Health Care Savings in Our Time

08/27/2007 09:14 AM |

Info via the Pink Sheet (in plain text) with comments (in bold) courtesy of drugwonks.com.

German Health Reform Law Could Shake Up Pharmaceutical Market

Drug companies in the United States and Europe are warily watching a new law in Germany that could change the competitive landscape.

Sure it'll hit their pocketbooks -- but the folks who will really get screwed are patients and physicians.

The legislation - The Act for the Enhancement of Competition in Statutory Health Insurance - includes several provisions aimed at reducing drug costs. Most significantly, the measure requires that cost-benefit analyses be performed on certain drugs, the results of which will be used to set reimbursement ceilings. Drug companies are mainly worried about how these analyses will be conducted.

Worried, but not wondering, because the studies that will be used are the studies that are already being used -- RCTs that were neither designed nor intended to be used for comparative effectiveness purposes.

Other provisions also could change the market. The law, which came into effect in April, requires consumers to obtain a second opinion from a physician to receive prescriptions for drugs that are expensive or have significant risks, and it allows health insurance funds to set up biddings between drug manufacturers with the aim of establishing rebate contracts.

Does this mean a second opinion from the first doc, or does the patient have to seek out and consult with an additional physician? If the former, where's the hammer, if the latter, it's just the latest move to disempower physicians from the appropriate practice of medicine as they see fit.

The GBA (or Joint Federal Committee of Physicians, Dentists, Hospitals and Health Insurance Funds) is responsible for determining which drugs will be subject to reimbursement. Since 2004, it has directed the Institute for Quality and Economy in the Health Care System (IQWiG) to conduct drug benefit analyses. Under the new law, it now will ask the institute to perform cost-benefit analyses for certain drugs. If the IQWiG finds there is an advantage for patients to use a drug, the GBA will allow its reimbursement.

But "advantage" is in the eye of the government, aka "the payor." So, just whose "advantage" do you think takes precedence?

"The idea is to ban all drugs from reimbursement which are more expensive than others but do not have a therapeutic advance," said Ralf-Thomas Hillebrand, a spokesperson for the German Association of Research-Based Pharmaceutical Companies (VFA).

How do you say "incremental innovation" in German?

Drugs that are therapeutically superior to other medicines are not subject to reference pricing.

I'm sure that looks terrific on paper -- as did Mr. Chamberlain's infamous "piece of paper" -- but what percent of medicines do you think are subject to reference pricing in Germany? This is nothing more than health care appeasement -- "health care savings in our time."

The legislation is the latest in a string of German reforms intended to rein in drug costs and bolster the country's public statutory health insurance system - the SHI - which covers about 90 percent of the population. The system is funded through wage deductions.

You mean it's not ... free?  Read More & Comment...

in PDUFA veritas

08/27/2007 08:35 AM |

Drug Industry Daily
Aug. 27, 2007 | Vol. 6 No. 168

PDUFA Provisions Could Harm FDA and Industry, Expert Say

Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,” he added.

The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,” he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.”

The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,” Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).

However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).

“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,” Pitts said. He added that $50,000 is an arbitrary limit.

Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,” Pitts said.

Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.

However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,” he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.

Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.” — Emily Ethridge  Read More & Comment...

Castro Dead?

08/24/2007 03:35 PM |

Rumors are flying.

If true, what will this mean for Michael Moore's favorite health care system?  Read More & Comment...

Stroke of Genius: Britain Health System Finds Another Way to Spend More Money On Worse Care

08/24/2007 10:02 AM |

From the London Times...

From The TimesAugust 24, 2007



Britain the worst for deaths from strokes

Nigel Hawkes, Health Editor

"Patients who suffer strokes receive worse treatment in Britain than anywhere else in Western Europe .

More die and more are left disabled, a leading expert says in this week’s British Medical Journal, even though Britain spends as much as, if not more than, other countries on stroke care. "

On the bright side...the NHS has reduced waiting times for access to explosive belts down to zero.

