Growing up on the south side of Chicago, with grandparents who immigrated from Ukraine and parents who didn’t finish high school, Dr. Tom Zdeblick had thick glasses, a lisp and a small build.

“I got to be pretty good with my fists,” he said.

Now the spine surgeon and orthopedics chairman at UW School of Medicine and Public Health is fighting for his reputation after years of being criticized nationally for his financial ties to the medical device maker Medtronic.

The intense public scrutiny, unprecedented for a UW-Madison doctor, coincided with deep personal loss: Two of Zdeblick’s children died four years apart. The emotional wounds toughened him against the professional criticism, he said, but also caused him to give up the main activities that caused the controversy.

Nearly 10 years ago, a former travel manager for Medtronic filed a lawsuit alleging the company gave kickbacks to Zdeblick and other doctors who used its spine surgery products.

The lawsuit triggered a U.S. Department of Justice investigation and two U.S. Senate committee probes. The second Senate probe revealed last year that Medtronic paid Zdeblick $34 million over 15 years, mostly in royalties for devices he invented.

Other spine surgeons said he downplayed the side effects of a key Medtronic product in journal articles and didn’t disclose his payments from the company. Some doctors called for him to step down as orthopedics chairman and give up his post as editor of a spine surgery journal, saying his conflict of interest compromised medicine.

Four months after the suit was filed, Zdeblick’s 17-year-old daughter died in her sleep, apparently from an overdose of the drug Oxycontin. Four years later, his son died at 23, also in his sleep. Zdeblick and his wife divorced in 2011, unable to endure the loss together, he said.

A report this month could absolve Zdeblick professionally or discredit him further. Yale University is expected to release a review of the safety and effectiveness of Medtronic’s most controversial spine surgery product, one closely tied to Zdeblick’s best known device.

In interviews with the State Journal from his sixth-floor office in UW Medical Foundation’s Centennial Building near UW Hospital, Zdeblick, 56, said he has done nothing wrong. He has been paid well for good ideas that improved medical care, he said. He doesn’t get royalties when he or other UW-Madison doctors use his devices, to minimize a conflict of interest.

“They paid Bill Gates a lot of money for good ideas,” Zdeblick said. “They paid Steve Jobs a lot of money for good ideas. Good ideas are good ideas. They help people. I don’t ever feel ashamed of that.”

Fit from snowboarding, cross-country skiing, running and bicycling, he answered questions about the accusations against him freely, occasionally conceding critics’ points but mostly defending himself against what he views as attacks on his success.

Plaques of his most noteworthy patents sit on shelves near photos of his two remaining children. Nearby is a portrait of the family when both parents and all four children were together. Zdeblick said his personal pain has put the professional controversy into perspective.

“When you lose a child, you can’t get hurt any worse, really,” he said.

Profitable inventions change spine surgery

When Zdeblick came to UW-Madison in 1989, spine surgery was in its infancy.

Surgeons removed pieces of bone or disc to free pinched nerves, or they took bone from the hip or ribs and spread it on vertebrae to fuse them and prevent painful movement. Spinal fusion patients spent months recovering in a brace, and half of the time the procedure didn’t work.

In the late 1980s, surgeons started using screws, rods, plates and cages to stabilize fused vertebrae, eliminating the need for braces and improving the success rate.

Zdeblick — the third of six siblings, who all got advanced degrees — studied engineering at Marquette University and went to medical school at Tufts University in Boston. After orthopedic surgery training at Case Western Reserve University in Cleveland and Johns Hopkins Hospital in Baltimore, he became UW-Madison’s first fulltime spine surgeon.

At Johns Hopkins, he sketched designs for devices that would enable surgeons to operate from the front of the spine instead of from the back, where cutting through more muscle can complicate recovery.

Zdeblick asked UW-Madison to purchase the brand of implants he used at Johns Hopkins. But the university put the order out for bid and awarded the contract to Danek, a little-known company in Memphis.

The company "agreed to look at my drawings and started building some of the products I had come up with,” he said.

Danek merged with the French company Sofamor and was acquired by Minneapolis-based Medtronic, one of the largest medical device companies in the world.

Zdeblick’s first device, the Z Plate, was approved in 1993. It can replace a broken segment of spine and allow people who are partially paralyzed to walk.

“That got me well known,” he said. “I lectured all around the country and the world, introducing that.”

Another device he designed, the LT Cage, was approved in 1996.

When surgeons remove collapsed discs between vertebrae during spinal fusion surgery, they need to fill the space with something that will bear weight. Most surgeons used bone from a cadaver or the patient’s own hip.

The LT Cage, made from titanium, acts as a scaffold that can be packed with bone. Zdeblick adapted the cage from a device used to stabilize the neck of 1977 Triple Crown winner Seattle Slew.

