Latest Drugwonks' Blog

Smart thinking from Bob Goldberg, CMPI’s new Vice President for Strategic Initiatives …

Meet the challenge
By Robert Goldberg
Published February 21, 2006
The Washington Times

Democrats are gearing up to make health savings accounts and Medicare battering rams against the Republican Party in in the midterm Congressional elections. Liberal think tanks and congressional Democrats first attacked the Medicare drug benefit as a “a complex program that does nothing to bring down the costs of soaring drug costs.” Now, they are trashing health savings accounts as a tax shelter for the rich without offering an alternative of their own.

They don’t have to. The Bush administration and congressional Republicans have done a poor job responding to criticisms of the Medicare drug benefit and HSAs. Conservatives and think tanks have largely stood on the sidelines as the beating has taken place. Many think they are standing on principle, but in fact it reflects a lack of vision on their part.

The fact is, most conservative think tanks and conservatives frame Medicare and health insurance in terms of reducing health-care costs. As a result, they cede the moral high ground on the health-care issue that is all about coverage and quality of care. Similarly, as I have argued before, conservative griping about the cost of the Medicare drug benefit has blinded Republicans to the fact that Medicare modernization is counterweight to single payer health care.

Liberals complain that even if HSAs become the norm, they won’t slow health-care costs because 80 percent of all health-care spending is incurred after the high deductible ($2,100) is met and would still be generated by consumers using insurers’ money instead of HSAs. That’s true. Then again, the same thing is even more true about single-payer systems or managed care plans where the out-of-pocket cost are nearly hidden.

In either case, it’s the 20 percent of people with chronic illness that generates 80 percent of the cost. Medical progress, not administrative machinations, will reduce the cost of disease.

Conservatives are doomed to lose the HSA debate because they regard them largely as cost cutting tools. To the extent that anxiety about health care coverage is at the heart of uneasiness about a vibrant economy, it behooves the Republican Party to retool their health-care message in general and their HSAs policy in particular.

Republicans must commit to expanding and protecting medical insurance for all Americans. HSAs should be hailed as one way for achieving that goal. Last year, people with incomes of $35,000 or less per year were the fastest growing segment of HSA-eligible health insurance plan purchasers. Sales to this segment grew 104 percent over 2004. MIT economist Jonathan Gruber estimates that more than 1 million working class people will lose their insurance as a result of HSAs being offered. He doesn’t explain why. Maybe the 1.5 million lower-and middle-income people, who were previously without insurance were too stupid to follow an MIT economist’s theory. They actually obtained obtain insurance that included well baby visits, prescription drugs, ob-gyn care and other medical care for about $125 a month, less than what they paid last year.

To continue to boost and maintain insurance coverage among low and middle income Americans, the Republicans should introduce legislation that allows employers to put the full amount of the deductible into HSAs in order to eliminate any out of pocket cost. Working-class and poor families should receive pre-funded debit cards for HSAs with the full deductible amount as well.

The Department of Health and Human Services could help people comparison shop by posting Medicare prices for every single service. It could work with WebMd and other private health-information services to share news about who is doing a good job delivering medical care. Further, since most people rarely spend more than a small percentage of their account, the legislation should allow unused funds — as well as any additional monies contributed by the individual to be used tax free to pay for health care premiums during periods of unemployment as well as any deductibles or co-pays.

Third, HSAs must be compared to liberal efforts to prop up a single-payer and an employer-based health system that is providing less coverage for more money each year. Liberals are responsible for the loss of health care coverage in America. Now they shriek that HSAs would leave less money for subsidizing the increasingly expensive health insurance demands of labor unions, demands that send jobs overseas. Meanwhile, HSAs are giving more working class people more coverage they can keep and call their own for less money.

HSAs are not for everybody or a panacea. They’re only part of a long-term effort to expanding access to health insurance. But if Republicans frame the HSA debate in terms of coverage, they can stop playing defense on health care. First, they have to get passionate about the value of medicine and not what it costs.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest.

According to an article in today’s edition of The New York Times, psychiatrists say they have been getting panicked phone calls from patients worried by an FDA advisory panel’s recommendation this month that drugs for attention-deficit disorder carry a prominent warning about heart risks.

Can you say “unintended consequences?”

The calls are coming not just from parents of children who take the drugs but from adult users, who the panel warned might be at the highest risk for heart problems.

Can you say, “irresponsible advisory committee causing increased non-compliance?”

