A Lone Wolf Takes on the Drug Leviathan: An Interview with Allen Jones
By John W. Whitehead
October 13, 2005
When Allen Jones was appointed lead investigator in July 2002 in a case concerning off-the-books payments from pharmaceutical companies, he had no idea that his discoveries would cost him his career and propel him to the core of President George W. Bush’s national drug policies. An investigator for the Pennsylvania Office of the Inspector General (OIG), Jones’ findings in the case showed that the drug company Janssen had paid honorariums to key state officials who held significant influence over the prescriptions issued for state institutions such as prisons and mental health hospitals. Although the accounts receiving these payments were marked for “educational grants,” funds were being channeled to state employees who developed guidelines recommending new, more expensive drugs rather than older, cheaper drugs with safe, proven effects. These companies were influencing officials with trips, perks and lavish travel accommodations as a means of inducing the officials to endorse their products. Jones discovered that one of the new drugs being recommended, Risperdal, has been shown to have potentially lethal side effects such as ketoacidosis, coma and possibly death.
After initially revealing his discoveries to OIG managers, Jones was taken off the case but told that he could pursue it on his own. In the words of the OIG supervisor who took Jones off the case and participated in threatening him, “Drug companies write checks to politicians… on both sides of the aisle.” When Jones went public with his findings, he was escorted out of his workplace and told not to reappear on OIG property. Jones then filed a suit against his supervisors, claiming that OIG’s policy of barring employees from speaking to the press is unconstitutional. Jones also claims that he is being harassed by his superiors and Pennsylvania governmental institutions in order to “cover up, discourage, or limit any investigations or oversight into the corrupt practices of drug companies and the corrupt public officials who have acted with them.” Jones’ attorney, John Bailey, has called the case “a critical test of the right to a free press.” Bailey said, “If they shut the employee up and they have all the documents locked up in a drawer, there is no free press.”
The Pennsylvania formulary investigated by Jones (known as PennMap) is based on the Texas Medication Algorithm Project (TMAP), which was named as a model program by President Bush’s New Freedom Commission on Mental Health. It has been revealed that TMAP personnel may have tampered with research results through a process known as “Retrospective Analysis.” Patients who had previously been treated with the new medications were researched, and files showing positive results were selected and reported on. Unsurprisingly, TMAP research “confirmed” that the new drugs were safer and more effective than older treatments. Ignoring the increasing body of contrary findings, TMAP employees referred to their algorithm as being “Evidence Based Best Practices.” Dr. Peter J. Weiden, a member of the project’s expert consensus, stated that the guidelines promoted by the programs are based on “opinions, not data” and that “most of the guideline’s authors have received support from the pharmaceutical industry.”
Just as Jones feared, the corruption extends much further than the Pennsylvania state health care systems. These flawed results are the basis for President Bush’s New Freedom Commission on Mental Health, which has announced its intent to administer a nationwide mental health screening. Bush also backs the controversial TeenScreen program, which is designed to diagnose mental illness in teenagers but has been shown to be coercive and unreliable. Jones firmly stated that “the same political/pharmaceutical alliance that generated the Texas project was behind the New Freedom Commission” and was “poised to consolidate the TMAP effort into a comprehensive national policy…with expensive, patented medications of questionable benefit and deadly side effects.”
Allen Jones has become the poster boy for the battle against the government as he pursues his case against OIG officials. He is hopeful that his efforts fighting industry and governmental corruption will not go to waste.
John Whitehead: Explain TMAP and the PennMay programs.
Allen Jones: Basically, they are treatment protocols. They are comprised of charts and text to guide the commission in prescribing practices for mental health.
JW: Prescribing drugs?
AJ: Yes, prescribing drugs. TMAP is totally a medication protocol. It has nothing to do with treatment or therapy with other means of dealing with illnesses. It is strictly medication.
JW: Does this tie into a drug formulary?
AJ: Yes. Each state has a menu of drugs from which a doctor can prescribe, which is called the formulary. That is the list of drugs that have been approved for use within a state. But before a drug can be prescribed by a state physician for somebody in the state system, it has to be on the list. TMAP and PennMap essentially create formularies within the formulary. If you walk into a drugstore and go to the pain relief section, there are 30, 40 or 50 headache remedies on the shelf which make up that particular drugstore’s menu of treatment for that ailment. However, when a new drug comes out, the pharmacist or clerk puts it on the shelf, along with the rest of them. It might be much more expensive, but the person can choose it if they like. What TMAP did was essentially take all the old generic drugs off the shelf and require exclusive usage of brand-new patented, very expensive medications.
