Planned Parenthood and Fetal Tissue Procurement

Unless you have been without any internet access for the past month or so, you have probably heard about the undercover videos made by David Daleiden of the Center for Medical Progress that feature the chief medical director of Planned Parenthood, Dr. Deborah Nucatola,  discussing the sale of fetal tissue that results from an abortion, and Dr. Mary Gatter, the Medical Directors’ Council President for Planted Parenthood doing essentially the same thing.

The emotional impact of these videos are immense, but I would like to try to step back from that and discuss the legal side of these videos.  Fetal tissue procurement is heavily regulated by the Federal government.  The specific laws that regulate human fetal tissue procurement are shown below:

42 U.S. Code § 289g–2 – Prohibitions regarding human fetal tissue
a) Purchase of tissue
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.
(b) Solicitation or acceptance of tissue as directed donation for use in transplantation
It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;
(2) the donated tissue will be transplanted into a relative of the donating individual; or
(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.
(c) Solicitation or acceptance of tissue from fetuses gestated for research purposes
It shall be unlawful for any person or entity involved or engaged in interstate commerce to—
(1) solicit or knowingly acquire, receive, or accept a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or
(2) knowingly acquire, receive, or accept tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal.
(d) Criminal penalties for violations
(1) In general
Any person who violates subsection (a), (b), or (c) shall be fined in accordance with title 18, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
(2) Penalties applicable to persons receiving consideration
With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.
(e) Definitions
For purposes of this section:
(1) The term “human fetal tissue” has the meaning given such term in section 289g–1 (g) of this title.
(2) The term “interstate commerce” has the meaning given such term in section 321 (b) of title 21.
(3) The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.

If we wade through the legalese, we can see that you cannot sell fetal tissue.  It has to be donated and it cannot come from a pregnancy whose sole purpose was to provide a source of fetal tissue.  You may not sell it for a profit.  You may also not transplant it.  All of this is meant to prevent women from having babies so they can sell their parts for money.  For this reason, abortion clinics may not use the possibility of fetal tissue donation as an inducement to persuade women to have an abortion.

In both of these videos, Planned Parenthood executives, not people who run individual centers, medical directors, which makes this official Planned Parenthood policy, actively discuss the prices of fetal organs.  That reflects an intent to sell fetal organs and that means that these videos reflect an intent to break a Federal law.  If this reflects routine Planned Parenthood policy and/or practice, then they are routinely breaking the law.

As you can see, at the very least, this deserves an investigation.  If Planned Parenthood clinics routinely charge biotechnology companies beyond their normal administrative and medical costs for fetal tissue, then they are breaking the law.  Maybe that is not the case (I highly doubt it frankly, but that’s my take), but we do not know without an investigation.  The Justice Department should become involved quickly and all federal funding of Planned Parenthood should be suspended pending full cooperation with a Federal investigation.  This should be the minimal results of these troubling videos.

StemCells, Inc., Sued by Former Employee Who Says Their Stem Cell Treatment is Unsafe

A California stem cell company, StemCells, Inc., that is developing cell-based therapies for several different neurological and eye conditions, is being sued by a former employee (whistleblower) who claims that the company did not follow proper protocols in the preparation of their treatments. Rob Williams, who was once a senior manager at StemCells, Inc., has alleged that the company fired him after he brought these problems to the attention of senior management.

According to the Courthouse New Service, Williams in the lawsuit stated that he “noted poor sterile technique, failure to adhere to current Good Manufacturing Practices in the company’s manufacturing process, and substantial deficiencies in the company’s Manual Aseptic Processing of HuCNS-SC (Human Central Nervous System Stem Cells) cell lines—failure and deficiencies that put patients at risk of infection or death during ongoing clinical trials.”

Ken Stratton, who serves as the general counsel for StemCells, Inc., has told the California Stem Cell Report that Williams’s employment “was terminated for performance deficiencies, and [the company] finds no merit to the allegations.” Stratton also said that “the elements of manufacturing practices that concerned Mr. Williams were immediately and carefully reviewed by the company.”

It might be worth noting that this lawsuit coincides with the departure this past April or May of StemCells, Inc.’s Executive VP of Manufacturing Operations and Regulatory Affairs, Stewart Craig, who took a position at Sangamo Biosciences.

