boost that could take them out of the multi-billion-dollar doldrums and propel them into one of the top slots in the overall pharmaceutical profit list. AstraZeneca’s schizophrenia drug Seroquel XR has been recommended by European regulators as an add-on treatment for depression, following an earlier rebuff in the Netherlands.

That means that a pill that was once a treatment for severe cases of schizophrenia and bipolar disorder has now been approved to be used on clinical depression, which raises the number of potential patients from a few hundred thousand to unknown millions of people. The profit potential boggles the mind. You see, Seroquel is one of AstraZeneca’s most profitable pills drawing in a whopping $4.87 billion dollars annually. To put that into perspective, that is more than the Gross Domestic Product of almost every country in Africa. A single pill.

Here’s where the problem comes in: the side effects can be deadly.

AstraZeneca and Seroquel XR

Last year was not Seroquel’s year. There were hundreds of lawsuits surrounding the side effects and the Dutch authorities, acting as reference member state under the European Union’s mutual recognition procedure, rejected Seroquel XR in depression. This prompted AstraZeneca to refer its application to the European Medicines Agency (EMA), which approves drugs centrally.

The EMA said on Friday came to a different conclusion that the drug could in fact help patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants. That decision falls into line with approval for the drug granted by the Food and Drug Administration (FDA), the agency that regulated pharmaceuticals in the Untied States, in December.

Adding to the largess of this decision is that it was not just Seroquel that was approved, but Seroquel XR. Plain old Seroquel is about to go into generic oblivion, which means that companies can produce it and charge far less for it. Seroquel XR is the milder “extended relief” version, which is supposed to have longer effect and easier for patients to take over a long period of time. Of course what it does for AstraZeneca is prolong the patent farther into the future.

Seroquel Side Effects

seroquelSeroquel was actually advertised to the healthcare community as a drug that treated severe mental disorders without the side effects that other pills had such as lithium. This assertion was, of course, incorrect because Seroquel has some very serious side effects. The company paid dearly for that misleading assertion to the tune of $520 million to the federal government.

The side effects include:

  • Neuroleptic malignant syndrome (NMS) – a serious and deadly drug reaction
  • High blood sugar (hyperglycemia)  – fat in the blood
  • Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol.
  • Increase in weight (weight gain) – in some instances severe obesity has occured
  • Tardive dyskinesia - uncontrolled movement in face and other body parts
  • Orthostatic hypotension (decreased blood pressure)
  • Increases in blood pressure in children and teenagers.
  • Low white blood cell count – lowered immune system
  • Cataracts – eyesight diminishes
  • Seizures
  • Abnormal thyroid tests – also related to weight gain
  • Increases in prolactin levels
  • Increases in liver enzymes
  • Long lasting and painful erection
  • Difficulty swallowing

The side effects are alarming to put it lightly. The largest concern of patients, and perhaps the most noticeable, is the weight gain. Patients have complained of becoming obese and suffered the symptoms of obesity such as Type II diabetes and heart attack.

These are called “secondary symptoms” and AstraZeneca, if their news hasn’t been great up to this point, also just won a major lawsuit filed by one of the early Seroquel sufferers who said that they have type II diabetes directly related to the drug.

Seroquel Lawsuits

Seroquel treating depressionThere are currently around 25,000 lawsuits brought against the popular drug and though they are all unique in their own way (some of them are wrongful death lawsuits) the majority of them are defective drug lawsuits revolving around the side effects of the drug, particularly alleging that it cases diabetes.

In a seperate case last year, Linda Guinn, of New Jersey, had her case thrown out over a technicality regarding her main witness. Guinn’s physician, Dr. Jennifer Marks, had given the district court an expert opinion stating that her patient gained about 40 pounds over five years while taking Seroquel and, as a result, Guinn developed diabetes.

AstraZeneca countered that the woman had a strong family history of diabetes and had other risk factors for the blood sugar disorder, including a sedentary lifestyle and high blood pressure and cholesterol (also side effects of the drug).

