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Supreme Court rules vaccine makers protected from lawsuits

By Robert Barnes
Washington Post Staff Writer

Federal law protects pharmaceutical companies from lawsuits by parents who claim that vaccines harmed their children, the Supreme Court ruled Tuesday.

The court ruled 6 to 2 that going before a special tribunal set up by Congress is the only way parents can be compensated for the negative side effects that in rare instances accompany vaccinations.

The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed.

The National Childhood Vaccine Injury Act of 1986 "reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries," Justice Antonin Scalia wrote, referring to the Food and Drug Administration.

Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products.

The decision "leaves a regulatory vacuum in which no one - neither the FDA nor any other federal agency, nor state and federal juries - ensures that vaccine manufacturers adequately take account of scientific and technological advancements," Sotomayor wrote.

The decision is a victory for vaccine makers such as Wyeth and GlaxoSmithKline. Kathleen Sullivan, who represented Wyeth in the case before the court, told justices that ruling against the company could lead to thousands of lawsuits in which parents claim, for instance, that the mumps, measles and rubella vaccine played a role in their children's autism.

It also marks another chapter in the court's evolving jurisprudence on "preemption," the question of when federal laws and regulations displace state actions or lawsuits. Those questions often divide the court on ideological grounds, but in this case, liberal Justice Stephen G. Breyer joined the court's consistent conservatives.

The Obama administration also backed the vaccine makers, and Justice Elena Kagan was recused because of her work on the case as President Obama's solicitor general.

The case was brought by Russell and Robalee Bruesewitz on behalf of their daughter Hannah, 18. Hannah began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The 1986 federal law said that all such claims must first go to a special tribunal commonly called the "Vaccine Court." The program has awarded nearly $2 billion for vaccine-injury claims in nearly 2,500 cases since 1989. It is funded by a tax on immunizations.

But the tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine harmed Hannah, who will need lifelong care.

The couple then sued under Pennsylvania tort law. The company had the case moved to federal court, and judges have consistently ruled that the suit cannot proceed, because federal law prohibits claims against "design defects" in vaccines.

The justices at oral argument debated ambiguous wording in the federal law. It says that no vaccine maker can be held liable for death or injuries arising from "side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Scalia said the word "unavoidable" would be meaningless "if a manufacturer could be held liable for failure to use a different design."

Sotomayor read the language to mean the opposite, and said "text, structure and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines."

Consumer groups and others had supported the Bruesewitzes, but the American Academy of Pediatrics applauded the decision.

"Today's Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country," AAP President O. Marion Burton said in a statement.

The case is Bruesewitz v. Wyeth.

Will publicly released complete response letters become the first example of the FDA’s transparency initiative? That’s the buzz.

"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," FDA Commissioner Peggy Hamburg.

Whether or not the FDA has the legal jurisdiction is certainly open to debate – but it’s becoming increasingly clear that the agency thinks it does. And many inside certainly want to:

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.

Regulatory cognoscenti believe that such releases would have to be redacted to protect commercial confidential information. Makes sense – but who decides what’s commercial confidential?

If the FDA decides to opt for the “release is good for the soul” track, they should also declare their intentions that redactions are to be agreed upon mutually and done in an aggressive timeframe that coincides with the actual release of the complete response letter to the sponsor.

Transparency and fairness should not be – mutually exclusive.

Watch my recent interview with David Asman on Fox Business News here:



Obama Rx Company

  • 02.21.2011

 

Updated: Sat., Feb. 19, 2011, 4:51 AM home


O's bogus Rx for medical innovation

Last Updated: 4:51 AM, February 19, 2011

Posted: 9:41 PM, February 18, 2011

To stoke future biomedical innovation, President Obama is proposing to turn the National Institutes of Health into a drug company.

The administration is set to establish a billion-dollar division of the NIH called the National Center for Advancing Translational Sciences that will develop pharmaceutical treatments for diseases the government perceives as underaddressed by private industry.

Unfortunately, recent evidence suggests the government is ill-suited for drug invention. In the case of the advanced cancer treatment Avastin, the NIH -- and the Food and Drug Administraion -- has hindered medical progress. If this new agency is serious about driving drug development, it needs to avoid making the mistakes the government made with this drug.

In the late 1980s, Nobel Prize-winning scientist Judah Folkman identified an antibody called "bevacizumab" that could shut off blood flow to tumors. For years, the NIH rejected Folkman's discovery as unproven and even went so far as to test its own version of the compound to show that it didn't work.

Folkman was open about his frustrations with the government's refusal to give his discovery a fair shake. He'd explained that "some breast cancers, for instance, make only one [growth] factor while others make six. That means that you have to balance the [antibody] dose against a specific tumor, as much as you would adjust the dose of insulin according to your blood sugar levels for diabetes."

