Cape Cod Personal Injury Lawyer - FDA & Prescription Drugs

Pfizer Settles Again...

Carrie Strasser — Thu, 03 Sep 2009 09:19:41 GMT

Today, the New York Times reported on Pfizer's $2.3 billion settlement payout over allegations that it conducted illegal marketing of Bextra, a painkiller that was taken off the market in 2005. This settlement is the largest health care fraud and criminal fine payout to date.

Since 2002, Pfizer has paid out settlements four times over allegations of illegal marketing activities. A large factor contributing to the high amount of this settlement figure was Pfizer's repeated misconduct over the years. Despite the fact that this may be the largest settlement sum of its kind, the $2.3 billion amount equals less than three weeks of Pfizer sales. This prompts one to wonder whether such a high amount targeted at addressing Pfizer's recidivism will actually have any effect whatsoever on Pfizer's behavior in the future.

John Kopchinski was the former Pfizer sales representative who initiated the complaint that prompted the government to investigate allegations surrounding Bextra.

"The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said Mr. Kopchinski, whose personal share of the Pfizer settlement is expected to exceed $50 million. Mr. Kopchinski left Pfizer in 2003.

Bextra, approved by the FDA in 2001 to treat arthritis and menstrual cramps, was marketed by Pfizer for the treatment of acute pain. This, despite the fact that it wasn't proved to be any more powerful than Ibuprofen and the side effects with increased doses were great. Pfizer urged its sales representatives to tell doctors to use Bextra to treat acute pain and surgical pain at high doses that were not FDA approved. Pfizer held weekend getaways to resort locations for doctors to promote their drugs, paying all the attendees' expenses.

Originally posted at InjuryBoard by Carrie Strasser

Hydroxycut Recalled

Carrie Strasser — Wed, 06 May 2009 12:00:01 GMT

On Friday, consumers were warned that Hydroxycut, a line of weight-loss products, was responsible for a death due to liver failure and other adverse health events. The company that produces Hydroxycut voluntarily recalled 14 of its products. The FDA has received 23 reports of adverse health effects in Hydroxycut users and one instance of a consumer who required a liver transplant.

The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.

This latest recall brings to light the issue of whether the FDA has the authority to regulate dietary supplements and protect the consumer. Unlike prescription drugs that require proof of safety and effectiveness before getting the federal approval to be sold, dietary supplements do not need such FDA approval before being placed on the market. Instead, it is up to the manufacturers of these products to ensure the safety of their dietary supplements.

In the past few months, the FDA has made efforts to clamp down on tainted weight-loss pills that illegally contain prescription drug ingredients. The Agency has determined that 70 different brands contain potentially hazardous drugs.

Until recently, it seemed that the manufacturer-led testing was enough to protect the consumer. The FDA uncovered this recent threat to consumers because of a new law requiring manufacturers to notify the FDA of adverse events linked to Hydroxycut use. Also, the FDA noted reports from medical journals referring to liver disease being diagnosed in formerly healthy people who had used Hydroxycut.

Vitamin Shoppe and GNC have removed Hydroxycut from their stores and websites.

To learn more, click here.

Originally posted at InjuryBoard by Carrie Strasser

Documents Show that Psychiatrist Promised Favorable Results for Drug Company

Carrie Strasser — Mon, 23 Mar 2009 18:02:39 GMT

Dr. Joseph Biederman, a prominent child psychiatrist at Harvard University, promised the drug company Johnson & Johnson that certain studies of its medicines in children would yield positive results for the company, reported the New York Times on Friday. Documents outlining these interactions between Dr. Biederman and Johnson & Johnson came to light as a result of the multistate litigation regarding the improper marketing of antipsychotic drugs. The New Jersey Superior Court Judge overseeing the multistate litigation ordered that Dr. Biederman be deposed and as a part of that process, Biederman released certain documents to his lawyers about his interactions with Johnson & Johnson.

Dr. Biederman is a staunch advocate of diagnosing bipolar disorder in young children and using antipsychotic drugs to treat this disease. However, much of his work has been funded by drug companies for whom he does private consulting.

