Biotech's Baddies

Biotech's Baddies More than 60 individuals have been blackballed by the FDA for criminal acts against the agency. Here are some of the worst offenders. By Bob Grant ©Tim Kiusalaas o matter how bad things seem for the United States Food and Drug Administration these days, 20 years ago they were arguably worse. In the late 1980s, the agency was embroiled in a generic-drug scandal, in which FDA administrators accepted bribes fo

By | April 1, 2009

Biotech's Baddies

More than 60 individuals have been blackballed by the FDA for criminal acts against the agency. Here are some of the worst offenders.

By Bob Grant

©Tim Kiusalaas
N

o matter how bad things seem for the United States Food and Drug Administration these days, 20 years ago they were arguably worse. In the late 1980s, the agency was embroiled in a generic-drug scandal, in which FDA administrators accepted bribes for quick drug approvals, and drug makers admitted to deliberately defrauding drug regulators. The days when the federal agency could rely solely on the trustworthiness of the industry it was supposed to be regulating were done.

But from the ashes of the generic-drug scandal, some positives did arise. One of the programs resulting from the scandal, and the subsequent Generic Drug Enforcement Act of 1992, was the FDA's mission to "debar" people or whole companies from participation in agency activities, such as applying for drug approval, if found guilty of deliberate fraud.

David Read, who was the FDA's first Debarment Task Force chair, says that when the agency first set out to ban investigators for fraudulent activities involved with the generic-drug scandal, the magnitude of dishonesty in the drug business was staggering. "[The Generic Drug Enforcement Act] resulted in a lot of investigations, which turned up a lot of surprises," he says. "As people started investigations, they found things that weren't expected."

What drives an individual to defraud the FDA and attempt to profit from potentially dangerous compounds? "I think what happens is you get people who have been first in their class their whole lives, and they feel like they can hurl thunderbolts," says James Sheehan, a former Associate United States Attorney and now the New York State Medicaid Inspector General. "They think they're saving the world."

Sheehan adds that the problem of policing fraud at the FDA has gotten even harder in recent years. "I think it's a very significant problem, and especially in the last 10 years," he says. "You have this medical-industrial establishment that needs to be fed, and the competition is very keen."

The FDA debars people as a remedial action and not as a punishment, per se, says Douglas Stearn, acting director in the FDA's Office of Enforcement in the Office of Regulatory Affairs. "Our main goal is to protect the [drug approval] process to ensure the safety and effectiveness of the drugs the American public uses," he says, adding that once an individual is on the agency's debarment list, he or she "can't even work in the cafeteria" of a company that files an Investigational New Drug Application with the FDA. Some cases are so egregious they make international news—for instance, Robert Ray Courtney, who was sentenced to 30 years in prison in 2002 for diluting cancer drugs, earned a New York Times–minted nickname, "The Toxic Pharmacist."

The following people are among the more than 60 individuals who have been permanently debarred from providing any services to anyone with a drug application with the FDA. They have all been found guilty of one or more felonies. Most went to prison. Some maintain their innocence.

Harry W. Snyder Jr. and Renee Peugeot Snyder

A former oncologist and his wife, a nurse, almost got away with a fraud that would have made them and an early-stage drug company millions of dollars by placing a largely ineffective topical treatment on the market. But a mistake committed by the oncologist, Harry Snyder, sealed their fate.

In the early 1990s, Snyder was vice president of clinical development at BioCryst Pharmaceuticals, a company based in Alabama; Renee Peugeot, his wife, was a registered nurse at the University of Alabama at Birmingham (UAB). In 1994, BioCryst's only drug, BCX-34, was in early FDA clinical trials for the treatment of psoriasis and cutaneous T-cell lymphoma, a rare form of skin cancer. BCX-34 is a phosphorylase inhibitor that researchers hoped would inhibit T cells, which play a role in both psoriasis and T-cell lymphoma.

At the urging of BioCryst executives, Peugeot was hired to work on the BCX-34 cancer trial at UAB, and she eventually oversaw much of the research involving the drug.

