Artificial joint makers lobby hard
Fri, 02 Nov 2007 07:33:28 GMTBy JOSHUA FREED, AP Business Writer
MINNEAPOLIS - The hips and knees are synthetic, but it's real money changing hands. Five makers of artificial joints have paid more than $200 million this year to doctors and hospitals, often the same ones who are deciding which company's joints to buy, according to an Associated Press calculation of disclosures required this week by a settlement with federal prosecutors.
The five companies were scrutinized by the U.S. attorney's office in New Jersey over allegations they gave money and trips to surgeons who used their products. Four of them — Biomet Inc., DePuy Orthopaedics Inc., Smith & Nephew Inc. and Zimmer Holdings Inc. — had their charges dropped when they paid a total of $310 million in fines and agreed to monitoring in a settlement announced in September. The fifth company, Stryker Corp., was never charged and paid no fines but agreed to disclose its payments.
The payments to doctors and hospitals ranged from a few dollars to individual doctors to about $3.9 million to Mayo Clinic. And the AP's calculation is conservative, because the companies were required to disclose payments within a $25,000 range, and the AP used the low end in its calculation.
The money includes items like royalties for inventions and payments for teaching classes. Prosecutors alleged that from at least 2002 through 2006, the companies paid exorbitant amounts for doctors to be consultants and to use their products exclusively.
They did not allege that all the money was illegitimate.
"Certainly it was not a majority of doctors who had contracts that were operating illegally," said Mike Drewniak, a spokesman for the U.S. attorney's office in New Jersey. Drewniak said the investigation into the five companies in the settlement has wrapped up, but that prosecutors are still looking into payments by smaller medical device companies.
The settlement required the companies to disclose who it paid during 2007, and to update the information quarterly. Later this year, it will also require them to disclose non-monetary payments, such as trips.
Mayo took in money from all the companies except Biomet, including almost $2.1 million from DePuy, which is a unit of Johnson & Johnson. Mayo spokesman Lee Aase said nearly all of the money it received was for royalties, as well as sponsored research. Doctors who invent medical devices get paid some of the royalty money through the clinic, he said.
"By lumping all this stuff together, you have some places like Mayo look like one of the bigger recipients of this, but it's because they're inventing things," Aase said.
Zimmer Holdings, the biggest maker of artificial hips and knees, paid the most to doctors — $85.8 million, according to the disclosure made on its Web site on Wednesday. DePuy paid $48.8 million, Stryker paid $27.8 million, Biomet paid $19.6 million, and Smith & Nephew paid $19.3 million.
DePuy said in a statement that it had begun to change its interactions with doctors before the Justice Department investigation was announced. It said that the payments are "critical to advancing patient care and keeping the orthopaedic community appropriately educated and trained on new products and surgical techniques."
Spokesmen for Zimmer, Stryker, and Smith & Nephew all declined to comment. Stryker posted its information in a way that made it difficult to sort the data and declined a request to make it available in a more usable format. A Biomet spokeswoman did not return a phone message seeking comment.
Cincinnati orthopedist Dr. Edward Lim has written about the relationship between doctors and the implant industry. He also was listed as receiving $14,794 from Zimmer.
He said the money was for teaching classes that demonstrate joint replacements, such as a new shoulder he put into a cadaver last week.
"By and large I think the industry is fairly up front in terms of, you provide a service and you expect to get paid for a service," he said. "What you're not expected to do is, say, get a kickback for doing a certain number of joints."
"I'm paid for my time and my expertise. I'm not paid for being their mouthpiece," he said.
The settlements with the companies include a limit of $500 per hour for consulting services. Companies that want to pay more must get a third-party evaluation of a fair price for the consulting.
Rosamond Rhodes, who is director of bioethics at Mount Sinai School of Medicine in New York, said the relationship between doctors and companies is more necessary with medical devices than in other areas, such as pharmaceuticals. Doctors need to learn how to implant an artificial joint, and that probably needs to happen at an event the company paid for, she said.
But even though those relationships may be necessary, she also believes they influence doctors to buy the product made by the company paying the bills.
"The amazing thing is each doctor who is involved believes with a totally pure heart that they are immune. So the influence is silent," she said. "But we know that it affects their judgment."
Doctors urged on signs of lead poisoning
Fri, 02 Nov 2007 01:05:26 GMTBy MIKE STOBBE, AP Medical Writer
ATLANTA - Children with blood lead levels lower than the U.S. standard may still suffer lower IQs or other problems, a government advisory panel said Thursday as it urged doctors to be more alert to signs of lead poisoning.
