What s In Your Medicine Cabinet?

Transcription

1 What s In Your Medicine Cabinet? Our Growing Dependence on China for Medicine Health Watch USA June 20, 2018 Rosemary Gibson Senior Advisor, The Hastings Center Author, China Rx: Exposing the Risks of America s Dependence on China for Medicine

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4 The Big Shift There s been a huge shift in where America s drugs are made

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6 What It Means for You Millions of Americans are taking medicines made in China by Chinese companies and don t know it and neither do their doctors. For now, China s biggest footprint is making the active ingredients for thousands of meds -- which give products their therapeutic value (think ascorbic acid as the active ingredient in Vitamin C) But China is ramping up production of generic drugs fast.

7 How Dependent Are We? If China for some reason decided to stop exporting active pharmaceutical ingredients, within three months all our pharmacies would be empty. Guy Villax CEO Hovione, European manufacturer From FiercePharmaManufacturing

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9 India is Dependent on China, Too India makes many generic drugs for the US and other countries But it also depends on China for active ingredients and raw materials for many generics it makes AND. It is more open about this fact to the public

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12 From the BBC India produces a third of the world's medicines, mostly in the form of generic drugs. China has a virtual monopoly over pricing and supply of active ingredients -- there are no domestic producers left for many essential medicines in India. The government is now worried that in the event of a dispute with China, India could face a public health crisis. What about a public health crisis in other countries, including the U.S.? Source: BBC News

13 What Are the Risks? If China shut the door on exports to the U.S. hospitals would cease to function China is unlikely to do that now. Why? China s aim is to become the pharmacy to the world and is unlikely to interfere with achieving this goal.

14 How Did We Get Here? Birth of generic drugs 1984 Hatch-Waxman Act Cheaper drugs led to a search for manufacturers that could make them more cheaply

15 The Result? 1996 internal FDA memo: We literally have no control over bulk drugs that enter the U.S. These drugs can reach anyone including the President.

16 Trade Policy and Our Medicines 2000: President Clinton and Congress passed legislation that made it easier for China to sell products to the U.S. The U.S.-China Relations Act normalized trade relations with China and removed tariffs on goods from there.

17 Within 4 Years of U.S. Opening Trade with China * Penicillin: last penicillin fermentation plant in U.S. closed and European and India producers were driven out of business * Vitamin C: cartel in China formed and drove up prices in the U.S. * Aspirin: dumped on American market, driving out the last remaining U.S. aspirin maker * Heparin: Baxter began importing heparin ingredient from China & 3 years later, American deaths reported to FDA associated with contaminated ingredient from China

18 In 2008, contaminated heparin was associated with the deaths of at least 250 people in the U.S. What happened? Baxter had switched to a supplier in China.

19 Globalization = De facto Deregulation In 2008, of the 714 establishments in China were making drug products for the U.S. that the FDA knew about Only 88 had been inspected by FDA from 2002 to 2007, a far lower proportion than any other country that sold drugs or ingredients to the U.S.

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22 China s Penicillin Cartel And how the U.S. lost control over a miracle drug

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25 How Could This Happen? How did the U.S. allow drugs to be sold with ingredients made in China for nearly 20 years without FDA oversight and inspection of the places where they were made?

26 Look in the Mirror We can blame the Chinese for this stuff as much as we want, but the truth of the matter is we are the people who are buying, said Joseph G. Acker, president of a chemical trade association. Source NYT, March 30,

27 Regulatory Oversight?? 2007: First leader of China s FDA was found guilty of taking bribes to approve untested and fake drugs and executed. As a developing country, China s current food and drug safety situation is not very satisfactory because supervision of food and drug safety started late. Its foundation is weak so the supervision of food and drug safety is not easy. Spokesperson for the China FDA

28 I think people have no idea in this country about the vulnerability of things that we count on every day, food, drugs, medical devices. We have a system that has big gaps in our protective mechanisms and it is a growing problem. Dr. Margaret Hamburg Then-FDA Commissioner January 31, 2011 Margaret Hamburg, Policy Challenges in a Globalized Era, Council on Foreign Relations, January 31,

29 2012: Congress Enacts Reforms * Requires all active ingredient and generic drug manufacturers to register annually with the FDA and pay a fee * FDA Inspections of foreign facilities will be on par with those in the U.S. * BUT: inspections don t guarantee quality and safety

30 2015: FDA Pre-Approval Inspection of Pfizer Plant in China

31 FDA Inspection of Pfizer Plant in China: April 2015 Employees at the Pfizer plant concealed quality failures, used expired materials, and retested failing products until they passed.

32 FDA Inspection of Pfizer Plant in China: April 2015 A manufacturing unit had only 1 stand-alone toilet in disrepair 50 yards from the aseptic manufacturing unit. Inside the facility inspectors saw no hand washing station and an open pit appeared to be used as a urinal. Blomberg

33 Safety Remains a Challenge FDA continues to find fake factories that say they re making drug products for the US when, in fact, they are actually a front for another company China has many state-of-the-art factories. But quality is uneven.

34 How Dependent Are We? Veterans: With pressure from industry, the U.S. government now permits the Veterans Health Administration to buy drugs made in China for veterans Military: The Department of Defense uses drug products made in China when no other source is available.

35 How Dependent Are We? The U.S. is so dependent on China that when FDA banned drug products from a Chinese company, the agency exempted 14 products, including key ingredients for chemotherapies used in cancer treatment, because of concerns about drug shortages.

36 Generic Drugs Made in China by Chinese Companies Sold in the U.S. Examples of generic drugs made in China and sold in the U.S. Antibiotics Anti-depressants Birth control pills High blood pressure medicine Alzheimer s, Parkinson s and epilepsy medicines Chemotherapies HIV/AIDs medicine

37 Americans Are Losing Jobs Western drug manufacturers have invested billions of dollars in research and development facilities in China

38 Americans Are Losing Jobs It was fashionable for (U.S.-based firms) to announce job cuts at home and expansions in China in almost the same breath. FiercePharma newsletter

39 Gutting U.S. Talent The top companies have laid off many top tier scientists and clinicians. They are outsourcing research to contract research organizations where salaries are much lower than in the U.S., meaning trouble for many talented, skilled people in the U.S. who have found it difficult to find work.

40 These chemists are being tossed aside often at the peak of their careers. Top chemists from prestigious universities with experience at the top pharmaceutical companies There is just no place to absorb all these scientists. Recruiter for pharma companies

41 China is an Existential Threat to U.S. Industry Unless very radical changes are made in how the U.S. funds, trains and builds for pharma development and manufacturing, I can t see very much left here in 20 years. Perhaps each U.S. based multinational company will consist of a government affairs and marketing HQ only, with everything else disbursed overseas. U.S. industry observer

42 I think it is a security concern. Cipro it is my understanding that it is not made in the U.S. It is made in China. If we have an anthrax attack, what if China is the anthrax attacker? U.S. industry leader

43 How To Find Out Where Your Medicines Are Made? The following label is for an Alzheimer s drug

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45 Find to Find Out Where Your Medicines are Made Find the labels on the box of your medicine by going to: Ask your pharmacist to show you the box and take a photo with your phone Call the company and ask

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48 Thank You