The Z Plate and the LT Cage became the most profitable of seven devices Zdeblick invented. In 2003, his most lucrative year, Medtronic paid him $4.6 million in royalties and for consulting. That was on top of his UW-Madison salary, which today is $1,060,000, the highest salary on campus outside of athletics.

Controversy soon erupted, initially over his consulting contract with Medtronic and then over a bone substitute used with the LT Cage.

But personal tragedy struck first.

Devastating losses

On March 5, 2004, after Zdeblick left for work, his wife Catherine went to wake their daughter Julie, a junior at Middleton High School.

Julie didn’t respond and died the next day. An A student and tennis player, she had sneaked out at night and overdosed on the painkiller Oxycontin. The man who sold her the drug was sentenced to five years in prison.

Julie's death led Zdeblick, who had become orthopedics chairman in 2000, to stop designing devices and end his consulting contract with Medtronic, he said.

Losing Julie “was a huge blow,” he said. “It made me rethink a lot of priorities. Immediately, I got rid of any priority that didn’t include the family.”

Zdeblick became “unbelievably sad,” said Dr. David Mahvi, a former UW-Madison surgeon who remains one of his closest friends.

Zdeblick’s son AJ had autism. He worked at the Copps grocery store in Middleton and lived with a roommate in an apartment.

On the morning of Sept. 4, 2008, the roommate found AJ dead. An autopsy showed an enlarged heart with a scar.

Cardiologists told Zdeblick the family must have a genetic heart arrhythmia, which could have contributed to Julie’s death. He, Catherine and their other children — John, now 23, and Maddie, now 20 — were tested, but nothing unusual was found.

After AJ died, Zdeblick’s sadness shifted toward anger, Mahvi said. “There was a certain, ‘Why is this happening to me?’ … Losing AJ made it seem like life was unfair.”

After being married for 33 years, Tom and Catherine divorced.

“There was just too much shared sadness,” Zdeblick said. “You can’t get away from it until you’re away from each other.”

Critics level conflict of interest charges

The lawsuit filed by the Medtronic travel manager was unsealed in 2006. It revealed a 10-year contract, starting in 1998, by which Medtronic paid Zdeblick $400,000 a year for as little as eight days of consulting work.

Zdeblick reported to UW-Madison only that the company paid him more than $20,000 a year. That complied with campus requirements but raised eyebrows with Sen. Chuck Grassley, R-Iowa, who served on the Senate Finance Committee and started to investigate.

In 2009, a letter from Grassley to the university showed that Medtronic had paid Zdeblick $19 million from 2003 to 2007, mostly in royalties for the devices he invented.

The Wall Street Journal broke the story, as national media coverage of conflicts of interest in medicine started focusing more on spine surgery and Zdeblick in particular. Articles noted that spine surgery is costly — $22,000 to $38,000 for typical spine fusions this year, according to Orthopedic Network News — and sometimes overused. Device companies sold $6.7 billion of spine implants to U.S. hospitals last year.

The UW medical school moved to require faculty to report specific amounts of outside income instead of ranges ending with “more than $20,000.” UW Hospital started posting signs telling patients how they could request their doctor’s disclosure form. Both steps were accelerated by the national attention to Zdeblick’s payments, said Dr. Robert Golden, dean of the medical school.

The Milwaukee Journal-Sentinel reported that Zdeblick published positive articles about Medtronic products in the Journal of Spinal Disorders and Techniques, which he became editor of in 2002, without disclosing his payments from the company. The newspaper ran at least 20 articles mentioning Zdeblick’s ties to Medtronic from 2009 to 2012, many of them quoting spine surgeons and ethicists who questioned his credibility.

Much of the scrutiny centered on Infuse, a Medtronic product approved in 2002. It’s a genetically engineered bone substitute that can be used, instead of bone from a cadaver or the patient’s hip, in spinal fusion surgery.

The Food and Drug Administration approved Infuse only for use with the LT Cage, but many spine surgeons started using it in other ways. Such “off-label” use is customary in medicine, but manufacturers aren't allowed to promote it.

As annual sales of Infuse soared to $700 million, with 85 percent of its use off-label, the Department of Justice started investigating whether Medtronic promoted off-label use.

Two developments raised questions about Zdeblick’s handling of one of the most troubling side effects reported with Infuse, a risk of sterility in men. Zdeblick and other doctors didn’t mention the sterility risk, known as retrograde ejaculation, in their report about the initial trial of Infuse in the Journal of Spinal Disorders in 2002.

A competing journal, The Spine Journal, devoted an entire issue to concerns about Infuse in 2011. It said retrograde ejaculation, cancer, infection and other risks from Infuse had long been known but weren't mentioned in 13 articles by doctors who received money from Medtronic, including three articles co-authored by Zdeblick.

“It harms patients to have biased and corrupted research published,” the journal’s editorial said.

