Latest Drugwonks' Blog
The battle continues apace. Please have a look at this new op-ed (penned by myself and Dr. Bob) that appears in today’s edition of The Washington Times.
And please pass it along.
Here’s the link:
http://www.washingtontimes.com/op-ed/20060621-085649-7788r.htm
I am being cautioned not to regard the two page summary upon which most of the news accounts of the Enzi-Kennedy bill are based as definitive or the final version. Indeed, the two page summary ignores the creation of an agency that would support the creation of tools that would accelerate drug development and promote targeted medicines. The agency would use public and private partnerships such as the Critical Path Institute to fufill the mission and objectives of the Critical Path initiative. This is an imaginative and thoughtful effort to modernize the FDA through scientific collaboration.
In context then, the onerous risk management proposals set forth in the two page summary seem to be totally inconsistent with the effort to improve drug safety post market by increasing the pre-marker ability of the FDA and companies to identify and select populations that would respond significantly to medicines and provide biomarker based screens to reduce the rare liver and heart problems associated with drugs.
Instead, the risk management program is mainly busy work and studies of the sort that will never identify rare events with the certainty hope for by proponents. In particular the risk management effort post market makes the nightmare Scott Gottlieb fears — of physicians too worry of prosecution or lawsuits or too busy to comply with yet another mound of risk management paperwork, tests, followups — controlling clinical decisionmaking of doctors. It is also an example of the agency — not the doctor or patient — deciding what is best for them.
How shameless can a politician be…Chuck Schumer attacking Merck for lowering it’s Zocor prices in response to impeding generic competition..Interestingly, when he introduced changes to the law promoting generic drugs he lauded his proposals as “all about promoting competition in the drug industry…” Except when it comes to creating competition for generic drug firms? Since when did they become a protected class and since when did protecting them become more important than consumers. Since about 15 percent of consumers stick with a generic after a switch, a Zocor price slash will save them money, Schumer rather than later.
June 20, 2006, 2:03PM
Senator Raps Drug Giant Over Zocor Price
By DEVLIN BARRETT Associated Press Writer
© 2006 The Associated Press
WASHINGTON â A New York senator accused the drug giant Merck & Co. on Tuesday of conspiring to undercut a cheaper generic alternative to its cholesterol-lowering drug Zocor just days before it becomes available to patients.
Sen. Charles Schumer, a Democrat, charged that Merck is quietly collaborating with health insurance companies to create lower copays for customers buying Zocor than for those buying the generic equivalent.
Zocor generated $4.4 billion in sales last year, and generic alternatives will be available for the first time on Friday. A company executive scoffed at Schumer’s allegations.
“It appears that Senator Schumer is criticizing us because he says that our prices are too low. That’s a new one,” said Ian Spatz, Merck’s vice president for public policy.
“The truth is that we support generic competition and the generic competition for Zocor is good for patients. It’s good for people who have to pay for medicine, which include health plans. We’re going to continue to price it competitively,” he said.
Both Peter and I were concerned about Gardiner Harris’ article in the NYT which depicted the Enzi-Kennedy FDA bill as a throwback to go slow paper gathering approaches to drug safety without regard to 21st century science orproposals to accelerate a response to the more expensive and prevalent ‘side effects’ of having a disease like Alzheimer’s without effective treatments.
As the Yiddish proverb goes: “A half truth is a whole lie.” The bill does encourage risk management activities and trial disclosures. But Senator Enzi and Kennedy have spent a whole lot of time on Critical Path issues and discussing the science behind it, how to fund it, etc. There is a considerable amount of attention and language devoted to accelerating drug development and using biomarkers and other methods to encourage targeted — and safer — medicines.
Why did Gardiner leave this out? Were his sources selective or was he?
One possible clue: Here’s a guy who has a problem differentiating between suicide and suicidal ideation, ignoring research that demonstrates that suicide has gone down with use of SSRIs and the role that genetic mutations play in causing adverse reactions to SSRIs and other antidepressants one of which is suicidal thinking (which is NOT suicide).
But, to be fair, he is not alone in this, so we’ll give Gardiner the benefit of the doubt.
The take away from all this: those opposed to the Critical Path and faster cures will use the MSM to shape public perception. The reality is more robust and hopeful. And as Anna Mathews mentions in the last line of her story in today’s Wall Street Journal, the bill “would authorize some resources for an FDA effort to spearhead research on drug evaluation.”
