[Thelma]

Seems your concerns about doctor's ties to drug companies has been around much longer that I ever thought,

Concerns over the often cosy relationships between doctors and pharmaceutical industry go back a long way - at least as far back as the
14th century. In his Canterbury Tales, Chaucer writes of the Doctor

All of his apothecaries in a tribe
Were ready with the drugs he would prescribe
And each made money from the other's guile
They had been friendly for a goodish while

Coghill translation from the Middle English

[paula_w]

I think it probably goes back to the beginning of bartering, we'll have to ask the caveman in the Geiko commercials ....sorry if you don't have that commercial in Canada.

But what a fantastic quote for an op ed! Thanks! I will use it.

Paula

[aftermathman]

see

http://news.bbc.co.uk/1/hi/programme...ma/6291773.stm

for more dastardly dealings by big pharma.

Are these really the guys we are looking to in hope ?

Aftermathman.

[paula_w]

They are one and the same....lol....yikes..... maybe this trend below will create more watchdogs...paula

Why Nonprofits Fund For-Profit Companies Doing Drug Research

Science Journal by Sharon Begley, Wall Street Journal

January 26, 2007

Science has made paralyzed rats walk, cured mice of cancer and eliminated Alzheimer's in more lab rodents than you can count. Human patients? Not so much.

"There's frustration that developments from academic labs don't get picked up by [drug and biotech] companies," says Dayton Coles. As a board member of the Juvenile Diabetes Research Foundation, he has seen promising discovery after promising discovery emerge from the university labs that JDRF has funded, but none has turned into a cure for type-1 diabetes, which his daughter has.

Fed up with breakthroughs that fill journals rather than medicine chests, private foundations and charities that have traditionally funded academic scientists have started doing the once-unthinkable: writing checks for millions of dollars to for-profit companies.

It's a sign of desperation. One reason there have been so few drug breakthroughs lately is that the profit motive actually works against the development of new pharmaceuticals. Drug companies suffer from blockbuster-itis, the belief that only billion-dollar almost-sure things need apply for development. As a result, even the most brilliant discovery may not be translated into a drug unless it has 10-figure sales potential. Also, short time horizons on the part of venture capitalists, who generally want to see their biotech bets pay off in three years, don't mesh well with the lengthy drug-development process.

Enter the charities. Earlier this month, JDRF announced that it was giving $2 million to MacroGenics Inc., a Rockville, Md., biotech, for a phase-2/3 clinical trial of an antibody that might slow progression of type-1 diabetes. The antibody basically puts an immune-system cell called CD3 in a headlock, preventing it from orchestrating an immune attack on cells that produce insulin. Destruction of those cells causes type-1 diabetes.

MacroGenics acquired the rights to the antibody in 2005, after a major pharmaceutical company got it through safety tests with flying colors but then dropped it for financial reasons, says Scott Koenig, MacroGenics president and CEO. "Only" 1.7 million people in the U.S. have type-1 diabetes, so anti-CD3 therapy will never ring up Lipitor-like profits. Blockbuster-itis had struck again.

The macrogenics deal follows three others JDRF unveiled in 2006. In October, it announced that it would pay up to $3 million to Sangamo BioSciences Inc., Richmond, Calif., for a phase-2 trial of a protein drug that shows promise against diabetic neuropathy, in which nerve damage due to diabetes causes numbness, pain and, eventually, loss of motor function. It is also funding a phase-2 trial by Transition Therapeutics Inc., Toronto, of a drug that might make insulin-producing cells regenerate, and a phase-3 trial by TolerRx Inc., Cambridge, Mass., of an antibody that, like MacroGenics', might protect insulin-making cells.

Transition Therapeutics's big-pharma partner for its clinical trial bowed out in 2006, so the trial "would have come to a halt," says JDRF's Richard Insel, vice president for research. "We wanted to see this go forward, which meant moving beyond our traditional support for academic research."

In every case, the companies are also sinking their own (or investors') money into the trials. But they say the JDRF check makes a difference. "We were locked and loaded for our phase-2 trial, but the JDRF funding will let us look more closely" at how the drug works, says Sangamo CEO Edward Lamphier.

Parents of kids with diabetes aren't the only ones fed up with the slow pace of translational research. This week the Michael J. Fox Foundation announced that it had awarded Sangamo $950,000 to apply its gene-regulation research to slowing Parkinson's disease. In March, Families of Spinal Muscular Atrophy, founded by parents of children with this rare disease, ponied up $402,500 to help Paratek Pharmaceuticals, Inc., Boston, develop a drug for the disease.

"With 10,000 SMA patients in the U.S., the market is too small for companies to see this [disease] as a worthwhile bet unless we help them take a compound past the initial stages," says Kenneth Hobby, executive director of the charity. "If that means funding a company, we have no problem with that."

