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time  Thursday, March 11, 2010 11:46
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Archive for the 'Steroids and Health' Category

Mar 11 2010

Trial of Doctors Involved in Illegal Steroids Prescriptions Continues

Doctors who were involved in prescribing anabolic steroids appeared in court for trial Anabolic steroids may not have a bad reputation if health professionals who are supposed to help regulate its use do not tolerate some patients and individuals to abuse the drug. There are already several cases where doctors and health care providers were involved in prescribing and selling anabolic steroids to people who are not supposed to take the drug. Steroids are beneficial to some patients because of its medical use. But when this drug is abused, it can lead to health problems and complications which can even lead to death.

In Staten Island, NY, a doctor who was charged with illegal prescriptions of steroids to more than a hundred patients appeared in court Monday. From 2005 to 2007, Dr Richard Lucente used his Anti-Aging and Wellness Center on Staten Island to prescribe steroids to bodybuilders and even to some cops. According to the report of Brooklyn Daily Eagle, the prosecution presented a witness detailing the fate of a customer bodybuilder who died due to complication from steroids use. In the testimony of Dr. David Mann, the steroid prescription to the bodybuilder is inappropriate since the bodybuilder underwent a heart transplant just a few months ago.

The bodybuilder, Joe Baglio, died of heart failure in March 2007 while attending a bodybuilding convention in Ohio. Court records shows that Baglio went to Dr Lucente and asked for a prescription for testosterone deficiency. Baglio is still under medication for the surgery since the heart transplant happened in October 2004. “This was a patient who’d probably been abusing growth hormones in the past and was seeking another medication that could lead to abuse,” said Mann. It is also probable that the heart problem of Baglio was caused by steroids. According to Dr Mann, even a person with a normal heart shouldn’t have gotten the dosage of testosterone that Dr Lucente prescribed to Baglio.

However, Dr Lucente argued that he made legal prescriptions of steroids to treat patients with hormonal imbalances. Investigators estimated that Dr Lucente made over $500,000 while running the New York Anti-Aging and Wellness Center. He also allegedly received kickbacks from the Lowen’s Pharmacy in Bay Ridge where he sends his patients to buy steroids.

Dr Lucente is facing more than 70 charges for illegal prescriptions of controlled substances. The minimum penalty that could be given to Dr Lucente is 5 years and 6 months if convicted.

Another case of a doctor involved in illegal prescription of steroids is Dr Jesse Haggard. He is a naturopathic doctor in Arizona who was implicated in the statewide conspiracy which involved the Applied Pharmacy Services. Dr Haggard recently pleads guilty for the charges of conspiracy to distribute steroids and conspiracy to commit money laundering. The doctor is already under the custody of the authorities after his return from Costa Rica last year. His lawyer is optimistic that Dr Haggard will only receive 1 year jail term as part of the plea agreement. The sentencing is set on June according to U.S. District Judge Ginny Granade.

There were already 5 people convicted in the conspiracy case which include several doctors and pharmacists. Before Dr Haggard fled the country when he was implicated in the case, he was able to write a book detailing his use of steroids when treating patients. The steroid book is entitled “Demystifying Steroids.”

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Mar 06 2010

Good Manufacturing Practices Should Be An Integral Part of Every Sports Nutrition Company

Sports nutrition companies must adopt Good Manufacturing Practices to ensure that supplements are free from steroids In the previous months, the FDA was busy issuing warning letters and even raided some sports nutrition companies for allegedly selling unapproved dietary supplements which may harm the consumers. The agency found several sports supplements that contains controlled substances specifically synthetic anabolic steroids or with steroid-like ingredients. Some companies have pulled out their products from the market in compliance with the FDA directive and to avoid possible charges for selling illegal supplements. However, with the large market for sports nutrition supplements, the FDA has to continue its efforts in monitoring and stopping the illegal market strategies of some sports nutrition companies.

