Wal-Mart hikes branded diabetes drug prices-study (Reuters)

SAN DIEGO (Reuters) – Big-box retailers Wal-Mart Stores and Kmart, pioneers in the push to cut consumer prices for generic drugs, have been raising prices for the most popular brand-name diabetes drugs, according to a new study.

Wal-Mart, the world's largest retailer began in 2006 to sell some generic drugs in the United States for $4 per monthly prescription -- a tactic since adopted by a number of other pharmacy operators.

"Since 2008, everybody has lowered generic prices to the level of Wal-Mart," said Dr. Ronald Tamler, an endocrinologist at New York's Mount Sinai Medical Center, and co-author of the price study. "But the differential in pricing for brand-name drugs is huge."

His study, presented here at the annual meeting of the American Diabetes Association, found that pharmacy prices for generic diabetes drugs fell 58 percent between 2008 and 2010, compared with an increase of 113 percent for brand-name drugs.

The study also showed that Wal-Mart has raised prices for the 10 most-prescribed diabetes treatments by 32 percent between 2008 and 2010, compared with an average industry-wide increase of 21 percent, which includes chain drugstores, mail-order firms and independent pharmacies.

Kmart, a unit of Sears Holding Corp, raised its prices by 35 percent over the same two-year period, according to the study.

Neither company responded to a request for comment.

The $4 generics have become a "loss leader" for stores looking to draw new customers, Dr. Tamler said.

"The message used to be to send uninsured and underinsured patients to Wal-Mart to get a great deal on generic drugs," he said. "Now, the message is to tell patients to shop around for their medications."

(Editing by Paul Simao)

Study: Most Addicts Get Painkillers from Friends or Family, Not Doctors (Time.com)

Only 1 in 5 people who misuse opioid painkillers like Vicodin get their drugs exclusively from doctors, and 69% never obtain any of these drugs from medical sources, according to a recent study published in the Archives of Internal Medicine.

Researchers led by Yale's Dr. William Becker examined 2006-08 data from the National Household Survey on Drug Use and Health (NHSDUH), an annual survey that includes information from interviews with thousands of people about their drug habits. (See the top 10 side effects of the war on drugs.)

Information was obtained for more 3,000 people over 18 who reported having taken an opioid painkiller that was not prescribed to them or for nonmedical reasons in the last month. In line with prior research, the new study found overwhelmingly that most opioid misusers were not being treated for pain and had obtained their drugs from friends, family or dealers, not doctors.

Younger drug misusers were less likely to get their drugs from doctors than middle-age and older ones: 77% of 18-to-25-year-olds got their painkillers exclusively from nonmedical sources, compared with 52% of those older than 50.

Prior research examining this question from the other direction - looking at the proportion of pain patients who develop first-time drug problems when given drugs by their doctors - finds that less than 3% become addicted this way. NHSDUH data also show that 80% of Oxycontin misusers have previously taken cocaine, suggesting that their addiction was not likely to have originated from being legitimately prescribed an opioid for pain. (Read "The New Drug Crisis: Addiction by Prescription.")

Nonetheless, efforts to fight opioid misuse are focused almost exclusively on trying to get doctors to write fewer prescriptions and using databases to track patients' medical records and doctors' prescribing habits. The new data suggest that it a more fruitful approach to the problem of painkiller misuse - and to the problem of legitimate pain patients not begin able to get drugs - may be to focus on what drives people with drug problems to seek out opioids and on supply sources other than doctors, including foreign drug companies, dealers and theft from factories, friends and family.

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Supreme Court strikes down state drug data-mining law (Reuters)

WASHINGTON (Reuters) – The Supreme Court struck down a law that prohibits the use of prescription drug records for marketing, ruling for free-speech rights over a state government's medical privacy concerns.

The high court handed a victory to data-mining companies IMS Health, Verispan and Source Healthcare Analytics, a unit of Dutch publisher Wolters Kluwer, which had challenged the law. The companies collect and sell such information.

