Agent Orange (Book)

• 01.29.2009

According to a new Harris poll, 81% of Americans say they prefer generics to brand-name drugs.

That’s good news.  It means the message that FDA-approved generic drugs are safe and effective is finally getting some traction.  And the cost savings are significant.

But, as usual, there are those who would use this news for their own selfish purposes.  In this case it’s the Generic Pharmaceutical Association (GPhA).

Earlier this month, the GPhA applauded the introduction of HR 573, a bill that would prohibit the marketing of authorized generics during the 180-day generic exclusivity period. Kathleen Jaeger, chief executive of the GPhA, sees the proposed legislation as a way to close a “loophole” in the 1984 Hatch-Waxman Act that allows innovator life science companies “to delay generic competition by discouraging generic companies from challenging weak and potentially unenforceable patents." She praised the bill’s sponsor, Republican Jo Ann Emerson, and colleagues for “working to close this loophole for the benefit of consumers struggling with health care costs during these difficult economic times."

Well, if we’re all in this to help consumers control costs – then this bill would achieve precisely the opposite.

If the GPhA gets its way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during the 180-day exclusivity period to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.)
 
Historical pricing data shows that brand companies launch their generics at a 50 percent discount off retail price compared to a 30 percent discount experienced when a generic drug has no competition. If HR 573 passes, consumers and taxpayers over the next two years would realize about $8 billion instead of $13 billion in savings.  Cui bono? The missing $5 billion will line the pockets of a handful of generics companies.  That’s quite a cui bonus. This end-run around Hatch-Waxman is an extended index finger to the FDA, the FTC and judicial precedent. (A Federal Appeals Court made it clear that Hatch-Waxman allows for authorized generics.)

Over the next few years about $60 billion in brand drugs will become generic; $30 billion of that will be sold without competition for 180 days if Ms. Jaeger and Representative Emerson get their way.

No wonder this “modest proposal” is being greedily embraced by the generics industry and Big Pharma bashers. And greedy is hardly hyperbole since profits on generic medicines exceed 45% -- even when there is a competitive branded generic on the market.

We all call the existing legislation by its inside-the-Beltway designation, “Hatch-Waxman” – but let’s not forget that the full name of the law that brought the generic industry into being is the Drug Price Competition & Patent Term Restoration Act -- not the Generic Drug Company Guaranteed Profit Act. When the media and generic drug lobbyists conflate suspicious stalling tactics with legal and consumer-friendly market actions, neither the truth nor the public health are served.

Ends, Means, Medical Devices and Felonies

• 01.28.2009

You mean the ends doesn’t justify the means?

According to an article in today’s edition of the New York Times, “Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.”

The complete New York Times story can be found here.  

If the FDA has undertaken such an investigation (and the agency will not confirm or deny), the reason is that these nefarious nine leaked confidential agency documents to the media.  That’s a felony.

The Nefarious Nine are unhappy that their complaints about device approvals aren’t being addressed with greater alacrity.  So, in their righteous indignation, they decided that their purity placed them above the law.

Unfortunately, not only will their behavior not speed up the agency’s investigation of their brief – it may very well slow it down.

Breaking the law is the wrong path to better regulatory oversight of medical devices. The ends doesn’t justify the means.  

Kennedy on Cost Effectiveness

• 01.28.2009

Ian Kennedy that is.

According to a Reuter’s report, “The healthcare spending watchdog NICE said it was reviewing how it values new technologies, a week after an industry report called for such a move.” NICE's announcement followed an industry report published last week calling for an enquiry to assess the long-term impact of NICE on the cost and the uptake of drugs, along with a series of tax breaks and other measures to support the crisis-hit biotechnology industry

The study (due this July) will be led by Ian Kennedy, Emeritus Professor of Health Law, Ethics and Policy at University College London.  He’s an academic lawyer who, for the past few decades, has lectured on the ethics of medicine.  A long-standing member of the General Medical Council, he is a former president of the Centre of Medical Laws and Ethics, which he founded in 1978.

On a releated note, the Pink Sheet reports that, “Third-party payer policies appear to have an effect on clinical trial participation, but the impact "is difficult" to quantify, according to a draft report by Duke Evidence-Based Practice Center researchers prepared for the Agency for Healthcare Research and Quality.”