Can you say penny-wise and pound foolish? This from Health IT News.. The GOP stalls a bill to encourage the diffusion of health IT because it might — I repeat might — drive up health care spending in the short term as people invest in new hardware and systems to achieve interoperability and patient-centered. Would these Republicans have stalled investment in the highway system or the transcontinental railroad because it drove up costs in the short term?
http://www.healthcareitnews.com/story.cms?id=5109
House Republicans stall healthcare IT bill
Healthcare IT News
By Bernie Monegain, Managing Editor 06/20/06
WASHINGTON â A healthcare IT bill the U.S. House of Representives was expected to vote on this week is expected be put on hold.
Congress Daily reports the move to hold off on the bill came after the Congressional Budget Office forecast the legislation would increase spending and reduce revenue.
The bill bill promotes the adoption of healthcare information technology and calls for national standards for implementing electronic health records.
EU, US To Cooperate Against Counterfeit Goods
BRUSSELS (AP) —The European Union and U.S. plan to tackle together the traffic of fake luxury items, pirated music and counterfeit medicines with a deal set to be signed Tuesday that aims to help improve intellectual property rights protection in countries such as China and Russia.
The 25-nation bloc plans to work with the U.S. to train customs officials, exchange information and send anti-piracy experts to countries where counterfeiting is rife. The E.U. warns that countries that tolerate black market counterfeit goods could lose out on foreign investment and trade.
E.U. Trade Commissioner Peter Mandelson and E.U. industry chief Guenter Verheugen plan to sign the anti-piracy strategy Tuesday and U.S. President George W. Bush and European leaders are to give it their backing Wednesday at an E.U.-U.S. summit in Vienna, Austria.
Initial efforts will focus on working with China and Russia, the E.U. said, but the plan also includes other countries in Asia, Latin America and the Middle East.
Trade in fake medicines is also flourishing, estimated to make up almost 10% of the world trade in medicines in 2004, according to the E.U. executive.
The Journal of the American Medical Association — JAMA — is an island unto itself that seeks to generate revenue and readership by taking politically correct and activist positions that the hit and run media will print. Such an approach comes at the expense of the public health. And the FDA’s commissioner for Medical Affairs Dr. Scott Gottlieb said so in dulcet and diplomatic tones to the AMA: In his speech Gottlieb said JAMA spends too much time and spending too much time politicking and not enough time teaching how to appropriately prescribe the new medicines coming to market. The failure to prescribe drugs according to how they are developed and approved is the single largest source of serious side effects drug that fearmongers like Grassley love to talk about. The simple solution is better communication, between companies and the FDA, and doctors and patients…a low tech solution in a high tech age… And there is another solution too — drugs can be tested to determine how well a person metabolizes them before they are prescribed. That includes drugs like warfarin, antidepressants, ibuprofen and beta blockers…That could avoid costly and serious problems. Where is the JAMA editorial calling on the profession for DNA typing in primary care?
Here’s an interesting and provocative story. Please note that one point I made to this reporter (not entirely represented in the final piece) was that RMPs play a very important role — but that they must be joined by other more innovative and inclusive programs.
Gottlieb Speech Signals a Sea Change in FDA Drug Safety Strategy, Advocate Says
Stephen Langel
Drug Industry Daily, June 19, 2006
A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.
Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, announced in a June 12 speech before the American Medical Association that risk management plans (RMPs), while important in some instances, may be too prevalent. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he added. “I worry about the future,” Gottlieb said.
Instead, the agency should look to a more collaborative approach, placing more responsibility on the medical community’s shoulders to ensure that medicines are used correctly, Gottlieb said.
“I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.
This announcement shows that the agency has realized that there is a better way to enhance drug safety than requiring RMPs, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID. This speech is a “very clear signal to people within the agency” that a change is necessary, he added. Drug safety “cannot be viewed as a punitive measure.”
Up to now the agency has used RMPs to show that they are doing something about drug safety, but these plans are an empty measure of success, he said. Gottlieb’s speech shows the agency is ready to stop “hiding behind” RMPs and take a better approach, Pitts added. Because doctors have the final say over their patients’ use of drugs, they must be more involved in the drug safety process. It is “crucial” for the collaboration that Gottlieb spoke about to take place, he said.
This speech may have been timed to coincide with ongoing Prescription Drug User Fee Act (PDUFA) negotiations and a growing call in Congress for a new FDA office to handle drug safety, Pitts said.
