how to improve drug testing

A board to discuss future MS therapies in early stage (Phase I or II) trials.

how to improve drug testing

Postby dignan » Wed Jan 14, 2009 9:11 am

I love this idea from economist Dean Baker on improving the clinical trial process. It's from an article he wrote on recommendations for the upcoming US stimulus package:

Publicly funded clinical trials

Start a system of publicly funded clinical trials. The point would be to take the conduct of trials out of the control of the drug industry so that doctors and researchers would have immediate and full access to all research findings.

As a quid pro quo for paying for the trials, the government would get control of the licensing of the patent. The drugs developed through this system would all be sold as generics costing somewhere near $4 a piece at Wal-Mart. The payback from this would be enormous, instead of spending $330 billion a year on prescription drugs in 2012, we might spend closer to $30 billion. We’ll be paying $30 billion a year or so for clinical trials, and maybe close to that much in licensing fees, and getting much better medicine.

And, as a side-benefit, people in developing countries would get cheap drugs too. We could put an end to “free-trade” agreements that try to jack up drug prices in poor countries through stronger patent protections. Total cost $30 billion a year.


<shortened url>

for more on this idea:

http://content.healthaffairs.org/cgi/co ... /28/1/w165

<shortened url>
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm

Advertisement

Postby Cojack » Thu Jan 15, 2009 4:55 pm

beautiful

jack
User avatar
Cojack
Family Member
 
Posts: 63
Joined: Tue Nov 11, 2008 3:00 pm

Postby ursula » Fri Feb 06, 2009 7:29 am

Brilliant!
But the lobbyists will surely know how to obstruct ideas like this.

Money makes the world go around.....

ursula
User avatar
ursula
Family Member
 
Posts: 83
Joined: Mon Sep 22, 2008 2:00 pm
Location: germany

Postby dignan » Fri Feb 06, 2009 8:23 am

I agree Ursula. The pharmaceutical lobby is probably strong enough to prevent this from happening. I wish they could at least test out the idea to see if it works...maybe in a country other than the US.
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm

Postby dignan » Tue Feb 10, 2009 7:04 pm

Here's a link to a related paper (they cite Dean Baker) from Arjun Jayadev and Nobel prize winner Joseph Stiglitz:

Link to PDF of paper
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm

A new kind of clinical trial

Postby Smilingface » Wed Feb 11, 2009 3:43 pm

It is a great idea but I doubt the incentive to push for new research with new ideas would be as great. Money unfortunately is a great motivator ....
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 2:00 pm
Location: North Carolina

Postby dignan » Wed Feb 11, 2009 7:46 pm

Smilingface, I agree that the owners of the big pharma companies wouldn't be motivated much by this system, but I think the lower barriers to entry would bring in a lot of smaller players. From what I've heard about the horrible inefficiency of the giant pharma companies, I'd guess that more smaller players would be a benefit for drug discovery. The system would still have to be set up so pharma companies could make money, so I think if you did it right, there would be a viable business model and potentially even more interest in the field.
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm

Postby dignan » Thu Mar 05, 2009 7:54 pm

There are a couple of other groups who are thinking of ways to change copyright / intellectual property laws to encourage innovation. I think these ideas would definitely be an improvement over the existing medical research system.

-- Markets outperform patents in promoting intellectual discovery, say economists

-- Economists say copyright and patent laws are killing innovation; hurting economy
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm

Harvard Medical School in Ethics Quandary

Postby Nemotoday » Fri Mar 06, 2009 6:42 am

Sorry about the size.

http://www.nytimes.com/2009/03/03/busin ... ml?_r=2&em

Harvard Medical School in Ethics Quandary

By DUFF WILSON
Published: March 2, 2009
BOSTON — In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

They say they are concerned that the same money that helped build the school’s world-class status may in fact be hurting its reputation and affecting its teaching.

The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money.

Harvard Medical School’s peers received much higher grades, ranging from the A for the University of Pennsylvania, to B’s received by Stanford, Columbia and New York University, to the C for Yale.

Harvard has fallen behind, some faculty and administrators say, because its teaching hospitals are not owned by the university, complicating reform; because the dean is fairly new and his predecessor was such an industry booster that he served on a pharmaceutical company board; and because a crackdown, simply put, could cost it money or faculty.

Further, the potential embarrassments — a Senate investigation of several medical professors, the F grade, a new state law effective July 1 requiring Massachusetts doctors to disclose corporate gifts over $50 — are only now adding to pressure for change.

The dean, Dr. Jeffrey S. Flier, who says he wants Harvard to catch up with the best practices at other leading medical schools, recently announced a 19-member committee to re-examine his school’s conflict-of-interest policies. The group, which includes three students, is to meet in private on Thursday.

Advising the group will be Dr. David Korn, a former dean of the Stanford Medical School who started work at Harvard about four months ago as vice provost for research. Last year he helped the Association of American Medical Colleges draft a model conflict-of-interest policy for medical schools.

The Harvard students have already secured a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school. (One Harvard professor’s disclosure in class listed 47 company affiliations.)

“Harvard needs to live up to its name,” said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders. “We are really being indoctrinated into a field of medicine that is becoming more and more commercialized.”

David Tian, 24, a first-year Harvard Medical student, said: “Before coming here, I had no idea how much influence companies had on medical education. And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.”