The warning, in a report from the U.S. Centers for Disease Control and Prevention, comes amid growing parent concerns over imported toys with lead.
Lead poisoning can cause irreversible learning disabilities and behavioral problems and, at very high levels, seizures, coma and even death.
The CDC has never set a threshold for what defines lead poisoning. But it created a standard of sorts in 1991 when it said a lead level of 10 micrograms per deciliter of blood should prompt a doctor to assess the child's environment and take other protective steps.
"You can have toxicity at levels all the way down to zero," said Dr. Morri Markowitz, director of the pediatric environmental sciences clinic at New York City's Montefiore Medical Center. He was not involved in the report.
However, the guideline of 10 micrograms has become the number that doctors use when deciding to refer a child for further attention. The same number is used in Canada and Britain.
This is the first time the Advisory Committee on Childhood Lead Poisoning Prevention has focused on the risks to children with lower levels of lead in their blood, said Dr. Helen Binns of Northwestern University, primary author of the report.
The panel isn't proposing a new standard, she said, but is "emphasizing that all levels are important."
The report is being published in the November issue of the medical journal Pediatrics.
Children with blood lead levels below 10, or even those up to 20, exhibit no obvious symptoms. But scientists believe intellectual development may be affected at lower levels.
The new report was driven by recent research that indicated differences in intellectual development of children with measurable levels of lead poisoning as compared to other kids.
The paper advises doctors how to talk to parents of children who have lower levels of lead and how to describe the risk, nutrition changes and safeguards to prevent any additional exposure, Binns said.
There's no treatment proven effective at reducing these lead levels in children, said Mary Jean Brown, chief of the CDC's lead poisoning prevention branch.
"We don't have an intervention that will lower a blood lead level from 8 to 4," she said.
The paper also recommends that doctors check the labs they use for testing blood, because some are more exact than others.
Approximately 310,000 U.S. children aged 1-5 years have blood lead levels greater than 10 micrograms of lead per deciliter of blood, according to CDC estimates. That's fewer than 2 percent of children in that age bracket.
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On the Net:
The CDC report: http://www.cdc.gov/mmwr
Device created for red wine headache
Fri, 02 Nov 2007 03:02:09 GMTBy MARCUS WOHLSEN, Associated Press Writer
BERKELEY, Calif. - The effects are all too familiar: a fancy dinner, some fine wine and then, a few hours later, a racing heart and a pounding headache. But a device developed by University of California, Berkeley, researchers could help avoid the dreaded "red wine headache."
Chemists working with NASA-funded technology designed to find life on Mars have created a device they say can easily detect chemicals that many scientists believe can turn wine and other beloved indulgences into ingredients for agony.
The chemicals, called biogenic amines, occur naturally in a wide variety of aged, pickled and fermented foods prized by gourmet palates, including wine, chocolate, cheese, olives, nuts and cured meats.
"The food you eat is so unbelievably coupled with your body's chemistry," said Richard Mathies, who described his new technology in an article published Thursday in the journal Analytical Chemistry.
Scientists have nominated several culprits for "red wine headache," including amines like tyramine and histamine, though no conclusions have been reached. Still, many specialists warn headache sufferers away from foods rich in amines, which can also trigger sudden episodes of high blood pressure, heart palpitations and elevated adrenaline levels.
The detector could prove useful to those with amine sensitivity, said Beverly McCabe, a clinical dietitian and co-author of "Handbook of Food-Drug Interactions," a book cited by the article for its descriptions of the effects of amines on the brain.
The prototype — the size of a small briefcase — uses a drop of wine to determine amine levels in five minutes, Mathies said. A startup company he co-founded is working to create a smaller device the size of a personal digital assistant that people could take to restaurants and test their favorite wines.
The researchers found the highest amine levels in red wine and sake and the lowest in beer. For now, the device only works with liquids.
Mathies suggests the device could be used to put amine levels on wine labels.
"We're aware of the consumer demand for information. But that has to be tempered by the manner in which wine is made," said Wendell Lee, general counsel for the Wine Institute, a California industry trade group.
Foreign drug makers face few inspections
Fri, 02 Nov 2007 01:04:57 GMTBy ANDREW BRIDGES, Associated Press Writer
WASHINGTON - Two-thirds of the foreign drug manufacturers subject to inspection by the Food and Drug Administration may never have been visited by agency inspectors, a government watchdog reported to Congress Thursday.
