Novel addresses problems in pharmaceutical industry

BY JENNIFER AMATO Staff Writer

Dr. Michael Rushnak was visited by a drug company representative in 1979.

Dr. Michael Rushnak Dr. Michael Rushnak The marketing salesperson, who did not have a clinical medical background, was trying to market the new drug Selacryn, which at the time was advertised to be the best blood pressure pill ever.

Rushnak initially said he would not prescribe any drug that was not on the market for at least a year or two, unless there is no alternative medicine and it had been proved to be safe and far superior to any other drug available. He said that most clinical trials performed by the Food and Drug Administration (FDA) focus on a small sector of the population, whereas most potential side effects occur on a much larger scale.

The internist and gastroenterologist said the drug rep insisted on trying again two more times that year to push Selacryn, but he continued to refuse. He said that although the representative was trying to convince him that most doctors were approving usage of the pill, he made the case that some doctors were not.

Then it turned out that there were 36 deaths and 500 cases of severe liver and kidney damage that resulted from use of the medication, and Selacryn was taken off the market the following year.

“That lesson was powerful to me. That lesson said there are good benefits, but drugs can also have deadly [effects],” the Jackson resident said. “The patient needs to understand the good and the bad, [and know about] time-tested medications.”

Rushnak has used personal experiences such as this one to form the basis of his fictional novel, “Terminal Neglect.” The plot focuses on an idealistic physician who battles against a group of power brokers who are interested in advancing a drug found to have serious problems in its clinical trials. Dr. Jonathan Rogers is a commissioner of health in Michigan and dreams of becoming the next U.S. surgeon general, even interviewing with the president, but he gets caught up in a world of seduction and corruption. When he is shot twice in the chest after leaving the White House, he wonders if the FBI is telling the truth about it being a random drive-by shooting.

The book is about “whether or not Dr. Rogers is willing to march into hell for a heavenly cause,” the former short story writer said. “It’s about many good doctors who refuse to be seduced by this process. The question is, Is Dr. Rogers able to resist that influence?”

Dreaming of becoming a doctor since the age of 16, Rushnak, a physician for 35 years, realized six years ago after a bout with cancer that he wanted to return to his “passion” of writing. Using his three decades of experience as a doctor in practice, government, managed-care companies and within the pharmaceutical industry, he wanted to tell the “real story of the medical world.”

“This shows the story of what definitely could happen, if it’s not happening already … if those positions of power in the medical field are not fully honest and are not fully transparent and are not fully dedicated toward the patient. Then, bad things could happen,” he said.

Rushnak’s medical background dates back to 1969 when he received a bachelor’s degree in science from St. Peter’s College in Jersey City. He attended Rutgers Medical School at Robert Wood Johnson Medical School in New Brunswick and received his medical degree in 1974.

The longtime East Brunswick resident opened his own practice in 1979 and then left the practice in the 1990s to go into the public health sector.

He is currently a senior medical consultant for the National Association for Managed Care Physicians in Virginia. He was the senior director of health affairs and medical and scientific affairs at the biotechnology pharmaceutical company MedImmune in Maryland. He was the assistant vice president and medical director at Caremark Inc. and for AdvancePCS Inc., both in Maryland. He served as the senior medical director for Horizon Blue Cross- Blue Shield of New Jersey.

He was the consulting medical director at Healthsource HMO/Chubb Managed Care, the executive medical director at Executive Health Group in New York City, and the chairman and founder of the nonprofit New Jersey Health Care Think Tank. He also served as a managing physician at the New Jersey State Department of Health.

He received his master’s in public

health from the Rutgers School of Public Health in 1998. Over the years, Rushnak has seen, heard, read and experienced several “dangerous” drug practices and regulation. He said a Consumer Reports study in April 2007 states that 96 percent of Americans think the government should have the power to include warning labels on medication without having the FDA negotiate those safety labels first, and that 84 percent of Americans think drug companies have too much

control over the FDA.

He cited PDUFA, or the Prescription Drug User Fee Act of 1992, in which Congress passed a law saying that pharmaceutical companies could contribute money to the FDA to pay for some expenses in reviewing drugs, since the FDA was so heavily inundated with new medication without having the proper staff to study them. Rushnak believes this to be a conflict of interest because although the funding started at 10 percent in 1992, nowadays drug companies can contribute about 50 percent of drug analysis funding.

“Fifty percent of the budget of the FDA — which is our consumer protection agency — is paid for by pharmaceutical companies. [The FDA’s] job is supposed to be reviewing those drugs independently and objectively,” the father of three said, blaming this on pharmaceutical company lobbyists.

Another case of conflict of interest that stands out for Rushnak is the recent voting down of a pharmaceutical ethics bill in Colorado that would ban pharmaceutical companies from giving gifts, weekend junkets and fancy dinners to doctors to whom they want to prescribe their drugs.

“I think it’s a conflict of interest because I think doctors should prescribe drugs not based on what the pharmaceutical companies tell them to do or influence them to do, but [because it is] what’s right for their patients,” Rushnak said.

Rushnak also believes more regulation is needed for prescriptions. He said that the majority of drug use is based on “expert opinion” and not scientific studies. He said physicians can use clinical judgment, but that “the public needs to know that not everything in medicine can be backed up by science.”

“In science, we talk about the generic patient. With you, we’re talking about you,” he said.

Rushnak said 4 billion prescriptions are being written in America each year, which translates to about 13 prescriptions per person per year, or more than one per month. Yet, he said, 45 percent of the money spent on drugs throughout the world is spent by the United States, though this country comprises only 5 percent of the world’s population. Since the nation’s life expectancy has dropped from 11th in the world in the 1990s to 42nd today, he said the focus needs to be more on diet, exercise and preventive measures versus just medicine.

“The trend is in the wrong direction,” he said. “Americans spend twice as much overall on health care as the rest of the world, but the result of the money is that we’re not living longer and there are people dying from taking these medications,” he said.

Yet Rushnak does have a positive outlook on the future. He has been featured on several radio stations to speak about health care, such as a national broadcast appearance Feb. 26 in support of President Barack Obama’s plan to have comparative, head-to-head research between existing drugs on the market, instead of comparing new drugs to placebos or sugar pills.

Rushnak, who has been married for the past 34 years to his wife, Francine, expects to release his second fictional book, “Run From Evil,” based on international terrorism and a vaccine, this fall.

To learn more about Rushnak, visit www.MichaelRushnakBooks.com.

Contact Jennifer Amato at jamato@

gmnews.com.