Latest Drugwonks' Blog

I have a son in the Israeli army. He deferred attending George Washington U (with a scholarship) to do so. John Kerry's remark might have been targeted at Bush in his own mind but his reference point was a stereotype of why people join the military. His comments reflect the elitism and hollow intellect of many in his party. They impugn those who voluntarily perform military service because they believe that supporting a democracy in a war against terror is a just and noble purpose.

Similarly, I believe that Democrats -- until proven otherwise -- are a danger to medical innovation. (Not that they won't have the help of some Republicans). Quick to invoke the stereotype that any involvement with corporations stink, their very rhetoric demoralizes and discourages those who engage in research because they care and hope to cure. And their actions -- as I blogged on the exodus of NIH scientists -- based on that rhetoric has consequences.

Talk is not cheap. Talk imposes a heavy cost on those who actually seek a newer and brighter world. I thought politicians were supposed to empower those with such intentions instead of embarassing and attacking them.
The biggest savings in the Democrats' plan would be a pledge to give the federal government the authority to negotiate lower drug prices for Medicare. Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry A. Waxman (D-Calif.) have estimated that Medicare could save $190 billion over the next decade if the seniors' program adopted the price-negotiating model of the Department of Veterans Affairs.

Let's translate: "The price negotiating model" is the one 40 percent of veterans want to LEAVE but can't, robs seniors of half the drugs now they choose from, forces them to buy from government run pharmacies, and denies them access to 90 percent of the 80 or more drugs the FDA gave priority approval to since 1997. Oh, and the whole process shortens the lives of seniors.

If seniors want many of the medicines they now depend on for their health, they will have to pay for them out of pocket to the tune of billions of dollars a year. And the loss of profits -- yes profits -- over ten years will hurt biotech firms and their investments, reducing the number of new medicines for fatal and degenerative illnesses by 50 percent.

Who Built the AHRQ?

  • 11.01.2006
Research, as the saying goes, is like a bikini. What it shows you is interesting – but what it conceals is essential.

Today’s case-in-point is a new study by AHRQ. The headline on the UPI wire is “Study: Brand-name drugs fuel cost increase."

The lede graph reads as follows:

WASHINGTON, Oct. 31 (UPI) -- U.S. brand-name drug spending helped fuel a doubling of spending on outpatient prescription drugs from 1999 to 2003, a new study says. During those years, total consumer spending on drugs purchased outside of hospitals increased to $178 billion per year, according to a new report by Health and Human Services' Agency for Healthcare Research and Quality.

Interesting numbers, big numbers – but without any real context. For example, what percentage of that spend is for medicines not previously available? What’s the breakdown between new and existing scripts? How does that increase corelate to reduced costs in, for example, hospitalization?

And what about improved patient outcomes?

Minus these important variables, all this new report will do is aid and abet the Evangelists of Evidence-Based Medicine and fuel the fire of those pundits and politicians for whom the crisis in American health care can be simplistically summed in the four words, “drugs are too expensive.”
I am preparing for my very first colonoscopy today. Scheduled for tomorrow morning at 10 am. I am looking at it as getting done to me what Democrats will do to seniors and medical progress if they win control of Congress and get a hold of Medicare.
Very important story by Steve Usdin in this week's edition of BioCentury.

The first paragraph sets the stage:

"FDA's rejection of Replidyne Inc.'s farapenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact that the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually."

And further ...

"The agency's action reflects arguments that the effectiveness of comparator antibiotics has not been established against placebo, making a non-inferiority result of doubtful value. And with the exception of CAP (community-acquired pneumonia), where the role an antibiotics isn't questioned and where FDA will still accept non-inferiority studies, the other indications are self-limiting, and thus the urgency to treat is said to be lower."

Many issues here, not the least of which are the ethical implications. As Usdin points out, "By requiring superiority trials in ABS (acute bacterial sinusitis) and AECB (acute exacerbation of chronic bronchitis), FDA has taken sides in a debate among clinicians, academic researchers, politicians and industry over whether it is necessary, ethical, or possible to conduct such trials."

On one side is Donald Poretz, Georgetown School of Medicine and a member of the FDA's Anti-Infective Drugs adcomm, "For years we thought is was unethical to do placebo-controlled trials in sinusitis, bronchitis, and otitis media, but now it seems it is ethical" ... because it isn't clear that antibiotics are helpful.

On the other side, James Hadley, University of Rochester Medical Center and past president of the American Academy of Otolaryngology, "It is very difficult in the U.S. under current law and regulations, and with IRBs that regulate clinical trials to offer a placebo to patients in view of an active disease process."

Show me the guidance!

WHO? Us!

  • 10.31.2006
While looking for a white paper on the WHO website I was surprised, excited, and pleased to see that their updated fact sheet on counterfeit drugs cites CMPI on the projected growth of global sales of fake medicines.

Here's the precise citation:

"The Centre for Medicine in the Public Interest, in the United States, predicts that counterfeit drug sales will reach US$75 globally in 2010, an increase of more than 90% from 2005."

So, now that we've given ourselves a nice pat on the back (and don't you love the quaint spelling of "Centre"), it's important to pass along the link for the WHO fact sheet. It's an important reference.

Have a look:

http://www.who.int/mediacentre/factsheets/fs275/en/print.html
Want to know what happens when the NIH toes the conflict free holier than thou line espoused by Marcia Angell, JAMA, NEJM.....

