Latest Drugwonks' Blog
Senator Dorgan’s amendment on drug importation goes down with a vote of 51-48 in favor. (60 votes were needed to prevail under a special rule.)
Senator Lautenberg’s amendment (importation with Secretarial certification) also went down (56-43). According to the AP, “His proposal permits drug imports but adds a requirement that the U.S. government certify that the imports will be safe — a guarantee that Democrats and Republicans agree would be impossible to make.”
Sweet sanity.
Can we debate healthcare reform now?
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VIDEO: WHO IS SPYING ON YOUR PRESCRIPTIONS?
Dec. 15: Pharmaceutical companies are increasingly peeking at doctor's prescription pads, raising many concerns. Dr. Nancy Snyderman talks with consumer health advocate Marcia Hams and Robert Goldberg, a pharmaceutical industry advocate. (Other)12/15/2009 23:20, msnbc
I didn't get a chance to be in this segment...I was in MSNBC's Green Room waiting to be led into the studio and saw the segment running. A producer (?) rushed in and told me to run into another studio where I was miked for the segment. Dr. Snyderman cut to commercial with a teaser about how kids who have a low sexual IQ are endangering themselves... (I was wondering if I had to shift gears and weigh in...) In any event, another MSNBC person came and told me I missed the segment, thanks but no thanks..
Anyways, what I would have said if had the chance.
First, as Peter noted previously, patient level data should not be used to market directly to patients.. That said, why is Ms. Hams organization proudly linked to a website from an insurance company that used patient prescribing data to bribe doctors to switch patients to generic drugs without telling them...
http://www.crainsdetroit.com/article/20090301/SUB01/902269981
Moreover, data mining and contacting patients is critical to promoting compliance and personalized medicine. Lack of compliance with prescription regimens is a source of increased illness, mortality and medical costs. It is a serious public health problem The generic uber alles approach pushed by The Prescription Project likely adds to the problem since studies show that tiered formularies and generic mandates tied to higher co-pays with other drugs are associated with increased illness.
http://www.managedcaremag.com/archives/0408/0408.drugtier.html
But even allowing drug companies to use data that patients and doctors voluntarily give is grounds for legal and political attacks. No surprise. Ms. Hams organization is lawsuit driven. It's Prescription Access Litigation Project generates revenue by suing drug companies and has partnered with tort law firms whose senior partners are now in the slammer for sleazy and illegal practices. Talk about putting profit ahead of patient wellbeing..
http://www.prescriptionaccess.org/press/pressreleases?id=0010
money.cnn.com/magazines/fortune/fortune_archive/2006/11/13/8393127/index.htm
In the last couple days Senator’s Dorgan drug importation amendment has proven a major stumbling block to passing a health care bill.
Whether or not Senator Dorgan is amenable to compromise remains to be seen. This puts President Obama in an incredibly difficult spot. On one hand, the more liberal members of his party are absolutely determined to squeeze more out of those evil pharmaceutical companies. But PhRMA struck a deal early on in this process with the Obama administration and has heavily assisted in promoting the president’s health care agenda.
Will President Obama risk creating another obstacle to passing a bill by challenging Dorgan, or does he throw PhRMA under the bus?
As for Dorgan, if he is truly interested in cost control, then why not focus his efforts on the genuine waste in the system (particularly in Medicare and Medicaid) instead of attacking an innovative industry?
Could it be his only reason for pushing this perpetually nonsensical proposal is that the pharmaceutical industry makes for a politically convenient target that distracts from the really asinine aspects of the Senate bill?
Senator Dorgan needs to ask himself three simple questions:
1. Do prescriptions drugs save the health care system money in the long-term by rendering surgeries and lengthy hospital stays unnecessary?
2. How would Canada respond to US legislation allowing for importation of drugs?
3. Is importing drugs from Canada safe?
On the issue of safety, The Hill reports on FDA Commissioner Margaret Hamburg’s letter to Senator Sam Brownback:
The Dorgan amendment “as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns,” Hamburg wrote in a letter to Sen. Sam Brownback (R-Kan.), related to preventing counterfeit or mislabeled medicines from being sold in U.S. pharmacies.
“We commend the sponsors for their efforts to include numerous protective measures in the bill that address the inherent risks of importing foreign products and other safety concerns relating to the distribution system for drugs within the U.S.,” Hamburg wrote, while emphasizing the legislation does not achieve those objectives.
What was Dorgan's response to the FDA's statement?
He called it "completely bogus."