The draft report, "Horizon Scan: To What Extent Do Changes In Third-Party Payment Affect Clinical Trials and the Evidence Base?" was posted on AHRQ's technology assessment Web site. Comments on the draft are due Jan. 23. The topic is of interest because there is no consensus on financial responsibility for clinical trial-related health care costs, resulting in uneven reimbursement policies. A lack of adequate coverage for those costs may discourage patients from participating in trials, reducing the body of available clinical evidence.

A 2000 survey of nearly 6,000 cancer patients who were aware of clinical trial availability revealed that about 75 percent chose not to participate, with 20 percent of that group citing uncertainty about insurance coverage as the reason for declining participation. The top responses given for not entering into a clinical trial were: standard treatment was believed to be better (37 percent) and fear of receiving a placebo (31 percent).

Yet another unintended consequence of cost-based versus patient-centric reimbursement policies.

Partial Sunshine With No Sign of Clearing

• 01.27.2009

What’s better than 1 FDA?  How about 50.

That would be the result of language inserted into the 2009 version of the Kohl/Grassley Physician Payments Sunshine Act. 

New language in the bill proposes to give states authority to require disclosure or the reporting of information not required by the FDA.

Result:  50 state FDAs … and chaos.

Chaos for drug companies, certainly.  But even worse -- chaos for patients and physicians.  Imagine a doctor in New York getting different information on a medicine than a doctor in Michigan.  Imagine a patient in Vermont getting different treatment than a patient in Arizona because their physicians weren’t sure who to listen to or what directions to follow.

Talk about emasculating the drug label.

And who should pharmaceutical companies go to with data and questions?  50 state health commissioners who may or may not have ever even looked at clinical trial data?  Are there any state health commissioners who hold a technical candle to even a mid-grade FDA reviewer?  Is there a state in the Union that employs a biostatistician?  And how would states pay for these new professional employees?  Likely source is lucre from lawsuits.  And it's even more likely these professional services would be provided by outside “experts" --  the same folks who earn a nice living from being “expert” witnesses.

Speaking of expert witnesses, the Physician Payments Sunshine Act makes no provision for reporting fees earned for such activities.

That ain’t sunshine.  

Sweden beyond the Welfare State

• 01.27.2009

As I mentioned in my presentation in Washington last October (“A Transatlantic Malaise”), politicians everywhere would do well to get the facts before referring to the Swedish model. As state provision of welfare services started earlier in Sweden, it also started creaking earlier, and alternatives emerged before relative to comparable countries.

New evidence of a healthy change in public opinion may be found in a survey released this week by our colleagues at Timbro. A positive result of the breakdown of the Swedish monopolistic health care system is that the young generation (especially age 16-29) looks with favour on private options in social services.

Try this for size:

- three out of ten people think that private financing may need to increase for health and elderly care
- about half of this population consider this a positive development, and the younger are the most positive: 55 per cent of people age 16-29, and 49 per cent of the age group 30-44 think this "rather or very good".

Perhaps more surprising is the figure for the population age 60 and above: 48 per cent (the same as for the overall population) of the oldest Swedes are rather or very positive (as a proportion of those who replied that private provision of welfare services will increase in at least one area).

Last but not least, 51 per cent also think it largely positive if citizens were able to access private insurance for welfare services, beyond what the state provides. (There was an ominous attempt in 2008 by the supposedly centre-right government to abolish this option.) And again, the strongest supporters are found among the 16-29 year-olds.

There is room for optimism in the home country of cradle-to-grave socialism.

Stupak P.I.

• 01.27.2009

Stupak food safety investigation expanded to include Salmonella in peanut butter

WASHINGTON - U.S. Congressman Bart Stupak (D-Menominee), chairman of the House energy and commerce subcommittee on oversight and investigations, and full Committee Chairman Henry Waxman (D-California), yesterday expanded the subcommittee’s food safety investigation to include the recent salmonella outbreak attributed to peanut butter.

The subcommittee on oversight and investigations held 16 hearings on food and drug safety over the past two years, including two involving a 2007 outbreak of salmonella from peanut butter.

