Patient Outcomes Research Rejected at Harvard/Mass General 100 Years Ago

Honoring a once-scorned voice for medical openness

DAVID L. RYAN/GLOBE STAFF

Dr. Ernest Amory Codman told his wife before he died in 1940 not to spend money on a headstone. Dr. Andrew Warshaw spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.

By Liz Kowalczyk GLOBE STAFF  JULY 21, 2014

Dr. Ernest Amory Codman was in his mid-40s when his golden career as a sought-after Harvard surgeon began to unravel. He had quit in exasperation from Massachusetts General Hospital, and when he took his dispute with hospital leaders public, colleagues turned against him. Many stopped sending him patients.

MASSACHUSETTS GENERAL HOSPITAL ARCHIVES

Dr. Ernest Amory Codman.

It was the early 1900s, and Codman was impatiently pushing hospitals and doctors to adopt a practice many considered heretical at the time: Record the “end results’’ for every patient — including harm caused by physicians’ errors — and make them public.

A century later, many of Codman’s ideas are the bedrock of modern medicine. And a group of doctors, including a former Mass. General surgery chief, plans to make sure he gets the wider appreciation he deserves this week.

Codman’s ashes are buried in his wife’s family plot in Mount Auburn Cemetery in Cambridge, with no personal marker. Dr. Andrew Warshaw, the hospital’s chief of surgery from 1997 to 2011, has spent the last two years raising $20,000 from medical organizations for a granite and bronze memorial that will be dedicated Tuesday.

The headstone is “an overdue homage” to Codman and the ideas he pushed at Mass. General and nationally, Warshaw said. “His senior doctors couldn’t be bothered. They said it wasn’t necessary. Of course, people were threatened.’’

Even after Mass. General began tracking some outcomes, making that information public was anathema. “The general executive committee does not consider it advisable,’’ Dr. Joseph Howland, the hospital’s assistant administrator, cryptically wrote Codman in April 1914.

Codman himself lived his beliefs with excruciating honesty.

“I made an error of skill of the most gross character and even failed to recognize that I had made it,’’ he wrote in a published report after a woman died following a gallbladder operation in 1917.

These days, there is little escaping Codman’s notions, as everyone from patient safety groups to President Obama pushes for measurable quality and transparency in medical care.

Codman’s close examination of patient cases led to weekly meetings now held at Mass. General and many other hospitals called “morbidity and mortality’’ conferences, and his insistence on “hospital standards’’ eventually prompted the formation in 1951 of the Joint Commission, a national organization that evaluates hospitals.

“He deserves to be much better recognized,’’ said Dr. William Mallon, a shoulder surgeon who wrote a comprehensive biography of Codman that was published in 1999.

But it was not until another Harvard physician, Dr. Lucian Leape, started publishing studies on the frequency of medical errors in the 1990s that the profession and government began to intently examine the issue.

And it has been only in the past 10 years that regulators, patient safety experts, and some doctors have advocated for making outcomes and errors public, as a way to further encourage improvement. As Mallon pointed out, however, few physicians are as open as Codman about their mistakes, in part because of the threat of lawsuits, and mortality and morbidity conferences remain highly confidential.

Dr. Lamar McGinnis, a cancer surgeon from Georgia who has researched Codman’s career, said it was not only his ideas, but his abrasive personality that hurt him professionally. “He was really stepping on toes,” McGinnis said.

‘He deserves to be much better recognized.’

Frustrated with Mass. General’s refusal to fully embrace his ideas, Codman left his full-time job there in 1911 to start his own 12-bed hospital in a Beacon Hill brownstone. He required his doctors to report their results and he tracked his own patients on hundreds of 3 x 5 cards. He advertised the “Medical Ethics of the Codman Hospital’’ — a mission statement of sorts that stated “large fees are only justifiable’’ when a surgeon’s skills have been proven.

Codman continued to pursue changes at Mass. General, and while the hospital began to track patient outcomes, it stopped short of investigating the reasons for poor results, according to letters Codman wrote to hospital administrators. He warned that his ideas were gaining traction in Philadelphia, threatening Mass. General’s position as a national leader.