According to industry reports, there is a continuous increase in the demand for sports supplements for the past years. The Nutrition Business Journal reported that the supplements industry grew at 7.6 percent to $2.7 billion in sales for 2008. Consumers who used sports nutrition products were reported to reach 22% in 2009 based on the report from NMI’s 2009 Health & Wellness Trends Database. The sports nutrition category include products such as amino acids, creatine, protein powders, sports hydration drinks, sports nutrition bars and other sports nutrition supplements.

Sports nutrition supplements became a necessity for many professional athletes. But because of some ingredients banned by sports organizations, it has caused some athletes’ career in demise. An of example of that is the case of U.S. Olympic swimmer Jessica Hardy who was banned in participating in the previous Olympics due to a banned stimulant, clenbuterol. She said that the dietary supplement she was taking has caused the positive test. Greek track and field athlete and Olympian Fani Halkia faced the same charges.

Several Chinese swimmers in the Beijing olympics were also banned due to tainted supplements. The list of professional athletes facing sanctions because of sports supplements is increasing. The recent case is the suspension of ex-NBA player Juan Dixon due to a positive test for steroids. Dixon admits that he is a supplements junkie but denied using any anabolic steroids to enhance performance. Actually he is one of the few athletes who supports anti-steroid campaign.

According to representatives of established and reputable sports nutrition companies, industry players could help the FDA in its effort to stop tainted dietary supplement products. One of the ways to ensure the safety of the consumer is to adopt GMP’s or good manufacturing practices in their companies. Alissa Marrapodi of Natural Products Insider website interviewed some of the sport nutrition companies’ representatives and provided insights on the issue. Patrick Luchsinger, marketing manager of Lipid Nutrition, said that the supply chain needs can be better guarded with ongoing GMP certifications and quality assurance education. “From a supplier point of view, the aftermath of the recent ingredient scandals involving sub-standard suppliers, activists, members of Congress and FDA are demanding action to prevent poor-quality ingredients reaching the consumer,” he said.

Nutra Bridge President Scott Steil also shares the same concern. “Given the upward shift in both health education and individual responsibility for maintaining one’s own health, consumers have clearly made living a healthy, active lifestyle a priority. The robust growth in the sports nutrition market proves supplements are a core part of such a commitment,” he said. Sports nutrition companies’ main priority should be the safety of the consumers since the consumer base is expanding from the hard-core bodybuilders to people who are just health conscious according to Nutratech President Bob Green. “The industry was all about bulking up, bodybuilding and performance enhancement; but today, sports nutrition products are attracting a much broader, mass audience. We’re now dealing with a new generation of consumers who have grown up knowing an active lifestyle has positive, long-term implications for health, fitness, weight management and longevity,” said Green.

Chief operating officer of OmniActive Health Technologies, Abhijit Bhattacharya, agreed to make the supply chain in the supplements industry undergo scrutiny. “Adulteration, mislabeling, sub-optimal levels or deliberate spiking of supplements with inappropriate or unauthorized ingredients are some of the undesirable practices of a few unscrupulous suppliers,” he said. “With the new GMPs coming into force, responsible suppliers and formulators will be able to cooperate in assuring each other and the end consumers that the products entering the market contain the right level of ingredients,” said Bhattacharya. To ensure the success of this effort, manufacturers should focus on product safety by undergoing safety certifications such as ISO-22000 food safety management systems and well-documented product literature.

To regain consumer trust, a good partnership between players in the sports nutrition industry should take place from the ingredient suppliers, manufacturers, marketing companies to retailers. More resources should be allocated to research and clinical studies to determine the safety of the ingredients used in sports supplements.

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Mar 03 2010

Long Term Abuse of Steroids May Harm Kidneys Based On a New Study

New study revealed that long term use of anabolic steroids may cause kidney problems A recent study on the long term abuse of steroids by bodybuilders was published in the February 2010 issue of Renal and Urology News. The findings may help people understand the effects of steroids if used for longer period of time. The respondents in the study were bodybuilders using anabolic steroids for 8 to 20 years. Researchers said that the kidney is one of the organs that suffer the most when the use of steroids is abused.

