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According to a letter released by Senator Grassley's office: "I have it on good authority that money from device companies can corrupt research and actually turn devices and procedures such a bypass surgery ineffective. There are serious questions as to whether or not Dr. DeBakey's devices were actually needed and whether bypass surgery is truly safe and effective. Indeed, there are questions as to whether Dr. DeBakey actually existed at all..."
As with other Gardiner Harris articles, the article on Dr. DeBakey consists of:
1. A leaked letter from Senator Grassley's office that is quoted uncritically
2. Linked in ad hominem fashion to other "scandals" such as a device manufacturer giving hospitals grants which in no way are related to Dr. DeBakey but Harris wrote about and since he is too lazy to do real reporting he recycles the material
3. Quotes from critics who never met Dr. DeBakey but hate industry in general and are on Harris' speed dial.
Grassley's office has issued a subpoena to Dr. DeBakey requesting he provide information relating to "all fees received from all device companies during periods specified by this office." When reminded that Dr. DeBakey was deceased, Senator Grassley remarked: "That in itself is no excuse for evading the wrath and reach of my office. Does anyone know if DeBakey was actually a ministry?
Those who advocate a government-run health system for the
Passed in 2004, the law's aim was noble – beat back the rising tide of counterfeit drugs by establishing a statewide system for tracking prescription drug shipments from point-of-production to point-of-sale.
The law's problem, however, was that it would have imposed back-breaking costs on pharmaceutical manufacturers and dramatically inflated drug prices for consumers – while doing little to undermine counterfeiters. That's why, rather than just delay the law, officials should scrap it entirely.
A universal tracking requirement is a shotgun-style solution to a problem better suited for a precision, SWAT-team approach.
Constructing and maintaining tracking technology is expensive. Under the law, every pharmacy in California would have to install equipment costing $10,000 to $40,000 – with no help from the state. Every other business along the distribution chain (drugmakers, hospitals, shipping companies, etc.) would also have to install this technology.
Those increased production costs mean higher drug prices for consumers, and less money for research and development and other promising technological investments like electronic medical records.
It's also unwise for state officials to dictate what kind of tracking technology companies should use. Counterfeiters are devising increasingly sophisticated ways to copy and sell brand-name pharmaceuticals. Drug carriers need to be given the freedom to respond in kind. This law locks them into a technology that could soon be antiquated.
Here's a real solution: Increase the criminal penalties for counterfeiting. As is, punishments aren't proportional to the threat posed to public health. Today, counterfeiting a prescription drug label is punishable with a decade of jail time. Counterfeiting the drug itself? A maximum of three years. That's just not acceptable.
Here’s the rest of the story as it appeared in the Orange County Register:
Orange County Register Op-Ed
Tracking legislation should come from the federal level – a single, uniform system administered by the FDA. A mishmash of state laws is wildly inefficient and will only create weak links in our national chain of custody that will certainly be exploited by criminals who don't think twice before putting counterfeit drugs into Americans' medicine chests.
"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said.
That’s rich, coming from someone who said: "everything about ethanol is good, good, good."
I have come to understand that money from the soybean and biofuels industry can shape the practices of a Senator from Iowa that purports to be independent in his viewspoints and actions and who makes a career implying that money alone is the sole factor in forming judgments.
Or how about taking responsibility for creating and propping up this monster called ethanol?
“According to the Global Subsidies Initiative of the International Institute for Sustainable Development, ethanol tax credits and incentives will cost U.S. tax payers between $6.3 and 8.7 billion dollars annually between 2006 and 2012. Additionally, according to a study conducted by the Center for Agricultural and Rural Development (CARD) at Iowa State University, the price of ethanol is being held artificially high by import tariffs imposed on foreign producers of ethanol. According to one of the authors, “Removing trade distortions would decrease the price for U.S. ethanol, while the world price would increase, as U.S. demand — and ethanol imports — would increase.” The drop in domestic ethanol prices could be as much as 18%.”
Now, I might be mistaken. But for a guy who is stressed about governmenet officials being too cozy with industry Grassley might want to start with himself. Here’s the record:
“Agribusiness giant Archer Daniels Midland Co. (ADM), the single largest beneficiary of a controversial federal ethanol tax subsidy, contributed more than $3 million in unregulated "soft money" to Republican and Democratic national party committees during the past 10 years, according to a study by Common Cause.
ADM gave direct political action committee contributions to congressional candidates: $700,170 to Democrats and $529,276 to Republicans from Jan. 1, 1987, to Dec, 31, 1997, according to the report.
