November 2013

Published Thursday, scientists at the National Cancer Institute wrote an article called “NIH Mouse Study Finds Gut Microorganisms May Determine Cancer Treatment Outcomes”.  The National Cancer Institute believes they may have found a connection between the presence of certain organisms living in the human gut and the success of cancer therapy.  Mice that had cancerous tumors were studied and the mice that did not have these microorganisms had an impaired ability to fight cancer growth and live longer.  These microorgansisms that live within the gut are called “commensal microbiota” and do not negatively affect their host.  Chemotherapy drugs such as oxaliplatin and cisplatin also had a diminished effect for the mice that lack commensal microbiota.

Some reports suggest that chemotherapy drugs harm the intestinal microbiota and affect the anti-tumor immune response intended by the drugs.  The bacterial composition in the gut does not return to normal after being treated with antibiotics and may permanently inhibit the effectiveness of anti-cancer therapy and people who have frequently used antibiotics throughout their life may be included for this decreased effectiveness of cancer drugs.  Researchers are now trying to determine how these microorganisms send messages to different parts of the body and increase levels of inflammation to infected parts; it is thought that this signal to change the type and level of inflammation in the infected body organ is related to the successful outcomes with cancer therapies.

The mice used for this study were raised in sterile environments so they did not acquire any bacteria and were given strong antibiotics to ensure they did not harbor any of the commensal microbiota.  Once the necessary precautions were taken to sterilize the mice, they were injected with cancer cells that would form tumors in the mice.  This study showed that the germ free mice did not respond well to the drugs meant to target their tumors.

Ellen Beck recently wrote an article for the “Smart Blog on Food and Beverage” website titled “FBI Makes Threats to U.S. Food Supply a Bigger Priority”, that discusses the food industry’s vulnerability to intentional food contamination.  In light of all the terrorist attacks taking place throughout the world, the FBI is becoming increasingly concerned that food might be used to carry out a large scale attack on the American people, for intentional contamination can lead to widespread food borne illnesses that have the potential of infecting millions of people.

The FBI has been tracking incidents of intentional food contaminations and taking a closer look for ways to reduce these incidents from people or organizations that infect food supplies.  Motives for these intentional food contaminations may include terrorism or economic gains.  In recent years, a defense mission has been created through the FBI with the ability to activate thousands of agents to defend the food supply.  This mission uses the Joint Terrorism Task Forces and Hazardous Evidence Response Teams to cover all possibilities and situations that may arise from an intentional food contamination attack.

Beefing up on the ability of the FBI to investigate and predict possible threats related to intentional food contamination started after the 2001 9/11 terrorist attacks.  In Ellen Beck’s article she quotes FBI agent Thomas Rosato who states “We get the fact that because of its systemic nature, our food supply would be a very effective dispersal device for weapons of mass destruction”.  While the FBI has a lot of experience with the investigatory process, the Bureau needs help and input from the Food and Drug Administration and other agencies that have intimate knowledge of how the American food systems work to be effective in preventing these kinds of attacks.

In an article published from the Oncology Report Digital Network by Elizabeth Mechcatie, titled “FDA Grants Full Approval to Crizotinib for NSCLC Indication”, the Food and Drug Administration announced that a new drug was approved for the treatment of small cell lung cancer.  Crizotinib is a kinase inhibitor that works by blocking the actions of cancer cells, and studies that have been done on this new medication showed the drug was able to delay progression of the cancer better than the traditional chemotherapy used to treat lung cancer.

Author Elizabeth Mechcatie states “The drug approval was based on objective response rates of 50% and 61% in two single-arm open-label trials; full approval was contingent on providing evidence that confirmed the clinical benefits.”  In all, 347 patients were studied in order to determine which form of treatment (crizotinib or chemotherapy) was more effective.  Some negative effects associated with crizotinib that were seen in 25 percent of the patients were fatigue, vomiting, constipation, and diarrhea.

Further safety evaluations of the new drug found that the most common adverse events were pulmonary embolisms (blockage of an artery that supplies blood to the lungs) and other respiratory distress complications.  Blockage of blood to the lungs can lead to cardiac arrest which can be fatal if the appropriate steps are not quickly taken.  The heart receives blood with oxygen from the lungs, and cells of the heart that do not receive oxygen will die and will not grow back.  Crizotinib was able to delay progression of the cancer by 7.7 months compared to chemotherapy which was able to delay progression by only 3 months.

