Archive for the ‘Health Research’ Category

You Can Always Ask: “Right to Try” Act of 2017

August 18, 2017

Out_of_dangerJust before the August recess, the U.S. Senate, in a rare show of unity, passed the FDA funding bill, which included the Trickett Wendler Right to Try Act of 2017.  The bill received little public attention, although versions of the law have passed in 37 states. It would require the federal government to facilitate terminally ill patients’s access to experimental agents. This access would be granted through bypassing the standard U.S. Food and Drug Administration (FDA) procedures and limiting the manufacturer’s liability. The experimental agents must have completed Phase 1 trials, which only prove safety. 

The Goldwater Institute, the patient advocacy group behind RTT (Right to Try), believes that bureaucratic procedures interfere with patients’ ability to access treatment. However, from 2010-2014, the FDA facilitated 5,995 requests for access to investigational therapies, with a 99.5% approval rate and a median turnaround time of 4 days. These statistics remained constant through 2016. A manufacturer’s refusal is the main reason patients don’t get access to drugs.


Stakeholders opposed to the RTT, including the American Society of Clinical Oncologists (ASCO), the Compassionate Use Advisory Committee (CompAC), Public Citizen and the FDA, maintain that the existing procedures work and that reducing regulation and adverse event reporting requirements is dangerous. Notably, the pharmaceutical industry has been noncommittal on this issue. 

The RTT Act fails to safeguard patient safety and attempts to weaken FDA oversight of drug development. Physicians and patients already have the right to ask through FDA regulated channels. RTT laws do not require drug manufacturers to provide their products to patients. Despite the liability limitations, manufacturers may still be worried about the risk of adverse effects that could jeopardize both public opinion and future approval of drugs. Providing patients with no other options access to potentially life-saving medications is imperative but passing this ill-conceived Act is reckless. 


Sugar-Sweetened Beverages’ Low Taxes in Maryland May Be a Poison for Children and Adults

March 12, 2017

Other group member: Mujan Varasteh Kia

In 2015, 30% of the people in Maryland were clinically obese. Sugar-Sweetened Beverages (SSB) is strongly associated with obesity which can lead to the number one leading cause of preventative deaths (1 in 4 deaths) due to heart disease, stroke, type 2 diabetes, and certain types of cancer, and can play a role in preterm delivery.

A constructive SSB taxation policy can help to reduce many of the obesity-related health problems and alleviate the amount of money spent to treat these cases long-term. The goal is that “increasing [the tax] will discourage individuals, especially children, and teenagers, from excessive consumption of these beverages.” Currently, Maryland imposes a 6% sale tax on SSBs. No significant reduction in obesity has been recognized as a result of this taxation. It has been argued that the sales tax is too little to prevent people from reducing their bad habits which urges the need for a more substantial taxation to reduce soda consumption. In a study, they found that participants would buy fewer SSBs with 20% tax and would completely eliminate their SSB consumption if 50-100% tax was implemented.

Shortly after Mexico passed soda tax law in 2013, there was an average 12% decline in soda sales and a 4% increase in bottled water purchases. The soda industries have argued that soda taxation is not going to “change the behaviors that lead to obesity,” and that the public will find their calories elsewhere. However, in the studies they referred to the taxes were too small or they were applied in the form of sales taxes that could have gone unnoticed by the consumers.

Philadelphia was the first big city in the nation to pass a soda taxation policy in 2016. Despite the approximate $5 million advertisements against this taxation by The American Beverage Association, a non-profit campaign was created with the help of the former New York City Mayor, Michael Bloomberg to support the soda taxation law. We also urge the Maryland state legislature to support and follow the same initiatives as those of Philadelphia mayor’s 1.5-cents-per-ounce levy on SSBs. These policies may not fully eliminate the obesity crisis, but even a small reduction in soda consumption will make a difference.


Image credit:



National Health Reform in Mexico

March 12, 2017

Photo credit: The Yucatan Times via google


In 2003, Mexico legalized a health reform policy that endorsed the introduction a health insurance mechanism called Seguro Popular de Salud (SPS).   SPS was designed to secure universal health coverage (UHC) for all citizens.

Dr. Julio Frenk, who was then the secretary of the health, led the team of reformers who drew upon years of accrued evidence to build support at the federal level through successful lobbying efforts and by sidelining opponents in the executive and legislature.  Their efforts proved successful at ensuring the program’s adoption into policy.

