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The two page bill (more like a placeholder) is just the first step designed not to step on the toes or in front of the cameras of those committee chairs who are inclined and will be likely to introduce much more draconian measures. To be sure the D's don't want to do anything to undermine the large but extremely soft numbers in support of "direct negotiations" which is why they came up with poll-tested and politically ambiguous piece of legislation ("nothing in this act should be construed as requiring the Secretary to wear a dress to work every morning, especially with white shoes, especially when not in season..")

I wonder what the poll numbers would be like if the pollsters asked intelligent questions like: Do you support government negotiating directly with drug companies even if it might result in restricting access to new medicines and less money for stem cell research?

I wonder.

Madam to Madam

  • 01.05.2007
And only in the nicest meaning of the term!

Here's an important new op-ed piece by Madam Grace-Marie Turner of the Galen Institute addressed to our new Madam Speaker. Topic: Medicare and the Part D benefit.

http://www.chron.com/disp/story.mpl/editorial/outlook/4447256.html

We're sure that Grace-Marie's advice is offered in the spirit of partnership rather than partisanship.
Here's another take on the "sleazy side" of Internet pharmacies:

http://www.cmpi.org/newsDetail.asp?contentdetailid=259&contenttypeid=3&page=1

Worth a read.

Final quote in the article says it all, "Rogue outfits wouldn't keep operating if they weren't profitable. Legitimate pharmacies are licensed for a reason. Sometimes a bargain is just too expensive."
Courtesy of Mr. Dingell and Mr. Rangel, please welcome the “Medicare Prescription Price Negotiation Act of 2007.”

Goodbye non-interference. Hello con-interference.

And if the devil is in the details this bill is as saintly as they come because, there ain’t no details – the bill runs just a tad over two whole pages, double spaced. Talk about Part D Deficit Disorder.

The good news/bad news is that there’s no there there.

Good news because there’s no there there.

Bad news because it is the beginning of the slippery slope towards choice controls (aka: price controls). And, because of that, it must be robustly fought.

According to the draft bill, “… the Secretary shall negotiate with pharmaceutical manufacturers the prices that may be charged for covered part D drugs for part D eligible individuals,” but “nothing shall be construed to authorize the Secretary to establish or require a particular formulary” and “… shall not be construed as affecting the Secretary’s authority to ensure appropriate and adequate access to covered part D drugs under prescription drug plans …”

So, the Feds can negotiate, but if the negotiations fail (whatever that means), the Secretary doesn’t have the authority to “ban” any drug from any federally-funded formulary (i.e., every single existing part D plan). Some hammer.

And, to remove yet another tooth, the bill makes clear that "government prices” need not even be the lowest ones. As the draft bill reads, “Nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan, or an organization offering an MA-PD plan, from obtaining a discount or reduction of the price for a covered part D drug below the price negotiated under paragraph (1)” – the “government price.”

A total toothless wonder – and no wonder. The new Congressional majority knows how to read a poll. Seniors like the prescription drug benefit. It works. It’s an entitlement – the newest political third rail.

This bill is a dodge. A face-saver. And it’s dishonest from every angle. For those who believe in real price controls (Rahm Emanuel, etc.) it’s a teensy-weensy baby step. Such folks (however wrong-minded) should be outraged at such a lame piece of legislation. For those opposed, it might very well be seen as an easy “yea” vote – since it really won’t do anything. But, as stated above – it’s a slippery slope with the slippery folks at the helm for the time being. "Least worst" alternatives must not acceptable when it comes to the public health.

Here is a link to the draft legislation:

Download file

See if you can read it in its entirely while holding your breath. And then take a deep breath – because the battle has begun.
So much for the one size fits all formulary plans of Marcia (one drug per disease will do ya) Angell and those in the EBM movement.....


Dr. Gualberto Ruano, President of Genomas, Inc. and a principal scientific adviser to The Center for Medicine in the Public Interest has identified DNA markers for risk and protective factors involved in diabetes-related metabolic side effects from treatment with common antipsychotic drugs used to treat schizophrenia and manic depression.

