UCSF v. Beth Israel on FDA on heart device safety

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

Coakley take note: State requires coverage for outdated breast cancer treatment

BHN did a double take this morning on the Globe story about the Senate candidates’ debate about mandated insurance coverage. Apparently, the state still requires insurers to cover the cost of bone marrow transplants for breast cancer, even though researchers concluded TEN years ago that the procedure doesn’t work. (WBUR had the story as well.)

In Mass and some other states, insurers are required to cover treatments for conditions like infertility and alcoholism. Repub Scott Brow has proposed a bill that would kill all the mandates since they drive up insurance costs. According to the Globe story:

Coakley’s campaign attacked the bill, saying it would allow insurance companies to get out of covering things such as mammograms, bone marrow transplants for breast cancer patients, and hospice care for seniors.

BHN thought it mighty be a Globe error. But, indeed, Coakley repeats her support for the coverage in a press release on her web site:

Today Scott Brown offered his own health care reform “solution” for rising health care costs in Massachusetts that would allow the removal of coverage for critical health services for women, children, and seniors. His plan would allow the removal of previously mandated insurance coverage for such basic care as mammograms, minimum maternity stays for new mothers, hospice care for seniors, and bone marrow transplants for breast cancers patients.

Here’s a 2000 New York Times story entitled “Cancer Study Shuns Bone Marrow Therapy.“

Bone marrow transplants are ineffective when breast cancer has spread to other organs in the body, a nationwide study released today by The New England Journal of Medicine has found.

The reason Mass added bone marrow transplants for BC to the list is that — even though women were demanding it –the procedure was unproven and considered experimental. Now the results are in and have been for a while– BMT doesn’t help. But the mandated coverage remains on the books. It’s far from the only outdated statute in Mass, but Coakley might want to reconsider her continuing support for it.

Radio Tinker on computers and health reform on WBUR

Tinker Ready reported on an  attempt to wire three Massachusetts towns for health on WBUR radio’s “World of Ideas” on 12/27. Her piece starts at 15:30 into the show.

Face transplants for soldiers

The Globe reports this morning that the U.S. military is sending them a group of injured soldiers to  Brigham and Women’s for face transplants.

Many of the veterans with damage to their faces were injured by improvised explosive devices and are recuperating at Walter Reed. Although some have other injuries such as brain damage and missing limbs that limit their ability to work, others return to military jobs, living on or near bases. As is the case with civilians who have lost portions of their faces to burns, disease, or traumatic injury, some of these veterans struggle with going out in public, relationships, and work.

Health bill a go, but no Snowe

The NYTime has a package on the the likelihood that the Senate will pass a striped down reform bill. But, without the support of the senator from Maine.

Senator Olympia J. Snowe, a Maine Republican who had been considered a possible Democratic ally, said she would oppose the measure because it was being rushed. “It is a take-it-or-leave-it package,” she said.

Also see Robert Pear’s story, which explains the details of the package.

The final deal was packed with provisions calculated to appeal to various constituencies. The bill would provide extra Medicaid money to Nebraska, long-term-care insurance to people with severe disabilities, new services for pregnant teenagers and financial breaks to nonprofit insurance companies.

But there were also potential losers. To bring in more revenue, the bill proposes a range of new fees and taxes that would affect some high-income people, profitable health insurance companies and people who use tanning salons.

The proposals were drafted by Mr. Reid as part of an amendment to a sweeping health care bill, which embodies President Obama’s top domestic priority.

Mr. Reid’s amendment would expand eligibility for a small-business tax credit, increase penalties on certain uninsured people and increase the payroll tax on higher-income individuals and families beyond the increase that Mr. Reid proposed last month.

The Washington Post says:

Speaking at the White House, Obama said it appears that a vote is certain on a bill that would provide coverage to more than 30 million uninsured Americans. “After a nearly century-long struggle, we are on the cusp of making health-care reform a reality,” said Obama, who had dispatched senior administration officials to help lock down Nelson’s support.