However, one issue of fragmentation in health services provision was not adequately addressed. Prior to the policy’s adoption, formal workers received services through either the Social Security Institute (IMSS) or the Institute for Social Security and Services for Civil Servants (ISSSTE).  Informal workers received health services under public assistance or from the private sector, with no financial protections. 

Frenk and his team pushed for a nationally integrated insurance scheme through the  Family Health Insurance Scheme (FHI) run by the IMSS that would be independent from a competitive market for services provision.  Threatened by Frenk’s competitive model , the IMSS and Ministry of Health providers resisted. So, rather than becoming a national insurance scheme, SPS was left to function as a subsidy service for the poor.

SPS has recorded notable successes in increasing coverage for mostly informal workers and for the poor. However, the program can ensure greater coverage and financial protection through risk sharing across the entire Mexican population. Additionally, the introduction of consumer choice through competition will ensure greater efficiency in service provision. To achieve these, the federal government must secure buy-in from the IMSS and MOH unions  to pass a nationally integrated insurance scheme that ensures a maximal pool and adequate competition among providers.


Emergency Funding for Zika Virus Response

August 19, 2016


On February 22nd, the Presidential office requested $1.9billion in emergency funding to support activities related to Zika virus, but these efforts have dangerously stalled in Congress. To date, nearly $600 million has been redirected by the Obama administration to fund Zika related research, front line response efforts, and vaccine development. More than half of this money was redirected from within the U.S. Department of Health and Human Services (DHHS).


Source: Healthcareit

On August 3rd, Sylvia Burwell, DHHS Secretary, informed Congress that due to the delay in approving the emergency funding, the DHHS had been forced to further reallocate up to $81 million from other programs, including the National Institutes of Health. This was extremely important because it could impact the progression of the vaccine studies currently underway, as Secretary Burwell suggested in her letter to Congress. Her letter also outlined the response by the CDC and predicted that they too would be out of Zika funding by the end of the fiscal year (Sept 2016).


Funding approval for Zika virus related activities from the U.S. is more urgent than ever. As of August 17th, the U.S. has confirmed 14 cases of locally acquired Zika virus disease – all from Florida. This was after the U.S. Centers for Disease Control (CDC) announced on August 2nd that an additional $16 million was awarded to 40 states and territories to support Zika related public health activities.

So what can you do? It is time we let our political leaders know that their constituency will not wait any longer. Follow Secretary Burwell’s lead – petition your local congressional representatives (House, Senate) and let them know this is an issue you care about. Or submit pre-formatted online petitions at Project Hope and AmeriCares. And spread the word and call to action amongst your peers.


Source: Project Hope


Use the Ballot Initiative Process To Pass a Soda Tax in California

August 19, 2016

Since 1990, adult obesity rates in California have increased nearly 250%. Over a similar period, type 2 diabetes and prediabetes rates have also risen steeply. Abundant research indicates that consumption of sweetened beverages contributes significantly to these and other public health problems. For example, the Nurses’ Health Study found that people who drank soda daily developed type 2 diabetes at almost twice the rate of people who did not.


Source: Daily Infographic

One tool to reduce sweet beverage consumption is to impose a tax on purchases of sugary drinks. A recent study found that Mexico’s soda tax reduced purchases of sugary beverages by as much as 17% in low-income households. A statewide soda tax could likewise help reduce Californians’ soda consumption. A statewide tax would be more effective than local regulation, because people cannot as easily evade a statewide tax by driving to another jurisdiction to buy groceries.  Further, proceeds from the tax could fund other statewide public health efforts and perhaps inspire similar measures in other states.

Unfortunately, the obstacles to legislative enactment of such a tax are formidable. Since 2009, the beverage industry  has spent more than $117 million nationwide to defeat proposed taxes. Statewide soda taxes have been introduced several times in the California legislature, but were defeated or withdrawn in the face of intense beverage industry lobbying.

For this reason, Public Health Advocates, the leading stakeholder supporting a soda tax in California, should launch a campaign to enact a soda tax via statewide ballot proposition, thus bypassing the legislature and taking the matter directly to the voters. A 2013 Field Poll found that 68 percent of Californians would support a soda tax if the proceeds were used to fund school nutrition and exercise programs.

A statewide ballot proposition would, of course, also face fierce soda industry opposition. But the recent success of a local soda tax initiative in Berkeley, California, which 75 percent of voters approved, provides a model for how advocacy groups can take on the beverage industry and win.

Berkeley Yes on D volunteers.jpg

Source: Bruce Azizuki, In Motion Magazine

The same grassroots organizing tactics that worked in Berkeley could help build statewide support for a soda tax – and enable California to become a public health pioneer.