Meanwhile liberals -- mostly in the form of The New Republic's Jonathan Cohn -- are wandering the globe in search of a health care system better than ours. They first went to Canada, then the VA, then the UK, then France, only to find or omitting real problems. Leave it to the Commonwealth Fund to remain steadfast in supporting the idea of shoving everyone into Medicaid or Medicare.

And as we speak the SCHIP proposal is tanking because -- strangely -- the idea of stealing Medicare money from poor seniors to pay for Medicaid for rich kids is not flying.

I can't wait for the health care debate in 2008.  Read More & Comment...

Wuthering Cites

08/24/2007 07:51 AM |

Yesterday I had the privilege to attend and participate in the third annual FDA Regulatory & Compliance Symposium held at Harvard University. (Or as we Martlets call it, "The McGill University of the South.)

My panel focused on federal preemption and DTC advertising issues. The title of my presentation was "FDA: Advancing the Public Health or Being Led by Political Whims." Needless to say, it was hard to limit my remarks to the requisite 45 minutes.

Two of the other panelists were Alex Sugerman-Brozan (of the Prescription Access Litigation Project) and Lauren Guth Barnes of the law firm Hagens Berman Sobol Shapiro. Perhaps the most polite way to put it is that we didn't agree on most issues.

And that's okay. A feisty, robust -- and respectful debate is always worthwhile. And this panel was certainly all of those things.

Of the many differences, I'm sure you can fill in the blanks vis-à-vis our divergent views on both federal preemption and DTC issues. But what I found most disturbing was that both Alex and Lauren relied, almost exclusively, on partial research data, one-sided anecdotes, and rather selective legal citations.

Their presentations were as one-sided as they were narrow and they lacked any perspective as to the unintended consequences of (what I viewed as) simplistic alternatives. They spoke of solutions driven by adjudication and legislation -- with nary a nod to science.

(Although we did find some common ground on the need for better and more disease awareness advertising and the banishment of reminder ads.)

But (and here's the good news) while their ideas are wrong -- their hearts are in the right place. I really believe that. I hope that, with more conversation (both face-to-face and otherwise) we can all work to help advance the public health through a strong and better funded FDA.  Read More & Comment...

FDA Preemption? Don't touch that dial!

08/23/2007 06:28 AM |

In Win for Drug Manufacturers, 3rd Circuit Rules Only FDA Can Regulate Ads

Shannon P. Duffy
The Legal Intelligencer

In a big win for drug manufacturers, the 3rd U.S. Circuit Court of Appeals has ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.

"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.

But a dissenting judge complained that such "implied conflict pre-emption" of state law was unwarranted and wrong since the FDA doesn't have the power to require preapproval of pharmaceutical advertisements and lacks the resources to police the ads that run after drugs are approved.

Senior U.S. Circuit Judge Robert E. Cowen said he would have revived the suit because the claims it alleges don't challenge any of the drug maker's claims before the FDA during its labeling process, and therefore posed no conflict with the FDA's mission.

"Given that there are limitations to the FDA's oversight over prescription drug advertisements -- both congressionally imposed limitations, such as the lack of authority to require preapproval, and practical limitations attendant to the sheer volume of drug advertisements in the media, the supplementation of state-law remedies would seem to aid the FDCA's objectives and purposes, not frustrate them," Cowen wrote.

The ruling upholds the dismissal of a proposed class action suit accusing Zeneca of misleading consumers and doctors by advertising the acid reflux drug Nexium as an improvement over Prilosec because it knew that the patent for Prilosec was about to expire and a generic version would soon be hitting the market.

The suit, filed in U.S. District Court in Delaware, alleged claims under the Delaware Consumer Fraud Act as well as the consumer protection statutes of the 50 states for false, misleading and deceptive advertising. It also alleged claims for unjust enrichment and negligent misrepresentation.

Nexium and Prilosec are both proton-pump inhibitors -- drugs that treat gastroesophageal reflux disease, or GERD, and erosive esophagitis, conditions that are commonly known as acid reflux disease and frequent heartburn.

