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Posted on Fri, Jun 22, 2012 : 5:36 p.m.

New report: Ann Arbor 2nd in clinical trials as Michigan builds pharma industry

By Amy Biolchini

A new industry-funded study shows clinical trials by national biopharmaceutical companies are a significant economic driver in Michigan.

Since 1999, 3,424 clinical trials for new medicines have been conducted in the state - 866 of which have happened in Ann Arbor, according to research released Friday by the Pharmaceutical Research and Manufacturers of America (PhRMA) in a press conference at the University of Michigan Health System.

Biopharmaceutical companies have generated about $1.6 billion in 95,000 Michigan employee salaries, which in part has contributed to $57 million in state tax revenue and more than $388 million in federal taxes in 2008.

Detroit leads the state in the number of clinical trials, with Ann Arbor second.

The millions of research dollars granted to faculty at the University of Michigan Medical School would mean nothing without clinical trials, said Dr. James Woolliscroft, dean of the school.

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James Woolliscroft

More than 400 clinical trials are ongoing at the Medical School, he said. Clinical trial research is also a growing area of study for many students studying to be physicians, Woolliscroft said.

As new medicines are developed, clinical trials are used to prove the safety and effectiveness of the treatments to meet standards set by the Food and Drug Administration.

The trials involve thousands of volunteer patient participants, and occur over seven years in three phases.

In the development of an average new biotechnology medicine - a price tag of about $1.2 billion, on average clinical trials would account for about 45 to 75 percent of the process cost.

About 25 percent of all the pharmaceutical clinical trials conducted in the state have happened in Ann Arbor - the majority of which have targeted cancer, as well as the remaining other major chronic diseases: Cancer, diabetes, heart disease, mental illness and stroke.

Though everyone wants newer and better medicines and treatments, the process is often stymied, said Jeff Trewhitt, senior director of communications for PhRMA.

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Jeff Trewhitt

Less than 5 percent of patients enroll in clinical trials, and more than 70 percent of clinical trials have patient enrollment problems that result in delays of the process and a lag in drug development, Trewhitt said.

The climate in Michigan - which includes a strong infrastructure for “top-notch” biopharmaceutical research - is why the state falls above the middle of the pack nationwide when it comes to clinical trial research, Trewhitt said.

“We do have a prevailing message,” Trewhitt said of PhRMA. “Keep that environment to sustain this very expensive research.”

California, Massachusetts, New York and Ohio lead the way with clinical trials, Trewhitt said.

Though there is no current legislation in the Michigan House or Senate that would threaten the industry, should the state put price controls on certain medicines, Trewhitt said the pharmaceutical companies would likely look elsewhere when conducting their clinical trials.

“It’s not just enough to do the trials… it takes a lot of focus on lateral policies,” said Stephen Rapundalo, CEO of MichBio and chairman of the Michigan chapter of We Work For Health.

Rapundalo noted Michigan leaders would like to see the industry grow, which was echoed by the two Republican state congressmen in attendance at the Friday press conference.

Michigan’s economy has been able to shoulder the decline of the auto industry by relying on its agricultural and tourism generators, said State Rep. Mark Ouimet, R-Scio Township, but noted that the entrepreneurial nature of pharmaceutical companies is important to the state.

“The research part of what goes on at our three research universities was our shining star in the last decade,” Ouimet said Friday in an interview with AnnArbor.com.

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Randy Richardville

Ouimet said that since the biopharmaceutical industry is heavily regulated, the state needs to make sure the environment remains friendly to the companies for growth.

“We, in the legislature, are going to continue to expand that in any way we can,” said Michigan Senate majority leader Randy Richardville, R-Monroe.

Retraining people displaced by lost auto industry jobs into new fields is something that’s very important in the legislature, Richardville said.

Amy Biolchini covers Washtenaw County, health and environmental issues for AnnArbor.com. Reach her at (734) 623-2552, amybiolchini@annarbor.com or on Twitter.

Comments

Henry Greenspan

Mon, Jun 25, 2012 : 5:36 p.m.

See today's New York Times article on the way Pfizer/Pharmacia misrepresented the results of a clinicial trial concerning Celebrex. Here is one summary: Iin February 2000, Pharmacia employees came up with a game plan on how they might present the findings. "Worse case: we have to attack the trial design if we do not see the results we want," "…If other endpoints do not deliver, we will also need to strategize on how we provide the data." Another document suggested explaining poor results as "statistical glitches." In fairness, some employees questioned the publication of a "cherry picked" (their term) study. But the study went on to be published in a major medical journal. What is needed is the same kind of integrity that generally does accompany the _doing_ of clinical trials with their use in promotion afterward. This where marketing can overtake medicine, as--in a different way--I believe it also did in the study and news conference originally reported on in this a2.com article.