Leal Herlitz, MD, an Assistant Professor of Pathology at Columbia University Medical Center in New York headed the research. According to her, athletes who use anabolic steroids and the doctors caring for them need to be aware of the potentially serious risks to the kidney. The group pioneered the study in describing injury to the kidneys following long-term abuse of anabolic steroids.

The study included 10 bodybuilders who were dependent on steroids for many years. Six of them were Caucasians and 4 were Hispanics. These bodybuilders were described as having highly muscular physiques and were using anabolic androgenic steroids between 1999 and 2009. These bodybuilders experienced proteinuria and severe reductions in kidney function.

The findings were presented below:

- respondents had proteinuria of 1g/day or greater
- a renal biopsy diagnosis of focal segmental glomerulosclerosis or FSGS
- the bodybuilders have an average 34.7 kg/m2 BMI which range from 27 to 43
- statistics on men with proteinuria: mean 10.1 g/day, range 1.3- 26.3 g/day
- statistics on the case of renal insufficiency: mean serum creatinine 3.0 mg/dL, range: 1.3- 7.8 mg/dL
- 5 men were diagnosed with full nephritic syndrome.

Focal segmental glomerulosclerosis or FSGS commonly occurs if the kidneys are overworked. This is also common to severely obese people but the group noted that the effects of steroids to the kidneys were more severe. FSGS was diagnosed in 9 patients and 4 of the 9 patients with FSGS had glomerulomegaly at the same time. The researchers conducted biopsies on the respondents and found out that 3 of them had collapsing lesions of FSGS and another 4 had perihilar lesions. There were also 7 bodybuilders who suffered tubular atrophy of 40% or greater and interstitial fibrosis.

Follow up on these bodybuilders were also conducted. The condition of one patient progressed to end-stage renal disease (ESRD) which required dialysis. Most of the respondents received renin-angiotensin system (RAS) blockade while one had received corticosteroid therapy. Seven of the bodybuilders who discontinued the use of anabolic steroids were able to recuperate from the condition. They were also advised to lessen their exercise regimens. Loss of weight was noted but the serum creatinine was stabilized and proteinuria decreased.

The doctors involved in the study concluded that the kidneys are forced to increase their filtration rate when there is an extreme increase in muscle mass. Therefore placing harmful levels of stress on the kidneys. “As in obese patients, the increased strain on the kidney from the elevated body mass leads to hyperfiltration injury,” said Dr. Herlitz. The findings also lead to the assumption that steroids have direct toxic effects on the kidneys. “Numerous animal models have shown adverse effects of androgens on the kidneys and we believe that the anabolic steroids themselves may be directly nephrotoxic,” she added.

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Feb 26 2010

Asthma Drugs Should be Taken With Steroids Based on New Criteria Issued by FDA

The FDA required the pharmaceutical companies to include in the labels of LABA drugs that it should be taken with steroids The FDA issued new guidelines for taking asthma drugs because of reported health risks to the patient. Long-acting beta-agonists or LABA drugs are used to relax muscles in the lung’s airways thus improving the patient’s ability to breathe freely and reducing asthma symptoms. But a recent study showed that taking LABA drugs alone can be dangerous and can even result to deaths.

As part of the agency’s campaign for safe use of every drug approved in the market, they have directed the pharmaceutical companies to put new labels on their drugs specifically informing the patient that it should not be taken for longer periods. FDA also recommended that LABA drugs should be taken with inhalable steroids. Dr. Diane Murphy, director of the FDA’s Office of Pediatric Therapeutics said in a statement that the risks of hospitalization and poor outcomes are of particular concern for children. “Parents need to know that their child with asthma should not be on a LABA alone,” she said.

The four popular asthma drugs available are Foradil, Serevent, Advair and Symbicort. These were commonly prescribed by doctors to children and adult asthma patients because of its efficacy in controlling the symptoms. However, the studies revealed that it can also mask other symptoms which can trigger serious asthma attacks. Patients may suffer exacerbations of asthma symptoms which can lead to hospitalizations and death for asthmatic children and adults.