“It is really easier to overturn a whole city than it is to wake up the trustees of Massachusetts General Hospital,’’ he said in a letter in March 1914, the month he cut ties completely with the hospital to protest the seniority system. Codman urged Mass. General to “do some house-cleaning’’ and stop promoting doctors because of their reputations instead of advancing those with good results.

Codman’s surgical career took a dive in January 1915, when he organized a meeting on hospital standards as chairman of the Suffolk District Surgical Society. Before dozens of colleagues, Codman unveiled a cartoon he had asked a friend to draw.

An ostrich with its head buried in the sand kicked out golden eggs to Back Bay doctors. The heads of Mass. General watched, scratching their heads and asking, “If we let her know the truth about our patients, do you suppose she would still be willing to lay?’’

The audience was aghast, Codman later wrote. He was told to resign as chairman of the group, and as referrals plummeted that year, so did his income — to $5,000 from $8,000 the prior year. He closed his hospital to help treat the injured after two army munitions ships collided and exploded in Halifax, Nova Scotia, in December 1917.

MASSACHUSETTS GENERAL HOSPITAL ARCHIVES

Dr. Ernest Amory Codman shocked colleagues with a cartoon critical of Back Bay doctors.

Still, Codman was hard to ignore back in Boston. He became an expert in shoulder surgery and bone sarcoma, and Mass. General reinstated him as a consultant in 1929. By the time he died in 1940 at his home in Ponkapoag, now Canton, the wounds appeared healed.

Two weeks after his death, trustees at Mass. General, which had begun to adopt his ideas, passed a resolution calling him a “champion of truth’’ who was “willing to sacrifice personal place and standing to achieve what he believed to be right.’’

Codman never recovered financially after his surgery practice dwindled, according to his biographer, and he told his wife before he died of melanoma in 1940 not to spend money on a headstone.

The memorial project took far longer than Warshaw expected.

Codman and his wife, Katherine Putnam Bowditch, did not have children, and doctors were unable to find a relative to give permission for the headstone. So Warshaw contacted Mount Auburn, which began researching the expansive cemetery plot, purchased by the prominent Bowditch family in 1845. Nathaniel Bowditch, Katherine’s great-grandfather and a ship’s captain from Salem, was a pioneer of modern maritime navigation.

Mount Auburn determined that it controlled a portion of the plot, and gave Warshaw permission to move forward with a memorial. Warshaw, who will become president of the American College of Surgeons in October, plans to make Codman’s accomplishments the theme of his opening speech in San Francisco.

A small private ceremony will be held at his gravesite on Tuesday. The memorial, which describes Codman as the “father of outcomes assessment and quality measurement in health care,’’ sits under a shady stand of eight Canadian hemlocks, just behind Nathaniel Bowditch’s grave.

Inscribed under Codman’s name and portrait in bronze are these words: “It may take a hundred years for my ideas to be accepted.’’

Liz Kowalczyk can be reached at kowalczyk@globe.com

Failed metal on metal hips: U.S. lab rats!

FDA probes safety issues with metal hip implants

By Matthew Perrone  Boston Globe

AP Health Writer / June 25, 2012  (FiDA blog bold)

WASHINGTON—Metal hip replacements implanted in a half-million Americans may be failing earlier than expected, but it could be years before U.S. health regulators have a clear picture of the problem.

The Food and Drug Administration holds a two-day meeting starting Wednesday to scrutinize the safety of metal-on-metal hip implants, following years of patient reports of pain and swelling that sometimes requires removal of the devices. It is a challenging, but familiar, predicament for the FDA: reviewing the safety of a device that was expected to be superior, but which may actually be more dangerous than what came before.

For decades nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years some surgeons began to favor implants made with metal stems and sockets. Laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered by surgeons in the U.K. appears to show just the opposite.

In March, British experts at the world's largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints. Both types of devices are prescribed for people suffering hip pain and limited movement due to arthritis or injury.

British regulators now recommend that people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies as the components rub against each other.

