MOTHER DOES RESEARCH

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Mother Does Research, Chooses Not to Vaccinate


FLINT, MI – Local mother of a 2 children, Denise Jacobson has decided after much research that she will not vaccinate her children. “Research is so easy these days, with Google and Bing. I was able to find a lot of information.”  Ms. Jacobsen has thousands of websites and Facebook groups bookmarked on her Firefox browser. She also has talked with countless self proclaimed experts who have concerns over vaccinations. 
Ms Jacobson laid out her case:  “Vaccines are targeted at diseases that don’t exist. I have never heard of someone having polio or rubella. Maybe I would get a vaccine for ear infections, my kids get those ALL the time. Mostly because their diet contains too much gluten, which I am trying to eliminate.” Sources say she claims her fear of needles stemmed from getting vaccines as a child which has given her PTSD. She went on to describe how the safety studies on these vaccines are over a short period of time, 50+ years, and that she wants more evidence. “Do vaccines cause college freshmen to binge drink? Where is the study that shows they don’t?” She also claims that non-vaccinated children score higher on geography tests than vaccinated kids.  “My Nathan beat Sammy on the South America geography test last week, obviously due to not having toxins in his brain.” Denise’s friend Janet also weighed in. “I heard to make vaccines they take mercury and aluminum to kill the virus, and then they take the mixture and inject it into your child! No thank you.” “Many famous people throughout history weren’t vaccinated including Jesus and hey did just fine,” Denise referring to Jesus Christ the man who was born 1,796 years before the first known vaccine. Denise also made a reference to non-internet sources, “The Mom’s group we are in all heard about the kid on Oak street who is a little weird.  And I know he got vaccines just last month!”

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ANTI-VACCINATION EPIDEMIC

The Anti-Vaccination Epidemic

Whooping cough, mumps and measles are making an alarming comeback, thanks to seriously misguided parents.

ENLARGE
GETTY IMAGES/IMAGEZOO
By 

PAUL A. OFFIT

Sept. 24, 2014 6:40 p.m. ET576 COMMENTS

Almost 8,000 cases of pertussis, better known as whooping cough, have been reported to California’s Public Health Department so far this year. More than 250 patients have been hospitalized, nearly all of them infants and young children, and 58 have required intensive care. Why is this preventable respiratory infection making a comeback? In no small part thanks to low vaccination rates, as a story earlier this month in the Hollywood Reporter pointed out.

The conversation about vaccination has changed. In the 1990s, when new vaccines were introduced, the news media were obsessed with the notion that vaccines might be doing more harm than good. The measles-mumps-rubella (MMR) vaccine might cause autism, we were told. Thimerosal, an ethyl-mercury containing preservative in some vaccines, might cause developmental delays. Too many vaccines given too soon, the stories went, might overwhelm a child’s immune system.

Then those stories disappeared. One reason was that study after study showed that these concerns were ill-founded. Another was that the famous 1998 report claiming to show a link between vaccinations and autism was retracted by The Lancet, the medical journal that had published it. The study was not only spectacularly wrong, as more than a dozen studies have shown, but also fraudulent. The author, British surgeon Andrew Wakefield, has since been stripped of his medical license.

But the damage was done. Countless parents became afraid of vaccines. As a consequence, many parents now choose to delay, withhold, separate or space out vaccines. Some don’t vaccinate their children at all. A 2006 study in the Journal of the American Medical Association showed that between 1991 and 2004, the percentage of children whose parents had chosen to opt out of vaccines increased by 6% a year, resulting in a more than twofold increase.

Today the media are covering the next part of this story, the inevitable outbreaks of vaccine-preventable diseases, mostly among children who have not been vaccinated. Some of the parents who chose not to vaccinate were influenced by the original, inaccurate media coverage.

For example, between 2009 and 2010 more than 3,500 cases of mumps were reported in New York City and surrounding area. In 2010 California experienced an outbreak of whooping cough larger than any outbreak there since 1947. Ten children died.

In the first half of 2012, Washington suffered 2,520 cases of whooping cough, a 1,300% increase from the previous year and the largest outbreak in the state since 1942. As of Aug. 29, about 600 cases of measles have occurred in the U.S. in 2014: the largest outbreak in 20 years—in a country that the Centers for Disease Control and Prevention declared measles-free in 2000.

Who is choosing not to vaccinate? The answer is surprising. The area with the most cases of whooping cough in California is Los Angeles County, and no group within that county has lower immunization rates than residents living between Malibu and Marina Del Rey, home to some of the wealthiest and most exclusive suburbs in the country. At the Kabbalah Children’s Academy in Beverly Hills, 57% of children are unvaccinated. At the Waldorf Early Childhood Center in Santa Monica, it’s 68%, according to the Hollywood Reporter’s analysis of public-health data.

These are the kind of immunization rates that can be found in Chad or South Sudan. But parents in Beverly Hills and Santa Monica see vaccines as unnatural—something that conflicts with their healthy lifestyle. And they have no problem finding fringe pediatricians willing to cater to their irrational beliefs.

