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A look back at thalidomide – 50 years later

Posted on February 17th, 2012 by Robert D. Rowland

Recently the FDA office of Women’s Health released a message authorized by Margaret Hamburg, M.D. about the beginning of the FDA and Thalidomide. It was called “one of the biggest medical tragedies of modern times.” Introduced as a sedative drug in the late 1950s, thalidomide was commonly used to treat the symptoms of morning sickness. From 1957 until 1961 it was sold across the world, but was taken off the market after being found to cause a number of birth defects. More than 10,000 children in 46 countries were born with deformities. These were the famous “flipper babies”.

Yet thalidomide never had a significant impact on the United States. Why? Because before it could reach the market in the U.S., pharmacologist and M.D. Frances Oldham Kelsey refused to give the Food and Drug Administration (FDA) approval to Richardson-Merrell to market thalidomide. She strongly believed further studies were needed. Kelsey discovered that although thalidomide was being used across the globe, it hadn’t received much testing; In fact, it hadn’t even been tested on pregnant animals. Her decision to deny FDA approval exemplified the need for scientific product development, regulation and review.

In the aftermath of the thalidomide tragedies, the United States Congress enacted the Kefauer-Harris amendments in 1962 requiring proof of safety and efficiency before a drug can receive approval for sale in the U.S.

This turning point led to a new era of medical responsibility and science that has continued to this day. All new drug applications must demonstrate “substantial evidence” of the drug’s efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety.

It’s funny to hear politicians argue that government regulation is holding back our economy. FDA regulation is holding back pharmaceutical companies who, in their rush to market, put profits over people. We still need a strong FDA, “one endowed with the necessary resources to ensue smart, sound, and science-based regulation”.

Contact Robert D. Rowland here.

GHAR Sponsors Price of Freedom Gala to aid wounded military members

Posted on February 13th, 2012 by The Firm

GHAR is once again proud to sponsor the Joshua Chamberlain Society in its second annual Price of Freedom Gala on February 18, 2012. Held at the Renaissance Grand Hotel in St. Louis, the Price Of Freedom Gala is a military-inspired evening at a Marine Mess Night to benefit the Joshua Chamberlain Society’s efforts of providing aid for severely wounded military service members and the families of killed-in-action members of our military.

The evening will honor current JCS heroes as it raises funds to support additional heroes. The formal evening will include silent and live auctions, a seated dinner and a premium open bar.

For more information on the Price of Freedom Event visit http://www.priceoffreedomgala.org/

Please visit the Joshua Chamberlain Society at http://www.chamberlainsociety.org/ to learn more about this extraordinary organization and to help donate to aid severely wounded military service members and the families of killed-in-action members of our military who sacrificed all in our service.

View the 2012 event program here:
jcs2012programfinal

A Closer Look at Why HCG Diet Products are Illegal

Posted on January 31st, 2012 by Robert D. Rowland

While last month we posted about the FDA’s HCG alert advising consumers to avoid all HCG weight loss products, I wanted to take a closer look at why HCG is considered dangerous.

Unsafe Claims

Most HCG diet products are marketed in conjunction with extremely low calorie diets – as low as 500 calories a day. These diets claim consumers will lose up to 30 pounds in 30-40 days.

The problem is, any weight loss experienced is a result from severe calorie restriction – not from HCG. The FDA has approved HCG as a prescription drug for the treatment of female infertility and other medical conditions – but not for weight loss. Its prescription drug label states there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

A Dangerous Diet

Eating 500 calories a day is extremely dangerous, and can leave you at an increased risk for gallstone formation, an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, and an irregular heartbeat. Without constant medical supervision for a condition such as obesity, such a restrictive diet could even be fatal.

FDA Legal Action

It’s illegal to sell products claiming to contain HCG as an OTC drug product. Companies marketing and selling these products could face enforcement actions, legal penalties or criminal prosecution. The FDA also advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions.

If you or a loved are on an HCG diet and have experienced any illnesses while taking HCG, contact Robert D. Rowland.