By a 6-3 vote, the justices on Thursday upheld a ruling by a U.S. appeals court that Vermont's law infringed on commercial free-speech rights in violation of the First Amendment of the U.S. Constitution.

The law, adopted in 2007, prohibited the sale, transmission or use of prescriber-identifiable information for marketing a prescription drug unless the prescribing doctor had consented.

Vermont, Maine and New Hampshire are the only states to have adopted such laws, although similar measures have been proposed in about 25 states in the last three years.

Pharmaceutical manufacturers use data about a doctor's prescribing habits to better inform their drug salespeople when they visit physician offices to market certain products.

According to evidence presented in the case, pharmaceutical manufacturers spend nearly $8 billion annually on marketing efforts directed at doctors.

"Speech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment," Justice Anthony Kennedy wrote in the court's majority opinion.

PRIVACY OF DOCTORS AT ISSUE

The case did not involve the privacy rights of patients, as that already is protected under federal law. But Vermont said its law was aimed at protecting the privacy of doctors.

Companies that collect the data have said the information about doctors' prescribing patterns can be used to help monitor safety issues of new medications, to reduce costs, and for research purposes like studying treatment outcomes.

The law's supporters, including the Obama administration, said it helped protect medical privacy and control escalating healthcare costs by promoting cheaper generic drugs over more expensive brand-name drugs.

Vermont pharmacies must collect prescription drug information. The law bars pharmacies from disclosing the data and gives prescribing doctors the right to consent before any information is sold or used in marketing.

Attorneys for the drug companies said the law discriminated against the companies, making it harder for them to get their message to doctors. They argued the law unfairly favored views espoused by the state and insurance companies that favor generic drugs.

Kennedy agreed and said the law imposed content-based and speaker-based burdens on protected free-speech expression.

While Vermont's goals of lowering the costs of medical services and promoting public health may be proper, the state does not achieve those goals in a permissible way, he said.

"The state may not burden the speech of others in order to tilt public debate in a preferred direction," Kennedy concluded in the 25-page opinion.

"We're extremely pleased with the outcome," said Thomas Goldstein, an attorney who represented the data companies.

"It validates what the companies have been saying about the implications of information for healthcare," Goldstein told reporters in a press briefing. "The court agrees with us that the use of information here like in other contexts is a public good and that it will help healthcare."

"The court says here that information is extremely valuable for good decision-making in our society and that's true in medicine as well," Goldstein said. "And that if doctors want to hear from detailers, they need to be able to hear from them without the government getting in the way."

Justices Stephen Breyer, Ruth Bader Ginsburg and Elena Kagan dissented. Breyer called it a lawful governmental effort to regulate a commercial enterprise.

Vermont Attorney General Bill Sorrell expressed disappointment with the ruling. "We knew going in that this Supreme Court has frequently sided with large corporations," he said. He called the decision "a step back, but not the end of the story."

Senator Patrick Leahy, a Vermont Democrat who chairs the judiciary committee, denounced the ruling. "This decision is another example of this court using the First Amendment as a tool to bolster the rights of big business at the expense of individual Americans," he said.

The Supreme Court case is Sorrell v. IMS Health, No. 10-779.

(additional reporting by Lewis Krauskopf in New York; editing by Gerald E. McCormick, Maureen Bavdek, John Wallace and Gunna Dickson)

Supreme Court rejects generic drug labeling suits (Reuters)

WASHINGTON (Reuters) – The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.

By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.

The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.

Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.

The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.

But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.

The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.

Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.

COURT 'HIT NAIL ON THE HEAD'

Attorney Jay Lefkowitz, who represented Teva, said, "The Supreme Court hit the nail on the head today by making clear that federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use."

Actavis CEO Doug Boothe called the ruling "an important and necessary step by the Supreme Court to clarify the proper interpretation of regulations governing pharmaceutical labeling."

Bob Billings, the trade group's executive director, said assessing liability would have placed "the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing."

