Tag Archives: HHS

2018: A MedShadow and FDA Year in Review

When the end of the year comes, many use it as a time of reflection. I am no different. I’d like to use my blog this week to reflect on some of the accomplishments MedShadow has achieved in 2018, as well as some observations about the FDA this year.

MedShadow’s Top 3 Achievements of 2018

1. The first thing to highlight about 2018 is that it was another year of growth in terms of people visiting the site and reading our content. We already have more than 1.3 million site visitors year-to-date, and we hope to make it to 1.4 million by Dec. 31. As far as content, we added the bi-weekly “Ask the Pharmacist” column from Dave Walker, who also happens to be on our MedShadow Medical Advisory Board. Also, this column, originally called FDA Watch, became known as Health Pulse and instead of running every other week, comes out weekly.

2. MedShadow also held its first-ever public event in November, Raising Awareness About the Side Effects of Medicines. It brought together patients, patient advocates, healthcare workers and political leaders to listen to medical professionals. The purpose was to improve efforts to inform the public about medications to improve their health care, as well as increase MedShadow’s exposure.

3. Last month, MedShadow filed an amicus curiae (“friend of the court”) brief in a US Supreme Court case, Merck v. Albrecht. The case involves the osteoporosis drug Fosamax (alendronate) and women who say their spontaneous fractures of the thigh bones were caused by the drug. At issue is how Merck dealt with updating the label of Fosamax when it became aware of the issue. Yesterday, Suzanne Robotti, MedShadow’s founder and executive director, had an op-ed piece published in STAT, one of the most well-respected health and medical websites that is followed by many in the pharmaceutical industry, about the case. The decision could impact how patients are able to hold drug companies accountable when they are harmed by a drug and seek damages in court.

Top 3 FDA Actions – and Inactions — of 2018

1. The FDA’s biggest offensive this year came in its assault on e-cigarettes amid growing numbers of young people using the devices. Between 2017 and 2018, the number of high school students using e-cigs increased by 78% from 2.1 million to about 3.6 million. Last month, the agency proposed new restrictions on the sale of flavored e-cigs, which are especially appealing to teens. In September, the FDA ordered the 5 biggest e-cig manufacturers to develop plans to curb use of their devices by teens. Earlier this year, the FDA conducted a surprise inspection of the offices of JUUL Labs, the nation’s largest e-cig manufacturer, seizing more than 1,000 documents.

2. Another product that found itself in the FDA’s crosshairs was kratom. The herb has a loyal following among many Americans who use it for its reported pain-relieving properties, as an alternative to opioids, to deal with the effects of opioid-use withdrawal, and even depression and anxiety. The FDA has issued several warnings on kratom this year. In February, the agency warned kratom has opioid-like qualities and can be potentially addictive. Earlier in the year, the agency issued several warnings about kratom products tainted with salmonella. Last month, the FDA said it found high levels of heavy metals in kratom samples it had tested. The FDA has linked at least 44 death to kratom, though kratom supporters say that is misleading as in nearly all those cases, the kratom was either adulterated with other substances or other potent drugs were found in the person’s system. The Drug Enforcement Agency may essentially ban kratom by making it a Schedule 1 substance – the same as heroin, LSD and marijuana – after the Department of Health and Human Services made the recommendation.

3. One area where the FDA could have – and should have – done more is to tighten regulation of the supplement industry. We have reported on many occasions about supplements being recalled for one reason or another. While drugs are also sometimes recalled, supplements do not have to conduct clinical trials to prove they actually say what they do in order to make it onto the market. Americans spend more than $40 billion a year on supplements, and in many, many cases, they are using products that are likely useless, and potentially harmful. It’s time for the FDA to require more rigorous testing of these products so that the claims on their labels are actually backed by scientific evidence.

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How Patients Could Be Harmed If Kratom is Banned

A long-simmering battle between the FDA, DEA and patient advocates over the popular, yet controversial, herbal supplement kratom may soon be coming to a head. A recent STAT report indicates that the Department of Health and Human Services (HHS) has pressured the DEA to ban the supplement, used by millions as an alternative to opioids for pain and opioid withdrawal, among other ailments.

In a November 2017 letter reecently made available thanks to a STAT Freedom of Information Act request, HHS is recommending to the DEA that mitragynine and 7-hydroxymitragynine, two active compounds in kratom, should be classified as Schedule 1 substances, meaning they have “no currently accepted medical use” and a “high potential for abuse.” That would put kratom in the same group as heroin, LSD and marijuana. [Yes, despite marijuana being legal for recreational and medical use in many states, the feds still consider possession illegal.]

The FDA has not held back in its opposition to kratom, and has frequently posted on what it considers dangers associated with it. Just last week, it said it had found unsafe levels of heavy metals in some samples it had examined. And earlier this year, the FDA said there were salmonella outbreaks linked to kratom products. Note that these issues are really ones surrounding kratom’s manufacture – the presence of heavy metals and the salmonella outbreak – rather than with the drug itself.

