Selkoe to discuss #amyloid and #Alzheimer’s in wake of another disappointing drug study

A recent story in The Atlantic asks “Is the Leading Theory About Alzheimer’s Wrong?

1905_otto_folin_in_biochemistry_lab_at_mclean_hospital_byahfolsom_harvard

1905: Research at McLean

For years, scientist have been arguing about whether amyloid protein in the brain is a cause,or just a symptom of condition.  Pharma has been confident — or desperate — enough in the science to bet on amyloid clearing drugs, but they haven’t turned out to be very good bets. So far, none has proved effective.

On Tuesday morning, one of the chief proponents of the theory, Harvard’s Dennis Selkoe, will give a talk at McLean Hospital, the storied psychiatric facility in Belmont.  Entitled  “New Insights into the Protein Biology of Alzheimer’s and Parkinson’s Diseases,” it takes place at 11 am in room 132 of at the hospital’s de Marneffe Building.

And, if those in audience have read the Atlantic piece — in which Selkoe is quoted — they may have questions about Merck’s recent decision to abandon test on what was once considering a promising treatment. .

 

 

After Merck’s announcement last week, one neurologist told Bloomberg that “there is mounting evidence—of which this is another piece—that removing amyloid once people have established dementia is closing the barn door after the cows have left.” An advisor to a life-sciences venture-capital firm tweeted, “I’ve been a long-term adherent of the amyloid hypothesis, but starting to feel like this”: “This” was a gif of the Black Knight from Monty Python, arms missing but still adamant he had suffered nothing worse than a flesh wound.

And well, the amyloid hypothesis is not dead yet. Large clinical trials targeting amyloid are still underway—either using new, potentially more powerful anti-amyloid drugs or trying out the previously failed drugs in patients with less advanced Alzheimer’s. These trials will likely affirm the amyloid hypothesis or kill it for good.

STAT, The Boston Globes’s national health and science website, tosses us a story

ssWe don’t know if the copy is going to be in the paper or just online, but today, STAT makes its debut — in both formats. The site promises “Reporting from the frontiers of health and medicine We take you inside the science labs and hospitals, biotech boardrooms and political backrooms. We dissect crucial discoveries. We examine controversies and puncture hype. We hold individuals and institutions accountable. We introduce you to the power brokers and personalities who are driving a revolution in human health.

Today’s story –how social media is gumming up clinical trials and riling  up pharma investors. It begins with a story of a woman who posts about being in a clinical trial.

The stock of a Cambridge-based biotech company would rise and fall with her updates. Investors would scrutinize Stracham’s words and pore over individual frames in her videos. Stracham herself would be subjected to uncomfortable questions from strangers: Could she control her bowels? What about her bladder? Was she faking the small gains in movement she chronicled online? Other strangers would help her raisess about $40,000 online to cover her medical bills — and, most unexpectedly, her posts would lead her to love.

This wasn’t the first time a patient had taken to social media, of course. Parents of terminally ill children have staged massive Twitter and Facebook campaigns to demand access to experimental drugs. They’ve rallied online for lower prices and faster approval of new therapies.

But Stracham’s upbeat posts pushed into new territory, raising unsettling questions about the integrity of clinical trials and the power of patients to move the market in the age of social media. “Whoop Whoop moving this process along!!” she wrote in March. “Oh you know just taking some small steps today!” she captioned a video of herself moving with the support of a physical therapist in May.

Don’t expect familiar bylines from the Globe’s strong health and science staff. Stat is separate from the Globe newsroom. The new site spent a few months rounding up health and science staff with impressive resumes. (They’ve already had one employee dust up.)

We wish them well and know they’ll produce much copy for us to share.

A bit more on Stat here from Poynter.

A lot more on patients and social media from Boston’s own PatientsLikeMe:

…(W)e continually enhance our platform, where patients can share and learn from real-world, outcome-based health data. We’ve also centered our business around these values by aligning patient and industry interests through data-sharing partnerships. We work with trusted nonprofit, research and industry Partners who use this health data to improve products, services and care for patients. 

Is Avandia safe? FDA to consider restrictions on the diabetes drug, local docs in the fray

Dr. Clifford J. Rosen, director of clinical and translational medicine at the Maine Medical Center in Portland,  led the advisory committee that on 2010 set strict limits on the use of the  diabetes drug Avandia after it was linked to  heart problems.

avandiaThe New York Times reported on Sunday on the FDA’s  meeting this week, where the restriction will be reconsidered.