The FDA has not made any recommendations of its own for the estimated 500,000 American patients with the devices.

FDA scientists say they want to consider all available information before making their recommendations -- not just the data from the U.K.

"Why look at a single registry when there's data from around the world?" said Dr. William Maisel, FDA's chief scientist for medical devices, in an interview with the Associated Press. "This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made."

Maisel said the FDA is working to combine data from foreign countries and the U.S. to determine which groups of patients and implants are most problematic. On Wednesday and Thursday the FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests.

But some U.S. orthopedic specialists say they have already reached their own conclusions about metal hips.

"In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective," said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.

The FDA's deliberative approach to tackling the hip implant issue is in some ways a necessity. Unlike other countries, the U.S. has no national registry to track the performance of implants over time.

The FDA received 16,800 negative event reports involving metal hips between 2000 and 2011, but regulators stress that number is not very useful. Many doctors do not report problems to the FDA, and the volume of reports is influenced by news reports on safety issues.

A registry set up by Minnesota's HealthEast Care System recorded four times as many replacement surgeries for patients with metal-on-metal hips as those with other implant types. However, a similar registry set up by health care provider Kaiser Permanente found no difference between the two groups.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the effects of metal particles that often seep into the bloodstream as the implants wear down.

But Sedrakyan and others say it could be a decade or more before that information is available. In a commentary published last week in the New England Journal of Medicine, Sedrakyan and two co-authors pointed out those studies must run at least eight years to return the information FDA is seeking. Based on the authors' analysis of FDA records, the FDA has reached agreements on the design of less than 25 percent of the studies, and it's unclear whether any of the studies have actually begun. The FDA notified the companies last May.

The prospect of safety findings arriving in eight or 10 years is little comfort to patients like Mary Weaver, 48, who had both hips replaced with a metal implant from Johnson & Johnson in 2007 and 2008. J&J recalled the ASR hip replacement in 2010, after reports that it was failing in some patients after only a few years of implantation.

Due to increasing pain and elevated metal levels in her blood, Weaver had both implants removed in 2011. She was let go from her job due to the time needed to undergo both surgeries, and is currently unemployed.

"I hope that no one has to go through this -- it's frustrating, it's emotionally draining," said Weaver, who lives in Mount Jackson, Va. "It's not just hard on you, it's hard on your whole family because your quality of life is not what it used to be."

Like 90 percent of medical devices sold in the U.S., most metal-on-metal hips were approved via the FDA's fast track program for medical devices. Under the so-called 510k system, the agency waives clinical testing requirements for devices which appear similar to others already in use. Since plastic and ceramic hip replacements had been on the market since the 1950s, most metal hip replacements were approved without new clinical testing.

"I am so furious they would use my wife as a lab rat, along with the other 500,000 people who don't have a clue what is happening," said Dwight Schrag, 69, of Bellevue, Wash. Schrag's wife Mary received J&J's ASR hip in 2006 and had it removed due to pain and other side effects in 2010. Schrag is one of a number of speakers who have signed up to speak during a public comment session at the FDA meeting.

It's not the first time the FDA's fast-track program for clearing devices has come under fire.

Last summer the Institute of Medicine said in a report that the FDA should abandon the 35-year-old system because it provides little assurance that the implants are actually safe. The Institute is composed of medical experts who advise the federal government.

Although the FDA itself requested the report from the Institute, agency officials rejected the group's conclusions, saying the 510k system works well for the vast majority of devices.

explanthis comment:   FiDA blog/Joleen Chambers
The profitable medical device industry has conflated justice so completely that the American citizenry blindly pays for the #1 expenditure of Medicare:  joint replacements.  The industry has so many entitlements:  no warranty on product, no clinical testing, no national registry, no need to report adverse events, pre-emption in state court because of FDA, no compensation to victims of failed products without a David/Goliath courtroom battle and unrestricted direct-to-consumer marketing.  Even with all these advantages, the industry fights a tax that would help fund the FDA/CDRH.  Do they not have faith that they can make $$ and produce a safe and effective product?  Consumer beware!

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