AstraZeneca successfully argued in January 2009, before that case was to go to trial, that Guinn’s doctor did not qualify as an expert under federal court rules and so her testimony should be excluded. They also persuaded the judge to grant a summary judgment motion in its favor, arguing that Guinn failed to establish that Seroquel caused her diabetes.

Since then the questioning of expert testimony has been their main defense and has begun to start paying dividends. If enough cases are won they may force a consolidated settlement, which will end up saving the company billions of dollars in both payouts and legal fees. Their legal fees up to this points have topped $1.51 billion and rising.

Defective Drug Lawsuits

As you can see, having an inexperienced legal team working against a giant pharmaceutical company with unlimited resources can end up in disaster. The FDA has not yet taken action or begun to test whether there is a connection between Seroquel and diabetes, even with the knowledge that AstraZeneca has in no way attempted to study the most widely detrimental effect of their drug.

The people this drug is meant for do not commonly express behavior that can counteract the side effects of the drug, such as regular exercise and healthy nutritional choices. The very ailment that the drug treats causes antisocial behavior. Now it is approved for people with depression. Clinically depressed people are not generally athletes and weight gain can only add to their depression. Stack other side effects on to that and there could be some major issues.

This may just become part of a combined drug treatment for depression in the future. If you or a loved one finds that you have been victim of a defective drug by either misdiagnosis or failure to prescribe the correct combination of drugs, then you may be entitled to compensation. To begin the process you will need to find a law firm that is experienced with defective drug litigation and medical malpractice lawsuits. Call Phillips Webster for your free consultation.

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Plavix: European Plavix Recall on Heels of FDA Black-Box Warnings

Defective Drugs, washington defective drug attorney

April 15th, 2010: Law Blogger

bristol-myers squibbEuropean countries announced the recall of popular blood thinner Plavix yesterday after recommendation of the European health authorities. This, right after the Food and Drug Administration (FDA) has issued several warnings regarding the conclusion of a series of 6 studies testing different aspects of the drug.

The scrutiny of these studies has been fairly heavy, not only by some in the medical community, but also by this blog. We brought to light the somewhat lax methodology of the Plavix tests, but the FDA has accepted the data and issued warnings and precautions to patients and the healthcare community. But one in particular warranted the infamous “black-box label”. The most severe they issue.

This news doesn’t do any favors for Sanofi-Aventis and Bristol-Myers Squibb who just freshly left the courtroom to stave off claims that the drug should go generic before the expiration in 2011. That would mean that their baby money machine, Plavix, the second largest selling drug in the world, would lose considerable revenue in its waning days, you see, 2.5 million to 3 million Plavix prescriptions are written in the United States alone every month. That’s a lot of medication.

First, lets find out what the drug actually does.

What is Plavix and What are Some Plavix Side Effects?

clotting 101Plavix is generally prescribed by physicians to prevent blood clots after a recent heart attack or stroke. It’s also taken by people with certain disorders of the heart or blood vessels. Plavix helps blood resist clotting to prevent blockage that can occur with certain heart or blood vessel conditions. Since the purpose is blood not clotting, Plavix has been known to make it easier for a patient to bleed for longer than they normally would have, even from a minor injury.

The active ingredient in Plavix is clopidogrel bisulfate, which is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Essentially what that means is that it prevents clots as stated above.

Most likely you are taking Plavix because you’ve already had a stroke or cardio event that requires a prescription blood thinner that is stronger than aspirin. If that is the case then the side effects may cause more fatigue and inhibit the healing process. Speak to your doctor if this is the case.

