Latest Drugwonks' Blog
By Ramsey Baghdadi
Agency transition team head Joshua Sharfstein to be FDA's number two in charge of drugs. Former New York City Health Commissioner Margaret Hamburg is preparing for confirmation hearings with the White House set to announce her nomination as FDA Commissioner shortly.Baltimore Health Commissioner Joshua Sharfstein will serve as Hamburg's principal deputy commissioner.
Hamburg's name was understood to be formally pushed by transition team co-chair and former White House Chief of Staff John Podesta, which explains her quick rise to the top of the Administration's FDA shortlist late in the process. Podesta is currently CEO of the liberal think tank Center for American Progress.
FDA's nationwide recall of peanut products due to salmonella tainting likely made Hamburg a more serious candidate for the job given her experience as head of health for the largest city in the US from 1991-1997.
Hamburg brings a number of important experiences and skills to the position. An MD who specializes in bioterrorism preparedness research, she served on the HHS transition for the Obama Administration.Hamburg's service under the Clinton Administration and head of a large health system appear to be two other important qualities for a top health post in this administration. In 1997, she left the NYC health department and was named assistant secretary for policy and evaluation at HHS under President Clinton.Hamburg will reportedly handle food and tobacco issues-assuming FDA is given regulatory authority over those products-while Sharfstein will oversee drug, biotech and medical device issues.While the arrangement raises questions over the effectiveness of a de facto two-headed agency, it serves as a palatable compromise among Congressional lawmakers and key industry stakeholders.It became common knowledge that the drug industry opposed Sharfstein as FDA Commissioner due to his close ties to House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.); he was previously a health policy advisor to Waxman on the Democratic staff for the House Government Reform Committee.Naming Sharfstein principal deputy gives Waxman access to FDA without the perception of total control over the agency, while also ceding authority over the drug industry to the former Waxman staffer. The number two position also saves Sharfstein from going through the Senate confirmation process.The nomination of Kansas Governor Kathleen Sebelius as HHS Secretary appears to have had little consequence on the choices at FDA and CMS, which were cemented before the withdrawal of Tom Daschle as HHS Secretary on Feb. 3.Institute for Health Care Improvement CEO Don Berwick is expected to be named CMS Administrator with an unusually large number of deputies as Medicare takes center stage in the health reform debate. Harvard economist David Cutler will serve as principal deputy with authority over Medicare coverage reform.
Uganda (the fourth-largest importer of Indian medicines in Africa) is discussing a draft proposal to prevent entry of drugs defined as “counterfeit” for breaching intellectual property claims. The anti-counterfeit bill being discussed there is similar to the one proposed by Kenya. The Kenyan parliament has accepted the amendment and the bill is awaiting presidential approval.
Africa accounts for 14 per cent of India’s $8-billion medicine exports.
The African nations’ move to link intellectual property issues in this manner has come despite the defeat (due to pressure from India and others) of a recent attempt to similarly change the World Health Organization definition of “counterfeiting.”
Both the Ugandan and Kenyan bills define “counterfeiting” as manufacture, production, packaging, re-packaging, labelling or making, whether in the country or elsewhere without the authority of the owner of any intellectual property right subsisting in the country or elsewhere.
The proposed law also intends to make transit or trans-shipment of counterfeit goods illegal and allows border measures against such goods. The Netherlands had recently seized drug consignments of Cipla, Dr Reddy’s and Ind-Swift Laboratories on charges of intellectual property right infringement. The issue had made India (the origin) and Brazil (destination) voice concerns over such border measures.
For those who support drug importation here at home, here's a question: what do the govenment's in Uganda and Kenya know that you need to know?
Wyeth v. Levine
After the Wyeth v. Levine argument, I worried that the Supreme Court might decide the case on such narrow grounds that it would do little good to confront the problem of trial-lawyer abuse. I now see I wasn’t nearly pessimistic enough.
We can put the nail in the coffin in the idea that this is a pro-business Supreme Court: the 6-3 Wyeth v. Levine decision is the worst anti-business decision since United States v. Von’s Grocery, 384 U.S. 270 (1966). Justice Thomas’s confused concurring opinion is especially disappointing, as it declares an abdication of the Supreme Court’s appropriate structural role to prevent individual states from expropriating the gains from interstate commerce.
Sell your pharmaceutical stocks now, because the Supreme Court just declared it open season on productive business. One should now fear the coming decision in the as-yet-to-be-briefed Clearinghouse v. Cuomo, and the effect that is going to have on an already battered banking economy, as well.
