Peering into the Future

10/31/2006 03:50 PM |

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.  Read More & Comment...

Non-Inferiority Complex

10/31/2006 11:20 AM |

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!  Read More & Comment...

WHO? Us!

10/31/2006 10:29 AM |

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  Read More & Comment...

NIH: Touched by an Angell

10/30/2006 09:08 PM |

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.  Read More & Comment...

MIT Happens

10/30/2006 08:22 AM |

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  Read More & Comment...

Breast Cancer Action's Halloween Scare Tactics Wont Work

10/29/2006 12:10 PM |

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.  Read More & Comment...

Drugwonks: We Report, We Decide

10/27/2006 08:48 AM |

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...  Read More & Comment...

And then 10 minutes later you want to get tested again

10/27/2006 08:40 AM |

In case your copy of the People's Daily didn't arrive this morning, some important news ...

Chinese get genetic tests to determine disease risk

More than 300 Chinese have undergone genetic testing to determine their odds of developing cancers and other diseases. According to China's first and only genetic testing clinic at the No.1 hospital affiliated with Zhejiang University School of Medicine, more than 300 Chinese have had their DNA sampled at the center since it opened last October. "We look at a patient's medical history and family history, take their blood to analyze their DNA to look for genes that would possibly cause diseases," said Qi Ming, director of the center and professor at the university. Such tests help identify people more likely to get a disease and allow patients to take action to reduce their risk, he said. More than 1,000 genes have been found to relate to diseases. Breast cancer, colon cancer, abnormal heart rate, amyotrophic lateral sclerosis and other diseases can be detected by the DNA tests, Qi said. The tests cost between 75 U.S. dollars and several hundred dollars, he said.

This needs to become standard practice in the US if we are to successfully scale the Great Wall of EBM (evidence-based medicine).  Read More & Comment...

Ambien Responsible for Worldwide Outbreak of Car Accidents

10/27/2006 08:24 AM |

On the heels of a report that a state legislator in NY wants to make it illegal to drive while under the influence of Ambien, this piece of chilling news....

There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.

Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him?  Read More & Comment...

First World Resources for Third World Diseases

10/27/2006 07:36 AM |

In the November issue of Commentary I make the point that Big Pharma needs to be seen as focusing more on promoting the public health than they do on promoting products.

Pfizer has just taken a significant step in that direction.

The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.

The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.

Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screening”, the researchers are seeking to identify “hits” – compounds that show initial activity against a range of tropical parasites.

Well done!  Read More & Comment...

The Democrat Drug Witch Hunt

10/26/2006 12:37 PM |

The WSJ reported a day ago that if the Dems take over control of Congress they plan to investigate Republicans who went to work or lobby for drug interests. No limit on how far back they will go. I guess that means William Seward (Lincoln) and Harvey WIley (first FDA commissioner under TR) are fair game.

I think I have a good idea just who ever made this threat had in mind. Let's be clear: this is either settling personal scores or a way to shakedown the GOP leaning lobbying firms in DC to create jobs for Democrat types. As in, we will call off the dogs if you hire our friends. The Republicans did the same thing when Delay pressured lobbying firms to hire more GOPers. The D's are adding a new thuggist wrinkle to the game by using the congressional supeona power as a job search engine for their pals.  Read More & Comment...

www.cheapdrugsfromrussia.com

10/24/2006 07:59 AM |

According to Mikhail Zurabov, the Russian Health and Social Protection Minister, the number of counterfeit drugs has "significantly" decreased, and now amounts to 3-4% of the Russian drug market. Mr. Zurabov relayed this information at a meeting with Russian President Vladimir Putin at the Kremlin earlier this week.

Most international organizations put the rate of counterfeits in the Russian health care system at 12%. Reducing this exposure to 3-4% is an exaggeration of truly Soviet agitprop proportions.

How did the Comrade Minister accomplish such a feat? Why he changed the law! (And we all know how much the Russian Mafia believes in the rule of law.)

Mr. Zurbov commented, "The penalties for such drugs has been defined and the decision was made to revoke the license of a company producing counterfeit drugs.”

That’s right, they reduced counterfeit medicines almost entirely by threatening to “revoke” the license of counterfeiters.

Surprisingly, the Minister neglected to mention the number of "licenses revoked," people arrested, or counterfeit medicines seized (and to reduce the Russion national volume from 12% to 3% there must have been quite a lot.) Maybe he's just really modest.

In any event, now that Russian drugs are so safe, maybe we should introduce legislation to allow importation into the US market.  Read More & Comment...

