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According to a report in the Sunday Telegraph, David Cameron, the leader of the British Conservative Party, wants all patients with cancer to have broader access to all approved medicines – whether or not their use is backed by the National Institute for Health and Clinical Excellence (NICE), the NHS' rationing body.
Last month, research found that up to 20,000 lives may have been shortened by decisions taken by the NICE in the past year.
The Telegraph writes that, “Handing decisions back to patients and their doctors is a significant dismantling of the current system … In making yesterday's pledge Cameron chose local decision-making – and its inherent risks – over state control.”
Oscar Wilde quipped, “Experience is the name everyone gives to their mistakes.”
If that’s the case, then we should learn from the experience of our trans-Atlantic cousins.
The complete Telegraph article can be found here.
According to a report in the Helena Independent Record:
Gov. Brian Schweitzer, who last month asked the federal government to approve a “waiver” so Montana could import prescription drugs at lower cost for state-funded health plans, has not submitted any of the usual documentation that accompanies a waiver request, his administration acknowledges. Instead, the governor wrote only a letter to U.S. Health and Human Services Secretary Kathleen Sebelius, asking that her agency grant Montana a “Medicaid waiver” allowing importation of lower-cost drugs from Canada.
“We have to work through the secretary’s office,” says Anna Whiting Sorrell, director of the state Department of Public Health and Human Services. “There is not another state that has requested this. We think the governor is forging a new path.”
News must travel slowly in Montana.
There have been numerous requests for such waivers. And they’ve all been denied – for good reason.
Let’s look at the record.
Minnesota
During pre-announced visits by Minnesota State officials, Canadian Internet pharmacies were observed engaging in dangerous practices. For example:
- One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that here is no way to assure safety.
- One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.
- Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.
- One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall “if they wished."
- One of the Canadian internet pharmacy presidents said, “We won’t have any problems getting drugs. We have creative ways to get them.”
- The FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. Some of them were headed for Minnesotans who ordered them over the state’s Web site. When opened, nearly half claimed to be of Canadian origin, but “85 percent of them were from 27 other countries including Iran, Ecuador and China. And 30 of them were counterfeit. One Minnesota resident discovered that one of his “Canadian” drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place,” he said.
According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state -- population: 5,167,101.
Wisconsin
Modeled on the Minnesota program, the Wisconsin site hawks its promise and hides its dangers. All of the legalese buries the fact that the state doesn’t except any responsibility for the safety or effectiveness of any medicines bought on the State’s website. For example, the State won’t even guarantee that the drugs ordered are what the customer will receive. Not only that, but the State also says that they will not accept any legal responsibility or liability should any of the drugs cause a problem. The Governor is hiding the fact that his website puts any user into a dangerous buyer beware situation. Here’s the exact verbiage from the Wisconsin site:
“In no event shall the State Portal or its employees be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this system, even if advised of the possibility of such damage. This disclaimer of liability applies to any damages or injury, including but not limited to those caused by any failure of performance, error, omission, interruption, deletion, defect, delay in operation or transmission, computer virus, communication line failure, theft or destruction or unauthorized access to, alteration of, or use of record, whether for breach of contract, tortious behavior, negligence or under any other cause of action.”
Illinois
Remember Wrong-Way Rod Blagojevich’s swagger over his “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
The City Experience
Remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006.
And speaking of Boston tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
And then, of course, there are those pesky safety issues.
Attention Governor Schweitzer -- The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
Last month Governor Schweitzer said that Montana could buy some of the drugs directly from wholesalers in Canada or place the orders and have them delivered to pharmacies around the state, for purchase by people covered by publicly funded health plans.
Someone should refer the Governor to Bartlett's Familiar Quotations:
“Those who cannot learn from history are doomed to repeat it”
And if that familiar quote from Santayana doesn’t get the point across, here’s a related one – “Remember the Alamo.”
The Montana state slogan is “the last best place.” Maybe so.
But not for drug importation.
I don't want to think in terms of repeal. Rather, I would prefer to use a medical or scientific analogy in describing how to respond to the effects of the legislation.The bill itself is a virus and we the people are the host if you will. Or consider it an experiment with every American forced into participation. Either way, we will be subject to new "solutions" that will have unknown consequences and side effects. As with any social experiment or massive program of social engineering, we will experience the end product in ways much different than promised. (If anyone has used on-line dating services, you know what I am talking about.)
Strategically, demanding outright repeal or defunding of health care reform sounds great to a small group. To build support for fundamental changes in what is now law will require exactly what the supporters of the current bill engaged in, nothing less and probably more:
1. Consistent and persistent evaluation of the performance of health care delivery systems. These standards should be easily grasped by most people and communicated easliy in visual form too. Are doctors leaving the system? Are people paying more or less for insurance? Are people any healthier?
2. Warning signs. The other side is hell bent on using health care reform to reduce our long term debt. Debt will rise because of spending unrelated to health care reform.To turn health care reform and by extension, every doctor and hospital, into any agent of deficit reduction first and foremost is a rationale for rationing care. And it is an immoral one at that.
3. An increasing reliance on the use of comparative effectiveness research to shape policy and health care coverage decisions. Increasiningly, to justify the need to avoid financial Armageddon, policymakers will rely upon CER to help make hard choices to slow health care spending in order to avoid “financial catastrophe.” If that sounds a lot like the narrative of the climate change crowd who used self-serving and secretive studies to support policies that also would lead to a decline in economic growth in order to save the planet, you are right. The “science” of CER demonstrating that a half to a third of health care spending is wasteful has much in common with the that of the hockey stick project about the atmosphere evaporating. It is not empirical or biological, it is speculative and has never been evaluated for it’s real impact on public health or human well-being. Should we take prescriptions that are not tested or are not based on an accurate representation of human or biological mechanisms? Yet CER is precisely that and it may be used to determine what preventive services are covered and what new benefits will qualify for reimbursement. It is possible to opt out of government run care because of conscientious objection to CER? I hope so..
4. Impact on innovation. Largely unnoticed, drug companies are filling up pipelines with new products.More and more of them are based on novel targets and rely on biomarkers linked to specific pathways and small populations. The number of molecular diagnostics to help predict, diagnose and monitor the progression of diseases or response to medicines are growing as is the business capacity to provide doctors and hospitals the ability to use this information. The progress will be incremental but it will come. The question is will future policies add to the cost and pace of progress or not? CER is only one such challenge. And alone it’s proponents will be left looking foolish and backwards. However changes to the FDA regulatory process can easily increase the time and cost of bringing new products to market and reduce the effective patent life of niche medicines. Demands to have a new center for drug safety review all NDAs before they go to market and for CER studies as a condition for approval would impose huge costs on innovation and the pubic health. Similarly, CER requirements can add more delay and uncertainty to the R&D process.
These are substantive concerns about the new health care bill that can be addressed through the writing of regulation and new legislation. We intend to track these issues as we have in the past. I don’t care if someone wants to call this approach repeal or reform or a do-over. I would like to think of restoring and improving the health of the system and all Americans.
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.
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.