JW: Expensive medications purchased from the pharmaceutical industry?
AJ: Yes. TMAP has the pharmaceutical industry’s fingerprints all over it—from inception to development through exportation to the different states and internationally.
JW: How did the pharmaceutical industry create TMAP? Wasn’t it conceived when George Bush was governor of Texas?
AJ: Yes. It was born under Bush’s stewardship as governor of Texas. The pharmaceutical industry started lavishing a lot of money on the Texas university system and Texas mental health officials during Bush’s tenure in the 1990s. And when you look at the TMAP project management team that was appointed to shepherd the program, you will find individuals who all have very strong personal financial ties to the drug industry. (Click here to view Jones' list of TMAP Project Team Directors and their ties to the pharmaceutical industry). The program began with the $1.6 million grant from the Robert Woods Johnson Foundation. It is the charitable arm of Johnson and Johnson, which owns Janssen Pharmaceutical, which had some of the principal drugs in the TMAP formularies in the TMAP algorithms.
JW: What year was this?
AJ: The 1990s were the formulative years. Although it was jumpstarted in Texas, it soon reached out elsewhere. By 1998, they were being sent to Beijing to push it internationally.
JW: To push what?
AJ: To push the TMAP and TMAP programs. This includes the medications, algorithms, the medication protocols that require the exclusive usage of the new atypical antipsychotic drugs and so on.
JW: When these drugs are administered to patients, for example in mental hospitals in states such as Texas, I assume it’s the taxpayer who pays for these expensive drugs.
AJ: Yes. In fact, the Medicaid program picked up the tab for a lot of these drugs. Moreover, money was pushed toward drugs at this time in the absence of any solid science whatsoever proving they were effective or safe.
JW: Are you saying there were no studies done?
AJ: I am saying there were studies done, but there was no conclusive science saying these drugs were better.
JW: Well, if they were no better than the present drugs, what was the motive?
AJ: The motive pushing it was profit, pure and simple.
JW: Are you saying that the pharmaceutical industry is making money off people’s illnesses without really helping them?
AJ: Absolutely. The pharmaceutical industry is not your friendly neighborhood pharmacist. These are multinational corporations with a cool eye on the bottom line, which is making money. They have made blockbuster drugs out of chemical compounds that not only are no more effective than what is on the market, they have evolved a deadly side effect profile that is more deadly than the existing drugs. Are you familiar with the recent release of the CATIE trials? The National Institute of Mental Health recently completed a multi-year, multi-sided study in which they put the new atypicals head to head against 50-year-old drugs. Atypical is a specific term for a new class of anti-psychotic medication used for treating schizophrenia, and it was touted through TMAP as being safe and far more effective than the old drugs. This is in the absence of any science to support that. The CATIE trials proved that they have no advantage over the older drugs. (Click here to view a report on the CATIE Drug Study).
JWW: They are just more expensive.
AJ: Hundreds of times more expensive. Another study that was done in the Veteran’s Administration Hospital showed that Haldo, an old drug at five cents per pill, performed as well as Risperdal and Zyprexa at $8 per pill. I mean, we are talking multiples.
JW: Hasn’t Risperdal been shown to have lethal side effects?
AJ: Absolutely. You can get all manner of deadly side effects. In fact, I looked at some material from the state of Pennsylvania that showed weight gains of up to 240 pounds with the psychotics and a high incidence of new onset diabetes. When they were bringing these drugs into Pennsylvania, they knew that they caused diabetes before the FDA made the official announcement. Risperdal in particular causes stroke in geriatric populations. What is key here is that such drugs were foisted upon people in the absence of science. What they did to establish the drug menu in TMAP was use a process they call the “expert” consensus process. A project management team tied to the industry selected other doctors whose opinions were then analyzed or accessed by the TMAP. They determined from that process that these drugs were safer and more effective, and that became their mantra. But they used a pseudo-science. And of the 55 doctors pooled for the first schizophrenia consensus, 27 had ties to the pharmaceutical industry.