At the Myelin Repair Foundation, "we decided we have to break the mold to bridge the translational research gap, which is getting bigger and bigger," says the foundation's chief operating officer, Russell Bromley. That means paying companies to conduct validation research, in which scientists test how a compound works in the body. Given how few bright ideas turn into FDA-approved drugs -- fewer than one in 1,000, according to the pharmaceutical industry -- companies want compounds "de-risked" for them. Translation: get someone else to do, or pay for, this step.

Charities realize that writing checks to for-profits might not be what their donors had in mind. "We debated whether it was right for our money to go to a company that might make a profit," says JDRF board member Michael White. "We're not unconcerned about that. But we've invested so much in discovery, what we need now is to take these things to market. We're taking on the role of 'venture philanthropists.' "

[vlhperry]

Hi Paula,

I also am advocating against private research but have my advocation centered on DNA. Patients are signing away their right to know their DNA information to private companies when participating in research. There is absolutely no rational reason why the patients cannot be told this very personal information to make better decisions about their health care.

If a patient knows his DNA mutation, he can focus on researching for research or participate in research specifically focused on his or her known mutation. I can understand a patient not being told until after a study whether he has received a experimental drug or placebo. When information is collected by taking blood samples from patients, then forcing the patient to sign away the right to personal information, then in turn make a profit of off the DNA string by copyrighting it and forcing other researchers to purchace the right to study the DNA for other diseases is wrong. Small research companies will not be able to afford the cost for the right to study the DNA which could apply to other neurological disorders.

The blood drawn is no more than information. The private company simply puts the information into a easily accessed form using a computer and then makes a hefty profit from information that cost them nothing to collect. The least they can do is allow the patient to know the results of his blood draw. It will not change the result of the study, and will only help the patient.

Private Research Companies are most definitely taking advantage of the patients.

Vicky

[paula_w]

Transparency, providing participants in trials with all results, is a major issue with patient groups of all illnesses. It doesn't get any more personal than your DNA...how offensive that it's for sale and kept from you.

Good luck!
Paula

[paula_w]

Vicki,
Along the same lines, your situation may be about property.
You may have seen this:

http://www.sciam.com/print_version.cfm?articleID=60AADF2C-E7F2-99DF-383C632C90DD1AA5





January 26, 2007

Open Access to Science Under Attack
Advocates of open access to scientific research may find themselves under fire from high-profile public relations flaks and high-powered lobbying groups.

By David Biello

The battle over public access to scientific literature stretches back to the late 1990s when Nobel Prize winner Harold Varmus began plans for PubMed Central—a repository for all research resulting from National Institutes of Health (NIH) funding—and, a few years later, launched the Public Library of Science (PLoS). These easily accessible journals and repositories have struck fear into the hearts of traditional publishers, who have enlisted the "pit bull" of public relations to fight back, reports news@nature. The Professional and Scholarly Publishing Division of the Association of American Publishers hired Eric Dezenhall, head of Dezenhall Resources, a public relations firm that specializes in "high stakes communications and marketplace defense," to address some of its members this past summer and potentially craft a media strategy. Dezenhall declined to comment for this article, citing "our longstanding policy due to strict confidentiality agreements neither to identify our clients nor comment on the work we do for them," in an e-mail response to a request for an interview. But "nobody disagrees on the goals of high-stakes communications—sell a controversial product, win an election, defuse conflict and so forth," Dezenhall notes in the "manifesto" on the firm's Web site. "The life-or-death public relations struggles facing businesses today are not about information, they are about power." In this case, the struggle is over access to scientific information.
Specifically, according to Dezenhall's suggestions in a memo to the publishers that they should "develop simple messages (e.g., Public access equals government censorship; Scientific journals preserve the quality/pedigree of science; government seeking to nationalize science and be a publisher) for use by Coalition members." In addition, Dezenhall suggests "bypassing mass 'consumer' audiences in favor of reaching a more elite group of decision makers," including journalists and regulators. This tack is necessary, he writes, because: "it's hard to fight an adversary that manages to be both elusive and in possession of a better message: Free information." Finally, Dezenhall suggests joining forces with think tanks like the American Enterprise Institute and National Consumers League in an attempt to persuade key players of the potential risks of unfiltered access. "Paint a picture of what the world would look like without peer-reviewed articles," he adds.
Of course, open access does not mean no peer review. While the National Institutes of Health (NIH) is not in the business of peer review, according to Norka Ruiz Bravo, NIH's deputy director for extramural research, the entirety of PLoS journals are peer-reviewed. "Open-access journals are peer-reviewed to the same standards," notes Mark Patterson, PLoS's director of publishing. "We wanted to provide an open-access alternative to the best journals to allow the very best work to be made publicly available."
To do that, PLoS shifted from the old model of subscribers paying to read content to an author-payment business model, in which scientific researchers pay the costs (from $1,250 to $2,500, depending on the journal) of immediately publishing their work, Patterson says. "The flagship journals PLoS Biology and PLoS Medicine are more expensive to run than the journals that are run by the community," he adds.
The American Association of Publishers declined to comment on Dezenhall's advice, but said in a statement: "Some commentators have expressed surprise that the publishing industry is making its case about an important issue that could affect the future of research and science. We believe it's important to be clear about serious unintended consequences of government mandated open access. & Legislation that would undermine the quality, sustainability and independence of science would have consequences on all those who rely on sound science."
One such piece of legislation was introduced in the Senate last year by Sens. Joseph Lieberman (I-Conn.) and John Cornyn (R-Tex.) that would require any published paper derived from U.S.-government-backed research to be published online within six months. PubMed Central, published by the NIH—a federal institution—has come under especially intense fire. Their efforts have been dubbed "socialized science," by Rudy Baum, editor in chief of the American Chemical Society's (ACS) Chemical and Engineering News. "Open access, in fact, equates with socialized science," he wrote in a 2004 editorial. "I find it incredible that a Republican administration would institute a policy that will have the long-term effect of shifting responsibility for communicating scientific research and maintaining the archive of science, technology and medical (STM) literature from the private sector to the federal government."