The top recipient in the Senate was Richard J. Durbin (D-Ill.), who got $34,500. The Senate Republican who received the most was Charles E. Grassley (R-Iowa), with $17,000.”
ADM has been a prime beneficiary of the federal tax credit on ethanol, which the refiner can apply to the tax it pays on corporate income. First implemented in 1978, the tax credit currently stands at 51 cents per gallon of ethanol sold. The Government Accounting Office estimates the subsidies to the ethanol industry from 1980-2000 at $11 billion. As the biggest ethanol producer in the US, ADM has received the largest portion of the government's generosity.
According to the Heritage Foundation:
Senator Charles Grassley (R-IA) has extensive farm interests, as do some members of his immediate family. Listing his home address as Arlington, Virginia, Grassley received $225,041 in USDA subsidies for corn and soybeans and disaster assistance between 1995 and 2005.[8]
In New Hartford, Iowa, Senator Grassley's son Robin has received $653,833 in subsidy payments, mostly for corn and soybeans.[9] Patrick Grassley, the Senator's grandson, who also lives in New Hartford, received $5,964 in subsidies in 2005.[10]
In 2003 an energy bill authorized $1.75 billion over seven years in "transition" assistance to MTBE manufactures, including oil companies and refiners, as they scaled back production because of state bans on the product. The bill extended a Senate-proposed federal MTBE phaseout from four years to 10 years.
The largest GOP recipient of cash who in turn supported the measure?
Chuck Grassley.
http://www.firstcoastnews.com/news/news-article.aspx?storyid=10915
Over the years Grassley has received $1.5 million in direct campaign contributions from agribusinesss and energy interests, the largest source of cash next to health insurance companies which has been part of a quid pro quo for all sorts of goodies for Iowa.
Here’s the Washington Post’s Steven Pearlstein on Grassley who objected to parts of the housing bill that might be used to underwrite failing investment banks:
Well, isn’t this rich: Max Baucus of Montana and Chuck Grassley of Iowa, chairman and ranking member, respectively, of the Senate Finance Committee are suddenly in a lather that taxpayer funds might be implicated in the Federal Reserve’s rescue of Bear Stearns.
Would that be the same Max Baucus and Chuck Grassley who have made careers out of protecting and enhancing the lavish system of import restrictions, price supports and other subsidies that have transformed American farming and ranching into a vast socialist enterprise? You betcha.
Washington Post Article
Setting aside the hypocrisy of Grassley’s inquisitions what about their legality or constitutionality. On what grounds does he request information about the funding sources or uses of funds from non-profit organizations, including churches. Should the dislike of a practice be sufficient? Should the assertion “"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions" be grounds enough to engage in a witch hunt?
Has anyone else found it peculiar that Grassley has gone after psychiatry and churches? Is this the same as going off the deep end?
There are some on Grassley’s staff, what’s left of it, that think so:
(S)enior staffers….have have expressed profound discomfort with Senator Grassley’s actions, and wondered, rightly, whether this was not a simple assault on American religious freedom. If the United States Senate can de facto audit these preachers at whim and absent evidence of wrongdoing, what’s the barrier to doing the same to Catholics, Baptists, Anglicans, Jews, Muslims, or Mormons? Is the standard now one of mere Senatorial dislike? How is this standard not inherently politicized? The conversation ended with both of them expressing displeasure with the Senator, and grave reservations on his sense of proportion — and Constitutional propriety.
Senator Grassley is a fixture in Washington, D.C., and in Iowa politics, and so he is used to getting what he wants. But when even his own office is riven with doubts on his pet causes — on Constitutional grounds, no less — it’s time to ask the good Senator to step back, and check the hubris.”
Then again, as others have noted, you can get Grassley to see your way by making sure your solution is “Iowa-based” if you know what I mean…
The American Psychiatric Association and pharma might be able to solve their problem by dumping every dime of CME into a new Grassley Center for Continuing Medical Education at the University of Iowa which would be run out of a new building that would rise up in flood ravaged downtown Des Moines.
I bet then Grassley’s understanding of how money from pharma shapes nonprofit practices would be transformed….
Years later, when Tony was working both for USA Today and Fox he would either quote my articles or chat with me briefly. I called to thank him and still remember the joy and enthusiasm in his voice for doing battle as well as the genuine feeling of interest he took in me and my writing.
His turn on Fox News and as the President's press secretary gave him visibility he richly desevered. His first love was his family and that was the focus of his efforts in the remaining years of his life.
