Latest Drugwonks' Blog
Much chatter about David Graham and his leaked Avandia report. It’s turning into a real whodunit. And it’s more complicated than it looks.
First, it’s important to understand that the FDA had already approved Dr. Graham’s request to submit his manuscript to JAMA. So the report (in the Wall Street Journal) that, “… Dr. Graham complained that senior FDA officials were holding up his efforts to publish his work,” is just completely wrong.
So why would Graham leak the report and torpedo his chances of getting it peer-reviewed and published? A few theories are being floated:
(1) The manuscript had been submitted and rejected by JAMA. So spurned, Dr. Graham took the next most expedient step and leaked his report.
(2) Same as above, except the leak came from a supporter inside JAMA either with or without the knowledge of Dr. Graham.
(3) JAMA accepted the paper but determined that it would also offer the FDA or GSK or both a chance for rebuttal. Dr. Graham or a JAMA editor felt this wasn’t fair and leaked the document.
(4) The report was leaked by some else inside the FDA.
Or, in the words of Sherlock Holmes, “When you have eliminated the impossible, whatever remains, however improbable, must be the truth.”...
Whatever the truth, “leaking” a confidential FDA report is not the act of a whistle-blower. Whistle-blowers have the courage of their convictions and are (appropriately) protected. Leakers, on the other hand, are just cowards with an agenda.
At the end of the day, the only thing that counts is that the FDA reach its conclusions based on sound science and not on media leaks – or politics.
It should be in a loose leaf folder.
The most recent example is the article in today's WSJ:
FDA Scientist Attacks Avandia Safety
By JEANNE WHALEN And ALICIA MUNDY
Medicare patients in the U.S. who took GlaxoSmithKline PLC's diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, a Food and Drug Administration scientist contends in a new study.
The unpublished study by outspoken Avandia critic David Graham, an FDA drug-safety official, echoes his earlier assertions and another study led by the Cleveland Clinic's Steven Nissen that linked Avandia to additional heart attacks and strokes.
The FDA is scheduled to review the drug's safety in a meeting next month. Dr. Graham and others have argued that Avandia should be withdrawn from the market. An FDA official said Thursday that Dr. Graham's study would be included in safety data to be reviewed for that mid-July meeting.
Why should it be included? Or rather, why, since it is just another example of assuming the worst based upon questionable data, is it being included at all.
Because the media and pols pressure the FDA to include it, whether it is crap or not.
Oh, but wait, this isn't just ANY study. This one was
"first published by the Pharmalot blog, which also posted a May 28 email from Dr. Graham to the FDA's senior leaders. In it, Dr. Graham said he wanted to submit the study to the Journal of the American Medical Association for publication. The Pharmalot blog is a respected blog covering the pharmaceutical industry written by Ed Silverman, an editor at large for the industry publication Med Ad News.
In the email, Dr. Graham complained that senior FDA officials were holding up his efforts to publish his work. However, an FDA official, who confirmed the email, said Thursday that the agency isn't suppressing the study and that it was subsequently submitted to the journal.
A JAMA spokeswoman said the journal doesn't ever confirm or deny receipt or acceptance of any manuscript until publication. Dr. Graham couldn't immediately be reached for comment."
We all know that respected peer-reviewed medical journal Pharmalot, which of course does not accept any advertising.
(Drugwonks is respected too but if we were part of such a stunt the Tabloid Medicine machine would rise up in anger and call us tools or something,)
In any event, the preceding is just fancy footwork around having to undergo peer-review (which for an article like this should not be a hard sell at JAMA) and to make all sorts of claims without having to answer serious questions. One of them being, if Nissen showed 43 percent increase risk cherry picking data even as he consults for Takeda, a company making a competitor product, how do you explain the 25 percent figure Graham came up with. Confidence intervals anyone? A second one, is this claims data (yes) and was it adjusted for severity of illness (no) and how many people were on multiple medications (many). Is there a dose effect. Perhaps and in my next blog I will take this on. Third, and the one the FDA will seek to address in adult fashion, do the risks of any of these medications (which all drugs carry) outweigh benefits with respect to controlling progression? The answer is likely no.
So here's the difference, traditional science is rapidly moving towards the personalization of medicine using biomarkers and real-time clinical data. In this new world, risks and benefits can be adjusted more precisely.
