Stem Cell Research

Michael Scally MD

Doctor of Medicine
10+ Year Member
Appeals court grants stay, allowing US government to fund stem cell research for now -
http://blogs.nature.com/news/thegreatbeyond/2010/09/appeals_court_grants_stay_allo.html

September 28, 2010

The United States Court of Appeals for the District of Columbia Circuit granted a stay late this afternoon, allowing US government funding of human embryonic stem cell research to continue unimpeded while a lawsuit challenging its legality works its way through the courts.

In a one-page pronouncement, the court, where a three-judge panel heard oral arguments on the matter yesterday, dissolved a temporary stay it had issued on 9 September and replaced it with a long-term stay. That stay will now remain in place until the appeals court decides on whether or not to overturn a 23 Augustinjunction by a lower court, which had halted federal funding for the research. The appeals court also said it would expedite the appeals process.

The government's lawyers, the appeals court wrote, "have satisfied the standards required for a stay pending appeal." Those standards included demonstrating irreparable harm if the injunction was not stayed, and establishing the government's likelihood of prevailing when the case is heard on its merits.

"This is a good step in the right direction," says Meri Firpo, a stem cell researcher at the University of Minnesota Stem Cell Institute. "But ultimately we are going to have to get some kind of permanent decision before we can really plan long term and make sure that our funding is secure."

"I'm glad that the court saw the wisdom in staying the injunction," adds Sean Morrison, the director of the Center for Stem Cell Biology at the University of Michigan in Ann Arbor. "This injunction has been, and would continue to be, very damaging to the field."

Tony Mazzaschi, the senior director of scientific affairs at the Association of American Medical Colleges in Washington, D.C., says that his group is "very grateful" to the court for understanding the harm to both intramural and extramural research support by the National Institutes of Health (NIH). "We look forward to a full airing of the legal issues involved," he adds.

In a statement issued this evening, Senator Tom Harkin (Democrat-Iowa), who chairs the Appropriations subcommittee that funds NIH, said, "While we celebrate the fact that the tide is turning in our favor, we realize that we must continue to fight for stem cell research. This stay gives us renewed hope that we will ultimately secure a legal ruling on the merits – one that will protect the ability of scientists to continue to explore the promise of stem cell research.”
 
I know this is a touchy subject filled with religious and political subplots......but the embryos and arboted fetuses are technicaly part of the mothers body. She owns them. She can make medical choices on how they are handled. Why doesn't the gov set up a legal donation system of aborted fetus and embryos but making it illigal for either the docotr or mother to get paid for it? Kind of like organ donation. The gov doesn't tell hospitals how they can use or research bodies donated.to science do they? Isn't it the same? Then one could hope funding could resume full force.
 
EDITORIAL: A Reprieve for Stem Cell Research
http://www.nytimes.com/2010/09/30/opinion/30thu2.html

September 29, 2010

A federal appeals court made the right choice on Tuesday when it allowed the Obama administration to keep financing embryonic stem cell research while legal arguments continue over whether to uphold or reject a temporary ban imposed by a lower court judge. Even a brief ban on financing would have disrupted research that scientists hope will lead to cures for devastating ailments like Parkinson’s disease and spinal cord injuries.

The plaintiffs in the case are two scientists who contend that federal support for embryonic stem cell research is illegal because embryos must be destroyed. They also claim, absurdly, that their ability to get government grants for their adult stem cell research would be diminished if the administration expands support for embryonic stem cell studies.

Any personal harm to their chances for a grant seems unlikely because the two kinds of research don’t compete head to head and there is no set limit on how much can be spent on either. On the more fundamental issue, we agree with longstanding legal interpretations that the Department of Health and Human Services can support embryonic stem cell research provided the stem cells are first derived (in a process that destroys the embryos) with private money.

Chief Judge Royce Lamberth of the Federal District Court for the District of Columbia concluded last month that the two scientists would suffer imminent and irreparable harm unless he granted a preliminary injunction against the financing while he presides over a trial on the legality of the program. He got it exactly wrong.

The two plaintiff scientists, one of whom has never even applied for a grant from the National Institutes of Health, would likely be unscathed if the financing goes ahead. If the federal money is blocked, some two dozen research projects would be abruptly terminated unless $54 million in private funds could be found. Eight intramural research projects at the N.I.H., with a combined budget of $9.5 million and a staff of 45 scientists and support personnel, would also have to shut down. And 20 new research projects that were about to receive financing would be stalled in their tracks.