One case involved Julie Demahy, who sued Actavis and said it should have warned her of the risks of developing a neurological movement disorder from metoclopramide, a generic drug for heartburn, nausea and vomiting.

The drug's brand name equivalent is Reglan.

In another case, Gladys Mensing sued the three generic drug makers in federal court in Minnesota after allegedly developing the same disorder after taking generic versions of Reglan.

When the women first took the drug, the approved labeling said that "therapy longer than 12 weeks has not been evaluated and cannot be recommended."

That warning was changed in 2004 to say simply that therapy should not exceed 12 weeks and in 2009 the FDA ordered that specific warnings about the movement disorder be added to Reglan and metoclopramide.

The Obama administration supported the two women. It said the companies could have sought changes to the drug's label.

Generic drugs account for more than 70 percent of all prescriptions filled in the United States.

Liberal Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented.

The Supreme Court cases are Pliva v. Mensing, No. 09-993, Actavis v. Mensing, No. 09-1039 and Actavis v. Demahy, No. 09-1501.

(Reporting by James Vicini, Editing by Gerald E. McCormick, Dave Zimmerman and Matthew Lewis)

Kidney improvement sustained by Abbott drug: study (Reuters)

NEW YORK (Reuters) – Diabetics with moderate to severe chronic kidney disease showed significant and sustained improvement in kidney function through 52 weeks of treatment with a novel drug being developed by Abbott Laboratories, according to data from a midstage clinical trial.

The oral drug, bardoxolone methyl, is the first medicine to demonstrate improvement in kidney function in patients with the deadly disease and could delay the need for expensive and inconvenient kidney dialysis, researchers said.

Current treatments, which are primarily blood pressure control medicines, have only been able to slow progression of chronic kidney disease.

"This is totally unique in my 20-plus years of treating patients with chronic kidney disease. There's nothing out there that increases kidney function," Dr. David Warnock, who presented the data at a European kidney meeting in Prague on Friday, said in a telephone interview.

"The important improvement we saw at the primary endpoint of week 24 is persisting and sustained throughout the entire 52 weeks of treatment," Warnock added.

Bardoxolone showed statistically significant kidney improvement compared with placebo at all three doses tested -- 150 milligrams, 75mg and 25mg -- researchers said.

Based on the results of the 227-patient study, Abbott and its partner, privately-held Reata Pharmaceuticals, which discovered the drug, selected the 75mg dose for a recently initiated pivotal Phase III trial.

Bardoxolone is the first drug from a new class called antioxidant inflammatory modulators that work by suppressing inflammation, researchers said.

Patients in the midstage trial had Type 2 diabetes and moderate to severe chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) of 20 to 45. A person with normally functioning kidneys has an eGFR -- a common measure of kidney function -- of 100.

The Abbott drug raised eGFR by nearly 30 percent compared with placebo at the two higher doses. Those who got the 75 mg dose had an average eGFR improvement of 10.5, while 150mg patients saw a 9.5 eGFR improvement.

About 21 percent of placebo patients suffered a significant loss of kidney function (more than 25 percent) over the course of the 52 weeks, which is typical for the progressive disease, researchers said.

That compared with just 9 percent with significant kidney function loss for bardoxolone patients, meaning 91 percent experienced beneficial effects on kidney function, Warnock explained.

"What we have now today is a very promising data set that would suggest there is a possibility we can actually improve kidney function even in patients who have far advanced severe chronic kidney disease," said Warnock, a professor of medicine in the division of nephrology at the University of Alabama in Birmingham.

"If this is confirmed as being clinically significant in terms of benefit to these patients, the prospects are very, very exciting," he added.

The 1,600-subject Phase III trial will determine whether the new drug can delay progression to dialysis or cardiovascular death among very high risk kidney patients with diabetes.

The most common adverse side effects seen with bardoxolone methyl included muscle spasm, transient elevations in liver enzymes and nausea.

Most of the side effects seen in the first 24 weeks of treatment had moderated or subsided during the latter portion of the study, Warnock said.