Failure of Ethics or Well-Supported Medical Intervention? The Debate on Supervised Injection Sites in Ottawa, Ontario

August 19, 2016
Image obtained from, Johnathan Hayward/Canadian Press

Photo Credit: Johnathan Hayward/Canadian Press

Supervised injection sites have been the topic of fiery debates across Canada for over a decade- but now we are feeling the heat here in Ottawa. Former Conservative Health minister Tony Clement once famously referred to Vancouver’s Insite program as a “failure of ethical judgment.”  However, since the landmark Supreme Court ruling in 2011 to allow Insite to continue operating, citing its ability to save lives with no discernable negative public health impacts, discussions about creation of new supervised injection sites have cropped up in nearly every major Canadian city.

Several Ottawa Community Health Centers, including Sandy Hill, have put forth proposals for supervised injection sites. However, Ontario Health Minister Eric Hoskins has stated that he will not consider any proposals that have not first been vetted at a municipal level.  Although Ottawa Mayor Jim Watson has historically been against the facilities, a vote held by the Ottawa Board of Health in June 2016 was overwhelmingly in favor of safe injection sites, leading the Mayor to soften his stance on the issue slightly. However, several key public figures, including local law enforcement, remain opposed to the idea.

Photo credit: M-J Milloy, TML Daily Newspaper

Photo credit: M-J Milloy, TML Daily Newspaper

Scientific literature from Insite, as well as from 90 other cities around the world with supervised injection sites, is consistently demonstrative of the benefits of these centers. Safe injection sites reduce deaths related to overdose, reduce new transmission of blood-borne diseases such as HIV and Hepatitis C, reduce health care costs, and increase likelihood of addicts seeking definitive treatment for their addiction. There has been no evidence to support the idea that they increase crime or violence. These statistics should hit home for us in Ottawa, as the 2012 Toronto and Ottawa Supervised Consumption Assessment Study (TOSCA) demonstrated that Ottawa has one of the highest rates of HIV and Hepatitis C among IV drug users in Canada, and rates of opioid overdose continue to climb.

As the final City Council decision approaches, these coming weeks represent a critical time for the future of supervised injection sites in Ottawa. Safe injection sites save lives, and now is the time to loudly advocate on their behalf. In this situation, withholding a scientifically and economically sound intervention from those struggling with addiction would be the true failure of ethics.

The Fate of Frozen Embryos

August 19, 2016

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An estimated 600,000 to two million frozen embryos are stored at fertility clinics and cryopreservation facilities in the United States. Some are destined for implantation but many will remain frozen in perpetuity because no one is willing to decide their fate. Intense disagreement over when life begins entangles these embryos in a complex web of legal, ethical, moral and religious debate and results in decisional paralysis. In contrast to Australia and the United Kingdom, the U.S. has no state or federal policies to regulate management of unneeded frozen embryos and the pendulum of support swings from one extreme to the other. Fertility clinics have inconsistent practices and professional societies such as American Society of Reproductive Medicine (ASRM) and American College of Obstetricians and Gynecologists (ACOG) have produced only position statements. With approximately 60,000 babies born via IVF each year and 4-6 frozen embryos for each live birth, the quantity of frozen embryos in storage will grow exponentially if we continue to allow indecision to be the de facto policy.

Federal or state regulations to manage the large population of unneeded frozen embryos is unlikely because religious and right to life groups wield strong political and financial power in this contentious debate.  The onus is on ASRM and ACOG to develop and enforce a comprehensive policy requiring an advance directive prior to creation of any embryos.  The directive, completed by the couple, will determine the fate of the embryos – disposal, donation for stem cell research, or donation to another couple –  if they are not used within a 5 year period.  In addition, the directive must address contingencies such as divorce or death.  Accreditation of fertility clinics predicated on policy compliance will be the mechanism for enforcement.  Only a clear, firm stance will turn the tide from benign neglect to thoughtful action.






The Agony of Ecstasy: Amend the Illicit Drug Anti-proliferation Act

March 4, 2016

By refusing to amend the Illicit Drug Anti-Proliferation Act, Congress continues to stand in the way of harm-reduction services as the number of drug-related deaths continues to mount in the night life and music communities.

What is the Illicit Drug Anti-Proliferation Act?

In 2003, the Illicit Drug Anti-Proliferation Act (Read the full text here.) was passed by Congress in an effort to combat deaths due to ‘club’ drugs, such as MDMA. This act states that organizers of an event where controlled substances are suspected to be present can be charged with a felony for contributing to drug use, punishable by up to 20 years imprisonment, a fine of up to $500,000, and can have their venue seized by law enforcement.