The United States Court of Appeals for the District of Columbia Circuit gave no reasons for staying the temporary injunction while it considers whether the ban should take effect. And no one can predict how the courts will ultimately rule. That is why Congress needs to pass legislation to ensure that federal financing for this important research can proceed.
 
Scientists overcome hurdles to stem cell alternatives
washingtonpost.com

By Rob Stein
Washington Post Staff Writer
Thursday, September 30, 2010; 12:14 PM

Scientists reported Thursday they had developed a technique that can quickly create safe alternatives to human embryonic stem cells, a major advance toward developing a less controversial approach for treating for a host of medical problems.

The researchers published a series of experiments showing they can use laboratory-made versions of naturally occurring biological signals to quickly convert ordinary skin cells into cells that appear virtually identical to embryonic stem cells. Moreover, the same strategy can then coax those cells to morph into specific tissues that would be a perfect match for transplantation into patients.

The work, by a team led by Derrick J. Rossi of the Children's Hospital Boston, was praised by other researchers as a breakthrough.

"This paper is a major paper, in my view, in the field of regenerative medicine," said Douglas A. Melton, who co-directs the Harvard Stem Cell Institute.

Opponents of human embryonic stem cell research, meanwhile, seized on the advance as the most convincing evidence yet that alternatives were sufficient, rendering the morally questionable cells unnecessary.

Rossi and other researchers, however, said that embryonic stem cell research was still crucial because, among other things, embryonic stem cells are irreplaceable for validating alternatives.

Nevertheless, the announcement, described in a paper published in the journal Cell Stem Cell, could mark a pivotal moment in the long, contentious history of embryonic stem cell research.

The advance comes as the future of federal funding for embryonic stem cell research hangs in doubt. A federal judge stunned the field Aug. 23 by ruling that the Obama administration's new more permissive policy for funding the research violated a federal law barring taxpayer dollars from being used for studies that involve destroying human embryos.

The National Institutes of Health said that it supports research only on cells that have been obtained by privately funded scientists. An appeals court Tuesday let the NIH continue the funding as the case winds through the legal system.

Scientists hope embryonic stem cells will lead to cures for diabetes, Alzheimer's disease, Parkinson's disease, spinal cord injuries and a host of other ailments because they can turn into almost any tissue in the body. But they can be obtained only by destroying days-old embryos, which some consider equivalent to killing human life.

In 2006, researchers discovered that they could coax adult cells into a state that appeared identical to embryonic stem cells, dubbed induced pluripotent stem cells (iPS cells), by activating four genes. Those cells could morph into various tissues in the same way that embryonic stem cells can. But the process involved inserting genes into cells using retroviruses, which raised the risk the cells could cause cancer. Since then, scientists have been racing to develop alternative methods. Several approaches, using chemicals or other types of viruses, have shown promise. But none has completely eliminated the safety concerns, and most have been slow and inefficient.

The new approach involves molecules known as "messenger RNA," or mRNA, which the DNA inside cells use to create proteins they need carry out various vital functions. The researchers created mRNA molecules carrying the instructions for the cell's machinery to produce the four key proteins needed to reprogram themselves into iPS cells.

After tinkering with the mRNA molecules in the laboratory to make signals that the cells would not destroy as dangerous invaders, the researchers found that a daily cocktail of their creations were surprisingly fast and efficient at reprogramming the cells. The approach converted the cells in about half the time of previous methods - only about 17 days - with surprising economy - up to 100 times more efficient than the standard approach.

Moreover, detailed tests indicated the cells had not experienced any disturbing changes in their DNA caused by previous methods and were virtually identical to embryonic stem cells. In addition, the researchers went one step further and showed that they could use the approach to then coax the iPS cells they created into a specific type of cell, in this case muscle cells.