Unfortunately for StemCells, Inc., this particular lawsuit comes soon after a second bit of bad press. Embryologist Alan Trounson led the California Institute for Regenerative Medicine (CIRM) until June of this year, but has joined the board of StemCells, Inc., shortly after leaving the state stem cell research funding agency. According to an opinion article written by Ron Leuty, who is a reporter for the San Francisco Business Times, Trounson has recused himself from discussions regarding a loan StemCells, Inc., received from CIRM in 2012 because of his close relationship with the company’s founder. “But the speed of his appointment to the StemCells board has raised questions” about a possible conflict of interest, Leuty wrote.

CIRM has been marred by conflicts of interest accusations since California voters in 2004 birthed CIRM through Proposition 71 and the subsequent sale of $3 billion in state bonds. Now it has one more strike against it.

Leuty called the situation an embarrassment for CIRM. “If the public perceives that individuals—researchers or CIRM employees or company executives—are feeding at the trough of the semiautonomous public agency, it isn’t going to help CIRM get more cash from that very same public that foots the bill.”

New Pluripotent Stem Cell Production Protein Identified

Large scale production of stem cells requires an intimate knowledge of the genetic networks that convert adult cells into induced pluripotent stem cells (iPSCs). The original protocol established by Shinya Yamanaka and his colleagues used four genes all clustered on a retrovirus vector, but there are safer, more technically subtle ways to make iPSCs.

Because iPSCs are made from a patient’s own cells, they are less likely to be rejected by the patient’s immune system. They also show tremendous developmental flexibility, they can potentially be differentiated into any adult cell type in the body.  The problem with iPSCs comes from the difficulty of making large quantities of them in a reasonable amount of time.  However, a new research publication from scientists at the University of Toronto, the University for Sick Children and Mount Sinai Hospital, in collaboration with colleagues from the United States and Portugal, identifies specific proteins that play central roles in controlling pluripotency that may mean a potential breakthrough in producing iPSCs.

Researchers discovered these proteins by using something called the “splicing code.”  Benjamin Blencowe discovered the splicing code a few years ago.  “The mechanisms that control embryonic stem cell pluripotency have remained a mystery for some time.  However, what Dr. Blencowe and the research team found is that the proteins identified by our splicing code can activate or deactivate stem cell pluripotency,” said Brendan J. Frey, from the University of Toronto Departments of Electrical Engineering and Medicine, who published with Benjamin Blencowe the paper that deciphered this splicing code (see Nature 2010 465: 53-59).  While a complete recipe for producing iPSCs may not be available yet, it is beginning to look more likely, according to Frey.

In this paper, Blencowe and his collaborators identified two proteins known as muscleblind-like RNA binding proteins, or MBNL1 and MBNL2.  These proteins are conserved and direct negative regulators of a large program of cassette exon alternative splicing events that are differentially regulated between embryonic stem cells and other cell types.

RNA splicing occurs in plant, animal, fungal, and protist cells (only very, very rarely in bacteria), and involves the removal of segments of primary RNA transcripts.  When RNA molecules are transcribed in eukaryotic cells, they are engaged by cellular machinery called the RNA spliceosome.  The RNA spliceosome removes segments known as “introns” and the excised introns are degraded and the remaining RNA segments, which are known as “exons, are ligated together to form a mature messenger RNA.

mRNA splicing

Some introns are removed from primary RNA transcripts by all cells, but others are removed in some cells but not others.  This phenomenon is known “alternative splicing” and it is responsible for the differential regulation of particular genes.


Alternative splicing is mediated by sequences called splicing enhancers and splicing silencers that are six to either nucleotides long and bind proteins that either induce or repress alternative splicing in those cells that express the proteins that bind these splicing enhancers or silencers.

Alternative RNA splicing mechanism

MBNL is one of these proteins that bind to RNA splicing silencers.  If the quantity of MBNL proteins in differentiated cells is decreased, then these cells switch to an embryonic stem cell-like alternative splicing pattern for approximately half of their genes.  Conversely, overexpression of MBNL proteins in ES cells promotes differentiated-cell-like alternative splicing patterns.  Among the MBNL-regulated events is an ES-cell-specific alternative splicing switch in a protein-coding gene called the forkhead family transcription factor FOXP1.  FOXP1 controls pluripotency, and consistent with a central and negative regulatory role for MBNL proteins in pluripotency, knockdown of MBNL significantly enhances the expression of key pluripotency genes and the formation of induced pluripotent stem cells during somatic cell reprogramming.

