Phase 2 Clinical Trial Case Study

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Proponents of patent reform largely focus on the cost of patent infringement litigation to the U.S. economy and companies. While some argue that the type of patents issued should be limited in order to uphold the intent of Article I, Section 8, others claim that standards for issuing patents should be strengthened in order to reduce the number of costly patent infringement lawsuits. The cost of litigation and standards for issuing a patent is the focus of the proceeding text and justification for patent reform in the United States.

We are sometimes manipulated into buying these products because it will work wonders or make us feel good about ourselves, well I could say that some products are good heck even amazing. However, there are those that are just plain wrong that are so egger to sell the product just to make profit off of us, not caring whether we are content with how it works. Have you ever wondered why the advertisements just keep repeating sometimes well it’s like they are just planting it in your head about this product that they are trying to sell you and that you must have according to the advertisers. According to writer Sienna Kossman she states how advertisers operate and how they get the consumers to buy the product she say that the way they get them

Over the years there is the discussion on the nature of off-label promotion. Promotion for an unapproved by the Food and Drug Administration usage of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions. On the other hand, off-label promotion is deemed to be a constitutional right protected by the First Amendment. Numerous debates, lawsuits and court rulings still don’t clear up the dilemma of off-label promotion.

claim that the First Amendment protects this type of speech. Healthcare professionals believe that it would be beneficial to revise the current approach to provide specialists with tools necessary to improve the health of the population (Pomeranz & Adler, 2015). Food marketing is an area that is particularly problematic because some of the products can be harmful. It would be reasonable to require companies that promote such products o reveal their harmful effects. The general public would benefit from such changes because t would be easier to make rational decisions regarding purchases.

Some people believe that the company has the right to do what they want, others feel there should be regulations on these types of products. The false advertising will mislead the consumer if they are not educated. This is because the celebrity endorsing the product

back up products claims. The FDA has thousands of scientists preforming tests on all of the new products pending to be released. Some of these scientist look at samples to see if products are contaminated with illegal substances. Some

This false sense of security held by the public at large leads the masses to believe in the complete truthfulness of drug advertisements which could and will lead many consumers to not do their research on a medication before seeking it out to get it prescribed.

As prescription drug is becoming more and more common and widespread among the American society, it is obvious that drugs should have high quality in order to protect the consumers from any substantial danger that the drug could pose. Not just prescription drugs but dietary supplements as well. There has been an 80 percent increase in dietary supplement consumptions. But sadly the The Dietary Supplement Health and Education Act (1994) has helped manufacturers from facing FDA regulations. Furthermore, dietary supplements are being labeled as food and I don’t believe that they should be because people are less educated when it comes to medication and drugs, so if they happen to take in contaminated drugs, they would not know how to deal with

I believe the best means of collecting good clinical trial data is not unilateral. I am a strong advocate of making clinical trials easily accessible through convenience and innovation. With that being said, I feel a mixture of technology through smart phone apps and e-diaries in addition to easy access of getting the clinical trial procedures done and investigational product/medical device to the patient population through mobile health clinics are the best means.

A group of researchers sought to get a closer look at how clinical trials were carried out by talking to nurses who were working with drug trials. While participants in this study were all located in the United States, their experiences are pertinent when considering the ethical concerns involved in all clinical trials. The nurses who participated voiced a variety of concerns while they were working with clinical trials. They reported that despite consent being voluntary, and patients being told that they could discontinue a study at any time, there were some conflicts between this and the actual practice. Nurses who lost subjects in the study were often penalized and reprimanded, seemingly encouraged to sacrifice the patient's rights and desires in order to keep them in the trial. They also talked about how higher ups, who might be in charge of funding or the legalities, are often out of touch with what is actually ideal in the practical sense, rather than the bottom line. One nurse gave the example of how legally, one official might want the consent form to be three pages long, another might want it cut down considerably, and the nurse, who is actually performing the study, wants a consent form which is both thorough as to protect the patient, but concise and clear enough to be easily understood by the patient. Furthermore, nurses might be asked about their own opinions by their patients, which leaves them in a difficult situation where they could be using their authority to pressure someone into a study. All of these are difficult things to balance, and very valid concerns brought forward by individals with hands on knowledge of these trials. (DeBruin, Fisher & Liaschenko,

If things go wrong with medicine when it does go out in the market, and it causes harmful side effects it could tarnish the brands reputation.

While health foods stores attract consumers to purchase health supplements, many manufacturers use health food stores to promote their bogus products. In March 1999, the FTC filed a complaint in federal court against the makers of Vitamin O. The company ran false ads claiming the Vitamin O supplement prevents cancer, heart, and lung disease by adding an extra oxygen supplement to the bloodstream. With no scientific evidence to prove the benefits of Vitamin O, the two companies from Washington agreed to a settlement of $375,000 for consumer compensation. The settlement prohibited the Vitamin O manufacturers from making claims that were unsupported about the Vitamin O health benefits. Testimonials and endorsements of product represented through previous experience from members of the public who used the product were also prohibited in the settlement. In conclusion, marketing agents with false science beliefs have one common goal: To sell! We as consumers must be aware and informed of unknown supplements that claims to have a great deal of impact to your life. These products are known for its testimonials by doctors and actors that make claims of using the product. Pseudoscience supplements have caused serious illnesses and even death due to consumers lack of knowledge when purchasing these products. It is strongly recommended that consumers research the companies and the product that advertise false products very carefully before purchasing a supplement that claims to

The concoction of deceptive business methods and unrestricted regulations have resulted in detrimental health concerns of dietary supplements consumers. Dietary supplements is virtually unrestricted, and expanding its markets, much like the “snake-oil” medicines of the early 1900s . In 1993, this industry was generating 4 billion a year, by 2003 consumers spent 16.8 billions on supplements, and it is currently at 37 billion a year.(Wingert,1993; Larsen, 2003; Bradley, 2015). This massive industry is gaining popularity from the increasing amount of health enthusiast, and aging population. However due to the introduction of the DSHEA and the limiting of the FDA’s regulatory power, this industry has become chaotic,dangerous but highly profitable. Consumers are in danger of ingesting unregulated and potentially dangerous pill, that are marketed to them as nature’s cures. The lobbyist and senators pass law in favor of this lucrative industry and it will continue to grow and prospers, until the victimized consumers stand up and strongly voice their opinions. Just like when the industry successfully campaign for supplements and limiting regulations, we consumers should use our democratic voice against the lack of obstacles, and safety measures of supplements.

But researchers once again prove that to be false. Researchers say that there is ¨an overwhelming lack of evidence to substantiate claims that the ingredients provide any benefits¨. Meaning that the companies are just saying what they want minus the fact that they have done almost no research on whether or not there are actually benefits at all. This only adds to the fact that these are scams because this shows that the companies really only say what will help their product instead of stating actual facts gained from