Warren L, Manos PD, Ahfeldt T, et al. Highly Efficient Reprogramming to Pluripotency and Directed Differentiation of Human Cells with Synthetic Modified mRNA. Cell stem cell. http://download.cell.com/cell-stem-cell/pdf/PIIS1934590910004340.pdf?intermediate=true

Clinical application of induced pluripotent stem cells (iPSCs) is limited by the low efficiency of iPSC derivation and the fact that most protocols modify the genome to effect cellular reprogramming. Moreover, safe and effective means of directing the fate of patient-specific iPSCs toward clinically useful cell types are lacking. Here we describe a simple, nonintegrating strategy for reprogramming cell fate based on administration of synthetic mRNA modified to overcome innate antiviral responses. We show that this approach can reprogram multiple human cell types to pluripotency with efficiencies that greatly surpass established protocols. We further show that the same technology can be used to efficiently direct the differentiation of RNA-induced pluripotent stem cells (RiPSCs) into terminally differentiated myogenic cells. This technology represents a safe, efficient strategy for somatic cell reprogramming and directing cell fate that has broad applicability for basic research, disease modeling, and regenerative medicine. º Modified mRNAs can express reprogramming proteins and evade antiviral response º Highly efficient derivation of human iPSCs without genomic integration º RNA-derived iPSCs faithfully recapitulate the properties of human ESCs º Efficient directed differentiation of iPSCs to differentiated myotubes
 
Bush stem cell policy may return
Bush stem cell policy may return - TheHill.com

By Julian Pecquet - 12/02/10 06:00 AM ET

Congress is running out of time to pass legislation allowing federal funding for embryonic stem cell research, potentially setting up the resumption of a Bush-era policy that President Obama reversed with fanfare shortly after taking office.

Without legislative action by year’s end, federal funding for the controversial research could once again be highly restricted, as it was under former President George W. Bush.

An appeals court could rule either way within the next few months, but legislation pending in the House and Senate could effectively make the decision moot by clarifying a 1996 law that bans the use of taxpayer money for research where human embryos are destroyed.

“Obviously, with every day that goes by, it becomes less likely” that the bill will pass, said Rep. Mike Castle (R-Del.), a co-sponsor of the legislation. “I’d like to see it happen, but I’m not exactly holding my breath.”

Obama’s order allows federal funding for biomedical research that uses embryonic stem cells to search for potential prevention or treatment of diseases such as Parkinson’s disease, Alzheimer’s and diabetes. Opponents say the practice is immoral and should not be funded by taxpayers because it requires the stem cells to be destroyed.

The mood among proponents of the legislation is a complete reversal from March 2009, when Obama signed an executive order reversing an eight-year moratorium. “We will vigorously support scientists who pursue this research, and we will aim for America to lead the world in the discoveries it one day may yield,” the president said at the time.

A federal judge struck down Obama’s order in August, saying it violated the 1996 Dickey-Wicker Amendment, a rider that makes it illegal to use federal monies to support research in which human embryos are created, destroyed or discarded. But an appeals court allowed the current policy to remain in place temporarily until it rules on the issue.

Rep. Diana DeGette (D-Colo.), who introduced the House bill, told The Hill she’s confident the bill could pass in both chambers. But she said House Majority Leader Steny Hoyer (D-Md.) has been reluctant to take time from the House’s busy schedule to pass the bill unless the Senate commits to taking it up.

“I’ve talked to my leadership about it and they say it’s still not off the table,” DeGette said. “The concern is ... an issue of time. Why would we have a vote on something like this if it’s not going to come up in the other body?”

The legislation has bipartisan support, and twice passed Congress before being vetoed by Bush. It first passed in 2005 by a 238-194 margin in the House, with 50 Republicans voting in favor. It passed again in 2007 by a vote of 247-176, with 37 Republicans voting yes. Eighteen Republican senators voted for it the first time, and 16 the second. Most are still in the Senate.

DeGette said she was also encouraged by the fact that Mark Kirk (R-Ill.), a member of the Congressional Stem Cell Whip Team when he was in the House, has been sworn in as a senator and can make a strong case directly to Senate Majority Leader Harry Reid (D-Nev.).

But asked about the likelihood of the Senate taking up the issue, a Reid spokesman pointed to a recent letter signed by every Senate Republican vowing to hold up all controversial legislation until the expiring Bush tax cuts are dealt with.

Even if the bill doesn’t pass this session, DeGette says the legislation could have a chance next year. She pointed to a recent Harris Interactive poll that found 72 percent of Americans are in favor of using embryonic stem cells left over from in vitro fertilization procedures for medical research.

