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From the Pink Sheet:
Pfizer is the fifth pharma company to post its payments to healthcare professionals but the first to include payments to principal investigators and institutions for conducting clinical trials.
The company posted the information on March 31, announcing that it paid a total of $35 million to 4,500 health care professionals for speaking, consulting and research services. The figure also includes meals and travel reimbursement. Of this sum, approximately $15.3 million went to research organizations for new clinical trials initiated after July 1, 2009, and for ongoing or new research between July 1 and December 31, 2009.
Pfizer said the clinical trial payments cover participant recruitment, coordinating and conducting the clinical trails and completing compliance activities to ensure regulatory requirements are met.
Pfizer was required to post all payments or transfers of value to physicians, including those relating to research, under a corporate integrity agreement with HHS' Office of Inspector General. The CIA accompanied Pfizer's $2.3 billion settlement with the Department of Justice to resolve allegations of off-label marketing of four drugs and kickbacks to healthcare providers involving nine other drugs.
The company's payment report also specifies non-cash payments, such as for meals or educations items worth $25 or more and totaling $500 or more during the six-month period. Pfizer is the first company to report these non-cash expenditures.
Lilly was the first to post payments to healthcare providers for consulting and speaking engagements, followed by Merck, GlaxoSmithKline and Cephalon. Cephalon was the first to do so under a CIA, which required it to report figures for a full year. The other three posted data for a single quarter.
Lilly's Top Speakers Earn $150,000 In Six Months
Cephalon has been the only company to clearly designate its highest-paid doctors, breaking out payments in $10,000 increments as required under its CIA. Pfizer's CIA gave it the option of listing the payments in $10,000 increments or in the actual amount paid and the company chose to report individual sums for 4,856 entities.
A Pfizer spokesperson said nine individuals received $50,000 to $150,000 and the remainder received less than $50,000. The company set a cap of $50,000 per year for individual speakers. But those with particular expertise can be cleared to receive a maximum of $150,000.
By comparison, Cephalon paid three doctors more than $140,000 in speaking fees during the year. And in a one quarter period GlaxoSmithKline's top speaker earned $99,375, Lilly's highest paid physician received $70,050 and Merck's top earner received $22,600.
Companies are now required to post payments to healthcare professionals under a provision included in the health care reform legislation signed into law last week. The law requires reporting of payments for consulting and speaking engagements, the value of certain meals and non-cash items like educational materials.
Pfizer said it will post its next report on March 31, 2011, which will include a full year of data for 2010 and include the value of all financial transactions, regardless of value. The company will post payment reports quarterly beginning in June 2011.
To repeat that quote from Theodore Roosevelt, “When you’re in a hole, stop digging.”
Note to Amphastar Pharmaceuticals – stop digging.
Back in August Amphastar was so unsatisfied with the way the FDA was dealing with their file for generic Lovenox, they decided to claim unfair treatment at the hands of CDER Director Dr. Janet Woodcock.
Amphastar claimed that its rival, Momenta, had a "leg up" and was getting "special access." And yet both companies were in the same place in the regulatory process and both companies are being asked for the same data sets. And this is unfair why?
According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.
Well, to nobody’s surprise, the inspector general of the Department of Health and Human Services has cleared Janet of all allegations of conflict of interest.
Not satisfied to acknowledge a boner of monumental proportions, Amphastar's general counsel, Jason Shandell, said that the FDA narrowly tailored its review to legal issues. "We never asserted she got any money—that would be illegal. Our focus was on the appearance of impropriety and its impact on the approval system.”
Remove foot from mouth, right?
Um – not so fast. According to Politico: “For more than two months in late 2008, private investigators working for a drug company gathered information on a high-ranking official at the Food and Drug Administration – unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand.
The drug company, Amphastar Pharmaceuticals Inc., paid more than $100,000 to Kroll, the New York-based private investigative firm, to uncover the information about Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who oversees the agency’s new-drug approvals.”
And it gets worse. At one point, the investigators hired a freelance reporter to file Freedom of Information Act requests, using her status as a journalist to request Woodcock’s emails, phone records, voicemails, calendar and expense reports, among other documents – without mentioning that she was being paid for her efforts by a private investigative firm. Oops.
And worse.
According to Politico, “On behalf of the drug company Kroll also investigated a second FDA official – Moheb Nasr, director of the FDA’s Office of New Drug Quality Assessment, creating a file on him that included his birth date, the price he paid for his home, and details of his education and professional background.”