Though the trial was designed to be double-blind, court documents show that Snyder, previously a viral oncologist at Cornell University and author of dozens of scientific papers from the 1970s through the 1990s, started alerting colleagues that BCX-34 was looking like a successful cancer treatment a full month before the studies were completed. He and Peugeot also bought additional shares in BioCryst before the trial ended. Eventually the couple owned company stock and options worth $600,000.

At the end of the trial, data suggested that BCX-34 was an effective treatment in the study's 22 T-cell lymphoma patients at UAB (there were some patients being treated at Washington University in St. Louis). In February 1995, BioCryst issued a press release trumpeting the effectiveness of the drug against both psoriasis and the deadly skin cancer, and informed the FDA that 59 percent of the trial participants either saw their cancer disappear or improve markedly.

BioCryst stock shot through the roof. One share in the company was worth $6 at the end of the trial, and almost $13 only months later. Investors sank millions of dollars into BioCryst and its new cancer blockbuster.

Then BioCryst's medical director and Snyder's superior, William Cook, started writing up the psoriasis arm of the trial for publication, and noticed some irregularities. He found that Snyder had altered the randomization schedule for both trials; reanalyzing the data using the original randomization schedule from the study coordinator, Cook found that only 30 percent of the trial patients who received BCX-34 experienced a benefit from the drug.

In June, BioCryst held an executive meeting and announced what Cook had uncovered. Snyder attempted to justify the discrepancy, to no avail. The company alerted the FDA and issued a press release saying that BCX-34 was not a miracle cure for cancer. The bottom fell out of BioCryst stocks. Investors ended up losing about $34 million.

At trial, prosecutors revealed that Peugeot had participated in the scheme by fudging clinical data in her direct interactions with patients, while Snyder forged a randomization schedule to make it appear that the people who showed improvements in their disorders were also the ones treated with BCX-34. "What made it work so perfectly was that they were on both sides of the double-blind study," says Adolph Dean, a former Assistant US Attorney and one of the prosecutors in Snyder and Peugeot's case. "She was a subinvestigator for the principal investigator and he was working at the company that was conducting the study. They were playing Russian roulette with people's lives."

After a short trial in which the jury took only 3 hours and 35 minutes to deliberate, according to Dean, Harry Snyder and Renee Peugeot were found guilty of mail fraud, conspiracy to defraud the United States, and making false statements to the FDA. Snyder was sentenced to approximately 3 years in prison and Peugeot to 2.5 years. They were permanently debarred from the FDA in January of 2003.

BioCryst declined to comment on the episode involving BCX-34, Snyder, and Peugeot. The duo filed for chapter 7 bankruptcy from jail in 2003. Snyder was released from prison in September 2006, and Peugeot was released in October of 2008.

According to Dean, the pair lives near San Antonio, TX, but phone calls to a Boerne, TX (roughly 30 miles from San Antonio) number registered to Harry W. Snyder, Jr., were not returned.

James T. Kimball

In the early 1990s, James Kimball founded Discovery Experimental & Development Inc. (DEDI), a Tampa-based company established to research, produce, and distribute health products on the US market. DEDI's star product was Liquid Deprenyl Citrate, which Kimball called a botanical.

The drug's label claimed it to be effective in treating a wide range of ills, from depression and Alzheimer's to autoimmune diseases and high blood pressure. Liquid Deprenyl Citrate, however, is a DEDI trade name for selegiline, a monoamine oxidase inhibitor that prevents dopamine breakdown in the central nervous system, and is used to treat early-stage Parkinson's disease. In the medical literature, there is evidence that selegiline can treat major depressive disorder (J Clin Psychopharmacol, 26:579–86, 2006) and Alzheimer's (Behav Brain Res, 190:224–32, 2008). There are several reports in the literature, however, that indicate the substance is ineffective against ALS, one of the conditions Kimball marketed it for (J Neurol, 241:223–27, 1994).

Kimball claimed that his formulation of selegiline was purer than Eldepryl, a brand-name drug sold by UK pharmaceutical company Somerset Pharmaceuticals. But in 1993, Somerset took Kimball to court claiming that he and DEDI had infringed on the drug marker's exclusive marketing rights to selegiline, the main active ingredient in Eldepryl, and sold selegiline, a prescription-only product, through the mail without requiring a prescription. That year, FDA investigators seized Kimball's financial records and found that from 1990 to 1993, the DEDI CEO had sold more than 7,700 bottles of the nonapproved Liquid Deprenyl Citrate at $75 dollars a piece. His total sales, which included income from selling aspirin and vitamin C, totaled more than $580,000.