Prilosec was an especially profitable drug for Zeneca, with sales of more than $6 billion in 2000. But the patent for Prilosec was due to expire in 2001, at which point it would be available for sale as the generic drug omeprazole.

In February 2001, Zeneca obtained final approval from the FDA for its labeling on Nexium, the brand name for esomeprazole magnesium.

A clinical study of Nexium compared both 20 mg and 40 mg doses of Nexium with the approved 20 mg dose of Prilosec and showed that 40 mg of Nexium had a statistically significant healing rate over 20 mg of Prilosec.

But the suit alleged that the higher dose of Nexium was not needed for most patients, and that Zeneca's ad campaign was therefore misleading because a fair comparison of 20 mg of Nexium with 20 mg of Prilosec would not have proven Nexium to be superior.

The suit also alleged that Zeneca initially sold Nexium at a price below Prilosec in order to establish brand loyalty, but "then raised the price of Nexium while the price of Prilosec dropped." Nexium now sells for more than $4 per pill versus about 67 cents for Prilosec, the suit alleged.

But U.S. District Judge Sue L. Robinson dismissed the suit, finding that since the Nexium advertisements complied with the FDA-approved labeling, they were not actionable under the state consumer protection laws.

Robinson concluded that the suit was pre-empted because the state law claims conflicted with federal law.

On appeal, plaintiffs lawyers argued that Robinson's application of federal pre-emption was incorrect because there is no irreconcilable conflict between the state consumer fraud laws and the federal Food, Drug and Cosmetic Act. The FDA's approval of Nexium's labeling, they argued, did not extend to an assertion of Nexium's superiority over Prilosec.

Smith disagreed, finding that Robinson's analysis was correct because the FDCA and its implementing regulations include extensive rules governing pharmaceutical advertising. "The degree of discretion inherent in the regulations demonstrates that the FDA envisioned itself occupying an ongoing and extensive role in the supervision of prescription drug advertising,"

Smith wrote in an opinion joined by visiting 6th Circuit Judge Eugene E. Siler. In the claims against Zeneca under state consumer fraud laws, Smith said, the FDCA is not a "critical element" because the plaintiffs wouldn't have to show noncompliance with the FDCA to prevail.

Nonetheless, Smith said, "allowing these claims to proceed would unnecessarily frustrate the FDCA's purpose and FDA regulations, as the extent of agency involvement in regulating prescription drug advertising is extensive and specific."

Implied conflict pre-emption of the state consumer fraud laws was therefore required, Smith said, because both the FDCA and FDA regulations provide specific requirements for prescription drug advertising.

"The high level of specificity in federal law and regulations with respect to prescription drug advertising is irreconcilable with general state laws that purport to govern all types of advertising," Smith wrote.

In dissent, Cowen complained that his colleagues were ignoring the teachings of U.S. Supreme Court decisions that cautioned against "seeking out conflicts between state and federal regulation where none clearly exists."

Cowen said courts must "start with the assumption that the historic police powers of the states were not to be superseded by [a] federal act unless that was the clear and manifest purpose of Congress."

Although the FDA has exclusive power to approve the sale and labeling of drugs, Cowen argued that the agency does not have the exclusive power to regulate drug advertising. "This is not an area of the law inherently requiring national uniformity and ousting all related state law," Cowen wrote.

In the suit against Zeneca, Cowen said, the plaintiffs are complaining that ads for Nexium contained a false and misleading drug comparison -- an issue that was never addressed by the FDA in its approval of Nexium's labeling.

"As a result, there is no risk that a successful state-law claim, alleging that Nexium advertisements contain false and misleading drug comparisons, would conflict with the FDA's approval of the statements in the Nexium labeling," Cowen wrote.

Lead plaintiffs attorney Craig R. Spiegel of Hagens Berman Sobol Shapiro in Seattle could not be reached for comment.

Zeneca was represented in the appeal by Mark E. Haddad of the Los Angeles office of Sidley Austin, along with Jack B. Blumenfeld, Rudolph J. Scaggs Jr. and Lisa K. Whittaker of Morris Nichols Arsht & Tunnell in Wilmington, Del.  Read More & Comment...