Henry Greenspan

Sun, Jun 24, 2012 : 3:50 a.m.

The U.S. has very strong guidelines about informed consent. When things go right, patients are informed that there is no evidence or suggestion that the drug being tested (or the placebo!) will be medically helpful to them. While trial adminsitrators cannot suggest the drug will be helpful, virtually all patients believe it.. If you have a terminal illness, and there are essentially no other options, how could you not? If a patient was appropriately informed, there would be little if any basis for a lawsuit of any kind. In the U.S., the problems have mainly to do with inadequate trial designs and trials that are deliberately set up for marketing rather than scientific purposes. This is especially true for trials conducted by private companies. In some cases, the same company designs the trials, recruits the docs who recruit their patients, arranges for the results to be written up (including supplying their own medical writers), finds ways to bury or spin trials that don't come out in the interest of the drug, and handles marketing of the drug to docs and consumers--"from test tube to boob tube," as the saying goes. Anyway, it is complicated. As I wrote in my initial post, we need clinical trials--no new drugs would be possible to develop without them. What I found objectionable was the staging of the release of the report about clinical trials in Michigan as a largely political/promotional event. See an important recent article and editioral in the May 2nd Journal of the American Medical Association raised key questions. Here, what we read here was mostly threats that if there is legislation that could "threaten the industry," Trewhitt (the representative of the industry), "said the pharmaceutical companies would likely look elsewhere when conducting their clinical trials." Pols and other industry reps--and, perhaps inadvertently, a2.com--joined the chorus.

fairfield

Sun, Jun 24, 2012 : 12:29 p.m.

"patients are informed that there is no evidence or suggestion that the drug being test will be medically helpful": no such suggestion in the pink sheet patients are asked to sign. But the doctor did tell my husband that "we have had good results" with that drug. What is written in the find print is not always what doctors say.

fairfield

Sun, Jun 24, 2012 : 12:15 a.m.

Are the volunteers fully informed of all side effects of the drugs being tested? Are the doctors and the patients informed of any pending lawsuit in other states, e.g. if a patient was killed, or alleged to have been killed, by the drugs being tested? If the drugs being tested hasten the death of a patient, who is deemed responsible: the drug manufacturer, or the doctors if they were too eager to test these drugs and did not stress the dangers to the patients, or just believed, and passed on, everything the drug companies told them? (My guess is that nobody feels responsible; patients, especially terminally ill patients, are "disposable"; that is the main difference between a doctor's patients and a farmer's cows: the cows are not "disposable"; new patients are a dime a dozen). Has any doctor ever been jailed for neglecting to "do her homework" and check carefully what the drug companies told her. I doubt it. When doctors get money from drug companies, can you still trust them?

whatsupwithMI

Sat, Jun 23, 2012 : 11:53 p.m.

It's worth noting that most clinical trials, phase I and II for sure, some phase III, take place in 3rd world nations. I guess Michigan met that last criteria- and just like a 3rd world nation, residents here cannot sue big pharma, due to a degree by the Emperor.

Henry Greenspan

Sat, Jun 23, 2012 : 10:32 p.m.

Strongly agree with WhatsUp. If anyone wonders about some of these issues, do a google search with the keywords "clinical trials impoverished." You'll be surprised (perhaps) by what you see.

whatsupwithMI

Sat, Jun 23, 2012 : 10:10 p.m.

Hey AA News blog: When reporting on topics like this, we seem to see a lot of spin in the blog article "all is great", but the reality is just not so (and informed comments have data to show this). You can find MANY ex-Pfizer folks (or whatever industry you would like to write about) available upon Linked-In. A small fee will give you business access and you will have even more details available about possible sources to contact-- so you can separate fact from fiction, spin from reality. You could be rewarded with national recognition, just like that blog writer from Ypsilanti has recently been rewarded. It isn't that some/this article is *badly written*, it just... is missing a lot of pertinent facts about the topic under discussion. People notice. Especially in as diverse and educated an area as the AA/ Ypsi region (and yes, I mean it re: Ypsi).

Henry Greenspan

Sat, Jun 23, 2012 : 9:04 p.m.