“Every single adult patient I saw today, the first thing out of their mouth was, ‘Am I going to drop dead on this?’ Every single one of them,” said Dr. Timothy Wilens, a psychiatrist at Massachusetts General Hospital in Boston.

Can you say “fear replacing caution?”

Can you say “Precautionary Principle?”

Because if you can’t say it, you can’t fight against it.

And fight against it we must.

WHO's Next?

  • 02.20.2006

The just completed WHO meeting on counterfeit prescription medicines is over. And what took place in Rome should have a chilling effect on us all.

Consider these few facts (direct from WHO, so nobody can say they’re “industry” numbers) —

Between 1998 and 2004 there has been a 1000% increase in seizures of counterfeit prescription drugs

That is not a typo. A 1000% increase.

Between 2001 and 2004 there were 170 official cases of counterfeit medicines originating from an illegitimate supply chain

And most frightening …

Between 2001 and 2004 there were 27 official cases of counterfeit medicines that originated from the legitimate supply chain.

Sound frightening? It is.

Action is required.

While some in the US still don’t believe that counterfeit prescription drugs are a real problem (“Show me the dead Canadians!”) Europe is taking it dead serious.

On Wednesday, the Center for Medicines in the Public Interest (home to this blog) and the Brussels-based Centre for the New Europe co-sponsored a conference titled, “A False Sense of Security — The Growing Threat of Counterfeit Prescription Products.”

Shortly I will post all of the presentations from that event. A book will follow.

The next day (last Thursday) the World Health Organisation and the international pharmaceutical industry launched a global taskforce aimed at stemming “the growing epidemic” of counterfeit drugs that has become a magnet for organized crime.

Here’s what the Financial Times wrote on the subject …

On some estimates, fake drugs account for more than 10 per cent of the medicines market worldwide, worth nearly 40bn US dollars (34bn euros, 23bn pounds) a year. But in developing countries that proportion is more like 25 per cent and in some countries it may be as high as 50 per cent.

Howard Zucker, WHO’s top official on pharmaceuticals, said: “People donç©° die from carrying a fake handbag or wearing a fake t-shirt. They can die from taking a counterfeit medicine.”

The taskforce will focus on strengthening national laws and enforcement, raising awareness by consumers and health professionals, improving international co-operation and developing “innovative technology solutions” including electronic tagging to track fakes.

However, WHO is no longer pressing for work to start on an international treaty to tackle counterfeit medicines, which critics feared could simply serve as an excuse for delay and inaction.

“Clearly what’s needed here is action and we don’t need a convention to take some action,” said Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which is co-sponsoring the Rome conference.

The Centre for Medicines in the Public Interest has predicted that counterfeit drug sales could nearly double to $75bn by 2010. While the problem is worst in poor countries with weak regulation and enforcement, where counterfeiters fake medicines for life-threatening diseases such as malaria, tuberculosis and Aids, much of the growth is fuelled by internet sales into western markets.Counterfeiters are now focusing not just on “lifestyle” drugs such as hormones and remedies for erectile dysfunction, but also expensive treatments for cancer and drugs in high demand, most recently the anti-viral Tamiflu.

The absence of criminal laws against counterfeiting in many countries has encouraged organised crime rings to enter the business.

“Organised crime is gravitating towards the industry because the risks are a lot less than forging currencies or trafficking heroin,” said Mr Bale. “You can make a fortune, at no risk.”

Dr Zucker said: “International police action against the factories and distribution networks should be as uncompromising as that applied to the pursuit of narcotic smuggling.”

WHO said it planned to extend to more regions a web-based system for tracking the activities of drug counterfeiters it set up last year to link national health authorities and other agencies in the western
Pacific.

As I arrived back in the US my mobile phone rang. It was a radio station in South Korea wanting to interview me on the fact that North Korea is now in the business of counterfeiting prescription drugs for profit. The world is paying attention. So must we.

It’s time for US regulators to join this working group and address the problem from a truly transatlantic perspective.

The lives we save may be our own.

Rep. Gil Gutknecht (R-Minn) and Rep. Rahm Emanuel (D-Ill.), the dumb and dumber of Congressional voices calling for drug importation, demanded an explanation on Wednesday for increased government seizures of drugs mailed to U.S. customers by Canadian pharmacies.

They don’t want an explanation — because they know the answer — uninspected, unregulated foreign drugs are unsafe and illegal. This is a recording.

“We believe this unannounced policy of increased enforcement is irresponsible,” the two said in a letter to the Food and Drug Administration and to U.S. Customs and Border Protection.

“There is a growing chorus of outraged Americans concerned that access to affordable prescription drugs is being denied to them,” reads the letter.