JWW: Was Texas the pilot state for all this?
JWW: Why was this?
AJ: Texas has the highest population of mental health and criminal justice prisons in the country. They have huge prison populations and overcrowded mental hospitals. And just before TMAP came into play, the Texas legislature placed the responsibility for medical treatment of all prisoners and mental health patients in the state with the University of Texas medical branch. Thus, all of a sudden, the drug industry had access to a few key decision-makers and into vast populations of captive persons who were potential customers for their drugs. Add to this the fact that the Texas legislature is biannual, meeting only 140 days every two years. There are two or three drug lobbyists for every legislator in the state of Texas. So the typical legislative oversight is not present. There was a situation in Texas where by influencing a few key decision-makers, the drug industry could have their sway and say.
JW: Is there any indication that George Bush knew or was involved in what was going on?
AJ: I don’t know if he was lied to. I don’t know if he was deceived. I don’t know if he thought it was a good idea. But he did endorse the legislation. He used his support of TMAP, even in his presidential campaign and debate with Al Gore. He was definitely on board.
JW: We now see this with Bush’s New Freedom Commission on Mental Health.
AJ: The New Freedom Commission on Mental Health is an out and out sham. They appointed 22 people to study the mental health service delivery system over our entire nation in a year. These people went here and there. They conducted a few public appearances and public meetings where people got to contribute three minutes of testimony. Supposedly, this commission of 22 people then put their minds together and all contributed to a report. If you read the report, it is absolutely seamless, which means it was written with one voice. Yet, it suggests and recommends programs that were already in place, already in place with the drug industry support and money. It’s another expert consensus project. If you look at the composition of the Board, many had direct or indirect ties with the pharmaceutical industry, to George Bush, to TMAP. And they were disproportionately Texans on that committee.
JW: You worked on the PennMap program, which was based on the TMAP program.
AJ: Yes. And the pharmaceutical industry was giving “educational grants” to Pennsylvania to bring people from Texas to Pennsylvania to sell the program and to send Pennsylvanians to meet with Texans. The industry was directly funding the importation of TMAP into Pennsylvania.
JW: When you were appointed the lead investigator in 2002, you uncovered some accounts marked for educational grants. What were the suspicions that led you to where you are today?
AJ: I discovered that an account had been set up “off the books” without registering with the Comptroller of the state. At the instruction of the people above her, a secretary took a check to a bank and opened a checking account, like you or I would do.
JW: And who was opening these educational grants?
AJ: The educational grants were what would be deposited into this account. The pharmaceutical industry would give grants, and checks would be made out to Harrisburg State Hospital. Thus, the chief pharmacist would get the money, endorse it and deposit it into this account. The checkbook was kept in his secretary’s drawer. From this account, flights and trips to New Orleans and other places were paid for, lavish dinners and the like, in order to meet with TMAP personnel and to import the program into Pennsylvania. And it was all off the books. It was the type of thing the drug industry could not do legally on its own. For instance, from some of the documents it was obvious that the drug industry was using this account and these people to float through money to further their objectives in ways that they could not legally have done directly. And it was all done for profit so the taxpayer eventually foots the bill. It is sad that they would tamper with critical practice just for profit. But the fact is that they were mandating the usage of hideously expensive drugs that are deadly, for heavens sake.
JW: What was your first indication that improper rewards were being given to state officials under the Pennsylvania program?
AJ: When I reviewed the documentation itself.
JW: What was your position at the time?
AJ: I was an investigator within the office of the Inspector General for the state of Pennsylvania. I initially had two tenures with the OIG. One was back in the late ‘80s and early ‘90s when it was a new and dynamic fraud-fighting entity. We had broad powers. We were good. We were effective. And then I came back to it after Tom Ridge had gutted it.
JWW: Tom Ridge gutted it?
AJ: Yes. Tom Ridge gutted it. He changed the OIG from a fraud-fighting entity to an entity that was designed to cover up the truth.
JW: Tom Ridge was appointed by President George W. Bush to be the head of the Homeland Security Department and wound up in Washington, D.C.
