Do you believe that theraonos failure to comply was intentional? I think when it comes to Theranos the main liability was a result of much ado about nothing. Holmes oversold the capacity of its technology well before securing its clinical utility, and overcoming the regulatory affair hurdles necessary for proper implementation of a service market company. Perhaps if the steps above would have been taken before implementing commercialization practices, she would have been able to provide a more accurate representation of her product, and still found success at a small scale. Then this success could have been used to build upon it, and develop the microfluidics technology she falsely claimed to have conquest. Frank.
The ALPES S.A. case deals with Charles River Laboratories (CRL) and their consideration of a joint venture proposal with an animal vaccine company in Mexico. The senior V.P. is preparing to present the proposal of a $2 million investment for the firm. The CEO, Jim Foster, is concerned with the associated risks that CRL would be undertaking if they accept this venture. Key issues of concern are; the partnership with a relatively small, family run business; having operations in Mexico, which could pose difficulties; maintaining CRL’s focus on U.S. expansion; and the proposed partner’s lack of funds to invest, which will leave CRL to bear the entire cost of the venture.
An independent report came out a few days ago validating some of the former employees’ claims – “The study concluded that Theranos’s results for total cholesterol were lower by an average of 9.3% than those produced by Quest and LabCorp. Doctors often use cholesterol-test results to determine whether to prescribe statins, a class of drugs that can help ward off heart disease. The Mount Sinai researchers wrote that the average gap on the cholesterol test between Theranos and the other labs was large enough that it could lead doctors to ‘either inappropriately initiate or fail to appropriately initiate statin therapy’ in some patients” (Carryrou,
We are presented with a proposal made by a cardiologist wishing to invest collaboratively with the hospital in establishing an outside heart scanning center. Physician investment in a health care business, to which the physician will then refer, creates a situation ripe for potential conflict of interests. While physician investors may honestly believe the services provided in their facilities are of greater value and higher quality than competing institutions, the utilization of services in which they have a financial interest may well be influenced by the profit motive. Therefore this proposal creates a perfect target for regulatory bodies looking to find physician financial conflict of interest violations.
Johnson and Johnson’s is a multi-billion dollar company that has been around for 129 years. The company was founded in 1886 by Robert Wood Johnson joined his brothers James Wood Johnson and Edward Mead Johnson to create a line of ready-to-use surgical dressings in 1885. The company produced its first products in 1886 and incorporated in 1887 (Johnson).Since then the company has built a reputation on its “Credo”. Simply stated, the first responsibility is to the doctors, nurses, patients, mothers and fathers who use the products then, employees, and finally shareholders. This lines up with the humanistic view of putting people over profits. As Johnson and Johnson’s grew, the company moved form a simple structure, offering just ready to use surgical dressings into a divisionalized form of many departments. With a host of products from band aids to high-margin medical devices: artificial hips and knees, heart stents, surgical tools and monitoring devices; and from still higher-margin prescription drugs targeting Crohn’s disease, cancer , schizophrenia , diabetes , psoriasis , migraines , heart disease and attention deficit disorder (Brill).This decentralized organization structure of management offered autonomy to mid and lower level manager . The issues that arose as the company grew under the structural from where Did Johnson and Johnson’s hide Risperdal study results from the Food and Drug Administration (FDA). Moreover, was there illegal marking of Risperdal?
EXECUTIVE SUMMARYSilicon Valley Medical Technologies (SIVMED) was founded as a research and development firm. In the beginning, SIVMED performed its own basic research, obtained patents on promising technologies, and then either sold or licensed the technologies to other firms which marketed the products. The firm has since then grown and is now contracted to perform research and testing for larger genetic engineering firms, biotechnology firms, the US government, and is now widely recognized as the leader in an emerging growth industry. SIVMED's founders were relatively wealthy individuals when they started company, and they committed a great deal of their own funds to the venture. Their personal funds, however, were soon exhausted by the
My experience at CVS/Pharmacy is a thorough illustration of the integration of ethics, technology and management. Since the time of Hippocrates, ethics have been at the forefront of importance in the healthcare field with pharmaceuticals bearing no exception. As members of the healthcare team, pharmacy staff have an ethical responsibility to ensure the safety of their patients; thus there is a need to make sure drug and other health information regarding the patient is accurate. Providing the wrong drug or drug dosage and issues of drug-drug interactions are just some of the very serious concerns associated with pharmaceuticals. Another ethical issue that is often related to the healthcare industry is privacy.
