Author Archives: Shruti Modi

Precision Medicine Is Coming

On January 20, 2015, in his State of the Union Address, President Obama launched a new Precision Medicine Initiative. This research initiative is a bold new effort to improve how we treat disease and how we cure diseases like cancer and diabetes. The Precision Medicine Initiative will pioneer a new model of patient-powered research that aims to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. Personalized medicine is often described as providing “the right patient with the right drug at the right dose at the right time.”

Currently, medical practitioners follow a trial-and-error approach when treating patients. In other words, if a patient has a disease, his or her doctor will prescribe a treatment plan based on general information, and re-assess after a few weeks. If the treatment is not working, the doctor will change some variable in the plan, and wait a few more weeks to see if there is any improvement. This approach can lead to patient dissatisfaction, adverse drug responses and interactions, and poor adherence to treatment regimens by the patient. While this may seem bleak, there have been rapid developments in a variety of medical fields like genomics, medical imaging, and computational biology that are making it possible for scientists and doctors to personalize diagnosis and treatment of diseases. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective. I believe the Precision Medicine Initiative is just what is needed to continue encouraging creative approaches to precision medicine and build the evidence base necessary to guide clinical practices.

The main objectives of this initiative are:

  • An increase in better cancer treatments: The National Cancer Institute (NCI) will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network,” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
  • Creation of a voluntary national research cohort: The National Institute of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the initiative and will have the opportunity to contribute diverse sources of data – including (but not limited to) medical records, profiles of patient genes, chemical makeup, and environmental and lifestyle data.
  • Commitment to protecting privacy: The White House will launch a multi-stakeholder process with Health and Human Services (HHS) and other Federal agencies to solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify and address any legal and technical issues related to the privacy and security of patient data.
  • Regulatory modernization: The Initiative will review the current regulatory landscape and work with the Food and Drug Administration (FDA) to determine whether changes are needed to support the development of this new research and care model.
  • Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort.

Key Investments to Launch the Precision Medicine Initiative:

  1. $130 million to NIH
  2. $70 million to NCI
  3. $10 million to FDA
  4. $5 million to The Office of the National Coordinator for Health Information Technology (ONC)

In sum, the Precision Medicine Initiative is a great endeavor and its greatest benefits will likely be seen many years in the future. However, this initiative will revolutionize the practice of medicine, and give patients a better chance at good health than they have ever had.

 

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Herbal Supplement Industry Under Fire

On February 3, the New York State Attorney General’s Office accused four major retailers of selling fraudulent and potentially dangerous herbal supplements, demanding that they cease the sale of these products. Law enforcement officials investigated herbal supplements sold at GNC, Target, Walgreens and Wal-Mart. The investigation found that four out of five products tested did not contain any of the herbs on their labels. The pills only contained cheap fillers like powdered rice, asparagus, and houseplants. In some cases, the supplements consisted of common allergens, such as wheat-products.

Health experts welcomed the investigation, having long complained about the quality and safety of dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) of 1994 exempts substances from the requirements to demonstrate safety and effectiveness and from the Food and Drug Administration’s (FDA) pre-market approval. In contrast, the European Union regulates dietary supplements and requires a demonstration of safety before they can be sold. On the other hand, the FDA strictly regulates pharmaceuticals. Under 21 U.S.C. § 355, a provision of the Federal Food, Drug, and Cosmetic Act, the FDA requires that new drugs demonstrate safety and effectiveness through scientific evidence before receiving market approval.

In the past, the FDA has issued warning letters to manufacturers of dangerous supplements requiring them to either change the recipe of their supplement or remove their product from the market. In the majority of these cases, the FDA has received several reports of adverse events from consumers. For example, in November 2014, the FDA issued a warning letter to V26 Slimming Coffee because it contained sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. Consumers may look at the FDA’s Consumer Updates web site for updates on recalls and alerts. However, this move by the New York State Attorney General’s Office is the first time a law enforcement agency has threatened the biggest retail and drugstore chains with legal action for selling “deliberately misleading herbal products.”

Some of the investigation’s findings at these retailers included:

  1. Walgreens: store brand of ginseng pills contained only powdered garlic and rice;
  2. Walmart: ginkgo biloba contained no ginkgo biloba, but radish, wheat, rice, and mustard;
  3. Target: six herbal products tested negative for the herbs on their labels but did contain powdered rice, beans, peas and wild carrots; and,
  4. GNC: pills contained unlisted ingredients used as fillers like powdered peanuts and soybeans.