An inquiry by Senator Charles E. Grassley, Republican of Iowa, revealed last year that Dr. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but $200,000 of this income to university officials.

Dr. Biederman is currently being investigated by both Harvard and the National Institutes of Health to determine whether the psychiatrist violated federal and university research rules.

In a number of the documents provided by Dr. Biederman, he promised a positive outcome in his research studies for Johnson & Johnson drugs such as Risperdal and Concerta.

Originally posted at InjuryBoard by Carrie Strasser

Study Shows Risk of Death Almost Double with Certain Drug Treatments of Alzheimer's Patients

Carrie Strasser — Sat, 10 Jan 2009 13:49:31 GMT

The New York Times reported on Thursday, that a recent study shows that certain anti-psychotic drugs used to treat patients with Alzheimer's disease may drastically increase their risk of death. The paper's lead author, Clive Ballard, suggested that the risks of this treatment may outweigh the benefits provided by the drugs.

Alzheimer's disease causes dementia and other symptoms including aggression, delusions and hallucinations. The anti-psychotic drugs are used to control the aggression and hallucinations that some patients experience.

The study, conducted in Britain from 2001 to 2004, followed 165 patients aged 67 to 100 with Alzheimer's. Half of these patients continued taking anti-psychotic drugs and the other half took placebos.

Of the 83 receiving drugs, 39 were dead after a year. Of the 82 taking fake pills, 27 were dead after a year. Most deaths in both groups were due to pneumonia.

After two years, 46 percent of Alzheimer's patients taking the anti-psychotics were alive, versus 71 percent of those not on the drugs. After three years, only 30 percent of patients on the drugs were alive, versus 59 percent of those not taking drugs.

Experts suggested that the drug treatment of Alzheimer's patients be personalized and some people may not receive any benefit from treating with anti-psychotic medications. Others suggested environmental or behavioral therapies instead of drug treatment.

It is not clear how these drugs are increasing patients' risk of dying but some speculated that the medications could be damaging patients' brains and the sedative effects cause patients to exercise less, thereby putting them at greater risk for infections.

If you are concerned about the care and treatment of a loved one affected by Alzheimer's disease, question the doctors to ensure that the treatment plan is what works best for the patient. Caring for a loved one with a debilitating disease is emotionally and physically exhausting, but constant vigilance is necessary to ensure that your loved ones are treated effectively.

Here is some information on Risperdal, one of the anti-psychotic drugs used to treat patients with Alzheimer's.

Originally posted at InjuryBoard by Carrie Strasser

Doctors Fail to Disclose Financial Incentives from Drug Companies

Carrie Strasser — Fri, 10 Oct 2008 10:45:44 GMT

A recent New York Times article stated that one of the nation’s most esteemed psychiatrists did not report approximately $1.2million of income he received from consulting arrangements with drug makers for a period of seven years. From 2000 to 2007, Dr. Charles B. Nemeroff of Emory University, earned over $2.8million according to documents being examined by Congressional investigators.

In 2004, Dr. Nemeroff signed a letter to Emory administrators promising that he would earn less than $10,000 a year from GlaxoSmithKline. If this were accurate, he would have complied with the federal rules. However, in 2004, Dr. Nemeroff actually earned $170,000 from GSK.

Republican Senator Charles E. Grassley of Iowa is leading the inquiry.

"After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere," Mr. Grassley said. "The current system for tracking financial relationships isn't working."

The main problem, suggested by the current Congressional findings, is that universities are failing to monitor their faculty members’ conflicts with the drug companies.

In response, Mr. Grassley has sponsored the Physician Payment Sunshine Act that would require public disclosure by drug and device companies of payments to doctors over $500.

While the National Institute of Health does have strict rules regarding conflicts of interest, it relies on universities to police the situation.

