Massachusetts doctors, hospitals received $35.8 million in gifts from device, drug companies.

The AP (11/23) reports, "Massachusetts doctors and hospitals have received nearly $35.8 million in payments from medical device manufacturers and drug companies during the last six months of 2009," according to a report. The "payments included speaking and consulting fees, meals, and education and marketing programs." The report "was the result of a 2008 state law that banned some types of gifts outright and required companies to report other types of payments."

Setting viewing preferences for recipients (in Acrobat)

From PDF for lawyers blog- a great PDF tip!

How do you set preferences for the recipient of a PDF document you created? Normally, you won't care about doing this, but there are times when you should.

For example, let's say the document below is a contract that controls a certain dispute.

I want to send this contract, which we'll pretend has dozens of parts (in reality you'll see that it only has 9 parts) to another lawyer for him to read over. To make it easier to navigate the document I'll probably quickly bookmark it so that all of the sections were listed along the left hand side in the bookmarks panel. Note, I'm creating these bookmarks for the other lawyer's benefit. And if he doesn't see the bookmarks then I've done extra work for nothing.

I could explain to him that there are bookmarks in the document, and then provide a short explanation of how to open the bookmarks panel. Odds are, though, that he wouldn't bother to open the bookmarks panel (trust me, I've field tested this proposition extensively). No, the easiest thing for me is to simply change the document preferences so that the bookmarks panel opens automatically.

Here's how you do that. Navigate the Acrobat menu as follows: FILE > PROPERTIES (or use the keyboard combo CONTROL + D, or COMMAND + D on a Mac). That will pull up the following dialogue box:

As noted on the image above, you should (1) click the 'Initial View' tab, and then (2) set the Navigation Tab to 'Bookmarks Panel and Page'. Finally, save the document with these changes and send it along to the recipient.

When he or she opens the document it will have the bookmarks panel already in view. Most people know what to do at this point. Of course, you can create bookmarks for pages that you specifically want to discuss too. You can use bookmarks all kinds of ways. But they're only helpful if the recipient knows they're there. And now you know how to make sure that happens.

For more information on using bookmarks, click here.

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GlaxoSmithKline to Pay $750 Million for Selling Contaminated Drugs

GlaxoSmithKline will pay a $750 million penalty to settle civil and criminal charges alleging it knowingly sold contaminated products, the New York Times reports.
The company sold 20 drugs with uncertain safety, including Avandia (rosiglitazone), Bactroban (mupirocin), Coreg (carvedilol), Paxil (paroxetine), and Tagamet (cimetidine).
Sent to a large Puerto Rico plant to fix problems cited by the FDA, a whistle-blower discovered contamination in the plant's water system and a faulty air system that permitted cross-contamination, according to the Times. In addition, the plant could not guarantee the sterility of intravenous cancer drugs, and different-strength pills were stored in the same bottles. The whistle-blower recommended drug recalls, but the company declined to issue them.
The company closed the plant in 2009.
New York Times story (Free)
GlaxoSmithKline news release (Free)

North Carolina Settles With Five Pharmaceutical Firms

The AP (10/21) reports, "North Carolina's Medicaid office and public schools are receiving millions of dollars after a settlement with five pharmaceutical companies over allegations the firms offered gifts or encouraged the use of certain drugs." HHS "announced agreements Wednesday with the five companies totaling $17.5 million," with $6 million going to the state. "The largest settlement surrounded allegations AstraZeneca encouraged the use of a drug approved for schizophrenia and bipolar depression to be used for other conditions such as dementia." North Carolina "also alleged Alpharma paid for trips for healthcare providers to resorts to encourage them to prescribe a morphine pain medication."

What You Need to Know About the DePuy Hip Implant Recall

AAJ Education's DePuy Hip Implant Recall Teleseminar, November 9, will teach you about symptoms of the hip implant failure, status of the class action and possible multidistrict litigation, and how FDA preemption and Riegel v. Medtronic affect your clients' claims. Numerous lawsuits have already been filed in state and federal court stemming from the August 2010 DePuy Hip Implant recall. Litigation will soon surge as victims of the medical device learn about the recall. For more information and to register, visit AAJ Education.