Regulating supplements has been hotly debated in Congress. Senator Orrin Hatch (R-UT), the sponsor of DSHEA, has successfully opposed potential amendments that would require supplement makers to register their products with the FDA. In 2013, Senators Richard Blumenthal (D-CT) and Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act, which would require dietary supplement manufacturers to register their products with the FDA and to disclose known risks of any ingredients on their labels. However, this bill remains in the Committee on Health, Education, Labor, and Pensions (HELP).

Industry representatives dispute the testing methods used in the investigation, arguing that only a handful of fringe companies have caused these problems. However, New York’s investigations targeted store generic brands at national drugstores and retail giants, suggesting that these problems are pervasive and extensive. Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety, stated, “If this data is accurate, then it is an unbelievably devastating indictment of the industry.”

Currently, tests are being conducted to confirm the results of New York’s investigation. Until the results are released, the debate continues. Consumers should be wary that the supplements they are taking may not contain the ingredient listed on their labels. James Hamblin, a physician and senior editor at The Atlantic, notes that even if these supplements do not contain their listed ingredients, there may be a legitimate placebo effect to taking these supplements. However, it is better for the public to know what’s in their supplements, rather than letting this “apparent institutionalized fraud” continue. Consumers have a right to know what is in their products, what they are putting in their bodies, and what they are spending their money on. The Dietary Supplement Labeling Act is a commendable step in the right direction, and the Senate HELP Committee should move it forward.

 

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Iodine Tablets as Protection Against Thyroid Cancer – Good Idea or Not?

From October 27, 2014 to December 5, Switzerland is distributing iodine tablets to more than half the country’s population for use in the event of a nuclear disaster. (Bloomberg). People living with a 31-mile radius of a nuclear power plant will receive packages of 12 pills that will keep for 10 years. Officials note that most often, a single dose of iodine is enough. (National Post). Tablets will also be distributed to companies located less than 50 kilometers from a nuclear power plant.

There are two types of iodine: radioactive iodine, and non-radioactive iodine. (National Post). In the event of a major nuclear accident, radioactive iodine can be released into the air and inhaled. (National Post). It can also contaminate local food and the water supply. (National Post).The thyroid gland absorbs both stable and radioactive iodine and cannot determine the difference between the two. (National Post). Iodine tablets can protect the thyroid because when a person takes the iodine tablets, the thyroid becomes “full.” (National Post). Once the thyroid is full, it will be unable to absorb any more iodine for the next 24 hours. People will then be protected from absorbing radioactive iodine and the potential of thyroid cancer.

Why is the Swiss government doing this?

After the nuclear disaster in Fukushima, Japan in March 2011, the Japanese government distributed iodine to people living near nuclear power plants. In fact, pharmacies around the world faced a rush on iodine pills and many pharmacies ran out of stock. (National Post). This is reminiscent of the increase in thyroid cancer after the Chernobyl disaster. In 2006, on the anniversary of Chernobyl, UNICEF stated that iodine could have saved many children from thyroid cancer. (UNICEF).

The fear of a nuclear disaster has caused the Swiss government to become skeptical of nuclear energy. (Bloomberg). According to the Swiss Federal Office for Energy, nuclear power plants produced 36 percent of Switzerland’s electricity last year. (Bloomberg). In May 2011, Switzerland announced plans to phase out atomic power by 2034 and the iodine pills are a protective measure until they are able to do so.

Supporters

Supporters of this move state that the tablets will protect infants and children under the age of 18, as they are the most vulnerable to harmful effects of radioactive iodine. In 2006, on the 20th anniversary of Chernobyl, a Regional Director of UNICEF, Maria Calivis stated that for about 4,000 children, iodized salt could have made all the difference in sparing children from thyroid cancer. (UNICEF).

With more research, it has been found that while iodized salt contains enough iodine to maintain a healthy thyroid, it does not contain enough to block radioactive iodine from being absorbed. (National Post). Therefore, iodine tablets will be most protective if there is a nuclear disaster. (National Post).

The Swiss are not alone in pre-distributing iodine tablets. According to a 2010 report by the European Commission, Finland, France, Germany, Lithuania, the Netherlands, Romania, Sweden, and the United Kingdom are all pursuing similar actions to distribute iodine tablets. (European Report).

Critics

David Brenner, professor of radiation biophysics at Columbia University stated “There’s a concern that this will be seen as a universal panacea to protect you from all types of radiation exposure.” (Bloomberg). He did note however, that the tablets would best serve children, rather than adults.

