Alabama: Jury Orders Makers of Sandoz to Pay State $78.4M

News from Alabama yesterday:

Jurors ordered Sandoz Inc. pay the State Government of Alabama $78.4 million for causing the state Medicaid program to pay too much for prescription drugs from 1991 to 2005.

Evidence at trial? The evidence included a company memo that said: "Go forward and take the position of a Roman legion, be greedy and take no prisoners."

Source here.

Vytorin: Cancer Risk for This Heart Drug?

From various sources, link below. Several larger studies say no, one smaller study suggests yes.

Last year, a heart researcher (Terje Pedersen) released a from an 1,800 patient study. According to it, 47% of those taking the cholesterol drug Vytorin were more likely to develop cancer than those taking a placebo.

Pedersen and other scientists conducting two Vytorin studies tried to refute the findings. An analysis of data from two larger but unfinished Vytorin studies showed no increased risk of cancer.

A 18,000-patient larger study, called IMPROVE-IT, which began in October 2005 and is set to continue until 2012, didn't have enough useful information to give any answers. Another 9,000 patient test (which began in June 2003) in patients with kidney issues, code-named SHARP, showed no increased risk of cancer.

Source here.

Happy Mardi Gras - From Our Family to Yours

For my 1,000th post, I'm happy to say to folks today, Happy Mardi Gras. For many, the beads tossed have a less than family oriented connotation, but make no mistake - Carnival in New Orleans is heavily family oriented (Yes, the French Quarter and that certain street are exceptions).

Mardi Gras for families is as much sitting along St. Charles all day, with a ladder for the kids to better catch trinkets as it is a time to laugh, eat, and be with friends. For college students, it's a day/night long tailgate without the football game.

For me, it was a time to dine at great restaurants (Antoine's, NOLA, Mr. B's), to enjoy a lawyer seminar (yes, held this past week, during Carnival), and to talk to folks enjoying the parades.

It's good to see that the City I love is coming back.

Outsourcing of Drug Trials

The most recent issue of the NEJM, here discusses the globalization of clinical trials.

Concerns noted in the article include:

Wide disparities in education, economic and social standing, and health care systems may jeopardize the rights of research participants;

There may be a relative lack of understanding of both the investigational nature of therapeutic products and the use of placebo groups; and

In some places, financial compensation for research participation may exceed participants' annual wages, and participation in a clinical trial may provide the only access to care for persons with the condition under study.

Worth a read.

Tech Talk: Lawyer(s) Suddenly Laid Off? Looking to Set up an Office?

A couple of friends across the USA have either suddenly been let go, or made the decision to depart before the ax fell. Most have the same problems: How to quickly set up an office presence if a lawyers decides to open up shop.

Here are a few quick - perhaps interim only - suggestions:

1.Email: When I left my prior firm, I was sweating the purchase of an email server. After a day of searching, I settled on MailTrust.com.For about $3-$5 per mail box, you get POP, IMAP, & Webmail, Business-class email, sharing, & mobility. I set up my system for $70 a month. Plus, no contract terms to worry about long term. I am able to control the number of users, add or remove mailboxes, and I have an email address with a specific domain.

2.FAX: I signed up and receive faxes through efax.com. I'm able to get a local FAX number, and within about 10 minutes I was ready to go.

3.Phones: Obviously a concern. I am able to tell you that we now use VOIP, but in the beginning we went cell. An attorney I know who was let go suddenly actually only had his personal cell. He went to tossabledigits.com for a disposable phone number.

At the very least, get another cell phone line for the first several days of your new career. You can always forward it to a main number when you're set up.

4.Internet/Website My suggestion to anyone reading this is to acquire and manage your own domain. I'm not talking about building a page, merely about controlling the domain name. That is, don't entrust any internet hosting company to build your site and administer/control the .com name. Why? I can tell you horror stories of a firm passing off its .com to a host, only to have that host go under, and with it the .com name. Another story involves a hosting company getting angry about losing business and refusing to turn over the domain name.

I simply use godaddy.com or yahoo.com, buy the domain name, and forward it to the site that is ultimately built. I can go into detail about modifying an A record, but that is for later.

5. Openoffice and PDF995.com: Openoffice is the free version of the typical office system like MS Word/MS Office. It allows you to create a document and save in .doc or other formats. It also allows you to save as a PDF. Pdf995.com is just that - converts a document into PDF. There is a free version as well.

Reglan and Movement Disorders

Reglan now has a blackbox warning, pursuant to the FDA. We're investigating those who may have been harmed by this drug.

Movement disorders describe a variety of abnormal movements of the body that have a neurological basis. These abnormal movements are characterized by changes in the coordination and speed of voluntary movement. They may also involve the presence of additional movements that are not voluntary.
Description

Movement disorders are sometimes referred to by medical professionals as extrapyramidal diseases because this class of disorders is distinct from the disorders caused by disorders of the pyramidal region of the brain. Researchers have determined that movement disorders are caused by diseases in various parts of the brain, including the substantia nigra, the subthalamic nucleus, the globus pallidus, the striatum, and the basal ganglia.