Meanwhile, Kimball took advantage of the burgeoning Internet and sold his products online, making more than $2.5 million through DEDI and other companies from 1991–1999, according to FDA investigators. In August 1999, the FDA's Center for Drug Evaluation and Research sent Kimball a warning letter informing him that manufacturing, selling, and exporting his selegiline formulation was illegal and would be met with swift punishment.

In 1999 a federal grand jury charged Kimball with conspiracy, unlawful distribution of Liquid Deprenyl Citrate, and shipping more than 100 bottles of the drug to England. In 2000, a federal jury found Kimball guilty of making false statements to the FDA and conspiracy to distribute an unapproved new drug; he was fined $25,000 and sentenced to 13 years in prison.

Kimball appealed the criminal ruling, maintained his innocence, and claimed that a wider conspiracy sought to undue his work with DEDI. He escaped from prison in 2005.

Kimball was permanently debarred from the FDA in 2007.

As of March 2009, his Web site said that he had passed away. The site also listed a phone number for his wife Jo. After calling and leaving a message at the phone number, I received a call from a man who declined to identify himself except to say that he was "very very close" to James Kimball. The man on the phone told me that Kimball was not dead, and "Mr. Kimball was railroaded" by the FDA and the government.


Thomas Ronald Theodore

Thomas Theodore already had a history of fraud before he ran afoul of the FDA in the mid 1990s: In 1987, he was convicted of mail fraud after falsely claiming that he was licensed to practice medicine in Massachusetts.

After having his doctor's license revoked, Theodore hatched another scheme. With his business partner Thomas Rodgers, Theodore, still posing as a doctor, enticed investors to pump $1.6 million into their Private Biologicals Corporation (PBC) by claiming that he had invented a new cancer drug called Lymphokine-200, or LK-200. He told them that the drug was being manufactured using a secret process at a foreign facility in the Bahamas because LK-200 was not FDA-approved in the United States. According to Adam Bookbinder, an Assistant US attorney and one of the prosecutors in Theodore's case, Theodore did acquire a medical degree from a medical school in the Dominican Republic, where he is considered a legal doctor.

In fact, Theodore did not invent the substance he called LK-200. The method needed to produce the substance, made up of cytokines derived from human hematopoietic cell lines, had been used in cancer research throughout the 1970s and 80s, and was well known. In fact, according to court documents, researchers at the University of Pennsylvania had been making the stuff for years. Theodore initially obtained LK-200 from U Penn scientists, and even drew up an agreement for PBC to get ten liters of LK-200 from U Penn, claiming that he was using the drug for research purposes. He instead shipped the LK-200 directly to cancer patients in Mexico. (The documents did not name the U Penn scientists, and a PubMed search did not turn up any relevant articles on LK-200.)

Theodore and Rodgers began producing LK-200 in 1994 at their Massachusetts laboratory, which was not licensed to produce drugs. The two covered their tracks by shipping LK-200 to the Bahamas before redirecting the shipments to physicians, patients, and pharmacists in the United States—in essence laundering their product in the same way that some criminals launder their money using offshore accounts.

This strategy succeeded for several months; Theodore and Rodgers then grew bold enough to ship LK-200 directly from the Private Biologics lab to doctors and patients in the United States. In August 1994, the pair began shipping the drug from Massachusetts using fake mailing labels indicating the Bahamas as the packages' place of origin.

In 2002, Theodore was sentenced to more than 10 years in prison and was ordered to pay more than $1.5 million in restitution to the investors he had defrauded. Rodgers pled guilty to his role in scamming the FDA, testified as a government witness at trial, and was sentenced to one year of probation and a $10,000 fine. The FDA permanently debarred Theodore in 2003 for his role in the scheme, and debarred Rodgers for 5 years starting in 2005.