Thus MBNL proteins should be one of the main targets for the mass production of iPSCs.

Federal Court Rules in Favor of Federal Funding for Embryonic Stem Cell Research Legal

On August 24, 2012, a three-judge panel ruled that the government had properly interpreted a law that bans the use of federal funds research that destroys human embryos. Many legal observers, however, opined that this ruling will not end the controversy over this issue, and one of the judges on the three-judge panel importuned Congress to clarify what the government could and could not do with respect to human embryos.

This ruling upholds the dismissal of the case by the US Court of Appeals for the District of Columbia Circuit. The case, Sherley v. Sebellius, 11-5241, sought to prevent the US Department of Health and Human Services from using federal money to fund human embryonic stem cell research. The plaintiffs contended that funding human embryonic stem cell research would violate the Dickey-Wicker Amendment, which was passed as a rider to other legislation in 1996.

Predictably, biotechnology companies interested in embryonic stem cell-based treatments and other more academic embryonic stem cell researchers were quite pleased with the ruling. For example, Gary Rabin of Advanced Cell Technology said: “This court ruling should be of considerable benefit to our embryonic stem cell-based clinical programs. It effectively removes major speed bumps for the National Institutes of Health in terms of approving the several stem cells lines that we have submitted for their consideration for funding. We expect that a number of our embryonic stem cell lines will be approved for funding in coming months.”

The plaintiffs in this case were: a) James L. Sherley, who is a former a former member of the MIT faculty, but presently works as a senior scientist at the Boston Biomedical Research Institute; b) Theresa Deisher, who is the founder, managing member, and research and development director of AVM Biotechnology; and Nightlight Christian Adoptions, which is a non-profit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization; c) the Christian Medical Association, a non-profit association of doctors dedicated to improving ethical standards of health care in the United States and abroad.

The main argument put forward by the plaintiffs in this lawsuit is that the present NIH Guidelines for the funding of embryonic stem cell projects violate existing federal law that bans the use of federal funds for the destruction of human embryos. Because the NIH created and sent its guidelines with a preconceived determination to fund human embryonic stem cell research and without considering scientifically and ethically superior alternatives, the guidelines are invalid regulations that violate the federal Administrative Procedure Act and, therefore, should be struck down.

With respect to the merits of the plaintiff’s case, it seems rather obvious, to me at least, that the NIH guidelines violate federal law. The Dickey-Wicker amendment was sponsored by former Congressman Jay Dickey (RAK) and Senator Roger Wicker (R-MS) who was then a member of the House of Representatives)], and applied to every Health and Human Services (“HHS”) appropriations bill governing the National Institutes of Health (NIH) since 1995. The bill states, “None of the funds made available by this Act may be used for . . . research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. § 289g(b).” Even for lawyer-speak, that seems pretty clear to me. Embryonic stem cell research includes the derivation of new embryonic stem cell lines from human embryos.  The derivation process destroys the embryo, which is precisely the thing that the Dickey-Wicker amendment prohibits the NIH from funding with federal money.

However, the federal judges did not see it that way for one reason:  funding for embryonic stem cell research also includes work on already established embryonic stem cell lines.  These lines are already in existence that the decision to kill the embryos has already occurred.  Therefore, the judges thought that the Dickey-Wicker amendment was simply not specific enough on the matter to merit stopping all funding for embryonic stem cell work.

While this argument has merit, it dodges the fact that embryo-destroying research will be funded by the NIH because of this ruling and some of this research will include laboratories that destroy embryos to make embryonic stem cells.  This is clear, since several sources have noted the increase in embryonic stem cell lines approved for NIH funding.  For example the Nature Medicine blog had this to say:  “Since the beginning of the month, the NIH has quietly kept adding ES cell lines to its registry, bringing the total tally up to 128.”  Thus the NIH funding policy has definitely led to the destruction of more embryos.