Plavix side effects are:

  • Dark, black, bloody, or sticky black stools
  • Cloudiness, confusion, blurred vision, slurred speech, or poor balance
  • Coughing up blood or vomit black or brown flecks
  • Chest pain, pain spreading to the arm or shoulder
  • Headaches
  • Ill feeling or flu-like fatigue
  • Profuse sweating
  • Pale skin
  • Sudden numbness or weakness on one side of the body
  • Sudden Nosebleeds
  • Unexplained bruising or bleeding

Black-box Warning

The FDA last month required Sanofi-Aventis and Bristol-Myers Squibb to print a warning label on the package regarding a genetic variation that can limit or block the active ingredient. This can prevent the drug from working, or can limit its effectiveness, increasing a patient’s risk for a potentially life-threatening heart attack. Since it is a genetically recessive trait, then only a few patients have this problem, but the problem can kill them.

The genetic limitation of the drug has been known for well over a year. But the FDA appeared to heighten the alert by placing on March 12 to a black-box warning, the FDA’s most severe safety advisory.

This surprised even well informed cardiologists who were cognizant of the issue since the number of patients with the genetic variation is so low. But it helps inform all healthcare professionals of the danger and helps avoid medical malpractice lawsuits.

European Clopidogrel Recall

The black-box warning hardly hit headlines since its effect was so small, but the European recall potentially affects thousands of patients. The European Medicines Agency (EMA), the EU equivalent to the FDA, found that there was a failure of good manufacturing practice at a factory in Visakhapatnam, India, where the active ingredient for the European version of Plavix is produced and then sold and distributed by Swiss drug maker Acino.

Acino said independent analyses had confirmed the quality of its clopidogrel, while inspecting regulatory authorities had also concluded the shortcomings found at the manufacturing site did not represent a health hazard.

Currently none of the clopidogrel produced for the American version of Plavix has been recalled.

FDA Warnings

PlavixMany of six Dutch studies focused on how patients reacted during surgery and after surgery while taking Plavix. As we have learned, once a patient starts bleeding they bleed a lot while taking the drug and this could cause a catastrophic surgical error or unduly prolong the crucial healing process after surgery.

If the wound does not clot it will not heal properly and could be susceptible to various infections. For a heart patient or stroke victim an infection can be devastating and potentially deadly.

The FDA also issued a warning regarding taking Plavix with other medications because of the sometimes fatal reactions. The current list of drugs is:

  • Intelence
  • Prozac
  • Luvox
  • Nolvadex
  • Orinase
  • Demadex
  • Lescol
  • Tagamet
  • Nexium
  • Kapidex
  • Prevacid
  • Prilosec
  • Prilosec OTC
  • Zegerid
  • Protonix
  • AcipHex
  • Diflucan
  • Nizoral
  • Vfend
  • Coumadin
  • Fragmin
  • Lovenox
  • Innohep
  • Activase
  • Persantine
  • Ticlid
  • Abbokinase
  • Felbatol
  • Dilantin

Defective Drug Lawsuits

Healthcare workers are there to help you and heal you. They are of course human and cannot memorize the whole of the side effects and drug interactions, but they can certainly research and inform. They can also recommend drugs and communicate with the pharmacist so that there is not a reaction to another medication that could possible cause a serious personal injury or fatal drug reaction.

If you or a loved one finds that you have been victim of a defective drug by either misdiagnosis or failure to prescribe the correct combination of drugs, then you may be entitled to compensation. To begin the process you will need to find a law firm that is experienced with defective drug litigation and medical malpractice lawsuits. Call Phillips Webster for your free consultation.

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Johnson & Johnson and Omnicare Face Lawsuits over Risperdal in Nursing Homes

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March 11th, 2010: Law Blogger

defective drugsIf you had any reservations as to the length a giant pharmaceutical company will go to make a profit then this story may be the one that convinces you.

The Attorney General of Massachusetts, Martha Coakley’s office joined a federal lawsuit yesterday against Johnson & Johnson. The suit contends that, beginning as early as 1999, J&J paid tens of millions of dollars in kickbacks to national nursing home medical products provider Omnicare to get its drugs, especially the powerful antipsychotic Risperdal, prescribed in nursing homes.