And here’s a lesson to all of you drugwonks out there – do NOT let your lawyer act as spokesperson.
“I feel like as a citizen you have a right to question your government and a right to look at public information,” said Amphastar’s general counsel, Jason Shandell. “There was no impropriety here.”
So now the conversation has moved Amphastar’s boner. Solid PR.
And to make things even worse for Amphastar, they’re now squarely in the crosshairs of Senator Max Baucus (D, MT), who said it was “an outrage,” and has demanded that Kroll tell him how often private detectives target public officials.
“Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families,” said the Senator.
An apology is in order.Now Waxman has summoned these CEO’s to appear before the House Energy and Commerce Committee to explain themselves.
No matter one’s view of the legislation, the piece is worth reading.
Patient choice: strike one.
Donald Berwick as CMS Administrator? By all accounts a good choice. But what does it mean for the upcoming battle royale over comparative effectiveness and patient choice?
According to Robert Pear, “Dr. Berwick could help shield the White House from Republican charges that Mr. Obama’s policies would lead to the rationing of care or even a government takeover.”
This conditional shield comes courtesy of remarks Dr. Berwick made last December. Speaking at the annual conference of the Institute for Healthcare Improvement (which he heads), he challenged the audience thus, “Over the next three years, reduce the total resource consumption of your health care system, no matter where you start, by 10%. Do that without a single instance of harm, without rationing effective care, without excluding needed services for any population you serve.”
Okay – sounds good and we should give Dr. Berwick the benefit of the doubt that when he says he’s against the rationing of “effective care,” he means effective care that’s defined by an MD in the field – and not Uncle Sam, MD inside the Beltway.
But vigilance is required, especially now that it’s precisely Uncle Sam who is going to be paying more and more of the bills for this “effective care.” And vigilance is even more important considering that AHRQ (now the nation’s leading practitioner of comparative effectiveness studies) plans to hire a PR firm to help create a “publicity center” for comparative effectiveness reports and materials.
If you recall the debacle that followed the government’s “publicity center” efforts behind CATIE and ALLHAT – you know why vigilance is the order of the day.
The “angry itch” is the desire for payers (both public and private) to opt for the least expensive treatment rather than the one that’s best for the patient. An itch that’s often penny-wise and pound-foolish. An itch that’s dangerous when scratched.
Let’s all wish Dr. Berwick great success. He has big shoes to fill and a tough road ahead.
The UK has launched a pilot of its "Innovation Pass" process, which will provide £25 million in funding for medicines that treat very rare diseases but are not evaluated at launch by the National Institute for health and Clinical Excellence (NICE).
Innovation passes were first proposed in the UK's office for life sciences' Life Sciences Blueprint, issued last year. The government has run a public consultation on the proposals since then.
There’s a maximum spending cap of only £8 million per year for each individual product – and uncertainty over long-term funding. The pilot is to run for three years, but government funding of £25 million has only been arranged for the first year.
Products included in the pilot Innovation Pass scheme will automatically be appraised by NICE after the end of three years, raising the suspicions that they could be rejected for use in the UK national health service (NHS) at that stage.
NICE giveth and NICE taketh away since it will set up and run an advisory committee that will select products based on defined criteria. These criteria include the medicine being a significant medical innovation (acting at a new target receptor, for example), it should satisfy an unmet clinical need, and is expected to have a substantial impact. Additional studies to gain further clinical data should be planned.
The government will pay an amount to the pharmaceutical company for supplying the medicine based on a price-volume agreement (the number of patients multiplied by the price), rather than paying for each dose of drug dispensed. This is to ensure a financial return for the company. Products would normally be submitted for consideration at around the same time as they are filed for marketing approval.
BUT … the sum asked for by the company will be judged to be reasonable or not by a governmental/NHS panel that will look at the cost of therapeutically similar medicines, the actual cost of the medicine in other European countries, and the cost of its research and manufacture.
This judgment on whether the cost is reasonable or not will then be passed to NICE's advisory committee, which will produce a list of drugs for funding, which will be approved by government ministers.
Sounds familiar.
NICE work … if you can get it.
FDA Chief Scientist Jesse Goodman to Representative Rosa DeLauro (D/CT and Chairwoman of the Agricultural Appropriations Subcommittee), "I think what FDA really needs is a 5- to 10-year building effort/re-building effort. And it's not just rebuilding to what was. I think it's being a part of building the science of the future."
Bravo. By all means. Rather than look backwards to “the good old days” (whatever that means) let’s improve and move forward. It’s not rocket science – but it’s good to hear the agency’s Chief Scientist say it.
