Miscellany / Weekly Wrapup

Miscellany / Weekly Wrapup

  • The House Oversight and Government Reform Committee hearing held on June 6 apparently did not provide any resolution to the Avandia diabetes drug controversy, although the FDA commissioner did announce that “the agency had asked that Avandia, made by GlaxoSmithKline, and Actos, made by Takeda Pharmaceuticals, carry the more prominent warning because ‘despite existing warnings, these drugs were being prescribed to patients with significant heart failure.'”
  • Dr. David Brailer, who was the Nation’s first health information technology czar, resigned his position as co-chair of the American Health Information Community, in order to pursue managing his private venture capital firm called Health Evolution Partners. The firm will be investing $700 million of CALPers assets.
  • The U.S. District Court for the District of Massachusetts approved on June 6, 2007, the class certification motion in the First Databank case that challenges the validity of the Average Wholesale Pricing (AWP) methodology widely used for prescription drug manager pricing purposes with third party payers. Third party payers, who form the class, will be receiving a notice of class certification this summer, and they have until October 22, 2007, to opt out of the class action as described in the order. The class has been certified solely for purposes of the proposed settlement between First Databank and the plaintiffs, e.g, the class certification does not extend to the complaint against McKesson. The Court also preliminarily approved the proposed settlement and has scheduled a fairness hearing on the proposed settlement for November 14, 2007.
  • On Monday June 4, the U.S. Court of Appeals for the Third Circuit upheld a proposed Equal Employment Opportunity Commission rule that exempts from the Age Discrimination in Employment Act the common employer practice of reducing or eliminating retiree healthcare benefits when the retiree becomes eligible for Medicare. The caption of the case is AARP v. EEOC, — F.3d — , No. 05-4594, and a copy of the opinion is here.

New Aon Survey

Business Insurance reports on a new Aon consulting survey “of more than 70 medical, dental, pharmacy and vision plan vendors” projecting that for health plan 12 month rating periods occuring between April and September 2007 increase will average “10.9% for health maintenance organizations; 10.8% for point-of-service plans; 11.2% for preferred provider plans; 12.7% for indemnity plans; and 10.7% for consumer-driven health plans.”

New Coalition Formed


It’s the latest thing for former members of Congress — push for a health care information technology law. Of course, former House Speaker Newt Gingrich has been preaching that paper kills for a few years. Now former Sen. John Breaux and former Rep. Nancy Johnson have formed the “Health IT Now Coalition!“. According to a press release,

Health IT Now! believes federal legislation should include:

— Permanence in statute for a federal responsibility to lead a public-
private process to establish standards for system interoperability,
product certification, and quality measures and an accelerated process
for standards improvement;
— Federal financial incentives to practitioners of care to facilitate the
adoption of Health IT, and for communities, states, and other entities
to plan HIT components and develop Health Information Exchanges;
— Federal focus on consumer empowerment through patient education tools
to encourage patient use of electronic health records and provider
quality information; and
— Federal leadership of a federal-state process to resolve policy issues
central to a secure and safe care system, like privacy and professional
licensure, to provide a secure and safe care system.

Note to Coalition — this is already occurring without a law.

ASCO Conference


The American Society of Clinical Oncology held its annual meeting over the past weekend (it actually ends tomorrow), and there was news about Genentech’s blockbuster cancer drug Avastin. According to a CNNMoney.com report,

Adding Genentech Inc.’s (DNA) Avastin cancer drug to a certain chemotherapy regimen produced a modest improvement in a measure of survival of people with an advanced form of lung cancer, a new study [reported at the ASCO conference] found. But the study could have negative financial implications for Genentech and its majority owner, Roche Holding AG (RHHBY), because it showed a lower dose of Avastin was just as good as a higher dose. If doctors begin to prescribe lower amounts of the drug, it could slow the blockbuster drug’s sales growth. * * * Genentech recorded $1.7 billion in U.S. Avastin sales in 2006, up 54% from the year before. The drug, which works by starving tumors of needed blood supply, is also approved to treat colorectal cancer. Data from a separate study showing Avastin was effective in kidney cancer patients also was released Saturday, and is among dozens of Avastin studies being presented here.