It is a chorus of two backed up by a supportive media echo chamber. But the music is out of tune and increasingly out of touch.

Here’s what these two elected representatives of the people are complaining about — recently 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, according to FDA investigators, 85 percent of them were from 27 other countries such as China, Iran, and Ecuador. And 30 of the drugs were counterfeit.

Why did FDA do what they did? Because it’s their job and it’s the right thing to do.

This is a recording. If you are looking for media attention, please leave your name and congressional district at the sound of the beep.

Bob Goldberg on the price-tag for survival …

It is both remarkable and tragic that at a time when we are finally winning the war against cancer, actually reducing the numbers of deaths due to that dreaded disease, the New York Times is editorializing against the value and use of the very medicines that have made such advances possible. Do we really need enemy combatants against medical progress?

The NYT claimed recently that Avastin at a retail price of $8000 for a month of treatment is too expensive for an average of 6 months of more life, without pain or toxic side effects for cancer patients that have not responded to other forms of cancer care. Here’s how I would have put the question: Is it worth having your insurance company pay about $5000 to keep you alive for 6 months or longer? What’s it worth to have drugs like Avastin around to keep tens of thousands of cancer patients alive longer and longer so they can live free of caregivers, can go to work, parent their kids, etc? The Times never asks that question.

Similarly, medical journals are now abandoning real science and are simply becoming collections of editorials by Monday morning quarterbacks. Most recent is the assault on the right of multiple sclerosis patients to use Tysabri to treat the devastating relapses associated with the disease. The British Medical Journal published “Lessons for Clinical Trials from Natalizumab in Multiple Sclerosis” by Abhlijt Chaudhuri, a physician known for believing that no drug for MS should be used without any rebuttal.

Unfortunately, his “lesson” seems to “grin and bear it.” Not acceptable.

The term ‘relapse’ sounds innocuous. It means losing balance, one’s sense of taste, eyesight, memory, etc. without warning. It can make walking impossible. The attack on Tysabri is simply an old saw applied to a new drug: since the drug doesn’t actually stop MS from progressing the possible long term safety problems aren’t worth the risk of returning to market. The article spews the same accusations made of every drug that is experimental: we don’t know what the optimal dose should be and how long people should take it. The fact that only clinical experience can help answer that question is ignored in favor of a standard of evidence that, if applied to the early release of penicillin, the measles vaccine, HIV drugs, and other breakthroughs, would have cost millions of lives.

That is like saying that since some drugs don’t cure a disease, don’t make them available at all. Again, the value of these medicines to people and their ability to give them back lives of productivity, dignity and independence means nothing.

On 2/4, blogging on a report that there was a backlog of generic drug applications at the FDA, I suggested that the agency seriously consider user-fees for this important area of responsibility. And it looks like that’s going to happen.

Scott Gottlieb, the FDA’s feisty and forward-looking deputy commissioner for medical and scientific affairs plans to tell the generic drug industry today that it is time for the government to charge its member companies fees so the agency can hire more staff and exprdite the processing of applications to market new generic medications.

In a speech he is scheduled to deliver to the Generic Pharmaceuticals Association in Florida, Gottlieb plans to say that user fees — like those paid by the makers of brand-name drugs, medical devices and animal drugs — are needed to keep up with generic reviews.

“From our perspective at FDA, we have seen user fee programs applied to our medical device and new drug programs with great success,” a copy of his speech says.

Gottlieb is scheduled to say in his speech that raising funds from generic-drug companies would allow the agency to review applications faster, to have more scientific data analyzing whether proposed new generics are equivalent to established brand-name drugs, and to address potential safety issues once the drugs are on the market.

Per Scott, “It’s not fair to compare our work in our generic drug office to our work in the new drug office, as some have done, without acknowledging that our new drugs program has benefited from funding tools that are not available to us when it comes to generic drugs.”

Use of generic drugs — which must be equivalent to the branded products that they duplicate — has been growing steadily, with more than 53 percent of prescriptions now filled with generics. That percentage could increase
quickly because an unprecedented number of major branded drugs will lose their patent protection in the next few years.

In addition to raising the user-fee issue, Gottlieb is set to outline a number of agency initiatives to speed generic reviews. One is a formal lifting of a ban on direct telephone conversations between FDA reviewers and generic drug makers. Another involves grouping bioequivalence review applications for the same or similar drugs.

You tell em Scott.