Salmeterol (Serevent) and Formoterol (Foradil) which are prescribed as a single agent LABA, will be prescribed in combination with an asthma controller medication such as an inhaled steroid. Additional information on the package insert of the drugs should also reflect the changes required by the FDA. The labels of each product should now contain the following warnings:

1.) LABAs should only be used long-term in patients with asthma not adequately controlled with inhaled steroids or other controller medications.
2.) The agents should be used for the shortest time possible to achieve symptom control. Once patients are no longer experiencing symptoms, LABAs should be discontinued if possible with patients maintained on controller medications alone.
3.) Children and adolescents needing a LABA should use a combination product that also contains an inhaled steroid to ensure compliance with both medications.

LABA drugs used for intermittent exercise-induced bronchospasm and chronic obstructive pulmonary disease (COPD) are not included in the directive.

Medpagetoday.com published additional information why the FDA issued the warnings. From a placebo-controlled trial called SMART, FDA said that salmeterol was associated with excess deaths at an overall rate of 8 per 10,000 patients (95% CI 3 to 13). African Americans were more prone to the risk where the excess death rate was 27 per 10,000 (95% CI 8 to 46). 60,000 patients who used salmeterol and formoterol suffered from side effects with a composite of hospitalizations, intubations, and deaths. The excess rate was recorded at 28 per 10,000 patients (95% CI 11 to 45). The study also found out that the case is more prevalent in adolescents and children at 58 cases per 10,000 and children 148 cases per 10,000 respectively.

Product recalls is not necessary according to the FDA since the benefits of the drugs still outweigh the risks involved. John Jenkins, MD, director of the FDA’s Office of New Drugs said that their concern is the benefit of the greater public and the action of the agency will reduce the use of LABA’s. These drugs are still available for patients who need additional therapy.

The agency also suggested that manufacturers must develop risk evaluation and mitigation strategies. New medication guide should be given to patients while healthcare professionals should be given enough education on the appropriate use of LABAs.

The FDA will monitor the prescribing patterns for long-acting beta-agonists (LABA) drugs to determine if these are still prescribed as a solo treatment. “If we find this is still happening, we can work with our partners [in the Safe Use Initiative] to directly provide information to those practitioners and patients to make sure they have the knowledge needed to use these drugs safely,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. The “Safe Use Initiative” is a collaboration of physicians, hospitals, pharmacies, insurers, and other groups to reduce preventable harms associated with drugs. It tackle issues such as medication errors and abuse as well as adverse biological effects of drugs in normal use.

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Feb 21 2010

Woman With High NK Cells Treated with the Help of Steroids

UK doctor used steroid treatment to woman with so many miscarriages After years of suffering from several miscarriages, a woman from Peacehaven near Brighton, UK, successfully gave birth to her first miracle baby. Angie Baker, 33, was already thinking of adopting a child when her 18th miscarriage happened. But with the help of a friend she was referred to a doctor in Epsom and St Helier University Hospitals NHS Trust in Surrey. Baker’s case is exceptional since the incidence of miscarriage is so high. According to experts, women usually suffer 3 to 5 miscarriage but experiencing it 18 times is something to look at.

The DailyMail reported that the case of Baker was referred to Dr. Hassan Shehata of Epsom Hospital by a friend who read in the newspaper about the new treatment pioneered by the doctor. She was treated with the help of steroids. During the tests conducted on Baker, the doctors found out that she had a high level of a subtype of white blood cell, known as Natural Killer (NK) cells. These NK cells are responsible for protection from viruses. However, the NK cells which acts as her first line of defense against viruses and diseases also attacks the fetus. Because of aggressiveness of the NK cells they mistook the fetus as a foreign body which causes the miscarriage.

The first treatment administered by Dr. Shehata was not successful since they found out that Baker was also a diabetic. The high dosages of steroids given to Baker caused the elevation of her blood sugar thus causing another miscarriage. In an interview, Baker said that it was giving her too much emotional burden. “Emotionally it was a roller-coaster. Every time I got pregnant I was hoping this was the one and it wasn’t going to end in a miscarriage. I never gave up. I was desperate for a baby so I persevered,” she said.

