Congressman Fitzpatrick compels the FDA to investigate the safety of power morcellation and review the effectiveness of medical device reporting.

Pennsylvania Congressman Michael Fitzpatrick is calling for an investigation into the safety of power morcellators. The call to action comes after a number of women underwent morcellator surgery and later died from uterine cancer.

Power morcellators are used in an estimated 60,000 fibroid procedures each year. The “minimally invasive” devices remove fibroids with a cutting tip that can shred and spread undetected cancer cells.

Fitzpatrick compels the Food and Drug Administration (FDA) to investigate the morcellator manufacturer Ethicon, a Johnson & Johnson subsidiary, along with three hospitals that failed to report morcellator-related deaths.

Calling For A Criminal Investigation Into Morcellation

“OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health,” according to the FDA website.
Image: CBS News

Fitzpatrick, a Republican who represents the 8th Congressional District of Pennsylvania, has been working to raise awareness about the dangers of power morcellators. The devices, approved through an expedited 510(k) process, were cleared for use more than two decades ago without a thorough clinical examination.

On December 18, 2015, Congressman Fitzpatrick wrote a letter to George Karavetsos, the director of the Office of Criminal Investigations at the FDA. The letter questions the effectiveness of the FDA’s Medical Device Reporting regulations, which “failed to catch the severe dangers posed to women’s health by morcellation.”

The Medical Device Reporting regulations require manufacturers and hospitals to disclose when a surgical  instrument “has or may have caused or contributed to the death of a patient.”

In the letter, Fitzpatrick directed attention to three hospitals that failed to report patient death related to morcellator side effects. Women who had morcellator procedures at Brigham and Women’s Hospital, Rochester General Hospital and University of Rochester Medical Center died from leiomyosarcoma within 1-2 years after surgery.

If there’s even a small chance that a medical device could have contributed to complications, hospitals have a legal obligation to contact the FDA within 10 days of a patient’s death. Medical device manufacturers, such as J&J’s Ethicon, are legally required to report device-related deaths within 30 days.

“In fact, the first time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was ‘from a physician citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used,” Fitzpatrick wrote.

“It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works [sic] as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation.”

Shedding Light On The ‘Horrific Consequences Of Morcellation’

Laparoscopic power morcellation can activate unseen cancer cells buried deep in uterine tissue.
Image: Cancer Box

Fitzpatrick made it his mission to raise awareness about the risks of morcellation, which are touted as a non-invasive way to remove uterine fibroids.

Although the devices are able to minimize infection and reduce recovery time, it’s become increasingly clear that morcellation surgeries can activate and spread hidden leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers.

“It appears that these patient safety regulations may not be working as intended, leaving patients in danger,” Fitzpatrick wrote in his letter. “As you may be aware, hundreds, if not thousands, of women are dead because of a medical device known as a laparoscopic power morcellator.”

Since the FDA first issued a morcellator safety alert in 2014, the devices have been identified as the culprit in wrongful death cases. More than 30 women diagnosed with late-stage cancer filed against the makers of the device. The lawsuits are condensed in multidistrict litigation 2652 that will be heard by Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas.

Women injured by morcellation have argued that they wouldn’t have agreed to the procedure if they had known about the risks. Attorneys question whether or not the manufacturers adequately warned patients about the potential consequences of morcellation surgeries.

If you developed cancer after having your uterine fibroids removed with a power morcellator, then you might be entitled to compensation for this medical side effect.

Complete a free, no-obligation case evaluation now to learn more about compensation eligibility. 

The post Congressman Calls For Investigation Into Morcellation Side Effects appeared first on Citizens Report.

After receiving results from a commissioned study on how Oxycontin affects pediatric patients, the FDA approved the drug as a long-term pain management therapy.

Oxycontin, a frequently abused drug that relieves serious pain, has been approved for children and teens between the ages of 11 and 16 years old.

The FDA approved the drug after commissioning trials that focused on the 11 to 16 demographic to collect reliable data on how it affects a younger age group. The study, conducted by pharmaceutical manufacturer Perdue Pharma, provides necessary information about dosages and side effects of Oxycontin when used by younger patients suffering from cancer, traumas or other serious illnesses.

What is Oxycontin?

Oxycontin is a narcotic opioid painkiller that is similar to morphine.
Via: LA Times

Oxycontin is a powerful opioid that relieves severe pain. It is controversial because of its highly addictive properties. Oxycontin is a partly synthetic, narcotic analgesic drug that is a derivative of the opium poppy, which was used to treat pain throughout ancient times.

The drug acts on the nervous system by stimulating opioid receptors in the brain and spine. When the drug is taken, it causes a variety of reactions, from reliving severe pain to slowing the breathing and putting the user in a euphoric state.

Oxycontin is the extended-release version of the drug oxycodone. The drug is considered better for long-term pain management because it needs to be taken less frequently than other drugs in its class. Oxycontin is taken every 12 hours, whereas oxycodone is taken every 4-6 hours.

In addition, Oxycontin is a different substance. Its thicker casing makes it more difficult for abusers to crush or dissolve the pill in order to snort or inject it.

What Prompted Approval For The Demographic?

The FDA approved the use of Oxycontin because of a lack of feasible pain management options for the 11 to 16 age demographic.
Via: Jennings Wire

The authorization was made because a lack of long-term, effective pain management therapies for pediatric patients. The FDA has approved the drug to eliminate the need for doctors to make educated guesses based on personal experiences.