In fact, the ACS paid lobbying firm Hicks Partners LLC at least $100,000 in 2005 to try to persuade congressional members, the NIH, and the Office of Management and Budget (OMB) that a "PubChem Project" would be a bad idea, according to public lobbying disclosures, and paid an additional $180,000 to the Wexler & Walker Public Policy Association to promote the "use of [a] commercial database." It also reportedly spent a chunk of its 2005 $280,000 internal lobbying budget as well as part of its $270,000 lobbying budget last year to push the issue, according to disclosure documents. The ACS publishes more than 30 journals covering all aspects of chemistry, and the organization did not return phone calls for comment.
Efforts for a PubChem Central have come to naught thus far and the NIH's efforts with PubMed Central have met with limited success. Of the as many as 65,000 articles derived from NIH-funded research, only 10,000 or so are available at PubMed Central. "We have authors sending in 4 percent of articles," says Neil Thakur, Ruiz Bravo's special assistant. "An additional 10 to 12 percent are submitted by publications."
"Having been at a research institution, if something is not mandatory for me and I'm a scientist and I'm focused on the science, then doing something like this is not something that I am going to pay attention to," Ruiz Bravo adds. "We could go to a mandatory policy with a six month deadline. We've been considering that."
The open-access movement is not confined to the U.S., of course. The Wellcome Trust in the U.K. has begun providing funds to its researchers explicitly to cover the costs of publishing in open-access journals. And the NIH has signed agreements with international repositories to make its publicly available material available there.
This open-access groundswell, ranging from the physics community's preprint arXiv to centralized, postprint PubMed Central, threatens many traditional publishers, though the most prestigious journals, such as the weekly Nature appear unthreatened. Nature declined to comment for this story (Note: Both Scientific American and Nature are owned by the same company: Holtzbrinck Publishers). Rather, it is the niche publishers that may have the most to lose. "If you are published in a journal that publishes every other month or quarterly and there is mandatory open-access in six months, then, as a librarian, you are going to cancel it," notes Martin Frank, executive director of the American Physiological Society (APS), which publishes 14 journals, including the American Journal of Physiology (started in 1898). "We consider ourselves a delayed open-access journal."
The APS makes all of its content free after 12 months or asks authors to pay for immediate free publication online, an opportunity 18 percent of authors have taken, Frank says. He also leads the Washington, D.C., Principles for Free Access to Science group, a coalition of not-for-profit publishers advocating such a middle way. "The author-pays business model has yet to be demonstrated to be viable," he notes. "Something can only be eclipsed if something else has been demonstrated that is better than it."
"I agree with public access, but it doesn't have to be immediate," he adds. "If it's immediate, it has to be paid for."
For example, the NIH could pay for publication as the Wellcome Trust does. At $3,000 per article that translates to roughly $200 million a year. "That's not a lot of money compared to $28 billion," the NIH budget in fiscal year 2006, Frank notes, "but that represents 100 research grants." Dezenhall expressed a similar sentiment in his memo to publishers: "In theory, this may provide free taxpayer access to research that they fund, but they will pay eventually with substandard articles and their money being used to develop and maintain an electronic article depot rather than to fund new research."
Regardless of the "attack dogs" hired by traditional publishers to craft their message, public access advocates remain undeterred. "We've got the technology to make this happen with the Internet. The only thing that's holding it back is this adherence to an old business model, which made sense in the world of print, but no longer makes sense," PLoS's Patterson says. "It's great for authors: anyone with an interest in their work can access it."

"There are some folks who feel very threatened by PubMed Central," the NIH's Ruiz Bravo adds. "We really are committed to having an archive. We will do everything we can to make this a successful endeavor."
"Change is in the wind, and change is hard," she continues. "I think this is inevitable."

[reverett123]

I've wondered when they would try to clamp down on Medline. This is a big one.

It should be pointed out that much/most research has either tax or grant money involved, so they want us to pay for it but don't want us to read it.