F.D.A. Imposes Long-Delayed Rule to Require Tracking of Prescription Drugs
By BARNABY J. FEDER

Long-delayed federal rules requiring most wholesalers to be able to track prescription drugs from factory floor to pharmacy door will finally take effect in December, the Food and Drug Administration said yesterday.

The regulations, stemming from a 1988 law intended to combat counterfeiting by verifying a drug's pedigree, were originally drafted in 1999. But the F.D.A. had repeatedly put a stay on the rules because the drug industry said it lacked practical methods for tracking and tracing all of its products. Now, though, the agency said further delay of the "pedigree" rules as they are known was no longer justified because of the development of electronic tracking technology, particularly digital identification tags that can be scanned with radio waves.

Justice Department accuses Abbott of fraudulent drug-pricing scheme

WASHINGTON (AP) — The Justice Department is accusing Abbott Laboratories of vastly inflating prices of its drugs as part of a fraudulent billing scheme alleged to have cost government health programs more than $175 million over 10 years.

Abbott bumped up the reported price of the intravenous antibiotic vancomycin as much as 18 times what it charged health care providers, knowing that the Medicare and Medicaid programs would reimburse the providers based on the manufacturer's price, according to a whistle-blower lawsuit unsealed Thursday.

Abbott, based in North Chicago, Ill., participated in such a billing scheme because hospitals, pharmacies and other providers would get to pocket the difference and would be more likely to prescribe the company's products again, the Justice Department contended.

Like you didn't know.

Comparison of Schizophrenia Drugs Often Favors Firm Funding Study
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, April 12, 2006; A01

Pharmaceutical giant Eli Lilly and Co. recently funded five studies that compared its antipsychotic drug Zyprexa with Risperdal, a competing drug made by Janssen. All five showed Zyprexa was superior in treating schizophrenia.

But when Janssen sponsored its own studies comparing the two drugs, Risperdal came out ahead in three out of four.

In fact, when psychiatrist John Davis analyzed every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study.

The Quote of Note is a series of links to previous P6 posts.

• Back to an old argument
• Pharmaceutical prices
• Pharmaceutical prices II
• See, I told you!

...and this, from the linked article:

The report found that more than one-quarter of the scientists who were awarded patents said they had started their own business — "an astonishingly high rate of entrepreneurship," the authors said.

"The investments in research and development are spilling out into the economy more than was appreciated," said David B. Audretsch, an economist at Indiana University, who also holds an appointment at the Max Planck institute. "These scientists are doing a lot more than sitting in labs and publishing papers."

...and this, from the abstract of the report cited by said article.

At present, only 20 percent of all basic research in the United States is performed by the private sector. Colleges and universities account for 60 percent of such research, with government accounting for the remaining amounts. Washington is the largest funder of basic research, paying for 57 percent of the total.

 “Federal investment in university research has a much bigger impact on the nation’s economy than previously thought,” said Lesa Mitchell, vice president of Advancing Innovation at the Kauffman Foundation.  “We are seeing much more commercialization coming out of universities that has not been measured.”

U.S. Research Funds Often Lead to Start-Ups, Study Says
By STEVE LOHR

A new study of university scientists who received federal financing from the National Cancer Institute found that they generated patents at a rapid pace and started companies in surprisingly high numbers.

Quote of note:

Dr. Jenkins emphasized that only 5 percent of the promised drug trials were officially considered "delayed." In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for the tests.

New Drugs Hit the Market, but Promised Trials Go Undone
By GARDINER HARRIS

WASHINGTON, March 3 — When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.

the agency bought computer systems, hired 2,500 employees, participated in 65,000 informational meetings and sent at least one letter to each of 19 million retirees who might qualify for the subsidized coverage. The goal, said Hinkle, was to cast as wide a net as possible.

The trouble is, said James Firman, president of the National Council on the Aging, it looks as though that net pulled in so many ineligible people that Social Security spent an enormous amount of time and money to process them. It has rejected close to 70 percent of applicants.

Millions Not Joining Medicare Drug Plan
Despite Outreach, Poor Seniors Miss Out On Low-Cost Coverage
By Ceci Connolly
Washington Post Staff Writer
Tuesday, February 21, 2006; A01

WASHINGTON -- More than a month after filling thousands of unpaid prescriptions for poor, sick customers, many of America's small and independent pharmacists, particularly those in low-income and rural areas, are facing a cash crunch as they await repayment from Medicare's private drug plans.

