Thursday, October 25, 2012

A Special Report on the writing of clinical study reports: is this a single incident (if it occurred) or is this a sign of something done commonly in the biopharma/medical device arena?

Special Report

Medtronic Helped Write, Edit Positive 'Infuse' Spine Studies

Highly positive studies published in peer-reviewed medical journals depicted Medtronic's spine fusion product as a major breakthrough in back surgery, but those studies drafted and edited with direct input from company employees, while the doctors listed as authors were paid millions, according to a U.S. Senate investigation.

The company's heavy, undisclosed manipulation of information about its bone morphogenetic protein-2 product called Infuse included removing and downplaying concerns about serious complications linked to the product and overstating its benefits.

The Money Trail

Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors who co-authored the series of now-repudiated papers about the product. The payments also included two corporate entities associated with some of the doctors.

The investigation by Senate Committee on Finance was prompted in part by Journal Sentinel/MedPage Today investigations that showed how the practice of medicine has been corrupted by conflicts of interest involving doctors, drug and device companies and medical journals.

The Senate report, to be released Thursday, details how Medtronic employees, including some working in the company's marketing department, covertly collaborated with the academic physician authors in producing 11 different papers between 2002 and 2009.

Such "ghostwriting," though not illegal, has been condemned as a breach of integrity and transparency because doctors and patients rely on information in those articles to make medical decisions, not knowing that the papers may contain biased, inaccurate or potentially harmful information.

The Senate's findings highlight problems that should have been reported as at least a decade ago, said Ray Baker, MD, a Kirkland, Wash., pain specialist who served on an advisory panel to Medicare and Medicaid on Infuse.

"I am just sad this happened," he said. "At every level when we thought, 'that wouldn't happen,' it happened. The integrity of our scientific literature is our foundation. It's what predicates our treatments."

Medtronic Denies

Medtronic disputed many of the findings in the Senate's report.

"Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events," a statement emailed by the company said.

The company said it reported the adverse events to the Food and Drug Administration and those risks also are listed the product label for Infuse. Medtronic also called the report's characterization of the payments to the doctors misleading and unfair.

"The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments," the company said.

In 2011, after the Spine Journal devoted an entire issue to repudiating Infuse research, the company, under its new CEO, Omar Ishrak, hired Yale University to oversee an independent review of the safety and effectiveness of Infuse.

"This sounds eerily familiar to many of the transgressions we've read about from the pharmaceutical industry," said Harlan Krumholz, MD, a professor of medicine at Yale University, when told of the Senate report. "It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit.

The Public Trust

"It's no wonder the public has lost confidence in the drug and device industries."

Krumholz is overseeing Yale's review of Infuse. Those results are expected in January.

Medtronic's behavior also drew sharp criticism from two key senators on the committee.

"Medtronic's actions violate the trust patients have in their medical care," Sen. Max Baucus, (D-Mont.), chairman of the committee, said in a statement. "Patients everywhere will be better served by a more open, honest system without this kind of collusion."

Senior member Chuck Grassley (R-Iowa) said the findings support the Physician Payments Sunshine Act that he and Sen. Herb Kohl (D-Wis.) authored. That legislation will require drug and device companies to disclose such payments beginning next year.

"The findings also should prompt medical journals to take a very proactive approach...," Grassley said in a statement. "...The public will benefit from more transparency and accountability on their part."

In response to the Senate investigation, Medtronic turned over more than 5,000 documents, including emails involving the doctors and Medtronic employees as well as 14 years of payments from Medtronic to the doctors.

The Infuse Story

In January 2002, Hal Mathews, MD, spoke glowingly about Infuse to a FDA advisory panel that was considering whether to recommend approval of the product.

Mathews, then a Richmond, Va. spine surgeon who had taken part in the pivotal Infuse clinical trial, told the panel he had no direct financial interest in the product and that he was not being paid to appear at the meeting.

However, a 2001 email shows that Medtronic worked with the New York-based public relations firm, Ketchum, to prepare Mathews' speech to the panel, which went on to recommend approval of the product.

In addition, though Medtronic told the committee that Mathews was not paid for any activity undertaken in January 2002, Mathews was paid under consulting arrangements with the company in 2001.