AJ: The connections to Washington, D.C. go past even that. The fellow who was the Pennsylvania head of the Mental Health System at the time that TMAP was brought into that state was there when illegal accounts were opened and used. He approved the implementation of TMAP in Pennsylvania and oversaw the people who oversaw the accounts. He was then appointed to go to Washington, D.C. by President Bush to head the federal SAMHSA or Substance Abuse and Mental Health Service Agency. From there, he has been championing TMAP, TeenScreen and the agenda of the New Freedom Commission. And when he left to go to D.C., Ridge appointed as the head of Mental Health Services of Pennsylvania the marketing director of Eli Lilly, the mega giant pharmaceutical corporation. It was this Eli Lilly marketing director who was at the helm of the mental health service agency in Pennsylvania at the time I tried to raise the alarm.
JW: What were the initial reactions of your co-workers and superiors when you began exposing what you saw as corruption within the OIG?
AJ: The initial reaction was shock, not at what I was finding but that I would expose corruption and rock the boat. I made two trips to the Janssen Pharmaceutical in New Jersey. During the first trip, I met with the Johnson and Johnson attorney, outlined my concerns and requested documents. The day before I left, my boss was supportive of the trip and of some of the things I was finding. The day after I got back, I was told to back off, to limit this investigation to the chief pharmacists and simply look at the account. I was told not to ask any more questions.
We had state officials accepting $2,000 honorariums. It’s a felony in Pennsylvania to take money for presentations in an official capacity. They wouldn’t even let me talk to the people, and I was an investigator. It was my job. I was not permitted to get any documentation. I was told to back off. We had other physicians who were taking trips, perks and gratuities. But I was forbidden to talk to them.
JW: What was the motivation for telling you to back off?
AJ: It was not subtle. I was told that drug companies not only write checks to hospitals, they also write checks to politicians. They write check to politicians on both sides of the aisle. They told me to back off for political reasons because these guys were big contributors.
JW: You finally saw enough and went public. How did you initially go public?
AJ: I filed my first lawsuit in November of 2002 when it was obvious to me that they wanted to fire me. I filed a civil lawsuit to try to hold my job in order to preserve the issues for the new administration of Governor Ed Rendell. He was to be the new governor of Pennsylvania. He was a Democratic governor and a new person. I thought he surely would want to expose this. I sued. I held my job, held the information and continued to investigate on my own. They took me off the case and refused to permit me to have anything to do with closing out the matter.
JW: So how did you go public?
AJ: I talked to the New York Times. But before that, there was a period of time in which I gathered information and held it for the new Rendell administration. Then I tried different avenues. I went public first with other government entities. I tried to interest inspector generals and attorney generals in other states. I went to my congressman, who forwarded my concerns to legal services, but nothing happened.
JW: Are you saying that everyone is on the take?
AJ: No. It’s just too politically hot. It is a complicated issue. Here you have an investigator saying that these drugs are dangerous and that there are problems all around. But it is politically difficult to take on the pharmaceutical industry. It is a hot issue.
JW: When you first started on this journey, did you have any idea that it would reach to the very core of the Bush administration’s drug policies and cost you your job?
AJ: I had no idea that it would get so big or that it was so large. I had so many “oh, my God” moments along the way. I remember sitting at my desk discovering some of these people from Pennsylvania being appointed by Bush. I said, “Oh, my God, it doesn’t stop in Pennsylvania.”
JW: What do you think is the extent of damages caused by the pharmaceutical companies by way of compensating government officials, both state and federal, to approve or endorse their medications?
AJ: It’s incalculable. The Medicaid program in the state of California in 2003 spent $500,000,000. In some other states, we are talking tens of billions of dollars annually for a period of nearly 10 years for drugs that have been clinically proven to be ineffective and dangerous. Every drug pushed in the TMAP program initially now has black box warnings for deadly side effects. How can we calculate the costs in human terms?
JW: Would you say conservatively that probably thousands of people have been poisoned by these drugs?
AJ: Yes, conservatively.
JW: Again, overpaid by the American taxpayer.
AJ: Grossly overpaid. I mean, we are talking about pennies per pill verses many dollars per pill. The drug corporations made multi-billion dollar blockbuster drugs out of chemical compounds that should not have even been put on the market for public consumption.
JW: Are you saying that there was no government oversight of the pharmaceutical industry?
AJ: Take a look at Vioxx. Take a look at Fen Phen. Take a look at all the drugs that have slipped their way through. We have to question whether so-called government oversight is meaningful in any way.