Vance Named AAJ President-Elect

The National Law Journal (7/14, Ingram) reported, "As Gulf Coast law firms bring lawsuits and push Congress on behalf of oil spill victims, one of their own is taking the helm of the trial lawyers' national lobby. C. Gibson Vance has begun his a one-year term as president of the American Association for Justice, after the organization's convention this week in Vancouver, Canada. Vance is a shareholder at Beasley, Allen, Crow, Methvin, Portis & Miles, a Montgomery, Ala., firm that has been among those suing BP PLC and others over the oil spill." Said Vance, "the importance of the civil justice system has never been more obvious."
The AP (7/15) reported, "Vance is a former president of the Alabama Association for Justice and is the first Alabamian to serve as president of the national organization."

Pfizer discloses $35M in payments to physicians, medical centers.

The New York Times (4/1, B2, Wilson) reports, "Pfizer, the world's largest drugmaker, said Wednesday that it paid about $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009." The company "also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period."
The disclosure is part of an agreement to settle a government probe into whether the company marketed certain drugs off-label, the Wall Street Journal (4/1, Rockoff, Loftus) reports. Pfizer also agreed to pay $2.3 billion and to plead guilty to a criminal charge under the settlement.
The AP (4/1, Johnson) reports, "The information, posted on its Website, was released...a week after passage of the national healthcare overhaul," which "includes provisions requiring detailed disclosures of even small payments and gifts to physicians by makers of drugs and medical devices, but not until 2013." The company's database includes information on whether physicians have "received payments for consulting services, giving speeches or participating in drug testing, as well as free meals or travel reimbursement." Reuters (4/1) and the Financial Times (4/1, Kirchgaessner) also cover the story.

301 Videos of Abdominal Surgeries Viewable Online for FREE!

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Insurance company reportedly sought to drop all HIV-positive customers.

Paul Thornton And Jon Healey wrote on the "Opinion LA" blog at the Los Angeles Times (3/17) that health insurers' "abusive cherry-picking practices keep giving lawmakers incentives to vote for the healthcare reform bill." As evidence, they point to the Reuters report below of "the case of Jerome Mitchell, a young South Carolinian who signed up for an insurance policy at age 17 but was later diagnosed with HIV. His insurer, Fortis -- now known as Assurant -- summarily canceled his policy after the HIV diagnosis." As the result of a lawsuit, it was disclosed that "Fortis had a company policy of targeting policyholders with HIV. A computer program and algorithm targeted every policyholder recently diagnosed with HIV for an automatic fraud investigation."
Reuters (3/18, Waas) reports that as a result of Mitchell's suit, a jury ordered the company to pay him $14 million, a decision that was mostly upheld by the South Carolina Supreme Court which limited the payment to $10 million. The suit reportedly revealed a company policy of investigating every policyholder with HIV for fraud in an effort to remove them from the roles. Reuters reports that the practice of rescission of policies is frequently done simply to save the company money and often has no valid support though it also says that no other insurance companies are known to have targeted HIV-positive policyholders.

Health Insurers Double Digit Premium Rate Hikes?!!

The AP (3/5, Sidoti) reports that HHS Secretary Kathleen Sebelius "told the nation's leading health insurers Thursday to publicly justify a spate of double-digit premium hikes that have infuriated consumers in at least a half dozen states." She met "with the CEOs of WellPoint, Aetna, Cigna, UnitedHealth Group, as well as several state insurance commissioners." After asking insurers to post "their justification for proposed rate hikes" online, Sebelius told reporters, "At the very least, we need some transparency. ... We need people to understand what's going on.
The New York Times (3/5, A13, Stolberg, Pear) notes that during the meeting "the president stopped by -- an appearance that was unscheduled, but clearly orchestrated -- to deliver a letter from an Ohio cancer survivor who had dropped her insurance after a 40 percent rate increase."
The Wall Street Journal (3/5, Adamy, Johnson) characterizes the meeting as the administration scolding insurers. For their part, insurers blamed healthcare companies including drugmakers, medical-device makers, and hospitals for driving up healthcare costs, according to the Journal. They also disagreed with Sebelius that they are highly profitable.
The Los Angeles Times (3/5, Sidot) focuses on the rate hikes, noting that "Sebelius has heard from many Americans who are concerned that they will be priced out of the market." Pushing the online justification of rate increases, Sebelius said, "That kind of rate increase is just unacceptable and unsustainable. ... At least the bright spotlight may help to discourage some of these wildly exorbitant increases from occurring."
By the end of the meeting, "the executives emerged saying they felt they were heard when they argued that the price hikes are due to rising medical costs and other factors beyond their control," CQ HealthBeat (3/5, Norman) reports. "But there were no accords or agreements, the executives said, beyond a general consensus that more transparency is needed."

