FDA Streamlining Access to Investigational Drugs

What happens when a person is suffering from a life-threatening illness, and the only hope is an untested, untried and experimental drug? For decades, the answer was that experimental drugs were unavailable in the United States unless you were a participant in a drug evaluation program.

Tragically, thousands of patients who have no options other than non-FDA approved, experimental drugs simply do not have the right or ability to have access to them.

Now, the FDA is looking into changing the process and allowing greater access to investigational drugs under certain limited circumstances. Peter Lurie, Acting Associate Commissioner for Policy and Planning, announced February 4th 2015 the use of a simplified draft form that should accelerate patient access to investigational drugs.

This draft document will be used by physicians who seek FDA permission to use of an experimental drug or biological product. The term of art for such request is “compassionate use” of experimental drugs. While the proposed documentation for seeking the requests has been streamlined, the criteria have not. To meet the standard for this compassionate use, the need for the drug must be one of “last resort.”

  • The disease must be serious or immediately life-threatening;
  • There must be no treatment available, or no approved treatments have helped for the disease;
  • The individual must not be eligible for clinical trials of the experimental/investigational drug;
  • The doctor agrees that the individual has no other options and may benefit from the experimental treatment;
  • The company that makes the drug must agree to provide it to the individual; and
  • The doctor feels that the individual is healthy enough to tolerate the medication.

Some states have made this process easier by passing laws that would allow terminally ill patients to access drugs that have not been approved by the government. This is known as the “Right to Try” bill. Arizona passed this in midterm elections in November 2014 and joined the ranks of Colorado, Missouri, Louisiana, and Michigan. February 3, 2015, House of Delegates in Virginia unanimously passed similar legislation. It is suggested another 25 states will soon follow in suit, passing their own, “Right to Try” legislation. The “Right to Try” laws do not eliminate the FDA’s regulatory authority. The state laws essentially say that patients and their doctors may seek to use drugs that have passed the FDA’s first phase of safety tests. Right-to-try laws allow patients and doctors to negotiate directly with drug companies for access to experimental drugs.

Ultimately, there is a real need for the FDA to police the drug manufacturers who have often had a strong financial incentive to push drugs to market, notwithstanding the severe side effects. Of course, when people are clinging to hope that an experimental drug can help them, there is a strong chance that they could be deceived into taking drugs that are costly and only create additional pain – as opposed to cures – for their terminal disease.

Hopefully, the FDA can find a real balance by providing access to experimental drugs that can save lives, while protecting our most vulnerable citizens from spending their life savings on “cure” that simply is not there.

Alexandra Bhatti, student intern Jacoby & Meyers.

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Using Januvia May Lead to Pancreatitis

An Ohio woman has filed a lawsuit against Merck & Co., Inc. (Merck), the manufacturer of the blockbuster drug Januvia. The lawsuit was brought on behalf of the plaintiff’s late spouse who was prescribed the drug as part of treatment for Type-2 diabetes. Nancy Fenter, the plaintiff, alleges that Januvia caused her late-husband (Ronald) to develop pancreatic cancer which proximately caused his untimely death. According to the complaint, Merck was negligent in the design, development, manufacturing, marketing, and distribution of Januvia. The case is currently pending in federal court.

Januvia (sitagliptin) is a medicine prescribed to control blood sugar levels for individuals diagnosed with Type-2 Diabetes, the most common form of the disease. Taken once a day in pill form, it works to lower blood sugar levels by increasing the levels of insulin the body produces and by decreasing the amount of sugar made in the liver. Effective management of diabetes also lowers the risk of heart disease and stroke, and is also prescribed to control high blood pressure.

Pointing to the findings published by the American Gastroenterological Association in February 2011, the complaint notes a correlation between pancreatitis and pancreatic cancer, and that Januvia usage causes a six-fold increase in the risk for pancreatitis.

Pancreatitis is an inflammation of the pancreas, a body organ that aids in food digestion by releasing enzymes into the small intestine and producing insulin to facilitate the absorption of glucose. Symptoms include upper abdominal pain, swollen and tender abdomen, nausea and vomiting, fever, and increased heart rate.