Direct to Consumer Ad Nausea

08/22/2007 12:32 PM |

What a great use of FDA user fees:

"Federal regulators plan to study whether relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks.

The announcement, posted Tuesday to the Food and Drug Administration's Web site, comes a week after a study published in the New England Journal of Medicine suggested the agency's drug-ad enforcement has steadily declined.

The FDA says it plans to study how 2,000 people react to television drug ads to determine whether they have an overwhelmingly positive impression of products despite audio warnings about potential side effects."

Matt Perrone of the AP zeroes in on my favorites...the Cialis ad which "features a middle-aged couple returning from a shopping trip while smooth jazz plays in the background. Toward the ad's end, a male voice lists common side effects, including headache, back pain and muscle aches." Note that the FDA put the kibosh on a female voice in ED drug ads...The agency found a female voice too....stimulating.

Leave it to the longest running joke in the so-called consumer movement, Sid Wolfe, to come up with what he thinks is a serious proposal but could be a great idea for a late night comedy sketch:


"If advertisers were really interested in getting information about drug risks out, they'd show pictures of those problems, but you almost never see that," said Dr. Sidney Wolfe of the advocacy group Public Citizen, which frequently criticizes drug industry marketing.

Yeah, I could see that. A couple in a hot tub about to engage in Clinton-like behavior only to have Sid Wolfe pop up from underneath the steamy H20 to begin reciting all the side effects.

Sid Wolfe in a hot tub droning on about drug safety. Now that's a good use of FDA user fees.

http://www.businessweek.com/ap/financialnews/D8R5I8900.htm  Read More & Comment...

Not Specifically

08/22/2007 07:31 AM |

I am a big believer in FDA-approved generic drugs. They are safe and effective and represent an enormous opportunity for health care savings -- and I applaud insurance company programs that seek to educate consumers about them. But I am a big opponent of forced switching. Disempowering physicians and patients results in bad outcomes.

I am a big believer in getting the right medicine to the right patient in the right dose at the right time. But I am a big opponent of the Me-Tooistas, who think that all drugs within the same therapeutic category are, more-or-less, the same.

I believe in honesty and ethical behavior, and I have strong feelings when it comes to the topic of insurance companies not being transparent about providing financial incentives to physicians in order to influence their prescribing habits -- while misleading patients along the way.

Sometimes the best of intentions have serious unintended consequences.

Consider the Blue Care Network of Michigan (BCN). A program (now discontinued) sent letters out to their participating primary care physicians offering a $100 payment “for each member in their panel with a BCN pharmacy benefit who fills a prescription for a generic lipid lowering agent.”

Translation: We will pay you $100 for switching your patients to a generic statin.

According to a recent ABC investigative report, “Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.”

Translation Update: We will pay you $100 to switch your patient to a generic statin that isn't even a generic version of what they are currently taking.

When asked by the ABC reporter if patients knew their doctors were receiving payments from the insurance company in return for a service that helps to increase the profits of the insurance company, the response from BCN was “not specifically.”

Translation: No.

What ever happened to informed consent?

Here’s what BCN wrote to their customers being prescribed Lipitor:

“Our prescription claim records indicate you may be taking Lipitor® for high cholesterol. Another lipid lowering drug, Simvastatin, works as well as Lipitor® but is available as a generic and costs a lot less.”

Please note – the preceding paragraph is a verbatim quote from the BCN letter.

A few comments:

* As to “ … as well as …”, imagine if a pharmaceutical company tried to pull that one? They’d be hit by a DDMAC truck as fast as you can say, well, DDMAC.

Talk about an unlevel playing field.

* Seems to me (maybe it’s just me) that somebody's trying to make it sound like Simvastatin is a generic version of Lipitor. “… works as well as Lipitor® but is available as a generic …” You be the judge.

“Not specifically” seems to be more than an evasive answer to a journalist's question – it appears to also be a creative viewpoint on bioequivalence -- a flawed and dangerous one. Honestly folks, how will the average consumer read and understand such verbiage? It’s also interesting to note that nowhere in the consumer letter does it mention that doctors will be spiffed for making the switch.