"Ethics rules send NIH scientists packing
By RITA BEAMISH, Associated Press WriterSat Oct 28, 6:06 PM ET
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.

Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.

The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.

Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings....."

What's so delicious about all this is Jim Greenwood, now chairman of BIO was one of the Congressman who beat up NIH on this COI issue. Now BIO is bemoaning the fact that NIH is losing the smartest people, particularly at NCI and testified before the NIH Blue Ribbon Panel on conflict of interest against the very limits that are sending scientists packing.

And if you think it's bad now, just wait till Dingell and Waxman get control of the relevant committees....Fewer scientists conducting less research in cooperation with scientists in academia and companies in such areas as stem cell research, Alzheimer's, cancer, etc. That means less investment in these critical areas and less progress. Way to go.

MIT Happens

  • 10.30.2006
When it comes to improving postmarketing surveillance there are a few acronyms to keep in mind: FDA, MIT, and AEGIS.

Note to publicity hungry politicians, pundits, and Prophets of the Precautionary Principle: One acronym not mentioned above (or in the important article below) is"CYA."

Have a look and see what real progress looks like:

Download file
My oped today in the NY Dailly News nydailynews.com

End sick crusade against breast cancer research
By ROBERT GOLDBERG
Saturday, October 28th, 2006

Every October, as Breast Cancer Awareness Month rolls around, we wear pink ribbons and focus our attention on a terrible disease that takes the lives of some 40,000 American women every year. But this year, a group known as Breast Cancer Action has seized the stage - and, claiming to speak on behalf of breast cancer patients themselves, is making conspiratorial, offensive and irresponsible statements. They must be exposed as the fearmongers they are.
In a national media campaign that includes newspaper and TV ads, the upstart organization is advising women to "think before you pink" because - get this - they consider corporate donations to fight cancer research tainted by the profit motive. The group warns women against the breakthrough treatments corporate-funded research might yield.

And most alarmingly, the organization has advised against mammograms, apparently believing that they too are part of some corporate conspiracy. According to Barbara Brenner, executive director of the group, "benefit of routine mammograms for healthy premenopausal women is unproven."

This is a blatant lie that threatens women's lives. The scientific consensus is that routine mammography reduces the risk of dying of breast cancer in women 50 and older by up to 30%.

And in their crusade against corporate-funded research, what kind of breakthroughs is Breast Cancer Action targeting? Work by people like Northwestern University's Dr. Boris Pasche. By identifying women with variations of two specific genes that have been linked to an increased risk of cancer, Pasche and his colleagues are approaching a breakthrough that could successfully test for cancer risk in 30% of women. That could spare mothers needless trips to the doctor, exhausting rounds of chemotherapy and hospitalitzation.

In the perverse world of Breast Cancer Action, Dr. Pasche's research is suspect - because part of his financial support comes from the Avon Foundation. What's wrong with the Avon Foundation? Well, it seems the mere fact that it's linked to a profit-making company is cause enough for concern: "Breast cancer has become the poster child of corporate cause-related marketing campaigns, as companies try to boost their image and their profits by connecting themselves to a good cause," Breast Cancer Action complains on its Web site.

Perversely, this organization blames corporations for doing too much - and, at the very same time, not enough. As Brenner recently explained, "I understand that people want to do something, but if shopping could cure breast cancer, it would be cured by now." Brenner apparently isn't aware that over the last decade, thanks to countless researchers and millions of dollars in funding, the death rate from breast cancer has declined by 2.3% per year for all women. And it could go down much further, much faster, if research accelerates.

Breast Cancer's Action's twisted crusade would have corporations forget research funding and have women forgo potentially livesaving treatments. And what should replace research and science? A fight for a cleaner environment. In particular, the group insists there is irrefutable proof that chemicals called PCBs - pollutants that were in some manufactured goods before being banned in 1977 - cause breast cancer. There's no biological evidence to support such a link.

During Breast Cancer Awareness Month, this terrible disease is a formidable enough target for America to fight. We shouldn't also have to contend with the lies and hysteria being peddled by Breast Cancer Action.
Here are some of the more interesting headlines from this week's health and medical breakthrough news:

From Sciencenewsdaily.com

Elderly Men With Low Testosterone Levels More Likely To Fall
Low testosterone levels may be associated with a higher risk of falling in older men, according to a report in the October 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals....

Punchlines are welcome

And then there's this from that cutting edge healthcare system North of the border

Unique Bra Eases Women's Recovery From Heart Surgery
A national clinical trial led by a University of Calgary researcher has found that wearing a specialized compression bra significantly reduces women's breast pain following heart surgery.

So let's get this straight. HealthCanada will pay for this but not Plavix or Herceptin...

The autism aliens will not be convinced that mercury (the element, not the planet) does not cause that disease not matter how much scientific evidence is amassed and no matter how many death threats they send to scientists and public health officials...



Government rejects vaccine petition
By ANDREW BRIDGES, Associated Press Writer

A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.

Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.

"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners.

Gee, what a surprise.


And speaking of not pleasing the paranoid, here's a headline that will make Steve Nissen, Curt Furberg and Ariana Huffington (who would ever think to see them in the same sentence?) miserable:

From Medical News Today

Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution

No heart problems guys. However, the study shows that in some kids side effects can include weight loss limits on height. It did not compare the impact of Ritalin with Strattera which is not a stimulant and does not have the same effect on appetite...
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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