The complaint asserts that Merck knew of the risks of pancreatitis when using the drug, but sought to downplay the risks by attributing the risk to Type-2 diabetes alone. The complaint further alleges that the FDA ordered additional testing, but Merck failed to submit a final study report. This prompted a warning letter from the FDA stating effectively that Januvia is “considered misbranded” and that the company failed to show good cause of not conducting additional testing on the risks of using Januvia, specifically “a serious risk of acute pancreatitis.”

The Journal Sentinel and MedPage Today, a consumer watchdog group analyzed case reports from 2004 through March 2014. Strikingly, they found diabetes drugs were the primary suspects for about 3,300 deaths and 20,000 hospitalizations. They then examined 30 diabetes drugs approved by the FDA 2004-2013. Januvia was found to be among the top three most deadly diabetes drugs. In fact, out of the three drugs found to have the most complications from side effects, Januvia tallied the most deaths at 964 reported deaths.

Recently, Ann Falcone of Staten Island, New York filed suit against Merck & Co., Inc., claiming that she developed pancreatic cancer while using Januvia as one of the two drugs prescribed for treatment of her Type-2 diabetes. This case is the latest in a string of mounting cases surrounding the drug as more consumers become aware of the grave risks associated with Januvia.

If you have used Januvia and developed pancreatitis or pancreatic cancer, you may be entitled to compensation for your injuries. Call 800-977-5614 to speak to a Jacoby & Meyers attorney today.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.

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Talk of “Tort Reform” in The Air?

It seems that in every political election, one candidate talks about the need for “Tort Reform.” Sometimes, it is framed as a “us” against “them” issue. Others seek to blame the lawyers, blame the insurance companies, blame careless doctors or blame greedy and irresponsible corporations. However, the concept itself is rarely and never fully, explained.

This leaves us with the question: What is this talk of “Tort Reform” all about?

The best way to explain the concept is to break the phrase down into its respective parts.

What is a tort? Formally, a tort is a civil wrong which can be redressed by awarding damages. Torts are non-criminal, civil cases where an act, intentionally or otherwise caused an injury. This injury can be physical, mental and/or monetary. When this tort is committed, the injured party has the right to sue the wrongdoer for damages. Examples include medical malpractice, assault, negligence, workers compensation, and product liability.

Since torts cover varying types of civil actions, tort reform can be focused on one particular area of wrongdoing, or across-the-board attempts to limit the ability of people who are harmed to obtain full redress in the Courts. The tools that advocates of tort reform use include procedural limits on the ability to file claims and caps (or limits) on the damages that a plaintiff can recover in court.

For example, Florida places a cap on the amount of non-economic damages claimants may recover. Non-economic damages include things like pain & suffering, mental anguish, and, in general, anything you do not have a fixed bill for.

“If the negligence resulted in a permanent vegetative state or death, the total non-economic damages recoverable from all practitioners, regardless of the number of claimants, under this paragraph shall not exceed $1 million.”

While this cap exists, the Florida Supreme Court in March 2014 struck down this legislative cap in wrongful death cases, even though they had previously held it did not violate the Equal Protection Clause of the United States Constitution. Justice Pariente stated there was no “rational relationship” between the cap and any benefit to physicians or patients, and ultimately, “only the insurance companies benefit in the form of an increase in profits.”

Not all states have caps on damages in medical malpractice cases. States that do not are Alabama, Arizona, Arkansas, Connecticut, Delaware, District of Columbia, Iowa, Kentucky, Minnesota, New Hampshire, New York, Pennsylvania (however, punitive damages are capped), Rhode Island, Vermont, Washington, and Wyoming.

Proponents of tort reform claim that through tort reform, frivolous lawsuits will be reduced and consequently lead to reduction in insurance and healthcare costs. They claim that medical malpractice lawsuits are making it difficult for doctors to make a good living.

Opponents of tort reform claim that the “fear tactics” of the tort reform movement are not supported by the facts. In 2012, the Institute of Medicine of the National Academies reported that one-third of hospitalized patients are harmed during their stay. In the Institute’s landmark study on hospital patient safety, To Err is Human found that nationwide up to 98,000 patients die from medical errors per year.