Imagine if a pharmaceutical company engaged in such behavior? Can you say OIG investigation? Big fine? Congressional investigation?

Lastly (and by no means least), where are the medical guidelines on the best ways to monitor a patient (particularly an already stabilized one) being switched from one statin to another (specifically, from one molecule to another)?

Maybe the $100 payment paid for some CME on that count.

Or maybe, well, “not specifically.”

Transparency please.  Read More & Comment...

Single Payer Purgatory

08/21/2007 10:13 AM |

My oped on how Arnold Relman is pleading with Canadians not to escape single payer purgatory.

http://washingtontimes.com/apps/pbcs.dll/article?AID=/20070821/EDITORIAL/108210009/1013/editorial&template=nextpage  Read More & Comment...

SICKO: The NHS War Against Cancer Patients or is it CMS?

08/21/2007 09:35 AM |

This from the AFP

Cancer Survival Rate Up in Europe

"Cancer survival has improved across Europe, with eastern European nations beginning to close the gap with western neighbours, according to a study covering the decade up to 2002, released Tuesday.

The study, published in the British journal The Lancet, showed a clear link between high rates of survival and the amount spent on health, but pointed out that Britain lagged well behind other countries with similar national health budgets.

An accompanying editorial in the influential journal called for a "fundamental reassessment" of Britain's cancer policy in light of the fact that survival rates were comparable to eastern European countries that spent two-thirds less.

"So has the cancer plan worked? The short answer is seemingly no," it concluded, suggesting that the National Health Service should be "divorced from political control and short-term political gains."

http://news.yahoo.com/s/afp/20070821/ts_afp/healthcancereurope

Oh you mean the effort to place health care budgets under the wise and experienced direction of bureaucrats seeking to bring costs under control by limiting access to drugs in the political spotlight is killing patients? The most the NHS spends the less it gets for its dollars.

As in NICE which is hailed as the gold standard of comparative effectiveness and cost effectiveness evaluation by the folks at AHIP, Commonwealth Fund, HealthDespairs, Medpac and now at CMS.

Our government -- in the form of the FDA and now at CMS -- is at war against cancer patients. It is a direct result of the policies pursued by those whose politics are shaped by unchecked hatred against the companies that make medicines. They are supported by a fawning media, by nuts on the net, and financially by trial attorneys. They are killing patients and crippling their lives. Well done.  Read More & Comment...

Now about those counterfeit condoms ...

08/20/2007 04:11 PM |

Sex is prime cause of China's HIV

By Jill McGivering
BBC News

Activists are pushing China to change the way it tackles HIV. China's state media says unsafe sex has, for the first time, become the main means of transmission of HIV/Aids, overtaking intravenous drug use.

http://news.bbc.co.uk/2hi/asia-pacific/6954859.stm

Attention must be paid.  Read More & Comment...

Capitalist Quislings at NFIB

08/17/2007 09:27 AM |

Would the National Federation of Independent Businesses support legislation that would restrict the right of it's members to decide which distributors to sell or ship products to at what price or make it a federal crime to refuse to do business with a particular company because they were re-selling your products from China into America at below market price that hurt your bottom line? That's unconstitutional, right?

Well it has by destroyed one of the pillars of capitalism by supporting the Pharmaceutical Market Access and Drug Safety Act of 2007 which contains such provisions.

Shame on the NFIB for selling out. I hope it was worth it.  Read More & Comment...

Larry Lesko: Pharmacogenomic Pioneer

08/17/2007 09:03 AM |

It's tough being the first. You are often called crazy. When the Human Genome Project was launched even David Baltimore derided it as a monumental waste of money. The researchers who claimed blood pressure was a marker for heart attacks were similarly attacked. So the chorus of "let's do the randomized studies" to validate what our genes tell us is so predictable in response to Larry Lesko's effort to push a gene testing label on a drug that I daresay the FDA has seen more safety data about than anyone who is criticizing Lesko has seen in their little lifetimes.