Movement disorders are usually broken down into two types of movement: hyperkinetic movement and hypokinetic movement. Hyperkinetic movement disorders are characterized by a significant and excessive amount of motor activity. This type also includes cases in which there is a significant amount of abnormal involuntary movement. Hypokinetic movement disorders are those in which there is an abnormally reduced amount of intentional motor activity.

Hyperkinetic movement disorders are characterized by two types of behavior: rhythmical and irregular. Tremor is a rhythmic movement that is further divided into three forms: rest, postural, and intention. Rest tremor is most prominent when an individual is at rest and decreases with voluntary activity. Postural tremor occurs when an individual attempts to support a position against gravity (such as holding an arm outstretched). Intention tremor occurs during voluntary movement toward a specific target.


A side effect is a movement disorder, like Dystonia:


What is Dystonia?

Dystonia is a movement disorder characterized by involuntary muscle contraction leading to abnormal postures and twisting movements. The frequency of this disorder is similar to multiple sclerosis.

Are there different types of dystonia?
Several types are known and they are classified according to age of onset, distribution of dystonia, and cause. The primary dystonias are diseases that are characterized with only dystonia as their clinical feature. They are classified as early onset or adult onset disease.

* Early onset dystonia
The characteristic form of early onset form is called "primary childhood onset dystonia" otherwise known as Oppenheim's dystonia or DYT1 dystonia. This disease begins frequently with dystonia in a limb and with onset under the age of 28. It characteristically progresses to involve other body parts and ultimately becomes generalized.

* Adult onset dystonia
The adult onset dystonias are far more common and cervical distribution (otherwise known as spasmodic torticollis) is the most common type. The adult onset dystonias usually remain localized to specific areas such as neck, face or vocal cords. And they generally do not spread and are much less frequently hereditary.

* Cervical dystonia (or spasmodic torticollis)
For cervical dystonia, typical age of onset is around 40 years and women are more affected than men.

What causes dystonia?
The cause of dystonia is unknown although genetic studies may shed some light on this in the next decade. The genetic nature of this disorder has recently come to light as it is autosomal dominant and a number of genes have been isolated.

How is dystonia treated?
The primary treatment for the focal adult onset dystonias is Botulinum toxin. There are currently two types of toxins - Type A (approved in 1989) and Type B (approved in 1999). The most recent advance in the treatment of dystonia is deep brain stimulation surgery similar to that utilized in Parkinson's disease and essential tremor.

Another side effect is an essential tremor

What is essential tremor?

Essential tremor is probably the most common of movement disorders affecting about 5-10% of the population.

What are its symptoms?
It is characterized by tremors. But unlike Parkinson's disease

* Essential tremor is associated with postural and action tremors, which interfere with such activities as writing, eating and performing fine motor movements.

* With Parkinson's disease, tremors occur while sitting at rest.

Essential tremor can occur at any age. It is sometimes very mild and not troublesome but it can be progressive and result in severe disability.

What causes essential tremor?
The cause of essential tremor is unknown. We do know that it is inherited in an autosomal recessive manner in many cases, meaning that each child of a person with this disease has a 25% chance of inheriting it. Two genes have recently been associated with essential tremor and further research may delineate a cause.

How is it treated?
Currently there are some medications that may be helpful in diminishing the tremor. These include:

Medical Treatments

* Propranolol
* Primidone
* Gabapentin
* Topiramate
* Benzodiazepines

Unfortunately, there is no medicinal treatment that is capable of completely stopping tremor.

Surgical Treatments
In the last 10 years, developments in surgical therapy have helped some to slow the progression of essential tremor. For those who are severely disabled by tremor and do not respond to medicinal treatments, a surgical procedure known as deep brain stimulation may ease symptoms. During deep brain stimulation, a part of the brain is exposed to electrical pulses to help abolish or partially abolish tremor, Patients who undergo deep brain stimulation have continued to experience symptom improvement for years after the procedure for years.

FDA Targets Starcaps and Other Diet Pills

The FDA says that certain weight-loss capsules, including StarCaps are promoted as natural dietary supplements using papaya, but could be hazardous to your health. In violation of the law, the FDA found, the capsules also contained a drug called bumetanide that can have serious side effects.

In a continuing investigation, the FDA has concluuded that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs.

Expect a detailed list to be published soon.

Our office is investigating alleged wrongdoing by the matkers of StarCaps. The recall information is here.

Source here.

FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs (Fentanyl)

From the FDA's very own site:

Certain ffected opioid drugs will be reviewed, and include brand name and generic products that are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks.

Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. The FDA, drug manufacturers, and others have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

Read more here.

GA: Medical Malpractice Ruled Unconstitutional

In Atlanta, State Court Judge Diane Bessen ruled that the Georgia statute that capped medical malpractice non-economic damages (O.C.G.A. Sec. 51-13-11) violated the Georgia Constitution. Known as the Nestlehutt decision, some highlights of the Order include: "A limit or cap on noneconomic damages ... invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury... ."

Read the Order here.

Consumers At Risk with Proposed Georgia Legislation

From the GTLA: Governor Perdue wants to place the safety of Georgia’s citizens in the hands of a mismanaged federal bureaucracy

Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval.

