Category: Blog

On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines on prescribing opioid painkillers that were aimed at primary care physicians. These guidelines were a response to the opioid epidemic that has resulted in opioid abuse, overdose, and death. Primary care physicians prescribe nearly half of the opioid painkillers consumed in the United States. These guidelines are not intended for physicians treating cancer patients or for end-of-life care. These guidelines come after several other attempts in recent years to curb the epidemic. In 2014, the Drug Enforcement Agency re-classified some controlled substances from Schedule 3 to the more restrictive Schedule 2. The Obama administration also stepped up general spending on treatment and prevention programs in response.

At the center of the guidelines is the recommendation that non-opioid therapy be the first line of treatment for chronic pain and that opioids only be prescribed when their benefits for pain and function outweigh the risks.

These guidelines have sparked a fierce debate. Some pain specialists and patient advocates have remarked that these guidelines could deny patients pain relief. The line between drug-addicted patients who do not truly need relief and legitimate patients is blurry and difficult to identify.

As the number of deaths from opioids has increased, state and federal agencies have implemented a variety of solutions in attempts to curb these deaths. Some states, like Nebraska, have mandated limits of opioid medications that patients may be prescribed per year. Other states have instituted “pain management contracts,” where patients must agree to random drug testing before receiving an opioid prescription. And many medical associations now offer doctors training in opioids and chronic pain, encouraging them to first try alternative remedies like physical therapy, acupuncture, anti-inflammatories, antidepressants, and counseling. While these other options can work, they don’t always work for some patients who legitimately have an immense amount of pain. These other options can also be much costlier than opioid medications, and not all insurance programs cover all of these remedies.

Critics of the CDC guidelines have argued that the guidelines are not based in strong evidence. However, Dr. Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, counters that evidence for the benefits of opioid medications is also lacking.

While the guidelines are not perfect, they play an important role in the debate around opioid therapy, and finding the line between drug-addicted patients and legitimate ones who need relief.

For years, researchers, survivors, and various interest organizations, have tirelessly sought to develop or fund cutting edge treatment protocols that would help increase survival rates for blood cancers and eventually lead to a much-desired cure.

According to the Leukemia and Lymphoma Society, there are currently 327,520 people in the United States are living with or are in remission from leukemia. Generally, achieving remission has more than quadrupled since the 1960s. The “overall relative survival rate” for all blood cancers was 60.3 percent between 2004 and 2010. More specifically, patients with Chronic Lymphocytic Leukemia (CLL) have a survival rate of 85.3 percent, the highest overall survival rate within the leukemia category; Acute Lymphoblastic Leukemia (ALL) has the highest survival rate for children at about 92 percent, but an overall survival rate of 70 percent. Acute Myeloid Leukemia (AML) has the lowest for adults at 25.4 percent. AML in children under 15 years old has a 66.3 percent survival rate.

In February, researchers from Boston University published a report with promising findings about an innovative treatment for patients with blood cancers. Dr. Hui Feng and her team, Dr. Nicole M. Anderson, Dr. Dun Li, and Dr. Fabrice Laroche, suggest that T-cell leukemia cells can support its growth and survival, leading to more patients achieving remission.

The Boston University team worked with 35 terminally ill leukemia patients, and 94 percent successfully went into remission utilizing genetically modified T-cells. The study suggests that the T-cell therapy has the greatest success with blood cancers, however, oncologists and researches are hopeful that similar results can be achieved with tumors.

Similar trials have been conducted in the United Kingdom, Italy and throughout the United States with great success. How do the oncologists and researchers perform the T-cell process that seems to be drastically changing therapy options for blood cancer patients? In the simplest terms, T-cells are removed from the patient’s body, genetically modified, and the modified T-cells are transfused back into the patient. The study suggests that the CARS (Chimeric Antigen Receptor) molecules “reduce the ability of the cancer to shield itself from the patient’s immune system, allowing the T-cells to attack the cancer.” Given the nature of blood cancers, a treatment that is able to weaken a cancer cell’s ability to fight the immune system is groundbreaking.

Other than the Boston University team, US San Diego announced that it is conducting three T-cell like trials: ZUMA-1, ZUMMA-2 and ZUMMA-3. With several research institutions conducting trials and furthering the research on this groundbreaking protocol, T-cell therapy could provide alternatives to aggressive and toxic therapies that, albeit, stops the cancer cells from rapidly expanding, also kill good cells as well. The Federal government, via the United States Food and Drug Administration (FDA) appears to be supportive of T-cell related trials. In 2014, the FDA granted Breakthrough Therapy status to an Investigation New Drug (IND) application submitted by University of Pennsylvania’s Perelman School of Medicine, focused on T-cell therapy treatments in ALL patients.

While researchers and oncologists posit that T-cell therapy is ground breaking and “extraordinary”, patients and families are also thrilled that a new treatment could potentially become widely available, particularly those patients that have tried traditional treatments and failed to achieve remission.