What does this mean for patients and individuals relying on studies or findings from universities concerning drugs or medical devices? Well, it certainly leads to a loss of objectivity and perhaps honesty in the conclusions reached about certain products. For example, in 2006, Dr. Nemeroff, citing a clerical error, failed to disclose his financial ties to Cyberonics. Cyberonics made a device that Dr. Nemeroff and his colleagues favorably reviewed in one of the journals he edits.

The Cyberonics paper led to a bitter e-mail exchange between Dr. Nemeroff and Claudia R. Adkison, an associate dean at Emory, according to Congressional records. Dr. Adkison noted that Cyberonics had not only paid Dr. Nemeroff and his co-authors but had also given an unrestricted educational grant to Dr. Nemeroff's department.

"I can't believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing," Dr. Adkison wrote on July 20, 2006.

This revelation has led many institutions to consider reevaluating these relationships and maybe going so far as to bar doctors from lecturing about drug/device marketing.

As concerned patients who may be affected by these drugs and medical devices, here is some information on prescription drugs. As the inquiry continues and changes are made, hopefully we can be assured that in the future, financial incentives will never again replace honest and objective research.

Originally posted at InjuryBoard by Carrie Strasser

AntiDepressants and Suicide

Bruce Bierhans — Sun, 27 Jul 2008 11:08:54 GMT

In todays Cape Cod Times, we learn more about the tragic death of David Hill. On October 17, 2006, David was killed after being shot multiple times by a local police officer. That evening, David was carrying and discharging a firearm and wearing a bullet proof vest. The tragedy is being referred to as a "suicide by cop" incident.

All but lost in the story is the fact that David had been prescribed "Ritalin, Zoloft and antidepressants, each with the broken promise of some return to normalcy."

I have represented and continue to represent families that have been broken as the result of suicides occuring while family memebers were being treated with antidepressants. Each has a common theme. The acts of suicide were violent events beyond the comprehension of family members. Hangings, selfinflicted gunshot wounds, or as in the Hill case, intentional self destructive behavior. Many will argue that depression related suicide is unavoidable. However, one must also wonder whether or not the use of antidepressants that are not appropriately monitored by a well trained physician create an "enabling" type of behavior that allows individuals not only to commit suicide, but do with an almost inexplicable act of violence.

A Harvard trained expert that I have worked with on my cases takes the position that antidepressants, WHEN USED PROPERLY, can be helpful in certain cases. However, what of the patients that are now prescribed them like candy, in an unsupervised or poorly monitored treatment plan? Much has been written about the "drugging" of America. The Hill case leaves many questions unanswered that may help us better understand this tragedy. What medications was he on at the time of death; what was the dosage; had the dosage recently been increased; was he in withdrawal from a recent change in medication; was he receiving talk therapy in addition to antidepressants; what was the experience of the physician that prescribed the medications in the admistration of these drugs?

If we carefully examine the Hill case, as well as others that have, or may have connections to the use of antidepressants, i.e the Virginia Tech massacre, we may learn more about the context in which the medications ought to be prescribed and how their use should be monitored. It's not just about money; it's about lives!

Originally posted at InjuryBoard by Bruce Bierhans

FDA Warns Bed Wetting Drug May Cause Seizures

Chrissie Cole — Mon, 10 Dec 2007 17:39:47 GMT

The FDA warns patients and physicians that desmopressin, a drug used to control bed-wetting in children, can increase the risk of seizures and death.

The FDA has received 61 reports of seizures - including two fatalities - amongst patients taking desmopressin.

Desmopressin is used to lower the amount of water eliminated in urine. In some cases the drug lowered the amount of sodium in the patient's blood to dangerously low levels creating an imbalance known as hyponatremia, which likely caused the seizures, according to the FDA.

It is unclear why the patients who suffered seizures were taking desmopressin, which is used to treat other various conditions in addition to bed-wetting.

Among the 25 patients younger than 17 who had seizures while taking desmopressin nasal spray (intranasal desmopressin), bed-wetting was the most common reason.
Children taking intranasal desmopressin to treat bed-wetting are "particularly susceptible to severe hyponatremia and seizures," states the FDA.

Originally posted at InjuryBoard by Chrissie Cole