At Rose Drugs in central Tampa, many customers are poor people with HIV infections and senior citizens on fixed incomes. When their drug coverage switched from Medicaid to Medicare on Jan. 1, store owner Rose Ferlita distributed medicines to combat their ailments even though she couldn't always verify their eligibility for the new Medicare drug benefit.

Quote of note:

"In response to the new premiums, some beneficiaries would not apply for Medicaid, would leave the program or would become ineligible due to nonpayment," the Congressional Budget Office said in its report, completed Friday night. "C.B.O. estimates that about 45,000 enrollees would lose coverage in fiscal year 2010 and that 65,000 would lose coverage in fiscal year 2015 because of the imposition of premiums. About 60 percent of those losing coverage would be children."

The budget office predicted that 13 million low-income people, about a fifth of Medicaid recipients, would face new or higher co-payments for medical services like doctor's visits and hospital care.

It said that by 2010 about 13 million low-income people would have to pay more for prescription drugs, and that this number would rise to 20 million by 2015.

Drug Changes Are Looming, and Providers Seek Answers
By ROBERT PEAR

WASHINGTON, Dec. 18 - Two weeks before the start of the Medicare prescription drug benefit, pharmacists and nursing homes are desperately trying to find out who will pay for the medicines taken by hundreds of thousands of their residents.

The new law relies on private insurers to deliver drug benefits to older Americans. About two-thirds of the 1.5 million residents of nursing homes are participants in both Medicare and Medicaid. The government has randomly assigned them to private drug plans, regardless of their needs.

In many cases, nursing home officials said, they do not know to which plans their patients have been assigned. As a result, they do not know who will pay the bills or what drugs will be covered. Each plan has its own list of approved drugs, known as a formulary.

[TS] Drugs, Devices and Doctors
By PAUL KRUGMAN

Merck, the pharmaceutical giant, is under siege. And one side effect of that siege is a public relations crisis for the Cleveland Clinic, a celebrated hospital and health care organization.

But the real story is bigger than either the company or the clinic. It's the story of how growing conflicts of interest may be distorting both medical research and health care in general.

Senate Dems predict Medicare win in ’06
By Carrie Sheffield

Senate Democrats and a handful of centrist Republicans are poised to strike a political blow to the White House early next year by passing legislation that would change the Medicare prescription drug benefit.

Sen. Bill Nelson (D-Fla.) has enough votes to pass a bill that would extend the Medicare prescription-drug-benefit enrollment period for seniors until the end of 2006 and allow seniors a one-time change in plans.

“We are going to try to attach our language to the first available vehicle when we come back in January,” said Nelson spokesman Brian Gulley. “It would be the quickest way to get our language passed, as opposed to having to go through the committee gantlet. We have to get this thing passed as quickly as we can.”

Quote of note:

Nobody knows how popular the drug benefit will ultimately be with the nation's retirees, who are a critical voting bloc. But Congressional Republicans, who pushed through the Medicare drug law in 2003, have clear political ownership of it, and whatever credit or blame it brings, strategists say.

Glen Bolger, a Republican pollster, said his advice was simple: "It's going to be associated with Republicans, so you better make sure it's something they understand and take advantage of."

Too late...it is what it is, now. And what it is, is confusing as fuck.

Republicans Find They Have to Sell Drug Benefit Plan
By ROBIN TONER and ROBERT PEAR

Quote of note:

...Among the other black politicians featured on the mailer who oppose Proposition 78 are: Rep. Juanita Millender-McDonald (D-Carson); Rep. Maxine Waters (D-Los Angeles); Rep. Diane Watson (D-Los Angeles); Assemblywoman Karen Bass (D-Los Angeles); Los Angeles County Supervisor Yvonne Brathwaite Burke; and former Assembly Speaker Herb Wesson.

...Only a notice in small print says that appearance in the mailer does not signify endorsement of the proposition.

Black Politicians Say Mailer Distorts Support
By Noam N. Levey
Times Staff Writer
November 5, 2005

A drug industry-supported campaign, which has been criticized for giving money to people who endorsed its ballot measure, is now under fire for misrepresenting the positions of black politicians.