In 2007, Mathews was hired by Medtronic as its vice president of medical and clinical affairs.

From the Pen of Medtronic

An email indicated that a Medtronic marketing employee, Julie Bearcroft, was involved in editing a 2005 Journal of Bone and Joint Surgery article and recommended against publishing a complete list complications related to the structural integrity of the fused area.

Those complications -- known as implant migration, subsidence and end-plate fracture -- had been observed in a clinical trial and had been formatted in a detailed table, according to an internal Medtronic email. But, following the advice of Bearcroft, that table was not included in the published paper.

"I personally think it is appropriate to simply report the adverse events were equivalent in the two groups without the detail," Bearcroft wrote in a note on a draft of the article.

After the editing change was made, the lead author of the paper, Ken Burkus, MD, a Columbus, Ga. surgeon, sent a draft of the paper to his co-authors with the note, "this manuscript documents the superiority in clinical and radiographic outcomes with (Infuse)..."

Burkus, who got $6.4 million from Medtronic between 1998 through 2010, did not respond to an email seeking his comment.

Medtronic officials inserted into papers language that attempted to portray Infuse as a better, less painful alternative to the standard technique of using a small amount of a patient's own hip bone for fusing vertebrae, a claim that has been questioned by independent spine surgeons.

Giving Infuse the Edge

In 2001 and 2002, after viewing early drafts of a 2002 Infuse paper, Neil Beals, a Medtronic marketing official recommended that the physician authors make "a bigger deal" out of the supposed pain reduction with Infuse.

Subsequently, a sentence was inserted in the paper stating that Infuse spared patients from being exposed to problems associated using their own bone for the fusion.

In its review of Infuse last year, doctors writing in the Spine Journal said the often-cited donor site pain was less frequent and serious than Infuse proponents suggested.

In addition, in a draft of a 2003 paper the authors said that any pain at the site of the hipbone graft site had been resolved in the study subjects within a year of the surgery. But Beals questioned that and inserted language saying residual effects of the donor site should be noted.

The final article appears to have adopted his suggestions, noting that even 24 months after the surgeries "some patients continued to experience residual pain at the donor site and rated the appearance of the site as only fair."

Downplaying Safety Concerns

The company also tried, unsuccessfully, to adopt weaker patient safety rules for a clinical trial testing the effectiveness of Infuse in the cervical spine, a use that remains unapproved and which has been linked to life threatening swelling in neck.

In 2008, the FDA warned doctors against using Infuse in cervical spine fusions, citing 38 cases of swelling in the neck and throat leading to compression of the airway. Some of those cases required emergency tracheotomies.

The weaker safety rules sought by Medtronic would have allowed the company to continue the clinical trial even if patients experienced severe swelling in neck.

Infuse is a powerful biological agent that stimulates the growth of new bone, but excess bone growth can be a serious problem when the product is used in certain off-label surgeries. It was approved in 2002 for lumbar spine fusions in which the surgical approach is from the front.

The unapproved use has caused serious problems for Patricia Caplinger and hundreds of other spine surgery patients like her, according to a lawsuit filed earlier this year against Medtronic in federal court in Oklahoma.

The complication experienced by Caplinger was the subject of a 2004 paper written by doctors who have received millions of dollars from Medtronic. That paper involved a clinical trial of Infuse that had to be halted five years earlier because of excess bone growth in the spinal canals of 70% of the patients.

That clinical trial used Infuse in a surgery similar to what Caplinger underwent in 2010.

The surgeons who wrote the article said that patients weren't harmed by the excess bone growth. But that claim that was refuted by an Oklahoma surgeon who took part in the trial and told the Journal Sentinel/MedPage Today last year that he had two patients who developed painful, excess bone growth that required additional surgeries. Caplinger who lives in Missouri was not one of those patients.

A helping hand in the OR

Caplinger says that her doctor and others surgeons were persuaded by Medtronic and its "paid physician promoters" to use Infuse in dangerous, off-label surgeries, according to her lawsuit.

In Caplinger's case, a Medtronic representative actually was present during her surgery and "was actively involved," providing information about use of Infuse in Caplinger's procedure, according to the lawsuit.