The Genentech stock analysts weighed in with their medical opinions:

Lazard Capital analyst Joel Sendek said in a note to clients that discussions with doctors have led him to conclude that they will prescribe the lower dosage, even though it uses a non-standard chemotherapy regimen. But he also forecast that the overall dosage decline “will be largely offset by increased duration in use as this dose is better tolerated.” Analyst Douglas Chow of Caris & Co., meanwhile, noted that since the study wasn’t designed to measure a statistically significant difference between the two dosages, “…we do not believe physicians have enough information to conclude that low-dose Avastin could provide the same benefit in overall survival as high-dose Avastin.” Prudential Equity analyst Jason Zhang agreed. He also called the progression- free survival differential between the two doses “relatively unimpressive,” triggering concern that neither of the patients groups taking Avastin in the study will experience a significant survival benefit over chemotherapy alone. ” If this is the case, Avastin expansion to treat non-small cell lung cancer in Europe could turn out to be a difficult process,” he said in a research note.

AP reports that “Genentech shares fell $1.55, or 2 percent [today], to close at $77.95.”

Legislative Battle Brewing

The Hill reports that a legislative battle is brewing over the FEHB Program appropriations restriction on abortion coverage that was routinely adopted while the Republicans controlled Congress. Of course, the Democrats are in the driver’s now. According to the Hill, President Bush “sent stern letters to House Speaker Nancy Pelosi (D-Calif.) and Senate Majority Leader Harry Reid (D-Nev.) [in May 2007] promising to veto ‘any legislation that weakens current Federal policies and laws on abortion.’”

Dr. Watson receives his genome sequence


Nobel laureate Dr. James Watson, who co-discovered DNA with fellow Nobel laureate Dr. Francis Crick in the 1950s (Watson left, Crick right in photo) and helped launch the successful Human Genome Project in 1990, received a DVD map of his own genome sequence last week. It was announced that Dr. Watson’s was the “first individual genome to be sequenced for less than $1 million.” Completing the sequence took two months.

A New York Times article today reported that “Soon enough, scientists say, we will all be able to decipher our own genomes — the six billion letters of genetic code containing the complete inventory of the traits we inherited from our parents — for as little as $1,000.” Comparing peoples’ genome sequences will permit improvements in medical treatments. “I think we’ll have a healthier and more compassionate world 50 years from now because of the technological advances we are celebrating today,” Watson said.

Dr. Watson plans to deposit his sequence with the GenBank database. Watson said that he planned to skip the section of the [genome sequence] map that would tell him if he was at risk for Alzheimer’s disease, which his grandmother died from. That, he said, he didn’t want to know.”

Miscellany / Weekend Wrap-up

  • The American Medical Association’s Physician Consortium for Performance Improvement approved ten new physician quality measures at a June 1 meeting. The Consortium has developed 184 performance measures that cover conditions that represent 80 percent of Medicare spending.
  • HHS has created a new “Health Care Report Card Compendium” web site that is a searchable directory of health care “report cards” which provide comparative information on the quality of health plans, hospitals, medical groups, individual physicians, nursing homes, and other providers of care.”
  • The House Oversight and Government Reform Committee will hold a hearing on the Avandia controversy next Wednesday June 6. The FDA Commissioner, the doctor who authored the NEJM study that kicked off the controversy, the NEJM editor who opined on the study and Glaxo’s pharmaceutical research chairman will be testifying. Business Week included a report on the “High Cost” of the controversy which observed:

    Caught in the middle [of the Avandia controversy] are the diabetes patients already taking Avandia, which sensitizes the body to insulin. Doctors in the trenches say many patients are confused and scared, which raises concerns that they may stop taking the drug without medical consultation. “This kind of controversy really frustrates the average doctor,” says Dr. Rob Lamberts, a primary-care physician with Evans Medical Group in Evans, Ga., who treats a number of diabetics. He finds the data in Nissen’s study questionable and would prefer to wait for the results of the large, rigorously designed safety trial of Avandia which is scheduled to end in 2009.

  • Wal-Mart announced at its annual meeting this week that 38% of its pharmacy sales are $4 generic drugs. Wal-Mart’s COO estimates that the $4 generic program has saved consumer $350 million since it was introduced in November 2006.

Avandia update

The Wall Street Journal is reporting that U.S. doctors have been “shunning” Glaxo Smith Kline’s blockbuster diabetes drug Avandia since last week’s New England Journal of Medicine study indicating that Avadia carries a higher heart attack risk than other diabetes drugs. The Times of London reports that Analyst Peter Cartwright at Evolution Securities said: “Our guess that [UK] patients already taking Avandia won’t switch, because of the risks involved, but in places like the US, particularly because they are so litigious, we expect to see a sharp fall in new prescriptions.” Glaxo has been mounting a spirited defense, but it appears to have been taken by surprise. Meanwhile, Glaxo’s stock price has “nose dived.”