I never knew Bobby Murcer. As a Yankee fan I had hoped he would be the "next" Mickey Mantle. But being Bobby Murcer was good enough. Great clutch hitting, Excellent outfielder and team leader. Then being the voice of the Yankees for so many years.
What many didn't know, even until he was diagnosed with a brain tumor, was that he devoted much of his life after baseball, to raising money for cancer research and for people in the baseball community who needed help paying for mortgages, medical bills etc.
It has been said by some that new cancer treatments that "only" add a few months of life are not worth the cost. I think of Tony Snow, who I know did for many what he did for me and who was able to provide for his family with the time science and G-d gave him and of Bobby Murcer who did so much for others suffering from cancer and of limited means and wonder what yardstick is applied by those who would sit on high. We have lost two great men whose contribution to society and involvement with their families will endure and outweigh the claims imposed by people who would rob us of their presence out of cost considerations.
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).
The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.
A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.
“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.
The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.
Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.
The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.
SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.
"We have to be very careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that," says Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel.
Which is precisely why people like Jeanne Lenzer, Shannon Brownlee and the crackpots who cluster at pharmalot.com push for black box warnings on all meds for mental illness and pols like Bart Stupak and Chuck Grassley seek them. And it's why someone like Steve Nissen would use meta-analysis and press conferences to try to get them for Avandia and drugs for ADHD or demand that Vytorin be yanked from the market.
Fear mongering based on shoddy science advances a political agenda or a financial interest.
Sadly, I am sure the expert panel exposed themselves to both abuse and threats of physical violence, often stimulated by the kind of reporting or misreporting and blogs I have mentioned above. When chelation therapy becomes a subject of NIMH funding and black box warnings become a political tool to drive effective drugs off the market based on indiscriminate data amplified through the media and politician's press releases you know that Tabloid Medicine is replacing real science in guiding medical practice. Once in a while you have some brave souls who follow the facts. But for how long?
The really sad thing about the new PhRMA marketing guidelines is that they, basically, match what Senator Charles Grassley is proposing. Talk about inside-the-Beltway groupthink.
Consider this – the big news is (are you sitting down) – no more pens or coffee mugs! Gadzooks.
(Is there a lobby for specialty goods manufacturers? We’ll soon find out.)
What's the attitude of the AMA is on this matter? It should be righteous indignation that the pfolks at PhRMA and too many members of the United States Congress, think that a physician can be bought for trinkets. Good thing these guys weren’t around for the negotiations over Manhattan Island.
But as silly and trivial as this sounds, the more serious issue at play is the caving in by the pharmaceutical industry to misguided political pressure. Silly in the instance of pens and coffee mugs perhaps – but what comes next? A “voluntary moratorium” on DTC advertising? The demonization of published articles on the off-label uses of medicines? It’s a long list.
When is a conflict not a conflict? If the answer is, “When Senator Grassley says so,” then the slope the industry is on is indeed a slippery one.
The only positive thing that will come from the Tchatchke Intifada is that pharmaceutical sales representatives won’t have to schlep them from office to office – thereby lightening their load, improving their gas mileage and decreasing the overall carbon footprint of the industry.
Where’s Nick Naylor when you need him?
British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.
Glaxo's new chief executive, Andrew Witty, said the effort is part of his drive to help the world's second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.
Was Witty really surprised then by this headline:
Blow for GSK’s breast cancer drug
By Andrew Jack
Published: July 8 2008 03:03 | Last updated: July 8 2008 03:03
"The British government’s medicines advisory body has advised against the use of GlaxoSmithKline’s oral cancer drug Tyverb in the National Health Service, dealing a blow to the UK-based pharmaceutical group in its home country.
The National Institute of Health and Clinical Excellence (Nice) on Monday issued a provisional recommendation that Tyverb for advanced breast cancer did not meet its threshold for clinical and cost effectiveness. That recommendation could effectively rule out the UK market for the GSK medicine."
Tykerb is a pill that targets a subgroup of women who are HER-2 positive for breast cancer. GSK even told NICE it would only accept payment for patients who got better.
It still said no.
What new drugs do regulatory authorities want:
Close your eyes and what do you see?
Witty should know better than to hand the future of his company and that of patients over to those who care only about costs.
And now the agency has addressed it head on. From now on there will be no more gradations of approvability. Say hello to the “complete response” letter.
Sound familiar? It should, it’s the same concept behind BLAs. In other words, the agency is embracing the concept of consistency. Good move.
Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.
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.