In early February, the Seattle Times reported on the case of David Morton, the face of a class-action lawsuit against private insurers Group Health and BridgeSpan Insurance.  In the case, Morton and others allege that the Washington state private insurers failed to pay for a new drug called Harvoni.  This drug not only treated Hepatitis C, but has the ability to cure it.  Group Bridgespan has already updated its policy to allow coverage of all Hepatitis C patients, while Group Health has expanded to coverage of those with lower levels of liver damage.

The insurance companies were limiting use of the drug, which costs more than $1,000 per pill or $95,000 for a 12-week course, to only those with a more “severe” infection.  Therefore, the class alleged that the decision by the insurance company was a cost-based one, not one of medical necessity.  This was further evidenced by the fact that other insurers in the state did cover the drug.

It is not only private insurers who are rationing the drug, but the Washington state Medicaid program (among others) which limits the use of the drug to people with the most severe fibrosis, or liver scarring.  This is despite the fact that the American Association for the Study of Liver Diseases (AASLD) espoused the benefits of the drug for all those with Hepatitis C.  This was a reversal of their previous recommendation which prioritized use of the drug with those of “greatest need” based on level of liver disease, due to the cost and availability of the drug.  The new recommendations from the AASLD have even been accepted by the Washington Insurance Commissioner, who is encouraging insurers to follow the guidelines as it considers what the standard of care should be.

However, not everyone is convinced of the drug’s effectiveness.  A report from the Center for Evidence-based Policy released in May 2014 evaluated the effectiveness of sofosbuvir, which is the active component in both Harvoni and another Hepatitis C drug called Sovaldi.  They noted that despite the claims of curing Hepatitis C, relapse is possible in patients who received a full treatment regimen.  Some figures suggest anywhere from a 5 to 28 percent relapse rate.

Two weeks after the case against the private insurance companies was filed, another case was filed, this time against the Health Care Authority (HCA), Washington State’s Medicaid provider.  Just as in the case against the private insurers, this one is alleging that cost – not medical necessity – is the determining factor in hepatitis drug coverage.  The Washington Medicaid Director, in a September letter to the U.S. Senate, estimated that it would cost $242 million just to cover the high risk patients.  If that coverage expanded to all Hepatitis C patients, it would balloon to $3 billion.

This issue has expanded well beyond Washington State.  All states across the country vary in coverage for the drug.  For example, Michigan has just decided to cover the drugs under its Medicaid programs while New York has decided to investigate the practices of its private insurers, and New Mexico begins to contemplate the financial effects of covering the medicine.  Even as far away as India, there are challenges to the patent itself in hopes of opening up more access to the drug.

On March 2, the Supreme Court of the United States heard oral arguments in the most significant case about abortion in decades: Whole Woman’s Health v. Hellerstedt. The outcome of this case has the potential to affect millions of women and revise the constitutional principles governing abortion rights.

Taking a look back at legislative history, in 1992 the Supreme Court affirmed the landmark abortion-related case, Roe v. Wade (1973), in Planned Parenthood v. Casey. The Court in Casey struck down abortion restrictions that imposed an “undue burden” on women. Restrictions included “unnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion.” Since the Casey decision, there have been many challenges to laws testing just what “undue burden” means.

At issue now in the Whole Woman’s Health case is a controversial Texas law, HB-2, which will dramatically change the way Texas women can access reproductive health care. The law, authored by pro-life activist Jodie Laubenberg (R-TX), requires abortion care providers to have admitting privileges at a hospital within 30 miles, and requires that abortion clinics comply with standards for ambulatory surgical centers (ASCs). Many clinics rely on physicians who are unable to obtain privileges at local hospitals for reasons unassociated with the quality of the doctor’s care. For example, some clinics are surrounded by religiously affiliated hospitals that deny abortion providers admitting privileges based on pro-life beliefs. This law was said to protect women’s health and safety, though some, such as the American Medical Association and the American College of Obstetricians and Gynecologists, find that the regulations put in place are medically unnecessary and burdensome. For example, the ASC requirement regarding the size of a janitor’s closet does not directly affect women’s health and safety. This law, known as a “TRAP” (Targeted Regulation of Abortion Providers) law, is designed to shut down more than 75 percent of all women’s health clinics that provide abortion services in the state. Additionally, it also impacts women seeking abortion care through higher costs, lengthier delays, and extra steps, such as traveling hundreds of miles, for women seeking abortion care. 

The petitioners in Whole Woman’s Health, a group of abortion providers represented by the Center for Reproductive Rights, filed a lawsuit in 2014 challenging the requirements for admitting privileges and the ambulatory surgical center standards. They said that the regulatory burdens imposed by these laws will dramatically reduce the number and geographic distribution of medical facilities in Texas where women would be able to access a safe abortion. They argued that this creates an undue burden on women’s right to access, which violates the 14th Amendment to the U.S. Constitution.