These parents are almost uniformly highly educated, but they are making an uneducated choice. It’s also a dangerous choice: Children not vaccinated against whooping cough are 24 times more likely to catch the disease. Furthermore, about 500,000 people in the U.S. can’t be vaccinated, either because they are receiving chemotherapy for cancer or immune-suppressive therapies for chronic diseases, or because they are too young. They depend on those around them to be vaccinated. Otherwise, they are often the first to suffer. And because no vaccine is 100% effective, everyone, even those who are vaccinated, is at some risk.

Parents might consider what has happened in other countries when large numbers of parents chose not to vaccinate their children. Japan, for example, which had virtually eliminated whooping cough by 1974, suffered an anti-vaccine activist movement that caused vaccine rates to fall to 10% in 1976 from 80% in 1974. In 1979, more than 13,000 cases of whooping cough and 41 deaths occurred as a result.

Another problem: We simply don’t fear these diseases anymore. My parents’ generation—children of the 1920s and 1930s—needed no convincing to vaccinate their children. They saw that whooping cough could kill as many as 8,000 babies a year. You didn’t have to convince my generation—children of the 1950s and 1960s—to vaccinate our children. We had many of these diseases, like measles, mumps, rubella and chickenpox. But young parents today don’t see the effects of vaccine-preventable diseases and they didn’t grow up with them. For them, vaccination has become an act of faith.

Perhaps most upsetting was a recent study out of Seattle Children’s Hospital and the University of Washington. Researchers wanted to see whether the whooping cough epidemic of 2012 had inspired more people to vaccinate their children. So they studied rates of whooping cough immunization before, during and after the epidemic. No difference. One can only conclude that the outbreak hadn’t been large enough or frightening enough to change behavior—that not enough children had died.

Because we’re unwilling to learn from history, we are starting to relive it. And children are the victims of our ignorance. An ignorance that, ironically, is cloaked in education, wealth and privilege.

Dr. Offit is a professor of pediatrics in the division of infectious diseases and director of the Vaccine Education Center at The Children’s Hospital of Philadelphia.

UNUSUAL DOCTOR BILLINGS

 

Taxpayers Face Big Medicare Tab for Unusual Doctor Billings

More Than 2,300 Providers Earned $500,000 or More From a Single Procedure or Service, Data Show

By 

JOHN CARREYROU, 
CHRISTOPHER S. STEWART and 
ROB BARRY 
June 9, 2014 10:00 p.m. ET
Ronald S. Weaver isn’t a cardiologist. Yet 98% of the $2.3 million that the Los Angeles doctor’s practice received from Medicare in 2012 was for a cardiac procedure, according to recently released government data.

The procedure is rarely used by the nation’s heart doctors. Patients are strapped to a bed with three large cuffs that inflate and deflate rhythmically to increase blood flow through the arteries—a last resort to treat severe chest pain in people who can’t have surgery.

The government data show that out of the thousands of cardiology providers who treated Medicare patients in 2012, just 239 billed for the procedure, and they used it on fewer than 5% of their patients on average. The 141 cardiologists at the Cleveland Clinic, renowned for heart care, performed it on just six patients last year. Dr. Weaver’s clinic administered it to 99.5% of his Medicare patients—615 in all—billing the federal health-insurance program for the elderly and disabled 16,619 times, according to the data.

Medicare Unmasked

Part of a series examining payments in the roughly $600 billion Medicare system.

In an interview, Dr. Weaver said he learned about the procedure by “reading lots of articles, studies and clinical trials” and decided to build his practice around it. There is no consensus in the cardiology community whether the treatment provides significant benefits. Dr. Weaver, who likens it to “exercise while lying on your back,” says it improves his patients’ health.

More than 2,300 providers earned $500,000 or more from Medicare in 2012 from a single procedure or service, according to a Wall Street Journal analysis of Medicare physician-payment data made public for the first time in April. A few of those providers, including Dr. Weaver, collected more from the single procedures than anyone else who billed for them—by very large margins. The data release was prompted by a Journal legal effort to make the information public.

There is nothing inherently wrong with medical professionals billing primarily for one thing. Some doctors specialize in certain procedures and fashion their practices around them. At times, the billings of one doctor can encompass the work of a staff, including other doctors, physician assistants and nurses, distorting comparisons with other doctors in that field.

A closer look at a few of the doctors who make most of their money from just a few procedures reveals that they are operating outside their areas of expertise or deviating from standard medical practice.

The doctors featured in this article say financial incentives play no role in their treatment patterns, and some argue that the procedures save the government money by keeping patients out of hospitals.

Among the doctors whose billings stand out is Evangelos G. Geraniotis, a urologist in Hyannis, Mass. Dr. Geraniotis received $2.1 million from Medicare in 2012, the most of any member of his specialty.

Nearly $1 million of that sum came from a procedure not considered routine in a urological practice. Known as a “cystoscopy and fulguration,” it involves threading a scope up the male urethra to burn potentially cancerous lesions inside the bladder.