According to the National Association of Insurance Commissioners, the total amount spent defending medical malpractice claims and compensating victims is $7.1 billion annually – just 0.3 percent of America’s $2.2 trillion in overall healthcare spending. Meanwhile, the real driver of healthcare costs are preventable medical errors, which are responsible for an additional – and unnecessary – cost of $29 billion annually. So, is this a battle of facts or just a powerplay by the medical community to reduce their financial responsibility for the malpractice caused by careless doctors? It is clear that this is a complicated issue; otherwise it would have been resolved long ago. Ultimately, your viewpoint on tort reform is likely to be shaped by whether or not you and/or someone you know have been affected by a serious medical error which resulted in a life altering condition or death. It seems that many people are for tort reform – until they are the victim of negligence.

It is important to stay educated and aware of “tort reform”, so you can better understand the ways it may affect you now and in the future.

At Jacoby & Meyers, we hope you never find yourself the victim of medical negligence, a car accident or any other preventable injury. However, if you are the victim of such negligence, please contact an experienced personal injury attorney affiliated with Jacoby & Meyers for a free case evaluation.

Alexandra Bhatti, student intern Jacoby & Meyers.

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Should The Choice Not To Vaccinate Be A Choice For Liability For Harm?

The recent outbreak of measles has brought the question of responsibility to vaccinate to the forefront of the issue. When parents choose not to vaccinate their child, should they be held liable if their child gets a preventable disease and passes it to others who get infected? There has been a strong response by leaders in the legal community who believe such liability is fair and makes sense.

Currently, all 50 states and U.S. territories, as well as the District of Columbia, have requirements for the MMR vaccination. Some states allow exemption for personal or religious beliefs. There are a large and growing number of individuals that adhere to a non-vaccination belief based on a multitude of reasons. The responses from this group to the possibility of liability for harm caused by non-vaccination have included, “if your child is vaccinated, why would my non-vaccinated child present a danger?” The answer to that question is “More than 95% of the people who receive a single dose of MMR will develop immunity to all 3 viruses. A second vaccine dose gives immunity to almost all of those who did not respond to the first dose.” That is not 100%.

The legal argument for criminal or civil liability is an interesting one and, of course, has two sides. In 2013, Arthur L. Caplan, et al., published an article in the Journal of Law, Medicine & Ethics proposing the basis for a claim of negligence for non-vaccination. The article reviews the necessary elements needed to establish a case for civil negligence. The elements include the need to establish that the person who caused the harm were required to conduct themselves in a manner that would not put others at risk (Have their child vaccinated). The person did not conform to the requirement (they did not have their child vaccinated). The non-conformity directly caused the harm (another child acquired the disease from their exposure to the non-vaccinated child). The non-conformity “proximately” caused the injury (the parent knew or should have known they were putting others at risk). The complaining party was harmed (cost of medical care, long-term disability or death).

On the other side of this legal debate, the non-vaccinating community believe that they should be immune from liability because of the various waivers that allow them to enroll their children in school or acquire an exemption from state vaccination requirements. Ultimately, this is an issue that the Court or State Legislatures will have to decide.

For example, the United States District Court For the Northern District of Ohio ruled in 2012 “that a parent’s refusal to vaccinate her children against diseases is not a “free exercise” of religion, and is tantamount to neglect.” The court went on to hold that, “although some states have chosen to provide a religious exemption from compulsory immunization, a state need not do so.” In Sherr v. Northport–East Northport Union Free Sch. Dist. (1987), a New York court stated that (“[I]t has been settled law for many years that claims of religious freedom must give way [to] the compelling interest of society in fighting … contagious diseases through mandatory inoculation programs.”).

This debate is not new, and the recent measles outbreak may see victims seeking recovery for harm caused by non-vaccinators. It is yet to be seen how the Courts will rule in this constantly evolving and emotionally charged issue.

Toni Zeller Kohlbeck, student intern-Jacoby & Meyers.

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E-Cigarettes Under Review by the FDA

Electronic Cigarettes (E-cigarettes) are battery-powered devices that turn liquid nicotine into a vapor that you inhale; many of these look like real cigarettes. For some smokers, electronic cigarettes may satisfy nicotine cravings. They can be used in nonsmoking areas and they may have less of the harmful chemicals that are in cigarette smoke. But they do contain small amounts of harmful chemicals.