But, he dourly noted, such balance is "not the way" the FDA wants scientists to do clinical trials.

It was left to the drug firm Genentech in 2000 to bet billions on Folkman and develop bevacizumab into a workable drug, eventually called Avastin. The FDA quickly approved Avastin for lung- and colon-cancer treatment.

Then, in 2008, the FDA authorized the drug for metastatic breast cancer. That approval came after Avastin showed impressive results with regard to what is known as "progression-free survival" -- a measure of its ability to stop tumor growth. For many trial patients, Avastin proved to restrict or shrink their tumors, improving quality of life and extending life span.

However, last summer, the FDA announced it would reevaluate Avastin under a new standard called "overall median survival," which essentially measures how much longer the average patient lives because of the drug.

This announcement surprised many because the overall survivability standard isn't appropriate for a drug like Avastin when it comes to breast-cancer treatment. The bulk of the drug's benefits fall on a key set of "super responders" that gain immense amounts of additional life. But for the "average" patient, Avastin improves the quality of life but doesn't significantly extend it.

Overall survivability doesn't take into account individual variances in treatment responses. The progression-free standard does.

Nonetheless, the FDA stuck with the "overall survivability" metric, determined Avastin doesn't "provide a sufficient benefit in slowing disease progression" and ruled to revoke its approval. Genentech is appealing the decision.

Avastin had been serving as the last, best hope for thousands of dying breast-cancer patients. But this ruling, if left unaltered, could wipe Avastin off the table as a treatment option, leaving many women to suffer and die prematurely.

Cases like Avastin are all too common. The NIH, FDA and other government bodies haven't done a good job applying reasonable, consistent approval standards to drugs. The result has been a steady decline in the number of new treatments hitting the market.

Indeed, just 21 drugs received FDA approval last year. That's down from 25 in 2009 and 24 in 2008. Applications for approval in 2010 were also lower than in previous years even though the number of products in the pipeline is increasing.

If the government is going to step into the drug-innovation business, it can't treat new drugs like its treated Avastin.

Dr. Robert Goldberg is vice president of the Center for Medicine in the Public Inter est and author of "Tabloid Medicine: How the Internet is Being Used To Hijack Med ical Science for Fear and Profit."

And the home of the brave -- and honest statement:

Peggy Hamburg:

 

“The user fee model has seen many major successes … including innovator prescription drugs, medical devices, animal drugs, and generic animal drugs, to name a few. Without a fair system of user fees, we simply cannot achieve for the public what we otherwise could.”


Medical Turbulence

  • 02.18.2011

Bring your own bier.

Consider this new announcement from the good folks at Turkish Airlines:

TURKISH AIRLINES MEDICAL TOURISM SUPPORT PACKAGE

In order to increase share of Turkish Health Care establishments in the market and support national economy, Turkish Airlines has prepared a support package for Health Care Establishments who invest in Medical Tourism.

The airline’s package includes (among other incentives), “No rebooking penalty will be charged if the rebooking is required for medical complications.”

And that’s a good thing considering that, once in the land of Atatürk, the accidental tourist will discover a nation where access to the latest medicines is 4-5 years behind the US, Canada, Australia, Japan or any nation in the EU.  From pain relievers to antibiotics, Turkey is the last country in Europe in terms of medical technology.

Medical tourist travelers on Turkish Airways should be reminded to bring their own prescription medicines.

Jack Calfee

  • 02.17.2011

I am very sad to report that our good friend and colleague Jack Calfee passed away last night, the victim of a heart attack.

Jack’s intelligence, honesty, wit and warmth were appreciated by those who knew him.  His professional reputation speaks for itself.

Jack was always kind and helpful to me and was an indispensible guide along the shoals of healthcare policy.

And his eyes always had that wonderful twinkle.

Farewell Jack.  Too soon.

Trade in counterfeit medicines needs an international fix
By ANDRÉ PICARD
Toronto Globe and Mail

It's time to stem the global flow of counterfeit medicines

Much is said and written about the global trade in illegal drugs such as cocaine and heroin: We know about the cartels and the drug wars, and we see the devastation wrought by drugs in the eyes of addicts and in crime statistics.

But rarely do we hear about an equally shady activity that almost rivals "recreational" drugs in size, scope and impact - the counterfeiting of medicines.

The U.S. Center for Medicine in the Public Interest estimates that the counterfeit drug market is worth about $75-billion a year.

About 15 per cent of all medicines sold worldwide are fakes. In developing nations of Africa, Asia and Latin America, it's about 30 per cent.

It's a deadly business, one that kills an estimated 700,000 people a year. That's because a lot of medicines for treating life-threatening diseases such as malaria and tuberculosis are fakes. So, too, are many antibiotics, painkillers, hormones, cancer meds and drugs for hypertension, high cholesterol and diabetes.