According to his Medicare billings, Dr. Geraniotis performed two variations of the procedure 1,757 times in 2012. Of the 8,791 providers whose specialty is listed in the Medicare data as urology, 973 billed for the procedure, doing so an average of 38 times. The urologist who billed for the second-most performed the procedure less than one-third as often as Dr. Geraniotis did, the data show.

Dr. Geraniotis said Cape Cod retirees account for the majority of his practice. He said many have bladder issues such as urinary bleeding, but otherwise he isn’t sure why he stands out in his use of the procedure.

“If I see something, I say: ‘Let’s cauterize it and take care of it,’ whereas someone else might wait and see,” he said. “I guess you could call it a more aggressive approach.”

Dr. Geraniotis said the more than $500 he received from Medicare each time he billed for the procedure played no role in his medical judgment and, by performing the procedure in his office, he keeps patients out of the hospital.

“My style of practice is an outlier, but I don’t think it reflects anything more than my trying to do good for my patients. I think I’m an honest guy,” he said.

In Port St. Lucie, Fla., Gary L. Marder, a dermatologist, specializes in treating melanoma with radiation. Dr. Marder’s website, which features photos of smiling elderly couples, says he has cured more than 100,000 skin cancers.

Medicare paid Dr. Marder $3.7 million in 2012—$2.41 million of which came from a radiation treatment billed by just two other doctors in the data, which doesn’t include hospital billings. Neither of them came close to billing as much for it as Dr. Marder.

David Beyer, a radiation oncologist in Scottsdale, Ariz., said the procedure code Dr. Marder used to bill Medicare corresponds to higher-voltage machines than the one pictured on Dr. Marder’s website. Such higher-voltage machines require substantial shielding and a contained room typically found in the radiation-oncology departments of hospitals, Dr. Beyer said.

Under Medicare guidelines, the lower-voltage machine pictured on Dr. Marder’s website was reimbursed at a rate of about $22 per treatment in 2012, radiation oncologists say. Dr. Marder received an average of $154 per treatment by billing under the code for the higher-voltage machine.

In an email exchange, Dr. Marder said he used a machine different than the lower-voltage one pictured on his website, but didn’t respond to a question about what kind. Dr. Marder said he had “professionals who can vouch for my correct coding,” although he didn’t provide their names.

Dr. Marder billed for the procedure, using the more lucrative code, 15,610 times in 2012, and performed the procedure on 94 patients, according to the Medicare data. That works out to 166 treatments per patient, on average.

Dr. Beyer, the Arizona radiation oncologist, said the maximum number of radiation treatments appropriate per skin-cancer lesion is 35, and a more normal regimen would be 20. When a patient has several lesions, they commonly get treated simultaneously and are billed for as a single treatment, he said.

Dr. Marder said he billed for each lesion separately and treated each lesion about 40 times, explaining his high billing count per patient.

In 1998, Dr. Marder was disciplined by Florida’s Board of Osteopathic Medicine for alleged “fraudulent” billing. The board fined him $2,500 and ordered him to take courses in medical record-keeping and medical risk management. He neither admitted nor denied the allegations.

Dr. Marder said his medical care “was never in question” and that the medical board merely asked him to better document in his medical charts the justifications for his billings, which he said he has done since then.

Some of the Medicare doctors whose billings stand out aren’t performing procedures that are particularly technical or specialized.

The practice of James E. Beale, an orthopedic surgeon in the Detroit area, received $3.7 million from Medicare in 2012, more than any other member of his specialty, according to the data.

Dr. Beale’s practice accomplished that despite not performing a single surgery on a Medicare patient. His chief Medicare revenue source was “manual therapy techniques,” which the coding manual used by Medicare to set reimbursements describes as a massage or manipulation of various regions of the body, lasting 15 minutes.

Dr. Beale’s practice billed Medicare for it 107,670 times and received $2.3 million. By contrast, the average doctor or physical therapist in the data who billed for the technique performed it 520 times and was reimbursed less than $11,000 for it.

How Dr. Beale’s practice came to bill for so many massages is unclear. In a brief interview on the doorstep of his large brick home, he said of the Medicare billing that appears under his name: “What you see, it wasn’t me.” He declined to answer additional questions.

Iris Winchester, who works with Dr. Beale at an orthopedic clinic in a Detroit suburb, said the Medicare payments for the manual therapy went to a company called Abyssinia Love Knot Physical Therapy that she and Dr. Beale worked for until July 2012. Although Ms. Winchester and Dr. Beale opened their own clinic at that time, Ms. Winchester said Abyssinia continued billing Medicare under Dr. Beale’s name, which Abyssinia denied.

“You need to follow the money,” she said, declining to comment further.

Abyssinia is owned by Shirley Douglas, a former home-health aide who founded a network of physical-therapy centers several years ago. Ms. Douglas, who also is a preacher and goes by “Pastor Shirley,” said she ran her facilities in partnership with Dr. Beale until mid-2012.

In 2012, “we did a lot of massages,” Ms. Douglas said, adding that the billing under Dr. Beale’s name reflected the work of a staff of doctors and physical therapists, not just one person.