This comes a year after the generic version of Risperdal was approved by the Food and Drug Administration (FDA). Officials J&J wrote in a business plan as recently as just a few months ago, “The geriatric market represents Risperdal’s second wave of growth. The aging population will continue to drive market growth well into the next century.”

This means that J&J intended to treat dementia patients with Risperdal even after learning about the side effects.

You see, the problem is that FDA specifically warned that Risperdal considerably raises a dementia patient’s chances of death. J&J might have intended to use early death of senior citizens with dementia as an engine for profit.

Risperdal

Risperdal is an antipsychotic drug that is used to treat schizophrenia. It quells symptoms of the mental disorder. In the mid 90’s it was also touted as a go-to drug for a myriad of mental disorders, but was severely reigned in by the FDA by the late 90’s because the side effects can be pretty severe. It is used for more mild conditions such as bi-polar disorder and over-aggression in autistic children.

The Risperdal side effects include:

  • Severe allergic reactions
  • Abnormal thoughts
  • Confusion
  • Drooling
  • Fainting
  • Irregular heartbeat
  • Persistent Flu Symptoms – fever, chills, or sore throat
  • Inability to control urination
  • Increased sweating
  • New or worsening mental or mood changes
  • Seizures; Severe dizziness
  • Stiff or rigid muscles
  • Suicidal thoughts or attempts
  • Trouble concentrating, speaking, or swallowing
  • Pensiveness
  • Unusual bruising
  • Vision changes

The drug now competes with the likes of Seroquel, another antipsychotic that is currently facing thousands of lawsuits for misstating the side effects.

Currently 1.1 percent of the US population is thought to have schizophrenia, but the antipsychotic market in the US alone was $14.6 billion in 2008. This is opposed to $580 million in 1997 to 2004’s total US sales of just $1.4 billion. It sounded as if J&J needed to find something that would really catapult the sales figures. They found it in Nursing homes.

Anatomy of a Crime

Medical MalpracticeFiles full of more than 5,000 pages of official documents were made public by J&J, ordered by the judge in the case as requested by news agencies. The records give a detailed account of a decade-long campaign by Janssen (a subsidiary of J&J) to convince doctors, regulators and insurers that Risperdal was superior to older, cheaper antipsychotics.

It is illegal for drug companies to sell their products for off label uses.

The federal lawsuit details an elaborate program by J&J and Omnicare to allegedly convince resident physicians in nursing homes to prescribe Risperdal. Within the documents released, one was from 1999 in which Omnicare offered J & J’s sales team a list of nursing home physicians who had been resistant to prescribing the antipsychotic.

“These names were provided to the sales force in an effort to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient,’’ the e-mail said.

Another J&J document, this one from 2003, showed that doctors accepted recommendations from Omnicare’s force of 900 consultant pharmacists more than 80 percent of the time.

Between 1999 and 2004 sales of J&J products to Omnicare nearly tripled from around $100 million to over $280 million. Annual purchases of Risperdal alone rose to over $100 million, the suit contends.

Omnicare then filed for reimbursement for these purchases, seeking payment from Medicaid, the joint federal and state health program for the poor, which pays for nursing home care for many seniors.

Protect Yourself and Loved Ones

Omnicare agreed in November of 2009 to pay $98 million to settle federal charges it took kickbacks. This may only be a fraction of what they actually received.

Johnson & Johnson is still fighting and are vowing to take this all the way.

J&J spokeswoman Carol Goodrich said yesterday that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.” She added, “We look forward to the opportunity to present our evidence in court.”

Making a profit something that drug companies are very good at. Accountability on the other hand is perhaps their worst trait. This is why lawsuits are so important. Profit is the only thing that the large corporations see and the loss of profit is the only way they’ll learn that they have rules that they need to follow. The rules aren’t there to punish them. The rules are there to protect consumers.

If you or a loved one have been adversely affected by the conduct of Johnson & Johnson, Omnicare, your nursing home, or Risperdal call Phillips Webster today for a consultation on your legal options.