"Yet there is strangely little outrage at this globalized evil," according to the authors of a paper about counterfeit medicines published in the Journal of International Criminal Justice this week.

Consider that if you are caught smuggling a kilo of heroin across a border, you will likely go to jail for a long time. But if you're caught with a kilo of counterfeit medicines, you will likely be treated the same as someone smuggling a box of T-shirts - with a fine and a slap on the wrist.

The authors of the paper - Amir Attaran and Megan Kendall of the University of Ottawa and Roger Bate of the American Enterprise Institute in Washington - want that incongruous situation to change, and quickly.

The paper, Why and How to Make an International Crime of Medicine Counterfeiting, points out that counterfeiting of currency became an international crime in 1929: If you decide to print up some fake U.S. money, you are liable to prosecution in any country in the world, not just in the country where the activity took place.

"Humanity and the defence of public health requires doing likewise for counterfeit medicines," Dr. Attaran and his team wrote.

It's true that counterfeit medicine is a peripheral issue in Canada, though some of our infamous Internet pharmacies have been known to sell phony meds transited through other countries.

But Canada is - or should be - a good global citizen and look beyond its borders. It should be tackling the problem of counterfeit medicines with the same vigour as terrorism. And, according to Interpol, there is a link - al-Qaeda generates a significant portion of its revenues from counterfeit drugs.

For the most part, medicine counterfeiting is organized crime. The guy selling phony malaria pills at a roadside stand in rural Kenya is just the last cog in a criminal machine that turns ersatz ingredients into pills, prints plausible packaging, forges trademarks, distributes the products by tricking, bribing and evading customs and health officials and police, then launders the revenues from the illegal sales.

A criminal enterprise of this sort is not haphazard, and the response to it shouldn't be either.

But the World Health Organization, in a study of the impact of counterfeit drugs, said the trade is flourishing because laws are so weak.

The WHO highlighted myriad problems with the current legal regime, including insufficient regulation of drug manufacturing in many countries, poor enforcement of existing legislation, weak penal sanctions for violations and, above all, a lack of co-operation between countries.

"Knowingly making fake medicines that do not help people, or that harm and kill them, ought to be considered a more serious transnational crime than it is," Dr. Attaran said.

But there is a right way and a wrong way to fashion international law.

The Council of Europe is currently promoting the Medicrime Convention, a treaty to criminalize the manufacturing and trading of counterfeit drugs. The approach is inadequate because a) it applies only to Europe and b) it focuses too narrowly on protecting intellectual property.

This treaty seeks to criminalize a lot of what generic drug companies do - test the limits of patent law - but it does nothing to protect the poor Nigerian who is buying crushed chalk that he thinks is lifesaving malaria medication. It's a cynical attempt to shore up market share for brand-name companies. If that is what governments want to do, they should do so, but they shouldn't allow the victims of counterfeit drugs to become collateral damage.

A much better model for a treaty, Dr. Attaran said, is the Framework Convention on Tobacco Control, which tackles an international health problem in both developed and developing worlds by promoting measures and laws that cut across borders and attack the problem at its root.

In their paper, Dr. Attaran and his colleagues note that what they are proposing is nothing radical, and such a treaty is easily achievable, just as it was for counterfeit money. The sole impediment is a lack of political will.

"Meanwhile, counterfeit medicines go on killing. ... Absolutely no country is immune," Dr. Attaran said. "A more dismal commentary on the contemporary state of public health diplomacy is scarcely imaginable."

A new directive to protect patients from counterfeit drugs has been approved by the European Parliament.

New safeguards include extra safety features on drug packaging and new measures for internet pharmacies.

According to a recent report on the BBC, an estimated 1% of medicines sold to the public in Europe through legal channels are fake.

The 27 EU governments - the Council - will now study the directive and they can still make amendments before it becomes law. The final text will then be incorporated into national laws EU-wide within two years.

The legislation introduces a product authentication system and new safety features on packaging. The key to the system is a two-dimensional barcode added to prescription medicines that can be read by a new scanner.

More on this as it develops.

The Seven Year Itch

  • 02.16.2011

A new study from BIO and BioMedTracker reports that the success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.

The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.

Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.

Well – nobody said innovation was easy. But wait – it gets worse.

After saying that he wanted America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.

The President’s proposed 2012 budget blueprint seeks to hasten availability of biosimilars by cutting the market exclusivity of innovators from 12 years to seven.

Bad idea since a longer period of exclusivity funds an innovator company’s research and development efforts.

12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.

If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”

I know the answer!  The answer lies within the heart of all mankind!  The answer is twelve?  I think I’m in the wrong building.

-- Charles Schulz

 

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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