Wow, now there’s a measured response.
If Dorgan loses re-election next year, maybe he can look into a future position as FDA Commissioner. He apparently has the credentials for the job.
“For all Americans, this legislation makes a big difference: no discrimination for pre-existing medical conditions, no dropped coverage if you are sick, no co-pays for preventive care. There is a cap on what you pay in but there is no cap on the benefits that you receive. It works for seniors closing the donut hole, offering better primary care, and strengthening Medicare for years to come. It works for women preventing insurance companies from charging women more than men for the same coverage. No longer will being a woman be a pre-existing medical condition.”
As I pointed out back in September, it is not the same coverage. Men and women share different medical risks. Insurance premiums are based on those risks. Just as men generally pay higher premiums for both auto and life insurance, women generally pay higher health insurance premiums. That is price discrimination based on financial risks.
But the point of this post is not to rehash that issue.
CMPI Vice-President Bob Goldberg posed the following question in his recent piece in the American Spectator:
Is health care reform designed to discriminate against women?
It’s a question worth asking. Bob cited the cosmetic surgery tax in the Senate health care bill as proof of the legislative assault on women.
Planned Parenthood protested Senator Ben Nelson’s abortion amendment holding signs that read, "Listen up senators: Women's health is not negotiable."
However, Planned Parenthood and other women’s groups are nowhere to be found on the issue of a cosmetic surgery tax. Something tells me if a tax was proposed on abortion procedures, they’d be out in full force speaking on behalf of women’s health.
A cosmetic surgery tax tinkers with one of the more productive sectors of the overall US health care system – more productive in the sense that there is a 93 percent satisfaction rate among patients who undergo cosmetic medical procedures. Moreover, inasmuch as patients typically pay out of pocket for many cosmetic procedures the sector has seen downward pressure on prices on account of the highly competitive market.
The primary problem with this tax is the government fails to make any distinction between a truly “cosmetic” procedure and a procedure for legitimate medical reasons. Senator Tom Coburn (R-OK) recently warned about this shortcoming saying, “They're going to tax having your breast rebuilt after your breast is taken off because it is elective plastic surgery. We're in trouble as a nation because we've taken our eye off the ball.”
The failure to distinguish between cosmetic procedures for medically elective and medically necessary reasons aside, the tax is still a terrible idea. Perhaps even more troubling, a tax on cosmetic procedures would be heavily borne by women. Indeed, 86 percent of cosmetic surgery patients are female. Contrary to popular opinion, this tax would not fall on the wealthy. About 70 percent of these patients earn less than $60,000 a year. Cosmetic surgeon Stephen Greenberg notes, “The misconception about people having cosmetic-surgery procedures is that they're wealthy. But it's . . . the average person who wants to feel better about themselves.”
Another significant shortcoming of this proposal is the belief that a tax will produce the revenues anticipated. It is important to recognize that New Jersey is the only state that taxes cosmetic surgeries and that tax has produced nearly 60 percent less revenues than originally projected. If New Jersey’s experience is any indication, the government will wind up investing more money for each dollar collected.
So does this tax discriminate against women? You make the call.
While Kohl's ban is unlikely now, supporters will continue to push for the measure in other ways, the senator's staff member said. "We hope it happens at some point."
I don’t agree.
While physician-prescribing data shouldn't be available for marketing purposes, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."
The AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered legislation on either the state or federal level now or in the future.
Bouquets to Senator Bob Menendez (D. NJ) who had the following to say about legalizing drug importation, “Health-care reform and lowering costs does not mean we should roll the dice with the health and safety of the American people.”
And Brickbats to Senator Byron Dorgan (D, ND), who said he will object to any amendments to the Senates healthcare reform bill until objections are lifted to a vote on his importation proposal.
“I fully expect to get a vote and I expect we will win,” Dorgan said.
But at what cost to drug safety and the public health?
According to the FDA -- in a December 8th letter to Senator Sam Brownback (R, KS) -- the Dorgan scheme doesn’t address “significant safety issues related to confusion in distribution and labeling” of foreign and domestic drugs.
Dorgan said the FDA letter overlooks “dramatic new safety provisions” in the legislation and said political concerns were prevailing in the decision to delay.
“There are people walking on egg shells” out of concern that the drug industry will oppose the bill, Dorgan said.
