AstraZeneca focuses on developing cancer treatments as patents draw to a close

AstraZeneca is a large British drug manufacturer and has done numerous studies on various ailments during its time of establishment. They’ve been making money for many years on their six main focuses, one of which is cancer. However, as patients die from their health problems, the drug company may be facing a loss. In response they have decided to increase their focus on developing cancer treatments since many of the paying customers have died from their specific type of cancer.

AstraZeneca focuses on developing cancer treatments as patents draw to a close

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Medications so far

Up to the present, AstraZeneca, one of the largest pharmaceutical services provider companies in the world, has been hard at work on developing several immuno-oncology drugs. These drugs work by fighting tumors, which can help people battle their cancer and survive. By concentrating on these medications, Astra-Zeneca can hopefully find the ones that work the best and get them approved so they can hit the market. This process takes some time but can help more patients survive. Though it may sound heartless, drug companies are out for the profit, just like any other business. That means that more patients means more money for them, though their life-saving medications are also a great benefit to people suffering from cancer.

Patents closing effects

When medications are in development, companies place a patent on the formulations which protect them from theft or a copycat drug as they research and conduct clinical trials. Some of the patents that the company holds are getting close to expiring. When that happens, other companies can use their public information to copy their trials and ideas. To prevent that from happening, Astra Zeneca is struggling to finish up their research on certain cancer medications so they can be approved before patents run out.

AstraZeneca certainly isn’t the only drug manufacturer out there. Many of them turn to services from firms such as G and l scientific to help them expedite their trial process. These types of companies offer assistance with research, data control and the process of sending their trial information to the FDA for approval.

The drug approval process can take years and a lot of money, so it makes sense that drug companies would want to get their trials done and approved so that they can start making a profit on their drugs.

Chinese scientists are planning to test a gene editing tool – a new world first

A new test by scientists in China aims to advance the gene-editing process in order to ultimately help patients fight deadly diseases.

Chinese scientists are planning to test a gene editing tool

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Using CRISPR-Cas9 gene editing, Lu You, an oncologist at West China Hospital at Sichuan University, will test the gene editing treatment on lung cancer patients.

The technique involves using CRISPR to alter the patients’ genes. In the process, Dr. You will take the patients’ T-cells from their blood and use CRISPR to locate genetic sequences within a chromosome. They will remove a piece of the chromosome and replace it with another. This gene is responsible for encoding a protein called PD-1. It is this protein that allows cancer cells to avoid detection by the immune system.

The biotechnology company Chengdu MedGenCell, which is collaborating on the project, will examine the genes to ensure they were edited correctly. From there, the altered genes will be multiplied and injected into the patients. If the test is successful, the immune cells will attack the cancer cells.

The other critical portion of the test is to make sure the immune cells do not attack other parts of the body, causing additional problems. If successful, this gene-editing treatment could open the door to revolutionary treatment in fighting cancer and other diseases with limited treatment options.

Patients in the trial

The ten patients selected for the study have tried multiple standard treatments for mestastatic, non-small-cell lung cancer without success.

Because this is the first human trial with CRISPR and there are some significant risks in not knowing how the immune cells will react, Dr. You is taking special precautions. A single patient will be treated first to make sure there are not any problems before treating the other patients.

Additional testing

A similar clinical trial involving CRISPR could occur in the United States later this year, but such trials require FDA 510K clearance submission. Such trials can be fast-tracked with a third party review program such as TPRG.

Advances in China

If Dr. You’s trial is successful, it could lead to additional trials and give China a jump start in the world of gene editing treatments. Regardless of the study’s success, it is likely to provide valuable information on the gene editing process and CRISPR, allowing future studies to build on the work of that done by Dr. You.

Legislation Aims To Clear Way For Essure Lawsuits

Looking at the history of surgically implanted medical devices i.e. neurostimulators and intraocular lens, it is safe to assume that these devices have revolutionized the medical field.

However, if we look at the recent trend, some of these devices have backfired. In other words, they have done more harm than good to the patient’s body. One of the companies that belong to the latter category is Essure. Its birth controls system has resulted in more enemies than friends.

How Essure functions?

Essure is famous for its birth control system. Being an alternative form of sterilization, the birth control system is manufactured in the form of two stainless steel coils. These coils are then inserted into the fallopian tubes to prevent pregnancy. According to an estimate, more than 750,000 women have used the aforementioned method to prevent pregnancy.