PDUFA is a vehicle for the agency to receive much of its funding, but that funding is tied to the FDA meeting specific performance goals. The speech may be a signal to Congress that the amount of RMPs the agency requires should not be used as a performance measure, Pitts said.
RMP meetings between the FDA and industry are considered part of the current PDUFA process. Congress must reauthorize PDUFA by Oct. 1, 2007.
The agency may also be using this concern about RMPs to head off lawmakers’ efforts to establish a new FDA drug safety office, by arguing that more collaboration, rather than further prescriptive approaches, is the right way
to go to increase safety, Pitts added.
But another industry source does not believe Gottlieb’s comments necessarily represent a new agency position. Gottlieb discussed many topics during the speech, including a balanced view about the importance and drawbacks of RMPs, Sara Radcliffe, the Biotechnology Industry Organization’s managing director of science and regulatory affairs said. Arguing that the portion of Gottlieb’s speech where he states his concerns with RMPs represents a change in the FDA’s view may be “reading too much into it,” she added.
The AP headline reads:
“Number of seniors with drug coverage down”
Here’s the first paragraph:
WASHINGTON (AP): About 500,000 fewer Medicare beneficiaries have prescription drug coverage than the federal government originally projected this month.
But here’s the story:
The drop occurred because many of the 3 million beneficiaries being counted as getting coverage through the Veterans Affairs Department had switched over to a private plan under Medicare Part D, so they were being counted twice, said Mark McClellan, administrator for the Centers for Medicare and Medicaid Services.
So, in fact, the number of seniors with drug coverage is NOT down.
Oops.
But, as usual, Mark McClellan — the hardest working man in health care — puts the story in the proper perspective:
McClellan said the new numbers reflect that the Medicare program was more popular with veterans than had been anticipated. When VA officials ran final numbers after the May 15 enrollment deadline, they found that about a third of those seniors participating in VA drug coverage had enrolled in a private plan under Medicare Part D.
And, at the end of the day, according to the story:
… the new numbers do little to change the overall percentage of seniors with some insurance coverage for their medicine. About 90 percent have some coverage, either through Medicare or through another program, officials say.
Talk about Headline News!
Scott Gottlieb doesn’t just talk the talk..this is a guy who cares about patients and knows that physician discretion is still a primary source of medical innovation. And he knows that real risk management comes with integrating advanced technologies early in the drug development process, not burdening doctors and patients with paperwork as with the Tysabri risk management program…Read the article below as a great example of how Scott and FDA staffers are making a difference and why they deserve more time, money and resources to innovate:
FDA Official Questions Key Drug Safety Policy - 16 June 2006 Drug Industry Daily - By Stephen Langel
The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said.
The FDA believes that RMPs, while important in some instances, may be too prevalent, Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, said in a speech before the American Medical Association. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he said during the June 12 speech. “I worry about the future,” he said.
An RMP is a method the agency uses to assess the risks and benefits of a drug and minimize the risks while maximizing the benefits. But Gottlieb believes these plans — which many times include physician training programs for proper use of the drug, public notices about its dangers and drug registration programs could become too much of a burden and restrict doctors’ discretion.
“The more we promulgate plans that attempt to guide or even control [medical] decisions, the more we encroach on professional autonomy,” he said. This is especially problematic when busy clinics do not have the time to go through the various steps these plans require, he added.
Industry groups such as PhRMA have also expressed concerns with the burden RMPs can represent. The group has argued that while it supported the idea of RMPs, the agency needs to ensure that they do not impose overwhelming burdens on the medical community. “Care must be taken not to overburden the healthcare system by using too many resource-intensive tools in RMPs,” the group said in a risk management presentation.
Both the FDA and the medical community are to blame for this trend, Gottlieb told DID in a follow-up interview. While doctors have not always done everything possible to police themselves, the agency has not always created opportunities for physicians to be involved in ensuring safe drug use, he said.
The agency believes that greater cooperation between the FDA and the medical community is the solution. “I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.
To reach this goal the agency is working to establish an office that will ensure more regular collaboration and communication about clinical issues with medical organizations, Gottlieb said. Terry Toigo, the agency’s acting associate commissioner for external relations is heading the team that is developing this new office, he added.
Gottlieb raised his concerns at a time when the agency has made RMPs a common requirement in granting drug approvals. For example, the FDA recently allowed multiple sclerosis drug Tysabri to be sold after the product was pulled from the market, but only if the company provided an RMP (DID, June 6).
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.