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FDA Warning: Fosamax, Actonel, Boniva, Reclast Bisphosphonates Fracture Side Effect

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March 10th, 2010: Law Blogger

Defective DrugYou may have seen famous actress Sally Field sitting on a couch or walking on the pier of a peaceful lake talking about the benefits of Boniva. She tells us that she has osteoporosis and that her doctor told her that Boniva could not only stop bone loss, but make bones grow denser. It turns out the opposite is true.

Today the Food and Drug Administration (FDA) announced that it will look into links alleged between the use of certain osteoporosis drugs such as Fosamax, Actonel, Boniva, and Reclast and a particular type of leg fracture. This follows extensive review of a study published in the Journal of Bone and Mineral Research.

Dr. Bo Abrahamsen of Department of Medicine and Endocrinology F, Copenhagen University Hospital in Denmark headed up the study, which did an analysis of data from two large observational studies on patients with osteoporosis.

Dr. Bo AbrahamsenIn the study the authors concluded that atypical femur fractures that happen right below the hip had many similar features in common with classical osteoporotic hip fractures. These include the patient’s age, gender, and trauma mechanism (cause of the injury).

They came to these conclusions because the data showed that patients taking bisphosphonates (a class of drugs that prevent bone loss) and those not taking bisphosphonates had similar numbers of femur fractures in the same place in the femur relative to classical osteoporotic hip fractures.

Side Effects Hit the Headlines

Today ABC News reported that numerous cases of women who had taken Fosamax (one drug in a class of bisphosphonates that also include Actonel, Boniva, and Reclast) for a long periods of time experienced their femur bones had just snapping while doing little more than taking a walk.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”

This is not the first time that doctors have reported an opposite effect for Fosamax. The drug, made by Merck, has already been linked to severe musculoskeletal pain, as well as to a serious osteonecrosis, a depletion of bone density in the jaw. You may remember Merck from their expensive and embarrassing recall of Vioxx in 2004. After taking a $5 billion PR bloodbath, Merck is still arguing against the settlement as if it would matter.

Defective Drug Denial

Defective ProductsAs early as 2008, the FDA sent a letter to Merck about the reports of bone fractures. It took Merck 16 months to add those reports to the list of possible side effects included in the drug’s package insert.

“Nothing is more important to Merck than the safety of its medicines,” said Merck. “As part of our commitment, Merck closely monitors post-marketing data and reports that information to FDA and other regulatory agencies.”

“A causal association has not been established between long-term bishphosphonate use and low energy femoral shaft and subtrochanteric fractures,” it said. “In clinical studies, Fosamax (alendronate sodium) has not been associated with increased fracture risk at any skeletal site.”

The company reported femoral fractures had been discovered in non-bisphosphonate users also. They are doing further investigation. The problem with this is that they have a history of foot dragging, particularly related to the highly profitable Fosamax.

The FDA doesn’t seem to be conducting themselves in the best manner either. After the Merck misconduct, the FDA turned around and rewarded them by approving the generic version of Fosamax. There’s a term for this in the pharmaceutical industry for this. It’s called, “cha-ching.”

Patients Speak Out

Stephanie George, a 67-year-old retired college teacher from Frisco, Texas, took Fosamax for eight years. She said she was advised not to have dental surgery for an abscess on her wisdom tooth until she had been off the drug for five years.

“They said there was a rare, but real chance that my bottom jaw would become infected and might have to be removed,” said George.

If that’s not scary enough, George is joined by literally millions of post-menopausal women, who were treated with bisphosphonates for low bone density.

Jeanett McLearen of Warren, Michigan is perplexed by the news. Her doctor wants her to have further injections for bone loss, but upon hearing about the risk, she cancelled her first appointment this week.

In an interview with ABC she said, “I am scared and I am confused. I don’t know what I think. I don’t know what to do.”