Because of the excess bone growth, Caplinger suffers continuous pain in her back and legs and developed a condition known as foot drop, which, in turn, led to a ligament tear in her right knee. She also has required revision surgery on her back and will need another revision surgery because the bone growth is continuing.

In an email, Caplinger, a nurse, said she is worried that the pain eventually will prevent her from doing what she loves the most, working in the emergency department.

"I live with pain every minute of every day," she said. "I have forgotten what not being in pain feels like."
A Medtronic spokesperson said the complaint lacks and the company has the court to dismiss the case.

Medtronic had answers

The Senate report and accompanying documents also show Medtronic employees -- in addition to editing drafts of a paper -- at times covertly drafted responses to questions raised by other doctors who were examining the work as part of medical journal peer review.

Case in point: A 2004 paper was published in the Spine Journal where co-author Charles Branch Jr., MD, also served as deputy editor. Branch, chairman of neurosurgery at Wake Forest University, received $3.1 million from Medtronic from 1998 to 2010. His royalty payments have been split with the university.

That article also was subject of a 2011 Journal Sentinel/MedPage Today investigation.

The Senate documents include a 2003 email, as the article was being drafted, in which Bill Martin, the company's vice president of spinal marketing, wrote: "We may want to steer clear of calling it a flawed technique. There are still quite a few surgeons utilizing this technique..."

About a week later, Rick Treharne, another Medtronic executive, wrote to one of the paper's authors: "In looking over the data, I was impressed with how well the BMP (Infuse) patients actually did. So much so that I added a few paragraphs at the end that you may not agree with."

As peer reviewers for the journal looked over the paper, they raised concerns that it was a slanted, advertising piece.

"This manuscript is full of biased statements that are a reflection of the data evaluators -- the company that markets the product," wrote one reviewer.

"Unless the authors can discuss the results in this study in an unbiased manner, which they have been unable to do in its present form, this data should not be published," wrote another.

Treharne then sent one of the co-authors a draft of a letter to be sent to the editor of the journal addressing the concern. Another Medtronic executive also helped formulate a response to the editor.

The letter that ultimately was sent to the journal's editor sought to reassure him, claiming that three of the co-authors were independent, the Senate investigation found.

But between 1997 and 2003, two of the "independent" authors had received $8.5 million from Medtronic.

"We were falsely reassured that there were independent people looking at the data," said Eugene Carragee, MD, who took over as editor of the Spine Journal in 2009. "It's a violation of the fundamental trust of peer review."

When published, the paper described the results of halted clinical trial as "encouraging."

This story was reported as a joint project of the Journal Sentinel and MedPage Today.
View 5 comments or Add Your Knowledge ™

Tuesday, October 23, 2012

Guess momma was right when she said "eat your beans" because now a new study shows it helps to lower cholesterol and triglycerides while improving glycemic control in diabetics.

Legumes May Aid Glycemic Control, Cut Lipids

In a randomized controlled trial, patients who ate at least an additional cup of legumes per day had a greater reduction in HbA1c than patients who increased their insoluble fiber consumption for 3 months (-0.5% versus -0.3%, P<0.001), David Jenkins, MD, PhD, of the University of Toronto, and colleagues reported online in the Archives of Internal Medicine.

Foods with a low glycemic index (GI) have been shown to improve glycemic control in patients with type 2 diabetes, and legumes -- such as beans, chickpeas, and lentils -- were among the first foods recognized to have low GI values.

They've been recommended in many nutrition therapy guidelines for diabetes, but their effects on glycemic control and other parameters still remain controversial, researchers say.

So Jenkins and colleagues randomized 121 patients with type 2 diabetes to one of two diets for 3 months: a low-GI legume diet that required them to eat at least a cup of legumes per day, or to a diet that increased their intake of insoluble fiber via consumption of whole wheat products.

The primary outcome was change in HbA1c, with a secondary endpoint of calculated coronary heart disease risk.

The difference they found in HbA1c reduction remained significant after adjustment for body weight change, they reported (P=0.005).

In terms of cardiac parameters, they found that the legume diet significantly lowered mean total cholesterol (-8 mg/dL, P<0.001) and triglycerides (-22 mg/dL, P<0.001), without any changes in HDL cholesterol levels.