But she said her facilities accounted for just $1.5 million of Dr. Beale’s $3.7 million in total Medicare billings in 2012. She said Dr. Beale and Ms. Winchester’s new clinic must have accounted for the remainder of the 2012 billings, something Ms. Winchester denies.

The Medicare payment data show that Dr. Beale’s practice performed the 15-minute massage an average of 149 times per patient for average Medicare billings per patient of $3,155.

Medicare since has capped the amount it reimburses for physical therapy at $1,920 per patient a year.

“Medicare said: ‘No more. This is too expensive,’ ” Ms. Douglas said, adding that her billings for the procedure have declined sharply this year.

Dr. Beale’s medical license was temporarily suspended by Michigan’s medical board in 1988 for letting a physician assistant use prescription pads bearing his signature to prescribe controlled substances. The medical board separately reprimanded him in 2003 for “negligence” in the treatment of a patient. Dr. Beale couldn’t be reached for comment on the sanctions.

Dr. Weaver, the Los Angeles internist whose practice billed Medicare the most for the seldom-used cardiac procedure, acknowledged having no specialized training in cardiology beyond a residency in internal medicine. He is rarely at his clinic, according to former employees. By his own account, he doesn’t see patients himself but employs two to three cardiologists for that purpose.

The former employees say the driving force behind Dr. Weaver’s clinic is a colleague, Sara Soulati, whose company manages the clinic. Though Ms. Soulati isn’t a doctor, she described herself in an interview as an “expert” in the procedure, which is called “enhanced external counterpulsation,” or EECP.

Medicare covers EECP only for patients who have “disabling” angina, a kind of persistent and extreme chest pain, and who can’t have surgery to treat it. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, characterizes EECP as “a treatment that is, and should be, rarely used” because there are many other more effective ways to address angina.

Ms. Soulati promotes the procedure as a broader preventive measure against cardiovascular disease. In a speech posted on YouTube that she gave at the City of Refuge Church in south Los Angeles, Ms. Soulati said EECP “grows new arteries” and will “save your life.” She asked for the names and numbers of congregants interested in the treatment. “God has been great to me because he allowed me to bring the service here,” she said. Dr. Nissen says it is improbable that EECP would grow new arteries.

Dr. Weaver says EECP costs about one-fifth as much as surgical procedures such as stenting and results in fewer hospital admissions. Ms. Soulati and Dr. Weaver said they follow “all applicable laws and regulations.”

Their clinic resembles a spa. In several dark treatment rooms, patients lay on about two dozen beds, as the EECP machines emitted pumping sounds. Outside, vans advertising a free EECP trial picked up and dropped off patients, most of them elderly.

Internal emails reviewed by the Journal show the staff was instructed to make frequent calls to patients. In September 2012, Ms. Soulati emailed her staff: “We had VERY low numbers today…please make sure everyone is on the phone all day long.” One day the following month when 135 patients were scheduled for treatment but only 83 showed up, she emailed: “Please work hard and get our numbers back to the 90’s. our goal is to stay above 90.”

A policy document from the clinic notes that “it is so hard to get EECP covered through insurance,” advising employees to reassure patients that “we are the experts at getting Medicare to pay when others wouldn’t be able to.”

Dr. Weaver said Ms. Soulati’s emails were “primarily motivated by a desire to assure that patients receive the greatest available benefit from their treatments…without interruption.”

The clinic’s patients receive tests at a neighboring laboratory, according to the former employees. Ms. Soulati owns the lab, GCC Imaging. Dr. Weaver said the patients who come for EECP tend to have conditions requiring diagnostic testing, and Ms. Soulati’s lab is “the only such facility in the building.” Ms. Soulati said she agreed with Dr. Weaver’s comments.

The government data show the lab collected nearly $1 million from Medicare in 2012. It billed the program for medical tests on 626 patients, roughly the same number as were treated with EECP at Dr. Weaver’s clinic.

—Matthew Dolan and Tom McGinty contributed to this article. 

 

POLITICAL TIES OF DISHONEST DOCTORS

Political Ties of Top Billers for Medicare

The New York Times

By FRANCES ROBLES and ERIC LIPTON
Top-paid Medicare doctors say they have reasons

FILE – This Jan. 31, 2010, file image released by Miami Dade College shows Dr. Salomon Melgen, posing for a photo at the book signing of “Growing American Roots”, a book by Sen. Robert Menendez, D-N.J., at the college in Miami. Topping Medicare’s list of highest paid physicians from it’s claims database was Florida ophthalmologist Salomon Melgen, whose relationship with Sen. Robert Menendez, D-N.J., made headlines last year after news broke that the lawmaker used the doctor’s personal jet for trips to the Dominican Republic. Medicare paid Melgen $20.8 million. (AP Photo/Miami Dade College, Phil Roche, File)

MIAMI — Two Florida doctors who received the nation’s highest Medicare reimbursements in 2012 are both major contributors to Democratic Party causes, and they have turned to the political system in recent years to defend themselves against suspicions that they may have submitted fraudulent or excessive charges to the federal government.

