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Claims of Gilead Scheme with Bristol-Myers and Johnson & Johnson

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A new lawsuit against drug manufacturer Gilead Sciences claims that the company created a monopoly on certain HIV medications while keeping the cost of drugs high. Gilead is supposed to have achieved this monopoly with the help of Bristol-Myers and Johnson & Johnson.

Claims of Monopoly

AIDS activists and supporters of those who have been diagnosed with HIV have filed a class action lawsuit against Gilead. Allegations claim that the three companies worked together to stick with ingredients that were protected by a patent for the drugs rather than developing lower-cost generic medications. This continued even when patents had expired on specific parts of the drugs.

The result of this strategy, according to the lawsuit, is higher prices even after exclusivity had expired. One drug, Complera, costs $35,000 per year per patient. Claims made against the manufacturer say that another version which has generic ingredients would cost about half.

This situation is just the latest in a string of lawsuits and claims about Gilead’s practices with HIV medications. The drug manufacturer also faces lawsuits about keeping lower-cost drug alternatives from the public while garnering as much revenue as possible from other older drugs. This lawsuit claims that Gilead was focused on revenue at the cost of patient safety.

The newest accusations against Gilead and the other companies focus on a scheme to reduce competition claiming they limited patient access to drugs while charging the government and insurance companies as well as patients more for expensive drugs.

According to the lawsuit, everyone suffers, from health insurance providers to state and local government programs to the individuals. Many aren’t even able to obtain the drugs because of the cost. Allegations cite a “no generics” clause in the agreements made between the companies as well as other agreements with manufacturers that wanted to put copycat drugs on the market.

Gilead’s Response

Gilead continues to maintain the claim that every decision was made to bring important therapies to patients who needed them. Partnerships with Bristol-Myers and Johnson & Johnson were made with this goal in mind. Bristol-Myers is reviewing the claim, and Johnson & Johnson has not responded to the accusations.

The manufacturer made a deal with the government to provide as many as 2.4 million free bottles of Truvada to those who are at risk for the disease. Generics are expected to be on the market for this medication by the end of 2019 instead of 2021 as originally expected.

Critics say that more needs to be done to ensure everyone benefits from reasonably priced medications designed to treat a deadly and life-changing disease. Highly recognizable activists are part of the plaintiffs in this case, and they are hoping to incite change to give people who need the drugs access.

Gilead continues to deal with multiple lawsuits regarding its practices and pushes for claims to be dismissed in various cases. A recent request was denied against Gilead in a claim which accused the manufacturer of delaying the release of other drugs which are safer and less expensive.

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Experimental Vaccine Fails Trial to Prevent HIV

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A trial of over 5000 people located in South Africa has ended because the vaccine failed to show indications that it could prevent HIV, the disease that causes AIDS. South Africa has one of the highest rates of HIV in the world.

Failure of the Trial

The drug, also called a jab, is a version of the RV144 vaccine, which showed potential to provide protection when tested in Thailand. This vaccine was developed to work with the most common subtype of the HIV strain found in South Africa.

Preliminary data showed that the differences between those who were given the vaccine versus those who were given a placebo were minimal. There was a total of 123 infections of HIV for those who received the placebo while 129 people were infected when they had been given the vaccine.

The experts were disappointed that the vaccine which had shown promise failed to provide protection from the virus. However, they say they will continue research to find other options. Other research is being conducted on various HIV vaccines with the hope that one will work.

Why Finding a Vaccine is Important

Currently, there exists a drug treatment with medication known as pre-exposure prophylaxis or PrEP that helps to prevent the infection of HIV to a healthy person. However, this medication needs to be taken on a regular basis. In some cases, it may be prescribed for daily use.

These treatments aren’t available in all countries. Even in the US, PrEP drugs can have serious side effects for those who take the medications. Some of them may have led to bone density loss and kidney failure. The medication would be prescribed to someone who tested negative for HIV but was in a relationship with a person who was HIV-positive or who had AIDS. The medication works to prevent HIV cells from multiplying and becoming full-blown AIDS. They don’t cure AIDS or reverse the HIV infection.

Risks of PrEP Drugs

High dosages of some of these PrEP drugs could lead to bone density loss, which can result in osteoporosis and broken bones. It can also place added stress on the kidneys, which can lead to failure. One of the jobs of the kidneys is to remove excess lactate acid from the bloodstream. If the kidneys can’t do their job adequately, it can cause multiple issues, including nausea and vomiting and difficulty breathing. If not treated quickly, the condition can be fatal.

A vaccine could potentially be a one-time treatment to prevent HIV in those who receive it. It would also be easier to access in other countries where alternative treatments aren’t as readily available and less expensive with one treatment over continuing medication.

While regular testing, abstinence or protected sex and the use of PrEP medications when necessary have reduced the spread of HIV to their loved ones, it hasn’t ended the HIV epidemic. Researchers still hope that the right vaccine will be found, which could mean the end of HIV for people in the US and around the world.

