Thoughts, essays, and writings on Liberty. Written by the heirs of Patrick Henry.

“There is nothing more unequal, than the equal treatment of unequal people.”     Thomas Jefferson

August 15, 2007

Does von Eschenbasch deserve a pension or probation?

by tarran

In 2001, two parents were convicted of manslaughter in Colorado for allowing their daughter to die from untreated diabetes-related infection. Had she been taken to a doctor, she would likely have lived. Several of her surviving siblings were also found to be sick with strep throat, with which they had apparently been infected for months.

The parents were punished with probation in lieu of confinement and are marked with the stigma of being felons.

This is most unjust, since regulators working for the FDA are committing the same crime and are being praised and rewarded, even though they are harming not a handful of defenseless children, but millions of their countrymen as the CATO institute points out:

Over the past five years, the Alliance has pushed for access to 12 exceptionally promising investigational cancer drugs which have subsequently been approved by the FDA and now represent standard care. At the time we began our advocacy, each of the drugs had cleared at least preliminary Phase 1 testing, and in some cases more-advanced Phase 2 or Phase 3 trials. In other words, they obviously worked for some patients. …

In sum, these 12 drugs — had they been available to people denied entry to clinical trials — might have helped more than one million mothers, fathers, sons and daughters live longer, better lives. We have actually underestimated the number of “life-years” lost at more than 520,000, because we have not included other safe and effective uses of these drugs that the FDA has yet to approve. …

The American Cancer Society reports that some 550,000 cancer patients die annually, making the number of cancer deaths from 1997 to 2005 about 4.8 million. Over that same period, the FDA reports granting individual access to an investigational drug to not more than 650 people per year for all diseases and drugs — a pathetic, even cruel, pittance. A few thousand more patients managed to gain access by enrolling in relatively small clinical trials or exceedingly rare expanded access programs. The other 4.7 plus million cancer patients, not to mention millions more with other diseases, were abandoned to die, denied access to progress by their own FDA when they needed it most.

The FDA, and its supporters put a different spin on the matter:

Public policy should discourage access to investigational drugs outside of clinical trials. Investigational treatments made available outside of clinical trials have the potential to undermine the clinical trials system. There is little incentive for a patient to participate in a clinical trial if she can obtain the investigational drug outside of the trial. This makes trial accrual difficult, and may significantly undermine the ability of the investigators to determine the efficacy and safety of the intervention. That was certainly the case with bone marrow transplant for breast cancer – because it was so widely available outside of clinical trials it was extremely difficult to accrue patients to trials, and it took many years longer than it should have to learn that the high-risk and expensive procedure provides no benefit to women with breast cancer.

Investigational treatments are by definition unproven; even the most promising data in earlier stages of trials often do not hold up. Further, there may be significant safety issues that do not emerge until well into a phase III trial. For example, the cardiotoxicity of Herceptin was not apparent in the phase II data, but emerged in the much larger phase III trial. …

It is compelling to argue that there is little harm in making an investigational therapy available to a seriously ill individual for whom there is no effective therapy, if someone is willing to pay for it. This argument does not hold upon scrutiny. To follow this to its logical conclusion completely undermines research and the concept of evidence based care. Where would the line be drawn? It would mean that any individual should have access to any drug, as long as she is willing to pay for it Emphasis added – tarran.

Single patient INDs or INDs with small numbers of patients under Tier 1 approval raise serious issues of fairness. Granting access to investigational drugs with Tier 1 approval to patients who can pay for them at a price higher than cost makes this proposed system highly inequitable. Patients with access to them would likely be very knowledgeable, well-connected, and financially privileged. They would have access to physicians who have the ability to develop a protocol for them, and are willing and able to implement it. This is not the case for most cancer patients. Resources devoted to fighting cancer should be based on the best evidence available. The off-trial process involves a great deal of time and expense for clinicians, regulators and investigators, with very little likelihood of benefit to the patient, or to accumulation of knowledge about the intervention in question, that would benefit all.

The FDA justifies its democidal campaign by claiming that while the testing delays kill tens or hundreds of thousands of people, the testing delays prevent millions more from being killed or injured by unsafe, or ineffective treatments. This is horseshit.

Dr Mary Ruwart, a former drug researcher, estimates that tens of millions of people who have died since 1962 have had their lives shortened by the FDA preventing new treatments from being sold, or having their benefits advertised. She calculates that these regulations have prevented at most 7,000 deaths from drug toxicity. Folks, these numbers are on a par with the number of people slaughtered by the Nazis in the Holocaust.

Furthermore, even if the FDA and its boosters were correct, that FDA roadblocks on treatments save more lives than they take, the FDA’s actions would be unjustified. Their actions would be unjustified for the simple reason that when an FDA official orders a pill-maker not to distribute a drug, it is an identical form of assault to the one I would be guilty of if I were to show up at the CEO’s office with a gun making a similar demand.