The pattern of large Medicare payments and six-figure political donations shows up among several of the doctors whose payment records were released for the first time this week by the Department of Health and Human Services. For years, the department refused to make the data public, and finally did so only after being sued by The Wall Street Journal.

Topping the list is Dr. Salomon E. Melgen, 59, an ophthalmologist from North Palm Beach, Fla., who received $21 million in Medicare reimbursements in 2012 alone. The doctor billed a bulk of his reimbursements for Lucentis, a medication used to treat macular degeneration made by a company that pays generous rebates to its doctors.

Dr. Melgen’s firm donated more than $700,000 to Majority PAC, a super PAC run by former aides to the Senate majority leader, Harry Reid, Democrat of Nevada. The super PAC then spent $600,000 to help re-elect Senator Robert Menendez, Democrat of New Jersey, who is a close friend of Dr. Melgen’s. Last year, Mr. Menendez himself became a target of investigation after the senator intervened on behalf of Dr. Melgen with federal officials and took flights on his private jet.

Another physician, Dr. Asad Qamar, an interventional cardiologist in Ocala, Fla., has sent at least $250,000 in donations over the last decade to the political campaigns of President Obama and other prominent Democrats; he has become the target of scrutiny related to cardiovascular treatment centers he runs in Central Florida.

Dr. Qamar was paid more than $18 million in 2012, making him and Dr. Melgen by far the largest payment recipients nationwide, according to the data. A pathologist from New Jersey received the third largest Medicare reimbursement, $12.6 million.

In an interview on Wednesday, Dr. Qamar said any questions about his Medicare bills were unjustified.

“Just looking at the sheer volume of work and billings from a single physician is not a sign of wrongdoing,” Dr. Qamar said, noting that his practice handles cardiac procedures in its outpatient clinics that would be done inside a hospital in many other states, which he said explained the large billable amounts.

The state of Florida was home to many of the physicians who received the largest payments, 28 out of the top 100. California, with a much larger population, was second, with 10 of the top 100.

Doctors in Florida have been frequent targets of Medicare fraud investigations, based on irregular patterns of bills or extremely high bills.

Just last month, two Florida medical clinic owners were sentenced on charges of Medicare fraud, both in cases involving more than $20 million in fraudulent payments. In addition, the Halifax Hospital Medical Center in Daytona Beach, Fla., agreed to pay the government $85 million to resolve allegations that it had billed Medicare for care based on referrals from doctors who had a financial relationship with the institution, a forbidden practice.

Dr. Melgen appeared on investigators’ radar when a Medicare contractor noticed that he, a single practitioner, was billing for Lucentis at a significantly higher rate than his peers, Justice Department lawyers wrote in response to a suit the doctor filed against the Health and Human Services Department.

Each vial of the medication comes with up to four times the amount that a patient requires. Investigators said the doctor was using one vial to treat three or four patients, and billing as if he had purchased a new vial each time. The doctor would be reimbursed $6,000 to $8,000 for a vial that cost him $2,000.

The investigation concluded that in 2007 and 2008 alone, he overbilled by $9 million, which he was forced to pay back.

The doctor, federal lawyers said, “seeks to game the system by seeking reimbursement of three to four times its actual costs.”

Dr. Melgen hired the former head of the Justice Department’s Medicare fraud task force,Kirk Ogrosky, to defend him. In a lawsuit that sought to recover the $9 million, Mr. Ogrosky argued that Dr. Melgen’s billing practice was not illegal and that even if the doctor had not spread the medication out, the government would not have saved any money.

As the dispute dragged on, the doctor reached out to his longtime friend, Mr. Menendez, for help. Mr. Menendez’s aides acknowledged that the senator called the Medicare director at the Center for Medicare and Medicaid Services in 2009 and brought it up at a meeting with the acting administrator in 2012. Now both Dr. Melgen and Mr. Menendez find themselves under federal scrutiny. F.B.I. agents have raided Dr. Melgen’s clinics twice.

“At all times, Dr. Melgen billed in conformity with Medicare rules,” Mr. Ogrosky said in a statement. “While the amounts in the CMS data release appear large, the vast majority reflect the cost of drugs. The facts are that doctors receive 6 percent above what they pay for drugs, the amount billed by physicians is set by law, and drug companies set the price of drugs, not doctors.”

He declined to discuss the doctor’s relationship with the senator or his campaign contributions.

Dr. Qamar and his Institute of Cardiovascular Excellence in Ocala, Fla., have for at least the last 16 months been subject to what is known as a “prepayment review,” he said on Wednesday. Medicare officials typically take this step, which requires a detailed examination of all Medicare bills before they authorize payment, after they have detected patterns that lead them to suspect there may have been inappropriate or excessive bills.

The money paid to Dr. Qamar in 2012 — $18.2 million — is much more than to any other cardiologist in the United States. The second-highest total is listed as $4.5 million, paid to Dr. Ashish Pal of Davenport, Fla.