More here from the FDA.
Rosen tells the NY Times that would be a bad idea :“It’s turning back the clock. …I  have no idea why they would revisit this issue. It’s a done deal.”

More from the Times here:

That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. It could also help rewrite one of the most embarrassing chapters in the F.D.A.’s recent history.

imagesBut critics, like Dr. Steven Nissen, the well-known Cleveland Clinic cardiologist who was the first to sound a public alarm about the drug, say it is far too dangerous to use in diabetes treatment. He said an analysis of more than 50 studies linked Avandia to an elevated risk of heart attack; one study linked the drug to more than 47,000 cases of heart attack, stroke or heart failure from 1999 to 2009.

Dr. Nissen and others contend that the F.D.A.’s decision to revisit the drug is more about saving face than protecting patients.

The issue is being takes at a joint meeting of the FDA’s endocrine and drug safety panels.

Dr. Ellen Seely of BWH and Robert J. Smith of Brown are members of the FDA’s Endocrinilogic and Metabolic Drugs Advisory Committee.

Sonia Hernandez-Diaz is a member of the Harvard School of Public Health is a member of the Drug Safety and Risk Management Advisory Committee.

Bloomberg has a different take on the story:

A second look at GlaxoSmithKline Plc (GSK)’s once-best-selling diabetes pill found it doesn’t increase overall cardiac death risk, U.S. regulators said.

Findings by London-based Glaxo that Avandia doesn’t raise the overall risk of death, heart attack or stroke appear to be supported in a reanalysis by independent researchers, some Food and Drug Administration staff said in a report today. FDA advisers will reconsider restrictions imposed on Avandia in 2010 at a meeting June 5-6, according to the report.

Undoing: BU aging study, MA disclosure laws

The take-down of the BU study began Wednesday and continues. More here on Nature Network Boston.

Also, the Mass House of Representatives voted to repeal the state’s disclosure law, which requires drug makers to report donation to researchers. From AP via the Globe:

House leaders defended the vote to repeal the ban, approved just two years ago, saying it has made it harder to attract companies to Massachusetts. The Senate version of the bill did not include the repeal. The bill now heads to a committee to work out a compromise

More here from  State House News Service via Mass Device:

Critics of the ban said it was discouraging out-of-state interests from doing business in Massachusetts and said the ban had not led to demonstrable reductions in health care costs. Supporters of the ban said the state had already heavily invested itself in implementing it and needed to give the law more time to work itself out.

Some companies are already disclosing their support for scientists. The Wall Street Journal rerport that J&J is not making it easy. Eli Lilly offers a “faculty registry.”

Lilly-contracted faculty are doctors and other healthcare professionals who provide a variety of services for the company. When selecting faculty, Lilly chooses leading clinicians who have the knowledge and clinical expertise to understand Lilly medicines—and the conditions and disease states for which they are approved—and to educate other healthcare providers about their use.

 

New info lets patients, researchers compare quality at hospitals nationwide

Check out your own hospital or compare it to others.

The updated information on Hospital Compare includes data on the rates of outpatient MRIs for low back pain, outpatient re-tests after a screening mammogram, as well as two ratios that explain how frequently outpatient departments gave patients “double” computed tomography (CT) scans when a single scan may be all that is needed. Hospital Compare also includes new measures that show how well outpatients are treated for suspected heart attacks, and how well outpatient surgical patients are protected from infection. Previously, Hospital Compare had provided data only about the quality of care provided to hospital inpatients.

 Here’s the Globe story:

The new data include information about whether hospitals overuse MRIs and other imaging tests. Massachusetts hospitals also did better than average on these measures, including providing appropriate follow-up with women who have had routine mammograms and may need further testing, although some hospitals within the state performed better than others.

For example, the agency tracked the percentage of patients with low back pain at a hospital who had an MRI, without trying physical therapy or other recommended treatments first. If a number is too high, it may mean a hospital is doing unnecessary imaging tests. In Massachusetts as a whole, 30 percent of patients had an MRI first, compared with nearly 33 percent of patients nationally. At the Boston teaching hospitals, the rate ranged from 24 percent of patients at Tufts Medical Center to 39 percent of patients at Caritas St. Elizabeth’s Medical Center.

 

The NYTimes and the Dartmouth Atlas

The Science Journalism Tracker, from the Knight science writing program at MIT, offers helpful analysis. Yesterday, it took on a New York Times story on the Dartmouth Atlas. The Times report cited take-downs of the program’s mapping of health care costs and practice pattern variations.  