JW: What about the FDA?
AJ: The FDA does not require head-to-head trials. All you have to do to get a drug approved is demonstrate that, in a specifically significant number of cases, it has more of an effect than a placebo. If there are side effects, they have to live with them.
JW: Are you saying that to some extent the American population becomes an experimental laboratory for the drug industry?
AJ: Absolutely. I have spoken with medical doctors who will not prescribe drugs for themselves or their families for the first three years after a drug is on the market. Some are very ethical or very reluctant to prescribe any new drug because they know the process is very shaky. They know that the pharmaceutical industry is very subtle and has figured out how to promote the unsafe drugs. They pay certain professionals to give their opinions.
JW: Are you talking about paying doctors or medical people to give invalid opinions on these drugs?
AJ: Yes. They pay other doctors to give their opinions circumventing the FDA. The FDA has no control over what an individual doctor does or says. Thus, the pharmaceutical industry has funded a mechanism whereby they can gather favorable opinions. They then amplify and magnify those opinions and put them in the form of a treatment protocol that can be implemented in any state with the approval of a few key decision-makers. And as we saw in Pennsylvania, the drug industry focuses on the decision-makers.
JW: These programs are now in Texas, Pennsylvania and all over the country. There is also Bush’s New Freedom Commission on Mental Health. Its goal is to administer mental health screening to the 50 million-plus children in public schools, as well as the 6 million public school teachers. Many believe these screening exams are to get the children on drugs. You were quoted in a newspaper article as saying, “The same political pharmaceutical alliance that generated the Texas project was behind the New Freedom Commission on Mental Health, and they are poised to do this nationwide.” What can people do? It seems so huge.
AJ: It is huge.
JW: The pharmaceutical industry is not just nationwide. It is a worldwide, trillion-dollar industry. What can we do?
AJ: Exposure. This isn’t a David versus Goliath battle. There is no stone big enough to whack the pharmaceutical industry in the forehead and knock it over. These guys are operating in the shadows. They are operating in the dark. They are operating by buying off decision-makers in an illegal manner. There needs to be exposure of that. (Click here to read reporter Jeanne Lenzer's roundtable discussion with five whistleblowers and their suggestions for ways to restore objectivity to medicine and medical research). It’s like fighting vampires, not fighting giants. If I had one wish come true, it would be a website or some accessible database that would tie pharmaceutical industry giving to politicians to the people who are identified as having died or been injured in that person’s district. I would like to see some accountability. These politicians and government officials are taking money from the drug industry. It’s an industry that is very organized and an industry that is ruthless. It is an industry with a long-term view and a long-term plan.
JW: When you are watching television—no matter what program—the commercials often involve drug companies pushing a drug. We are told to ask our doctor for the medication—like self-prescribed drugs. Is there really any hope when you have a nation that is over-drugged and when our President sets up a commission that may lead to our children and teachers being drugged? Certainly there needs to be a widespread investigation. But you say that it is not a David versus Goliath battle. There is no stone big enough to knock down these folks. They are just going to come back and corrupt the politicians because, as we all know, politicians tend toward corruption.
AJ: That’s why it would be nice for every voter to be able to go to a website, make a few clicks and find out how much money his congressman takes from the drug industry. We must begin with exposure of all the corruption from our government officials to the drug magnates. I would love to see a website with the congressman’s photo on the screen listing all the money he takes from the drug industry. I would also like to see the photos of any child or person in his district who has died from these drugs as a side effect. I would like to see a situation where the only safe number in terms of pharmaceutical contributions for any politician is zero. The bottom line is these are the people who create the conditions in which the drug industry is working, and it is because of money. It is pure and simple. They have brought the decision-making process from our government officials all the way to the guy who decides what drugs to get on the formulary. Their money was there. It was there illegally in Pennsylvania. It was my job to track down fraud. And I was fired for tracking down that fraud.
JW: What you are saying is that the people who are in the pharmaceutical industry don’t really care about people’s health. They care about making money off of people taking their drugs.
AJ: Absolutely. It is a business.
DISCLAIMER: THE VIEWS AND OPINIONS EXPRESSED IN OLDSPEAK ARE NOT NECESSARILY THOSE OF THE RUTHERFORD INSTITUTE.