For consumers who have been losing trust and patience with Johnson & Johnson over its manufacturing and quality control issues, the announcement of a recall on Thursday from a company unit that makes neurology drugs may seem all too familiar.

The Johnson & Johnson unit, the neurologics division of Ortho-McNeil-Janssen Pharmaceuticals, said it was recalling about 57,000 bottles of Topamax, a drug that can be prescribed as an anti-seizure medication for epilepsy or to prevent migraine headaches. The company said it was recalling the drug after receiving four complaints from consumers of a strange odor, but added that there had been no reports of serious health problems associated with the complaints.

In 2009 and 2010, similar odor complaints led another unit of Johnson & Johnson, McNeil Consumer Healthcare, to conduct nationwide recalls of millions of bottles of over-the-counter drugs including Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph’s aspirin. A company investigation determined that the moldy odor had been caused by contamination from a byproduct of a chemical used to treat wooden pallets used to transport the drugs.

The recall of Topamax involves two lots of 100mg strength tablets shipped at the end of last year, the company said. Less than 6,000 bottles of the product are believed to remain in stores, the company said.

People taking Topamax who notice a strange odor with the pills should return the tablets to their pharmacist, the company said. Consumers or physicians can contact the Topamax hotline for further information on weekdays between 9am and 5pm at: (866) 536-4398. Read more…

Changes to Medicare may seem ever more likely, with President Obama expected on Wednesday to talk about ways to lower the deficit and eke savings out from entitlement programs. He is speaking just a week after Republicans laid out a proposal that would privatize Medicare, the insurance program for people over 65.

In an article published in The Times on Wednesday, Robert Pear outlines ways that Medicare could be altered, or re-engineered. He lists these leading proposals:

¶Increase the age of eligibility for Medicare to 67, from 65.

¶Charge co-payments for home health care services and laboratory tests.

¶Require beneficiaries to pay higher premiums.

¶Pay a lump sum to doctors and hospitals for all services in a course of treatment or an episode of care. The new health care law establishes a pilot program to test such “bundled payments,” starting in 2013.

¶Reduce Medicare payments to health care providers in parts of the country where spending per beneficiary is much higher than the national average. (Payments could be adjusted to reflect local prices and the “health status” of beneficiaries.)

¶Require drug companies to provide additional discounts, or rebates, to Medicare for brand-name drugs bought by low-income beneficiaries.

¶Reduce Medicare payments to teaching hospitals for the cost of training doctors.

Last week, our readers expressed their views on privatizing Medicare. Of the changes listed above, which seem most likely to help contain costs and be palatable to the public — and, especially, to Medicare recipients?

(Mr. Obama’s speech about the deficit is at 1:30 p.m., at George Washington University.)

Federal officials announced a new public-private effort called the Partnership for Patients: Better Care, Lower Costs on Tuesday in which hospitals, doctors, nurses, patient advocates, health plans and employers will work together to try to improve the quality of the nation’s medical care. The idea is to work together to save lives and money by reducing hospital errors, injuries and complications that could be prevented.

“Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents,” said Kathleen Sebelius, the secretary of health and human services, in a statement. “Working closely with hospitals, doctors, nurses, patients, families and employers, we will support efforts to help keep patients safe, improve care, and reduce costs. Working together, we can help eliminate preventable harm to patients.”

It’s a program that nearly everyone in the health care system supports, and you can take a look at the growing list of organizations pledging to help here: The site also has posted more about the partnership on this fact sheet.

While Congress and the Obama administration averted a government shutdown late last week, federal lawmakers and presidential aides will continue to debate how to cut spending — with Medicare and Medicaid often in the cross hairs.

Several articles in The Times offered a preview of some of the discussions that will be under way this week in Congress, as lawmakers take up votes on the budget agreement. Carl Hulse, the chief Congressional correspondent, laid out divisions among House Republicans as they move forward toward votes on the agreement.

Robert Pear notes provisions in the federal health law that would be scrapped under the budget deal:

The budget agreement also takes aim at two provisions of the new health care law. It would cut more than $2 billion set aside for the creation of private nonprofit health insurance cooperatives.

It also eliminates a program that would have allowed hundreds of thousands of lower-income workers to opt out of employer-sponsored health plans and use the employer’s contribution to buy coverage on their own, through new insurance exchanges.

Senator Ron Wyden, Democrat of Oregon, the architect of this provision, lamented its demise.

“Publicly,” Mr. Wyden said, “both parties say they are champions of choice and competition and making health insurance more affordable for everyone. But then behind closed doors they kill a program that does exactly that. This seems like a victory for special interests.”