There is no doubt in my mind that many people who work in the FDA sincerely believe that they are, in the aggregate, helping people. I’m certain that Randy and Colleen Bates felt that they were helping their dying daughter too as they anointed her fevered forehead with oil and prayed over her as she gasped her last breaths. In the end, good intentions are no excuse for slaughter on an industrial scale. We cannot subject Randy and Coleen to the sanction of law while lauding government officials who do the same thing.

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4 Comments

  1. No arguments here. Good post.

    Comment by UCrawford — August 16, 2007 @ 9:19 am
  2. Excellent article and Thank You! for bringing the plight of Cancer Patients to the public!

    I believe you are looking at the wrong FDA man regarding cancer… it should be Dr. Richard Pazdur, of the FDA’s CDER division. From sources on the net, it appears that he’s annointed himself “King” of the FDA Oncology Division because he was not appointed as FDA Commissioner and he does not take lightly to having a cancer treatment reviewed by another FDA unit (CBER).

    The recent and particular case of Dendreon’s Provenge is an excellent example. Provenge treats TERMINAL prostate cancer victims (having about 18 months of life left) and who have but 1 other treatment available–the horrible chemo, Taxetore, which actually kills 1 to 2% of the patients taking this treatment. Ironic the “cure” is worse than the disease for those men taking Taxetore!

    Prostate cancer kills 82 men each and every day; far more by multiples than the loss of our young men and women in the Iraq and Afghanistan Wars. If the Nightly News media put up these statistics, we’d get something done about this tragedy… “Tonight, 8 U.S. military were lost in the Middle East; on the home front, 82 men died in the U.S. today from prostate cancer”.

    On March 29th, the FDA called a meeting of 17 experts in immunotherapy, oncology, statistics and other disciplines. This expert group voted 17 to 0 that Provenge was safe; they voted 13 to 4 that it showed substantial efficacy.

    Two ONCOLOGY experts… Maha Hussain of Michigan and Howard Isador Scher of Sloan-Kettering voted NO on the efficacy vote, but voted YES that Provenge was safe.

    Despite the overwhelmingly positive recommendation of this Advisory Committee–a vote which the FDA has traditionally followed–the FDA postponed for perhaps up to 2 or 3 years allowing Provenge to Market last May 9th. This action followed an unprecedently PUBLIC lobbying by these two ONCOLOGISTs (chemo treating doctors) where each actually wrote “CONFIDENTIAL” letters to the FDA imploring the FDA to deny approval; these private letters were leaked to and printed by “The Cancer Letter” PRIOR to the FDA’s decision.

    It’s speculated in the media that Pazdur had knowledge of or a hand in writing/having these letters written in an attempt to delay/derail Provenge which could have become the “standard of care” for cancer patients.

    Provenge is an immunotherapy revving up the body’s own defenses to fight the cancer; Taxetore is a deadly poinson–a chemotherapy–which kills both the cancer cells and “good” body cells.

    In order to sit on the FDA’s Advisory Committee judging Provenge, members were required to tell the FDA of any/all Conflict of Interests (COI). Scher reported only 3 COI’s to the FDA which appears to be composed of ownership of 1 stock and 2 competing industry interest.

    Internet research shows the following for Scher thus far–PLEASE note items #1 and #16 in particular!!!!

    1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge

    2. GPB BIOTECH: financial conflict of interest per Scher in MedPage

    3. PHARMION: financial conflict of interest per Scher in MedPage

    4. SANOFI-AVENTIS: grants & research support

    5. BRISTOL MYERS SQUIBB: consultant, grants & research

    6. MILLENNIUM PHARMCEUTICALS: grant of research support

    7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;

    8. INNOVIVE PHARMACEUTICALS: principal investigator

    9. INFINITY PHARMACEUTICALS: principal investigator

    10. BIOGEN-IDEC: jointly held stock with spouse

    11. PFIZER: jointly held stock with spouse

    12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)

    13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

    14. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

    15. MEDIVATION, INC: principal investigator MDV3100

    16. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest

    There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI’s found so far on the internet. For Scher to “forget” so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.

    Even more disturbing is the FDA’s Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI’s than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.

    As a “temporary government employee” at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn’t, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.

    Cancer advocates, patients, physicians and others are gathering at the Washington FDA offices Sept 18th – 10 a.m. – to Rally in support of cancer patients. Info is at http://www.caretolive.com and at http://www.arighttolive.com Come join in supporting cancer victims or help cancer patients in your local area however you can!

    Thanks, again, for a wonderful article in support of cancer victims!!!

    Comment by Tony F — August 16, 2007 @ 10:13 am
  3. hi nice post, i enjoyed it

    Comment by Walker — August 18, 2007 @ 8:06 pm
  4. hi nice post, i enjoyed it

    Comment by Phoenix — August 18, 2007 @ 9:05 pm

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