The operators of Switzerland’s five nuclear power plants, who are paying for these tablets to be distributed, believe the move could be counter-productive. (Bloomberg). They say that people receiving these pills are becoming unsettled, and that the older system of keeping pills in central storage sites was more effective. (Bloomberg).

The nuclear expert at Greenpeace, Florian Kasser, states that iodine tablets do not do anything to help other risks, like cesium. (Bloomberg). He states that the best protection for the population is to shut down the reactors altogether. (Bloomberg).

Conclusion

The Swiss government has learned from Chernobyl and Fukushima and has taken a protective measure while they work to phase out atomic power. This is a commendable and proactive undertaking. However, there are both benefits and risks to iodine tablets, and people who take them should do their research and listen to the advice of public health or emergency management officials.

(The Center for Disease Control offers more information on stable iodine: http://www.bt.cdc.gov/radiation/ki.asp.)

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To Translate or Not? A Look at Pharmacy Labels and Language

In California, there is a debate over the translation of medicine labels. Currently, 44 percent of Californians speak a language other than English at home. Most medicine labels in California are printed in English, which places patients who do not understand written English in danger of taking their medications incorrectly. (NPR) This can be very dangerous and can cause serious harm.

Currently, California’s Board of Pharmacy’s website includes translations of basic instructions (such as “take one pill at bedtime”) in Chinese, Korean, Russian, Spanish, and Vietnamese. (Board) According to members of the California Board of Pharmacy and the California Pharmacist’s Association, however, these translations are not regularly used. (NPR) Perhaps this is a contributing factor to the California Board of Pharmacy’s reluctance to spend time and money translating medicine labels.

In August, California’s Board of Pharmacy discussed new regulations that would require all pharmacies to provide translated labels on prescription drug bottles. New York approved a similar rule last year. (NY) Though it would seem that such a rule would have only positive effects, some stakeholders have serious concerns. (Pharmacy)

One concern is that pharmacists who don’t speak multiple languages could face liability. If there is a mistake in a translation that pharmacists are unable to catch, pharmacists may be dis-incentivized from using translated labels. (AARP) Another concern is that the potential for translation errors could also lead to a need for higher malpractice insurance, which would eventually lead to higher costs for consumers. NPR.

California’s Board of Pharmacy raised a concern over the size of prescription drug bottles. (NPR) Translated labels would require larger bottles of pills, which patients do not like. This would lead to patients pouring their medication in a bag or putting their pills in a pocket and dumping the bottle. (NPR) Dumping a prescription medication bottle in the trash can have a whole host of problems. For example, patients may realize they actually do want the instructions on their bottle and can’t get it back, or someone could fill the bottle with another pill and sell that for quick cash.

The risk to limited English-speakers of improperly taking medicine, translation supporters argue, is greater than any liability that could result from translating labels. (KevinMD) Sarah de Guia, director of Government Affairs for the California Pan Ethnic Health Network, argues that because of expanded insurance coverage through the Affordable Care Act, the government would want to have more rather than fewer instructions available to the public. (NPR)

Considering other perspectives, such as those of patients, doctors, and insurance companies, it seems that having translations of medicine labels is in the best interests of everyone. While pharmacists may be worried about liability, if their patients do not ever have directions that they understand, then they are just as likely, or even more so, to use their medications incorrectly as they would be with a problematic translation. Having translations of medicine labels could actually lower the risk of liability that pharmacists face, rather than raising it because the chances of a patient using their medication incorrectly is lessened.

What are possible solutions? (1) Labels could be folded around bottles, keeping bottles the same size. (2) Pharmacists could print out the translated labels and hand those to the patient separately or place the printouts in a bag or folder. (3) The California Board of Pharmacy could expand the translations available on their website to more than basic instructions and include more languages. This would need to be complemented with some sort of advertising strategy that encourages more use of their website. (4) The technology industry, researchers, physicians, pharmacists, and policymakers could collaborate to develop initiatives that best address the language barriers that contribute to disparities in healthcare. (Pediatrics)

While translating labels may cost more money and require more work for the California Board of Pharmacy, it is likely that these costs will be saved in the long run if patients are using their medications safely and properly. There will always be risks and potential for something to go wrong, and the fear of badly translated labels is a legitimate one. Nevertheless, the current concerns appear to outweigh the concerns of badly translated labels.

 

 

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