Where did this legal battle originate?  It began in 1994, during the presidency of Bill Clinton.  Before 1994, there was a ban on human embryo experimentation.  The Clinton Administration took steps to reverse this ban, and allow embryo-destructive research on donated embryos left over from fertility clinics while still prohibiting research that created its own embryos for research purposes.;  This policy shift was in response to the recommendation of an advisory committee known as the Human Embryo Research Panel (“HERP”).  This was an ad hoc committee formed to address the question of embryo research.  The phrase “ad hoc” is a Latin phae that means “for this.”  It simply means that this committee was formed for to address this particular question.  In testimony before the House Appropriations Committee, NIH Director Varmus stated that NIH would have funded six out of nine applications for grants involving embryo-related research “if the NIH had been able to proceed according to the recommendations and the President’s directive.”  Varmus also stated that he “firmly agree[d]” with particular sections of the HERP report, and further told the Committee that NIH was currently deciding whether to go forward with funding embryo-destructive research on donated human embryos.

However, before NIH was able to approve any grants that funded embryo-destructive research, Congress passed the Dickey-Wicker Amendment for the first time.  Opponents of the amendment argued that prohibiting federal funding of embryos research would push such research into the dark recesses of private industry where it would not be properly regulated.  Also, the understanding of the amendment was universal throughout Congress: it would prohibit ALL federal funding of embryo-destructive research.  Democratic senator from California, Barbara Boxer, understood the Dickey-Wicker Amendment as creating “a total prohibition of Federal funding for human embryo research,” and Republican Congressman John Porter understood the amendment in this way as well.  In fact Porter tried to pass an alternative rider to the Dickey-Wicker Amendment that would have prohibited federal funding for only creation of new embryos, but not other types of embryo-destructive research with donated embryos, but his rider was defeated.

Even more significantly, the NIH understood the amendment that way from 1996-1999 when they enforced it.  DNA research with DNA from human embryos that did not necessarily kill the embryos was prohibited from receiving federal funding under the NIH’s understanding of the Dickey-Wicker Amendment.  In a 1996 letter (October 10)  to Georgetown University Medical School researcher Mark Hughes who was using federally funded equipment to conduct tests on DNA derived from embryos, NIH “clarif[ied] . . .the NIH position on embryo research.” The agency explained that “analysis from DNA derived from a human embryo” violated the federal prohibition on research involving embryos and that NIH equipment “may not be used for embryo work of any kind.”

However, four years later, the NIH altered its position and issue Guidelines authorizing the funding of human embryonic stem cell research (65 Fed. Reg. 51976, Aug. 25, 2000).  Before the 2000 Guidelines were published, then-HHS General Counsel Harriet S. Rabb issued a memorandum on January 15, 1999, that supported the National Institutes of Health (NIH) claim that the Dickey-Wicker Amendment ought to be re-interpreted to ban federal funding of the derivation of embryonic stem cells – the procedure by which human embryos are destroyed to harvest their embryonic stem cells – but not research utilizing the derived embryonic stem cells.  This is in direct contradiction to the clear understanding of the Dickey-Wicker amendment put forward by Congress.

To remedy this reinterpretation of the Dickey-Wicker Amendment (DWA), seven senators sent a letter to then Secretary of Human Health and Services, Donna Shalala.  In that letter they stated that “Congress never intended for the National Institutes of Health to give incentives for the killing of human embryos for the purpose of stem cell research.”  The warnings of the senators and the comments from many dissenting parties were ignored by the NIH.

When President Bush took office, he rescinded the Clinton rules and upheld the original interpretation of the DWA.  This ended when Barak Obama became president in 2008.  President Obama revoked President Bush’s Executive Order 13435 (June 22, 2007) and ordered NIH “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”

This was the reason for the lawsuit filed by Sherley and his co-plaintiffs.  They wanted the Federal government to simply recognize the law as it was originally written and interpreted.  Unfortunately, the judges ignored all that and went with their own shtick.  This is sad, and it should be remedied, but for now the situation seems to be that Congress’ laws do not mean what they originally say.

New Skin for Claudio

Michele De Luca from the University of Modena and Reggio Emilia in Italy specialize in culturing skin cells to make sheets of skin layers in culture that can be transplanted onto the bodies of patients with skin injuries or skin diseases. Patients with full-thickness burns or other types of injuries can benefit greatly from this type of therapy. Dr. De Luca is also interested in a genetic disease known as epidermolysis bullosa (EB). EB is really a group of diseases of the skin characterized by blistering in response to minor injury, heat, or friction from rubbing, scratching or even adhesive tape. There are four main types of EB and most of them are inherited.

Dr, De Luca had a patient named Claudio who suffered from EB. Claudio had been tortured all his life with huge open wounds all over his body. Dr. De Luca was able to grow Claudio’s skin in culture and form large sheets of skin, but, unfortunately, these skin sheets were just as abnormal his Claudio’s native skin, and the transplanted sheets would have done little good.