One of the many reasons for the worldwide success of the Essure birth control system is its utility. Being described as a fast procedure, the Essure birth control system takes only 10-minutes to complete. Moreover, there is no need for providing anesthesia to the patients as the whole procedure is pain-free.

After the coils have been inserted in the vagina, they expand to a length of about 1.5 inches after which they attach themselves to the wall of the tubes. This process is so normal that no bed rest is recommended for the patients after the procedure.

Why is Essure under criticism?

Contrary to the aforementioned explanation, not all the women who have undergone the procedure give it full marks. As our body is sensitive to external intrusions, some women have complained that their body has reacted badly to the insertion of these coils.

In those cases where the body has reacted strongly, the women were subjected to a migraine, hair loss or perforation of the other organs of the body. In other cases, when the coils aren’t properly aligned with the body of the patient, the surgeon might have to take a second attempt to go through with the task.

Yet, in other cases, several women have reported that after undergoing the procedure, their menstrual cycle has changed dramatically. However, the worst possible disadvantage of Essure birth control system is yet to follow.

According to experts, this is a one way street with no looking back. For example, the intervention of Essure birth control system is an irreversible process. In other words, women cannot have children even if they want after undergoing the procedure.

In addition to the damage caused by these devices, one thing that infuriated the patients more was the firewalls that Essure erected around it to save the company from litigation. For example, if you’re a patient in whose body an Essure device has malfunctioned, you cannot sue the manufacturers of the company. Thus, while you could sue the device and get damages, the real culprit will remain unharmed.

How the lawmakers have responded?

Thus, in light of the above-mentioned disadvantages of Essure, it seems appalling that, for the victims of this procedure, they couldn’t sue the makers.

However, thanks to the members of Congress, the whole scenario could change in the upcoming months. Complying with the public demand, the lawmakers have argued that it seems crazy that a company couldn’t be held liable when one of its products has backfired.

“Every once and a while there’s a medical device that will get approved through either a fast track approval or a more rigorous approval that may do more harm than good — and that’s what we’re here to talk about,” said U.S. Rep. Mike Fitzpatrick,  a Republican from Pennsylvania.

The first time the disadvantages of Essure surfaced was three years ago. Since then, according to a conservative estimate, more than 25,000 women have voiced their concerns regarding the procedure.

Why Essure cannot be sued under the present legislature?

While the question seems complex, the answer is simple. The birth control device of Essure was approved by the FDA years ago. At that time, looking at the track record of its manufacturer, FDA decided to grant a pre-emption status to Essure.

A pre-emption status is granted by FDA when it wants to shield a company from tort claims relating to products that have been approved by it. While this is a highly controversial issue, this law finds its relevance in cases like these.

Thus, no matter how much damage a medicine has inflicted on patients, get a pre-emption status and you cannot be sued by the patients. However, thanks to the efforts of lawmakers like Fitzpatrick, such legislation has now been introduced in front of the Congress that will change this law and allow patients to fill lawsuit against essure.

This new legislation will not only give the patients a right to sue the company, but it will also change the way medical devices are reviewed. Hence, as for patients who have suffered long and hard, this is a win-win situation for them.

Most Dangerous Prescription Drugs in the US

Most Dangerous Prescription Drugs in the US

Within recent years, United States has seen a drastic rise in the use of prescription drugs. Most of these medications are safe, but we’re going to inform you about a few that might not be.

In recent years, the dangers of prescription medications have become much more established. This is exacerbated by the fact that a patient will oftentimes assume their doctor’s advice is trustworthy. But doctors are humans too, and are prone to errors in judgment and at times even immoral behavior. It’s also unrealistic for every physician to spot a patient with potentially-addictive tendencies.

Studies show that blood thinners, heart medications and chemotherapeutic agents are the ones that cause the most deaths. These drugs come with side effects which range from liver damage and birth defects to suicidal behavior, heart attacks, bladder cancer, heart failure, Crohn’s disease, blood clots, strokes and uncontrollable bleeding.

What’s worse is that the number of injuries resulting from prescription drugs is estimated to be in the millions. The solution? For patients themselves to be knowledgeable regarding what they put in their body. This’s why we are here, so read on and discover which prescription drugs to avoid.

The following is our list of the most dangerous prescription drugs in the US today:

Diabetes Drugs – Avandia

Avandia is a type-2 diabetes drug, launched in 1999, but was implicated later on in heart attacks. The FDA estimates that this drug caused 83,000 heart attacks and ailments from 1999 to 2007, the year wherein the FDA added a black box warning to the drug. The FDA considerably restricted use of Avandia in September 2010, allowing access-only to a select group of physicians and patients. The 2-year investigation by the US SFC (Senate Finance Committee) revealed that the drug company was familiar with of the heart risks related to Avandia for a long time and attempted to hide concerns about the drug.

