Latest Drugwonks' Blog
So with this said, how interesting that Avandia is the drug used (because of it's insulin producing properties) to determine if "insulin, by shielding memory-forming synapses from harm, may slow or prevent the damage and memory loss caused by toxic proteins in Alzheimer’s disease."
You can read about the research here. Note that neither Steve Nissen or Curt Furberg were asked to comment:
Here
And here.
The In Vivo observers state:
"The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years. Compare that to $117 billion that the health insurers are being asked to give up from reductions to Medicare Advantage payment rates and you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them."
SInce brand Rx is only 7-9 percent of total health care spending does it make sense for drug spending -- which will come in the form of formulary driven rebates that ultimately hurt the mentally il and seniors the most -- to shoulder such a big chunk.
And that's just the start...
"The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a good climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics."
CBO estimates $70 billion over ten years for FOBs. A lot of the "savings" are expected to come from restricting access to drugs based on comparative effectiveness reviews. Tack on another $100 billion. That doesn't include 15 percent mandatory rebates some in Congress want to stick to drug companies for the privilege of participating in Part D. CBO estimates another $100 billion out of that. Let's round off to $400 billion over ten years or about 25 percent of total revenues for that time period. Add to that the drop off in sales due to patent losses.... As the WSJ health blog noted a while back.... "Generic competition is expected to wipe $67 billion from top companies' annual U.S. sales between 2007 and 2012 as more than three dozen drugs lose patent protection. That is roughly half of the companies' combined 2007 U.S. sales." There will be some offsets thanks to new products but with government policies slashing revenues with rebates, formularies, etc. the combined effect of all these proposals and the generic shift will be huge.
So, is PhRMA just preserving an eroding status quo in order to innovate another day or are buying into policies that will make innovation more difficult given their cumulative impact on the bottom line? It remains to be seen.
Read Article
One thing is certain, I think the In Vivo folks are -- like many so-called "stakeholders" -- confusing having a seat at the table with what is really best for the industry and the public. Especially now when the requirement for keeping that seat is suggesting that even legitimate questions about the direction of health policy are "land mines" that could block the way of the Obama heatlh care express.
Read the In Vivo Blog Here
The article (by Jim Edwards) can be found here.
"Interesting" because he (refreshingly) calls it like he sees it -- specifically:
"Peter Pitts, a former FDA official and an executive at Manning, Selvage & Lee, a PR firm that represents pharmaceutical companies, informed producers of his financial ties to drug companies when he appeared as a guest on the show."
Here's what Bill Lichenstein (the producer of the Infinite Mind) had to say about that:
"… as executive producer of The Infinite Mind, I was not the producer of the episode in question. But with regard to our failure to disclose the pharmaceutical connections of one guest, Peter Pitts, Pitts was a guest on the show due to his being a former FDA official. We were not aware, nor was PBS’s NewsHour nor NPR, when they had Pitts on as a guest, of his pharmaceutical PR ties."
So, even though he wasn't aware he was aware. Now that's an infinite mind!
Edwards continues:
That stands in contrast to Pitts’ own assertion, also on BNET Pharma, that he did disclose his ties to drug company clients:
And Edwards ends the article as follows:
"Side note: There’s a slight “Rashomon” aspect as to whether Pitts disclosed his ties to MS&L and drug companies. It should not have mattered, however. Although Pitts was an FDA executive, he is now better known as a pro-industry voice and his clients are not a secret. The only reason Pitts is famous enough to make it onto radio shows is because he is tied to these companies. The mistake here was the show’s failure to do a simple internet search and disclose Pitts’ current job, not with whether Pitts mentioned his job prior to the interview. If you’ve ever met Pitts you’ll know that of all the things you can accuse him of, operating in a subtle, sub rosa fashion is not one of them."
Thanks for the clarification and (I think) the complement.
What remains curious and frustrating is that no one wants to discuss the actual content of the program.
Here is a link to my initial comments on the program (which also include a link to the actual program).
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.”
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.