Key problem of note:

"A majority of NAACP dollars don't come from memberships. They come from corporate America," she said. "A lot of the time we don't agree. But if we can agree on an issue that's mutually supportive of corporate America, I think we should."

Nonsense statement of note:

Huffman said her decision was based on the merits of the two proposals. She said she feared Proposition 79 could deny patients in the state's health care system for the poor access to certain brands of medications.

She's hinting at the provision that would get your butt kicked off the formulary if your pricing is wrong. But California's market is too big...Big Pharma won't abandon that market any more than they abandoned Canada.

Black Leaders Question NAACP on Prop. 78
By STEVE LAWRENCE
Associated Press Writer
8:47 AM PST, November 5, 2005

SACRAMENTO, Calif. — The pharmaceutical industry has spent $76.5 million to line up support for its prescription drug initiative on next week's ballot -- and some of the money is causing a rift among black leaders.

The spending includes $1.4 million paid to groups run by blacks, much of it to consulting firms run by two prominent black leaders: Assembly speaker and San Francisco Mayor Willie Brown and Alice Huffman, head of the National Association for the Advancement of Colored People in California.

Democratic Rep. Maxine Waters said Huffman and others had "dishonored the NAACP."

The industry spending is aimed at supporting passage of Proposition 78, a measure on Tuesday's ballot that would provide discounted medications to uninsured Californians making up to three times the federal poverty level -- about 5 million people.

Although most of the $1.4 million went to the firms run by Brown and Huffman, some of the money went to the NAACP and several other black organizations for Proposition 78 campaign work.

The criticism began after the state NAACP and about 15 local chapters of the organization endorsed the proposal and opposed the competing Proposition 79, which is backed by labor and consumer groups and would cover twice as many people by including uninsured Californians making up to four times the poverty level.

Assemblyman Mark Ridley-Thomas of Los Angeles said Friday that the NAACP endorsements were "starkly inconsistent" with the group's record as an advocate for minorities and the poor.

Huffman said black leaders critical of her position on the two propositions "want the NAACP to be the enemy of corporate America."

"A majority of NAACP dollars don't come from memberships. They come from corporate America," she said. "A lot of the time we don't agree. But if we can agree on an issue that's mutually supportive of corporate America, I think we should."

Anthony Wright, co-chairman of a group campaigning for Proposition 79, said the drug companies recruited black organizations "to find groups with friendlier faces" to carry their message.

"We know that once voters find out that the drug companies are behind Proposition 78, they reject it and are more likely to join consumer groups in supporting Proposition 79," he said.

Huffman said her decision was based on the merits of the two proposals. She said she feared Proposition 79 could deny patients in the state's health care system for the poor access to certain brands of medications.

Quote of note:

The drug manufacturers have spent about $76 million so far in favor of Proposition 78 and against Proposition 79, a competing measure pushed by organized labor and some consumer groups.

"The list of groups saying Yes to 78 grows bigger every day," says an ad airing across California. The spot does not disclose that many endorsers have received payments.

Drug Firms Gave Money to Some Who Endorsed Proposition 78
By Dan Morain
Times Staff Writer
November 4, 2005

SACRAMENTO — The nation's drug makers have given hundreds of thousands of dollars to political leaders and civil rights groups that have endorsed the industry's initiative on the Nov. 8 ballot.

Quote of note:

Proposition 78 would also require the state to administer discounts and rebates on drugs, but here the similarity ends. Company participation would be entirely optional, discounts might be very small because they are not tied to Medi-Cal rates, and there would be no enforcement mechanism, such as Proposition 79's ability to remove drugs from Medi-Cal's preferred list. It would also cover about half as many people as Proposition 79 — uninsured Californians with maximum incomes of $29,000 for individuals or $58,000 for a family of four.

Big drug companies' Rx for victory
They are using Proposition 78 as a decoy to draw votes from the real reforms of 79.
By Marcia Angell
MARCIA ANGELL, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of the New England Journal of Medicine, is the author of "The Truth About the Drug Companies"
October 28, 2005

One-Fifth of Human Genes Have Been Patented, Study Reveals
Stefan Lovgren
for National Geographic News
October 13, 2005

A new study shows that 20 percent of human genes have been patented in the United States, primarily by private firms and universities.