The students say they worry that pharmaceutical industry scandals in recent years — including some criminal convictions, billions of dollars in fines, proof of bias in research and publishing and false marketing claims — have cast a bad light on the medical profession. And they criticize Harvard as being less vigilant than other leading medical schools in monitoring potential financial conflicts by faculty members.

Dr. Flier says that the Harvard Medical faculty may lead the nation in receiving money from industry, as well as government and charities, and he does not want to tighten the spigot. “One entirely appropriate source, if done properly, is industrial funds,”

Dr. Flier said in an interview.

And school officials see corporate support for their faculty as all the more crucial, as the university endowment has lost 22 percent of its value since last July and the recession has caused philanthropic contributors to retrench. The school said it was unable to provide annual measures of the money flow to its faculty, beyond the $8.6 million that pharmaceutical companies contributed last year for basic science research and the $3 million for continuing education classes on campus. Most of the money goes to professors at the Harvard-affiliated teaching hospitals, and the dean’s office does not keep track of the total.

But no one disputes that many individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.

The rules, though, do not require them to report specific amounts received for speaking or consulting, other than broad indications like “more than $30,000.” Some faculty who conduct research have limits of $30,000 in stock and $20,000 a year in fees. But there are no limits on companies’ making outright gifts to faculty — free meals, tickets, trips or the like.

Dr. Jeffrey S. Flier, dean of the Harvard Medical School, appointed a 19-member committee to examine conflict-of-interest policies.

Related

Dr. Marcia Angell, a faculty member, wants to ban drug companies from providing any academic funding.

Other blandishments include industry-endowed chairs like the three Harvard created with $8 million from sleep research companies; faculty prizes like the $50,000 award named after Bristol-Myers Squibb, and sponsorships like Pfizer’s $1 million annual subsidy for 20 new M.D.’s in a two-year program to learn clinical investigation and pursue Harvard Master of Medical Science degrees, including classes taught by Pfizer scientists.

Dr. Flier, who became dean 17 months ago, previously received a $500,000 research grant from Bristol-Myers Squibb. He also consulted for three Cambridge biotechnology companies, but says that those relationships have ended and that he has accepted no new industry affiliations.

That is in contrast to his predecessor as dean, Dr. Joseph B. Martin. Harvard’s rules allowed Dr. Martin to sit on the board of the medical products company Baxter International for 5 of the 10 years he led the medical school, supplementing his university salary with up to $197,000 a year from Baxter, according to company filings.

Dr. Martin is still on the medical faculty and is founder and co-chairman of the Harvard NeuroDiscovery Center, which researches degenerative diseases, and actively solicits industry money to do so. Dr. Martin declined any comment.

A smaller rival faction among Harvard’s 750 medical students has circulated a petition signed by about 100 people that calls for “continued interaction between medicine and industry at Harvard Medical School.”
A leader of the group, Vijay Yanamadala, 22, said, “To say that because these industry sources are inherently biased, physicians should never listen to them, is wrong.”

Encouraging them is Dr. Thomas P. Stossel, a Harvard Medical professor who has served on advisory boards for Merck, Biogen Idec and Dyax, and has written widely on academic-industry ties. “I think if you look at it with intellectual honesty, you see industry interaction has produced far more good than harm,” Dr. Stossel said. “Harvard absolutely could get more from industry but I think they’re very skittish. There’s a huge opportunity we ought to mine.”

Brian Fuchs, 26, a second-year student from Queens, credited drug companies with great medical discoveries. “It’s not a problem,” he said, pointing out a classroom window to a 12-story building nearby. “In fact, Merck is right there.”

Merck built a corporate research center in 2004 across the street from Harvard’s own big new medical research and class building. And Merck underwrites plenty of work on the Harvard campus, including the immunology lab run by Dr. Laurie H. Glimcher — a professor who also sits on the board of the drug maker Bristol-Myers Squibb, which paid her nearly $270,000 in 2007.

Dr. Glimcher says industry money is not only appropriate but necessary. “Without the support of the private sector, we would not have been able to develop what I call our ‘bone team’ in our lab,” she said at a recent student and faculty forum to discuss industry relationships. Merck is counting on her team to help come up with a successor to Fosamax, the formerly $3 billion-a-year bone drug that went generic last year.

But Dr. Marcia Angell, a faculty member and former editor in chief of The New England Journal of Medicine, is among the professors who argue that industry profit motives do not correspond to the scientific aims of academic medicine and that much of the financing needs to be not only disclosed, but banned. Too many medical schools, she says, have struck a “Faustian bargain” with pharmaceutical companies.

“If a school like Harvard can’t behave itself,” Dr. Angell said, “who can?”
Keep smiling as who knows what good things might be around the corner and if the road snakes a bit keep going.
User avatar
Nemotoday
Family Member
 
Posts: 72
Joined: Fri May 21, 2004 2:00 pm

Postby dignan » Sat Jan 23, 2010 11:41 am

Here is another fantastic idea about how to improve the current drug discovery / patent system:

The Health Impact Fund, our flagship proposal, is a new way of stimulating research and development of life-saving pharmaceuticals. To provide wide access, medicines need to be affordable-but low prices don't create strong incentives for innovators to invest in research and development. The Health Impact Fund is an optional mechanism that offers pharmaceutical innovators a supplementary reward based on the health impact of their products, if they agree to sell those products at cost. The proposed Fund is to be financed mainly by governments.

http://www.yale.edu/macmillan/igh/
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 2:00 pm


Return to Drug Pipeline

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service