Tag Archives: safety

MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany.

Jesse Dougherty: The Washington Post, June 3, 2020


One season is ending, another is beginning, and the intersection of the two — Major League Baseball and Bundesliga soccer — shows how risky it is to restart sports in the United States right now.

On Saturday, Bayern Munich and Bayer Leverkusen will meet in the German Cup final in Berlin, capping a successful six-week schedule. Across the Atlantic Ocean and all over North America, MLB will begin summer camp during the novel coronavirus pandemic. The models for the two are similar in that, unlike the NBA, they are operating outside of a bubble, traveling between cities and having players, coaches and staff live at home.

But here’s a key difference: Germany’s response to the pandemic was much more successful — and much more proactive — than the United States’. It enabled the Bundesliga, the country’s top-tier soccer league, to resume in mid-May and handle sporadic coronavirus cases. Baseball, on the other hand, is about to make a similar attempt in a much different environment.

The United States topped 50,000 new daily cases for the first time Wednesday. That was more than a fourth of Germany’s total cases to date. Germany has had around 9,000 coronavirus deaths, and by mid-May, when soccer returned, it had almost completely flattened the curve.

“Germany was able to pull it off, but we are not Germany. Many of the markets that MLB wants to play in do not look like Germany,” said Zachary Binney, an epidemiologist at Oxford College of Emory University. “The baseline risk is much higher. So unfortunately, because of our response to covid-19, sports leagues need stricter return plans, and I don’t know that MLB has really wrestled with that yet.”

Both plans hinge on players, coaches, staff and their families being cautious and smart away from team facilities. That’s the reality of not playing inside a bubble, which the NBA will use in Florida to negate travel and limit exposure to the outside world. But MLB and the Bundesliga took near-opposite approaches for regulating off-site behavior.

MLB’s 113-page operations manual dedicated one paragraph to it, writing individuals “must exercise care,” adding that they should avoid restaurants, bars and other crowded areas. MLB left each team to craft and enforce its own policy. Four players, who spoke on the condition of anonymity to freely discuss a sensitive topic, said this is MLB’s way of avoiding responsibility should an outbreak occur.

[….]

Here is where baseball picks up this weekend, starting with testing. Before training begins, all players, coaches and staff have to take a coronavirus test and self-quarantine while awaiting results. After that, they will be tested every other day. A lab in suburban Salt Lake City will be tasked with fielding thousands of tests and turning around results in “approximately 24 hours,” according to MLB’s operations manual. There is, however, already skepticism within the sport that results will come that quickly.

Before training began in Germany, players, coaches and staff did a week-long quarantine at a hotel. They ate meals separately and, each morning, completed a questionnaire to check for possible symptoms. Testing was frequent during that period, then slowed to around twice a week during the season. The Bundesliga contracted five labs to process results and, according to news accounts, was comfortable doing so because the country wasn’t stretched for resources.

Since the Bundesliga was the first league to return, it provided a template for how to play outside of a bubble. But environmental influences serve as the trickiest element there. Baseball’s plan, while similar, is less detailed in critical areas, according to public health experts, and set to unfold where the virus is still rampant.

“The biggest risk for baseball is location,” said Diana Zuckerman, president of the nonprofit think tank National Center for Health Research. “The greatest weakness of the plan is sending teams and having teams in states where the governor is unwilling to have strict rules.”

Read the full article here

NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

National Center for Health Research, January 21, 2020


National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.