Republicans excoriated the bill as a threat to Medicare — cuts to the program for the elderly would offset much of the cost — and to the employer-based insurance system, which provides health coverage to most Americans.

“This bill is a monstrosity,” said Minority Leader Mitch McConnell (R-Ky.). “This is not renaming the post office. Make no mistake — this bill will reshape our nation and our lives.”

GOP leaders, who have vowed to use every available tactic to keep the measure from advancing, invoked a rarely used Senate rule to require that the entire 383-page package of amendments introduced by Reid Saturday morning be read aloud on the floor, a process that consumed about seven hours.

But Republicans were running out of options in their quest to derail the overhaul. Securing Nelson’s support allows Reid to maneuver the legislation through a complex parliamentary minefield without obstruction. A bloc of 60 votes is the exact number required to choke off the filibuster, the Senate minority’s primary source of power, and the GOP‘s best hope of defeating the bill.

Dean, Snowe, Sanders and Lieberman

Health reform appears to be crumbling under a conservative assault and the inability of most people to understand what is at stake and how to fix it. New England pols and Senator have starring roles.

First, Kaiser Health News has the latest round-ups.  

Up for a rant? Try Bob Cesca on Huff Po. He’s pissed.

Now, on the so-called Northeaster liberal elite:   

Dean: Not real reform

12/18

KHN round-up: White House Rejects Dean’s Challenge To Senate Health Bill

 Newsweek says: Howard Dean Is Just Joe Lieberman’s Mirror Image

Raina Kelley steams about the inability to find middle ground: And it is this same refusal to compromise is what upsets me about former Democratic Party chairman Howard Dean and independent Sen. Joe Lieberman getting in the way of health-care reform. Why, when a bill finally seems possible, do they feel the need to destroy it?

 5/17

Matt Wright/flicker

 WBUR’s On Point  this morning featured Howard Dean, former governor of Vermont, and 2004 presidential candidate backpedalling a little bit. His comments last night on Rachel Maddow  sounded more like “kill the bill” than they did today. Dean’s was all over the place this morning, including on Wash Post op-ed page.

If I were a senator, I would not vote for the current health-care bill. Any measure that expands private insurers’ monopoly over health care and transfers millions of taxpayer dollars to private corporations is not real health-care reform. Real reform would insert competition into insurance markets, force insurers to cut unnecessary administrative expenses and spend health-care dollars caring for people. Real reform would significantly lower costs, improve the delivery of health care and give all Americans a meaningful choice of coverage. The current Senate bill accomplishes none of these.

 Bernie Sanders: Single-payer caught in crossfire

 From KHN: Sen. Tom Coburn, R-Okla., used a procedural maneuver during the Senate’s health care debate Wednesday to require that a 767-page amendment be read aloud before discussion could begin. The reading delayed the Senate’s consideration of the measure for three hours before the amendment’s sponsor, Sen. Bernard Sanders of Vermont, withdrew it. That may only be the beginning of a full-fledged campaign by opponents to delay the legislation. 

Joe Lieberman: The Spoiler

12/18

NY Times: Anti-Lieberman Drive Tops $1 Million. Moveon.org’s site includes a very entertaining sock puppet video.

12/17

MSNBC’s Rachel Maddow on the JL’s previous support for Medicare buy- in:Senator Joe Lieberman has been vocal recently regarding the power he holds by way of the filibuster, especially as it relates to the filibuster.  But that’s Joe speaking now.  What would Joe say a little over a decade ago about the matter?  

Take this quote given during a press conference that followed a vote on a piece of legislation Lieberman co-sponsored that would end the filibuster: ”Senators are not too good at yielding individual power.”  Joe then, meet Joe now, your walking, talking, picture perfect look at the types of congressional abuse you so rightly warned the country of 14 years ago

From NPR: In Washington, many Democrats and progressives were furious at Lieberman; some called for him to be stripped of his chairmanship of the Senate Homeland Security Committee. But for his constituents back home in Connecticut, it’s more of a mixed bag.