Having doctors translate adult data to treat teens just wasn’t going to cut it for the FDA. The goal of the study was to provide sound information on how Oxycontin affects younger demographics. In 2012, Perdue Pharma conducted a pediatric trial in 150 children to test the drug.

Sharon Hertz, M.D., Director, Division of Anesthesia, Analgesia, and Addiction Products, commented on the study and its results. The study focuses on how Oxycontin moves through the body in pediatric patients.

“Pediatric patients don’t usually have the same kind of chronic pain conditions as adults, so patients in the study were prescribed OxyContin in situations where they were expected to require pain management with an opioid for many weeks – for example, after extensive trauma, or after major spinal surgery or other types of major surgery to correct of birth defects.

The studies supported the addition of a pediatric indication to the OxyContin label for patients 11 to 16 years old, and provided the much-needed data to health care providers.The new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients following these types of surgery or traumas,” Hertz said.

The FDA believes that Oxycontin will be a great benefit to pediatric patients and fill a necessary gap in pain management.

“Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner, and may help them to sleep through the night without waking up from pain. So from that perspective it’s very useful,” Hertz said.

Risks Involved With Opioid Use

According to the Centers for Disease Control and Prevention, 44 people die from opioid overdose every day.
Via: Oxy-Addiction

Doctors usually prescribe opioids as post-operative pain relievers. But many patients who are prescribed these drugs become dependent on the effects, even after recovery is complete.

Opiates are classified as schedule II controlled substances because of high potential for abuse, which calls for stricter regulations. Oxycontin is a popular black market drug that often leads to heroin use. Nicknamed ‘hillbilly heroin,’ Oxycontin can at times be a less costly alternative that is similar enough to the street drug.

Critics argue that prescribing opiates to teens is dangerous because it could introduce them to a high that would prompt them to seek out drugs later in life. In addition, the caretaker needs to carefully monitor the dosage. If the wrong dosage is administered, the drug could be deadly.

The FDA Disclaimer And Projected Future

The FDA approval comes with warnings and precautions for pediatric patients using Oxycontin.
Via: Smart Tan

The FDA includes warnings for Oxycontin use as a treatment for children, which are the same as the general precautions for adults. In addition, the FDA regulates that the drug should only be used in pediatric patients who have been previously exposed to opiates.

Hertz said patients “must already be responding to, and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone per day before they can be prescribed an equivalent dose of OxyContin.”

Hospital staff should be careful not administer the drug with other pharmaceuticals that will add to the sedating effects of Oxycontin. Hertz also comments on how caretakers and patients should store the drug if it has been prescribed for use outside of the hospital setting.

Click here to read the interview with FDA Director Sharon Hertz, which includes more information on how the drug should be used to treat the younger demographic.

It is impossible to predict if pediatric patients who use opiates as a pain management treatment will go on to abuse drugs later in life. For now, children and teens with severe and unmanageable pain will have an additional treatment option. And Hertz predicts expects there will be even more options in the future.

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Playing Devil’s Advocate: The FDA

Enacted at the height of the AIDS epidemic in the 1980s, the original ban was put in place when the virus was not yet understood. Although a lot has changed since then, the FDA still depends on a wide margin of error for all blood donations, claiming that the policy change is consistent with existing limitations placed on other individuals.

For example, the current policy indicates that a one-year deferral period is necessary for people who are at risk from exposure to malaria or from engaging in sex with prostitutes or intravenous drug users, according to The New York Times.

Via: Imgarcade

The medical reason for not lifting the ban entirely is the “window period” between infection and a positive test result. But thanks to the quickness and accuracy of modern HIV-testing, some scientists argue that it is unlikely for infected blood to be introduced into the system. The FDA, guided by an advisory committee to the U.S. Department of Health and Human Services, disagrees.

“At this time we simply do not have the scientific evidence to show that you can go to a shorter period,” said Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research.

Playing Devil’s Advocate: LGBT Activists

While it is the FDA’s responsibility to be cautious, rights groups believe that the ban is unsupported by scientific claims, and that it continues to play on outdated stereotypes. Lambda Legal calls for a shorter deferral period of two months or less, claiming “within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV,” according to an article from The Wall Street Journal.

Activists believe that these regulations hold gay men to a different standard, asserting that many men who have sex with other men are in monogamous relationships and consistently use protection during sexual encounters. According to the Huffington Post, the American Medical Association supports conducting individual risk assessments, which focus on behavior instead of sexual orientation.

Via: Ars Technica

The Numbers

“The Williams Institute on Sexual Orientation and Gender Identity Law at the University of California, Los Angeles said in September in a study that eliminating the ban would bring in 615,300 pints of blood annually. Instituting a one-year deferral period would bring in 317,000 pints, the study found,” according to Reuters.

While some are satisfied with taking incremental steps, others claim that if the ban were removed entirely, the expected supply could potentially double. Although the nation’s reserve is reported to be relatively stable, the American Red Cross asserts that there is always a need for more blood.

The indicated policy change will increase the supply by hundreds of thousands of pints per year, but it will not go into effect right away. The FDA is expected to publish a draft guidance that will be followed by a comment period in early 2015, which will decide whether or not the policy change will become final.

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