Last Wednesday (11/6/2013), Reuters reported that the approval of a new cancer drug by Curis Inc. has stalled after a patient died while taking the drug.

Curis Inc. is a company that develops many new drugs used for in cancer treatment.  In collaboration with other major drug companies, Curis created Erivedge, the only medication for the treatment of basal cell carcinoma that has been approved by the FDA.

Recently, Curis has had some trouble with one of its newest cancer drugs after a death of a patient using the drug in a trial setting.  The patient passed away due to liver failure, and this most recent set back has stopped the company from enrolling any new patients in the trial.  The cancer drug is in an early stage trial and the risks involved are clearly not well known.  The deceased patient had advanced breast cancer and died about one month after the treatment had stopped.

After screening for candidates that were appropriate for the trial, the company selected patients with advanced solid tumors or lymphomas.  Lymphoma is one type of blood cancer.  The body’s immune system is there to protect the person from infection and disease, however there are times when some protective agents of the immune system called B or T Lymphocytes are deformed in some way.  This deformation may cause the Lymphocytes to divide faster than normal or live longer than they were meant to live.  Apoptosis, or programmed cell death, is a key part in keeping the working, functioning cells healthy and able to do their job.  When the body loses the ability to kill and recycle old and malfunctioning Lymphocytes, cancer (lymphoma) is a likely outcome.

The FDA is looking deeply into this most recent death and has many questions for Curis Inc.  Curis said it will work together with the FDA and answer all of their questions in an attempt to make sure this type of thing does not happen again in the future.  Financially, the company’s shares have fallen by 10 percent in the premarket trading and their shares have dropped to as low as 3.89 dollars.

On 11-9-2013, the FDA announced a recall of dietary supplement OxyElite Pro (USPlabs LLC, Dallas) “after officials linked it to cases of liver failure and acute hepatitis in 29 people” in Hawaii, CNN reports.

Several sources now report that one of two patients who required liver transplants has died.  WebMD writes that other people “are awaiting liver transplants in connection with the supplements, which are used for weight loss.”

Due to the fact that OxyElite Pro is classified as a “dietary supplement,” not a drug per se, FDA approval for the compound was not required.  WebMD continues, stating “The FDA sent a warning letter to USPlabs last month telling the company they must stop distributing OxyElite Pro and another dietary supplement, VERSA-1.The supplements contain the ingredient aegeline. The FDA says the ingredient ‘lacks history of use or other evidence of safety.’”

“In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking.” (Outbreaks > FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro)

 

The FDA writes “Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.  Investigations are ongoing into a potential causal relationship.  [USPlabs, LLC] agrees with FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.”

Here is a list of products subject to this OxyElite Pro recall:

“OxyElite Pro Super Thermo capsules

2 count capsules UPC #094922417275

10 count capsules UPC #094922417251

10 count capsules UPC #094922417268

21 count capsules UPC #094922426604

90 count capsules UPC #094922395573

90 count capsules “Pink label” UPC #094922447906

180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules

3 count capsules UPC #094922447883

3 count capsules UPC #094922447876

90 count capsules UPC #094922395627

180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder

Fruit Punch 0.15 oz UPC #094922417237

Fruit Punch 0.15 oz UPC #094922447517

Fruit Punch 4.6 oz UPC #094922426369

Fruit Punch 5 oz. UPC #094922447487

Blue Raspberry 4.6 oz UPC #094922426376

Grape Bubblegum 4.6 oz UPC #094922447500

Green Apple 4.6 oz. UPC #094922426499”

FDA on symptoms of acute hepatitis:

“Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.”

If you or someone you know has purchased OxyElite Pro, stop using the product immediately, and advise loved ones to do the same.  The FDA states that one can “return it to where [one] purchased it for a refund.”  If you or a loved one experienced adverse effects while taking OxyElite Pro, contact your health care professional or go to the nearest emergency room.

A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats.

Nutrition is an ever-changing area of research.  Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health.  During the 1950’s, 1960’s, and 1970’s, trans fats exploded onto the American scene and were heavily used in major food chains and in popular foods we ate.  And this made economic sense: saturated fats such as butter (animal fat), are more expensive than partially hydrogenated oils (trans fats).

Now, heart disease as the leading cause of death in the United States, and health consciousness is becoming increasingly popular.  Rightly so.  While artificial trans fats have been significantly reduced in the everyday foods Americans eat, they are still found in microwave popcorn, frozen foods, and margarine.