This is understandable. Women are told to check bone density and trust what their doctors say. Their doctors in turn must trust that the FDA is up to date on the most recent studies on the thousands of types of drugs. And the drug companies are supposed to closely monitor specific studies and warn the FDA of results. Yet there is a major flaw at every level of the chain. The drug companies make too much money to report, the FDA is too under-funded to adequately report, and it is impossible for doctors to fill the gaps.

Treatment vs. Natural Occurrence

Dr. Norton HadlerDr. Nortin Hadler is a professor of medicine and microbiology at University of North Carolina. He is opposed to the treatment of osteopenia. He claims it is just part of the natural course of aging.

“We have a history of over treatment and over-medicalization of people in this country and we need a discussion that’s out loud and up front,” said Hadler, author of “Worried Sick”. He went on to contend, “For those who are in their 50s and otherwise healthy, there is no reason to have a bone density test.”

In some cases testing is important, especially for people who are prone to osteoporosis because they take steroids, struggle with nutritional issues, or have inflammatory bowel disease.

“Our nation has been taught to fear the consequences of our thinning bones,” he said

Dr. Ethel SirisDr. Ethel Siris is the professor of clinical medicine at Columbia University’s College of Physicians and Surgeons and director of the Toni Stabile Osteoporosis Center, and she agrees that not all women with osteopenia need to be treated with bisphosphonates, but the issue is complicated.

“When we get stuff like this on the news, we get millions of calls and people with bad osteoporosis on the drug and at risk for fractures throw away the drugs and are afraid,” she said.

“First of all, these are unusual fractures and hard to interpret and a fair number occur in people without bisphosphonates,” she said. “This is a rare complication.”

Patients Need to Be Protected

Amongst all of the disputes, the warnings, the studies, and the different treatment methods, the ones who seem to suffer the most are the very people who are suffering in the first place; the patients. When it comes down to it, patients who are suffering from bone density are being told by celebrities on television that they can reverse the serious problem and the patient is getting worse.

This class of drugs have been on the market and tested for almost two decades, but yet a side effect that can manifest itself within five years and neither the drug companies nor the FDA did anything about the complaints until now. That is not acceptable when it affects millions of women.

If you or a loved one are taking this class of bisphosphonates it is important that you contact your doctor. Then protect yourself by contacting legal council that has experience in protecting patients from giant pharmaceutical companies. Call Phillips Webster for a consultation on your legal options.

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Seroquel: Testimony Begins in Trial against AstraZeneca

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March 8th, 2010: Law Blogger

AstraZeneca SeroquelTed Baker’s lawsuit resumed today in New Jersey. His is the first of 26,000 legal cases being brought against the British pharmaceutical giant AstraZeneca. Baker’s suit reflects the basis of most of the other cases. He contends that the company did not adequately inform patients and healthcare representatives of the risk of contracting diabetes from weight gain after taking the popular pill Seroquel, an atypical antipsychotic used to treat schizophrenia.

These are serious charges, because weight gain is a significant side effect. The lawsuits allege that the company knew about the of the side effects and still resisted changing their labeling. A study released in 2003 in the American Journal of Psychiatry found drugs like Seroquel were associated with an increased risk of diabetes.

Yet, even the Food and Drug Administration (FDA) has seemed to underscore the importance of the 2003 study. In their drug safety description of Seroquel provided to healthcare providers they mention weight gain, but nothing further related to the side effect, only that the patient should weight themselves.

The Experts Take the Stand against Seroquel

It’s becoming apparent that experts and ex-employees of AstraZeneca are going to have a significant role in the trial. If the trial turns out in Baker’s favor, that could be damaging to AstraZeneca.

One of those witnesses, Seroquel’s former global safety officer Dr. Wayne Geller, testified today that some colleagues fought his urgings in June of 2000 to strengthen AstraZeneca’s internal description of Seroquel’s weight gain side effects. He told the jury that all he and other researchers wanted was the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight.

“I did question why the word limited was not taken out of the core-data sheet” Geller said. “I found out there were people from the commercial side who opposed the change.”