Theodore currently resides at Canaan Federal Penitentiary in northeast Pennsylvania and is scheduled for release in January of 2011.


George Kindness and Roy Page

George Kindness and his partner-in-crime Roy Page are the most recent inductees into the FDA's debarment list. Kindness, the president and co-owner of Ohio biotech Amscot Medical Labs, and Page, formerly an oncologist, were part of a criminal feedback loop to produce and distribute cancer therapies that were not FDA approved.

Kindness—who according to different court documents is an MD, an immunology PhD, or neither—joined Amscot in 1992 and became lab director, helping the company produce vaccines. Kindness's name appears sporadically in the scientific literature, his latest paper a 1997 review article on causal modeling and alternative medicine (Altern Ther Health Med, 3:40–47, 1997).

Over two days in April of 1999, FDA inspectors visiting Amscot's Cincinnati labs discovered that the company was producing an autologous cancer vaccine made from blood and tumor samples provided by Page, a physician practicing in Memphis, Tenn.

The company would formulate an autologous vaccine tailored to individual cancer patients by using their own tumor and blood cells, and then ship the finished products back to Page's Memphis clinic, where he would administer them to the patients. The idea was that such autologous vaccines could incite the patients' immune systems to mount a reinvigorated response to the cancer cells and attack their cancer with more gusto. Some studies in the biomedical literature do indicate successes in treating cancer with autologous vaccines using immune cells harvested from patients (Science, 314:126–29, 2006).

Amscot was calling the administration of the vaccines a part of its Gene Activated Therapy (GAT) clinical trial. FDA officials informed Kindness that an Investigational New Drug (IND) application had to be filed with the agency before any such clinical trial could be conducted.

About two days after their visit to Amscot, the FDA received an IND application from Kindness, listing the company as the GAT trial sponsor and the provider of the investigational vaccine. The FDA placed a clinical hold on the trial, meaning that all GAT trial activity was supposed to stop until the IND application was approved by the agency. It never was.

Meanwhile, in early December, FDA inspectors dropped in on Page and found that the doctor had been administering Theracine, a vaccine very similar to the GAT vaccine, to his patients all year. Like GAT, there was no IND application filed for Theracine, which was also manufactured by Amscot under the auspices of Kindness.

Upon further investigation, the FDA learned that Kindness had apparently attempted to disguise his continued fraud by having an Amscot employee ship unlabeled vials of Theracine to Page by mailing packages using a United Parcel Service center rather than shipping the vaccine directly from the company. Kindness and Amscot charged patients for the vaccines, while Page charged for surgeries and office visits.

Throughout 2000, Kindness continued to make and ship Theracine to Page, who injected his patients with the vaccine. During subsequent FDA inspections of Amscot, Kindness allegedly instructed staffers to conceal vaccine logs documenting the manufacture of Theracine during the year. The FDA failed to turn up evidence of any research data being collected or analyzed to study the effects of the GAT vaccine or Theracine. Candace Crouse, an attorney at the Cincinnati law firm of Sirkin, Pinales, and Schwartz and one of Kindness's representatives at trial, says that she couldn't recall any patients getting sick or dying due to the Amscot cancer treatments. "My understanding is that several of the patients' lives were prolonged due to the treatments," she says.

In 2003, a federal jury handed down a 21-count indictment, charging Kindness and Amscot with, among other crimes, "conspiracy to introduce and deliver misbranded and adulterated drugs into interstate commerce with the intent to defraud and mislead the Food and Drug Administration." Page was eventually named in the case, and last year surrendered his Tennessee medical license (which he had held since 1956). Page admitted to treating at least 74 patients with either the GAT vaccine or Theracine between 1997 and 2003, and several more with other cancer treatments not approved by the FDA.

In 2006, Kindness pled guilty to one count of selling a misbranded drug and was sentenced to one year of probation and a $1,000 fine. Both Kindness and Page were permanently debarred from the FDA in November 2008.

Amscot Medical Labs no longer seems to be in existence. When I dialed the two telephone numbers found online for the company, one call was answered by a "Digital Broadcasting" and the other by a recording for a "talk-line" where "exciting people" could be reached.