To solve this problem, Dr. De Luca used gene therapy to fix the genetic problem in Claudio’s skin cells. Claudio suffered from a mutation in the gene that encodes Laminin 5, a cell adhesion protein that is essential for getting the skin layers to stick together.  In order to fix this mutation, De Luca used a completely novel method for placing genes into cells that included viruses that inactivate themselves once they insert into the genome of the cultured cells, but the inserted gene is still under the control of sequences that cause it to be expressed only in skin cells.

After introducing a normal copy of the laminin 5 gene into Claudio’s cultured skin cells, Dr. De Luca was able to grow Claudio’s skin in cultured into tough, resilient, skin sheets that were then transplanted onto Claudio’s legs. The transplanted skin provided large swaths of normal skin that did not suffer from open wounds or pain. The grafts have now been in place and stable for several years.

The combination of two technologies, gene therapy and tissue engineering gave Claudio a new lease on life. Unfortunately, because genetically engineered cells are, legally speaking, drugs, many new safety criteria must be met before this technology is ready for use in an off-the-shelf kind of treatment for patients.

Wall Street Journal Opines on FDA and Stem Cells

Scott Gottlieb (physician) and Coleen Klasmeier (attorney) have penned an excellent op-ed piece in the Wall Street Journal that tasks the FDA for their unbending regulatory caprice and unwillingness to adapt to the new advances in medicine. It is definitely in line with what Centeno has been saying for these long years. Read it here.

They are reasonable troubled by the DC court’s uncritical acceptance of the FDA’s arguments and note:

“The FDA has repeatedly sought to blur the line between manufacturing medical products and practicing medicine whenever new techniques emerge. But the standard for regulation isn’t whether the agency feels a technique is novel but whether it meets the definition of being a medical product.

Federal regulators have stretched that definition to the point where a reasonable limit no longer exists. The law provided a clear impediment to unrestrained exercise of FDA authority. Something needed to be an “article”—not a medical procedure—in order to become a drug. The constraint that a drug needed to be a “thing” has been read out of the law by FDA, and the district court appears to have accepted that position.

If the FDA’s victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency’s reach.”

They also sadly note:  “Most of the science of using adult stem cells for regenerative medicine is unfolding in Britain, Singapore and Israel precisely because of the FDA’s bent to hold with misgiving anything novel in medicine.”  Reform the FDA.  To do that we need a new president.

Centeno Responds to the FDA: Part 3

In the last post, we saw that Centeno responded to the FDA by noting that in their own history, the FDA regarded cells as drugs by changing the wording in a statute in a manner that did not conform to standard legislative practice and by making a deal with a drug company that involved assigning a status to that product (fast-track) for which it did not qualify. The next cog in the FDA’s regulatory wheel is that of evidence-based medicine (EBM). This is a tough one for me to visit because EBM represents as large part of my own training in research and biomedical sciences. Therefore, Centeno will be calling me to challenge many of my own presuppositions.

A formal definition of EBM isa method that attempts to apply the best available evidence gained from the scientific method to clinical decision-making. EBM does this by assessing the degree of risks and benefits of treatments or a lack of treatment, and diagnostic tests. The ultimate goal of EBM is to help clinicians understand if a treatment will do more good than harm.

This sounds wonderfully academic and objective, and surely EBM provides an excellent method for developing and evaluating new medicines, procedures and devices. However, EBM asserts that this is the ONLY way to perform medical studies.

Centeno at this point makes a very profound historical point. The history of medicine is filled with discoveries that did not utilize the methods of EBM. He gives the following example: Emergency Medicine. Car crash victims are treated with methods that have not been vetted by EBM. If EBM were the rule in the emergency room, most emergency medicine physicians and nurses would have to stand there with their hands tied while the patient on the table dies before them. This suggests that there is more than one way to acquire medical knowledge and test the quality of it.

Historically, there were two schools of thought as to how one should interpret scientific findings. The Bayesian and Frequentist school differed in their approaches to such data. The Bayesian approach comes from Thomas Bayes who argued that future decisions should be dictated largely by past experiences. Thus, for Bayesians, the best way to make a decision lies in mathematical probability calculations that tell you if A is more likely to work better than B, or something like that. Frequentism comes from the work of thinkers such as Aristotle who said that the probable is “that which, for the most part, happens.” The frequentist looks for those events that occur frequently under the controlled conditions found in a laboratory.

