Healthy Skepticism Library item: 17381
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Schwab D
No letup in drug industry debate
Star-Ledger 2002 Dec 29
Full text:
Is the pharmaceutical industry a savior or a scoundrel?
It is one of the most contentious debates in the country and one that is sure to continue into the new year.
Arnold Relman and Richard Smith could not have more divergent views on the matter.
Relman, a professor emeritus of medicine and social medicine at Harvard Medical School, was editor of the influential New England Journal of Medicine from 1977 to 1991 and co-authored a recent cover story for the New Republic on the pharmaceutical industry entitled “America’s Other Drug Problem.”
Smith, senior vice president for policy and research for the Pharmaceutical Research and Manufacturers Association of America, is the industry’s point man in Washington.
In separate interviews with The Star-Ledger, the two strongly disagreed on everything from drug pricing and consumer advertising to whether the industry holds too much sway over doctors.
What is your opinion of the pharmaceutical industry?
Relman: The country can’t get along without the drug companies. Some of the products they manufacture and market have made important contributions to the care of sick people.
They do some important things, but they do a lot of bad things too. Their behavior, and the behavior of society towards them, meaning doctors and government, has to be changed in order for us to live with them.
Smith: This industry has an extraordinary record of creating value for patients.
It accounts for considerably less than 10 cents out of the health-care dollar and for that, patients are receiving drugs that literally change their lives from lives of misery and solitude to lives that can be productive and happy.
What is wrong with the industry?
Relman: The industry spends too much on marketing and promotion and on influencing government, and that includes Congress and the Food and Drug Administration, and not enough money and effort on doing what they ought to be doing, namely hunting for new drugs.
Smith: This industry invests far more in research than any other industry.
This year, it is investing about $30 billion in discovering new medicines.
The argument that we are spending too little on research and too much on advertising is simply dead wrong.
It attempts to label all spending on marketing or informing consumers about medicines as wasteful or unnecessary. We live in a country in which we have good, effective treatments for a broad range of diseases, yet we have a large number of patients with illnesses such as diabetes and asthma and depression who are not now getting treatment.
Doesn’t the industry invent many life-saving drugs?
Relman: What the pharmaceutical industry does wrong is concentrate research on developing drugs that are not significantly different from existing drugs, minor variations of drugs that already are being marketed very successfully.
In the last 10 years, the FDA said only 15 percent of the drugs that were approved represented significant advances in medical therapy. Last year, only 10 percent were considered to be significant advances.
Smith: This is an industry that has invented, just in recent years, the first treatment for Alzheimer’s disease. We have anti-psychotic medicines that have revolutionized treatment. The industry has invented new generations of medicines to treat diabetes in the last seven years, and the list goes on and on.
To critics who make this claim — and it is a claim that has been especially fueled by front groups of Blue Cross Blue Shield companies — I would say: What are your ideas for new medicines? Where have you found great new medicines that have not been invented by the pharmaceutical and biotechnology companies?
Relman: The great majority of new scientific discoveries that lead to ideas for new drugs come from outside the industry. What the pharmaceutical companies do is buy the patent or contract to use it.
Without the research funded by the taxpayer that goes on, often for years, at the National Institutes of Health and in the universities and medical schools, the pharmaceutical industry would be dead.
Smith: Look at the data put out by the NIH itself. It looked at 47 top-selling drugs and found it had a role in four. So this notion that the government invents drugs is myth rather than fact. The NIH is a fabulous organization, but it doesn’t invent medicines.
What about the role of doctors?
Relman: I am just as critical of our profession as I am of the drug industry. It takes two to tango.
Doctors are required by state licensing boards to continue their education and get credits for taking courses, which they have to attest to in order to renew their licenses. The pharmaceutical industry pays for more than half of that now and increasingly is being allowed by the professional societies to give credits. The industry has no right to pretend to be educating doctors.
The medical profession is, in essence, being bought by the pharmaceutical industry. If the profession wanted to, it could stop it tomorrow. But the medical establishment is unwilling to do that because of the huge amount of money they take from the industry. It’s kind of a bribe.
Smith: There is an appropriate role for the pharmaceutical companies in assisting with continuing medical education.
Remember that the kind of education the pharmaceutical companies engage in with physicians, the content is regulated by FDA rules. Second, we have example after example of areas in which this type of education has been very helpful to patients and physicians alike.
When pharmaceutical companies first invented a new class of medicines to treat depression, depression was a stigmatized illness and undertreated.
As a result of a combination of educating physicians about the new medicine, better side-effect profiles and advertising to consumers, we actually saw an increase in patients being treated.
So the question is, do we want to just wipe away this type of progress?
Should the drug approval process be changed?
Relman: FDA regulations should be changed so before approving a drug, the FDA would require evidence a new drug has some advantages over the old drug, that it is more safe or effective.
The companies are allowed under existing laws and regulations to get approval if they can simply show their new drug is safe, that it doesn’t kill people and that it is better than nothing, a placebo. That’s ridiculous.
Smith: First, the FDA strongly urges sponsors to compare new drugs to placebos for classes of drugs where measures are more subjective than objective.
Second, this goes to the truly fallacious charge of “me-too” medicines.
One thing we have learned increasingly in recent years is different patients respond differently to medicines that may be chemically similar.
For instance, many patients with depression who don’t get better with one medicine get better with a different one. So there is tremendous value in having several different medicines in a therapeutic category. Finally, the cost of these studies would be immense.
What do you think about television advertising?
Relman: The industry says it educates people about new drugs that are available and that they can talk with their doctors. Well that is hypocrisy.
This direct-to-consumer advertising should be outlawed in the United States, as it is in Canada and in Western Europe, because it serves no useful function. It’s the doctor’s responsibility to know about the new drugs that are available.
Smith: That would be an absolutely terrible step back for patients. The range of opinion that is solidified around the beneficial aspects of direct-to-consumer (DTC) advertising in recent years is truly impressive.
Why we would want to stifle innovation — this is FDA-regulated information — is beyond me.
Surveys by numerous organizations show DTC has brought millions of patients in for treatment who would not be treated otherwise.