There was a study published by British researchers indicated that the use of e-cigarettes could assist in smoking cessation. For those wishing to quit the harmful habit this was brilliant news. The study found that those who wanted to quit smoking were 60% more likely to succeed if they used an e-cigarette as opposed to the patch or gum. But is this traditional cigarette alternative actually being well received in the community? Is it actually lowering the number of people who smoke traditional cigarettes?

Research indicates that while this was thought to be a way to reduce smoking, it has had no significant effect on decreasing smoking rates. Additionally there are growing concerns on the safety of e-cigarettes as well as the possibility that the e-cigarette is actually a gateway to introduce nonsmokers to smoking.

For these reasons the organizations and groups such as American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects.

In April 2014, the FDA (Food and Drug Administration) proposed a “deeming rule”, which was basically a blueprint for a regulatory framework for e-cigarettes. This proposal includes provisions such as a ban on sale to minors and a requirement to disclose ingredients.

The FDA said it expects to publish a final rule in June 2015. The FDA said in a statement it needed “ample time to fully review and analyze these issues.” It said the subject involved “complicated rulemaking.” Meanwhile, U.S. e-cigarette sales topped $2.5 billion at retail last year and are expected to surpass $3.5 billion this year.

States have begun to propose regulations regarding e-cigarettes. Over 60 bills designed to rein in the “vape” industry are being considered in 21 state legislatures from Oregon to Virginia. Wednesday, January 28, 2015, California declared e-cigarettes a health threat and issued a 21-page report warning young people could become nicotine addicts if lawmakers don’t step in to regulate the fast-growing industry soon.

Ultimately, we must wait until June to see what the FDA decides but it is clear that while there are benefits to the use of e-cigarettes to assist in smoking cessation, there are growing concerns on whether the benefits outweigh the known and unknown risks of its use. The Centers for Disease Control and Prevention last year, reported that more than 250,000 youths who had never smoked a cigarette used e-cigarettes in 2013. This number reflects a three-fold increase, from about 79,000 in 2011, to more than 263,000 in 2013.

Alexandra Bhatti, student intern Jacoby & Meyers.

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Study Suggest Strong Links between Xanax Use and Alzheimer’s

Older adults who use Xanax or other benzodiazepines may be increasing their risk of developing Alzheimer’s, according to a recent study published in the British Medical Journal (BMJ). Alzheimer’s is a chronic neurodegenerative disease that is reportedly the most common cause of dementia. Taking into account the broad impact of dementia as “the main cause of dependency in older people and a major public health concern,” as well as the prevalence of use among elderly populations ranging “from 7% to 43%” in developed countries, the study explored the possible link between the use of benzodiazepines and developing Alzheimers. The findings of the study fall in line with a 2012 report by the same researchers which suggested a link between taking anti-anxiety medications from the same class of drugs and developing dementia.

Xanax (alprazolam) is a medication prescribed to treat anxiety disorders, panic disorders, and insomnia. It is a member of the benzodiazepines class of drugs which also includes Valium.

The study, which included 8,980 elderly people over the age of 66, focused on 1,796 people already diagnosed with Alzheimer’s over a six year period and compared them with 7,184 control subjects. The participants were selected randomly among older people living in Quebec, Canada who were also members of the public drug plan from January 1, 2000 to December 31, 2009. Data was collected from an administrative claims database for prescription and medical services records.

The study found that among those patients who had used benzodiazepines in the past, the risk of Alzheimer’s was increased by 43-51%. In addition, the findings suggested that the greater the use and also the use of more “long acting” benzodiazepines further increased the risk.

While the study does not conclusively rule out other possible contributing factors in developing Alzheimer’s, it does show a “dose-effect” relation between using drugs like Xanax and an increased risk in Alzheimer’s disease in older patients whose treatment last for more than three months. Based on the findings of the study the researchers conclude that in accord with already established guidelines, use of these drugs should not last more than three months. Nevertheless, as the study notes, these findings should raise public health concerns especially for older patients who use drugs like Xanax chronically or in large doses.

Zachary Mayberry, student intern Jacoby and Meyers.

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