The research, which was published in the January 2, 2007 online issue of Nature Publishing Group’s Molecular Psychiatry, highlights how understanding a patient’s DNA can predict an individual’s profile of risk or protection from the antipsychotic drugs prescribed, and paves the way for using genetic tests to personalize the treatment of mental illness. The study, entitled “Physiogenomic comparison of weight profiles of olanzapine- and risperidone-treated patients”, looked at two of the leading atypical antipsychotic medicines on the market and found that a series of unique DNA variations could predict a patient’s likelihood for developing pre-diabetic side effects such as weight gain.

The use of antipsychotic drugs is on the rise, with an estimated 14 million patients suffering from chronic mental health disorders -- such as schizophrenia, bipolar disorder, obsessive-compulsive disorder, and generalized anxiety disorder -- for which these drugs are increasingly being prescribed. Atypical antispychotics (AAPs) can induce diabetic symptoms in nearly one third of patients, most notably characterized by increased weight gain in some patients but not in others. However, the side effect profiles for these drugs even within the same drug class may differ, raising the possibility of drug-specific side effects.

Dr. Ruano's research demonstrates that risk varies by individual and can be predicted and limited in ways to offer hope and reduce suffering. His research and dedication to the making medicine more predictive underscores the immense opportunity of personalized medicine as well as the human price we will pay if policymakers persist in imposing one size fits all solutions on patients and the public as a whole.

CMPI plans to conduct a study to determine the value of widespread DNA testing for AAPs in terms of the time and money saved by avoiding unnecessary, ineffective of unsafe treatments.

The battle is joined. And Dr. Ruano will be joining us at our Media and Medical Science conference in DC on Feb 21.
It is not for nothing that the WSJ ran its piece on Abbott's strategery regarding the re-pricing upward of Norvir the week that Democrats are planning to push through price controls on prescription drugs. (See New Regimen Inside Abbott's Tactics To Protect AIDS Drug Older Pill's Price Hike Helps Sales of Flagship; A Probe in Illinois By JOHN CARREYROU)

But then again, the article does offer some valuable lessons from drug and biotech firms as does a seemingly unrelated article by Alan Murray today dealing with the demise of Home Depot's CEO Bob Nardelli for not understanding that today's corporate chieftain is now in charge of a group of stakeholders (that's why it's called a public company) and not just the bottom line. Indeed, it is the persistent failure of drug and biotech companies to fail to plan for the political and consumer impact of it's corporate decisions.

Abbott raised the price of Norvir when it became clear it was being used as a booster for a competitor product. But the company did a horrible job of clearing the path for what it knew would be a controversial move. In the end, the furor died down but not until Abbott took steps it should have integrated at the outset into an overall package to both explain and insure that both Norvir and it's new product, Kaletra, could be used a suite of products en route to delivering outstanding care. Abbott undertook damage control when it should be been planning for a reconfiguration and relaunch, working and talking to the groups affected and interested in its products.

The fact is what drug and biotech companies do interest people far beyond the immediate group of patients and clinicians that use them. They generate headlines for news organizations and politicians alike. Companies have yet to understand that public policy is just as important to the launch and reimbursement of a product as the science behind it. Similarly, CEOs in the industry seem to be the last of the bunch to understand that their role is not just making the numbers and steering firms through a transition in the science of drug discovery, tough as those tasks are.

Rather, as Alan Murray notes about Home Depot's Bob Nardelli can still be said for many CEOs in the pharma and biotech community:

What Mr. Nardelli missed, however, is that in the post-Enron world, CEOs have been forced to respond to a widening array of shareholder advocates, hedge funds, private-equity deal makers, legislators, regulators, attorneys general, nongovernmental organizations and countless others who want a say in how public companies manage their affairs. Today's CEO, in effect, has to play the role of a politician, answering to varied constituents. And it's in that role that Mr. Nardelli failed most spectacularly.' See Alan Murray's article: Executive's Fatal Flaw:
Failing to Understand New Demands on CEOs in today's WSJ.