Talk about being a Nabob of Negativism! Families USA (the political lobbying group that masquerades as a “citizens advocate”) is downright gleeful in it’s grossly premature burial of Medicare Part D. According to its new report (a love note to the Intelligensia of Interference issued on Valentine’s Day) the Bush Administration has “significantly lowered” its enrollment projections for the new drug benefit.

Really? I don’t recall anyone from the White House saying that? Maybe Ron Pollack, the Families USA “Godfather,” meant White Castle? And I certainly didn’t hear Mark McClellan say anything remotely like that during his recent, highly publicized congressional testimony. And I didn’t read it in a Robert Pear column. So could it really be true?

No. I think that the Godfather must be hearing voices — and that those voices are “interfering” with his cognitive processes.

Giving a new and draconian meaning to “family-friendly,” Godfather Ron also concludes that a vast majority of those enrolled in Part D already had drug coverage before the benefit began and that only “a very small fraction” of beneficiaries eligible for the low-income subsidy have entered the program.

Methinks that the Godfather would like the truth to sleep with the fishes. This new report is just another example of reality non-interference.

I suppose that Families USA expected 100% sign-ups with zero problems after almost a month and a half! Can’t this administration do anything right!

Proving that they are most decidedly living in a Pelosi-induced fantasyland, Godfather Ron commented, “It’s truly disappointing to see such a large number of seniors not get the benefits to which they are entitled.” He further added that the drug benefit has so far “produced rather meager results.”

I guess he thinks that if he keeps saying that enough times people may actually start believing him.

CMS spokesman Gary Karr politely suggested that Families USA spend its time and energies more productively by helping to expand the number of seniors enrolled in Part D instead of taking “ill-informed partisan potshots.”

Good for you Gary.

Karr then said that CMS has not downgraded their enrollment estimates. “The numbers that [Families USA] cite come directly from us. We’ve been open and above board about exactly what those numbers are and where we get our estimate of the 28-to-30 million.” Families USA, citing a January 28, 2005 CMS Federal Register notice, said that the administration had been projecting that 39 million beneficiarieswould enroll.

But it’s the Godfather of Garbage and his “Family” who are doing the projecting. For them it’s all about political spin and vituperative spittle. Anything for the cause.

Well, isn’t this wonderful? The Wall Street Journal reports today that “… the G-8 nations [propose] to subsidize the purchase of new vaccines—-for between $800 million and $6 billion—-if pharmaceuticals companies develop ones that meet standards of efficacy and safety. Once the G-8 spends the pledged amount, the drug companies would sell the vaccine at a set discount in the developing world.”

So: Having damaged the vaccine sector seriously with a combination of price controls, regulatory hurdles, and absurd tort liabilities, the bureaucrats and politicians now propose to undo the damage using taxpayer resources, all the while, of course, congratulating themselves for their compassion. Well, how is it that the private sector ever produced vaccines at all? To say the same thing differently, we now are reaping the fruits of decades of destructive policies; now taxpayers will have to assume investment risks that the private sector is in a far better position to evaluate and bear. Moreover, the risk allocation issue is only the beginning; which vaccines will receive favor? The ones that offer the biggest health bang for the buck? Or the ones that are most favored among the politically corrrect? And will “profits,” however defined, be limited while losses are not? Will the various governments attempt to use profits from other investments implicitly to subsidize these favored vaccines? Etc. Just asking.

A recent inspection by the U.S. Food and Drug Administration found some of the drugs Minnesotans order from Canada may not be from the country at all.

Wallace Greenfield discovered 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,” Greenfield said.

The U.S. government says it happens all the time and is a growing concern.

“We were beginning to see a pattern of products coming that were purporting to be of Canadian origin coming from various countries from throughout the world,” said Steve Niedelman of the FDA. “We wanted to determine how widespread this was.”

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,” Niedelman said.

“We saw product coming through from Germany, from Australia, from China, from Iran, from Ecuador,” Niedelman said.

The FDA said 30 drugs were counterfeit.

The Minnesota Senior Federation says 25 prescription orders from Minnesota were among those that were confiscated in recent months.

According to Tom Sheck of Minnesota Public Radio (a media never accused of slanting to the right), “When Gov. Pawlenty announced the MinnesotaRXConnect program two years ago, he predicted that it could cover 700,000 Minnesotans and save millions of dollars for consumers. The actual numbers are well short of those projections, and demand for the program has been declining sharply in recent months.”

It’s time for Governor Pawlenty to relenty and stop his unlawful, unsafe and (fortunately) seldomly used state-sponsored program.

Because today it’s just folly, but it could very well turn into state-sponsored health care terrorism.

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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