Basically what that means is that the sales department thought it would be bad for business. Geller’s testimony shows a clear intent to sugar coat the seriousness of diabetes related to weight gain in Seroquel.

Geller pushed to change the language because after reading the AJP report and others since that show Seroquel could “produce significant weight gain in select individuals,” he felt that he had to say something.

Geller revealed that the reports showed that the average weight gain was 27 pounds. In some cases that can mean a significant raise in an individual’s body mass index. When accompanied with other side-effects of the drug not independent of the weight gain such as higher cholesterol and higher blood sugar levels, this is a perfect combination for diabetes. So, this shows that diabetes is not a secondary side effect, but because of the combination of side effects, it is a primary side effect. Seroquel causes diabetes and the label failed to warn of the risk.

Upon cross examination, AstraZeneca’s lawyers decided to focus on specific language. The initial report regarding Seroquel’s side effects written by Geller had the word “limited” in it. He admitted having mistakenly left the word in other reports since reading studies to the contrary.

Mike Brock, an AstraZeneca lawyer, asked Geller, whether the company ever used the “limited weight-gain” language in Seroquel’s  warning label in the United States. “It’s never been in there,” the doctor replied.

AstraZeneca Decides to Blame the Victim; Will it Work?

Defective Drug MakerThe company may be seeing the writing on the wall. They may be helping schizophrenics, but they’re also making them obese, which lowers their life expectancy considerably.

Officials at AstraZeneca indicated earlier today that they will end research and development into psychiatric medications at its United States corporate headquarters in Wilmington, Delaware, as part of a mass corporate restructuring.

They also announced that they would cut 11 percent of their workforce by the end of this year as part of the $2 billion restructuring, the bill for the whole shake up that’s happening between now and 2013.

The 11 percent cut means 550 jobs will be lost in Wilmington, Delaware. The loss of those jobs is obviously significant to the existence of the global conglomerate, but how it unclear. This is a corporation that made almost $5 billion off of Seroquel alone. The layoff may just a punishment to the United States.

In a classic tactic called “blame the victim”, lawyers for the company told jurors in opening statements that Seroquel doesn’t cause diabetes. They accused Baker (a Vietnam War veteran) that his weight-gain and disease stemmed from his lifestyle and diet. The lawyers went on to say that the company provided adequate warnings about the drug’s risks on the medication’s warning label and marketed it as according to clinical findings.

“From the very first label for Seroquel, AstraZeneca had in its label the risk of weight gain and the risk of diabetes,” Diane Sullivan, of the AstraZeneca legal team, told jurors in opening statements.

The blame the victim tactic has not gone well in the past for other legal cases. It tends to alienate the jury. Some high profile cases have had disastrous results because of it, an example was RJ Reynolds during their unprecedented $144 billion tobacco lawsuit loss. People feel alienated from massive global conglomerates as it is, being British and eliminating American jobs in the process doesn’t help their public relations. We shall see.

Seroquel and the Side Effects

According to both AstraZeneca and the FDA the list of side effects remains the same and there is no warning or even acknowledgement of the many studies showing of significant chance of diabetes.

Some of the side effects include:

    Defective Drugs

  • Difficulty swallowing
  • Long lasting and painful erection
  • Increases in liver enzymes
  • Increases in prolactin levels
  • Abnormal thyroid tests
  • Seizures
  • Cataracts
  • Low white blood cell count
  • Increases in blood pressure in children and teenagers.
  • Orthostatic hypotension (decreased blood pressure)
  • Tardive dyskinesia uncontrolled movement in face, tongue, or other body parts
  • Increase in weight (weight gain)
  • HDL (good) cholesterol.
  • High blood sugar (hyperglycemia
  • Neuroleptic malignant syndrome (NMS) A rare and serious condition that can lead to death.

The FDA also mentions that there is a chance of suicidal thoughts. Not a welcome side effect for a drug that is taken for schizophrenia.