However, writes Tavernise, “The Food and Drug Administration proposed measures on Thursday that would all but eliminate artery-clogging, artificial trans fats from the food supply, the culmination of three decades of effort by public health advocates to get the government to take action against them.”

Some experts believe that if trans fats were eliminated in the American diet, there would be 20,000 less heart attacks each year.  Though the American populace believed for many years that trans fats were healthy and safe to use, we must rid ourselves of this notion.  Medical research has determined there is no safe level of trans fat consumption, and that trans fats carry no nutritional value.  Now, the FDA “has proposed that partially hydrogenated oils, the source of trans fats, no longer be ‘generally recognized as safe.’”

The link between trans fats and heart attack is now being further explored, and in some places the use of trans fats is already illegal.  An F.D.A ruling in 2003 required food that contains trans fats to be properly labeled as such. (Foods that contain less that 0.5 grams per serving are labeled as containing 0.0 grams of trans fat, in general.)  Not long after, cities such as Cleveland, New York, and California established a similar stance on trans fats and are encouraging the practice of banning the use and sale altogether.  The steps taken by the F.D.A and like-minded cities have already produced beneficial results.  The Center for Disease Control and Prevention has claimed the blood levels of trans fats for many Americans has been reduced.  In 2006, Americans were eating an average of 4.6 grams a day.  We now see that number is down to 1.0 gram per day.

Thankfully, the freedom of American corporations is here limited in favor of better health for all.

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill.

The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source of some recent controversies and have taken the stoplight in the medical world.  A large outbreak of fungal meningitis linked to “tainted steroid injections” from a compounding pharmacy killed 64 people this year.  More than 750 cases of infection were reported in that outbreak.

Such problems with compounding centers are not novel, but this most recent incident has pushed some to call for more federal oversight of the compounding process.  While the FDA is not necessarily looking for new responsibilities to shoulder, in light of the developing health and safety problems the Administration feels it can help create a better national standard.

FDA Commissioner Margaret Hamburg praised a bill being brought to the Senate for a vote in the coming weeks titled, “The Drug Quality and Security Act,” a bill that will hopefully help tackle some of the problems we have seen with compounding pharmacies.  Hattem states, “It would give the FDA power to regulate large compounding facilities but leave smaller plants to be overseen by state boards of pharmacy.”  Margaret Hamburg notes that the bill would not solve all the problems we are facing, but is a step in the right direction, stating “I don’t think it’s going to be as comprehensive as we initially had hoped,” but recognizes that it is “a step.”

However, the White House is not yet completely sold on the new legislation and has some concerns over the authority that will be given to the federal government with the oversight process.

According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to reduce the abuse seen with these painkillers.  The FDA would like to cut in half the number of prescription refills a patient can get before seeing their doctor, thus ensuring closer monitoring of both patients’ health and pharmaceutical requirements, allowing refills only for patients who truly require the drugs.

The FDA would also like to classify all prescription medications with hydrocodone as “Schedule II” medications.  The agency will begin to make that push next month, and will also seek to require that patients take their prescriptions to a pharmacy for refills, disallowing doctors the privilege of simply phoning prescriptions in.

In order for the recommendation to be used by the U.S. Drug Enforcement Administration, the U.S. Department of Health and Human Services must first approve the recommendation, and an FDA advisory panel held a vote which resulted in favor of the reclassification of hydrocodone.

The U.S. National Institutes of Health reports that one in five Americans have used prescription drugs in a recreational manner and since 2002, and that 22 million Americans have abused prescription painkillers in some way in the course of their lives.  NIH further reports that 47 million people were issued medications containing hydrocodone, filling around 131 million prescriptions.  The new classification will mean that less hydrocodone will be prescribed, and in turn, less available to be abused.  Patients will be required to visit the doctor’s office more frequently and the addition co-pays will increase health care costs.

Classifying hydrocodone as a Schedule II drug will allow the FDA to control hydrocodone in the same manner as other strong painkillers with high potential for abuse.  This push, however, is not only related to painkillers, and the ADD/ADHD drug Adderall would also face similar regulations.  The director of the agency’s Center for Drug Evaluation and Research has come out and explained that the push for this action has been driven by epidemic levels of prescription drug abuse.  Dennis Thompson of HealthToday.com believes that while the new changes may have some difficult implications for some people, the public health concerns have reached a point where something needs to be done.  I agree.