Beck and Herrmann have first thoughts, but are likely to be relatively quiet thereafter.
http://overlawyered.com/2009/03/wyeth-v-levine/
The majority wrote that:
"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.12 The agency’s 2006 preamble represents a dramatic change in position. "
The court fails to provide any evidence of unknown drug hazards, but that's nitpicking. But if the court does find one I guess that includes information that was already on the label? Or how about "information" based on a meta-analyses or conjecture that a plaintiff brings forward that was perhaps discussed and dismissed by the FDA and companies? If a jury decides that such "information" reveals a safety risk should that be considered a "failure to warn"?
The impact of this decision will be threefold:
1. Like the Cutter polio decison, Wyeth v. Levine breaks new legal ground. In Cutter a jury found that "pharmaceutical companies are liable for damage without negligence, even if they make a product according to industry standards using the best science available." Here the court finds that companies are liable for damage even when the risks are clearly stated and for risks that may not be obvious or proving using the best science available.
2. The decision will raise the cost of making new drugs and vaccines.
3. The decision should dash the hopes of the HMOs who thought that a comparative effectiveness commission would shield them from denying access based on a quasi-government study. If anything, comparative effectiveness, since it is more of squishy methodology than measuring biological response to medicines, will be easier to attack from a legal or class action standpoint. Want to deny using genetic tests on grounds of cost-effectiveness? Just wait till the first lawsuit comes along claiming damages because of a refusal to test for adverse events or response.
Ironically, pharma and biotech firms could be in a better position to adapt to the new ruling with biomarker based development and post market technologies. Meanwhile, health plans that seek to rely on the FDA label as a basis for denying coverage should think very hard about the implications of this decision.
A majority of the Court, in an opinion written by Justice John Paul Stevens, sided with Ms. Levine. But the ruling is difficult to square with the Riegel decision last term, where a 7-2 majority held that FDA approval shields medical devices from most lawsuits. Moreover, it's unclear that a stronger warning would have mattered.
The drug's label clearly stated that the "IV push" method employed to deliver the drug to Ms. Levine should be used as a last resort and that "INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY." As Justice Samuel Alito explains in his dissent, "the physician assistant who treated [Ms. Levine] disregarded at least six separate warnings that are already on Phenergan's labeling, so [Ms. Levine] would be hard pressed to prove that a seventh would have made a difference."
But Justice Alito's larger point is that "drug labeling by jury verdict" undermines the workability of the federal drug-labeling regime. Juries are presented with tragic plaintiffs who were injured, not the unknown patients who are helped, by a product. Hence, they tend to focus on risks more than overall benefits. By contrast, federal regulators are tasked to take the long view and factor in the interests of all potential users of a drug. Just as importantly, "the FDA conveys its warning with one voice," writes Justice Alito, "rather than whipsawing the medical community with 50 (or more) potentially conflicting ones."
“Such women must wait up to five years until their condition worsens by up to 60 per cent before they are allowed alternative medication, such as the drug strontium ranelate.”
Yesterday I debated Peter Lurie (Deputy Director of Public Citizen’s Health Research Group) at The First Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies (keynote speaker was Senator Charles Grassley). Our session was billed as a “cage match.” We agreed on many points – and disagreed – very strongly – on others.
Here’s what I had to say:
Four months ago the New York Times reported that:
“The Journal of the American Medical Association cited “concerns about misleading reporting of industry-sponsored research” to justify its stricter standards for any such research to be considered for publication. The new policy, requiring researchers with no financial connections to the sponsor to vouch for the data and perform statistical work, was promptly criticized in an editorial in The British Medical Journal as “manifestly unfair” because it created a “a hierarchy of purity among authors.”
Considering that JAMA accepts advertising from the pharmaceutical industry and openly promotes the sales and marketing of reprinted articles – the concept of a “hierarchy of purity” is a nice turn of a phrase. It sounds better than “hypocrisy.”
Facts are an even better indicator. Consider an analysis published in The International Journal of Obesity and financed not by industry but by the National Institutes of Health. After analyzing weight-loss research conducted over four decades, they’ve found that the quality of data reporting in industry-sponsored research does indeed seem to be different from that in other research: It’s better.
The researchers found that the quality of data was significantly better in industry-supported research than in nonindustry-supported research, particularly in studies involving drug treatments. The researchers conclude:
According to the New York Times, “This suggests that, while continued efforts to improve reporting quality are warranted, such efforts should be directed at nonindustry-funded research at least as much as at industry-funded research.”