“I don’t think it’s the last chance,” DeGette said. “We’re now beginning to see some real results from the research that’s happened. There’s been two human-subject studies that have been approved by the Food and Drug Administration just in the past two months, so you’re going to see more scientific advances. And so, if the new Republican majority in the House starts trying to put limitations on research or ban research, or if the court decision comes out the wrong way, then you’re going to see a renewed emphasis on codifying this.”

But Castle wasn’t as sanguine about the bill’s reception in a Congress controlled by his Republican colleagues.

“It’s evident that absolutely nothing will pass in the next Congress,” Castle told The Hill, “so if we’re going to do it, we have to do it during this lame duck.”

Paradoxically, the appeals court’s stay may have dampened the urgency for getting legislation passed, Castle suggested.

“I think that’s an important factor in all of this,” he said, “because then the whole thing could have stopped if we didn’t get something done [in Congress]. Now, with the injunction, things can go on limping along.”
 
frankly i have very serious issues with the mere concept of turning embryonic human beings into medical crops-for-harvest. yes, there is a titanic ethical difference between an embryo/zygote/blastomere/blastgocyst etc failing to attach to the wall of the womb n being flushed from a woman's body naturally on one hand, and cloning that proto-person by the uncounted trillions for the purposes of industry.

that there r left-over fertilized eggs from fertility clinics is regrettable, but the degree of objection skyrockets astronomically when that scientific inefficiency is offered as the logical pretext for accepting the industrialization of human life. to the poster above: human life will never be property, and any view otherwise is a benighted relic of the past.

ironically, i am an abortion-rights ABSOLUTIST who is often accused of being otherwise when arguing this topic, but the very concept of "the unborn human is not 'a person'" is simply a relic of the twisted logic of Roe v Wade. that decision was argued in an era when lawyers were afraid to argue for personal ownership of the self, since that would open the door to drug legalization, the right to suicide, "sodomy" rights and UNrestricted abortion...so the Roe lawyers argued FETAL VIABILITY instead. "we would NEVER question the legal rights of the 3rd trimester unborn, which is VIABLE, but the 1st and 2nd trimester unborn is not a person vis-a-vis the 14th Amendment".

THAT logical strategm trickled down into pop culture as "the fetus isn't alive" "the fetus isn't human" etc etc, with DISASTROUS consequences for American culture...recall the the Equal Rights Amendment was voted down by WOMEN. find me a pregnant woman who considers her WANTED gestating pregnancy to be anything less than "my baby"...in 20+ years of arguing this topic, only one woman (a certain popular NYC socialist activist) actually called her 4th-month pregnancy "fetal tissue"...and she was visibly awkward doing so.

luckily, Casey vs Planned Parenthood replaced Roe fully, setting the Right To Choose on the premise that restricting abortion under most circumstances "places an undue burden" on the mother...THIS is far closer to the concept of Liberty, and far more scientifically justifiable...and less politically radioactive.

in the 20 years between the 2 abortion decisions, America developed a gigantic culture war...putting the struggle for women's rights under far more duress than it deserved...and then there's the scientific trickledown: the invention of a self-selecting biolethical priesthood that presumes to help the public decide these issues. the reluctance to consider viruses as living things even...i've argued with fellow AIDS patients who don't even understand viral adaptation and mutation bcuz they've bought the useless construct that viruses r not living things!

there is certainly a place for embryonic stem cell research, but it is tremendously morally and ethically problematic, drastically oversold scientifically, and feeds a useless culture war. some of us will consider an unfettered future embryonic stem-cell industry to be the functional equivalent of Soylent Green, and act out against it accordingly, rest assured.

flame on. :)
 
But at what point does the mother/parents no longer hanve control of the embryo? If thru in vitro a couple is left with unwanted embryos and wanted to donate them, should that be illegal? As it stands its not illegal for a parent to harvest blood and stem cells from one child to donate to another no matter the age. The embryo is alive yes, but again, when is the cut off? heartbeat? sustainability outside the womb? Is a 4 celled zygote the same as a hundred celled embryo?

The areas are to grey to imagine. But at the same time the need is there for this research...Personally im still all for a mother, when knowingly having an abortion, should have the option to donate...as in NO MONEY....the fetal tissue. Regulate the abortion like organ transplants maybe?
 