 

Snow: Slow Down 

12/18: NYTimes 

Ms. Snowe has said repeatedly that she thinks the health care bill is vitally important and would love to be able to vote for it. But she has also contended that Democrats are rushing the process unnecessarily and that as a result the bill will be rife with errors that could take years to fix.

In an interview with reporters at the Capitol on Thursday, Ms. Snowe described her conversations with Mr. Obama as productive.

“They are helpful,” she said. “We have a chance to share our views. So I get a better understanding of his vantage point, his perspective, where he’s coming from on these issues, and likewise he gets to hear my concerns and what I’m thinking at this moment in time. It helps to keep those lines of communications open. We have good free-flowing, straightforward, constructive, productive conversations.”

From “The Hill”:: Democrats from the White House to Capitol Hill are still holding out hopes of winning the support of Republican Sen. Olympia Snowe (Maine) for their healthcare bill. But despite major concessions made to centrist Democrats, Snowe has not yet jumped aboard.

“Yes, I do have misgivings because I understand that there are a lot of unintended consequences,” Snowe said Tuesday. “We haven’t had this bill laid down in its entirety so it makes it difficult, I think, to make a decision on a bill in such a short timeframe.”

Reformers Rally Here, Opponents Head for the Hill

Health reform proposals are constantly morphing, so it’s hard to keep track of who is supporting what.  This week, various combinations of overlapping local reform advocates are planning two different rallies. 

Some in Boston are targeting the insurance industry “for driving up premiums and opposing equitable health reform.” So, they’ll be gathering outside the Mass Association of Health Plans at noon on Thursday. The coalition has a heavy union presence but includes groups with positions that sit on various points in the health reform spectrum — from single-payer advocates to mandate coverage supporter: Greater Boston Labor Council, North Shore Labor Council, SEIU Local 615, MoveOn.org, Mass-Care, Health Care for America Now, Jobs with Justice, Northeast Action

 Then, a somewhat different group will be out in front of Sen. Kerry’s office tonight to demand that immigrants be included in the health plan. Supporters include Health Care for America Now, NALAAC Massachusetts Chapter, MoveOn.org Massachusetts, Health Care for All, MIRA Coalition, Commonwealth Care, Irish Immigration Center and Jobs with Justice.

 Health reform opponents are off to Capitol Hill for a rally this afternoon. Buses headed out this morning from the Mid-Atlantic to Virgina — but none from New England.

Boston meeting Monday on aging and health

WBUR’s Commonhealth features a post from Walter Leutz of  Brandeis University who“ describes the current challenges facing the state as the population ages and faces more chronic illnesses and rising health-care costs. “ 

He will speak Monday December 14, at a health policy forum in Boston, “Healthy Aging in the Commonwealth: Pathways to Lifelong Wellness:” 

This from a brief he wrote for the meeting:  

In the next few decades the U.S., including the Commonwealth of Massachusetts, will experience a rapid aging of its population and related rises in chronic illnesses, disability, health care and long-term care costs, and demands on family caregivers. The changes will challenge our care and financing systems. However, this should not be seen as a gloom and doom scenario. 

Rather, we should celebrate the advances in health care, public health, and economic status thathave made it possible to extend life expectancy far beyond what it was a century ago. Moreover, there is ever-stronger evidence that the “price of success” for living longer does not need to be added years of chronic illness and disability, as some feared.    

Medicare buy-in: Single payer or not?

If the Medicare buy-in is the back door to single payer health care, why does the Physicians for a National Health Plan group oppose it?

 According to Steffie Woolhandler “Lowering the eligibility age for Medicare to 55 only works if it is mandatory. Otherwise it becomes the place where all the sickest patients get dumped. That might be okay for the sick people since Medicare is often better and more secure than private coverage, but it would drive total health care costs (and premiums) up, not down.”