Meanwhile the Tabloid Medicine machine -- which includes Nissen, Graham, Mundy, Silverman, Grassley -- see risk everywhere and insist upon a system that seeks to anticipate every risk before it happens.
As Cass Sunstein has noted, the precautionary principle, with it's standard of not allowing any technology absent evidence of zero harm, carries it's own risks. One of them is that people will stop taking medicines that help, including Avandia. The other is that medical innovation will slow to a crawl and that personalized medicine in particular will be crushed by those who, because of cultural and ideological biases, will spread rumors about risk in a unscientific and unbalance fashion. More people will be harmed by adopting the slant of this most recent article in the WSJ.
Where you stand often depends on where you sit. Former Governor George Pataki supports repeal and reform. Some are for, others against. Judge for yourself via this recent interview with the former Empire State Chief Executive.
One thing he points out that we can all agree on is that this shouldn’t be a debate about politics – but rather about policy.
Here’s an excellent article by Dick Gephardt. Remember Dick Gephardt? Smart guy with an important message. Buzz is that he may be sharing this message from a more prominent perch in the near future. But buzz, as you know, often turns out to be just that.
In any case, enjoy this article (from Politico):
Medical innovation is economic key
By: Dick Gephardt
As Washington searches for solutions to continue our nation’s economic recovery, it’s time to cultivate new growth strategies.
Medical innovation should be key. It can create millions of high-paying jobs, increase our global competitiveness and help reduce our nation’s growing deficit.
Experts project that the health care sector will generate 3 million jobs from 2006 to 2016, with significant growth due to medical innovation. From lab coats to hard hats, medical innovation creates an array of high-paying positions across academic disciplines, management fields, health services and skilled trades.
Much of the promise from medical discoveries, new technologies and cutting-edge procedures is a direct result of America’s longtime leadership in medical innovation. Yet global leadership is now ours to lose unless we make a national commitment to needed strategic and sustained investments and partnerships to keep the U.S. competitive.
For medical and life sciences, research can transform local economies. Even in Michigan, which has seen serious job losses in many sectors, the number of people working in life sciences increased by more than 10 percent between 1999 and 2006. Average wages jumped 29 percent.
In Iowa, medical schools and teaching hospitals have a combined economic impact of $4.1 billion, according to the Association of American Medical Colleges. In Virginia, the economic impact is $9.9 billion. In Ohio and California, it is $27.2 billion and $41.6 billion, respectively.
One need only look to the Cleveland Clinic to see what’s possible. In addition to its world-renowned health care, the Cleveland Clinic has helped launch more than 200 cutting-edge inventions per year . It has spun off 24 separate companies in the past decade.
Cultivating this sort of activity on a national scale can spur new businesses and establish a truly 21st-century work force, fueled by the skilled workers and increased productivity that are byproducts of continued innovation.
Today, many experts suggest that we could forfeit our leadership if we do not address the challenges that have emerged. We are plagued with a shortage of capital and arbitrary limits on private investment. The U.S. Food and Drug Administration’s approval process is lengthy, costly and presents more uncertainty for struggling entrepreneurs.
Worst of all, our talent pool is shrinking. The U.S. ranked 16 out of 29 Organization for Economic Cooperation and Development countries in science literacy, according to the latest scorecard from the National Center for Education Statistics, and 24 out of 29 OECD countries in mathematics.
We must do more to produce the next generation of highly educated scientific innovators. And we must train and retrain students and adults for jobs to support medical innovation.
With high unemployment and skyrocketing deficits, we need a national strategy that will help us innovate our way out of our current economic crisis and create a path that ensures long-term opportunities.
This strategy could draw on the best of what we’ve learned from public and private sectors. It would create incentives for sustained public and private investment in medical research, education and training.
It would encourage public policies that spur technology transfer, appropriately protect intellectual property and help attract venture financing at all stages of research and development. It also would establish a tax and regulatory climate that encourages private enterprises — large and small — to participate in medical innovation.
For more than a century, the U.S. has been synonymous with medical discovery and achievement. This excellence has dramatically improved our quality of life, driven our ability to compete globally and created countless new domestic employment and economic opportunities.