The insoluble fiber diet increased average HDL cholesterol levels (2 mg/dL, P=0.004), although the reasons for this are unclear, given that such an association hasn't been seen before in the literature, the researchers noted.

And the legume diet reduced blood pressure and heart rate relative to the high insoluble fiber diet, they added.

Thus, the legume diet overall reduced heart risk significantly more than the insoluble fiber diet (-0.8%, P=0.003), and the researchers concluded that incorporating legumes into a low-GI diet can help improve glycemic control and reduce heart risk.

In an accompanying editorial, Marion Franz, MS, RD, questioned whether the modest benefits come from the dietary components or from a reduced energy intake overall.

She warned that low-GI diet has been controversial, with some smaller studies showing a benefit in terms of improved glycemic control but larger studies showing no such benefit.

Franz conceded that legumes are part of a healthy diet for diabetics and the general population, but "whether people with diabetes can eat the amount necessary to improve glycemic control is debatable, and, if legumes do improve glycemia, is it because of their low GI or high soluble fiber content?"

She concluded that nutrition therapy for diabetes is effective but "just as there is no one medication or insulin regimen appropriate for all persons with diabetes, there is no one nutrition therapy intervention."

The study was supported by the Agricultural Bioproducts Innovation Program through the Pulse Research Network and the Saskatchewan Pulse Growers.
The researchers reported relationships with Sanitarium, Agri-Culture, Agri-Food Canada, Canadian Agriculture Policy Institute, California Strawberry Commission, Loblaw Supermarket, Herbal Life International, Nutritional Fundamental for Health, Pacific Health Laboratories, Metagenics, Bayer Consmer Care, Orafti, Dean Foods, Kellogg's, Quaker Oats, Procter & Gamble, Coca-Cola, Abbott, Canola Council of Canada, Almond Board of California, American Peanut Council, International Tree Nut Council, the Peanut Institute, Barilla, Unilever, Solae, Oldways, Haine Celestial, Pepsi, Alpro, Pulse Research Network, Advanced Food Materials, American Pistachio Growers, Danone, General Mills, Paramount Farms, Archer Daniels Midland, and Glycemic Index Laboratories.
The editorialist reported no conflicts of interest.

From the American Heart Association:

Monday, October 15, 2012

According to this study on children, "More Sleep = Better School Activity" as its findings mirror other studies demonstrating improved performance for children and adults following quality sleep.

More Zzzs Earn A's for Behavior at School

Giving children an average of just 27 more minutes of sleep than they usually got on school nights improved their emotional stability and cut down on restless and impulsive behavior at school, Reut Gruber, PhD, of McGill University in Montreal, and colleagues found.

Taking away about an hour of sleep from a similar group of healthy 7- to 11-year-0lds had the opposite effect in the experiments reported in the November issue of Pediatrics.

"Healthy sleep is essential for supporting alertness and other key functional domains required for academic success," the group wrote. "Sleep must be prioritized, and sleep problems must be eliminated."

Previous, mostly observational studies have linked more sleep to better grades among teens and less sleep to development of psychiatric problems in children.

An estimated 43% of boys ages 10 to 11 don't get the recommended amount each night, and almost two-thirds of school-age kids don't get to bed by 9 p.m., Gruber and colleagues noted.

Moderately increasing children's sleep is both feasible and beneficial, they concluded, arguing for parents, teachers, and students to be educated about "the critical impact of sleep on daytime function."

For their study, the researchers randomized 34 healthy children ages 7 to 11 who had no sleep problems or behavioral or academic troubles to receive an extra hour of sleep at home each night for 5 nights or to have 1 hour taken away from their usual nightly sleep time for 5 nights. No napping was allowed.

Actinography showed that the children in the sleep extension group actually got only an average of 27 minutes more than their baseline of 9.3 hours, while the sleep-restriction group had 54 minutes cut from their similar baseline sleep time.

Those who slept less than usual had a drop in sleep fragmentation (P<0.03) reflecting better quality sleep, but they were still more sleepy during the day than before the experiment, with Modified Epworth Sleepiness Scale score rising to a mean of 6 from 4 at baseline on the 24-point scale.