 The maps “appeared to show where the waste in the system could be found. Beige meant hospitals and regions that offered good, efficient care; chocolate meant bad and inefficient.  

The maps made reform seem relatively easy to many in Congress, some of whom demanded the administration simply trim the money Medicare pays to hospitals and doctors in the brown zones. The administration promised to seriously consider doing just that.

But while the research compiled in the Dartmouth Atlas of Health Care has been widely interpreted as showing the country’s best and worst care, the Dartmouth researchers themselves acknowledged in interviews that in fact it mainly shows the varying costs of care in the government’s Medicare program. Measures of the quality of care are not part of the formula.

For all anyone knows, patients could be dying in far greater numbers in hospitals in the beige regions than hospitals in the brown ones, and Dartmouth’s maps would not pick up that difference. As any shopper knows, cheaper does not always mean better.

Here’s what the science trackers had to say:

Their bias is evident from the start. They describe the study in the lede as coming from “a once obscure research group” at Dartmouth. You see how clever that is? Without actually pointing to any problems with the study, they suggest that there’s something fishy about it. How important could this study be if it comes from an obscure research group?

 Actually, Elliott Fisher, one of the authors of the Dartmouth atlas who is quoted lower in the story, is one of the nation’s leading health-care economists. I’m sure he was obscure once (wasn’t everybody?), but he’s not anymore, and he hasn’t been for a long time.

 

The once obscure Abelson and Harris then note that the study has been “widely interpreted” as showing the country’s best and worst care, but that all it does is show the variations in cost. Here’s the problem with that observation: Showing the difference in costs is precisely what the study’s authors say it does. Fisher says so in the story!

Fisher does, however, admit that both he and others have miscast the findings at times.

No doubt in the truth that cheaper is not always better, as the Times story says.  But it is also true that  more-is-better has been the mantra of both patients and provider for years. The result: massive waste and poor care. While cost may be a crude measure, it is an important red flag.  Studies like these need to control for as much as possible and recognize the limits of the findings.

Gooz News call is an “important debate.”

 No letters up on the Time yet but find some reaction on the Dartmouth site.  More from the blogs here.

Screen baby, screen — News coverage of new mammography guidelines

 BHN is a big fan of the health news blog produced by fellow health writer/journalism prof Gary Schwitzer at the University of Minnesota. And while we hate gratuitous attacks on the so-called “lamestream” media, there is a lot of really, really bad health reporting out there. Schwitzer follows and rates the coverage and he is always spot on.

So, check out his comments on the coverge of the new mammography guidelines, which brought out the worst in health journalism.  He calls it the “screen, screen, screen mentality.” 

Start with his “10 things that stand out from the mammography week to remember (forget?)”

Many of us might rather move on and end all of the discussion about the US Preventive Task Force’s mammography recommendations last week. But I think it’s essential that we reflect on ten things that stand out from last week:

1. Many in the general public (most of those quoted in news stories) are not prepared for evidence to be used in making health care recommendations. They haven’t been prepared by the health care industry, by their physicians, or by the news media. 

 
2. Many in health care (many of those quoted in news stories) are too invested in their own preferences to allow evidence to make a difference in their practices.

3. There is an undeniable and clear bias in many news stories, reporters and news organizations for promoting screening – evidence be damned. I’ve reported on this before and last week provided overwhelming new evidence. (Mind you – I said “many”, not “all.”)

4. The USPSTF, which is a collection of independent experts, has no public relations arm. They simply review the evidence and publish their recommendations.

5. The public relations machinery of the American Cancer Society, the American College of Obstetrics and Gynecology – and other groups that opposed the USPSTF recommendations – helped the anti-USPSTF message rule the media all of last week.

6. Politicians chimed in – sometimes distorting the evidence beyond all recognition. The clash between politics and science at such times is predictable and disgusting.

7. The rhetoric used to oppose the USPSTF recommendations was the ugliest and most ill-founded I can remember.

8. There was some excellent journalism done on the issue last week, but it was overwhelmed by and drowned out by the drumbeat of dreck shoveled out by many news organizations – including in much (not all) of what was provided on network TV.

9. The week may have caused harm to the nation’s discussion of health care reform.

10. The week was certainly a setback for the nation’s understanding of science, of evaluation of evidence, of the potential harms of screening tests.

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