The FDA this year listed 3,249 foreign pharmaceutical manufacturers subject to its inspection — yet the agency cannot determine whether it has ever inspected 2,133 of them, according to a Government Accountability Office report released during a House subcommittee hearing.
While some of the more than 3,000 firms may never have exported prescription drugs or drug ingredients to the United States, others likely have.
Who are those firms and what are they shipping? asked Rep. Bart Stupak, D-Mich., during Thursday's hearing of the House Energy and Commerce subcommittee on oversight and investigations.
"We don't know and we are not certain the FDA knows," Marcia Crosse, director of health care at the GAO, replied.
The few foreign inspections the FDA does conduct in any given year hit just 7 percent of the foreign drug makers exporting to the U.S., the GAO estimates. That means more than 13 years can pass before a foreign manufacturer is visited even once, Crosse said.
In the case of China, which with 714 drug firms boasts the largest number subject to FDA scrutiny of any country, the record is far worse. The FDA is slated to inspect just 13 Chinese establishments this year, meaning just 1.8 percent will see an FDA inspector, according to the GAO report.
In India, the No. 2 country, the record is far better. There, 65 of its 410 firms, or 15.8 percent, are slated for inspection this year, according to the GAO. That's in line with the 16.8 percent of Swiss drug firms the FDA likely will inspect in 2007.
The GAO and Congress have long warned of the FDA's shortcomings in its foreign drug inspection program. The GAO findings released Thursday largely reprise many of the same warnings outlined in a 1998 report.
"It's deja vu all over again," said Rep. John Dingell, D-Mich.
Nearly all U.S. drug makers are inspected at least once every two years, as mandated by a law drawn up long before imports seized a sizable chunk of the drug market. There is no such requirement that the FDA conduct foreign inspections with any regularity, even as imports of all kinds grow in volume. Concerns about the safety of imported drugs, food, toys and other consumer products have been at the fore for months.
"We're finding ourselves again on the brink of one more problem dealing with imports into our country," said Rep. Michael Burgess, R-Texas, adding that current FDA laws and regulations were never intended to handle the increasing volume of imports.
An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad.
The FDA plans to inspect just 300 foreign drug firms this year, announcing in advance its intent to do so each time. That can hinder the FDA's ability to view normal, day-to-day operations, the GAO found. Further, FDA inspectors aren't provided with translators, leaving them to rely on English-speaking firm employees.
Of those foreign inspections, 88 percent are of firms that make drugs awaiting FDA approval, according to the GAO. The balance are of the type of periodic assessment meant to ensure a company's products remain safe in the years following FDA approval. Within the U.S., the proportion is flipped, with 78 percent of FDA drug inspections of the routine, surveillance variety.
The head of the FDA, meanwhile, said the issue is larger than just one of inspection numbers.
"The solution to ensuring the quality of imports does not rely solely on increasing the number of inspections we conduct abroad — or even at the border," Dr. Andrew von Eschenbach said, adding that the FDA seeks to revamp its whole import strategy to focus on ensuring quality is built into agency-regulated products from the start. He also proposed posting FDA employees abroad, where they could help build up the agency's foreign counterparts.
When FDA does visit foreign plants, its inspectors can make sometimes harrowing findings. A warning letter released Thursday by the FDA cited a Chinese manufacturer of pharmaceutical ingredients for a litany of problems, including rust, flaking paint and holes in the ceiling of the production area for an unnamed product.
Much of the uncertainty in the FDA's handling of foreign drug makers stems from its outdated computer systems, which rely on multiple databases that contain sometimes conflicting information that can be compared only manually, the GAO found. Those databases, for instance, contain tallies of foreign drug firms subject to FDA inspection that range from roughly 3,000 to about 6,800, the GAO found.
"How can we have any confidence FDA is truly managing the risk that may come from foreign-made drug products if the FDA doesn't know the exact number or location of foreign drug manufacturers," Stupak said.
Some clarity should be forthcoming: The FDA is soliciting bids to have its worldwide registration database verified, said Margaret Glavin, the FDA's associate commissioner for regulatory affairs.
Von Eschenbach acknowledged his agency's computer infrastructure remains a problem. Still, he said the U.S. drug supply is among the world's safest.
"We shouldn't leave people with the impression the drug supply is unsafe — " said William Hubbard, a former FDA associate commissioner.
"It's vulnerable," interjected Rep. Greg Walden, R-Ore., finishing his sentence.
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On the Net:
Food and Drug Administration — http://www.fda.gov