Their behavior in school also worsened as assessed by their teachers, who were unaware of study group assignment, using the Conners' Global Index Scale.

Total normalized T-scores rose from an average of 50 at baseline to 54 after sleep restriction, whereas they fell to an average of 47 points from 50 at baseline among the group that got extra sleep all week (P<0.05 for interaction).

A score of 60 or above is considered clinically significant, the researchers pointed out.

Likewise, the component T-scores for "emotional lability" -- crying, losing one's temper, or becoming easily frustrated -- rose from 48 to 51 after sleep reduction but fell from 50 to 47 after extended sleep.

The restless and impulsive behavior subscale T-scores rose from 52 to 55 for those who got less sleep and fell from 50 to 47 for those who got extra sleep.

The researchers cautioned about the relatively small size of the study and convenience sample used and thus suggested that the results be considered preliminary in nature.

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Canadian Institutes of Health Research.
The researchers reported having no conflicts of interest to disclose.

Friday, October 12, 2012

In reading this report on how ERs should assess for neck injuries, it seems as if they may finally be considering doing exactly what doctors of chiropractic have been doing for years.

Neck Injury Screens Not Equivalent

There's a better way to screen for cervical spine injury in the emergency department, a systematic review comparing two decision rules showed.

The Canadian C-spine rule had better sensitivity and specificity for clinically important cases than the NEXUS (National Emergency X-Radiography Utilization Study) criteria, Zoe A. Michaleff, BAppSc, of the George Institute for Global Health at the University of Sydney, Australia, and colleagues reported online in CMAJ.

Both methods use patient history, physical exam characteristics, and simple diagnostic tests to determine the probability of fracture, dislocation, or ligament instability that can lead to spinal cord injury or death if missed.

Screening helps reduce the number of unnecessary referrals for imaging, cutting down on costs, radiation exposure, and psychological stress for the patient, they noted.

Many international guidelines recommend using clinical decision rules to assess the need for imaging cervical spine injuries after car accidents and other blunt trauma but without consensus on which to use.

For a comparison, the review included 15 cohort studies of patients with blunt trauma looking at a differential diagnosis of clinically important cervical spine injury detectable by diagnostic imaging.

Eight of the studies used NEXUS criteria only, which recommends diagnostic imaging for patients with neck trauma unless they meet all of the following:

  • No tenderness in the posterior midline cervical spine
  • No evidence of intoxication
  • No focal neurologic deficit
  • No painful distracting injuries
  • Normal alertness with a score of 15 or better on the Glasgow Coma Scale

Six of the studies used only the Canadian C-spine rule, which uses the following criteria to send alert patients to radiography:

  • Any high-risk factor, including age 65 or older, a dangerous mechanism of trauma (such a high-speed crash or fall from more than 3 ft. elevation), or paresthesias in extremities
  • Absence of a low-risk factor that allows for safe assessment of range of motion (such as being ambulatory at any point, delayed onset of neck pain, or a simple rear-end car crash)
  • Inability to rotate the neck 45° to the left and right

Both tests were highly sensitive with ranges from 0.83 to 1.0 for NEXUS and 0.90 to 1.0 for the Canadian C-spine rule. False negative rates were low at 1.0% or less across all studies.

These rates suggested "that a negative test result is highly informative in excluding a clinically important cervical spine injury and, therefore, the need for radiographic examination," Michaleff's group explained.

Both also showed similar potential to reduce imaging rates, by an average 31% with NEXUS and 42% with the Canadian criteria, without missing a clinically important cervical spine injury.

"However, the lower specificity and false-positive results indicate that many people will continue to undergo unnecessary imaging," the researchers noted.

Specificity ranged from 0.13 to 0.46 with NEXUS criteria and 0.01 to 0.77 with the Canadian C-spine rule
.
Only one study directly compared the two screening tools, and it gave the edge to the Canadian C-spine rule for diagnostic accuracy in terms of sensitivity, specificity, likelihood ratios, and reduction in unnecessary imaging.

The researchers cautioned about the modest methodologic quality of the studies, inability to pool data for comparison, and within-trial variations in how the rules were interpreted and applied.

"Future studies of diagnostic test accuracy need to ensure that rigorous methodologic procedures are followed to reduce bias" and to test use outside of the emergency department and in pediatric and older populations, they noted.