The Abbott article is a cautionary tale of the cost of continuing to fail. As we enter a high dry political season for pharma-bio, leadership on a grander scale will be required. Above all, if CEOs fail to defend the mission and value of their enteprise, no one else well. Ultimately, the pharma CEO must create a constituency for his corporation. And simply paying lobbyists to keep the wolves away will not do.
In case you missed.

(Of particular interest is that the Part D provider having the biggest problems -- at least according to one pharmacist -- is the AARP.)

Medicare drug benefit signup less bumpy this year
By Kevin Freking
ASSOCIATED PRESS

WASHINGTON – Seniors are experiencing fewer problems at the start of the Medicare drug benefit's second year, even as hundreds of thousands come into the program for the first time or change plans.

The smoother start was reported Wednesday by federal health officials and representatives of seniors and pharmacists.

“It's not perfect, but it seems a lot better than last year,” said Carol Cooke, spokeswoman for the National Community Pharmacists Association, which represents about 24,000 pharmacies.

“It's nothing overwhelming like last year,” said Deane Beebe of the Medicare Rights Center. “But, yes, there is a smattering of problems we're hearing about. We've also spoken with pharmacists who say it's too soon to tell.”

With the start of a new year, hundreds of thousands of people are coming into the program for the first time, while hundreds of thousands more have switched insurance plans. The changes have the potential of causing havoc for consumers and health care providers if they weren't properly plugged into computer databases before Jan. 1.

The Centers for Medicare and Medicaid Services said it had seen nothing like the barrage of complaints that had marked the drug program's first week in 2006, when consumers were not listed in insurers' databases and pharmacists had problems verifying coverage.

“It's very quiet, but we're always on the lookout. There's nothing that has risen to the level of crisis,” said Jeff Nelligan, spokesman for the agency, which oversees the drug benefit. Cooke said pharmacists had reported problems billing UnitedHealthCare, which administers drug plans with the AARP brand and has the highest enrollment. She read an e-mail from a pharmacist: “It is now 1 a.m. and I am still at work since 9 a.m. transmitting claims for Part D. During the day, I could get no AARP claims to go through.”

“We had initial issues that affected our systems, but at the present time, we are seeing high service levels and 99 percent of all claims submitted are being processed within one second,” replied Peter Ashkenaz, a spokesman for UnitedHealthCare.

Last year, Cooke and her colleagues returned from the New Year's holiday to find their telephone message systems overflowing with complaints.

Under the program, beneficiaries can choose from 50-plus plans serving their states. They pay a monthly premium and for some of the costs of their medicine. The federal government picks up most of the initial expense. But once total drug costs reach $2,400, there is a gap in coverage – the so-called “doughnut hole” when the plan will pay nothing toward the cost of the drugs. That gap continues until total drug costs total $5,451. Then, the government begins paying again at a rate of 95 percent.

The poor get extra help with the cost of their medicine.

About 23 million people are enrolled in drug plans. People could switch plans or enroll for the first time from Nov. 15 through Dec. 31. Deadline exceptions will be allowed for some seniors, particularly about 250,000 people enrolled in plans that failed to properly notify them of changes in their coverage. The federal government gave them another six weeks to make a switch if they want.

Going into the new year, federal officials were most worried about those seniors who waited until the final few days to change plans. However, surveys indicated that few seniors would do so. The Kaiser Family Foundation polled seniors in early November about whether they would change drug plans. Only 5 percent said yes. About 66 percent said no. The remainder said they had yet to make that determination.