Stupak issued the following statement:

“My subcommittee’s two-year investigation into the safety of our nation’s food supply essentially began when peanut butter contaminated with salmonella was discovered in February 2007,” Stupak said. “Today our investigation has been expanded to include the latest outbreak involving salmonella in peanut butter, which has sickened at least 448 people nationwide including 25 in Michigan.‬‪

“We have held 16 hearings over the past two years on food and drug safety, and have drafted legislation to provide the FDA the regulatory and financial tools to protect the American people. Food safety will remain a top priority for the Subcommittee and I remain committed to advancing legislation to address the weaknesses that allow 76 million Americans to be sickened by food borne illness every year.”

Good thing  he is on the case.  And good thing he has requested more money for the FDA in this latest disgorgement of tax dollars.

By the way salmonella happens all the time.  It's not the result of FDA oversight or lack thereof now or in the past...The idea that food borne illneses be prevented by putting more FDA cops in facilities is absurd.  And in terms of value per dollar spent how about investing in the Critical Path to pursue personalized medicine instead of spreading fear about peanut butter. 

Dr. Offit Under Siege By Anti-Vaccine Zealots

• 01.26.2009

The New York Times reports that Dr. Paul Offit, the author of “Autism’s False Prophets,” is facing death threats for writing a book discrediting the supposed link between vaccines and autism.

Pfizer, Wyeth and "P-Value"

• 01.26.2009

No doubt there is much yet to be written about the Pfizer/Wyeth deal.  But going forward, it's good to see that the key word of the day isn't "profits" or "patents" or "promotion" or "PhRMA" (which will now have one less dues-paying member) -- but "patients."

Here's the verbiage straight from the press materials:

For Patients Today – Broad Range of Health Care Solutions and Treatments: The new company will offer customers and patients a broad range of products for every stage of life.  Unique and valuable insights will be gleaned from a portfolio that spans wellness and preventive care, such as vitamins and vaccines, as well as therapies for a wide range of illnesses and diseases, such as Alzheimer’s disease and cancer.  We will leverage research across our portfolio and input from an extensive network of customer, physician and stakeholder relationships to accelerate, improve and expand the health solutions and treatments we offer.

For Patients Tomorrow – Robust Discovery and Development Program: The new company will have more resources to invest in research and development than any other biopharmaceutical company.  We will have access to all leading scientific technology platforms – enhancing the opportunity to produce significant breakthroughs in key disease areas.  As a result, we will be better able to help patients and invest in pursuing multiple avenues to address a wide range of unmet health needs.

At All Times – A Patient-Centric Business: We will operate small, distinct business units tailored to patients and customers that also benefit from being part of a premier global organization.  Each business unit will oversee product development from early stage research to clinical trials to commercialization.  This approach will allow for more customer input into the development process, rapid decision making and a better use of resources.  As a result, we will have the ability to invest in long-term opportunities while optimizing near-term patient access to existing products.

"Patients Today."  "Patients Tomorrow."  "Patient-Centric."  That's what I call real p-value.

The words are right.  Now let's see what happens. 

California Dreamin' About Pre-emption

• 01.26.2009

The California Supreme Court is allowing a lawsuit to go ahead against Wyeth (soon to be Pfizer) for a drug that it invented but does not make.  

That is sort of like suing the Wright Brothers for every airplane crash. 

Here is a blog that puts this awful decision in perspective. As the blog notes:  "55 years of product liability law out the window." 

And that's just the beginning.   Ultimately, it's all about dinging the drug companies on labeling.

Accuracy in Media

• 01.24.2009

The other day Bob Grant of The Scientist interviewed me on who might be the next FDA commissioner.  He mostly got it right. 

There is one bit of reportage that does, however, need to be corrected.  Here’s what was written:

“Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) and former FDA staffer, confirmed those rumors, both on DrugWonks.com -- CMPI's blog -- and when I called him yesterday. Pitts, who has advised the Obama transition team, said that Sharfstein and Califf were the only two names receiving serious consideration.”

Almost right.  What I told Grant was that I thought the two most serious candidates for the job are Sharfstein and Califf.  Whether or not the Obama team is considering others is above my pay grade.

To view the complete interview in The Scientist, see here.