Warning Signs No. 2: Metal-on-Metal Hips,
Lung Cancer Death Rates, Ecigarette and Food Safety

It’s a new year and here’s another segment on warning signs. I am glad to see that this month, the hazards of metal-on-metal hips, covered in the first warning signs issue, are being examined.

40% Failure Rate of Johnson and Johnson’s Metal-on-Metal Hip

People contemplating a joint replacement should take a close look at this story. Barry Meier, reporter at the New York Times, reported on Jan. 22. that Johnson & Johnson , knew about its Articular Surface Replacement hip, or A.S.R.’s 40% failure rate within 5 years of surgery.

“The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.” Barry Meier, NYT, Jan. 22, 2013. 

Thousands of patients have brought lawsuits concerning the A.S.R. A trial begins today in California Superior Court in Los Angeles. Will this be the straw that breaks the camel’s back in terms of inadequate patient protection in medical device regulation? Will we see a more vigilant FDA?

Lung Cancer Death Rates for Women On Par with Men’s

You may be thrilled, as I was, earlier this week, when President Obama called attention to our nation being inclusive. One milestone that I wish women were spared is their achieving near parity with men in their risk for lung cancer death:

A study in the Jan. 24 New England Journal of Medicine, reveals that as women’s smoking habits have become more like men’s, namely starting to smoke at a younger age and smoking more cigarettes each day, their risk of lung cancer death has risen to the same as men. Removal of the stigma against smoking for women began after World War II, and women in their fifties and older, who smoked are part of this surge.

A related study, by Prabhat Jha at the Center for Global Health Research in Toronto, underscores the value of quitting in helping prevent early smoking-related deaths. Using the Centers for Disease Control and Prevention National Health Interview Survey (NHIS) data, researchers report  threefold greater risk for lung cancer death in current smokers, compared with people who never smoked.

Questionable Oversight of the Electronic (e)cigarette Business.

You can see the advertising all over: electronic cigarettes are marketed as a safer non-tobacco alternative. Is the data in? I have my doubts.

insert on electronic cigarette safety

Thanks @Dirk57 at The Addiction Inbox, who flags the lack of regulation in the e-cigarette business, in a post this week. Big tobacco is moving into this lucrative business quickly, Dirk points out. But do we have reason to trust industry marketing. Additionally, safety data has been inconsistent. Long-term safety data concerning e-cigarettes is unclear.  Dirk raises some important questions.

FDA Belatedly Ramps Up Food Safety

Last fall, Center for Science in the Public Interest made a compelling case for the FDA failing to put food safety preventive programs in place. I called attention to it here. Could some of the produce safety outbreaks (e.g. cantaloupe, peanut butter) we heard about last year been averted? Probably.

Finally, FDA is requiring the food industry to perform a hazard analysis of their facilities and put control programs in place to prevent food pathogens from getting into produce and other parts of the food supply.

Still wanting: regulations for food produced in other countries, warns CSPI.

Warning Signs

“Warning Signs” is a new concept for Patient POV. In it, I plan to point to unanticipated changes in health care that warrant a closer look. In some cases, all we see is a snapshot of something awry in one locale, but the change is ominous, has the potential to spread, and the public ought to know about it. I hope to point to exemplary shifts in medicine as well.

In the past week, I found these warning signs particularly worrisome, and applaud the work done by other reporters and bloggers to document them:

  1. If you thought the peanut butter-salmonella scare sounded bad enough on its own, think again. The Center for Science in the Public Interest explains that even though the FDA Food Safety and Modernization Act was passed in 2011, FDA has not implemented measures essential for food safety. “Deadline after deadline has come and gone with the agency taking no action, leaving consumers vulnerable and industry without guidance. Peanut butter and other foods are no safer than they were at the beginning of the President’s term, when he rightfully expressed concern about the peanut butter in his daughter’s sandwiches.”
  2. Concerns over the future of Medicare have gotten lots of attention, but the future of Medicaid has gotten far less scrutiny, particularly for seniors and the disabled. An editorial in the Tampa Bay Tribune takes up Romney’s mean, lean plans for Medicaid and nursing home residents.” The editorialists point to the public’s confusion that nursing home care is solely a Medicare issue and that Medicaid is strictly for the poor.  “But Medicaid is the program that provides long-term care to the elderly and disabled…It was Ryan who authored the plan to convert Medicaid from a strong federal-state entitlement to a block grant program to the states that Romney has incorporated into his campaign. The plan, passed as a budget blueprint by the Republican-controlled House, would gut Medicaid’s safety net and focus instead on cutting funds. The nonprofit Center for Budget and Policy Priorities says Medicaid funding would decline by one-third by 2022 under Ryan’s plan.” Take a closer look.
  3. Electronic health records have enormous potential for improving patient care and tracking health outcomes, but abuses in Medicare billing, identified in a NY Times article, are worrisome. Readers will want to be aware of:
  • cloning, where a doctor copies information from a previous visit to a later one, or duplicates information from one record to another;
  • upcoding, which The Times defines as exaggerating “the intensity of care provided or the severity of a patient’s condition to justify higher billings.”

In response to this article, Attorney General Eric Holder Jr. and Health and Human Services Secretary Kathleen Sebelius sent a letter to five hospital associations, noting “troubling indications” and their intent to prosecute for billing for services never permitted.

4. Ever wonder, why, all of a sudden, you see higher out-of-pocket costs for doctors’ visits. Consider this: the Cleveland Plain Dealer describes how ordinary doctors’ offices have become “hospital departments,” and along with it, come new facility fees for simple primary care.  In one example at Cleveland Clinic’s MetroHealth Center, , a patient was charged a facility fee of $1,655, about four times the doctor’s bill, for 30 minutes in an exam room to have a suspicious lesion removed. The patient states: “There is a much bigger issue and that’s that people won’t get the care they need because they can’t afford these charges. It’s totally wrong.”

“Warning Signs” is new. Let me know if you like it, think of something that I missed, and most importantly, your POV.