Protect Yourself

The massive legal teams that can be accumulated by a company that makes 5 billion dollars per year off of a single pill amongst in their extensive line of pharmaceuticals can seem disheartening and slightly overwhelming. That makes some patient’s feel as if they can’t be represented or it just isn’t worth it. That is not true if the legal council representing the case is experienced with defective drug litigation.

If you or a loved one has been seriously injured or killed by a defective drug or pharmaceutical company negligence then call Phillips Webster for a consultation on your legal options.

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Avandia Lawsuit: GlaxoSmithKline Rebuttal, 30 Pages of Empty Denial

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March 3rd, 2010: Law Blogger

AvandiaGlaxoSmithKline (GSK or Glaxo for short) have thrown together a 30 page rebuttal to the Senate Finance Committee’s recent report that was a hefty 374 pages of hurt upon the company and their conduct regarding the production, distribution, and sale of Avandia. Glaxo felt the need to respond to a Senate Finance Committee panel because the committee stated:

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

Strong words for a panel of elected officials. To warrant that kind of decisive language there must be some overwhelming evidence. The charges are serious and the numbers are overwhelming. The Senate report says:

1)      Avandia has been linked to 83,000 heart attacks since 1999

2)      GlaxoSmithKline experts verified an outside study showing the cardiac problem, but then the company did an immediate about-face and publicly attacked the findings as incorrect.

3)      Two Food and Drug Administration (FDA) safety officials said the ongoing FDA study between rosiglitazone (the active ingredient in Avandia) and pioglitazone (a rival diabetes drug treatment) was unethical. They said rosiglitazone clearly causes heart attacks. Yet the study keeps going and the FDA has yet to call for a recall.

GlaxoSmithKline Responds Regarding Avandia

Glaxo of course disagrees; there are literally billions of dollars on the line. They say:

“Glaring omissions” in the Senate report included a lack of discussion of the final results of important clinical trials that were assessed by Food and Drug Administration (FDA) advisors, who voted to keep Avandia on the market.

They went on to say that criticisms of Avandia by FDA official David Graham were “flawed and unreliable and, most importantly, do not represent the formal opinion of the FDA.”

Their report cites studies conducted by outside research teams that heavily favor or exonerate Avandia and vindicate Glaxo. Of course in the thirty pages there is no mention as to how some of these studies came to being and who funded them. Some of them were just flatly paid for by GSK.

Of course it is good that companies pay for their own further research of drugs currently on the market so to find any problems that may arise after clinical trials. That is the honorable thing to do. The dishonorable thing to do is to ignore those findings.

By the way, the Senate report also mentions how they ignored even their own findings.

Avandia is Too Profitable to Let Go

Defective DrugsYou see, what Glaxo is fighting against is the evidence presented by two powerhouses in the medical research field, the New England Journal of Medicine 2007 study and the American Medical Association 2008 study. They try to throw less legitimate studies at the wall and hope that the recent data is more substantial than long term studies conducted over an extended time period. They say:

“In the case of RECORD, final results have been publically available for eight months and, in the case of ADOPT and DREAM, final results were published over three years ago.”

This is an attempt to retain the status quo because According to reports, GSK makes $3 billion from Avandia alone per year, $2 billion of that in straight profit. Regardless of the justifications or reasons, the average of 4000 plus heart attacks caused by Avandia pales in comparison to the profit.

To the company it’s worth it. Of course to the individuals and families who lose, according to heart attack statistics, 7 to 8 of their loved ones per say to Avandia, it is a devastating hole left in their lives that could have been prevented if GSK put patients before protfit.

Protect Yourself

If you or a loved one are currently taking Avandia and show signs of a serious heart condition or have suffered serious side effects due to taking the drug it is important that you find council that is experienced in taking on massive pharmaceutical global conglomerates with money and legal teams.

You can protect yourself by calling Phillips Webster, because they know Avandia, know its side effects, and have worked with others like you who have been hurt by a drug that was supposed to help you. Call today.