Many employers had objected to the Wyden provision, saying it would increase their costs by allowing younger and healthier entry-level employees to opt out of employer-sponsored plans.

The Times’s Jackie Calmes offers a glimpse of President Obama’s proposals to be released later this week on lowering deficit spending, and what he may say about Medicare spending and overall health care costs. His top spokesman, David Plouffe, made the rounds of the Sunday news shows, and acknowledged that the president’s plans would include looking at savings in Medicare and Medicaid. Read more…

As part of their budget proposal, Republican lawmakers are now talking about replacing the Medicare program with a private system that would rely on commercial insurers to provide coverage to the elderly instead of the federal government.

The insurers already offer coverage to Medicare recipients through Medicare Advantage plans, but this would be a tremendous business opportunity for the industry, notes Ana Gupte, an analyst with Bernstein Research. The private Medicare market, she estimates, could be a $1.2 trillion business by 2031. She describes this bullish scenario as “unlikely,” however.

There is, of course, a lot more being proposed than just giving private insurers many more potential customers. One of the selling points is that private insurers would do a better job holding down costs and improving quality than the federal government can.

What kind of job do you think the insurers offering Medicare Advantage plans are doing and do you think Medicare should be privatized?

Just days after the Obama administration unveiled regulations on how doctors and hospitals can band together to offer coordinated care, Kaiser Permanente will open on Tuesday a demonstration center near the Capitol Building to show what it believes such coordination should look like.

Kaiser, one of the nation’s largest insurers and care providers, intends to use the center and a large adjoining clinic to help influence the debate about overhauling the health care system.

“Historically, no matter how successful we were in California, it didn’t seem to matter,” Dr. Robert Pearl, chief executive of the Permanente Medical Group, said Monday during a preview of the clinic and center. “We want to be the model for the nation.”

To do that, the company felt that it had to expand its presence in the Washington metropolitan region to one that more closely mirrors those it has in California and Hawaii. It is completing five integrated health clinics in the region that will provide for nearly every patient need, from visits to primary care doctors to specialists to critical care.

One of those integrated centers is located next to the Securities and Exchange Commission building, a brief walk from the Capitol Building.
Read more…

More than 1,800 health care company leaders and top government officials are expected at the 8th Annual World Health Care Congress in Washington Monday through Wednesday.

Among the speakers on Monday: Douglas W. Elmendorf, the director of the Congressional Budget Office; Phil Bredesen, the Democratic governor of Tennessee; George C. Halvorson, chairman and chief executive officer of Kaiser Permanante; Mark Bertolini, president and chief executive of Aetna; and Susan Voss, president of the National Association of Insurance Commissioners.

Then we turn to Tuesday and another group of keynote speakers including Dr. Toby Cosgrove, president of the Cleveland Clinic, and Scott Armstrong, president and chief executive of Group Health Cooperative.

On Wednesday, Dr. Francis Collins, director of the National Institutes of Health, and Joe Jimenez, chief executive of Novartis, headline a panel on personalized medicine. The meetings close with Senator Max Baucus, the Democrat from Montana who is chairman of the Senate Finance Committee and a leading lawmaker on the health care legislation.

Here’s the full agenda for the event at the Gaylord National Resort and Convention Center

In addition, two scientific advisory committees to the Food and Drug Administration meet this week.

The panel on anti-infective drugs meets Tuesday to discuss an application to market fidaxomicinm, a new type of antibiotic for diarrheal disease, from Optimer Pharmaceuticals.

And on Wednesday and Thursday, the Vaccines and Related Biological Products Advisory Committee meets to hear a wide range of research updates and to consider licensing approaches for vaccines to meningococcal serogroup B, which is currently responsible for most meningococcal infections.

They’re finally out. The much-awaited, much-speculated-about proposed rules that would govern accountable care organizations, the new and somewhat nebulous entities that are a key part of the federal government’s health care legislation, were announced on Thursday morning.

These are the regulations that would start answering questions about exactly what federal regulators have in mind when they talk about accountable care organizations, which are supposed to encourage hospitals and doctors and the like to better work together to provide more effective and less costly medical care. The organizations will be able to share the cost-savings they generate under the Medicare program if they demonstrate those savings are being produced by providing better and smarter care to patients.

“Accountable care organizations will improve coordination and communication among doctors and hospitals, improve the quality of the care their patients receive, and help lower costs,” the secretary of heath and human services, Kathleen Sebelius, said in a release about the new rules.

Federal officials have also provided a handy fact sheet.

So the debate begins.