Is Kratom Really As Dangerous As the FDA Claims?

The agency has also linked 44 deaths to kratom use. However, as a Huffington Post article points out, most of the 44 victims were found to have other substances in their body at the time of death, including illegal drugs that have deadly risks of their own. One was even shot before their death and another fell out a window.

The FDA has also said kratom has opioid-like qualities and is concerned that it could potentially be addictive. Mitragynine, one of the kratom compounds, does partially active a receptor in the brain that is also activated by other opioids like heroin, but kratom “seems to be much safer in the way it activates that receptor, so it avoids side effects like respiratory depression,” Columbia University researcher chemist Andrew Kreugel told the Huffington Post. He added that in 2014, there were 28,000 deaths from opioids (both legal and illicit) from respiratory depression compared to just one death potentially related to kratom.

If the DEA were to ban kratom anytime soon, the results would have a serious impact on patients – and not necessarily in a positive fashion.

Ban Would Make Studying Kratom More Difficult

Scheduling a drug as a Schedule 1 substance means it will make it far more difficult to determine the medicinal benefits of kratom. Why? Researchers need to get special permission from the DEA to study Schedule 1 substances, and that requires a ton of paperwork, special security and bureaucracy. It’s why there is relatively little research being conducted on the therapeutic benefits of marijuana.

The second is that banning kratom doesn’t mean that people will stop using it. It will simply create a black market where kratom product quality will get poorer and the potential for dangerous substances being added will increase. Even worse, people who have sought kratom as an alternative to opioid medication and have found success with it will likely return to prescription and illicit opioids — and the dangers inherent in those.

Could New Regulations Avoid Scheduling?

The FDA has not done due diligence in listening to groups that support kratom and scheduling meetings they have requested. Perhaps that’s why last week, the American Kratom Association, a leading kratom advocacy group, sent a letter to the heads of the DEA, FDA, HHS and National Institute on Drug Abuse (NIDA) asking to reconsider the Schedule 1 recommendation. It was signed by 12 scientists that have researched kratom.

The letter makes plenty of legitimate, fair arguments. In coming to its assessment on kratom, the scientists argue that the FDA neglected to include input from NIDA or kratom researchers. They want the DEA, along with NIDA, to examine the FDA’s abuse potential claim, as well as propose other regulatory alternatives to avoid scheduling kratom.

The letter also asks the FDA to work with industry groups to develop regulations on manufacturing kratom products. The American Kratom Association says it already has a good manufacturing practices program.

The FDA and DEA owe it to patients who are benefitting from kratom to address the issues laid out in the letter. While federal agencies like the FDA and the DEA have a responsibility in protecting the public, they should not make decisions zealously and without a complete assessment of all the facts. With kratom, a rush to move it to a Schedule 1 drug could lead to serious consequences for patients.

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Trump Administration Censoring Women’s Health Info on Government Sites

Without much fanfare, valuable health information is being scrubbed from government websites.

Haven’t heard about this? That’s because it hasn’t gotten the press it should. While much media attention is spent on the Trump administration’s position on DACA or the latest trade agreement, the administration’s systematic withdrawal of health content – especially women’s health – from Health and Human Services run websites is a serious danger that can potentially harm patients.

In its THIRD report on censorship at the Office of Women’s Health, the Sunshine Foundation found that office’s breast cancer website and a page on reproductive health organization is now gone. If you try to go to either one, it redirects to a different page.

So, why is the administration doing such a thing? Good question. A spokesperson for HHS recently told ThinkProgress the following:

“The pages were removed on December 6, 2017 because content was not mobile-friendly and very rarely used. Before we update any of the information…we engage in a comprehensive audit and use analysis process that includes reviewing other federal consumer health websites to ensure we are not duplicating efforts or presenting redundant information.”

I find this information hard to believe considering breast cancer is the most common cancer among women. Also, this isn’t the first time the administration has launched a salvo against health information that it apparently finds objectionable for some reason.

Back in December, the administration informed officials at the Centers for Disease Control and Prevention – part of HHS – of a list of 7 prohibited words and phrases not to be used in documents for the agency’s budget request. And those words and phrases? “Vulnerable,” “entitlement,” “diversity,” “transgender,” “fetus,” “evidence-based” and “science-based.”

If this all sounds ridiculous, it’s more than that – it is deplorable, a word the administration is all too familiar with. But instead of getting angry, do something about this.

Contact HHS Secretary Alex and let him know you won’t stand for this kind of dangerous censorship. His email is [email protected] and phone number is 202-690-7000. And if you want to tell him via President Trump’s favorite medium, Twitter, Azar’s handle is @SecAzar.

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