Dr. Pal said in an interview on Wednesday that his billing was entirely appropriate and fair, although he acknowledged it was high because he has multiple cardiology-related specialties, and because he works in an outpatient setting and bills the government for facility fees.

Dr. Qamar said his payments were high because his practice, which has 150 employees and a caseload of 23,000 patients, routinely handles complicated procedures like opening blocked arteries in the legs of older patients, which normally would be billed by a hospital.

Dr. Qamar has sent more than $100,000 to the Democratic National Committee and other state-based branches of the Democratic Party around the United States, and has donated to President Obama’s presidential campaigns and groups with ties to Mr. Obama, federal records show. He has also made donations to congressional candidates — almost all of them Democrats — from Nevada, Pennsylvania, Indiana, Iowa and Florida, among other states, the records show.

At the same time some of those donations were being made, the prominent law and lobbying firm Greenberg Traurig — and a former Justice Department official and Capitol Hill aide from the firm named Gregory W. Kehoe — helped Mr. Qamar contact more than a dozen members of Congress asking them to help him address why he was subject to such intense scrutiny from Medicare auditors.

The political donations, Dr. Qamar said, are unrelated to the Medicare scrutiny, but he acknowledged he had reached out to lawmakers in Congress to persuade the federal government to back down.

“The auditors put an astronomical burden on us, in terms of manpower,” he said. “I would just hope there is some end to it.”

Both Dr. Qamar and Dr. Melgen are still certified to receive Medicare payments, although Dr. Melgen at one point was suspended from the Medicare program, which accounts for 70 percent of his practice. He has been reinstated. And an official at the Department of Health and Human Services declined to comment on either physician or to confirm that they were a subject of special scrutiny.

The New Jersey pathologist ranked third among doctors nationwide in terms of Medicare billing, Dr. Michael C. McGinnis, is the medical director of the Pathology Corporation of America in Wrightstown, N.J., which performs analytical work on medical specimens for other doctors, perhaps explaining his high ranking on the list. Dr. McGinnis could not be reached for comment.

Frances Robles reported from Miami, and Eric Lipton from Washington. Michael Strickland contributed research.

Correction: April 9, 2014, Wednesday

This article has been revised to reflect the following correction: An earlier version of this article misidentified a political action committee to which Dr. Salomon E. Melgen contributed more than $700,000. It was Majority PAC, a super PAC run by former aides to the Senate majority leader Harry Reid, not the political action committee of Senator Robert Menendez, a New Jersey Democrat.

 

ACETAMINOPHEN & ADHD

Mental Health

Prenatal acetaminophen exposure may affect ADHD in childhood

FROM JAMA

Major finding: Children exposed prenatally to acetaminophen were at a greater risk of being diagnosed with hyperkinetic disorder, having ADHD-like behaviors, or being on an ADHD medication, an association that was increased with exposure during more than one trimester and with more weeks of exposure.

Data source: A large prospective study using the Danish National Birth Cohort data and other national health registries evaluated the association between the three outcomes, and maternal use of acetaminophen, based on information obtained from the mothers of more than 64,000 children.

Disclosures: The study was supported by the Danish Medical Research Council. One of the authors was at the University of Arizona, Tucson, when she was involved in the study, but now works at Novartis Farmaceutica SA, in Barcelona.

Prenatal exposure to acetaminophen was associated with a significantly increased risk of attention-deficit/hyperactivity–like behavioral problems, a hospital diagnosis of hyperkinetic disorder (HKD), or being on ADHD medications in children at age 7 years, based data from more than 60,000 children obtained from the national birth registry and other health registries in Denmark.

The study was published online on Feb. 24, in JAMA Pediatrics (doi:10.1001/jamapediatrics.2013.4914). The risk of ADHD-like behaviors in children at age 7 years increased by 13% among those whose mothers had used acetaminophen overall during pregnancy. When acetaminophen was used in the second and third trimesters, the risk increased by 44%, and when used during all three trimesters, the risk increased by 24%.

Courtesy: Cleveland Clinic

The associations with these three outcomes were greater when acetaminophen (paracetamol) was used in more than one trimester and with increasing frequency of use (more than 20 weeks during pregnancy). Because exposure to acetaminophen is common, “these associations might explain some of the increasing incidence in HKD/ADHD, but further studies are needed,” Zeyan Liew, MPH, and his coauthors concluded. Mr. Liew is with the department of epidemiology, Fielding School of Public Health, University of California, Los Angeles.

The prospective study included 64,322 live-born children and their mothers who were enrolled in the Danish National Birth Cohort during 1996-2002, and data from the national hospital, psychiatric and prescription registries. The mothers had participated in three interviews about acetaminophen use during pregnancy: at the 12th and 30th weeks of gestation, and 6 months after giving birth (28,254 women who had missed at least one of these interviews and their children were excluded).

A subgroup of approximately 41,000 women who had responded to a self-administered questionnaire (the Strengths and Difficulties Questionnaire), when their child was 7 years of age were used to evaluate ADHD-like behaviors; 55% of the women in this group had used acetaminophen at some point in their pregnancy. In the entire group of 64,322 mothers, 56% had used acetaminophen during pregnancy.