Let’s make the decisions and investments necessary to continue to reap the enormous economic and human benefits made possible through medical innovation.
Dick Gephardt, former House majority leader, is now president and chief executive officer of Gephardt Government Affairs and serves as chairman of the Council for American Medical Innovation.
Samuel Goldwyn
A recent article in Health Affairs tries to prove what we all knew: there were cheaper, better ways to reform healthcare but political realities got in the way. The article:
"Could We Have Covered More People At Less Cost? Technically, Yes; Politically, Probably Not", concludes using a mathematical model believe it or not that shows only a few different approaches would produce both more newly insured people and a lower cost to the government. However, these are characterized by design options that seemed political untenable, such as higher penalties, lower subsidies, or less generous Medicaid expansion.
A few means more than two, so let's say five different aproaches. What made them politically untenable was not the burden it would place on taxpayers but the fact that politicians wanted to increase government control to the fullest extent possible.
Now what if the November elections become a vote on Obamacare and a new Congress reforms the current law to reduce the cost and government control?
You can read the abstract of the article here: content.healthaffairs.org/cgi/content/abstract/29/6/1142
Meanwhile the Health IT community is still trying to convince doctors that spending billions on new systems will improve quality and reduce costs even as physician payment under Medicaid will be slashed and reporting requirements will multiply. It seems to me that the only valuable contribution health IT can really make is to allow doctors and patients to improve health by the development of personaized and predictive approaches to care and paying for that approach. The rest is simply like remodeling a restaurant to look trendy and assuming it will increase the chef's ability to produce five star meals for twice as many customers even as his salary and food budget are cut in half. So much of health It is not only beside the point but created to establish new approaches to delivering care that have nothing to do with how medicine is practiced, or should be.
My recent op-ed on the new Independent Payment Advisory Board (IPAB) generated a lot of comments – and a lot of corrections. And so, in the spirit of transparency and disclosure and (most of all) thanks, here are some important emendations
1. In the article’s fourth paragraph, the last sentence reads, "And the IPAB's policy recommendation automatically will be institute unless Congress overrides them." Technically, it will be implemented automatically unless Congress comes up with its own proposal that meets the same spending cut targets. Congress can also (with 3/5 majority in both houses) pass a resolution rejecting the IPAB proposal, but that can be vetoed by the President and would then be subject to a 2/3 override. I oversimplified. Mea culpa.
2. Sixth paragraph, second sentence reads, "For one, it doesn't have any authority over the biggest cost-drivers in Medicare." I stand corrected. IPAB cannot make recommendations (before 2019) that would "reduce payment rates" to Medicare Part A providers or Part B suppliers. However, IPAB could nevertheless make recommendations with respect to those entities that would have the effect of implementing policies that would be viewed as unfavorable or harmful by those entities (or beneficiaries that rely on Parts A and B.) For example, IPAB could utilize the LCA policy for Part B drugs, establish a Part B national formulary, etc.
3. Ninth paragraph, first sentence reads, "Yet the IPAB has no power over Part A or Part B." While the IPAB cannot make recommendations to cut provider payments in Part A or B before 2019, but that does not mean they have no power over providers in Part A and B and in fact that there are lots of recommendations they could come up with that impacts these providers without cutting their payment.
4. Eleventh paragraph, first sentence, "The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements." Let me clarify. There is a prohibition on recommendations that would increase Medicare beneficiary cost-sharing (including deductibles, coinsurance and copayments) or otherwise restrict benefits or modify eligibility criteria – but the prohibition on raising premiums does not apply to Part D - but these other prohibitions do (rationing, cutting benefits and restricting eligibility.
As George Bernard Shaw wrote, “A life spent making mistakes is not only more honorable, but more useful than a life spent doing nothing."
And many thanks to all you drugwonks out there for the smart and savvy corrections. The devil is in the details.
These two articles demonstrate the importance of commercialization in addressing the clinical and logistical barriers to personalized medicine.
Medco, CVS Caremark Gear Up to Expand Genetic Testing Management Services
www.aishealth.com/Bnow/hbd060710.html
23andMe Partner to Provide Genetic Counseling
www.genomeweb.com//node/942414
This movement will be the counterweight to one size fits all comparative effectiveness...
