Pharmaceutical Industry Disclosure Practices

Drug makers role in mental health plan
spurs debate in Texas
by Mark Horvit, Fort Worth Star-Telegram (January 9, 2005)

Steven Shon has done a lot of traveling in the past few years, spreading the word about the way Texas cares for its mentally ill.

In more than 80 out-of-state trips since 1997, he's promoted treatment guidelines that include advice for doctors on which drugs to prescribe.

Often, the guidelines say the best medications are the newest and most expensive.

And often Shon's trips have been paid for by the companies that make those drugs.

The trips, the guidelines they support and the more than $1 million that pharmaceutical companies have donated to the state for the program have spotlighted the thorny ethical landscape where industry money and patient care intertwine.

Many doctors and advocacy groups nationwide praise the Texas program as an important step forward in how states care for the mentally ill. They say it's a thoughtful plan for showing doctors in the public mental health system the best ways to prescribe drugs that many were already giving patients.

But the program has also been portrayed as a windfall for the pharmaceutical industry, which sells more than a billion dollars worth of psychiatric drugs in Texas alone. By one estimate, if the treatment plan were expanded to state prisons, an additional $16 million would be needed in the first year.

Although the guidelines have been slow to catch on with Texas doctors, they've become influential nationwide since they were unveiled seven years ago. Shon, medical director of Texas' programs for treating the mentally ill, said about a dozen states have adopted their own versions and others are considering doing so.

Now the Department of State Health Services is preparing to require doctors who treat patients in its programs to follow similar plans for treating children and teen-agers.

Those guidelines recommend the new generation of antidepressants -- the same drugs the federal government recently decided must carry prominent warnings of an increased risk for suicidal thoughts or action when used in anyone younger than 18.

Child psychiatrists from around the country will gather in Irving on Thursday to discuss whether that requirement or others in the plan need to be changed.

The concept behind the treatment plans is simple:

Gather top experts and have them review studies to determine which medications and methods work best. Get advice from doctors and patients in the state health care system as well.

Using that formula, Texas created plans for major psychiatric disorders in children and adults.

The plans -- known as the Texas Medication Algorithm Project -- offer layers of advice, including dosage recommendations, frequency of office visits, details to be kept in patients' records and how long to try a drug before moving to another.

They recommend which drugs to try first, then what to try next if those don't work.

Shon said there's a simple reason the plans usually recommend that doctors first try the latest medications, only a few of which are available as generics. The new drugs, he said, are better.

Newer antidepressants, starting with Prozac and moving to top-selling drugs such as Zoloft, gained popularity because they cause fewer debilitating side effects than older drugs. But the new medications can lead to long-term health risks, including diabetes, in some patients.

The state's motives came under scrutiny because it accepted donations from drug companies.

Psychiatric drugs are among the industry's biggest sellers, with sales exploding over the past few years. In the state's community mental health centers, drug expenditures increased from $37.3 million in 1999 to a high of $75.7 million in 2002. Last year it was $70.9 million, likely a result of budget cuts, Shon said. In state hospitals, where the treatment plans are also used, drug expenditures jumped from $12.5 million in 2000 to $16.5 million in 2004.

Overall Medicaid sales of the most popular psychiatric drugs in Texas tripled during the past five years and surpassed $400 million last year, following a national trend that reflects both the higher cost of the newest drugs and the growing number of people taking them.

No drug company money was used to create the treatment plans, Shon said. The money came later, to help develop training materials and to cover travel and other expenses associated with getting the word out.

"We kept all pharmaceutical dollars away" during the creation of the plans, Shon said. "And we had offers from all the companies."

Shon said pharmaceutical companies initially donated about $285,000 to help pay for pilot programs.

The total cost exceeded $6.5 million, Shon said. Much of the money came from foundations, including the Robert Wood Johnson Foundation, which donated about $2 million.

That foundation was established by the founder of Johnson & Johnson, which owns Janssen Pharmaceutica Products, which makes some of the recommended drugs. A Janssen spokesman said the foundation is independent of the company.

The money for the study was only the beginning. Since 1997, a state account created for donations supporting the guidelines has received more than $1 million from drug companies. Shon's office provided the Star-Telegram with several documents related to the account, but no single set of figures details all the donations and expenditures, making it difficult to get a complete picture. Shon also acknowledges that in the early stages, his agency did not always follow guidelines and seek approval from the department's governing board before accepting donations.