"The adverse effect profile was something that we're quite comfortable with, and we feel comfortable moving forward now with the definitive Phase III outcomes study," he said.

An estimated 20 million Americans have chronic kidney disease; about 500,000 are on dialysis or in need of transplants, according to the National Kidney Foundation.

Diabetes is the most common cause of end stage renal disease, which progresses to a need for kidney dialysis and death.

"To keep patients off the dialysis machine will be a huge impact in terms of quality of life," Warnock said.

In addition, end stage renal disease patients consume a huge portion of the Medicare budget compared to their numbers, he said.

"If we can keep people off dialysis, which costs about $75,000 a year, that would be just absolutely huge," he said.

SOURCE: http://bit.ly/kEYznL New England Journal of Medicine, online June 24, 2011.

September cutoff for bare-bones health plan waivers (Reuters)

LOS ANGELES (Reuters) – Providers of bare-bones health insurance plans have until September to seek exemption from certain coverage requirements set under the 2010 health care reform law, according to the Centers for Medicare and Medicaid Services.

The agency said on Friday that insurers will need to file by September 22 for waivers regarding annual coverage limits under such "mini-med" health plans.

The plans, generally designed for low-wage restaurant and retail workers, provide lower benefits than the average health insurance plan.

As the health law required, in September 2010 insurance plans began phasing out their annual limits. Today, most plans cannot impose an annual limit that is lower than $750,000. Beginning in September 2011, that allowable limit increases to $1.25 million and in September 2012 it will rise to $2 million.

Such limited benefit plans are to be phased out when subsidies and new coverage options provided for in the health law come on line in 2014. The law prohibits plans from setting annual and lifetime spending limits after that point.

"Until then, annual limits are phased out in order to preserve access to needed benefits and affordability of coverage," CMS said in a statement.

The total market for limited benefit plans is about 1.4 million people.

Shire drug for rare swelling worked in trial: FDA (Reuters)

NEW YORK (Reuters) – Shire Plc's drug to treat severe swelling caused by a rare genetic disorder showed effectiveness in a key clinical trial, U.S. Food and Drug Administration staff said on Tuesday.

The injected drug, Firazyr, is under U.S. review for treating attacks suffered by patients with hereditary angioedema.

FDA staff issued a report on the drug, which is approved in other countries, ahead of a federal advisory committee meeting to review the medicine on Thursday.

The clinical trial, known as FAST-3, was conducted to address the FDA's concerns over the drug's efficacy from two earlier studies. The agency declined to approve the drug in April 2008, citing clinical deficiencies.

In FAST-3, Firazyr, or icatibant, showed a statistically significant decrease in time to primary symptom relief, FDA staff said.

"Collectively, the findings from the Phase 3 clinical program support the efficacy of icatibant for the proposed indication," FDA staff said in their documents.

The agency also found no pattern of serious adverse events across the studies that appeared attributable to Firazyr.

The FDA is expected to make a decision on Firazyr by August 25.

Shares of Shire were up 0.6 percent in London.

Hereditary angioedema is a rare and dangerous genetic disease characterized by sudden attacks of swelling in areas such as hands, arms, feet, face or breathing passages. It is estimated to affect one in 50,000 people.

Firazyr is already approved in more than 35 countries in Europe and elsewhere. Analysts on average expect the drug's sales to reach $107 million by 2015, according to Thomson Reuters Pharma, after Shire reported $11 million in Firazyr sales last year. The company reported overall revenue of nearly $3.5 billion in 2010.

Deutsche Bank analyst Mark Clark said he was confident the drug would win approval following the FDA staff release of the documents. Shire initially put Firazyr's sales potential at as much as $450 million, but the U.S. delay and arrival of competitors has dampened expectations, Clark said in a research note.

U.S. sales of Viropharma Inc's Cinryze, a rival drug approved in October 2008, reached $177 million last year, Clark said.

Shire has a significant business in drugs for rare genetic disorders, such as Gaucher disease and Fabry disease.

(Reporting by Lewis Krauskopf; Editing by Lisa Von Ahn)