Former Senate Democratic leader Tom Daschle and Victoria Kennedy, the late senator’s wife, are expected to be named co-chairs this week of a $125 million campaign White House allies are rolling out to defend health reform amid growing signs the party is failing to get political traction on the issue.
The extraordinary campaign, which could provide an unprecedented amount of cover for a White House in a policy debate, reflects urgency among Democrats to explain, defend and depoliticize health reform now that people are beginning to feel the new law's effects.
The Health Information Center is being started by Andrew Grossman, a veteran Democratic operative who founded Wal-Mart Watch, a labor-backed group to challenge the world’s largest retailer.
Even without issuing one press release, this "Health Information Center" misleads by ripping off the name of a "National Health Information Center" which is run by the federal government.
Here is the link to the site www.health.gov/nhic/. According to the site NHIC puts health professionals and consumers who have health questions in touch with those organizations that are best able to provide answers. NHIC was established in 1979 by the Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Office of the Secretary, U.S. Department of Health and Human Services.
NHIC also provides key support for the healthfinder.gov Web site, your gateway to reliable consumer health information.
And what does the new Health Information Center funded by cash raised by the Democrats claim to do:
The center’s rollout is part of a Democratic Party-wide effort to bolster support for health reform as the provisions begin kicking in.
Democrats and the White House will hold more than 100 simultaneous events nationwide as President Obama plunges back into health reform, selling the historic plan all over again as its provisions kick in. More than 10,000 people will be on the phone with the president as he holds a “national tele-town hall” meeting, 22 minutes from the White House at the Holiday Park Multipurpose Senior Center in Wheaton, Md.
This is, as noted above, an effort to "depoliticize" the implementation of the new health care law.
Which is why you want to call the propaganda effort THE HEALTH INFORMATION CENTER and not the Campaign to Neutralize Healthcare As An Issue In The Midterms Center
Calling it the Health Information Center reminds me of the restaurant Eddie Murphy worked at in "Coming to America" named McDowells. Cleo McDowell who runs the restaurant explains why McDonalds might have a problem with the name:
"Me and the McDonald's people got this little misunderstanding. See, they're McDonald's... I'm McDowell's. They got the Golden Arches, mine is the Golden Arcs. They got the Big Mac, I got the Big Mick. We both got two all-beef patties, special sauce, lettuce, cheese, pickles and onions, but their buns have sesame seeds. My buns have no seeds."
(I couldn't find the clip of this scene on youtube but here's another slice www.youtube.com/watch)
McDonald's. McDowell's. National Health Information Center. Health Information Center. What's the difference, right?
Oh, and there is also a Health Information Center on the web. www.healthinfocenter.org
If you have to hide what you really are and what your real goals are, how can the NATIONAL HEALTH INFORMATION be trusted?
Read more: http://www.politico.com/news/stories/0610/38199.html#ixzz0qC8awJUU
The buzz at ASCO is about more (and more expensive) personalized treatments – but the word on everyone’s lips is “diagnostics.”
And the question is whether FDA is going to be part of the problem or of the solution?
As the science of biologics necessitated the agency’s invention of CBER, so too does the promise of "personalized medicine" demand a new FDA bureau to further the development of 21st century diagnostics.
As CDER begat CBER so too must CDRH bring forth a new progeny. Let’s call it the Center for Diagnostics Advancement.
And let’s end the unfortunate ambiguity over the regulatory pathway for diagnostics.
FDA and NIH have launched a new website for reporting safety data.
The hope is that the Safety Reporting Portal (SRP) will streamline the process of reporting product safety issues to the FDA and NIH, with manufacturers, healthcare professionals, researchers, public health officials and consumers all able to submit an online safety report.
Currently, the site can be used to report safety problems relating to food (both human and animal), animal drugs as well as adverse events occurring on clinical trials involving human gene transfer.
Consumers can also report problems regarding pet foods and pet treats.
The website will eventually allow for safety problems with other clinical trials to be reported, as well as encompassing safety issues from products regulated by a broad array of federal agencies, such as the Environmental Protection Agency (EPA).
The FDA said it sees the site as the "first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event."
Organizations and individuals in certain professional roles, including drug manufacturers, researchers and food manufacturers, may be required by law to submit safety reports.
"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA commissioner, Margaret A Hamburg. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