The researchers reported having no conflicts of interest to declare.

Saturday, October 6, 2012

The biggest danger in trying to build on the body of scientific evidence, or provide patients with up-to-date information. is when published papers turn out to be retracted due to fraud or simply being erroneous. Those numbers, luckily, are small in number. However, the number of studies being retracted is on the rise.

Editorial

Fraud in the Scientific Literature


A surprising upsurge in the number of scientific papers that have had to be retracted because they were wrong or even fraudulent has journal editors and ethicists wringing their hands. The retracted papers are a small fraction of the vast flood of research published each year, but they offer a revealing glimpse of the pressures driving many scientists to improper conduct.

Last year, Nature, a leading scientific journal, calculated that published retractions had increased tenfold over the past decade — to more than 300 a year — even though the number of papers published rose only 44 percent. It attributed half of the retractions to embarrassing mistakes and half to “scientific misconduct” such as plagiarism, faked data and altered images. 

Now a new study, published in the Proceedings of the National Academy of Sciences, has concluded that the degree of misconduct was even worse than previously thought. The authors analyzed more than 2,000 retracted papers in the biomedical and life sciences and found that misconduct was the reason for three-quarters of the retractions for which they could determine the cause. 

The problem is global. Retracted papers were written in more than 50 countries, with most of the fraud or suspected fraud occurring in the United States, Germany, Japan and China. The problem may even be greater than the new estimates suggest, the authors say, because many journals don’t explain why an article was retracted — a failure that calls out for uniform guidelines. 

There are many theories for why retractions and fraud have increased. A benign view suggests that because journals are now published online and more accessible to a wider audience, it’s easier for experts to spot erroneous or fraudulent papers. A darker view suggests that publish-or-perish pressures in the race to be first with a finding and to place it in a prestigious journal has driven scientists to make sloppy mistakes or even falsify data. The solutions are not obvious, but clearly greater vigilance by reviewers and editors is needed.

Friday, October 5, 2012

With a rise in reported cases of spinal meningitis, the CDC reports that the vector causing the disease may be a fungus found in drugs used to control back pain via epidural injections.

CDC and FDA: Meningitis Toll Rising


Thirty-five people in six states have been sickened by a rare form of meningitis, which has been linked to three recalled lots of an injectable steroid, and five have died, the CDC said in a press briefing Thursday afternoon.

Hardest hit is Tennessee, which is reporting 25 cases and three deaths, according to Benjamin Park, MD, of the CDC's mycotic diseases division.

"We expect to see additional cases as this investigation unfolds," Park told reporters in the telephone briefing.

While the cause of the outbreak remains unclear, officials suspect three lots of preservative-free methylprednisolone acetate manufactured by the New England Compounding Center in Framingham, Mass.

FDA investigators, examining an unopened vial of the substance at the company's plant, found "foreign matter" that turned out under microscopic study to be a fungus, according to Ilisa Bernstein, PharmD, of the agency's Center for Drug Evaluation and Research.

The exact type of fungus is still under study, she told reporters.

So far, analysis has also identified a fungus in the CSF of five of the affected patients, according to Park.
The compounding pharmacy has voluntarily stopped making and distributing its products, and the FDA is urging doctors to avoid use of any part of the recalled lots or any other product intended for intrathecal injection.

The company's website was offline Thursday.

The steroid is used to control back pain and the people involved in all 35 cases had been given epidural steroid injections, Park said.

Aside from the 25 cases in Tennessee, there have been four reported cases in Virginia, two each in Maryland and Florida, and one each in North Carolina and Indiana. Virginia and Maryland have each reported one death associated with the outbreak.

The incubation period for the fungal infection is not known, and more cases might yet be detected, although the suspect lots of the steroid are no longer being used.

Park said parts of the three lots of steroid were shipped to 23 states -- the six reporting cases, plus California, Connecticut, Georgia, Idaho, Illinois, Michigan, Minnesota, New Hampshire, Nevada, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, and West Virginia.

Symptoms include new or worsening headache, nausea, dizziness and fevers and possibly slurred speech, unsteady gait, urinary retention, weakness, and sensory deficit.

