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The Practice of Medicine

Genetic Screening: A Step Forward in Determining Cancer Risk?

by Angela Sams

What if you could get a test to tell whether or not you are at risk for cancer? This is already somewhat possible with the BRCA1 test, which searches the BRCA1 gene for mutations that may lead to breast or ovarian cancer in women. One well-known example of someone who has taken the test is Angelina Jolie, who then had a double mastectomy and both ovaries removed based on the results.

Not all mutations of this gene are bad, however, and a lot about it is still unknown. Because of this, “a test might return with a ‘variant of unknown significance,’ or VUS,” according to a recent Atlantic article. This basically means a mutation that we really know nothing about. For the BRCA1 gene, at least 350 VUS exist, and they could be harmful or benign.

A new approach is being taken here in Seattle, where MCN’s corporate office is located. Researchers from the University of Washington are trying to understand what the mutations could mean by beginning with “genes of great interest” and then figuring out what happens if these genes are mutated in every way possible. Even mutations never before seen in humans are being accounted for – that way scientists will have an answer if the mutation does show up in a future patient.

As important as this information is proving to be, it would seem like a no-brainer to publish it. Unfortunately, that is not the case, as many companies are keeping the data a secret. One such company is Myriad Genetics, a molecular diagnostic company who was at one time caught up in a legal battle regarding a patent on the BRCA1 and BRCA2 genes.

Politics aside, this research is positive news in the science and health realm. While our genes are what make each one of us unique, they may also be the key to unlocking disease prevention. And, while many may not go to the same extremes as Angelina Jolie, we can choose what to do with the enlightening information given to us.

And The Nobel Prize Goes To…

by Jen Jenkins, Market Analyst

Three scientists have received the prestigious award this year for what the Nobel Prize committee said were “therapies that have revolutionized the treatment of some of the most devastating parasitic diseases.”

Dr. William Campbell, Dr. Satoshi Omura and Dr. Tu Youyou are the recipients of the award; the doctors originate from Ireland, Japan, and China respectively. Dr. Campbell and Dr. Omura collaborated, as well as worked on independent aspects, to develop the medicine Avermectin and will share one half of the prize money; Dr. Tu will claim the other half of the money for the medicine Artemisinin, her discovery of which was inspired by traditional Chinese medicine.

Parasitic diseases threaten approximately one-third of the world’s population today, especially in the poor areas of Africa, South Asia, and Latin America. These two newly developed medicines address the parasitic diseases transferred to humans from black flies and mosquitoes and have been included in the World Health Organization’s list of essential medicines. Both medicines are distributed to areas in need either for free or at very low cost.

“These two discoveries have provided humankind with powerful new means to combat these debilitating diseases that affect hundreds of millions of people annually. The consequences in terms of improved human health and reduced suffering are immeasurable” because parasitic diseases “represent a huge barrier to improving human health and well-being.”

-The Nobel Committee, as reported by The New York Times

Read more in depth about these fascinating scientists, their discoveries, what led to their discoveries in this New York Times article.

The Price is Right? Wrong!

by Jen Jenkins, Market Analyst

The most recent case of a pharmaceutical company exorbitantly raising the price of an otherwise inexpensive drug has brought certain “Big Pharma” issues careening back into the spotlight. Turing Pharmaceuticals acquired a 62-year-old drug called Daraprim back in August. This drug, used mainly to treat a rare parasitic infection in patients with compromised immune systems such as babies, or adults with AIDS/HIV and cancer, originally rang in at $13.50 a tablet; that is until Turing acquired it and the price per tablet soared to $750. More attention is typically bestowed upon the high prices of new drugs, but this particular situation brings to light an evolving issue of mind-boggling price increases in drugs that have been around a long time and are mainstays in certain types of care.

A huge concern with these increases is that hospitals are more likely to turn to alternatives that may not prove as effective. Although high prices are known to happen within the industry due to shortages, the cases described here are happening merely due to business strategy. Other examples, just to name a few, include a drug called Cycloserine, which increased from $500 for 30 pills to $10,800; also, just last month two members of Congress investigated another incident where two separate heart drugs, Isuprel and Nitropress, were acquired by Valeant Pharmaceuticals and subsequently raised in price by 525% and 212% respectively.

The 32-year-old founder and chief executive of Turing explained the recent price hike away by saying it is now more in line with other drugs that treat rare diseases and that most patients use the drug for far less than a year anyway. The sad truth of it all is that the CEO’s unapologetic response to the backlash of the situation is far from unusual, as is the fact that his drug company is only one of many that has and will continue to unconscionably inflate prices.

Read about this  in further detail in these New York Times and Washington Post articles.