Updated: Medicare announced on Wednesday that it would pay for Dendreon’s prostate cancer drug Provenge, whose $93,000 price tag had ignited debate about the cost and effectiveness of cancer drugs.

The Centers for Medicare and Medicaid Services said in a memo posted on its Web site that Provenge was a “reasonable and necessary” treatment for Medicare patients who had the stage of prostate cancer for which the drug was approved by the Food and Drug Administration last April.

However, it said the evidence was “virtually nil” that Provenge was effective for men who had other stages of the disease and therefore it did not believe those so-called off-label uses should be reimbursed.

The proposed coverage plan was generally expected since it was line with the findings of a Medicare advisory committee last November. The proposed decision will be open for public comment, with a final decision expected in June.

Medicare generally pays for drugs that receive F.D.A. approval. So the decision of the agency to even undertake a formal “national coverage determination” aroused some controversy.

Some securities analysts, investors in Dendreon and patient advocates said Medicare’s move represented the start of a crackdown on high-price drugs, or even the beginning of the “health care rationing” that critics of the new federal health care legislation assert would accompany it.

Medicare officials denied this, saying they merely wanted a uniform payment policy, rather than leaving the decision to regional Medicare contractors. The officials also said that Provenge raised some novel questions because it resembled a treatment process more than a mass-produced drug.

Some health care experts have been arguing that society cannot continue to pay for cancer drugs that extend lives by only a few months, if that much. In the main clinical trial testing of Provenge, men with advanced prostate cancer who received the drug lived a median of about 26 months, about four months longer than those who got a placebo.

In November, an advisory committee to Medicare expressed a fairly high level of confidence in the evidence demonstrating that Provenge prolonged lives, at least for the type of patients included in the clinical trials.

But the committee, which did not consider the cost of the drug, said the evidence was not convincing that Provenge would help men who had earlier-stage or later-stage prostate cancer than the men in the trials.

In the memo on Wednesday, Medicare officials said they would not put in place a blanket national ban on reimbursement for off-label uses of Provenge, leaving it instead to local Medicare contractors to develop policies. But the memo said Medicare officials hoped all such off-label uses would be only in clinical trials.

“We may, if this turns out to be an overly optimistic viewpoint, reconsider this N.C.D. to ensure that Medicare coverage is restricted to uses that are supported by robust evidence,” the memo said.

Provenge is approved for men whose cancer has spread beyond the prostate gland and who are no longer responding to androgen-deprivation therapy, yet still have minimal or no symptoms.

Medicare said it received 657 public comments during its deliberations over Provenge, of which 620, or 94.4 percent, were in favor of it paying for the drug.

Provenge is sometimes called a cancer vaccine because it harnesses the body’s own immune system to fight the cancer. Immune system blood cells are removed from a patient and incubated by Dendreon with a genetically engineered protein that, in a sense, trains the immune cells to recognize and attack prostate tumors. The immune system cells are then infused back into the patient.

Dr. J. Leonard Lichtenfeld, deputy medical director of the American Cancer Society, said Wednesday’s decision was one “that they had to come to” given Medicare statutes. He said he was surprised that the decision left open the door for off-label use by delegating those decisions to local Medicare carriers.

“If they were going to pick a battle, they elected not to pick it at this particular point in time,” Dr. Lichtenfeld said, referring to the cost of the cancer drugs. But he added, “I think inevitably we’re going to have that discussion in one way, shape or form,” he said.

Just last week, Bristol-Myers Squibb set a price of $120,000 for a full course of treatment with its newly approved drug for the skin cancer melanoma.

As with Provenge, that drug, Yervoy, prolonged survival by about four months. In a clinical trial, those who got the drug lived a median of 10 months, compared with 6.4 months for those in a control group.

4/4/11 | Updated to fix link to list of recalled products.

It’s yet another recall from the makers of Tylenol.

McNeil Consumer Healthcare, a unit of Johnson & Johnson, announced Tuesday afternoon that it was recalling more of its over-the-counter Tylenol products. In a statement, the company said that it was conducting a voluntary consumer recall of one product lot of eight-hour extended-release caplets because of a “musty or moldy odor.”

About 34,000 bottles are being recalled, according to a McNeil spokeswoman. The company says any health risk from the caplets is “remote.”

The company also announced it was expanding a previous recall announced in January. Unlike the Tylenol caplet recall, the expanded recall, which involves 10 lots of other products, is being undertaken on the wholesale level and is not based on adverse events, according to the company.

About 718,000 bottles or packages of Tylenol, Benadryl and Sudafed products were involved in the recall. Here’s a complete list of affected products.
Read more…