Archive for the ‘Medical Controversy’ Category

Hospitals around the country plagued by drug shortages

Tuesday, August 16th, 2011

Many Americans in need of health care are being forced to hold off on various treatments due to a growing number of drug shortages.

The Food and Drug Administration reports that many hospitals lack necessary medications used in cancer treatments, surgical procedures, intravenous feedings and more. For example, USA Today recently highlighted Monika McBride, whose chemotherapy appointment for her acute myeloid leukemia (a deadly blood cancer) was canceled because the hospital ran out of the drug she needed.

“I thought, ‘Maybe this is it. I’m done. I won’t have any more chemo,” the 55-year-old Idaho native told the news provider. “I didn’t want to stress about it, because I believe stress could make the cancer worse. I thought, ‘I’m just going to give it up to God.’”

McBride did not receive her chemotherapy for two weeks, and when she did receive the treatment, it was only because she drove 4 1/2 hours to find a hospital that carried the drug she needed – cytarabine. It is unknown whether the delay will affect her chance of survival.

This problem is running rampant throughout the country, with more than 80 percent of hospitals reporting that it has caused delayed care for patients, according to the American Hospital Association. The news source reports that there are currently shortages of 180 medications, which has pharmaceutical companies scrambling to manufacture the drugs at a faster level. This has also increased the drug prices for hospitals.

Deborah Banker of the Leukemia and Lymphoma Society attributes the shortages to the complex way in which some drugs are manufactured, quality issues and various regulations. Additionally, many of the ingredients are foreign, so shipment can pave the way for delays at times as well.

Currently, drugmakers are not required to alert the FDA when there are shortages, and the FDA does not have the authority to order the companies to manufacture certain drugs either. The latter is true even for drugs that save millions of lives. However, the Senate and House of Representatives are reviewing legislation that would make it mandatory for shortages to be reported to the FDA.

FDA pulls Avastin off the market despite pleading from breast cancer patients

Thursday, June 30th, 2011

Despite pleading from breast cancer patients around the country, the U.S. Food and Drug Administration (FDA) has officially revoked its approval of Avastin for treatment of the disease, according to Reuters.

Although many of those who suffer from breast cancer have claimed that the Roche Holding AG medication saved their lives, the FDA has ruled that it is neither safe nor beneficial for patients, basing their decision off of a multitude of different studies.

“No matter what way we look at it, there’s nothing we can hang our hat on in these studies that would make me feel comfortable continuing to expose a lot of patients to risk without a clear benefit,” Mikkael Sekeres, FDA panel member and associate professor at the Cleveland Clinic Taussig Cancer Institute, told the news source.

According to Reuters, approximately 17,000 women are currently being treated with Avastin, with a few of them making emotional testimonies in court in favor of the drug. Without approval from the FDA, health insurance providers may not cover the cost of the treatment, which is about $8,000 per month. While the agency stands its ground, the American Cancer Society (ACS) has mixed views on the subject.

“There are other highly qualified experts … who are clearly on the other side of [the FDA's] assessment,” Dr. Leonard Litchenfeld, ACS’ deputy chief medical officer, told the news outlet.

Roche reportedly requested that Avastin be made available to patients while researchers could perform more studies, but was denied by the FDA, which claimed it would take more than three years for further trials to be completed. The manufacturer’s breast cancer sales are expected to fall by 50 percent to $400 million this year.

While initial studies showed a significant deceleration in the development of breast cancer, additional research did not support this data. Patients also reported major side effects, including “holes in the stomach and intestines, severe bleeding and blood clots.”

The source reports that despite Avastin being taken off the market, Roche will perform further trials in hopes of presenting a viable case to the FDA in the future.

The Planned Parenthood Controversy

Wednesday, February 23rd, 2011

The House of Representatives recently voted to eliminate federal funding to Planned Parenthood, an organization that allows free access to numerous services that benefit women’s health. More than three million people are now at risk of losing this important resource because of the controversial focus on the abortion services that the organization also provides.

Politics aside, Planned Parenthood is an asset to many people, especially those without health insurance. It is not simply an abortion clinic – its 800 health centers around the country give men and women access to educational information about reproductive and sexual health, as well as access to birth control, preventative screenings for conditions like ovarian cancer, and potentially life-saving tests for HIV, HPV, and other sexually transmitted diseases.

While the legality of abortion remains a constant topic of controversy, Hillary Clinton has been a major proponent for reproductive health care over the years and has much to say about keeping open access to these crucial services.

“Family planning is an important part of women’s health, and reproductive health includes access to abortion that I believe should be safe, legal and rare. Keeping women and men in ignorance and denied the access to services actually increases the rate of abortion,” Clinton said at a hearing regarding reproductive rights in 2009.

What are your thoughts on the Planned Parenthood controversy? Is access to the organization’s services a valuable necessity or are there other alternatives?

Click here to read Planned Parenthood’s open letter to congress.

UPDATE: Drug Makers Covered Up Knowledge of Diabetes Treatment Issues

Wednesday, July 14th, 2010

As we previously blogged, studies published two weeks ago reported diabetes drug Avandia had significant cardiovascular side effects, prompting a debate over whether it should be pulled from the market. According to a documents obtained by the New York Times, Avanadia manufacturer GlaxoSmithKline performed a study on the drug in 1999 and the results were the same: the medication increased the risk of heart complications, including heart attack, stroke, heart failure and even death.

Data like this is required to be submitted to federal drug regulators, but the drug maker has spent 11 years covering it up.

The reason for the cover-up was for business only. GlaxoSmithKline would suffer a $600 million loss in two years’ time if the information was released, and they had no other marketable products to offer at that time. The Food and Drug Administration will meet today to discuss the ethics of further testing Avandia against its healthier competitor, Actos, and if it will cease production.

How do you feel about your health industry putting you at risk for a profit? With Healthetreatment, patients experiencing negative side effects can sound off as it happens and search for alternative treatments in our database. Real-time insight from patients, Healthetreatment can become an early-warning system for patients like you.

New Studies Raise Debate Over Diabetes Medication

Tuesday, June 29th, 2010

Two new studies published yesterday are adding fuel to the fire of whether Type 2 Diabetes medication Avandia should be pulled from the market.

Type 2 Diabetes is a condition in which the body is unable to properly respond to insulin, and Avandia helps increase the body’s sensitivity to the pancreatic secretion. A study published in the Journal of the American Medical Association reports that the drug, manufactured by GlaxoSmithKline, increases the risk of cardiovascular complications, including heart attack, stroke, heart failure and even death up to 17 percent. Another study in the Archives of Internal Medicine shows that Avandia can raise the risk of heart attack up to almost 40 percent.

Actos, a competing medication prescribed for Type 2 Diabetes, has not been found to have the same negative effects on patients, which raises the question as to why Avandia is still on the market if Actos is seemingly a safer alternative. Researchers have been trying to conduct a study comparing the safety of both treatments, however they are facing slow recruitment and critics questioning study’s ethics. The Food and Drug Administration is scheduled to hold an advisory committee meeting on July 13 to discuss the fate of Avandia.

With technology like Healthetreatment, we are able to deliver real-time post-marketing research (i.e, research performed after a drug has been approved by the FDA). At the very least, Healthetreatment is able to provide a mechanism to reach people taking a certain medication to take part in a survey or study. Are you currently taking any medications and experiencing side effects or complications? Tell us here, your insight could prevent others from unnecessary suffering.