Last year, the Senate Finance Committee revealed a PowerPoint slide Zdeblick presented in 2001. It said Infuse patients had a higher rate of retrograde ejaculation than other patients, a risk labeled “statistically different.”

By not disclosing the risk in journal articles, Zdeblick was “essentially ... writing advertising copy,” Dr. Gene Carragee, spine surgery chief at Stanford University and editor of The Spine Journal, said in an interview with the State Journal this year. “If you sterilize someone, that is a big deal.”

The Senate investigation also showed that Medtronic paid Zdeblick $34 million from 1996 to 2010, mostly in royalties. He has received another $2 million since then.

Explanations downplayed

Zdeblick said it's his explanations that have been downplayed.

“I’ve always said from the very beginning that I have a conflict of interest,” but he is careful about managing the conflict, he said.

He has reported his Medtronic payments as required by the university and various journals, he said, as their policies shifted from vague disclosures to specific sums.

A consent form tells his surgery patients he might have a financial tie to the manufacturer of their implant. If they’re receiving a device he designed, he tells them directly and explains he’ll get no additional royalties, he said.

“Many patients come to me because I designed these things,” he said.

He never owned Medtronic stock and hasn’t consulted for the company since 2007, he said.

Once Danek got acquired by Medtronic, "I didn’t have that much to do with them anymore," he said.

His royalties are up to 5 percent of the sales of each device. He didn’t use federal grants or UW-Madison labs to design the devices, so he didn’t have to go through the Wisconsin Alumni Research Foundation to patent them or share the royalties with the university.

The sterility risk’s link to Infuse wasn’t reported in journal articles because it wasn't statistically significant, Zdeblick said. In hindsight, however, he said it should have been mentioned in the 2002 journal article.

The PowerPoint slide came before Medtronic reanalyzed data from the Infuse trial and found that the risk of retrograde ejaculation was tied to a surgical technique, not to the substance, he said. Other doctors reported that finding.

Zdeblick said he gets no royalties for Infuse, so he has no incentive to minimize its risks.

Carragee, editor of The Spine Journal, said that “doesn’t pass the chuckle test” because Infuse is approved only with the LT Cage. But most of its use hasn’t been with the LT Cage, Zdeblick said.

The Department of Justice dropped its investigation against Medtronic last year, and a court threw out the lawsuit from the Medtronic travel manager after the company settled a similar suit for $40 million.

The remaining dispute over Zdeblick's connection to Infuse could be settled by the Yale review expected this month. Medtronic gave $2.5 million to Dr. Harlan Krumholz, a Yale cardiologist, to oversee an independent review of the scientific data on Infuse.

An exoneration of Zdeblick from Krumholz, whom Forbes magazine called “the most powerful doctor you never heard of,” could carry a lot of weight.

But skeptics might focus on Medtronic’s funding of the review. “If it’s favorable for Medtronic, you’ve got to question it,” said Dr. Dan Spengler, a spine surgeon at Vanderbilt University and former editor of the Journal of Spinal Disorders.

Moving forward

In 2008, as president of the Cervical Spine Research Society, Zdeblick gave a speech called, “The Second Half.”

In the first half of his career, he said, he learned how to operate efficiently. But he also realized that surgeons’ long hours keep them from family and friends, which can make them unfulfilled. He vowed to carry out the second half of his career differently.

“I have learned to lean on others,” he said in the speech. “To be vulnerable, and human, is what makes for deeper connections.”

He started opening up more on skiing and golf trips with friends, said Bob Childers, who owns a library equipment company in Waunakee and goes on most of the trips.

Zdeblick, who became a pilot eight years ago, flies his own plane to the trips.

He still keeps a busy surgical practice, operating on more than 200 patients a year.

Many patients, like Peter Fronsee, 61, of Appleton, seek him out because of his surgical reputation. Before Fronsee had spinal fusion surgery last year, back pain made it nearly impossible for him to walk, he said. Now he’s walking, bicycling and doing yoga.

Fronsee said he doesn’t care about Zdeblick's payments from Medtronic. “He’s got the skilled hands,” he said. “That’s good enough for me.”

Zdeblick is playing a key role in UW Health’s new hospital, going up on Madison’s East Side. Much of the facility will be devoted to orthopedics, one of the health system’s top revenue generators.

The new hospital has drawn criticism from competitors and business leaders who question the need for it, but Zdeblick said the facility will also contain a wellness center that could help some back pain patients avoid surgery.

His lectures are no longer about widgets, he said. Today, he encourages other surgeons to say "no" more often when patients request surgery and to keep their own professional and personal lives balanced.

“I think of living the rest of my life in a better way," he said.

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ctraczyk
ctraczyk

I'm so sorry for your loss, and the pain in your life. You
seem to be a very intelligent and driven individual, don't let anything take you down. We need more people like you.