Anti-depressants – Prozac

Prozac (fluoxetine) is an antidepressant manufactured by Eli Lilly and hit the market in 1987. This medicine is part of the SSRI drug class mainly used to treat depression, bulimia nervosa, obsessive compulsive disorder (OCD) and panic disorder. Prescribed to more than 50 million people globally, this medication may cause serotonin syndrome as well as increase in the risk of violent behavior and suicidal thinking. In 2006, the FDA added label to all SSRIs warning of the amplified risk of PPHN (pulmonary hypertension in the newborn), which can be fatal.

Blood Thinners – Xarelto

Millions of Americans take blood thinners in order to reduce the risk of stroke resulting from atrial fibrillation (irregular heartbeat). Xarelto (rivaroxaban) is one of the newest blood thinners, approved in July 2011 by the FDA for use after knee and hip replacement surgery so as to reduce the risk of blood clots. The drug’s indications were expanded to consist of atrial fibrillation (AF) in November 2011. There is no bleeding antidote for Xarelto, and this means that users of the medication can experience unsafe, uncontrollable bleeding events. In addition, since the drug was fast tracked, unknown side effects may also be placing patients at risk.

Birth Control Pills – Yaz and Yasmin

Yaz (ethinyl estradiol/drospirenone) is a birth-control pill manufactured by Bayer and released in the United States in 2006. It’s a sister drug to Yasmin, which got approved by the FDA in 2001. Both medications contain the ingredient drospirenone/ethinyl estradiol, and so they carry the same risk. Despite being the top-selling birth-control pill in the US from 2008 to 2009, several studies have shown that Yaz puts women at an amplified risk for blood clots. Blood clots may contribute to DVTs (deep vein thrombosis), PE (pulmonary embolism), heart attack, or stroke. On April 10, 2012, the FDA required that Yaz include a warning that drospirenone containing pills raises the risk of blood clots by threefold.

What to Expect from Botox Treatments

Botox treatments are no longer for the rich and famous only. However, it is certainly true that you will be hard pressed to find a Hollywood star over 40 who haven’t used it themselves! The reason why this treatment is so popular is because it is quick, painless and really works.

Where to Apply Botox

The FDA approved Botox in 2002 as a treatment for frown lines (moderate to severe) between the eyebrows. Since then, it has becoming increasingly popular with every passing year. Today, Botox consistently ranks as one of the 5 most popular non-surgical cosmetic treatments. The frown lines between the eyebrows are known as glanbellar lines and this is where Botox is most commonly used. However, it is also used on forehead wrinkles, crow’s feet and the lines around the mouth. Besides being FDA approved as a cosmetic treatment, it was originally approved as a medical treatment for spams in ocular muscle, eye coordination, excessive sweating and migraines. The fact that it is also the Fountain of Youth is just a welcome side-effect, in other words.

How Does it Work?

When you go for Botox treatments in San Jose, a physician will essentially paralyze some of the muscles in your face, as scary as that sounds. This stops them from moving, meaning you can’t see the wrinkles anymore either. You should see the results within no more than a week, and they should last for between 3 and 6 months. Over time, the proteins in your body absorb the Botox itself, which means that the paralysis stops.

The Procedure

A physician will inject quantities of Botox in the affected areas using a sterile needle. The physician must be Botox certified, which is particularly important if you go to a medical spa rather than a cosmetic surgery clinic. It will generally take just 20 minutes to complete the procedure. Someone who is certified in injecting Botox is able to know where to inject the substance and they will first mark your face accordingly. Botox itself is then injected just below the skin on those marked spots.

Problem Injections

In almost every case, Botox treatment is very quick and easy. However, it is important to understand that they are a medical procedure and there are always risks involved in it. This is why it is so important that you find a physician who is properly qualified to deliver the injections. Plastic surgeons are generally the best, because they have an in-depth understand of the different muscles of the face. However, plastic surgeons are often very expensive, which is why people will turn to other types of clinics instead. This is not a problem, but you do have to make sure that whoever administers the procedure is fully Botox certified. Most of us have heard of horror stories of people who can no longer make expressions with their face, which happens when the treatment is administered in to great amounts or too often, clear signs of someone who doesn’t know what they are doing.