The delay between the injection and the appearance of symptoms has been between 1 and 4 weeks, Park said. The severity of symptoms has varied widely, he added.

Officials have emphasized that the condition is not contagious, unlike viral or bacterial meningitis.

Park said the outbreak came to light when Tennessee officials called the CDC on Sept. 21 with a report of a patient with meningitis that became apparent 19 days after an epidural steroid injection.

Initial cultures from the cerebrospinal fluid were negative, but later work discovered a fungus in the cerebrospinal fluid (CSF), he said.

A week later, on Sept. 28, the agency was notified of a case outside Tennessee, "possibly indicating contamination of a widely distributed medication," he said.

Healthcare personnel should take all products from the Framingham pharmacy off their shelves, Park said.
Doctors should contact all patients who got an epidural steroid injection with a drug from one of the three recalled lots to see if they are experiencing any symptoms, however mild, he added.

Patients who got other types of injections using a drug from one the three lots should also be investigated, Park said.

Monday, October 1, 2012

Is the CDC "lobbying" or "educating" the public about obesity? Or is the food and beverage industry lobbying Congress to slow health concerns about sugary and fast foods? Just what is going on here?

CDC on Obesity: Public Health or Politics?


WASHINGTON -- The CDC has operated generally with bipartisan support for several decades regardless of who was in the White House or which party controlled Congress.

Campaigns targeting the issues the CDC has championed -- such as tobacco cessation and obesity prevention -- were funded and backed with little objection. Its hallmark issues have varied little with the political ideology of whichever party controlled Washington.

But now, projects the CDC funds are gaining increased attention from Republicans in Washington, who are saying the CDC's latest efforts are blurring the line between lobbying and what a federal agency can support.

OIG Report Issued

In March, congressional Republicans asked Health and Human Services (HHS) Secretary Kathleen Sebelius for a report on CDC's advocacy activities.

"We urge you to launch a full investigation and accounting to determine whether CDC grantees ... have misappropriated federal tax dollars for lobbying activity," representatives Ed Whitfield and Brett Guthrie, both Republicans from Kentucky, wrote in a letter.

"We respectfully request that you clarify your various understanding of the various federal anti-lobbying prohibitions involving tax dollars and how these prohibitions apply to CDC grantees engaged in seeking to influence state and local government bodies."

The HHS Office of Inspector General (OIG) investigated the issue. In a June letter on its findings to CDC Director Thomas Frieden, MD, MPH, the OIG agreed with the representatives' concerns, saying it also was concerned about "inappropriate lobbying activities" by some of the agency's grantees.

The grants in question -- namely, the Community Transformation Grants and Communities Putting Prevention to Work grants -- went toward fund preventing obesity through limiting children's access to fatty foods and sugary drinks, a once bipartisan issue that has suddenly become partisan.

"What's happening with food and beverages and obesity, I think, is quite different historically" from other CDC advocacy efforts, Gene Matthews, the CDC's chief legal officer for 25 years before leaving in 2004, told MedPage Today.

The CDC has traditionally used its knowledge of public health problems to educate the public and policymakers on possible solutions, and public health experts hope this new-found interest from Congress in the CDC doesn't change the public health agency's mission of preventing communicable and chronic disease.

"What's wrong is to take federal money, learn something, and not tell anybody," Scott Burris, director of the Center for Health Law at Temple University, said in an interview.

"What's going on here is a systematic effort to keep experts ... as much as possible out of the policy debate," Scott said. "This is about translating research into action."

Past Policy Areas Varied

Issues the CDC has backed have changed slightly over the past few decades as different public health events called for action.

During the Nixon to Carter administrations, the CDC backed state immunization laws for school attendance, said Matthews, who is now at the University of North Carolina. The CDC also has supported fluoridation of public water supplies, stricter seat-belt laws, maternal health programs, and anti-violence campaigns. The issue of bioterrorism preparedness was pushed by the CDC after the Sept. 11 terrorist attacks.

All of those issues enjoyed support from Republicans and Democrats alike, CDC advocates said.

There have been some controversial topics that have fallen on or off the radar depending on who controlled the White House and majority in Congress. For example, the Bush administration used the CDC to push abstinence-only education in public schools, Matthews said.