And change starts from within. According to Goodman, "What I want to do is begin to use the resources we have and the leadership we have to encourage and identify and free-up some of the time of our promising junior and mid-level people to beef up their education. Because if we just do it as leaders of the center or agencies, that doesn't have all the transformational power."
Absolutely right. When I served at the FDA (along with Jesse), one of the most valuable lessons I learned was that dictates from “on high” don’t get the job done. Real change happens because all levels of the agency understand and embrace the philosophy of those changes. Change may begin at the top – but success or failure is determined by the agency’s 11,000+ career professionals.
Change is never easy but, as W. Edwards Deming commented, "Change is not required. Survival is not mandatory."
Goodman: “"It's very challenging. It's almost like taking the current state of the agency from sort of always swimming to keep our heads just above the water to something that is a truly outstanding scientific partner and really has the power and relationships it needs. And by power I don't mean power over people, but the mental and scientific tools to have the ability to make decisions. So it's a process and it's going to take a while and we need to get the best and the brightest."
Now maybe Representative DeLauro will finally embrace the Reagan/Udall Foundation.
- 24 March 2010, The Washington Post (By Ruth Marcus)
In fact, the occasion called for more humility than hyperbole, however unlikely that may have been given the setting. If I were a member of Congress, my floor speech before casting a yes vote would have boiled down to:
Gee, I hope this works.
One of the astonishing aspects of the health-care debate is how little is actually known about the implications of a change this far-reaching. Everyone has a theory, and a model to match, but even some of the most fundamental questions remain the subject of debate.
On the most basic of all -- does having health insurance lead to better health? -- the evidence is solid but not unanimous. The Institute of Medicine , reviewing the literature in 2009, found that "the body of evidence on the health consequences of health insurance is stronger than ever before. . . . Simply stated: Health insurance coverage matters ."
But a study that same year by Richard Kronick, a former health-care adviser to President Bill Clinton, found "little evidence to suggest that extending insurance coverage to all adults would have a large effect on the number of deaths in the United States ." Kronick's study has been criticized because it did not adjust for the fact that those in poor health are more likely to seek insurance. But the disagreement underscores the difficulty of knowing precisely what changes are in store.
To take another example, one common assertion has been that the uninsured end up getting health care -- just more expensive health care, in emergency rooms and when conditions have worsened, with the costs passed on to the rest of the population. The notion that the tab is being picked up one way or another makes intuitive sense.
A new National Bureau of Economic Research paper by Michael Anderson, Carlos Dobkin and Tal Gross questions this assumption. The researchers examined health-care consumption by 19-year-olds who had just been dropped from their parents' coverage. They found that not having insurance resulted in a 40 percent reduction in emergency room visits -- "contradicting the conventional wisdom that the uninsured are more likely to visit" the emergency room and a 61 percent drop in hospital admissions.
"Overall, these results suggest that an expansion in health insurance coverage would substantially increase the amount of care that currently uninsured individuals receive and require an increase in net expenditures," the authors write. Emergency room visits could increase by 13 million annually, and hospital admissions by 3.8 million, they project.
So prudence is in order when tinkering with such an interconnected system and when making confident predictions about the effects of reform, for good or ill. Will younger adults, who account for about half the population of uninsured non-elderly adults, sign up for coverage -- or will they pay the fine instead? How will that decision affect premium levels and the adequacy of federal subsidies?
Will the expansion of coverage create a shortage of health-care providers and result in higher prices, or will, for example, higher Medicaid payments for primary-care doctors stem an exodus of doctors from the program? Will employers add coverage because workers facing the mandate to obtain insurance will press for it, or will they drop it because it will be cheaper to pay the penalty and let employees fend for themselves?
Will increased coverage of preventive care save money because diseases will be caught earlier -- or will the added cost of widespread screening exceed the economic benefits? The Congressional Budget Office has concluded that, "for most preventive services, expanded utilization leads to higher, not lower, medical spending overall ."
The legislation is a risk worth taking. Millions of Americans are without insurance, a national scandal that should have been addressed long ago. Rising health-care costs threaten the nation's fiscal security, and the new law holds the promise of beginning to stem the increases.
The status quo is unsustainable. A new study by the Urban Institute shows how, without reform, the numbers of the uninsured will rise, employers will continue to drop coverage and premiums will climb.
Still, for those who express cocky certitude about how this is going to turn out, the best prescription is a generous dose of caution
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.