A Complicated System

by Jen Jenkins, Market Analyst

In this article, Dr. Aaron E. Carroll, a professor of pediatrics at Indiana University School of Medicine, provides an anecdotal reference to something that is too often overlooked within the American health care system. Issues about the affordability of obtaining insurance and the quality of care are constantly highlighted and debated, but how care is actually delivered is an issue all on its own.

The Affordable Care Act was passed in an effort to ensure a significant decrease in the number of people who did not have insurance. Regardless of where you stand on the topic, the fact is that having insurance is only one access point within the American health care system. What happens after you have insurance? What is the process of receiving care actually like?

In the aforementioned article, Dr. Carroll describes his difficult journey with ulcerative colitis and the obstacle of every three months obtaining the only medicine that has ever worked for him. Just reading his account is frustrating and confusing. He ends this anecdote with wonder at how the majority of people, especially anyone suffering worse problems than his, could possibly manage the often dizzying twists and turns of correlating insurance protocols, with doctor’s visits, with lab testing, with pharmaceutical companies, and more.

Reform in the medical world is long, difficult road. The Affordable Care Act was  a vehicle to get more people health insurance and it is still being vehemently argued. Once that piece of the puzzle is solved in some capacity then maybe we can look further into reforming the actual system and access to the care that is delivered.

Malaria Control: A 21st Century Public Health Success Story

According to a report in the journal Nature, 663 million cases of malaria have been prevented in the past 15 years; that’s a drop of 60% over pre-2000 levels.

Since the year 2000, a concerted campaign against malaria has led to unprecedented levels of intervention coverage across sub-Saharan Africa.The bulk of malaria cases, 80%, occur in Africa, where even with this major progress, a child still dies from malaria once every minute.

About 2/3 of the reduction in cases is being attributed to the distribution of a billion insecticide-treated bed nets. The drug Artemisinin and the spraying of insecticides in homes account for the rest of the decline. Interestingly, the leaves of the tree Artemisia annua, from which Artemisinin is derived, have been used for treating malaria for over two thousand years.  The combination of methods in combating malaria is a vital part of the continued fight against the disease, given serious concerns on the development of drug-resistant parasites as expressed by the World Health Organization (WHO).

The executive director of UNICEF, Anthony Lake, noted: “We know how to prevent and treat malaria. Since we can do it, we must.”

 

The Cost of Medicine

by Jen Jenkins, Market Analyst

In most lines of business, the cost of goods and services is known down to the penny. Typically this information is essential in order to set prices and ensure the business is operating efficiently. In the world of medicine though, a field where everything else is succinctly measured, this is not the case.

A recent New York Times article delves into this topic using a question posed by Dr. Vivian Lee, Chief Executive of the University of Utah Health Care. Several years ago, Dr. Lee simply asked her team what the goods and services provided by the hospital system cost; no one had the answers. Due to this revelation, she initiated a project in order to get such answers, which presently are not only saving money but are also improving care.

The key element in this project at the University of Utah Health Care has been a fascinating computer program, which is continuously being developed. The program has 200 million rows of costs for nearly anything that can be thought of in the medical field as well as a way to track hospital stays and re-admissions, among other things.

The progress made here as far as determining costs of care was labeled by a Harvard economist as “epic.” In comparison, there are hardly any other medical institutions that have even a remote idea what their costs are. Fortunately as this is issue is glaringly brought to attention, more and more establishments in the medical field are following the lead of Dr. Lee and the University of Utah Health Care since there is now a tried and true way to solve what was previously labeled a serious problem.

The Physician Who Saved Countless Babies from Birth Defects

Dr. Frances Oldham Kelsey, who died last week at the age of 101, became a 20th-century North American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States  from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.

In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she was one of only seven full-time and four young part-time physicians reviewing drugs for the FDA. One of her first assignments there was to review an application for the drug thalidomide as a tranquilizer and painkiller for pregnant women for morning sickness. Even though it had already been approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested further studies. Despite pressure from thalidomide’s manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.

After  the story received press coverage in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation. Companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies. Read more about Dr. Kelsey…

Making (Common) Sense out of HIPAA

by Brian L. Grant MD

That HIPAA is misunderstood is an understatement. As this article in The New York Times describes, HIPAA is used as an excuse for absurd interpretations and ultimately a denial of rights to communicate by non-covered entities, a refusal to receive information from family members, churches who erroneously believe they can no longer share the fact that a congregant may be ailing, and other forms of nonsense.

If I had a quarter for every person who made declarative but incorrect statements about HIPAA, it would buy a lot of coffee, and some pastries to boot!