Reducing HIV transmission through needle-exchange programs was another issue the CDC looked at. In the 1990s, after studying 36 different needle-exchange programs, the CDC found the programs reduced HIV transmission with no evidence of increasing drug use.

"In fact, several of the people who participated got into drug treatment programs," said David Satcher, MD, the CDC director under President Bill Clinton from 1993 to 1998.

dle-exchange programs. However, the president changed his mind about an hour before a press conference to announce the support and decided not to push for that funding, Satcher told MedPage Today.

The issue of gun control was never really tackled by the CDC because of its touchy political nature, Matthews said.

As for advocating on the obesity issue, "I think historically the anti-obesity campaign that evolved with the recognition of the epidemic about 15 years ago ... I think that started as bipartisan," Matthews said. "Just within the last several years, it seems to be partisan."

Current Activities Called into Question

The current controversy comes from grant programs funded through the Affordable Care Act and the American Recovery and Reinvestment Act (the latter is more commonly called the stimulus bill). Each was intended to support changes in nutrition, physical activity, and tobacco use.

But the OIG identified what it considered to be questionable grants, such as $2.2 million to the California Department of Public Health to "advance policy changes to limit the availability" of soda in schools. Another was $12 million that went to King County, Wash., to influence policy, including efforts to "change zoning policies to locate fast food retailers farther from ... schools."

The grants may have violated laws that prevent federal dollars from being used for lobbying. But these were efforts generally allowed and supported in the past.

The House of Representatives has held a series of hearings since 2010 drawing attention to these programs. Republicans questioned HHS Secretary Kathleen Sebelius about the grants at a House Energy and Commerce Health Subcommittee hearing on March 1, and earlier at an April 2010 hearing.

The movement reminds Matthews of tobacco controversies that occurred in the 1980s and 1990s. Some of the tactics that tobacco companies used to dissuade public discourse -- and to discourage public health initiatives such as smoking bans and higher cigarette taxes -- are now being used by the food and beverage industries to discourage the soda and obesity initiatives.

"This feels very similar, although the topic appears to be sugary drinks and fast foods," Matthews said.
The quest to add calorie counts to fast food menus, ban sodas in schools, and define pizza not as a vegetable seems to be creating upheaval in the public because they are lifestyle issues.

"These changes seem to be controversial in communities ... and we're having some political backlash because of it," said Marice Ashe, founder and chief executive of ChangeLab Solutions, a public health advocacy group.

Where Does CDC Go From Here?

Congress has now taken additional steps to limit CDC action. Lawmakers inserted language into an appropriations bill in December that distorts 30 years of public advocacy, Matthews said.

The change says agencies can't use federal dollars for grassroots efforts or to lobby on behalf of specific legislation. The language extends the prohibition, which was previously limited to legislative branch actions, to the executive branch.

"It appears to be a deliberate attempt to blur the lines between illegal lobbying and advocacy," Matthews said. "I think the CDC has done a very good job at trying to demystify that to the extent that it can be demystified."

But it's a change that many CDC supporters don't agree with and are still trying to figure out. "Educating people about what steps need to be taken to prevent disease is not lobbying," Ashe said.

Even if the CDC is more limited in what it can fund, public health advocates can still generate money and interest from state funding and private donations.

"I hope that the public health community at large ... is not going to see a lot of change," Ashe said. "Whether the CDC is going to be as up front in the public policy, I don't know."

So far, lawyers are also saying the new law isn't changing things, Scott, from Rutgers, said.

In its June 29 letter to CDC director Frieden, HHS Inspector General Daniel Levinson proposed that the CDC clarify any misleading statements about lobbying activities from its grantees and provide updated and more detailed guidance describing how to avoid violating anti-lobbying statutes in the future.

"Additionally, OIG plans to review CDC grants to reduce chronic disease and promote healthy lifestyles funded with money subject to the lobbying provisions in the FY 2012 HHS appropriation," Levinson wrote.

Leaders of the House Energy and Commerce Committee wrote HHS Secretary Kathleen Sebelius in August asking for information from the two grant programs in question and a detailed correction action plan in response to the OIG letter.

"We certainly haven't heard the last of this from Congress," Matthews said.