What I also find interesting in that the people criticizing Lesko are some of the very same people who have been writing articles in the past touting the value of genetic testing, albeit to promote THEIR research. That goes for Anne Wittkowsky of the University of Washington who has written optimistically about gene testing for warfarin in the past only to piss all over Lesko for the benefit of Anna Mathews piece. And of course insurers want all the data in the world to pay for new things but have no problem switching statins on folks without the slightest hint of evidence that doing so will improve patient care.

I know the plural of anecdotes is not evidence. But I have seen the impact of genetic testing in my family. I used both the Roche Amplichip and a battery of tests from Genomas to improve the dosing of certain drugs for my daughter and avoid the painful side effects of statin drugs. So has my mother who was on the cheapest generic statin that was causing the dizziness and muscle cramps she associated with fibromyalgia.

Lesko and Felix Frueh work largely alone to move the FDA -- and health care -- into the era of personalized medicine. It is symptomatic of the scientific community to exhibit pettiness, jealousy and hypocrisy when someone tries to move medicine into the clinic. But to my mind they should get a special award for their efforts. For now, a thank you from drugwonks will have to do.

http://online.wsj.com/article/SB118722561330199147.html  Read More & Comment...

Strip Search

08/16/2007 08:19 AM |

China Counterfeit Diabetes Tests Tracked by J&J

By Allan Dodds Frank and Lisa Rapaport

Aug. 16 (Bloomberg) -- A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels.

Potentially dangerous copies of the OneTouch Test Strip sold by J&J's LifeScan unit surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. New Brunswick, New Jersey-based J&J, the world's largest consumer-health products maker, learned of the counterfeit tests after 15 patients complained of faulty results last September.

Tipped off by J&J, the U.S. Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. Fake medicines are a $32 billion global business, says the World Health Organization, and the FDA says it ran 54 counterfeit investigations in 2006, almost double the year before.

"Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease,'' says Peter Pitts, director of the Center for Medicine in the Public Interest in New York and formerly an FDA official investigating knockoff drugs.

The court filings disclose, for the first time, that China is the source of about one million phony test strips that have turned up in at least 35 states and in Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia, and Turkey.

`China, Through Canada'

``The source was from China, through Canada, to the United States,'' says Steven Gutman, director of the Office of In Vitro Diagnostic Devices and Evaluation at the FDA in Rockville, Maryland. ``As far as we can tell, the counterfeiter has been put out of business in the U.S.''

KEY PHRASE: “As far as we can tell …”

TRANSLATION: Nobody has been caught and they are still very likely in business.

Here’s a link to the rest of the story:

http://www.bloomberg.com/apps/news?pid=20601103&sid=a5XA7.yplw9k&refer=news

Kudos to J&J for aggressively investigating and openly communicating -- and being loud and proud about the quality of the real product.  Read More & Comment...

Would you like some beef with that whine?

08/15/2007 08:50 PM |

Where oh where would some people be if they didn't have the trial bar and the NEJM to give them a platform.

http://content.nejm.org/cgi/content/full/357/7/633?query=TOC  Read More & Comment...

Innovation vs. Importation. Pick One.

08/15/2007 04:49 PM |

And while we're on the topic, check out the new paper "Importation and Innovation," by Columbia University's Dr. Frank Lichtenberg. You can find the paper at this link ...

http://www.nber.org/papers/w12539

For those of you (yes, you Senator Dorgan and Senator Snowe and you Representative Emerson and Representative Emanuel) who think that drug importation is a good idea -- think again.

Think about the unintended consequences of a world without pharmaceutical innovation.  Read More & Comment...

Small Business. Small Minds.

08/15/2007 08:06 AM |

The National Federation of Independent Business (NFIB) has announced its support for the Pharmaceutical Market Access and Drug Safety Act (S. 242 / H.R. 380) to permit drug importation.

According to the NFIB, "Importation offers a means of reducing one of the most rapidly rising healthcare costs facing consumers today - spending on prescription drugs.”