So, all of the righteous indignation about “bad” industry tainting “good” researchers is mostly hyperbole. But it makes for great copy.
When it comes to the future of medicine and the treatment of patients, we all need to move beyond one-dimensional attitudes – despite the fact that it makes for great speeches on CSPAN and headlines for “investigative” journalists.
New York Times reporter Gina Kolata recently reported that some prominent medical researchers are starting to shun any financial support from industry — not because they think it leads to bad research but because they’re tired of having their integrity impugned. By stigmatizing industry-sponsored research, is the “hierarchy of purity” doing more harm than good?
Is there an unintended negative consequence of transparency? Yes, when it is usurped by those who would put politics ahead of the public health.
A recent editorial on Nature Biotechnology put it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”
Transparency is important. It is urgently important. Transparency permits trust. Sunshine is the best disinfectant – but what’s good for the goose must also be good for the gander.
But let’s be honest. The Sunshine Act with all of its high-minded language about transparency is really just about slamming the pharmaceutical industry.
That’s politics trumping the public health.
Why isn’t anyone concerned about the payments physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?
If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
Who’s pure and who isn’t? Here’s the answer – nobody is 100% pure. Not even Ivory Soap is 100% pure – and it floats! And politicians are certainly not 100% pure. Not even ones from
In the February 7th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
His main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism." It's what's in the best interest of the patient.
- Health care costs are out of control
- Coverage is unaffordable
- We need to invest in quality and prevention and provide incentives for both
- Health IT will allow us to deliver better care at a lower cost
- We need to increase access and increase spending on prevention (but all of the above cost money)
Is there enough overutlization to pay for underutilization?
Are there enough smart people in that room to decide what is overutilized and underutilized?
Hardly.
Drug Imports May Become Legal in U.S. Under Obama, McCain Plans
By Tom Randall
March 4 (Bloomberg) -- Americans may soon be able to buy cheap drugs imported from other countries without fear of breaking the law, now that a five-year push in Congress for new rules has gained support in President Barack Obama’s budget.
A proposal to allow drug imports was introduced today by Senator John McCain, an Arizona Republican defeated by Obama for the presidency, along with Democratic Senator Byron Dorgan, of North Dakota, and Republican Senator Olympia Snowe, of Maine. Obama called for the changes in his budget last week, and views the measure as one way to reduce health-care costs so that medical coverage for the uninsured can be expanded.
Brand-name drugs in other countries cost as much as 70 percent less than in the U.S. Allowing imports would save Americans $50 billion over the next decade, including $10 billion for the U.S. government, the lawmakers said. Dorgan and Snowe previously introduced similar legislation opposed by the pharmaceutical industry and former President George W. Bush.
$50 billion? That's based on all consumers paying retail prices at the drugstore and presumes a significant increase in the amount of consumption of imported drugs paid at the difference in retail prices...
Sorry but the reality is that every drug importation program at the state level has been a failure. Meanwhile the threats to the safety of medicines have grown.
Randall claims that a " 30-pill prescription of 20- milligram doses ( Lipitor) costs $124.99 at the U.S. site, compared with $60.78 from Canada.
Not exactly. The internet sites CLAIM they are Canadian but the drugs from such countries as Turkey and Singapore. Meanwhile HealthCanada will not guarantee the safety of medicines brought through Canada and resold into the states.
Meanwhile, the legislation would force companies to sell their drugs to foreign wholesalers at the government set price in any amount they want. Imagine if McCain or someone else introduced legislation forcing car companies to re-import cars made in China at the Chinese market price.
http://www.bloomberg.com/apps/news?pid=20601103&sid=abzWU.GPNrjc&refer=us
(1) People can sue drug companies for risks that are already on the drug label.
(2) But companies cannot unilaterally change the label when new information arises.
(3) And patients can also sue innovator companies for adverse events caused by generic versions of their molecules produced by other companies.
(4) And somehow this isn't going to impact either innovation or cost.
(5) The current majority party wants to restrict drug marketing through increased FDA regulatory authority.
(6) Yet they defenestrate the agency's ability to enhance safety by denuding ... the drug label.
(7) And politicians want the FDA to guarantee the safety of drugs from a gaggle of nations.
(8) But the FDA label doesn't count within our own borders.
(9) So now people can sue innovator companies for adverse events from medicines imported from foreign countries.
(10) One wonders about medicines that are compulsory licensed in places like Thailand (and manufactured in India).
(11) Can people sue when these drugs go bad as well?
Is it just me, or does it seem that the government wants to regulate everything except for what benefits the tort bar?
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.