In the 1930s, the debate between frequentism and Bayesianism came to a head when Sir Harold Jeffreys, and theoretical physicist who used mathematical models to study the Earth and its solar system, and Sir Ronald Fischer, a population geneticist. Jeffreys used Bayesian probability to construct forma theories of scientific reasoning, but Fischer used frequentism. Because frequentism is very “on” and “off” with respect to its assertions, it seemed more certain. Because frequentism seemed to make a complex work simpler, it won the day because of its perceived explanatory power and elegance. Bayesianism, was viewed as wish-washy and not worth the time of the researcher.

Frequentism works quite well in the laboratory where the conditions are well controlled. However, once the clinical trials go from the laboratory into inbred animals that all have the same genetic background, to people who can differ wildly in their metabolism, digestion, absorption, or receptor binding, receptor densities, or response to receptor binding, such scientific reasoning does seem to represent reality accurately. In order to deal with the shortcomings of frequentism, some clinical researchers has suggested using so-called “adaptive clinical trials” in which the data gathered as the trial progresses are used to change some aspect of the trial midstream.

The real problem with frequentist thinking in medicine is that it tends to cultivate a one-size-fits-all mentality. Centeno uses the following analogy: The average height for men in the US is 5 feet, 9.5 inches. Therefore, if this information was used to make men’s clothes, it would be an unmitigated disaster.

Centeno thinks that this is the entire problem with EBM – its application to medicine that essentially says that there is no other way to treat a patient, and that if the physician does not follow that recommendation, then you are a quack, instead to tailoring your treatment to the individual patient’s needs.

Frequentist thinking also leads to long, massively expensive drug trials that are often unsuccessful that wastes not only gazillions of dollars, but precious time that very sick patients to not have. Furthermore, since universities receive large sums of money from the National Institutes of Health (NIH), they are married to the frequentist system, as are large pharmaceutical companies. Therefore, these two institutions tend to oppose major reform of the FDA.

One other point at this time is this – socialized medicine is frequentism on steroids. If we take the British National Health Service for example, this institution publishes treatment guidelines for a variety of maladies. If the doctor deviates from the treatment protocol, then the NHS will not pay for it. Also, the NHS also specifies who will receive these treatments. It is a cost-analysis that determines if you get treated and what kind of treatment you get, individual variation in patients be damned.

Many medical breakthroughs that led to things such as in vitro fertilization, modern open-heart surgery, and the surgically-implanted plates and screws that stabilize fractures were all developed outside the frequentist system. Instead of working on a narrow clinical trial that includes a handful of people, why not share information about particular drugs and procedures, which the internet allows, and run clinical trials that make sense the observations of a global village of physicians?

An example might be helpful. Hyaluronic acid (HA) is a complex, charged carbohydrate that acts as a lubricant for joints. Arthritis can be treated by injections of HA into arthritic joints and this “WD-40” for the joints help relieve the pain of arthritis and the inflammation associated with it. Physicians who have used HA have shown that it works well for arthritic hips and shoulders as well as knees. According to Centeno, there are some 104 research studies on the use of HA in the hip. However, the FDA will not approve the use of HA outside the knee unless it goes through the same lengthy, expensive trials in which arthritic patients are given placebos that do not help them. Clearly physician experience has shown that HA works outside the knee. Instead of approving it on a limited basis and then subjecting it to past-marketing research, the FDA is stuck in its frequentist way of thinking and this keeps them from seeing the light when it comes to HA.

There is another factor at play here and this is beautifully covered by an article by the Independent Institute. The FDA is motivated to delay or deny potentially useful drugs because of the exposure of their work. Consider the following scenario: If the FDA approves a drug that turns out to be dangerous, victims are hurt and they appear in the press and television. The FDA repents, fires someone and then pulls the drug. If, however, they do not approve a good drug that can save lives, there are no victims, no sob stories in the press and no terrible news stories on MSNBC. Nevertheless these delays have genuine victims. Robert Goldberg of Brandeis University has stated (how exactly he calculated this remains a mystery to me) that the delays in drug and device approvals have cost around 20,000 lives over the past 30 years.

Thus we have a FDA that works with a system that cannot handle the 21st century and the medical advances it will bring.