Have a comment? E-mail us at mail@the-scientist.com

Comments

Avatar of: anonymous poster

anonymous poster

Posts: 19

April 1, 2009

I think the article is interesting and informative. Informative on how one can get screwed by the FDA for simply stepping out the line, like not staying with the mainstream and "Big Pharma".\n\nI find it appaling that neither in the case of Kindness/Page nor in the case of Kimball not a single word is wasted on whether or not their "drugs" had any effect. And I mean either way: harming or curing. There is just a flyby note that "some studies do indicate succes". And that "some study" was published in the obscure, low-ranking journal called "Science", so most likely it's just some piece of junk science!! It's not even saying "they put people's lives at risk because they gave them false hopes and prevented them for undergoing chemo and the sorts".\n\nI'd suppose (from how slanted the article is) that no one complained about the effects (or lack of them), or else it would have been bolstered. \n\nI am not saying that any crook should be able to brew a potion in the garrage and then sell it to unsuspecting and desperate patients. I am saying that if we are losing (for more than 50 years now) the "war on cancer" with the "traditional approach", maybe we should keep an open ear and not only an open pocket. Maybe the FDA should not reject "par default" any study design which comes from small companies, nor should they discard it just because "it does not make sense at a first glance". Maybe the law should be changed, so that not any food can become a "drug" when used with the intent to mitigate or prevent a disease in man. ("The term `drug' means [...] (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; [...]" (The Food, Drug and Cosmetic Act, Section 301 et seq., Title 21, U.S.C.). Please note that "other than food" is only point (3) and "or dietary supplements" --like Vitamines-- is nowhere to find. Just think about it!
Avatar of: Ellen Hunt

Ellen Hunt

Posts: 199

April 1, 2009

The Kindness case appears to be quite different from the others. I can completely understand how a couple of physicians who thought that they were possibly saving lives (and absolutely doing no harm) could choose to continue their treatments instead of toe some bureaucrat's line and allow their patients to die without a chance. Now, by what stretch of inane brain-pretzeling are these "criminals"? You can indict a ham sandwich. The slap on the wrist penalties indicate that the judge had some sanity. \n\nNeither of these men made significant money off the treatments. They covered their costs, but that's about it. There is nobility to their willingness to go down in flames in hopes that they were saving people's lives. It is clear that is what they were focused on. That is not true of the others on this list. \n\nYes, I know, "journalistic ethics", and "don't get in the way of the story" and all the rest of that pompous drivel. May I remind you "journalists" that your "ethics" has landed our nation in two unnecessary foreign wars and a meltdown of our financial system? May I remind you the "fourth estate" has a responsibility? \n\nWhat this story says to me is that the FDA should modify its rules to include exceptions for people that break the rules in order to uphold their hippocratic oath. Breaking the rules should not be the primary criteria for anything except taking a look. The FDA should let cowboy trials that are not doing harm, which have a scientific basis, and are done for the sake of patient's lives and well being to continue. Fine them for not filing paperwork properly - ok. Make them criminals for doing their best to save lives? That is criminal.
Avatar of: Louis Curacao

Louis Curacao

Posts: 3

April 2, 2009

The tenor of the above comments are right on. Covering criminality, misconduct and malfesance in science is necessary, but there seems to be a whiff sulfur about the approach the folks at the Scientist take. The assumption always seems to be that the worst is probably true. The latter case cited in the article does suggest the possibility that these 2 guys got caught in the maw of the FDA and may have been ground to pieces. What recourse is there in such instances - especially when magazines such as the Scientist pile on ?
Avatar of: anonymous poster