A Preview of the FDA From the Mind of IOM and Senator Grassley

10/23/2006 11:41 PM |

I had the opportunity to be briefed by the chair and staff of the IOM committee responsible for the drug safety report that came out recently. I was pretty rough on the study when it first came out and was hoping that a second pass might lead me to a sunnier set of conclusions.

But the thrust of the IOM report -- increasing the amount of time and money the FDA spends on claims data from HMOs to search for safety signals in order to generate post market studies to seek out rare safety problems -- is simply asking for troubling instead of eliminating it in the first place. And worse, it smacks of self dealing: after all once the IOM group decided to have nothing to do with anyone who had expertise in the science of drug development it was left with people that had ties to HMOs and the CERTs who just happen to rely on the purchase of claims data and contracts for data dredging to form the "expert" panel.

And the idea of increasing the number of safety reviews and adding people from the Office of Drug Safety to "restore the balance" between efficacy and safety as IOM safety chair Sheila Burke stated is overkill. What is preclinical, Phase I and Phase II dosing studies but safety related research? Or am I missing something? Maybe Ms. Burke could point to some evidence apart from the so -called culture gap she kept on referring to in her meeting and in the report since it was not to be found.

Finally, the IOM folks claimed that they did not believe that their recommendations would slow down drug approvals in any way and that they were not responsible for the actions of members of Congress who used the IOM report to support their pet regulations....Fat chance. It is already happening.

Following on the heels of Senator Grassley and Congressman Waxman beating up on the FDA for using non-inferiority trials to approve antibiotics we now see the FDA rejecting two new antibiotics just after asking sponsors to provide data that they were as effective as existing drugs. Now the FDA is asking Replidyne for example to conduct four additional trials to demonstrate faropenem's superiority - compared to a placebo or existing drug right after the company had completed 11 late-stage clinical trials and a safety database of more than 5,000 patients. The additional research will take at least two years and require millions more.

The company said it was disappointed. What it was cannot be published on a family blog. And unfortunately it is a harbinger of what will happen when the folks from the Office of Drug Safety empowered and encouraged by Grassley et al make their way on to the committees reviewing drugs will be doing. Drug development, even in those areas where medicines are badly needed, will become more expensive and more time consuming. And why in the world would a company take the Critical Path seriously after a stunt like this?  Read More & Comment...

Staying the Course on Part D

10/23/2006 12:03 PM |

No matter which party controls Congress, the effort to impose price controls (let's stop pretending that the government negotiates) on drug companies and money losing biotech firms (yes, most drug and biotech companies are not profitable) will be blocked by one the few people in Washington who gets it, President Bush:

October 22, 2006 -- "Who should be making decisions for consumers? Obviously, there's
a group of folks that feel like the government can do a better job than
the consumers themselves. We strongly believe that empowering
consumers is the appropriate way to promote quality in health care. As
a matter of fact, we will resist any changes to weaken the program."
- President Bush on Friday, urging Republican candidates
to talk up his administration's Medicare drug-benefit plan  Read More & Comment...

Breast Cancer Inaction

10/23/2006 11:29 AM |

If you want to know why people would whine about corporate sponsorship of breast cancer awareness and research...here's the reason: they don't like the emphasis on pharmaceutical intervention. To them -- and by them I specifically mean the group Breast Cancer INAction headed up by Barbara Brenner, it's all about the environment.

Brenner had made some of the silliest and emptiest statements about breast cancer or any disease for that matter. Here are two:

"We have to keep in mind that with all of this 'light a candle,' that people are dying," Brenner of Breast Cancer Action explained.

"We have got to just stop throwing money at it. We have been throwing money at it since the early 1970s and we still have no answers.

And her she is on the campaign of linking a share of retail sales to breast cancer research: "I understand that people want to do something," she said. But "if shopping could cure breast cancer, it would be cured by now."

All of these gems pale in comparison to Brenner's claim that regular mammograms for women are actually dangerous and cause cancer.


“The benefit of routine mammograms for healthy premenopausal women is unproven,” Brenner’s group asserts in a Web page entitled “What You Should Know About Mammograms.”

This is a lie. The scientific consensus is that routine mammography -- until something better comes along (and it will) -- reduces the risk of dying of breast cancer in women 50 and older by up to 30 percent.

But here is what Brenner claims:

“Healthy premenopausal women should not have mammograms as a routine matter. The risk of radiation, combined with the high incidence of both false negatives and positives, means that routine mammography for premenopausal women may well do more harm than good,” Breast Cancer Action asserts.

Of course she leaves out the increase chance of survival due to new drugs. That's because Breast Cancer Action endorses the "Prevention First" principle. The group opposes reliance on drugs and stresses the right to safe water, air and food. It claims irrefutable proof that PCBs cause breast cancer. In fact there is no mechanistic or biological evidence and the body of epidemiology work -- including that which has been refined by genotype -- shows an association.