Beebe said a federal mandate that insurers provide an emergency 30-day supply of medicine has helped limit problems. She also said that some consumers learned from last year. They filled their prescriptions just before the end of 2006 so that they wouldn't have to deal with problems that they encountered last January.
Hybrid Molecule Causes Cancer Cells To Self-destruct
Science Daily — By joining a sugar to a short-chain fatty acid compound, Johns Hopkins researchers have developed a two-pronged molecular weapon that kills cancer cells in lab tests. The researchers cautioned that their double-punch molecule, described in the December issue of the journal Chemistry & Biology, has not yet been tested on animals or humans. Nevertheless, they believe it represents a promising new strategy for fighting the deadly disease.

Could we link a sugar to Pelosi's price control plan for seniors and get the same therapeutic explosion. Heck, I would even support Byron Dorgan in opposing stuffed molasses in from Canada at a lower price for that to happen... apparently the Senator who supports using price controls from Canada on medicines opposes reimportation of stuffed molasses from the same country to get around sugar tariffs imposed on behalf of sugar producers in the US, particularly in Lousiana, home of Senator David Vitter who courageously blocked a vote to confirm Andy von Eschenbach in order to bar customs officials from seizing counterfeit drugs at the Canadian border.

When VA means STOP

  • 01.04.2007
CMPI's Dr. Bob Goldberg, as quoted in today's Wall Streeet Journal Review and Outlook editorial:

The need for scrutiny is even more compelling on price controls for Medicare prescription drugs. Under the Medicare Part D benefit that took effect last year, private companies negotiate prices. Democrats want to allow the government to deal directly with drug companies. They argue that this would lead to lower prices for medicines, but the more likely outcome is fewer drug choices and price controls.

Democrats point to the Department of Veteran Affairs as a model, but we doubt seniors will like that story when they learn about it. The government already negotiates drug prices directly with the VA. But as Robert Goldberg wrote last month in the Weekly Standard, "Far from negotiating prices, the VA imposes them. Federal law requires companies to sell to the VA at 24% below wholesale price. If they won't, they are banned from selling medicines to Medicaid, Medicare and the public health service."

The VA has created a list of approved drugs for its patients. Companies that don't pay the VA price don't make the list, and a slew of drugs fall into that category. They include Azilect and Tysabri, two of the newest therapies for Parkinson's and multiple sclerosis, respectively. That's what happens when keeping prices down takes priority over getting the best available medicines to patients. Both drugs are available through Medicare Part D, by the way. Maybe Congress ought to debate this.

Wood Eye!

  • 01.04.2007
You know the joke.

The other joke is how Senators can be for unfair trade practices (like "drugs from Canada") one day, and against them (like, for example, "lumber from Canada") the next . The difference? You guessed it -- politics.

Many thanks to the drugwonks reader who sent in the following US Senate "colloquy" between Senators Baucus and Crapo. Here's how you play: Whenever you see the words "Canadian lumber," replace them with "Canadian drugs."

(And if you'd like more Senatorial Inconsistencies, check out Senator Byron "Mr. Importation" Dorgan's statements on Canadian wheat.) Talk about Washington DC log rolling!


CANADIAN SOFTWOOD LUMBER DISPUTE -- (Senate - January 24, 2005)

Mr. CRAIG. Mr. President, I rise today to discuss the latest developments regarding the Canadian softwood lumber dispute. With yet another curious and ultimately inconsequential lumber unfair trade determination due today at the behest of a NAFTA dispute panel, it is important to place this matter in proper perspective.

Would the distinguished Senator from Montana and my colleague from Idaho engage in a colloquy with me concerning the Canadian softwood lumber dispute?

Mr. BAUCUS. I would be pleased to engage in such a colloquy.

Mr. CRAPO. I would also like to join my colleagues in a colloquy on this matter.

Mr. CRAIG. The Commerce Department has found repeatedly that Canadian lumber is subsidized and dumped. World Trade Organization and NAFTA dispute settlement panels have definitively rejected Canada's long-time arguments that its underpricing of timber cannot be deemed a subsidy. The panels have also upheld findings that Canadian lumber is unfairly dumped in the U.S. market. The International Trade Commission has found repeatedly that the unfair imports threaten our industry with harm.