Data obtained by the investigators included parental reports of ADHD-like behaviors at age 7 years; a hospital diagnoses of HKD at or after 5 years; and use of ADHD medications, mostly Ritalin. The researchers adjusted for possible confounders, including birthweight; sex; maternal age at child’s birth; socioeconomic status; drug and alcohol use during pregnancy; mother’s self-reports of psychiatric illnesses and childhood behavioral problems; and diseases or conditions that may have prompted the mothers to have used acetaminophen.

The associations between the use of prenatal acetaminophen and the increased risks of HKD or using an ADHD medication also increased when acetaminophen was used during two or more trimesters, and a significant trend appeared with the increasing weeks of use: When used for 20 or more weeks, the risk for an diagnosis of HKD increased by 84% and the risk of having received an ADHD medication increased by 53%, the researchers noted. These results were similar “when restricting to mothers who did not report psychiatric illnesses or episodes of fever, inflammation, and infections during pregnancy,” they added.

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The risk of ADHD-like behaviors in children at age 7 years increased by 13% among those whose mothers had used acetaminophen overall during pregnancy. When acetaminophen was used in the second and third trimesters, the risk increased by 44%, and when used during all three trimesters, the risk increased by 24%. 

Referring to evidence from animal and human studies suggesting that acetaminophen may be an endocrine disruptor, the authors wrote: “Maternal hormones, such as sex hormones and thyroid hormones, play critical roles in regulating fetal brain development, and it is possible that acetaminophen may interrupt brain development by interfering with maternal hormones or via neurotoxicity, such as the induction of oxidative stress that can cause neuronal death.”

The study strengths included the availability of different endpoints to evaluate different levels of ADHD and the use of prospective data (interviews with the mothers). But the findings were limited by the inability to evaluate the effect of dosage or number of pills, because the mothers were not able to provide this information. Despite the adjustment for confounding variables, “the possibility of unmeasured residual confounding by indication for drug use, ADHD-related genetic factors, or coexposures to other medications cannot be dismissed,” the researchers said.

In an accompanying editorial, Miriam Cooper, MRCPsych, of the Institute of Psychological Medicine, Cardiff, Wales, and her associates wrote that while the study’s results are potentially important, “caution should be exercised in ascribing causation to statistical associations between prenatal risk factors and adverse outcomes” and the results “should not change practice.” However, the findings should be used as a basis for future research and “underline the importance of not taking a drug’s safety during pregnancy for granted” (doi:10.1001/jamapediatrics.2013.5292).

The study was supported by the Danish Medical Council. Neither the researchers nor the editorialists had relevant financial conflicts to disclose.

Be cautious in interpreting this cohortThere are quite a few problems with the interpretation of this cohort. Most importantly, there is potential bias by indication. For example, women who needed more acetaminophen might have had conditions that could cause the outcome, rather than the acetaminophen. In addition, the doses were not known and more than 20,000 cases were excluded for missing interviews. Therefore, it is possible that they had many more parents with ADHD, which is often a genetic condition. The acetaminophen users had more muscle and joint diseases, more infections, and more psychiatric disease-which can affect the results, independent of acetaminophen.

Dr. Gideon Koren is director of the Motherisk Program at the Hospital for Sick Children, Toronto, and professor of pediatrics, pharmacology, pharmacy, and medical genetics, at the University of Toronto. He has no relevant disclosures.

CREEPY MEDICAL TOUR

A Vintage Yet Creepy Medical Tour (28 pics / facts)

February 6, 2014 – Seriously for real

1) Masks worn by doctors during the Plague. The beaks held scented substances

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 2) Children in an iron lung before the advent of the polio vaccination. Many children lived for months in these machines, though not all survived. c. 1937

 

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3) Corset damage to a ribcage. 19th century London

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4) Dr. Kilmer’s Female Remedy

 

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5) Tanning babies at the Chicago Orphan Asylum, 1925, to offset winter rickets

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6) Woman with an artificial leg, too embarrassed to show her face c. 1890-1900

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7) Wooden prosthetic hand, c. 1800

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8) Selection of some items used to disguise facial injuries. Early plastic surgery.

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9) Blood transfusion bottle, England 1978

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10) Dr. Clark’s Spinal Apparatus advertisement, 1878

 

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11) Neurological exam with electrical device, c. 1884

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12) Antique prosthetic leg

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13) US Civil War surgeon’s kit

 

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14) ”Walter Reed physiotherapy store” 1920′s

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15) Boy in rolling “invalid cart” c. 1915

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16) Obstetric phantom, Italy 1700-1800. Tool to teach medical students and midwives about childbirth

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17) Radioactive yummies

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18) Lewis Sayre’s scoliosis treatment

 

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19) Claude Becks early defibulator

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20) Antique birthing chair used until the 1800s

 

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21) Knives for surgery, China, 1801-1920.