Competition, Mud, and Speed on Two Wheels

Posted on January 18th, 2012 by The Firm

Congratulations to GHAR’s own Elizabeth Heller, who took second place in the UCI Master’s World Championships this past Sunday in Louisville, KY, and third place in the USA Cycling Cyclo-cross National Championships, held in Verona, WI, earlier this month.

Cyclo-cross isn’t a typical bike race. It’s a fast course on pavement, wooded trails, grass, steep hills and obstacles requiring the rider to quickly dismount, carry the bike while navigating the obstructions and remount. And since races are usually held during the Fall and Winter, rain, wind, snow – and mud – is common. Competitors often change bicycles mid-race so mud can continually be power-washed washed off in the pit area. Falls are common in cyclo-cross, and so are broken bones.

“It was four inches of frozen, muddy ruts, but it was a great course,” Heller said of the 1.5-mile, 50 minute race on Jan. 14. “I hope to win next year.”

Elizabeth began competing in triathlons after graduating from Beloit College in 1980. A natural-born competitor, she decided to switch to cycling, and has continued to pursue it as a passion over the years.

She started with triathlons, but soon put all her training toward cycling, which served her well. She was the Missouri State Road Race Champion 10 years in a row (1988-1996) and the Missouri State Mountain Bike Champion for five consecutive years (1990-1995). She is also a five-time Missouri State Criterium Champion, five-time Missouri State 40-K Time Trial Champion and has four U.S.C.F. National Masters Championship titles to her name (1989 and 1990). In 1992, she and a blind male partner won silver medals in the Paralympics Tandem Road Race in Barcelona, Spain.

After joining Goldenberg Heller Antognoli & Rowland in 1991, she continued to cycle competitively in the 1990s. In 1999 she was named Cyclist of the Decade by the St. Louis Cycling Club. Then, after a 15 year break, she returned to competitive racing in the form of cyclo-cross.

“It’s no walk in the park. When you’re 54 you’re as old as your mother used to be. I think I’m crazy, but then I see others out here who are just as crazy as I am,” Elizabeth says. “I’ll keep doing it as long as I can.”

The Power of Volunteering, and Giving Children a Voice

Posted on December 26th, 2011 by Tina Italiano

For a little over two years, I have been a volunteer for Voices for Children – the CASA program in the City of St. Louis. The mission of the National Court Appointed Special Advocate (CASA) Association, together with its state and local members, is to support and promote court-appointed volunteer advocacy for abused and neglected children so they can thrive in safe, permanent homes.

I chose to volunteer because I wanted to do something to help out in the community and I knew I wanted to work with kids. In order to be appointed as a CASA advocate, you have to be committed to the cause – you must complete a 16-hour training course and be sworn in by the Judge. CASA advocates dedicate their hearts and minds to improving life for children in St. Louis, maintaining the child welfare system’s focus on the child. It’s my responsibility to provide the court a full picture of a child’s life and recommend what I think is best for him or her. CASA advocates can truly change the lives of abused children by helping them move from foster care to safe, stable homes where they have a chance for a brighter future.

Here’s an example of how a case can unfold: my very first case involved an infant who was left in a car on a hot summer day, as his mother passed out from drug use. Once the child was taken into custody by Children’s Division and placed into relative foster care (with a Great Aunt), the Court became his legal guardian.

The main goal, as with any case, is reunification with the child’s biological parent(s). In order to do that, the parent(s) is/are required to complete Court required services. In addition to a parenting course and psychological evaluation, this child’s mother needed to complete drug rehabilitation. She was in and out of several programs, but kept relapsing. She finally determined that she was not and would not be in a good place to raise her child. Currently, she has found a program that is working for her, but she still granted permission for the child’s Great Aunt to have guardianship so that he could get out of the Children’s Division custody. If, in the future, the mother is able to provide a stable, healthy lifestyle, she can petition the court for custody of the child.

During this entire process, the CASA advocates “speaks” for the child – giving them a voice in all critical decisions affecting their well being while in foster care.

It’s been a rewarding experience, and I’m glad I decided to volunteer my time. If you would like more information on Voices for Children, or are interested in volunteering or becoming a CASA advocate, visit their website at www.voices-stl.org.