The account now includes money for projects beyond the treatment plans, such as continuing education, Shon said.

"States don't have tons of money," he said. "Where do they turn? To the people who can pay for this: pharmaceutical companies."

As word of the Texas guidelines spread, Shon and others associated with the project started receiving requests to speak and provide training to officials in other states and nations, including Italy, Japan and South Korea.

Some of the donations reimbursed the Texas mental health agency for hotel stays, airline flights and meals, Shon said.

Other times, the trips were paid for by the groups inviting Shon and his colleagues. Some of those groups used industry money to pay for honorariums and travel.

Shon said all the money he received has gone to the state to reimburse taxpayers for his time away from the office.

"I don't keep any of those dollars," he said.

Researchers from Texas universities who have accompanied him on some trips have been able to keep the money, he said.

The chapter of the National Alliance for the Mentally Ill in Washington state received about $15,000 in drug company grants to bring Shon and other experts in to speak and provide honorariums, said Bill Pilkey, who said he was the group's treasurer at the time.

Although Pilkey said he was a little uncomfortable with the amount of money involved, he said drug companies have a right to pay for such events. Oftentimes, Pilkey said, the companies are the only ones willing to spend money on behalf of the mentally ill.

There is some indication, though, that more than altruism is behind those donations. In the paperwork for the reimbursement for one of Shon's trips, a Janssen Pharmaceutica employee wrote that the purpose of the $1,765 expenditure was to cover Shon's expenses -- and to expand the use of new antipsychotic drugs.

A Janssen spokesman declined to comment about that, but said the company's donations on behalf of the Texas project were meant to help doctors.

"They asked for support, and we did it to help physicians assess treatment options for the patients," spokesman Doug Arbesfeld said.

"We had no participation in the development of the guidelines," he said.

Critics say drug companies didn't have to participate to influence the results.

That's because many experts on the state's panels conducted the research for the drugs that were ultimately listed as the top choices for the treatment plan.

Much of their research was funded by the companies that make the drugs. And some panelists have received consulting and speaking fees from drug companies.

"It's no coincidence that the drugs that are favored by the algorithm are the drugs that are on patents," said Houston attorney Andy Vickery, who represents clients against drug companies. "You're weighting the scales so the drugs are prescribed preferentially."

Vickery and other critics believe that the drugs' negative side effects are being minimized and their effectiveness exaggerated.

Lynn Crismon, a clinical psychopharmacology professor at the University of Texas at Austin who oversaw the children's plans, said the idea was that the best minds, armed with the best research, would provide the best standards.

"A group of experts looking at the data are probably going to come up with a better consensus than any one clinician doing it," he said.

As proof that drug companies don't influence the process, Shon points to his decision to ask that doctors choose the cheapest treatment option available within each step if there's no clinical reason not to. One company fired off angry letters saying that Shon had betrayed the treatment plans.

"So it's not been just arm in arm with the pharmaceutical companies," he said.

He also said that because patients are often prescribed multiple medications for a single illness, the plans could reduce costs because they initially recommend using only one drug.

Dr. Madhukar Trivedi, a UT Southwestern Medical School professor of psychiatry who helped oversee creation of the guidelines, said that at a time when much of the information available about drugs comes from company-funded studies, the Texas plans should be welcomed as an exception.

"We in this country have actually abandoned pharmaceutical research to drug companies, " said Trivedi, who has participated in industry-funded studies. "This is an effort by nondrug companies to evaluate how best to use these treatments."

Allen Jones was new to the Pennsylvania Office of Inspector General when he became intrigued by an account with several thousand dollars donated by drug companies.

As Jones investigated, he said, he learned the money was being used by state employees for travel and other expenses tied to considering whether Pennsylvania should adopt the Texas guidelines.

Jones said he became suspicious because it seemed that research questioning the effectiveness and safety of some of the new-generation drugs was being ignored.

"What was alarming to me was that the decisions to go with these programs and those medications was being made by Pennsylvania employees who were getting money, trips ... from the pharmaceutical companies," said Jones, who was fired after going public with his criticism.

Jones has filed a federal lawsuit claiming his First Amendment rights were violated, and the fund is the subject of a state investigation.