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22) Anatomical Model. Doctors were not allowed to touch the women’s bodies, so they would point to describe pain locations

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23) Radiology nurse technician, WWI France 1918

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24) 1855-1860. One of first surgical procedures using ether as an anesthetic

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25) Rush Medical College lecture auditorium, 1900, Chicago

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26) Treatments for insanity

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27) Leonid Rogozov, the only surgeon on an Antarctic expedition, performing surgery on himself after suffering from appendicitis. April 30, 1961

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28) Edward Mordrake

 

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SHAM SURGERY

The FDA Wants You for Sham Surgery

There are better ways to test medical devices than by having patients be placebos who get fake operations. 

By 

SCOTT GOTTLIEB
Feb. 18, 2014 7:17 p.m. ET
In a landmark study of a new cardiovascular device unveiled last month, patients received anesthetics, had a large-bore catheter inserted through a cut into one of their major arteries, and had dye injected into their bloodstream. Their surgeons worked on them for about an hour, with unnecessary pokes and prods, while a monitor displayed the false progress using radioactive fluoroscopy.

The patients weren’t being treated. They had agreed to undergo the angiogram procedure without knowing if they’d get the real treatment. They were part of a Food and Drug Administration-approved study of a new medical device from Medtronic MDT +0.47% to treat serious high blood pressure that is resistant to conventional medicines. Some patients were randomly assigned to this sham surgery. They were placebos.

Medtronic, Inc.World Headquarters Courtesy Medtronic, Inc.

Was their sacrifice worth it? That is a question many patients may want to consider as the FDA insists on a new study methodology with uncertain benefits. The methodology’s high costs mean that some new products will reach patients many years later than they need to—or not at all.

Everyone is familiar with the long-standing practice of randomly assigning patients to placebo pills in clinical trials that test new drugs. One group of patients will get the experimental medicine, and another group will get a dummy sugar pill. The FDA began encouraging some medical-device makers to use dummy surgical procedures a few years ago, and a review of Clinicaltrials.gov shows that dozens of such studies are under way.

The goal is to isolate the observed effect of a new treatment from other factors that could affect the results. For instance, the blood-pressure device works by ablating, or destroying small nerves in arteries that feed the kidneys with blood. The activity of these nerves contributes to hypertension. So the FDA would want to know things like whether patients getting the real procedure and device achieved lower blood pressure from the psychological influence of the surgery, rather than from the new device.

Yet other scientific approaches also allow us to get rigorous evidence of safety and benefits, while enabling patients to get real rather than fake therapies. In the case of the high-blood-pressure device, 10 years ago the FDA would have requested a reasonably sized “non inferiority” trial. That is a study in which patients getting the new procedure are randomly compared with patients getting a different standard treatment for the same condition—to see if the new device is about as effective as conventional treatment.

New device technologies can offer other advantages, such as faster recovery times, lower risk to patients, or easier use by doctors and patients. Non-inferiority studies are often better for evaluating these secondary benefits.

But for several years the FDA has clamped down on these approaches in favor of sham surgeries, which it sees as more statistically scrupulous and free from bias. The high-blood-pressure device, for example, is already available in Europe, where regulators approved it based on traditional studies. The FDA disregarded those results in favor of the new and larger trial using a sham.

Preliminary results from the sham study suggested that the device might not deliver the hoped-for benefits. While some people think the problem wasn’t with the device but more with the way the procedure was designed in that trial, the negative results are already emboldening proponents of sham studies.

Sham procedures could be defensible in certain narrow cases—for example, when a minimally invasive (very low risk) device is used to affect symptoms that are subjective and hard to measure. One example is devices aimed at treating pain. Another is when surgery is already under way, and the sham might be an experimental step that the surgeon forgoes in some patients.

Yet research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans. Some of these are reflected in the Declaration of Helsinki, an international treaty concerning the conduct of medical research. Other experiments using sham surgeries are obligating patients to undergo unnecessary anesthetics, radiation, abdominal incisions, endoscopy and injections into the rectum, to mention a few examples. The needless cutting means pain as well as the risk of anesthesia and infection.

The FDA tries to address ethics issues by letting patients who get sham treatments eventually join the real treatment group. But this often requires a second surgery. The sham trials can also be costly because they involve unnecessary operations. They are hard to recruit for when patients know they may get a fake surgery and are reluctant to consent to being cut unnecessarily.

All of this raises development costs—and it encourages firms to skip the U.S. market and commercialize new products overseas. This can suppress innovation. When a sham trial doesn’t produce positive results, the company may have exhausted its resources and have no capital left to refine a good idea into a beneficial product.

Instead of clinging to inflexible testing requirements, the FDA should allow trials that are feasible, reflect clinical practice and are morally defensible. There are methods for evaluating science that don’t require such contrived experiments on people. The agency doesn’t need to rely on research models that raise the opportunity costs so high that some valuable treatments or devices may never become available to patients.

Dr. Gottlieb is a physician and resident fellow at the American Enterprise Institute. He also consults with firms that invest in medical device companies.