Well, actually, the biggest costs to small business – and large business for that matter – are an aging workforce, an antiquated focus on acute care, and insurance premiums. For every dollar spent on health care in the U.S., only 11.5 cents is for prescription drugs. And medicines, properly prescribed, reduce healthcare costs by keeping people healthy, productive – and out of the hospital.

Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48. What about the other $82.14? That’s a good question. And America deserves an answer.

The NFIB is thinking short term and being sold a false bill of goods. Here’s how …

"Today's NFIB endorsement reflects a clear consensus among America's small businesses that we must no longer pay the world's highest prices for prescription drugs," Senator Olympia Snowe (R-ME) said. The press release continues, stating that NFIB members “recognize overwhelmingly … that competition will help reduce drug costs and make health care more affordable for all Americans.”

Well, that’s a good point. But it depends what you mean by competition. When the rest of the developed world shackles costs via price controls placing almost the entire burden of pharmaceutical R&D costs on the backs of the American healthcare consumer. This is what members of Congress and the NFIB should be up in arms about.

And as far as “dramatically lowering” costs is concerned, the Congressional Budget Office Study has reported that such a program would reduce the drug spend in the US by less than one percent -- and that doesn't include the monies needed to set up an entirely new, international system for drug regulation.

Of course no such press release would be complete without a list of the usual suspects who support this bozo proposition, including the AARP, AFL-CIO, Consumer’s Union, and Families USA.

And here’s the biggest falsehood, “"The Pharmaceutical Market Access and Drug Safety Act secures a framework for the safe and legal importation of prescription drugs.”

Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few? Because that’s what S. 242 / H.R. 380 would allow since, for example, it would allow importation of drugs from the United Kingdom – which also means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere.

America’s small business owners deserve better, smarter Washington, DC representation.  Read More & Comment...

Abigail Force Winds

08/14/2007 08:42 AM |

The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.

Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.

But over-heated rhetoric generally means that each side demonizes the other and neither is listening.

Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.

But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.

The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.

In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.

The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.

Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.  Read More & Comment...

What Paris Hilton and the Commonwealth Fund Have in Common

08/13/2007 04:40 PM |

Paris Hilton told the media that her friend Nicole Ritchie, who will be heading to jail to serve 4 days for a DUI (this after a history of drug abuse) "will be the best mom ever."

The Commonwealth Fund tells us that single payer health systems provide the best health care to the happiest patients anywhere, according to the NY Times.

Except the next day we find out that the courts in the UK say it is just fine for NICE to keep on depriving patients dying of cancer and Alzheimer's access to new medicines. Yes indeed, that's an marker of excellent care.

And as if we needed another example of just how many intellectual underachiever clutter the field of health care policy we get 101 irrelevant and incorrect explanations about why the infant mortality rate in the US is higher than anywhere else. The NY Times citing Michael Moore (!) despaired about how crappy America's health care system is because we do such a lousy job of keeping babies alive -- which in turn drags down our life expectancy.

In fact, if we counted live births like other nations and simply withdrew care from low birth weight babies like the UK, Canada, Netherlands and other places our life expectancy would exceed everyone else. I guess that would make the folks over the Commonwealth Fund and the NY Times really happy which is more important than anything else in the whole wide world.

Let me spell it out: Moore/NYTimes/Commonwealth makes a big deal about how America’s infant mortality rates are lower than El Salvador’s. That is a lie. First, many countries such as France, Switzerland, El Salvador and others do not count the deaths of very small babies as live births which brings the total number of deaths down. Meanwhile American advances in medical treatment now make it possible to save babies who would have surely died only a few decades ago. Until recently, very low birth-weight babies - less than 3 pounds - almost always died. Now, some of these babies survive. While such vulnerable babies may live with advanced medical assistance and technology, low birth-weight babies (weighing less than 5.5 pounds) recently had an infant mortality rate 20 times higher than heavier babies, according to the very same World Health Organization.