• In-licensing. One issue was whether to in-license compounds from a biotech company to diversify Sirtris’s drug development platform beyond its narrow focus on SIRT1, one of seven sirtuin variants in the human body. Several members of the Sirtris executive team were advocating a more balanced risk portfolio as the company started to increase investment in its drug development efforts. Partnership with Pharma. As is almost always the case in biotech, the team was in discussions about a partnership with a few large pharmaceutical firms. They were considering (a) what it would mean for the organization to become tied to a pharmaceutical company at this stage of its development and (b) whether to postpone a deal until Sirtris had more clinical data. Was this the right point in the company’s history to do a deal? Nutraceuticals. Sinclair received a near-constant stream of emails and phone calls from the public requesting Sirtris’s proprietary version of resveratrol, SRT501. For some time, he had contemplated selling SRT501 as a nutraceutical, an off-the-shelf health supplement that would not require FDA approval. This idea raised many questions about market opportunity, commercialization strategies, and the potential impact of a nutraceuticals offering on the Sirtris brand and
The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.
“Historically, the banana trade symbolized economic imperialism, injustices in the global trade market, and the exploitation of agriculture-dependent third-world countries”(2). However, they remain to be one of the most profitable items in grocery stores. Making bananas crucial to economic and global food stability for countries all over the world. They are the third largest staple crop, coming only after wheat and coffee. Since bananas are such a sought after fruit, many companies have gone to extensive lengths in the to fight for a share of the market. Chiquita Brands International was one of the pioneer companies to try and globalize bananas. They took a risk and made some very critical mistakes along the way.
While some have identified Merck as a visionary company dedicated to a "core values and a sense of purpose beyond just making money" (Collins & Porras, 2002, p. 48), others point out corporate misdeeds perpetrated by Merck (e.g., its role in establishing a dubious medical journal that republished articles favorable to Merck products) as contradictory
Successful IPO offerings by Quintiles and PPD and their subsequent growth to top 5 CROs in the industry (refer appendix 1), Kendle can follow the same strategy and obtain required capital through IPO. Threats: Kendle is losing contracts to larger CRO’s with international presence, industry consolidation, presence of numerous fragmented CRO’s worldwide, growth of many start-ups through financial roll-up strategy, many CRO’s are on an acquisition spree and Kendle is losing bids to companies such as Collaborative due to shortage of capital, ClinTrials negative performance is affecting other CRO stocks. Competitors: The fragmented CRO industry has hundreds of players ranging from small, limited-service providers to full-service CRO’s, and global drug development corporations which possess significantly greater capital, and other resources than Kendle. CROs compete on the basis of experience, medical and scientific expertise in particular therapeutic areas, quality of work, the capability to handle extensive trials worldwide, medical database management capabilities, and relevant technology to advance research. International presence with strategically located facilities, proximity to clients, and financial capability and cost efficiency are also necessary. In order to build these capabilities for competing effectively, the CRO industry is consolidating as
It was quite alarming when a large and supposedly reputable company failed to provide an adequate risk assessment.
For instance, the testing for breast cancer used to only be one thousand dollars and now the owner of the gene patent to breast cancer has now almost double price to three thousand dollars, stated in Crichton’s piece. Therefore, not a lot of people can afford to pay that huge amount of money. Because of this issue, Calfee mentions that a cancer patient filed a lawsuit against Myriad Genetics, “a biotech firm that owns a patent to a diagnostic test for breast cancer.”(443). So if you want to take the test to see if you have the breast cancer gene the only place you can get the testing is at their property in Utah. “Myriad does not only own the patent for the test but for the genes themselves.”(443). Since the first lawsuit was filed, there has been six others that have been filed as well but they have all been either dismissed or settled out of court. So not only do you have to pay the three thousand dollars for the test, you now have to pay for the travel and stay in
The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there
Technical risk, a large portion of all development costs are spent on drugs that never reach the market.