 Gooz News argues for the plan.

Allowing the uninsured, the laid off and those with financially burdensome employer-provided plans to buy into Medicare at 55 will allow them to get good preventive care and intervention when it has the most potential to be  effective and to reduce Medicare’s long-term costs.

In the meantime HHS says current plans for reform won’t cut costs, contradicting CBO estimates:

A new report from government economic analysts at the Health and Human Services Department found that the nation’s $2.5 trillion annual health care tab won’t shrink under the Democratic blueprint that senators are debating. Instead, it would grow somewhat more rapidly than if Congress does nothing.

More troubling was the report’s assessment that the Democrats’ plan to squeeze Medicare for $493 billion over 10 years in savings relies on specific policy changes that ”may be unrealistic” and could lead to cuts in services. The Medicare savings are expected to cover about half the nearly $1 trillion, 10-year cost of expanding coverage to the uninsured.

Ouch.

 

Also Swine Flu is going away in Mass.

And, Health Wonk Review — the best of the health policy blogs — is up.

The secret payment pacts between Mass hospitals and insurers

Like most, BHN’s family has had to cope with the slow erosion of health coverage over the years — higher premiums, higher co-pays and poorly explained charges like co-insurance. 

Now dad’s NYC-based company has changed insurers and given staff no other option. And our new plan doesn’t cover Harvard Vanguard, where we have been happy for 11 years. 

So, yesterday, my son and I went to have a bittersweet “exit” visit with the pediatrician who has taken care of him for my boy’s entire life. My husband and I will leave behind a primary care doc we love, a gastroenterologist, ear nose and throat specialist, a surgeon and all the other specialist in the practice who know our medical history.  If I think about it too hard, it makes us nuts. 

Today the Globe reports that health insurers are refusing to talk to the state about how they negotiate prices that pay some docs 300 percent more than some others. ”They explained their companies had signed confidentiality agreements with certain hospital or physician groups that prevented them from disclosing the information publicly because doing so would put the insurers at a competitive disadvantage.”

 Price setting between hospitals, docs and insurers amounts to a game of chicken. If the insurer refuses to pay — say, Partners — what the hospital system wants, the people who buy that insurance won’t have access to the Partners system. (See Globe story on Partners for details.) But, if the insurer covers a huge number of patients, they have the strong hand and can insist on lower prices. Don’t accept our price or we send all our patients elsewhere.

 Since our NYC-based insurance likely represents relatively few people in Boston, it was easy for HVMA to turn them — and us — away.

 Who’s missing in here — the patient, according to yesterday’s Department of Insurance hearing, The agency is looking : “into the reasons for disproportionately high health insurance rates paid by small businesses; but the agency has expanded its investigation to determine what is behind the soaring increases in insurance costs overall, including the large disparities in payments to providers….

In one instance,  (Kevin) Beagan, the deputy commissioner, pressed (Tufts Health Plan VP Marc)Spooner to explain whether Tufts health plan considers the impact on employers when it sits down to negotiate expensive contracts with health care providers. Those contract costs are passed on to employers.

“Do you start,’’ Beagan asked, “with what you think employers are willing to pay?’’

Spooner replied that contract talks with providers are “an interactive process’’ that takes into account the competition among providers.

Undaunted, Beagan pressed again.

“So the amount the employer would pay is not your target?’’ Beagan asked.

“No,’’ Spooner said

A pat on the back to the Globe’s Kay Lasar for covering an important but plodding under the radar hearing. I’ve covered similar and rarely leave without a headache, a notebook full of acronyms and a head full of jargon.

She herself took note of the lack of interest.

The sparsely attended hearing, in a drab fifth-floor conference room at the agency’s headquarters, featured mostly dense, bureaucratic answers to pointed questions.

Finally, take note of another Atul Gawande piece in the New Yorker holding up agricultural reform as a model that might address health costs. He suggests smaller decentralized efforts might get the job done.

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