The federal district court granted declaratory and injunctive relief of the measures, finding both requirements in violation of the 14th Amendment. The U.S. Court of Appeals for the Fifth Circuit, however, partially reversed the injunctions because the plaintiffs failed to show that they placed a substantial burden in the path of a woman seeking an abortion.

Since Justice Scalia’s untimely death, all eyes are on Justice Kennedy, who some say would likely be the possible swing vote in this case. Should the Court rule 4-4, the Fifth’s Circuit decision will remain in place. This would mean that the Texas law will stay in effect and for many women, their decision to exercise their constitutional right to end a pregnancy will be severely hindered.

See that cigarette butt on the street? Tobacco manufacturers could be cleaning up after their own cigarette litter in California under a model ordinance proposed by ChangeLab Solutions of Oakland, California.

The model ordinance is designed to help local counties and cities curb tobacco litter in their communities. Under the model ordinance, producers of filtered tobacco products, including cigarettes, are prohibited from selling their products unless they agree to one of the following two choices: 1) participate in a tobacco disposal program or 2) pay an annual in-lieu fee. Depending on which entity has the most control over the sale of tobacco in a respective community, “producers” can be defined to encompass manufacturers, importers, distributors, wholesalers and/or retailers.

Changelab Solutions released the model ordinance earlier this February 2016. The document spans twenty-two pages, and at its heart is the idea that tobacco producers can be incentivized to create a tobacco litter waste program. The model ordinance encourages counties and cities to set their own parameters for the litter program. One potential model would be a litter clean-up system jointly operated by a group of producers, and the producers could hire a third-party waste management company to conduct the actual waste control. The scope of the waste management could be as simple as situating ash trays or ash cans throughout the city. It may also be more extensive by providing a collection service of tobacco waste from residential areas, commercial areas, and public spaces. The model ordinance also requires participants to prepare an annual report summarizing the impact of the program.

Producers that decide against participating in the litter program can instead pay an optional in-lieu fee, which is collected annually to cover the reasonable costs of tobacco waste mitigation. Under the model ordinance, the in-lieu fee is calculated to reflect the amount of filtered tobacco products that are sold by the non-participating tobacco producer.

The model ordinance is the first of its kind in the country. Although intriguing, the ordinance rests upon interests that may not be as immediately compelling. The fight against tobacco litter may be subsumed in favor of other battles against the tobacco industry, such as federal cigarette taxes to mitigate overall smoking rates. That, compounded with the influential tobacco lobby, would likely stymie the momentum that the tobacco waste model ordinance would gain from the early stages of its adoption.

A press release from the Centers for Disease Control and Prevention (CDC), a federal agency under the Department of Health and Human Services, is making national headlines for all of the wrong reasons.  The release, entitled “More than 3 million US women at risk for alcohol-exposed pregnancy,” appeared to have the best of intentions – proposing a number of best practices to help women prevent fetal alcohol spectrum disorders (FASDs) in their potential pregnancies.  In particular, the report notes that “Sexually active women who stop using birth control should stop drinking alcohol,” due to the fact that drinking while unknowingly pregnant can cause damage to the fetus.  However, many women viewed the report as insulting and another instance of the federal government having too much to say about women’s health choices.

The report starts by defining their at-risk population (which numbers 3.3 million) as women between 15 and 44 years old engaging in three practices: drinking, being sexually active, and not using birth control to prevent pregnancy. The report is not specifically about women who are actively trying to have a child, though the report notes that 3 of 4 women actively trying to have children also continue drinking.  The report is more about women who may become accidentally pregnant, and thus would unknowingly expose a fetus to alcohol.  From here, a number of contentions arise.

One contention is that the CDC is suggesting complete abstention from alcohol while the effects of limited drinking on fetuses is not a settled debate.  One response notes that it would be very difficult to do a study on the effects of alcohol on pregnancy because it would be unethical to conduct a double-blind experiment on pregnant women.  Furthermore, when limited studies have been done, there has been no link found between one to two drinks a week and fetal issues. Therefore, the recommendation of full abstention comes off as a pretense to otherwise try to control women’s behavior.

Another contention is that among the risks of alcohol consumption listed, the CDC included “injuries/violence” and “sexually transmitted disease.” As another response notes, there is a missing step in logic when one suggests alcohol consumption leads to violence and STDs. To say that puts all the onus on the woman for leaving herself open to such abuse, and not on those who would take advantage of someone who had been drinking.  There is no similar claim that men should also abstain from alcohol, whether actively using birth control or not.

Both responses recognize the ultimate goal of the report was noble – prevent FASDs. Furthermore, the report was lauded by some including the American College of Obstetricians and Gynecologists for its message of preventing FASDs. But by reducing women down to nothing but potential child-bearers, and saying nothing of the role men play in unwanted pregnancies or violence and STD spread, the CDCs ultimate point was lost on many.