anonymous poster

Posts: 4

April 2, 2009

The previous comments overlook the fact that doctors bypassing the system to give what they think are helpful drugs to their patients run directly afoul of the Belmont Report and the current standards of human drug trials, created because of the Tuskegee Syphilis experiments and the Nazi doctors (who saw themselves as good scientists trying to understand the human body). Somehow the correspondents assume the patients' rights were not violated by playing around with drugs in badly designed or completely undesigned trials. Unethical science = bad science, no matter what the intention. All proposals for human research must be reviewed BEFORE the research is conducted to ascertain whether the research plan has adequately included the ethical dimensions of the project. Three principles are critical (1) Beneficence-maximizing good outcomes for science, humanity and the individual research participants while avoiding or minimizing unnecessary risk, harm or wrong (2) Respect- protecting the autonomy of autonomous persons, with courtesy and respect for individuals as persons, including those who are not autonomous (e.g., infants, mentally retarded or senile persons) and (3) Justice- ensuring reasonable, non-exploitative and carefully considered procedures and their fair administration; fair distribution of costs and benefits among persons and groups (i.e., those who bear the risks of the research should benefit from it). These principles have been in place for over 25 years, yet the writers responded as if they'd never heard of these foundations of human subjects research-and that's part of the problem. \n\nAmong the issues addressed in FDA reviews are subject selection, recruitment and justification for the number and kind of subjects proposed (it does no good to test a drug if the experiment is not designed correctly-the result then is inconclusive and people are put at risk for no reason), benefits to subjects and others, and informed consent ("this might help" spoken by a doctor is NOT informed consent).\n\nIn other words, getting FDA approval is not just a bureaucratic hoop to jump through-its meant to save lives and protect people's dignity. I would argue that doctors and scientists who ignore this are NOT heroes, but criminals.\n
Avatar of: Lillian Green

Lillian Green

Posts: 1

April 2, 2009

My family and I have experience serious medical problems-that caused unexpected loss of our loving father, brother, husband and grandfather-all due to the corruption and influence of the medical profession, healthcare industries, hospitals and the horrors of the pharmaceuticals.\n\nU S Health nd Human Services, thrir \nInstitutes and healthcare agencies are not protecting the general public.\n\nElected and appointed are to blame. \n\nIn the 1930's American Medical\nAssociation hireed Dr. Grimes to study and investigate the conditions of mental hospitals. Since he told the truth, they refused to publish his findings. \n1950's Dr. Henry Welch director of special drugs at FDA received from pharmaceuticals almost $3000,000. It still continues today with no action of improvement.
Avatar of: anonymous poster

anonymous poster

Posts: 1

April 2, 2009

For posting about funding non-mainstream ideas--yes, I agree. EXCEPT: there's not nearly enough funding as it is right now for sensical, mainstream ideas. Can we get more funding for that first? When you hear a knock at the door do you run and open your dishwasher first to see if someone's there? It would be nice to have money to investigate all directions, but too many scientists' labs are closing down daily for us to afford not staying focused on the most logical "next step" according to main stream thinking. True breakthroughs on alternative ideas will certainly happen, and perhaps they're being impaired by lack of funding, but it's more costly financially and physically to people with disease to have alternative thought funded first. Thankfully within academic science there are checks and balances, so it'd be pretty darn hard to have incorrect science models succeed over the long run. Let's focus on funding labs so junior scientists who have spent years in training at Ivy League schools (like several I know!) don't have to end up flipping burgers because they can't find a job and couldn't get an RO1 from the NIH because of dismal funding levels.
Avatar of: anonymous poster