Jones is not alone in his skepticism, and the plan has been a hard sell even for some in Texas. But some groups elsewhere that have not received industry funding have arrived at similar recommendations.

A set of guidelines developed at Harvard University with federal money also recommends newer-generation drugs, said Dr. David Osser, who heads the project.

Research supports that decision, he said, even though the evidence "isn't as robust as one might like."

But a schizophrenia treatment study based at the University of Maryland does not recommend the new drugs over the older ones, said Dr. Anthony Lehman, who headed the project.

"We thought it should be left open," said Lehman, whose project also was federally funded. "If someone says it's deficient care if you started someone on a first-generation medication, I don't think that's based on science."

He praised the Texas treatment plans for helping doctors determine appropriate dosages and understanding when a particular drug is not working for their patient. Both he and Osser said they doubt pharmaceutical money led to any bias.

The greater concern, Lehman said, is the role companies take in directing research. Lehman said his panel considered trials funded by drug companies, but declined to make recommendations unless at least one independently funded trial came to the same conclusion.

"But it's very hard," he said, "because a lot of the stuff is pharmaceutical-company funded."

Within Texas, the reception for the guidelines has been mixed.

Shon said the number of doctors following the plans has climbed slowly, to more than half of those in the state system. In part that's because many psychiatrists bristle at what they see as a "cookie-cutter" approach to medicine that ignores their expertise.

Shon and other guideline supporters say doctors have the option of skipping steps if they prefer an option farther down the list. They must, however, put in writing the reason they deviated from the plan.

Others familiar with the program say that in many cases physicians are following the drug recommendations but not the guidelines' other components, including additional patient visits and more detailed record keeping. That's because the state hasn't provided money to cover the costs.

The treatment guidelines were also intended to be used in the state prison system, but that hasn't happened.

"It all has to do with costs and outcomes," said Dr. Ben Raimer, chief physician executive for the Correctional Managed Care program at the University of Texas Medical Branch.

A study was conducted to determine how much it might cost. The answer: $16 million a year added to a budget of $7.9 million.

"There was no justification for spending that much more money," Raimer said.

Prison systems in Texas and elsewhere have been criticized for an unwillingness to pay for the newest medications. But saving money is not the only factor, Raimer said.

Experience with the new-generation psychotropic drugs showed no difference in outcome from older medication, he said. One possible reason is that in a prison, the side effects of the older medications can be more easily controlled.

Raimer also said it makes little sense to put prisoners on medications that they won't be able to afford upon release.

At least one state that has adopted the Texas treatment plans has found preliminary signs that they could save money.

Pennsylvania began testing a version of the schizophrenia treatment plan in its state hospitals, said Aidan Altenor, director of the state's Bureau of Hospital Operations.

A pilot program showed that costs dropped 8 percent because fewer patients received multiple drugs, Altenor said. The higher cost of the newer drugs didn't wipe out the savings because, he said, Pennsylvania had already been putting most patients on them.

The debate over the guidelines is about more than money.

As experts gather this week in Irving, they'll consider fundamental questions: Do their recommendations put children at risk? Do the medicines work?

Since 1999, the guidelines for treating children and teens have called for the very antidepressants that now carry the Food and Drug Administration warning. FDA reviews have also determined that of all the new antidepressants tested, only Prozac has proved effective for patients younger than 18.

The guidelines have been posted on the state's Web site without change since their creation, but Shon said the state hasn't promoted them.

Because many new antidepressants are similar to Prozac, committee members in 1999 believed all should work in children, said Crismon, the UT-Austin professor.

Dr. Graham Emslie, a psychiatrist at UT Southwestern Medical Center, said changes are likely.

Emslie, a committee member who conducted the trials showing Prozac's effectiveness, said one option may be to recommend only that drug -- which is available as a generic -- as the top option.

He also said the guidelines should caution physicians to monitor their patients carefully for signs of suicidal thoughts or behavior.

But Emslie, who has conducted company-funded research of several recommended drugs, doesn't support removing most of the new-generation medications from the plan.

Trivedi, the UT Southwestern psychiatrist, said that if more physicians followed the guidelines, some risks could be minimized.

"We should take these medications, all of them, very seriously -- not hand them out like candies -- and monitor patients," Trivedi said. "Which is exactly what the Texas algorithm says."

Pharmaceutical Industry Disclosure Practices