Scientists Grow Parts For Kids With Urinary Damage
Scientists Grow Parts For Kids With Urinary Damage : NPR

By RICHARD KNOX
March 8, 2011

For going on 30 years, scientists have been trying to grow replacement parts for diseased, defective or damaged tissues and organs. They've had more disappointments than successes. But now and again, they come up with results that rekindle the flame.

The latest involves five Mexican boys between 10 and 14 who suffered terrible damage to their urinary tracts from auto accidents. They were unable to urinate normally.

"When they first came in, they had a leg bag that drains urine, and they have to carry this bag everywhere they go," says Dr. Anthony Atala of Wake Forest University in North Carolina. "It's uncomfortable and painful. So these children were mostly sitting or bed-bound."

Atala and his colleagues, including doctors at Metropolitan Autonomous University in Mexico City, figured out a way to grow a new urethra, the tube that empties urine from the bladder, for the children.

The first thing they did was remove a small patch of each boy's bladder.

"The piece of tissue we take is very small -– less than half the size of a postage stamp," Atala says. The tissue contains two types of cells –- muscle cells and endothelial cells, which form the lining of the urethra and other hollow tubes in the body, such as blood vessels.

The researchers multiplied these cells in the lab until there were 100 million of them. Then they used the cells to "seed" a cylinder made out of biodegradable material. A week or so later, the cells covered the cylinder, creating a tube of tissue about as long as a deck of cards, with a diameter a little bigger than a soda straw.

The researchers stitched these made-to-order tissue tubes into the gaps in the boys' urinary systems. Eventually, the biodegradable "scaffolding" melts away.

That was as long as six years ago. Today, in every case, the boys' re-engineered urinary tracts are functioning normally, the researchers say.

The unusually long follow-up is perhaps the most important aspect of the new report, which appears online in the British journal The Lancet.

Dr. Anthony Atala of the Wake Forest University School of Medicine says more studies are needed to see if the technique, which has only been tried in children, works in adults.

"Typically, if you're going to see these structures fail, they can fail early or they can fail late," Atala says. "But if you have them with this long of a follow-up, then you know they're going to do well over time."

Atala says the tissue grafts have grown along with the boys, who have had major growth spurts since their urinary repairs. "So the body is recognizing the implant as its own," Atala says.

He says the procedure has transformed the boys' lives. "These children are now totally normal," he says. "They're running around and doing the things they usually do."

The procedure might ultimately help thousands of children — not only those who suffer injury, but those with urinary birth defects, which afflict about one in every 150 male births.

But it won't happen tomorrow. First the trick has to be replicated in many more cases.

"We are only talking about five patients, which is certainly not enough for widespread, meaningful conclusions," says Dr. Dario Fauzo of Children's Hospital in Boston, a researcher not connected with Atala's research.

Fauzo welcomed the new results but says he'd like more evidence that the implanted cells actually stuck around. Alternatively, they might have somehow stimulated other cells in the boys' systems to heal the damage. Either way, he says, it appears they "did something helpful," but it would be important to know how they did it.

Atala says animal studies have shown that existing cells can't grow more than a half-centimeter into the kind of biodegradable "scaffolding" like the ones implanted in the Mexican children. So he thinks the implanted cells must have persisted.

In 2009, Atala's Wake Forest group implanted tissue-engineered bladders in nine patients, seven of whom were followed long-term. He says all seven of those replacement bladders are still functioning normally.

Other researchers have reported success in growing windpipes and blood vessels — though no one has yet grown a solid organ, such as a liver or kidney.

But, in another sign that the field of tissue engineering may be entering a new phase, Fauzo is set to try correcting some birth defects diagnosed by ultrasound in gestating fetuses. If the experiment wins Food and Drug Administration approval, he plans to harvest fetal cells from the amniotic fluid, multiply them in the laboratory, and direct them into becoming tissues that can replace a defective windpipe or repair a hernia in the fetus's diaphragm.

If it works, the replacement part would be ready by the time the baby is born. Beyond that, Fauzo hopes it will be possible to use the lab-grown tissues to repair birth defects before birth.


Atlantida R-R, Diego RE, James JY, Esther L-B, Shay S, Anthony A. Tissue-engineered autologous urethras for patients who need reconstruction: an observational study. The Lancet. Tissue-engineered autologous urethras for patients who need reconstruction: an observational study : The Lancet

Background - Complex urethral problems can occur as a result of injury, disease, or congenital defects and treatment options are often limited. Urethras, similar to other long tubularised tissues, can stricture after reconstruction. We aimed to assess the effectiveness of tissue-engineered urethras using patients' own cells in patients who needed urethral reconstruction.