Studies have shown that women suffering from depression during pregnancy can put the child at risk of developing malformations.  As such, selective serotonin reuptake inhibitors (SSRIs) are most commonly prescribed to the mother to avoid such complications.  Unfortunately, using these drugs during pregnancy may also put the child at risk of malformations.  To date, the research is still inconsistent in illustrating a causal link between pregnant women using SSRI’s and malformations of the child, but the association is clear.

One study analyzing the data on the effects of SSRI usage during pregnancy is titled “Increasing the risk of spontaneous abortion and major malformations in newborns following use of serotonin reuptake inhibitors during pregnancy: A systematic review and updated meta-analysis.”  The study was conducted by Nikfar et al. within the Department of Toxicology and Pharmacology Research Center of the Tehran University of Medical Sciences.  The authors’ stated goal of the study was to update their previous meta-analysis about the outcomes of pregnancies following usage of SSRIs.

Databases were searched from 1990 to 2012, in order to collect studies to include in this meta-analysis.  The studies investigated the outcomes of pregnancies following exposure to any “therapeutic dosage” of any SSRI including fluoxetine, paroxetine, citalopram, escitalopram, sertraline, and fluvoxamine.  The outcomes considered were spontaneous abortion, major malformations, cardiovascular malformations, and minor malformations.  The results of the meta-analysis revealed odds ratio values of 1.87 (95% CI: 1.5 to 2.33, P< 0.0001) for spontaneous abortion, 1.272 (95% CI: 1.098 to 1.474, P = 0.0014) for major malformations, 1.192 (95% CI: 0.39 to 3.644, P= 0.7578) for cardiovascular malformations, and 1.36 (95% CI: 0.61 to 3.04, P= 0.4498) for minor malformations.  After considering the data, the authors stated “The results demonstrated that SSRIs increase the risk of spontaneous abortion and major malformations during pregnancy while they don’t increase the risk of cardiovascular malformations and minor malformations. Our previous meta-analysis only showed an increase in the risk of spontaneous abortion following the use of SSRIs during pregnancy.”  The authors go on to explain that the differing conclusions of the meta-analyses may be due to an increase in the number of studies included and/or the addition of two new SSRIs (citalopram and escitalopram).

Due to the fact that many women have used SSRI during pregnancy unaware of the risks associated with their use, a number of SSRI birth defect lawsuits have been filed.  If you or a loved one used SSRIs during pregnancy and your child was born with a congenital malformation, please do not hesitate to contact our team of SSRI birth defects lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Erectile dysfunction is a medical condition that plagues millions of men in the united states alone.  When the pharmacologic route doesn’t adequately solve the problems seen with erectile dysfunction, men may turn a penile prosthesis implant for the solution.  There are several different types of implants available on the market today, but the most commonly used penile prostheses are those manufactured by American Medical Systems (AMS).  The surgery required for these implants are delicate by nature and are often accompanied with serious complications such as infections and painful reoperations.

Author A. Natali from the Uro-Andrological Unit within The Department of Urology at University of Florence, in Florence, Italy, conducted a study called “Penile Implantation in Europe:  Successes and Complications with 253 Implants in Italy and Germany”, where the goal of the study was assess complications and patient satisfaction with AMS penile implants.  The study consisted of 253 consecutive patients who had clinically diagnosed erectile dysfunction.  Natali A. states “Pre, intra- and postoperative data were obtained from chart review, with a mean follow-up of 60 months; 200 patients were available for evaluation. Patient satisfaction data were collected using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire.”  Major postoperative complications were seen in 20 percent of the patients.  In all, 9 men experience prosthesis infections, 18 had mechanical failure, and 13 men experienced erosion of the prosthesis.  Natali A. further states “ Partner satisfaction with the AMS 700CX, AMS Ambicor, and AMS 600-650 was 91%, 91%, and 75%, respectively; dissatisfaction was 0%, 5%, and 6%, respectively.”  The study noted that patients claimed they had more natural erections than before the operation, but hardness was the same as before.  The use of standardized assessment tools for patient satisfaction will allow future comparison of data between different centers performing similar penile prosthesis implants.

Due to the fact that many men have used AMS penile implants that required reoperation, unaware of the risk for infection or complications, a number of AMS penile implant lawsuits have been filed.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.
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