Bioidentical

Obama should have second thoughts about deals with drug companies
By Erika Schwartz, MD, Kent Holtorf MD and David Brownstein MD

The summer recess is allowing Congress to gauge first-hand the public’s rising concern for the cost and substance of the proposed healthcare reform. The concern, however, does not seem to be shared in Washington by the Administration and its new fast friends – the drug companies.

The Obama-drug company alliance was on display for the first time last week when the White House vowed to block a measure supported by some House Democrats that would allow the government to negotiate lower drug prices and demand additional rebates from drug manufacturers.

It brought to light a private agreement between the White House and drug lobbyists: In return for pledging $8 billion a year in cost reductions and supporting any overhaul legislation President Obama signs, the drug industry would not be asked to shoulder any further costs. The total of $80 billion over 10 years represents 8% of the projected cost of the entire health care overhaul and is a drop in the ocean compared to the financial windfall that awaits drug companies when healthcare reform, in whatever shape it takes, gives millions more people access to health care and to their products.

The deal also ensures the pharmaceutical industry a “seat at the table” to influence the final outcome of legislation and underscores the lobby’s immense and ever-tightening grip on the levers of power in D.C. No wonder drug companies have agreed to pump $150 million in advertising to support health care reform.

Such a deal flies in the face of meaningful reform since it places special interests ahead of the health of country. The President should be having second thoughts about this cozy arrangement.

Last week it was also revealed that Wyeth pharmaceuticals had been secretly paying ghostwriters to put their names on published scientific documents that influence the way physicians practice medicine. As reported in the New York Times, Wyeth was using hired ghostwriters to promote its multibillion dollar synthetic hormone replacement therapy. The articles strongly de-emphasized proven risks of synthetic HRT that had been known to the scientific community for decades.

Court documents revealed Wyeth paid a medical communications company to outline articles, draft them and then solicit high profile physicians from academic institutions to sign their names to the articles, even though the physicians had contributed little or no content.

The articles, published in trusted medical journals between 1998 and 2005, promoted the use of Wyeth’s market-leading hormone therapies Premarin and Prempro as protectors against cancer, heart disease, osteoporosis and dementia. As a direct consequence, Premarin and Prempro were endorsed and recommended by academic institutions and practicing physicians as the standard of care for millions of menopausal women. By 2001, sales of the products had soared to over $2 billion a year.

The next year Wyeth suffered a setback when the Women’s Health Initiative Study, a joint venture of the National Institutes of Health, a dozen top-notch academic institutions and Wyeth, was abruptly halted after interim data revealed that Premarin and Prempro, in fact, significantly increased the risks of breast cancer, heart disease and stroke. Further reviews of the study found the drugs raised the risk of dementia in older women. Wyeth’s response was to recommend doctors keep prescribing Premarin and Prempro – albeit in lower doses.

Not much has happened to improve the situation since 2002. Wyeth now faces more than 8,400 lawsuits from women harmed by Premarin and Prempro and more than 50 million women are suffering menopausal symptoms and left wondering what to do.

Wyeth’s actions and their dealings are noteworthy on several levels: Although the company knows that all doctors rely on medical literature for their practice updates, it never disclosed its involvement with ghostwriters.

Wyeth used its huge marketing muscle to prop up Premarin and Prempro, while at the same time muddying the waters by further undermining other safer and more effective therapies such as Bioidentical Hormones. Bioidentical hormones have not been shown to have the adverse effects that Wyeth’s synthetic hormones have. Over the years, Wyeth has continued to obfuscate the truth through deceptive medical literature practices and by subsidizing medical groups and academic endeavors.

Drug companies like Wyeth – which is currently being acquired by Pfizer – are in business principally to make money for their shareholders. President Obama should bear that in mind when he entrusts them with a very different role: helping to improve the healthcare system.

The example of Wyeth must be taken to heart. Promoting unsafe drugs on the market and keeping safer alternatives - Bioidenticals - out of the mainstream negatively affects the healthcare system and raises costs by reducing choices for patients. Through the use of Bioidentical hormones, proven tools in the armamentarium of prevention and wellness, millions of women stay healthy and no longer need to take antidepressants or many other medications. This directly and positively affects the expenses poured into the health care system.

This example of underhanded marketing techniques and now the drug money used to promote the health care bill is a warning that improvement in the health care system cannot be left in the hands of special interests – rather it must be returned to both doctors and patients and focused on prevention and wellness.

Drs. Schwartz, Holtorf and Brownstein are founding members of the Bioidentical Hormone Initiative, a nonprofit group of physicians dedicated to patient and physician education.