President Bush was well prepared to answer the Canadian Prime Minister when they last met. The President told the Prime Minister that the problem of subsidies and dumping is caused by Canada, and the solution lies with Canada, unless Canada wants the solution to be permanent duties to offset the subsidies and the dumping. In over two decades, Canadian officials have not gotten the message, at least not in a way that takes, that this problem will not be resolved by Canada's investing hundreds of millions of dollars in legal fees on more than 30 Washington law firms to circumvent U.S. laws in countless appeals to the WTO, to NAFTA panels and to the U.S. courts--several more were filed just this month. And it will not be solved by the cottage industry that has grown up in Canada to mount PR campaigns in the United States.

The U.S. timber industry vigorously supports the administration's view that the unfair Canadian lumber problem could most appropriately and productively be resolved through negotiations--although perhaps there just ought to be permanent duties in place. But the U.S. timber industry is taking the statesmanlike high road, and I support it. Some vested interests in Canada do not see this, and prefer endless litigation, probably based on misguided advice that this will be productive from those who have made a living defending Canadian subsidies.

Mr. CRAPO. Specifically, the problem remains that the market is grossly distorted by Canadian unfair trade practices. Absent termination of or an offset to the unfair practices, the U.S. timber industry will be severely impacted by subsidized and dumped Canadian imports. We in the Congress have been assured that those responsible in the administration will not allow this further injury to our industry occur.

A solution can be either border measures imposed by the United States or Canadian border measures agreed to with the United States pending adequate Canadian timber policy reforms.

The Bush administration has concluded that the November 2004 determination of the International Trade Commission that Canadian imports threaten the U.S. industry with injury--the ``Section 129'' determination--represents an independent basis authorizing and necessitating retention of the countervailing and antidumping duty orders. The United States has faith in winning the NAFTA Extraordinary Challenge Committee proceeding on the injury issue, but even a negative outcome before the committee would not be the end of the matter.

The Bush administration has concluded that duty deposits, amounting to approximately $3 billion and growing daily, cannot and will not be returned absent a negotiated settlement between the Canadian and U.S. Governments. The panels can provide prospective but not retroactive relief. In any event, these funds are rightly due under U.S. law to the injured domestic timber industry. If there is a negotiated solution, the funds can be apportioned fairly as part of the settlement.

There is zero likelihood that the countervailing duty, antisubsidy, order will disappear absent settlement of the lumber subsidy and dumping issues, no matter how often a NAFTA panel tries to achieve this outcome.

The U.S. right to challenge Canadian log export restrictions at the WTO is clear under the WTO, and Canada is clearly in violation of its WTO obligations. I understand that the Bush administration is evaluating this issue.

I also understand that the U.S. timber industry intends to bring a constitutional challenge to NAFTA dispute settlement if the lumber dumping issue is not resolved. The future of U.S. sawmills and millworkers cannot be allowed to be ruined by outlandish decisionmaking by NAFTA dispute panels and a panelist's service with an obvious, undisclosed conflict of interest.

Mr. BAUCUS. I agree completely with my colleagues. As suggested, a NAFTA dispute panel is requiring that the Commerce Department issue today yet another revised version of the original 2002 lumber-subsidy determination. Given the panel's pattern of overreaching, it may be a relatively low subsidy estimate. If so, this will be trumpeted in headlines across Canada as a victory for Canada's lumber policies. Before all those editorial writers seize on this supposed ``victory,'' they should understand that this determination will have absolutely no legal effect. It is the Commerce Department's December 2004 findings of a subsidy of over 17 percent and dumping of 4 percent that controls. Hyping the January 24 decision as having any meaning performs a disservice to Canadian interests, which lie in a mutually beneficial negotiated settlement.

Nothing can change the facts. The Canadian provinces provide timber to their lumber companies for a fraction of its value. This harms not only U.S. sawmills, millworkers and family forest landowners, but also the Canadian forest. Environmental groups have long decried the overharvesting of timber caused by undervaluing the resource.
CMPI

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.

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