Her case, according to her doctor, could happen to about 15 per cent of women. Baker’s case is special because of her other health condition. “Eighteen miscarriages is a huge number. This is the most unusual case I’ve come across. You’re more likely to win the lottery than have 18 miscarriages through bad luck. Therefore there must be an underlying cause,” Dr. Shehata said.

Dr. Shehata adjusted his dosage of steroids during the second treatment. The steroids were given before the start of conception. The doctor also adjusted her levels of insulin which help the next conception a succesful one. According to the Telegraph, Baker took one 25mg tablet of steroids a day for two weeks before conception and 12 weeks after. It costs just £20 per tablet but the lab equipment used to carry out the treatment costs around £150,000 to £200,000 and the each test costs an additional £200.

The success rate of the treatment for high NK cells is around 80%. Dr. Shehata and his fellow doctors have already treated more than 1,000 patients with a similar condition with Baker. They have conducted this procedure at their private practice and at the NHS.

After 18 miscarriages, Baker is so happy with the result. Her baby, Raiya, is now 10 weeks old. “She’s my little miracle. I can’t explain how I feel. I’m overwhelmed. It seems like a dream and I still have to pinch myself. She’s perfect in every way,” said Baker.

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Feb 15 2010

Man Sues Manufacturer of P-Drol for Permanent Liver Damage

Manufactuer of P Drol dietary supplement sued for serious side effects caused by the product Angel Brito from Dickinson claimed that a dietary supplement manufactured by TF Supplements caused severe and permanent damage to his liver and has consequently filed a lawsuit against the company. Brito claimed that he became jaundiced, suffered several weeks of uncontrollable itching, and experienced extreme pains in his side after taking P-Drol, which is a steroid precursor and manufactured by TF Supplements. P-Drol is marketed to weight lifters and fitness enthusiasts as a muscle-building supplement.

The original complaint was filed in February 4 in the Gavelston County District Court. In it, Brito stated that he experienced liver failure after taking P-Drol. He also claimed that the supplement contained an ingredient that was known to be taxing to the liver, yet the product was marketed as a dietary supplement.

The Food and Drug Administration issued a public health advisory on July 28, 2009, warning consumers against taking steroids or steroid precursors marketed as dietary supplements and advised the public that those who took these supplements and showed signs of liver problems should immediately seek medical attention.

According to Brito’s story, he became ill on October 5, 2009 and went straight to the Clear Lake Regional Hospital emergency room. In the suit, Brito claimed that the doctors detected extremely elevated levels of bilirubin in his system and that his liver was swollen and enlarged, both side effects from taking the supplement. After taking P-Drol, Brito said that his weight dropped almost 30 pounds and that he spent several days in the hospital as doctors monitored his bilirubin number. Brito even contemplated a liver transplant. Brito was eventually discharged from the hospital and was instead referred to a liver specialist for continued medical care. He underwent weekly checkups that included CAT scans, blood sampling and MRIs.

Brito also alleged that he continues to suffer from constant itching, debilitating fatigue, weight loss, and nausea. He has also developed a mass behind his pectoral muscle. In filing the suit, Brito seeks damages for mental anguish, pain and suffering, impairment, disfigurement, and medical expenses, and is demanding a trial by jury. Representing the plaintiff is the Gibson Law Firm in Houston. The case will be presided by Galveston County 56th District Judge Lonnie Cox.

TF Supplements has yet to comment regarding the lawsuit. It seems that the product P-Drol has been pulled out of their inventory since it is no longer available in their website as well as in other bodybuilding sites. There are also no online reviews available on the supplement, as well as complete product information on P-Drol on the web. TF Supplements has a large catalog of bodybuilding and fitness products, as well as supplements for enlarging muscle mass. Some of the products that can be viewed and bought from their site include creatine, glutamine and anabolics. They also market and distribute mood enhancer, libido enhancer, post-workout products, pre-workout products, fitness accessories, meal replacements, protein stacks, vitamins, and testosterone boosters. They distribute products from various manufacturers and labels. On their website, there is no information regarding their origin, history or background.

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