Clinical trials are, indeed, a necessary part of new drug development. But the industry-funded study that is cited in this article, and the solicited comments, are misleading in a number of ways. Michigan recently lost more than $20 million dollars because of a one-of-kind shield law that literally makes it possible for citizens--and now the state itself--to bring damage claims against pharmaceutical companies. In this case, the U.S. Dept. of Justice ruled that Merck had mispresented both safety and efficacy data for the drug, Vioxx. The misrepresented data came from the company inaccurately reporting and spinning the results of clinical trials.Civil penalties in this case amounted to more than $600,000, of which one-third went to the states. Michigan was the only state not allowed to collect on its share because of our drug shield law. Representatives of the pharmacentical and biotech industry and their friends in the state house would like to scare Michigan citizens into not seeing the obvious. Why are so many clinical trials conducted in Detroit? Because unemployed and impoverished people are willing to take the risk of trial participation to feed themselves and their families for another day. Pharma should simply say "thank you," rather than creating studies mostly aimed to induce fear and advance self-interest.

Henry Greenspan

Sat, Jun 23, 2012 : 9:06 p.m.

errata: "possible" should have been "impossible." "$600,000" should have been "$600,000,000."

Vivienne Armentrout

Sat, Jun 23, 2012 : 1:37 a.m.

Clinical trials are necessary to have good data about drugs' effectiveness and are indisputably beneficial to the overall health of the broader population. But there are some darker sides to them, and to see them promoted as a growth industry is disconcerting. I worked for a couple of years at Parke-Davis in the late 80s-early 90s. I became very affected by what I learned about cancer clinical trials, especially later after my mother died of cancer. Phase I trials, which are conducted to determine dose levels, are almost never beneficial to the clinical experimental subject. They are usually conducted on terminally ill patients, who undergo additional trauma in order to produce data useful in developing the drug. My mother was persuaded to undergo additional chemotherapy two weeks before she died. I'm grateful to be using pharmaceuticals that were developed with clinical investigation. But enrollment problems stem from the fact that this is often an altruistic offering on the part of patients. I'd hate to see any policy changes that coerce participation.

Trisha Carey

Sat, Jun 23, 2012 : 3:03 p.m.

I also have concerns about the people being used in these experiments, especially when they haven't had full information given to them. Both Detroit and UMichigan have collaborations with VA Hospital systems which is a whole entire other problem as medication followups are problematic for the regular medications let alone any experimental ones AND Michigan still being one of the few states where you can not sue pharmaceutical companies.

Townie

Sat, Jun 23, 2012 : 12:10 a.m.

Funny to hear Richardville talking about this given all the obstacles and endless Big Gobermint stuff he's pushed on UM. The problem is that this new pharma industry doesn't pay off politicians like Pfizer did. And it creates jobs that pay decently which is also 'anti-business' since it puts the Walmart employers in an uncomfortable position ('benefits?' - we gave you a bathroom, what more do you want?'). Mark - have you paid all the money back to Washtenaw County? AA.com - confirm?

xmo

Fri, Jun 22, 2012 : 11:48 p.m.

I just love to talk about stem cells! Adult Stem Cells or Tissue-specific Stem Cells have given us many drugs and cures. Researchers continue to work on these because of the benefits they reap both Financial and medical. On the other hand, Embryonic stem cells, the kind that come from abortions, currently there are no treatments using embryonic stem cells accepted by the medical community. Therefore, little or no research is being done because there is no pay off. These also raise serious ethical questions which Liberal/Progressives/Democrats refuse to talk about except in an emotional state.

clownfish

Sat, Jun 23, 2012 : 12:28 p.m.

"All the human embryonic stem cell lines currently in use come from four to five day old embryos left over from in vitro fertilization (IVF). " "I'm opposed to abortion. Can embryonic stem cell lines come from aborted fetuses? No. Cells with the potential to form embryonic stem cells in a lab dish only exist in these very young, four to five day old blastocysts. They are a fleeting cell type that disappears after that point in time. A common misconception is that the cells can come from older embryos or from aborted fetuses, which is in fact not possible." http://www.cirm.ca.gov/StemCellBasics_Questions It is important to have our facts straight before we Whine. I know that can be an issue for you XMO. IF your beliefs were based on facts then there would be an internal logic to them and I could understand why you believe the way you do, but so many of your posts are filled with fallacy, propaganda and misinformation that the only conclusion I can come is that you make up your ideology then find ways to bend the world to fit it.

clownfish

Sat, Jun 23, 2012 : 12:20 p.m.

- http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960028-2/abstract Are you aware that Blastocysts are regularly discarded from fertility clinics anyway? Why no laws against that?

leaguebus

Fri, Jun 22, 2012 : 10:08 p.m.

Must be Randy is forgetting about the Stem Cell rules he and his Merry Band of Republikans have legislated this year. LOL