The United States devotes about twice as much money keeping each infant alive as most other countries. In some Western countries, doctors do not tell parents when they are withholding care to a vulnerable infant. Still others, countries that offer the “free” universal healthcare such as Britain and Canada set a birth weight and gestational age below which no intensive care is offered. So our infant mortality rate is really a measure of how much we care and the lengths we go to keep vulnerable infants alive just as our cancer expenditures at the end of life are as well.

That applies with greater force to Cuba where infants who are born at less than 28 weeks, weighing less than 1,000 grams or measuring less than 35 centimeters are not counted as live births if they die within seven days. The communist system stressed the need to keep infant mortality low. And in Cuba today hospitals and medical staff face penalties (prison) if they reported increases. As a result, they sometimes report the deaths of babies in their care as miscarriages or stillbirths.

The rest of the Commonwealth Measures -- taken from survey data -- are process measures and highly subjective. Pure junk. Wonder why it ignored stuff like access to new drugs, cancer survival rates, mortality after by-pass surgery, treatment for high blood pressure, etc. Because those are meaningful clinical endpoints which reveal lousy performance in Europe relative to the US of A. Ditto, the comparative rates of increase in glucose and cholesterol levels in UK, France and the US. We are going down, they are going up for the most part. Medicine is doing something about disease either prevention or intervention.

Which is why when either Paris Hilton or the Commonwealth Fund weigh in on a serious subject you can expect a serious answer. Neither are serious. They are 24/7 publicity machines designed to advance one thing: themselves.  Read More & Comment...

Commonwealth of Nations

08/13/2007 09:16 AM |

On Sunday the New York Times ran a 1292 word jihad against the American healthcare system. The thesis of the editorial is that “Many Americans are under the delusion that we have the best health care system in the world” because, in the words of the Gray Lady, we lag "well behind other advanced nations in delivering timely and effective care.”

For its facts and figures, the Times largely relies on “the highly regarded Commonwealth Fund” that has “pioneered” comparative studies with other advanced nations.

Let’s pause for a moment and shed a little light on the Commonwealth Fund and their most recent (heavily touted) comparative study of national healthcare systems.

The “highly regarded” Commonwealth Fund is also the same “highly Liberal” Commonwealth Fund that has been consistently lobbying for a U.S. single-payor healthcare system. It’s also important to note that the “pioneering” comparative study the Times refers to failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care.

Why didn’t the Times mention this? At over 1290 words it certainly wasn’t because of space constraints. It’s worth repeating the old maxim that “research is like a bikini – what it shows you is interesting, but what it conceals is essential.”

There are so many variables when it comes to healthcare. The Times mentions only the ones that fits its thesis. For our national newspaper of record (and on a Sunday, no less) it’s amazingly simplistic. According to the editorial, our system is bad and single payor systems are good. Almost like a print version of SiCKO penned by Paul Krugman on an off-day.

One point of discussion, conspicuous by its absence, is that Americans are the ones paying for global medical innovation. Indeed, what would survival rates for any number of diseases look like if a nation could only use medicines they helped pay to develop? This "disparity" is unfair to the American consumer and not sustainable. The rest of the world must accept its fair share of the burden for healthcarer R&D. Zero discussion of this by Andy Rosenthal and his associates.

Another issue absent from the Times editorial is the general state of healthcare record keeping from country to country. Perhaps the most polite way to address this issue is to say that it is uneven. And to allow the findings of the Commonwealth Foundation to drive the debate, while ignoring other, more detailed European-based research findings (such as those by Populus and the pan-European Stockholm Network) which point to significant dissatisfaction among EU citizens of single-payor nations on a wide swath of healthcare delivery issues is, well, curious.

But, most importantly, it’s crucial that we not allow slanted studies by folks at the Commonwealth Foundation or ill-considered propaganda like SiCKO to sucker us into believing that there is some universal “best” model for the delivery of healthcare – when what we really need to be debating is how to construct a healthcare system that provides the right care for the right patient at the right time. “Comparing” various national healthcare systems through poor research is as dangerous and fruitless as “comparing” the relative effectiveness of medicines using large scale population studies that weren’t designed for that purpose.

Unless, of course, you only want to use research that tells you what you want to hear.  Read More & Comment...