Methods - Five boys who had urethral defects were included in the study. A tissue biopsy was taken from each patient, and the muscle and epithelial cells were expanded and seeded onto tubularised polyglycolic acid:poly(lactide-co-glycolide acid) scaffolds. Patients then underwent urethral reconstruction with the tissue-engineered tubularised urethras. We took patient history, asked patients to complete questionnaires from the International Continence Society (ICS), and did urine analyses, cystourethroscopy, cystourethrography, and flow measurements at 3, 6, 12, 24, 36, 48, 60, and 72 months after surgery. We did serial endoscopic cup biopsies at 3, 12, and 36 months, each time in a different area of the engineered urethras.

Findings - Patients had surgery between March 19, 2004, and July 20, 2007. Follow-up was completed by July 31, 2010. Median age was 11 years (range 10—14) at time of surgery and median follow-up was 71 months (range 36—76 months). AE1/AE3, ? actin, desmin, and myosin antibodies confirmed the presence of cells of epithelial and muscle lineages on all cultures. The median end maximum urinary flow rate was 27•1 mL/s (range 16—28), and serial radiographic and endoscopic studies showed the maintenance of wide urethral calibres without strictures. Urethral biopsies showed that the engineered grafts had developed a normal appearing architecture by 3 months after implantation.

Interpretation - Tubularised urethras can be engineered and remain functional in a clinical setting for up to 6 years. These engineered urethras can be used in patients who need complex urethral reconstruction.
 
Stem cell research may go on: D.C. Circuit
The D.C. Circuit Court supports the Obama Administration view that Congress has not sought to ban all use of federal funds for any form of research on human embryos.
Stem cell research may go on: D.C. Circuit : SCOTUSblog

Rejecting the argument that Congress intended to go as far as it could to stop any research based on human embryos, the D.C. Circuit Court on Friday cleared the way for the government to continue to pay for research that uses “stem cells” that were previously taken from embryos, so long as new cell lines are not created with federal money. The creation of a cell line requires the destruction of a human embryo, and that is what Congress has barred from federal funding, the panel ruled in a 2-1 decision in a case that seems likely to go to the Supreme Court.


Appeals court overturns stem cell research ban
http://news.yahoo.com/s/ap/20110429/ap_on_sc/us_stem_cells

WASHINGTON – A divided federal appeals court has ruled that opponents of taxpayer-funded stem cell research are not likely to succeed in a lawsuit to stop it.

In a 2-1 decision Friday, the panel of the U.S. court of appeals in Washington overturned a judge's order that would have blocked taxpayer funding for stem cell research.

The panel reversed an opinion last August by U.S. District Judge Royce Lamberth, who said the research likely violates the law against federal funding of embryo destruction.

The 1996 law prohibits the use of taxpayer dollars in work that harms an embryo, so private money has been used to cull batches of the cells. Those batches can reproduce in lab dishes indefinitely, and the Obama administration issued rules permitting taxpayer dollars to be used in work on them.
 

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Judge dismisses suit on federal stem cell research
http://news.yahoo.com/judge-dismisses-suit-federal-stem-cell-research-142427343.html

WASHINGTON (AP) — A lawsuit that had threatened to end the Obama administration's funding of embryonic stem cell research was dismissed Wednesday, allowing the U.S. to continue supporting a search for cures to deadly diseases over protests that the work relies on destroyed human embryos.
 
Judge dismisses suit on federal stem cell research
http://news.yahoo.com/judge-dismisses-suit-federal-stem-cell-research-142427343.html

"The lawsuit was filed in 2009 by two scientists who argued that Obama's expansion jeopardized their ability to win government funding for research using adult stem cells — ones that have already matured to create specific types of tissues — because it will mean extra competition"

Bet you can trace the money back to Big Pharma.
 
"The lawsuit was filed in 2009 by two scientists who argued that Obama's expansion jeopardized their ability to win government funding for research using adult stem cells — ones that have already matured to create specific types of tissues — because it will mean extra competition"

Bet you can trace the money back to Big Pharma.

Follow the money. Always follow the money.
 
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