Hence Brenner and her group advise women to avoid mammograms and the medicines that can save their lives and instead ask them -- instead of shopping for products that might contribute to such activities -- to donate to their twisted and life denying movement.

Such a deal.  Read More & Comment...

Health Care. Who cares?

10/20/2006 01:01 PM |

According to a new study in Health Affairs by (among others) the talented Kelly Hunt (now with the New York State Health Foundation), opinion surveys conducted in 2006 show that health care is an important but second-tier issue in terms of priorities for government action.

“The results suggest that in terms of priority for government action, health care is a second-tier issue. Today it ranks as the fourth most important issue for government to address, behind the war, the economy, and gasoline/oil prices/energy. This is a lower ranking for health care than in 1993, a time of major national debate about health care reform.

In the 2006 survey, health care was one of the top two issues for 13 percent of the population. This compares to 31 percent in 1993, when it was ranked second, and 9 percent in 2002, when it also ranked fourth.”

Here is a link to the full article

http://content.healthaffairs.org/cgi/content/abstract/hlthaff.25.w508  Read More & Comment...

The 100 Hour Reign of Terror

10/20/2006 08:22 AM |

Today's New York Times carries a story by Robert Pear on the Pelosi agenda for health care should the Democrats become the majority party in the House after the upcoming midterms. No surprise that top of the list "in the first 100 hours" would be an attempt to repeal the Medicare non-interference clause.

Those first 100 hours are beginning to sound like a real Reign of Terror for the American public health. Does anyone really believe that government can negotiate better than private industry -- for anything? One need only look at the VA system to see how government "negotiating" leads to restricted choice.

That fact, by the way, is not in the Times' story. Neither is the fact that the Part D program is HUGELY popular with American seniors.

Mr. Pear quotes Representative Pete Stark of California (who would be chairman of an important health subcommittee if Democrats were in the majority) as saying, "I don’t know that we could undo all the private plans. But at least we could offer a government-administered drug benefit."

Terrific! If the government thinks it can provide plans that offer as broad a range of choice as those presently available at lower costs, then I say have at it. But this does not require the non-interference clause to be repealed.

If the 100 hour Reign of Terror thinks to replace Part D with a VA-like plan, they will hear about it from the voters. Do they really think they can replace patient choice with price controls?

Here's something else to chew on -- I heard through the inimitable drugwonks.com grapevine that Mr. Pear interviewed the executive director of a certain large disease organzation and asked what his biggest concern would be should the Democrats win a House majority. The executive director's answer was "the repeal of non-interference."

That didn't make it into the story either.  Read More & Comment...

Beating the Price Connundrum

10/19/2006 08:16 AM |

We've previously called to your attention "The Emerging Market Dynamics of Targeted Therapeutics," a new paper by Jack Calfee (of AEI and also a CMPI advisory board member) and Elizabeth DuPre (see the drugwonks.com October 2nd posting, "Jacks ... or better").

Here's an interesting discussion of that paper in the current edition of the excellent European publication Pharma Marketletter.

Have a look and let us know what you think.

Download file  Read More & Comment...

Hello Dolley!

10/19/2006 07:30 AM |

Meat and milk from cloned animals! Calls for absurd, unscientific labeling!

Just another day at the FDA.

According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS. Plans to regulate cloned animals and food derived from them, should be released by the end of this year.

Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.

You want fries with that?

In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.

By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.

"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.

Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.

Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.

(Sorry about that.)  Read More & Comment...

Thin as a ... Reid

10/18/2006 09:52 AM |

Here's what Maurice Hinchey (D-Inflated Ego) said about Les Crawford's misdemeanor plea:

"Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical. The American public has the right to know what else Lester Crawford may have done in office that could have lasting, detrimental effects on the FDA. "

We could apply that same standard to lots of public officials. Like Harry Reid for instance. Or maybe Hinchey's own dealings with the casino interests allied with Indian tribes in his own Sullivan County. According to the AP the entire Indian casino process is just a pass through for non-Indian interests:

"The tribal preference law gives Indian-owned companies and Seneca joint ventures cost breaks over non-Indian firms on casino projects. But most of the joint venture companies are using Senecas only as brokers or consultants, according to a review by the newspaper of casino contracts, as well as interviews with Seneca leaders, contractors and disgruntled Senecas."

Nothing illegal here. But maybe there is something inappropriate or unethical. Applying Hinchey's sanctimonious standards we can ask....What did Hinchey know about these deals and when did he know it?

As the highly moral Maurice says:

"Leadership starts at the top. "

Or does it start by looking in the mirror?  Read More & Comment...