The study, which is reported this week in the journal Science, is the first time that a detailed map has been created to match patents to specific physical locations on the human genome.

Researchers can patent genes because they are potentially valuable research tools, useful in diagnostic tests or to discover and produce new drugs.

Quote of note:

Ms. Sullivan continued to protest angrily as Judge Higbee continued to reprimand her loudly. The lawyer quieted only after the judge threatened to have her forcibly removed from the courtroom. The antagonism could be a problem for Merck beyond this one case, because Judge Higbee is overseeing all 2,400 Vioxx-related suits that have been filed in New Jersey state court.

Testimony by Witness for Merck Disallowed
By ALEX BERENSON

Merck's defense in the second Vioxx lawsuit to reach trial sustained a serious blow yesterday when the New Jersey judge overseeing the case threw out testimony from the company's first witness and then shouted down a defense lawyer who tried to protest the decision.

Quote of note

The initiative would set up a state drug-discount program for low-income residents and give pharmaceutical companies the option to participate. A competing measure, Proposition 79, would set up a more extensive program and give the state power to punish drug makers that don't join.

The trade organization spearheading the Proposition 78 campaign — with more than $80 million in funding from Johnson & Johnson, Merck & Co., Pfizer Inc., GlaxoSmithKline and other drug companies — prefers to focus on what the measure offers

I wonder why... 

...skyrocketing drug costs, and a corresponding rise in industry profits, issues at the heart of the rival ballot initiatives.

Oh! That explains it... 

Prop. 78 May Suffer From Drug Makers' Poor Image
The industry is spending millions on the discount plan but a poll shows distrust of the backers.
By Lisa Girion
Times Staff Writer
September 30, 2005

Quote of note:

Private insurers take, on average, 13% of premium dollars for overhead and profit. Overhead/profits are even higher, about 30%, in big managed care plans like U.S. Healthcare. In contrast, overhead consumes less than 2% of funds in the fee-for-service Medicare program, and less than 1% in Canada’s program.

...According to U.S. Congress’ General Accounting Office, administrative savings from a single payer reform would total about 10% of overall health spending. These administrative savings, about $100 billion annually, are enough to cover all of the uninsured, and virtually eliminate co-payments, deductibles and exclusions for those who now have inadequate plans - without any increase in total health spending.

Why the US Needs a Single Payer Health System
June 29, 1995
by David U. Himmelstein, MD & Steffie Woolhandler, MD
Our pluralistic health care system is giving way to a system run by corporate oligopolies. A single payer reform provides the only realistic alternative.

Drug Maker Named in Lawsuits Over OxyContin

About 1,000 people filed separate lawsuits on Staten Island against the manufacturer of the painkiller OxyContin yesterday, claiming they were victims of accidental addiction.

The plaintiffs are seeking damages from the maker, Purdue Pharma, which is based in Stamford, Conn., claiming the company dishonestly marketed the pain pill by failing to tell doctors, pharmacists and patients about the drug's addictive qualities, according to an attorney in the case, Tor Hoerman.

A state judge on Staten Island recently declined to certify a class-action suit, saying the cases involved different issues and injury claims. Instead, a coordinating judge in New York State Supreme Court was assigned to preside over each case.

Quote of note:

California joins a list of at least 10 other states who have filed similar lawsuits in an attempt to ratchet down spiraling health costs by seeking lower drug prices. In June 2004, Texas settled a suit filed in 2000 against three drug makers for $45 million.

...The case is being consolidated with those filed by other states in federal court in Boston, Massachusetts.

California accuses drug companies of inflating prices
Suit claims firms have overcharged by hundreds of millions of dollars
- Greg Lucas, Chronicle Sacramento Bureau
Thursday, August 25, 2005

(08-25) 15:48 PDT Sacramento (SF Chronicle) --

California sued 39 pharmaceutical companies Thursday for allegedly inflating their prices and causing the state’s health care program for the poor to potentially pay out hundreds of millions more than it should.

Quote of note:

"They know truth, and they know justice," said Mark Lanier, an attorney for Ernst's widow, Carol. "Anyone who said they are too 'small-town' or won't understand -- they are crazy."

Merck Found Liable in Vioxx Case
Texas Jury Awards Widow $253 Million
By Marc Kaufman
Washington Post Staff Writer
Saturday, August 20, 2005; Page A01