Some Fosamax Users Have Had Their Femur Fracture Without Any Fall Or Other Trauma

(Posted by Tom Lamb at DrugInjuryWatch.com)
The side effects of Fosamax include osteonecrosis of the jaw (ONJ), esophageal irritation, and musculoskeletal pain. In addition, cases of femur fractures associated with prolonged Fosamax (alendronate) use have been reported.
In the December 18, 2009 edition of the medical journal Clinical Orthopaedics and Related Research (CORR), there is an article about the Fosamax-related femur fractures, "Case Reports: Subtrochanteric Femoral Stress Fractures after Prolonged Alendronate Therapy".
From this December 2009 CORR article about Fosamax:
CASE DESCRIPTION: We report the cases of four women who sustained low-energy subtrochanteric or femoral shaft stress fractures while being on alendronate therapy for more than 5 years. All radiographs showed typical patterns consisting of a transverse fracture line with external cortical bone reaction and medial cortical spike. Alendronate discontinuation along with nonoperative treatment was sufficient for one patient, whereas surgical stabilization was required in three patients.
A February 18, 2010 TV news report, "Sudden bone breaks reported in patients taking Fosamax", provides us with some insight about these femur fractures which might be caused by Fosamax. For this report, WCBD elicited the following comments and observations from rheumatologist Dr. Robert Bunnin, of the National Rehabilitation Hospital in Washington, DC:
"The drugs are supposed to work by shutting down the cells that re-absorb the bone, the osteoclasts. The ones that make the bone, the osteoblasts, are supposed to keep working. However in biopsies of patients who have had the fracture, it shows that both are shut down."
Bunning calls it "frozen bone," which is brittle and more susceptible to these types of clean fractures. He says in the U.S. There have been 50 to 60 reported cases of this.
"Even thought [sic] it’s rare, I think we’re going to be seeing quite a few more cases."
Dr. Bunning says that in all of the reported cases, most patients had been taking Fosamax or another type of bisphosphonate for more than 5 years.
"The drugs clearly were designed to make the bones stronger and I think they do for the first few years. They make them denser."...
Dr. Bunning says typically, patients with that condition will suffer breaks in the hip area—and that usually occurs after a fall.
With all of these patients, the breaks are occurring in the thigh and without any sort of trauma.
Dr. Bunning says that in many of these patients they had experienced vague thigh pain before their femur broke.
So Dr. Bunning says if you or someone you know is taking one of these drugs, make sure to see your doctor right away if something doesn’t feel right.

Dental chain settles suit over billing Medicaid for allegedly unnecessary procedures.

On its website, ABC News (1/20, Ruppel, Thomas) reported, "FORBA Holdings LLC, the parent company of the nationwide pediatric dental chain 'Small Smiles,' reached a $24 million settlement with the Department of Justice Wednesday for allegedly performing medically unnecessary or substandard procedures on children insured by Medicaid, to turn a profit."
ABC World News (1/20, story 8, 2:00, Thomas) reported that the government describes the scheme "as an assembly line approach by a healthcare company where dollars apparently mattered more than children." Daniel Levinson, HHS, was shown saying, "This was a matter of profit over compassion." Thomas continued, "The government claims in many cases, Small Smiles Dental Services, which has 68 clinics in 22 states, did procedures on children that were completely unnecessary, including removing teeth, x-rays, anesthesia, even root canals."
CQ HealthBeat (1/20, Reichard) reported, "Federal officials depicted the company as putting great pressure on its dentists to bill Medicaid for dental services and that dentists responded by doing shoddy work and performing unnecessary procedures to boost company revenues."
Bloomberg News (1/20, O'Reilly) reported, "The company admitted no wrongdoing," although Assistant US Attorney General Tony West said that "FORBA fired some dentists for failing to meet standards as a result of the investigation." The Denver Business Journal (1/20) reported, "As part of the settlement, FORBA signed an agreement to change policies at its clinics and establish procedures to detect and ultimately avoid performing unnecessary dental work."