The goal of HIPAA is to maintain the privacy of medical information. But many questions remain. For example, why is unencrypted email apparently unacceptable but a fax is OK, though many senders or recipients of faxes send the faxed documents as Internet attachments? Is an email less secure than the US mail, which could result in a piece of paper lying on a desk in plain sight of the wrong people? I imagine that if the NSA or North Korea has an interest in the files of a medical practice, they may view them with minor effort. But does encrypting email actually solve a problem of files being compromised? The reality is that unencrypted email use is not prohibited. What is prohibited is accessing and reading such information by an individual or more who are not authorized. That raises the theoretical concern that people with time on their hands at Yahoo or Google are opening and viewing emails containing PHI (protected health information).

Protecting medical privacy is important and HIPAA is well-intended and to the degree it compels the profession to establish guidelines, training and evaluating of who and how one shares medical information, it is a good thing. But we have a ways to go to achieve clarity, reduce barriers to good care, and maintain compassion along with common sense.

Hepatitis C: Who Can Afford to Be Cured?

In October U.S. Food and Drug Administration approved a new pill, Harvoni, that can cure hepatitis C, which afflicts about 170 million people worldwide and annually kills 350,000 people.

The price on the new treatment will be a hard pill to swallow for most: $94,500 for a 12-week treatment course with Harvoni, manufactured by Gilead Sciences.

Hepatitis C is a chronic blood-borne infection that attacks the liver, eventually causing cirrhosis or liver cancer and leading to death if not treated. The US Centers of Disease Control and Prevention believes 3.2 million people in the United States could be infected.

Patients who receive these treatments almost never see the total cost, but their insurers do. More than two dozen state Medicaid programs for low-income patients, as well as for-profit insurers, have restricted coverage for the treatment to only those with severe liver damage. While researching the subject for this blog post, we found such distressing – and sadly accurate – soundbites as “The $84,000 Cure – Cheaper than a Liver Transplant.” Last July two members of the Senate Finance Committee, including Ron Wyden, Committee Chair, Democrat from Oregon, asked the manufacturer to defend the cost. They are not alone.

“Never before have drugs been priced so high to treat such a large population,” says Steve Miller, chief medical officer at Express Scripts, the country’s largest manager of drug benefits for employers and insurers. In December, Express Scripts announced it would reject coverage for one-pill-a-day Harvoni and instead steer patients to a less pricey rival drug that requires four to six pills a day.

Just how profitable are drugs like Harvoni and Sovaldi, a Hepatitis C medication released last year? In 2014 Sovaldi, also manufactured by Gilead,  generated $10.3 billion in sales, making it one of the most lucrative pharmaceutical launches ever. Harvoni sales totaled more than $2.1 billion in the last 3 months of the year. Gilead’s market capitalization has soared from $29 billion to $167 billion in five years. The net worth of its chief executive officer, John Martin, exceeds $1 billion. “For a long time we’ve had innovation after innovation,” Martin noted. For many patients, Gilead’s drugs are indeed miraculous. But is the U.S. health-care system paying too much for them? And with 170 million carriers worldwide, what will the impact of this transmittable disease be on governments and citizens with much less spending power?

Medicine is a Science, Medicine is an Art

by Jen Jenkins, MCN Market Analyst

An address first delivered in 1926 at Harvard Medical School, The Care of the Patient by Francis W. Peabody, MD explores a topic that seems to remain relevant in the practice of medicine today. Dr. Peabody (1881-1927) was renowned for setting himself apart from his colleagues throughout his career by treating each patient as a real person and not just according to their disease or disorder. The premise of this essay is the belief that “One of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.” 

As science and technology improved then, and continue to improve now, the practice of medicine puts a greater emphasis on the science and less on the actual care of patients. Students are exiting medical school with excellent knowledge where medicine is concerned but the actual practice of medicine has been somewhat neglected.  Dr. Peabody believed caring for patients is something learned over time, not necessarily in the 4 to 5 years it takes to complete medical school, but he also believed it to be the medical institution’s job to provide the foundation for this type of care. The pressure to effectively diagnose and treat often overlooks the necessity of conversation and the vital importance of creating a personal relationship with the patient. The fundamental sciences will always be imperative but intimately knowing a patient as a human being and not just as a sick individual is the practice of medicine in the broadest sense.

The diagnosis and treatment of disease is a very limited aspect of practicing medicine. A quote that stood out was “The art of medicine and the science of medicine are not antagonistic but supplementary to each other.” Oftentimes, it is not just the disease that needs treating but the individual who needs to be treated. This takes time, which more now than ever is a commodity difficult to obtain in most settings, and it also takes compassion and understanding. The practice of medicine is intensely personal and the more impersonal and clinical the profession becomes the further we stray from the main objective of it all – the actual care of the patient.

See the related 1984 commentary in the Journal of the American Medical Association (JAMA) on this article.