Not so. The concern is over drug safety. And appropriately so.
http://online.wsj.com/article/SB10001424052748704240504574586260904799386.html?mod=rss_Today%27s_Most_Popular
Inside-the-Beltway chatter has it that some members of the Republican caucus are getting ready to support Senator Dorgan’s drug importation amendment in the misguided belief that it will serve as a healthcare reform “poison pill.”
Not.
The theory is that if the Dorgan Organ passes, then Big Pharma will throw its weight against the legislation.
Not.
This strategy is ill-considered for a multitude of reasons. Let me mention three:
(1) Volume. Big Pharma has more immediate big fish to fry, most notably protection of the Non-Interference Clause and a future with many more Medicare-eligible seniors having their on-patent prescription medicines paid for via Part D. And filling the doughnut hole (another part of “the deal”) is a crucial part of this strategy. Immediate (and likely permanent) increases in volume trumps the many negatives of drug importation. Short sighted? Certainly. But these are public companies with patent expiry issues, reimbursement worries and questionable pipelines. Big Pharma – while against drug importation – won’t go to the mat at this stage in the process.
A vote for drug importation minus Secretarial Certification is a very big mistake – regardless of motivation.
He explains his giddiness as follows:
“…the emerging bills will deliver what most on the left would have considered a miracle a few years back. Nearly $900 billion will be spent over ten years to achieve near-universal coverage. Insurance companies will never again deny people coverage based on pre-existing conditions. New limits on out-of-pocket costs as a percent of income will mean that no American will ever go bankrupt from medical costs again. And, thanks to the Senate’s Tuesday deal, Americans aged 55 to 64 who lose coverage (and can't find affordable new coverage on their own) would be able to buy into Medicare, with help via new subsidies—an idea the left has craved since President Clinton first pushed for it in the late 1990s.”
Miller continues: “Make no mistake: these changes would bring America at long last into the community of civilized wealthy nations.”
Ah, yes, socialized medicine is upon us.
In the words of Hillary Clinton: “The sky will open, the light will come down, celestial choirs will be singing and everyone will know we should do the right thing and the world will be perfect.”
One hates to burst Mr. Miller’s bubble of euphoria, but his comments bear no resemblance to the realities of the health care situation. Government-run health systems have been unmitigated disasters around the world.
Let’s take Canada for instance, our neighbor to the north.
Why are so many Canadians coming to a country with an uncivilized medical system every year? Especially when the Canadians are light years ahead of us as a civilized wealthy nation?
Mr. Miller bemoans medical bankruptcies, all the while pretending as if people in those other civilized wealthy nations of which he speaks do not take out loans and declare bankruptcy on account of medical bills.
Newsflash: People do take out private loans, mortgage their homes, declare bankruptcy, and even pull their own teeth because government denies them medical treatment in these countries.
Senate Majority Leader Harry Reid recently cited questionable medical bankruptcy numbers on the Senate floor. But as Keith Hennessey notes, even if the numbers are accurate that’s no reason to justify a massive transformation of the existing health care system.
Ontario’s Hamilton Spectator ran a series of pieces last month detailing the problems with the health system up north.
Case in point: They tell the story of a teenager named Brandon Taylor who had to contend with the pain of a herniated disc.
The Spectator reports:
The now 22-year-old Hamilton student and his father, Stuart, were told open-back surgery at Brandon's age could be dangerous.
The wait to see a specialist who could help decide treatment was up to a year, they were told. The best the Ontario health system could offer was prescription painkillers.
In August 2007, Stuart Taylor packed up his son and agreed to pay $28,000 in Florida for minimally invasive laser microsurgery. The treatment worked for Brandon, now a fourth-year engineering student at McMaster University.
Brandon’s father remortgaged his house to pay for the $28,000 surgery.
Get this, though – the use of lasers is considered “experimental” in Ontario.
We’re talking about procedures that are relatively routine here in the United States, but out of reach for so many Canadians.
So after the drama of this whole episode, what is the Taylor family doing now?
They are trying to secure reimbursement for the out-of-pocket expenses.
As this article explains, not only do these Canadians have to spend money out pocket to come to the United States for quality medical care, but they have to jump through bureaucratic hoops in a mostly vain attempt to get expenses reimbursed. Some people can afford an attorney to represent them, but many cannot.
Brandon’s father believes the process is an uphill battle that is draining his family emotionally and physically and will end only in loss of their case. He said, "Mentally, I'd love to abandon it because it's dragging me down ... but I can't imagine (doing that) now after all this work."
This is the sort of civilized health care system you can look forward to in Matt Miller’s brave new world.
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.