What are the effects of this act?

This act has proven to be ineffective as stories of deaths at music events due to drug use continue to emerge. The Drug Abuse Warning network recently reported that national ED visits due to MDMA toxicity increased 120% between 2004 and 2011 while levels of MDMA use have remained relatively constant.

ecstasy graph

Past Month Ecstasy Use among People Aged 12 or Older, by Age Group: Percentages, 2002-2014. Figure produced by 2014 Drug Use report sponsored by HHS


One victim of this act was 19 year-old Shelly Goldsmith, a student at the University of Virginia, who died of dehydration and heatstroke after consuming MDMA at a rave in Washington D.C. Shelley collapsed while attempting to make her way through the hot, crowded venue to the bar to buy a bottle of water.  The current act discourages venues from distributing free water to prevent heat stroke or any other harm-reduction services, else they face federal prosecution for suspicion of contributing to drug use.


Shelley Goldsmith died at 19 years old from heatstroke after ingesting MDMA at an Electronic Dance Music concert where no free water was available, is seen here posing with Vice President Joe Biden, who authored the Anti Illicit Drug Proliferation Act

Advocates such as Shelley’s mother, Dede Goldsmith, have spoken to Congress on the importance of harm reduction and educating the public on safe drug use.  Senator Tim Kaine has recently announced that he intends to propose an amendment to current law which will allow venues to provide harm-reduction services without bearing the risk of legal consequences.

Unfortunately, the bill is unlikely to easily pass. Most members of Congress are nervous about appearing ‘soft’ on drug policies and will need to be shown that harm-reduction is the will of the people and that passing this amendment will save lives.

What can we do to show Congress how important this amendment is?

  • Sign the Petition! Send Congress a message that the American people want to stop the unnecessary deaths: Petition:
  • Donate! The organization, ATRA ( creates and distributes campaign materials to educate the public on the harms caused by this amendment
  • Speak out! By explaining the benefit of harm reduction, and the differences between harm-reduction and the promotion of drug use, you can help turn the tide of public opinion against using an abstinence only strategy to reduce drug related-deaths.


Roadblocks to medical marijuana research

August 13, 2015

TMedical-Cannabis-MarijuanaMinnesota was the most recent and 24th state to legalize medical marijuana. Medical marijuana has been used to reduce nausea, increase appetite, decrease pain, decrease inflammation and to help control muscle spasms. Unfortunately, unlike other medical drugs on the market, the studies on marijuana have been very limited. For example, there are only two cannabinoids currently being investigated for medical purposes: delta-9-tetrahydrocannabinol (THC) and cannabinoid (CBD). In reality, marijuana contains more than 100 cannabinoids. (Institute of Drug Abuse)

One reason for this lack of research is that marijuana is classified as a category I drug. This means, among other things, that marijuana has not been deemed beneficial in any medical setting and that no prescriptions may be written for it. (Drug Categories). Because of this categorization, there is much red tape to get through in order to secure funding for, get human subjects for and get clearing for research. Therefore, in reality, we are providing a drug to patients that we have little scientific data on its benefits and risks.

The first thing that needs to be done is have this category changed. Then, resources need to be committed so that large scale, quality research can be done on this particular drug. Only then can medical providers be certain that they are not doing their patients harm.

Public-Private Partnerships to Improve PTSD Care

August 13, 2015

More than 1.8 million U.S. troops have deployed to war zones since 2001. It is estimated that almost 20% of U.S. service members who have returned from Afghanistan and Iraq currently have PTSD or depression.

PTSD Chart.jpeg

Source: Congressional Research Service: A Guide to U.S. Military Casualty Statistics (2015)

Many affected service members return home to families who have little understanding of what the veteran experienced and even less for how the veteran will react to those experiences. Studies show that when trauma reactions are severe and lengthy they can cause major problems in a veteran’s family by negatively impacting attachment, communication, and intimacy.

Veterans can seek care for PTSD and other behavioral health issues through the VA (though many do not). However, their family members obtain healthcare services through the private market, where providers are often not well-versed on conditions affecting veterans and their families. There is limited communication between civilian and military health care systems to share knowledge and coordinate care across families.

I urge the VA to allocate funding to examine how it could collaborate with private organizations to help bridge the behavioral health care needs of veterans and their families. A recent RAND Corp. study outlined how this type of public-private partnership might be developed:

The challenge of helping veterans with behavioral health issues becomes even more significant when care is not connected across the family!