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Metformin Not Recommended for Recall

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The FDA doesn’t have any recommendations to recall the drug metformin, which is used to treat type 2 diabetes. The government agency had conducted testing on these products for evidence that they contained NDMA or N-nitrosodimethylamine at levels that were higher than acceptable.

NDMA has been found in various heartburn medications and drugs used to treat hypertension. Several drugs have been recalled in 2018 and 2019. According to the tests conducted by the FDA, the presence of NDMA was low to not detectable.

This is good news for those with a diagnosis of type 2 diabetes. According to statistics, over 30 million people have a diagnosis of diabetes in the United States with all but about 5 to 10 percent being listed as type 2. Metformin is one of the most popular treatment drugs in use. No one should stop taking the medication without talking to a medical professional, warns the FDA. It could be dangerous for their health to stop without supervision.

The FDA says it will continue to monitor for any future concerns. If the rate of NDMA exceeds the allowed amount in the future, it will issue a recall.

Other Impacts of NDMA

Metformin isn’t the first drug to be tested for the presence of NDMA. Zantac, a well-known OTC medication for heartburn, was recalled because of the levels of the chemical found in the product. Blood pressure medications also received the same scrutiny and tested too high for NDMA to be considered safe. They included valsartan, losartan and irbesartan. There are concerns that the chemical was present in some of these drugs for up to four years.

NDMA is an organic compound, which is often seen in cured foods or smoked meats. It’s also found in manufacturing as a by-product. One of the most alarming uses for this chemical is that it is used in scientific research to cause cancer in lab rats. Many experts believe it is a possible carcinogen for humans as well if it is found in a high enough concentration. The Centers for Disease Control and Prevention (CDC) indicates that it can lead to damage of the liver. While it is found in drinking water, the level is expected to be at seven nanograms per liter.

A high level of NDMA or chronic exposure to lower levels could potentially cause cancer. It is found naturally in certain foods and beer as well as the smoke from tobacco. These amounts are considered safe.

High levels in laboratory animals caused cancer of the liver and lung. In humans, it has been shown to cause internal bleeding and liver damage. This is one reason for the monitoring of drinking water because the chemical can get into the ground where it seeps into water. While NDMA breaks down quickly in sunlight, it can’t break down in the ground where no sunlight can penetrate. The FDA says it is unacceptable to find traceable amounts of the chemical in medications, which is why products are recalled for levels over the legal amount.

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Simple Change in Hospital Procedure Could Reduce Opioid Prescription Use

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Research indicates that by lowering the number of pills given in an opioid prescription could reduce use of opioid painkillers. Prescription medications are a major part of the opioid epidemic that has spread throughout the US.

Two hospitals in California tested this theory and changed the default settings on computers to a lower number of pills given out in opioid prescriptions. Researchers believe this small change will help prevent opioid use disorder.

What is Opioid Use Disorder?

While not categorized as an addiction, opioid use disorder occurs when a person has a strong desire to take the pills and has developed tolerance to the medication. They may have difficulty reducing use and even suffer from withdrawal. Addiction and the likelihood of addiction to opioids can be classified under opioid use disorder.

This condition usually requires treatment for addiction. It can lead to withdrawal symptoms and further addiction. Both dependence and addiction are part of the disorder.

The Study on Opioid Use in Hospitals

The researchers reviewed how opioids were prescribed in two hospitals for the period between November 2016 and July 2017. They changed the default settings on medications commonly prescribed that contain opioids. This included Percocet, oxycodone and Norco. At one hospital, the default was at 12 pills while the other hospital sent out 20 pills per prescription. The numbers were changed to five, ten and fifteen along with a setting that remained blank for the prescribing doctor to input the number.

When analyzing the results, researchers found that the lower settings reduced the amount prescribed and the number that went above the recommendations from the CDC. Researchers admit this one change won’t stop the epidemic with opioid use, but it’s one small step that can help. It doesn’t cost anything to make these changes to default settings, and the study indicates it has a positive impact.

The Dangers with Prescription Opioid Use

Prescription opioids are meant only for short-term use in most cases. Long-term use has been shown to lead to addiction. While the medications are best used to treat acute pain, they have been prescribed for chronic conditions. The longer a person takes a prescription opioid, the higher the chance they have of developing a dependence on the drug.

When a patient is taking more of the drug than what is allowed, they may resort to visiting multiple doctors to get more than one prescription. The body continues to develop a tolerance which means it takes more of the drug to achieve the desired effect.

One concern with prescription opioid use is that it will lead to illicit drug use, specifically with heroin – another opioid. Research has shown that many people resort to street drugs when they can’t get more of their prescription drugs. A full-blown addiction often develops, which can be difficult to treat.

While prescription opioids aren’t the only cause of addiction, they do play a key role. Researchers are trying to find effective ways to reduce the risk in medications handed out by doctors.

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