J&J issues recall of over-the-counter drugs.

The New York Times (1/17, Singer) reported that "McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines" after "receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets." According to a warning letter from the FDA, the move "came 20 months" after the company "began receiving the complaints." Consumers have since "also reported temporary digestive problems like nausea, vomiting, and stomach pain, the agency said."
The AP (1/18) reported that the recall "includes some batches of regular and extra-strength Tylenol, children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph's aspirin." The products include "caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji." The odor "is caused by small amounts of a chemical associated with the treatment of wooden pallets, [J&J] said."
CQ HealthBeat (1/16, Norman) reported that the FDA "criticized McNeil Consumer Healthcare for failing to act more quickly to expand" the recall following consumer complaints. The warning letter from the agency cited "multiple violations of current good manufacturing practice requirements, and said the company didn't report quality problems to the agency." The Wall Street Journal (1/16, Favole, Dooren) and the Financial Times (1/16, Kirchgaessner) also covered the story.

J&J accused of drug kickback scheme.

The New York Times (1/16, B2, Singer) reported, "Johnson & Johnson paid kickbacks to the nation's largest nursing home pharmacy to increase the number of elderly patients taking" several of its medications, "according to a complaint filed...by the office of the United States attorney in Boston." The complaint alleges that Omnicare received "tens of millions of dollars...to buy and recommend Risperdal [risperidone]," as well as "prescription pain relievers Duragesic and Ultram, and the antibiotic Levaquin."
The Washington Post (1/16, Hilzenrath) reported that Omnicare received payments that were "sometimes disguised as grants or educational funding" to use "its influence with doctors to get prescriptions switched, the government said." As a result, the drugmaker "allegedly caused false or fraudulent claims to be filed with Medicaid." The government claims that between 1999 and 2004, "Omnicare increased its annual drug purchases from [J&J], from about $100 million to more than $280 million."
The Wall Street Journal (1/16, Rockoff) reported that J&J paid Omnicare rebates for switching prescriptions. Under federal law, rebates are legal unless Medicaid does not receive the same benefit. The complaint alleges that J&J disguised its rebates to Omnicare as physician-prescriber-data payments in order to avoid reporting them.
The AP (1/16) reported that US Attorney Carmen Ortiz's office "is seeking triple damages, restitution and other penalties under the federal False Claims Act and other laws. The damages would be based on the amount of false claims charged to Medicaid, which paid for about two-thirds of the claims on the care submitted for J&J drugs."
Forbes (1/16, Swanekamp) reported that the "Department of Justice said that [J&J] was aware of the influence Omnicare representatives have on the recommendations of nursing home doctors, claiming the drug manufacturer knew Omnicare suggestions were accepted about 80 percent of the time."

JAMA Focuses on Fallout from Breast Cancer Screening Recommendations

Physician's First Watch
Several commentaries in JAMA focus on the controversial 2009 U.S. Preventive Services Task Force recommendations on breast cancer screening.
In one, a former member of the task force reminds readers that the organization does not represent the government. He faults the recommendation's "poor wording" as one cause of the controversy and observes that it was "unwise" for the task force not to plan for the inevitable political fallout.
In another brief essay, two experts in health outcomes research examine the real harms of overdiagnosis and decry the politicization of healthcare. "Promoting screening irrespective of the evidence may garner votes," they write, "but will not create healthier voters."
There are two other commentaries. One argues for better prescreening assessment and discussion of possible screening harms. The other commentary, by a breast-imaging radiologist, argues for annual screening after age 40 among those "willing to accept the downsides of false positives" -- a willingness, she writes, shared by "the overwhelming majority of women."

Physician's First Watch coverage of the USPSTF recommendations (Free)