anonymous poster

Posts: 19

April 3, 2009

Yes, you're right: there's never enough money for mainstream research. I've been lucky enough to do my PhD and postdocs in top research institutions (and by "Top" I mean even in TheScientist's 'Best places to work') flush with money. I've heard maybe once or twice in 10 years a statement like "we can't afford that", so I am a bit spoiled.\n\nBut I could not help from cringing when I was seeing some colleagues stating "I don't care how much it costs". And even more when I was seeing colleagues embarking on the "-omics" crap. Because that's not science: you just turn the crank and get another set of genes with an effect on cell division, publish that, adding in the Discussion section a statement to the line of "this work opens the way for developing new strategies in the fight against cancer" and move on to the next big screen. You've learnt nothing or next to nothing, wasted a few hundred thousands Euros or Dollars or British Pounds (of taxpayer's money --Britain excluded) and, if cunning enough, added a Science or Nature Systems Biology paper to your CV. This is one reason why there's no money for everybody: on the one hand there are a few groups seizing a good fraction of the available money for such projects and, on the other hand, the average research project is now much more expensive because of this kind of projects.\n\nSo the argument "there is not enough money for mainstream research" does not hold because a) there's a lot of money, but it's being thrown (in part) out of the window and b) because the direction of mainstream research is, alas, the same for all of them.\n\nYou want an example: skin inflammatory disease (e.g. neurodermatitis) was treated with cortisone, which is antiinflammatory by its antimitotic virtue. This leads to thinner, "glass-like" skin. Next step was to use specific inhibitors for T lymphocites (calcineurin inhibitors like Tacrolimus/Elidel/Protopic), which do not interfere with skin regeneration. There are two major problems with both approaches: they treat the symptoms (inflammatory condition) and not the cause (immune system deregulation, which does not happen out of the blue). The second problem is that, being immunosupresants, the skin's ability to defend itself is anihilated, which leads to suprainfections (Staph aureus being most prevalent), which leads to even more inflammation once you drop the treatment. But, neverthelss, is "mainstream", so it's got to be correct and pretty much every dermatologist on the planet blissfuly prescribes them. And hence no one bothers to financially support a trial which would show that healing the skin suprainfections and eliminating toxins (like heavy metals, PCBs etc) from the body leads to serious improvement of the symptoms over very long time periods (5-10 years, even 20 years and counting). And you know what? This "non-mainstream" approach is working for over 20 years now! So much about "mainstream"!
Avatar of: anonymous poster

anonymous poster

Posts: 43

April 3, 2009

The number of scientists committing fraud is indeed staggering! Many of the scientists end up at one time in their life (usually after retirement) as mentors for other budding scientists or as teachers. What kind of traditional value system will the young ones be learning from these individuals? What are these scientists teaching their own kids? It is alright to cheat as long as you have your own reason? \nWithout being "preachy" let us formulate set of rules that every scientist has to take an oath to follow this specified code of conduct at the time of their graduation. Medical students do- why not scientists? Well, something positive and permanent has to get done.
Avatar of: Berry Muhl

Berry Muhl

Posts: 4

April 3, 2009

...Really? Sounds to me like what we're dealing with is the failure of the regulatory body itself. \n\n"What drives people to violate the regulations they're supposed to obey?" asks the article. The answer is obviously "the regulations" themselves! Regulations create corruption, create the black market, and create vast classes of criminals.\n\nThe problem is with how we regulate. That's what needs an overhaul.\n
Avatar of: anonymous poster

anonymous poster

Posts: 3

April 4, 2009

Fraud in any situation should be punished by law particularly if the health of patients is involved, but these cases do not seem to have had the detrimental outcome of say Vioxx. Surprisingly we didn't see the CEO of Merck go to jail for his company falsifying data. So, is it one law for the giants of Pharma (who can afford to pay millions in fines and walk away) and another for the smaller fry who do it either to make money or with a misguided sense of helping their patient.s
Avatar of: anonymous poster

anonymous poster

Posts: 77

April 13, 2009

At the risk of piling on, I call your attentions to a recent review article by Marcia Angell - a Senior Lecturer in Social Medicine at Harvard Medical School, a physician, and a former Editor in Chief of The New England Journal of Medicine. Her article in V. 56, No. 1, Jan 15, 2009 of the New York Review of Books is entitled "Drug Companies & Doctors: A Story of Corruption". It is available at http://www.nybooks.com/articles/22237 (without registration or limitation).\n\nFor any who think the problems described here are in the past, be advised that they have simply been refined and incorporated into much more sophisticated ploys by the most prestigious medical schools in company of Big Pharma. \n\nAnother here said... "Thankfully within academic science there are checks and balances, so it'd be pretty darn hard to have incorrect science models succeed over the long run." However, Angell's article leaves little doubt that such an opinion is an overly rosey picture of the incestuous relationship between big money and prestige research. \n\nAs we look toward "Health Care Reform", one cannot help but demand that a full top-to-patient-outcome audit of all aspects of the industry be a prerequisite to the commitment of any (more) major moneys "thrown" at the problem of the uninsured.
Avatar of: anonymous poster

anonymous poster

Posts: 77

April 13, 2009

...to add to my immediately previous post...\n\nhttp://www.nytimes.com/2009/03/04/health/policy/04doctors.html?_r=1

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