In essence SB 101 seeks to rely on the federal Food and Drug Administration (FDA) amidst grave controversy while giving large pharmaceutical companies who harm Georgians a “Get out of Jail Free” card

Governor Perdue suggests that a federal bureaucracy embroiled in heavy controversy, the FDA, should have all the power in deciding the safety of pharmaceuticals and medical devices. SB 101 bars any Georgia citizen from bringing a products liability claim against a pharmaceutical corporation so long as it is headquartered or has 200 employees in Georgia and the product in question, either a drug or a medical device, is FDA approved.

“Vioxx was an FDA approved drug that harmed at least 139,000 people. If there were to be a drug or medical device made here in Georgia that injured or killed people like Vioxx did, Georgia residents would have absolutely no recourse. A person in Phoenix City, Alabama could pursue justice; a person in Columbus could not,” said Fred Orr, President of the Georgia Trial Lawyers Association. “The Governor believes SB 101 will bring corporations to Georgia. But I don’t think we want the kind of business this legislation would attract as this bill says, “Move to Georgia! You can harm or kill our citizens and you will not be held accountable!”

The Governor stated early in the session that FDA approval “should mean something” and that it should protect corporations from lawsuits.

“The FDA can’t protect us from peanut butter. How can we possibly rely on the FDA to protect us from dangerous drugs and medical devices?” said Orr. “If a pharmaceutical corporation manufactures a drug or medical device that seriously harms or kills an innocent person, that corporation should not, under any circumstance, be shielded from accountability. The Governor has simply gone too far with this proposal.”

On February 2, 2009 President Obama had harsh words for the FDA and he urged Congress to conduct a complete review of the FDA after the agency failed to protect the public from contaminated peanut butter. At this time the contaminated peanut butter has killed 8 people and sickened over 500 people.

In addition to the agency’s failure to protect the public from peanut butter, as recently as the last month, the FDA has been at the center of three other nationally publicized controversies concerning alleged corruption, mismanagement, and claims of serious financial conflicts of interest. First the federal Government Accountability Office (GAO) released a report revealing that the FDA has failed to comply with a congressional mandate set nineteen years ago that requires manufacturers of medical devices to provide proof of rigorous testing and safety analysis to the FDA for all Tier 3 medical devices (classified as those devices that are implanted or that a person relies on for life) prior to approval.

Second, a group of FDA scientists went public with their allegations of corruption, mismanagement and coercion within the FDA. The scientists stated that the scientific review process for medical devices “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” They allege that managers at the FDA lacked scientific knowledge and clinical expertise regarding medical devices and that they have ignored the experts and scientists within the FDA. The authors stated that they had been ordered to modify their findings and evaluations of medical devices—allowing for the approval of products that may not be safe.

And third, the Inspector General of the Department of Health and Human Services (HHS) issued a report uncovering a troublesome conflict of interest inherent in the FDA approval system. The FDA failed to collect information on financial ties between those that perform clinical tests and the pharmaceutical companies that manufacture the product being tested in an alarming 42% of the cases. HHS claims that such financial ties may compromise the safety of the people in the clinical trials and the authenticity and integrity of the final research data.

“The scientists working at the FDA think that Americans are in danger. Other governmental entities report that the FDA is inept at keeping the American public safe. Yet Governor Perdue inexplicably thinks we should trust a corrupt federal bureaucracy to keep Georgians safe,” said Andy Childers, an Atlanta attorney.

National leaders in medicine don’t think that FDA approval is enough to keep people safe either. In a friend-of-the-court brief filed in association with the case of Wyeth v Levine, multiple editors of the New England Journal of Medicine stated, “The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety." The doctors went on to say that without civil lawsuits and the discovery they produce, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."


NOTE: For more information on the FDA approval process and other Government reports, please contact Rebecca DeHart at GTLA.



The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgians

FDA Advisory Committee Hearing Will be Webcast 2/3/09

Te Cardiovascular and Renal Drug Advisory Committee Meeting scheduled for February 3rd, 2009 will be webcast.

The FDA's Cardiovascular and Renal Drug Advisory Committee Meeting is being held to decide whether or not to approve a competitor drug to Plavix, the second-biggest selling drug in the world. The new drug in question is called prasugrel and would be marketed by Eli Lilly & Co with potential co-marketing by Japan's Daiichi Sankyo Co., the drug's discoverer.

Reports issued suggest that prasugrel may be more effective than Plavix in preventing heart attacks, but also a higher risk to cause dangerous bleeding. These are the issues that have been considered and will likely be commented upon as the Advisory Committee decides on approval.

Webcast here.

Source here.

Pres. Obama Weighs in on FDA: Critical Comments

Nice to hear he is going to have a complete review of the agency that is failing Americans every day:

"President Obama had critical words for the Food and Drug Administration yesterday in the midst of a massive recall of peanut products linked to a nationwide outbreak of salmonella illness that has killed eight people and sickened another 550.

"I think the FDA has not been able to catch some of these things as quickly as I expect them to catch them, so we're going to be doing a complete review of FDA operations," Obama told Matt Lauer during an interview broadcast on NBC's "Today" show."

Source here.